Country: Bretland
Tungumál: enska
Heimild: VMD (Veterinary Medicines Directorate)
Amoxicillin, Clavulanic Acid
Norbrook Laboratories Limited
QJ01CR02
Amoxicillin, Clavulanic Acid
Tablet
POM-V - Prescription Only Medicine – Veterinarian
Dogs
Antimicrobial
Authorized
2006-04-26
Revised: October 2012 AN: 00697/2012 Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Noroclav 500 mg Palatable Tablets for Dogs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: Active Ingredients: Amoxicillin (as amoxicillin trihydrate) 400 mg Clavulanic acid (as potassium clavulanate) 100 mg Colouring Agent: Carmoisine Lake (E122) 2.45mg For a full list of excipients, see Section 6.1. 3. PHARMACEUTICAL FORM Tablet. Pink divisible circular tablet with score line on one face and figure 500 embossed on opposing face. The tablet can be divided into equal halves. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Treatment of the following infections caused by beta-lactamase producing strains of bacteria sensitive to amoxicillin in combination with clavulanic acid: - Skin infections (including superficial and deep pyodermas) caused by susceptible _Staphylococci_. - Urinary tract infections caused by susceptible _Staphylococci_ or _Escherichia coli_. - Respiratory infections caused by susceptible _Staphylococci_. - Enteritis caused by susceptible _Escherichia coli_. It is recommended to carry out suitable tests for sensitivity when initiating the treatment. The treatment should only proceed if sensitivity is proven to the combination. Revised: October 2012 AN: 00697/2012 Page 2 of 6 4.3 CONTRAINDICATIONS Do not use in animals with known cases of hypersensitivity to penicillins or other substances of the beta-lactam group. Do not use in rabbits, guinea pigs, hamsters or gerbils. Do not use in animals with serious dysfunction of kidneys accompanied by anuria or oliguria. Do not use where resistance to the combination is known to occur 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. 4.5 SPECIAL PRECAUTIONS FOR USE i. Special precautions for use in animals: Inappropriate use of the product may increase the prevalence of bacteria resistant to amoxicillin/clavulanic acid. In animals with hepatic and renal failu Lestu allt skjalið