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Endofluke (Triclabendazole)
Endofluke (Triclabendazole)
Endofluke (Triclabendazole)

Endofluke (Triclabendazole)

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Information

Endofluke 100 mg/ml Oral Suspension is an orally administered drench used for the treatment of liver fluke in cattle and sheep. Endofluke 100 mg/ml fluke drench for cattle and sheep will treat mature, immature and early immature liver fluke (fasciola hepatica). Endofluke's active ingredient is triclabendazole which is the only active ingredient licensed in Ireland that has been proven to kill all three stages of liver fluke in sheep and cattle. Endofluke 100 mg/ml Oral Suspension has been approved for use in dairy cattle by the Irish Medicines Board (IMB).

Active Ingredient: Triclabendazole

Target Species: Cattle, sheep

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

Administration Method: Oral drench

Withdrawal Time: Animals should not be treated within 56 days of slaughter for human consumption. Cattle producing milk for human consumption need a withdrawl period of 48 hours after calving. Not intended for use within 45 days of calving. Should a cow calf earlier than 45 days after the last treatment, milk for human consumption may only be taken from 45 days plus 48 hours (47 days) after the last treatment.  Not permitted for use in sheep producing milk for human consumption.

Dosage for cattle: 6 ml per 50 kg of bodyweight

Body WeightDose VolumeNumber of full doses per pack:
2.5 Litre5 Litre
50kg6 ml416833
100kg12 ml250416
150kg18 ml138277
200kg24 ml104208
250kg30 ml83166
300kg36 ml69138
350kg42 ml59119
400kg48 ml52104
450kg54 ml4692
500kg60 ml4183
550kg66 ml3775
600kg72 ml3469
Animals over 600 kg give an aditional 6 ml per 50 kg 

Dosage for sheep:1ml per 10kg Bodyweight

Dosage Rates For Sheep
Body WeightDose VolumeNumber of full doses per pack:
2.5 Litre5 Litre
10kg1ml25005000
20kg2 ml12502500
30kg3 ml8331666
40kg4 ml6251250
50kg5 ml5001000
60kg6 ml416833
70kg7 ml357714
Animals over 70 kg give an additional 1 ml per 10 kg 

Always read the label and all enclosed information for Endofluke Oral Suspension before administering to animals!

What are the effects of liver fluke infection?

  • Oedema under the jaw (bottle jaw)
  • Anaemia
  • Diarrhoea
  • Poor coat or poor wool production
  • Lack of appetite
  • Weight loss
  • Reduction in rate of growth.
  • Decrease in fertility
  • Decrease of milk yield
  • In severe cases liver fluke can even cause death

What are the benefits of using Endofluke100 mg/ml Oral Suspension?

  • Kills three stages of liver fluke. Early immature, mature and adult
  • Tried and tested triclabendazole formula that is trusted by farmers
  • Complete chronic and acute fluke control in both cattle and sheep
  • Low volume dose establishes a quick and accurate dosing regime

What else can I do to help prevent liver fluke?

  • Make sure you have proper drainage on your land.
  • Where possible fence off wet areas.
  • Prevent grazing on "flukey areas".
  • Dose bought in animals before introducing them to pastures.
  • Dose animals mid summer to reduce the presence of liver fluke while grazing.
  • Dose animals at housing and if required four to six weeks later.

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

Data Sheet

Summary of Product Characteristics

1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Endofluke 100 mg/ml Oral Suspension

2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Substance per ml
Triclabendazole 100mg
Excipients
Methyl Parahydroxybenzoate(E218) 2mg (preservative)
Propyl Parahydroxybenzoate (E216) 0.2mg (preservative)
For a full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM
Oral Suspension.
A white to off-white suspension.

4 CLINICAL PARTICULARS
4.1 Target Species
Cattle & Sheep

4.2 Indications for use, specifying the target species
For the treatment of adult, immature and early immature stages of liver fluke (Fasciola hepatica) susceptible to
triclabendazole.

4.3 Contraindications
Do not use in animals known to be hypersensitive to the active substance.

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 bodyweight, 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 and 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.

4.5 Special precautions for use
i) Special precautions for use in animals
Care should be taken when dosing animals to avoid causing injury to the mouth and pharynx.
ii) Special Precautions to be taken by the person administering the product to animals
When using, do not eat, drink or smoke.
Wash splashes from eyes and skin immediately.
Take off immediately any contaminated clothing.
Wash hands and exposed skin before meals and after use.
iii) Other precautions
The use of this product may have harmful effects on fish and aquatic invertebrates. Cattle and
sheep must not have any access to the surface water such as streams, ponds or ditches within 7
days after treatment. When spreading manure from treated animals on arable lands, a safety distance of 10m 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
The product is safe for use during pregnancy and lactation. However, the product is not permitted for use during
lactation in animals 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 single oral administration only using properly calibrated dosing equipment. The product is suitable for most types
of automatic drenching guns. Shake the container before use.
Use unaltered from original container.
Clean drenching equipment before and after use.
Dosage:
Endofluke 100 mg/ml is given as an oral drench and is suitable for most types of automatic drenching guns.
The recommended dose rate is 12 mg triclabendazole per kg bodyweight in cattle and 10 mg triclabendazole per kg
bodyweight in sheep.
Practical Dosage Guide: Cattle: 6 ml per 50 kg bodyweight
Sheep: 1 ml per 10kg bodyweight
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 overdosing.
The timing for re-treatment should be based on epidemiological risk patterns and should be customised for each
individual farm.
To avoid the potential for the accumulation of residues following repeat administration of the product; animals should
not be treated with a frequency of less than 10 weeks.
AnimalWeight Dose of product
50 kg 6 ml
100 kg 12 ml
150 kg 18 ml
200 kg 24 ml
250 kg 30 ml
300 kg 36 ml
350 kg 42 ml
400 kg 48 ml
For each additional 50 kg 6 ml
AnimalWeight Dose of product
10 kg 1 ml
20 kg 2 ml
30 kg 3 ml
40 kg 4 ml
50 kg 5 ml
60 kg 6 ml
For each additional 10 kg 1 ml

