Kraj: Hiszpania
Język: angielski
Źródło: HMA (Heads of Medicines Agencies)
pasteurella multocida 70 %survival X73, pasteurella multocida 70 %survivalCU, pasteurella multocida 70 %survivalP1059, pasteurella multocida 70 %survivalP1662
Pfizer
QI01AB02
Emulsion for injection
Pasteurella vaccine
Chicken Females, Other Birds, Turkeys
2011-07-24
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT POULVAC PABAC IV [POULVAC iP (Spain only)] emulsion for injection in chickens, ducks, and turkeys 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Per dose of 0.5 ml ACTIVE SUBSTANCES : _Pasteurella multocida_, strain X-73 (serovar 1 * ) ,inactivated min. 70% survival (chickens) * * _Pasteurella multocida_, strain P-1059 (serovar 3 * ), inactivated min. 70% survival (turkeys) * * _Pasteurella multocida_, strain P-1662 (serovar 4 * ), inactivated min. 70% survival (turkeys) * * _Pasteurella multocida_, strain CU (serovar 3x4 * ), inactivated min. 70% survival (turkeys) * * * according to Heddleston classification ** in vaccinated birds , following virulent challenge, according to Ph. Eur. 1945 requirements ADJUVANT: Light liquid paraffin 0.325 ml Sorbitan sesquioleate 0.025 ml Polysorbate 80 0.004 ml EXCIPIENTS: Formaldehyde traces For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Emulsion for injection White creamy emulsion, with no extraneous particles. A separation of the emulsion can occur over time, leading to a biphasic appearance where the upper layer appears as a white to an off-white milky suspension and the bottom layer appears as a grey to tan aqueous phase. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Chickens (future laying and future breeding hens), Ducks and Turkeys. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES In chickens (future laying and future breeding hens) and ducks: - active immunization in order to reduce mortality caused Przeczytaj cały dokument