Vitalipid n adult

Package leaflet: Information for the user

Warning! Keep this leaflet. Information on the immediate packaging is in a foreign language.
VITALIPID N ADULT (Vitalipid Adultos)
concentrate for preparing infusion emulsion
VITALIPID N ADULT and Vitalipid Adultos are different trade names for the same medicinal product.
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 further 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 other people, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any adverse reactions 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 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, the active substances, 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 solution, e.g. 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 all medications containing vitamin A that you are taking.
Your doctor may order regular blood tests for patients receiving Vitalipid N Adult to monitor their health status.

Vitalipid N Adult with 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 anticoagulant medicines (blood thinners) or medicines containing vitamin A.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she might be pregnant, or is planning to have a baby, 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 doctor 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-allergic reactions between peanuts and soy 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 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 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 doubts regarding the use of this medicinal product, consult your 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 symptoms 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 the sight and reach of children.
Your doctor or nurse is responsible for ensuring appropriate storage, use, and disposal of Vitalipid N Adult.
Store below 25°C. Do not freeze.
Store 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.
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 packaging 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 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 (Type I glass), packed 10 ampoules per cardboard box.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing Authorisation Holder in Spain, the country of export:
FRESENIUS KABI ESPAÑA S.A.U.
C/ Marina 16-18
08005-Barcelona
Spain
Manufacturer:
Fresenius Kabi AB
Uppsala
Sweden
Parallel Importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Spanish Marketing Authorisation Number (country of export): 680405.6
Parallel Import Licence Number: 213/16

Information intended exclusively for healthcare professionals:

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 method of administration
Dosage
The recommended dose meeting daily requirements in 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 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 increased serum concentrations of vitamin D metabolites, potentially resulting 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 following infusion of Vitalipid N Adult.

Preparation of the medicinal product for use
Pharmaceutical compatibility and instructions for preparation
When mixing with other medicinal products, aseptic techniques must be observed.
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 gently rotated several times immediately before infusion.
Vitalipid N Adult may also 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
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 of the mixture 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 other 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 use.

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

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