SOLUBENOL 100 MG/G ORAL EMULSION FOR PIGS AND CHICKENS

Nazione: Irlanda

Lingua: inglese

Fonte: HPRA (Health Products Regulatory Authority)

Principio attivo:

FLUBENDAZOLE

Commercializzato da:

Elanco Animal Health, Eli Lilly and Company Limited

Codice ATC:

QP52AC12

INN (Nome Internazionale):

FLUBENDAZOLE

Dosaggio:

100 mg/g

Forma farmaceutica:

Oral Emulsion

Tipo di ricetta:

POM

Gruppo terapeutico:

Fowl - Chicken, Porcine

Area terapeutica:

Flubendazole

Indicazioni terapeutiche:

Endoparasiticide

Stato dell'autorizzazione:

Authorised

Data dell'autorizzazione:

2012-09-14

Scheda tecnica

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.
HEALTH PRODUCTS REGULATORY AUTHORITY
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_Date Printed 09/06/2015_
_CRN 7020666_
_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 the same class, over an extended period of time.
•
Underdosing, which