מדינה: האיחוד האירופי
שפה: אנגלית
מקור: EMA (European Medicines Agency)
live attenuated Muscovy duck parvovirus
Merial
QI01BD03
live attenuated Muscovy duck parvovirus
Ducks
Immunologicals for aves, duck parvovirus, Live viral vaccines
Active immunisation of ducks to prevent mortality1 and to reduce weight loss and lesions of duck parvovirosis and Derzsy's disease.1In absence of maternally derived antibodies.
Revision: 2
Withdrawn
2014-04-11
Medicinal product no longer authorised 17 _ _ B. PACKAGE LEAFLET Medicinal product no longer authorised 18 PACKAGE LEAFLET: PARVODUK CONCENTRATE AND SOLVENT FOR SUSPENSION FOR INJECTION FOR MUSCOVY DUCKS 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT Marketing authorisation holder: MERIAL 29 avenue Tony Garnier 69007 Lyon, FRANCE Manufacturer responsible for batch release: MERIAL Laboratory of Lyon Porte des Alpes Rue de l’Aviation, 69800 Saint Priest FRANCE 2. NAME OF THE VETERINARY MEDICINAL PRODUCT Parvoduk concentrate and solvent for suspension for injection for Muscovy ducks 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS Each reconstituted dose of 0.2 ml contains: Active substance: Live attenuated Muscovy duck parvovirus strain GM 199 ...................... 2.6–4.8 log 10 CCID 50 * * Cell culture infectious dose 50%. Concentrate and solvent for suspension for injection. The concentrate is opalescent and homogeneous. The solvent is clear and colourless. 4. INDICATION(S) Active immunisation of Muscovy ducks to reduce weight loss and lesions of Muscovy duck parvovirosis and Derzsy’s disease and, in the absence of maternally derived antibodies, to also prevent mortality. Onset of immunity: 11 days after the primary vaccination course Duration of immunity: 26 days after the primary vaccination course The demonstrated duration of immunity protects the birds during the period when they are most susceptible to Muscovy duck parvovirosis and Derzsy’s disease. Medicinal product no longer authorised 19 5. CONTRAINDICATIONS Do not use in birds in lay. 6. ADVERSE REACTIONS None. If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon. 7. TARGET SPECIES Muscovy ducks. 8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION For subcutaneous use. Administer one dose of 0.2 ml by s קרא את המסמך השלם
Medicinal product no longer authorised 1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Parvoduk concentrate and solvent for suspension for injection for Muscovy ducks 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each reconstituted dose of 0.2 ml contains: ACTIVE SUBSTANCE: Live attenuated Muscovy duck parvovirus strain GM 199 ............................... 2.6–4.8 log 10 CCID 50 * * Cell culture infectious dose 50%. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Concentrate and solvent for suspension for injection. The concentrate is opalescent and homogeneous. The solvent is clear and colourless. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Muscovy ducks. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Active immunisation of Muscovy ducks to reduce weight loss and lesions of Muscovy duck parvovirosis and Derzsy’s disease and, in the absence of maternally derived antibodies, to also prevent mortality. Onset of immunity: 11 days after the primary vaccination course Duration of immunity: 26 days after the primary vaccination course The demonstrated duration of immunity protects the birds during the period when they are most susceptible to Muscovy duck parvovirosis and Derzsy’s disease. 4.3 CONTRAINDICATIONS Do not use in birds in lay. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Vaccinate healthy animals only. Medicinal product no longer authorised 3 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals The entire flock should be vaccinated to lower the risk of any circulation of the vaccine strain and virus recombination. Special precautions to be taken by the person administering the veterinary medicinal product to animals Not applicable. 4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS) None. 4.7 USE DURING PREGNANCY, LACTATION OR LAY Do not use in birds in lay (see section 4.3). 4.8 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION No information is avail קרא את המסמך השלם