国: イギリス
言語: 英語
ソース: VMD (Veterinary Medicines Directorate)
Neomycin
Laboratorios e Industrias IVEN S.A.
QA07AA01
Neomycin
Powder for use in drinking water/milk
POM-V - Prescription Only Medicine – Veterinarian
Cattle, Chickens, Duck, Goose, Partridge, Pigs, Quail, Turkeys
Antimicrobial
Authorized
2018-07-11
Unlimited renewal: May 2023 AN: 00156/2023 Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT NEOIVEN 500 000 IU/g powder for use in drinking water/milk replacer 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each g contains: ACTIVE SUBSTANCE: Neomycin (as neomycin sulphate)500 000 IU EXCIPIENTS: For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for use in drinking water/milk replacer. White or almost white powder. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle (calves), pigs (weaned and fattening pigs), chickens, layer hen, ducks, turkeys, turkey hen, goose, quail and partridge. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For treatment of gastrointestinal infections caused by _E. coli_ sensitive to neomycin. 4.3 CONTRAINDICATIONS Do not use in case of hypersensitivity to the active substance, to aminoglycosides or to the excipients or in the presence of intestinal obstruction. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Medicated drinking water intake can be affected by the severity of the disease. In case of insufficient intake of water, animals should be treated parenterally. 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals Powder for oral solution that is to be dissolved in water and cannot be used as it is. Special care should be taken when considering to administer the product to the newborn calf due to the known higher gastrointestinal absorption of neomycin 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 the benefit/risk determination from the attending veterinarian. Unlimited renewal: May 2023 AN: 00156/2023 Page 2 of 5 Use of the product should be based on susceptibility testing of the bacteria isolated from the animal. If this is not possible, therapy should be based on local (regional, farm level) epidemiological information about susceptibility of the target bacteria. Official, national and regiona 完全なドキュメントを読む