MILBEMAX CHEWABLE TABLETS FOR DOGS
Country: Portugal
Language: English
Source: HMA (Heads of Medicines Agencies)
Patient Information leaflet
(PIL)
21-08-2013
Summary of Product characteristics
(SPC)
21-08-2013
Active ingredient:
milbemycin A<3>-oxim 12.5 mg, praziquantel 125 mg
Available from:
NOVARTIS SA
ATC code:
QP54AB51
Pharmaceutical form:
Chewable tablet
Therapeutic group:
Milbemycin, combinations
Therapeutic area:
Dogs
Authorization date:
2011-07-09
Patient Information leaflet
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
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
