Stamaril

Stamaril

vaccine, yellow fever

Manufacturer:

Kalventis Sinergi Farma
Concise Prescribing Info
Contents
Live, attenuated yellow fever virus (produced in specified pathogen-free chick embryos) 17D-204 strain
Indications/Uses
Prevention of yellow fever for travelers to endemic areas.
Dosage/Direction for Use
Primary vaccination Adult & childn ≥9 mth 0.5 mL as a single SC dose at least 10 days before entering an endemic area. Re-vaccination May be needed in patients who had an insufficient immune response after their primary vaccination. Duration: At least 10 yr & may be life-long. May administer IM inj if in accordance w/ applicable official recommendations.
Contraindications
Hypersensitivity to eggs, & chicken proteins. Serious hypersensitivity reactions (eg, anaphylaxis) after a previous dose of any yellow fever vaccine. Immunosuppression whether congenital, idiopathic or acquired, or as a result of treatment w/ high-dose systemic steroids, RT or cytotoxic drugs. History of thymus dysfunction (including myasthenia gravis, thymoma, thymectomy). Symptomatic or asymptomatic HIV infection w/ evidence of impaired immune function. Moderate or severe febrile or acute illness. Infant <9 mth.
Special Precautions
Not to be inj intravascularly. Do not give IM in patients w/ bleeding disorder eg, haemophilia or thrombocytopenia, or those on anticoagulant therapy. Syncope. Yellow fever vaccine-associated neurotropic/viscerotropic disease. Thymectomy or history of thymus dysfunction. Do not administer to immunosuppressed patients; symptomatic or asymptomatic HIV infection w/ evidence of impaired immune function. Delay vaccination until at least 1 mth after completing the course in patients who received systemic corticosteroids for ≥14 days. May not protect 100% of vaccinated individuals. Contains sorbitol (E420) 1 mg/dose. Avoid pregnancy a mth after vaccination. Discontinue breast-feeding for atleast 2 wk after vaccination. Childn born to HIV +ve mothers. Elderly ≥60 yr.
Adverse Reactions
Loss of appetite; drowsiness, cephalalgia; vomiting; myalgia; irritability, crying, fever, asthenia, inj site pain/tenderness. Nausea; rash; arthralgia; inj site erythema/redness, haematoma, induration, oedema/swelling.
Drug Interactions
Do not mix w/ other vaccine or medicinal product in the same syringe. Immunodepression w/ immunosuppressants eg, high-dose systemic steroids, biological products w/ known immunosuppressive properties, RT, cytotoxic drugs. Can induce false +ve results w/ lab &/or diagnostic tests for other flavivirus related diseases eg, dengue or Japanese encephalitis.
MIMS Class
Vaccines, Antisera & Immunologicals
ATC Classification
J07BL01 - yellow fever, live attenuated ; Belongs to the class of yellow fever viral vaccines.
Presentation/Packing
Form
Stamaril vaccine (inj) ≥1000 U/dose
Packing/Price
(vial + 0.5 mL pre-filled syringe (diluent)) 1's (Rp433,230/boks)
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