VERORAB

Land: Indonesia

Språk: indonesisk

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

Aktiv ingrediens:

RABIES VACCINE

Tilgjengelig fra:

BIO FARMA - Indonesia

INN (International Name):

RABIES VACCINE

Dosering :

2,5 IU

Legemiddelform:

SERBUK INJEKSI

Enheter i pakken:

DUS, 1 VIAL @ 1 DOSIS + 1 SYRINGE @0,5 ML NaCl 4 %

Produsert av:

SANOFI PASTEUR - France

Autorisasjon dato:

2019-07-22

Preparatomtale

VERORAB
PURIFIED INACTIVATED RABIES VACCINE, PREPARED ON VERO CELLS
COMPOSITION
After reconstitution, 1 dose (0.5 mL) contains:
Rabies virus*, WISTAR Rabies PM/WI38 1503‐3M strain (inactivated)
≥ 2.5 IU**
* Produced in VERO cells
** Quantity measured according to the NIH test against the
international standard
List of excipients
Powder:
- Maltose
- 20% Human albumin solution
- Basal Medium Eagle (mixture of mineral salts including potassium,
vitamins, dextrose and amino-
acids including L-Phenylalanine)
- Water for injections
- Hydrochloric acid and sodium hydroxide for pH adjustment
Solvent:
-
Sodium chloride
- Water for injections
PHARMACEUTICAL FORM
Powder and diluent for suspension for injection.
Before reconstitution, the powder is a white and homogeneous pellet.
The solvent is a clear and
colorless solution.
THERAPEUTIC INDICATIONS
This medicinal product is a vaccine.
PRE-EXPOSURE
This vaccine is recommended for the prevention of rabies in subjects
at a high risk of exposure. All
subjects at a permanent risk, such as diagnostic, research and
production laboratory staff working
on rabies virus, should be vaccinated. A serological test is
recommended every 6 months. A booster
injection should be administered when the antibody titre is below the
level considered to guarantee
protection: 0.5 I.U./mL. The following categories should be vaccinated
given the frequency of
exposure to the risk:
-
Veterinarians (and assistants), gamekeepers, hunters, forest rangers,
slaughter- house personnel,
cavers, taxidermists.
-
Subjects exposed enzootic areas: children, adults and travelers
visiting these areas.
POST-EXPOSURE
-
After confirmed or suspected exposure, vaccination must be started
immediately at the risk of
contamination with rabies. It must be performed in a rabies treatment
centre. The treatment is
adapted to the type of wound and the status of the animal.
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
The vaccination schedule should be adapted according to the
circumstances of the vaccination
and the subject