Omegaflex Especial emulsion for infusion

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Omegaflex special emulsion for infusion

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again. If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Omegaflex special is and what it is used for
2. What you need to know before using Omegaflex special
3. How to use Omegaflex special
4. Possible adverse effects
5. How to store Omegaflex special
6. Contents of the pack and other information

1. What Omegaflex especial is and what it is used for

Omegaflex especial contains liquids and substances called amino acids, electrolytes, and fatty acids that are essential for growth or recovery of the body. It also provides calories in the form of carbohydrates and fats.

Omegaflex especial is administered to adults, adolescents, and children over two years of age.

Omegaflex especial is given when there is an inability to take food normally. There are many situations in which this may occur, for example, during recovery phases following surgical procedures, trauma, or burns, or when there is an inability to absorb food in the stomach and intestine.

2. What you need to know before using Omegaflex especial

Do not use Omegaflex especial

? if you are allergic to any of the active substances, to egg, peanut, soy, or fish, or to any of the other components of this medicine (listed in section 6).

? this medicine must not be administered to newborns, infants, or children under two years of age.

Also, do not use Omegaflex especial if you have any of the following conditions:

? potentially life-threatening circulatory problems, such as those that may occur in cases of collapse or shock

? myocardial infarction or stroke

? severe coagulation disorders, risk of bleeding (severe coagulopathy, worsening haemorrhagic diathesis)

? blockage of blood vessels by blood clots or fat (embolism)

? severe hepatic insufficiency

? impaired bile flow (intrahepatic cholestasis)

? severe renal insufficiency when dialysis equipment is not available

? disturbances in the body's electrolyte composition

? fluid deficiency or excess water in your body

? fluid in your lungs (pulmonary edema)

? severe cardiac insufficiency

? certain metabolic disorders such as:

• excessive lipids (fats) in the blood
• congenital amino acid metabolism disorders
• abnormally high blood sugar levels requiring more than 6 units of insulin per hour to control
• metabolic disturbances that may occur after surgery or trauma
• coma of unknown origin
• inadequate oxygen supply to tissues
• abnormally high levels of acids in the blood

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting to use Omegaflex especial.

Inform your doctor if:

? you have heart, liver, or kidney problems

? you have certain types of metabolic disorders such as diabetes, abnormal blood lipid levels, or disturbances in the body's fluid, electrolyte, or acid-base balance.

You will be closely monitored for early signs of an allergic reaction (such as fever, chills, skin rash, or shortness of breath) when receiving this medicine.

Additional monitoring and tests, such as various blood tests, will be performed to ensure your body is properly assimilating the administered nutrients.

Healthcare professionals may also take measures to ensure your body's fluid and electrolyte needs are met. In addition to Omegaflex especial, you may receive supplementary nutrients (food) to fully meet your requirements.

Children

This medicine must not be administered to newborns, infants, or children under two years of age.

Use of Omegaflex especial with other medicines

Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might need to take any other medicines.

Omegaflex especial may interact with certain medicines. Inform your doctor, pharmacist, or nurse if you are taking or receiving any of the following:

? insulin

? heparin

? medicines that prevent unwanted blood clotting, such as warfarin or other coumarin derivatives

? medicines that promote urine flow (diuretics)

? medicines for treating high blood pressure or heart problems (ACE inhibitors and angiotensin II receptor antagonists)

? medicines used in organ transplantation, such as cyclosporine and tacrolimus

? medicines for treating inflammation (corticosteroids)

? hormonal preparations affecting your fluid balance (adrenocorticotropic hormone [ACTH])

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine. If you are pregnant, you will only receive this medicine if your doctor or pharmacist considers it absolutely necessary for your recovery. There are no available data on the use of Omegaflex especial in pregnant women.

Breastfeeding is not recommended in mothers receiving parenteral nutrition.

Driving and using machines

This medicine is usually administered to immobilized patients, e.g., in a hospital or clinic setting, which excludes the possibility of driving or operating machinery. However, the medicine itself has no effect on the ability to drive or use machines.

