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Twenty Fourth Edition | Winter 2013

Produced by Sanofi Pasteur MSD

Support and resources for shingles and HPV

In the News

Welcome to the
Winter 2013 edition
of Vaccination

When Typhoon Haiyan struck the Philippines on


89 November, it left a trail of destruction affecting
more than 10 million people.1 According to the
Philippines National Disaster Risk Reduction
and Management Council (NDRRMC), by 22
November, the death toll had reached 5209, with
23,404 injured and 1611 still missing.1

Zostavax wins
Prix Galien award
Merck*, a parent company of Sanofi Pasteur MSD and known in the UK as
MSD, has announced that Zostavax (shingles (herpes zoster) vaccine (live)), the
companys vaccine to help prevent shingles and post-herpetic neuralgia, received
the Prix Galien USA 2013 Award for Best Biotechnology Product.1

This issue
In the News

Shingles vaccination

Wise Up kits support sexual health


education for teens
10
14

Keeping the lines open

UK routine childhood immunisation


programme
16
17

Ask the experts

If you have any ideas for future articles or topics you think others
may enjoy, get in touch and let us know. You can contact us
at the SanofiPasteurMSD Communications Department on
01628 587610 or email us at: vaccination@spmsd.com.
Many thanks for your feedback on the last issue we look
forward to hearing from you!
We are committed to protecting
our environment, this newsletter is
printed using vegetable oil based
inks on FSC paper
Editing and production for
Sanofi Pasteur MSD by
MA Healthcare Limited
Sanofi Pasteur MSD, 2013

Sanofi* supports
victims of typhoon

Among the many agencies working to help


those affected by the typhoon, Sanofis affiliate
in the Philippines has provided local employees
with emergency funds and is working to provide
temporary housing, transport and other forms of
emergency relief.

Merck is honoured to have been chosen as a recipient of this prestigious award,


said Dr. Roger M Perlmutter, president, Merck Research Laboratories. This
achievement is a testament to the remarkable contributions of everyone at Merck
who played a role in helping to bring Zostavax to market.

Local Sanofi teams are evaluating which medicines


and vaccines to donate, including antibiotics,
diabetes treatments, statins, and the tetanus and
flu vaccines. An initial batch of medicines and
vaccines was donated to the Pharmaceutical and
Healthcare Association of the Philippines Cares
Foundation, the corporate social responsibility arm
of the local industry association.2

The Prix Galien Award recognises the pharmaceutical industrys outstanding


achievement in the development of new medicines. The Prix Galien was founded in
France in 1969 by French pharmacist Roland Mehl and is recognised internationally
as the highest accolade for pharmaceutical research and development.

Sanofi also donated six batches of medicines


through Tulipe (the French organization that
federates donations made by Sanofi and
other health companies) to First-Aid Workers
Without Borders.2

This latest award for Zostavax is Mercks sixth Prix Galien USA award in seven years.

References

Reference
1. Merck. ZOSTAVAX (Zoster Vaccine Live) awarded Prix Galien USA 2013 Best Biotechnology Product. Press release 23 October
2013. http://www.mercknewsroom.com/news-release/prescription-medicine-news/zostavax-zoster-vaccine-live-awarded-prixgalien-usa-2013-be (last accessed 9December 2013).

*Sanofi Pasteur MSD was founded in 1994 as a joint venture between SanofiPasteur (the vaccines
division of Sanofi) and MerckandCo,Inc. (known in the UK as MSD). SanofiPasteurMSD supplies
vaccines originating from research by both shareholders to help provide protection against disease for all
age groups.

Prescribing information can be found on the last four pages

1. Republic of the Philippines National Disaster Risk Reduction and


Management Council. SitRep No. 35 Effects of Typhoon Yolanda
(Haiyan). NDRRMC Update. http://ndrrmc.gov.ph/attachments/
article/1125/NDRRMC%20UP%20SitRep%20No35%20Effects%20of%20
TY%20Yolanda.pdf (last accessed 9December 2013).
2. Sanofi Espoir Foundation. Solidarity with the Philippines: Together, lets unite
our forces to help victims in the Philippines. News, 14 November 2013.
http://fondation-sanofi-espoir.com/en/news-2013-11-14-solidarity-withphilippines.php (last accessed 9December 2013).

*Sanofi Pasteur MSD is part of the Sanofi Group of companies.


Sanofi Pasteur MSD was founded in 1994 as a joint venture
between SanofiPasteur (the vaccines division of Sanofi) and
MerckandCo,Inc. (known in the UK as MSD). SanofiPasteurMSD
supplies vaccines originating from research by both shareholders to
help provide protection against disease for all age groups.

Child vaccine
coverage improving
According to Public Health England, 96.3% of children
reaching their first birthday in the April to June quarter
of 2013 in England had completed a full course of
primary immunisations against diphtheria, tetanus, polio,
pertussis and Haemophilus influenzae type b (DTaP/IPV/
Hib).1 Increases in coverage were recorded in seven out
of ten strategic health authorities.1
By five years of age, 88.9% of children had received their
DTaP/IPV booster, a small improvement on the previous
year (87.4% coverage) and up from 80.1% in 2008/09.1
The uptake of the measles, mumps and rubella (MMR)
vaccine has reached 92.3%, the highest coverage
since the vaccines introduction in 1988.1 Meanwhile
the incidence of measles is declining, with 21 cases
recorded in August.2

References
1. Health and Social Care Information Centre. NHS Immunisation Statistics England
2012-13. 26 September 2013. http://www.hscic.gov.uk/catalogue/PUB11665 (last
accessed 9December 2013).
2. Public Health England. Vaccine Update 208, October 2013. https://www.gov.uk/
government/publications/vaccine-update-issue-208-october-2013 (last accessed
9December 2013).

Prescribing information can be found on the last four pages

Awareness campaign to improve flu vaccine uptake


Public Health England launched a public
communications campaign on 11 October
to raise awareness of the importance of
flu vaccination.1
The campaign is aimed at adults under 65
and parents of children aged 417 years
with long-term conditions and pregnant
women. Parents of 2 and 3 year olds will
also be encouraged to get their children
vaccinated with the new nasal flu vaccine.1
To help to support frontline staff in delivering
the flu vaccination campaign this year, an
algorithm has been added to the Green

Public Health England publishes updated


figures on flu consulation rates and flu
vaccination uptake each week. The
national influenza reports are available
to download at: http://www.hpa.org.uk/
Topics/InfectiousDiseases/InfectionsAZ/
SeasonalInfluenza/EpidemiologicalData/03in
flusweeklyreportpdfonly/

Book chapter on flu summarising the


governments recommendations on who
should receive the flu vaccine.2
At the time of going to print, GP
consultations in the UK for the 2013/14
winter remain at low levels, according
to Public Health England (Table 1).3
So far, uptake of flu vaccination among
the recommended groups is highest in
those 65 years and over (Table 2).
The Secretary of State for Health has also
introduced measures to encourage much
greater uptake of the flu vaccine by frontline
healthcare professionals, including setting
an uptake target of 75% this year.1
In 2012/13, flu vaccine uptake among
frontline health and social care workers
was just 45.6%, described as disappointingly
low by the government.4
The updated code of practice on the
prevention and control of infections came

Prescribing information can be found on the last four pages

into force for primary care providers on


1April 2012.2,5 The guidance highlights the
responsibility of NHS and social care bodies
to ensure, so far as is reasonably practicable,
that health and social care workers are free
of, and are protected from exposure to
infections that can be caught at work.2

References
1. NHS England. PHEs national seasonal flu campaign. News.
http://www.england.nhs.uk/2013/10/11/phe-flu/ (last accessed
9December 2013).
2. Department of Health. Influenza. In: Immunisation against Infectious
Disease. Chapter 19, September 2013. https://www.gov.uk/
government/publications/influenza-the-green-book-chapter-19 (last
accessed 9December 2013).
3. Public Health England. PHE Weekly National Influenza Report.
Summary of UK surveillance of influenza and other seasonal
respiratory illnesses, 5 December 2013 Week 49 report (up
to week 48 data). http://www.hpa.org.uk/webc/HPAwebFile/
HPAweb_C/1317140406449 (last accessed 9December 2013).
4. Department of Health, Public Health England, NHS England.
Vaccination of health and social care workers against flu, 2013/14.
25 September 2013. https://www.gov.uk/government/publications/
flu-vaccination-increasing-uptake-by-health-and-social-care-workers
(last accessed 9 December 2013).
5. Department of Health. The Health and Social Care Act 2008 Code
of Practice on the prevention and control of infections and related
guidance. December 2010. https://www.gov.uk/government/
publications/the-health-and-social-care-act-2008-code-of-practiceon-the-prevention-and-control-of-infections-and-related-guidance
(last accessed 9December 2013).

Table 1. GP flu consultations


per 100,000, week 48, 2013
(week ending 1 December)4
England

5.6

Wales

4.9

Scotland

8.7

Northern Ireland

11.9

Table 2. Seasonal flu vaccine


uptake in England to week 48, 2013*3
2-year-olds

36.5%

3-year-olds

32.9%

Under-65s in a clinical risk group 45.7%


Pregnant women

35.6%

65 years and over

68.8%

Figures from 80.3% of GP practices

Website provides hand


hygiene educational tools
Hand and respiratory hygiene among young children becomes particularly important during
the winter months as a way to help reduce the spread of flu. A fun and interactive website,
Hygiene4Health, offers a range of interactive resources which healthcare professionals may
find helpful to educate children and their parents about better hand and respiratory hygiene.
The Hygiene4Health website has been designed and provided by Sanofi Pasteur
MSD in association with healthcare and Early Years Foundation Stage (EYFS)
teaching professionals. It aims to provide fun and hands on materials for children
aged 2 to 5 years and their families, to encourage best practice in handwashing
and hygiene to help limit the spread of infection.
There are downloadable interactive resources, which can be used at GP
surgeries, health centres and family clinics. These include posters, stickers and
certificates which can be used as rewards for patients.
The materials include the hygiene hero characters, Captain Handwash and Trisha Tissue,
whose special powers help children to learn effective handwashing and tissue disposal practices.

