Omegaflex Peri emulsion for infusion

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Omegaflex peri Emulsion for infusion

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet. 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. Do not pass it on to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, talk to your doctor, pharmacist or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of this leaflet

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

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

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

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

2. What you need to know before using Omegaflex peri

Do not use Omegaflex peri

• if you are allergic to any of the active substances, egg, peanut, soy, fish, or 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 peri if you have any of the following conditions:

• potentially life-threatening circulatory problems, such as those occurring in cases of collapse or shock

• myocardial infarction or stroke

• severe blood coagulation disorders, risk of bleeding (severe coagulopathy, aggravating hemorrhagic diatheses)

• 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 deficit or excess water in your body

• fluid in your lungs (pulmonary edema)

• severe heart failure

• 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 be controlled
• 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 treatment with Omegaflex peri.

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) while receiving this medicine.

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

Healthcare professionals will also take measures to ensure your body's fluid and electrolyte needs are met. In addition to Omegaflex peri, 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 peri 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 peri 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 used to treat inflammation (corticosteroids)

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

Pregnancy and breastfeeding

If you are pregnant, 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 peri in pregnant women.

Breastfeeding is not recommended in mothers receiving parenteral nutrition.

Driving and using machines

This medicine is typically 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 effects on the ability to drive or use machines.

Omegaflex peri contains sodium

This medicine contains 0.931 mg of sodium (main component of table/cooking salt) per ml. This corresponds to 0.047% of the maximum recommended daily sodium intake for an adult.

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

3. How to use Omegaflex peridel

This medicine is administered by intravenous infusion (drop by drop), i.e. through a small tube into a vein. This medicine may be given through one of your small (peripheral) veins or 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 for how long you should receive 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 for how long your child should receive treatment with this medicine.

If you use more Omegaflex peridel than you should

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

? fluid overload and electrolyte disturbances
? fluid in your lungs (pulmonary edema)
? loss of amino acids in urine and disturbances in amino acid balance
? vomiting, nausea
? chills
? high blood sugar levels
? glucose in urine
? fluid deficiency
? blood much more concentrated than normal (hyperosmolality)
? altered or loss of consciousness due to extremely high blood sugar levels
? enlargement of the liver (hepatomegaly) with or without jaundice
? enlargement of the spleen (splenomegaly)
? 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
? disturbances in blood coagulation (as seen by changes in bleeding time, coagulation time, prothrombin time, etc.)
? fever
? high levels of fat 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:

Common (may affect up to 1 in 10 people):

• irritation or inflammation of the veins (phlebitis, thrombophlebitis)

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 clot

• bluish discoloration of the skin

• dyspnea

• headache

• flushing

• redness of the skin (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 of lipids may cause overload syndrome; for further 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 adverse effect, talk to your doctor, pharmacist or nurse, including any possible adverse effects not listed in this leaflet.

You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines. Website: www.notificaRAM.es

5. Storage of Omegaflex peri

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.

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

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

6. Contents of the package and other information

Composition of Omegaflex peri

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

From the upper chamber (glucose solution)	in 1,000ml	in 1,250ml	in 1,875ml	in 2,500ml
Glucose monohydrate	70.40 g	88.00 g	132.0 g	176.0 g
equivalent to glucose	64.00 g	80.00 g	120.0 g	160.0 g
Sodium dihydrogen phosphate dihydrate	0.936 g	1.170 g	1.755 g	2.340 g
Zinc acetate dihydrate	5.280 mg	6.600 mg	9.900 mg	13.20 mg

Medium-chain triglycerides (fat emulsion)	in 1,000 ml	in 1,250 ml	in 1,875 ml	in 2,500 ml
Medium-chain triglycerides	20.00 g	25.00 g	37.50 g	50.00 g
Refined soybean oil	16.00 g	20.00 g	30.00 g	40.00 g
Omega-3 fatty acid triglycerides	4.000 g	5.000 g	7.500 g	10.00 g

