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Date: Tuesday, October 19, 2021 15:12

Description: Chanelle_Phara_Logo_cmyk
Release 2.115
Tribex 5% Oral Suspension for Sheep
 
Species: Sheep
Therapeutic indication: Pharmaceuticals: Endoparasiticides: Anthelmintics for sheep, Flukicides
Active ingredient: Triclabendazole
Product:Tribex 5% Oral Suspension for Sheep
Product index: Tribex 5% Oral Suspension for Sheep
Sheep - meat: 56 days
Withdrawal notes: Milk: Not authorized 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.
Presentation
An aqueous blue-coloured suspension. Each ml contains 50 mg Triclabendazole. g.
Each ml also contains 2.0mg methyl parahydroxybenzoate (E218) and 0.2mg propyl parahydroxybenzoate (E216) as preservatives and 17.5mg brilliant blue (E133)
Uses
Tribex 5% is indicated for the treatment of acute, subacute and chronic fascioliasis in sheep caused by early immature, immature and adult stages of liverfluke (Fasciola hepatica) susceptible to triclabendazole.
Dosage and administration
For oral administration only using properly calibrated dosing equipment. Estimate bodyweight accurately. Shake container before use
Recommended dose rate
10 mg triclabendazole per kg bodyweight as a single administration.
DOSAGE GUIDE:
Bodyweight
Dosage
Bodyweight
Dosage
Up to 10 kg
2 ml
40 kg
8 ml
15 kg
3 ml
50 kg
10 ml
20 kg
4 ml
60 kg
12 ml
25 kg
5 ml
70 kg
14 ml
30 kg
6 ml
80 kg
16 ml
For animals over 80 kg - give an additional 2 ml for each additional 10 kg bodyweight.
Dosing Programme:
Routine treatment (Areas of heavy fluke infection)
As a guide, dose all sheep exposed to fluke infected pastures preventatively at regular intervals of 10 weeks from March/April through to October/November. In situations where stock are out-wintered another dose in January may be required. All animals grazing the pasture should be treated at these times. All bought in animals should be dosed before joining the main flock. Veterinary advice should be sought with regard to specific preventative dosing regimes.
Routine treatment (Areas of moderate fluke infection)
Dose all sheep on fluke infected pastures at intervals of 10 weeks throughout the fluke season, usually September to January/ February. All bought in animals should be dosed before joining the main flock.
An additional preventative treatment in the Spring will assist in reducing the amount of new infestation on pasture in the following autumn.
Treatment of sub-acute and acute outbreaks
The flock should be treated immediately after diagnosis and veterinary advice should be sought for subsequent dosing intervals. If a preventative fluke dosing programme is employed, the occurrence of acute fluke is greatly reduced. Retreatment may not be carried out within 8 weeks.
Contra-indications, warnings, etc
Do not use in cases of known hypersensitivity to the active ingredient.
Special warnings
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.
• Under dosing, which may be due to under estimation 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 triclabendazole has been reported in Fasciola hepatica in sheep. Therefore, the use of this product should be based on local (regional / farm) epidemiological information about susceptibility of the Fasciola hepatica and recommendations on how to limit further selection for resistance to anthelmintics.
Special precautions for use in animals
Only use for liverfluke strains susceptible to triclabendazole. Care must be taken not to damage the mouth or pharyngeal region when dosing. Clean drenching equipment before and after use. Shake container before use. Use unaltered product from the original container.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
When using the product do not eat, drink or smoke. Wear gloves. Wash splashes from eyes and skin immediately. Take off any contaminated clothing immediately. Wash hands and exposed skin before meals and after work. In cases of hypersensitivity and contact allergy, direct skin contact and inhalation should be avoided.
Other precautions
The use of Tribex 5% may have harmful effects on fish and aquatic invertebrates. Sheep must not have any access to surface water such as streams, ponds or ditches within 7 days after treatment with Tribex. When spreading manure from treated animals on arable lands a safety distance of 10 m to adjacent surface waters must be kept.
Adverse reactions (frequency and seriousness)
None known
Use during pregnancy, lactation or lay
The product can be safely given to pregnant sheep .
Interaction with other medicinal products and other forms of interaction
None known.
Overdose (symptoms, emergency procedures, antidotes)
No adverse effects were reported following a dose of 12.5 times the recommended dose. At higher doses (up to 20-fold), mild transient ataxia and weight loss were observed in some animals 3-6 days after treatment.
Withdrawal Period(s)
Meat and offal: 56 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.
Pharmaceutical precautions
Do not store above 25°C. Protect from frost.
Any unused veterinary medicinal product or waste material derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Legal category
Legal category: POM-VPS
Packaging quantities
0.8L, 2.2L and 5L pack sizes.
Marketing Authorisation Number
Vm 11990/4033
Significant changes