Gallifen 40 mg/g Premix for Medicated Feeding Stuff for Chickens and Pheasants

Nazione: Regno Unito

Lingua: inglese

Fonte: VMD (Veterinary Medicines Directorate)

Principio attivo:

Fenbendazole

Commercializzato da:

Huvepharma N.V.

Codice ATC:

QP52AC13

INN (Nome Internazionale):

Fenbendazole

Forma farmaceutica:

Premix for medicated feeding stuff

Tipo di ricetta:

POM-V - Prescription Only Medicine – Veterinarian

Gruppo terapeutico:

Chickens, Pheasants

Area terapeutica:

Anthelmintic

Stato dell'autorizzazione:

Authorized

Data dell'autorizzazione:

2017-01-24

Scheda tecnica

Revised: December 2021
AN: 00167/2021 & 00168/2021
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Gallifen
40 mg/g premix for medicated feeding stuff for chickens and pheasants
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
Chickens.
Pheasants.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of chickens infected with _Heterakis gallinarum _(L5 and
adult stages) and
_Ascaridia galli _(adult stages).
Treatment of pheasants infected with _Heterakis gallinarum _(adult
stages).
4.3
CONTRAINDICATIONS
Do not use in cases of hypersensitivity to the active substance, other
benzimidazoles
or any of the excipients_._
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
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.
Revised: December 2021
AN: 00167/2021 & 00168/2021
Page 2 of 6
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).
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
The safety of the product at overdose has not been evaluated in
chickens less than
8 weeks old.
Do not use in cases of _Capillaria _spp. infestations. The eff