Riik: Iirimaa
keel: inglise
Allikas: HPRA (Health Products Regulatory Authority)
Selamectin
Krka, d.d., Novo mesto
QP54AA05
Selamectin
120 mg/pipette
Spot-on solution
POM: Prescription Only Medicine as defined in relevant national legislation
selamectin
Authorised
2018-12-21
Health Products Regulatory Authority 19 April 2021 CRN00C756 Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Selames 120 mg spot-on solution for dogs 10.1–20.0 kg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1 ml pipette contains: ACTIVE SUBSTANCE: Selamectin 120 mg EXCIPIENTS: Butylhydroxytoluene (E321) 0.8 mg For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Spot-on solution. Clear, colourless to yellow to brown solution. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs (10.1-20.0 kg) 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES TREATMENT AND PREVENTION OF FLEA INFESTATIONS caused by _Ctenocephalides _spp. for one month following a single administration. This is as a result of the adulticidal, larvicidal and ovicidal properties of the product. The product is ovicidal for 3 weeks after administration. Through a reduction in the flea population, monthly treatment of pregnant and lactating animals will also aid in the prevention of flea infestations in the litter up to seven weeks of age. The product can be used as part of a treatment strategy for flea allergy dermatitis and through its ovicidal and larvicidal action may aid in the control of existing environmental flea infestations in areas to which the animal has access. TREATMENT OF EAR MITES (_Otodectes cynotis_). TREATMENT OF BITING LICE INFESTATIONS (_Trichodectes canis_) TREATMENT OF SARCOPTIC MANGE (caused by _Sarcoptes scabiei_) TREATMENT OF ADULT INTESTINAL ROUNDWORMS (_Toxocara canis_) PREVENTION OF HEARTWORM DISEASE caused by _Dirofilaria immitis _with monthly administration. 4.3 CONTRAINDICATIONS Do not use in animals under 6 weeks of age. Do not use in cases of hypersensitivity to the active substance or to any of the excipients. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Do not apply when the animal's hair coat is wet. Avoid frequent swimming or shampooing the animal because the ma Lugege kogu dokumenti