From the lower chamber (amino acid solution)	in 1.000ml	in 1.250ml	in 1.875ml	in 2.500ml
Isoleucine	1.872 g	2.340 g	3.510 g	4.680 g
Leucine	2.504 g	3.130 g	4.695 g	6.260 g
Lysine hydrochloride	2.272 g	2.840 g	4.260 g	5.680 g
equivalent to lysine	1.818 g	2.273 g	3.410 g	4.546 g
Methionine	1.568 g	1.960 g	2.940 g	3.920 g
Phenylalanine	2.808 g	3.510 g	5.265 g	7.020 g
Threonine	1.456 g	1.820 g	2.730 g	3.640 g
Tryptophan	0.456 g	0.570 g	0.855 g	1.140 g
Valine	2.080 g	2.600 g	3.900 g	5.200 g
Arginine	2.160 g	2.700 g	4.050 g	5.400 g
Monohydrate histidine hydrochloride	1.352 g	1.690 g	2.535 g	3.380 g
equivalent to histidine	1.000 g	1.251 g	1.876 g	2.502 g
Alanine	3.880 g	4.850 g	7.275 g	9.700 g
Aspartic acid	1.200 g	1.500 g	2.250 g	3.000 g
Glutamic acid	2.800 g	3.500 g	5.250 g	7.000 g
Glycine	1.320 g	1.650 g	2.475 g	3.300 g
Proline	2.720 g	3.400 g	5.100 g	6.800 g
Serine	2.400 g	3.000 g	4.500 g	6.000 g
Sodium hydroxide	0.640 g	0.800 g	1.200 g	1.600 g
Sodium chloride	0.865 g	1.081 g	1.622 g	2.162 g
Sodium acetate trihydrate	0.435 g	0.544 g	0.816 g	1.088 g
Potassium acetate	2.354 g	2.943 g	4.415 g	5.886 g
Magnesium acetate tetrahydrate	0.515 g	0.644 g	0.966 g	1.288 g
Calcium chloride dihydrate	0.353 g	0.441 g	0.662 g	0.882 g

Electrolytes	in 1,000ml	in 1,250ml	in 1,875ml	in 2,500ml
Sodium	40 mmol	50 mmol	75 mmol	100 mmol
Potassium	24 mmol	30 mmol	45 mmol	60 mmol
Magnesium	2.4 mmol	3.0 mmol	4.5 mmol	6.0 mmol
Calcium	2.4 mmol	3.0 mmol	4.5 mmol	6.0 mmol
Zinc	0.024 mmol	0.03 mmol	0.045 mmol	0.06 mmol
Chloride	38 mmol	48 mmol	72 mmol	96 mmol
Acetate	32 mmol	40 mmol	60 mmol	80 mmol
Phosphate	6.0 mmol	7.5 mmol	11.25 mmol	15.0 mmol

Amino acid content	32 g	40 g	60 g	80 g
Nitrogen content	4.6 g	5.7 g	8.6 g	11.4 g
Carbohydrate content	64 g	80 g	120 g	160 g
Lipid content	40 g	50 g	75 g	100 g

Energy as lipids	1.590 kJ(380 kcal)	1.990 kJ(475 kcal)	2.985 kJ(715 kcal)	3.980 kJ(950 kcal)
Energy as carbohydrates	1.075 kJ(255 kcal)	1.340 kJ(320 kcal)	2.010 kJ(480 kcal)	2.680 kJ(640 kcal)
Energy as amino acids	535 kJ(130 kcal)	670 kJ(160 kcal)	1.005 kJ(240 kcal)	1.340 kJ(320 kcal)
Non-protein energy	2.665 kJ(635 kcal)	3.330 kJ(795 kcal)	4.995 kJ(1.195 kcal)	6.660 kJ(1590 kcal)
Total energy	3.200 kJ(765 kcal)	4.000 kJ(955 kcal)	6.000 kJ(1.435 kcal)	8.000 kJ(1.910 kcal)

Osmolality	950 mOsm/kg	950 mOsm/kg	950 mOsm/kg	950 mOsm/kg
Theoretical osmolarity	840 mOsm/l	840 mOsm/l	840 mOsm/l	840 mOsm/l
pH	5.0 – 6.0	5.0 – 6.0	5.0 – 6.0	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 inserted into a vein.

