SmofKabiven Electrolyte Free Emulsion for Infusion

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

ISOLEUCINE; ARGININE; LEUCINE; HISTIDINE; METHIONINE; PHENYLALANINE; SERINE; THREONINE; TRYPTOPHAN; VALINE; LYSINE ACETATE; MEDIUM CHAIN TRIGLYCERIDES; GLYCINE; GLUCOSE MONOHYDRATE; FISH OIL; OLIVE OIL; TAURINE; Tyrosine.; Soya Bean Oil, Refined Ph. Eur; L-Alanine; Proline,

Available from:

FRESENIUS KABI MALAYSIA SDN. BHD

INN (International Name):

ISOLEUCINE; ARGININE; LEUCINE; HISTIDINE; METHIONINE; PHENYLALANINE; SERINE; THREONINE; TRYPTOPHAN; VALINE; LYSINE ACETATE; MEDIUM CHAIN TRIGLYCERIDES; GLYCINE; GLUCOSE MONOHYDRATE; FISH OIL; OLIVE OIL; TAURINE; Tyrosine.; Soya Bean Oil, Refined Ph. Eur; L-Alanine; Proline,

Units in package:

986ml mL; 1970ml mL; 2463ml mL; 1477ml mL; 1970ml2Units mL; 1970 ml 4 Units mL; 2463 ml 3 Units mL; 2463ml2Units mL; 986ml4Units mL; 1477ml4Units mL

Manufactured by:

FRESENIUS KABI AB

Patient Information leaflet

Leafl et no
SMOFKABIVEN EF LEAFL ET
(ersätter)
Tryckspecifi kation
Format:
630 x 210 mm
Färger:
PMS svart
Utskrift:
anpassat till A3
12:e korr 08-04-21
Johanna Eriksson, 018 64 40 46
xxx xxx
_SMOFKABIVEN ELECTROLYTE FREE_
Emulsion for infusion
The other ingredients are: glycerol, purifi ed egg phospholipids,
all-rac-
α
-tocopherol, sodium hydroxide (pH-adjustment), sodium
oleate,
acetic
acid
(pH-adjustment),
hydrochloric
acid
(pH-
adjustment) and water for injections.
_What SmofKabiven Electrolyte Free looks like and contents _
_of the pack_
Glucose- and amino acid solutions are clear, colourless or slightly
yellow and free from particles. The lipidemulsion is white and
homogenous.
_Pack sizes:_
1 x 986 ml, 4 x 986 ml
1 x 1477 ml, 4 x 1477 ml
1 x 1970 ml, 2 x 1970 ml
1 x 2463 ml, 2 x 2463 ml
Marketing Authorisation Holder and Manufacturer
Manufacturer:
Fresenius Kabi AB, SE-751 74 Uppsala, Sweden
To be completed nationally
Marketing authorisation holder:
Fresenius Kabi
(country specifi c name and address will be added)
This leafl et was last approved in {MM/YYYY}
To be completed nationally
-----------------------------------------------------------------------------
_The following information is intended for medical or health _
_care professionals only:_
Warnings and precautions for use
To avoid risks associated with too rapid infusion rates, it is
recommended to use a continuous and well-controlled infusion,
if possible by using a volumetric pump.
Since an increased risk of infection is associated with the use of
any central vein, strict aseptic precautions should be taken to
avoid any contamination especially during catheter insertion.
Serum
glucose,
electrolytes
and
osmolarity
as
well
as
fl uid
balance, acid-base status and liver and enzyme tests should be
monitored.
Any sign or symptom of anaphylactic reaction (such as fever,
shivering, rash or dyspnoea) should lead to immediate interruption
of the infusion.
SmofKabiven Electrolyte Free should not be given simultaneously
with
blood
in
the
same
infusi

Summary of Product characteristics

Page 1 of 8
PI83190542000
Package Insert
_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
250ml
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
1477 ml
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
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
Page 2 of 8
PI83190542000
• Carbohydrates
- Glucose (anhydrous)
63 g
125 g
187 g
250 g
313 g
127 g
• Lipids
19 g
38 g
56 g
75 g
94 g
38 g
• Acetate
1)
37 mmol
73 mmol
110 mmol
147 mm