SARS-COV-2 VACCINE (VERO CELL), INACTIVATED

Țară: Indonezia

Limbă: indoneziană

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

Ingredient activ:

INACTIVATED SARS-COV-2 VIRUS

Disponibil de la:

KIMIA FARMA Tbk. - Indonesia

INN (nume internaţional):

INACTIVATED SARS-COV-2 VIRUS

Dozare:

6.5 U

Forma farmaceutică:

INJEKSI

Unități în pachet:

DUS, 1 PRE-FILLED SYRINGE @ 4 MCG/0.5 ML

Produs de:

BEIJING BIO-INSTITUTE BIOLOGICAL PRODUCTS CO., LTD - China

Data de autorizare:

2022-03-10

Caracteristicilor produsului

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