Gallifen 200 mg/ml suspension for use in drinking water for chickens and pheasants

Država: Irska

Jezik: angleščina

Source: HPRA (Health Products Regulatory Authority)

Aktivna sestavina:

Fenbendazole

Dostopno od:

Huvepharma NV

Koda artikla:

QP52AC13

INN (mednarodno ime):

Fenbendazole

Odmerek:

200 milligram(s)/millilitre

Farmacevtska oblika:

Suspension for use in drinking water

Tip zastaranja:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapevtska skupina:

Chickens

Terapevtsko območje:

fenbendazole

Terapevtske indikacije:

Anthelmintic

Status dovoljenje:

Authorised

Datum dovoljenje:

2018-03-29

Lastnosti izdelka

1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Gallifen 200 mg/ml suspension for use in drinking water for chickens
and pheasants
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Fenbendazole
200 mg
EXCIPIENTS:
QUALITATIVE
COMPOSITION OF EXCIPIENTS AND OTHER
CONSTITUENTS
QUANTITATIVE
COMPOSITION_ _
Sodium benzoate (E211)
3 mg
Docusate sodium
Povidone
Hydrochloric acid, concentrated (for pH adjustment)
Water for injections
White to almost white suspension for use in drinking water.
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Chickens
Pheasants
3.2
INDICATIONS FOR USE FOR EACH TARGET SPECIES
Treatment of chickens infected with
_Heterakis gallinarum _
(adult stages),
_ Ascaridia galli _
(adult stages),
_Capillaria obsignata _
(adult stages) or
_Raillietina echinobothrida_
(adult stages).
Treatment of pheasants infected with
_Heterakis gallinarum _
(adult 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
The veterinary medicinal product is to be used at the maximum
recommended dose of 3 mg/kg/day for
10 consecutive days for the treatment of
_Raillietina_
_echinobothrida_
which is encountered in free-
ranging and traditionally reared poultry. Intensively reared broiler
chickens are unlikely to be infected
with
_Raillietina_
_echinobothrida._
Unnecessary use of antiparasitics or use deviating from the
instructions given in the SPC may increase
the resistance selection pressure and lead to reduced efficacy. The
decision to use the veterinary
medicinal product should be based on confirmation of the parasitic
species and burden, or of the risk
of infection based on its epidemiological features, for each flock.
Repeated use for an extended period, particularly when using the same
class of substances, increases
the risk of resistance development. Within a flock, maintenance of
susceptible refugia is essential to
reduce that risk. Systematically applied interval-based treatment and
treatment of a whole fl