SmofKabiven Emulsion for Infusion

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Alanine; Arginine; Calcium Chloride Dihydrate; Fish oil, rich in omega -3 acids; Glucose monohydrate; Glycine; Histidine; Isoleucine; Leucine; Lysine Acetate; Magnesium sulphate heptahydrate; Methionine; Olive oil, refined; Phenylalanine; Potassium Chloride; Proline; Serine; Sodium Acetate Trihydrate; Sodium glycerophosphate anhydrous; Soya bean oil, refined; Taurine; Threonine; Triglycerides, Medium Chain; Tryptophan; Tyrosine; Valine; Zinc Sulphate Heptahydrate

Available from:

FRESENIUS KABI (SINGAPORE) PTE LTD

ATC code:

B05BA10

Dosage:

14.0g/1000ml

Pharmaceutical form:

INJECTION, EMULSION

Composition:

Alanine 14.0g/1000ml; Arginine 12.0g /1000ml; Calcium Chloride Dihydrate 0.74g /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; Magnesium sulphate heptahydrate 2.47g /1000ml; Methionine 4.3g /1000ml; Olive oil, refined 50g /1000ml; Phenylalanine 5.1g /1000ml; Potassium Chloride 4.48g /1000ml; Proline 11.2g /1000ml; Serine 6.5g /1000ml; Sodium Acetate Trihydrate 5.62g /1000ml; Sodium glycerophosphate anhydrous 4.18g /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; Zinc Sulphate Heptahydrate 0.023g /1000ml

Administration route:

INTRAVENOUS

Prescription type:

Prescription Only

Manufactured by:

Fresenius Kabi AB

Authorization status:

ACTIVE

Authorization date:

2013-01-08

Patient Information leaflet

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1
PACKAGE LEAFLET: INFORMATION FOR THE USER
SmofKabiven 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 is and what it is used for
2.
What you need to know before you use SmofKabiven
3.
How to use SmofKabiven
4.
Possible side effects
5.
How to store SmofKabiven
6.
Contents of the pack and other information
1.
WHAT SMOFKABIVEN IS AND WHAT IT IS USED FOR
SmofKabiven 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 when other forms
of feeding are not good enough or
have not worked.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE SMOFKABIVEN
DO NOT USE SMOFKABIVEN
-
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 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
uncontrolled
-
if you have high blood (serum) levels of the salts (electrolytes)
included in SmofKabiv

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
SmofKabiven emulsion for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
SmofKabiven consists of a three chamber bag system. Each bag contains
the following partial
volumes depending on the five pack sizes.
Amino acid solution with
electrolytes
493 ML
250 ml
986 ML
500 ml
1477 ML
750 ml
1970 ML
1000 ml
2463 ML
1250 ml
PER 1000 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
Calcium chloride
0.14 g
0.28 g
0.42 g
0.56 g
0.69 g
0.28 g
(as dihydrate)
Sodium glycerophosphate
1.1 g
2.1 g
3.1 g
4.2 g
5.2 g
2.1 g
(as hydrate)
Magnesium sulphate
0.30 g
0.60 g
0.90 g
1.2 g
1.5 g
0.61 g
(as heptahydrate)
Potassium chloride
1.1 g
2.2 g
3.4 g
4.5 g
5.7 g
2.3 g
Sodium acetate
0.9 g
1.7 g
2.6 g
3.4 g
4.2 g
1.7 g
(as trihydrate)
Zinc sulphate
0.0033 g
0.0065 g
0.0097 g
0.013 g
0.016 g
0.0066 g
(as heptahydrate)
Glucose
63 g
125 g
187 g
250 g
313 g
127 g
(as monohydrate)
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.