Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: GlaxoSmithKline Biologicals S.A., Rue de lInstitut 89, B-1330 Rixensart, Belgium
Shingrix is indicated for prevention of herpes zoster (HZ) and post-herpetic neuralgia (PHN), in:
The use of Shingrix should be in accordance with official recommendations.
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).
The safety and efficacy of Shingrix in children and adolescents have not been established. No data are available.
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.
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.
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:
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.