Ország: Ausztria
Nyelv: angol
Forrás: HMA (Heads of Medicines Agencies)
amoxicillin trihydrate 400 mg, clavulanic acid 105 mg
Norbrook Laboratories Limited
QJ01CR01
Tablet
ampicillin and enzyme inhibitor
Dogs
2011-02-16
Revised: May 2011 AN: 00894/2010 Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Noroclav 500 mg Palatable Tablets for Dogs Noroclav Tablets 400mg/100mg for Dogs (Sweden) Noroclav Comprimés 400mg/100mg pour Chiens (France) 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) 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: May 2011 AN: 00894/2010 Page 2 of 6 Olvassa el a teljes dokumentumot