MILBEMAX TABLETS FOR DOGS
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
20-04-2024
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Active ingredient:
MILBEMYCIN OXIME PRAZIQUANTEL
Available from:
Novartis Animal Health UK Ltd
ATC code:
QP54AB51
Pharmaceutical form:
Tablets
Therapeutic group:
Endoparasiticide
Therapeutic area:
Canine
Authorization date:
2010-05-07
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Milbemax tablets for Dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
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_
_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.
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
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 23/05/2011_
_CRN 7010359_
_page number: 1_
4.3 CONTRAINDICATIONS
Do not use in dogs weighing less than 5 kg.
See also point "Special precautions for use".
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
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 recommended dose should be strictly observed.
The tolerance of Milbemax in young puppies from these breeds has not been investigated.
Clinical signs in Colli
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