Country: Portugal
Language: English
Source: HMA (Heads of Medicines Agencies)
milbemycin A<3>-oxim 12.5 mg, praziquantel 125 mg
Norvartis Animal Health UK Ltd
QP54AB51
Tablet
Milbemycin, combinations
Dogs
2011-04-17
MILBEMAX dogs Final RENEWAL SPC July 2007 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT MILBEMAX ® Tablets for dogs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCES: Milbemycin oxime 12.5 mg Praziquantel 125.0 mg EXCIPIENTS: QSP one tablet of 625 mg For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet Round shaped, white. One side bears the imprint “CCA”, 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: - Cestodes: _Dipylidium caninum _ _Taenia spp. _ _Echinococcus spp. _ _Mesocestoides spp. _ _ _ - Nematodes: _Ancylostoma caninum _ MILBEMAX dogs Final RENEWAL SPC July 2007 _Toxocara canis _ _Toxascaris leonina _ _Trichuris vulpis _ _Crenosoma vulpis_ (Reduction of the level of infection)_ _ _Angiostrongylus vasorum_ (Reduction of the level of infection; see specific treatment schedule under SPC point “4.9 Amounts to be administered and administration route”)_ _ _ _ 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 dogs weighing less than 5 kg See also point "Special precautions for use" 4.4 SPECIAL WARNINGS Studies with milbemycin oxime indicate that the margin of safety in certain dogs of Collie or related breeds is less than in other breeds. In these dogs, the Read the complete document