Država: Velika Britanija
Jezik: angleščina
Source: VMD (Veterinary Medicines Directorate)
Histophilus somni, Mannheimia haemolytica
Laboratorios Hipra SA
QI02AB
Histophilus somni, Mannheimia haemolytica
Emulsion for injection
POM-V - Prescription Only Medicine – Veterinarian
Cattle
Inactivated Bacterial Vaccine
Authorized
2007-05-15
Revised: November 2014 AN: 00037/2014 Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Hiprabovis Somni/Lkt Emulsion for Injection for Cattle 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCES: _Mannheimia haemolytica _Biotype A serotype_ _A1, inactivated cell free suspension containing leukotoxoid ELISA > 2.8 (*)/dose Inactivated_ Histophilus somni_ Bailie strain MAT > 3.3 (**)/dose (*) A minimum of 80 % of vaccinated rabbits show ELISA value of > 2.0; the mean ELISA is >2.8. (**) A minimum of 80 % of vaccinated rabbits show a log 2 MAT value of ≥ 3.0; the mean log 2 MAT >3.3. ADJUVANT: Liquid paraffin 18.2 mg/dose EXCIPIENTS: Thiomersal 0.2 mg/dose For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Emulsion for injection. Ivory-coloured homogeneous emulsion. 4. CLINICAL PARTICULARS 4.1. TARGET SPECIES Cattle from 2 months of age. 4.2. INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES To reduce the clinical signs and lung lesions caused by _Mannheimia _ _haemolytica_ serotype A1 and _Histophilus somni_ in calves from 2 months of age. Onset of immunity: 3 weeks. Duration of protection: Not demonstrated. Revised: November 2014 AN: 00037/2014 Page 2 of 5 4.3. CONTRAINDICATIONS Do not vaccinate unhealthy animals. Do not use in case of hypersensitivity to the active substances, to the adjuvant or to any of the excipients. 4.4. SPECIAL WARNINGS FOR EACH TARGET SPECIES None. 4.5. SPECIAL PRECAUTIONS FOR USE i) Special precautions for use in animals Do not use in animals which are underweight for their age. ii) Special precautions to be taken by the person administering the veterinary medicinal product to animals To the user: This veterinary medicinal 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 w Preberite celoten dokument