Mektix 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:

QP54AB51

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, combinations

authorization_status:

Authorised

authorization_date:

2021-09-17

SPC

1
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Mektix 12.5 mg/125 mg
film-coated tablets for dogs weighing at least 5 kg (ES, IE)
Mektix CHEWABLE 12.5 mg/125 mg
film-coated tablets for dogs weighing at least 5 kg (AT, BE,
CY, DE, FR, GR, HU, IT, LT, LV, NL, PT, RO, UK (NI))
Mektix vet 12.5 mg/125 mg
film-coated tablets for dogs weighing at least 5 kg (DK, FI, SE)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains:
ACTIVE SUBSTANCES:
Milbemycin oxime
12.5 mg
Praziquantel
125.0 mg
EXCIPIENTS:
QUALITATIVE
COMPOSITION OF EXCIPIENTS AND
OTHER CONSTITUENTS
Cellulose, microcrystalline
Lactose monohydrate
Povidone
Croscarmellose sodium
Silica, colloidal anhydrous
Meat Flavour
Yeast powder
Magnesium stearate
Hypromellose
Talc
Propylene Glycol
Liver Flavour
Pale yellowish brown, oval, biconvex, mottled, film coated tablets.
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Dogs (weighing at least 5 kg).
3.2
INDICATIONS FOR USE FOR EACH TARGET SPECIES
Treatment of mixed infections by adult cestodes and nematodes of the
following species:
- Cestodes:
_Dipylidium caninum _
_Taenia_
spp.
2
_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 3.9
Administration routes and dosage)
_Thelazia callipaeda_
(see specific treatment schedule under section 3.9 Administration
routes and
dosage)
The veterinary medicinal product can also be used in the prevention of
heartworm disease (
_Dirofilaria _
_immitis_
) if concomitant treatment against cestodes is indicated.
3.3
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 3.5 Special precautions for use.
3.4
SPECIAL WARNINGS
Parasite r