Tribex 10% 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: Cattle

Administration Method: Oral Drench

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

Withdrawal Time: 56 days for animals intended for meat and offal. 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 betaken after 41 days plus 84 hours after the treatment.

Dosage: 6 ml per 50 kg of bodyweight

Always read the label and all enclosed information for Tribex 10% before administering to animals!

Key Features of Tribex 10%

• Is an oral drench for cattle
• Used for the treatment and control of all three stages of liver fluke, mature, immature and early immature.
• 56 days withdrawal period for animals intended for meat and offal

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 when metacercariae 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 absent from any area of Ireland.

This product is only licensed for sale within the Republic of Ireland

Click here to Download Data Sheet

Summary of Product Characteristics

1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Tribex 10% Oral Suspension for Cattle

2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains

Active substance:
Triclabendazole 100 mg

Excipient(s):
Methyl Parahydroxybenzoate (E2I8) 2.0 mg
Propyl Parahydroxybenzoate (E216) 0.2 mg
Carmoisine supra (EB122). 22.5 mg
For a full list of excipients, see section 6.1

3 PHARMACEUTICAL FORM
Oral suspension
An aqueous pink-coloured suspension

4 CLINICAL PARTICULARS

4.1 Target Species
Cattle

4.2 Indications for use, specifying the target species
The product is indicated for the treatment of acute, sub-acute and chronic fasciolosis in cattle 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.

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 is safe for use during pregnancy. However, the product is not permitted for use in animals producing milk
for human consumption, including pregnant animals intended to produce 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: 12 mg triclabendazole per kg bodyweight as a single administration.

DOSAGE GUIDE:
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 the spring will assist in reducing the amount of new infestation 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 the product 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.

4.10 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.

4.11Withdrawal Period(s)

Meat and offal: 56 days.

The product is not permitted for use during lactation in animals producing milk for human consumption.
When used innon-lactating cattle: Milk for human consumption may only be taken from 84 hours after calving.
Not intended for usewithin 41 days of calving.
If calving occurs before 41 days after treatment, milk for human consumption may only betaken after 41 days plus 84 hours after the treatment. 


5 PHARMACOLOGICAL or IMMUNOLOGICAL PROPERTIES

Pharmacotherapeutic group:
Anthelmintics,
Benzimidazoles and related substances

ATC vet-code:
QP52ACOI

Bodyweight Dosage    Bodyweight Dosage
Up to 50 kg                  6ml
100 kg                        12ml
150 kg                        18ml
200 kg                        24ml
250 kg                        30ml
300 kg                        36ml
350 kg                        42ml
400 kg                        48ml

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 cattle the sulphoxide and sulphone metabolites reached a Cmax of approx. 13 microgram/ml and 26 microgram/ml at 18 and 48 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)
Carmoisine supra (E122)
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.

7 MARKETING AUTHORISATION HOLDER
Channelle Animal Health Ltd
7 Rodney Street
Liverpool
L1 9HZ
England

8 MARKETING AUTHORISATION NUMBER(S)
VPA 10879/013/002

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

10 DATE OF REVISION OF THE TEXT
29th April 2010
26th November 2010

Drench correctly
 Cattle Oral drenches
Oral drenching guns are designed to deliver the treatment towards the back of the mouth over the tongue, so the entire dose is swallowed at once to optimise efficacy.
• Make sure animals are properly restrained, with their head held up • Slide the nozzle of the dosing gun in the side of the mouth and over the tongue so that the entire dose is swallowed immediately
• Drenching equipment must be correctly calibrated and in good working order
• Calibrate the gun using the product just before treatment starts by delivering two or more doses into a graduated measuring cylinder Faulty equipment, or attempting to dose too quickly, may mean that the barrel of the gun does not fill properly or that the liquid is full of bubbles.

Dosing Weight – do not guess. Underestimating the weight of an animal is a common cause of underdosing. Select and weigh the biggest animal in the group to determine the correct dose. If there is a wide range of weights, consider splitting the group, then weigh the heaviest in each section. Do not forget to check that the weigh crate is accurate before starting!

Calibrate and maintain the drench gun
Always check the gun is delivering the right amount before you drench. Remove the plunger from a 10 ml syringe, put a thumb over the end and squirt the dose into it, making sure there are no air bubbles left. Adjust the gun until the dose delivered is correct. Drenching guns should also be well maintained and replaced regularly. Clean with warm soapy water after use and check springs and tubes to make sure there are no kinks that will form air bubbles.

Withholding food
Research has shown that the efficacy of the white (BZ) and clear (AV) drenches can be improved by withholding food for 12–24 hours before treatment. It is not advised to deprive heavily pregnant ewes of food, so if you treat this class of stock with anthelmintics, you may wish to use yellow drenches (LV) because their efficacy is less dependent on rumen fill.

