Milprazon 2.5 mg/25 mg tablets for small dogs and puppies weighing at least 0.5 kg

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

Milbemycin oxime; Praziquantel

Tilgjengelig fra:

Krka, d.d., Novo mesto

ATC-kode:

QP54AB51

INN (International Name):

Milbemycin oxime; Praziquantel

Dosering :

2.5, 25.0 mg/tablet

Legemiddelform:

Tablet

Resept typen:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapeutisk gruppe:

Dogs

Terapeutisk område:

milbemycin oxime, combinations

Indikasjoner:

Endoparasiticide

Autorisasjon status:

Authorised

Autorisasjon dato:

2015-03-06

Preparatomtale

Health Products Regulatory Authority
10 June 2021
CRN00C8RQ
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Milprazon 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 section 4.5 "Special precautions for use".
Health Products Regulatory Authority
10 June 2021
CRN00C8RQ
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