SmofKabiven Peripheral, emulsion for infusion, Biofine bag

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 Limited

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;

Dosage:

Unknown

Pharmaceutical form:

Emulsion for infusion

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Solutions for parenteral nutrition; combinations

Authorization status:

Marketed

Authorization date:

2009-09-18

Patient Information leaflet

Leaflet no
335 080X
(ersätter 333 729)
Tryckspecifikation
Format:
630 x 210 mm
Färger:
PMS svart
Utskrift:
anpassat till A3
PERFORERING
3:e korr 2016-04-05
Johanna Eriksson, 018 64 40 46
xxx xxx
_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),
salts (electrolytes), Lipids (fat) and salts (electrolytes) in a
plastic bag
and can be given to adults and children above 2 years of age.
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 soybean oil
-
if you have too much lipids in the blood (hyperlipidaemia)
-
if you have a serious liver disorder
-
if you have blood clotting problems (coagulation disorders)
-
if your body has problems

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
SmofKabiven Peripheral, emulsion for infusion, Biofine bag
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.
This corresponds to the following total compositions:
Corresponding to
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
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
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
• Lipids
34 g
41 g
54 g
28 g
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