FLIMABEND 100 MG/G SUSPENSION FOR USE IN DRINKING WATER FOR CHICKENS AND PIGS
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
10-11-2016
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Active ingredient:
FLUBENDAZOLE
Available from:
Krka, d.d., Novo mesto
ATC code:
QP52AC12
INN (International Name):
FLUBENDAZOLE
Dosage:
100 mg/g
Pharmaceutical form:
Oral Suspension
Prescription type:
POM
Therapeutic group:
Fowl - Chicken, Porcine
Therapeutic area:
Flubendazole
Therapeutic indications:
Endoparasiticide
Authorization status:
Authorised
Authorization date:
2013-03-27
Summary of Product characteristics
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 of suspension for use in drinking water 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 known hypersensitivity to the active substance or to any of the excipients.
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 26/10/2016_
_CRN 7023568_
_page number: 1_
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.
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
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