H
H

Instilling good hygiene habits in young children is thought to be particularly important as poor
hygiene and physical closeness in families with children traditionally allow the influenza virus
to thrive.1
Sharon White, Professional Officer at the School and Public Health Nurses Association
(SAPHNA), an organisation involved with the campaign, stated: Introducing children to good
hand and respiratory hygiene practices from an early age will equip them with life-long skills
which are essential in the fight to reduce and protect them from infection.2
More information: Visit www.hygiene4health.com

References
1. Oxford J. Viewpoint - Influenza A H1N1: past and future. GP Online 10 March 2011. http://www.gponline.com/Clinical/article/1058411/
viewpoint-influenza-h1n1-past-future/ (last accessed 28 October 2013).
2. Sanofi Pasteur MSD. www.hygiene4health.com (last accessed 9December 2013).

Prescribing information can be found on the last four pages

Shingles vaccination
for patients aged 70 and 79
A variety of materials are available to support surgeries in calling in patients for shingles vaccination.
6

Prescribing information can be found on the last four pages

Shingles is a painful condition associated


with declining immunity and older age.1
It occurs in about 1 in 4 people who
have previously had chickenpox,2 when
the varicella zoster virus reactivates after
remaining dormant in nerve tissue following
the chickenpox infection.
Shingles is characterised by prodromal
pain (tingling or burning sensation) prior
to formation of the typical shingles rash, a
unilateral vesicular rash with a dermatomal
distribution. The acute pain over the rash
area may be described as stabbing, tender,
throbbing, itchy or hot. Shingles can have a
negative impact on quality of life, impairing
sleep, daily activities and enjoyment of life.3
The most common complication following
shingles is post-herpetic neuralgia,4 i.e.
chronic nerve pain that persists for 90 days
after rash onset. Post-herpetic neuralgia
occurs more often in older patients.4
A national shingles vaccination programme
for all adults aged 70 and 79 years began
on 1September 2013.5 Because of supply
constraints, you may not have been able to
offer the shingles vaccine to eligible patients
during flu clinics, but there are a number of
ways to vaccinate eligible patients now that
vaccine supplies have returned to normal.

Eligible patients can be vaccinated


against shingles at any time during the
year,6 which means that the workload
can be spread across the year. Surgeries
have until the end of August 2014 to
vaccinate their eligible 70- and 79-year-old
patients. However, for surgeries to receive
their payment this financial year, they have
until the end of March 2014 to vaccinate
eligible patients.

Table 1. Eligibility for shingles vaccine7


Eligible

Age on 1 September 2013

Date of birth

70 years

2/9/1942 to 1/9/1943

79 years*

2/9/1933 to 1/9/1934

7178 years

2/9/1941 to 1/9/1935

In 2013/14

In future years

*Patients who are 79 on 1 September 2013 may become 80 before attending for vaccination. These patients should still be offered the vaccine.

Tips on calling in patients for vaccination


Practices may take a twin approach
to calling in patients for vaccination
in order to meet the recommendations
for the vaccination campaign.5
For instance:
1. Active identification of those
who are eligible for the vaccine
2. Awareness raising among registered
patients and staff.
A register of all patients in the practice
who are eligible for the shingles vaccine
can be created based on a Read code
search of the practice register by age.
All patients aged either 70 or 79 on 1st
September 2013 may be eligible for the
shingles vaccine (Table 1).

Adding an electronic flag to the notes of each


patient who is eligible for the shingles vaccine
may help staff to identify eligible patients
opportunistically when they visit the surgery for
other reasons. If there is vaccine stock in the
practice on the day, the nurse or doctor could
offer the shingles vaccination there and then.
There are a number of ways to inform patients
about the national shingles immunisation
programme and encourage those who are
eligible to enquire about vaccination. Putting
up posters and leaflets in the surgery waiting
room may encourage patients to talk about
the campaign amongst themselves and ask
the doctor, nurse or appropriate staff for
more information. Sanofi Pasteur MSD has
produced a variety of support materials that
can help raise awareness in surgeries.

Information on the vaccine can also be


included on the practice website and in the
newsletter if they exist. It may also be useful
to brief the surgerys patient representatives
group and the carers group if they have one.
One way to bring the shingles vaccine to an
eligible patients attention is to add a note at
the bottom of patients repeat prescriptions,
stating that the shingles vaccine will be
available to them during the year.
It is important that all practice staff who interact
with patients understand the age eligibility for
the shingles vaccine, so that they can provide
accurate information when patients enquire.
Eligible patients who are housebound or
living in a care home must not be forgotten

Prescribing information can be found on the last four pages

either. It may be necessary to work with the


district nurse team to arrange for housebound
patients to have the shingles vaccine or
arrange a visit to the care home to vaccinate
the eligible patients living there.

as the 23-valent pneumococcal


polysaccharide vaccine.8

These measures can help surgeries to


vaccinate all eligible patients during the
first year of this programme. At the end of
the year it may be neccesary to mop up
the remainder of unvaccinated eligible
patients by sending them a personal letter
from the GP inviting them to come in for
immunisation.

Have a primary or acquired


immunodeficiency state due to conditions
such as acute and chronic leukaemias,
lymphoma, other conditions affecting
the bone marrow or lymphatic system,
immunosuppression due to HIV/AIDS (see
below) and cellular immune deficiencies

Administration
Zostavax (shingles (herpes zoster)
vaccine (live)) is given as a single dose
by subcutaneous injection, preferably in
the deltoid region. The vaccine is supplied
as a powder in a vial for reconstitution
with a pre-filled syringe containing solvent
for suspension.8

Shingles rash (V1 distribution) on the forehead of a 72-year-old man. In this case, the rash occurs
along the superior (ophthalmic) sensory nerve, which supplies sensation to the forehead.

Prescribing information can be found on the last four pages

Zostavax can be given regardless of


a patients history of shingles. It can be
given at the same time as the inactivated
flu vaccine but should be injected at a
different site.5 However, as stated in the
summary of product characteristics, the
vaccine cannot be given at the same time

Zostavax is a live, attenuated vaccine, and


therefore it is contraindicated in people who:

Are receiving immunosuppressive therapy


(including high-dose corticosteroids)
Have an active untreated TB infection
Have had a confirmed anaphylactic reaction
to a previous dose of varicella vaccine
Have had a confirmed anaphylactic
reaction to any component of the vaccine,
including neomycin or gelatin.5
However, Zostavax is not contraindicated
for people who are receiving topical or
inhaled corticosteroids or low-dose systemic
corticosteroids or in patients who are receiving
corticosteroids as replacement therapy, for
example, for adrenal insufficiency.5 For full

information on contraindications, warnings


and precautions, please refer to summary of
product characteristics.8

References
1. Department of Health. Shingles (herpes zoster). In: Immunisation
against Infectious Disease. Chapter 28a, July 2013. https://www.
gov.uk/government/publications/shingles-herpes-zoster-the-greenbook-chapter-28a (last accessed 9December 2013).
2. Bowsher D. The lifetime occurrence of herpes zoster and
prevalence of post-herpetic neuralgia: A retrospective survey in an
elderly population. Eur J Pain. 1999;3(4):335-342.
3. Drolet M, et al. The impact of herpes zoster and postherpetic
neuralgia on health-related quality of life: a prospective study. CMAJ
2010;182(16):1731-6.
4. Gauthier A et al. Epidemiology and cost of herpes zoster and
post-herpetic neuralgia in the United Kingdom. Epidemiol Infect
2009;137(1):38-47.
5. NHS England, Public Health England, Department of Health.
Introduction of shingles vaccine for people aged 70. Tripartite letter,
12 July 2013. https://www.gov.uk/government/publications/
introduction-of-shingles-vaccine-for-people-aged-70-and-79-years
(last accessed 9December 2013).
6. Public Health England. Shingles vaccine special edition. Vaccine
Update 205, September 2013. https://www.gov.uk/government/
uploads/system/uploads/attachment_data/file/239832/vaccine_
update_12_9_v3.pdf (last accessed 9December 2013).
7. Public Health England. Clarification of eligibility for the shingles
vaccine. Vaccine Update 204, August 2013. https://www.gov.uk/
government/uploads/system/uploads/attachment_data/file/230857/
vaccine_update_204.pdf (last accessed 9December 2013).
8. Sanofi Pasteur MSD. Zostavax. Summary of product characteristics.
13 February 2013. http://www.medicines.org.uk/emc/
medicine/25927/SPC/Zostavax/ (last accessed 9December 2013).

Box 1. Surgery support materials

Box 2. Further information

Box 3. Shingles Aware website

Sanofi Pasteur MSD has developed a


variety of materials to support healthcare
professionals in the implementation of
the national vaccination programme.
These materials include surgery support
packs with patient leaflets, prescription
reminder stickers, posters, leaflet
dispensers, bunting, and badges for
reception staff.

To find out more about Zostavax,


please arrange an appointment with
your local Vaccine Account Manager or
call our Customer Services department
on Freephone 0800 085 5511. For
medical information enquiries please
contact our Medical Information
department on 01628 587693.

The Shingles Aware website has


been developed by Sanofi Pasteur
MSD to help improve understanding
of shingles and shingles vaccination
among both healthcare professionals
and the public.

How to order Zostavax


To order materials, please visit
www.spmsd.co.uk and click on
the healthcare professional section
of the website.

