PROWORMER Flavoured tablets for large dogs

Maa: Irlanti

Kieli: englanti

Lähde: HPRA (Health Products Regulatory Authority)

Aktiivinen ainesosa:

Febantel; Pyrantel ; Praziquantel

Saatavilla:

Ceva Santé Animale

ATC-koodi:

QP52AA51

INN (Kansainvälinen yleisnimi):

Febantel; Pyrantel ; Praziquantel

Annos:

525,175,175 mg/tablet

Lääkemuoto:

Tablet

Prescription tyyppi:

CAM: Companion Animal Medicine as defined in relevant national legislation

Terapeuttinen ryhmä:

Dogs

Terapeuttinen alue:

praziquantel, combinations

Käyttöaiheet:

Endoparasiticide

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2012-05-25

Valmisteyhteenveto

Health Products Regulatory Authority
18 February 2021
CRN00C055
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
PROWORMER 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.
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.
Health Products Regulatory Authority
18 February 2021
CRN00C055
Page 2 of 5
Fleas serve as intermediate hosts for one common type of tapeworm –
_Dipylidium caninum_. Tapeworm infestation