SmofKabiven Electrolyte Free Emulsion for Infusion

Maa: Singapore

Kieli: englanti

Lähde: HSA (Health Sciences Authority)

Aktiivinen ainesosa:

Alanine; Arginine; Fish oil, rich in omega -3 acids; Glucose monohydrate; Glycine; Histidine; Isoleucine; Leucine; Lysine Acetate; Methionine; Olive oil, refined; Phenylalanine; Proline; Serine; Soya bean oil, refined; Taurine; Threonine; Triglycerides, Medium Chain; Tryptophan; Tyrosine; Valine

Saatavilla:

FRESENIUS KABI (SINGAPORE) PTE LTD

ATC-koodi:

B05BA10

Annos:

14.0g/1000ml

Lääkemuoto:

INJECTION, EMULSION

Koostumus:

Alanine 14.0g/1000ml; Arginine 12.0g /1000ml; Fish oil, rich in omega -3 acids 30g /1000ml; Glucose monohydrate 462g /1000ml; Glycine 11.0g /1000ml; Histidine 3.0g /1000ml; Isoleucine 5.0g /1000ml; Leucine 7.4g /1000ml; Lysine Acetate 9.3g /1000ml; Methionine 4.3g /1000ml; Olive oil, refined 50g /1000ml; Phenylalanine 5.1g /1000ml; Proline 11.2g /1000ml; Serine 6.5g /1000ml; Soya bean oil, refined 60.0g /1000ml; Taurine 1.0g /1000ml; Threonine 4.4g /1000ml; Triglycerides, Medium Chain 60g /1000ml; Tryptophan 2.0g/1000ml; Tyrosine 0.4g /1000ml; Valine 6.2g /1000ml

Antoreitti:

INTRAVENOUS

Prescription tyyppi:

Prescription Only

Valmistaja:

Fresenius Kabi AB

Valtuutuksen tilan:

ACTIVE

Valtuutus päivämäärä:

2013-01-16

Pakkausseloste

kipdips217,413/1.0
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
SmofKabiven Electrolyte Free emulsion for infusion
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, pharmacist or
nurse.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What SmofKabiven Electrolyte Free is and what it is used for
2.
What you need to know before you use SmofKabiven Electrolyte Free
3.
How to use SmofKabiven Electrolyte Free
4.
Possible side effects
5.
How to store SmofKabiven Electrolyte Free
6.
Contents of the pack and other information
1.
WHAT SMOFKABIVEN ELECTROLYTE FREE IS AND WHAT IT IS 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 and can be given to adults and
children aged 2 years and above.
A healthcare professional will give you SmofKabiven Electrolyte Free
when other forms of feeding are not
good enough or have not worked.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE SMOFKABIVEN ELECTROLYTE FREE
DO NOT USE SMOFKABIVEN ELECTROLYTE FREE
-
if you are allergic (hypersensitive) to active substances or any of
the other ingredients of this medicine
(listed in section 6)
-
if you are allergic to fish or egg
-
if you are allergic to peanuts or soya you should not use this
product. SmofKabiven Electrolyte Free
contains soya-bean oil
-
if you have too much lipids in the blood (hyperlipidemia)
-
if you have serious liver disorder
-
if you have blood clotting problems (coagulation disorder)
-
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 yo

Valmisteyhteenveto

SmPC 16-460 RoW, 2016-06-22
1 (11)
SUMMARY OF
PRODUCT CHARACTERISTICS
NAME OF THE MEDICINAL PRODUCT
SmofKabiven Electrolyte Free emulsion for infusion
QUALITATIVE AND QUANTITATIVE COMPOSITION
SmofKabiven Electrolyte Free consists of a three chamber bag system.
Each bag contains the
following partial volumes depending on the five pack sizes.
493 ML
986 ML
1477 ML
1970 ML
2463 ML
PER 1000 ML
Amino acid solution
250 ml
500 ml
750 ml
1000 ml
1250 ml
508 ml
Glucose 42%
149 ml
298 ml
446 ml
595 ml
744 ml
302 ml
Lipid emulsion
94 ml
188 ml
281 ml
375 ml
469 ml
190 ml
This corresponds to the following total compositions:
ACTIVE INGREDIENTS
493 ML
986 ML
1477ML
1970 ML
2463 ML
PER 1000 ML
Alanine
3.5 g
7.0 g
10.5 g
14.0 g
17.5 g
7.1 g
Arginine
3.0 g
6.0 g
9.0 g
12.0 g
15.0 g
6.1 g
Glycine
2.8 g
5.5 g
8.2 g
11.0 g
13.8 g
5.6 g
Histidine
0.8 g
1.5 g
2.2 g
3.0 g
3.7 g
1.5 g
Isoleucine
1.3 g
2.5 g
3.8 g
5.0 g
6.2 g
2.5 g
Leucine
1.9 g
3.7 g
5.6 g
7.4 g
9.4 g
3.8 g
Lysine (as acetate)
1.7 g
3.3 g
5.0 g
6.6 g
8.4 g
3.4 g
Methionine
1.1 g
2.2 g
3.2 g
4.3 g
5.4 g
2.2 g
Phenylalanine
1.3 g
2.6 g
3.8 g
5.1 g
6.4 g
2.6 g
Proline
2.8 g
5.6 g
8.4 g
11.2 g
14.0 g
5.7 g
Serine
1.6 g
3.2 g
4.9 g
6.5 g
8.1 g
3.3 g
Taurine
0.25 g
0.50 g
0.75 g
1.0 g
1.2 g
0.5 g
Threonine
1.1 g
2.2 g
3.3 g
4.4 g
5.4 g
2.2 g
Tryptophan
0.5 g
1.0 g
1.5 g
2.0 g
2.5 g
1.0 g
Tyrosine
0.10 g
0.20 g
0.30 g
0.40 g
0.49 g
0.20 g
Valine
1.6 g
3.1 g
4.6 g
6.2 g
7.6 g
3.1 g
Glucose (as monohydrate)
63 g
125 g
187 g
250 g
313 g
127 g
Soya-bean oil, refined
5.6 g
11.3 g
16.9 g
22.5 g
28.1 g
11.4 g
Medium-chain triglycerides
5.6 g
11.3 g
16.9 g
22.5 g
28.1 g
11.4 g
Olive oil, refined
4.7 g
9.4 g
14.1 g
18.8 g
23.4 g
9.5 g
Fish oil, rich in omega-3-acids
2.8 g
5.6 g
8.4 g
11.3 g
14.0 g
5.7 g
SmPC 16-460 RoW, 2016-06-22
2 (11)
Corresponding to
493 ML
986 ML
1477 ML
1970 ML
2463 ML
PER 1000 ML
•
Amino acids
25 g
50 g
75 g
100 g
125 g
51 g
•
Nitrogen
4 g
8 g
12 g
16 g
20 g
8 g
•
Carbohydrates
- Glucose (anhydrous)
63 g
125 g
187 g
250 g
313 g
127 g
•
Lipids
19 g
38 g