Pigfen 40 mg/g Premix for Medicated Feeding Stuff for Pigs

Land: Storbritannien

Språk: engelska

Källa: VMD (Veterinary Medicines Directorate)

Aktiva substanser:

Fenbendazole

Tillgänglig från:

Huvepharma N.V.

ATC-kod:

QP52AC13

INN (International namn):

Fenbendazole

Läkemedelsform:

Premix for medicated feeding stuff

Receptbelagda typ:

POM-V - Prescription Only Medicine – Veterinarian

Terapeutisk grupp:

Pigs

Terapiområde:

Anthelmintic

Bemyndigande status:

Authorized

Tillstånd datum:

2016-12-07

Produktens egenskaper

Revised: September 2021
AN: 01897/2020 & 01915/2020
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
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:
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Premix for medicated feeding stuff.
Off-white to light yellow granules.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Pigs
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of pigs infected with _Ascaris suum _(adult, intestinal and
migrating larval
stages) susceptible to fenbendazole.
4.3
CONTRAINDICATIONS
Do not use in known cases of hypersensitivity to the active substance,
other
benzimidazoles or any of the excipients_._
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.
•
Under dosing, 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
Revised: September 2021
AN: 01897/2020 & 01915/2020
Page 2 of 6
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.
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
produc