3 years ago

The Irish Medicines Board

The Irish Medicines Board


Irish Medicines BoardPart IISummary of Product Characteristics1 NAME OF THE VETERINARY MEDICINAL PRODUCTCoopers Spot-On CY2 QUALITATIVE AND QUANTITATIVE COMPOSITIONActive SubstanceCyhalothrin2.0 %w/vFor a full list of excipients, see section 6.13 PHARMACEUTICAL FORMSpot on solutionClear amber coloured solution.4 CLINICAL PARTICULARS4.1 Target SpeciesCattle.4.2 Indications for use, specifying the target speciesAs a topical application for the control of lice and flies on cattle.On cattle: for the control of both sucking and biting lice, including Damalinia bovis, Solenopotes capillatus,Linognathus vituli and Haematopinus eurysternus on all ages of cattle.Also as an aid in the control of both biting and nuisance flies including Haematobia irritans, Stomoxys calcitrans,Musca species and Hydrotaea irritans.4.3 ContraindicationsNone.4.4 Special warnings for each target speciesIn some calves less than six months of age which received a 10 ml dose, transient signs of mild irritation have beenseen 24 hours after treatment.______________________________________________________________________________________________________________________Date Printed 05/12/2009 CRN 7006238 page number: 2

Irish Medicines Board4.5 Special precautions for useSpecial precaution(s) for use in animalsThere are no special precautions recommended.Special precautions to be taken by the person administering the veterinary medicinal product to animalsA transient tingling sensation on the skin may occur if cyhalothrin comes in contact with the face of some individuals.It is advisable that the following precautions should be observed:Wear protective gloves when applying the product or when handling recently treated animals.Remove heavily contaminated clothing immediately and wash before re-use.Wash splashes from skin immediately with soap and plenty of water.Wash hands and exposed skin before meals or smoking and after work.In case of contact with eyes, rinse immediately with plenty of water and seek medical advice.In case of accidental ingestion, wash out mouth with water and seek medical advice.4.6 Adverse reactions (frequency and seriousness)Minor signs of discomfort have been seen in some cattle during the 48 hours after treatment. This is of no long termdetriment to the animal.In some calves less than 6 months of age which received a 10 ml dose, transient signs of mild irritation were seen 24hours after dosing.4.7 Use during pregnancy, lactation or layNo special precautions are recommended.4.8 Interaction with other medicinal products and other forms of interactionDo not mix any other insecticide or acaricide with the product.______________________________________________________________________________________________________________________Date Printed 05/12/2009 CRN 7006238 page number: 3

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