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OMEFLEX SPECIAL WITHOUT ELECTROLYTES EMULSION FOR INFUSION

Active substance(s): ALANINE / ARGININE / ASPARTIC ACID / GLUCOSE MONOHYDRATE / GLUTAMIC ACID / GLYCINE / HISTIDINE / ISOLEUCINE / LEUCINE / LYSINE MONOHYDRATE / MEDIUM-CHAIN TRIGLYCERIDES NEUTRAL / METHIONINE / OMEGA-3-ACID TRIGLYCERIDES / PHENYLALANINE / PROLINE / SERINE / SOYA-BEAN OIL RE

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SUMMARY OF PRODUCT CHARACTERISTICS
1

NAME OF THE MEDICINAL PRODUCT

Omeflex special without electrolytes emulsion for infusion

2

QUALITATIVE AND QUANTITATIVE COMPOSITION

The ready-for-use emulsion for intravenous infusion contains after mixing the
chamber contents:
from the top chamber
(glucose solution)
Glucose monohydrate
equivalent to anhydrous glucose

in 1000
in 625 ml in 1250
in 1875
ml
ml
ml
158.4 g
99.00 g
198.0 g
297.0 g
144.0 g
90.00 g
180.0 g
270.0 g

from the middle chamber
(fat emulsion)
Medium-chain triglycerides
Soya-bean oil, refined
Omega-3-acid triglycerides

in 1000
in 625 ml in 1250
in 1875
ml
ml
ml
20.00 g
12.50 g
25.00 g
37.50 g
16.00 g
10.00 g
20.00 g
30.00 g
4.000 g
2.500 g
5.000 g
7.500 g

from the bottom chamber
(amino acid solution)
Isoleucine
Leucine
Lysine monohydrate
equivalent to lysine
Methionine
Phenylalanine
Threonine
Tryptophan
Valine
Arginine
Histidine
Alanine
Aspartic acid
Glutamic acid
Glycine
Proline
Serine

in 1000
in 625 ml in 1250
in 1875
ml
ml
ml
3.284 g
2.053 g
4.105 g
6.158 g
4.384 g
2.740 g
5.480 g
8.220 g
3.576 g
2.235 g
4.470 g
6.705 g
3.184 g
1.990 g
3.979 g
5.969 g
2.736 g
1.710 g
3.420 g
5.130 g
4.916 g
3.073 g
6.145 g
9.218 g
2.540 g
1.588 g
3.175 g
4.763 g
0.800 g
0.500 g
1.000 g
1.500 g
3.604 g
2.253 g
4.505 g
6.758 g
3.780 g
2.363 g
4.725 g
7.088 g
1.752 g
1.095 g
2.190 g
3.285 g
6.792 g
4.245 g
8.490 g
12.73 g
2.100 g
1.313 g
2.625 g
3.938 g
4.908 g
3.068 g
6.135 g
9.203 g
2.312 g
1.445 g
2.890 g
4.335 g
4.760 g
2.975 g
5.950 g
8.925 g
4.200 g
2.625 g
5.250 g
7.875 g

in 1000
in 625 ml in 1250
in 1875
ml
ml
ml
56.0
35.0
70.1
105.1
8
5
10
15
144
90
180
270
40
25
50
75

Amino acid content [g]
Nitrogen content [g]
Carbohydrate content [g]
Lipid content [g]
Excipient(s) with known effect:
Sodium (from sodium oleate and sodium hydroxide) with max. 0.5 mmol/l in the
ready to use emulsion.
For the full list of excipients, see section 6.1.

