Cattle and Sheep.

For the treatment of mixed trematode (fluke) and nematode or arthropod infestations due to gastrointestinal roundworms, lungworms, eyeworms, warbles, mites and lice of cattle.

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.

Dictyocaulus viviparus (adult and 4th stage larvae)

Treatment of fluke at 12 weeks (mature) >99% efficacy.

Treatment of fluke from 7 weeks (late immature) >90% efficacy

Thelazia spp

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.

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

For the treatment of mixed trematode (fluke) and nematode or arthropod infestations due to gastrointestinal roundworms, trematodes, lungworms, nasal bots and mites of sheep.

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]

Dictyocaulus filaria (adult and 4th stage larvae)

Protostrongylus rufescens (adult)

Treatment of fluke at 12 weeks (mature) >95% efficacy.

Treatment of fluke at 7 weeks (late immature) 100% efficacy.

Benzimidazole – resistant strains of Haemonchus contortus and Ostertagia circumcincta are also controlled.

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.

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:

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.

None.

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.

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.

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.

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.

Do not administer concomitantly with chlorinated compounds. The effects of GABA agonists are increased by ivermectin. Please refer to section 4.3 of the SPC.

Closamectin Injection should be administered at a dosage rate of 200 μg ivermectin per kg bodyweight and 5 mg closantel per kg bodyweight (1 ml per 25 kg). It should only be injected subcutaneously into the neck. A maximum dose of 10ml should be administered at any one site with any residual volume administered at another site in the neck. A sterile 16-gauge, one-inch needle is recommended.

For the treatment and control of sheep scab an injection of Closamectin Injection for Sheep may be administered but must be followed with a second injection of an ivermectin only product seven days after the initial injection to treat clinical signs of scab and to eliminate mites. This injection should be administered at the other side of the neck.

This product does not contain an antimicrobial preservative. Swab septum before removing each dose. Use a dry sterile needle and syringe. For 250 ml and 500 ml pack sizes, use of a multiple dose syringe is recommended. To refill the syringe, use of a draw-off needle is recommended to avoid excessive broaching of the stopper.

Do not exceed 40 broachings per vial. If more than 40 broachings are required, use of a draw off needle is recommended.

The timing for treatment should be based on epidemiological factors and should be customised for each individual farm. As with other anthelmintics, veterinary advice should be sought on appropriate dosing programmes and stock management to achieve adequate parasite control and reduce the likelihood of resistance developing.

To ensure administration of a correct dose, bodyweight should be determined as accurately as possible; accuracy of the dosing device should be checked.

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 over-dosing.

Single doses of 4.0 mg/kg ivermectin (20 times the recommended dosage) administered subcutaneously, result in ataxia and depression. No antidote has been identified. Symptomatic treatment may be beneficial.

Closantel like other salicylanilides is a potent uncoupler of oxidative phosphorylation and the safety index is not as high as is the case of many other anthelmintics. However where used as directed there are unlikely to be any untoward effects. Signs of overdosage can include loss of appetite, decreased vision, loose faeces and increased frequency of defaecation. High doses may cause blindness, hyperventilation, hyperthermia, general weakness, inco-ordination, convulsions, tachycardia and in extreme cases death. Treatment of overdosage is symptomatic as no antidote has been identified.

Oral closantel doses in excess of 82.5 mg/kg in cattle may cause blindness, hyperventilation, hyperthermia, general weakness, in-coordination, convulsions, tachycardia and in extreme cases death.

Meat and offal: 49 days.

Milk: Not authorised for use in cattle producing milk for human consumption including during the dry period. Do not use during the last trimester of pregnancy in heifers which are intended to produce milk for human consumption.

Meat and offal: 28 days.

Milk: Not authorised for use in ewes producing milk for human consumption including during the dry period. Do not use within 1 year prior to the first lambing in ewes intended to produce milk for human consumption.