Land: Irland
Sprog: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
Pyrantel embonate ; Praziquantel; Febantel
Bayer Animal Health GmbH
QP52AC55
Pyrantel embonate ; Praziquantel; Febantel
175, 504, 525 mg/tablet
Tablet
CAM: Companion Animal Medicine as defined in relevant national legislation
febantel, combinations
Authorised
2003-10-17
Health Products Regulatory Authority 22 June 2020 CRN009RCY Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Drontal Plus XL Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 2.1 ACTIVE CONSTITUENTS MG PER TABLET Febantel 525.0 Pyrantel embonate 504.0 Praziquantel 175.0 2.2 RELEVANT CONSTITUENTS OF THE EXCIPIENTS None For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. Yellow oval shaped 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 tapeworms and roundworms in adult dogs: Ascarids: _Toxocara canis, Toxascaris leonine_ (adult and late immature forms). Hookworms: _Uncinaria stenocephala_, _Ancylostoma canium_ (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 Fleas serve as intermediate hosts for one common type of tapeworm-_Dipylidium caninum_. Tapeworm infestation is certain to reoccur 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 Europena countries. As a precautionary measure to prevent establishment of _Echinococcus multilocularis_ in the UK and Ireland it is recommended that all dogs entering the country be treated with praziquantel. Health Products Regulatory Authority 22 June 2020 CRN009RCY Page 2 of 4 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTION(S) FOR USE IN ANIMALS Any part-used tablets should be discarded. Do not exceed the stated dosage when treating pregnant bitches SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE MEDICINAL PRODUCT TO ANIMALS In the interests of good hygiene, persons administ Læs hele dokumentet