To order supplies of Zostavax visit


the Department of Healths ImmForm
website: www.immform.dh.gov.uk

This site has disease information on


shingles for members of the public.
The healthcare professionals section
includes information about the
pathophysiology of shingles, including
the phases of the illness, the areas of
the body affected, and post-herpetic
neuralgia. There is also important
information about Zostavax, how it
works, and its tolerability profile.
The public section of the Shingles
Aware website provides clear and
straightforward information about the
symptoms of shingles, what to do if
people suspect they have shingles,
and a useful myth-buster section
explaining the facts behind some
commonly held beliefs about shingles.
www.shinglesaware.co.uk

Prescribing information can be found on the last four pages

Wise Up kits support sexual health education for teens


School nurses and personal, social and health education (PSHE) teachers will soon be able to select from a range of innovative multimedia tools on sexual health to suit the
age and needs of teenage pupils.

Sanofi Pasteur MSD will soon launch a set


of innovative audio-visual and printed
teaching materials to help educate
young teens about sexually transmitted
infections (STIs) and girls about the human
papillomavirus (HPV) vaccination.
The educational materials have been
developed and produced by Sanofi Pasteur
MSD in association with the School and
Public Health Nurses Association (SAPHNA)
and the PSHE Association.
Two educational kits employ funky graphics,
colourful illustration, rap music and, for the
STI version, a celebrity montage. The kits are
designed to engage teenagers in learning
about sexual health, STI prevention and
sexual relationships through fun classroom
activities and open discussions.
School nurses and teachers can use the
materials during science or PSHE lessons,
or to give a sexual health presentation. The
materials challenge a number of common
myths about safe sexual behaviour and STIs,
and are designed to help young people to
arrive at a more informed understanding of
the issues and take greater responsibility for
their own sexual health.
The educational kits are modular, comprising a
variety of different materials that school nurses,
teachers and schools can select from to best suit
the age and needs of their pupils, in line with the
schools sex and relationship education policy.
10

Prescribing information can be found on the last four pages

There are two distinct learning zones. Each


zone includes lesson plans, worksheets,
rap music videos and presentations in Preziformat (a cloud-based software). The two
learning zones are:
Wise Up Me, for eduction on STIs for both
boys and girls aged 12 years and over

Wise Up Me

The Story of Jade and Zac

The most unique aspect of the educational


materials are the videos. These deliver
educational messages about sexual health
in a variety of innovative ways, including the
use of rap music. The videos are designed to
engage teenagers in sexual health education
by appealing to their interests.

A cutting-edge rap video shows a young


couple (both aged 17) telling the story of their
relationship. Jade and Zac have been dating
for 2 years and now feel ready to take the next
step. However, when Jade discovers condoms
that Zac has bought to prepare for having sex
with her, an argument ensues.

The story is presented as a music video,


with computer generated imagery (CGI)
characters used to represent the main
STIs mentioned. The music video enables
pupils to explore the reactions of the two
main characters and consider the value of
being in a long-term relationship, the risks of
different STIs and the reasons for not having
casual sex.

Wise Up HPV Girl Talk, for girls aged


1213 years with information on HPV
and HPV vaccination.

Prescribing information can be found on the last four pages

11

The video is available in two versions: one


version includes more information about
specific STIs than the other to allow educators
to select the video most appropriate for the
age group they are teaching.

Myth or fact
A second video comprises a celebrity
montage, which is intended to dispel many
of the myths about STIs that teenagers may
possess, such as the idea that you have to
be 16 to buy condoms.
Many teens identify with celebrities from
TV and the music industry, and those
who appear in the montage include
many that they may recognise, including
Tinchy Stryder, Gemma Cairney, Abi
Phillips, Blaise, District 3, Jade Ramsey,
Louise Thompson, Andy Jordan, Luciel
Johns, Luke Franks, Neev Spencer and PJ
Brennan. The video features the celebrities
discussing sexual health myths and facts.
This approach helps teenagers learn about
sexual health through identification with
people they look up to and trust.
A Prezi-format presentation provides
an introduction to the key themes and
learning objectives of the STI learning zone.
Entitled Zac and Jade Wise up to STIs it
includes the ground rules of good sexual
health behaviour, questions on the law on
sex, recognising the symptoms of STIs, and
methods of protection against STIs.
12

Lesson plans
The Basic Stuff Take 5
This lesson provides an introduction for boys
and girls to the topic of sexually transmitted
infections (STIs), by facilitating learning about
STIs and forms of contraception. This lesson
helps pupils to recognise that entering a sexual
relationship calls for them to take responsibility
for considering the risk of STIs and unwanted
pregnancy. Pupils are introduced to what STIs
are, how contraception such as condoms can
help to protect against STIs, and where they
can obtain advice.
Boys!
Directed at boys alone this lesson builds on
knowledge acquired in other lessons. It looks at
issues specific to males and STIs, highlighting
mens responsibilities in a sexual relationship
and the choices that they can make to protect
themselves and their sexual partners.
Introducing STIs
This lesson helps pupils to think about their
health and how to protect themselves against
STIs. Key facts are provided about Chlamydia,
herpes, genital warts, HIV, hepatitis B,
gonorrhoea, syphilis and pubic lice, and helps
to inform pupils and stimulate discussion.
Dont be surprised by STIs
The purpose of this lesson is to cement
previous learning in the context of risk taking
behaviours. A rap video is used to raise
awareness of the risk of STIs among young

Prescribing information can be found on the last four pages

people, with key messages appearing in


word clouds. The idea was that the best way
to deliver key messages to teenagers would
be via the medium of music they relate to.
Two Sides of the Same Story
The aim of this lesson is to explore the
reactions of the main characters in the
video, The story of Jade and Zac. Entitled
two sides of the same story it enables
pupils to explore their understanding of safe
sexual relationships and questions they
may have about how to protect themselves
against STIs.
The lesson plans are also supported by a
set of worksheets which help to reinforce
the learning messages of the lesson plans.
The topics cover the basics of sexual
health, the key messages of the rap songs,
STI prevention advice, learning points
from the Jade and Zac rap video, and two
worksheets on the myths and facts of STIs,
one with more detail so educators can
select the one most appropriate to the pupils
they are teaching.

Further information
www.wise-up.me
A password-protected website is
being set up to hold all of the materials
and educational content in a modular
format that enables school nurses and
teachers to create their own bespoke
lessons. Teacher notes for each of
the lesson plans and other support
materials will be available to download
from the site.

A separate learning zone for girls


comprises a video, lesson plan,
worksheet and a presentation in Prezi
format (a cloud-based software) to inform
and support girls aged 1213 years
through the HPV vaccination programme.

Everything You Wanted to Know


about HPV
This video uses CGI and interviews
with girls aged 1214 years to discuss
the answers to questions about HPV
and the HPV vaccine.

Prezi

Wise Up HPV Girl Talk

This presentation in Prezi format


entitled HPV and Cervical Cancer helps
school nurses or teachers explain the
link between HPV and cervical cancer.
It highlights the different types of HPV,
the symptoms of HPV infection, the risk
factors and preventive measures. There
is detail about the vaccine including the
possibility of side effects. This Prezi is
supported by notes for presenters.

Prescribing information can be found on the last four pages

13

Keeping the lines open


Brook and the Family Planning Association (FPA) are working together with support from five pharmaceutical companies to continue their sexual health advisory services.
We talked with the FPAs Natika Halil.

Two sexual health enquiry services are


continuing to serve the public and health
professionals despite losing their government
funding last year.
Five pharmaceutical companies stepped in
with grant aid when Department of Health
funding ceased. Unrestricted grants from
Sanofi Pasteur MSD, Bayer, Consilient Health,
HRA Pharma and Merck Sharp & Dohme run
up to April 2014.
Brook provides free and confidential sexual
health advice and contraception to young
people under 25 and the FPA provides
straightforward information, advice and
support to people on all aspects of sexual
health, sex and relationships.
Brook and the FPA have combined their
operations but continue to offer separate
services with separate phone numbers and
websites. There have been some service
reductions during the transition, but both
charities are maintaining phone and webbased enquiry services on weekdays.
The FPA helpline has two full-time advisers,
who are both registered nurses with a postregistration family planning qualification; one
is also a midwife. In the past six months, they
have handled over 6300 enquiries.
14

