SOLUBENOL 100 MG/G ORAL EMULSION FOR PIGS AND CHICKENS

Negara: Irlandia

Bahasa: Inggris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

FLUBENDAZOLE

Tersedia dari:

Elanco Animal Health, Eli Lilly and Company Limited

Kode ATC:

QP52AC12

INN (Nama Internasional):

FLUBENDAZOLE

Dosis:

100 mg/g

Bentuk farmasi:

Oral Emulsion

Jenis Resep:

POM: Prescription Only Medicine as defined in relevant national legislation

Kelompok Terapi:

Fowl - Chicken, Porcine

Area terapi:

flubendazole

Indikasi Terapi:

Endoparasiticide

Status otorisasi:

Authorised

Tanggal Otorisasi:

2012-09-14

Karakteristik produk

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