Click here to Download Data Sheet Summary of Product Characteristics 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Fenben 10 Oral Suspension 2 QUALITATIVE AND QUANTITATIVE COMPOSITION For a full list of excipients see section 6.1. Each ml contains: Active substance Fenbendazole 100 mg Excipients Potassium Sorbate 1.8 mg Formaldehyde Solution 2.0 mg 3 PHARMACEUTICAL FORM Oral suspension. 4 CLINICAL PARTICULARS 4.1 Target Species Mature Cattle and Calves. 4.2 Indications for use, specifying the target species Effective against benzimidazole sensitive mature and immature roundworms, including Type II Ostertagia, lungworms and tapeworms in cattle. 4.3 Contraindications Do not use in animals with known hypersensitivity to active ingredient. Do not use in cattle producing milk for human consumption. Each ml contains: Active substance Fenbendazole 100 mg Excipients Potassium Sorbate 1.8 mg Formaldehyde Solution 2.0 mg 4.4 Special warnings for each target species Cattle with heavy lungworm infection may suffer an allergic response to the treatment as a result of killing worms in situ. 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 bodyweight, misadministration of the product, or lack of calibration of the dosing device. Suspected clinical cases of resistance to anthelmintics should be further investigated using appropriate tests (e.g. Faecal Egg Count Reduction Test). Where the results of the tests strongly suggest resistance to a particular anthelmintic, an anthelmintic belonging to another pharmacological class and having a different mode of action should be used. 4.5 Special precautions for use Special precautions for use in animals As with all oral drenches, care must be taken to avoid injury to the mouth and pharynx when using standard drenching equipment. Special Precautions to be taken by the Person Administering the Medicinal Product to Animals Any contact with skin or eyes should be washed away immediately with water. 4.6 Adverse reactions (frequency and seriousness) None. 4.7 Use during pregnancy, lactation or lay Fenbendazole is not embryotoxic. Can be used during pregnancy. 4.8 Interaction with other medicinal products and other forms of interaction Do not use at the same time as Bromsalans. 4.9 Amounts to be administered and administration route The product is administered orally. The recommended dosage rate is 7.5 ml of the product per 100 kg bodyweightequivalent to 7.5 mg Fenbendazole/kg bodyweight. To ensure administration of a correct dose, bodyweight should be determined as accurately as possible. If animals are to be treated collectively rather than individually, they should be grouped according to their bodyweight and dosed accordingly, in order to avoid under- or overdosing. Use properly calibrated dosing equipment. The veterinary surgeon should give advice regarding appropriate dosing programmes and stock management to achieve adequate parasite control. 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary Fenbendazole is extremely safe with a safety factor in excess of 100 times the recommended dose. 4.11 Withdrawal Period(s) Animals intended for human consumption must not be slaughtered during treatment. Cattle intended for human consumption may only be slaughtered from 21 days after the last treatment. Not for use in animals producing milk for human consumption. 5 PHARMACOLOGICAL or IMMUNOLOGICAL PROPERTIES Pharmacotherapeutic group: Anthelmintics, benzimadazoles and related substances ATCvet code: QP52AC13 5.2 Pharmacokinetic properties Fenbendazole is slowly absorbed from the gut and peak blood levels are attained 28-30 h post treatment. Amongst the many metabolites are the corresponding sulphone and sulphoxide, the latter is identical to Oxfendazole and may be mresponsible for its activity. Up to 35% of the dose is eliminated in the urine, most is excreted in the faeces. 6 PHARMACEUTICAL PARTICULARS 6.1 List of excipients Potassium Sorbate Formaldehyde Solution Colloidal Anhydrous Silica Xanthan Gum Propylene Glycol Polyoxyl 40 Stearate Polyethylene Glycol Citric Acid Purified Water 6.2 Incompatibilities None known. 6.3 Shelf-life Shelf-life of the veterinary medicinal product as packed for sale: 2 years. 6.4 Special precautions for storage Do not store above 25oC. Protect from light. Protect from frost. Store in a dry place in the original container. Keep the container tightly closed. 6.5 Nature and composition of immediate packaging White HDPE packs with polypropylene screw caps. Packs contain 1 litre (flat bottom backpack), 2.5 litre (jerrican) and 5 litre (jerrican). Not all pack sizes may be marketed. 6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials Any unused product or waste material should be disposed of in accordance with national requirements. 7 MARKETING AUTHORISATION HOLDER Ancare (Ireland) Limited, 30 Coolmine Business Park, Clonsilla Road, Dublin 15. 8 MARKETING AUTHORISATION NUMBER(S) VPA: 10915/002/001 9 DATE OF THE FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 9th February 2009 10 DATE OF REVISION OF THE TEXT June 2013
