Country: Ireland
Bahasa: Inggeris
Sumber: HPRA (Health Products Regulatory Authority)
Pyrantel embonate ; Praziquantel; Febantel
Vetoquinol SA
QP52AC55
Pyrantel embonate ; Praziquantel; Febantel
144, 50, 150 mg/tablet
Tablet
CAM: Companion Animal Medicine as defined in relevant national legislation
febantel, combinations
Authorised
2005-10-21
Health Products Regulatory Authority 16 October 2020 CRN009Z8N Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Drontal Plus Flavour Bone Shaped Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCE MG/TABLET Febantel 150.0 Pyrantel embonate 144.0 Praziquantel 50.0 RELEVANT CONSTITUENTS OF THE EXCIPIENT Artificial beef flavour Irradiated 116.5 For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Tablet. A pale brown to brown, bone shaped tablet scored on both sides 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 roundworms and tapeworms in dogs and puppies: Ascarids: _Toxocara canis, Toxascaris leonina _(adult and late immature forms) Hookworms: _Uncinaria stenocephala, Ancylostoma canium _(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 Do not exceed the stated dosage when treating pregnant bitches. 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. 4.5 SPECIAL PRECAUTIONS FOR USE I) SPECIAL PRECAUTIONS FOR USE IN ANIMALS Any part-used tablets should be discarded. II) SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE MEDICINAL PRODUCT TO ANIMALS In the interest of good hygiene, persons administering the tablet directly to a dog or by adding it to the dog's food, Health Products Regulatory Authority 16 October 2020 CRN009Z8N Page 2 of 4 should wash their hands afterwards. III) OTHER PRECAUTIONS None. 4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS) In very rare cases slight and transient digestive tract disorders such as vomiting and/or diarrhoe Baca dokumen lengkap