Prescribing information can be found on the last four pages

About one tenth of the advisers calls come


from healthcare professionals, the vast majority
of whom are practice nurses seeking advice
either on a patients behalf or with professional
concerns. Half of calls from healthcare
professionals are about contraception; a large
proportion are about the combined pill, patch
or ring, or long-acting reversible contraception.
Some healthcare professionals also seek
guidance on emergency contraception.
Specific topics include missed pill advice,
switching contraceptive methods or brands,
managing bleeding problems for women
using hormonal contraceptive methods,
drug interactions with hormonal methods
or medical eligibility for women with specific
health conditions. On occasions they need
information about abortion services for
women outside their practice catchment area.
Some practice nurses seek advice on
patient group directions (PGDs), the latest
guidance, policy or best practice on
professional accountability or where to get
training to fit implants or intrauterine devices.
Professionals sometimes need guidance on
the law regarding sex involving people aged
under 16 or vulnerable adults.
Contraception is the main concern for
members of the public calling the FPA

helpline, although callers may also seek


advice about abortion, sexually transmitted
infections (STIs) and any sexual health story
that is currently in the press.
Brook targets its services at young people
under 25. Its advice line has five full-time
advisers whose backgrounds are in education
or counselling. Last year Brook handled 8400
calls, 6200 texts and 460 web chats. Only a
tiny proportion came from health professionals.
Contraception is also the most popular topic
raised by callers from the general public, but
there are also enquiries about pregnancy,
STI screening, relationships, body issues,
rape and abuse, terminations and general
counselling. Those wanting full counselling
services are referred on, while those seeking
clinical advice are referred to FPA advisers.
The FPAs advisers are clinically trained and so
can offer callers an independent conversation
on clinical issues, but this does not constitute
a consultation. Calls to the Brook line are free.
Both helplines signpost callers to other services;
to this end, they keep a database of sexual
health services, which advisers keep updated
by regularly ringing the appropriate clinics.
Brook and the FPA battled to save their
advice line at a time of grave concern about

restrictions being placed on access to


contraception and sexual health advice.
An audit of primary care trusts (PCTs) by the
Advisory Group on Contraception in 2012
found that 3.2 million women of reproductive
age are living in areas that have restrictions
in place on the prescribing or availability
of contraceptives through GP or other
commissioned contraceptive services.1
In 2010, PCTs which confirmed some form
of restriction in access to contraception had
an abortion rate higher than the national
average: 20.4 per 1000 resident women
aged 15-44 compared with 18.6 per 1000
resident women aged 15-44 respectively.1
The 2012 audit also found that less than
one fifth of PCTs could provide information
about the number of professionals in general
practice trained to fit sub-dermal implants or
intrauterine devices.1
A campaign by Brook and the FPA
warned that reforms to contraceptive
and sexual health services could cost the
NHS and the welfare state 136.7 billion
by 2020,2 as a result of an increase in
unintended pregnancies, abortions and
STIs. By contrast, improving access to
sexual health services and contraception
has the potential to save the public purse

Table 1. Sexual health advice lines


Charity

Service

Available

Number/URL

Brook

Free, confidential helpline


Text service
(standard SMS rate)
Webchat

11am to 3pm, MonFri


9am to 3pm, MonFri

0808 802 1234


07717 989 023

9am to 3pm, MonFri

Helpline England,
Scotland and Wales

9am to 3pm MonThurs,


9am to 12pm Fri (except
bank holidays)

www.askbrook.org.uk/
chat.asp
0845 122 8690

Helpline Northern Ireland

9am to 5pm MonFri


(except bank holidays)

FPA

Ask WES: anonymous


and confidential online
enquiry service

0845 122 8687


www.fpa.org.uk/ask-wes

up to 5.1 billion in the same time frame,


according to an analysis commissioned by
Brook and the FPA.3
Anne Connolly, a GP at Ridge Medical
Practice in Bradford, and Chair of the
Primary Care Womens Health Forum,
said: There is a clear danger that
imminent changes to commissioning could
significantly undermine the good work that
professionals are doing.2

References
1. Advisory Group on Contraception. Sex, Lives and Commissioning:
An audit by the Advisory Group on Contraception of the
commissioning of contraceptive and abortion services in England.
April 2012. http://cleregolfserver.co.uk/bayer/sex-lives-andcommissioning/index.html (last accessed 9December 2013).
2. We Cant Go Backwards. Cuts to services set to saddle UK with a
136.7 billion NHS and welfare burden by 2020. Press release, 30
January 2013. http://www.wecantgobackwards.org.uk/news/57/
Unprotected-Nation-report-cuts-cost-UK-1367bn/ (last accessed
9December 2013).
3. Lucas S. Unprotected Nation: The Financial and Economic
Impacts of Restricted Contraceptive and Sexual Health Services.
A report by Development Economics. January 2013. http://www.
wecantgobackwards.org.uk/uploads/media/17/15738.pdf (last
accessed 9December 2013).

Prescribing information can be found on the last four pages

15

UK routine childhood immunisation programme


Age when Immunised

Vaccine

Diseases

Pediacel

Diphtheria, Tetanus, Pertussis, Polio, Haemophilus influenzae


type b (Hib) (DTaP/IPV/Hib)

Prevenar 13

Pneumococcal disease

Rotarix

Rotavirus

Pediacel

DTaP/IPV/Hib

Menjugate Kit or NeisVac-C

Meningitis C (MenC)

Rotarix

Rotavirus

Pediacel

DTaP/IPV/Hib

Prevenar 13

Pneumococcal disease

Menitorix

Hib/MenC

MMRvaxPro or Priorix

Measles, Mumps, Rubella (MMR)

Prevenar 13

Pneumococcal disease

Repevax or Infanrix-IPV

Diphtheria, Tetanus, Pertussis


and Polio (dTaP/IPV or DTaP/IPV)

MMRvaxPro or Priorix

MMR

Gardasil

Cervical cancer and other genital diseases* related to human


papillomavirus (HPV) types 6, 11, 16 and 18

Revaxis

Tetanus, Diphtheria and Polio (Td/IPV)

Meningitec or Menjugate Kit


or NeisVac-C

Men C

Number of Injections

2 Months

3 Months

One oral dose

One oral dose

4 Months

1213 Months

3 Years 4 Months
or soon after

Girls 1213 Years


Girls 13 to less than
18 Years (catch-up)

Around 14 Years

3 doses at
0, 1 and 46 months

*As defined in the summary of product characteristics for Gardasil. This vaccination will be introduced during the 2013/14 academic year. Note: 2- and 3-year olds will also receive the nasal flu vaccine FluenzTM as part of the seasonal flu vaccination programme. Infanrix-IPV, Priorix,
Menitorix and Rotarix are trademarks of the GlaxoSmithKline group of companies; Menjugate is a trademark of Novartis Vaccines; NeisVac-C is a trademark of Baxter Healthcare; Meningitec and Prevenar 13 are trademarks of Pfizer Limited; Fluenz is a trademark of AstraZeneca.

Reference: NHS Immunisation Information. Routine child immunisations from June 2013. https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/204061/DoH_Imm_schedule_poster_A4_2013_07_accessible.pdf (last accessed 9December 2013).

16

Prescribing information can be found on the last four pages

Ask the experts about


Gardasil
Q. Is Gardasil licensed for use in males?
A. Yes. Gardasil is licensed for use in 9
to 26 year old males for the prevention of
genital warts related to specific HPV types.
This is based on the demonstration of
immunogenicity in 9 to 15 year old boys
and efficacy in 16 to 26 year old men.1
Q. Should antibody titres be measured
after completion of a course of Gardasil?
A. Antibody testing is not recommended.
The level of antibodies required to protect
against diseases, the protective threshold, is

not yet known.1 Therefore knowing


the antibody levels in a vaccine recipient
would not provide information about
whether they are protected from disease.

Q. Is there any flexibility to the primary


schedule for Gardasil when it is
not possible to complete the course
at the recommended intervals?

Q. Will vaccinees still need to attend


cervical screening appointments?

A. The recommend schedule of 0, 2


and 6 months should be adhered to.
However, where it is not possible to
adhere to the recommended intervals,
an alternative schedule for Gardasil
may be used, allowing a minimum
interval of 1 month between doses
one and two, and a minimum interval
of at least 3 months between doses
two and three. All three doses of the
primary schedule should be given
within a 1-year period.

A. Vaccination is not a substitute for


routine cervical screening. Since no
vaccine is 100% effective and available
HPV vaccines do not provide protection
against every HPV type, nor against
existing infections or disease, routine
cervical screening remains critically
important and should follow local
recommendations.1

Reference
1. Sanofi Pasteur MSD. Gardasil. Summary of product
characteristics.

Prescribing information can be found on the last four pages

17

Ask the experts about


Childhood vaccines
Q. We are writing guidelines for what to do
if a child inadvertently receives a vaccine
outside the expiry date. Are you aware of
any recommendations?
A. Any inadvertent administration should be
reported to the Medicines and Healthcare
products Regulatory Agency (MHRA) through
the yellow card reporting system1 and to the
vaccine manufacturer. Public Health England
(PHE) has published Vaccine incident
guidance: actions to take in response to
vaccine errors.1 This document provides
advice and guidance on the management of
serious untoward vaccine incidents including:
How to respond to errors in vaccine
storage and breaches in the cold chain
General principles of managing
an adverse vaccine incident
How to address errors that have
occurred in vaccine preparation
and vaccine administration
Considerations that need to be taken
into account when deciding whether
to revaccinate individuals.
This publication is available on the
PHE website.1
Q. How can I ensure that a child who
has just come to the United Kingdom
is brought into line with the current
childhood schedule?

18

A. A useful video on this subject is


available from Public Health England
via YouTube: http://www.youtube.com/
watch?v=SwXvJWaLDyE.
Firstly, try to establish which vaccines
the child has received; the parent may
have documentation from their country of
origin. The World Health Organization has
a database of immunisation schedules
from different countries, although you
cannot assume that a child has received
all the vaccines that are recommended in a
particular country.2
PHE provides an algorithm which is designed
to help produce a schedule to bring a child
into line with the current UK childhood
schedule.3 The PHE advises the following
general principles:
If a primary course of immunisations has been
started, continue where left off, no matter
how long the interval since the last dose.
There is no need for repeated doses of
vaccines unless a measles-containing
vaccine has been given under one year of
age when it should be repeated.
For those coming to the UK part way through
a course, transfer to the UK schedule as
appropriate for age. However, it may be
appropriate to complete already started
courses, such as hepatitis B vaccine in a
low risk individual. Alternative arrangements
for providing such vaccines may need to
be made if they are not part of the routine
schedule in the UK.

