SMOFKABIVEN

Israel - English - Ministry of Health

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Active ingredient:
AMINOACETIC ACID; CALCIUM CHLORIDE DIHYDRATE; FISH OIL; GLUCOSE MONOHYDRATE; L- ALANINE; L- ISOLEUCINE; L- LEUCINE; L- LYSINE ACETATE; L- METHIONINE; L- PHENYLALANINE; L- PROLINE; L- SERINE; L- THREONINE; L- TRYPTOPHAN; L- TYROSINE; L- VALINE; L-ARGININE; L-HISTIDINE; MAGNESIUM SULFATE HEPTAHYDRATE; OLIVE OIL; POTASSIUM CHLORIDE; SODIUM ACETATE TRIHYDRATE; SODIUM GLYCEROPHOSPHATE HYDRATE; SOYBEAN OIL; TAURINE; TRIGLYCERIDES, MEDIUM-CHAIN; ZINC SULFATE HEPTAHYDRATE
Available from:
CURE MEDICAL & TECHNICAL SUPPLY
Pharmaceutical form:
EMULSION FOR INFUSION
Composition:
FISH OIL 30 G / 1000 ML; OLIVE OIL 50 G / 1000 ML; TRIGLYCERIDES, MEDIUM-CHAIN 60 G / 1000 ML; SOYBEAN OIL 60 G / 1000 ML; ZINC SULFATE HEPTAHYDRATE 0.023 G / 1000 ML; SODIUM ACETATE TRIHYDRATE 5.62 G / 1000 ML; POTASSIUM CHLORIDE 4.48 G / 1000 ML; MAGNESIUM SULFATE HEPTAHYDRATE 2.47 G / 1000 ML; SODIUM GLYCEROPHOSPHATE HYDRATE 4.18 G / 1000 ML; CALCIUM CHLORIDE DIHYDRATE 0.74 G / 1000 ML; L- VALINE 6.2 G / 1000 ML; L- TYROSINE 0.40 G / 1000 ML; L- TRYPTOPHAN 2.0 G / 1000 ML; L- THREONINE 4.4 G / 1000 ML; TAURINE 1.0 G / 1000 ML; L- SERINE 6.5 G / 1000 ML; L- PROLINE 11.2 G / 1000 ML; L- PHENYLALANINE 5.1 G / 1000 ML; L- METHIONINE 4.3 G / 1000 ML; L- LEUCINE 7.4 G / 1000 ML; L- ISOLEUCINE 5.0 G / 1000 ML; L-HISTIDINE 3.0 G / 1000 ML; L-ARGININE 12.0 G / 1000 ML; L- ALANINE 14.0 G / 1000 ML; GLUCOSE MONOHYDRATE 462 G / 1000 ML; L- LYSINE ACETATE 9.3 G / 1000 ML; AMINOACETIC ACID 11.0 G / 1000 ML
Administration route:
I.V
Prescription type:
Required
Manufactured by:
FRESENIUS KABI AB, SWEDEN
Therapeutic indications:
Parenteral nutrition for adults and children aged 2 years and above when oral or enteral nutrition is impossible, insufficient or contraindicated.
Authorization number:
147 81 33335 00
Authorization date:
2017-03-31

S

UMMARY

O

F

T

HE

P

RODUCT

C

HARACTERISTICS

1

N

AME OF THE

M

EDICINAL

P

RODUCT

SmofKabiven

emulsion for infusion

2

Q

UALITATIVE AND

Q

UANTITATIVE

C

OMPOSITION

SmofKabiven consists of a three chamber bag system. Each bag contains the following partial volumes

depending on the four pack sizes.

