FLUAD TETRA Suspension for injection in pre-filled syringe Ref.[27852] Active ingredients: Influenza, inactivated, surface antigen

Posology

One 0.5 ml dose.

Paediatric population

The safety and efficacy of Fluad Tetra in children from birth to less than 18 years has not been established. Currently available safety and immunogenicity data in children from 6 months to less than 6 years of age are described in sections 4.8 and 5.1 but no recommendation on posology can be made.

Method of administration

For intramuscular injection only.

The preferred injection site is the deltoid muscle of the upper arm.

The vaccine must not be injected intravenously, subcutaneously or intradermally and must not be mixed with other vaccines in the same syringe.

For instructions for preparation of the medicinal product before administration, see section 6.6.

Overdosage is unlikely to have any untoward effect.

1 year.

Store in a refrigerator (2°C–8°C). Do not freeze. Discard if the vaccine has been frozen.

Keep the pre filled syringe in the outer carton in order to protect from light.

0.5 ml of suspension for injection in pre-filled syringe (type I glass) with a plunger stopper (bromobutyl rubber), presented with or without needle.

Pack of 1 pre-filled syringe with needle
Pack of 1 pre-filled syringe without needle
Pack of 10 pre-filled syringes with needles
Pack of 10 pre-filled syringes without needles

Not all pack sizes may be marketed.

Gently shake before use.

After shaking, the normal appearance of the vaccine is a milky-white suspension.

Visually inspect the contents of each pre-filled syringe for particulate matter and/or variation in appearance prior to administration. If either condition is observed, do not administer the vaccine. Do not use if the vaccine has been frozen. Any unused product or waste material should be disposed of in accordance with local requirements.

When using a pre-filled syringe supplied without a needle, remove the tip cap from the syringe and then attach a suitable needle for administration. For Luer Lock syringes, remove the tip cap by unscrewing it in a counter-clockwise direction. Once the tip cap is removed, attach a needle to the syringe by screwing it on in a clockwise direction until it locks. Once the needle is locked in place, remove the needle protector and administer the vaccine.