Fasinex 10% w/v Oral Suspension

Land: Irland

Sprog: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv bestanddel:

Triclabendazole

Tilgængelig fra:

Elanco Europe Ltd

ATC-kode:

QP52AC

INN (International Name):

Triclabendazole

Dosering:

10 percent weight/volume

Lægemiddelform:

Oral suspension

Recept type:

LM: Licensed Merchant as defined in relevant national legislation

Terapeutisk gruppe:

Cattle

Terapeutisk område:

Benzimidazoles and related substances

Terapeutiske indikationer:

Endoparasiticide

Autorisation status:

Authorised

Autorisation dato:

2016-10-21

Produktets egenskaber

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
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