SHINGRIX POWDER AND SUSPENSION FOR SUSPENSION FOR INJECTION 50MCG/0.5ML

Indications

Shingrix is indicated for the prevention of herpes zoster (HZ) and post-herpetic neuralgia (PHN), in:

• adults 50 years of age or older;
• adults 18 years of age or older at increased risk of HZ due to immunodeficiency or immunosuppression caused by known disease or therapy.

The vaccine’s effect on the prevention of PHN can be attributed to the effect of the vaccine on the prevention of HZ.

The use of Shingrix should be based on official recommendations.

Contraindications

Hypersensitivity to the active substances or to any component of the vaccine (see Qualitative and Quantitative Composition and Excipients – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Dosage and Administration

The immunisation schedule for Shingrix should be based on official recommendations.

Posology

The primary vaccination schedule consists of two doses of 0.5 ml each; an initial dose followed by a second dose 2 to 6 months later.

For subjects who are immunodeficient, immunosuppressed or likely to become immunosuppressed due to known 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 Pharmacodynamic Effects – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

The need for booster doses has not been established.

Shingrix can be given with the same schedule in individuals previously vaccinated with live attenuated HZ vaccine (see Pharmacodynamic Effects – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Shingrix is not indicated for prevention of primary varicella infection.

Method of administration

Shingrix is for intramuscular injection only, preferably in the deltoid muscle.

For instructions on reconstitution of the medicinal product before administration, see Instructions for Use/Handling – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.