Exitel Plus XL 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:

175,504,525 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:

2012-03-02

Summary of Product characteristics

1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Exitel Plus XL Tablets For Dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
ACTIVE SUBSTANCES:
Praziquantel
175 mg
Pyrantel Embonate
504 mg (equivalent to 175 mg pyrantel)
Febantel
525 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 yellow coloured oblong tablet with a breakline on both sides.
The tablets can be divided into two equal parts.
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Dogs.
3.2
INDICATIONS FOR USE FOR EACH TARGET SPECIES
In adult dogs: 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.
2
Do not use in cases of hypersensitivity to the active substances or to
any of the excipients.
3.4
SPECIAL WARNINGS
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.
Care should be taken to avoid the following practices because they
increase the risk of
development of resistance and could ultimately result in ineffective
therapy:
•
Too frequent and repeated use of anthelmintics from the same class,
over an extended
period of time.
•
Underdosing, which may be due to underestimation of body weight,
misadministration
of the product.”
3.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for safe use in the target sp