Milbemax Tabletten fuer Hunde ab 5 kg
Negara: Austria
Bahasa: Inggris
Sumber: HMA (Heads of Medicines Agencies)
Karakteristik produk
(SPC)
21-08-2013
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Bahan aktif:
milbemycin A<3>-oxim 12.5 mg, praziquantel 125 mg
Tersedia dari:
Norvartis Animal Health UK Ltd
Kode ATC:
QP54AB51
Bentuk farmasi:
Tablet
Kelompok Terapi:
Milbemycin, combinations
Area terapi:
Dogs
Tanggal Otorisasi:
2011-04-17
Karakteristik produk
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
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