Vitalipid n adult

Package leaflet: Information for the user

Warning! Keep this leaflet. Information on the immediate packaging in a foreign language.
Vitalipid N Adult (Vitalipide Adultes)
concentrate for preparation of emulsion for infusion
Vitalipid N Adult and Vitalipide Adultes are different trade names for the same medicine.
Please read all of this leaflet carefully before using this medicine, because it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of the leaflet

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 parenteral nutrition, together with proteins, fats, carbohydrates, electrolytes 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, the active substances, or 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 your doctor about the use of all medications containing vitamin A.
Patients receiving Vitalipid N Adult may be required by their doctor to undergo regular blood tests to monitor their health status.

Vitalipid N Adult and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently using or has recently used, as well as any medicines they plan to use.
Inform your doctor 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 her doctor 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 decision to use Vitalipid N Adult in pregnant or breastfeeding women will be made by the doctor.

Driving and operating machinery
Not applicable.

This medicine contains soybean oil, egg yolk 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 yolk phospholipids
This medicine contains egg yolk 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 by intravenous infusion (intravenous drip).
The dosage is determined individually for each patient 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
Vitalipid N Adult 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, so 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 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 reactions occur, including any adverse reactions not listed
in this leaflet, inform a doctor, pharmacist, or nurse. Adverse reactions
can also 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

The medicine should be stored out of sight and reach of children.
Your doctor or nurse is responsible for ensuring appropriate storage, use, and disposal of Vitalipid N Adult.
Keep away from light and do not store above 25°C.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Any unused portion of the medicine must not be used later.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will 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) are: purified soybean oil, purified egg phospholipids, glycerol, sodium hydroxide 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 oil-in-water emulsion for infusion, containing fat-soluble vitamins in the oil phase.
Each ampoule contains 10 ml of concentrate for preparing infusion emulsion.
Vitalipid N Adult is available in glass ampoules, packed 10 units per cardboard box.
For further information, please contact the marketing authorisation holder or the parallel importer.
Marketing Authorisation Holder in France, country of export:
Fresenius Kabi France SA
5, Place du Marivel
92316 Sèvres Cedex, France
Manufacturer:
Fresenius Kabi AB
Rapsgatan 7
751 74 Uppsala, Sweden
Parallel Importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź, Poland
Repackaged by:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź, Poland
Marketing Authorisation Number in France, country of export: 34009 365 849 6 9
Parallel Import Authorisation Number: 737/15

Information intended exclusively for professional medical personnel:

Warnings and precautions for use
Vitalipid N Adult contains soybean oil and egg yolk 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 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 use.

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 use
Pharmaceutical compatibility and preparation instructions
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 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 contained in a plastic bag.

Storage after mixing
The addition of Vitalipid N Adult to Intralipid 10% or Intralipid 20% should be performed within one hour prior to starting the infusion. The infusion should be completed within 24 hours after preparation to avoid microbiological contamination. Any unused contents 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 the medicinal product with other medicinal products except those mentioned in the section: Preparation of the medicinal product for use.

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

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