Bisleri Injection

Bisleri -S 100mg/5ml Injection

(Iron Sucrose Complex)

For IV use only
DESCRIPTION:

BISLERI -S (Iron Sucrose complex Injection) is an aqueous complex of Iron (III) hydroxide with
sucrose Bisleri -S is a dark brown, non transparent aqueous solution

CHEMICAL STRUCTURE:
Bisleri -S structural formula is:
[Na2Fe5O8(OH).3(H2O)]n).m(c12H22O11)
Where: n is the degree of Iron polymerization and m is the number of sucrose molecules
associated with the Iron(III)-hydroxide

COMPOSITION:
Each 5ml contains:
Iron Sucrose Complex MS
equivalent to elemental Iron 100mg i.e. each ml contains 20mg elemental iron as iron sucrose

CLINICAL PHARMACOLOGY:
In healthy adults treated with intravenous doses of Bisleri -S Injection (Iron Sucrose Complex),
its iron component exhibited first-order kinetics:
Elimination half life T1/2
6 hours
Total clearance
1.2 Liters per hour
Non-Steady-State apparent volume of distribution
10.0 Liters
Steady-state apparent volume of distribution
7.9 Liters
Since iron disappearance from the serum depends on the need for iron in the iron stores and
iron utilizing tissues of the body, serum clearance of iron is expected to be more rapid in irondeficient patients treated with Bisleri -S Injection (Iron Sucrose Complex) as compared with
healthy individuals

Distribution:
In healthy adults, the iron component of Iron Sucrose Complex appears to distribute mainly in
the blood and to some extent in extravascular fluid

Metabolism:
Iron sucrose is dissociated into iron and sucrose by the reticuloendothelial system

Elimination:
The sucrose component is eliminated mainly by urinary excretion. Some iron is also eliminated
in the urine (approximately 5%)

INDICATIONS:
Iron deficiency anemia in patients on chronic hemodialysis and who have received
supplemental erythropoietin therapy
Iron deficiency because of other reasons e.g. before and after surgery, final stages of
pregnancy. Intolerance, non-responsiveness or non-compliance to oral iron therapy
malabsorption etc.

CONTRA-INDICATIONS:
The use of Bisleri -S is contra-indicated in cases of:
Anemias not attributable to iron deficiency
Iron overload or disturbances in utilization of iron
A history of hypersensitivity to parenteral iron preparations
Patients with a history of asthma, eczema or other atopic allergy, because they are more
susceptible to experience allergic reactions
History of cirrhosis or hepatitis or the presence of serum transaminases greater than three
times the upper limit of normal values
First trimester of pregnancy
INTERACTION WITH OTHER MEDICATION:
As with all parenteral iron preparation, Iron sucrose should not be administered concomitantly
with oral iron preparations since the absorption of oral iron is reduced. Therefore an oral iron
therapy should at least be started 5 days after the last injection
PRECAUTIONS:
Pregnancy Category B:
Reproductive toxicity studies in animals have shown that Iron sucrose is not teratogenic or
empryocidal in non-anemic pregnant animals. However the use of parenteral iron preparations
during the first three months has to be discouraged. During the second and third term the
application has to be done with caution
Nursing Mothers:
Iron Sucrose Complex is excreted in milk of rats. It is not known whether this drug is excreted
in human milk. Because many drugs are excreted in human milk; caution should be exercised
when Iron Sucrose Complex is administered to a nursing woman.
Paediatric Use:
Safety and effectiveness of Iron Sucrose Complex in paediatric patients have not been established

Bisleri Injection
DOSAGE AND ADMINISTRATION
Normal dosage:
Adults and Elderly:
5 - 10ml (100 to 200 mg Iron) once to three times a week depending on the hemoglobin level
Children:
There is limited data on children under study conditions. If there is a clinical need, it is
recommended not to exceed 0.15ml (=3mg Iron/kg body weight) once to three times a week
depending on the hemoglobin level
Maximum tolerated single dose:
Adults and Elderly:
As Injection: 10ml (200mg Iron) Injection in at least 10 minutes
As Infusion: When the clinical situation demanded, doses up to 500 mg have been administered.
The maximum tolerated single dose is 7mg Iron per kg body weight given once per week but
not exceeding 500mg Iron
ADMINISTRATION:
Bisleri -S is exclusively to be administered intravenously by drip infusion
Before administration a test dose should be administered. If any allergic reaction or intolerance
occurs during administration, therapy must be stopped immediately
Bisleri -S may preferably be administered by drip infusion (in order to reduce the risk of
hypotensive episodes). 1ml (20mg iron) has to be diluted exclusively in max. 20ml of 0.9% w/v
NaCI solution, immediately prior to infusion (i.e. 5ml in max 100ml 0.9% w/v NaCI up to 25
ml in max. 500ml 0.9% w/v NaCI). The solution should be infused at a rate of:
100ml in at least 15min
200ml in at least 30min
300ml in at least 1.5h
400ml in at least 2.5h
500ml in at least 3.5h
SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE:
Iron sucrose should only be administered where the indication is confirmed by appropriate
investigations (e.g serum ferritin, or hemoglobin (Hb), or hematocrit, or erythrocyte count, or
red cell indices-MCV, MCH, and MCHC)
Parenterally administered iron preparations can cause allergic or anaphylactoid reactions. In the
case of a mild allergic reaction, antihistamines should be administered; in the case of a serious
anaphylactoid reaction adrenaline should be administered immediately. Patients with bronchial
asthma, with low iron binding capacity and / or folic acid deficiency are particularly at risk of
an allergic or anaphylactoid reaction. Iron sucrose must be used with care in patients with serious
hepatic dysfunction. Hypotensive episodes may occur if injection is administered too rapidly
INCOMPATIBILITIES:
Bisleri -S must only be mixed with 0.9% w/v NaCI solution. No other introavenous dilution
solutions and therapeutic agent should be used as there is a potential for precipitation and/or
interaction. The compatibility with containers other than glass, polyethylene and PVC is not
known

