X-Spectra Flavoured Tablets for Large Dogs

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Febantel, Praziquantel, Pyrantel

Available from:

Ceva Animal Health Ltd

ATC code:

QP52AA51

INN (International Name):

Febantel, Praziquantel, Pyrantel

Pharmaceutical form:

Tablet

Prescription type:

NFA-VPS - Non-Food Animal – Veterinarian, Pharmacist, Suitably Qualified Person

Therapeutic group:

Dogs

Therapeutic area:

Anthelmintic

Authorization status:

Authorized

Authorization date:

2010-11-26

Summary of Product characteristics

Revised: October 2022
AN: 01742/2022
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
X-SPECTRA Flavoured tablets for large dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
ACTIVE SUBSTANCES:
Febantel
........................................................................................525
mg
Pyrantel (as embonate)
................................................................175 mg
Praziquantel
..................................................................................175
mg
EXCIPIENTS
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
Yellow brown, oval tablet with a score line on one side.
The tablets can be divided into equal halves
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of mixed infections by cestodes and nematodes 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).
Revised: October 2022
AN: 01742/2022
Page 2 of 6
4.3
CONTRAINDICATIONS
Do not use in animals with a known sensitivity to the active
ingredients or to any of the
excipients.
See section 4.7 below.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Dogs kept together or in kennels should be treated at the same time.
Parasite resistance to any particular class of anthelmintic may
develop following
frequent, repeated use of an anthelmintic of that class.
Fleas serve as intermediate hosts for one common type of tapeworm –
_ Dipylidium _
_caninum_. Tapeworm infestation may reoccur unless control of
intermediate hosts such
as fleas, mice etc is undertaken.
4.5
SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE I