Elanco Milbemycin - Praziquantel 12.5 mg/125 mg Chewable Tablets for Dogs

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:

Chewable tablet

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Dogs

Therapeutic area:

Anthelmintic

Authorization status:

Authorized

Authorization date:

2023-02-20

Summary of Product characteristics

Issued: February 2023
AN: 01730/2022
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Elanco Milbemycin - Praziquantel 12.5 mg/125 mg chewable tablets for
dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One chewable tablet contains:
ACTIVE SUBSTANCES:
Milbemycin oxime
12.5 mg
Praziquantel
125.0 mg
EXCIPIENTS:
Propylene glycol (E 1520)
4.54 mg
Iron oxide, brown (E 172)
3.29 mg
Butylhydroxyanisole (E 320)
1.32 mg
Propyl gallate (E 310)
0.46 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Chewable tablet
Oval shaped, dark brown.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
In dogs: treatment of mixed infections by adult cestodes and nematodes
of the
following species susceptible to praziquantel and milbemycin oxime:
- Cestodes:
_Dipylidium caninum_
_Taenia spp._
_Echinococcus spp._
_Mesocestoides spp._
- Nematodes:
_Ancylostoma caninum_
_Toxocara canis_
_Toxascaris leonina_
_Trichuris vulpis_
Issued: February 2023
AN: 01730/2022
Page 2 of 7
_Crenosoma vulpis_
_Angiostrongylus vasorum_ (Reduction of the level of infection by
immature adult (L5)
and adult parasite stages (see specific treatment and prevention
disease schedules
under SPC point “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 dogs weighing less than 5 kg.
Do not use in cases of hypersensitivity to the active substances or to
any of the
excipients.
See also section 4.5 "Special precautions for use".
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
It
is
recommended
to
treat
all
the
animals
living
in
the
same
household
concomitantly.
When infection with the cestode _ D. caninum_ has been confirmed,
concomi