Country: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
Febantel; Pyrantel embonate ; Praziquantel
Bayer Animal Health GmbH
QP52AF30
Febantel; Pyrantel embonate ; Praziquantel
150, 144, 50 mg/tablet
Tablet
CAM: Companion Animal Medicine as defined in relevant national legislation
combinations of tetrahydropyrimidines
Authorised
2009-01-25
Health Products Regulatory Authority 19 June 2020 CRN009RFJ Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Drontal Plus Flavour Tablets for Dogs 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: mg per tablet Febantel 150.0 Pyrantel embonate 144.0 Praziquantel 50.0 EXCIPIENTS Artificial beef flavour, irradiated 116.5 For the full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Tablet. A light brown to brown, round, flat tablet, cross scored on one side for oral administration to dogs. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the control of the following gastrointestinal tapeworms and roundworms in dogs and puppies. Ascarids: _Toxocara canis, Toxascaris leonina _(adult and late immature forms). Hookworms: _Uncinaria stenocephala, Ancylostoma caninum _(adults) Whipworms: _Trichuris vulpis _(adults) Tapeworms: _Echinococcus _spp., _Taenia _spp., _Dipylidium caninum _(adult and immature forms) 4.3 CONTRAINDICATIONS Do not use simultaneously with piperazine compounds. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES As a precautionary measure to prevent establishment of _Echinococcus multilocularis _in the UK and Ireland it is recommended that all dogs and cats entering the country be treated with praziquantel. Fleas serve as intermediate hosts for one common type of tapeworm-_Dipylidium caninum_. Tapeworm infestation is certain to re-occur unless control of intermediate hosts such as fleas, mice etc is undertaken. 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS Any part used tablet should be discarded Consult a veterinary surgeon before treating pregnant animals for roundworms. Do not exceed the stated dose when treating pregnant bitches. Health Products Regulatory Authority 19 June 2020 CRN009RFJ Page 2 of 4 SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL PRODUCT TO ANIMALS In case of accidental ingestion, seek medical advice Lestu allt skjalið