Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Mannheimia haemolytica biotype a, serotype a1 leukotoxoid; Haemophilus somnus bailie strain, inactivated
Laboratorios Hipra S.A.
QI02AB
Mannheimia haemolytica biotype a, serotype a1 leukotoxoid; Haemophilus somnus bailie strain, inactivated
.
Emulsion for injection
POM: Prescription Only Medicine as defined in relevant national legislation
Cattle
Inactivated bacterial vaccines (including mycoplasma, toxoid and chlamydia)
Immunological - Inactivated Vaccine
Authorised
2005-10-27
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT HIPRABOVIS SOMNI/Lkt Emulsion for injection for cattle. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 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. 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. ACTIVE SUBSTANCES: _Mannheimia haemolytica_ Biotype A serotype A1, inactivated cell free suspension containing leukoxid Ph. Eur. - 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 a full list of excipients, see section 6.1. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _D_ _a_ _t_ _e_ _ _ _P_ _r_ _i_ _n_ _t_ _e_ _d_ _ _ _1_ _8_ _/_ _1_ _2_ _/_ _2_ _0_ _1_ _4_ _C_ _R_ _N_ _ _ _7_ _0_ _1_ _7_ _6_ _2_ _8_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ 4.4 SPECI Read the complete document