986 ml

1477 ml

1970 ml

2463 ml

Per 1000 ml

Amino acid solution with electrolytes

500 ml

750 ml

1000 ml

1250 ml

508 ml

Glucose 42%

298 ml

446 ml

595 ml

744 ml

302 ml

Lipid emulsion

188 ml

281 ml

375 ml

469 ml

190 ml

This corresponds to the following total compositions:

Active ingredients

986 ml

1477ml

1970 ml

2463 ml

Per 1000 ml

Alanine

7.0 g

10.5 g

14.0 g

17.5 g

7.1 g

Arginine

6.0 g

9.0 g

12.0 g

15.0 g

6.1 g

Glycine

5.5 g

8.2 g

11.0 g

13.8 g

5.6 g

Histidine

1.5 g

2.2 g

3.0 g

3.7 g

1.5 g

Isoleucine

2.5 g

3.8 g

5.0 g

6.2 g

2.5 g

Leucine

3.7 g

5.6 g

7.4 g

9.4 g

3.8 g

Lysine (as acetate)

3.3 g

5.0 g

6.6 g

8.4 g

3.4 g

Methionine

2.2 g

3.2 g

4.3 g

5.4 g

2.2 g

Phenylalanine

2.6 g

3.8 g

5.1 g

6.4 g

2.6 g

Proline

5.6 g

8.4 g

11.2 g

14.0 g

5.7 g

Serine

3.2 g

4.9 g

6.5 g

8.1 g

3.3 g

Taurine

0.50 g

0.75 g

1.0 g

1.2 g

0.5 g

Threonine

2.2 g

3.3 g

4.4 g

5.4 g

2.2 g

Tryptophan

1.0 g

1.5 g

2.0 g

2.5 g

1.0 g

Tyrosine

0.20 g

0.30 g

0.40 g

0.49 g

0.20 g

Valine

3.1 g

4.6 g

6.2 g

7.6 g

3.1 g

Calcium chloride (as dihydrate)

0.28 g

0.42 g

0.56 g

0.69 g

0.28 g

Sodium glycerophosphate (as hydrate)

2.1 g

3.1 g

4.2 g

5.2 g

2.1 g

Magnesium sulphate (as heptahydrate)

0.60 g

0.90 g

1.2 g

1.5 g

0.61 g

Potassium chloride

2.2 g

3.4 g

4.5 g

5.7 g

2.3 g

Sodium acetate (as trihydrate)

1.7 g

2.6 g

3.4 g

4.2 g

1.7 g

Zinc sulphate (as heptahydrate)

0.0065 g

0.0097 g

0.013 g

0.016 g

0.0066 g

Glucose (as monohydrate)

125 g

187 g

250 g

313 g

127 g

Soya-bean oil, refined

11.3 g

16.9 g

22.5 g

28.1 g

11.4 g

Medium-chain triglycerides

11.3 g

16.9 g

22.5 g

28.1 g

11.4 g

Olive oil, refined

9.4 g

14.1 g

18.8 g

23.4 g

9.5 g

Fish oil, rich in omega-3-acids

5.6 g

8.4 g

11.3 g

14.0 g

5.7 g

Corresponding to

986 ml

1477 ml

1970 ml

2463 ml

Per 1000 ml

Amino acids

50 g

75 g

100 g

125 g

51 g

Nitrogen

12 g

16 g

20 g

Electrolytes

- sodium

40 mmol

60 mmol

80 mmol

100 mmol 41 mmol

- potassium

30 mmol

45 mmol

60 mmol

74 mmol

30 mmol

- magnesium

5.0 mmol

7.5 mmol

10 mmol

12 mmol

5.1 mmol

- calcium

2.5 mmol

3.8 mmol

5.0 mmol

6.2 mmol

2.5 mmol

- phosphate

12 mmol

19 mmol

25 mmol

31 mmol

13 mmol

- zinc

0.04 mmol

0.06 mmol 0.08 mmol

0.1 mmol

0.04 mmol

- sulphate

5.0 mmol

7.5 mmol

10 mmol

13 mmol

5.1 mmol

- chloride

35 mmol

52 mmol

70 mmol

89 mmol

36 mmol

- acetate

104 mmol

157 mmol

209 mmol

261 mmol 106 mmol

Carbohydrates

- Glucose (anhydrous)

125 g

187 g

250 g

313 g

127 g

Lipids

38 g

56 g

75 g

94 g

38 g

Energy content

- total (approx.)

