Country: United Kingdom
Language: English
Source: VMD (Veterinary Medicines Directorate)
Flubendazole
Krka d.d., Novo Mesto
QP52AC12
Flubendazole
Oral suspension
POM-VPS -Prescription Only Medicine – Veterinarian, Pharmacist, Suitably Qualified Person
Chickens, Pigs
Anthelmintic
Authorized
2013-07-18
Revised: November 2017 AN: 00620/2017 Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT FLIMABO 100 mg/g suspension for use in drinking water for chickens and pigs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each g contains: ACTIVE SUBSTANCE: Flubendazole 100 mg EXCIPIENTS: Methyl parahydroxybenzoate (E218) 2.0 mg Sodium benzoate (E211) 5.0 mg Disodium edetate 0.1 mg For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Suspension for use in drinking water. White to brownish white suspension. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Pigs (piglets, pigs for fattening, pregnant and lactating sows) and chickens (layer hens, chickens for reproduction, pullets, broilers). 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES In hens/chickens: Treatment of helminthiasis caused by _Ascaridia galli_ (adult stages), _Heterakis gallinarum _ (adult stages), _Capillaria _spp. (adult stages). In pigs: Treatment of helminthiasis caused by _Ascaris suum_ (adult and intestinal larval stages) in piglets, fattening pigs, pregnant and lactating sows. 4.3 CONTRAINDICATIONS Do not use in cases of hypersensitivity to the active substance or to any of the excipients. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES In chickens, optimal results can only be achieved if strict rules of hygiene are respected in the maintenance of the cages. Revised: November 2017 AN: 00620/2017 Page 2 of 7 In both species: Care should be taken to avoid the following practices because they increase the risk of development of resistance and could ultimately result in ineffective therapy: • Too frequent and repeated use of anthelmintics from the same class, over an extended period of time. • Underdosing, which may be due to underestimation of body weight, misadministration of the product, or lack of calibration of the dosing device (if any). Suspected clinical cases of resistance to anthelmintics should be further investigated using appropriate tests (e.g. Faecal Egg Count Reduction Test). Where t Read the complete document