Fasinex 100 10% (w/v) Oral Suspension for Cattle and Sheep

מדינה: הממלכה המאוחדת

שפה: אנגלית

מקור: VMD (Veterinary Medicines Directorate)

מרכיב פעיל:

Triclabendazole

זמין מ:

Elanco Europe Ltd

קוד ATC:

QP52AC01

INN (שם בינלאומי):

Triclabendazole

טופס פרצבטיות:

Oral suspension

סוג מרשם:

POM-VPS -Prescription Only Medicine – Veterinarian, Pharmacist, Suitably Qualified Person

קבוצה תרפויטית:

Cattle, Sheep

איזור תרפויטי:

Anthelmintic flukicide

מצב אישור:

Expired

תאריך אישור:

2008-01-23

מאפייני מוצר

Revised: December 2015
AN. 01134/2015
Page 1 of 7
SUMMARY OF PRODUCTS CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Fasinex 100 10%(w/v) Oral Suspension for Cattle & Sheep
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Qualitative composition
Active substance:
Triclabendazole
Excipient(s):
Antimicrobial preservatives:
Methyl hydroxybenzoate (E218)
Propyl hydroxybenzoate (E216)
Benzoic acid (E210)
Quantitative composition
10.000% w/v
0.110% w/v
0.024% w/v
0.100% w/v
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral suspension.
A cream-coloured aqueous suspension.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle and Sheep.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
CATTLE
For the treatment and control of liver fluke infections in cattle
caused by all stages
of triclabendazole-susceptible _Fasciola hepatica_ from 2 week old
immature to
adult fluke.
SHEEP
For the treatment and control of liver fluke infections in sheep
caused by all
stages of triclabendazole susceptible _Fasciola hepatica_ from 2 day
old immature
to adult fluke.
4.3
CONTRAINDICATIONS
None known.
Revised: December 2015
AN. 01134/2015
Page 2 of 7
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Shake the container thoroughly before use.
Assess bodyweight as accurately as possible before calculating dose.
Intensive use or misuse of anthelmintics can give rise to resistance.
To reduce
this risk, dosing programmes should be discussed with your veterinary
adviser.
Efficacy of this product against liver fluke is reduced if
triclabendazole-resistant
strains are present.
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
(if any).
Suspected clinical cases