Fluboral 200 mg/ml, suspension for use in drinking water for pigs and chickens

Страна: Ірландія

мова: англійська

Джерело: HPRA (Health Products Regulatory Authority)

Активний інгредієнт:

Flubendazole

Доступна з:

Dechra Regulatory B.V.

Код атс:

QP52AC12

ІПН (Міжнародна Ім'я):

Flubendazole

Фармацевтична форма:

Suspension for use in drinking water

Тип рецепту:

POM: Prescription Only Medicine as defined in relevant national legislation

Терапевтична области:

flubendazole

Дата Авторизація:

2023-05-05

Характеристики продукта

1
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Fluboral 200 mg/ml, suspension for use in drinking water for pigs and
chickens
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Flubendazole
200.0 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
_ _
Methyl parahydroxybenzoate (E218)
2.7 mg
Propyl parahydroxybenzoate
0.75 mg
Propylene glycol
Poloxamer 407
Sodium chloride
Simethicone (as an emulsion)
Purified water
White to off-white suspension
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Pigs and chickens.
3.2
INDICATIONS FOR USE FOR EACH TARGET SPECIES
Chickens:
Treatment of helminthiasis caused by:
-
_Ascaridia galli_
(adult stages)
-
_Heterakis gallinarum_
(adult stages)
-
_Capillaria_
spp. (adult stages)
Pigs:
Treatment of helminthiasis caused by
_Ascaris suum_
(adult and L4 intestinal 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
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 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.
The use of this product should take into account local information
about susceptibility of the target
parasites, where available.
2
It is recommended to further investigate cases of suspected
resistance, using an appropriate diagnostic
method (e.g. Faecal Egg Count Reduction Test (FECRT)). 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.
Optimal results can only be achieved if strict rules of hygiene are
applied.
Con