Vitalipid n adult

Patient Information Leaflet

Keep this leaflet! The 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 you.

• Keep this leaflet, as you may need to read it again.
• 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. This medicine may harm others, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your 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 normal body function.
Vitalipid N Adult is indicated as a component of 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 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 their 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 use.
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 might be pregnant, or is planning to have a child, she should consult a 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 administer Vitalipid N Adult to women who are pregnant or breastfeeding.

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, meaning it is considered "sodium-free".

3. How to use Vitalipid N Adult

Vitalipid N Adult is administered as an intravenous infusion (intravenous drip).
The dosage is determined individually 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, thus the likelihood of administering a higher than recommended dose is low. 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 in doubt about any further aspects concerning the use of this medicinal product, consult a physician 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 reactions occur, including any adverse reactions 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 helps to provide more information on the safety of the medicine.

5. How to store Vitalipid N Adult

Keep this medicine out of sight and reach of children.
Your doctor or nurse is responsible for ensuring the proper storage, handling, and disposal of Vitalipid N Adult.
Store below 25°C. Do not freeze. Keep the ampoules in the original packaging to 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 later.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the package 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) are: purified soybean oil, purified egg yolk phospholipids, glycerol, sodium hydroxide 1M, 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 ampoules made of colourless glass (type I), with a break point, packed in cardboard boxes of 10 units.
For further information, please contact the Marketing Authorisation Holder or the Parallel Importer.
Marketing Authorisation Holder in Romania, country of export:
Fresenius Kabi AB
Rapsgatan 7, SE-751 74 Uppsala
Sweden
Manufacturer:
Fresenius Kabi AB
Rapsgatan 7, SE-751 74 Uppsala
Sweden
Parallel Importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Poland
Repackaged at:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland
Marketing Authorisation Number in Romania, country of export: 8308/2015/01
Parallel Import Licence Number: 59/21

Information intended exclusively for medical professionals:

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

Dosage and administration
Dosage
The recommended dose meeting daily requirements in adult patients and children aged 11 years and older is 10 ml (1 ampoule).

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 regarding 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 rates 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 rotated several times immediately before infusion.
Vitalipid N Adult may 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 then added to Intralipid 10% or Intralipid 20%.
Vitalipid N Adult may also be used as a component of a total parenteral nutrition mixture in a plastic bag.

Storage after mixing
Addition of Vitalipid N Adult to Intralipid 10% or Intralipid 20% should be performed within one hour before starting the infusion, and the infusion should be completed within 24 hours after preparation to avoid microbiological contamination. Unused contents of opened bottles/vials/ampoules must be discarded; they should not be stored 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 mentioned in the section: Preparation of the medicinal product for administration.

Storage conditions
Store below 25°C. Do not freeze. Keep ampoules in their original packaging to protect from light.

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