DEPAN BELAKANG

STAMARIL PASTEUR It is preferable to delay vaccination in the event of fever, acute disease or active chronic disease.

Pregnancy
ATTENUATED YELLOW FEVER VACCINE There is generally no indication for vaccinating women during pregnancy; nevertheless, vaccination
administered to a women who is unaware of being pregnant does not justify the recommendation of a
therapeutic abortion. If you discover that your are pregnant, consult your doctor.

Lactation
Yellow fever vaccination can be carried out during the breast-feeding period if a stay or travel to
endemic area can not be postponed.

Use with other medicinal products

Please read these instructions carefully before using this medicine. Contraindicated combinations:
Keep this insert, you may need to refer to read it again. + Cytotoxic agents: risk of systemic vaccinal disease, with a fatal outcome.
If you need further information and advice, contact your doctor or
pharmacist Combinations to be taken into account:
+ other immunosuppressants: cyclosporin, tacrolimus, globulins, antilymphocyte agents, glucocortico-
Dosage form: Powder for injection steroids, except for hydrocortisone employed as replacement therapy in Addison’s disease (systemic and
Description: freeze-dried white odourless reconstituting with diluent. topical routes: intra-articular, cutaneous and enema), tetracosactide.
COMPOSITION Risk of systemic, potentially fatal disease. This risk is enhanced in subjects who are already suffering from
Composition for 1 dose of 0.5 ml: immunodepression because of their underlying disease.
• The active ingredients is: This vaccine may be administered at the same time with measles vaccine.
-attenuated yellow fever virus, 17 D/AB 237 strain, cultured on chick embryos..........................≥ 1000 U* Please inform your physician or pharmacist of any ongoing treatment, or if any other medicinal products,
• The other components for the powder are stabilizer medium containing lactose, sorbitol, L-histidine even if non-prescription, have been taken recently.
hydrochloride, L-alanine and buffer saline solution and 4% sodium chloride solution for the diluent.
* These units correspond to the LD50 for mice. 3. HOW TO USE STAMARIL PASTEUR?
Posology
MARKETING AUTHORIZATION HOLDER AND MANUFACTURER This vaccine against yellow fever comprises a single injection of 0.5 ml reconstituted vaccine.
Sanofi Pasteur SA, 2, avenue du Pont Pasteur, 69007 Lyon -France Become for children ages ≥9 months and adults. Vaccination was injected single dose 0.5 mL of reconstitu-
tion vaccine as subcutaneous or intramuscular.
1. WHAT IS STAMARIL PASTEUR, AND WHEN SHOULD IT BE USED? Vaccination certificates are valid for period of 10 years commencing 10 days after initial vaccination or
STAMARIL PASTEUR is a powder with diluent for single-dose suspension for injection (0.5 mL). revaccination.
This medicine is indicated in the prevention of yellow fever for travelers to endemic area. Yellow fever
vaccination should not be prescribed for individuals who are not risk of exposure to infection. Method and route(s) of administration
Subcutaneous or intramuscular route.
2. INFORMATION YOU SHOULD HAVE BEFORE USING STAMARIL PASTEUR Reconstitute the suspension by injecting the 0.5 ml solvent in pre-filled syringe into the vial of powder.
Drug mechanism of action: Agitate until the powder has completely dissolved. Withdraw the solution obtained into the solvent syringe.
This medicine is live attenuated, stabilized vaccine intended for the prevention of yellow fever, immunity The vaccine must be administered immediately after reconstitution.
appears 7 to 10 days after the injection.
4. POSSIBLE UNDESIRABLE EFFECTS
Do not use STAMARIL PASTEUR, in the event of: As with all medicinal products, STAMARIL PASTEUR, may cause undesirable effects.
- True allergy to one of the vaccine components, and notably egg albumin, A reaction may occur after between 4 and 7 days, taking the form of stiffness with fever, fatigue and
- Congenital or acquired immunodeficiency except HIV infections (see Warnings and Special precautions for headache. In such cases, simple symptomatic treatment is recommended.
use), Neurological disorders such as meningitis, enchepalitis and meningoencephalitis have been described in
- Active malignant disorders, exceptional cases, without it being possible to formally ascribe these symptoms to the vaccine.
- Infants below the age of 9 months, - Very rare cases of local reactions at the injection site have been reported;
- Combination with cytotoxic agents (medicines used during chemotherapy), - Anaphylactic reactions have been exceptionally reported;
- Same serious disease. - One case of fatal multivisceral deficiency has been reported after a vaccination with yellow fever vaccine
prepared from 17D strain. The first sysmtoms occurred a few days after vaccination.
Special precautions for use The physiopathological mechanism of such a reaction has not been determined.
Inform your doctor in the event of:
- Illness with or without fever, 5. HOW TO STORE STAMARIL PASTEUR?
- Any ongoing treatment affecting your organism defences, Storage conditions and shelf life
- 65 years old above (increase of the frequency of serious undesirable effects lasting more than 48 hours) Keep out of the reach and sight of children.
- HIV-seropositive, The product should be stored at +2°C to +8°C. Do not freeze.
- Suffer from allergy. Do not use after the expiry date indicated on the label or the package.

Warnings Warnings in the event of visible signs of deterioration, if necessary

STAMARIL PASTEUR should not be administered by the intravascular route: ensure that the needle does not
enter any blood vessel.
In the case of HIV-positive patients who are symptomatic, in whom CD4 levels are below 200/mm3 or those
with a high viral load, it is preferable to avoid vaccination against yellow fever.
Vaccination may be undertaken in other HIV-positive patients.
In certain particular cases, vaccination against yellow fever may be planned in patients who have received
immunosuppressant therapy; it is wise to delay vaccination for a month after treatment discontinuation,
when the return to normal in all cases of all laboratory parameters has been verified.
A tolerability test is indicated in allergic subjects: if intradermal injection of 0.1 ml vaccine is not followed
within 10 to 15 minutes by any reaction, the remaining 0.4 ml may be injected via the subcutaneous route.
Do not use STAMARIL PASTEUR if you notice cloudy solution or deposit.
Presentation
1 box, 1 vial of lyophilized + 1 pre-filled syringe 0.5 ml of diluent; Reg. No. DKI1059702744A1
1 box, 10 vials of lyophilized + 10 pre-filled syringe 0.5 ml of diluent; Reg. No. DKI1059702744A1
Imported by: PT Aventis Pharma, Jakarta, Indonesia
Manufactured by: Sanofi Pasteur SA, 2 avenue du Pont Pasteur, 69007, Lyon -France
Harus dengan resep dokter

SP/533315/A-1084 ---.---.---

SAP / ID. number : PI STAMARIL / 533315

Version number : 5A
Country : Indonesia
Date : 08.09.2014
Dimensions : 115 x 220 mm
Film code : SP/533315/A-1084
Min. point size of text : 7 pt
Colour : PMS Pantone Black CVC
Type of Fonts : Myriad Pro
Material : HVS Paper 60 g/m²
Type of Prefolded : 4x Horizontal
Dimensions after folded : 115 mm X 28 mm
Pharmacode : 33151
Position of Pharmacode : 38-38.5mm, 39.5-40mm, 41-41.5mm, 42.5-43mm, 44-44.5mm,
45.5-46mm, 47-47.5mm, 48.5-50mm, 51-52.5mm, 53.5-54mm,
55-55.5mm, 56.5-57mm, 58-58.5mm, 59.5-60mm, 60.5-61mm,
61-61.5mm
Position of Visual Codes : 18-19mm, 22-23mm
Prepared by : Rahmat Hafid