Omegaflex especial contains sodium

This medicine contains 1.244 mg of sodium (main component of table/cooking salt) per ml. This corresponds to 0.062% of the maximum daily sodium intake recommended for an adult.

The maximum recommended daily dose of this medicine contains 3048 mg of sodium (present in table salt). This corresponds to 152% of the maximum daily sodium intake recommended for an adult.

Consult your doctor or pharmacist if you need one or more bags per day over a prolonged period, especially if you have been advised to follow a low-salt (low-sodium) diet.

3. How to use Omegaflex special

This medicine is administered by intravenous infusion (drop by drop), that is, through a small tube into a vein. This medicine will only be given through one of your large (central) veins. The recommended duration for the infusion of one bag of parenteral nutrition is a maximum of 24 hours.

Your doctor or pharmacist will decide how much of this medicine you need and how long you will require treatment with it.

Use in children

This medicine must not be given to newborns, infants, and children under two years of age.

Your doctor will decide how much of this medicine your child needs and how long your child will require treatment with it.

If you use more Omegaflex special than you should

If you have received too much of this medicine, you may experience the so-called "overload syndrome" and the following symptoms:

• Excess fluid and electrolyte imbalances
• Fluid in your lungs (pulmonary edema)
• Loss of amino acids through urine and disturbances in amino acid balance
• Vomiting, nausea
• Tremor
• High blood sugar levels
• Glucose in urine
• Fluid deficiency
• Blood much more concentrated than normal (hyperosmolality)
• Impaired or loss of consciousness due to extremely high blood sugar levels
• Enlargement of the liver (hepatomegaly) with or without jaundice
• Enlargement of the spleen (splenomegalia)
• Fat deposition in internal organs
• Abnormal liver function test results
• Reduced red blood cell count (anemia)
• Reduced white blood cell count (leukopenia)
• Reduced platelet count (thrombocytopenia)
• Increased immature red blood cells (reticulocytosis)
• Breakdown of blood cells (hemolysis)
• Bleeding or tendency to bleed
• Blood coagulation disorders (as seen by changes in bleeding time, coagulation time, prothrombin time, etc.)
• Fever
• High levels of fats in the blood
• Loss of consciousness

If any of the following symptoms occur, the infusion must be stopped immediately.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

The following adverse effects may be serious. If you experience any of the following, inform your doctor immediately, who will stop administering this medicine to you:

Rare (may affect up to 1 in 1,000 people):

? allergic reactions such as skin reactions, dyspnea, swelling of the lips, mouth and throat, difficulty breathing

Other adverse effects include:

Uncommon (may affect up to 1 in 100 people):

? nausea, vomiting, loss of appetite

Rare (may affect up to 1 in 1,000 people):

? increased tendency for blood to coagulate

? bluish discoloration of the skin

? dyspnea

? headache

? flushing

? skin redness (erythema)

? sweating

? chills

? feeling of cold

? high body temperature

? somnolence

? chest, back, bone or lumbar pain

? decrease or increase in blood pressure

Very rare (may affect up to 1 in 10,000 people):

? abnormally high levels of sugar or fat in the blood

? elevated levels of acidic substances in your blood

? excess lipids may cause the lipid overload syndrome; for more information, see section 3, “If you use more Omegaflex than you should.” Symptoms usually disappear when the infusion is stopped.

Frequency not known (cannot be estimated from available data):

? decrease in white blood cell count (leukopenia)

? decrease in platelet count (thrombocytopenia)

? disturbances in bile flow (cholestasis)

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet.

You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products. Website: www.notificaRAM.es

5. Special storage instructions for Omegaflex

Keep this medicine out of the sight and reach of children.

Do not store above 25 °C.

Do not freeze. Discard the bag if it has been accidentally frozen.

Do not use this medicine after the expiry date stated on the label. The expiry date refers to the last day of the month indicated.

Store the bag in the outer packaging to protect it from light.

