Država: Irska
Jezik: engleski
Izvor: HPRA (Health Products Regulatory Authority)
AMOXICILLIN (AS AMOXICILLIN TRIHYDRATE), CLAVULANIC ACID (AS POTASSIUM CLAVULANATE PH.EUR.)
Norbrook Laboratories Limited
QJ01CR02
AMOXICILLIN (AS AMOXICILLIN TRIHYDRATE), CLAVULANIC ACID (AS POTASSIUM CLAVULANATE PH.EUR.)
140/35 Mg/Ml
Suspension for Injection
POM
Bovine, Canine
Amoxicillin and enzyme inhibitor
Antibacterial
Authorised
2002-09-27
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Noroclav Injection for Cattle and Dogs 2 QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCE: Amoxycillin (as Amoxycillin trihydrate) 14.0% w/v Clavulanic acid (as Potassium clavulanate) 3.5% w/v EXCIPIENTS: For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM A suspension for injection. An off-white suspension. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle and Dogs. HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 30/09/2016_ _CRN 7024420_ _page number: 1_ 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Noroclav Injection has a broad-spectrum of bactericidal activity against the bacteria commonly found in cattle and dogs. (a) _In vitro _Noroclav 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, _Pasteurellae _spp, _Fusobacterium_ _necrophorum_, Bacteroides (including beta-lactamase producing strains), _Haemophilus _spp, _Moraxella _spp and _Actinobacillus lignieresi_. (b) Noroclav Injection is indicated for the treatment of diseases including: Cattle: Respiratory infections Soft tissue infections (e.g. joint/navel ill, abscesses etc.) Metritis Mastitis. Dogs: Respiratory tract infections Urinary tract infections Skin and soft tissue infections (e.g. abscesses, pyoderma, anal sacculitis and gingivitis.) 4.3 CONTRAINDICATIONS The product sh Pročitajte cijeli dokument