Fasinex 240, 24% W/V Oral Suspension For Cattle
Revised: December 2015
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Fasinex 240, 24% w/v Oral Suspension for Cattle.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of the product contains:
Triclabendazole 240 mg
Methyl parahydroxybenzoate (E218) 1.1 mg
Propyl parahydroxybenzoate (E216) 0.4 mg
Benzyl alcohol (E1519) 5.0 mg
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
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.
4.4 Special warnings
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, and 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
(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 or lactation
FASINEX is neither embryotoxic nor teratogenic, and can be used in all stages of pregnancy. Concerning use during lactation refer to section 4.11.
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 240 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, cattle not producing milk intended for human consumption or dry cattle.
Fasinex 240 is given once. The administration may be repeated several weeks or months after the first treatment depending on the epidemiological situation. In case of acute fasciolosis, treat immediately, then repeat in approximately 4-6 weeks, and consult a veterinarian for advice.
Body Weight (kg)
Volume to Administer (ml)
Up to 50 kg
Add 5 mL for each additional 100 kg
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
A single oral dose of 150-200 mg triclabendazole/kg of body weight 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
Meat and offal: 52 days.
Milk: Milk for human consumption may only be taken from 48 hours after calving. Not intended for use within 48 days of calving. Should a cow calve earlier than 48 days after the last treatment, milk for human consumption may only be taken from 50 days after the last treatment.
5. PHARMACOLOGICAL PROPERTIES
Pharmacotherapeutic group:triclabendazole is a benzimidazole anthelmintic
ATC Vet 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 synthesis.
5.2 Pharmacokinetic particulars
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
6.3 Shelf life
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. Shake well before use.
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 product or waste materials derived from the use of such products
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements. The product may adversely affect aquatic organisms. Do not contaminate ponds, waterways or ditches with the product or empty containers.
7. MARKETING AUTHORISATION HOLDER
Elanco Europe Ltd
8. MARKETING AUTHORISATION NUMBER
9. DATE OF FIRST AUTHORISATION
5 August 2008
10. DATE OF REVISION OF THE TEXT
Approved: 15 December 2015
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