Χώρα: Ολλανδία
Γλώσσα: Αγγλικά
Πηγή: HMA (Heads of Medicines Agencies)
Amoxicillin as amoxicillin trihydrate 40 mg, clavulanic acid 10.5 mg
Norbrook Laboratories Limited
QJ01CR02
Tablet
amoxicillin and enzyme inhibitor
Dogs Non Food
2011-11-24
Revised: November 2011 AN: 01187/2011 Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Nisamox 250 mg Tablets for Dogs (in all CMS and RMS UK, BE, FR, IT, NL, PT, ES.) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE INGREDIENTS: Amoxicillin (as amoxicillin trihydrate) 200 mg Clavulanic acid (as Potassium clavulanate) 50 mg EXCIPIENTS: Carmoisine Lake (E122) 1.225 mg For a full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Tablet. Round pink biconvex tablet with a score line and 250 embossed on opposing faces. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Treatment of the following infections caused by 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 infection 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 testing when initiating the treatment. The treatment should only proceed if sensitivity is proven to the combination. Revised: November 2011 AN: 01187/2011 Page 2 of 6 4.3 CONTRAINDICATIONS Do not use in animals with known cases of hypersensitivity to penicillin or other substances of the be Διαβάστε το πλήρες έγγραφο