देश: आयरलैंड
भाषा: अंग्रेज़ी
स्रोत: HPRA (Health Products Regulatory Authority)
Selamectin
Norbrook Laboratories Limited
QP54AA05
Selamectin
240 mg/pipette
Spot-on solution
POM: Prescription Only Medicine as defined in relevant national legislation
selamectin
Authorised
2018-10-26
Health Products Regulatory Authority 26 October 2018 CRN000WFZ Page 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT SELAPRO 240 mg spot-on solution for large dogs (20.1–40.0 kg) 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 2.0ml pipette contains: ACTIVE SUBSTANCE: Selamectin 240 mg EXCIPIENTS: Butylhydroxytoluene (E321) 1.6 mg For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Spot-on solution. A clear, colourless to yellow solution. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs. 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. PREVENTION OF HEARTWORM DISEASE caused by _Dirofilaria immitis _with monthly administration. Selamectin may be safely administered to animals infected with adult heartworms, however, it is recommended, in accordance with good veterinary practice, that all animals 6 months of age or more living in countries where a vector exists should be tested for existing adult heartworm infections before beginning medication with Selamectin. It is also recommended that dogs should be tested periodically for adult heartworm infections, as an integral part of a heartworm Health Products Regulatory Authority 26 October 2018 CRN000WFZ Page 2 of 9 prevention strategy, even when S पूरा दस्तावेज़ पढ़ें