Страна: Європейський Союз
мова: англійська
Джерело: EMA (European Medicines Agency)
live gE- tk- double-gene-deleted bovine herpes virus type 1, strain CEDDEL: 106.3–107.3 CCID50
Laboratorios Hipra S.A
QI02AD01
live gene-deleted vaccine for intramuscular use for active immunisation of cattle against infectious bovine rhinotracheitis
Cattle
Immunologicals
For the active immunisation of cattle from three months of age against bovine herpes virus type 1 (BoHV-1) to reduce the clinical signs of infectious bovine rhinotracheitis (IBR) and field virus excretion.Onset of immunity: 21 days after completion of the basic vaccination scheme.Duration of immunity: 6 months after completion of the basic vaccination scheme
Revision: 4
Authorised
2011-01-27
19 B. PACKAGE LEAFLET 20 PACKAGE LEAFLET: HIPRABOVIS IBR MARKER LIVE lyophilisate and solvent for suspension for injection for cattle. 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT Marketing authorisation holder and manufacturer responsible for batch release: LABORATORIOS HIPRA, S.A. Avda la Selva, 135 17170 Amer (Girona) SPAIN 2. NAME OF THE VETERINARY MEDICINAL PRODUCT HIPRABOVIS IBR MARKER LIVE lyophilisate and solvent for suspension for injection for cattle. 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Lyophilisate: Each dose of 2 ml contains: Live gE - tk - double-gene deleted bovine herpes virus type 1 (BoHV-1), strain CEDDEL: 10 6.3 – 10 7.3 CCID 50. _Abbreviations: _ _gE_ _-_ _: deleted glycoprotein E; tk_ _-_ _: deleted thymidine kinase; CCID: cell culture infectious dose _ Solvent: Phosphate buffer solution. Suspension after reconstitution: transparent pinkish liquid. Lyophilisate: white to yellowish powder. Solvent: transparent homogenous liquid. 4. INDICATION(S) For the active immunisation of cattle from 3 months of age against bovine herpes virus type 1 (BoHV-1) to reduce the clinical signs of Infectious bovine rhinotracheitis (IBR) and field virus excretion. Vaccinated animals can be differentiated from field virus infected animals due to the marker deletion (gE - ) by means of commercial diagnostic kits, unless the animals were previously vaccinated with a conventional vaccine or infected with field virus. Onset of immunity: 21 days after completion of the basic vaccination scheme. Duration of immunity: 6 months after completion of the basic vaccination. 5. CONTRAINDICATIONS Do not use in case of hypersensitivity to the active substance or to any of the excipients. 21 6. ADVERSE REACTIONS Common adverse reactions: A slight increase in body temperature up to 1 °C is common within 4 days following vaccination. Commonly, an increase in rectal temperature up to 1.63 ºC in adult c Прочитайте повний документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT HIPRABOVIS IBR MARKER LIVE lyophilisate and solvent for suspension for injection for cattle. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose of 2 ml contains: Lyophilisate: ACTIVE SUBSTANCE: Live gE - tk - double-gene deleted bovine herpes virus type 1 (BoHV-1), strain CEDDEL: 10 6.3 – 10 7.3 CCID 50. _ _ _Abbreviations: _ _gE_ _-_ _: deleted glycoprotein E; tk_ _-_ _: deleted thymidine kinase; CCID: cell culture infectious dose _ Solvent: Phosphate buffer solution. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Lyophilisate and solvent for suspension for injection. Suspension after reconstitution: transparent pinkish liquid. Lyophilisate: white to yellowish powder. Solvent: transparent homogenous liquid. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle (calves and adult cows). 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the active immunisation of cattle from 3 months of age against bovine herpes virus type 1 (BoHV- 1) to reduce the clinical signs of Infectious bovine rhinotracheitis (IBR) and field virus excretion. Onset of immunity: 21 days after completion of the basic vaccination scheme. Duration of immunity: 6 months after completion of the basic vaccination scheme. 4.3 CONTRAINDICATIONS Do not use in case of hypersensitivity to the active substance or to any of the excipients. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. 3 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals Vaccinate healthy animals only. Special precautions to be taken by the person administering the veterinary medicinal product to animals Not applicable. 4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS) Common adverse reactions: A slight increase in body temperature up to 1 °C is common within 4 days following vaccination. Commonly, an increase in rectal temperature up to 1.63 ºC in adult cows and up to 2.18 ºC in calves may be observed. This transient rise in temperature Прочитайте повний документ