Ország: Indonézia
Nyelv: indonéz
Forrás: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
DUS, 10 VIAL @ 10 DOSIS (5,0 ML)
2022-09-24
FACT SHEET FOR HEALTH CARE PROVIDERS EMERGENCY USE AUTHORIZATION (EUA) OF INDOVAC Badan POM, the Indonesia Food and Drug Administration, has issued AN EMERGENCY USE AUTHORIZATION (EUA) to permit the emergency use of IndoVac. IndoVac is a recombinant COVID- 19 vaccine which may prevent from getting COVID-19. Read this Fact Sheet for information about IndoVac prior to provide vaccination THE EMERGENCY USE AUTHORIZATION OF the IndoVac is for active immunization for prevention of COVID-19 caused by SARS-CoV-2 in individuals aged ≥ 12 years and above. IndoVac is contraindicated in person who is Hypersensitivity to the active substance or to any of the excipients listed in section COMPOSITION. ADMINISTRATION: Each vaccine dose of 0.5 ml is withdrawn into a syringe for injection to be administered intramuscularly. Shake well the product before injection. Primary immunization: The vaccination course of IndoVac consists of two separate doses of 0.5 mL each dose. The second dose of the vaccine should be administered approximately 28 days after the first dose. (see section Pharmacodynamic Properties). It is recommended that individuals who receive a first dose of IndoVac complete the vaccination course with IndoVac (see section Special warnings and precautions for use). The safety and immunogenicity of IndoVac in children (aged <12 years old) have not yet been established. No data are available. Booster immunization (heterologous): Single dose of 0.5 mL should be given at least 6 months after the second dose of primary immunization of Sinovac Vaccine, AstraZeneca Vaccine and Pfizer Vaccine for people aged 18 years and above. IndoVac is available as a suspension for injection packed in a 5 mL vial (10 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 IndoVac. This Fact Sheet may have been updated. For more recen Olvassa el a teljes dokumentumot