Nchi: Ayalandi
Lugha: Kiingereza
Chanzo: HPRA (Health Products Regulatory Authority)
Permethrin (80:20) technical
Floris Holding BV
QP53AC04
Permethrin (80:20) technical
40 milligram(s)/millilitre
Pour-on solution
POM: Prescription Only Medicine as defined in relevant national legislation
permethrin
Authorised
2013-06-21
1 1. NAME OF THE VETERINARY MEDICINAL PRODUCT BE, DE, IE, IT, PT, UK (NI): Z-Itch 40 mg/ml pour-on solution DK, SE: Zitch Vet 40 mg/ml Pour-on Solution PL: Zetronil 40 mg/ml Pour-on Solution 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: ACTIVE SUBSTANCE: Permethrin (80:20) 40 mg EXCIPIENTS: QUALITATIVE COMPOSITION OF EXCIPIENTS AND OTHER CONSTITUENTS QUANTITATIVE COMPOSITION IF THAT INFORMATION IS ESSENTIAL FOR PROPER ADMINISTRATION OF THE VETERINARY MEDICINAL PRODUC t _ _ Butyl dioxitol A clear, colourless to pale yellow, non-aqueous pour-on solution. 3. CLINICAL INFORMATION 3.1 TARGET SPECIES Horses and donkeys. 3.2 INDICATIONS FOR USE FOR EACH TARGET SPECIES For use as an aid in the control of sweet itch due to its repellent effect on the biting insect _Culicoides_ spp. 3.3 CONTRAINDICATIONS Do not use in cases of hypersensitivity to the active substance or to any of the excipients. Do not use in equids suffering from hepatic disease. Do not use in cats. 3.4 SPECIAL WARNINGS Sweet itch is believed to be caused by hypersensitivity to the bites of flying insects e.g. _Culicoides_ species. In addition to treatment, other measures should be taken to reduce exposure to such insects where practicable. It may be appropriate for owners to seek veterinary advice on management of horses with sweet itch. It is also recommended that owners seek veterinary advice in severe cases of sweet itch and in cases of sweet itch which do not respond to treatment. Washing or exposure to rain after application of the veterinary medicinal product may affect protection. Unnecessary use of antiparasitics or use deviating from the instructions given in the SPC may increase the resistance selection pressure and lead to reduced efficacy. The decision to use the product should be based on confirmation of the parasitic species and burden, or of the risk of infestation based on its epidemiological features, for each individual animal. 2 3.5 SPECIAL PRECAUTIONS FOR USE Special precautions for safe use in the target species: For Soma hati kamili