Land: Irland
Sprog: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
Paromomycin
Huvepharma NV
QA07AA06
Paromomycin
140 milligram(s)/millilitre
Oral solution
POM: Prescription Only Medicine as defined in relevant national legislation
Cattle, Pigs
paromomycin
Antibiotics
Authorised
2017-08-04
1 _ _ _ _ ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Parofor 140 mg/ml solution for use in drinking water, milk or milk replacer for pre-ruminant cattle and pigs. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Per 1 ml: ACTIVE SUBSTANCE: Paromomycin sulfate 200 mg, equivalent to paromomycin base 140 mg or 140.000 IU of paromomycin activity EXCIPIENTS: Methyl parahydroxybenzoate (E218) 1.0 mg Propyl parahydroxybenzoate 0.1 mg Sodium metabisulphite (E223) 4.0 mg For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for use in drinking water, milk or milk replacer. A clear yellow to amber solution. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle (pre-ruminant calves), pigs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Treatment of gastro-intestinal infections caused by _Escherichia coli_ . 4.3 CONTRAINDICATIONS Do not use in animals with hypersensitivity to paromomycin, other aminoglycosides or any of the excipients. Do not use in cases with impaired function of the kidneys or liver. Do not use in ruminating animals. Do not use in turkeys due to the risk of selection for antimicrobial resistance in intestinal bacteria. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Cross-resistance has been shown between paromomycin and some antimicrobials in the aminoglycosides class in Enterobacterales. Use of the product should be carefully considered when susceptibility testing has shown resistance to aminoglycosides because its effectiveness may be reduced. 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals 3 The uptake of medication by animals can be altered as a consequence of illness. In case of insufficient uptake of water/milk animals should be treated parenterally using a suitable injectable product following the advice of the veterinarian. _ _ The use of the product should be combined with good management practices e.g. good hygiene, proper ventilation, no overstocking. Since the product is potentially ototoxic and nephro Læs hele dokumentet