Prescribing information can be found on the last four pages

Q. A mother has refused vaccinations for


her young baby because she has read
on the internet that they contain mercury.
What can I do?
A. The mother is concerned about the
presence of thiomersal in the vaccines.
Thiomersal used to be used as a preservative
in certain vaccines but you can reassure the
mother that there is no thiomersal in any of the
vaccines used in the primary immunisations
recommended in the routine UK childhood
schedule.4 The internet can be a helpful
source of information but it is unregulated and
anyone can set themselves up as an expert.
You could suggest the mother looks at the
following site which gives balanced information
on vaccines: NHS Choices Vaccination
information: http://www.nhs.uk/Planners/
vaccinations/Pages/Landing.aspx
Q. If a baby has received MMR at 9
months because of an outbreak of
measles, does he need the 12/13 month
dose or should he just wait until the preschool booster to give a second dose?
The first dose of MMR is usually given between
12 and 13 months because a younger infant
may still have residual maternal antibodies,
which can interfere with the response to the
vaccine. However, MMR can be given earlier
than the infants first birthday if there is an
urgent need for it, either as in this case, to
provide protection in an outbreak or if the infant
is travelling to a country where they may be at
increased risk. If the first dose is given before
the child is one year old, this dose should be
discounted and two doses of MMR should

be given according to the usual schedule at


12/13 months and as a pre-school booster.5

References
1. Public Health England. Vaccine incident guidance: actions to
take in response to vaccine errors. http://www.hpa.org.uk/
webc/HPAwebFile/HPAweb_C/1267551139589 (last accessed
9December 2013).
2. World Health Organization. WHO Vaccine Preventable Diseases
Monitoring System: Immunization schedules by antigen,
selection centre. http://apps.who.int/immunization_monitoring/
globalsummary/schedules (last accessed 9December 2013).
3. Public Health England. Vaccination of individuals with uncertain or
incomplete immunisation status. 1 September 2013. http://www.
hpa.org.uk/webc/hpawebfile/hpaweb_c/1194947406156 (last
accessed 9December 2013).
4. Department of Health. Vaccine safety and the management of
adverse events following immunisation. In: Immunisation against
Infectious Disease. Chapter 8. August 2012. https://www.gov.
uk/government/publications/vaccine-safety-and-adverse-eventsfollowing-immunisation-the-green-book-chapter-8 (last accessed
9December 2013).
5. Department of Health. Measles. In: Immunisation against Infectious
Disease. Chapter 21. January 2013. https://www.gov.uk/
government/publications/measles-the-green-book-chapter-21 (last
accessed 9December 2013).

Diary dates
School Nurses and Community
Childrens Nurses Master Class

RCN Public Health Forum conference


and exhibition 2014: Contacts that Count

The science and behaviour behind hand


washing at home, work and on the move

British Pain Society 2014


Annual Scientific Meeting

15 January 2014
Manchester: Crowne Plaza

21 March 2014
University of Warwick, Coventry

3 April 2014
Royal Society for Public Health

29 April to 1 May 2014


Manchester Central

In conjunction with the Department of


Health, this master class will provide
updates for school nurses and community
childrens nurses on the support of local
young carers.

This one day conference is aimed at all nursing


disciplines within public health and specifically
include those working in sexual health, travel
health, public health, health visiting and TB.

Why cant we sustain the impact beyond


Global Handwashing Day (15 October) or the
regular Government campaigns? Can new
behavioural approaches make more people
wash their hands? This timely conference will
examine whether some sectors of society
are disadvantaged by poor provision of
hand washing facilities and address ways of
promoting both these and good hand
washing practice.

The aim of the annual scientific meeting is


to encourage healthcare professionals, from
all disciplines involved in the understanding
and management of pain, to exchange
ideas and increase understanding in all
aspects of pain and pain management.

https://www.rcn.org.uk/newsevents/event_
details/rcn_eventsms/school_nurses_and_
community_childrens_nurses_master_
class_-_manchester

https://www.rcn.org.uk/newsevents/event_
details/rcn_eventsms/rcn_public_health_
forum_conference_and_exhibition

http://www.britishpainsociety.org/industry_
asm.htm

http://www.rsph.org.uk/en/coursesconferences-and-events/events/index.cfm/
the-science-and-behaviour-behind-handwashing-at-home-work-and-on-the-move

Prescribing information can be found on the last four pages

19

ABRIDGED PRESCRIBING INFORMATION

ZOSTAVAX powder and solvent for suspension


for injection in a pre-filled syringe [shingles
(herpes zoster) vaccine (live)]
Refer to Summary of Product Characteristics for full product
information.
Presentation: Vial containing a lyophilised preparation of live
attenuated varicella-zoster virus (Oka/Merck strain) and a prefilled syringe containing water for injections. After reconstitution,
one dose contains no less than 19400 PFU (Plaque-forming
units) varicella-zoster virus (Oka/Merck strain). Indications:
Active immunisation for the prevention of herpes zoster
(zoster or shingles) and herpes zoster-related post-herpetic
neuralgia (PHN) in individuals 50 years of age or older. Dosage
and administration: Individuals should receive a single dose
(0.65ml) administered subcutaneously, preferably in the deltoid

ABRIDGED PRESCRIBING INFORMATION

PEDIACEL suspension for injection in pre-filled


syringe
Diptheria, tetanus, pertussis (acellular, component), poliomyelitis
(inactivated) and Haemophilus type b conjugate vaccine (adsorbed).
Refer to Summary of Product Characteristics for full product
information.
Presentation: 0.5 mL single dose of vaccine supplied in a prefilled syringe. Each dose of vaccine contains 30 IU purified
diphtheria toxoid, 40 IU purified tetanus toxoid, 20 g purified
pertussis toxoid, 20 g purified filamentous haemagglutinin, 5g
purified fimbriae types 2 and 3, 3 g purified pertactin, 40 D
antigen units of inactivated type 1 poliovirus, 8 D antigen units
of inactivated type 2 poliovirus, 32 D antigen units of inactivated
type 3 poliovirus and 10 g of Haemophilus influenzae type
b polysaccharide conjugated to tetanus toxoid. Indications:
Active immunisation of infants and children, from 6 weeks of
age up to the 4th birthday, against diphtheria, tetanus, pertussis,
poliomyelitis and invasive infections caused by Haemophilus
influenzae type b. PEDIACEL can be considered for the booster
if the composition is in accordance with the applicable official
recommendations. Dosage and administration: Primary
immunisation in infants: with either 2 doses or 3 doses of
0.5 mL with at least one month between doses, according
to applicable official recommendations. Booster dose: A
single 0.5 mL dose may be given at least 6 months after
the last priming dose in accordance with applicable official

region. Do not inject intravascularly. It is recommended that the


vaccine be administered immediately after reconstitution, to
minimize loss of potency. Discard reconstituted vaccine if it is
not used within 30 minutes. Contraindications: Hypersensitivity
to the vaccine or any of its components (including neomycin).
Individuals receiving immunosuppressive therapy (including
high-dose corticosteroids) or who have a primary or acquired
immunodeficiency. Individuals with active untreated tuberculosis.
Pregnancy. Warnings and precautions: Appropriate facilities
and medication should be available in the rare event of
anaphylaxis. Zostavax is not indicated for the treatment of Zoster
or PHN. Deferral of vaccination should be considered in the
presence of fever. In clinical trials with Zostavax, transmission of
the vaccine virus has not been reported. However, post-marketing
experience with varicella vaccines suggest that transmission of
vaccine virus may occur rarely between vaccinees who develop

a varicella-like rash and susceptible contacts (for example,


VZV-susceptible infant grandchildren). Transmission of vaccine
virus from varicella vaccine recipients who do not develop a
varicella-like rash has also been reported. This is a theoretical
risk for vaccination with Zostavax. The risk of transmitting the
attenuated vaccine virus from a vaccinee to a susceptible contact
should be weighed against the risk of developing natural zoster
and potentially transmitting wild-type VZV to a susceptible
contact. As with any vaccine, vaccination with Zostavax may
not result in protection in all vaccine recipients. Zostavax and
23-valent pneumococcal polysaccharide vaccine should not be
given concomitantly because concomitant use in a clinical trial
resulted in reduced immunogenicity of Zostavax. Pregnancy
and lactation: Zostavax is not intended to be administered to
pregnant women. Pregnancy should be avoided for one month
following vaccination. Caution should be exercised if Zostavax is

administered to a breast-feeding woman. Undesirable effects:


Very common side effects: Pain/tenderness, erythema,
swelling and pruritus at the injection site. Common side effects:
Warmth, haematoma and induration at the injection site, pain in
extremity, and headache. Other reported side effects that may
potentially be serious include hypersensitivity reactions including
anaphylactic reactions, arthralgia, myalgia, lymphadenopathy,
rash and at the injection site, urticaria, pyrexia and rash. For a
complete list of undesirable effects please refer to the Summary
of Product Characteristics. Package quantities and basic cost:
Vial and pre-filled syringe with two separate needles. The cost
of this vaccine is 109.20. Marketing authorisation holder:
Sanofi Pasteur MSD SNC, 8 Rue Jonas Salk, F-69007 Lyon,
France. Marketing authorisation number: EU/1/06/341/011.
Legal category: POM. Registered trademark. Date of last
review: October 2013

recommendations. The vaccine should be administered by


the intramuscular route. Do not administer intravascularly or
subcutaneously. Contraindications: Known hypersensitivity to
diphtheria, tetanus, pertussis, polio or Hib vaccines, to any other
component of the vaccine, to any residual substances carried
over from manufacture (neomycin, streptomycin, polymyxin B,
glutaraldehyde, formaldehyde and bovine serum albumin), which
may be present in undetectable trace amounts. (see Summary
of Product Characteristics for full details). Encephalopathy of
unknown aetiology within 7 days of administration of a previous
dose of any vaccine containing pertussis antigens. In these
circumstances pertussis vaccination should be discontinued
and the vaccination course should be continued with diphtheria,
tetanus, polio and Hib vaccines. Progressive neurologic disorder,
uncontrolled epilepsy, or progressive encephalopathy. Pertussis
vaccine should not be administered to children with such
conditions until a treatment regimen has been established and
the condition has stabilized. Administration of PEDIACEL should
be postponed in children suffering from acute severe febrile
illness. The presence of a minor infection (e.g., mild upper
respiratory infection) is not a contraindication. Warnings and
precautions: Appropriate medical treatment and supervision
should be immediately available in the event of rare anaphylactic
reaction following the administration of the vaccine. If any
of the following events have occurred after administration of
a pertussis-containing vaccine, the decision to administer
PEDIACEL should be based on careful consideration of potential
benefits and possible risks: Temperature of 40C within

