KABIVEN G 11% 1440mL injection bag

Nchi: Australia

Lugha: Kiingereza

Chanzo: Department of Health (Therapeutic Goods Administration)

Nunua Sasa

Taarifa za kipeperushi Taarifa za kipeperushi (PIL)
24-08-2020
Tabia za bidhaa Tabia za bidhaa (SPC)
24-08-2020

Viambatanisho vya kazi:

alanine,arginine,aspartic acid,calcium chloride dihydrate,glucose monohydrate,glutamic acid,glycine,histidine,isoleucine,leucine,lysine hydrochloride,magnesium sulfate heptahydrate,methionine,phenylalanine,potassium chloride,proline,serine,sodium acetate trihydrate,sodium glycerophosphate,Soya Oil,threonine,tryptophan,tyrosine,valine

Inapatikana kutoka:

Fresenius Kabi Australia Pty Ltd

INN (Jina la Kimataifa):

Alanine,Arginine,Aspartic acid,calcium chloride dihydrate,glucose monohydrate,Glutamic acid,Glycine,Histidine,Isoleucine,Leucine

Idhini hali ya:

Registered

Taarifa za kipeperushi

                                Page 1 of 3
KABIVEN
® G11% AND G19%
G11% contains 2.4% amino acids, 3.5% triglycerides, 6.8% glucose and
0.7% electrolytes.
G19% contains 3.3% amino acids, 3.9% triglycerides, 9.7% glucose and
0.7% electrolytes
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This
leaflet
answers
some
common
questions
about
Kabiven. It does not contain all
the
available
information.
It
does
not
take
the
place
of
talking
to
your
doctor
or
pharmacist. All medicines have
risks and benefits. Your doctor
has
weighed
the
risks
of
you
being given Kabiven against any
benefits they expect it will have
for you.
PLEASE
READ
THIS
LEAFLET
CAREFULLY.
IF
YOU
HAVE
ANY
QUESTIONS OR ARE UNSURE ABOUT
ANYTHING,
PLEASE
ASK
YOUR
DOCTOR OR PHARMACIST.
KEEP
THIS
LEAFLET
WITH
THE
MEDICINE. YOU MAY NEED TO
READ IT AGAIN.
WHAT IS KABIVEN USED
FOR AND HOW DOES IT
WORK
Kabiven
is
a
sterile
emulsion
which provides your body with
nutrition
by
the
intravenous
route.
When
the
intake
of
nutrients or food into the mouth
or
directly
into
the
gut
is
not
possible, or it is not enough to
supply the body’s needs, then
intravenous
nutrients
or
foods
can be given. This is especially
important
for
people
whose
bodies are under physical stress
from illness or recent surgery.
During
illness
or
after
surgery
the
body
requires
nutrition
or
food.
Kabiven
G19%
contains
3.3%
amino acids, 3.9% triglycerides
(soya
oil),
9.7%
glucose
and
0.7% electrolytes.
Kabiven
G11%
contains
2.4%
amino acids, 3.5% triglycerides,
6.8%
glucose
and
0.7%
electrolytes.
Kabiven
is
usually
given
together with trace elements and
vitamins to provide a complete
intravenous diet.
BEFORE YOU ARE GIVEN
KABIVEN
You
should
NOT
be
given
Kabiven if
•
You
have
had
an
allergic reaction to egg-
yolk
containing
foods,
peanut or soy products.
•
You have an allergy to
any
of
the
ingredients
contained in Kabiven as
listed at the end of this
leaflet.
•
You have an inability to
break down fats
•
You have an inability to
break
down
amino
acids,
for
example
an
inherited
condition
known
as
phenylketonuria.

                                
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Tabia za bidhaa

                                Australian Product Information – Kabiven
®
G 11% intravenous infusion
Page 1 of 13
1
NAME OF THE MEDICINE
Glucose monohydrate, alanine, arginine, aspartic acid, glutamic acid,
glycine, histidine, isoleucine,
leucine, lysine hydrochloride, methionine, phenylalanine, proline,
serine, threonine, tryptophan,
tyrosine, valine, calcium chloride dihydrate, magnesium sulfate
heptahydrate, potassium chloride,
sodium acetate trihydrate, sodium glycerophosphate, soya oil.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
KABIVEN is a three-chamber bag of amino acid solution with
electrolytes, glucose solution and lipid
emulsion for intravenous infusion. The glucose and amino acid
solutions are clear solutions while the
fat emulsion is white.
The active ingredients are:
▪
AMINO ACIDS 2.4%: alanine, arginine, aspartic acid, glutamic acid,
glycine, histidine, isoleucine,
leucine, lysine hydrochloride, methionine, phenylalanine, proline,
serine, threonine, tryptophan,
tyrosine and valine.
▪
ELECTROLYTES 0.7%: calcium chloride dihydrate, magnesium sulfate
heptahydrate, potassium
chloride, sodium acetate trihydrate and sodium glycerophosphate.
▪
GLUCOSE 6.8%: glucose monohydrate.
▪
LIPIDS 3.5%: soya oil.
Each bag contains the following different volumes depending on the
three pack sizes.
2400 mL
1920 mL
1440 mL
Glucose (11%)
1475 mL
1180 mL
885 mL
Amino acids and electrolytes (_Vamin 18 Novum)_
500 mL
400 mL
300 mL
Triglycerides (_Intralipid 20%)_
425 mL
340 mL
255 mL
This corresponds to the following compositions.
Active Ingredients (g)
2400 mL
1920 mL
1440 mL
Soya Oil
85
68
51
Glucose monohydrate
_Corresponding to glucose (anhydrous)_
178
_162_
_ _
143
_130_
_ _
107
_97_
_ _
Alanine
8.0
6.4
4.8
Arginine
5.6
4.5
3.4
Aspartic acid
1.7
1.4
1.0
Glutamic acid
2.8
2.2
1.7
Glycine
4.0
3.2
2.4
Histidine
3.4
2.7
2.0
Isoleucine
2.8
2.2
1.7
Leucine
4.0
3.2
2.4
Lysine hydrochloride
_Corresponding to lysine_
5.6
_4.5_
4.5
_3.6_
_ _
3.4
_2.7_
_ _
Methionine
2.8
2.2
1.7
Page 2 of 13
Active Ingredients (g)
2400 mL
1920 mL
1440 mL
Phenylala
                                
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