FASINEX 10% ORAL SUSPENSION
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
05-11-2016
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Active ingredient:
TRICLABENDAZOLE
Available from:
Elanco Europe Ltd
ATC code:
QP52AC
INN (International Name):
TRICLABENDAZOLE
Dosage:
10 %w/v
Pharmaceutical form:
Oral Suspension
Prescription type:
LM-Licensed Merchant
Therapeutic group:
Bovine
Therapeutic area:
Benzimidazoles and related substances
Therapeutic indications:
Endoparasiticide
Authorization status:
Authorised
Authorization date:
2016-10-21
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Fasinex 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.
White to cream-coloured suspension.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Bovines.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment and control of adult, immature and early immature liver fluke.
Target parasite species: _Fasciola hepatica_
4.3 CONTRAINDICATIONS
Do not use in animals with known hypersensitivity to the active substance.
Do not use the product in sheep.
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.
Each ml comtains:
Active Substance
Triclabendazole
100 mg
Excipients
Methyl Parahydroxybenzoate (E218) 1.1 mg
Propyl Parahydroxybenzoate (E216) 0.24 mg
Benzoic Acid (E210)
1.0 mg
HEALTH PRODUCTS REGULATORY AUTHORITY
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_Date Printed 21/10/2016_
_CRN 7022992_
_page number: 1_
4.
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