Flubenol 5% w/w Oral Powder for Pigs

Država: Velika Britanija

Jezik: engleski

Izvor: VMD (Veterinary Medicines Directorate)

Aktivni sastojci:

Flubendazole

Dostupno od:

Eli Lilly and Company Limited

ATC koda:

QP52AC12

INN (International ime):

Flubendazole

Farmaceutski oblik:

Oral powder

Tip recepta:

POM-VPS -Prescription Only Medicine – Veterinarian, Pharmacist, Suitably Qualified Person

Terapijska grupa:

Pigs

Područje terapije:

Anthelmintic

Status autorizacije:

Authorized

Datum autorizacije:

2000-09-17

Svojstava lijeka

Revised: June 2012
AN: 00170/2012
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Flubenol 5 % w/w Oral Powder for Pigs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
MG/G
ACTIVE INGREDIENT/S:
Flubendazole
50
EXCIPIENT/S:
Titanium dioxide (E171)
20
For full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral powder
White powder
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Pigs
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Flubendazole is a broad spectrum anthelmintic, effective against
mature and
immature stages of the following nematodes of the gastro-intestinal
tract:
_Ascaris suum,_ (large roundworm) including migrating larvae,
_Hyostrongylus _
_rubidus_, (red stomach worm), _Oesophagostomum dentatum_ (nodular
worm),
_Trichuris suis_ (whipworm) and _Strongyloides ransomi_ (threadworm)
(adult).
Flubendazole is ovicidal.
4.3
CONTRAINDICATIONS
Do not use in case of hypersensitivity to the active substance or to
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.
Page 1 of 5
Revised: June 2012
AN: 00170/2012

Underdosing, 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 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.
4.5
SPECIAL PRECAUTIONS FOR USE
i.
Special precautions for use in animals
Not applicable.
ii.
Special precautions to be taken by the person administering the
veterinary
medicinal