FASINEX 240 MG/ML ORAL SUSPENSION FOR CATTLE
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:
QP52AC01
INN (International Name):
TRICLABENDAZOLE
Dosage:
240 Mg/Ml
Pharmaceutical form:
Oral Suspension
Prescription type:
LM-Licensed Merchant
Therapeutic group:
Bovine
Therapeutic area:
Triclabendazole
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 240 mg/ml oral suspension for cattle
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Oral Suspension.
White to cream-coloured aqueous suspension.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle.
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.
4.3 CONTRAINDICATIONS
Do not use in case of hypersensitivity to the active substance or to any of the ingredients.
ACTIVE SUBSTANCE:
Triclabendazole
240 mg
EXCIPIENTS:
Methyl parahydroxybenzoate (E218)
1.1 mg
Propyl parahydroxybenzoate (E216)
0.4 mg
Benzyl alcohol (E1519)
5.0 mg
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 21/10/2016_
_CRN 7022995_
_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 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 anthelminti
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