- Approval Id
- a4a6774abc41eafb
- Drug Name
- SHINGRIX POWDER AND SUSPENSION FOR SUSPENSION FOR INJECTION 50MCG/0.5ML
- Product Name
- SHINGRIX POWDER AND SUSPENSION FOR SUSPENSION FOR INJECTION 50MCG/0.5ML
- Approval Number
- SIN16079P
- Approval Date
- 2021-01-12
- Registrant
- GLAXOSMITHKLINE PTE LTD
- Licence Holder
- GLAXOSMITHKLINE PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- INJECTION, POWDER, LYOPHILIZED, FOR LIPOSOMAL SUSPENSION
- Dosage
- **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_.
- Route Of Administration
- INTRAMUSCULAR
- Indication Info
- **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
- **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_).
- Atc Code
- J07BK
- Atc Item Name
- 水痘带状疱疹疫苗
- Pharma Manufacturer Name
- GLAXOSMITHKLINE PTE LTD
- Company Detail Path
- /organization/cac9b4e7bceb9ea7/glaxosmithkline-pte-ltd
