Milbactor 16 mg/40 mg film-coated tablets for cats weighing at least 2 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:

16, 40 mg/tablet

pharmaceutical_form:

Film-coated tablet

prescription_type:

POM: Prescription Only Medicine as defined in relevant national legislation

therapeutic_group:

Cats

therapeutic_area:

milbemycin oxime, combinations

therapeutic_indication:

Ectoparasiticide

authorization_status:

Authorised

authorization_date:

2015-02-13

SPC

Health Products Regulatory Authority
23 August 2021
CRN00C8RG
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Milbactor 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.
Health Products Regulatory Authority
23 August 2021
CRN00C8RG
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 class.
4.5 SPECIAL PRECAUTIONS FO