Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2020 Publisher: Sanofi Pasteur Europe, 14 Espace Henry Vallée, 69007 Lyon, FRANCE Distributed in the UK by: Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK
STAMARIL is indicated for active immunization against yellow fever in persons:
See Sections 4.2, 4.3 and 4.4 regarding the minimum age for vaccination of children under special circumstances and guidance for vaccination of other specific patient populations.
For updated yellow fever vaccination requirements and recommendations consult the WHO dedicated website or refer to resources provided by national health authorities.
In order to comply with vaccine regulations and to be officially recognized, yellow fever vaccines must be administered in an approved World Health Organization (WHO) vaccination centre by a qualified and trained health care professional and registered on an International Certificate of Vaccination. The validity period of this Certificate is established according to International Health Regulations (IHR) recommendations, and starts 10 days after primary vaccination and immediately after re-vaccination (see Section 4.2).
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.
A single dose of 0.5 mL of the reconstituted vaccine.
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).
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).
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.
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.
For instructions on reconstitution of the medicinal product before administration, see Section 6.6.
Cases of administration of more than the recommended dose (overdose) have been reported with STAMARIL. When adverse reactions were reported, the information was consistent with the known safety profile of STAMARIL described in Section 4.8.
3 years.
After reconstitution, the medicinal product must be used immediately.
Store in a refrigerator (2°C–8°C). Do not freeze. Keep the vial of powder and the syringe of solvent in the outer carton in order to protect from light.
For storage conditions after reconstitution of the medicinal product, see Section 6.3.
Powder in vial (type I glass), with a stopper (chlorobutyl) and a flip-off cap (aluminium) + 0.5 mL of solvent in a pre-filled syringe (type I glass), with a plunger-stopper (halobutyl), and an attached needle and needle-shield (natural rubber or polyisoprene) – pack size of 1, 10 or 20.
Powder in vial (type I glass), with a stopper (chlorobutyl) and a flip-off cap (aluminium) + 0.5 mL of solvent in a pre-filled syringe (type I glass), with a plunger-stopper (halobutyl), and a tip-cap (styrene – butadiene) – pack size of 1 or 10. The tip caps of the prefilled syringes contain a natural rubber latex derivative.
Powder in vial (type I glass), with a stopper (chlorobutyl) and a flip-off cap (aluminium) + 0.5 mL of solvent in a pre-filled syringe (type I glass), with a plunger-stopper (halobutyl) and a tip cap (styrene – butadiene) with 1 or 2 separate needles attached in the blister – pack size of 1 or 10. The tip caps of the prefilled syringes contain a natural rubber latex derivative.
Not all pack sizes may be marketed.
For syringe without attached needle only: after removing the syringe tip cap, a needle should be firmly placed on the tip of the syringe and secured by rotating a quarter of a turn (90°).
The vaccine is reconstituted by adding the solvent provided in the pre-filled syringe to the vial of powder. The vial is shaken and, after complete dissolution, the suspension obtained is withdrawn into the same syringe for injection.
Before administration, the reconstituted vaccine should be vigorously shaken.
Use immediately after reconstitution.
After reconstitution the suspension is beige to pink beige, more or less opalescent.
Contact with disinfectants is to be avoided since they may inactivate the virus.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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