SMOFKABIVEN NTENSE amino acid 6.5% with 0.7% electrolytes, lipids 2.9% & glucose 8.5 % emulsion for intravenous infusion 1518 mL 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 hydroxide; sodium oleate; water for injections

Administration route:

Intravenous

Units in package:

4 x 1518 mL, 1 x 1518 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; Container Closure: Child resistant closure

Authorization status:

Registered

Authorization date:

2020-01-22

Patient Information leaflet

Page 1 of 2
SMOFKABIVEN NTENSE
®
Amino acids 6.5%, Lipids 2.9%, Glucose 8.5% & Electrolytes 0.7%
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
SmofKabiven NTense
®
. 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 NTense
®
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
NTENSE
® USED FOR
SmofKabiven NTense
®
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 NTense
®
when
other forms of feeding are not
good enough or have not worked.
BEFORE YOU ARE GIVEN
SMOFKABIVEN NTENSE
®
You must NOT use this product:

if you are allergic
(hypersensitive) to any of the
ingredients of SmofKabiven
NTense
®

if you are allergic to fish or egg

if you are allergic to peanuts,
soya or corn (maize) as
SmofKabiven NTense
®
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

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION – SMOFKABIVEN NTENSE
®
(AMINO ACIDS 6.5%, ELECTROLYTES 0.7%, LIPIDS 2.9% AND GLUCOSE
8.5%)
Page 1 of 22
1.
NAME OF THE MEDICINE
SmofKabiven NTense
®
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 6.5%: Alanine, Arginine, Glycine, Histidine, Isoleucine,
Leucine, Lysine acetate,
Methionine, Phenylalanine, Proline, Serine, Taurine, Threonine,
Tryptophan, Tyrosine, Valine.
ELECTROLYTES 0.7%: Calcium chloride dihydrate, Sodium glycerophosphate
hydrate, Magnesium
sulfate heptahydrate, Potassium chloride, Sodium acetate trihydrate,
Zinc sulfate heptahydrate.
LIPIDS 2.9%: Soya oil, Fish oil - rich in Omega-3 acids, Medium-chain
triglycerides, Olive oil.
GLUCOSE 8.5%: Glucose monohydrate.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
SmofKabiven NTense
®
consists of a three chamber bag system. Each bag contains the
following
partial volumes depending on the five pack sizes.
506 ML
1012 ML
1518 ML
2025 ML
2531 ML
PER 1000 ML
Amino acid solution
10% with electrolytes
331 mL
662 mL
993 mL
1325 mL
1656 mL
654 mL
Glucose solution 42%
102 mL
204 mL
306 mL
408 mL
510 mL
202 mL
Lipid emulsion 20%
73 mL
146 mL
219 mL
292 mL
365 mL
144 mL
This corresponds to the following total compositions:
ACTIVE INGREDIENTS
506 ML
1012 ML
1518 ML 2025 ML
2531 ML PER 1000 ML
Alanine
4.6 g
9.3 g
14 g
19 g
23 g
9.2 g
Arginine
4.0 g
7.9 g
12 g
16 g
20 g
7.9 g
Glycine
3.6 g
7.3 g
11 g
15 g
18 g
7.2 g
Histidine
1.0 g
2.0 g
3.0 g
4.0 g
5.0 g
2.0 g
Isoleucine
1.7 g
3.3 g
5.0 g
6.6 g
8.3 g
3.3 g
Leucine
2.4 g
4.9 g
7.3 g
9.8 g
12 g
4.8 g
Lysine acetate
_corresponding to _Lysine
2.2 g
4.4 g
6.6 g
8.7 g
11 g
4.3 g
Methionine
1.4 g
2.8 g
4.3 g
5.7 g
7.1 g
2.8 g
Phenylalanine
1.7 g
3.4 g
5.1 g
6.8 g
8.4 g
3.3 g
Proline
3.7 g
7.4 g
11 g
15 g
19 g
7.3 g
Serine
2.2 g
4.3 g
6.5 g
8.6 g
11 g
4.3 g
Taurine
0.33 g
0.66 g
1.0 g
1.3 g
1.7 g
0.65 g
Threonine
1.5 g
2.9 g
4.4 g
5.8 g
7.3 g
2.9 g
Tryptophan
0.66