Vitalipid n adult

Patient Information Leaflet

Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
Vitalipid N Adult
concentrate for preparation of emulsion for infusion
Please read this leaflet carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform the doctor, pharmacist, or nurse. See section 4.

Table of contents

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

Vitalipid N Adult is a medicine containing fat-soluble vitamins, administered intravenously (e.g. together 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 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 this medicine:

• if the patient is allergic to egg protein, soy, peanuts, to the active substances, or to any of the other ingredients of this medicine (listed in section 6);
• in its undiluted form. Vitalipid N Adult must be added to another solution, such as Intralipid 10% or Intralipid 20%, before administration to the patient. The physician or nurse is responsible for the proper preparation of the infusion.

Warnings and precautions
Inform the physician about the use of all medications containing vitamin A.
The physician may order regular blood tests for patients receiving Vitalipid N Adult to monitor health status.

Vitalipid N Adult and other medicines
Inform the physician 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 the physician if the patient is taking anticoagulant drugs (blood thinners) or medications containing vitamin A.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her physician before using this medicine.
This medicine contains vitamin A. High doses of vitamin A, especially during the first trimester of pregnancy, may cause congenital malformations. The physician will decide whether to use Vitalipid N Adult in pregnant or breastfeeding women.

Driving and operating machinery
Not applicable.

Vitalipid N Adult contains soybean oil, egg phospholipids, and sodium

Soybean oil
Do not use if hypersensitivity to peanuts or soy has been diagnosed.
Cross-reactive allergic reactions between soy and peanuts have been observed.

Egg phospholipids
This medicine contains egg phospholipids, which may rarely cause allergic reactions.

Sodium
This medicine contains less than 1 mmol (23 mg) of sodium per 10 ml; therefore, it is considered "sodium-free".

3. How to use Vitalipid N Adult

Vitalipid N Adult is administered by intravenous infusion (intravenous drip).
The dosage for each patient is determined by the physician.
Dosage
Adults and children aged 11 years and older
The usual daily dose for adult patients and children aged 11 years and older is 10 millilitres (10 ml).
Children under 11 years of age
This medicinal product must not be used in children under 11 years of age.
Administration of a higher than recommended dose of Vitalipid N Adult
The physician or nurse will monitor the patient's health condition during the infusion; therefore, the likelihood of receiving a dose higher than recommended is small. However, if the patient believes they have received a higher than recommended dose of Vitalipid N Adult, they should immediately inform the physician or nurse. Symptoms of overdose may include headache, nausea, vomiting, and drowsiness.
If you have any further questions about the use of this medicine, consult your doctor or nurse.

4. Possible adverse reactions

No adverse reactions related to the use of Vitalipid N Adult have been reported.
Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed
in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions
can be reported directly to the Department of Monitoring Adverse Drug Reactions 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 adverse reactions enables continued monitoring of the safety of the medicinal product.

5. How to store Vitalipid N Adult

Keep this medicine out of the sight and reach of children.
The doctor or nurse is responsible for ensuring appropriate storage, handling, 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 container. The expiry date refers to the last day of the specified month.
Any unused portion of the medicine must not be used.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required.
These measures help protect the environment.

6. Contents of the pack and other information

What Vitalipid N Adult contains

• The active substances are:

1 ml contains:
retinyl palmitate 194.1 μg
(corresponds 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 D 0.5 μg (20 IU)
vitamin E 0.91 mg (1 IU)
vitamin K 15 μg

10 ml contains:
retinyl palmitate 1941 μg
(corresponds 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 D 5 μg (200 IU)
vitamin E 9.1 mg (10 IU)
vitamin K 150 μg

• Other components (excipients): purified soybean oil, purified egg yolk phospholipids, glycerol, sodium hydroxide 1 M, and water for injections.

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 preparing an oil-in-water emulsion for infusion, containing fat-soluble vitamins in the oil phase.
Each ampoule contains 10 ml of concentrate for preparing an emulsion for infusion.
Vitalipid N Adult is available in glass ampoules with a break point, packed 10 units per cardboard box.
For further information, please contact the marketing authorization holder or parallel importer.
Marketing Authorization Holder in Greece, 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 in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249, 04-458 Warsaw
Marketing Authorization Number in Greece, country of export: 38035/10/18-04-2011
77428/11/10-02-2014
Parallel Import Authorization Number: 353/22

Information intended exclusively for healthcare professionals:

Warnings and precautions for use
Vitalipid N Adult contains soybean oil and egg yolk phospholipids, which rarely may cause
allergic reactions. Cross-reactivity between soy and peanuts has been observed.
Vitalipid N Adult must not be used in undiluted form.

Dosage and method of administration
Dosage
The recommended dose meeting daily requirements for adult patients and children aged 11 years and older is 10 mL (1 ampoule).

Method of administration
For instructions on dilution prior to administration, see section:
Preparation of the medicinal product for administration.

Overdose
Overdose of fat-soluble vitamins may cause symptoms of toxicity; however, there are no data on toxicity associated with the use of Vitalipid N Adult at recommended doses.
After a single overdose of fat-soluble vitamins, adverse effects are not expected. Specific treatment is not required.
Prolonged infusion of excessive doses of vitamin D may lead to elevated serum concentrations of vitamin D metabolites, which may result in osteopenia.
Infusion of vitamin K in a colloidal aqueous solution at a rate exceeding the recommended rate may cause flushing, bronchospasm, tachycardia, and hypotension. Such effects have not been reported with the infusion of Vitalipid N Adult.

Preparation of the medicinal product for administration
Pharmaceutical compatibility and instructions for preparation
Aseptic techniques must be observed when mixing with other medicinal products.
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 inverted 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, then added to Intralipid 10% or Intralipid 20%.
Vitalipid N Adult may also be used as a component of a total parenteral nutrition mixture contained in a plastic bag.

Storage after mixing
Addition of Vitalipid N Adult to Intralipid 10% or Intralipid 20% should be performed within one hour prior to starting the infusion, and the infusion should be completed within 24 hours after preparation to avoid microbiological contamination. Any unused portion of opened bottles/vials/ampoules must be discarded; do not store for later use.
Data on stability and pharmaceutical compatibility with parenteral nutrition products are available upon request from the marketing authorization holder.

Pharmaceutical incompatibilities
Do not mix Vitalipid N Adult with other medicinal products except those listed in the section: Preparation of the medicinal product for administration.

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

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