FASINEX 5 % ORAL SUSPENSION

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

TRICLABENDAZOLE

Available from:

Novartis Animal Health UK Ltd

ATC code:

QP52AC

INN (International Name):

TRICLABENDAZOLE

Dosage:

5 %w/v

Pharmaceutical form:

Oral Suspension

Prescription type:

LM-Licensed Merchant

Therapeutic group:

Ovine

Therapeutic area:

Benzimidazoles and related substances

Therapeutic indications:

Endoparasiticide

Authorization status:

Transfer Pending

Authorization date:

2010-10-15

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Fasinex 5% 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
Ovines.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment and control of adult, immature and early immature stages of liver fluke susceptible to triclabendazole.
Target Species: _Fasciola hepatica_.
4.3 CONTRAINDICATIONS
Do not use in animals with known hypersensitivity to the active substance.
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 contains:
ACTIVE SUBSTANCE
Triclabendazole
50
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 21/03/2016_
_CRN 7023313_
_page number: 1_
4.5 SPECI