国: スペイン
言語: 英語
ソース: HMA (Heads of Medicines Agencies)
bovine respiratory syncytial virus 10000 TCID50, bovine viral diarrhoea virus inactivated 20 SN, parainfluenza 3 Virus inactivated 16 HAI
Laboratorios Hipra S. A.
QI02AH
Powder and solvent for suspension for injection
Live and Inactivated viral vaccines
Cattle Food
2010-09-16
_[Version 7.3, 04/2010] _ ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT HIPRABOVIS BALANCE 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Composition per dose (3 ml): Active substances: Parainfluenza-3 virus, inactivated, strain SF4 ………...……..…………… HAI* ≥ 16 (≥ 480 HAU before inactivation) Bovine viral diarrhoea virus, inactivated, strain NADL …………..…….... SN** ≥ 20 (≥ 10 6 TCID 50 before inactivation) Bovine respiratory syncytial virus, live, strain Lym-56 ………..…... ≥ 10 4 TCID 50 *** * HAI: mean haemagglutination inhibition titre induced in rabbits. * SN: mean serum neutralisation titre induced in rabbits. *** TCID 50 : Tissue culture infective dose 50 Adjuvants: Aluminium hydroxide (Al 3+ ) ................................................................................. 6.34 mg Excipients Thimerosal (preservative) ....................................................................................... 0.3 mg For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Lyophilisate and solvent for suspension for injection. The lyophilisate is a yellowish tablet. The solvent is a pinkish liquid. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Bovine (cows, heifers and calves; as of 4 weeks old) 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Adult cattle (cows and heifers): prevention of bovine viral diarrhoea (including the disease of the mucosas) (BVD). Calves: prevention of the Parainfluenza 3 (PI3) virus, disease of the mucosas or bovine viral diarrhoea (BVD) and pneumonia by bovine respiratory syncytial virus (BRS). Immunity starts thre 完全なドキュメントを読む
_[Version 7.3, 04/2010] _ ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT HIPRABOVIS BALANCE 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Composition per dose (3 ml): Active substances: Parainfluenza-3 virus, inactivated, strain SF4 ………...……..…………… HAI* ≥ 16 (≥ 480 HAU before inactivation) Bovine viral diarrhoea virus, inactivated, strain NADL …………..…….... SN** ≥ 20 (≥ 10 6 TCID 50 before inactivation) Bovine respiratory syncytial virus, live, strain Lym-56 ………..…... ≥ 10 4 TCID 50 *** * HAI: mean haemagglutination inhibition titre induced in rabbits. * SN: mean serum neutralisation titre induced in rabbits. *** TCID 50 : Tissue culture infective dose 50 Adjuvants: Aluminium hydroxide (Al 3+ ) ................................................................................. 6.34 mg Excipients Thimerosal (preservative) ....................................................................................... 0.3 mg For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Lyophilisate and solvent for suspension for injection. The lyophilisate is a yellowish tablet. The solvent is a pinkish liquid. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Bovine (cows, heifers and calves; as of 4 weeks old) 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Adult cattle (cows and heifers): prevention of bovine viral diarrhoea (including the disease of the mucosas) (BVD). Calves: prevention of the Parainfluenza 3 (PI3) virus, disease of the mucosas or bovine viral diarrhoea (BVD) and pneumonia by bovine respiratory syncytial virus (BRS). Immunity starts thre 完全なドキュメントを読む