Country: United Kingdom
Language: English
Source: VMD (Veterinary Medicines Directorate)
Rabies virus
MSD Animal Health UK Limited
QI07AA02
Rabies virus
Suspension for injection
POM-V - Prescription Only Medicine – Veterinarian
Cats, Dogs
Inactivated Viral Vaccine
Authorized
2005-10-25
Revised: December 2021 AN: 00973/2021 Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Canigen Rabies Suspension for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1 ml dose contains: ACTIVE SUBSTANCE: Inactivated rabies virus strain Pasteur RIV: ≥ 0.95 AIU* equivalent to ≥ 2 IU** _ * Batch control is performed with an in vitro potency test according to Ph. Eur. monograph 451._ _ AIU = rabies antigenic mass AlphaLISA International Units._ _** Corresponding potency in the in vivo mouse challenge test according to Ph. Eur. Monograph 451._ ADJUVANT: Aluminium phosphate (adjuvant) 0.60 - 0.88 mg Al 3+ EXCIPIENTS: Thiomersal (preservative) 0.1 mg For the full list of excipients see section 6.1. 3. PHARMACEUTICAL FORM Suspension for injection Light yellow/orange to slightly red/purple with a whitish sediment. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs and cats. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the active immunisation against rabies to reduce clinical signs and mortality. Onset of immunity: an adequate serological response ( 0.5 IU) has been demonstrated 2 to 3 weeks after vaccination. Duration of immunity: 3 years. 4.3 CONTRAINDICATIONS None. Revised: December 2021 AN: 00973/2021 Page 2 of 5 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Vaccinate healthy animals only. The vaccine may not be effective in animals incubating the disease at the time of vaccination. Some animals may be immunologically incompetent and fail to respond to vaccination. A good immune response is reliant on the reaction of an immunogenic agent and a fully competent immune system. Immunocompetence of the animal may be compromised by a variety of factors including poor health, nutritional status, genetic factors, concurrent drug therapy and stress. 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals The presence of maternal antibodies can interfere with the response to vaccination. This product should not be administered for at least one m Read the complete document