Fasinex Sheep is an oral drench for sheep that is used for the treatment and control of all three stages of liver fluke, mature, immature and early immature. Fasinex Sheep is a concentrated, low volume drench that is easy to administer.

​Active Ingredient: Triclabendazole

Target Species: Sheep

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

Administration Method: Oral Drench

Withdrawal Time: 55 days for animals intended for meat and offal.

Dosage: 2 ml per 10 kg of bodyweight

Always read the label and all enclosed information for Fasinex  before administering to animals!

Key Features of Fasinex 

• is an oral drench that is used for the treatment and control of all three stages of liver fluke, mature, immature and early immature. 
• Fasinex Sheep is a concentrated, low volume drench that is easy to administer.
• 55 days withdrawal when intended for Meat or 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

Health Products Regulatory Authority

Summary of Product Characteristics

1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Fasinex 5% w/v Oral Suspension

2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
Active Substance
Triclabendazole 50 mg

Excipients
Methyl Parahydroxybenzoate (E218)1.1 mg
Propyl Parahydroxybenzoate (E216) 0.24 mg
Benzoic Acid (E210) 1.0 mg
For a full list of excipients see section

6.1. 3 PHARMACEUTICAL FORM
Oral Suspension.
White to cream-coloured suspension.

4 CLINICAL PARTICULARS
4.1 Target Species
Ovines.

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

Target Species:
Fasciola hepatica.

4.3 Contraindications
Do not use in animals with known hypersensitivity 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.
- Underdosing which may be due to underestimation of bodyweight, misadministration of the product, or lack of calibration of the dosing device.
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 tests strongly suggest resistance to a particular anthelmintic, an anthelmintic belonging to another pharmacological class and having a different mode of action should be used.

4.5 Special precautions for use
Special precautions for use in animals
Only use for liver fluke strains susceptible to Triclabendazole.
Clean drenching equipment before and after use.
Where a dosing gun is used to administer the product, care must be taken to avoid the occurrence of dosing gun pharyngitis.

Special precautions to be taken by the person administering the veterinary medicinal product to animals Wash hands after use.

4.6 Adverse reactions (frequency and seriousness)
None.

4.7 Use during pregnancy, lactation or lay
This product may be given to pregnant and lactating animals. See section 4.11.

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

4.9 Amounts to be administered and administration route
Fasinex is given as an oral drench and is suitable for most types of automatic drenching guns.
Fasinex can safely be given to young, pregnant or stressed sheep.
The recommended dose rate is 10 mg per kg bodyweight.

Practical Dosage Guide: 2 ml per 10 kg bodyweight.
To ensure administration of a correct dose, bodyweight should be determined as accurately as possible.
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.
Use properly calibrated dosing equipment.

Dosing Programme:
Areas of heavy fluke infection (the western seaboard) In areas such as these where traditionally more than 4 treatments per year have been administered, Novartis recommend that under veterinary advice, 3 spring/summer treatments should be administered and one in November instead of autumn/winter treatments.
In situations where stock are outwintered another dose in January may be required.
Jan - Feb - Mar - Apr - May - Jun - Jul - Aug - Sept - Oct - Nov - Dec
* * * * * Dose Dose Dose Dose Dose

These treatment times are guidelines and should be customised under veterinary advice for each individual farm. Spring/summer treatments prevent the flukes entering the mud snail and so the life cycle is broken.
Every animal on the same land including cattle should be included in the programme and all animals should be treated on the same day.
When cattle are included in the programme they should be treated with Fasinex 10%.
All bought in animals should be dosed before joining the main flock.
Areas of Average Fluke Infection:

Dose all sheep on fluke infected pastures at regular intervals of 8 to 10 weeks throughout the fluke season, usually from September to January/February.

Guidance from the Department of Agriculture fluke forecast may be useful when deciding to start treatment.

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 is employed the occurrence of acute fluke is greatly reduced.
The veterinary surgeon should give advice regarding appropriate dosing programmes and stock management to achieve adequate parasite control. 

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 3 days. An antidote is not known.

4.11 Withdrawal period(s)
Meat and offal: 55 days
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
Pharmacotherapeutic group:
Anthelmintics, benzimidazoles.

ATCvet code:
QP52AC01

5.1 Pharmacodynamic properties
The mode of action of triclabendazole is not known but is probably different from that of other benzimidazoles as it does not exert its activity by association with tubulin.
Triclabendazole and its sulfoxide metabolite are anthelmintically active.

5.2 Pharmacokinetic particulars
About half 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.
Triclabendazole sulfoxide reaches peak concentrations (ca. 15ppm) 20 hours after administration of FASINEX and the sulfone reaches peak concentrations (ca. 10ppm) 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% of the total dose of FASINEX 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
Microcrystalline Cellulose andCarmellose Sodium
Povidone
Disodium Phosphate Dodecahydrate
Methyl Parahydroxybenzoate (E218) 
Propyl Parahydroxybenzoate (E216)
Benzoic Acid (E210)
Purified Water

6.2 Major incompatibilities
None known.

6.3 Shelf-life
Shelf-life of the veterinary medicinal product as packaged for sale: 5 years.

6.4 Special precautions for storage
Store below 25°C.
Protect from frost.
Protect from light.

6.5 Nature and composition of immediate packaging
0.8, 2.2 and 12 litre HDPE containers.
Not all pack sizes may be marketed.

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

7 MARKETING AUTHORISATION HOLDER
Elanco GmbH
Heinz-Lohmann-Strasse 4
27472 Cuxhaven
Germany

8 MARKETING AUTHORISATION NUMBER(S)
VPA22020/004/001

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 1st October 1999
Date of last renewal: 30th September 2009

Drench correctly
Sheep Oral Drench
The drenching technique is a vital part of ensuring that the wormer does its job effectively.
Make sure the sheep are properly restrained and cannot leap around when they are being drenched so they swallow the whole amount.
Sheep can also suffer serious injury, or even death, if they are unrestrained and the gun penetrates the tissues at the back of the mouth.
Place a hand under the head and tilt slightly to the side.
Slot the nozzle in the gap between molar and incisor teeth and then over the back of the tongue.
If the wormer is just put into the mouth, it will bypass the rumen as it escapes down the oesophageal groove and will be less effective.
This is particularly important for white (BZ) drenches.

Dosing Weigh – do not guess Underestimating the weight of sheep is a common cause of underdosing. Select and weigh the biggest sheep 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.