Flubendazole Elanco 50 mg/g oral powder for pigs

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Flubendazole

Available from:

Elanco Animal Health, Eli Lilly and Company Limited

ATC code:

QP52AC12

INN (International Name):

Flubendazole

Dosage:

50 milligram(s)/gram

Pharmaceutical form:

Oral powder

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Pigs

Therapeutic area:

flubendazole

Therapeutic indications:

Endoparasiticide

Authorization status:

Authorised

Authorization date:

2013-02-22

Summary of Product characteristics

Health Products Regulatory Authority
09 March 2018
CRN000VNC
Page 1 of 5
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Flubendazole Elanco 50 mg/g oral powder for pigs.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each g contains:
ACTIVE SUBSTANCE:
Flubendazole 50mg
EXCIPIENT(S):
Titanium dioxide (E171) 20mg
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Oral Powder.
White to slightly yellow powder.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Pigs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of helminthiasis due to mature and immature stages of the
following
nematodes of the gastro-intestinal tract:
_Ascaris suum_, (large roundworm), _Hyostrongylus rubidus_, (red
stomach worm),
_Oesophagostomum dentatum_ (nodular worm), _Trichuris suis_
(whipworm),
_Strongyloidesransomi_ (threadworm) (adult).
Flubendazole is ovicidal.
4.3 CONTRAINDICATIONS
Do not use in cases of hypersensitivity to the active substance or to
any of the
excipients.
Health Products Regulatory Authority
09 March 2018
CRN000VNC
Page 2 of 5
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, which may be due to underestimation of body weight,
misadministration of the product, or lack of calibration of the dosing
device (if any).
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 test(s) strongly suggest resistance to a particular anthelmintic,
an anthelmintic
belonging to another pharmacological class and having a different mode
of action
should be used.
4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
None.
Special precautions to be taken by the person administering the
veterinary medicinal
pr