- Approval Id
- 530b4b2deeb4bc94
- Drug Name
- ZOSTAVAX Refrigerator Stable Formulation
- Product Name
- ZOSTAVAX Refrigerator Stable Formulation
- Approval Number
- SIN13564P
- Approval Date
- 2008-10-30
- Registrant
- MSD PHARMA (SINGAPORE) PTE. LTD.
- Licence Holder
- MSD PHARMA (SINGAPORE) PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION
- Dosage
- **III. DOSAGE AND ADMINISTRATION**
FOR SUBCUTANEOUS ADMINISTRATION.
Do not inject intravascularly.
Individuals should receive a single dose. At present, the duration of protection after vaccination with ZOSTAVAX is unknown. In the Shingles Prevention Study (SPS), protection was demonstrated through 4 years of follow-up. The need for revaccination has not yet been defined.
ZOSTAVAX is not a treatment for zoster or PHN.
ZOSTAVAX can be administered concomitantly with inactivated influenza vaccine using separate syringes.
Reconstitute immediately upon removal from the refrigerator.
To reconstitute the vaccine, use only the diluent supplied, since it is free of preservatives or other antiviral substances which might inactivate the vaccine virus.
Prefilled syringe of diluent:
To reconstitute the vaccine, inject all the diluent in the syringe into the vial of lyophilized vaccine and gently agitate to mix thoroughly. Withdraw the entire contents into a syringe and inject the total volume of reconstituted vaccine subcutaneously, preferably into the upper arm (preferably in the deltoid region).
**IT IS RECOMMENDED THAT THE VACCINE BE ADMINISTERED IMMEDIATELY AFTER RECONSTITUTION, TO MINIMIZE LOSS OF POTENCY. DISCARD RECONSTITUTED VACCINE IF IT IS NOT USED WITHIN 30 MINUTES.**
Do not freeze reconstituted vaccine.
CAUTION: A sterile syringe free of preservatives, antiseptics, and detergents should be used for each injection and/or reconstitution of ZOSTAVAX because these substances may inactivate the vaccine virus.
A separate sterile needle and syringe should be used for administration of ZOSTAVAX to prevent transfer of infectious diseases.
Needles should be disposed of properly and should not be recapped.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. ZOSTAVAX when reconstituted is a semi-hazy to translucent, off white to pale yellow liquid.
- Route Of Administration
- SUBCUTANEOUS
- Indication Info
- **II. INDICATIONS**
ZOSTAVAX is indicated for prevention of herpes zoster (shingles).
ZOSTAVAX is indicated for immunization of individuals 50 years of age or older.
- Contraindications
- **IV. CONTRAINDICATIONS**
History of hypersensitivity to any component of the vaccine, including gelatin.
History of anaphylactic/anaphylactoid reaction to neomycin (each dose of reconstituted vaccine contains trace quantities of neomycin). Neomycin allergy generally manifests as a contact dermatitis. However, a history of contact dermatitis due to neomycin is not a contraindication to receiving live virus vaccines.
ZOSTAVAX is a live, attenuated varicella-zoster vaccine and administration to individuals who are immunosuppressed or immunodeficient may result in disseminated varicella-zoster virus disease, including fatal outcomes.
Primary and acquired immunodeficiency states due to conditions such as: acute and chronic leukemias; lymphoma; other conditions affecting the bone marrow or lymphatic system; immunosuppression due to HIV/AIDS (see **XIV. CLINICAL PHARMACOLOGY** and **XI. ADVERSE EVENTS** – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_); cellular immune deficiencies.
Immunosuppressive therapy (including high-dose corticosteroids) (see **XI. ADVERSE EVENTS** – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_); however, ZOSTAVAX is not contraindicated for use in individuals who are receiving topical/inhaled corticosteroids or low-dose systemic corticosteroids or in patients who are receiving corticosteroids as replacement therapy, e.g., for adrenal insufficiency.
Active untreated tuberculosis.
Pregnancy (see **VI. PREGNANCY** – _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
- MSD PHARMA (SINGAPORE) PTE. LTD.
- Company Detail Path
- /organization/msd-pharma-singapore-pte-ltd
