Diclazuril Premix 0.5% ww Granular

Country: Malaysia

Language: English

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

Active ingredient:

DICLAZURIL

Available from:

Weissen Company (m) Sdn. Bhd.

INN (International Name):

DICLAZURIL

Units in package:

25.00 mcg/mL

Manufactured by:

Shandong Luxi Animal Medicine Share Co., Ltd

Summary of Product characteristics

PACKAGE INSERT
Brand or product
Name
Diclazuril Premix 0.5% w/w Granular
Name and strength
of active
substance(s)
Diclazuril 0.5% (w/w)
Product
Description
Yellow to brown granular
Pharmacodynamics
Diclazuril is a chemical anticoccidial, a benzeneacetonitrile
derivative-
synthetic compound of the triazinone family. Diclazuril is has a mode
of
action completely different from the existing ionophores and
chemicals,
available
on
the
market.
According
to
the
anticoccidial
properties
of
triazinones, diclazuril is active against intracellular development
stages of
coccidia,
namely
during
schizogony
and
gametogony.
After
diclazuril
treatment,
the
first-
and
second-
generation
schizonts
show
extensive
degenerative
changes
which
are
characterised
by
the
loss
of
internal
structure,
the
appearance
of
many
intracytoplasmic
vacuoles
and
incomplete
merogony.
Ultrastructural
findings
indicate
that
diclazuril
treatment primarily affects the normal differentiation of the
respective
endogenous stages during parasite development. This leads to complete
degeneration of schizonts and gamonts.
Pharmacokinetics
The
absorption
of
diclazuril
in
animal
is
poor
after
administration.
Maximum
concentrations
in
plasma
are
reached
about
24
hours
after
dosing. The absorption decreases with the animals’ age. The
elimination
half-life
is
about
30
hours.
In-vitro
studies
on
sheep
hepatocytes
demonstrated that metabolic transformation of diclazuril is limited.
This
was equally observed in other animal species. Excretion occurs almost
completely via the faeces.
Environmental
Properties
None known
Indication
Prevention of coccidiosis disease in broiler chickens
Recommended
Dosage
Thoroughly mix 200 g of Diclazuril Premix 0.5 % per ton of feed obtain
a
concentration of 1 ppm Diclazuril (1 gram per ton).
Mode of
Administration
Orally via feed mixing.
Contraindication
None known
Warning and
precaution
Treated poultry must not be slaughtered for human consumption during
treatment.
As with all medicated feedstuffs, operators are advised to use
protectiv