3

PHARMACEUTICAL FORM

Emulsion for infusion
Amino acids and glucose solutions: clear, colourless up to straw-coloured solutions
Fat emulsion: oil-in-water emulsion, milky white

Energy in the form of lipids
[kJ (kcal)]
Energy in the form of
carbohydrates [kJ (kcal)]
Energy in the form of amino acids
[kJ (kcal)]
Non-protein energy [kJ (kcal)]

in 1000 ml in 625 ml
1590 (380) 995 (240)

2415 (575) 1510 (360) 3015 (720)
940 (225)

585 (140)

4005 (955) 2505 (600)

Total energy [kJ (kcal)]

Osmolality [mOsm/kg]
Theoretical osmolarity
[mOsm/l]
pH

in 1250 ml in 1875 ml
1990 (475) 2985 (715)

4945
(1180)

3090 (740)

4520
(1080)
1170 (280) 1755 (420)
5005
(1195)
6175
(1475)

7510
(1795)
9265
(2215)

1840
1330
5.0 - 6.0

4

CLINICAL PARTICULARS

4.1

Therapeutic indications

Supply of energy, essential fatty acids including omega-3 and omega-6 fatty acids,
amino acids, and fluids for parenteral nutrition of patients in states of moderate to

severe catabolism when oral or enteral nutrition is impossible, insufficient or
contraindicated.
Omeflex special without electrolytes is indicated in adults.

4.2

Posology and method of administration

Posology
The dosage should be adapted to the patients’ individual requirements.
It is recommended that Omeflex special without electrolytes be administered
continuously. A stepwise increase of the infusion rate over the first 30 minutes up to
the desired infusion rate avoids possible complications.

Adults
The maximum daily dose amounts to 35 ml/kg body weight, corresponding to
2.0 g amino acids /kg body weight per day
5.04 g glucose /kg body weight per day
1.4 g lipid
/kg body weight per day.
The maximum rate of infusion is 1.7 ml/kg body weight per hour, corresponding to
0.1 g amino acids /kg body weight per hour
0.24 g glucose /kg body weight per hour
0.07 g lipid
/kg body weight per hour.
For a patient weighing 70 kg this corresponds to a maximum infusion rate of 119 ml
per hour. The amount of substrate administered is then 6.8 g of amino acids per hour,
17.1 g of glucose per hour and 4.8 g of lipids per hour.
Paediatric population
Omeflex special without electrolytes is contraindicated in newborn infants, infants
and toddlers < 2 years of age (see section 4.3).
The safety and efficacy in children > 2 years have not yet been established. No data
are available.Patients with renal/hepatic impairment
The doses should be adjusted individually in patients with hepatic or renal
insufficiency (see also section 4.4).
Duration of treatment
The duration of treatment for the indications stated is not limited. During the
administration of Omeflex special without electrolytes it is necessary to provide an
appropriate amount of electrolytes, trace elements and vitamins.

Duration of infusion of one single bag
The recommended duration of infusion for a parenteral nutrition bag is maximum 24
h.
Method of administration
Intravenous use. For central venous infusion only.

4.3

Contraindications



hypersensitivity to the active substances, to egg, fish, peanut or soya protein or
to any of the excipients listed in section 6.1.

inborn errors of amino acid metabolism

severe hyperlipidaemia characterized by hypertriglyceridaemia (≥ 1000 mg/dl
or 11.4 mmol/l)

severe coagulopathy

hyperglycaemia not responding to insulin doses of up to 6 units insulin/hour

acidosis

intrahepatic cholestasis

severe hepatic insufficiency

severe renal insufficiency in absence of renal replacement therapy

aggravating haemorrhagic diatheses

acute thrombo-embolic events, lipid embolism.
On account of its composition, Omeflex special without electrolytes must not be used
in newborn infants, infants and toddlers under 2 years of age.
General contraindications to parenteral nutrition include:

unstable circulatory status with vital threat (states of collapse and shock)

acute phases of cardiac infarction and stroke

unstable metabolic condition (e.g. severe postaggression syndrome, coma of
unknown origin)

inadequate cellular oxygen supply

disturbances of the electrolyte and fluid balance

acute pulmonary oedema

decompensated cardiac insufficiency.

4.4

Special warnings and precautions for use

Caution should be exercised in cases of increased serum osmolarity.
Disturbances of the fluid, electrolyte or acid-base balance must be corrected before
the start of infusion.