1100 kcal

4.6 MJ

1600 kcal

6.7 MJ

2200 kcal

9.2 MJ

2700 kcal

11.3 MJ

- non protein (approx.)

900 kcal

3.8 MJ

1300 kcal

5.4 MJ

1800 kcal

7.5 MJ

2200 kcal

9.2 MJ

Osmolality

approx. 1800 mosmol/kg water

Osmolarity

approx. 1500 mosmol/l

pH (after mixing)

approx. 5.6

Contribution from both the lipid emulsion and the amino acid solution.

For a full list of excipients, see section 6.1.

3

P

HARMACEUTICAL

F

ORM

Emulsion for infusion.

Glucose and amino acid solutions are clear and colourless to slightly yellow and free from particles. The lipid

emulsion is white and homogenous.

4

C

LINICAL

P

ARTICULARS

4.1

Therapeutic indications

Parenteral nutrition for adult patients when oral or enteral nutrition is impossible, insufficient or contraindicated.

4.2

Posology and method of administration

The appearance of the product after mixing the 3 chambers is a white emulsion.

The patient’s ability to eliminate fat and metabolise nitrogen and glucose, and the nutritional requirements

should govern the dosage and infusion rate, see section 4.4.

The dose should be individualised with regard to the patient’s clinical condition and body weight (bw).

The nitrogen requirements for maintenance of body protein mass depend on the patient’s condition (e.g.

nutritional state and degree of catabolic stress or anabolism).

The requirements are 0.10-0.15 g nitrogen/kg bw/day (0.6-0.9 g amino acids/kg bw/day) in the normal

nutritional state or in conditions with mild catabolic stress. In patients with moderate to high metabolic stress

with or without malnutrition, the requirements are in the range of 0.15-0.25 g nitrogen/kg bw/day (0.9-1.6 g

amino acids/kg bw/day). In some very special conditions (e.g. burns or marked anabolism) the nitrogen need

may be even higher.

Dosage

The dosage range of 13 ml – 31 ml SmofKabiven/kg bw/day corresponds to 0.10-0.25 g nitrogen/kg bw/day

(0.6-1.6 g amino acids/kg bw/day) and 14-35 kcal/kg bw/day of total energy (12-27 kcal/kg bw/day of non-

protein energy). This covers the need of the majority of the patients. In obese patients the dose should be

based on the estimated ideal weight.

Infusion rate

The maximum infusion rate for glucose is 0.25 g/kg bw/h, for amino acid 0.1 g/kg bw/h, and for fat 0.15 g/kg

bw/h.

The infusion rate should not exceed 2.0 ml/kg bw/h (corresponding to 0.25 g glucose, 0.10 g amino acids, and

0.08 g fat/kg bw/h). The recommended infusion period is 14-24 hours.

Maximum daily dose

The maximum daily dose varies with the clinical condition of the patient and may even change from day to

day. The recommended maximum daily dose is 35 ml/kg bw/day.

The recommended maximum daily dose of 35 ml/kg bw/day will provide 0.28 g nitrogen/kg bw/day

(corresponding to 1.8 g amino acids/kg bw/day), 4.5 g glucose/kg bw/day, 1.33 g fat/kg bw/day and a total

energy of 39 kcal/kg bw/day (corresponding to 31 kcal/kg bw/day of non-protein energy).

Method of administration

Intravenous use, infusion into a central vein.

The four different package sizes of SmofKabiven are intended for patients with high, moderately increased or

basal nutritional requirements. To provide total parenteral nutrition, trace elements, vitamins and possibly

electrolytes (taking into account the electrolytes already present in SmofKabiven) should be added to

SmofKabiven according to the patients need.

Pediatric patients

SmofKabiven is not recommended for use in children, see section 4.4.

