Vitalipid N Adult

Package Leaflet: Information for the User

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Vitalipid N Adult

Concentrate for solution for infusion

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

• Keep this leaflet, so you can read it again if you need to.
• In case of any doubts, consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of Contents of the 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%), when oral nutrition 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, along 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 the patient is 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 the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Inform your doctor if the patient is taking medicines that prevent blood clotting (anticoagulants) or medicines containing vitamin A.

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 using this medicine.
The medicine contains vitamin A. High doses of vitamin A, especially in 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 in case of known hypersensitivity to peanuts or soy.
Cross-allergic reactions have been observed between soy and peanuts.
Egg phospholipids
The medicine contains egg phospholipids, which may rarely cause allergic reactions.
Sodium
The medicine contains less than 1 mmol (23 mg) of sodium per 10 ml, which means the medicine is considered "sodium-free".

3. How to use Vitalipid N Adult

Vitalipid N Adult is administered as an 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 under 11 years of age

This medicine should not be used in children under 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 the patient thinks they have received a higher dose of Vitalipid N Adult than recommended, they should immediately inform their doctor or nurse. Symptoms of overdose may include headaches, nausea, vomiting, and drowsiness.
In case of any further doubts about using this medicine, consult a doctor or nurse.

4. Possible side effects

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

Reporting side effects

If any side effects occur, including any side effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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.
Reporting side effects will help gather more information on the safety of the 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.
Do not store above 25°C. Protect from light.
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.
Unused medicine should not be used. 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:
retinol palmitate
194.1 μg
(corresponding to retinol)
(99 μg)
phylloquinone
15 μg
ergocalciferol
0.5 μg
all-rac-α-tocopherol
0.91 mg
which corresponds 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:
retinol palmitate
1941 μg
(corresponding to retinol)
(990 μg)
phylloquinone
150 μg
ergocalciferol
5 μg
all-rac-α-tocopherol
9.1 mg
which corresponds to:
vitamin A
990 μg
(3300 IU)
vitamin D
5 μg
(200 IU)
vitamin E
9.1 mg
(10 IU)
vitamin K
150 μg

• Other ingredients (excipients) are: purified soybean oil, purified egg phospholipids, glycerol, sodium hydroxide 1M, 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 concentrate for solution for infusion.
Vitalipid N Adult is available in glass ampoules with a break point, packaged in cartons of 10.
For more detailed information, consult the marketing authorization holder or parallel importer.

Marketing authorization holder in Greece, the country of export:

Fresenius Kabi Hellas A.E.
Mesogeion 354, 153 41 Agia Paraskevi, Attica, Greece

Manufacturer:

Fresenius Kabi AB
Rapsgatan 7, S-751 74 Uppsala, Sweden

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11, 03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249, 04-458 Warsaw
Marketing authorization number in Greece, the country of export:38035/10/18-04-2011
77428/11/10-02-2014

Parallel import authorization number: 353/22 Date of approval of the leaflet: 26.09.2022

[Information on the trademark]

Information intended for healthcare professionals only:

Warnings and precautions for use

Vitalipid N Adult contains soybean oil and egg phospholipids, which may rarely cause allergic reactions. Cross-allergic reactions have been observed between soy and peanuts.
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 may 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 reactions 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%. 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.
The contents of one vial of SOLUVIT N should be dissolved by adding 10 ml of Vitalipid N Adult and added to Intralipid 10% or Intralipid 20%.
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% should be performed within 1 hour before the start of the 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 marketing authorization holder.

Pharmaceutical incompatibilities

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

Storage conditions

Do not store above 25°C. Protect from light.

Disposal of unused medicine

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