Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-01-15&atto.codiceRedazionale=15A00162&elenco30giorni=false&atto.tipoProvvedimento=DECRETO
Decree No. 134 of December 16, 2014 decentralised procedure # 0283/004/IE/V/DC.
Veterinary medicinal product: NOROCLAV 75 mg tablets flavored chewable tablets for cats and dogs.
A.I.C. holder: Norbrook Laboratories Limited,-Station Works Camlough Road-Newry Co Down, BT35 6JP Northern Ireland.
Manufacturer responsible for batch release: Norbrook Laboratories Limited,-Station Works Camlough Road-Newry Co. Down, BT35 6JP Northern Ireland.
Authorised pack sizes and numbers of A.I.C.: box containing 2 blister packs of 14 tablets each A.I.C. # 104396193;
box containing 4 blisters of 14 tablets each A.I.C. # 104396205;
box containing 16 blisters of 14 tablets each A.I.C. # 104396217;
box of 36 packs of 14 tablets each A.I.C. # 104396229.
Composition: each tablet contains: active ingredients: amoxicillin (such as amoxicillin trihydrate) 60.00 mg;
clavulanic acid (as potassium clavulanate) 15.00 mg;
excipients: so as stated in the documentation of pharmaceutical techniques acquired to acts.
Target species: cats and dogs.
Medical indications: treatment of the following infections caused by susceptible strains of bacteria beta-lactamase producers to amoxicillin in combination with clavulanic acid;
skin diseases (both the deep and superficial Pyoderma) caused by staphylococcus spp sensitive;
urinary tract infections caused by staphylococcus spp or sensitive escherichia coli. Respiratory tract infections caused by staphylococcus spp sensitive;
enteritis caused by escherichia coli sensitive;
Dental infections (eg. gingivitis).
It is recommended to perform adequate tests of sensitivity before starting treatment. The therapy should be initiated only after confirming the sensitivity to the combination of the two substances.
Waiting time: not applicable.
Validity: validity of the veterinary medicinal product as packaged for sale: 15 months;
dispose of any unused half tablets.
Dispensing scheme: to be supplied only upon presentation of medical veterinary repeatable recipe.
Effectiveness of the Decree: immediate effect.
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