Country: Индонезија
Језик: Индонежански
Извор: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
LIVE ATTENUATED VARICELLA ZOSTER VIRUS (OKA STRAIN)
ORGANON PHARMA INDONESIA TBK - Indonesia
LIVE ATTENUATED VARICELLA ZOSTER VIRUS (OKA STRAIN)
13500 PFU
SERBUK INJEKSI
DUS, 1 VIAL @ 1 DOSE + 1 PRE-FILLED SYRINGE PELARUT @ 0,7 ML
MERCK SHARP & DOHME CORP. - United States of America
2021-09-11
_ _ VARIVAX (REFRIGERATED) [VARICELLA VIRUS VACCINE LIVE (OKA/MERCK), REFRIGERATOR-STABLE FORMULATION] (POWDER FOR INJECTION) I. THERAPEUTIC CLASS VARIVAX (Refrigerated) is a live, attenuated virus vaccine (a lyophilized preparation of the Oka/Merck strain of varicella). Each 0.5 mL dose contains a minimum of 1350 PFU (plaque-forming units) of Oka/Merck varicella virus. II. INDICATIONS VARIVAX (Refrigerated) is indicated for vaccination against varicella in individuals 12 months of age and older. III. DOSAGE AND ADMINISTRATION FOR SUBCUTANEOUS ADMINISTRATION. Do not inject intravenously. Children 12 months to 12 years of age should receive a 0.5 mL dose administered subcutaneously. If a second dose is administered, there should be a minimum interval of 3 months between doses (see CLINICAL PHARMACOLOGY). 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. The outer aspect of the upper arm (deltoid region) is the preferred site of injection. DISETUJUI OLEH BPOM: 27 SEPTEMBER 2023 ID EREG100373VR12300285 _ _ 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. Before reconstitution, the lyophilized vaccine is a white compact crystalline plug. VARIVAX ( Прочитајте комплетан документ