TP-DICOCCI SOL Diclazuril 0.5% wv Solution

Quốc gia: Malaysia

Ngôn ngữ: Tiếng Anh

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

Thành phần hoạt chất:

DICLAZURIL

Sẵn có từ:

Thye Pharma Sdn. Bhd

INN (Tên quốc tế):

DICLAZURIL

Sản xuất bởi:

Thye Pharma Sdn. Bhd

Đặc tính sản phẩm

VETERINARY PACKAGE INSERT
TP-DICCOCCI SOL (0.5% W/V DICLAZURIL)
PRODUCT DESCRIPTION
A
yellow
to
brown
colour
liquid,
which
contains
0.5%w/v of diclazuril in 1L bottle.
PHARMACODYNAMICS & PHARMACOKINETICS
Diclazuril
is
an
anticoccidial
of
the
benzene
acetonitrile group and has an anticoccidial activity
against _ Eimeria_ species. Depending on the coccidia
species, diclazuril has a coccidiocidal effect on the
asexual or sexual stages of the development cycle of
the
parasite.
Treatment
with
diclazuril
causes
interruption of the coccidial cycle and of excretion of
oocysts
for
approximately
2
to
3
weeks
after
administration. This allows the lambs to bridge the
period of decrease of maternal immunity (observed
at
approximately
4
weeks
of
age)
and
calves
to
reduce the infection pressure of their environment.
After oral administration, the absorption of diclazuril
in
lambs
and
calves
is
poor.
The
maximum
concentration in plasma is reached between 24 h and
48 h after dosing. The absorption decreases with the
age of the lambs. The elimination half-life is about 30
hours.
The
metabolism
of
diclazuril
was
studied
in
vitro using sheep hepatocytes. Studies indicate that
at 24 hours after administration, the concentrations in
edible
tissues
are
far
below
the
Acceptable
Daily
Intake.
As
a
result,
it
is
not
essential
to
establish
Maximum
Residue
Limits
or
to
determine
a
Withdrawal Period.
In
calves,
kinetic
profiles
have
been
studied
after
administration of a single dose of 5 mg diclazuril per
kg body weight and after dosing for 3 consecutive
days at respectively 1 mg, 3 mg and 5 mg diclazuril
per kg body weight. Following the single dose of
5 mg peak plasma concentrations in the range of 21
to
75 ng/ml
were
reached
after
8
to
24 hours.
Thereafter
the
concentrations
decreased
with
a
half-life
of
16 hours
to
concentrations
below
10 ng/ml after 48 hours. Following the 3 consecutive
daily doses of 1 mg diclazuril per kg body weight,
mean
peak
plasma
concentrations
of
65.6 ng/ml
were
reached
10.5 hours
after
the
last
dose.
Thereafter