Too rapid infusion can lead to fluid overload with pathological serum electrolyte
concentrations, hyperhydration and pulmonary oedema.
Any sign or symptom of anaphylactic reaction (such as fever, shivering, rash or
dyspnoea) should lead to immediate interruption of the infusion.
Controls of the serum electrolytes, the water balance, the acid-base balance and of
blood cell counts, coagulation status, hepatic and renal function are necessary.
Omeflex special without electrolytes is almost electrolyte free and therefore, used
especially in patients with limited and/or specific electrolyte requirements. Sodium,
potassium, calcium, magnesium and phosphate should be replaced according to
clinical status related specific requirements. Close monitoring of electrolyte levels are
required.
Refeeding or repletion of malnourished or depleted patients may cause hypokalaemia,
hypophosphataemia and hypomagnesaemia. Close monitoring of serum electrolytes is
mandatory. Adequate supplementation of electrolytes according to deviations from
normal values is necessary.
The serum triglyceride concentration should be monitored when infusing Omeflex
special without electrolytes.
Depending on the patient’s metabolic condition, occasional hypertriglyceridaemia
may occur. If the plasma triglyceride concentration exceeds 4.6 mmol/l (400 mg/dl)
during administration of lipids, it is recommended to reduce the infusion rate. The
infusion must be interrupted if the plasma triglyceride concentration exceeds
11.4 mmol/l (1000 mg/dl), as these levels have been associated with acute
pancreatitis.
Patients with impaired lipid metabolism
Omeflex special without electrolytes should be administered cautiously to patients
with disturbances of lipid metabolism with increased serum triglycerides, e.g. renal
insufficiency, diabetes mellitus, pancreatitis, impaired hepatic function,
hypothyroidism (with hypertriglyceridaemia), sepsis, and metabolic syndrome. If
Omeflex special without electrolytes is given to patients with these conditions, more
frequent monitoring of serum triglycerides is necessary to assure triglyceride
elimination and stable triglyceride levels below 11.4 mmol/l (1000 mg/dl).
In combined hyperlipidaemias and in metabolic syndrome, triglyceride levels react to
glucose, lipids and overnutrition. Adjust dose accordingly. Assess and monitor other
lipid and glucose sources, and drugs interfering with their metabolism.
The presence of hypertriglyceridaemia 12 hours after lipid administration also
indicates a disturbance of lipid metabolism.
Like all solutions containing carbohydrates, the administration of Omeflex special
without electrolytes can lead to hyperglycaemia. The blood glucose level should be
monitored. If there is hyperglycaemia, the rate of infusion should be reduced or
insulin should be administered. If the patient is receiving other intravenous glucose

solutions concurrently, the amount of additionally administered glucose has to be
taken into account.
An interruption of administration of the emulsion may be indicated if the blood
glucose concentration rises to above 14 mmol/l (250 mg/dl) during administration.
Trace elements and vitamins should be supplemented according to nutritional and
clinical requirements.
Omeflex special without electrolytes should not be given simultaneously with blood
in the same infusion set due to the risk of pseudoagglutination (see also section 4.5).
Omeflex special without electrolytes is a preparation of complex composition. It is,
therefore, strongly advisable not to add other solutions (as long as compatibility is not
proven – see section 6.2).
As with all intravenous solutions, especially for parenteral nutrition, strict aseptic
precautions are necessary for the infusion of Omeflex special without electrolytes.
Paediatric population
There is as yet no clinical experience of the use of Omeflex special without
electrolytes in children and adolescents.
Elderly patients
Basically the same dosage as for adults applies, but caution should be exercised in
patients suffering from further diseases like cardiac insufficiency or renal
insufficiency that may frequently be associated with advanced age.
Patients with diabetes mellitus, impaired cardiac or renal function
Like all large-volume infusion solutions, Omeflex special without electrolytes should
be administered with caution to patients with impaired cardiac or renal function.
There is only limited experience of its use in patients with diabetes mellitus or renal
failure.
In patients with renal insufficiency close monitoring of phosphate levels is required to
prevent hyperphosphataemia. In contrast, in patients treated with continuous renal
replacement therapy regular monitoring and adequate replacement of phosphate is
necessary to prevent hypophosphataemia.
Special warnings/precautions regarding excipients
This medicinal product contains less than 1 mmol sodium (23 mg) per multichamber
bag, i.e. it is essentially ‘sodium- free’.
Interference with laboratory tests
The fat content may interfere with certain laboratory measurements (e.g. bilirubin,
lactate dehydrogenase, oxygen saturation) if blood is sampled before fat has been
adequately cleared from the blood stream.

