Olimel N7e

Patient Information Leaflet: User Information

OLIMEL N7E, infusion emulsion

Read the leaflet carefully before administering 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 or nurse.
• If the patient experiences any side effects, including any not listed in this leaflet, they should inform their doctor or nurse. See section 4.

Table of Contents of the Leaflet

• 1. What OLIMEL N7E infusion emulsion is and what it is used for
• 2. Important information before administering OLIMEL N7E infusion emulsion
• 3. How to use OLIMEL N7E infusion emulsion
• 4. Possible side effects
• 5. How to store OLIMEL N7E infusion emulsion
• 6. Contents of the pack and other information

1. What OLIMEL N7E infusion emulsion is and what it is used for

OLIMEL is an infusion emulsion. The preparation is supplied in a triple-chamber bag.
In the first chamber, there is a glucose solution with calcium, in the second - a fat emulsion, and in the
third - an amino acid solution with other electrolytes.
OLIMEL is used for intravenous nutrition through a tube in adults and children over 2 years of age, when oral nutrition is not appropriate.
OLIMEL can only be used under medical supervision.

2. Important information before administering OLIMEL N7E infusion emulsion

When not to use OLIMEL N7E infusion emulsion:

• in preterm infants, newborns, and children under 2 years of age;
• if the patient is allergic to eggs, soy, peanut proteins, corn/corn products (see also "Warnings and precautions" below) or any of the other ingredients of this medicine (listed in section 6);
• if the use of certain amino acids causes an abnormal reaction in the patient's body;
• if the patient has a particularly high level of fats in the blood;
• if the patient has hyperglycemia (too high blood sugar levels);
• if the patient's blood has an abnormally high content of any of the electrolytes (sodium, potassium, magnesium, calcium, and/or phosphorus).

In each case, the doctor will decide whether to administer the medicine based on factors such as age, body weight, and the patient's health status, including the results of any tests performed.

Warnings and precautions

Before starting OLIMEL N7E administration, discuss it with your doctor or nurse.
Too rapid administration of total parenteral nutrition solutions may result in injury or death of the patient.
If unusual signs or symptoms of an allergic reaction occur (such as sweating, fever, chills, headache, skin rash, or breathing difficulties), the infusion should be stopped immediately. The medicine contains soybean oil and egg phospholipids. Soy and egg proteins may cause hypersensitivity reactions. Cross-allergic reactions have been observed between soy and peanut proteins.
OLIMEL contains glucose derived from corn, which may cause hypersensitivity reactions if the patient is allergic to corn or corn products (see "When not to use OLIMEL N7E infusion emulsion" above).
Breathing difficulties may also be a sign that small particles have formed, blocking blood vessels in the lungs (pulmonary embolism). If any breathing difficulties occur, the doctor or nurse should be informed. They will decide on the appropriate course of action.
The antibiotic ceftriaxone should not be mixed or administered simultaneously with any calcium-containing solutions (including OLIMEL) via intravenous infusion. These medicines should not be administered simultaneously, even through different infusion lines or sites.
However, OLIMEL and ceftriaxone can be administered sequentially, one after the other, if the infusion lines are inserted at different sites or are changed or thoroughly flushed with physiological saline solution between infusions to avoid precipitate formation.
Certain medicines and diseases may increase the risk of infection or sepsis (presence of bacteria in the blood). There is a particular risk of infection or sepsis after inserting a tube (central venous catheter) into the patient's vein. The doctor will closely monitor the patient to detect any signs of infection. Patients requiring parenteral nutrition (administration of nutrients through a tube inserted into a vein) are, due to their clinical condition, more susceptible to developing infections. Maintaining aseptic conditions during catheter placement, handling, and preparation of the nutrition product (total parenteral nutrition) can reduce the risk of infection.
If the patient is severely malnourished and needs to receive food through a vein, the doctor should start treatment slowly. At the same time, the doctor should closely monitor the patient to prevent sudden changes in fluid volume, vitamin, electrolyte, and mineral levels.
Before starting the infusion, any water and electrolyte imbalances and metabolic disorders in the patient should be corrected. The doctor will monitor the patient during therapy and may adjust the dosage or prescribe additional nutritional supplements such as vitamins, electrolytes, and trace elements if necessary.
In patients receiving intravenous nutrition therapy, liver function disorders have been reported, including difficulties in removing bile (cholestasis), fat accumulation (fatty liver), fibrosis, possibly leading to liver failure, as well as gallbladder inflammation and gallstones. The causes of these disorders are thought to be different in different patients. If the patient experiences symptoms such as nausea, vomiting, abdominal pain, yellowing of the skin or eyes, they should consult their doctor to identify possible causes and therapeutic measures.
The doctor should be informed about:

