Flubenol 5 % w/w Premix for Medicated Feeding Stuff

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Flubendazole

Available from:

Elanco GmbH

ATC code:

QP52AC12

INN (International Name):

Flubendazole

Dosage:

5 percent weight/weight

Pharmaceutical form:

Premix for medicated feeding stuff

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Pigs, Poultry

Therapeutic area:

flubendazole

Therapeutic indications:

Endoparasiticide

Authorization status:

Authorised

Authorization date:

2012-05-25

Summary of Product characteristics

Health Products Regulatory Authority
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE VETERINARY MEDICINAL PRODUCT
Flubenol 5 % w/w Premix for Medicated Feeding Stuff
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each g contains:
Active substance
Flubendazole
50
mg
Excipients
Titanium dioxide (E171)
20
mg
For a full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Premix for medicated feeding stuff.
White powder.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Pig and Poultry.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Flubendazole is a broad spectrum anthelmintic, effective against
mature and
immature stages of the following nematodes of the gastro-intestinal
and respiratory
tract:
In pigs: _Ascaris suum, _(large roundworm) including migrating larvae,
_Hyostrongylus _
_rubidus, _(red stomach worm), _Oesophagostomum dentatum _(nodular
worm). _Trichuris _
_suis _(whipworm), _Strongyloides ransomi _(adult) and _Metastrongylus
apri _(lungworm).
In poultry: _Syngamus trachea _(gapeworm)_, Ascaridia galli _(large
roundworm)_, Heterakis _
_gallinarum _(caecal worm)_, Capillaria G allinarum _(hair worm_),
Amidostomum anseris _
(gizzard worm)_, Trichostrongylus tenuis. _
Flubendazole is ovicidal.
Health Products Regulatory Authority
Page 2 of 6
4.3
CONTRAINDICATIONS
Do not use in animals with known hypersensitivity to the active
ingredient.
4.4
SPECIAL WARNINGS FOR EACH TARGET 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.
Suspected clinical cases of resistance to anthelmintics should be
further investigated using
appropriate tests (e.g. Faecal Egg Count Reduction Test). Where the
results of the tests
strongly suggest resistance to a particular anthelmintic, an
anthelmintic belonging to
another pharmacological class and having a different mode of action