6. Contents of the pack and other information

Composition of Omegaflex especial

The active substances in the ready-to-use mixture are:

From the upper chamber (glucose solution)	in 1,000ml	in 625ml	in 1,250ml	in 1,875ml
Glucose monohydrate	158.4 g	99.00 g	198.0 g	297.0 g
equivalent to glucose	144.0 g	90.00 g	180.0 g	270.0 g
Sodium dihydrogen phosphate dihydrate	2.496 g	1.560 g	3.120 g	4.680 g
Zinc acetate dihydrate	7.024 mg	4.390 mg	8.780 mg	13.17 mg

Medium-chain triglycerides (fat emulsion)	in 1,000ml	in 625ml	in 1,250ml	in 1,875ml
Medium-chain triglycerides	20.00 g	12.50 g	25.00 g	37.50 g
Refined soybean oil	16.00 g	10.00 g	20.00 g	30.00 g
Omega-3 fatty acid triglycerides	4.000 g	2.500 g	5.000 g	7.500 g

From the lower chamber (amino acid solution)	in 1,000 ml	in 625 ml	in 1,250 ml	in 1,875 ml
Isoleucine	3.284 g	2.053 g	4.105 g	6.158 g
Leucine	4.384 g	2.740 g	5.480 g	8.220 g
Lysine hydrochloride	3.980 g	2.488 g	4.975 g	7.463 g
equivalent to lysine	3.186 g	1.991 g	3.982 g	5.973 g
Methionine	2.736 g	1.710 g	3.420 g	5.130 g
Phenylalanine	4.916 g	3.073 g	6.145 g	9.218 g
Threonine	2.540 g	1.588 g	3.175 g	4.763 g
Tryptophan	0.800 g	0.500 g	1.000 g	1.500 g
Valine	3.604 g	2.253 g	4.505 g	6.758 g
Arginine	3.780 g	2.363 g	4.725 g	7.088 g
Monohydrate histidine hydrochloride	2.368 g	1.480 g	2.960 g	4.440 g
equivalent to histidine	1.753 g	1.095 g	2.191 g	3.286 g
Alanine	6.792 g	4.245 g	8.490 g	12.73 g
Aspartic acid	2.100 g	1.313 g	2.625 g	3.938 g
Glutamic acid	4.908 g	3.068 g	6.135 g	9.203 g
Glycine	2.312 g	1.445 g	2.890 g	4.335 g
Proline	4.760 g	2.975 g	5.950 g	8.925 g
Serine	4.200 g	2.625 g	5.250 g	7.875 g
Sodium hydroxide	1.171 g	0.732 g	1.464 g	2.196 g
Sodium chloride	0.378 g	0.237 g	0.473 g	0.710 g
Sodium acetate trihydrate	0.250 g	0.157 g	0.313 g	0.470 g
Potassium acetate	3.689 g	2.306 g	4.611 g	6.917 g
Magnesium acetate tetrahydrate	0.910 g	0.569 g	1.137 g	1.706 g
Calcium chloride dihydrate	0.623 g	0.390 g	0.779 g	1.169 g

	in 1,000ml	in 625ml	in 1,250ml	in 1,875ml
Content of amino acids [g]	56.0	35.0	70.1	105.1
Content of nitrogen [g]	8	5	10	15
Content of carbohydrates [g]	144	90	180	270
Content of lipids [g]	40	25	50	75

Electrolytes [mmol]	in 1,000ml	in 625ml	in 1,250ml	in 1,875ml
Sodium	53.6	33.5	67	100.5
Potassium	37.6	23.5	47	70.5
Magnesium	4.2	2.65	5.3	7.95
Calcium	4.2	2.65	5.3	7.95
Zinc	0.03	0.02	0.04	0.06
Chloride	48	30	60	90
Acetate	48	30	60	90
Phosphate	16	10	20	30

	in 1.000ml	in 625ml	in 1.250ml	in 1.875ml
Energy as lipids [kJ (kcal)]	1.590 (380)	995 (240)	1.990 (475)	2.985 (715)
Energy as carbohydrates [kJ (kcal)]	2.415 (575)	1.510 (360)	3.015 (720)	4.520 (1.080)
Energy as amino acids [kJ (kcal)]	940 (225)	585 (140)	1.170 (280)	1.755 (420)
Non-protein energy [kJ (kcal)]	4.005 (955)	2.505 (600)	5.005 (1.195)	7.510 (1.795)
Total energy [kJ (kcal)]	4.945 (1.180)	3.090 (740)	6.175 (1.475)	9.260 (2.215)

Osmolality [mOsm/kg]	2.115
Theoretical osmolarity [mOsm/l]	1.545
pH	5.0 – 6.0

The other components are citric acid monohydrate (for pH adjustment), injectable egg phospholipids, glycerol, sodium oleate, all-rac-alpha-tocopherol, sodium hydroxide (for pH adjustment), and water for injections.

