Closamectin Injection

Name:

 Closamectin Injection

Category:

 Anthelmintics

Region:

 United Kingdom

Closamectin Injection is a ready-to-use solution, containing 0.5%w/v ivermectin and 12.5%w/v closantel.

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 at 9 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.

Bodyweight and dosage should be accurately determined prior to treatment to avoid underdosing.

Closamectin Injection should be administered at a dosage rate of 200 mcg ivermectin per kg and 5 mg closantel per kg bodyweight. It should be injected subcutaneously in the middle portion of the neck using the aseptic technique. A maximum volume of 10ml should be administered at any one site with any residual volume administered at another site in the neck. The first dose should be injected in the right neck with any residual volumes injected into separate sites on the left and right neck. A sterile 16-gauge, one-inch needle is recommended. Use of a draw-off needle is recommended to avoid excess broaching of the stopper.

Over 300 kg bodyweight give 1 ml per 25 kg bodyweight

The timing for treatment should be based on epidemiological factors and should be customised for each individual farm. A dosing programme should be established by a Suitably Qualified Person.

Animals must not be slaughtered for human consumption during treatment. Cattle must not be treated within 35 days of slaughter for human consumption. Do not use in cattle producing milk for human consumption. Do not use in non-lactating dairy cows including pregnant heifers within 60 days of calving. Do not use any closantel-containing products during the 35 day withdrawal period. If an ivermectin-only product is used during this period, the withdrawal periods for all products must be observed.

This product is not for intravenous or intramuscular use.
Do not smoke, eat or drink while handling the product. Direct contact of the product with the skin should be kept to a minimum. 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.

Keep out of reach of children.

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).
Transitory discomfort has been observed in some cattle following subcutaneous administration. Tissue swellings at the injection site have been observed. These reactions resolve without treatment.

Do not use in cases of known hypersensitivity to the active ingredient.

To avoid secondary reactions due to the death of Hypoderma larvae in the oesophagus or in the spine it is recommended to administer the product at the end of warble fly activity and before the larvae reach their resting sites. Consult your veterinarian on the correct timing of treatment.

Overdose: Symptoms of serious closantel overdose are decreased vision or blindness, anorexia, inco-ordination and general weakness

EXTREMELY DANGEROUS TO FISH AND AQUATIC LIFE. Do not contaminate surface water or ditches with the product or used container. Dispose of any unused product and empty containers in accordance with guidance from your local waste regulation authority.

Do not store above 25°C.
Protect from light.
This product does not contain a preservative.
Avoid the introduction of contamination during use.
Should any apparent growth or discolouration occur, the product should be discarded.
Use of a draw-off needle is recommended to avoid excess broaching of the stopper.
Discard 28 days after first removing a dose. This date should be recorded on the label. Discard unused material.

POM - VPS
To be supplied on veterinary prescription only, UK authorised veterinary medicinal product.

Closamectin Injection is available in three ready-to-use sizes - 100 ml, 250 ml and 500 ml volumes.

Marketing Authorisation Holder:
Norbrook Laboratories Limited
Newry
Northern Ireland

Distributed By:
Norbrook Laboratories Limited
The Green, Great Corby
Carlisle, Cumbria
CA4 8LR

Patent Application No: EP03702765.3

Marketing Authorisation number:

Vm: 02000/4254

Ivermectin belongs to the avermectin [3-AV] class of anthelmintics in the endectocides. Chemical group of anthelmintic endectocides [3-AV]. Closantel is a member of the salicylanilide class of anthelmintics.

Further information for the treatment programmes for mixed infestations consisting of nematodes and/or ectoparasite concurrent with fluke.

The treatment schedule should be based on the local epidemological situation. The dosing programme should be established by a suitably qualified person. Observe minimum interdosing periods due to possible closantel accumulation.

FOR ANIMAL TREATMENT ONLY