Country: Germany
Language: English
Source: HMA (Heads of Medicines Agencies)
milbemycin A<3>-oxim 12.5 mg, praziquantel 125 mg
NOVARTIS SA
QP54AB51
Chewable tablet
Milbemycin, combinations
Dogs
2011-07-09
SUMMARY OF PRODUCT CHARACTERISTICS MILBEMAX chewable tablets for dogs Summary of Product Characteristics September 2012 Novartis Animal Health Inc. CONFIDENTIAL Page 2 of 6 1. NAME OF THE VETERINARY MEDICINAL PRODUCT MILBEMAX chewable tablets for dogs SE: Milbemax vet. chewable tablets for dogs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One chewable tablet contains: ACTIVE SUBSTANCES: Milbemycin oxime 12.5 mg Praziquantel 125.0 mg EXCIPIENTS: Glycerol (E422) 460.46 mg Propylene glycol (E 1520) 4.54 mg Iron oxide, brown (E 172) 3.29 mg Butylhydroxyanisole (E 320) 1.32 mg Propyl gallate (E 310) 0.46 mg For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Chewable tablet Oval shaped, dark brown. 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 _ _Toxocara canis _ _Toxascaris leonina _ _Trichuris vulpis _ _Crenosoma vulpis_ (Reduction of the level of infection)_ _ MILBEMAX chewable tablets for dogs Summary of Product Characteristics September 2012 Novartis Animal Health Inc. CONFIDENTIAL Page 3 of 6 _Angiostrongylus vasorum_ (Reduction of the level of infection) (see specific treatment schedule under section 4.9 “Amounts to be administered and administration route”)_ _ _ _ The produ Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS MILBEMAX chewable tablets for dogs 25-Sep-2009 Summary of Product Characteristics (MRP Day 85) Novartis Animal Health Inc. CONFIDENTIAL Page 2 of 6 1. NAME OF THE VETERINARY MEDICINAL PRODUCT MILBEMAX chewable tablet for dogs SE: Milbemax vet. chewable tablet for dogs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One chewable tablet contains: ACTIVE SUBSTANCES: Milbemycin oxime 12.5 mg Praziquantel 125.0 mg EXCIPIENTS: Glycerol (E422) 460.46 mg Propylene glycol (E 1520) 4.54 mg Iron oxide, brown (E 172) 3.29 mg Butylhydroxyanisole (E 320) 1.32 mg Propyl gallate (E 310) 0.46 mg For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Chewable tablet Oval shaped, dark brown. 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 _ _Toxocara canis _ _Toxascaris leonina _ _Trichuris vulpis _ _Crenosoma vulpis_ (Reduction of the level of infection)_ _ MILBEMAX chewable tablets for dogs 25-Sep-2009 Summary of Product Characteristics (MRP Day 85) Novartis Animal Health Inc. CONFIDENTIAL Page 3 of 6 _Angiostrongylus vasorum_ (Reduction of the level of infection) (see specific treatment schedule under section 4.9 “Amounts to be administered and administration route”)_ _ _ _ The product can also be used in the prevention of heartwor Read the complete document