Vitalipid N Adult

Package Leaflet: Information for the User

Vitalipid N Adult

Concentrate for solution for infusion

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

• Keep this package 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 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 package leaflet

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

1. What is Vitalipid N Adult and what is it used for

Vitalipid N Adult is a medicine containing fat-soluble vitamins, administered intravenously (e.g., with Intralipid 10% or Intralipid 20% medicine) when oral feeding is not possible. Vitamins are organic substances required in small amounts for the proper functioning of the body. Vitalipid N Adult is indicated for use as a component of clinical parenteral nutrition, together with proteins, fats, carbohydrates, salts, and other vitamins.

2. Important information before using Vitalipid N Adult

When not to use Vitalipid N Adult

Do not use the medicine:

• if you are allergic to egg protein, soy, peanuts, or any of the other ingredients of this medicine (listed in section 6).
• in its undiluted form. Vitalipid N Adult must be added to another medicine, e.g., Intralipid 10% or Intralipid 20%, before administration to the patient. The doctor or nurse is responsible for properly preparing the medicine for infusion.

Warnings and precautions

Tell your doctor about taking all medicines containing vitamin A. In patients using Vitalipid N Adult, the doctor may order regular blood tests to check the patient's health.

Vitalipid N Adult and other medicines

Tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and about any medicines you plan to use. Inform your doctor if you are taking medicines that prevent blood clotting (anticoagulants) or medicines containing vitamin A.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor for advice before using this medicine. The medicine contains vitamin A. High doses of vitamin A, especially during the first trimester of pregnancy, may cause birth defects. The doctor will decide whether to use Vitalipid N Adult in pregnant or breastfeeding women.

Driving and using machines

Not applicable.

The medicine contains soybean oil, egg phospholipids, and sodium

Soybean oil

Do not use if you are hypersensitive to peanuts or soy. Cross-allergic reactions between soy and peanuts have been observed.

Egg phospholipids

The medicine contains egg phospholipids, which can rarely cause allergic reactions.

Sodium

The medicine contains less than 1 mmol (23 mg) of sodium per 10 ml, i.e., the medicine is considered "sodium-free".

3. How to use Vitalipid N Adult

Vitalipid N Adult is administered by intravenous infusion (drip). The dosage for each patient is determined by the doctor.

Dosage

Adults and children from 11 years of age

The usual daily dose for adult patients and children from 11 years of age is 10 milliliters (10 ml).

Children up to 11 years of age

Do not use this medicine in children up to 11 years of age.

Using more than the recommended dose of Vitalipid N Adult

The doctor or nurse will monitor the patient's health during the infusion, so there is little chance of administering a higher dose than recommended. However, if you think you have received a higher dose of Vitalipid N Adult than recommended, tell your doctor or nurse immediately. Symptoms of overdose may include headaches, nausea, vomiting, and drowsiness. If you have any further questions about using this medicine, ask your doctor or nurse.

4. Possible side effects

No side effects have been reported with the use of Vitalipid N Adult.

Reporting side effects

If you experience any side effects, including any possible side effects not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Post-Marketing Surveillance 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 Vitalipid N Adult

Store the medicine out of sight and reach of children.

The doctor or nurse is responsible for ensuring proper storage, use, and disposal of Vitalipid N Adult. Store in a temperature below 25°C. Do not freeze. Store in the original package to protect from light. Do not use this medicine after the expiry date stated on the package. The expiry date refers to the last day of the month stated. Unused portions of the medicine are not suitable for further use. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Vitalipid N Adult contains

• The active substances of the medicine are:

1 ml contains: retinyl palmitate (corresponding to retinol) 194.1 μg (99 μg), phytomenadione 15 μg, ergocalciferol 0.5 μg, all-rac-α-tocopherol 0.91 mg, corresponding to: vitamin A 99 μg (330 IU), vitamin D 0.5 μg (20 IU), vitamin E 0.91 mg (1 IU), vitamin K 15 μg. 10 ml contains: retinyl palmitate (corresponding to retinol 990 μg) 1941 μg, phytomenadione 150 μg, ergocalciferol 5 μg, all-rac-α-tocopherol 9.1 mg (3300 IU), vitamin D 5 μg (200 IU), vitamin E 9.1 mg (10 IU), vitamin K 150 μg.

• The other ingredients (excipients) are: purified soybean oil, purified egg phospholipids, anhydrous glycerol, sodium hydroxide 1 M, and water for injection.

Osmolality: approximately 300 mOsm/kg water, pH: approximately 8.

What Vitalipid N Adult looks like and contents of the pack

Vitalipid N Adult is a sterile concentrate for solution for infusion of the oil-in-water type, containing fat-soluble vitamins in the oil phase. Each ampoule contains 10 ml of the concentrate for solution for infusion. Vitalipid N Adult is available in glass ampoules (type I glass), packaged in 10 pieces in a cardboard box.

Marketing authorization holder and manufacturer:

Fresenius Kabi AB, S-751 74 Uppsala, Sweden. For further 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 package leaflet:

corresponding to: 990 μg, vitamin A.

Information intended for healthcare professionals only:

Warnings and precautions for use

Vitalipid N Adult contains soybean oil and egg phospholipids, which can rarely cause allergic reactions. Cross-allergic reactions between soy and peanuts have been observed. Vitalipid N Adult must not be used in its undiluted form.

Dosage and administration

Dosage: The recommended dose to cover the daily requirement in adult patients and children from 11 years of age is 10 ml (1 ampoule). Administration: Instructions for diluting the medicine before administration, see section: Preparation of the medicine for use.

Overdose

Overdose of fat-soluble vitamins may cause toxicity symptoms, but there are no data on toxicity during the use of Vitalipid N Adult in the recommended doses. After a single overdose of fat-soluble vitamins, no side effects should occur. No specific treatment is necessary. After prolonged infusion of excessive doses of vitamin D, elevated levels of vitamin D metabolites in serum may occur, which can cause osteopenia. Infusion of vitamin K in a colloidal aqueous solution at a rate greater than recommended may cause flushing, bronchospasm, tachycardia, and hypotension. Such effects have not been reported after infusion of Vitalipid N Adult.

Preparation of the medicine for use

Pharmaceutical compatibility and instructions for preparation for use: During mixing with other medicines, aseptic rules must be followed. 10 ml (1 ampoule) of Vitalipid N Adult should be added to 500 ml of Intralipid 10% or Intralipid 20% medicine. To ensure homogeneity of the mixture, the container should be turned several times immediately before infusion. Vitalipid N Adult can be used to dissolve SOLUVIT N medicine. The contents of one vial of SOLUVIT N medicine should be dissolved by adding 10 ml of Vitalipid N Adult and added to Intralipid 10% or Intralipid 20% medicine. Vitalipid N Adult can also be used as a component of a total parenteral nutrition mixture in a plastic bag. Storage after mixing: The addition of Vitalipid N Adult to Intralipid 10% or Intralipid 20% medicine should be performed within 1 hour before the start of infusion, and the infusion should be completed within 24 hours of preparing the mixture to avoid microbial contamination. Unused contents of opened bottles/vials/ampoules should be destroyed; they should not be stored for further use. Data on stability and pharmaceutical compatibility with medicines used for parenteral nutrition are available on request from the representative of the marketing authorization holder.

Pharmaceutical incompatibilities

Do not mix the medicine with other medicines, except those mentioned in the section: Preparation of the medicine for use.

Storage conditions

Store in a temperature below 25°C. Do not freeze. Store in the original package to protect from light.

Disposal of unused medicine

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