Country: United Kingdom
Language: English
Source: VMD (Veterinary Medicines Directorate)
Amoxicillin, Clavulanic Acid
Norbrook Laboratories Limited
QJ01CR02
Amoxicillin, Clavulanic Acid
Suspension for injection
POM-V - Prescription Only Medicine – Veterinarian
Cattle
Antimicrobial
Authorized
2003-09-24
Revised: July 2018 AN: 02259/2017 Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Combiclav Suspension for Injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCE(S) mg/ml Amoxicillin (as Amoxicillin trihydrate) 140 Clavulanic acid (as Potassium clavulanate) 35 EXCIPIENTS: Butylated Hydroxyanisole 0.08 Butylated Hydroxytoluene 0.08 For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Suspension for injection. An off-white to cream oily suspension. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Combiclav Injection has a broad spectrum of bactericidal activity against the bacteria commonly found in cattle. (a) _In vitro_ Combiclav Injection is active against a wide range of clinically important bacteria including: Gram-positive: Staphylococci (including beta-lactamase producing strains), Streptococci, Corynebacteria, Clostridia, _Bacillus anthracis_, _Actinomyces bovis_. Gram-negative: _Escherichia _ _coli_ (including beta-lactamase producing strains), _Salmonella_ spp (including beta-lactamase producing strains), _Campylobacter_ spp, _Klebsiella_ spp, _Proteus_ spp, _Pasteurella_ spp, _Fusobacterium_ _necrophorum_, Bacteroides (including beta-lactamase producing strains), _Haemophilus_ spp, _Moraxella_ spp and _Actinobacillus lignieresi._ Revised: July 2018 AN: 02259/2017 Page 2 of 6 (b) Treats: Cattle: Respiratory infections Soft tissue infections (e.g. joint/navel ill, abscesses etc.) Metritis Mastitis. Combined Therapy for the treatment of bovine mastitis. In the situation where systemic treatment as well as intramammary treatment is necessary, Combiclav Injection can be administered in combination with Combiclav Lactating Cow Intramammary Suspension. 4.3 CONTRAINDICATIONS Do not use in cases of hypersensitivity to the active substances or to any of the excipients. The product should not be administered to rabbits, guinea pigs, hamsters or gerbils. Caution is advised in its use Read the complete document