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Clinical particulars
Target species
Sheep and lambs.
Indications for use, specifying the target species
For the control of fascioliasis (due to Fasciola hepatica) and gastrointestinal nematodes and cestodes in sheep and lambs. The combination is active against lungworm, roundworms, tapeworms (heads and segments) and fluke (mature and immature).
For the control of the larval stages of Oestrus ovis (Sheep Nasal Bot fly).
For the control of inhibited, immature and adult stages of Haemonchus contortus (Barber Pole worm) including benzimidazole resistant strains.
Also effective against benzimidazole susceptible strains of the following:
Gastro-intestinal roundworms: Ostertagia spp, Trichostrongylus spp, Nematodirus spp, Cooperia spp, Oesophagostomum spp, Chabertia ovina, Bunostomum spp, Trichurus ovis, Strongyloides papillosus.
Lungworm: Dictyocaulus filaria
Tapeworm: Moniezia spp.
Fluke activity:
Percentage kill
97-100 %
6-8 weeks immature
91-95 %
5 weeks immature
91 %
3-4 weeks immature
23-73 %
Ticks (Ixodes ricinus) feeding on sheep at the time of treatment are likely to produce fewer viable eggs.
Special warnings for 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 body weight, misadministration of the product, or lack of calibration of the dosing device (if any).
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 test(s) 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 benzimidazoles (which includes mebendazole) has been reported in Teladorsagia, Haemonchus, Cooperia and Trichostrongylus species in small ruminants in a number of countries including the EU. Resistance to closantel has been reported in Haemonchus in sheep outside the EU. Therefore the use of this product should be based on local (regional, farm) epidemiological information about susceptibility of nematodes and recommendations on how to limit further selection for resistance to anthelmintics
To reduce the risk of anthelmintic resistance, dosing programmes should be discussed with a veterinary surgeon.
Special precautions for use
i. Special precautions for use in animals
As overdosage may result in signs of toxicity such as incoordination and blindness, care should be taken to ensure animals are not overdosed by volume. If the product is spilled, care should be taken to ensure animals do not ingest it.
ii. Special precautions to be taken by the person administering the veterinary medicinal product to animals
This product may be irritating to skin and eyes and users should be careful not to accidentally splash it on themselves or others. Wear impermeable rubber gloves when applying the product. Remove any contaminated clothing immediately.
In case of accidental spillage onto skin or into eyes, rinse the affected area with large amounts of clean water. If irritation persists, seek medical advice immediately and show the package leaflet or label to the physician.
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, seek medical attention and show the package leaflet or label to the physician. Wash hands after use.
iii. Other precautions
This product is toxic to aquatic organisms and dung insects. Long-term effects on dung insects caused by continuous or repeated use cannot be excluded. Repeat treatments on a pasture within a season should only be given on the advice of the prescriber. To reduce the risk for dung fauna, if the worming protocol allows, treated and untreated animals should be grazed on the same field. The risk to aquatic ecosystems will be reduced by keeping treated animals away from water bodies for 48 hours after treatment.
Adverse reactions (frequency and seriousness)
At therapeutic doses, the combination is not toxic and causes no side effects.
Use during pregnancy, lactation or lay
May be administered to pregnant animals.
The product may be used during the lactation period but not where milk is used for human consumption. See Withdrawal Periods.
Interaction with other medicinal products and other forms of interaction
None known.
Amounts to be administered and administration route
1 ml per 5 kg bodyweight (ie 10 mg/kg bodyweight closantel and 15 mg/kg bodyweight mebendazole).
For example:
Up to 5 kg
1 ml
6-10 kg
2 ml
11-20 kg
4 ml
21-30 kg
6 ml
31-40 kg
8 ml
41-50 kg
10 ml
51-60 kg
12 ml
61-70 kg
14 ml
71-80 kg
16 ml
Give orally as a drench by careful administration with a drenching gun. Suitable for use with most types of standard drenching equipment. To ensure administration of a correct dose, body weight should be determined as accurately as possible; accuracy of the dosing device should be checked.
Shake container well before each use. Do not mix with other products.
Gastrointestinal worms
The frequency of treatment will depend on the level of pasture contamination. A suggested programme is to treat ewes prior to lambing, 6 weeks after lambing and prior to tupping to reduce pasture contamination. Dose lambs at regular intervals during high risk periods. Rams may be treated at any time as necessary.
H. contortus
For the treatment and prevention of inhibited, immature and adult stages of benzimidazole resistant and susceptible H. contortus, dose at lambing to help prevent pasture contamination by infected ewes. Treat all animals at 6 weekly intervals during high risk periods in summer and autumn.
All sheep on infested pasture should be dosed at regular intervals during the fluke season (Sept‑Mar).
Since closantel has been shown to delay egg‑laying for up to 13 weeks after artificial infection, treatment intervals of 10‑12 weeks throughout the fluke season are recommended. In severe fluke seasons, more frequent dosing may be necessary.
The treatment of ewes with a single dose in the spring will contribute to reducing pasture contamination during the following summer and autumn.
Any sheep brought in from fluke areas should be dosed before they join the flock.
Overdose (symptoms, emergency procedures, antidotes), if necessary
Symptoms of serious closantel overdosage are decreased vision or blindness, anorexia, in-coordination and general weakness.
Sheep(Meat): 65 days
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.