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

? 1,250 ml (500 ml amino acid solution + 250 ml lipid emulsion + 500 ml glucose solution)
? 1,875 ml (750 ml amino acid solution + 375 ml lipid emulsion + 750 ml glucose solution)
? 2,500 ml (1,000 ml amino acid solution + 500 ml lipid emulsion + 1,000 ml glucose solution)

Figure A Figure B

Figure A: The multi-chamber bag is enclosed in a protective overwrap. 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 lipid emulsion, and the lower chamber contains an amino acid solution.

The glucose and amino acid solutions are clear and colourless to pale yellow. The lipid emulsion is milky white in appearance.

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 1,250 ml, 5 x 1,875 ml and 5 x 2,500 ml

Only certain pack sizes may be marketed.

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

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

Austria NuTRIflex Omega peri B.Braun
Belgium Nutriflex Omega peri, 32 g/l AA + 64 g/l G, emulsie voor infusie
Bulgaria Nutriflex Omega peri emulsion for infusion
Croatia Nutriflex Omega peri emulzija za infuziju
Cyprus Nutriflex Omega peri
Czech Republic Nutriflex Omega peri
Denmark Nutriflex Omega Peri
Estonia Nutriflex Omega peri infusiooniemulsioon
Finland Nutriflex Omega 32/64/40 perifer
France LIPOFLEX OMEGA G64/N4,6/E, émulsion pour perfusion
Germany NuTRIflex Omega peri novo
Greece Nutriflex Omega peri
Ireland Omeflex peri emulsion for infusion
Italy Nutriplus Omega AA32/G64
Lithuania Nutriflex Omega peri infuzine emulsija
Luxembourg NuTRIflex Omega peri B.Braun
Latvia Nutriflex Omega peri emulsija infuzijam
Netherlands Nutriflex Omega peri 32 g/l + 64 g/l, emulsie voor infusie
Norway Nutriflex Omega Peri
Poland Nutriflex Omega peri
Portugal Nutriflex Omega peri emulsão para perfusão
Romania Nutriflex Omega peri emulsie perfuzabila
Slovakia Nutriflex Omega peri
Slovenia Nutriflex Omega peri 32/64 emulzija za infundiranje
Spain Omegaflex peri emulsión para perfusión
Sweden Nutriflex 32/64/40 perifer
United Kingdom (Northern Ireland) Omeflex peri emulsion for infusion

Date of most recent review 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 should be visually inspected before use for damage, discolouration, 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 colourless to pale yellow, and if the lipid emulsion is homogeneous and milky white. Do not use if solutions contain particles.

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

Before opening the overwrap, check the colour 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.

For opening: tear the overwrap starting at the tear 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. Bags with leaks must be discarded, as sterility cannot be assured.

Bag mixing 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 aluminium 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 should be a homogeneous oil-in-water emulsion with a milky white appearance. There must be no signs of phase separation.

Omegaflex peri may be mixed with the following additives up to the maximum concentration limits specified below or up to the 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 of 200 mmol/l of sodium + potassium (sum), 9.6 mmol/l magnesium, and 6.4 mmol/l calcium in the ternary mixture.

• Phosphate: stability has been demonstrated up to a maximum concentration of 20 mmol/l for inorganic phosphate.

• Alanyl-glutamine, up to 24 g/l.

• Trace elements and vitamins: stability has been demonstrated with commercial multi-trace elements and multivitamins (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 aluminium strip from the infusion port (Fig. 7) and connect the infusion set (Fig. 8). Use an infusion set without air vent or close the air vent if using a vented set. Hang the bag on an infusion stand (Fig. 9) and administer by 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 in accordance with local regulations.

Do not reconnect partially used containers.

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

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

Chemical and physicochemical stability during use of the amino acid, glucose and lipid mixture 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 additional mixing with additives. Otherwise, the in-use storage times and conditions prior to use are the responsibility of the user.

After first opening (perforation of the infusion port)

The emulsion must be used immediately after container opening.

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

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