Pays: Nouvelle-Zélande
Langue: anglais
Source: Ministry for Primary Industries
rabies virus (inactivated)
Schering-Plough Animal Health Limited
rabies virus (inactivated)
rabies virus (inactivated) 0 vaccine
Vaccine
ACVM Registered
2005-04-05
NOBIVAC RABIES 1x1 dose (1 mL) – Leaflet, Carton and Label A009450 Page 1 of 8 NOBIVAC RABIES 02-Mar-22 Leaflet (multiple country) PACKAGE LEAFLET FOR: NOBIVAC ® RABIES SUSPENSION FOR INJECTION 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT Marketing authorisation holder MSD Animal Health UK Ltd. Walton Manor, Walton Milton Keynes Buckinghamshire MK7 7AJ Manufacturer for the batch release: Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands 2. NAME OF THE VETERINARY MEDICINAL PRODUCT Nobivac Rabies Suspension for injection 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS 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 Light yellow/orange to slightly red/purple with a whitish sediment. 4. INDICATION(S) 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. NOBIVAC RABIES 1x1 dose (1 mL) – Leaflet, Carton and Label A009450 Page 2 of 8 NOBIVAC RABIES 02-Mar-22 5. CONTRAINDICATIONS None. 6. ADVERSE REACTIONS Transient local reactions such as non-painful diffuse to firm swellings of approximately 1 cm in diameter may be observed for up to 3 weeks after subcutaneous vaccination. A transient acute hypersensitivity reaction - with signs that may include, facial oedema, vomiting, pruritus or diarrhoea - may occur shortly after vaccination in very rare cases. Such rea Lire le document complet