STABILITY: See expiry on the pack

PRESENTATION:
Pack of 5 x 5ml ampoules
INSTRUCTIONS:
Keep out of reach of children
Avoid exposure to heat and light
Store at 25oC or below
Improper storage may deteriorate the medicine
CAUTIONS:
Avoid freezing and Injection should not be used if container is leaking, solution is cloudy
or it contains un-dissolved particles

Manufactured by:
SAMI PHARMACEUTICALS (PVT) LTD.
F-95, S.I.T.E., Karachi-Pakistan

BISLERIChewable Tablets/Capsules BISLERISyrup

Iron (III) Hydroxide

Polymaltose
Complex + Folic Acid

Iron (III) Hydroxide

Polymaltose Complex

CONTRA-INDICATIONS:
- Overloading of iron (haemochromatosis, chronic haemolysis)
- Disturbances in iron utilisation (lead anemia, sidero-achrestic anemia), thalassemia
- Megaloblastic anemia due to Vitamin B-12 deficiency

PRECAUTIONS:

DESCRIPTION:

Bisleri is a novel iron preparation used in the treatment of iron deficiency anemia. Iron, an
essential constituent of the body, is necessary for haemoglobin formation and for the oxidative
process of living tissue
Bisleri (Iron (III) Hydroxide Polymaltose Complex) is a low molecular weight carbohydrate
polymer (Polymaltose). This prevents the iron from causing any harm in the gastrointestinal
system. This protection inhibits interactions of the iron with food. Moreover, it ensures the
bioavailablity of the iron

As with all oral iron preparations, a dark colouration of the stool may occur which is without
clinical significance

COMPOSITION:

INTERACTIONS:

Bisleri Chewable Tablets:

Each tablet contains: 100mg of iron as Ferric hydroxide-polymaltose plus 350mcg of folic acid
Bisleri Capsules:
Each capsule contains: 100mg of iron as Ferric hydroxide-polymaltose plus 350mcg of folic acid
Bisleri Syrup:
Each 5ml contains: 50mg of iron as Ferric hydroxide-polymaltose

PROPERTIES AND ACTIONS:

Iron Polymaltose, the active iron ingredient of Bisleri essentially non-ionic, therefore, it has the
following properties unlike ionized iron salt preparations:
- It does not cause irritation of the intestinal mucosa
- It has palatable, non metallic taste (vanilla and toffee flavor)
- It has excellent tolerance

Bisleri can be taken with meals as appropriate to the patient, with any beverage or medicaments
Bisleri Chewable Tablets and Capsules:
Bisleri chewable tablets/capsules a novel preparation for the treatment of iron and folic acid
deficiencies of all origins during pregnancy and lactation period. The folic acid content corresponds
to the recommendation of the WHO
Bisleri Syrup:
Bisleri syrup is pleasant tasted preparation tailored particularly for infants, children and elderly
to cover the required demand of iron especially during pregnancy and lactation adolescents and
woman capable of bearing children and adults

INDICATIONS:

Bisleri Chewable Tablets and Capsules:

Prevention and treatment of iron and folic acid deficiencies of all origins during pregnancy and
lactation period

UNDESIRABLE EFFECTS:
Occasionally GI irritation, pressure in the epigastric region, nausea, constipation or diarrhoea may
occur. Allergic reactions have been reported rarely with folic acid

Since, the iron is complex bound, ionic interactions with foodstuff components (phytins, oxalates,
tannin, etc.) and concomitantly administered medicaments (tetracycline, antacids) are unlikely to
occur

PRESENTATIONS:
Bisleri Chewable Tablets:
Iron (111) Hydroxide Polymaltose Complex + Folic Acid in pack of 10s
Bisleri Capsules:
Iron (111) Hydroxide Polymaltose Complex + Folic Acid in pack of 10s
Bisleri Syrup:
Iron (111) Hydroxide Polymaltose Complex in 60ml & 120ml bottle

STABILITY:
See expiry on the pack

INSTRUCTIONS:
Keep out of reach of children
Avoid exposure to heat, light and humidity
Store at 25C or below
Improper storage may deteriorate the medicine

Bisleri Syrup:
For infants, children and adults specifically women of child bearing age facing deficiency of iron
DOSAGE AND ADMINISTRATION:
Dosage and duration of therapy are dependent upon the extent of iron deficiency
Bisleri Chewable Tablets and Capsules:
One chewable tablet or capsule 2 or 3 times daily until a normalisation of haemoglobin value is
achieved. Afterwards the therapy should be continued with one chewable tablet or capsule daily
for a further month after normalisation of the blood values
Bisleri chewable tablets or capsules should be chewed or swallowed during or immediately after
meal
Bisleri Syrup:
Dosage and duration of therapy are dependant upon the extent of iron deficiency and should be
taken as directed by the physician

Age Group
Infant (upto 1 year)

Manifest Iron
Deficiency

Latent Iron
Deficiency

Prophylactic
Therapy

2.5 5ml daily

Children (upto 1 -12) 5 10ml daily

2.5 5ml daily

Children (> 12 yrs)

Adults & nursing women

10 30ml daily 5 10ml daily

Pregnant Women

20 30ml daily

10ml daily

Manufactured by:

SAMI PHARMACEUTICALS (PVT) LTD.

F-95, S.I.T.E., Karachi-Pakistan

5 10ml daily

08 May 2008 EM 5908 Beupron

08 May 2008 EM 5908 Beupron