SmofKabiven Peripheral (Emulsion for Infusion)

Country: Malaysia

Language: English

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

Active ingredient:

Zinc Sulphate.; Tyrosine.; Calcium chloride.; TAURINE; Magnesium Sulphate.; TRYPTOPHAN; HISTIDINE; Sodium Acetate.; METHIONINE; Sodium Glycerophosphate; Potassium Chloride.; THREONINE; ISOLEUCINE; PHENYLALANINE; VALINE; SERINE; Lysine; LEUCINE; Glycine; Proline,; ARGININE; FISH OIL; ALANINE; OLIVE OIL; Glucose monohydrate; MEDIUM CHAIN TRIGLYCERIDES; Soya bean oil.

Available from:

FRESENIUS KABI MALAYSIA SDN. BHD

INN (International Name):

Zinc Sulphate.; Tyrosine.; Calcium chloride.; TAURINE; Magnesium Sulphate.; TRYPTOPHAN; HISTIDINE; Sodium Acetate.; METHIONINE; Sodium Glycerophosphate; Potassium Chloride.; THREONINE; ISOLEUCINE; PHENYLALANINE; VALINE; SERINE; Lysine; LEUCINE; Glycine; Proline,; ARGININE; FISH OIL; ALANINE; OLIVE OIL; Glucose monohydrate; MEDIUM CHAIN TRIGLYCERIDES; Soya bean oil.

Units in package:

1448ml mL; 1904ml mL; 1206ml mL; 1904ml3Units mL; 1206ml4Units mL; 1448ml4Units mL

Manufactured by:

FRESENIUS KABI AB

Patient Information leaflet

The active substances are
Glucose (as monohydrate)
71
Alanine
4.4
3.8
3.5
0.93
Isoleucine
1.6
Leucine
2.3
Lysine (as acetate)
2.1
1.3
Phenylalanine
1.6
3.5
Serine
2.1
Taurine
0.32
Leaflet no
SMOFKABIVEN PI-42
(ersätter)
Tryckspecifikation
Format:
630 x 210 mm
Färger:
PMS svart
Utskrift:
anpassat till A3
2:a korr 2016-06-22
J Eriksson, 018 64 40 46
Package leaflet: Information for the user
- if you have too much body fluid (hyperhydrated)
If you use more SmofKabiven Peripheral than you should
Threonine
1.4
shivering, rash or dyspnoea) should lead to immediate interruption
The maximum daily dose varies with the clinical condition of the
- if you have heart failure that is not treated
It is unlikely that you will receive too much medicine as SmofKabiven
Tryptophan
0.63
of the infusion.
patient and may even change from day to day. The recommended
_SMOFKABIVEN PERIPHERAL_
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 Peripheral is and what it is used for
2.
What you need to know before you use SmofKabiven Peripheral
3.
How to use SmofKabiven Peripheral
4. Possible side effects
5.
How to store SmofKabiven Peripheral
6.
Contents of the pack and other information
1.
What SmofKabiven Peripheral is and what it is used for
SmofKabiven Peripheral 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
and can be given to adults and children aged 2 years and above.
A healthcare professional will give you SmofKabiven Peripheral
when

Summary of Product characteristics

Page 1 of 9
PI83191142000
PACKAGE INSERT
SMOFKABIVEN PERIPHERAL
_EMULSION FOR INFUSION_
Description: Glucose and amino acid solutions are clear and colourless
to slightly yellow and free from
particles. The lipid emulsion is white and homogenous.
SmofKabiven Peripheral consists of a three chamber bag system. Each
bag contains the following partial
volumes depending on the three pack sizes.
1206 ML
1448 ML
1904 ML
PER 1000 ML
Glucose 13%
656 ml
788 ml
1036 ml
544 ml
Amino acid solution with electrolytes
380 ml
456 ml
600 ml
315 ml
Lipid emulsion
170 ml
204 ml
268 ml
141 ml
This corresponds to the following total compositions:
ACTIVE INGREDIENTS
1206 ML
1448 ML
1904 ML
PER 1000 ML
Glucose (as monohydrate)
85 g
103 g
135 g
71 g
Alanine
5.3 g
6.4 g
8.4 g
4.4 g
Arginine
4.6 g
5.5 g
7.2 g
3.8 g
Glycine
4.2 g
5.1 g
6.6 g
3.5 g
Histidine
1.1 g
1.3 g
1.8 g
0.93 g
Isoleucine
1.9 g
2.3 g
3.0 g
1.6 g
Leucine
2.8 g
3.3 g
4.4 g
2.3 g
Lysine (as acetate)
2.5 g
3.0 g
4.0 g
2.1 g
Methionine
1.6 g
1.9 g
2.6 g
1.3 g
Phenylalanine
1.9 g
2.3 g
3.1 g
1.6 g
Proline
4.2 g
5.1 g
6.7 g
3.5 g
Serine
2.5 g
3.0 g
3.9 g
2.1 g
Taurine
0.38 g
0.46 g
0.60 g
0.32 g
Threonine
1.7 g
2.0 g
2.6 g
1.4 g
Tryptophan
0.76 g
0.91 g
1.2 g
0.63 g
Tyrosine
0.15 g
0.17 g
0.24 g
0.12 g
Valine
2.4 g
2.9 g
3.7 g
2.0 g
Calcium chloride (as dihydrate)
0.21 g
0.26 g
0.34 g
0.18 g
Sodium glycerophosphate (as hydrate)
1.6 g
1.9 g
2.5 g
1.3 g
Magnesium sulphate (as
heptahydrate)
0.46 g
0.55 g
0.72 g
0.38 g
Potassium chloride
1.7 g
2.0 g
2.7 g
1.4 g
Sodium acetate (as trihydrate)
1.3 g
1.6 g
2.0 g
1.1 g
Zinc sulphate (as heptahydrate)
0.005 g
0.006 g
0.008 g
0.004 g
Soya-bean oil, refined
10.2 g
12.3 g
16.1 g
8.5 g
Medium-chain triglycerides
10.2 g
12.3 g
16.1 g
8.5 g
Olive oil, refined
8.5 g
10.1 g
13.4 g
7.0 g
Fish oil, rich in omega-3-acids
5.1 g
6.1 g
8.0 g
4.2 g
Page 2 of 9
PI83191142000
Corresponding to
1206 ML
1448 ML
1904 ML
PER 1000 ML
Carbohydrates
- Glucose (anhydrous)
85 g
103 g
135 g
71 g
Amino acids
38 g
46 g
60 g
32 g
Nitrogen
6.2 g
7.4 g
9.8 g
5.1 g
Lip