Cattle

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

Ostertagia ostertagi (including inhibited O. ostertagi), Haemonchus placei, Trichostrongylus axei, Trichostrongylus colubriformis, Cooperia spp, Oesophagostomum radiatum, Nematodirus helvetianus (adult), Strongyloides papillosus (adult).

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

Treatment of fluke at 7 weeks (late immature) >95% efficacy.

Thelazia spp

Chorioptes bovis, Sarcoptes scabiei var bovis

Do not use in cases of known hypersensitivity to the active substances or to any of the excipients.

Do not apply to areas of skin which have mange, scabs or other lesions or to areas contaminated with mud or manure.

Avermectins may not be well tolerated in 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).

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.

The effect of rain on the pour-on formulation at the time of and after application has not been investigated. For maximum effect animals should be kept indoors or undercover following treatment, when there is rain or an imminent risk of rain.

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 Ostertagia ostertagi and Cooperia spp in cattle. Therefore the use of this product should be based on local (regional, farm) epidemiological information about the susceptibility of these species and recommendations on how to limit further selection for resistance to anthelmintics.

Due to the significant likelihood of cross-contamination of non-treated animals with this product due to grooming (licking), all animals in a group should be treated at the same time and treated animals should be kept separately from non-treated animals throughout the withdrawal period. Non-compliance with this recommendation may lead to residues violations (see section Withdrawal Periods) or in very rare cases, it can lead to adverse events (see section Adverse Reactions (Frequency and Seriousness)) in non-treated animals.

It is not advisable to administer the product when Hypoderma lineatum larvae are localised in the periaesophagic region, or when Hypoderma bovis larvae are situated in the spinal canal. Seek professional veterinary advice to determine the best period of use.

Care should be taken to ensure animals are not overdosed by the application volume, accidental spillage or oral ingestion, as overdosage may result in signs of toxicity such as inco-ordination and blindness. It is recommended that animals are not clipped prior to treatment to reduce the risk of increased drug absorption and hence bioavailability, or oral ingestion through mutual grooming.

Care should be taken when treating animals which may be of low nutritional status as this may increase susceptibility of adverse events occurring.

Special precautions to be taken by the person administering the veterinary medicinal product to animals

This product may be irritating to human skin and eyes or cause hypersensitivity. Avoid skin and/or eye contact with the product during treatment, when handling recently treated animals or when cleaning the used equipment. Operators should wear nitrile rubber gloves and boots with a waterproof coat when applying the product. Protective clothing should be washed after use. If accidental skin contact occurs, wash the affected area immediately with soap and water. If accidental eye exposure occurs, flush the eyes immediately with water and get medical attention.

This product may be toxic after accidental ingestion. Avoid ingestion by hand-to-mouth contact. Do not eat, drink or smoke whilst handling the product. If accidental ingestion occurs, get medical attention and show the package leaflet to the physician. Wash hands after use. This product is flammable. Keep away from sources of ignition. Use only in well ventilated areas or outdoors.

The product 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 repeat treatments on a pasture within a season should only be given on the advice of a veterinarian.

In very rare cases (less than 1 animal in 10,000 animals, including isolated reports), neurological signs such as blindness, ataxia, and recumbency may occur after administration of the product. These cases may also be associated with gastrointestinal signs such as anorexia, diarrhoea and in extreme cases signs may persist and may result in death of the animal.

Even though the overall incidence of adverse events is very rare, it has been noted that, when there is an adverse event in a herd, several animals may be affected. Therefore, should neurological signs be observed in one animal, it is recommended to reinforce surveillance, at the herd level, of all treated animals.

Closamectin Pour-On can be administered to cattle (including dairy, beef/suckler cattle) at any stage of pregnancy or lactation provided that the milk is not intended for human consumption. See Section Withdrawal Periods

None known.

The veterinary medicinal product should be administered topically at a dosage rate of 500 μg ivermectin per kg bodyweight and 20 mg closantel per kg bodyweight (1 mL per 10 kg).

The formulation should be applied along the midline of the back in a narrow strip between the withers and the tail head.

Assess bodyweight carefully prior to administration.

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 veterinary professional.

HANDY DOSING GUIDE		ANIMALS SHOULD BE WEIGHED AND GROUPED ACCORDING TO BODYWEIGHT TO AVOID UNDER OR OVER-DOSING*
BODYWEIGHT	DOSE VOLUME	NUMBER OF FULL DOSES PER PACK
		250ml	500ml	1 litre	2.5 litre	5 litre
100kg*	10ml	25	50	100	250	500
150kg	15ml	16	33	66	166	333
200kg	20ml	12	25	50	125	250
250kg	25ml	10	20	40	100	200
300kg	30ml	8	16	33	83	166
350kg	35ml	7	14	28	71	142
400kg	40ml	6	12	25	62	125
450kg	45ml	5	11	22	55	111
500kg	50ml	5	10	20	50	100
550kg	55ml	4	9	18	45	90
600kg	60ml	4	8	16	41	83

* Dose rate 1ml per 10kg bodyweight

Avoid introduction of contamination.

If stored at temperatures below 0°C, Closamectin Pour-On Solution for Cattle may appear cloudy. Allowing to warm at room temperature will restore the normal appearance without affecting efficacy.

At doses of three times the recommended dose, no significant clinical signs were recorded. No antidote has been identified for ivermectin or closantel overdose. 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 slight loss of appetite, loose faeces, decreased vision and increased frequency of defecation. High doses may cause blindness, hyperventilation, general weakness and inco-ordination, hyperthermia, convulsions, tachycardia and in extreme cases death.

Meat and offal: 58 days.

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

Due to the significant likelihood of cross-contamination of non-treated animals with this product due to grooming (licking), all animals in a group should be treated at the same time and treated animals should be kept separately from non-treated animals throughout the withdrawal period. Non-compliance with this recommendation may lead to residues violations in non-treated animals.