Click here to Download Data Sheet Summary of Product Characteristics 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Bayticol 10 mg/ml Pour-On Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: Active Substance Flumethrin 10 mg For a full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Pour-on solution. 4 CLINICAL PARTICULARS 4.1 Target Species Cattle 4.2 Indications for use, specifying the target species For the control of ticks (Ixodes ricinus), biting lice (Damalinia bovis) and sucking lice (Linognathus vituli, Haemotopinus eurysternus) and psoroptic mange in cattle. 4.3 Contraindications None. 4.4 Special warnings for each target species None. 4.5 Special precautions for use Special precaution(s) for use in animals: None. Special precautions to be taken by the person administering the veterinary medicinal product to animals: Avoid contact with the skin and eyes. Avoid breathing in the vapour. Wear protective gloves provided when applying the product or when handling recently treated animals. Wash splashes from the skin immediately with soap and plenty of water. Wash hands and exposed skin before meals and after work. 4.6 Adverse reactions (frequency and seriousness) Slightly irritant to the skin and mucous membranes. 4.7 Use during pregnancy, lactation or lay Bayticol is safe to use in pregnant and lactating animals. 4.8 Interaction with other medicinal products and other forms of interaction None known. 4.9 Amounts to be administered and administration route Ascertain the weight of the animals to be treated. Squeeze the required dose volume into the dosemeter (provided) and apply the contents along the back line of the animal from the front of the shoulder to the tail setting. Treat at 14 day intervals according to tick pressure. Control of ticks and biting lice 1 mg/kg b.w. of the active ingredient equivalent to 1 ml of the solution for every 10 kg bodyweight. Control of Sucking lice and mange 2 mg/kg b.w. of the active ingredient equivalent to 2ml of the solution for every 10 kg bodyweight. In cases of clinically severe mange a repeat treatment is necessary after 14 days. Bayticol may be used in beef and dairy cattle including pregnant animals. All animals in the herd should be treated. Bought-in-animals should also be treated and yarded for some hours before joining the herd. 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary In trials 10 times the recommended dose rate (10 mg/kg b.w.) applied to calves did not cause any detectable side effects. Symptoms of poisoning:- Ataxia, dyspnoea, apathy. Treat symptomatically. Gastric lavage or saline laxative may be used. No data available on specific antidote. 4.11Withdrawal Period(s) Animals must not be slaughtered for human consumption during treatment. Animals must not be slaughtered for human consumption until 5 days after the last treatment. Milk for human consumption may be taken only after 10 days following the last treatment. 5 PHARMACOLOGICAL or IMMUNOLOGICAL PROPERTIES Pharmacotherapeutic group: Ectoparasiticides for topical use, pyrethroids ATCvet code: QP53AC05 5.1 Pharmacodynamic properties Flumethrin is an ectoparasticide of the synthetic pyrethroid group. According to current knowledge the synthetic pyrethroids interfere with the sodium channel of nerve cell membranes, resulting in a delay in repolarization of the nerve. Alpha-cyano pyrethroids (type-II pyrethroids) like Flumethrin appear to be much more potent in this regard causing long-lasting trains of repetitive firing in nerve cells. In studies on the structure-activity relationship of a number of pyrethroids, interference with receptors of a certain chiral conformation was noted thereby causing selective activity on ectoparasites. No anti-cholinesterase activity was noted with these compounds. Flumethrin was found to have an outstanding acaricidal activity. 6 PHARMACEUTICAL PARTICULARS 6.1 List of excipients 2-Octyldodecanol Butylhydroxytoluene Liquid paraffin 6.2 Incompatibilities None known. 6.3 Shelf-life Shelf life of the veterinary medicinal product as packaged for sale: 3 years. Following withdrawal of the first dose, use remainder of the product within 9 months. Discard unused material. 6.4 Special precautions for storage Do not freeze. 6.5 Nature and composition of immediate packaging Container material: Polyethylene/polyamide bottles of litre. Closure: Polypropylene screw closure, blue. Contents: Viscous yellow-brown oil. Dosemeter: Graduated polypropylene measuring cup with a polyethylene lid. 6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials Toxic to bees and fish and other aquatic organisms. Do not contaminate ponds, streams or other waterways with unused product or empty containers. Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements 7 MARKETING AUTHORISATION HOLDER Bayer Limited, Animal Health Division, The Atrium, Blackthorn Road, Dublin 18 8 MARKETING AUTHORISATION NUMBER(S) VPA 10021/010/001 9 DATE OF THE FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 30th September 2009
