MILBACTOR 2.5 MG/25 MG TABLETS FOR SMALL DOGS AND PUPPIES WEIGHING AT LEAST 0.5 KG
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
09-12-2016
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Active ingredient:
MILBEMYCIN OXIME, PRAZIQUANTEL
Available from:
Krka, d.d., Novo mesto
ATC code:
QP54AB51
INN (International Name):
MILBEMYCIN OXIME, PRAZIQUANTEL
Dosage:
2.5mg/25
Pharmaceutical form:
Tablets
Prescription type:
POM
Therapeutic group:
Canine
Therapeutic area:
Milbemycin, combinations
Therapeutic indications:
Endectoparasiticides
Authorization status:
Authorised
Authorization date:
2015-01-09
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Milbactor 2.5 mg/25 mg tablets for small dogs and puppies weighing at least 0.5 kg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
3 PHARMACEUTICAL FORM
Tablet.
Yellowish-white with brown spots, oval, biconvex tablets scored on one side.
The tablets can be divided into equal halves.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs (small dogs and puppies).
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 by immature adult (L5) and adult parasite stages; see
specific treatment and disease prevention schedules under section 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.
Each tablet contains:
Active substances
Milbemycin Oxime
2.5 mg
Praziquantel
25.0 mg
Excipients
For the full list of excipients, see section 6.1.
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 24/11/2016_
_CRN 7025046_
_page number: 1_
4.3 CONTRAINDICATIONS
Do not use in puppies of less than 2 weeks of age and/or weighing less than 0.5 kg.
Do not use in case of hypersensitivity
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