Elanco Milbemycin - Praziquantel 16 mg/40 mg Film-Coated Tablets for Cats

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Milbemycin Oxime (A3 and A4), Praziquantel

Available from:

Elanco Europe Ltd

ATC code:

QP54AB51

INN (International Name):

Milbemycin Oxime (A3 and A4), Praziquantel

Pharmaceutical form:

Coated tablet

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Cats

Therapeutic area:

Anthelmintic

Authorization status:

Authorized

Authorization date:

2022-12-29

Summary of Product characteristics

Issued: December 2022
AN: 00876/2022
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Elanco Milbemycin – Praziquantel 16 mg/40 mg film-coated tablets for
cats
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains:
ACTIVE SUBSTANCES:
Milbemycin oxime
16 mg
Praziquantel
40 mg
EXCIPIENTS:
Iron oxide (E172)
0.288 mg
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Oblong shaped, reddish to reddish brown, artificial beef flavoured
tablet with a score on
both sides. One side bears the imprint “KK”, the other side
“NA”.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cats
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.
Issued: December 2022
AN: 00876/2022
Page 2 of 6
4.3
CONTRAINDICATIONS
Do not use in cats weighing less than 2 kg.
4.4
SPECIAL WARNINGS
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.
It is recommended to treat all the animals living in the same
household concomitantly.
When infection with the cestode _D. caninum_ has been confirmed,
concomitant
treatment against intermediate hosts, such as fleas and lice, should
be discussed with a
veterinarian to prevent re-infection.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
As per good veterinary practice, animals should be weighed to ensure
accurate dosing.
Ensure cats and kittens weighing between 0.5 kg and ≤2 kg receive
the appropriate
tablet strength (4 mg MBO/10 mg praziquantel) and the appropriate dose
(1/2 or 1
tablet) for the corresponding weight band (1/2 tablet for cats