48hours, not attributable to another identifiable cause, collapse


or shock-like state (hypotonic-hyporesponsive episode) within
48 hours, persistent crying lasting 3 hours within 48 hours,
convulsions with or without fever within 3 days. If Guillain-Barr
syndrome or brachial neuritis has occurred following receipt of
prior vaccine containing tetanus toxoid, the decision to give any
vaccine containing tetanus toxoid should be based on careful
consideration of the potential benefits and possible risks. A history
of febrile convulsions, a family history of convulsions or Sudden
infant death syndrome (SIDS) do not constitute a contraindication
for the use of PEDIACEL.Vaccinees with a history of febrile
convulsions should be closely followed up as such adverse
events may occur within 2 to 3 days post vaccination. The
potential risk of apnoea and the need for respiratory monitoring
for 48-72h should be considered when administering the primary
immunization series to very premature infants (born 28 weeks
of gestation) and particularly for those with a previous history
of respiratory immaturity. As the benefit of vaccination is high
in this group of infants, vaccination should not be withheld or
delayed. Immunocompromised children (whether from disease
or treatment) may not obtain the expected immune response. If
possible, consideration should be given to delaying vaccination
until after the completion of any immunosuppressive treatment.
HIV infection is not considered as a contraindication. The expected
immunological response may not be obtained after vaccination
of immunosuppressed patients. Intramuscular injections should
be given with care in children with thrombocytopenia or bleeding
disorders. As with any vaccine, a protective immune response

may not be elicited in all vaccinees. Vaccines that contain Hib


antigen do not provide protection against infections caused by
other types of Haemophilus influenzae or against meningitis of
other origin. Granuloma or sterile abscess at the injection site
has been reported with vaccines containing aluminium. Since
the Hib capsular polysaccharide antigen is excreted in the
urine, a positive urine test can be observed within 1-2 weeks
following vaccination. Other tests should be performed in order
to confirm Hib infection during this period. Undesirable effects:
Very common side effects: Appetite loss, irritability, abnormal
crying, vomiting, decreased activity, injection site tenderness,
erythema, swelling and pyrexia. Common side effects: Diarrhoea,
injection site bleeding and bruising. Other reported side effects
that may potentially be serious include febrile and afebrile
convulsions, hypotonic hyporesponsive episodes, apnoea,
extensive limb swelling, oedematous reaction affecting one
or both lower limbs, pallor, somnolence and hypersensitivity
or anaphylactic reaction (such as urticaria, angioedema).
For a complete list of undesirable effects please refer to the
Summary of Product Characteristics. Package Quantities
and basic NHS cost: Single dose of 0.5ml of suspension in
pre-filled syringe. NHS cost 32.00. Available free as part of
the national childhood immunisation programme. Marketing
authorisation holder: Sanofi Pasteur MSD Ltd., Mallards Reach,
Bridge Avenue, Maidenhead, Berkshire, SL6 1QP. Marketing
authorisation number: PL 06745/0128. Legal category: POM.

Registered trademark. Date of last review: February 2013

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard.
Adverse events should also be reported to Sanofi Pasteur MSD. Tel: 01628 785291
20

Prescribing information can be found on the last four pages

ABRIDGED PRESCRIBING INFORMATION

REPEVAX
Diphtheria, Tetanus, Pertussis (acellular, component)
and Poliomyelitis (inactivated) Vaccine (adsorbed,
reduced antigen(s) content)
Refer to Summary of Product Characteristics for full product
information.
Presentation: 0.5 mL single dose of vaccine supplied in prefilled
syringe. Each dose of vaccine contains 2 IU Diphtheria Toxoid,
20 IU Tetanus Toxoid, 2.5 g Pertussis Toxoid, 5 g Filamentous
Haemagglutinin, 5 g Fimbriae Types 2 and 3, 3 g Pertactin,
40 D antigen units of inactivated type 1 poliovirus, 8 D antigen
units of inactivated type 2 poliovirus, 32 D antigen units of
inactivated type 3 poliovirus and 1.5 milligrams of aluminium
phosphate as adjuvant. Indications: Active immunisation
against diphtheria, tetanus, pertussis and poliomyelitis in
persons from the age of three years as a booster following
primary immunisation. Dosage and administration: All age
groups should receive one 0.5 mL dose, according to official

ABRIDGED PRESCRIBING INFORMATION

M-M-RVAXPRO
vaccine (live)).

(Measles, mumps, and rubella

Refer to Summary of Product Characteristics for full product


information before prescribing.
Presentation: M-M-RVAXPRO is provided as a vial of powder
and pre-filled syringe of solvent for suspension for injection.
Each 0.5mL dose contains live, attenuated Measles virus
(Enders Edmonston strain) not less than 1x103 CCID50, Mumps
virus (Jeryl Lynn Level B strain) not less than 12.5x103
CCID50 and Rubella virus (Wistar RA 27/3 strain) not less than
1x103 CCID50. Indications: Simultaneous vaccination against
measles, mumps, and rubella in individuals from 12 months of
age or older. M-M-RVAXPRO can be administered to infants from
9 months of age under special circumstances. For use in measles
outbreaks, or for post-exposure vaccination, or, for use in previously
unvaccinated individuals older than 9 months who are in contact with
susceptible pregnant women, and persons likely to be susceptible to
mumps and rubella. M-M-RVAXPRO is to be used on the basis of
official recommendations. Dosage and administration: Individuals
12 months of age or older should receive one dose at an elected
date. A second dose may be administered at least 4 weeks after
the first dose in accordance with official recommendations. The
second dose is intended for those who do not respond to the first
dose. M-M-RVAXPRO can be administered to infants between 9 and
12 months of age, in accordance with official recommendations or

recommendations. The vaccine should be administered by


the intramuscular route. Contraindications: REPEVAX should
not be administered to individuals who have previously had a
hypersensitivity reaction to any vaccine containing diphtheria or
tetanus toxoids, poliomyelitis viruses or pertussis (acellular or
whole cell) or to any other component of the vaccine (including
formaldehyde, glutaraldehyde, streptomycin, neomycin,
polymyxin B and bovine serum albumin). Vaccination should
be deferred in the presence of any acute, including febrile,
illness. REPEVAX should not be administered to persons who
experienced an encephalopathy of unknown origin within
7 days of previous immunization with a pertussis-containing
vaccine. As with other vaccines, administration of REPEVAX
should be postponed in persons suffering from an acute severe
febrile illness. The presence of a minor infection (e.g., mild
upper respiratory infection) is not a contraindication. Warnings
and precautions: Repevax should not be used for primary
immunization. Appropriate facilities and medication should be
available in the event of anaphylaxis. A persistent nodule at the
site of injection may occur, particularly if administered into the

subcutaneous tissue. Intramuscular injections should be given


with care in patients at risk of haemorrhage. In these situations
subcutaneous injections may be considered although there is a
risk of increased local reactions. If Guillain-Barr syndrome or
brachial neuritis has occurred following receipt of prior vaccine
containing tetanus toxoid, the decision to give any vaccine
containing tetanus toxoid should be based on careful consideration
of the potential benefits and possible risks. Immunogenicity of
the vaccine may be reduced by immunosuppressive treatment
or immunodeficiency. REPEVAX should not be administered to
persons with a progressive or unstable neurological disorder,
uncontrolled seizures or progressive encephalopathy until a
treatment regimen has been established and the condition
has been stabilized. Intramuscular injections should be given
with care in patients on anticoagulant therapy or suffering from
coagulation disorders because of the risk of haemorrhage. In
these situations and following official recommendations the
administration of REPEVAX by deep subcutaneous injection
may be considered, although there is a risk of increased local
reactions. A persistent nodule at the site of injection may occur

with all adsorbed vaccines, particularly if administered into the


superficial layers of the subcutaneous tissue. Undesirable
effects: Common side effects include: injection site pain,
erythema, pruritis, swelling, bruising and dermatitis, fatigue, fever,
irritability, nausea, diarrhoea, vomiting, rash, headache, asthenia,
chills, myalgia, arthralgia and joint swelling. The following have
also been reported: pain in vaccinated limb, dizziness, malaise,
pallor and injection site induration. Rarely, serious side effects
have been reported including lymphadenopathy, anaphylactic
reactions, extensive limb swelling, convulsions, vasovagal
syncope, facial palsy, myelitis, brachial neuritis and GuillainBarr syndrome. For a complete list of undesirable effects please
refer to the Summary of Product Characteristics. Package
Quantities and basic NHS cost: Single pack containing one
prefilled syringe. Available free to NHS professionals as part of
the UK national childhood immunisation programme. Marketing
authorisation holder: Sanofi Pasteur MSD Ltd., Mallards Reach,
Bridge Avenue, Maidenhead, Berkshire, SL6 1QP, UK. Marketing
authorisation number: PL06745/0121. Legal Category: POM.
Date of last review: 03/2011

