البلد: المملكة المتحدة
اللغة: الإنجليزية
المصدر: VMD (Veterinary Medicines Directorate)
Paromomycin
Huvepharma N.V.
QA07AA06
Paromomycin
Powder for use in drinking water
POM-V - Prescription Only Medicine – Veterinarian
Cattle, Pigs
Antimicrobial
Authorized
2014-09-17
Revised: September 2019 AN: 01429/2018 Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Parofor 70 000 IU/g powder for use in drinking water, milk or milk replacer for pre- ruminant cattle and pigs. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Per 1 gram: ACTIVE SUBSTANCE: 70 000 IU of paromomycin activity (as paromomycin sulfate) EXCIPIENTS: For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for use in drinking water, milk or milk replacer A white to almost white powder. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle (pre-ruminant calves), pig. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Treatment of gastro-intestinal infections caused by _ Escherichia coli_ susceptible to paromomycin. 4.3 CONTRAINDICATIONS Do not use in cases of 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 None. 4.5 SPECIAL PRECAUTIONS FOR USE Revised: September 2019 AN: 01429/2018 Page 2 of 6 SPECIAL PRECAUTIONS FOR USE IN ANIMALS 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 nephrotoxic, it is recommended to assess kidney function. Special care should be taken when considering administration of the product to newborn animals due to the known higher gastrointestinal absorption of paromomycin in neonates. This higher absorption could lead to an increased risk of oto-and nephrotoxicity. The use of the product in neona اقرأ الوثيقة كاملة