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סטמריל STAMARIL (YELLOW FEVER VIRUS STRAIN 17D204 (SUBSTRAIN AB237))

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צורת מתן:

תוך-שרירי, תת-עורי : I.M, S.C

צורת מינון:

אבקה וממס להכנת תרחיף להזרקה : POWDER AND SOLVENT FOR SUSPENSION FOR INJECTION

Posology : מינונים

4.2     Posology and method of administration

Posology
• Primary vaccination
The vaccine should be given at least 10 days before entering an endemic area since protective immunity may not be achieved until at least this time has elapsed.
Adults: a single dose of 0.5 mL of the reconstituted vaccine.
Older people
The dose is the same as for adults. However due to a potentially higher risk of yellow fever vaccine- associated severe and potentially fatal disease in persons from 60 years of age, the vaccine should only be given when it is considered that there is a significant and unavoidable risk of acquiring yellow fever infection such as travel to an area where there is current or periodic risk of yellow fever transmission (see Sections 4.4 and 4.8).
Paediatric population
- Children aged 9 months and older: a single dose of 0.5 mL of the reconstituted vaccine.
- Children from 6 to 9 months of age: Vaccination against yellow fever is not recommended in children aged from 6 months up to 9 months except in specific circumstances and in accordance with available official recommendations (see Section 4.4), in which case the dose is the same as in children aged 9 months and older.
- Children under 6 months of age: STAMARIL is contraindicated in children less than 6 months of age (see Section 4.3).
• Re-vaccination
The duration of protection following administration of one single 0.5 mL dose of STAMARIL is expected to be at least 10 years and may be life-long.
Re-vaccination with one dose of 0.5 ml.
Re-vaccination may be required, depending on official recommendations of local Health Authorities, as a condition of entry in some countries.

Method of administration
It is preferable that the vaccine is injected by the subcutaneous route.
Intramuscular injection may be performed if this is in accordance with applicable official recommendations.
For intramuscular use, the recommended injection sites are the anterolateral aspect of the thigh in children less than 12 months of age, the anterolateral aspect of the thigh (or the deltoid muscle if muscle mass is adequate) in children 12 months through 35 months of age or the deltoid muscle in children from 36 months of age onwards and adults.
DO NOT INJECT INTRAVASCULARLY.
Precautions to be taken before handling or administering the medicinal product For instructions on reconstitution of the medicinal product before administration, see Section 6.6.


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בעל רישום

SANOFI ISRAEL LTD

רישום

133 30 30951 00

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0 ₪

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