ToltraCox-25 Oral Solution
Country: Malaysia
Language: English
Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Summary of Product characteristics
(SPC)
21-09-2016
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Active ingredient:
TOLTRAZURIL
Available from:
Life Biopharma Sdn. Bhd.
INN (International Name):
TOLTRAZURIL
Units in package:
1.00 mcg/mL; 5.00 mcg/mL
Manufactured by:
Life Biopharma Sdn. Bhd.
Summary of Product characteristics
ToltraCox-25
Oral
Solution
FOR
AMMAL
USE
ONLY
Brand
or Produc't
Name
:
Tollra0ox-2s
Oral
Solution
Name
and
Shength
ot Active
Substance(s)
Each
ml
contains
25
mg
toltazuril"
Prodtrct
Description
ToltraCox-25
Oral
Solution
is a clear,
colorless
to light
yelloinish
or bnomish
liquid.
Pharmacodyrnmics
Tdbazwil
indlc€s
changes
in the
ftne
s{ructure
of
coccidhl
development
slags trat de mainfi
die to the
slelling
of the
en@lasnb reticulum
and
of
the
Golgi
apparatus
and
ta
abnomalilies
in ttle
painuclear
space
and
disfurbances
in nuclear
divbion-
Toltrarnil
abo
causes
a reduction
of enzymes
in the
respiratory
chain
of
the
parasites.
Pharmacodynamic
studies
in laboratory
animals
ittdicated
fiat toltauil had
no
antboagulant,
fibrinolytb,
analgesic,
diuretic
or
anticonvubant
effecl.
lt had
no
efect
on
gsbointestinal
tansit
time.
0ral doses
of up
to 30
mgtkg
bw
had
no
haemodynamic
or cardiac
effects
in anaesthetbed
dogs
although
100m9/kg
bw
caused
a slight
tensor
effect
m
refbcted
by
an
increase
in
pedpheral
resistance.
Pharmacokinetics
lnpoUltrto|tauri|isabsorbedatarateofat|east50o6.Thehighestequivalentconcent"ationsatefoundinlive|.Theactjvesubstarrceisrapidfmetabo|id|npu|$
metabolite
b characterised
as
a sulfon+derivative.
About
1 upek
afrer
the
last
dose
his meholite represents
bv
far
the
mosl
relevant
residue
rn
the
animal.
Indication
Fs
he treatnent
of Coccidiosis
in Broilers
and
Broiler
Breders.
It iseffective
againslEineia
aerwlin4 E-
brunetti,
E.
nu.ina,
E. necdrk,
E.tenella,
E. nitis.
Recommended
Dorags
The
reccrnmended
dose
rate
is 7 mg
Toltrauril
per
kg
bo{weight
per
day
given
fof
2 consecutive
days.
This
conesponG
to : 28
ml
Tolta0ox-2s
Oral
Solution
(equivalent
to 700
mg
tolbaz$it)
per
100
kg
of bodyweight
per
day
br
2
consecutive
days.
Asag!idefof6agethisisnormallyequiva|enlto25pgn(equiva|entto1m|ToltaCox.25salSo|ution)pelikeofdinkingr,rnterforcontinuo!smedicationover48hos'$b75
ppm
(equivalent
to 3 ml
TolbaCox-25
&al
Solution)
pa
libe
of dinking
$at€r
given
fu
I
hours
pa'
day,
on
2 consecutive
days.
Tredrn
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