Pigfen 200 mg/ml suspension for use in drinking water for pigs

Šalis: Airija

kalba: anglų

Šaltinis: HPRA (Health Products Regulatory Authority)

Veiklioji medžiaga:

Fenbendazole

Prieinama:

Huvepharma NV

ATC kodas:

QP52AC13

INN (Tarptautinis Pavadinimas):

Fenbendazole

Dozė:

200 milligram(s)/millilitre

Vaisto forma:

Suspension for use in drinking water

Recepto tipas:

POM: Prescription Only Medicine as defined in relevant national legislation

Farmakoterapinė grupė:

Pigs

Gydymo sritis:

fenbendazole

Terapinės indikacijos:

Anthelmintic

Autorizacija statusas:

Authorised

Leidimo data:

2018-03-29

Prekės savybės

1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Pigfen 200 mg/ml suspension for use in drinking water for pigs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Fenbendazole
200 mg
EXCIPIENTS:
QUALITATIVE
COMPOSITION OF EXCIPIENTS AND OTHER
CONSTITUENTS
QUANTITATIVE COMPOSITION IF THAT
INFORMATION IS ESSENTIAL FOR PROPER
ADMINISTRATION OF THE VETERINARY MEDICINAL
PRODUCT
Sodium benzoate (E211)
3 mg
Docusate sodium
Povidone
Hydrochloric acid, concentrated (for pH
adjustment)
Water for injections
White to almost white suspension.
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).
3.3
CONTRAINDICATIONS
Do not use in cases of hypersensitivity to the active substance 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