Stamaril

Stamaril

vaccine, yellow fever

Manufacturer:

Sanofi Pasteur
Full Prescribing Info
Contents
Attenuated yellow fever virus (17D/AB 237 strain).
Description
Freeze-dried white odourless reconstituting with diluent.
Attenuated yellow fever virus, 17D/AB 237 strain, cultured on chicken embryos  ≥1,000 U*.
Excipients/Inactive Ingredients: Powder: stabilizer medium containing lactose, sorbitol, L-histidine hydrochloride, L-alanine and buffer saline solution and 4% sodium chloride solution for the diluent.
*These units correspond to the LD50 for mice.
Action
Drug mechanism of action: This medicine is live attenuated, stabilized vaccine intended for the prevention of yellow fever, immunity appears 7 to 10 days after the injection.
Indications/Uses
STAMARIL PASTEUR is a powder with diluent for single-dose suspension for injection (0.5 mL).
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 at risk of exposure to infection.
Dosage/Direction for Use
This vaccine against yellow fever comprises a single injection of 0.5 ml reconstituted vaccine.
Become for children ages ≥ 9 months and adults. Vaccination was injected single dose 0.5 ml of reconstitu­tion vaccine as subcutaneous or intramuscular.
Vaccination certificates are valid for period of 10 years commencing 10 days after initial vaccination or revaccination.
Method and route(s) of administration: Subcutaneous or intramuscular route.
Reconstitute the suspension by injecting the 0.5 ml solvent in pre-filled syringe into the vial of powder. Agitate until the powder has completely dissolved. Withdraw the solution obtained into the solvent syringe. The vaccine must be administered immediately after reconstitution.
Contraindications
Do not use STAMARIL PASTEUR, in the event of: True allergy to one of the vaccine components, and notably egg albumin; Congenital or acquired immunodeficiency except HIV infections (see Precautions); Active malignant disorders; Infants below the age of 9 months; Combination with cytotoxic agents (medicines used during chemotherapy); Some serious disease.
Special Precautions
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.
It is preferable to delay vaccination in the event of fever, acute disease or active chronic disease.
Inform the doctor in the event of: Illness with or without fever; Any ongoing treatment affecting organism defenses; 65 years old & above (increase of the frequency of serious undesirable effects lasting more than 48 hours); HIV-seropositive; Suffer from allergy.
Use In Pregnancy & Lactation
Pregnancy: There is generally no indication for vaccinating women during pregnancy; nevertheless, vaccination administered to a woman who is unaware of being pregnant does not justify the recommendation of a therapeutic abortion. Consult the doctor if the patient is discovered pregnant.
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.
Adverse Reactions
As with all medicinal products, STAMARIL PASTEUR, may cause undesirable effects.
A reaction may occur after between 4 and 7 days, taking the form of stiffness with fever, fatigue and headache. In such cases, simple symptomatic treatment is recommended.
Neurological disorders such as meningitis, enchepalitis and meningoencephalitis have been described in exceptional cases, without it being possible to formally ascribe these symptoms to the vaccine.
Very rare cases of local reactions at the injection site have been reported;
Anaphylactic reactions have been exceptionally reported;
One case of fatal multivisceral deficiency has been reported after a vaccination with yellow fever vaccine prepared from 17D strain. The first symptoms occurred a few days after vaccination.
The physiopathological mechanism of such a reaction has not been determined.
Drug Interactions
Contraindicated combinations: Cytotoxic agents: risk of systemic vaccinal disease, with a fatal outcome.
Combinations to be taken into account: other immunosuppressants: cyclosporin, tacrolimus, globulins, antilymphocyte agents, glucocortico­steroids, except for hydrocortisone employed as replacement therapy in Addison's disease (systemic and topical routes: intra-articular, cutaneous and enema), tetracosactide.
Risk of systemic, potentially fatal disease. This risk is enhanced in subjects who are already suffering from immunodepression because of their underlying disease.
This vaccine may be administered at the same time with measles vaccine.
Please inform the physician or pharmacist of any ongoing treatment, or if any other medicinal products, even if non-prescription, have been taken recently.
Caution For Usage
Do not use STAMARIL PASTEUR if you notice cloudy solution or deposit.
Storage
Keep out of the reach and sight of children.
The product should be stored at +2°C to +8°C. Do not freeze.
Do not use after the expiry date indicated on the label or the package.
ATC Classification
J07BL01 - yellow fever, live attenuated ; Belongs to the class of yellow fever viral vaccines.
Presentation/Packing
Powd for inj (vial) ≥1,000 U/0.5 mL + 0.5 mL pre-filled syringe (diluent) x 1's.
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