SMOFKABIVEN amino acids 5.1% / lipids 3.8% / glucose 12.7% / electrolytes 0.7% emulsion for intravenous infusion bag 1970 mL

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

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Patient Information leaflet (PIL)

21-01-2021

Summary of Product characteristics (SPC)

25-03-2022

Public Assessment Report (PAR)

28-11-2017

Active ingredient:

Fish oil - rich in Omega-3 acids, Quantity: 30 g/L; Soya Oil, Quantity: 60 g/L; Olive Oil, Quantity: 50 g/L; medium chain triglycerides, Quantity: 60 g/L

Available from:

Fresenius Kabi Australia Pty Ltd

INN (International Name):

Alanine,Arginine,calcium chloride dihydrate,Fish oil - rich in Omega-3 acids,glucose,Glycine,Histidine,Isoleucine,Leucine,Lysine

Pharmaceutical form:

Injection, intravenous infusion

Composition:

Excipient Ingredients: sodium hydroxide; sodium oleate; egg lecithin; glycerol; water for injections; dl-alpha-tocopherol

Administration route:

Intravenous Infusion

Units in package:

1 x 1970 mL, 4 x 1970 mL (Biofine bag)

Prescription type:

Not scheduled. Not considered by committee

Therapeutic indications:

Parenteral nutrition for adult patients and paediatric patients aged 2 years and above when oral or enteral nutrition is impossible, insufficient or contraindicated.

Product summary:

Visual Identification: White homogenous emulsion.; Container Type: Bag; Container Material: Composite plastic laminate; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2012-01-09

Patient Information leaflet

Page 1 of 2
SMOFKABIVEN
®
Amino acids 5.1%, lipids 3.8%, glucose 12.7% & electrolytes 0.7%
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This
leaflet
answers
some
common
questions
about
SmofKabiven. 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 given SmofKabiven 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. YOU MAY NEED
TO READ IT AGAIN.
WHAT
IS
SMOFKABIVEN
USED FOR
SmofKabiven
is
an
emulsion
for
infusion given into your blood by a
drip
(intravenous
infusion).
The
product
contains
amino
acids
(components
used
to
build
proteins), glucose (carbohydrates),
lipids (fat) and salts (electrolytes)
in a plastic bag.
A health care professional will give
you
SmofKabiven
when
other
forms
of
feeding
are
not
good
enough or have not worked.
BEFORE
YOU
ARE
GIVEN
SMOFKABIVEN
You must NOT use this product:
•
if
you
are
allergic
(hypersensitive) to any of
the
ingredients
of
SmofKabiven
•
if you are allergic to fish or
egg
•
if
you
are
allergic
to
peanuts,
soya
or
corn
(maize)
as
SmofKabiven
contains soya oil
•
if you have too much fat in
the
blood
(hyperlipidaemia)
•
if
you
have
serious
liver
disease
•
if
you
have
blood
clotting
problems
(coagulation
disorders)
•
if your body has problems
using amino acids
•
if you have serious kidney
disease without access to
dialysis
•
if you are in acute shock
•
if you have too much sugar
in
your
blood
(hyperglycaemia) which is
uncontrolled
•
if
you
have
high
blood
(serum) levels of the salts
(electrolytes)
•
if you have fluid in the lungs
(acute pulmonary oedema)
•
if you have too much body
fluid (hyperhydrated)
•
if you have heart failure that
is not treated
•
if you have a defect in your
blood
clotting
system
(haemophagocytotic
syndrome)
•
if
you

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Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION - SMOFKABIVEN
®
(AMINO ACIDS 5.1%, LIPIDS 3.8%, GLUCOSE 12.7% &
ELECTROLYTES 0.7%)
Page 1 of 21
1 NAME OF MEDICINE
_AMINO ACIDS 5.1% _
Alanine, Arginine, Glycine, Histidine, Isoleucine, Leucine, Lysine
acetate, Methionine,
Phenylalanine, Proline, Serine, Taurine, Threonine, Tryptophan,
Tyrosine, Valine
_LIPIDS 3.8% _
Soya oil
Fish oil - rich in Omega-3 acids
Medium chain triglycerides
Olive oil
_GLUCOSE 12.7% _
Glucose monohydrate
_ELECTROLYTES 0.7% _
Calcium chloride dihydrate
Magnesium sulfate heptahydrate
Potassium chloride
Sodium acetate trihydrate
Sodium glycerophosphate hydrate
Zinc sulfate heptahydrate
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
SmofKabiven is a three chamber bag system of amino acid solution with
electrolytes,
glucose solution and lipid emulsion for intravenous infusion.
Each bag contains the following partial volumes depending on the four
pack sizes.
986 ML
1477 ML
1970 ML
2463 ML
PER 1000 ML
Amino acid solution with
electrolytes (mL)
500
750
1000
1250
508
Glucose 42% (mL)
298
446
595
744
302
Lipid emulsion (mL)
188
281
375
469
190
This corresponds to the following total compositions:
ACTIVE INGREDIENTS (G)
986 ML
1477ML
1970 ML
2463 ML
PER 1000 ML
Alanine
7.0
10.5
14.0
17.5
7.1
Arginine
6.0
9.0
12.0
15.0
6.1
Glycine
5.5
8.2
11.0
13.8
5.6
Histidine
1.5
2.2
3.0
3.7
1.5
Isoleucine
2.5
3.8
5.0
6.2
2.5
Leucine
3.7
5.6
7.4
9.4
3.8
Lysine acetate
_corresponding to_ Lysine
3.3
5.0
6.6
8.4
3.4
Methionine
2.2
3.2
4.3
5.4
2.2
Phenylalanine
2.6
3.8
5.1
6.4
2.6
Proline
5.6
8.4
11.2
14.0
5.7
Page 2 of 21
ACTIVE INGREDIENTS (G)
986 ML
1477ML
1970 ML
2463 ML
PER 1000 ML
Serine
3.2
4.9
6.5
8.1
3.3
Taurine
0.50
0.75
1.0
1.2
0.50
Threonine
2.2
3.3
4.4
5.4
2.2
Tryptophan
1.0
1.5
2.0
2.5
1.0
Tyrosine
0.20
0.30
0.40
0.49
0.20
Valine
3.1
4.6
6.2
7.6
3.1
Calcium chloride dihydrate
_corresponding to _
Calcium chloride
0.28
0.42
0.56
0.69
0.28
Sodium glycerophosphate hydrate
_corresponding to_
Sodium glycerophosphate
2.1
3.1
4.2
5.2
2.1
Magnesium sulfate heptahydrate
_corresponding

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