Country: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
Paromomycin
Huvepharma NV
QA07AA06
Paromomycin
140000 international unit(s)/millilitre
Oral solution
POM: Prescription Only Medicine as defined in relevant national legislation
paromomycin
Authorised
2019-06-07
1. NAME OF THE VETERINARY MEDICINAL PRODUCT Parofor crypto 140 000 IU/ml oral solution for pre-ruminant cattle 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: ACTIVE SUBSTANCE: 140 000 IU of paromomycin activity EXCIPIENTS: QUALITATIVE COMPOSITION OF EXCIPIENTS AND OTHER CONSTITUENTS QUANTITATIVE COMPOSITION IF THAT INFORMATION IS ESSENTIAL FOR PROPER ADMINISTRATION OF THE VETERINARY MEDICINAL PRODUCT Methyl parahydroxybenzoate (E218) 1.0 mg Propyl parahydroxybenzoate 0.1 mg Sodium metabisulfite (E223) 4.0 mg A clear yellow to amber solution. 3. CLINICAL INFORMATION 3.1 TARGET SPECIES Cattle (pre-ruminant). 3.2 INDICATIONS FOR USE FOR EACH TARGET SPECIES Reduction in the occurrence of diarrhoea due to diagnosed _Cryptosporidium parvum_ . _ _ Calves should only receive the veterinary medicinal product upon confirmation of cryptosporidial oocysts in their faeces and before the onset of diarrhoea. Paromomycin reduces faecal oocyst shedding. 3.3 CONTRAINDICATIONS Do not use in cases of hypersensitivity to the active substance, to other aminoglycosides or to any of the excipients. Do not use in cases with impaired function of the kidneys or liver. Do not use in ruminating animals. 3.4 SPECIAL WARNINGS In field studies investigating the effect of the veterinary medicinal product on diarrhoea associated with cryptosporidiosis, 23% to 32% of calves in treated groups presented with diarrhoea, in comparison to 53% to 73% of calves in untreated groups, during the 7-day treatment period. 3.5 SPECIAL PRECAUTIONS FOR USE Special precautions for safe use in the target species: The use of the veterinary medicinal product should be combined with good management practices e.g. good hygiene, proper ventilation and no overstocking. Repeated use of the veterinary medicinal product on farms should be avoided by improving management practices and through cleaning and disinfection. Aminoglycosides are considered as critically important in human medicine. Use of the veterinary medicinal product deviating from the instructio Lestu allt skjalið