Vitalipid n infant

Package leaflet: Information for the user

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

• Keep this leaflet, so that you may read it again if necessary.
• 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. This medicine may harm others, even if their symptoms are identical.
• If any adverse reactions occur in the patient, 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 Infant is and what it is used for
2. Important information before using Vitalipid N Infant
3. How to use Vitalipid N Infant
4. Possible side effects
5. How to store Vitalipid N Infant
6. Contents of the pack and other information

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

Vitalipid N Infant is a medicine containing fat-soluble vitamins, administered intravenously to infants and children when oral feeding is not possible. Vitamins are organic substances required in small amounts for normal body function. Vitalipid N Infant is indicated for use as a component of parenteral nutrition, together with proteins, fats, carbohydrates, salts, and other vitamins.

2. Information before using Vitalipid N Infant

When not to use Vitalipid N Infant
Do not use the 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 Infant must be added to another solution, such as Intralipid 10% or Intralipid 20%, prior to administration to the patient. The physician or nurse is responsible for the proper preparation of the infusion.

Warnings and precautions
Inform the doctor about all medications containing
vitamin A currently being administered to the child.
In patients receiving Vitalipid N Infant, the doctor may order regular blood tests to monitor health status.

Vitalipid N Infant and other medicines
Tell the doctor or pharmacist about all medicines the child is currently taking, has recently taken, or might take in the future.
Inform the doctor if the patient is taking medications that prevent blood clotting (anticoagulants) or medicines containing vitamin A.

Vitalipid N Infant 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 soy and peanuts have been observed.

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

Sodium
The medicine contains less than 1 mmol (23 mg) of sodium per 10 ml, meaning the medicine is considered "sodium-free".

3. How to use Vitalipid N Infant

Vitalipid N Infant is administered by intravenous infusion (intravenous infusion).
The dose is determined individually for each patient by the physician.
Dosage
Premature infants and newborns with low birth weight (up to 2.5 kg)
The usual daily dose of Vitalipid N Infant is 4 ml per kilogram of body weight.
Newborns and children up to 11 years of age and with body weight above 2.5 kg
The usual daily dose of Vitalipid N Infant is 10 ml.
Children aged 11 years and older, and adults
Vitalipid N Adult is recommended for use.
Administration of a higher than recommended dose of Vitalipid N Infant
The physician or nurse will monitor the patient's health condition during the infusion, so the
likelihood of receiving a higher than recommended dose is low. However, if the patient believes they
have received a higher than recommended dose of Vitalipid N Infant, 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 Infant 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 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 obtain more information on the safety of the medicinal product.

5. How to store Vitalipid N Infant

Keep this medicine out of sight and reach of children.
The doctor or nurse is responsible for ensuring appropriate storage, use, and disposal of Vitalipid N Infant.
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 stated 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.
This will help protect the environment.

6. Contents of the pack and other information

What Vitalipid N Infant contains

• The active substances are:

1 ml contains:
retinyl palmitate 135.3 μg
(corresponds to retinol) (69 μg)
phytomenadione 20 μg
ergocalciferol 1.0 μg
all-rac-α-tocopherol 0.64 mg
corresponding to:
vitamin A 69 μg (230 IU)
vitamin D 1.0 μg (40 IU)
vitamin E 0.64 mg (0.7 IU)
vitamin K 20 μg

10 ml contains:
retinyl palmitate 1353 μg
(corresponds to retinol) (690 μg)
phytomenadione 200 μg
ergocalciferol 10 μg
all-rac-α-tocopherol 6.4 mg
corresponding to:
vitamin A 690 μg (2300 IU)
vitamin D 10 μg (400 IU)
vitamin E 6.4 mg (7 IU)
vitamin K 200 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 Infant looks like and contents of the pack
Vitalipid N Infant 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 Infant is available in glass ampoules, packed 10 ampoules in a cardboard box.
For further information, please contact the Marketing Authorisation Holder or the Parallel Importer.
Marketing Authorisation 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 Authorisation number in Greece, country of export: 38030/10/18-04-2011
77429/11/10-02-2014
Parallel Import Licence number: 354/22

Information intended exclusively for healthcare professionals:

Warnings and precautions for use
Vitalipid N Infant 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 Infant must not be administered in undiluted form.

Dosage and method of administration
Dosage
The recommended dose meeting requirements in premature infants and newborns with low birth
weight (up to 2.5 kg) is 4 ml/kg body weight/day.
The recommended dose meeting requirements in newborns and children up to 11 years of age and
with body weight above 2.5 kg is 10 ml/day.

Method of administration
For instructions on dilution of the medicinal product 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 Infant at recommended doses.
Following a single overdose of fat-soluble vitamins, adverse effects should not occur. Specific
treatment is not required.
Prolonged infusion of excessive doses of vitamin D may lead to increased 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 Infant.

Preparation of the medicinal product for administration
Pharmaceutical compatibility and instructions for preparation
Aseptic techniques must be observed when mixing with other medicinal products.
No more than 10 ml (1 ampoule) of Vitalipid N Infant should be added to Intralipid 10% or
Intralipid 20%. To ensure homogeneity of the mixture, the container should be inverted several
times immediately before infusion.
Vitalipid N Infant may be dissolved in SOLUVIT N and administered to children with body weight
above 10 kg.
The mixture obtained by dissolving SOLUVIT N in Vitalipid N Infant is not recommended for use in
children with body weight below 10 kg due to differences in dosing.

Storage after mixing
Addition of Vitalipid N Infant 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 of the mixture to avoid microbiological contamination. Any 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 the medicinal product with other medicinal products except those mentioned 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 of the medicinal product or waste materials must be disposed of in
accordance with local regulations.