CORONAVAC

Negara: Indonesia

Bahasa: Bahasa Indonesia

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

Bahan aktif:

INACTIVATED SARS-COV-2 VIRUS

Tersedia dari:

BIO FARMA - Indonesia

INN (Nama Internasional):

INACTIVATED SARS-COV-2 VIRUS

Dosis:

3 MCG

Bentuk farmasi:

INJEKSI

Unit dalam paket:

DUS, 40 VIALS @ 1 ML (2 DOSIS)

Diproduksi oleh:

SINOVAC LIFE SCIENCES CO., LTD - China

Tanggal Otorisasi:

2021-09-21

Karakteristik produk

EUA-CoronaVac Health Care Provider Fact Sheet, Approved version date
05/02/2021, BPOM,
ID EREG10040912100012
1
FACT SHEET FOR HEALTH CARE PROVIDERS
EMERGENCY USE
AUTHORIZATION (EUA) OF CORONAVAC
Badan
POM,
the
Indonesia
Food
and
Drug
Administration,
has
issued
AN
EMERGENCY
USE
AUTHORIZATION (EUA) to permit the emergency use of CoronaVac.
CoronaVac is a vaccine which may
prevent from getting COVID-19. Read this Fact Sheet for information
about CoronaVac prior to
provide vaccination
THE EMERGENCY USE AUTHORIZATION OF the CoronaVac is to induce immunity
against SARS-CoV-2 for
the prevention of COVID-19. This product is suitable for people aged
18 years old and above.
CoronaVac 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. Shake
well before use.
Adults, 18-59 years old
_ _
•
For emergency situation, the immunization schedule is 2 doses at
2-week interval (0 and 14
days), each dose is 0.5 mL.
•
For routine situation, the immunization schedule is 2 doses at 4-week
interval (0 and 28
days), each dose is 0.5 mL.
Elderly 60 years and above
For immunization in elderly, schedule is 2 doses at 4-week interval (0
and 28 days, each dose is
0.5 mL.
The study of CoronaVac in the elderly above 70 years old is still
limited (see Clinical Studies).
Booster dose has not yet been determined.
CoronaVac is available as a suspension for injection packed in a 0,5
mL vial.
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 CoronaVac.
This Fact Sheet may have been updated. For more recent Fact Sheet see
www.pom.go.id
For information on clinical trials that are testing the use of
CoronaVac in
COVID-19, please see
www.clinicaltrials.gov
EUA-CoronaVac Health Care