Zenalb-20 50ml (20% Human Albumin)

País: Malásia

Língua: inglês

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

Ingredientes ativos:

ALBUMIN HUMAN

Disponível em:

GERMAX SDN. BHD.

DCI (Denominação Comum Internacional):

ALBUMIN HUMAN

Unidades em pacote:

50ml mL

Fabricado por:

BIO PRODUCTS LABORATORY LIMITED

Folheto informativo - Bula

ZENALB@
20
(20
_%_ human
albumin
solution)
ABL23
This
leaflet
is a summary
ot
information
available
about
your
medicine.
Please
read
ft
carefully
and
ft
anything
is
unclear
or
you
want
to
know more,
ask
your
doctor.
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or
l00ml
of
liGuid.
There
IS also
a plastic
sling
in the
pack
which
is used
to hang
up Ihe
bonle
when
you
are being
given
the
medicine.
The
product
is for
Intravenous
inlusion
Ian
injection
given
slowly
into
a vein)
and
is only
available
on a docto~s
orescnDlion
Your
medicine
has
been
made
frDm blood
plasma
from screened
donors.
These
donors
are selected
from the
USA.
tt
contains
proteins,
which
are substances
lhat
occur
naturally
in your
bocIy and
are needed
for
many
difterent
functions.
The
steritised
liquid
in the
glass
bottle
contains
~~~r;:t~e~sp~n;~~ro~;~J~~~~~~eige~:
:~~
~\p~~a~o/b~fa~g~r:;:~Jth1't,:ct~':t~;~~~)c~~~:~ ~~m~~~%~:
potassium
cilrate,
and
may
also
confain
a very
small
quantfty
of
aluminium
which
dissolves
out
of
the
glass
bottle.
Zenalb'
20 does
not
contain
any
preservatives.
Other
substances,
such
as
the
factors
that
help
blood
clot
and
those
that
detenmine
a
person's
blood
group,
have
been
taken
out
because
they
can
cause
certain
side-effects.
WHO
MAKES
ZENALBo
2O?
Your
medicine
is
made
by the
product
licence
holder
BPL,
Bio
Products
Laboratory,
Dagger
Lane,
Eistree,
Herts.
WD63BX.
PL 08801/0007.
WHAT IS YOUR MEDICINE USED FOR? "
is very important
Ihat
the
right
amount
of
fluid
is circulating
in your
blood
stream.
II
you
lose
a lot
01 fluid,
you
will
need
to have
extra
tluid
put
back
inlo
your
body
to
replace
iI.
Zenalb"
20
has
four
times
the
amount
of
albumin
and
twice
the
amount
of
protein
as
plasma.
This
medicine
is also
suitable
for
premature
babies
and
patienls
on kidney
dialysis
(blood
"cleaning"
by a machine)
as
ft conlains
only
very
small
quantilies
of
aluminium.
WHEN
SHOULD
YOU
NOT
USE
THIS
MEDICINE?
Tell
your
doclor
"
you:
.
have
ever
had
to stop
taking
this
or
a

Características técnicas

GPS Limited
Tel: [phone]
Job No: 18547
Text Sizes:
Main Body Text 6pt
Line Spacing 7pt
Fonts used:
Helvetica Neue
55 Roman
75 Bold
Project Name:
Zenalb 20 PIL Malaysia ABMY5
Contact:
Laura Ambrose
Client Order No.
P53744
Date:
26/06/2020
Proof No.
5
Operator:
Hema Joshi
Doc. Size:
170 x 220mm
PACKAGE LEAFLET: INFORMATION FOR THE USER
ZENALB 20
HUMAN ALBUMIN 20% SOLUTION
ABMY5
COLOURS: PANTONE PROCESS BLACK
1.
NAME OF THE MEDICINAL PRODUCT
Zenalb 20, Human Albumin 200 g/l solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Zenalb 20 is a solution containing 200 g/l (20%) of total protein of
which at least 95% is human albumin.
A vial of 100 ml contains 20 g of human albumin.
Zenalb 20 has a mildly hyperoncotic effect.
Excipient with known effect:
Zenalb 20 contains approximately 50-120 mmol/l sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for infusion.
A clear, slightly viscous liquid, it is almost colourless, yellow,
amber
or green.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Zenalb 20 is indicated in all patients for the restoration and
maintenance of circulating blood volume where volume deficiency
has been demonstrated, and use of a colloid is appropriate.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The concentration of the albumin preparation, dosage and the
infusion-rate should be adjusted to the patient’s individual
requirements.
POSOLOGY
The dose required depends on the size of the patient, the severity
of trauma or illness and on continuing fluid and protein losses.
Measures of adequacy of circulating volume, and not plasma albumin
levels, should be used to determine the dose required.
If human albumin is to be administered, haemodynamic performance
should be monitored regularly; this may include:
–
arterial blood pressure and pulse rate
–
central venous pressure
–
pulmonary artery wedge pressure
–
urine output
–
electrolyte
–
haematocrit/haemoglobin
METHOD OF ADMINISTRATION
Human albumin can be directly administered by the