RECOMBINANT COVID-19 VACCINE

দেশ: ইন্দোনেশিয়া

ভাষা: ইন্দোনেশীয়

সূত্র: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

প্যাকেজ ইউনিট:

DUS, 10 VIAL @ 10 DOSIS (5,0 ML)

অনুমোদন তারিখ:

2022-09-24

পণ্য বৈশিষ্ট্য

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Each vaccine dose of 0.5 ml is withdrawn into a syringe for injection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