Country: United Kingdom
Language: English
Source: HMA (Heads of Medicines Agencies)
amoxicillin trihydrate 625 mg/g
Novartis Animal Health d.o.o.
QJ01CR02
Powder for oral solution
amoxicillin and enzyme inhibitor
Pigs Food
2013-12-08
COMBINATION OF THE PROPOSED INFORMATION REQUIRED FOR LABELLING AND PACKAGE LEAFLET NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT Marketing authorisation holder: Novartis Animal Health Inc. Manufacturer: Lek Pharmaceuticals d.d., Penicillin Production Plant Perzonali 47, SI-2391 Prevalje Slovenia NAME OF THE VETERINARY MEDICINAL PRODUCT STRENZEN 500 / 125 mg/g powder for use in drinking water for pigs STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Each gram contains: ACTIVE SUBSTANCE Amoxicillin 500 mg (corresponding to 573.88 mg of Amoxicillin trihydrate) Clavulanic acid 125 mg (corresponding to 148.88 mg of Potassium clavulanate) EXCIPIENTS Sodium citrate, Citric acid, Mannitol INDICATION(S) Treatment of clinical infections respiratory tract infections caused by _Actinobacillus pleuropneumoniae, Pasteurella multocida, _ _Streptococcus suis. _ gastrointestinal infections caused by _Clostridium perfringens., E. 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. CONTRAINDICATIONS Do not use in case of hypersensitivity to penicillin or cephalosporin antibiotics or any of the exc Read the complete document
REVISED 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 (corresponding to 573.88 mg of Amoxicillin trihydrate) Clavulanic acid 125 mg (corresponding to 148.88 mg of Potassium clavulanate) EXCIPIENTS: For a 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 infections respiratory tract infections caused by _Actinobacillus pleuropneumoniae, Pasteurella multocida, _ _Streptococcus suis. _ gastrointestinal infections caused by _Clostridium perfringens., E. 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 case of hypersensitivity to penicillin or cephalosporin antibiotics or any of the excipients. The product should not be given to rabbits, guinea pigs, hamsters, gerbils or small herbivores. 4.4 SPECIAL WARNINGS The product should be given to pigs only. 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS The uptake of medication by animals can be Read the complete document