Target species
Sheep
Indications for use, specifying the target species
For the treatment of chronic and subacute fasciolosis (due to Fasciola hepatica). The product is effective against mature and late immature flukes (from 5 weeks immature).
For the treatment of Oestrus ovis (Sheep Nasal Bot Fly).
For the treatment of inhibited, L4 and adult stages of Haemonchus contortus.
Contraindications
Do not use in animals with known hypersensitivity to the active substance or to any of the excipients.
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 closantel has been reported in Haemonchus species outside the EU. 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.
Special precautions for use
i. Special precautions for safe use in the target species
When using a drenching gun, take care not to injure the mouth or pharynx.
Do not exceed the stated dose.
The product can be used in all age groups of sheep and lambs.
ii. Special precautions to be taken by the person administering the veterinary medicinal product to animals
This veterinary medicinal product may be irritating to skin and eyes and users should be careful not to accidentally splash it on themselves or others.
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.
Personal protective equipment consisting of nitrile rubber gloves should be worn when handling the veterinary medicinal product.
Wash hands after use.
Do not eat, drink or smoke while handling the veterinary medicinal product
iii. Special precautions for the protection of the environment:
Closantel is very toxic to dung fauna.
The risk to dung fauna can be reduced by avoiding too frequent and repeated use of closantel (and products of the same anthelmintic class) in sheep and lambs. Animals should not normally be treated in excess of three times a year with closantel.
Adverse reactions (frequency and seriousness)
None known.
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or the national competent authority via the national reporting system.
See the package leaflet for respective contact details.
Use during pregnancy, lactation or lay
The product can be used at any time during pregnancy. It can also be used in rams at any time including during the breeding season. The safety of the product for use during lactation has not been established.
Interaction with other medicinal products and other forms of interaction
None known.
Amounts to be administered and administration route
Oral Use.
The veterinary medicinal product is to be given as a drench. The recommended dosage rate is 10 mg of closantel per kg bodyweight (i.e. 1 ml of the veterinary medicinal product per 5 kg bodyweight).
For example:
Bodyweight | Dose |
Up to 5 kg | 1 ml |
10 kg | 2 ml |
20 kg | 4 ml |
30 kg | 6 ml |
40 kg | 8 ml |
50 kg | 10 ml |
60 kg | 12 ml |
70 kg | 14 ml |
80 kg | 16 ml |
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 body weight and dosed accordingly in order to avoid under- or over-dosing.
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.
Suitable for use with most types of standard drenching equipment.
Shake well before use.
Symptoms of overdose (and where applicable, emergency procedures and antidotes):
Symptoms of acute overdosage are decreased vision or blindness, anorexia, in-coordination and general weakness.
Withdrawal period(s)
Meat and offal: 56 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.