Pigfen 40 mg/g premix for medicated feeding stuff for pigs

Land: Irland

Sprache: Englisch

Quelle: HPRA (Health Products Regulatory Authority)

Wirkstoff:

Fenbendazole

Verfügbar ab:

Huvepharma NV

ATC-Code:

QP52AC13

INN (Internationale Bezeichnung):

Fenbendazole

Dosierung:

40 milligram(s)/gram

Darreichungsform:

Premix for medicated feeding stuff

Verschreibungstyp:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapiegruppe:

Pigs

Therapiebereich:

fenbendazole

Anwendungsgebiete:

Anthelmintic

Berechtigungsstatus:

Authorised

Berechtigungsdatum:

2016-12-09

Fachinformation

1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Pigfen 40 mg/g premix for medicated feeding stuff for pigs.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram contains:
ACTIVE SUBSTANCE:
Fenbendazole
40 mg
EXCIPIENTS:
QUALITATIVE
COMPOSITION OF EXCIPIENTS AND OTHER CONSTITUENTS
Maize starch
Pregelatinised starch
Off-white to light yellow granules.
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Pigs.
3.2
INDICATIONS FOR USE FOR EACH TARGET SPECIES
Treatment of pigs infected with
_Ascaris suum _
(adult, intestinal and migrating larval stages) susceptible
to fenbendazole.
3.3
CONTRAINDICATIONS
Do not use in cases of hypersensitivity to the active substance, to
other benzimidazoles or to any of the
excipients
_._
3.4
SPECIAL WARNINGS
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.
•
Under dosing, which may be due to underestimation of body weight,
misadministration of
the veterinary medicinal 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.
The uptake of medication by animals can be altered as a consequence of
illness. In case of insufficient
uptake of feed, animals should be treated parenterally.
3.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for safe use in the target species
None.
Special precautions to be taken by the person administering the
veterinary medicinal product to
animals.
Embryotoxic effects cannot be excluded. Pregnant women must take extra
precautions when handling
this veterinary medicinal product.
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