Country: United Kingdom
Language: English
Source: VMD (Veterinary Medicines Directorate)
Cefalexin, Kanamycin
Boehringer Ingelheim Animal Health UK Ltd
QJ51RD01
Cefalexin, Kanamycin
Intramammary suspension
POM-V - Prescription Only Medicine – Veterinarian
Cattle
Antimicrobial intramammary
Authorized
2008-09-04
Revised: November 2018 AN: 00959/2018 Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Ubrolexin intramammary suspension for lactating dairy cows 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 10 g (12 ml) intramammary syringe contains: ACTIVE SUBSTANCES: Cefalexin (as monohydrate): 200 mg Kanamycin (as monosulphate): 100,000 I.U. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Intramammary suspension. Off-white, oily paste. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle (lactating dairy cows) 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Treatment of clinical mastitis in lactating dairy cows for bacteria susceptible to the combination of cefalexin and kanamycin such as _Staphylococcus aureus _(see section 5.1), _Streptococcus dysgalactiae_, _Streptococcus uberis _and _Escherichia coli_. 4.3 CONTRAINDICATIONS Do not use in lactating dairy cows with a known hypersensitivity to cefalexin and/or kanamycin. Do not use in non-lactating cattle. Do not use in the case of known resistance of cefalexin and/or kanamycin. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS Recommendations for prudent use The product should be used for treatment of clinical mastitis only. Revised: November 2018 AN: 00959/2018 Page 2 of 6 Use of the product should be based on susceptibility testing of the bacteria isolated from the animal. If this is not possible, therapy should be based on local (regional and farm level) epidemiological information about susceptibility of the target bacteria as well as by taking into account official national antimicrobial policies. Inappropriate use of the product may increase the prevalence of bacteria resistant to cefalexin and kanamycin and may decrease the effectiveness of treatment with other cephalosporins or aminoglycosides due to the potential for cross-resistance. SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL PROD Read the complete document