Flimabend 100 mg/g Suspension for Use in Drinking Water for Chickens and Pigs

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Flubendazole

Available from:

Krka d.d., Novo Mesto

ATC code:

QP52AC12

INN (International Name):

Flubendazole

Pharmaceutical form:

Suspension for use in drinking water

Prescription type:

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

Therapeutic group:

Chickens, Pigs

Therapeutic area:

Anthelmintic

Authorization status:

Authorized

Authorization date:

2013-03-27

Summary of Product characteristics

Revised: November 2017
AN: 00626/2017
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
FLIMABEND 100 mg/g suspension for use in drinking water for chickens
and pigs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each g contains:
ACTIVE SUBSTANCE:
Flubendazole
100 mg
EXCIPIENTS:
Methyl parahydroxybenzoate (E218)
2.0 mg
Sodium benzoate (E211)
5.0 mg
Disodium edetate
0.1 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for use in drinking water.
White to brownish white suspension.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Pigs (piglets, pigs for fattening, pregnant and lactating sows) and
chickens (layer
hens, chickens for reproduction, pullets, broilers).
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
In hens/chickens:
-
Treatment of helminthiasis caused by _ Ascaridia galli_ (adult
stages), _ Heterakis _
_gallinarum _(adult stages), _Capillaria _spp. (adult stages).
In pigs:
-
Treatment of helminthiasis caused by _ Ascaris suum_ (adult and
intestinal larval
stages) in piglets, fattening pigs, pregnant and lactating sows.
4.3
CONTRAINDICATIONS
Do not use in cases of hypersensitivity to the active substance or to
any of the
excipients.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
In chickens, optimal results can only be achieved if strict rules of
hygiene are
respected in the maintenance of the cages.
Revised: November 2017
AN: 00626/2017
Page 2 of 7
In both 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 (if any).
Suspected clinical cases of resistance to anthelmintics should be
further investigated
using appropriate tests (e.g. Faecal Egg Count Reduction Tes