Closamectin Injection C&S 2 X 500Ml

Target Species Cattle and Sheep. Indications for Use (Specifying the Target Species) Cattle: For the treatment of mixed trematode (fluke) and nematode or arthropod infestations due to gastrointestinal roundworms, lungworms, eyeworms, warbles, mites and lice of cattle. •Gastrointestinal roundworms Ostertagia ostertagi (including inhibited larval stages), Ostertagia lyrata (adult), Haemonchus placei (adult and immature), Trichostrongylus axei (adult and immature), Trichostrongylus colubriformis (adult and immature), Cooperia oncophora (adult and immature), Cooperia punctata (adult and immature), Cooperia pectinata (adult and immature), Oesophagostomum radiatum (adult and immature), Nematodirus helvetianus (adult), Nematodirus spathiger (adult), Strongyloides papillosus (adult), Bunostomum phlebotomum (adult and immature), Toxocara vitulorum (adult), Trichuris spp. •Lungworms Dictyocaulus viviparus (adult and 4th stage larvae) •Liver Fluke (trematodes) Fasciola gigantica, Fasciola hepatica Treatment of fluke at 12 weeks (mature) >99% efficacy. Treatment of fluke from 7 weeks (late immature) >90% efficacy •Eyeworms (adult) Thelazia spp •Cattle grubs (parasitic stages) Hypoderma bovis, Hypoderma lineatum •Lice Linognathus vituli, Haematopinus eurysternus, Solenopotes capillatus •Mange Mites Psoroptes ovis (syn P communis var bovis), Sarcoptes scabiei var bovis Closamectin Injection may also be used as an aid in the control of the biting louse Damalinia bovis and the mange mite Chorioptes bovis, but complete elimination may not occur. Persistent activity in cattle When cattle have to graze on pasture contaminated with infective larvae of cattle nematodes, treatment with Closamectin Injection at the recommended dose rate of 200 μg ivermectin per kg bodyweight and 5 mg closantel per kg bodyweight controls re-infection with: Prolonged activity Dictyocaulus viviparus Up to 21 days Ostertagia ostertagi Up to 21 days Oesophagostomum radiatum Up to 21 days Cooperia spp Up to 14 days Trichostrongylus axei Up to 14 days Haemonchus placei Up to 14 days Sheep: For the treatment of mixed trematode (fluke) and nematode or arthropod infestations due to gastrointestinal roundworms, trematodes, lungworms, nasal bots and mites of sheep. •Gastrointestinal roundworms Ostertagia circumcincta (including inhibited L4), Ostertagia trifurcata (adult and L4), Haemonchus contortus (including inhibited L4), Trichostrongylus axei (adult), Trichostrongylus colubriformis (adult and L4), T. vitrinus (adult) Cooperia curticei (adult and L4), Oesophagostomum columbianum (adult and L4), O. venulosum (adult) Chabertia ovina (adult and L4) Nematodirus filicollis (adult and L4), Trichuris ovis (adult). [L4 = fourth stage larvae] •Lungworms Dictyocaulus filaria (adult and 4th stage larvae) Protostrongylus rufescens (adult) •Liver Fluke (trematodes) Fasciola gigantica, Fasciola hepatica Treatment of fluke at 12 weeks (mature) >95% efficacy. Treatment of fluke at 7 weeks (late immature) 100% efficacy. •Nasal Bots Oestrus ovis •Mange Mites Psoroptes ovis (Treatment requires a second injection of an ivermectin-only containing product 7 days later. See section Special Warnings for Each Target Species and Amounts to be Administered and Administration Route. Benzimidazole – resistant strains of Haemonchus contortus and Ostertagia circumcincta are also controlled. Contraindications Closamectin Injection is not for intravenous or intramuscular use. Avermectins may not be well tolerated in all non-target species (cases of intolerance with fatal outcome are reported in dogs – especially Collies, Old English Sheepdogs and related breeds or crosses, and also in turtles/tortoises). Do not use in cases of known hypersensitivity to the active substances or to any of the excipients. Special Warnings for Each Target 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 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. Resistance to ivermectin has been reported in Cooperia spp in cattle. Therefore the use of this product should be based on local epidemiological information about the susceptibility of the Cooperia spp and recommendations on how to limit further selection for resistance to anthelmintics. Resistance to ivermectin and closantel has been reported in Haemonchus contortus in sheep. Therefore the use of this product should be based on local epidemiological information about the susceptibility of the Haemonchus contortus and recommendations on how to limit further selection for resistance to anthelmintics. In sheep, treatment of psoroptic mange (sheep scab) with one injection of this product will not be effective in eliminating all the mites. A suitable ivermectin–only injectable product must be administered seven days after the treatment with this product to treat clinical signs and to eliminate the mites. Sheep scab (Psoroptes ovis) is an extremely contagious external parasite of sheep. To ensure complete control great care must be taken to avoid re-infestation, as mites may be viable for up to 15 days off the sheep. It is important that all sheep which have been in contact with infected sheep are treated with an appropriate product. Contact between treated, infected and untreated flocks must be avoided until at least seven days after treatment. Special Precautions for Use Special precautions for use in animals None. Special precautions to be taken by the person administering the medical veterinary product to animals Do not smoke, eat or drink while handling the product. Avoid direct contact of the product with the skin. In case of spillage onto the skin rinse immediately with fresh water. Wash hands after use. Take care to avoid self-injection. Inadvertent self-injection may result in local irritation and/or pain at the injection site. In case of accidental self-injection, seek medical advice immediately and show the package leaflet to the physician. Other Precautions Ivermectin is very toxic to aquatic organisms and dung insects. Treated cattle should not have direct access to ponds, streams or ditches for 14 days after treatment. Long term effects on dung insects caused by continuous or repeated use cannot be excluded. Therefore repeated treatment of animals on a pasture with an ivermectin-containing product within a season should only be given in the absence of alternative treatments or approaches to maintain animal/flock health, as advised by a veterinarian. Adverse Reactions (Frequency and Seriousness) Transitory discomfort has been observed in some cattle following subcutaneous administration. Tissue swellings at the injection site are common up to 48 hours after injection which resolve thereafter without treatment. Hardness on palpation may be observed up to 7 days following administration. Transitory swelling has occasionally been observed in sheep at the injection site. Occasionally this swelling is accompanied by pain and discomfort. This swelling completely resolves within 14 days of treatment. Use During Pregnancy, Lactation or Lay Closamectin Injection can be administered to cattle and sheep at any stage of pregnancy or lactation provided that the milk is not intended for human consumption. Interactions with Other Medicaments and Other Forms of Interaction Do not administer concomitantly with chlorinated compounds. The effects of GABA agonists are increased by ivermectin. Please refer to section Contraindications of the SPC.