Pays: Indonésie
Langue: indonésien
Source: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
INACTIVATED SARS-COV-2 VIRUS
KIMIA FARMA Tbk. - Indonesia
INACTIVATED SARS-COV-2 VIRUS
6.5 U
INJEKSI
DUS, 1 PRE-FILLED SYRINGE @ 4 MCG/0.5 ML
BEIJING BIO-INSTITUTE BIOLOGICAL PRODUCTS CO., LTD - China
2021-04-28
FACT SHEET FOR HEALTH CARE PROVIDERS EMERGENCY USE AUTHORIZATION (EUA) OF SARS- COV-2 VACCINE (VERO CELL), INACTIVATED Badan POM, the Indonesia Food and Drug Administration, has issued an Emergency Use Authorization (EUA) to permit the emergency use of SARS-COV-2 Vaccine (Vero Cell) Inactivated. SARS-COV-2 Vaccine (Vero Cell) Inactivated is a vaccine which may prevent from getting COVID-19. Read this Fact Sheet for information about SARS-COV-2 Vaccine (Vero Cell) Inactivated prior to provide vaccination. THE EMERGENCY USE AUTHORIZATION of the SARS-COV-2 Vaccine (Vero Cell) Inactivated is to induce immunity against SARS-CoV-2 to prevent COVID-19 for adults 18 years old and above. SARS-COV-2 Vaccine (Vero Cell) Inactivated is contraindicated in person who is: 1. Hypersensitive to any component of this vaccine, or 2. Primary Immunodeficiency. ADMINISTRATION: The recommended route of administration is intramuscular injection at deltoid muscle. Shakewell before use. Immunization Program and Dosage : Two doses of containing 4 mcg (6,5 Unit) antigen with an interval of 21-28 days. BOOSTER IMMUNIZATION (HOMOLOGOUS). Single dose of 0.5 mL containing 4 mcg (6.5 Unit) should be given 6 months after primary immunization for people aged 18 years and above who have received the primary immunization of one of SARS-COV-2 Vaccines (Vero Cell inactivated-Sinopharm SARS- COV-2 Vaccine). BOOSTER IMMUNIZATION (HETEROLOGOUS). Single dose of 0.5 mL containing 4 mcg (6.5 Unit) should be given 6 months after completed the primary dose (2 doses of Sinovac Vaccine / CoronaVac) immunization for people aged 18 years and above. SARS-COV-2 Vaccine (Vero Cell) Inactivated is available as a injection packed in a 1.1 mL vial (2 doses). This product contains no preservative. See the Full EUA Prescribing Information for complete dosage, administration, and preparation instructions. Health care providers must submit a report on all medication errors and ALL SERIOUS ADVERSE EVENTS related to SARS-Cov-2 Vaccine (Vero Cell), Inactivated. This Fact Shee Lire le document complet