Country: Germany
Language: English
Source: HMA (Heads of Medicines Agencies)
cefoperazone 250 mg
Pfizer Limited
QJ51DD12
Intramammary suspension
cefoperazone
Cattle
2012-11-16
ISSUED: December 2012 AN: 01574/2011 Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Pathozone 250 mg Intramammary Suspension for Cattle 2. QUALITATIVE AND QUANTITATIVE COMPOSITION MG/10ML ACTIVE SUBSTANCE: Cefoperazone 250 (as the sodium salt) 258.9 EXCIPIENTS: all-rac- α-Tocopherol (E307) 4.6 For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Intramammary Suspension. White to off-white oily suspension 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle (lactating dairy cows). 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES The product is indicated for the treatment of clinical mastitis in lactating cows. Clinical mastitis caused by a wide range of organisms including the following pathogens have been shown to respond to treatment with cefoperazone. - Streptococcus dysgalactiae - Streptococcus uberis - Streptococcus agalactiae - Staphylococcus aureus (including penicillinase producing strains) - Escherichia coli - Trueperella pyogenes - Pseudomonas aeruginosa - Micrococcus spp. - Klebsiella spp. 4.3 CONTRAINDICATIONS Do not use in case of hypersensitivity to cephalosporins or to any of the excipents or in case of severe disturbance of kidney function. ISSUED: December 2012 AN: 01574/2011 Page 2 of 4 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES It is not envisaged for this product to be administrated to species other than lactating cattle. 4.5 Read the complete document