when an early protection is considered necessary (e.g., day-care,


outbreak situations, or travel to a region with high prevalence of
measles). Such infants should be revaccinated at 12 to 15 months. A
further dose of a measlescontaining vaccine should be considered
according to official recommendations. The vaccine is to be injected
intramuscularly or subcutaneously. Do not inject intravascularly. The
vaccine should be administered subcutaneously in patients with
thrombocytopenia or any coagulation disorder. Contraindications:
Pregnancy. Furthermore, pregnancy should be avoided for 1 month
following vaccination. Hypersensitivity to any measles, mumps, or
rubella vaccine, or to any of the excipients, including neomycin. Active,
untreated tuberculosis. Blood dyscrasias, leukaemia, lymphomas of
any type, or other malignant neoplasms affecting the haematopoietic
and lymphatic systems. Any current immunosuppressive therapy
(including high doses of corticosteroids). M-M-RVAXPRO is not
contraindicated in individuals who are receiving topical or low dose
parenteral corticosteroids (e.g. for asthma prophylaxis or replacement
therapy). Severe humoral or cellular (primary or acquired)
immunodeficiency, e.g. severe combined immunodeficiency,
agammaglobulinemia and AIDS or symptomatic HIV infection or
an age-specific CD4+ T-lymphocyte percentage in children below
12months: CD4+ <25% ; children between 12-35 months: CD4+
< 20%; children between 36-59 months: CD4+ < 15%. Family
history of congenital or hereditary immunodeficiency unless immune
competence of potential vaccine recipient is demonstrated. Postpone
during any illness with fever >38.5C. Warnings and precautions:
As with all injectable vaccines, appropriate medical treatment

should always be available in case of rare anaphylactic reactions.


Adults and adolescents with a history of allergies may potentially be
at increased risk of anaphylaxis or anaphylactoid reactions. Chick
embryo culture and recombinant human albumin are used during
vaccine manufacture. Caution in those with a history of anaphylactic
or anaphylactoid reaction to eggs or hypersensitivity to recombinant
human albumin. Caution should be exercised in those with an
individual or family history of convulsions or a history of cerebral injury.
Vaccination may be considered in patients with selected immune
deficiencies where the benefits outweigh the risks (asymptomatic HIV
patients, IgG subclass deficiencies, congenital neutropenia, chronic
granulomatous disease, and complement deficiency diseases).
Immunocompromised patients who have no contraindication for
this vaccination may not respond as well as immunocompetent
patients; therefore, some of these patients may acquire measles,
mumps, or rubella in case of contact, despite appropriate
vaccine administration. These patients should be monitored
carefully for signs of measles, parotitis, and rubella. Infants aged
9-12 months may fail to respond due to the presence of circulating
maternal antibodies or for other reasons. Caution in individuals
with a history of thrombocytopenia or any coagulation disorder.
Vaccine should be administered subcutaneously in these individuals.
Excretion of live rubella virus has been demonstrated although
no confirmed evidence of transmission has been documented.
M-M-RVAXPRO should be used with caution when administered to
lactating women. Patients with rare hereditary problems of fructose
intolerance should not take this vaccine as it contains sorbitol.

M-M-RVAXPRO should be given concomitantly at separate injection


sites, or one month before or after administration of other live virus
vaccines. Undesirable effects: Very common side effects include:
fever (38.5C or higher), injection site erythema, injection site pain,
injection site swelling. Common side effects include: injection site
bruising, rash morbilliform or other rash. Other reported side
effects that may potentially be serious include: aseptic meningitis,
thrombocytopenia, anaphylaxis and anaphylactoid reactions,
angioneurotic oedema, bronchial spasm, pneumonia, afebrile
convulsions or seizures, ataxia, encephalitis, encephalopathy,
febrile convulsion (in children), polyneuritis, polyneuropathy,
Guillain-Barr syndrome, measles inclusion body encephalitis,
optic neuritis, retrobulbar neuritis, ocular palsies, retinitis, subacute
sclerosing panencephalitis, epididymitis, orchitis, parotitis, vasculitis,
Stevens-Johnson syndrome, urticaria, nerve deafness, arthritis,
arthralgia and myalgia. For a complete list of undesirable effects
please refer to the Summary of Product Characteristics. Package
quantities and cost: One single dose vial (powder) and one single
dose 0.5 millilitre pre-filled syringe (solvent) with two unattached
needles. Cost: 11.00. Marketing authorisation holder:
Sanofi Pasteur MSD SNC, 8 rue Jonas Salk, F-69007, Lyon,
France. Marketing authorisation number: EU/1/06/337/011
(vial of powder and pre-filled syringe of solvent with two unattached
needles). Legal category: POM. Registered trademark. Date of
last review: October 2013

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard.
Adverse events should also be reported to Sanofi Pasteur MSD. Tel: 01628 785291
Prescribing information can be found on the last four pages

21

ABRIDGED PRESCRIBING INFORMATION

Inactivated Influenza Vaccine (Split Virion) BP


Refer to Summary of Product Characteristics for full product
information.
Presentation: Inactivated Influenza Vaccine (Split Virion) BP
contains 15 micrograms of antigen (per 0.5 millilitre) from each
of the three virus strains recommended by the World Health
Organization for the present influenza season. It is supplied
as single dose prefilled syringes each containing 0.5 millilitre
of suspension for injection. The vaccine may contain traces of
eggs, such as ovalbumin, neomycin, formaldehyde and octoxinol
9 which are used during the manufacturing process. Indications:
Prophylaxis of influenza especially in those who run an increased

ABRIDGED PRESCRIBING INFORMATION

INTANZA 9 microgram/strain suspension for


injection
[Influenza vaccine (split virion, inactivated)]
Refer to Summary of Product Characteristics for full product
information.
Presentation: Intanza 9 microgram contains 9 micrograms of
antigen (per 0.1 millilitre) from each of the three virus strains
recommended by the World Health Organization for the present
influenza season. It is supplied as a 0.1 millilitre suspension in
a pre-filled syringe with a Micro-Injection System, with attached
micro-needle. Indications: Prophylaxis of influenza in adults

ABRIDGED PRESCRIBING INFORMATION

INTANZA 15 microgram/strain suspension for


injection
[Influenza vaccine (split virion, inactivated)]
Refer to Summary of Product Characteristics for full product
information.
Presentation: Intanza 15 microgram contains 15 micrograms
of antigen (per 0.1 millilitre) from each of the three virus strains
recommended by the World Health Organization for the present
influenza season. It is supplied as a 0.1 millilitre suspension in
a pre-filled syringe with a Micro-Injection System, with attached
microneedle. Indications: Prophylaxis of influenza in individuals

reported and include, allergic reactions (in rare cases leading to


shock, angioedema), convulsions, transient thrombocytopenia,
vasculitis with transient renal involvement and neurological
disorders such as encephalomyelitis, neuritis and Guillain-Barr
syndrome. For a complete list of undesirable effects please refer
to the Summary of Product Characteristics. Package quantities
and basic NHS cost: Single dose prefilled syringes in single packs,
basic NHS cost 6.59; packs of 10 single dose prefilled syringes,
basic NHS cost 65.90. Marketing authorisation holder:
Sanofi Pasteur MSD Limited, Mallards Reach, Bridge Avenue,
Maidenhead, Berkshire, SL6 1QP. Marketing authorisation
number: PL 6745/0095. Legal category: POM. Date of last
review: April 2012

risk of associated complications. Inactivated Influenza Vaccine


(Split Virion) BP is indicated in adults and children from 6months
of age. Dosage and administration: Adults and children from
36 months should receive one 0.5 millilitre dose. In children
aged 6 months to 35 months clinical data are limited and
dosages of 0.25 or 0.5 millilitre have been used. Children who
have not been previously vaccinated should receive a second
dose of vaccine after an interval of at least 4 weeks. Doses
should be administered intramuscularly or deep subcutaneously.
Contraindications: Hypersensitivity to the active substances,
to any of the excipients, to eggs, chicken protein, neomycin,
formaldehyde, and octoxinol 9. Immunisation should be
postponed in patients with febrile illness or acute infection.

Warnings and precautions: Do not administer intravascularly.


Medical treatment should be available in the event of rare
anaphylactic reactions following administration of the vaccine.
Immunosuppressed subjects may not produce adequate
antibodies. Other vaccines may be given at the same time at
different sites, however adverse reactions may be intensified.
Pregnancy and lactation: Inactivated influenza vaccines can be
used in all stages of pregnancy. May be administered during
lactation. Undesirable effects: Common side effects include:
injection site reactions (redness, swelling, pain, ecchymosis,
induration) and systemic reactions (fever, malaise, shivering,
fatigue, headache, sweating, myalgia, arthralgia). These usually
disappear within 1 to 2 days. Other serious side effects have been

from 18 to 59 years of age. Dosage and administration: Adults


from 18 to 59 years of age should receive one 0.1 millilitre dose.
Doses should be administered intradermally. The deltoid is the
recommended site of administration. Intanza 9 microgram is
not recommended for use in children and adolescents below
18 years. Contraindications: Hypersensitivity to the active
substances, to any of the excipients, to residues of eggs,
such as ovalbumin, and to chicken protein. The vaccine may
also contain residues of the following substances: neomycin,
formaldehyde and octoxinol. Warnings and precautions: Do
not administer intravascularly. Medical treatment should be
available in the event of rare anaphylactic reactions following
administration of the vaccine. Immunosuppressed subjects

may not produce adequate antibodies. Other vaccines may


be given at the same time at different sites, however adverse
reactions may be intensified. Re-vaccination is not required in
the event that liquid is present at site of injection. Pregnancy
and lactation: Inactivated influenza vaccines can be used
in all stages of pregnancy. The vaccine may be used during
lactation. Undesirable effects: Very common side effects:
headache, myalgia, malaise and injection site reactions
(redness, swelling, pain, induration, pruritus). Common side
effects: fever, shivering, and ecchymosis at the injection site.
Other side effects that may potentially be serious include
allergic reactions (in rare cases leading to shock, angioedema),
febrile convulsions, transient thrombocytopenia, vasculitis with

transient renal involvement and neurological disorders such as


encephalomyelitis, neuritis and Guillain-Barr syndrome. For a
complete list of undesirable effects please refer to the Summary
of Product Characteristics. Package quantities and basic
NHS cost: Single dose pre-filled syringes in single packs,
basic NHS cost 9.05, packs of 10 single dose pre-filled
syringes, basic NHS cost 90.50. Marketing authorisation
holder: Sanofi Pasteur MSD SNC, 8 rue Jonas Salk,
F-69007, Lyon, France. Marketing authorisation number:
EU/1/08/505/001 EU/1/08/505/002. Legal category: POM.