Appearance of the product and contents of the pack

The ready-to-use product is an emulsion for infusion, meaning it is administered through a small tube into a vein.

Omegaflex special is supplied in flexible multi-chamber bags containing:

? 625 ml (250 ml amino acid solution + 125 ml fat emulsion + 250 ml glucose solution)
? 1,250 ml (500 ml amino acid solution + 250 ml fat emulsion + 500 ml glucose solution)
? 1,875 ml (750 ml amino acid solution + 375 ml fat emulsion + 750 ml glucose solution)

Figure A Figure B

Figure A: The multi-chamber bag is enclosed in a protective overwrap. Inside the space between the bag and the overwrap are an oxygen absorber and an oxygen indicator; the oxygen absorber sachet is made of inert material and contains iron hydroxide.

Figure B: The upper chamber contains a glucose solution, the middle chamber contains a fat emulsion, and the lower chamber contains an amino acid solution.

The glucose and amino acid solutions are clear and colorless to pale yellow in appearance. The fat emulsion is milky white in color.

The upper and middle chambers can be connected to the lower chamber by opening the intermediate seals.

Different pack sizes are available in cartons containing five bags.

Pack sizes: 5 x 625 ml, 5 x 1,250 ml, and 5 x 1,875 ml

Only certain pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

• Braun Melsungen AG
  Carl-Braun-Straße 1 Postal address:
  34212 Melsungen, Germany 34209 Melsungen, Germany
  Phone: +49-5661-71-0
  Fax: +49-5661-71-4567

For further information regarding this medicinal product, please contact the local representative of the Marketing Authorization Holder:

• Braun Medical, S.A.
  Ctra. de Terrasa, 121
  08191 Rubí, Spain

This medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Austria NuTRIflex Omega special B.Braun
Belgium Nutriflex Omega special 56 g/l AA144g/lG, émulsion pour perfusion / emulsie voor infusie / Emulsion zur Infusion
Bulgaria Nutriflex Omega 56/144 emulsion for infusion
Croatia Nutriflex Omega 56/144 specijal emulzija za infuziju
Czech Republic Nutriflex Omega special 56/144
Denmark Nutriflex Omega Special
Estonia Nutriflex Omega 56/144 infusiooniemulsioon
Finland Nutriflex Omega 56/144/40
France LIPOFLEX OMEGA G144/N8/E, émulsion pour perfusion
Germany NuTRIflex Omega special novo
Greece Nutriflex Omega 56/144 special γαλάκτωμα για έγχυση
Ireland Omeflex special emulsion for infusion
Italy Omegaflex AA56/G144 emulsione per infusione
Latvia Nutriflex Omega 56/144 emulsija infūzijām
Lithuania Nutriflex Omega 56/144 infuzinė emulsija
Luxembourg NuTRIflex Omega special B.Braun
Netherlands Nutriflex Omega, 56 g/l + 144 g/l special, emulsie voor infusie
Norway Nutriflex Omega Special
Poland Omegaflex special
Portugal Omegaflex especial emulsão para perfusão
Romania Omegaflex special emulsie perfuzabilă
Slovakia Nutriflex Omega special 56/144
Slovenia Nutriflex Omega special 56/144 emulzija za infundiranje
Spain Omegaflex especial emulsión para perfusión
Sweden Nutriflex Omega 56/144/40
United Kingdom (Northern Ireland) Omegaflex special emulsion for infusion

Date of latest revision of this leaflet: 01/2024

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)

___________________________________________________________________

This information is intended for healthcare professionals only:

Parenteral nutrition products must be visually inspected before use for signs of damage, color changes, and emulsion instability. Do not use bags showing damage. The overwrap, main bag, and peelable seals between chambers must be intact. Use only if the amino acid and glucose solutions are clear and colorless to pale yellow, and if the lipid emulsion is homogeneous and milky white in appearance. Do not use if particles are present.

