SmofKabiven extra Nitrogen Electrolyte free, emulsion for infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Soya bean oil, refined; Methionine; Tryptophan; Olive oil, refined; Phenylalanine; Triglycerides medium-chain; Proline; Isoleucine; Alanine; Tyrosine; Serine; 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; Methionine; Tryptophan; Olive oil, refined; Phenylalanine; Triglycerides medium-chain; Proline; Isoleucine; Alanine; Tyrosine; Serine; Arginine; GLUCOSE MONOHYDRATE; Taurine; GLYCINE; Valine; Lysine acetate; Fish oil, rich in omega-

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

337 104
_SMOFKABIVEN EXTRA NITROGEN _
_ELECTROLYTE FREE _
emulsion for infusion
- 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 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
Electrolyte free 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 symptoms
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 Electrolyte free is not meant
for newborn babies or children younger than 2 years of age.
SmofKabiven extra Nitrogen Electrolyte free can be given to
children and adolescents from 2 to 16/18 years old.
Other medicines and SmofKabiven extra Nitrogen
Electrolyte free
Tell your doc

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
SmofKabiven extra Nitrogen Electrolyte free, emulsion for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
SmofKabiven extra Nitrogen Electrolyte free 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:
Corresponding to
506 ML
1012 ML
1518 ML
2025 ML
2531 ML
PER 1000 ML
Amino acid solution 10%
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
Glucose monohydrate
_corresponding to_
Glucose
43 g
86 g
129 g
171 g
214 g
85 g
Soya-bean oil, refined
4.4 g
8.8 g
13 g
18 g
22 g
8.7 g
Medium-chain triglycerides
4.4 g
8.8 g
13 g
18 g
22 g
8.7 g
Olive oil, refined
3.7 g
7.3 g
11 g
15 g
18 g
7.2 g
Fish oil, rich in omega-3-
acids
2.2 g
4.4 g
6.6 g
8.8 g
11 g
4.3 g
506 ML
1012 ML
1518ML
2025 ML
2531 ML
PER 1000
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