4.3

Contraindications

Hypersensitivity to fish-, egg, soya- or peanut protein or to any of the active substances or excipients

Severe hyperlipidemia

Severe liver insufficiency

Severe blood coagulation disorders

Congenital errors of amino acid metabolism

Severe renal insufficiency without access to hemofiltration or dialysis

Acute shock

Uncontrolled hyperglycaemia

Pathologically elevated serum levels of any of the included electrolytes

General contraindications to infusion therapy: acute pulmonary oedema, hyperhydration, and

decompensated cardiac insufficiency

Hemophagocytotic syndrome

Unstable conditions (e.g. severe post-traumatic conditions, uncompensated diabetes mellitus, acute

myocardial infarction, stroke, embolism, metabolic acidosis, severe sepsis, hypotonic dehydration and

hyperosmolar coma)

4.4

Special warnings and precautions for use

The capacity to eliminate fat is individual and should therefore be monitored according to the routines of the

clinician. This is in general done by checking the triglyceride levels. The concentration of triglycerides in serum

should not exceed 4 mmol/l during infusion. An overdose may lead to fat overload syndrome, see section 4.8.

SmofKabiven should be given with caution in conditions of impaired lipid metabolism, which may occur in

patients with renal failure, diabetes mellitus, pancreatitis, impaired liver function, hypothyroidism and sepsis.

This medicinal product contains soya-bean oil, fish oil and egg phospholipids, which may rarely cause allergic

reactions. Cross allergic reaction has been observed between soya-bean and peanut

To avoid risks associated with too rapid infusion rates, it is recommended to use a continuous and well-

controlled infusion, if possible by using a volumetric pump.

Disturbances of the electrolyte and fluid balance (e.g. abnormally high or low serum levels of the electrolytes)

should be corrected before starting the infusion.

SmofKabiven should be given with caution to patients with a tendency towards electrolyte retention. Special

clinical monitoring is required at the beginning of any intravenous infusion. Should any abnormal sign occur,

the infusion must be stopped.

Since an increased risk of infection is associated with the use of any central vein, strict aseptic precautions

should be taken to avoid any contamination during catheter insertion and manipulation.

Serum glucose, electrolytes and osmolarity as well as fluid balance, acid-base status and liver enzyme tests

should be monitored.

Blood cell count and coagulation should be monitored when fat is given for a longer period.

In patients with renal insufficiency, the phosphate and potassium intake should be carefully controlled to

prevent hyperphosphatemia and hyperkalaemia.

The amount of individual electrolytes to be added is governed by the clinical condition of the patient and by

frequent monitoring of serum levels.

Parenteral nutrition should be given with caution in lactic acidosis, insufficient cellular oxygen supply and

increased serum osmolarity.

Any sign or symptom of anaphylactic reaction (such as fever, shivering, rash or dyspnoea) should lead to

immediate interruption of the infusion.

The fat content of SmofKabiven may interfere with certain laboratory measurements (e.g. bilirubin, lactate

dehydrogenase, oxygen saturation, hemoglobin) if blood is sampled before fat has been adequately cleared

from the bloodstream. Fat is cleared after a fat-free interval of 5-6 hours in most patients.

Intravenous infusion of amino acids is accompanied by increased urinary excretion of the trace elements, in

particular copper and zinc. This should be considered in the dosing of trace elements, especially during long-

term intravenous nutrition. Amounts of zinc administered with SmofKabiven should be taken into account.

In malnourished patients, initiation of parenteral nutrition can precipitate fluid shifts resulting in pulmonary

oedema and congestive heart failure as well as a decrease in the serum concentration of potassium,

phosphorus, magnesium and water soluble vitamins. These changes can occur within 24 to 48 hours,

therefore careful and slow initiation of parenteral nutrition is recommended in this patient group, together with

close monitoring and appropriate adjustments of fluid, electrolytes, minerals and vitamins.

SmofKabiven should not be given simultaneously with blood in the same infusion set due to the risk of

pseudoagglutination.

In patients with hyperglycaemia, administration of exogenous insulin might be necessary.

Due to composition of the amino acid solution in SmofKabiven it is not suitable for the use in new-borns or

infants below 2 years of age. There is at present no clinical experience of the use of SmofKabiven in children

(age 2 years to 11 years).