Storage
Wormers should be stored securely, away from direct sunlight at 4–25°C. Check the use-by date and, once open, use within the time shown on the packaging. Shake white (BZ) products well before use.

Pharmacodynamics

Triclabendazole and its metabolites are active against both the immature and mature worms of Fasciola hepatica and Fasciola gigantica helminths.

Mechanism of action

Triclabendazole is an anthelmintic agent against Fasciola species.
The mechanism of action against Fasciola species is not fully understood at this time.
In vitro studies and animal studies suggest that triclabendazole and its active metabolites (sulfoxide and sulfone) are absorbed by the outer body covering of the immature and mature worms, causing a reduction in the resting membrane potential, the inhibition of tubulin function as well as protein and enzyme synthesis necessary for survival. These metabolic disturbances lead to an inhibition of motility, disruption of the worm outer surface, in addition to the inhibition of spermatogenesis and egg/embryonic cells.

A note on resistance
In vitro studies, in vivo studies, as well as case reports suggest a possibility for the development of resistance to triclabendazole.
The mechanism of resistance may be multifactorial and include changes in drug uptake/efflux mechanisms, target molecules, and changes in drug metabolism.

Delivery Information

Delivery Service

Here at Agridirect we have joined forces with DPD to ensure all packages are delivered promptly and safely to you. We ship to all mainland countries within the EU. Deliveries take place Monday to Friday excluding bank holidays. Once your order has been dispatched from our warehouse you will be notified by email. If there is a delay with your order for any reason you will be contacted immediately. 

Due to Brexit we are temporarily unable to ship to the UK. Shipping to Northern Ireland will remain in place.

Delivery Times

Some products have an extended delivery time, this is noted on the products.

Delivery Rates

A selection of the products we sell are only licensed for sale within the Republic Of Ireland and can not be shipped outside of the country. These products are noted as only being available within the Republic of Ireland on the individual product pages.

There may be an addition charge on certain bulky items. This charge will be clearly marked on an applicable products and will be explained on the checkout page before payment has been made.

Agridirect Returns Policy

We’re sorry your purchase didn’t work out. But don’t worry; we have a great returns policy to help you out.

All purchases can be returned to us within 14 days of delivery and returned goods must be received within 14 days from the date you informed us of the return.

Purchases may be opened for inspection but must not be used and must be repackaged securely in the original packaging if you wish to return it.

If we discover goods have been used or there has been a loss in value of the goods due to damage to the goods, while in your care or whilst being returned to us, we will reduce the amount refunded, which may amount to the full cost of the product, to cover loss of value of goods.

All returns should be complete which includes boxes, manuals and accessories that may have been included with the order.

All returns must be packaged appropriately for shipping, we will not accept responsibility for damages or loss which occur during shipping of a return product.

We accept no responsibility for goods damaged or lost while in transit to us. 

How do I return a product?

We have partnered with DPD to make your returns process easy and secure. simply follow the steps below and bring your package to an official DPD pickup point.

1) All returns must be accompanied with a fully filled out returns form which can be downloaded here.

2) To print off your return label click here or visit www.dpd.ie/returns and follow the on-screen instructions. Make sure and use your order number as your reference.

• Select “Continue as Guest”
• Select “Agridirect” from the drop-down menu
• Select your reason for returning
• Select the size of the package you wish to return
• Accept DPD’s terms and conditions
• Fill in your payment details
• Fill in your own details
• Follow the instructions to print off your label

3) Bring your package to a DPD pickup point. To find your nearest drop off point here.

Once the returned product has been received into our warehouse and been fully inspected a refund will be issued.

If you choose not to use the DPD returns service we recommend that you use a method that can be tracked.

For the return of bulk products please contact us at sales@agridirect.ie

I have received a damaged product from you, what should I do?

First off, if you have received a damaged electrical product from us, do not plug it in. Any electrical products that are plugged in are deemed ‘as used and accepted’ and are not accepted as returns. All damages must be reported to us via phone or email within 24hours of receipt of goods. Please ensure you check your items upon delivery.

How do I begin the returns process?

If you wish to begin the return process, please email us at sales@agridirect.ie and ensure the following information is included in your email. Your name, phone number, Order id, the item you wish to return, reason for return and if the product is damaged we require photos of the product.

Once you have sent us all required information a member of our team will assess your claim and will contact you as soon as possible. Please hold off on returning products until a member of our team has called you to confirm.

Refunds

Once the returned product has been returned to us and fully inspected a refund will be issued.

Please Note: A typical timeline for a refund to show in your account is up to 10 working days from the date processed, depending on your bank.