Omegaven

Package Leaflet: Information for the User

Omegaven

Fat emulsion for infusion

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• 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 symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please inform your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

• 1. What is Omegaven and what is it used for
• 2. Important information before using Omegaven
• 3. How to use Omegaven
• 4. Possible side effects
• 5. How to store Omegaven
• 6. Contents of the pack and other information

1. What is Omegaven and what is it used for

Omegaven is a fat emulsion for parenteral nutrition. The medicine contains highly purified fish oil, which provides the body with omega-3 fatty acids necessary for energy production and normal metabolic processes. The medicine is administered by intravenous infusion. Indications for use: Omegaven is indicated for use in parenteral nutrition as a source of long-chain omega-3 fatty acids (especially eicosapentaenoic acid and docosahexaenoic acid), when oral or enteral nutrition is impossible, insufficient, or contraindicated.

2. Important information before using Omegaven

When not to use Omegaven

Do not use the medicine:

• if you are allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6);
• if you have severe blood coagulation disorders;
• if you are allergic to fish protein or egg;
• if you are in shock or have a collapse (a set of symptoms caused by insufficient oxygenation of vital organs);
• if you have recently had a heart attack;
• if you have had a stroke;
• if you have an embolism (sudden blockage of an artery, e.g., by a blood clot);
• if you are in a coma of unknown origin;
• if you have severe liver or kidney failure;
• if you have hypokalemia (low potassium levels in the blood);
• if you have hyperhydration (excess water in the body);
• if you have hypotonic dehydration (lack of water and sodium in the body);
• if you have metabolic disorders (unstable metabolism);
• if you have acidosis (accumulation of excessive amounts of acidic substances or decreased concentration of alkaline substances in the blood);
• in premature infants, newborns, infants, and children.

Warnings and precautions

The medicine should be used with caution in patients with lipid metabolism disorders and uncontrolled diabetes (large fluctuations in blood sugar levels). During the administration of Omegaven, the doctor will order regular blood tests (daily measurement of triglyceride levels and systematic measurement of glucose and electrolyte levels), fluid balance control (amount of fluids taken in and excreted from the body), and acid-base balance control (proper ratio of acidic and alkaline compounds in the body). In patients taking anticoagulant medications (to prevent blood clot formation), the doctor will also order platelet count and bleeding time control.

Children

Omegaven should not be used in premature infants, newborns, infants, and children.

Omegaven and other medicines

Tell your doctor about all the medicines you are taking or have recently taken, as well as any medicines you plan to take. Omegaven may cause prolonged bleeding time and inhibition of platelet aggregation. Inform your doctor if you are taking anticoagulant medications.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor before using this medicine. The doctor will decide whether to use this medicine in women during pregnancy or breastfeeding.

Driving and using machines

Not applicable.

3. How to use Omegaven

This medicine is administered only by medical personnel. Do not use the medicine yourself. In case of doubts, consult your doctor. The dosage is determined by the doctor individually for each patient, depending on body weight and health status. Medical personnel may monitor the patient's health status during treatment. The treatment period should not exceed 4 weeks.

Using a higher dose of Omegaven than recommended

It is unlikely that a patient will receive too high a dose of Omegaven, as the medicine is administered by medical personnel. In case of overdose, there is a risk of excessive fat intake. This symptom is called "fat overload syndrome". For more information, see section 4. If you notice the above symptoms or think you have received a higher dose of Omegaven than recommended, inform your doctor or nurse immediately. In case of any further doubts about using this medicine, consult your doctor or nurse.

4. Possible side effects

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

Side effects observed during the use of Omegaven:

Rare side effects(less than 1 in 1000 patients, but more than 1 in 10,000 patients):

• prolonged bleeding time and inhibition of platelet aggregation;
• fishy taste in the mouth.

Side effects observed during the use of fat emulsions:

Uncommon side effects(less than 1 in 100 patients, but more than 1 in 1000 patients):

• abdominal pain;
• nausea;
• vomiting;
• fever;
• chills;
• shivering;
• fatigue;
• hypertriglyceridemia (elevated triglyceride levels in the blood);
• headache.

