Milprazon 16 mg/40 mg film-coated tablets for cats weighing at least 2 kg

Χώρα: Ιρλανδία

Γλώσσα: Αγγλικά

Πηγή: HPRA (Health Products Regulatory Authority)

Δραστική ουσία:

Milbemycin oxime; Praziquantel

Διαθέσιμο από:

Krka, d.d., Novo mesto

Φαρμακολογική κατηγορία (ATC):

QP54AB51

INN (Διεθνής Όνομα):

Milbemycin oxime; Praziquantel

Δοσολογία:

16, 40 mg/tablet

Φαρμακοτεχνική μορφή:

Film-coated tablet

Τρόπος διάθεσης:

POM: Prescription Only Medicine as defined in relevant national legislation

Θεραπευτική ομάδα:

Cats

Θεραπευτική περιοχή:

milbemycin oxime, combinations

Θεραπευτικές ενδείξεις:

Endoparasiticide

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2015-05-01

Αρχείο Π.Χ.Π.

Health Products Regulatory Authority
10 June 2021
CRN00C8RK
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Milprazon 16 mg/40 mg film-coated tablets for cats weighing at least 2
kg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains:
​
ACTIVE SUBSTANCES: ​
​
Milbemycin oxime
​16 mg
​
Praziquantel
​40 mg
​
​
​
EXCIPIENTS: ​
​
Iron Oxide, red (E172)
​0.20 mg
​
Titanium dioxide (E171)
​0.51 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Brown red, oval, biconvex film-coated tablets with score line on one
side.
The tablets can be divided into halves.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cats (weighing at least 2 kg).
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
In cats: treatment of mixed infections by immature and adult cestodes
and nematodes of the following species:
- Cestodes:
_Dipylidium caninum_
_Taenia _spp.
_Echinococcus multilocularis_
- Nematodes:
_Ancylostoma tubaeforme_
_Toxocara cati_
Prevention of heartworm disease (_Dirofilaria immitis_) if concomitant
treatment against cestodes is indicated.
4.3 CONTRAINDICATIONS
Do not use in cats weighing less than 2 kg.
Do not use in known cases of hypersensitivity to the active substances
or to any of the excipients.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
It is recommended to treat all the animals living in the same
household concomitantly.
In order to develop an effective worm control programme local
epidemiological information and the risk of exposure of the cat
should be taken into account, and it is recommended to seek
professional advice.
Health Products Regulatory Authority
10 June 2021
CRN00C8RK
Page 2 of 5
When _D. caninum_ infection is present, concomitant treatment against
intermediate hosts, such as fleas and lice, should be
considered to prevent re-infection.
Parasite resistance to any particular class of anthelmintic may
develop following frequent, repeated use of an anthelmintic of
that cl