Ország: Írország
Nyelv: angol
Forrás: HPRA (Health Products Regulatory Authority)
Amprolium hydrochloride
HUVEPHARMA SA
QP51AX09
Amprolium hydrochloride
400 milligram(s)/millilitre
Solution for use in drinking water
POM: Prescription Only Medicine as defined in relevant national legislation
amprolium
Authorised
2019-08-30
1. NAME OF THE VETERINARY MEDICINAL PRODUCT Amproline 400 mg/mL solution for use in drinking water for chickens and turkeys 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL contains: ACTIVE SUBSTANCE(S): Amprolium..................................400.0 mg (equivalent to amprolium hydrochloride 452.4 mg) EXCIPIENT(S): QUALITATIVE COMPOSITION OF EXCIPIENTS AND OTHER CONSTITUENTS QUANTITATIVE COMPOSITION IF THAT INFORMATION IS ESSENTIAL FOR PROPER ADMINISTRATION OF THE VETERINARY MEDICINAL PRODUC t _ _ Sorbic acid (E200) 0.5 mg Purified water Solution for use in drinking water Clear and yellow solution 3. CLINICAL INFORMATION 3.1. TARGET SPECIES Chickens (broilers, pullets, layers and breeder hens), turkeys. 3.2. INDICATIONS FOR USE FOR EACH TARGET SPECIES Treatment of intestinal coccidiosis caused by _Eimeria _ spp. 3.3. CONTRAINDICATIONS Do not use in cases of hypersensitivity to the active substance or to any of the excipients. 3.4. SPECIAL WARNINGS As with any antimicrobial, frequent and repeated use of antiprotozoal agents of the same class can lead to resistance development. Cross-resistance has been shown between amprolium and anticoccidial drugs having the same mode of action. Use of the veterinary medicinal product/amprolium should be carefully considered when susceptibility testing has shown resistance to amprolium/anticoccidials because its effectiveness may be reduced. As with all anticoccidials, prolonged use may result in the development of resistant strains. In case of detection of lack of efficacy during treatment, communicate it to competent national authorities. 3.5. SPECIAL PRECAUTIONS FOR USE Special precautions for safe use in the target species The veterinary medicinal product is not intended for prophylaxis. This veterinary medicinal product should be reserved in case of coccidiosis outbreaks due to non- availability of vaccine, in case of lack of efficacy of vaccine and in vaccinated flocks if a severe coccidial challenge is diagnosed before immunity has fully developed. Use of the veterin Olvassa el a teljes dokumentumot