• severe kidney diseases. The doctor should also be informed if the patient is undergoing dialysis (artificial kidney) or other blood purification methods;
• severe liver diseases;
• blood coagulation disorders;
• adrenal gland disorders (adrenal insufficiency). The adrenal glands are triangular-shaped glands located on top of the kidneys;
• heart failure;
• lung disease;
• fluid accumulation in the body (overhydration);
• insufficient fluid in the body (dehydration);
• untreated high blood sugar levels (diabetes);
• heart attack or shock caused by sudden heart failure;
• severe metabolic acidosis (too acidic blood);
• sepsis (blood infection);
• coma.

To check the effectiveness and safety of the medicine, the patient will undergo clinical and laboratory tests ordered by the doctor during treatment. If the medicine is administered for several weeks, the patient's blood will be regularly tested.
A reduced ability of the body to remove lipids contained in the administered preparation may result in a so-called fat overload syndrome (see section 4 - "Possible side effects").
If pain, burning, or swelling occurs at the infusion site or if the infused fluid leaks during infusion, the doctor or nurse should be informed.
The administration of the preparation will be stopped immediately and then resumed in a different vein.
If blood sugar levels increase excessively, the doctor should adjust the rate of administration of OLIMEL or administer a medicine to regulate blood sugar levels (insulin).
OLIMEL can be administered through a tube (catheter) inserted into a large vein in the patient's chest (central vein).

Children and adolescents

When used in children under 18 years of age, particular caution should be exercised to administer the correct dose of the preparation. Due to the increased susceptibility of children to the risk of infection, increased precautions should also be taken. Vitamin and trace element supplementation is always required. For children, pediatric compositions and quantities must be used.

OLIMEL and other medicines

The doctor should be informed about all medicines currently being taken or used by the patient, as well as any medicines planned to be taken or used.
Concomitant use of other medicines is usually not contraindicated. However, the doctor should be informed about all medicines taken recently, including those available without a prescription, to check their compatibility.
The doctor should be informed about the use or administration of:

• insulin,
• heparin.

OLIMEL should not be administered simultaneously with blood through the same infusion set.
OLIMEL contains calcium. It should not be administered together with the antibiotic ceftriaxone or through the same tube, as particles may form. If these medicines are administered sequentially using the same device, it should be thoroughly flushed.
Due to the risk of precipitate formation, OLIMEL should not be administered through the same infusion line or added to ampicillin (an antibiotic) or phenytoin (an antiepileptic medicine).
The olive and soybean oil present in OLIMEL contain vitamin K. This usually has no effect on the action of blood-thinning medicines (anticoagulants) such as warfarin. However, if the patient is taking anticoagulant medicines, they should inform their doctor.
The fats in the emulsion may interfere with the results of certain laboratory tests if the blood sample for testing is taken before the fats are removed from the patient's bloodstream (they are removed from the blood after 5 to 6 hours after fat administration).
OLIMEL contains potassium. Particular caution should be exercised in patients taking diuretic medicines, ACE inhibitors, angiotensin II receptor antagonists (medicines used in hypertension), or immunosuppressive medicines. These types of medicines may cause an increase in potassium levels in the blood.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before administering this medicine.
There is limited experience with the use of OLIMEL N7E in pregnant or breastfeeding women. If necessary, OLIMEL N7E may be considered during pregnancy and breastfeeding. OLIMEL N7E should be administered to pregnant or breastfeeding women only after careful consideration.

Driving and using machines

Not applicable.

3. How to use OLIMEL N7E infusion emulsion

Dosage

OLIMEL should only be used in adults and children over 2 years of age.
The medicine is an infusion emulsion administered through a tube (catheter) into a large vein in the patient's chest.
Before use, OLIMEL should be at room temperature.
OLIMEL is for single use only.
Infusion of one bag usually lasts from 12 to 24 hours.

