SHINGRIX Powder for suspension for injection Ref.[27522] Active ingredients: Human varicela zoster immunoglobulin

Posology

The primary vaccination schedule consists of two doses of 0.5 mL each: an initial dose followed by a second dose 2 months later.

If flexibility in the vaccination schedule is necessary, the second dose can be administered between 2 and 6 months after the first dose (see section 5.1).

For subjects who are or might become immunodeficient or immunosuppressed due to disease or therapy, and whom would benefit from a shorter vaccination schedule, the second dose can be given 1 to 2 months after the initial dose (see section 5.1).

The need for booster doses following the primary vaccination schedule has not been established (see section 5.1).

Shingrix can be given with the same schedule in individuals previously vaccinated with live attenuated HZ vaccine (see section 5.1).

Shingrix is not indicated for prevention of primary varicella infection (chickenpox).

Paediatric population

The safety and efficacy of Shingrix in children and adolescents have not been established. No data are available.

Method of administration

For intramuscular injection only, preferably in the deltoid muscle.

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

No case of overdose has been reported.

3 years.

After reconstitution:

Chemical and physical in-use stability has been demonstrated for 24 hours at 30°C.

From a microbiological point of view, the vaccine should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 6 hours at 2°C to 8°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 reconstitution of the medicinal product, see section 6.3.

• Powder for 1 dose in a vial (type I glass) with a stopper (butyl rubber)
• Suspension for 1 dose in a vial (type I glass) with a stopper (butyl rubber).

Shingrix is available in a pack size of 1 vial of powder and 1 vial of suspension or in a pack size of 10 vials of powder and 10 vials of suspension.

Not all pack sizes may be marketed.

Shingrix is presented as a vial with a brown flip-off cap containing the powder (antigen) and a vial with a blue-green flip-off cap containing the suspension (adjuvant).

The powder and the suspension must be reconstituted prior to administration.

The powder and suspension should be inspected visually for any foreign particulate matter and/or variation of appearance. If either is observed, do not reconstitute the vaccine.

How to prepare Shingrix:

Shingrix must be reconstituted prior to administration.

1. Withdraw the entire contents of the vial containing the suspension into the syringe.
2. Add the entire contents of the syringe into the vial containing the powder.
3. Shake gently until the powder is completely dissolved.

The reconstituted vaccine is an opalescent, colourless to pale brownish liquid.

The reconstituted vaccine should be inspected visually for any foreign particulate matter and/or variation of appearance. If either is observed, do not administer the vaccine.

After reconstitution, the vaccine should be used promptly; if this is not possible, the vaccine should be stored in a refrigerator (2°C–8°C). If not used within 6 hours it should be discarded.

Before administration:

1. Withdraw the entire contents of the vial containing the reconstituted vaccine into the syringe.
2. Change the needle so that you are using a new needle to administer the vaccine.

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