COVOVAX

Negara: Indonesia

Bahasa: Bahasa Indonesia

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

Bahan aktif:

RECOMBINANT SPIKE PROTEIN OF SARS-COV-2 VIRUS

Tersedia dari:

INDOFARMA - Indonesia

INN (Nama Internasional):

RECOMBINANT SPIKE PROTEIN OF SARS-COV-2 VIRUS

Dosis:

5 MCG

Bentuk farmasi:

LARUTAN INJEKSI

Unit dalam paket:

DUS, 50 VIAL @ 5 ML (10 DOSIS)

Diproduksi oleh:

SERUM INSTITUTE OF INDIA PVT. LTD. - India

Tanggal Otorisasi:

2021-10-31

Karakteristik produk

PAGE 1 OF 20
FACT SHEET FOR HEALTH CARE PROVIDERS
EMERGENCY USE AUTHORIZATION (EUA) OF
COVOVAX
Badan POM, the Indonesia Food and Drug Administration, has issued AN
EMERGENCY USE
AUTHORIZATION (EUA) to permit the emergency use of COVOVAX. COVOVAX is
a vaccine
which may prevent from getting COVID-19. Read this Fact Sheet for
information about
COVOVAX prior to provide vaccination.
THE EMERGENCY USE AUTHORIZATION OF the COVOVAX is to induce immunity
against SARS-CoV-2 to prevent
COVID-19 for adults 18 years old and above.
COVOVAX is contraindicated in person who is have hypersensitivity to
the active substance or to any of
the excipients of this vaccine.
ADMINISTRATION:
COVOVAX™ is intended for Intramuscular (IM) injection only,
preferably in the deltoid muscle.
Do not inject the vaccine intravascularly, subcutaneously or
intradermally.
The vaccine should not be mixed in the same syringe with any other
vaccines or medicinal products.
Do not dilute.
Immunization Program and Dosage :
COVOVAX vaccination course consists of two separate doses of 0.5 ml
each.
The second dose should be administered not less than 21 days after the
first dose.
It is recommended that individuals who receive a first dose of COVOVAX
complete the vaccination course
with COVOVAX
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 COVOVAX .
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 COVOVAX
in COVID-19,
please see www.clinicaltrials.gov
EUA-Covovax, Health Care Provider Fact Sheet, Approved version date
29/10/21, BPOM, ID EREG10021812100121
PAGE 2 OF 20
INSTRUCTIONS FOR ADMINISTRATION
This section provides essential information on the use of
COVOVAX
which is to induce
immunity against SARS-CoV-2 to prevent COVID-19 for adults 18 years
old and above.
Please refer to this fact sheet