Riik: Iirimaa
keel: inglise
Allikas: HPRA (Health Products Regulatory Authority)
Inactivated infectious bovine rhinotracheitis virus strain LA; Inactivated parainfluenza-3 virus, strain SF4; Inactivated bovine diarrhoea virus strain NADL; Live bovine respiratory strain lym-56
Laboratorios Hipra S.A.
QI02AH
Inactivated infectious bovine rhinotracheitis virus strain LA; Inactivated parainfluenza-3 virus, strain SF4; Inactivated bovine diarrhoea virus strain NADL; Live bovine respiratory strain lym-56
- percent
Powder and solvent for suspension for injection
POM: Prescription Only Medicine as defined in relevant national legislation
Cattle
Live and inactivated viral vaccines
Immunological - Mixed Vaccine (L & A)
Authorised
2003-06-06
Health Products Regulatory Authority 17 June 2019 CRN0094D9 Page 1 of 3 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT HIPRABOVIS-4 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Composition per dose (3 ml) of vaccine: Inactivated Infectious Bovine Rhinotracheitis Virus (IBR), strain LA ≥ 10 7 TCID 50 Inactivated Parainfluenza-3 Virus (PI3), strain SF4 ≥ 480 HAU Inactivated Bovine Diarrhoea Virus (BVD), strain NADL ≥ 10 6 TCID 50 Live Bovine Respiratory Syncytial Virus, strain Lym-56 ≥ 10 5 TCID 50 Adjuvant Aluminium hydroxide gel (as Aluminium per dose) 5.39-6.67 mg Saponine 0.30 mg Thiomersal 0.30 mg Excipient q.s 3.00 ml For a full list of excipients see section 6.1 3 PHARMACEUTICAL FORM Powder for reconstitution for suspension for injection. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle from 2 months of age. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES To stimulate active immunity against IBR, PI3, BVD and BRS viruses in cattle. For active immunisation of cattle to reduce clinical signs of Bovine Respiratory Syndrome associated with Infectious Bovine Rhinotracheitis, Parainfluenza-3 virus and Bovine Viral Diarrhoea virus, as well as to reduce virus shedding and duration of shedding of BRSV. Onset and duration of immunity: Immunity conferred by HIPRABOVIS-4 appears at 30-50 days after first vaccination and lasts for at least 1 year. 4.3 CONTRAINDICATIONS None. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES It is advisable to vaccinate all animals in a herd in order to minimise spread of infection. Maternal antibodies will reduce the efficacy of the vaccine if administered to calves less than 2 months of age. 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS Vaccinate only healthy animals. SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL PRODUCT TO ANIMALS Health Products Regulatory Authority 17 June 2019 CRN0094D9 Page 2 of 3 Lugege kogu dokumenti