Krajina: Írsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
Praziquantel; Pyrantel embonate ; Febantel
Vetoquinol SA
QP52AF30
Praziquantel; Pyrantel embonate ; Febantel
175, 504, 525 mg/tablet
Tablet
CAM: Companion Animal Medicine as defined in relevant national legislation
combinations of tetrahydropyrimidines
Authorised
2009-03-20
Health Products Regulatory Authority 16 October 2020 CRN009Z8V Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Drontal Plus XL Flavour Tablets for Dogs 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: mg per tablet Febantel 525.0 Pyrantel embonate 504.0 Praziquantel 175.0 EXCIPIENTS: Artificial beef flavour irradiated 408.0 For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Tablet. Pale brown to brown oval shaped divisible tablet scored on both sides. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the control of the following roundworms and tapeworms in adult dogs: 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. and_ Dipylidium caninum _(adult and immature forms). 4.3 CONTRAINDICATIONS Do not use simultaneously with piperazine compounds. 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 re-occur unless control of intermediate hosts such as fleas, mice etc. is undertaken. Since it contains praziquantel, the product is effective against _Echinococcus multilocularis,_ which does not occur in the UK or Ireland but is becoming more common in some European countries. As a precautionary measure to prevent establishment of _E._ _multilocularis_ in the UK and Ireland, it is recommended that all dogs entering the country be treated with praziquantel. 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS Any part-used tablets should be discarded. Do not exceed the stated dose when treating pregnant bitches. Health Products Regulatory Authority 16 October 2020 CRN009Z8V Page 2 of 4 SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE MEDI Prečítajte si celý dokument