Prazitel Plus XL Tablets for Dogs

Land: Storbritannien

Språk: engelska

Källa: VMD (Veterinary Medicines Directorate)

Aktiva substanser:

Febantel, Praziquantel, Pyrantel Embonate

Tillgänglig från:

Chanelle Pharmaceuticals Manufacturing Ltd

ATC-kod:

QP52AA51

INN (International namn):

Febantel, Praziquantel, Pyrantel Embonate

Läkemedelsform:

Tablet

Receptbelagda typ:

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

Terapeutisk grupp:

Dogs

Terapiområde:

Anthelmintic

Bemyndigande status:

Authorized

Tillstånd datum:

2012-12-21

Produktens egenskaper

Revised: June 2023
AN: 00417/2022
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Prazitel 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:
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
A yellow coloured oblong tablet with a breakline on both sides.
The tablets can be divided into two equal parts.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs.
4.2
INDICATIONS FOR USE, SPECIFYING THE 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).
4.3
CONTRAINDICATIONS
Do not use simultaneously with piperazine compounds.
Do not use in animals with a known sensitivity to the active
ingredients or to
any of the excipients.
Revised: June 2023
AN: 00417/2022
Page 2 of 6
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
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.”
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautio