IMVANEX Suspension for injection Ref.[28029] Active ingredients: Smallpox, live attenuated

Posology

Primary vaccination (individuals previously not vaccinated against smallpox)

A first dose of 0.5 ml should be administered on an elected date.

A second dose of 0.5 ml should be administered no less than 28 days after the first dose. See sections 4.4 and 5.1.

Booster vaccination (individuals previously vaccinated against smallpox)

There are inadequate data to determine the appropriate timing of booster doses. If a booster dose is considered necessary then a single dose of 0.5 ml should be administered. See sections 4.4 and 5.1.

Special population

Immunocompromised patients (e.g. HIV infected, patients under immunosuppressive therapy) who have been previously vaccinated against smallpox should receive two booster doses. The second booster vaccination should be given no less than 28 days after the first dose.

Paediatric population

The safety and efficacy of IMVANEX in children below 18 years have not been established.

Method of administration

Immunisation should be carried out by subcutaneous injection, preferably into the upper arm (deltoid).

For instructions on administration, see section 6.6.

No case of overdose has been reported.

2 years at -20°C +/-5°C
5 years at -50°C +/-10°C
5 years at -80°C +/-10°C

After thawing, the vaccine should be used immediately or if previously stored at -20°C +/-5°C, the vaccine can be stored at 2°C-8°C in the dark for up to 8 weeks prior to use.

Do not re-freeze a vial once it has been thawed.

Store in a freezer (at -20°C +/-5°C or -50°C +/-10°C or -80°C +/-10°C). Expiry date depends on storage temperature.

If previously stored at -20°C +/-5°C, the vaccine can be stored short-term in a refrigerator at 2°C–8°C for up to 8 weeks prior to use.

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

0.5 ml suspension in a vial (Type I glass) with stopper (bromobutyl rubber).

Pack size of 20.

The vaccine should be allowed to reach room temperature before use. Swirl the vial gently before use for at least 30 seconds.

The suspension should be visually inspected for particulate matter and discoloration before use. In the event of any damage to the vial, foreign particulate matter and/or variation of physical aspect being observed, discard the vaccine. A dose of 0.5 ml is withdrawn into a syringe for injection.

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