4.5

Interaction with other medicinal products and other forms of interaction

Some drugs, like insulin, may interfere with the body’s lipase system. This kind of
interaction seems, however, to be of only 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 K1. This may interfere with the
therapeutic effect of coumarin derivatives which should be closely monitored in
patients treated with such drugs.
Omeflex special without electrolytes should not be given simultaneously with blood
in the same infusion set due to the risk of pseudoagglutination (see also section 4.4).

4.6

Fertility, pregnancy and lactation

Pregnancy
There are no or limited amount of data from the use of Omeflex special without
electrolytes in pregnant women. Animal studies are insufficient with respect to
reproductive toxicity (see section 5.3).
Parenteral nutrition may become necessary during pregnancy. Omeflex special
without electrolytes should only be given to pregnant women after careful
consideration.
Breast-feeding
Components/metabolites of Omeflex special without electrolytes are excreted in
human milk, but at therapeutic doses no effects on the breastfed newborns/infants are
anticipated. Nevertheless, breast-feeding is not recommended for mothers on
parenteral nutrition.
Fertility
No data from the use of Omeflex special without electrolytes available.

4.7

Effects on ability to drive and use machines

Omeflex special without electrolytes has no or negligible influence on the ability to
drive and use machines.

4.8

Undesirable effects

Under conditions of correct use, in terms of dosing monitoring, observation of safety
restrictions and instructions, undesirable effects may still occur. The following listing
includes a number of systemic reactions that may be associated with the use of
Omeflex special without electrolytes.
Undesirable effects are listed according to their frequencies as follows:
Very common
(≥ 1/10)
Common
(≥ 1/100 to < 1/10)
Uncommon
(≥1/1,000 to <1/100)
Rare
(≥1/10,000 to <1/1,000)
Very rare
(<1/10,000)
Not known
(frequency cannot be estimated from the available data)
Blood and lymphatic system disorders
Rare:
Hypercoagulation
Not known: Leucopenia, thrombocytopenia
Immune system disorders
Rare:
Allergic reactions (e.g. anaphylactic reactions, dermal eruptions,
laryngeal, oral and facial oedema)
Metabolism and nutrition disorders
Very rare: Hyperlipidaemia, hyperglycaemia, metabolic acidosis
The frequency of these undesirable effects is dose-dependent and may be
higher under the condition of absolute or relative lipid overdose.
Nervous system disorders
Rare:
Headache, drowsiness
Vascular disorders
Hypertension or hypotension, flush
Rare:
Respiratory, thoracic and mediastinal disorders
Rare:
Dyspnoea, cyanosis
Gastrointestinal disorders
Uncommon: Nausea, vomiting
Metabolism and nutrition disorders
Uncommon: Loss of appetite
Hepatobiliary disorders
Not known: Cholestasis
Skin and subcutaneous tissue disorders
Rare:
Erythema, sweating

Musculoskeletal and connective tissue disorders
Rare:
Pain in the back, bones, chest and lumbar region
General disorders and administration site conditions
Elevated body temperature, feeling cold, chills
Rare:
Very rare: Fat overload syndrome (details see below)
Should adverse reactions occur, the infusion must be stopped.
Should the triglyceride level rise to above 11.4 mmol/l (1000 mg/dl) during infusion,
the infusion must be stopped. With levels above 4.6 mmol/l (400 mg/dl), the infusion
may be continued at a reduced dosage (see section 4.4).
If the infusion is restarted, the patient should be carefully monitored, especially at the
beginning, and serum triglycerides should be determined at short intervals.
Information on particular undesirable effects
Nausea, vomiting and lack of appetite are symptoms often related to conditions for
which parenteral nutrition is indicated, and may be associated with parenteral
nutrition at the same time.
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 hypertriglyceridaemia, 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
hyperlipidaemia, fever, fat infiltration, hepatomegaly with or without icterus,
splenomegaly, anaemia, leucopenia, thrombocytopenia, coagulation disorder,
haemolysis and reticulocytosis, abnormal liver function tests and coma. The
symptoms are usually reversible if the infusion of the fat emulsion is discontinued.
Should signs of a fat overload syndrome occur, the infusion of Omeflex special
without electrolytes should be discontinued immediately.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is
important. It allows continued monitoring of the benefit/risk balance of the medicinal
product. Healthcare professionals are asked to report any suspected adverse reactions
via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

