FLIMABEND 100 mg/g suspension for use in drinking water for chickens and pigs

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Flubendazole

Available from:

Krka, d.d., Novo mesto

ATC code:

QP52AC12

INN (International Name):

Flubendazole

Dosage:

100 milligram(s)/gram

Pharmaceutical form:

Oral suspension

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Chickens, Pigs

Therapeutic area:

flubendazole

Therapeutic indications:

Endoparasiticide

Authorization status:

Authorised

Authorization date:

2013-03-27

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:
QUALITATIVE
COMPOSITION OF EXCIPIENTS AND
OTHER CONSTITUENTS
QUANTITATIVE
COMPOSITION
IF THAT INFORMATION
IS ESSENTIAL
FOR PROPER ADMINISTRATION OF THE
VETERINARY MEDICINAL PRODUC
t
_ _
Methyl parahydroxybenzoate (E218)
2.0 mg
Sodium benzoate (E211)
5.0 mg
Disodium edetate
0.1 mg
Carmellose sodium
Xanthan gum
Citric acid monohydrate
Carbomers
Propylene glycol
Water, purified
White to brownish white suspension.
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Pigs (piglets, pigs for fattening, pregnant and lactating sows) and
chickens (layer hens, chickens for
reproduction, pullets, broilers).
3.2
INDICATIONS FOR USE
FOR EACH 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, pigs
for fattening, pregnant and lactating sows.
3.3
CONTRAINDICATIONS
Do not use in cases of hypersensitivity to the active substance or to
any of the excipients.
3.4
SPECIAL WARNINGS
In chickens, optimal results can only be achieved if strict rules of
hygiene are respected in the
maintenance of the cages.
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
veterinary medicinal 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. Fae