Country: United Kingdom
Language: English
Source: VMD (Veterinary Medicines Directorate)
Amoxicillin, Clavulanic Acid
Elanco Europe Ltd
Amoxicillin, Clavulanic Acid
Powder for use in drinking water
POM-V - Prescription Only Medicine – Veterinarian
Pigs
Antimicrobial
Expired
2013-12-03
Revised: November 2017 AN: 02002/2016 Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT STRENZEN 500/125 mg/g powder for use in drinking water for pigs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each gram contains: ACTIVE SUBSTANCE Amoxicillin 500 mg (equivalent to 573.88 mg of Amoxicillin trihydrate) Clavulanic acid 125 mg (equivalent to 148.88 mg of Potassium clavulanate) EXCIPIENTS: For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for use in drinking water. Yellowish to yellow fine powder. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Pigs 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Treatment of clinical respiratory tract infections caused by _Actinobacillus pleuropneumoniae, _ _Pasteurella multocida, Streptococcus suis. _ gastrointestinal infections caused by _Clostridium perfringens, Escherichia coli_ and _Salmonella _Typhimurium where the causative pathogens are beta-lactamase-producing strains of bacteria susceptible to amoxicillin in combination with clavulanic acid and where clinical experience and/or susceptibility testing indicates the combination as the drug of choice. 4.3 CONTRAINDICATIONS Do not use in animals with known hypersensitivity to penicillin or other substances of the beta-lactam group or to any of the excipients. Do not use in rabbits, guinea pigs, hamsters, chinchillas, gerbils or small herbivores. Revised: November 2017 AN: 02002/2016 Page 2 of 7 Do not use in known cases of resistance to the combination of amoxicillin and clavulanic acid. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals The uptake of medication by animals can be altered as a consequence of illness. In case of insufficient uptake of water animals should be treated parenterally. Use of the product should be based on susceptibility testing and should take into account official national and regional policies with respect to the use of broad-spectrum antibiotics. D Read the complete document