This page is for general information. Consult a doctor for personal advice. Call emergency services if symptoms are severe.

How to use OMEGAFLEX PERI EMULSION FOR INFUSION

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 further questions, ask your doctor, pharmacist, or nurse.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

What Omegaflex peri is and what it is used for
What you need to know before you use Omegaflex peri
How to use Omegaflex peri
Possible side effects
Storage of Omegaflex peri
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 the growth or recovery of the body. It also contains 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 administered when there is an inability to ingest food normally. There are many situations where this can occur, such as during the recovery phases of surgical interventions, trauma, or burns, or when there is an inability to absorb food in the stomach and intestine.

2. What you need to know before you use Omegaflex peri

Do not use Omegaflex peri

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

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

Also, do not use Omegaflex peri if you have any of the following disorders:

? potentially life-threatening blood circulation problems, such as those that can occur in cases of collapse or shock

? myocardial infarction or stroke

? severe blood coagulation disorders, bleeding risk (severe coagulopathy, hemorrhagic diathesis)

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

? severe liver failure

? altered bile flow (intrahepatic cholestasis)

? severe kidney failure where dialysis equipment is not available

? alterations in the body's salt composition

? fluid deficit or excess water in your body

? water in your lungs (pulmonary edema)

? severe heart failure

? certain metabolic disorders, such as:

too much fat (lipids) in the blood
congenital disorders of amino acid metabolism
abnormally high blood sugar levels that require more than 6 units of insulin per hour to be controlled
metabolic disorders that can occur after surgical interventions or trauma
coma of unknown origin
insufficient oxygen supply to the tissues
abnormally high acid levels in the blood

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Omegaflex peri.

Tell your doctor if:

? you have heart, liver, or kidney problems

? you have certain types of metabolic disorders, such as diabetes, abnormal blood fat values, and disorders of body fluid and salt composition or acid-base balance.

You will be closely monitored to detect the first signs of an allergic reaction (such as fever, chills, skin rash, or shortness of breath) when you receive this medicine.

Additional monitoring and tests, such as various blood sample tests, will be applied to ensure that your body is adequately assimilating the administered food.

The healthcare staff will also take measures to ensure that your body's fluid and electrolyte needs are met. In addition to Omegaflex peri, you may receive additional nutrients (food) to fully meet your needs.

Children

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

Using Omegaflex peri with other medicines

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

Omegaflex peri may interact with some medicines. Tell your doctor, pharmacist, or nurse if you are taking or receiving any of the following medicines:

? 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 that affect your fluid balance (adrenocorticotropic hormone [ACTH])

Pregnancy and breastfeeding

If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine. If you are pregnant, you will receive this medicine only if your doctor or pharmacist considers it absolutely necessary for your recovery. There are no data available on the use of Omegaflex peri in pregnant women.

Breastfeeding is not recommended in mothers treated with parenteral nutrition.

Driving and using machines

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

Omegaflex peri contains sodium

This medicine contains 0.931 mg of sodium (a major component of table/cooking salt) in each ml. This is equivalent to 0.047% of the maximum recommended daily sodium intake for an adult.

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

3. How to use Omegaflex peri

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

Your doctor or pharmacist will decide what dose of this medicine you need and for how long.

Use in children

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

Your doctor will decide what dose of this medicine your child needs and for how long your child will require treatment with this medicine.

If you use more Omegaflex peri than you should

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

? excess fluid and electrolyte disturbances

? water in your lungs (pulmonary edema)

? loss of amino acids through the urine and disturbances in amino acid balance

? vomiting, nausea

? chills

? high blood sugar levels

? glucose in urine

? fluid deficit

? blood much more concentrated than normal (hyperosmolality)

? alteration or loss of consciousness due to extremely high blood sugar levels

? enlarged liver (hepatomegaly) with or without jaundice

? enlarged spleen (splenomegaly)

? fat deposits in internal organs

? abnormal liver function test values

? 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 of blood coagulation (as can be seen by changes in bleeding time, coagulation time, prothrombin time, etc.)

? fever

? high fat levels 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 on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects may be serious. If you experience any of the following side effects, tell 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, shortness of breath, swelling of the lips, mouth, and throat, difficulty breathing

Other side 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 of blood to clot

? bluish discoloration of the skin

? shortness of breath

? headache

? flushing

? redness of the skin (erythema)

? sweating

? chills

? feeling of cold

? high body temperature

? drowsiness

? pain in the chest, back, bones, or lumbar region

? decreased or increased blood pressure

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

? abnormally high sugar or fat levels in the blood

? high levels of acidic substances in your blood

? an excess of lipids can cause overload syndrome; for more information, see the heading "If you use more Omegaflex peri than you should" in section 3. The symptoms usually disappear when the infusion is stopped.

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

? reduced white blood cell count (leukopenia)

? reduced platelet count (thrombocytopenia)

? disturbances of bile flow (cholestasis)

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this leaflet.

You can also report side effects directly via the Spanish Pharmacovigilance System for Human Use 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 which is stated on the label. The expiry date is the last day of the month stated.

