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 (Vitalipid Adult)

Concentrate for solution for infusion
VITALIPID N ADULT and Vitalipid Adult are different trade names for the same medicinal product.

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

• Keep this leaflet, so that you can read it again if you need to.
• In case of any doubts, consult a doctor, pharmacist, or nurse.
• This medicinal product has been prescribed to you specifically. Do not pass it on to others. The medicinal product 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 medicinal product 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, 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 medicinal product:

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

Warnings and precautions

Tell your doctor about taking all medicinal products 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 medicinal products

Tell your doctor or pharmacist about all medicinal products the patient is taking or has recently taken, as well as any medicinal products the patient plans to use.
Inform your doctor if the patient is taking anticoagulant medicinal products or medicinal products 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 medicinal product.
The medicinal product 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 medicinal product contains soybean oil, egg phospholipids, and sodium

Soybean oil

Do not use in case of known hypersensitivity to peanuts or soy. Cross-allergic reactions between soy and peanuts have been observed.

Egg phospholipids

The medicinal product contains egg phospholipids, which may rarely cause allergic reactions.

Sodium

The medicinal product contains less than 1 mmol (23 mg) of sodium per 10 ml, which means the medicinal product 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 medicinal product in children up to 11 years of age.

Using a higher dose of Vitalipid N Adult than recommended

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 headache, nausea, vomiting, and drowsiness.
In case of any further doubts about using this medicinal product, 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 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
Reporting side effects will help gather more information on the safety of the medicinal product.

5. How to store Vitalipid N Adult

Store the medicinal product 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 at a temperature below 25°C. Protect from light.
Do not use this medicinal product after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.
Unused contents of the medicinal product should not be used. Medicinal products should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicinal products that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Vitalipid N Adult contains

• The active substances of the medicinal product are: 1 ml contains: retinol palmitate 194.1 μg (corresponding to retinol) (99 μg) phytomenadione 15 μg ergocalciferol 0.5 μg all-rac-α-tocopherol 0.91 mg

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

• The other ingredients (excipients) are: purified soybean oil, purified egg phospholipids, 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, packaged in cartons of 10.
For more detailed information, consult the representative of the marketing authorization holder or the parallel importer.

Marketing authorization holder in Greece, the country of export:

Fresenius Kabi Hellas A.E.
Mesoghion Avenue 354
153 41 Agia Paraskevi
Athens, Greece

Manufacturer:

Fresenius Kabi AB
Rapsgatan 7
S-751 74 Uppsala
Sweden

Parallel importer:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Marketing authorization number in Greece, the country of export: 38035/10/18-04-2011
77428/11/10-02-2014

Parallel import authorization number: 6/13 Date of approval of the leaflet: 22.12.2022

[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 between soy and peanuts have been observed.
Vitalipid N Adult must not be used in an undiluted form.

Dosage and administration

Dosage
The recommended daily dose to meet the daily needs of adult patients and children from 11 years of age is 10 ml (1 ampoule).
Administration
Instructions for dilution of the medicinal product before administration, see section: Preparation of the medicinal product 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 are expected to 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 medicinal product for use

Pharmaceutical compatibility and instructions for preparation of the medicinal product for use
During mixing with other medicinal products, 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 adding it to Intralipid 10% or Intralipid 20%.
Vitalipid N Adult can also be used as a component of a mixture for total parenteral nutrition in a plastic bag.
Storage after mixing
Adding Vitalipid N Adult to Intralipid 10% or Intralipid 20% should be done within 1 hour before the start of infusion, and the infusion should be completed within 24 hours of preparation of 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 medicinal products used for parenteral nutrition are available on request from the representative of the marketing authorization holder.

Pharmaceutical incompatibilities

Do not mix the medicinal product with other medicinal products, except those listed in the section: Preparation of the medicinal product for use.

Storage conditions

Store at a temperature below 25°C. Protect from light.

Disposal of unused medicinal product

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