Maa: Irlanti
Kieli: englanti
Lähde: HPRA (Health Products Regulatory Authority)
MANNHEIMIA HAEMOLYTICA BIOTYPE A, SEROTYPE A1, STRAIN 2806, LEUKOTOXOID, INACTIVATED HAEMOPHILUS SOMMUS BAILIE STRAIN
Laboratorios Hipra S.A.
QI02AB
MANNHEIMIA HAEMOLYTICA BIOTYPE A, SEROTYPE A1, STRAIN 2806, LEUKOTOXOID, INACTIVATED HAEMOPHILUS SOMMUS BAILIE STRAIN
Unknown
Emulsion for Injection
POM
Bovine
Inactivated bacterial vaccines (including Mycoplasma, Toxoid and Chlamydia vaccines)
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. HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 18/12/2014_ _CRN 7017628_ _page number: 1_ 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals Do not use in animals which are underweight for their age. Special precautions to be taken by the person administering the veterinary medicinal product to animals To the user: This veterinary medic Lue koko asiakirja