Milbactor 12.5 mg/125 mg tablets for dogs weighing at least 5 kg

Riik: Iirimaa

keel: inglise

Allikas: HPRA (Health Products Regulatory Authority)

Toimeaine:

Milbemycin oxime; Praziquantel

Saadav alates:

Krka, d.d., Novo mesto

ATC kood:

QP54AB51

INN (Rahvusvaheline Nimetus):

Milbemycin oxime; Praziquantel

Annus:

12.5, 125.0 mg/tablet

Ravimvorm:

Tablet

Retsepti tüüp:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapeutiline rühm:

Dogs

Terapeutiline ala:

milbemycin oxime, combinations

Näidustused:

Endectoparasiticides

Volitamisolek:

Authorised

Loa andmise kuupäev:

2015-01-09

Toote omadused

Health Products Regulatory Authority
23 August 2021
CRN00C8R9
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Milbactor 12.5 mg/125 mg tablets for dogs weighing at least 5 kg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
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ACTIVE SUBSTANCES
Milbemycin Oxime
12.5
mg
Praziquantel
125.0
mg
​
​
​
EXCIPIENTS
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
Yellowish-white with brown spots, round, slightly biconvex tablets.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs (weighing at least 5 kg).
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 dogs weighing less than 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, repeated use of an anthelmintic of
that class.
It is recommended to treat all the animals living in the same
househ