SOLUBENOL 100 MG/G ORAL EMULSION FOR PIGS AND CHICKENS
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
24-06-2015
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Active ingredient:
FLUBENDAZOLE
Available from:
Elanco Animal Health, Eli Lilly and Company Limited
ATC code:
QP52AC12
INN (International Name):
FLUBENDAZOLE
Dosage:
100 mg/g
Pharmaceutical form:
Oral Emulsion
Prescription type:
POM
Therapeutic group:
Fowl - Chicken, Porcine
Therapeutic area:
Flubendazole
Therapeutic indications:
Endoparasiticide
Authorization status:
Authorised
Authorization date:
2012-09-14
Summary of Product characteristics
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
________________________________________________________________________________________________________________________
_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
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