VERORAB

Χώρα: Ινδονησία

Γλώσσα: Ινδονησιακά

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

Μονάδες σε πακέτο:

DUS, 1 VIAL @ 1 DOSIS + 1 SYRINGE @ 0,5 ML NACL 0.4 %

Ημερομηνία της άδειας:

2022-09-24

Αρχείο Π.Χ.Π.

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)
3.25 IU**
* Produced in VERO cells
** Quantity measured according to the ELISA test against the
international standard (corresponds to ≥
2.5 IU in the NIH test)
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.
DISETUJUI BPOM: 24 OKTOBER 2023
ID REG: EREG100022VR12300144
POSOLOGY AND METHOD OF ADM