FLIMABO 100 mg/g suspension for use in drinking water for chickens and pigs
Country: Austria
Language: English
Source: HMA (Heads of Medicines Agencies)
Summary of Product characteristics
(SPC)
31-08-2013
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Active ingredient:
flubendazole 100 mg/ml
Available from:
Krka d.d.
ATC code:
QP52C
Pharmaceutical form:
Oral suspension
Therapeutic group:
AGENTS AGAINST NEMATODOSIS
Therapeutic area:
Chicken, Pigs
Authorization date:
2012-12-19
Summary of Product characteristics
1.3.1
Flubendazole
SPC, Labeling and Package Leaflet
FR
SmPCPIL034187/7
12.11.2012 – Updated: 02.01.2013
Page 1 of 20
SUMMARY OF PRODUCT CHARACTERISTICS
1.3.1
Flubendazole
SPC, Labeling and Package Leaflet
FR
SmPCPIL034187/7
12.11.2012 – Updated: 02.01.2013
Page 2 of 20
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
FLIMABO 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 a 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 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 and pregnant sows.
4.3
CONTRAINDICATIONS
Do not use in cases of known hypersensitivity to the active substance or to any of the
excipients.
4.4
SPECIAL WARNINGS FOR
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