ADJUPANRIX Emulsion for injection Ref.[50412] Active ingredients: Influenza, inactivated, split virus

Posology

Adults from the age of 18 years

One dose of 0.5 ml at an elected date.

A second dose of 0.5 ml should be given after an interval of at least three weeks and up to twelve months after the first dose for maximum efficacy.

Based on very limited data, adults aged >80 years may require a double dose of Adjupanrix on an elected date and again after an interval of at least three weeks in order to achieve an immune response (see section 5.1).

Paediatric population

Children aged 6 months to <36 months

One dose of 0.125 ml (equals quarter the adult dose per injection) at an elected date. A second dose of 0.125 ml at least three weeks after the first dose for maximum efficacy.

Children and adolescents aged 36 months to <18 years

One dose of 0.25 ml (equals half the adult dose per injection) at an elected date. A second dose of 0.25 ml at least three weeks after the first dose for maximum efficacy.

Children aged <6 months

The safety and efficacy of Adjupanrix in children less than 6 months have not been established.

Method of administration

Immunisation should be carried out by intramuscular injection.

If a double dose is given, the injections should be given into opposite limbs preferably into the deltoid muscle or anterolateral thigh (depending on the muscle mass).

For instructions on mixing of the medicinal product before administration, see section 6.6.

No case of overdose has been reported.

5 years.

After mixing, the vaccine should be used within 24 hours. Chemical and physical in-use stability has been demonstrated for 24 hours at 25°C.

Store in a refrigerator (2°C–8°C).

Do not freeze.

Store in the original package in order to protect from light.

For storage conditions after mixing of the medicinal product, see section 6.3.

One pack containing:

• one pack of 50 vials (type I glass) of 2.5 ml suspension with a stopper (butyl rubber).
• two packs of 25 vials (type I glass) of 2.5 ml emulsion with a stopper (butyl rubber).

The volume after mixing 1 vial of suspension (2.5 ml) with 1 vial of emulsion (2.5 ml) corresponds to 10 doses of vaccine (5 ml).

Adjupanrix consists of two containers:

Suspension: multidose vial containing the antigen,

Emulsion: multidose vial containing the adjuvant.

Prior to administration, the two components should be mixed.

Instructions for mixing and administration of the vaccine:

1. Before mixing the two components, the emulsion (adjuvant) and suspension (antigen) should be allowed to reach room temperature (for a minimum of 15 minutes); each vial should be shaken and inspected visually for any foreign particulate matter and/or abnormal physical appearance. In the event of either being observed (including rubber particles from the stopper), do not mix the vaccine.

2. The vaccine is mixed by withdrawing the entire contents of the vial containing the adjuvant by means of a 5 ml syringe and by adding it to the vial containing the antigen. It is recommended to equip the syringe with a 23-G needle. However, in the case this needle size would not be available, a 21-G needle might be used. The vial containing the adjuvant should be maintained in upside down position to facilitate the withdrawal of the full content.

3. After the addition of the adjuvant to the antigen, the mixture should be well shaken. The mixed vaccine is a whitish to yellowish homogeneous milky liquid emulsion. In the event of other variation being observed, do not administer the vaccine.

4. The volume of the Adjupanrix vial after mixing is at least 5 ml. The vaccine should be administered in accordance with the recommended posology (see section 4.2).

5. The vial should be shaken prior to each administration and inspected visually for any foreign particulate matter and/or abnormal physical appearance. In the event of either being observed (including rubber particles from the stopper), do not administer the vaccine.

6. Each vaccine dose of 0.5 ml or 0.25 ml or 0.125 ml is withdrawn into a syringe with appropriate graduation for injection and administered intramuscularly. It is recommended to equip the syringe with a needle gauge not larger than 23-G.

7. After mixing, use the vaccine within 24 hours. The mixed vaccine can either be stored in a refrigerator (2°C-8°C) or at room temperature not exceeding 25°C. If the mixed vaccine is stored in a refrigerator, it should be allowed to reach room temperature (for a minimum of 15 minutes) before each withdrawal.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.