After mixing the three chambers, do not use if the emulsion shows color change or signs of phase separation (oil droplets, oil layer). Immediately stop the infusion if color change or phase separation occurs.

Before opening the overwrap, check the color of the oxygen indicator (see Figure A). Do not use if the oxygen indicator has turned pink. Use only if the oxygen indicator is yellow.

Preparation of the mixed emulsion

Strict adherence to aseptic handling principles must be observed.

To open: tear the overwrap starting at the notches (Fig. 1). Remove the bag from its protective overwrap. Discard the overwrap, oxygen indicator, and oxygen absorber.

Visually inspect the main bag for leaks. Discard any bags with leaks, as sterility cannot be guaranteed.

Mixing the chambers and addition of additives

To open and mix the chambers sequentially, roll the bag with both hands, first opening the peelable seal separating the upper chamber (glucose) from the lower chamber (amino acids) (Fig. 2).

Then continue applying pressure to open the peelable seal separating the middle chamber (lipids) from the lower chamber (Fig. 3).

Once all chambers have been mixed and after removing the aluminum seal (Fig. 3A), compatible additives may be added via the medication port (Fig. 4). Mix the bag contents thoroughly (Fig. 5) and visually inspect the mixture (Fig. 6). The mixture is a homogeneous oil-in-water emulsion with a milky white appearance. There must be no signs of phase separation.

Omegaflex special may be mixed with the following additives up to the specified maximum concentration limits or maximum additive amounts after supplementation. The resulting mixtures are stable for 7 days at +2 °C to +8 °C and for an additional 2 days at 25 °C.

• Electrolytes: consider electrolytes already present in the bag; stability has been demonstrated up to a total amount of 200 mmol/l of sodium + potassium (combined), 9.6 mmol/l of magnesium, and 6.4 mmol/l of calcium in the ternary mixture.

• Phosphate: stability has been demonstrated up to a maximum concentration of 20 mmol/l for inorganic phosphate or up to a maximum concentration of 30 mmol/l for organic phosphate (not both simultaneously).

• Alanyl-glutamine, up to 24 g/l.

• Trace elements and vitamins: stability has been demonstrated with commercial multi-trace element and multivitamin preparations (e.g., Tracutil, Cernevit) up to the standard dosage recommended by the micronutrient manufacturer.

The manufacturer can provide, upon request, detailed information on the above-mentioned additives and the corresponding shelf life of such mixtures.

Preparation for infusion

The emulsion must always be brought to room temperature before infusion.

Remove the aluminum film from the infusion port (Fig. 7) and connect the infusion set (Fig. 8). Use an infusion set without an air vent or close the air vent if using a vented set. Hang the bag on an infusion hook (Fig. 9) and administer according to standard infusion technique.

For single use only. The container and unused waste must be disposed of after use.

Disposal of unused medicine and all materials that have been in contact with it must be carried out in accordance with local regulations.

Do not reconnect partially used containers.

If filters are used, they must be lipid-permeable (pore size ≥ 1.2 µm).

Shelf life after removal of the protective overwrap and after mixing the bag contents

Chemical and physicochemical stability of the amino acid, glucose, and lipid mixture during use has been demonstrated for 7 days at 2–8 °C and for an additional 2 days at 25 °C.

Shelf life after additional mixing with compatible additives

From a microbiological standpoint, the product should be used immediately after mixing with additives. Otherwise, the storage times and conditions prior to use are the responsibility of the user.

After first opening (puncture of the infusion port)

The emulsion must be used immediately after opening the container.

Omegaflex special must not be mixed with other medicinal products whose compatibility has not been documented.

Omegaflex special must not be administered simultaneously with blood through the same infusion set due to the risk of pseudoagglutination.