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Health Products Regulatory Authority 

Summary of Product Characteristics

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

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

3 PHARMACEUTICAL FORM
Oral suspension.

Description:
An aqueous pink-coloured suspension.

4 CLINICAL PARTICULARS
4.1 Target Species
Cattle

4.2 Indications for use, specifying the target species
Triclaben 10% is indicated for the treatment of 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.
Each ml contains

Active substance:
Triclabendazole 100mg

Excipient(s):
Methyl Parahydroxybenzoate (E218) 2.0 mg
Propyl Parahydroxybenzoate (E216) 0.2 mg
Carmoisine supra (E122). 22.5 micrograms
For a full list of excipients, see section 6.1

4.4 Special warnings for each 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.
• 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.

4.5 Special precautions for use Special precautions for use in animals
Only use for liverfluke 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.
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 Triclaben 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 Triclaben. When spreading manure from treated animals on arable lands a safety distance of 10 m to adjacent surface waters must be kept.

4.6 Adverse reactions (frequency and seriousness)
Occasionally, inflammation of the unpigmented skin, including the udder and the teats, may occur after treatment in cattle exposed to intense sunshine.

4.7 Use during pregnancy, lactation or lay
Triclaben 10% can be used in pregnant cattle.

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.
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 bodyweight and dosed accordingly, in order to avoid under- or over-dosing.
Recommended dose rate: 12 mg triclabendazole per kg bodyweight as a single administration, i.e., 6 ml per 50 kg body weight.

DOSAGE GUIDE:
For animals over 400 kg - give an additional 6 ml for each additional 50 kg bodyweight.

DOSING PROGRAMME:
The timing for treatment should be based on epidemiological factors and should be customized for each individual farm. A dosing programme should be established by the veterinary surgeon. A lasting result, however, can only be expected by involving all potential hosts (domestic ruminants, horse, game animals) in an extensive control programme.
The same treatment days should be used for cattle and sheep when a liver fluke dosing programme is implemented and they are grazing the same pasture concurrently; an appropriate authorised product should be used in sheep. All bought in animals, suspected to be infected with liver fluke, should be dosed before joining the main herd.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
The administration of the product is well tolerated in target species when given on a single occasion at 3 times the recommended dose.
A single oral dose of 150-200 mg triclabendazole/kg of live bodyweight may lead to side effects such as unsteady gait, dullness and reduced appetite.
These side effects are slight and last 1 to 5 days.
An antidote is not known.

4.11 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.

5 PHARMACOLOGICAL or IMMUNOLOGICAL PROPERTIES

Pharmacotherapeutic group:
Anthelmintics,
Benzimidazoles and related substances.

ATC vet-code:
QP52AC01
 

5.1 Pharmacodynamic properties
Triclaben 10% contains triclabendazole, a benzimidazole anthelmintic with a narrow spectrum of activity.
The precise molecular mode of action of this fasciolicidal drug remains to be elucidated.

5.2 Pharmacokinetic properties
After oral administration, 50-75% of the dose of triclabendazole is absorbed from the gastrointestinal tract. It is then 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 oral dose triclabendazole is eliminated in faeces after 7 days.
Urinary excretion is minimal.
Less than 1% is excreted in milk.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients
70% non-crystallising sorbitol (E420)
Methyl hydroxybenzoate (E218)
Propyl hydroxybenzoate 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: 3 years.

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: 1L pack contains 0.8L of product or 1L of product 2.5L pack contains 2.2L of product or 2.5L 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
Triclaben 10% may have toxic effects on fish and aquatic invertebrates.
Do not contaminate ponds, waterways or ditches with the product or empty container.
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
Chanelle Pharmaceuticals Manufacturing Ltd.,
Loughrea,
Co. Galway,
Ireland.

8 MARKETING AUTHORISATION NUMBER(S)
VPA 10987/059/001

9 DATE OF THE FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Renewal of the last authorisation: 17th April 2008

10 DATE OF REVISION OF THE TEXT
April 2015 

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.

Triclaben 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

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.

Legal Status: POM

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 the loss of value of the 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 that occurs 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 returns form PDF.

2) To print off your return label click DPD Returns page 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 DPD pickup shops.

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.