Pays: Irlande
Langue: anglais
Source: HPRA (Health Products Regulatory Authority)
Inactivated antigen of cytopathogenic BVDV strain C-86
Intervet Ireland Limited
QI02AA01
Inactivated antigen of cytopathogenic BVDV strain C-86
.
Suspension for injection
POM (E): Prescription Only Exempt as defined in relevant national legislation
Cattle
bovine viral diarrhea (BVD)
Immunological - Inactivated Vaccine
Authorised
1999-08-30
Health Products Regulatory Authority 07 August 2020 CRN009WSS Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Bovilis BVD Suspension for injection for cattle 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose of 2 ml contains: ACTIVE COMPONENT: Inactivated cytopathogenic bovine viral diarrhea (BVD) virus type 1 strain C-86, containing 50 ELISA Units (EU) and inducing at least 4.6 log 2 VN units* *Mean virus neutralizing titre obtained in the potency test ADJUVANT: Aluminium 3+ (as Al-phosphate and Al-hydroxide): 6-9 mg EXCIPIENTS: Methyl parahydroxybenzoate: 3 mg (preservative) For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Suspension for injection Red to pink-coloured turbid suspension 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle (cows and heifers) 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For active immunisation of cows and heifers from eight months of age onwards to protect the foetus against transplacental infection with bovine viral diarrhoea virus. 4.3 CONTRAINDICATIONS None. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Vaccinate healthy animals only. 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals Not applicable. Special precautions to be taken by the person administering the veterinary medicinal product to animals In the case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician. Health Products Regulatory Authority 07 August 2020 CRN009WSS Page 2 of 4 4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS) In very rare cases a slight swelling may be observed for 14 days at the site of injection. Also in very rare cases transient mild pyrexia may occur. In very rare cases, hypersensitivity reactions including anaphylactic shock may occur. In the event of anaphylactic type reactions, appropriate treatment such as with antihistamine, corticosteroid or adrenaline is recommended. The frequency of adverse reactions is defined using the followin Lire le document complet