Smoflipid

Package leaflet: Information for the user

SMOFlipid, 200 mg/ml, emulsion for infusion
composite product
Please read all of this leaflet carefully before using this medicine, because it contains
important information for the patient.
­ Keep this leaflet, so that you can read it again if necessary.
­ If you have any further questions, please ask your doctor or nurse.
­ If you experience any side effects, including any not listed in this leaflet, tell your doctor or nurse. See section 4.
Contents of the leaflet

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

1. What SMOFlipid is and what it is used for

SMOFlipid contains four different types of fat (lipids): soybean oil, medium-chain triglycerides, olive oil, and fish oil rich in omega-3 fatty acids. The solution is a mixture of fats and water, known as a "fat emulsion".

• The medicine works by providing energy and fatty acids to the body.
• SMOFlipid is administered into the bloodstream via intravenous infusion or infusion pump. Healthcare professionals administer SMOFlipid to patients when other forms of nutrition are insufficient, impossible, or contraindicated.

2. Important information before using SMOFlipid

Do not use SMOFlipid if the patient has:

• Hypersensitivity to soybean oil, medium-chain triglycerides, olive oil, fish oil, or any of the other components of this medicine (listed in section 6);
• Hypersensitivity to products containing fish, eggs, soy, or peanuts;
• Excess fat in the blood (severe hyperlipidemia);
• Severe kidney or liver failure;
• Severe coagulation disorders (coagulation disorders);
• Acute shock;
• Fluid in the lungs (pulmonary edema), excess body water (hypervolemia), or heart failure (caused by excess body water);
• Unstable clinical condition, e.g. severe trauma, myocardial infarction, stroke, blood clot (embolism), metabolic acidosis (a metabolic disorder causing high levels of acid in the blood), uncontrolled diabetes, severe infection (systemic inflammatory response syndrome – sepsis), or dehydration.

Warnings and precautions
Before starting treatment with SMOFlipid, inform the doctor or nurse if the patient has excessively high levels of fat in the blood due to the body's inability to properly eliminate fat (impaired fat metabolism).
When administering to newborns and children under 2 years of age, the solution (in the bag and administration set) must be protected from light until the end of administration. Exposure of SMOFlipid to light, particularly after addition of trace elements and/or vitamins, may lead to the formation of peroxides and other degradation products, which can be minimized by protecting from light.

Allergic reactions
If an allergic reaction occurs during administration of SMOFlipid, treatment must be stopped immediately. Inform the doctor or nurse immediately if any of the following symptoms occur during infusion:

• Fever (high temperature);
• Chills;
• Rash;
• Difficulty breathing.

Children
Consult a doctor or nurse if SMOFlipid is administered to a newborn who has:

• Excessively high levels of a substance called "bilirubin" in the blood (hyperbilirubinemia);
• High blood pressure in the lungs (pulmonary hypertension).
  During prolonged administration of SMOFlipid to newborns, the doctor will order blood tests to monitor the patient's health status.

SMOFlipid with other medicines
Inform the doctor about all medicines currently used or recently used by the patient, as well as any medicines the patient plans to use.
In particular, inform the doctor if the patient is currently or recently using anticoagulant medicines such as warfarin and heparin.

• SMOFlipid contains vitamin K, which may affect warfarin. However, the amount of vitamin K in SMOFlipid is so small that such interactions are unlikely to occur.
• Heparin administered in clinical doses may transiently increase levels of free fatty acids in the blood due to release of fatty acids from tissues into circulation, followed by a reduction in fatty acid clearance (reduced triglyceride clearance).

Pregnancy and breastfeeding
There are no data on the use of SMOFlipid in pregnant or breastfeeding women. Therefore, SMOFlipid should be administered to pregnant or breastfeeding women only if the doctor considers it necessary.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.

Driving and operating machinery
Not applicable, as this medicine is administered in a hospital setting.

SMOFlipid contains sodium
This medicine contains 5 mmol (115 mg) of sodium per 1000 ml. This should be taken into account in patients who are on a sodium-restricted diet.

