Milbemycin / Praziquantel (EU Generics) 12.5 mg/125 mg Flavoured Tablets for Dogs

Land: Vereinigtes Königreich

Sprache: Englisch

Quelle: VMD (Veterinary Medicines Directorate)

Wirkstoff:

Milbemycin Oxime (A3 and A4), Praziquantel

Verfügbar ab:

EU Generics Limited

ATC-Code:

QP54A

INN (Internationale Bezeichnung):

Milbemycin Oxime (A3 and A4), Praziquantel

Darreichungsform:

Tablet

Verschreibungstyp:

POM-V - Prescription Only Medicine – Veterinarian

Therapiegruppe:

Dogs

Therapiebereich:

Anthelmintic

Berechtigungsstatus:

Authorized

Berechtigungsdatum:

2020-01-29

Fachinformation

Issued January 2020
AN: 02040/2017
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Milbemycin / Praziquantel (EU Generics) 12.5 mg/125 mg Flavoured
Tablets for
Dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCES:
Milbemycin oxime
12.5 mg
Praziquantel
125.0 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
A brown flat round shaped tablet with a break line on one side.
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”)
Issued January 2020
AN: 02040/2017
Page 2 of 6
_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 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 Milbemycin / Praziquantel (EU Generics) Flavoured
Tablets for
Dogs in young puppies from these breed