Very rare side effects(less than 1 in 10,000 patients):

• thrombocytopenia (decreased platelet count, manifesting as bruising, easy bruising, and bleeding);
• hemolysis (red blood cell breakdown);
• reticulocytosis (increased number of immature red blood cells);
• allergic reaction (hypersensitivity), which manifests as skin rash, swelling (especially of the lips, face, eyelids, tongue, and throat), difficulty breathing, or fainting. In this case, contact your doctor immediately.
• transient elevation of liver enzyme activity;
• priapism (prolonged, painful erection);
• skin rash;
• urticaria (hives, skin swelling with redness and itching);
• increased or decreased blood pressure.

During long-term treatment:

• thrombocytopenia has been observed in infants;
• transient elevation of liver enzyme activity has been observed with or without the use of Omegaven.

Metabolic overload

Metabolic overload occurs when the body has problems metabolizing fats due to genetic reasons (individual differences in metabolism) or due to past illnesses. The following symptoms may occur:

• enlargement of the liver with or without jaundice (yellowing of the skin and whites of the eyes);
• changes or decreases in certain blood coagulation parameters (e.g., bleeding time, coagulation time, prothrombin time, platelet count);
• enlargement of the spleen;
• decreased number of red and white blood cells and platelets (anemia, leukopenia, thrombocytopenia);
• bleeding or increased tendency to bleed;
• abnormal liver enzyme activity;
• fever;
• hyperlipidemia (significantly elevated fat levels in the blood);
• headache;
• stomach pain;
• fatigue;
• hyperglycemia (elevated glucose levels in the blood).

Fat overload syndrome

Fat overload syndrome occurs when the body has problems with fat metabolism due to excessive intake of Omegaven. It can also occur due to a sudden change in the patient's health status (e.g., kidney problems or infection). Possible symptoms include fever, elevated fat levels in the blood, cells, and tissues, disorders in the functioning of multiple organs, and coma. All these symptoms usually disappear after discontinuation of the infusion.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Omegaven

Store the medicine out of sight and reach of children. Store in a temperature below 25°C. Do not freeze. Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.

6. Contents of the pack and other information

What Omegaven contains

• The active substances of the medicine are: highly purified fish oil, glycerol, and purified egg phospholipids.

100 ml of the emulsion contains: highly purified fish oil containing: 10.0 g, eicosapentaenoic acid (EPA) 1.25-2.82 g, docosahexaenoic acid (DHA) 1.44-3.09 g, dl-α-tocopherol (as an antioxidant) 0.015-0.0296 g, glycerol 2.5 g, purified egg phospholipids 1.2 g.

• Other ingredients (excipients) are: sodium oleate, sodium hydroxide (for pH adjustment), water for injections.

Total energy: 470 kJ/100 ml = 112 kcal/100 ml, pH: 7.5 to 8.7, acidity of the solution: <1 mmol hcl l, osmolality: 308-376 mosm kg water.< p>

What Omegaven looks like and contents of the pack

The medicine is a white, homogeneous emulsion. The packaging of the medicine is a colorless glass type II bottle, closed with a bromobutyl rubber stopper and sealed with an aluminum cap. Pack sizes: 50 ml in 1 bottle, 100 ml in 1 bottle. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Fresenius Kabi Deutschland GmbH, D-61346 Bad Homburg v.d.H., Germany.

Manufacturer

Fresenius Kabi Austria GmbH, Hafnerstrasse 36, A-8055 Graz, Austria. For more information, contact the representative of the marketing authorization holder: Fresenius Kabi Polska Sp. z o.o., Al. Jerozolimskie 134, 02-305 Warsaw, tel.: +48 22 345 67 89. Date of last revision of the leaflet:04.11.2024.

Information intended for healthcare professionals only:

Special warnings and precautions for use

Omegaven should be administered with caution to patients with lipid metabolism disorders and uncontrolled diabetes. It is necessary to monitor triglyceride levels in the blood serum daily. It is also necessary to regularly monitor glucose levels in the blood, acid-base balance, electrolyte levels in the blood serum, fluid balance, and blood cell count and bleeding time in patients who have been treated with anticoagulant medications. During the infusion of the fat emulsion, the triglyceride level in the blood serum should not exceed 3 mmol/l.