3. How to use SMOFlipid

SMOFlipid is administered into the bloodstream via an intravenous infusion or infusion pump.
The doctor determines the individual dose based on age, body weight, and the patient's ability to utilize the administered fat.
When used in newborns and children under 2 years of age, the solution (in the bag and administration set) must be protected from light until administration is completed (see section 2).
Detailed information on dosage and administration can be found at the end of the leaflet in the section entitled “Information intended exclusively for healthcare professionals”.
Use of a higher than recommended dose of SMOFlipid
If a patient receives a higher than recommended dose of SMOFlipid, there is a risk of excessive fat intake and problems with fat metabolism. This is known as the "fat overload syndrome". More information can be found in section 4. Possible side effects.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Fat overload syndrome
Fat overload syndrome occurs when the body has difficulty metabolizing fats due to receiving an excessive amount of SMOFlipid. It may also occur due to a sudden change in the patient's health status (e.g. kidney problems or infection). Possible symptoms include increased fat levels in the blood (hyperlipidemia) and in cells and tissues, fever, disturbances in the function of multiple organs, and coma. All these symptoms usually resolve after stopping the infusion.
Common adverse reactions (may occur in up to 1 in 10 patients):

• slight increase in body temperature.

Uncommon adverse reactions (may occur in up to 1 in 100 patients):

• chills;
• loss of appetite;
• nausea;
• vomiting.

Rare adverse reactions (may occur in up to 1 in 1,000 patients):

• allergic reactions (e.g. high temperature, swelling, low blood pressure, rash, redness, headache);
• feeling cold or hot;
• pallor;
• bluish discoloration of the skin and mucous membranes (caused by reduced oxygen content in the blood);
• pain in the neck, back, bones, chest, and lumbar region;
• increased or decreased blood pressure;
• shortness of breath.

Very rare adverse reactions (may occur in up to 1 in 10,000 patients):

• prolonged and painful penile erection.

Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department for Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Email: [email protected]
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store SMOFlipid

Keep out of the sight and reach of children.
Do not store above 25°C. Do not freeze.
Do not use the medicinal product after the expiry date stated on the container. The expiry date refers to the last day of the stated month.
Do not use SMOFlipid if the packaging is damaged. Use only if the emulsion is white and homogeneous. For single use only. Any unused portion should be discarded. Do not reuse.
When used in neonates and children under 2 years of age, the solution (in the bag and administration set) must be protected from light until the end of administration (see section 2).

6. Contents of the package and other information

What SMOFlipid contains

• The active substances are: soybean oil, purified 60 mg/ml, medium-chain triglycerides 60 mg/ml, olive oil, purified 50 mg/ml, fish oil, rich in omega-3 fatty acids 30 mg/ml.
• Other ingredients are: egg lecithin, glycerol, sodium oleate, all-rac-α-tocopherol, sodium hydroxide, water for injections.

What SMOFlipid looks like and contents of the pack
SMOFlipid is a white, homogeneous emulsion available in glass bottles or Biofine-type bags.
Pack sizes:

• glass bottle: 1 x 100 ml, 10 x 100 ml, 1 x 250 ml, 10 x 250 ml, 1 x 500 ml and 10 x 500 ml;
• Biofine-type bag: 1 x 100 ml, 10 x 100 ml, 20 x 100 ml, 1 x 250 ml, 10 x 250 ml, 1 x 500 ml, 12 x 500 ml, 1 x 1000 ml and 6 x 1000 ml.

Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Fresenius Kabi AB
SE-75174 Uppsala
Sweden
Manufacturer
Fresenius Kabi AB
Rapsgatan 7
SE-75174 Uppsala
Sweden
Fresenius Kabi Austria GmbH
Hafnerstrasse 36
A-8055 Graz
Austria
For further information, contact the Marketing Authorisation Holder's representative:
Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw
Tel: +48 22 345 67 89
This medicinal product is authorised for marketing in the Member States of the European
Economic Area under the following names:
Austria, Belgium, Finland, France, Germany, Iceland, Ireland, Italy, the Netherlands, Norway, Slovenia,
Sweden, United Kingdom: SMOFlipid 200 mg/ml
Cyprus, Czech Republic, Estonia, Greece, Hungary, Latvia, Lithuania, Luxembourg, Spain: SMOFlipid 20 %
Denmark, Poland, Portugal, Slovakia: SMOFlipid

Information intended exclusively for medical professionals:

