Amprolium 20% ww Water Soluble Powder

Country: Malaysia

Language: English

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

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Active ingredient:

Amprolium Hydrochloride

Available from:

Nam Pharma Sdn. Bhd.

INN (International Name):

Amprolium Hydrochloride

Units in package:

100 gm; 1 kg

Manufactured by:

Nam Pharma Sdn. Bhd.

Summary of Product characteristics

                                AMPROLIUM 20%
w/w Water Soluble Powder
AMPROLIUM 20% W/W WATER SOLUBLE POWDER appears to be a light yellow
color powder.
COMPOSITION:
Each g contains
Amprolium (as Hydrochloride) 200 mg
PHARMACODYNAMICS:
Amprolium is an anticoccidial agent that acts as a competitive
inhibitor of
thiamine in the parasite metabolism, and interferes with the
metabolism of
glucides necessaries for coccidian multiplication and survival.
In in-vitro studies, it was shown that the uptake of thiamine by
schizonts of
Eimeria
tenella
and
by
host
intestinal
cells
can
occur
through
passive
diffusion or by an active, energy-and pH-dependent process. Amprolium
competitively inhibited both systems, however, the parasite was shown
to be
more sensitive to amprolium than the host.
As shown with Eimeria maxima inoculated chicken, the administration of
Amprolium
resulted
in
a
proportion
of
morphologically
abnormal
macrogametes and oocysts which may be considered the reason for a
reduced sporulation rate.
PHARMACOKINETICS:
Absorption is low after oral administration as maximum concentration
was
achieved only after 4 hours. Excretion is mainly through faeces.
INDICATIONS:
For the treatment of coccidiosis in growing chickens, turkeys and
laying
hens.
DIRECTIONS FOR USE:
Administer 100g of product to 170.55 liters of drinking water as soon
as
coccidiosis is diagnosed and continue for three to five days. (In
severe
outbreaks, administer 200g of product to 170.55 liters of drinking
water).
Continue with 50g of product to 170.55 liters for an additional 1 to 2
weeks.
No other source of drinking water should be available to the birds
during this
time.
Use as sole source of amprolium.
MODE OF ADMINISTRATION:
Oral Administration.
CONTRAINDICATION:
None known.
WARNING AND PRECAUTIONS:
_Special warnings for each target species _
Same
goes
with
any
antiparasiticide,
frequent
and
repeated
use
of
antiprotozoals
from
the
same
class
may
lead
to
the
development
of
resistance. In case of detection on the lack of efficacy during
treatment, do
communicate to the nationa
                                
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