Dosage and administration

Dosage: Daily dose: 1 ml to a maximum of 2 ml of Omegaven/kg body weight. = 0.1 g to a maximum of 0.2 g of fish oil/kg body weight. = 70 ml to a maximum of 140 ml of Omegaven for a patient with a body weight of 70 kg. Maximum infusion rate: The infusion rate should not exceed 0.5 ml of Omegaven/kg body weight/hour, which corresponds to 0.05 g of fish oil/kg body weight/hour. It is necessary to strictly follow the recommendation for the maximum infusion rate, as non-compliance may cause a significant increase in triglyceride levels in the blood serum. Omegaven should be administered simultaneously with other fat emulsions. According to the recommendations for the intake of total daily fat dose of 1-2 g/kg body weight, the fish oil present in Omegaven should account for 10-20% of this dose. Administration: For intravenous infusion. The container should be shaken before use. If Omegaven is administered together with other infusion solutions (e.g., amino acid solutions, carbohydrate solutions) through a common infusion line (bypass, Y-connection), it is necessary to ensure the compatibility of the used solutions and/or emulsions. Duration of administration: The duration of administration should not exceed 4 weeks.

Overdose

Overdose leading to fat overload syndrome may occur when the triglyceride level during the infusion of the fat emulsion increases above 3 mmol/l. This can occur both as a result of administration at a higher rate than recommended and during the use of recommended infusion rates in connection with a sudden change in the patient's clinical condition, e.g., due to kidney dysfunction or infection. Overdose may lead to the occurrence of side effects (see section 4.8 of the Summary of Product Characteristics). In such cases, the infusion of the fat emulsion should be discontinued or, if necessary, continued at a reduced dose. Fat administration should also be discontinued if a significant increase in glucose levels in the blood occurs during the infusion of Omegaven. Acute overdose caused by the administration of Omegaven without simultaneous infusion of a carbohydrate solution may lead to the development of metabolic acidosis.

Preparation of the medicine for use

Before use, the container should be shaken. Use only if the emulsion is white and homogeneous, and the packaging is undamaged. It is recommended to use equipment that does not contain phthalate compounds. Unused contents of bottles, as well as any remaining mixture after infusion, should be destroyed. Omegaven can be mixed with fat emulsions, as well as with fat-soluble vitamins, under aseptic conditions. If Omegaven is administered simultaneously with other fat emulsions or diluted before administration with other fat emulsions, the fish oil present in Omegaven should account for 10-20% of the total daily fat intake. Data on the compatibility of Omegaven with other medicines are available on request from the representative of the marketing authorization holder.

Incompatibilities

Incompatibilities may occur after the addition of polyvalent cations, e.g., calcium, especially in combination with heparin.

Interactions with other medicines

Infusion of Omegaven may cause prolonged bleeding time and inhibition of platelet aggregation. Therefore, Omegaven should be used with caution in patients requiring anticoagulant treatment, even if the dose of anticoagulant medications is reduced.

Storage conditions

Store in a temperature below 25°C. Do not freeze. After dilution or mixing: The chemical and physical stability of mixtures containing Omegaven has been demonstrated for 24 hours at 25°C; data are available on request from the representative of the marketing authorization holder. From a microbiological point of view, mixtures containing fat emulsion or fat emulsions containing fat-soluble vitamins should be used immediately. If not used immediately, the responsibility for the storage conditions and storage time after mixing lies with the person administering the medicine. Storage conditions can be determined based on stability data from the manufacturer only if the mixing is performed under controlled and validated aseptic conditions. From a microbiological point of view, the mixture prepared in uncontrolled and non-validated conditions should be used within 24 hours, taking into account the infusion time (further information - see section 6.6 of the Summary of Product Characteristics).

Disposal of unused medicine

Any unused medicine or waste material should be disposed of in accordance with local regulations.