SmofKabiven Low Osmo Peripheral 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; Threonine; Tryptophan; Tyrosine; Valine; Calcium chloride dihydrate; Sodium glycerophophate hydrate; Magnesium sulphate 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; Threonine; Tryptophan; Tyrosine; Valine; Calcium chloride dihydrate; Sodium glycerophophate hydrate; Magnesium sulphate 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:

Not marketed

Authorization date:

2019-04-26

Patient Information leaflet

Leaflet no
_SMOFKABIVEN LOW OSMO PERIPHERAL MOCK-UP_
(replace)
Printspecifikation
Format:
420 x 420 mm
COlor:
PMS svart
Fontsize:
anpassat till A3
5:e korr 18-10-24
Martina Eriksson, 018-64 40 46
xxx xxx
_SMOFKABIVEN LOW OSMO PERIPHERAL _
emulsion for infusion
contains soya-bean oil
- if you have too much lipid in the blood
(hyperlipidaemia)
- If you have a 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 Low Osmo
Peripheral
- 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
(haemophagocytotic 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 Low Osmo
Peripheral 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
S

Summary of Product characteristics

Health Products Regulatory Authority
16 August 2023
CRN00DC95
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
SmofKabiven Low Osmo Peripheral emulsion for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
SmofKabiven Low Osmo Peripheral consists of a three chamber bag
system. Each bag contains the following partial volumes
depending on the four pack sizes.
850 ML
1
1400 ML
1950 ML
2500 ML
1
PER 1000 ML
Amino acid solution 10% with electrolytes
213 ml
350 ml
488 ml
625 ml
250 ml
Glucose 11.8%
489 ml
805 ml
1121 ml
1438 ml
575 ml
Lipid emulsion 20%
149 ml
245 ml
341 ml
438 ml
175 ml
This corresponds to the following total compositions:
ACTIVE INGREDIENTS
850 ML
1400 ML
1950 ML
2500 ML
PER 1000 ML
Alanine
3.0 g
4.9 g
6.8 g
8.8 g
3.5 g
Arginine
2.6 g
4.2 g
5.9 g
7.5 g
3.0 g
Glycine
2.3 g
3.9 g
5.4 g
6.9 g
2.8 g
Histidine
0.64 g
1.1 g
1.5 g
1.9 g
0.75 g
Isoleucine
1.1 g
1.8 g
2.4 g
3.1 g
1.3 g
Leucine
1.6 g
2.6 g
3.6 g
4.6 g
1.9 g
Lysine (as acetate)
1.4 g
2.3 g
3.2 g
4.1 g
1.7 g
Methionine
0.92 g
1.5 g
2.1 g
2.7 g
1.1 g
Phenylalanine
1.1 g
1.8 g
2.5 g
3.2 g
1.3 g
Proline
2.4 g
3.9 g
5.5 g
7.0 g
2.8 g
Serine
1.4 g
2.3 g
3.2 g
4.1 g
1.6 g
Taurine
0.21 g
0.35 g
0.49 g
0.63 g
0.25 g
Threonine
0.94 g
1.5 g
2.1 g
2.8 g
1.1 g
Tryptophan
0.43 g
0.70 g
0.98 g
1.3 g
0.50 g
Tyrosine
0.085 g
0.14 g
0.20 g
0.25 g
0.10 g
Valine
1.3 g
2.2 g
3.0 g
3.9 g
1.6 g
Calcium chloride dihydrate _corresponding to_
Calcium chloride
0.12 g
0.20 g
0.27 g
0.35 g
0.14 g
Sodium glycerophosphate (hydrate) _corresponding to_
Sodium glycerophosphate
0.89 g
1.5 g
2.0 g
2.6 g
1.0 g
Magnesium sulphate heptahydrate _corresponding to_
Magnesium sulphate
0.26 g
0.42 g
0.59 g
0.75 g
0.30 g
Potassium chloride
0.95 g
1.6 g
2.2 g
2.8 g
1.1 g
Sodium acetate trihydrate _corresponding to_
Sodium acetate
0.72 g
1.2 g
1.7 g
2.1 g
0.85 g
Zinc sulphate heptahydrate
_corresponding to_
Zinc sulphate
0.0027 g
0.0045 g
0.0063 g
0.0081 g
0.0032 g
Glucose monohydrate _corresponding to_
Glucose
58 g
95 g
130 g
170 g
68 g
Soya-bean oil, refin