4.5

Interaction with other medicinal products and other forms of interaction

Some medicinal products, like insulin, may interfere with the body’s lipase system. This kind of interaction

seems, however, to be of limited clinical importance.

Heparin given in clinical doses causes a transient release of lipoprotein lipase into the circulation. This may

result initially in increased plasma lipolysis followed by a transient decrease in triglyceride clearance.

Soya-bean oil has a natural content of vitamin K

. However, the concentration in SmofKabiven is so low that it

is not expected to significantly influence the coagulation process in patients treated with coumarin derivatives.

4.6

Pregnancy and lactation

There are no data available on exposure of SmofKabiven in pregnant or breast-feeding women. There are no

studies available on reproductive toxicity in animals. Parenteral nutrition may become necessary during

pregnancy and lactation. SmofKabiven should only be given to pregnant and breast-feeding women after

careful consideration.

4.7

Effects on ability to drive and use machines

Not relevant.

4.8

Undesirable effects

Common

1/100, <1/10

Uncommon

1/1000, <1/100

Rare

1/10000, <1/1000

Cardiac disorders

Tachycardia

Respiratory, thoracic and

mediastinal disorders

Dyspnoea

Gastrointestinal disorders

Lack of appetite, nausea,

vomiting

Metabolism and nutrition

disorders

Elevated plasma levels of

liver enzymes

Vascular disorders

Hypotension,

hypertension

General disorders and

administration site

conditions

Slight increase in body

temperature

Chills, dizziness,

headache

Hypersensitivity-reactions

(e.g. anaphylactic or

anaphylactoid reactions,

skin rash, urticaria, flush,

headache), heat or cold

sensation, paleness,

cyanosis, pain in the neck,

back, bones, chest and

loins.

Should these side-effects occur the infusion of SmofKabiven should be stopped or, if necessary, continued at

a reduced dosage.

Fat overload syndrome

Impaired capacity to eliminate triglycerides can lead to “Fat overload syndrome” which may be caused by

overdose. Possible signs of metabolic overload must be observed. The cause may be genetic (individually

different metabolism) or the fat metabolism may be affected by ongoing or previous illnesses. This syndrome

may also appear during severe hypertriglyceridemia, even at the recommended infusion rate, and in

association with a sudden change in the patient’s clinical condition, such as renal function impairment or

infection. The fat overload syndrome is characterised by hyperlipemia, fever, fat infiltration, hepatomegaly with

or without icterus, splenomegaly, anemia, leukopenia, thrombocytopenia, coagulation disorder, hemolysis and

reticulocytosis, abnormal liver function tests and coma. The symptoms are usually reversible if the infusion of

the lipid emulsion is discontinued.

Excess of amino acid infusion

As with other amino acid solutions, the amino acid content in SmofKabiven may cause undesirable effects

when the recommended infusion rate is exceeded. These effects are nausea, vomiting, shivering and

sweating. Amino acid infusion may also cause a rise in body temperature. With an impaired renal function,

increased levels of nitrogen containing metabolites (e.g. creatinine, urea) may occur.

Excess of glucose infusion

If the glucose clearance capacity of the patient is exceeded, hyperglycaemia will develop.

4.9

Overdose

See section 4.8 “Fat overload syndrome”, “Excess of amino acid infusion” and “Excess of glucose infusion”.

If symptoms of overdose of fat or amino acids occur, the infusion should be slowed down or discontinued.

There is no specific antidote for overdose. Emergency procedures should be general supportive measures,

with particular attention to respiratory and cardiovascular systems. Close biochemical monitoring would be

essential and specific abnormalities treated appropriately.

If hyperglycaemia occurs, it should be treated according to the clinical situation either by appropriate insulin

administration and/or adjustment of the infusion rate.

Additionally, overdose might cause fluid overload, electrolyte imbalances and hyperosmolality.

In some rare serious cases, haemodialysis, haemofiltration or haemo-diafiltration may be considered.

5

P

HARMACOLOGICAL

P

ROPERTIES

5.1

Pharmacodynamic properties

Pharmacotherapeutic group: Solutions for parenteral nutrition.

