Milbemycin / Praziquantel Tablets 2.5 mg/25 mg Flavoured Tablets for Small Dogs and Puppies

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Milbemycin Oxime (A3 and A4), Praziquantel

Available from:

EU Generics Limited

ATC code:

QP54A

INN (International Name):

Milbemycin Oxime (A3 and A4), Praziquantel

Pharmaceutical form:

Tablet

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Dogs

Therapeutic area:

Anthelmintic

Authorization status:

Authorized

Authorization date:

2020-01-29

Summary of Product characteristics

Issued January 2020
AN: 02041/2017
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Milbemycin / Praziquantel Tablets 2.5 mg/25 mg Flavoured Tablets for
Small Dogs
and Puppies
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCES:
Milbemycin oxime
2.5 mg
Praziquantel
25 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
A brown oblong shaped tablet with a break line on both sides.
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:
- Cestodes:
_Dipylidium caninum_
_Taenia spp._
_Echinococcus spp._
_Mesocestoides spp._
- Nematodes:
_Ancylostoma caninum_
_Toxocara canis_
_Toxascaris leonina_
_Trichuris vulpis_
_Crenosoma vulpis_ (Reduction of the level of infection)
_Angiostrongylus vasorum_ (Reduction of the level of infection by
immature adult (L5)
and adult parasite stages; see specific treatment and disease
prevention 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”)
Issued January 2020
AN: 02041/2017
Page 2 of 6
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 in puppies of less than 2 weeks of age and/or weighing
less than 0.5
kg.
Do not use in case of hypersensitivity to the active substances or to
any of the
excipients.
See also point "Special precautions for use".
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Studies with milbemycin oxime indicate that the margin of safety in
certain dogs of
Collie or related breeds is less than in other breeds. In these dogs,
the recommended
dose should be strictly observed.
The tolerance of the product in young puppies from these breeds has
n