ZANTEL

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:

Dogs

Therapeutic area:

praziquantel, combinations

Therapeutic indications:

Anthelmintic

Authorization status:

Authorised

Authorization date:

2003-11-04

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
ZANTEL
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCES:
Per tablet
Praziquantel
50.0 mg
Fenbendazole
500.0 mg
EXCIPIENTS
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
A round buff-coloured tablet with a quarter score
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
A broad spectrum anthelmintic for the treatment of mixed infections by
nematodes and cestodes in dogs.
Ascarids
_Toxocara canis _
(immature, adult)
_ _
Toxascaris leonina (immature, adult)
Hookworms
_ _
_Uncinaria stenocephala _
(immature, adult)
_ _
_ _
_Ancylostoma caninum _
(immature, adult)
Whipworms
_Trichuris vulpis (adult)_
Tapeworms
_Echinococcus granulosus _
_ _
_Echinococcus multilocularis _
_ _
_Dipylidium caninum _
_ _
_Taenia pisiformis _
_ _
_Taenia hydatigena _
_ _
4.3
CONTRAINDICATIONS_ _
Do not use in puppies under the age of 2 weeks
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.
Parasite resistance to any particular class of anthelmintic may
develop following frequent, repeated use
of an anthelmintic of that class.
Refer to Section 4.3
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 the administration to the animal
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
Vomiting has been reported in dogs administered the product at the
recommended dose.
4.7
USE DURING PREGNANCY, LACTATION OR LAY
Laboratory studies in rats, mice and rabbits, have not produced any
evidence of a teratogenic or
foetotoxic effect for praziquantel and fenbendazole. The safety was
not