Pays: Irlande
Langue: anglais
Source: 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
Fort Dodge Animal Health Limited
QI01AB
Suspension for Injection
Immunological - Inactivated vaccine
Fowl - Chicken
2003-03-03
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Poulvac Past M. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION For a full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Suspension for injection. Inactivated, liquid, adjuvanted bacterin suspension. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Chickens and turkeys. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES To reduce clinical signs and mortality of Fowl Cholera (Pasteurellosis) infection. The duration of immunity is 16 weeks 4.3 CONTRAINDICATIONS Do not administer via the intramuscular route Refer to section 4.4 and 4.7. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Vaccinate only healthy animals. Active Ingredients Per dose (0.5ml) _Pasteurella multocida _strain X-73 3.75 x 10 8 – 1 x 10 9 CFU* _Pasteurella multocida _strain P-1059 5.02 x 10 8 – 1 x 10 10 CFU* _Pasteurella multocida _strain P-1662 3.75 x 10 8 – 1 x 10 9 CFU* *CFU: Colony Forming Units CONSTITUENTS Sterile Saline 0.235000 ml Formalin Solution 0.000875 ml Tween-80 0.003000 ml White Oil 0.240000 ml Arlacel-83 0.010000 ml IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 16/11/2006_ _CRN 7002450_ _page number: 1_ 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS None. SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE PRODUCT TO ANIMALS TO THE USER This product contains mineral oil. Accidental injection/self injection may result in severe pain and swelling, particularly if injected into a joint or finger, and in rare cases could result in the loss of the affected finger if prompt medical attention is not given. If you are accidentally injected with this product, seek prompt medical advice even if only a very Lire le document complet