SmofKabiven NTense

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Alanine 14 g/L;  ;  ; Arginine 12 g/L;  ;  ; Calcium chloride dihydrate 0.574 g/L equivalent to calcium chloride 0.434 g/L;  ; Glycine 11 g/L;  ;  ;  ; Histidine 3 g/L;  ;  ;  ; Isoleucine 5 g/L;  ;  ;  ; Leucine 7.4 g/L;  ;  ;  ; Lysine acetate 9.3 g/L equivalent to L-Lysine 6.6 g/L;  ;  ; Magnesium sulfate heptahydrate 1.92 g/L equivalent to magnesium sulfate 0.931 g/L;  ; Methionine 4.3 g/L;  ;  ; Phenylalanine 5.1 g/L;  ;  ; Potassium chloride 3.48 g/L;  ; Proline 11.2 g/L;  ; Serine 6.5 g/L;  ;  ;  ; Sodium acetate trihydrate 4.1 g/L equivalent to sodium acetate 2.47 g/L;  ;  ;  ; Sodium glycerophosphate 3.48 g/L; Sodium glycerophosphate hydrate equivalent to sodium glycerophosphate 3.48 g/L;  ; Taurine 1 g/L;  ; Threonine 4.4 g/L;  ;  ;  ; Tryptophan 2 g/L;  ;  ; Tyrosine 0.4 g/L;  ; Valine 6.2 g/L;  ;  ;  ;  ; Zinc sulfate heptahydrate 0.0178 g/L equivalent to zinc sulfate 0.0100 g/L;  ; Glucose monohydrate 462 g/L equivalent to to glucose 420 g/L;  ;  ; Fish oil 30 g/L; Medium-chain triglycerides 60 g/L;  ; Olive oil 50 g/L;  ; Soya oil 60 g/L;  

Available from:

Fresenius Kabi New Zealand Limited

Pharmaceutical form:

Emulsion for infusion

Composition:

Active: Alanine 14 g/L     Arginine 12 g/L     Calcium chloride dihydrate 0.574 g/L equivalent to calcium chloride 0.434 g/L   Glycine 11 g/L       Histidine 3 g/L       Isoleucine 5 g/L       Leucine 7.4 g/L       Lysine acetate 9.3 g/L equivalent to L-Lysine 6.6 g/L     Magnesium sulfate heptahydrate 1.92 g/L equivalent to magnesium sulfate 0.931 g/L   Methionine 4.3 g/L     Phenylalanine 5.1 g/L     Potassium chloride 3.48 g/L   Proline 11.2 g/L   Serine 6.5 g/L       Sodium acetate trihydrate 4.1 g/L equivalent to sodium acetate 2.47 g/L       Sodium glycerophosphate 3.48 g/L Sodium glycerophosphate hydrate equivalent to sodium glycerophosphate 3.48 g/L   Taurine 1 g/L   Threonine 4.4 g/L       Tryptophan 2 g/L     Tyrosine 0.4 g/L   Valine 6.2 g/L         Zinc sulfate heptahydrate 0.0178 g/L equivalent to zinc sulfate 0.0100 g/L   Excipient: Glacial acetic acid Nitrogen Water for injection Active: Glucose monohydrate 462 g/L equivalent to to glucose 420 g/L     Excipient: Hydrochloric acid Nitrogen Water for injection Active: Fish oil 30 g/L Medium-chain triglycerides 60 g/L   Olive oil 50 g/L   Soya oil 60 g/L   Excipient: Egg lecithin Glycerol Nitrogen Sodium hydroxide Sodium oleate Tocoferols Water for injection

Prescription type:

General sale

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:

Package - Contents - Shelf Life: Bag, plastic, Biofine film inner three chamber bag, and overpouch - 506 mL - 24 months from date of manufacture stored at or below 25°C 36 hours opened stored at or below 25°C - Bag, plastic, Biofine film inner three chamber bag, and overpouch - 1012 mL - 24 months from date of manufacture stored at or below 25°C 36 months opened stored at or below 25°C - Bag, plastic, Biofine film inner three chamber bag, and overpouch - 1518 mL - 24 months from date of manufacture stored at or below 25°C 36 hours opened stored at or below 25°C - Bag, plastic, Biofine film inner three chamber bag, and overpouch - 2025 mL - 24 months from date of manufacture stored at or below 25°C 36 hours opened stored at or below 25°C - Bag, plastic, Biofine film inner three chamber bag, and overpouch - 2531 mL - 24 months from date of manufacture stored at or below 25°C 36 hours opened stored at or below 25°C

Authorization date:

2019-05-17

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

NEW ZEALAND DATA SHEET – SMOFKABIVEN NTENSE
® (AMINO
ACIDS 6.5%, ELECTROLYTES 0.7%, LIPIDS 2.9% AND GLUCOSE 8.5%)
Page 1 of 21
1.
PRODUCT NAME
SmofKabiven NTense
®
(Amino acids 6.5%, Electrolytes 0.7%, Lipids 2.9%, and Glucose 8.5%).
Emulsion for intravenous infusion.
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 (as acetate)
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 g
1.3 g
2.0 g
2.7 g
3.3 g
1.3 g
Tyrosine
0.13 g
0.26 g
0.40 g
0.53 g
0.66 g
0.26 g
Valine
2.1 g
4.1 g
6.2 g
8.2 g
10 g
4.1 g
Calcium chloride dihydrate
_corresponding to_
Calcium chloride
0.14 g
0.29 g
0.43 g
0.58 g
0.72 g
0.28 g
Sodium glycerophosphate
hydrate _corresponding to_
Sodium glycerophosphate
1.2 g
2.3 g
3.5 g
4.6 g
5.8 g
2.3 g
Magnesium sulfate
heptahydrate
_corresponding to_
Magnesium sulfate
0.31 g
0.62 g
0.92 g
1.2 g
1.5 g
0.61 g
Potassium chloride
1.2 g
2.3 g
3.5 g
4.6 g
5.8 g
2.3 g
NEW ZEALAND DATA SHEET – SMOFKABIVEN NTENSE
® (AMINO
ACIDS 6.5%, ELECTROLYTES 0.7%, LIPIDS 2