SmofKabiven Low Osmo

Nazione: Nuova Zelanda

Lingua: inglese

Fonte: Medsafe (Medicines Safety Authority)

Principio attivo:

Alanine 14 g/L;  ;  ; Arginine 12 g/L;  ;  ; Calcium chloride dihydrate 0.74 g/L equivalent to calcium chloride 0.56 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 2.47 g/L equivalent to magnesium sulfate 1.2 g/L;  ; Methionine 4.3 g/L;  ;  ; Phenylalanine 5.1 g/L;  ;  ; Potassium chloride 4.48 g/L;  ; Proline 11.2 g/L;  ; Serine 6.5 g/L;  ;  ;  ; Sodium acetate trihydrate 5.62 g/L equivalent to sodium acetate 3.4 g/L;  ;  ;  ; Sodium glycerophosphate 4.18 g/L; Sodium glycerophosphate hydrate equivalent to sodium glycerophosphate 4.18g/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 0.023 g/L equivalent to zinc sulfate 0.0129 g/L;  ; Glucose monohydrate 130 g/L equivalent to glucose 118 g/L;  ;  ; Fish oil 30 g/L; Medium-chain triglycerides 60 g/L;  ; Olive oil 50 g/L;  ; Soya oil 60 g/L;  

Commercializzato da:

Fresenius Kabi New Zealand Limited

Forma farmaceutica:

Emulsion for infusion

Composizione:

Active: Alanine 14 g/L     Arginine 12 g/L     Calcium chloride dihydrate 0.74 g/L equivalent to calcium chloride 0.56 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 2.47 g/L equivalent to magnesium sulfate 1.2 g/L   Methionine 4.3 g/L     Phenylalanine 5.1 g/L     Potassium chloride 4.48 g/L   Proline 11.2 g/L   Serine 6.5 g/L       Sodium acetate trihydrate 5.62 g/L equivalent to sodium acetate 3.4 g/L       Sodium glycerophosphate 4.18 g/L Sodium glycerophosphate hydrate equivalent to sodium glycerophosphate 4.18g/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 0.023 g/L equivalent to zinc sulfate 0.0129 g/L   Excipient: Acetic acid Nitrogen Water for injection Active: Glucose monohydrate 130 g/L equivalent to glucose 118 g/L     Excipient: 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

Tipo di ricetta:

General sale

Indicazioni terapeutiche:

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

Dettagli prodotto:

Package - Contents - Shelf Life: Bag, plastic, Biofine 3-chamber bag, 5 x 850 mL - 850 mL - 24 months from date of manufacture stored at or below 25°C. Store in overpouch 36 hours opened stored at or below 25°C. Store in overpouch - Bag, plastic, Biofine 3-chamber bag, 4 x 1400 mL - 1400 mL - 24 months from date of manufacture stored at or below 25°C. Store in overpouch 36 hours opened stored at or below 25°C. Store in overpouch - Bag, plastic, Biofine 3-chamber bag, 4 x 1950 mL - 1950 mL - 24 months from date of manufacture stored at or below 25°C. Store in overpouch 36 hours opened stored at or below 25°C. Store in overpouch - Bag, plastic, Biofine 3-chamber bag, 3 x 2500 mL - 2500 mL - 24 months from date of manufacture stored at or below 25°C. Store in overpouch 36 hours opened stored at or below 25°C. Store in overpouch

Data dell'autorizzazione:

2020-04-01

Foglio illustrativo

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
not treated

if you have a

Scheda tecnica

NEW ZEALAND DATA SHEET
Page 1 of 21
1.
PRODUCT NAME
SmofKabiven Low Osmo (Infusion, emulsion).
Amino acids 2.5%, Electrolytes 0.4%: Lipids 3.5% and Glucose 6.8%.
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 (as acetate)
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
Tyrosine
0.085 g
0.14 g
0.20 g
0.25 g
0.10 g
Valine
1.3 g
2.2 g
3.0 g
3.9 g
1.6 g
Calcium chloride dihydrate
_corresponding to_
Calcium chloride
0.12 g
0.20 g
0.27 g
0.35 g
0.14 g
Sodium glycerophosphate
(hydrate)
_corresponding to_
Sodium glycerophosphate
0.89 g
1.5 g
2.0 g
2.6 g
1.0 g
Magnesium sulphate
heptahydrate
_corresponding to _
Magnesium sulphate_ _
0.26 g
0.42 g
0.59 g
0.75 g
0.30 g
1
The total volume for bags is shown as the sum of the non-rounded
chamber volumes
Page 2 of 21
ACTIVE INGREDIENTS
850 ML
1400 ML
1950 ML
2500 ML
PER 1000 ML
Potassium chloride
0.95 g
1.6 g
2.2 g
2.8 g
1.1 g
Sodium acetate trihydrate
_corresponding to_
Sodium acetate
0.72 g
1.2 g
1.7 g
2.1 g
0.85 g
Zinc sulphate heptahydrate
_corresponding to_
Zinc sulphate
0.0027 g
0.0045 g
0.0