国家: 爱尔兰
语言: 英文
来源: HPRA (Health Products Regulatory Authority)
PASTEURELLA MULTOCIDA STRAIN X-73 (SEROVAR 1), INACTIVATED, PASTEURELLA MULTOCIDA STRAIN P-1059 (SEROVAR 3), INACTIVATED, PASTEURELLA MULTOCIDA STRAIN P-1662 (SEROVAR 4), INACTIVATED, PASTEURELLA MULTOCIDA, STRAIN CU (SEROVAR 3X4), INACTIVATED
Zoetis Ireland Limited
QI01AB02
PASTEURELLA MULTOCIDA STRAIN X-73 (SEROVAR 1), INACTIVATED, PASTEURELLA MULTOCIDA STRAIN P-1059 (SEROVAR 3), INACTIVATED, PASTEU
Unknown
Emulsion for Injection
POM
Fowl - Chicken, Fowl - Duck, Fowl - Turkey
Pasteurella vaccine
Immunological - Inactivated vaccine
Authorised
2013-12-09
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT POULVAC PABAC IV 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 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. ADJUVANT: QUANTITY: 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. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 10/12/2013_ _CRN 7016253_ _page number: 1_ 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 by _Pasteurella multocida _serovar 1 (Heddleston classification). Onset of immunity against serovar 1 阅读完整的文件