VARIVAX (Refrigerated)

MSD PHARMA (SINGAPORE) PTE. LTD.

MSD PHARMA (SINGAPORE) PTE. LTD.

Therapeutic

Prescription Only

INJECTION

**DOSAGE AND ADMINISTRATION** FOR SUBCUTANEOUS ADMINISTRATION. Do not inject intravascularly. _Children_ Children 12 months to 12 years of age should receive a 0.5 mL dose administered subcutaneously. If a second 0.5 mL dose is administered, it should be given a minimum of 3 months later (see **CLINICAL PHARMACOLOGY** – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). _Adolescents and Adults_ Adolescents and adults 13 years of age and older should receive a 0.5 mL dose administered subcutaneously at elected date and a second 0.5 mL dose 4 to 8 weeks later. Refrigerator-stable VARIVAX is for subcutaneous administration. The outer aspect of the upper arm (deltoid region) is the preferred site of injection. Methods of administration _Prefilled syringe of diluent_ To reconstitute the vaccine, inject all of the diluent (0.7 mL) in the prefilled syringe into the vial of lyophilized vaccine and gently agitate to mix thoroughly. Withdraw the entire contents into the syringe and inject the total volume (about 0.5 mL) of reconstituted vaccine subcutaneously, preferably into the outer aspect of the upper arm (deltoid region) or the anterolateral thigh. **IT IS RECOMMENDED THAT THE VACCINE BE ADMINISTERED IMMEDIATELY AFTER RECONSTITUTION, TO MINIMIZE LOSS OF POTENCY. DISCARD IF RECONSTITUTED VACCINE IS NOT USED WITHIN 30 MINUTES.** Do not freeze reconstituted vaccine. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. VARIVAX (Refrigerated) when reconstituted is a clear, colorless to pale yellow liquid. _Vial of diluent_ To reconstitute the vaccine, first withdraw 0.7 mL of diluent into a syringe. Inject all of the diluent in the syringe into the vial of lyophilized vaccine and gently agitate to mix thoroughly. Withdraw the entire contents into the syringe and inject the total volume (about 0.5 mL) of reconstituted vaccine subcutaneously, preferably into the outer aspect of the upper arm (deltoid region) or the anterolateral thigh. **IT IS RECOMMENDED THAT THE VACCINE BE ADMINISTERED IMMEDIATELY AFTER RECONSTITUTION, TO MINIMIZE LOSS OF POTENCY. DISCARD IF RECONSTITUTED VACCINE IS NOT USED WITHIN 30 MINUTES.** CAUTION: A sterile syringe free of preservatives, antiseptics, and detergents should be used for each injection and/or reconstitution of refrigerator-stable VARIVAX because these substances may inactivate the vaccine virus. It is important to use a separate sterile syringe and needle for each patient to prevent transmission of infectious agents from one individual to another. To reconstitute the vaccine, use only the Merck sterile diluent supplied with refrigerator-stable VARIVAX, since it is free of preservatives or other anti-viral substances which might inactivate the vaccine virus. Do not freeze reconstituted vaccine. Do not give immune globulin, including Varicella Zoster Immune Globulin, concurrently with refrigerator-stable VARIVAX (see also **PRECAUTIONS** – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Refrigerator-stable VARIVAX when reconstituted is a clear, colorless to pale yellow liquid.