Fasifree 10% w/v Oral Suspension

Country: Ireland

Bahasa: Inggeris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Triclabendazole

Boleh didapati daripada:

Bimeda Animal Health Limited

Kod ATC:

QP52AC01

INN (Nama Antarabangsa):

Triclabendazole

Dos:

10 percent weight/volume

Borang farmaseutikal:

Oral suspension

Jenis preskripsi:

POM: Prescription Only Medicine as defined in relevant national legislation

Kawasan terapeutik:

triclabendazole

Status kebenaran:

Authorised

Tarikh kebenaran:

2002-02-22

Ciri produk

Health Products Regulatory Authority
03 May 2019
CRN008M6G
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Fasifree 10% w/v Oral Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
​
ACTIVE SUBSTANCE
​
​
​
Triclabendazole
100 mg
EXCIPIENTS
Methyl Parahydroxybenzoate (E218) Ph.Eur.
2.0
mg (preservative)
Propyl Parahydroxybenzoate (E216) Ph.Eur.
0.2
mg (preservative)
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral suspension.
A white to off-white oral suspension.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle and Sheep.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment and control of adult, immature and early immature
stages of liver fluke (_Fasciola hepatica) _susceptible to
triclabendazole.
4.3 CONTRAINDICATIONS
Do not use in animals known to be hypersensitive 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 body weight,
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 test(s) strongly
suggest resistance to a particular anthelmintic, an anthelmintic
belonging to another pharmacological class and having a different mode
of action should be used.
Resistance to triclabendazolehas been reported in _Fasciola hepatica
_in cattle and sheep.Therefore, the use of this product
should be based on local (regional, farm) epidemiological information
about susceptibility of the _Fasciola hepatica _and
recommendations on how to limit further selection for resistance to