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Date: Saturday, June 15, 2024 1:05

Release 2.199
Tribex 10% Oral Suspension for Cattle
 
Species: Cattle
Therapeutic indication: Pharmaceuticals: Endoparasiticides: Anthelmintics for cattle, Flukicides
Active ingredient: Triclabendazole
Product:Tribex 10% Oral Suspension for Cattle
Product index: Tribex 10% Oral Suspension for Cattle
Cattle - milk: See notes
Cattle - meat: 56 days
Withdrawal notes: The product is not permitted for use during lactation in animals producing milk for human consumption.When used in non-lactating cattle: Milk for human consumption may only be taken from 84 hours after calving. Not intended for use within 41 days of calving. If calving occurs before 41 days after treatment, milk for human consumption may only be taken after 41 days plus 84 hours after the treatment.
Incorporating:
Presentation
An aqueous pink-coloured suspension. Each ml contains 100 mg Triclabendazole.
Each ml also contains 2.0mg methyl parahydroxybenzoate (E218) and 0.2mg propyl parahydroxybenzoate (E216) as preservatives and carmoisine supra (E122).
Uses
Tribex 10% is indicated for the treatment of acute, subacute and chronic fascioliasis in cattle 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
12 mg triclabendazole per kg bodyweight as a single administration.
DOSAGE GUIDE:
Bodyweight
Dosage
Bodyweight
Dosage
Up to 50 kg
6 ml
250 kg
30 ml
100 kg
12 ml
300 kg
36 ml
150 kg
18 ml
350 kg
42 ml
200 kg
24 ml
400 kg
48 ml
For animals over 400 kg - give an additional 6 ml for each additional 50 kg bodyweight.
Dosing Programme
Routine treatment (Areas of heavy fluke infection)
As a guide, dose all cattle 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 cattle on fluke infected pastures at intervals of 10 weeks throughout the fluke season, usually September to January/February. An additional preventative treatment in Spring will assist in reducing the amount of new infection on the pastures in the following Autumn. All bought in animals should be dosed before joining the main herd.
In-wintered Cattle
Where cattle are in-wintered, a single dose of Tribex 10% should be given 2 weeks after housing.
Treatment of sub-acute and acute outbreaks
Affected cattle 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 cattle. Therefore, the use of this product should be based on local epidemiological information about susceptibility of the Fasciola hepatica and recommendations on how to limit further selection for resistance to anthelmintics.Do not use in cases of known hypersensitivity to the active ingredient.
Special precautions for use in animals
Only use for liver fluke strains susceptible to triclabendazole. Frequent and repeated use may lead to the development of resistance. Care must be taken not to damage the mouth or pharyngeal region when dosing. Clean drenching equipment before and after 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 10% may have harmful effects on fish and aquatic invertebrates. Cattle 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 cattle
Interaction with other medicinal products and other forms of interaction
None known.
Overdose (symptoms, emergency procedures, antidotes), if necessary
No adverse effects were reported following a 3-fold overdose in cattle. A single dose of 200 mg/kg causes inappetence, transient weight loss and slight effects on motor activity and serum glucose lactate dehydrogenase (GLDH) in calves.
Withdrawal Period(s)
Meat and offal: 56 days.
Milk: The product is not permitted for use during lactation in animals producing milk for human consumption. When used in non-lactating cattle: Milk for human consumption may only be taken from 84 hours after calving. Not intended for use within 41 days of calving. If calving occurs before 41 days after treatment, milk for human consumption may only be taken after 41 days plus 84 hours after the treatment.
Pharmaceutical precautions
Do not store above 25°C. Protect from frost.
Any unused veterinary medicinal product or waste materials 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 11990/4034
Significant changes