Rabisin

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Rabies virus glycoprotein

Available from:

Boehringer Ingelheim Vetmedica GmbH

ATC code:

QI07AA02

INN (International Name):

Rabies virus glycoprotein

Dosage:

.

Pharmaceutical form:

Suspension for injection

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

rabies virus

Authorization status:

Authorised

Authorization date:

2004-08-10

Summary of Product characteristics

Health Products Regulatory Authority
15 July 2020
CRN009VN8
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Rabisin
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 ml dose of vaccine contains:
ACTIVE SUBSTANCE(S):
Inactivated rabies virus, G52 strain
≥ 2.09 log
10
OD
50
*and ≥1 IU**
ADJUVANT(S):
Aluminium (as hydroxide)
1.7 mg
EXCIPIENT(S):
Excipient
q.s. 1 ml
*when batch control is performed with an_ in vitro _ELISA test
**when batch control is performed according to Ph. Eur. monograph 451
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Suspension for injection
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle, dogs, horses, cats, mustelids and sheep
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For active immunisation of cattle, dogs, horses, cats, mustelids and
sheep, to reduce mortality and clinical signs due to rabies
infection.
Immunity has been demonstrated 1 month after primary vaccination, and
has been shown to persist up to the first booster
dose (1 year after primary vaccination).
In cats and dogs immunity has been shown to persist for up to 3 years
following booster vaccination.
4.3 CONTRAINDICATIONS
Do not inject the vaccine subcutaneously in horses. Do not inject the
vaccine intramuscularly in cats and dogs.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Do not vaccinate unhealthy animals
Health Products Regulatory Authority
15 July 2020
CRN009VN8
Page 2 of 4
4.5 SPECIAL PRECAUTIONS FOR USE
(I) SPECIAL PRECAUTIONS FOR USE IN ANIMALS:
Where a dog or cat was vaccinated before 12 weeks of age, the primary
vaccination scheme should be completed by an
injection given at 12 weeks of age or older.
Where horses, cattle or sheep were vaccinated before 4 months of age,
the primary vaccination scheme should be completed
by an injection given at 4 months of age or older.
(II) SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
VETERINARY MEDICINAL PRODUCT TO THE ANIMALS:
In the case of accidental self-injection, seek medical