ATC code: B05BA10

Lipid emulsion

The lipid emulsion of SmofKabiven is composed of Smoflipid and has a particle size and biological properties

similar to those of endogenous chylomicrons. The constituents of SmofKabiven; soya-bean oil, medium-chain

triglycerides, olive oil and fish oil have except for their energy contents, their own pharmacodynamic

properties.

Soya-bean oil has a high content of essential fatty acids. The omega-6 fatty acid linoleic acid is the most

abundant (approx. 55-60%). Alpha-linolenic acid, an omega-3 fatty acid, constitutes about 8 %. This part of

SmofKabiven provides the necessary amount of essential fatty acids.

Medium-chain fatty acids are rapidly oxidised and provide the body with a form of immediately available

energy.

Olive oil mainly provides energy in the form of mono-unsaturated fatty acids, which are much less prone to

peroxidation than the corresponding amount of poly-unsaturated fatty acids.

Fish oil is characterised by a high content of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA).

DHA is an important structural component of cell membranes, whereas EPA is a precursor of eicosanoids as

prostaglandines, thromboxanes and leucotrienes.

Two studies providing home parenteral nutrition in patients in need of long-term nutrition support have been

performed. The primary objective in both studies was to show safety. Efficacy was the secondary objective in

one of the studies, which was done in paediatric patients. This study was stratified by age groups (1 month -

<2 years, and 2 – 11 years respectively). Both studies showed that Smoflipid has the same safety profile as

the comparator (Intralipid 20%). Efficacy in the paediatric study was measured by weight gain, height, body

mass index, pre-albumin, retinol binding protein and fatty acid profile. There was no difference between the

groups in any of the parameters except the fatty acid profile after 4 weeks treatment. The fatty acid profile in

the Smoflipid patients revealed an increase in omega-3 fatty acids in plasma lipoproteins and red blood cells

phospholipids and hence reflects the composition of the infused lipid emulsion.

Amino acids and electrolytes

The amino acids, constituents of protein in ordinary food, are utilised for tissue protein synthesis and any

surplus is channelled to a number of metabolic pathways. Studies have shown a thermogenic effect of amino

acid infusion.

Glucose

Glucose should have no pharmacodynamic effects apart from contributing to maintain or replete the normal

nutritional status.

5.2

Pharmacokinetic properties

Lipid emulsion

The individual triglycerides in Smoflipid have different clearance rate but Smoflipid as a mixture is eliminated

faster than long chain triglycerides (LCT). Olive oil has the slowest clearance rate of the components

(somewhat slower than LCT) and medium chain triglycerides (MCT) the fastest. Fish oil in a mixture with LCT

has the same clearance rate as LCT alone.

Amino acids and electrolytes

The principal pharmacokinetic properties of the infused amino acids and electrolytes are essentially the same

as for amino acids and electrolytes supplied by ordinary food. However, the amino acids of dietary protein first

enter the portal vein and then the systemic circulation, while intravenously infused amino acids reach the

systemic circulation directly.

Glucose

The pharmacokinetic properties of infused glucose are essentially the same as those of glucose supplied by

ordinary food.

5.3

Preclinical safety data

Preclinical safety studies with SmofKabiven have not been performed. However, preclinical data for Smoflipid

as well as amino acid and glucose solutions of various concentrations and sodium glycerophosphate reveal no

special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity and

genotoxicity. No teratogenic effects or other embryotoxic injuries could be observed in rabbits with amino acid

solutions and are not to be expected from fat emulsions and sodium glycerophosphate when giving at the

recommended doses as substitution therapy.Nutritional products (amino acid solutions, fat emulsions, and

sodium glycerophosphate) used in replacement therapy at physiological levels are not expected to be

embryotoxic, teratogenic, or to influence reproductive performance or fertility.

In a test on guinea pigs (maximisation test) fish oil emulsion showed moderate dermal sensitisation. A

systemic antigenicity test gave no indication of evidence of anaphylactic potential of fish oil.

