FASIFREE 10% W/V ORAL SUSPENSION
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
05-09-2015
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Active ingredient:
TRICLABENDAZOLE
Available from:
Cross Vetpharm Group Limited
ATC code:
QP52AC01
INN (International Name):
TRICLABENDAZOLE
Dosage:
10 %w/v
Pharmaceutical form:
Oral Suspension
Prescription type:
LM-Licensed Merchant
Therapeutic group:
Bovine, Ovine
Therapeutic area:
Triclabendazole
Therapeutic indications:
Endoparasiticide
Authorization status:
Authorised
Authorization date:
2002-02-22
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Fasifree 10% w/v Oral Suspension.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral suspension.
A white to off-white oral suspension.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle and Sheep.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment and control 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.
Each ml contains:
ACTIVE SUBSTANCE
Triclabendazole
100 mg
EXCIPIENTS
Methyl Parahydroxybenzoate (E218) Ph.Eur.
2.0 mg (preservative)
Propyl Parahydroxybenzoate (E216) Ph.Eur.
0.2 mg (preservative)
HEALTH PRODUCTS REGULATORY AUTHORITY
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_Date Printed 21/08/2015_
_CRN 7021598_
_page number: 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.
Underdosing, which may be due to underestimation of body weight, 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 test(s) strongly suggest resistance to a particular anthelmintic, an
anthelmintic belonging to another pharmacological class and having a different mode of action shoul
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