SOLUBENOL 100 MG/G ORAL EMULSION FOR PIGS AND CHICKENS

Land: Irland

Sprog: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv bestanddel:

FLUBENDAZOLE

Tilgængelig fra:

Elanco Animal Health, Eli Lilly and Company Limited

ATC-kode:

QP52AC12

INN (International Name):

FLUBENDAZOLE

Dosering:

100 mg/g

Lægemiddelform:

Oral Emulsion

Recept type:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapeutisk gruppe:

Fowl - Chicken, Porcine

Terapeutisk område:

flubendazole

Terapeutiske indikationer:

Endoparasiticide

Autorisation status:

Authorised

Autorisation dato:

2012-09-14

Produktets egenskaber

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Solubenol 100 mg/g oral emulsion for pigs and chickens.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
3 PHARMACEUTICAL FORM
Oral emulsion.
White homogeneous viscous fluid.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Pigs (piglets, pigs for fattening and pregnant sows) and chickens
(layer hens, chickens for reproduction and pullets).
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
In chickens:
Treatment of helminthiasis caused by:
-_ Ascaridia galli_ (mature stages)
-_ Heterakis gallinarum_ (mature stages)
-_ Capillaria spp.(mature_ stages)
In pigs:
Treatment of infection by mature stages and intestinal larval stages
of_ Ascaris suum_ in piglets,
pigs for fattening and
pregnant sows.
4.3 CONTRAINDICATIONS
Do not use in the case of hypersensitivity to the active substance or
to any of the excipients.
Each gram contains:
ACTIVE SUBSTANCE
Flubendazole
100.0 mg
EXCIPIENTS
Propyl parahydroxybenzoate (E216)
4.0
mg
Methyl parahydroxybenzoate (E218)
4.0
mg
Butylhydroxytoluene (E321)
0.2
mg
Propylene glycol (E1520)
50.0
mg
For a full list of excipients, see section 6.1.
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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