4.9

Overdose

Symptoms of fluid overdose
Hyperhydration, electrolyte imbalance and pulmonary oedema

Symptoms of amino acid overdose
Renal amino acid losses with consecutive amino acid imbalances, sickness, vomiting
and shivering
Symptoms of glucose overdose
Hyperglycaemia, glucosuria, dehydration, hyperosmolality, hyperglycaemichyperosmolar coma
Symptoms of lipid overdose
See section 4.8.
Treatment
Immediate cessation of infusion is indicated for overdose. Further therapeutic
measures depend on the particular symptoms and their severity. When infusion is
recommenced after the symptoms have declined, it is recommended that the infusion
rate be raised gradually with monitoring at frequent intervals.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties

Pharmacotherapeutic group: Solutions for parenteral nutrition, combinations
ATC code: B 05BA10
Mechanism of action
The purpose of parenteral nutrition is to supply all necessary nutrients and energy for
the growth and/or regeneration of tissue as well as for the maintenance of all body
functions.
Amino acids are of particular importance since some of them are essential
components for protein synthesis. The simultaneous administration of energy sources
(carbohydrates/lipids) is necessary to reserve amino acids for tissue regeneration and
anabolism and prevent their utilisation as energy source.
Glucose is ubiquitously metabolised within the organism. Some tissues and organs,
such as CNS, bone marrow, erythrocytes, tubular epithelium, cover their energy
requirement exclusively from glucose. In addition glucose acts as a structural building
block for various cell substances.
On account of their high energy density, lipids are an efficient form of energy supply.
Long-chain triglycerides provide the organism with essential fatty acids for the
synthesis of cell components. For these purposes the fat emulsion contains mediumchain and long-chain triglycerides (deriving from soya-bean oil and fish oil).

The long-chain triglyceride fraction contains omega-6 and omega-3 triglycerides for
supply of polyunsaturated fatty acids. They are primarily intended for the prevention
and treatment of essential fatty acid deficiency, but also as a source of energy.
Omeflex special without electrolytes contains essential omega-6 fatty acids, mainly in
the form of linoleic acid, and omega-3 fatty acids in the form of alpha-linolenic acid,
eicosapentaenoic acid, and docosahexaenoic acid. The ratio of omega-6/omega-3 fatty
acids in Omeflex special without electrolytes is approximately 2.5:1.
Medium-chain triglycerides are more rapidly hydrolysed, eliminated from the
circulation and completely oxidised than long-chain triglycerides. They are a favoured
energy substrate, particularly when there is disturbance of the degradation and/or
utilisation of long-chain triglycerides, e.g. when there is a lipoprotein lipase
deficiency and/or a deficiency in lipoprotein lipase cofactors.

5.2

Pharmacokinetic properties

Absorption
Omeflex special without electrolytes is infused intravenously. Hence, all substrates
are available for metabolism immediately.
Distribution
The dose, rate of infusion, metabolic situation and individual factors of the patient
(level of fasting) are of decisive importance for the maximum triglyceride
concentrations reached. When used according to the instructions with due regard to
the dosage guidelines, the triglyceride concentrations do not, in general, exceed
4.6 mmol/l (400 mg/dl).
Medium-chain fatty acids have a low affinity to albumin. In animal experiments
administering pure medium-chain triglyceride emulsions, it has been shown that
medium-chain fatty acids can cross the blood-brain barrier, if overdosed. No adverse
effects were observed with an emulsion providing a mixture of medium-chain
triglycerides and long-chain triglycerides, as long-chain triglycerides have an
inhibiting effect on medium-chain triglyceride hydrolysis. Therefore, toxic effects on
the brain can be excluded after the administration of Omeflex special without
electrolytes.
Amino acids are incorporated in a variety of proteins in different organs of the body.
In addition each amino acid is maintained as free amino acid in the blood and inside
cells.
As glucose is water-soluble, it is distributed with the blood over the whole body. At
first, the glucose solution is distributed in the intravascular space and then it is taken
up into the intracellular space.

