SmofKabiven extra Nitrogen, emulsion for infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Alanine; Arginine ; Glycine; Histidine; Isoleucine; Leucine ; Lysine acetate; Methionine; Phenylalanine; Proline; Serine; Taurine; Tryptophan; Tyrosine; Valine; Calcium chloride dihydrate; Sodium glycerophophate hydrate; Magnesium sulfate heptahydrate; Potassium chloride; Sodium acetate trihydrate ; Zinc sulphate heptahydrate; Glucose monohydrate; Soya bean oil, refined; Triglycerides medium-chain ; Olive oil, refined; Fish oil, rich in omega-3 acids

Available from:

Fresenius Kabi Deutschland GmbH

ATC code:

B05BA; B05BA10

INN (International Name):

Alanine; Arginine ; Glycine; Histidine; Isoleucine; Leucine ; Lysine acetate; Methionine; Phenylalanine; Proline; Serine; Taurine; Tryptophan; Tyrosine; Valine; Calcium chloride dihydrate; Sodium glycerophophate hydrate; Magnesium sulfate heptahydrate; Potassium chloride; Sodium acetate trihydrate ; Zinc sulphate heptahydrate; Glucose monohydrate; Soya bean oil, refined; Triglycerides medium-chain ; Olive oil, refined; Fish oil, rich in omega-3 acids

Pharmaceutical form:

Emulsion for infusion

Therapeutic area:

Solutions for parenteral nutrition; combinations

Authorization status:

Marketed

Authorization date:

2017-08-25

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
SmofKabiven extra Nitrogen 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.
WHATS IS IN THIS LEAFLET
1.
What SmofKabiven extra Nitrogen is and what it is used for
2.
What you need to know before you use SmofKabiven extra Nitrogen
3.
How to use SmofKabiven extra Nitrogen
4.
Possible side effects
5.
How to store SmofKabiven extra Nitrogen
6.
Contents of the pack and other information
1.
WHAT SMOFKABIVEN EXTRA NITROGEN
IS AND WHAT IT IS USED FOR
SmofKabiven extra Nitrogen 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 extra Nitrogen
when other forms of feeding are not
good enough or have not worked.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE SMOFKABIVEN EXTRA NITROGEN
DO NOT USE SMOFKABIVEN EXTRA NITROGEN
-
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 extra Nitrogen
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 su

Summary of Product characteristics

Health Products Regulatory Authority
23 June 2023
CRN00DJTT
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
SmofKabiven extra Nitrogen, emulsion for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
SmofKabiven extra Nitrogen consists of a three chamber bag system.
Each bag contains the following partial volumes
depending on the five pack sizes.
506 ML
1012 ML
1518 ML
2025 ML
2531 ML
PER 1000 ML
Amino acid solution 10% with electrolytes
331 ml
662 ml
993 ml
1325 ml
1656 ml
654 ml
Glucose 42%
102 ml
204 ml
306 ml
408 ml
510 ml
202 ml
Lipid emulsion 20%
73 ml
146 ml
219 ml
292 ml
365 ml
144 ml
This corresponds to the following total compositions:
ACTIVE INGREDIENTS
506 ML
1012 ML
1518ML
2025 ML
2531 ML
PER 1000 ML
Alanine
4.6 g
9.3 g
14 g
19 g
23 g
9.2 g
Arginine
4.0 g
7.9 g
12 g
16 g
20 g
7.9 g
Glycine
3.6 g
7.3 g
11 g
15 g
18 g
7.2 g
Histidine
1.0 g
2.0 g
3.0 g
4.0 g
5.0 g
2.0 g
Isoleucine
1.7 g
3.3 g
5.0 g
6.6 g
8.3 g
3.3 g
Leucine
2.4 g
4.9 g
7.3 g
9.8 g
12 g
4.8 g
Lysine (as acetate)
2.2 g
4.4 g
6.6 g
8.7 g
11 g
4.3 g
Methionine
1.4 g
2.8 g
4.3 g
5.7 g
7.1 g
2.8 g
Phenylalanine
1.7 g
3.4 g
5.1 g
6.8 g
8.4 g
3.3 g
Proline
3.7 g
7.4 g
11 g
15 g
19 g
7.3 g
Serine
2.2 g
4.3 g
6.5 g
8.6 g
11 g
4.3 g
Taurine
0.33 g
0.66 g
1.0 g
1.3 g
1.7 g
0.65 g
Threonine
1.5 g
2.9 g
4.4 g
5.8 g
7.3 g
2.9 g
Tryptophan
0.66 g
1.3 g
2.0 g
2.7 g
3.3 g
1.3 g
Tyrosine
0.13 g
0.26 g
0.40 g
0.53 g
0.66 g
0.26 g
Valine
2.1 g
4.1 g
6.2 g
8.2 g
10 g
4.1 g
Calcium chloride dihydrate _corresponding to_
Calcium chloride
0.14 g
0.29 g
0.43 g
0.58 g
0.72 g
0.28 g
Sodium glycerophosphate (hydrate) _corresponding to_
Sodium glycerophosphate
1.2 g
2.3 g
3.5 g
4.6 g
5.8 g
2.3 g
Magnesium sulphate heptahydrate _corresponding to_
Magnesium sulphate
0.31 g
0.62 g
0.92 g
1.2 g
1.5 g
0.61 g
Potassium chloride
1.2 g
2.3 g
3.5 g
4.6 g
5.8 g
2.3 g
Sodium acetate trihydrate _corresponding to_
Sodium acetate
0.82 g
1.6 g
2.5 g
3.3 g
4.1 g
1.6 g
Zinc sulphate heptahydrate
_corresponding to_
Zinc sulphate
0.0033 g
0.0066 g
0.010