Quanifen (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

SUMMARY OF THE PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Quanifen (50mg Praziquantel / 500mg Fenbendazole) Tablets for Cats and
Dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
EACH TABLET CONTAINS:
ACTIVE SUBSTANCES:
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, SPECIFYING THE TARGET SPECIES
For the treatment of mixed parasitic infections in dogs and cats
caused by roundworms and
tapeworms of the following species:
Ascarids
_Toxocara canis _
(adult)
_Toxocara cati_
(adult)
_Toxascaris leonina_
(adult)
Hookworms
_ _
_Uncinaria stenocephala _
(adult)
_Ancylostoma caninum _
(adult)
Whipworms
_Trichuris vulpis _
(adult)
Tapeworms
_Echinococcus granulosus _
_Echinococcus multilocularis _
_Dipylidium caninum _
_Taenia spp. _
_Mesocestoides spp _
4.3
CONTRAINDICATIONS
Do not use in case of hypersensitivity to the active substances.
Do not use in kittens less than 8 weeks of age.
Do not use in pregnant cats.
Do not use in pregnant bitches up to day 39 of pregnancy.
For further information on treatment of pregnant bitches refer to
section 4.7 (Use during pregnancy,
lactation or lay)
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
Echinococcosis represents a hazard for humans. As Echinococcosis is a
notifiable disease in the OIE,
specific guidelines on the treatment and follow-up, and on the
safeguard of persons, n