No data are available concerning transport of the components through the placental
barrier.
Biotransformation
Amino acids that do not enter protein synthesis are metabolised as follows. The amino
group is separated from the carbon skeleton by transamination. The carbon chain is
either oxidised directly to CO2 or utilised as substrate for gluconeogenesis in the liver.
The amino group is also metabolised in the liver to urea.
Glucose is metabolised to CO2 and H2O via the known metabolic routes. Some
glucose is utilised for lipid synthesis.
After infusion triglycerides are hydrolysed to glycerol and fatty acids. Both are
incorporated in physiological pathways for energy production, synthesis of biological
active molecules, gluconeogenesis and resynthesis of lipids.
In detail, long-chain omega-3 polyunsaturated fatty acids replace arachidonic acid as
an eicosanoid substrate in cell membranes and decrease the generation of
inflammatory eicosanoids and cytokines in the body. This may be of benefit in
patients at risk of developing a hyperinflammatory state and sepsis
Elimination
Only minor amounts of amino acids are excreted unchanged in urine.
Excess glucose is excreted in urine only if the renal threshold of glucose is reached.
Both the triglycerides of soya-bean oil and medium-chain triglycerides are completely
metabolised to CO2 and H2O. Small amounts of lipids are lost only during sloughing
of cells from skin and other epithelial membranes. Renal excretion does virtually not
occur.

5.3

Preclinical safety data

Non-clinical studies have not been performed with Omeflex special without
electrolytes.
Toxic effects of mixtures of nutrients given as substitution therapy at the
recommended dosage are not to be expected.
Reproductive toxicity
Phytoestrogens such as ß-sitosterol can be found in various vegetable oils, especially
in soya-bean oil. Impairment of fertility was observed in rats and rabbits after
subcutaneous and intravaginal administration of ß-sitosterol. After administration of
pure ß-sitosterol a decrease of the testicular weight and a reduction of the sperm
concentration in male rats and a lowered pregnancy rate in female rabbits were

recorded. However, according to the current state of knowledge the observed effects
in animals do not seem to have relevance for clinical use.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients

Citric acid monohydrate (for pH adjustment)
Glycerol
Egg lecithin
Sodium oleate
all-rac-alpha-tocopherol Sodium hydroxide (for pH adjustment)
Water for injections

6.2

Incompatibilities

This medicinal product must not be mixed with other medicinal products for which
compatibility has not been documented. See section 6.6.
Omeflex special without electrolytes should not be given simultaneously with blood,
see sections 4.4 and 4.5.

6.3

Shelf life

Unopened
2 years
After removing the protective overwrap and after mixing of the contents of the bag
After mixing the contents of the chambers the final emulsion is to be used
immediately.After admixture of compatible additives
From a microbiological point of view, the product should be used immediately after
admixture of additives. If not used immediately after admixture of additives, in-use
storage times and conditions prior to use are the responsibility of the user.
After first opening (spiking of the infusion port)
The emulsion is to be used immediately after opening of the container.

6.4

Special precautions for storage

Do not store above 25 °C.
Do not freeze. If accidentally frozen, discard the bag.
Keep the bag in the protective overwrap in order to protect from light.

