Prowormer flavoured tablets for large dogs
Country: Ireland
Language: English
Source: HMA (Heads of Medicines Agencies)
Summary of Product characteristics
(SPC)
06-08-2012
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Active ingredient:
febantel 525 mg, praziquantel 175 mg, pyrantel 175 mg
Available from:
CEVA Animal Health
ATC code:
QP52AA51
Pharmaceutical form:
Tablet
Therapeutic group:
praziquantel, combinations
Therapeutic area:
Dogs
Authorization date:
2011-11-23
Summary of Product characteristics
Revised: December 2011
AN: 00112/2011
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
PROWORMER Flavoured tablets for large dogs [UK, IE]
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains:
ACTIVE SUBSTANCES:
Febantel ............................................................................................. 525 mg
Pyrantel (as embonate) .................................................................... 175 mg
Praziquantel ...................................................................................... 175 mg
For a 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
Revised: December 2011
AN: 00112/2011
Page 2 of 6
Do not use in animals with a known sensitivity to the active ingredients or to any of the
excipients.
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
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