RABISIN

국가: 아일랜드

언어: 영어

출처: HPRA (Health Products Regulatory Authority)

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제품 특성 요약 제품 특성 요약 (SPC)
04-05-2024

유효 성분:

RABIES VIRUS GLYCOPROTEINS G52 RABIES VIRUS STRAIN

제공처:

Merial Animal Health Limited

ATC 코드:

QI07AA02

INN (International Name):

RABIES VIRUS GLYCOPROTEINS G52 RABIES VIRUS STRAIN

복용량:

Per Cent

약제 형태:

Suspension for Injection

처방전 유형:

POM

치료 그룹:

Bovine, Canine, Equine - Food, Feline, Mustelids, Ovine

치료 영역:

Rabies virus vaccine

치료 징후:

Immunological - Inactivated vaccine

승인 상태:

Authorised

승인 날짜:

2004-08-10

제품 특성 요약

                                SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Rabisin
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
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
.
Each 1 ml dose of vaccine contains:
ACTIVE SUBSTANCE(S):
Rabies virus glycoproteins
1 IU
ADJUVANT(S):
Aluminium (as hydroxide)
1.7
mg
EXCIPIENT(S):
Excipient
q.s. 1
ml
For a full list of excipients, see section 6.1.
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 04/09/2014_
_CRN 7016682_
_page number: 1_
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
                                
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