Quenazole (50 mg praziquantel / 500 mg Fenbendazole) Tablets for Cats and Dogs

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Praziquantel; Fenbendazole

Available from:

Chanelle Pharmaceuticals Manufacturing Limited

ATC code:

QP52AA51

INN (International Name):

Praziquantel; Fenbendazole

Dosage:

50/500 mg/tablet

Pharmaceutical form:

Tablet

Prescription type:

CAM: Companion Animal Medicine as defined in relevant national legislation

Therapeutic group:

Cats, Dogs

Therapeutic area:

praziquantel, combinations

Therapeutic indications:

Anthelmintic

Authorization status:

Authorised

Authorization date:

2005-04-22

Summary of Product characteristics

1.
NAME OF THE VETERINARY MEDICINAL PRODUCT:
Quenazole (50mg praziquantel / 500mg Fenbendazole) Tablets for Cats
and Dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION:
PER TABLET
Praziquantel
50.0 mg
Fenbendazole
500.0 mg
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM:
Tablet.
A round buff-coloured tablet with a score line. The tablets can be
divided into equal quarters.
4.
CLINICAL PARTICULARS:
4.1
TARGET SPECIES:
Dogs and cats.
4.2
INDICATIONS FOR USE:
For the treatment of mixed infections of roundworms and tapeworms in
dogs and cats.
ASCARIDS:
_Toxocara canis (immature, adult) _
_ _
_ _
_Toxocara cati (adult) _
_ _
_ _
_Toxascaris leonina (immature, adult) _
HOOKWORMS:
_Uncinaria stenocephala (immature, adult) _
_ _
_ _
_Ancylostoma caninum (immature, adult) _
WHIPWORMS:
_Trichuris vulpis (adult) _
_ _
TAPEWORMS:
_ Echinococcus granulosus (immature. adult) _
_ _
_ _
_Echinococcus multilocularis (immature. adult) _
_ _
_ _
_Dipylidium caninum (adult) _
_ _
_ _
_Taenia spp. (adult) _
_ _
_ _
_Mesocestoides spp (adult) _
This product may also be used as an aid in the control of Giardia
protozoa in dogs and
Aelurostrongylus abstrusus lungworm infection in cats.
4.3
CONTRAINDICATIONS:
Do not use in kittens less than 8 weeks of age.
Do not use in puppies under the age of 2 weeks or under 0.5kg in
weight
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES:
Since one of the most common tapeworms of the dog and cat (Dipylidium
caninum) is
transmitted by a flea and has a very short pre-patent period, it is
important to pay
attention to flea control to reduce the incidence of tapeworm and the
risk of re-
infection.
4.5
SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
None.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
VETERINARY
MEDICINAL PRODUCT TO ANIMALS
Wash hands after handling tablets
4.6
ADVERSE EFFECTS (FREQUENCY AND SERIOUSNESS):
None known.
4.7
USE DURING PREGNANCY AND LACTATION:
Do not exceed the stated dose when treating pregnant bitches. Do not
use in pregn