Tribex 5%

Tribex 5% is an oral drench for cattle that is used for the treatment and control of all three stages of liver fluke, mature, immature and early immature.

​Active Ingredient: Triclabendazole

Target Species: Sheep

Treats and Controls: Mature, immature and early immature liver fluke

Administration Method: Oral Drench

Withdrawal Time: 56 days for animals intended for meat and offal, not permitted for use on animals producing milk for human consumption.

Dosage:2 ml per 10 kg of bodyweight

Always read the label and all enclosed information for Tribex 5% before administering to animals!

How Livestock Contracts Liver Fluke

Animals are infected by ingesting encapsulated larvae (metacercariae) on contaminated grass. Typically,individual farms will have wet “flukey areas” that should not be used or grazed at times of the year whenmetacercariae are likely to be present, i.e. late summer to winter (depending on climatic conditions). However,cattle and sheep often graze on such areas. Therefore, it cannot be assumed that liver fluke infection is absentfrom any area of Ireland.

Summary of Product Characteristics

1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Tribex 5% Oral Suspension for Sheep

2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance: Each ml contains 50mg Triclabendazole
Excipient(s): Each ml contains: 2.0mg Methyl Parahydroxybenzoate (E2I8)
0.2mg Propyl Parahydroxybenzoate (E216)
17.5 microgram Brilliant Blue (E133).
For a full list of excipients, see section 6.1

3 PHARMACEUTICAL FORM
Oral suspension
An aqueous blue-coloured suspension.

4 CLINICAL PARTICULARS
4.1 Target Species
Sheep

4.2 Indications for use, specifying the target species
The product is indicated for the treatment of acute, sub-acute and chronic fasciolosis in sheep caused by early immature, immature
and adult stages of liverfluke (Fasciola hepatica) susceptible to triclabendazole.

4.3 Contraindications
Do not use in cases of known hypersensitivity to the active ingredient

4.4 Special warnings for each target species
None

4.5 Special precautions for use
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.
Anthelmintics are agents that destroy or result in the expulsion of susceptible parasitic worms. Parasite resistance to a particular
class of anthelmintic may develop following frequent, repeated use of an
anthelmintic of that class. To reduce this risk, dosing programmes should be discussed with a veterinary surgeon.
Tribex contains the anthelmintic Triclabendazole. Fluke (Fasciola hepatica) resistance to triclabendazole has been identified and
losses associated with resistant strains of fluke in sheep flocks treated with triclabendazole can be significant. If signs of
fascioliasis continue after treatment with Tribex, DO NOT REPEAT THE DOSE and do not dose with other products containing
triclabendazole. Seek veterinary advice. If resistance is suspected or confirmed, you should change active ingredient on veterinary
advice.
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.

4.6 Adverse reactions (frequency and seriousness)
None known

4.7 Use during pregnancy, lactation or lay
The product can be safely given to pregnant sheep. Do not administer to sheep producing milk for human consumption.

4.8 Interaction with other medicinal products and other forms of interaction
None known.

4.9 Amounts to be administered and administration route
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:
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 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. Re-treatment may not be
carried out within 8 weeks.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
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.

4.11Withdrawal Period(s)
Meat and offal: 56 days.
Not permitted for use in lactating animals producing milk for human consumption.

5 PHARMACOLOGICAL or IMMUNOLOGICAL PROPERTIES
Pharmacotherapeutic group: Anthelmintics, Benzimidazoles and related substances
ATC vet-code: QP52ACOI
Bodyweight Dosage Bodyweight Dosage
Up to 10 kg
15 kg
20 kg
25 kg
30 kg
2 ml
3 ml
4 ml
5 ml
6 ml
40 kg
50 kg
60 kg
70 kg
80 kg
8 ml
10 ml
12 ml
14 ml
16 ml

5.1 Pharmacodynamic properties
Triclabendazole differs from other benzimidazoles in that it is a narrow spectrum anthelmintic. The drug accumulates
significantly in both immature and adult stages of Fasciola hepatica and stimulates the major routes of the parasite’s energy
generating system, as demonstrated by glucose derived acetate and propionate formation. However, under these conditions the
parasite’s motility decreased, indicating that the drug is not associated with inhibition of the energy generating pathways.
Triclabendazole inhibits colchicine binding to microtubular proteins suggesting interference of the drug with microtubular
structure and function. The drug strongly inhibits the release of proteolytic enzymes in immature and adult parasites, a process
dependant on microtubular functions. The precise molecular mode of action of this fasciolicidal drug remains to be elucidated.

5.2 Pharmacokinetic properties
After oral administration, triclabendazole is rapidly metabolised to its sulphoxide and sulphone metabolites. The sulphoxide is
thought to be the active moiety. In sheep the sulphoxide and sulphone metabolites reached a Cmax of approx. 13 microgram/ml
and 11 microgram/ml at 18 and 30 hours, respectively. The vast majority of orally administered triclabendazole is eliminated in
faeces after 7 days. Urinary excretion is minimal.

6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
70% non-crystallising sorbitol, (E420)
Methyl hydroxybenzoate, (E218)
Propyl hydroxybenzoate, (E216)
Polysorbate 80, (E433)
Aluminium Magnesium silicate
Microcrystalline cellulose & Carmellose sodium, (E460 and E466)
Brilliant blue (E133)
Simethicone emulsion
Purified water

6.2 Incompatibilities
None known.

6.3 Shelf-life
Shelf life of the veterinary medicinal product as packaged for sale: 18 months

6.4 Special precautions for storage
Do not store above 25°C.
Protect from frost.

6.5 Nature and composition of immediate packaging
Pack sizes:
IL pack contains 0.8L of product,
2.5L pack contains 2.2L of product,
5L pack contains 5L of product
Container: High density polyethylene
Closure: Copolymer polypropylene with tamper evident seal
Cap Liner: Polyfaced Steran Wad
Spout: Polypropylene
Not all pack sizes may be marketed.

6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials
Any unused veterinary medicinal product or waste materials derived from such veterinary
medicinal products should be disposed of in accordance with local requirements.

8 MARKETING AUTHORISATION NUMBER(S)
VPA 10879/013/001

9 DATE OF THE FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
20th June 2007

10 DATE OF REVISION OF THE TEXT
27th June 2011

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Agridirect
Drumrahan Retail Ltd
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Ballyconnell
Co. Cavan

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