In a local tolerance study in rabbits with Smoflipid a slight, transient inflammation after intra-arterial,

paravenous or subcutaneous administration was observed. After intra-muscular administration a moderate

transient inflammation and tissue necrosis were seen in some animals.

6

P

HARMACEUTICAL

P

ARTICULARS

6.1

List of excipients

Glycerol

Purified egg phospholipids

all-rac-α-Tocopherol

Sodium hydroxide (pH adjuster)

Sodium oleate

Acetic acid, glacial (pH adjuster)

Hydrochloric acid (pH adjuster)

Water for injections

6.2

Incompatibilities

SmofKabiven may only be mixed with other medicinal products for which compatibility has been documented.

6.3

Shelf life

Shelf life of the medicinal product as packaged for sale : 2 years

Shelf life after mixing

Chemical and physical in-use stability of the mixed three chamber bag has been demonstrated for 36 hours at

C. From a microbiological point of view the product should be used immediately. If not used immediately,

in-use storage times and conditions prior to use are the responsibility of the user and would normally not be

longer than 24 hours at 2-8

Shelf life after mixing with additives

From a microbiological point of view, the product should be used immediately when additions have been

made. If not used immediately, the in-use storage time and conditions prior to use are the responsibility of the

user and should normally not be longer than 24 hours at 2-8

C.

6.4

Special precautions for storage

Do not store above 25°C. Do not freeze. Store in overpouch.

Shelf life after mixing: See section 6.3.

Shelf life after mixing with additives: See section 6.3.

6.5

Nature and contents of container

The container consists of a multichamber inner bag and an overpouch. The inner bag is separated into three

chambers by peelable seals. An oxygen absorber is placed between the inner bag and the overpouch. The

inner bag is made of a multilayer polymer film, alternatively Excel or Biofine. The Excel innerbag film consists

of three layers. The inner layer consists of poly (propylene/ethylene) copolymer and

styrene/ethylene/butylene/styrene thermoplastic elastomer (SEBS). The middle layer consists of SEBS and

the outer layer consists of copolyester-ether. The infusion port is equipped with a polyolefine cap. The

additive port is equipped with a synthetic polyisoprene (latex-free) stopper.

The Biofine inner bag film consists of poly(propylene-co-ethylene), synthetic rubber poly[styrene-block-

(butylene-co-ethylene)] (SEBS) and synthetic rubber poly(styrene-block-isoprene) (SIS). The infusion and

additive ports are made of polypropylene and synthetic rubber poly[styrene-block-(butylene-co-ethylene)]

(SEBS) equipped with synthetic polyisoprene (latex-free) stoppers. The blind port, which is only used during

manufacturing, is made of polypropylene equipped with a synthetic polyisoprene (latex-free) stopper.

Pack sizes:

1 x 986 ml, 4 x 986 ml

1 x1477 ml, 4 x 1477 ml

1 x 1970 ml, 2 x 1970 ml (Excel), 4 x 1970 ml (Biofine)

1 x 2463 ml, 2 x 2463 ml (Excel), 3 x 2463 ml (Biofine)

Not all pack sizes may be marketed.

6.6

Special precaution for disposal

Instructions for use

Do not use if package is damaged. Use only if the amino acid and glucose solutions are clear and colourless

or slightly yellow and the lipid emulsion is white and homogenous. The contents of the three separate

chambers have to be mixed before use, and before any additions are made via the additive port.

After separation of the peelable seals the bag should be inverted on a number of occasions to ensure a

homogenous mixture, which does not show any evidence of phase separation.

Compatibility

Only medicinal or nutrition solutions for which compatibility has been documented may be added to

SmofKabiven. Compatibility for different additives and the storage time of the different admixtures will be

available upon request.

Addition should be made aseptically.

For single use only. Any mixture remaining after infusion must be discarded.

7 Manufacturer: Fresenius Kabi AB, Uppsala, Sweden.

8 Registration holder: Cure Medical & Technical supply Ltd, Hashiloach 6, P.O.B. 3340, Petach Tikva.

The format of this leaflet was determined by the Ministry of Health and its

content was checked and approved in June 2013.

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