6.5

Nature and contents of container

Omeflex special without electrolytes is supplied in flexible multichamber bags of
multilayer foil. The inner layer in contact with the solution consists of polypropylene.
The twin base port is made of polypropylene and styrene ethylene butylene styrene.
The multichamber bags contain:

625 ml (250 ml of amino acids solution + 125 ml of fat emulsion + 250 ml of
glucose solution)

1250 ml (500 ml of amino acids solution + 250 ml of fat emulsion + 500 ml of
glucose solution)

1875 ml (750 ml of amino acids solution + 375 ml of fat emulsion + 750 ml of
glucose solution)

Figure A

Figure B

Figure A: The multichamber bag is packed in a protective overwrap. An oxygen
absorber and an oxygen indicator are placed between the bag and the overwrap; the
oxygen absorber sachet is made of inert material and contains iron hydroxide.
Figure B: The top chamber contains a glucose solution, the middle chamber contains a
fat emulsion, and the bottom chamber contains an amino acid solution.
The top chamber and the middle chamber can be connected with the bottom chamber
by opening the intermediate seams (peel seams).
The design of the bag permits mixing of the amino acids, glucose and lipids in a
single chamber. Opening the peel seams results in sterile mixing to form an emulsion.
The different container sizes are presented in cartons containing five bags.
Pack sizes: 5 x 625 ml, 5 x 1250 ml, 5 x 1875 ml.

Not all pack sizes may be marketed.

6.6

Special precautions for disposal

No special requirements for disposal.
Parenteral nutrition products should be visually inspected for damage, discolouration
and emulsion instability before use.
Do not use bags which are damaged; neither overwrap nor the primary bag should be
damaged. Use only if the peel seams between the chambers are intact, if amino acid
and glucose solutions are clear and colourless up to straw-coloured, and the emulsion
is a homogenous liquid with milky white appearance. Do not use if the solutions are
discoloured or contain particulate matter. Do not use if the emulsion shows signs of
phase separation (oil drops, oil layer).
Before opening the overwrap, check the colour of the oxygen indicator (see Figure A).
Do not use if the oxygen indicator is pink. Use only if the oxygen indicator is yellow.
Preparation of the mixed emulsion
Strict adherence to aseptic handling principles must be complied with.
To open: Tear overwrap starting from the tear notches (Fig. 1). Remove the bag from
its protective overwrap. Discard overwrap, oxygen indicator and oxygen absorber.
Visually inspect the primary bag for leaks. Leaky bags must be discarded, since the
sterility cannot be guaranteed.

To open and mix the chambers sequentially, roll the bag with both hands, starting first
by opening the peel seam that separates the top chamber (glucose) and the bottom
chamber (amino acids) (Fig. 2a). Then continue applying pressure so that the peel
seam separating the middle chamber (lipids) and the bottom chamber opens (Fig. 2b).
Addition of additives

After removing the aluminium seal (Fig. 3) one can add compatible additives via the
medication port (Fig. 4).
Omeflex special without electrolytes can be mixed with following additives:
N(2)-L-alanyl-L-glutamine
Aqua ad injectabilia
Calcium gluconate 10%
Sodium chloride 20%
Potassium chloride 14.9%
Magnesium sulphate 50%
Potassium dihydrogenphosphate 1M
Tracutil (trace elements)

Mix the contents of the bag thoroughly (Fig. 5) and visually inspect the mixture
(Fig. 6). There should be no signs of emulsion phase separation.
The mixture is a milky white homogenous oil-in-water emulsion.
Preparation for infusion
The emulsion should always be brought to room temperature prior to infusion.
Remove the aluminium foil from the infusion port (Fig. 7) and attach the infusion set
(Fig. 8). Use a non-vented infusion set or close the air vent when using a vented set.
Hang the bag on an infusion stand (Fig. 9) and carry out infusion using the standard
technique.

For single use only. Container and unused residues must be discarded after use.

Do not reconnect partially used containers.
If filters are used they must be lipid-permeable (pore size ≥ 1.2 µm).

7

MARKETING AUTHORISATION HOLDER

B. Braun Melsungen AG
Carl-Braun-Straße 1
34212 Melsungen
Germany

8

MARKETING AUTHORISATION NUMBER(S)

PL 03551/0146

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
12/07/2016

10

DATE OF REVISION OF THE TEXT
12/07/2016

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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