SMOFKABIVEN LOW OSMO amino acids 2.5%, electrolytes 0.4%, lipids 3.5% & glucose 6.8% emulsion for intravenous infusion1950 mL biofine bag

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

Pharmaceutical form:

Injection, intravenous infusion

Composition:

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

Administration route:

Intravenous Infusion

Units in package:

4 x 1950 mL, 1 x 1950 mL

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 homogeneous emulsion; Container Type: Bag; Container Material: Other composite material; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2020-08-27

Patient Information leaflet

CMI - SmofKabiven Low Osmo
Page 1 of 2
SMOFKABIVEN LOW OSMO
Amino acids 2.5%, Lipids 3.5%, Glucose 6.8% & Electrolytes 0.4%
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
SmofKabiven Low Osmo. 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 Low Osmo 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
LOW OSMO USED FOR
SmofKabiven Low Osmo 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 Low Osmo when
other forms of feeding are not
good enough or have not worked.
BEFORE YOU ARE GIVEN
SMOFKABIVEN LOW
OSMO
You must NOT use this product:

if you are allergic
(hypersensitive) to any of the
ingredients of SmofKabiven
Low Osmo

if you are allergic to fish or egg

if you are allergic to peanuts,
soya or corn (maize) as
SmofKabiven Low Osmo
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
no

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION – SMOFKABIVEN LOW OSMO
(AMINO ACIDS 2.5%, ELECTROLYTES 0.4%, LIPIDS 3.5% AND GLUCOSE
6.8%)
Page 1 of 24
1.
NAME OF THE MEDICINE
SmofKabiven Low Osmo is a three chamber bag system of amino acid
solution with electrolytes,
glucose solution and lipid emulsion for intravenous infusion.
The active ingredients are:
AMINO ACIDS 2.5%: Alanine, Arginine, Glycine, Histidine, Isoleucine,
Leucine, Lysine acetate,
Methionine, Phenylalanine, Proline, Serine, Taurine, Threonine,
Tryptophan, Tyrosine, Valine.
ELECTROLYTES 0.4%: Calcium chloride dihydrate, Sodium glycerophosphate
hydrate, Magnesium
sulfate heptahydrate, Potassium chloride, Sodium acetate trihydrate,
Zinc sulfate heptahydrate.
LIPIDS 3.5%: Soya oil, Fish oil - rich in Omega-3 acids, Medium-chain
triglycerides, Olive oil.
GLUCOSE 6.8%: Glucose monohydrate.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
SmofKabiven Low Osmo consists of a three chamber bag system. Each bag
contains the following
partial volumes depending on the four pack sizes.
850 ML
1
1400 ML
1950 ML
2500 ML
1
PER 1000 ML
Amino acid solution 10%
with electrolytes
213 mL
350 mL
488 mL
625 mL
250 mL
Glucose 11.8%
489 mL
805 mL
1121 mL
1438 mL
575 mL
Lipid emulsion 20%
149 mL
245 mL
341 mL
438 mL
175 mL
This corresponds to the following total compositions:
ACTIVE INGREDIENTS
850 ML
1400 ML
1950 ML
2500 ML
PER 1000 ML
Alanine
3.0 g
4.9 g
6.8 g
8.8 g
3.5 g
Arginine
2.6 g
4.2 g
5.9 g
7.5 g
3.0 g
Glycine
2.3 g
3.9 g
5.4 g
6.9 g
2.8 g
Histidine
0.64 g
1.1 g
1.5 g
1.9 g
0.75 g
Isoleucine
1.1 g
1.8 g
2.4 g
3.1 g
1.3 g
Leucine
1.6 g
2.6 g
3.6 g
4.6 g
1.9 g
Lysine acetate
_corresponding to_ Lysine
1.4 g
2.3 g
3.2 g
4.1 g
1.7 g
Methionine
0.92 g
1.5 g
2.1 g
2.7 g
1.1 g
Phenylalanine
1.1 g
1.8 g
2.5 g
3.2 g
1.3 g
Proline
2.4 g
3.9 g
5.5 g
7.0 g
2.8 g
Serine
1.4 g
2.3 g
3.2 g
4.1 g
1.6 g
Taurine
0.21 g
0.35 g
0.49 g
0.63 g
0.25 g
Threonine
0.94 g
1.5 g
2.1 g
2.8 g
1.1 g
Tryptophan
0.43 g
0.70 g
0.98 g
1.3 g
0.50 g
1
The total volume for bags is shown as the sum of the non-rounded
cha