RABIPUR

Land: Singapore

Sprog: engelsk

Kilde: HSA (Health Sciences Authority)

Aktiv bestanddel:

Inactivated rabies virus (strain Flury LEP)

Tilgængelig fra:

AENON PHARMACEUTICALS SEA PTE. LTD.

ATC-kode:

J07BG01

Dosering:

Potency≥2.5IU

Lægemiddelform:

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

Sammensætning:

Inactivated rabies virus (strain Flury LEP) Potency≥2.5IU

Indgivelsesvej:

INTRAMUSCULAR

Recept type:

Prescription Only

Fremstillet af:

GSK Vaccines GmbH (bulk product, filling, lyophilisation, QC testing)

Autorisation status:

ACTIVE

Autorisation dato:

2006-04-26

Indlægsseddel

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.OVARTIS
0

'ERMANY


Produktets egenskaber

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1.
NAME OF THE MEDICINAL PRODUCT
Rabipur
Potency ≥ 2.5 IU/ml
Powder and solvent for solution for injection
Rabies, inactivated, whole virus vaccine
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
After reconstitution, 1 dose (1.0 ml) contains:
Rabies virus* (Inactivated, strain Flury LEP)
...........................................
≥
2.5 International Units
*produced on purified chick embryo cells
The vaccine contains residues of chicken proteins (e.g. ovalbumin),
Human Serum Albumin, and may
contain traces of neomycin, chlortetracycline, and amphotericin B. See
sections 4.3 Contraindications
and 4.4 Special warnings and special precautions for use.
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Powder and solvent for solution for injection.
The powder is white. The solvent is clear and colourless.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Rabipur is indicated for active immunization against rabies in
individuals of all ages. This includes pre-
exposure prophylaxis (i.e. before possible risk of exposure to
rabies), in both primary series and booster
dose, and post-exposure prophylaxis (i.e. after suspected or proven
exposure to rabies).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The immunisation schedules for Rabipur should be based on official
recommendations.
_Posology _
The recommended single intramuscular (IM) dose is 1.0 ml in
individuals of all ages.
_P_
_RE_
_-_
_EXPOSURE _
_P_
_ROPHYLAXIS _
_(PrEP) _
Pre-exposure prophylaxis is recommended for anyone who is at
continual, frequent or increased risk for
exposure to the rabies virus, as a result of their residence or
occupation, such as laboratory workers
dealing with rabies virus and other lyssaviruses, veterinarians and
animal handlers. Travellers in high-
risk areas should be vaccinated after a risk assessment. Children
living in or visiting rabies-affected areas
are at particular risk and should be given pre-exposure prophylaxis on
an individual basis or in mass
campaigns when there are n