Pro-Tel 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: 01685/2022
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
PRO-TEL 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 (over 17.5 kg).
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of mixed infections by adult 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 _spp_., Taenia _spp., _Dipylidium caninum_
(adult and immature
forms).
4.3
CONTRAINDICATIONS
Do not use in animals with a known sensitivity to the active
ingredients or to any of the
excipients.
Revised: October 2022
AN: 01685/2022
Page 2 of 6
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
As
a
precautionary
measure
to
prevent
the
establishment
of
_Echinococcus _
_multilocularis_, it is recommended that all dogs entering the country
be treated with
praziquantel.
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, m