Fludosol 200 mg/ml Suspension for use in drinking water for pigs and chickens

Negara: Irlandia

Bahasa: Inggris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Flubendazole

Tersedia dari:

Dopharma Research B.V.

Kode ATC:

QP52AC12

INN (Nama Internasional):

Flubendazole

Bentuk farmasi:

Suspension for use in drinking water

Jenis Resep:

POM: Prescription Only Medicine as defined in relevant national legislation

Area terapi:

flubendazole

Tanggal Otorisasi:

2023-06-30

Karakteristik produk

_ _
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Fludosol 200 mg/ml suspension for use in drinking water for pigs and
chickens
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml contains:
ACTIVE SUBSTANCE:
Flubendazole
200 mg
EXCIPIENTS:
QUALITATIVE
COMPOSITION OF EXCIPIENTS AND
OTHER CONSTITUENTS_ _
QUANTITATIVE
COMPOSITION
IF THAT INFORMATION IS
ESSENTIAL
FOR PROPER ADMINISTRATION OF THE
VETERINARY MEDICINAL PRODUC
t
_ _
Adipic acid
_ _
Simethicone emulsion
Methyl parahydroxybenzoate (E218)
0.8 mg
Propyl parahydroxybenzoate
0.2 mg
Polysorbate 80
Propylene glycol
Water, purified
White to off-white suspension for use in drinking water.
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Pig and chicken
3.2
INDICATIONS FOR USE FOR EACH TARGET SPECIES
In pigs:
Treatment of helminthiasis caused by
_Ascaris suum_
(adult, migratory (L3) and intestinal (L4)
larval stages).
In chickens:
Treatment of helminthiasis caused by
_Ascaridia galli _
(adult stages),
_Heterakis gallinarum _
(adult
stages),
_Capillaria _
spp
_._
(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
Treatment with this veterinary medicinal product only gives optimal
results, if a strict hygiene of the
livestock building and the pen is taken into account concurrently.
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
herd/flock.
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;
- underdosing, which may be due to underestimation of body