Pigfen 40 mg/g granules for pigs

Land: Ierland

Taal: Engels

Bron: HPRA (Health Products Regulatory Authority)

Werkstoffen:

Fenbendazole

Beschikbaar vanaf:

Huvepharma NV

ATC-code:

QP52AC13

INN (Algemene Internationale Benaming):

Fenbendazole

Dosering:

40 milligram(s)/gram

farmaceutische vorm:

Granules

Prescription-type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutische categorie:

Pigs

Therapeutisch gebied:

fenbendazole

therapeutische indicaties:

Anthelmintic

Autorisatie-status:

Authorised

Autorisatie datum:

2015-09-11

Productkenmerken

1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Pigfen
40 mg/g granules for pigs.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each g 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
Pïgs.
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.
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
medicinal product to animals.
Embryotoxic effects cannot be excluded. Pregnant women must take extra
precautions when handling
this veterinary medicinal product.
This veterinary medicinal product may be toxic to humans after
ingestion.
Accidental ingestion of the veterinary medicinal product should be
avoided.
In
case
of
accidental
ingestion,
rinse
mouth
with
plenty
of
clean
water,