Registered trademark. Date of last review: February 2013

60 years of age and over. Dosage and administration: Adults


of 60 years of age and over should receive one 0.1 millilitre
dose. Doses should be administered intradermally. The deltoid
is the recommended site of administration. Intanza 15 is not
recommended for use in children and adolescents below
18 years. Contraindications: Hypersensitivity to the active
substances, to any of the excipients, to residues of eggs, such as
ovalbumin, and to chicken protein. The vaccine may also contain
residues of the following substances: neomycin, formaldehyde
and octoxinol. Warnings and precautions: Do not administer
intravascularly. Medical treatment should be available in the event
of rare anaphylactic reactions following administration of the

vaccine. Immunosuppressed subjects may not produce adequate


antibodies. Other vaccines may be given at the same time at
different sites, however adverse reactions may be intensified. Revaccination is not required in the event that liquid is present at site
of injection. Pregnancy and lactation: This vaccine is intended
for individuals aged 60 years of age and over. Therefore, this
information is not applicable. Undesirable effects: Very common
side effects: headache, myalgia and injection site reactions
(redness, swelling, pain, induration, pruritus). Common side
effects: fever, malaise, shivering, and ecchymosis at the injection
site. Other side effects that may potentially be serious include
allergic reactions (in rare cases leading to shock, angioedema),

febrile convulsions, transient thrombocytopenia, vasculitis with


transient renal involvement and neurological disorders such as
encephalomyelitis, neuritis and Guillain-Barr syndrome. For a
complete list of undesirable effects please refer to the Summary
of Product Characteristics. Package quantities and basic
NHS cost: Single dose pre-filled syringes in single packs, basic
NHS cost 9.05, packs of 10 single dose pre-filled syringes,
basic NHS cost 90.50. Marketing authorisation holder:
Sanofi Pasteur MSD SNC, 8 rue Jonas Salk, F- 69007, Lyon,
France. Marketing authorisation number: EU/1/08/505/004
EU/1/08/505/005. Legal category: POM. Registered trademark.
Date of last review: February 2013

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard.
Adverse events should also be reported to Sanofi Pasteur MSD. Tel: 01628 785291
22

Prescribing information can be found on the last four pages

ABRIDGED PRESCRIBING INFORMATION

GARDASIL (Human Papillomavirus Vaccine


[Types 6, 11, 16, 18] (Recombinant, adsorbed)).
Refer to Summary of Product Characteristics for full product
information.
Presentation: Gardasil is supplied as a single dose pre-filled
syringe containing 0.5 millilitre of suspension. Each dose of the
quadrivalent vaccine contains highly purified virus-like particles
(VLPs) of the major capsid L1 protein of Human Papillomavirus
(HPV). These are type 6 (20 g), type 11 (40 g), type 16 (40 g)
and type 18 (20 g). Indications: Gardasil is a vaccine for use
from the age of 9 years for the prevention of premalignant genital
lesions (cervical, vulvar and vaginal) and cervical cancer causally
related to certain oncogenic Human Papillomavirus (HPV) types and
genital warts (condyloma acuminata) causally related to specific
HPV types. The indication is based on the demonstration of efficacy
of Gardasil in females 16 to 45 years of age and in males 16 to
26 years of age and on the demonstration of immunogenicity of

ABRIDGED PRESCRIBING INFORMATION

REVAXIS
Diphtheria, tetanus and poliomyelitis (inactivated)
vaccine (adsorbed, reduced antigen(s) content)
Refer to Summary of Product Characteristics for full product
information.
Presentation: 0.5 millilitre single dose of vaccine supplied in a
prefilled syringe. Each dose of vaccine contains 2 IU of purified
diphtheria toxoid, 20 IU of purified tetanus toxoid, 40D antigen
units of inactivated type 1 polio virus, 8D antigen units of
inactivated type 2 polio virus, 32D antigen units of inactivated

Gardasil in 9 to 15 years old children and adolescents. The use of


Gardasil should be in accordance with official recommendations.
Dosage and administration: The primary vaccination series
consists of 3 separate 0.5 millilitre doses administered according
to the following schedule: 0, 2, 6 months. If an alternate schedule
is necessary the second dose should be administered at least one
month after the first dose and the third dose at least three months
after the second dose. All three doses should be given within a
1 year period. The need for a booster dose has not been
established. The vaccine should be administered by intramuscular
injection. Gardasil must not be injected intravascularly. Neither
subcutaneous nor intradermal administration has been studied.
These methods of administration are not recommended.
Contraindications: Hypersensitivity to any component of the
vaccine. Hypersensitivity after previous administration of Gardasil.
Acute severe febrile illness. Warnings and precautions: The
decision to vaccinate an individual should take into account the risk
for previous HPV exposure and potential benefit from vaccination.
As with all vaccines, appropriate medical treatment should always

be available in case of rare anaphylactic reactions. The vaccine


should be given with caution to individuals with thrombocytopaenia
or any coagulation disorder because bleeding may occur following
an intramuscular administration in these individuals. Syncope,
sometimes associated with falling, can occur before or after
vaccination with Gardasil as a psychogenic response to the
needle injection. Vaccinees should be observed for approximately
15 minutes after vaccination; procedures should be in place to
avoid injury from faints. There is insufficient data to recommend
use of Gardasil during pregnancy therefore the vaccination should
be postponed until after completion of the pregnancy. The vaccine
can be given to breastfeeding women. Gardasil will only protect
against diseases that are caused by HPV types 6, 11, 16 and 18
and to some limited extent against diseases caused by certain
related HPV types. Vaccination is not a substitute for routine cervical
screening. Individuals with impaired immune responsiveness, due
to either the use of potent immunosuppressive therapy, a genetic
defect, or other causes, may not respond to the vaccine. As with
any vaccine, vaccination with Gardasil may not result in protection

in all vaccine recipients. There are no safety, immunogenicity or


efficacy data to support interchangeability of Gardasil with other
HPV vaccines. Undesirable effects: Very common side effects
include: headache and at the injection site, erythema, pain and
swelling. Common side effects include hematoma and pruritus
at the injection site, pyrexia, nausea, and pain in the extremity.
Rarely urticaria and very rarely bronchospasm has been
reported. Idiopathic thrombocytopenic purpura, Guillain-Barr
Syndrome and hypersensitivity reactions including, anaphylactic/
anaphylactoid reactions have also been reported. For a complete
list of undesirable effects please refer to the Summary of Product
Characteristics. Package quantities and basic NHS cost: Single
pack containing one 0.5 millilitre dose pre-filled syringe with
two separate needles. NHS cost: 86.50 per dose. Marketing
authorisation holder: Sanofi Pasteur MSD SNC, 8 rue Jonas
Salk, F-69007, Lyon, France. Marketing authorisation number:
EU/1/06/357/007 (pre-filled syringe with two separate needles)
Legal category: POM. Registered trademark. Date of last
review: May 2013

type 3 polio virus and 0.35 mg of aluminium hydroxide


as adsorbent. Indications: Active immunisation against
diphtheria, tetanus and poliomyelitis in adults, adolescents
and children from six years of age, as a booster following
primary vaccination. Dosage and administration: Adults and
children from six years of age should receive one 0.5 mL dose,
according to official recommendations. The vaccine should be
administered by the intramuscular route. Contraindications:
Hypersensitivity to any component of the vaccine (including
neomycin, streptomycin and polymyxin B). Acute severe
febrile illness. Neurological complications following previous
immunisation against diphtheria and/or tetanus. Warnings

and precautions: Appropriate facilities and medication should


be available in the event of anaphylaxis. Immunogenicity of the
vaccine may be reduced by immunosuppressive treatment or
immunodeficiency. Intramuscular injections should be given
with care in patients at risk of haemorrhage. Do not administer
to subjects who completed a primary vaccination course
or received a booster of a vaccine containing diphtheria or
tetanus toxoids within the previous five years. Pregnancy and
lactation: REVAXIS should not be administered to pregnant
women unless it is considered urgent to boost immunity, but
it may be administered to breastfeeding women. Undesirable
effects: Common side effects include: pain, erythema,

induration, oedema and nodule at the injection site, vertigo,


nausea, vomiting, pyrexia and headache. Very rarely, serious
side effects have been reported and include systemic allergic
or anaphylactic reactions. For a complete list of undesirable
effects please refer to the Summary of Product Characteristics.
Package quantities and basic NHS cost: Single pack
containing one prefilled syringe, basic NHS cost 6.50 per
dose. Marketing authorisation holder: Sanofi Pasteur MSD,
Mallards Reach, Bridge Avenue, Maidenhead, Berkshire, SL6
1QP. Marketing authorisation number: PL 06745/0123.
Legal category: POM. Date of last review: November 2010.

Registered Trademark

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard.
Adverse events should also be reported to Sanofi Pasteur MSD. Tel: 01628 785291

UK17010a 12/13

23

Prescribing information can be found on the last four pages

23

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