Milbemax chewable tablets for dogs
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
25-04-2024
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Active ingredient:
milbemycin oxime praziquantel
Available from:
Novartis Animal Health UK Ltd
ATC code:
QP54AB51
Dosage:
Unknown
Pharmaceutical form:
Tablets Chewable
Therapeutic group:
Canine
Therapeutic area:
Endoparasiticide
Authorization status:
Authorised
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Milbemax Chewable Tablets for Dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
3 PHARMACEUTICAL FORM
Chewable tablet.
Oval shaped, dark brown.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs.
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.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 27/03/2014_
_CRN 7017150_
_page number: 1_
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 leonine_
_Trichuris vulpis_
_Crenosoma vulpis _(Reduction of the level of infection)
_Angiostrongylus vasorum _(Reduction of the level of infection by immature adult (L5) and adult parasite stages;
see specific treatment and disease prevention schedules under SPC point “4.9 Amounts to be administered and
administration route”)
_ _
_Thelazia callipaeda _(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 heartworm disease (_Dirofilaria immitis_) if concomitant treatment
against cestodes is indicated.
4.3 CONTRAINDICATIONS
Do not use in dogs weighing less than 5 kg.
Do not use in case of hypersensitivity to the active substances or to any of excipients
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