SmofKabiven Peripheral, emulsion for infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

SOYA BEAN OIL, REFINED PH. EUR.; Medium chain triglycerides; Refined olive oil; Fish oil, rich in omega-3 acids; Isoleucine; Leucine ; Methionine; Lysine acetate; Phenylalanine; Threonine; Tryptophan; Valine; Arginine ; Histidine; Alanine; Glycine; Proline; Serine; Tyrosine; Taurine; Calcium chloride dihydrate; Sodium glycerophophate hydrate; Magnesium sulphate heptahydrate ; Potassium chloride; Sodium acetate trihydrate ; Zinc sulphate heptahydrate; Glucose monohydrate

Available from:

Fresenius Kabi Deutschland GmbH

ATC code:

B05BA; B05BA10

INN (International Name):

SOYA BEAN OIL, REFINED PH. EUR.; Medium chain triglycerides; Refined olive oil; Fish oil, rich in omega-3 acids; Isoleucine; Leucine ; Methionine; Lysine acetate; Phenylalanine; Threonine; Tryptophan; Valine; Arginine ; Histidine; Alanine; Glycine; Proline; Serine; Tyrosine; Taurine; Calcium chloride dihydrate; Sodium glycerophophate hydrate; Magnesium sulphate heptahydrate ; Potassium chloride; Sodium acetate trihydrate ; Zinc sulphate heptahydrate; Glucose monohydrate

Pharmaceutical form:

Emulsion for infusion

Therapeutic area:

Solutions for parenteral nutrition; combinations

Authorization status:

Marketed

Authorization date:

2009-09-18

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
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
other forms of feeding are not good
enough or have not worked.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE SMOFKABIVEN PERIPHERAL
DO NOT USE SMOFKABIVEN PERIPHERAL
-
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 Peripheral
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 you have too much sugar in your blood (hyperglycaemia) which is
u

Summary of Product characteristics

Health Products Regulatory Authority
21 August 2023
CRN00DHXK
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
SmofKabiven Peripheral, emulsion for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
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
Corresponding to
Health Products Regulatory Authority
21 August 2023
CRN00DHXK
Page 2 of 10
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