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
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)
Cattle (meat and offal): 56 days
Milk:
Cattle (milk): Milk for human consumption may only be taken from 48 hours after calving. Not intended for use within
45 days of calving. Should a cow calve earlier than 45 days after the last treatment, milk for human consumption may
only be taken from 45 days + 48 hours (47 days) after the last treatment.
Sheep (meat & offal): 56 days
Sheep (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.

5 PHARMACOLOGICAL or IMMUNOLOGICAL PROPERTIES
ATCvet code: QP52AC01
Pharmacotherapeutic group: anthelmintics; benzimidazoles and related substances.

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
50-75% of the orally administered dose of triclabendazole is absorbed from the gastrointestinal tract. Very rapidly,
absorbed triclabendazole is almost completely oxidised to its sulfoxide and sulfone.
In cattle triclabendazole sulfoxide reaches peak concentrations approximately 27 hours after administration of the
product and the sulfone reaches peak concentrations 64 to 72 hours after administration.
In sheep triclabendazole sulfoxide reaches peak concentrations approximately 20 hours after administration of the
product and the sulfone reaches peak concentrations 30 to 32 hours after administration.
Both metabolites bind strongly to plasma proteins, particularly albumin.
Metabolites are excreted via the bile mainly as conjugates. More than 90%- 95% of the total dose of triclabendazole is
excreted in the faeces, about 2% in the urine and less than 1% in the milk. The elimination is virtually complete by 10
days after administration.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients
Xanthan Gum
Methyl Parahydroxybenzoate
Propyl Parahydroxybenzoate
Citric Acid Anhydrous
Sodium Citrate
Polysorbate 80
Silica Colloidal
Anhydrous Simethicone Emulsion
Water, purified

6.2 Incompatibilities
None Known.

6.3 Shelf-life
Shelf life of the veterinary medicinal product as packaged for sale: 2 years

6.4 Special precautions for storage
Protect from frost.

6.5 Nature and composition of immediate packaging
1 litre, 2.5 and 5 litre high-density polyethylene flat bottom backpack containers containing a white to off-white smooth
suspension. The closures used for all pack sizes are 38 mm propylene standard caps with an induction heat seal liner.
A 38 mm polypropylene spouted cap is also provided with each pack size for dispensing purposes.

6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials
The product may have toxic effects on fish and aquatic invertebrates. Any unused product or waste material must not
enter surface water and should be disposed of in accordance with national requirements

7 MARKETING AUTHORISATION HOLDER
Cross Vetpharm Group Ltd.
Broomhill Road,
Tallaght,
Dublin 24.

8 MARKETING AUTHORISATION NUMBER(S)
VPA 10960/046/001

9 DATE OF THE FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 1st August 2002
Date of last renewal: 19th February 2008

10 DATE OF REVISION OF THE TEXT
November 2013

Delivery

 

Delivery Information

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. 

Delivery Times
Ireland (ROI & NI)United Kingdom (Mainland Only)EU (Mainland Only)
1-3 Working Days2-4 Working Days4-6 Working Days

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

Delivery Rates

Delivery Rates
CountryOrders Under €70Orders Over €70
Ireland (ROI & NI)€4.99€0.00
Austria€17.99€13.00
Belgium€14.99€10.00
Czech Republic€17.99€13.00
Denmark€17.99€13.00
Finland€29.99€25.00
France€14.99€10.00
Germany€14.99€10.00
Hungary€21.99€17.00
Italy€27.99€23.00
Luxenburg€14.99€10.00
Netherlands€14.99€10.00
Poland€14.99€13.00
Portugal€29.99€25.00
Slovakia€21.99€17.00
Slovenia€21.99€17.00
Spain€27.99€23.00
Sweden€27.99€23.00
United Kingdom (Mainland Only)€14.99€10.00

 

 

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.

 

Returns

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.
 

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

The cost of the return, including all packaging and freight, lies solely with the consumer.
 

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.

 

Packaging

All returns must be the complete product which includes boxes, manuals and accessories that may have been include 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.
 

Address: Please ship the product to the following address: Agridirect, Drumrahan Retail, Church Street, Ballyconnell, Co Cavan
 

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.

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