Country: United Kingdom
Language: English
Source: VMD (Veterinary Medicines Directorate)
Milbemycin Oxime (A3 and A4), Praziquantel
Elanco Europe Ltd
QP54AB51
Milbemycin Oxime (A3 and A4), Praziquantel
Tablet
POM-V - Prescription Only Medicine – Veterinarian
Dogs
Anthelmintic
Authorized
2022-12-29
Issued: December 2022 AN: 00872/2022 Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Elanco Milbemycin - Praziquantel 2.5 mg/25 mg tablets for small dogs and puppies 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One tablet contains : ACTIVE SUBSTANCES: Milbemycin oxime 2.5 mg Praziquantel 25.0 mg For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet Oblong shaped, white, with a score on both sides. One side bears the imprint “AA”, the other side “NA”. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES In dogs: treatment of mixed infections by adult cestodes and nematodes of the following species susceptible to praziquantel and milbemycin oxime: - Cestodes: _Dipylidium caninum_ _Taenia spp._ _Echinococcus spp._ _Mesocestoides spp._ - Nematodes: _Ancylostoma caninum_ _Toxocara canis_ _Toxascaris leonina_ _Trichuris vulpis_ _Crenosoma vulpis_ (Reduction of the level of infection) _Angiostrongylus vasorum_ (Reduction of the level of infection by immature adult (L5) and adult parasite stages; see specific treatment and prevention disease schedules under section 4.9 “Amounts to be administered and administration route”) _Thelazia callipaeda_ (see specific treatment schedule under section 4.9 “Amounts to be administered and administration route”) Issued: December 2022 AN: 00872/2022 Page 2 of 7 The product can also be used in the prevention of heartworm disease (_Dirofilaria _ _immitis_) if concomitant treatment against cestodes is indicated. 4.3 CONTRAINDICATIONS Do not use in puppies of less than 2 weeks of age and/or weighing less than 0.5 kg. Do not use in cases of hypersensitivity to the active substances or to any of the excipients See also section 4.5 "Special precautions for use". 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES It is recommended to treat all the animals living in the same household concomitantly. When infection with the cestode _ D. caninum_ has been confirmed, conc Read the complete document