Warnings and precautions
During infusion, serum triglyceride concentration should not exceed 3 mmol/l.
Overdose may lead to fat overload syndrome. Particular caution is required in patients at increased risk of hyperlipidemia (e.g. patients receiving high fat doses, patients with severe sepsis, and very low birth weight infants).
Administration of medium-chain fatty acids alone may cause metabolic acidosis. Concurrent administration of long-chain fatty acids present in SMOFlipid significantly reduces this risk. Concurrent administration of carbohydrates may further reduce this risk. Therefore, it is recommended to co-infuse carbohydrate solutions or amino acid solutions with carbohydrates. Regular laboratory monitoring related to parenteral nutrition is required, including blood glucose concentration, liver function tests, acid-base balance, fluid balance, complete blood count, and electrolyte concentrations.
This medicinal product contains soybean oil, fish oil, and egg phospholipids, which may rarely cause allergic reactions. Cross-allergic reactions between soy and peanuts have been observed.
If any objective or subjective symptoms of anaphylactic reaction occur (such as fever, chills, rash, or dyspnea), infusion must be stopped immediately.
SMOFlipid should be administered with caution in neonates and preterm infants with hyperbilirubinemia or pulmonary hypertension. In neonates, especially preterm infants receiving prolonged parenteral nutrition, platelet count, liver enzyme activity, and serum triglyceride concentration should be monitored regularly.
SMOFlipid contains up to 5 mmol of sodium per 1000 ml. This should be taken into account in patients on a sodium-restricted diet.
Other medicinal products or additional substances should not be added to SMOFlipid unless their compatibility has been established.

Route of administration
Intravenous infusion via central or peripheral vein.
When used in neonates and children under 2 years of age, the solution (in the bag and administration set) must be protected from light until the end of administration.

Instructions for use and handling
Special warnings and precautions for use
Use only if the emulsion is homogeneous.
Exposure of parenteral nutrition solutions to light, particularly after addition of trace elements and/or vitamins, may have undesirable clinical effects in neonates due to formation of peroxides and other degradation products. When used in neonates and children under 2 years of age, SMOFlipid must be protected from light until the end of administration.
For Biofine-type bags: before removing the outer protective bag, check the package integrity indicator (Oxalert). If the indicator is black, oxygen has penetrated through the outer bag and the product must be discarded.
Before administration, inspect the emulsion to ensure it is homogeneous. Ensure that the emulsion for infusion shows no signs of phase separation.
For single use only. Any unused portion must be discarded.

After mixing with additional substances
SMOFlipid may be mixed aseptically with amino acid solutions, glucose, and electrolytes to prepare an "all-in-one" total parenteral nutrition mixture.
Information on compatibility with additional substances and storage periods of prepared mixtures is available on request from the marketing authorization holder. All additional substances must be added under aseptic conditions. Any unused portions of the medicinal product or waste must be disposed of in accordance with local regulations.
Do not store above 25°C. Do not freeze.

Storage after mixing
If SMOFlipid is mixed with additional substances, from a microbiological standpoint, the resulting mixture should be used immediately. Otherwise, the user is responsible for in-use storage duration and storage conditions prior to use. This period should not generally exceed 24 hours at 2–8°C, unless mixing was performed under controlled and validated aseptic conditions.

Special precautions for disposal and preparation of the medicinal product for use
When used in neonates and children under 2 years of age, protect from light until the end of administration. Exposure of SMOFlipid to light, particularly after addition of trace elements and/or vitamins, leads to formation of peroxides and other degradation products, which can be minimized by providing light protection.

SMOFlipid – Instructions for preparing the Biofine bag for use

Check the package integrity indicator (Oxalert) A before removing the outer bag.
If the indicator is black, this indicates that the outer bag is damaged and the product must be discarded.

Remove the outer bag by tearing the seal at the top and pulling along the package.
Remove the package integrity indicator (Oxalert) A and the oxygen absorber B.

If adding additional substances, remove the single-use closure plug marked with an arrow, protecting the white port for adding substances.
If no additional substances are added, proceed to step 5.

Insert the needle horizontally through the center of the injection site and inject the additional substances (with established compatibility). Use syringes with needles of 18 to 23 G gauge and maximum length of 40 mm.

Use an infusion set without an air vent, or close the air inlet if using a set with a vent. Follow the instructions for use of the infusion set. Use an infusion set with an internal diameter as specified in ISO 8536-4: 5.6 ± 0.1 mm.

Remove the single-use closure plug protecting the blue infusion port.

Hold the base of the infusion port. Insert the spike of the infusion set into the infusion port and gently screw it in until fully inserted.

Hang the bag using the designated hole and start the infusion.