Dosage - adults

The rate of administration, according to the patient's needs and clinical condition, will be determined by the doctor.
The medicine can be used for as long as necessary, depending on the patient's clinical condition.

Dosage - children over 2 years of age and adolescents

The dose of the medicine and the duration of administration are determined by the doctor, depending on the patient's age, body weight, height, health status, and ability to metabolize the components of OLIMEL N7E.

Administration of a higher dose of OLIMEL N7E infusion emulsion than recommended

If the patient is administered too high a dose of the medicine or too rapid an infusion, the contained amino acids may contribute to an increase in blood acidity and the occurrence of symptoms of hypervolemia (increased blood volume). Blood sugar levels and urine sugar levels may increase, and hyperosmolar syndrome (excessive blood viscosity) may occur, and the fats in the emulsion may increase triglyceride levels in the blood. Administration of an excessively rapid infusion or too large a volume of OLIMEL may cause nausea, vomiting, chills, headache, heat strokes, excessive sweating (hyperhidrosis), and electrolyte disturbances. In such a situation, the infusion should be stopped immediately.
In some severe cases, to support the patient's kidneys in eliminating the excess medicine, the doctor may be forced to subject the patient to temporary kidney dialysis.
To prevent such situations, the doctor regularly monitors the patient's condition and checks blood parameters.
In case of doubts related to the use of the medicine, the doctor should be consulted.

4. Possible side effects

Like all medicines, OLIMEL can cause side effects, although not everybody gets them.
If any changes in well-being are observed during treatment or after its completion, the doctor or nurse should be informed immediately.
Tests performed by the doctor during the patient's treatment with the medicine should minimize the risk of side effects.
If any unusual signs or symptoms of an allergic reaction occur, such as excessive sweating, fever, chills, headache, skin rash, or breathing difficulties, the infusion should be stopped immediately.
The following side effects have been reported during the use of OLIMEL:

• increased heart rate (tachycardia);
• decreased appetite;
• increased blood fat levels (hypertriglyceridemia);
• abdominal pain;
• diarrhea;
• nausea;
• increased blood pressure (hypertension).

The following side effects have also been reported:

• allergic reactions, including sweating, fever, chills, headache, skin rash (erythematous, papular, pustular, maculopapular, generalized rash), itching, heat strokes, and breathing difficulties;
• leakage of the infusion into the surrounding tissue (infiltration) may lead to pain, irritation, swelling/edema, redness (erythema)/warmth, necrosis of skin cells (necrosis) or blisters/bullae, inflammation, thickening, or contraction of the skin at the infusion site;
• vomiting.

The following side effects have been reported with the use of similar parenteral nutrition products:

• fat overload syndrome associated with a sudden deterioration in the patient's condition. The symptoms of fat overload syndrome usually resolve after stopping the fat emulsion infusion. These include:

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Administration

For single use only.
Administer the product only after breaking the welds separating the 3 chambers and mixing their contents.
Ensure that the ready-to-use infusion emulsion does not exhibit phase separation.
After opening the bag, the contents must be used immediately. Do not store
the opened bag for the next infusion. Do not reconnect partially used bags.
To avoid the possibility of air embolism caused by the presence of gas
contained in the first bag, do not connect bags in series.
Any unused product or waste and the entire infusion set should be
destroyed.
Extravasation
The site of catheter placement should be regularly monitored for signs of extravasation.
In the event of extravasation, administration of the preparation should be immediately discontinued, leaving the inserted catheter or cannula in place to immediately initiate therapeutic measures. If
possible, before removing the inserted catheter/cannula, aspiration of fluid through the
catheter/cannula should be performed to reduce the amount of fluid in the tissues.
Depending on the type of extravasated product (including product(s) mixed with OLIMEL product, if applicable) and the degree/extensity of potential injury, appropriate specific measures should be taken. Treatment options may include non-pharmacological, pharmacological, and (or) surgical intervention. In the event of large extravasation, consultation with a plastic surgeon should be sought within 72 hours.
The extravasation site should be monitored at least every four hours during the first
24 hours, and then once a day.
Infusion should not be resumed in the same central vein.
Baxter and Olimel are trademarks of Baxter International Inc.