Mektix 2.5 mg/25 mg film-coated tablets for small dogs and puppies weighing at least 0.5 kg

Pays: Irlande

Langue: anglais

Source: HPRA (Health Products Regulatory Authority)

Ingrédients actifs:

Milbemycin oxime; Praziquantel

Disponible depuis:

Krka, d.d., Novo mesto

Code ATC:

QP54AB51

DCI (Dénomination commune internationale):

Milbemycin oxime; Praziquantel

Dosage:

2.5,25 mg/tablet

forme pharmaceutique:

Film-coated tablet

Type d'ordonnance:

POM: Prescription Only Medicine as defined in relevant national legislation

Domaine thérapeutique:

milbemycin oxime, combinations

Statut de autorisation:

Authorised

Date de l'autorisation:

2021-09-17

Résumé des caractéristiques du produit

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1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Mektix 2.5 mg/25 mg
film-coated tablets for small dogs and puppies weighing at least 0.5
kg (ES, IE)
Mektix CHEWABLE 2.5 mg/25 mg
film-coated tablets for small dogs and puppies weighing at least
0.5 kg (AT, BE, CY, DE, FR, GR, HU, IT, LT, LV, NL, PT, RO, UK (NI))
Mektix vet 2.5 mg/25 mg
film-coated tablets for small dogs and puppies weighing at least 0.5
kg (DK,
FI, SE)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains:
ACTIVE SUBSTANCES:
Milbemycin oxime
2.5 mg
Praziquantel
25.0 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,
scored on one side.
The tablets can be divided into equal halves.
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Dogs (small dogs and puppies).
3.2
INDICATIONS FOR USE FOR EACH TARGET SPECIES
Treatment of mixed infections by adult cestodes and nematodes of the
following species:
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- 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 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