Ülke: İrlanda
Dil: İngilizce
Kaynak: HPRA (Health Products Regulatory Authority)
Paromomycin
Huvepharma NV
QA07AA06
Paromomycin
70000 international unit(s)/gram
Powder for use in drinking water
POM: Prescription Only Medicine as defined in relevant national legislation
Cattle, Pigs
paromomycin
Antibiotics
Authorised
2014-09-12
Health Products Regulatory Authority 06 September 2019 CRN008V67 Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Parofor 70000 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 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 neonates should be based on benefit-ri Belgenin tamamını okuyun