SMOFKABIVEN ELECTROLYTE FREE amino acids 5.1% / lipids 3.8% / glucose 12.7% emulsion for intravenous infusion bag 2463 mL

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

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

Available from:

Fresenius Kabi Australia Pty Ltd

INN (International Name):

Alanine,Arginine,Fish oil - rich in Omega-3 acids,glucose,Glycine,Histidine,Isoleucine,Leucine,Lysine acetate,medium chain trigl

Pharmaceutical form:

Injection, intravenous infusion

Composition:

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

Administration route:

Intravenous Infusion

Units in package:

1 x 2463 mL, 3 x 2463 mL (Biofine bag), 1 x 2463 mL, 2 x 2463 mL (Excel bag)

Prescription type:

Not scheduled. Not considered by committee

Therapeutic indications:

Parenteral nutrition for adult patients 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:

Licence status A

Authorization date:

2012-01-09

Patient Information leaflet

Page 1 of 2
SMOFKABIVEN
® ELECTROLYTE FREE
Amino acids 5.1%, lipids 3.8% & glucose 12.7%
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This
leaflet
answers
some
common
questions
about
SmofKabiven Electrolyte Free. 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
Electrolyte
Free
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
ELECTROLYTE
FREE
USED
FOR
SmofKabiven
Electrolyte
Free
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) and lipids (fat) in a
plastic bag.
A health care professional will give
you SmofKabiven Electrolyte Free
when other forms of feeding are
not
good
enough
or
have
not
worked.
BEFORE
YOU
ARE
GIVEN
SMOFKABIVEN
ELECTROLYTE FREE
You must NOT use this product:

if
you
are
allergic
(hypersensitive) to any of
the
ingredients
of
SmofKabiven
Electrolyte
Free

if you are allergic to fish or
egg

if
you
are
allergic
to
peanuts,
soya
or
corn
(maize)
as
SmofKabiven
Electrolyte
Free
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 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
syst

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION - SMOFKABIVEN
®
ELECTROLYTE FREE (AMINO ACIDS 5.1%, LIPIDS 3.8%,
GLUCOSE 12.7%)
Page 1 of 17
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
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
SmofKabiven is a three chamber bag system of amino acid solution,
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 (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
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
Glucose monohydrate
_corresponding to _
Glucose (anhydrous)_ _
125
187
250
313
127
Page 2 of 17
ACTIVE INGREDIENTS (G)
986 ML
1477ML
1970 ML
2463 ML
PER 1000 ML
Soya oil
11.3
16.9
22.5
28.1
11.4
Medium chain triglycerides
11.3
16.9
22.5
28.1
11.4
Olive oil
9.4
14.1
18.8
23.4
9.5
Fish oil - rich in Omega-3 acids
5.6
8.4
11.3
14.0
5.7
Corresponding to:
986 ML
1477 ML
1970 ML
2463 ML
PER 1000 ML

Amino acids (g)
50
75
100
125
51

Nitrogen (g)
8
12
16
20
8

Lipids (g)
38
56
75
94
38

Carbohydrates - Glucose
(an