Zipyran XL Tablets for Dogs

Land: Storbritannien

Sprog: engelsk

Kilde: VMD (Veterinary Medicines Directorate)

Aktiv bestanddel:

Febantel, Praziquantel, Pyrantel

Tilgængelig fra:

Laboratorios Calier, SA

ATC-kode:

QP52AA51

INN (International Name):

Febantel, Praziquantel, Pyrantel

Lægemiddelform:

Tablet

Recept type:

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

Terapeutisk gruppe:

Dogs

Terapeutisk område:

Anthelmintic anticestodal

Autorisation status:

Authorized

Autorisation dato:

2014-05-12

Produktets egenskaber

Revised: February 2019
AN: 01345/2018
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
ZIPYRAN XL TABLETS FOR DOGS
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains
ACTIVE SUBSTANCES:
Praziquantel
..............................................................................175
mg
Pyrantel (as pyrantel
embonate)...............................................175 mg
Febantel
....................................................................................525
mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
Yellowish oblong scored tablet, divisible into two equal parts .
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of mixed infections by adult cestodes and nematodes of the
following
species:
Nematodes:
Hookworms:
_Ancylostoma caninum_
_Uncinaria Stenocephala_
Ascarids_:_
_Toxocara canis_
_Toxascaris leonina_
Cestodes:
Tapeworms_: _
_Taenia spp_
_Dipylidium caninum_
4.3
CONTRAINDICATIONS
Revised: February 2019
AN: 01345/2018
Page 2 of 7
See section 4.7.
Do not use in cases of hypersensitivity to the active substances or to
any of the
excipients.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
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 and source of infection for one
common type of
tapeworm – _Dipylidium caninum_.
Tapeworm infestation may reoccur unless control of intermediate hosts
as well as the
environment is undertaken concurrently to the treatment.
4.5
SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
In debilitated or heavily infested animals, the product should be used
only after
evaluation of the risk / benefit by the veterinarian
Digestive haemorrhages (diarrhoea, bloody stools and even deaths)
provoked by
worm lysis may result from anthelminthic treatment in cases of heavy
infestations.
In dogs less than 6