STAMARIL VACCINE

INJECTION

**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. _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 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_), 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). _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 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). 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. In accordance with WHO advice and International Health Regulations, the validity of a certificate of vaccination against yellow fever shall extend for the life of the person vaccinated. However, re-vaccination with one dose of 0.5 mL may be needed in individuals who had an insufficient immune response after their primary vaccination if they continue to be at risk for yellow fever virus infection. Re-vaccination may also be required, depending on official recommendations of local Health Authorities. **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 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_.