Milgusto 12.5 mg/125 mg film-coated tablets for dogs weighing at least 5 kg

Country: Իռլանդիա

language: անգլերեն

source: HPRA (Health Products Regulatory Authority)

active_ingredient:

Milbemycin oxime; Praziquantel

MAH:

Krka, d.d., Novo mesto

ATC_code:

QP54AB01

INN:

Milbemycin oxime; Praziquantel

dosage:

12.5/125 mg/tablet

pharmaceutical_form:

Film-coated tablet

prescription_type:

POM: Prescription Only Medicine as defined in relevant national legislation

therapeutic_area:

milbemycin oxime

authorization_status:

Authorised

authorization_date:

2021-09-17

SPC

Health Products Regulatory Authority
17 September 2021
CRN009WM6
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Milgusto 12.5 mg/125 mg film-coated tablets for dogs weighing at least
5 kg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains:
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
Film-coated tablet.
Pale yellowish brown, oval, biconvex, mottled, film coated tablets.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs (weighing at least 5 kg).
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
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 cases of hypersensitivity to the active substances or to
any of the excipients.
See also section 4.5 Special precautions for use.
Health Products Regulatory Authority
17 September 2021
CRN009WM6
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 in the same household