Prazitel Plus Tablets for Dogs

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Praziquantel; Pyrantel embonate ; Febantel

Available from:

Chanelle Pharmaceuticals Manufacturing Limited

ATC code:

QP52AA51

INN (International Name):

Praziquantel; Pyrantel embonate ; Febantel

Dosage:

50,50,150 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:

Endoparasiticide

Authorization status:

Authorised

Authorization date:

2009-02-27

Summary of Product characteristics

1
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Prazitel Plus Tablets For Dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
ACTIVE SUBSTANCES:
Praziquantel
50 mg
Pyrantel
50 mg (equivalent to 144 mg pyrantel embonate)
Febantel
150 mg
EXCIPIENTS:
QUALITATIVE
COMPOSITION OF EXCIPIENTS AND OTHER CONSTITUENTS
Lactose monohydrate
Microcrystalline cellulose
Magnesium stearate
Colloidal anhydrous silica
Croscarmellose sodium
Sodium laurilsulfate
Pork flavour
A pale yellow tablet with a cross breakline on one side.
The tablets can be divided into 2 or 4 equal parts.
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Dogs.
3.2
INDICATIONS FOR USE FOR EACH TARGET SPECIES
Treatment of mixed infections by nematodes and cestodes of the
following species
NEMATODES:
ASCARIDS:
_Toxocara canis_
,
_Toxascaris leonina_
(adult and late immature forms).
HOOKWORMS:
_Uncinaria stenocephala_
,
_Ancylostoma caninum_
(adults).
WHIPWORMS:
_Trichuris vulpis_
(adults).
CESTODES:
TAPEWORMS:
_Echinococcus_
species
_(E. granulosus, E. multilocularis), Taenia_
species
_(T. hydatigena, T. pisiformis, T. taeniformis), Dipylidium caninum_
(adult and immature forms).
3.3
CONTRAINDICATIONS
Do not use simultaneously with piperazine compounds.
Do not use in cases of hypersensitivity to the active substances or to
any of the excipients.
3.4
SPECIAL WARNINGS
2
Fleas serve as intermediate hosts for one common type of tapeworm –
_Dipylidium caninum_
.
Tapeworm infestation is certain to reoccur unless control of
intermediate hosts such as fleas, mice, etc.
is undertaken.
Tapeworm infestation is unlikely in pups less than 6 weeks of age.
Parasite resistance to any particular class of anthelmintic may
develop following frequent, repeated use
of an anthelmintic of that class.
3.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for safe use in the target species:
Not applicable.
Special precautions to be taken by the person administering the
veterinary medicinal product to
animals:
In case of accidental ingestion, seek medical advice immediately an