البلد: الاتحاد الأوروبي
اللغة: الإنجليزية
المصدر: EMA (European Medicines Agency)
canine distemper virus, strain CDV Bio 11/A, canine adenovirus type 2, strain CAV-2 Bio 13, canine parvovirus type 2b, strain CPV-2b Bio 12/B and canine parainfluenza type 2 virus, strain CPiV-2 Bio 15 (all live attenuated)
Zoetis Belgium SA
QI07AD04
canine distemper virus, canine adenovirus, canine parvovirus, canine parainfluenza virus
Dogs
Immunologicals for canidae, Live viral vaccines
Active immunisation of dogs from six weeks of age.to prevent mortality and clinical signs caused by canine distemper virus,to prevent mortality and clinical signs caused by canine adenovirus type 1,to prevent clinical signs and reduce viral excretion caused by canine adenovirus type 2,to prevent clinical signs, leukopenia and viral excretion caused by canine parvovirus,to prevent clinical signs and reduce viral excretion caused by canine parainfluenza virus.
Revision: 7
Authorised
2014-07-03
17 B. PACKAGE LEAFLET 18 PACKAGE LEAFLET: VERSICAN PLUS DHPPI LYOPHILISATE AND SOLVENT FOR SUSPENSION FOR INJECTION FOR DOGS 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT Marketing authorisation holder: Zoetis Belgium SA Rue Laid Burniat 1 1348 Louvain-la-Neuve BELGIUM Manufacturer responsible for batch release: Bioveta, a.s., Komenského 212, 683 23 Ivanovice na Hané, CZECH REPUBLIC 2. NAME OF THE VETERINARY MEDICINAL PRODUCT Versican Plus DHPPi lyophilisate and solvent for suspension for injection for dogs 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Each dose of 1 ml contains: ACTIVE SUBSTANCES: LYOPHILISATE (LIVE ATTENUATED): MINIMUM MAXIMUM_ _ Canine distemper virus, strain CDV Bio 11/A 10 3.1 TCID 50 * 10 5.1 TCID 50 Canine adenovirus Type 2, strain CAV-2 Bio 13 10 3.6 TCID 50 * 10 5.3 TCID 50 Canine parvovirus Type 2b, strain CPV-2b Bio 12/B 10 4.3 TCID 50 * 10 6.6 TCID 50 Canine parainfluenza Type 2 virus, strain CPiV-2 Bio 15 10 3.1 TCID 50 * 10 5.1 TCID 50 SOLVENT: Water for injections ( _Aqua ad iniectabilia_ ) 1 ml * Tissue culture infectious dose 50%. Lyophilisate: spongy matter of white colour. Solvent: clear colourless liquid. 4. INDICATION(S) Active immunisation of dogs from 6 weeks of age: − to prevent mortality and clinical signs caused by canine distemper virus, − to prevent mortality and clinical signs caused by canine adenovirus type 1, 19 − to prevent clinical signs and reduce viral excretion caused by canine adenovirus type 2, − to prevent clinical signs, leucopoenia and viral excretion caused by canine parvovirus, and − to prevent clinical signs (nasal and ocular discharge) and reduce viral excretion caused by canine parainfluenza virus. Onset of immunity: − 3 weeks after the first vaccination for CDV, CAV, CPV, and − 3 weeks after completion of the primary course for CPiV. Duration of immunity: At least three years following the primary vaccination course اقرأ الوثيقة كاملة
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Versican Plus DHPPi lyophilisate and solvent for suspension for injection for dogs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose of 1 ml contains: ACTIVE SUBSTANCES: LYOPHILISATE (LIVE ATTENUATED): MINIMUM MAXIMUM_ _ Canine distemper virus, strain CDV Bio 11/A 10 3.1 TCID 50 * 10 5.1 TCID 50 Canine adenovirus Type 2, strain CAV-2 Bio 13 10 3.6 TCID 50 * 10 5.3 TCID 50 Canine parvovirus Type 2b, strain CPV-2b Bio 12/B 10 4.3 TCID 50 * 10 6.6 TCID 50 Canine parainfluenza Type 2 virus, strain CPiV-2 Bio 15 10 3.1 TCID 50 * 10 5.1 TCID 50 SOLVENT: Water for injections ( _Aqua ad iniectabilia_ ) 1 ml * Tissue culture infectious dose 50%. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Lyophilisate and solvent for suspension for injection. The visual appearance is as follows: Lyophilisate: spongy matter of white colour. Solvent: clear colourless liquid. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Active immunisation of dogs from 6 weeks of age: − to prevent mortality and clinical signs caused by canine distemper virus, − to prevent mortality and clinical signs caused by canine adenovirus type 1, − to prevent clinical signs and reduce viral excretion caused by canine adenovirus type 2, − to prevent clinical signs, leucopoenia and viral excretion caused by canine parvovirus, and − to prevent clinical signs (nasal and ocular discharge) and reduce viral excretion caused by canine parainfluenza virus. Onset of immunity: − 3 weeks after the first vaccination for CDV, CAV, CPV, and − 3 weeks after completion of the primary course for CPiV. 3 Duration of immunity: At least three years following the primary vaccination course for canine distemper virus, canine adenovirus type 1, canine adenovirus type 2 and canine parvovirus. The duration of immunity against CAV-2 was not established by challenge. It was shown that 3 years after the v اقرأ الوثيقة كاملة