ZIFIVAX

Land: Indonesien

Sprache: Indonesisch

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

Wirkstoff:

RECOMBINANT PROTEIN NCP-RBD OF SARS COV-2 VIRUS

Verfügbar ab:

Jakarta Biopharmaceutical industry - Indonesia

INN (Internationale Bezeichnung):

RECOMBINANT PROTEIN NCP-RBD OF SARS COV-2 VIRUS

Dosierung:

0,025 MG

Darreichungsform:

INJEKSI

Einheiten im Paket:

Dus, 1 vial @ 1 dosis (0,5 mL)

Hergestellt von:

ANHUI ZHIFEI LONGCOM BIOPHARMACEUTICAL CO.,LTD - China

Berechtigungsdatum:

2021-10-07

Fachinformation

FACT SHEET FOR HEALTH CARE PROVIDERS EMERGENCY USE
AUTHORIZATION (EUA) OF ZIFIVAX
Badan
POM,
the
Indonesia
Food
and
Drug
Administration,
has
issued
AN
EMERGENCY
USE
AUTHORIZATION (EUA) to permit the emergency use of Zifivax. Zifivax is
a vaccine which may prevent
individuals from getting COVID-19. Read this Fact Sheet for
information about Zifivax prior to providing
vaccination.
THE EMERGENCY USE AUTHORIZATION OF Zifivax is to induce immune
response to SARS-CoV-2 for the
prevention of COVID-19 in individuals 18 years of age and above
Zifivax is contraindicated in person who is
1.
hypersensitive to any component of this vaccine, or
2.
suffers from Primary Immunodeficiency.
ADMINISTRATION
The recommended route of administration is intramuscular injection in
deltoid muscle in the
upper arm. Shake well before injection.
The Zifivax vaccination series is 3 doses given at 1-month intervals
(months 0, 1, and 2), 0.5 mL
per dose.
Booster dose has not yet been determined.
Zifivax is available as a suspension for injection packed in 0,5 mL (1
dose) and 1,0 mL (2 doses)
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 Zifivax.
This Fact Sheet may have been updated. For more recent Fact Sheet see
www.pom.go.id
For more information on clinical trials that are testing the use of
Zifivax, please see
www.clinicaltrials.gov
EUA-Zifivax, Health Care Provider fact Sheet, Approved Version date
04/10/21
BPOM, ID EREG17202712100004, EREG17202712100005
INSTRUCTIONS FOR ADMINISTRATION
This section provides essential information on the use of Zifivax
which is to induce immune response
against SARS-CoV-2 for the prevention of COVID-19 in individuals aged
18 years and above.
Please refer to this fact sheet for information on use of Zifivax
under the EUA.
COMPOSITION
Each dose (0.5 mL) contains Recombinant Novel Coronavirus Vaccin