Milprazon 4 mg/10 mg film-coated tablets for small cats and kittens weighing at least 0.5 kg

Država: Irska

Jezik: angleščina

Source: HPRA (Health Products Regulatory Authority)

Aktivna sestavina:

Milbemycin oxime; Praziquantel

Dostopno od:

Krka, d.d., Novo mesto

Koda artikla:

QP54AB51

INN (mednarodno ime):

Milbemycin oxime; Praziquantel

Odmerek:

4, 10 mg/tablet

Farmacevtska oblika:

Film-coated tablet

Tip zastaranja:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapevtska skupina:

Cats

Terapevtsko območje:

milbemycin oxime, combinations

Terapevtske indikacije:

Endoparasiticide

Status dovoljenje:

Authorised

Datum dovoljenje:

2015-04-24

Lastnosti izdelka

Health Products Regulatory Authority
10 June 2021
CRN00C8RK
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Milprazon 4 mg/10 mg film-coated tablets for small cats and kittens
weighing at least 0.5 kg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
​
Each film-coated tablet contains: ​
​
​
​
ACTIVE SUBSTANCES: ​
​
Milbemycin oxime
​
4​
mg
​
Praziquantel
​
10 mg
​
​
​
EXCIPIENTS: ​
​
Iron Oxide, yellow (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 yellow, 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 (small cats and kittens).
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 of less than 6 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.
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