SN-FLUBENDAZOLE 5% ww ORAL POWDER

País: Malàisia

Idioma: anglès

Font: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Compra'l ara

Fitxa tècnica Fitxa tècnica (SPC)
20-06-2019

ingredients actius:

FLUBENDAZOLE

Disponible des:

Shennong Animal Health (Malaysia) Sdn. Bhd.

Designació comuna internacional (DCI):

FLUBENDAZOLE

Unidades en paquete:

600 gm

Fabricat per:

Shennong Animal Health (Malaysia) Sdn. Bhd.

Fitxa tècnica

                                SN-FLUBENDAZOLE 5%W/W
Oral
Powder
(FOR VETERINARY USE ONLY)
COMPOSITION
Flubendazole
….………………..……………………….…………................
5 %w/w
PRODUCT DESCRIPTION
The finished product is a white color powder.
TARGET SPECIES
Pigs
PHARMACODYNAMIC
Flubendazole
is
a
synthetic
anthelmintic
belonging
to
the
benzimidazole carbamates which acts by inhibiting the microtubular
assembly in absorptive cells of nematodes. Flubendazole acts by
binding to tubulin, the dimeric subunit protein of the microtubules.
It
inhibits microtubular assembly in absorptive cells: i.e. of intestinal
cells of nematodes. This is shown by disappearance of cytoplasmic
microtubules, accumulation of secretory granules in the cytoplasm
due to a block in their transport, leading to an impaired coating of
the cellular membrane and a decreased digestion and absorption of
nutrients.
Irreversible
lytic
degeneration
of
the
cell,
due
to
the
accumulation
of
secretory
substances
(hydrolytic
and
proteolytic
enzymes), results in the death of the parasite. These changes are
relatively fast and are primarily seen in those organelles directly
involved in the secretory and absorptive functions of the cells. In
contrast the changes are not seen in host cells.
PHARMACOKINETIC
Flubendazole is very poorly soluble in aqueous systems, such as the
gastrointestinal tract, which results in a low dissolution rate and a
very low absorption. This is reflected by a high faecal excretion of
unchanged
parent
drug.
The
very
small
fraction
absorbed
is
extensively
metabolised
by
first-pass
metabolism
in
the
liver,
involving
carbamate
hydrolysis
and
ketone
reduction.
The
biotransformation
products
are
conjugated
to
glucuronides
or
sulphate conjugates and excreted in the bile and the urine. The
excretion in urine is relatively low and consists almost exclusively
of
metabolites with only small amounts of unchanged compound. In
pigs, highest tissue levels are measured in liver and kidneys. The
half-
life of flubendazole in tissues is 1 to 2 days.
INDICATIO
                                
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