SmofKabiven extra Nitrogen, emulsion for infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

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

Available from:

Fresenius Kabi Limited

ATC code:

B05BA; B05BA10

INN (International Name):

Soya bean oil, refined; Calcium chloride dihydrate; Methionine; Potassium chloride; Tryptophan; Olive oil, refined; Zinc sulphate heptahydrate; Phenylalanine; Triglycerides medium-chain; Proline; Isoleucine; Magnesium sulfate heptahydrate; Alanine; Tyrosin

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:

Authorised

Authorization date:

2017-08-25

Patient Information leaflet

337 103
_SMOFKABIVEN EXTRA NITROGEN _
emulsion for infusion
- 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 SmofKabiven extra Nitrogen
- if you have fluid in the lungs (acute pulmonary oedema)
- if you have too much body fluid (hyperhydrated)
- if you have heart failure that is not treated
- if you have a defect in your blood clotting system (hemo-
phagocytotic syndrome)
-
if you are in an unstable condition, such as after serious
trauma, uncontrolled diabetes, acute heart attack, stroke,
blood clot, metabolic acidosis (a disturbance resulting in
too much acid in the blood), serious infection (severe
sepsis), coma and if you don’t have enough body fluid
(hypotonic dehydration)
- in newborn babies or children under 2 years of age
Warnings and precautions
Talk to your doctor before using SmofKabiven extra Nitrogen
if you have:
- kidney problems
- diabetes mellitus
- pancreatitis (inflammation of the pancreas)
- liver problems
- hypothyrodism (thyroid problems)
- sepsis (serious infection)
If you during the infusion get fever, rash, swelling, difficulty
in breathing, chills, sweating, nausea or vomiting, tell the
healthcare professional immediately because these symp-
toms might be caused by an allergic reaction or that you
have been given too much of the medicine.
Your doctor may regularly need to check your blood for
liver function tests and other values.
Children and adolescents
SmofKabiven extra Nitrogen is not meant for newborn ba-
bies or children younger than 2 years of age. SmofKabiven
extra Nitrogen can be given to children and adolescents
from 2 to 16/18 years old.
Other medicines and SmofKabiven extra Nitrogen
Tell your doctor if you are taking, have recently

Summary of Product characteristics

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.
This corresponds to the following total compositions:
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
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
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