Fasinex 5% w/v Oral Suspension

Kraj: Irlandia

Język: angielski

Źródło: HPRA (Health Products Regulatory Authority)

Składnik aktywny:

Triclabendazole

Dostępny od:

Elanco Europe Ltd

Kod ATC:

QP52AC

INN (International Nazwa):

Triclabendazole

Dawkowanie:

5 percent weight/volume

Forma farmaceutyczna:

Oral suspension

Typ recepty:

LM: Licensed Merchant as defined in relevant national legislation

Grupa terapeutyczna:

Sheep

Dziedzina terapeutyczna:

Benzimidazoles and related substances

Wskazania:

Endoparasiticide

Status autoryzacji:

Authorised

Data autoryzacji:

2016-10-21

Charakterystyka produktu

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
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