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)

Active ingredient:

Milbemycin oxime; Praziquantel

Available from:

Krka, d.d., Novo mesto

ATC code:

QP54AB51

INN (International Name):

Milbemycin oxime; Praziquantel

Dosage:

2.5, 25.0 mg/tablet

Pharmaceutical form:

Tablet

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Dogs

Therapeutic area:

milbemycin oxime, combinations

Therapeutic indications:

Endectoparasiticides

Authorization status:

Authorised

Authorization date:

2015-01-09

Summary of Product characteristics

Health Products Regulatory Authority
23 August 2021
CRN00C8R9
Page 1 of 5
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
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.
3 PHARMACEUTICAL FORM
Tablet.
Yellowish-white with brown spots, oval, biconvex tablets scored on one
side.
The tablets can be divided into 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.
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 known cases of hypersensitivity to the active substances
or to any of the excipients.
See also point "Special precautions for use".
Health Products Regulatory Authority
23 August 2021
CRN00C8R9
Page 2 of 5
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Parasite resistance to any particular class of anthelmintic may
develop following frequent, repeat