Fasinex 240 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.Fasinex 240 is a concentrated, low volume drench that is easy to administer.
Active Ingredient: Triclabendazole
Target Species: Cattle
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. For dairy cattle milk for human consumption may only be taken from 48 hours after calving. If calving occurs before 35 days after treatment, milk for human consumption may only be taken after 35 days plus 48 hours after the treatment.
Dosage:2.5 ml per 50 kg of bodyweight
|Body Weight||Dose Volume||Number of full doses per pack:|
|2.2 Litre||5 Liter|
Always read the label and all enclosed information for Fasinex 240 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.
This product is only licensed for sale within the Republic of Ireland
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Fasinex 240 mg/ml oral suspension for cattle.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Triclabendazole 240 mg
Methyl parahydroxybenzoate (E218) 1.1 mg
Propyl parahydroxybenzoate (E216) 0.4 mg
Benzyl alcohol (E1519) 5.0 mg
3 PHARMACEUTICAL FORM
White to cream-coloured aqueous suspension.
4 CLINICAL PARTICULARS
4.1 Target Species
4.2 Indications for use, specifying the target species
For the treatment of acute, subacute and chronic infection due to early immature, immature, and mature stages of
Fasciola hepatica. If infected animals are treated before disease has developed, fasciolosis can be prevented.
Do not use in case of hypersensitivity to the active substance or to any of the ingredients.
Triclabendazole 240 mg
Methyl parahydroxybenzoate (E218) 1.1 mg
Propyl parahydroxybenzoate (E216) 0.4 mg
Benzyl alcohol (E1519) 5.0 mg
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 (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 a number of countries including ones in the EU.
Therefore the use of this product should be based on local epidemiological information about susceptibility of F.
hepatica and recommendations on how to limit further selection for resistance to anthelmintics. Dosing programmes
should be discussed with your Veterinary Adviser.
4.5 Special precautions for use
i) Special precautions for use in animals
Only for use for liver fluke strains susceptible to triclabendazole. Intensive use or misuse of anthelmintics can give rise
to resistance. To reduce the risk, dosing programs should be discussed with your veterinary practitioner. Efficacy of
this product against liver fluke is reduced if triclabendazole resistant strains are present.
Where a dosing gun is used to administer the product, care must be taken to avoid the occurrence of dosing gun
Not intended for use within 35 days of calving.
ii) Special precautions to be taken by the person administering the veterinary medicinal product to animals
Do not eat, drink, or smoke while handling the product. Wash hands and exposed skin after handling the product.
In case of accidental spillage onto skin or in eyes, wash immediately with water. Take off any contaminated clothes.
iii) Other precautions
4.6 Adverse reactions (frequency and seriousness)
4.7 Use during pregnancy, lactation or lay
Fasinex is neither embryotoxic nor teratogenic, and is safe for use in all stages of pregnancy and lactation. However,
the product is not permitted for use in lactating animals producing milk for human consumption.
4.8 Interaction with other medicinal products and other forms of interaction
4.9 Amounts to be administered and administration route
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.
Administer 5 ml/100 kg body weight, equivalent to 12 mg triclabendazole per kg of body weight. Fasinex is
administered orally after thorough shaking of the suspension. Most types of automatic drenching guns are suitable.
Clean drenching gun before and after use. Fasinex can safely be given to young, pregnant or stressed cattle.
However, the product is not permitted for use in lactating animals producing milk for human consumption.
Fasinex is given once. The administration may be repeated several weeks or months after the first treatment depending
on the epidemiological situation. In case of sub-acute and acute fasciolosis, affected cattle, usually young animals,
should be treated immediately after diagnosis is reached. Advice from your prescriber or veterinary surgeon should be
sought for subsequent dosing intervals.
Shake container well before use.
Add 5 ml for each additional 100 kg
On land where sheep are being treated according to a preventative programme and where cattle are also grazing these
areas, Fasinex should be administered to the cattle on the same treatment dates as the sheep. Fasinex 5% should be used
Treatment times should be customised under veterinary advice for each individual farm.
Bought in animals:
All bought in animals should be dosed before joining the main herd unless there is evidence of triclabendazole
resistance in those cattle.
Dose cattle, which have grazed fluke infected pasture in the autumn at the time of or shortly after housing. Dosing may
be required to be started at the beginning of the fluke season when animals are still outdoors depending on the specific
Treatment of acute outbreaks:
The herd should be treated immediately after diagnosis and veterinary advice should be sought for subsequent dosing
BodyWeight (kg) Volume to Administer (ml)
Up to 50 kg 2.5
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
A single oral dose of 150-200 mg triclabendazole/kg of body weight (more than 12 times the recommended dose rate)
was shown to lead to side effects such as stumbling gait, depression, and decreased 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: 56 days.
Milk: Milk for human consumption may only be taken from 48 hours after calving. If calving occurs before 35 days
after treatment, milk for human consumption may only be taken after 35 days plus 48 hours after the treatment.
5 PHARMACOLOGICAL or IMMUNOLOGICAL PROPERTIES
Pharmacotherapeutic group: triclabendazole is a benzimidazole anthelmintic
ATCvet code: QP52AC01
5.1 Pharmacodynamic properties
Triclabendazole inhibits cellular transport mechanisms and binds to a different tubulin receptor, possibly the tubulozole
receptor, than do other benzimidazoles, which bind to the colchicine receptor. Triclabendazole also inhibits protein
5.2 Pharmacokinetic properties
Triclabendazole is readily absorbed and oxidised to its sulfoxide and sulfone. Triclabendazole sulfoxide reaches peak
concentrations approximately 1 day after administration of Fasinex and the sulfone reaches peak concentrations
approximately 3 days after administration. Both metabolites bind strongly to plasma protein, particularly albumin.
Metabolites are excreted via the bile, primarily as conjugates. More than 90% of the total dose of Fasinex is excreted in
the faeces, about 5% in the urine and 1% in milk. Elimination is virtually complete by 10 days after administration.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Methyl parahydroxybenzoate (E218)
Propyl parahydroxybenzoate (E216)
Benzyl alcohol (E1519)
Microcrystalline cellulose and carmellose sodium
Shelf-life of the veterinary medicinal product as packaged for sale: 3 years.
Shelf-life after first opening the immediate packaging: 12 months.
6.4 Special precautions for storage
Store in tightly closed original container.
6.5 Nature and composition of immediate packaging
High density polyethylene bottles of 0.8, 2.2, 5.0, and 12.0 litres.
Not all pack sizes may be marketed.
6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials
Any unused veteinary medicinal product or waste materials derived from such veterinary medicinal product should be
disposed of in accordance with local requirements. Do not contaminate ponds, waterways or ditches with the product or
7 MARKETING AUTHORISATION HOLDER
Novartis Animal Health UK Limited
Frimley Business Park
Surrey GU16 7SR
8 MARKETING AUTHORISATION NUMBER(S)
9 DATE OF THE FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 5th September 2008
Date of last renewal: 24th May 2013
10 DATE OF REVISION OF THE TEXT
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|Ireland (ROI & NI)||United Kingdom (Mainland Only)||EU (Mainland Only)|
|1-3 Working Days||2-4 Working Days||4-6 Working Days|
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|Country||Orders Under €70||Orders Over €70|
|Ireland (ROI & NI)||€4.99||€0.00|
|United Kingdom (Mainland Only)||€14.99||€10.00|
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