Fasinex 240 mg/ml oral suspension for cattle

Država: Irska

Jezik: angleščina

Source: HPRA (Health Products Regulatory Authority)

Aktivna sestavina:

Triclabendazole

Dostopno od:

Elanco GmbH

Koda artikla:

QP52AC01

INN (mednarodno ime):

Triclabendazole

Odmerek:

240 milligram(s)/millilitre

Farmacevtska oblika:

Oral suspension

Tip zastaranja:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapevtska skupina:

Cattle

Terapevtsko območje:

triclabendazole

Terapevtske indikacije:

Endoparasiticide

Status dovoljenje:

Authorised

Datum dovoljenje:

2008-09-05

Lastnosti izdelka

Health Products Regulatory Authority
01 June 2018
CRN000YK1
Page 1 of 6
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:
​
​
​
ACTIVE SUBSTANCE:
​
​
​
Triclabendazole
240​
mg​
​
EXCIPIENTS:
​
​
​
Methyl parahydroxybenzoate (E218)
1.1​
mg​
​
Propyl parahydroxybenzoate (E216)
0.4​
mg​
​
Benzyl alcohol (E1519)
5.0​
mg​
​
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.
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.
Health Products Regulatory Authority
01 June 2018
CRN000YK1
Page 2 of 6

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 anthelmintic,
an anthelmintic
belonging to another pharmacological class and having a different mode
of action
should be used.
Resistance to triclabendazole has been reported in _Fasciola h