6. Container Content and Additional Information

Composition ofOmegaflex peri

The active principles of 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

*From the middle chamber(fat emulsion)***	in 1,000ml	in 1,250ml	in 1,875ml	in 2,500ml
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
Histidine hydrochloride monohydrate	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 from lipids	1,590 kJ (380 kcal)	1,990 kJ (475 kcal)	2,985 kJ (715 kcal)	3,980 kJ (950 kcal)
Energy from carbohydrates	1,075 kJ (255 kcal)	1,340 kJ (320 kcal)	2,010 kJ (480 kcal)	2,680 kJ (640 kcal)
Energy from 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 (1,590 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 osmolality	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 injectable preparations.

Appearance of the product and container content

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

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

? 1,250 ml (500 ml of amino acid solution + 250 ml of fat emulsion + 500 ml of glucose solution)

? 1,875 ml (750 ml of amino acid solution + 375 ml of fat emulsion + 750 ml of glucose solution)

? 2,500 ml (1,000 ml of amino acid solution + 500 ml of fat emulsion + 1,000 ml of glucose solution)

Infusion bag with components indicated: infusion port, oxygen indicator, oxygen absorber, and amino acid solution

Figure A Figure B

Figure A: The multi-chamber bag is inserted into a protective wrapper. Between the bag and the wrapper are an oxygen absorber and an oxygen indicator; the oxygen absorber package is made of an 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. The fat emulsion is white and milky.

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

The different container sizes are presented in boxes containing five bags.

Container sizes: 5 x 1,250 ml, 5 x 1,875 ml, and 5 x 2,500 ml

Only some container 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 Member States of the European Economic Area 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 the last revision of this leaflet: 01/2024

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

__________________________________________________________________________

This information is intended only for healthcare professionals:

Parenteral nutrition products should be visually inspected before use to detect damage, color changes, and emulsion instability.

Do not use damaged bags. The wrapper, main bag, and tear-off seams between the 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 has a white, milky color. Do not use if the solutions contain particles.

After mixing the three chambers, do not use if the emulsion shows a color change or signs of phase separation (oil droplets, oil layer). Stop the infusion immediately in case of a color change in the emulsion or signs of phase separation.

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

Preparation of the mixed emulsion

A strict adherence to aseptic handling principles must be observed.

For opening: open the wrapper starting from the tear-off notches (Fig. 1). Remove the bag from its protective wrapper. Discard the wrapper, oxygen indicator, and oxygen absorber.

Hands opening a blister pack of medication with a curved arrow indicating the direction of opening

Visually inspect the main bag for leaks. Bags with leaks must be discarded, as their sterility cannot be guaranteed.

Mixing the bag and adding additives

To open and mix the chambers sequentially, roll the bag with both hands, first opening the tear-off seam that separates the upper chamber (glucose) from the lower chamber (amino acids) (Fig. 2).

Hand with glove holding an inhaler device with mouthpiece and arrow indicating direction of inhalation

Then, continue to apply pressure so that the tear-off seam that separates the middle chamber (lipids) from the lower chamber opens (Fig. 3)

Hands holding a cold compress bag on the skin with an arrow indicating pressure and another hand applying a small cylindrical device

Once all chambers have been mixed and the aluminum seal has been removed (Fig. 3A), it is possible to add compatible additives through the medication port (Fig. 4). Mix the bag contents well (Fig. 5) and visually inspect the mixture (Fig. 6). The mixture is a homogeneous oil-in-water emulsion with a white, milky color. There should be no signs of phase separation.

Hand holding a syringe with a needle attached and ready for injection into the skin with a safety device activated Hand holding a transparent rectangular device with lines and an arrow indicating movement of opening Drainage bag connected to a catheter with curved lines indicating flow inside the transparent bag

Omegaflex peri can be mixed with the following additives up to the specified maximum concentration limits or up to the maximum amount of additives after supplementation. The resulting mixtures are stable for 7 days at 2-8°C and for 2 additional days at 25°C.

Electrolytes: the electrolytes already present in the bag should be taken into account; stability has been demonstrated up to a total of 200 mmol/l of sodium + potassium (sum), 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.

Alanine-glutamine, up to 24 g/l.

Oligoelements and vitamins: stability has been demonstrated with commercial multi-oligoelements and multivitamins (e.g., Tracutil, Cernevit) up to the standard recommended dosage by the manufacturer of the micronutrients.

The manufacturer may provide, upon request, detailed information on the aforementioned additives and the corresponding validity period of these mixtures.

Preparation for infusion

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

Remove the aluminum foil from the infusion port (Fig. 7) and connect the infusion equipment (Fig. 8). Use a non-ventilated infusion set or close the air vent if a ventilated set is used. Hang the bag from an infusion hook (Fig. 9) and perform the infusion according to standard technique.

Hands opening a medication package with notches, showing the contents and preparing it for use

For single use. The container and unused contents should be discarded after use.

The disposal of unused medicinal products and all materials that have come into contact with them should be carried out in accordance with local regulations.

Do not reconnect partially used containers.

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

Validity period after removal of the protective wrapper and after mixing the bag contents

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

Validity period after additional mixing of compatible additives

From a microbiological point of view, the product should be used immediately after the addition of additives. Otherwise, the storage times and conditions before use are the responsibility of the user.

After the first opening (perforation of the infusion port)

The emulsion should be used immediately after opening the container.

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

Omegaflex peri should not be administered simultaneously with blood in the same infusion equipment due to the risk of pseudoagglutination.

OMEGAFLEX PERI EMULSION FOR INFUSION