RABIVAX-S

국가: 인도네시아

언어: 인도네시아어

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

유효 성분:

INACTIVATED RABIES VIRUS (PITMAN-MOORE STRAIN 3218-VERO)

제공처:

INDOFARMA - Indonesia

INN (International Name):

INACTIVATED RABIES VIRUS (PITMAN-MOORE STRAIN 3218-VERO)

복용량:

2,5 IU

약제 형태:

MASSA LIOFILISASI

패키지 단위:

DUS, 50 VIAL @ 1 DOSIS + DUS, 50 AMPUL PELARUT @ 1 ML

Manufactured by:

SERUM INSTITUTE OF INDIA PVT. LTD - India

승인 날짜:

2020-02-25

제품 특성 요약

INACTIVATED RABIES VIRUS
(PITMAN-MOORE STRAIN 3218-VERO)
SII
_Freeze dried_
RABIVAX-S
DESCRIPTION
RABIVAX-S [Rabies Vaccine Inactivated (Pitman-moore strain 3218-vero)
Freeze dried] is a sterile, purified inactivated rabies
vaccine prepared on vero cells. RABIVAX-S vaccine is freeze dried and
is provided with diluent (1 dose of powder in vial and
1 ml of diluent in ampoule). The vaccine has the appearance of a white
dry cake. The vaccine conforms to the World Health
Organization (W.H.O.) requirements.
COMPOSITION
Each 1 ml contains inactivated rabies virus (Pitman-Moore strain
3218-vero) not less than 2.5 IU.
Reconstitute with 1 ml of Sterile Water for Injections.
Dose: 1 ml by intramuscular or 0.1 ml by intradermal injection.
Diluent: Sterile Water for Injections.
Excipients: Sucrose, glycine, human serum albumin (HSA).
INDICATIONS
RABIVAX-S is indicated or the prevention of rabies in children and
adult. It can be used before or after exposure, as a primary
immunization.
a) Pre-Exposure prophylaxis
Pre-exposure vaccination should be offered to subjects at high risk of
contamination by the rabies virus. This vaccination is
particularly recommended for veterinarians, veterinary medicine
students, animal keepers, hunters, forestry workers,
animal handlers, butchers, personnel in rabies research laboratories
etc., children at high risk of exposure or prior to visits
to areas in which rabies is endemic.
b) Post-Exposure prophylaxis
RABIVAX-S is indicated in post-exposure prophylaxis of rabies
infection, when given to individuals with suspected rabies
exposure. RABIVAX-S must always be used as per recommendations of the
World Health Organization (WHO), depending on
the type of contact with a suspected rabid animal.
For all categories, immediate washing and flushing of all wounds and
scratches is recommended. If indicated tetanus
prophylaxis should also be given with tetanus toxoid. Treatment should
be started as early as possible after exposure, but in
no case should it be denied to exposed persons whatever time inter