Package leaflet: Information for the user

WARNING! Keep this leaflet. The information on the immediate packaging is in a foreign language.
VITALIPID N INFANT (Vitalipid Infantil)
concentrate for solution for infusion
VITALIPID N INFANT and Vitalipid Infantil are different trade names for the same medicine.
Please read this leaflet carefully before using the 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 of the leaflet

What Vitalipid N Infant is and what it is used for
Important information before using Vitalipid N Infant
How to use Vitalipid N Infant
Possible side effects
How to store Vitalipid N Infant
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 the proper functioning of the body. Vitalipid N Infant is indicated as a component of parenteral nutrition, together with proteins, fats, carbohydrates, electrolytes, and other vitamins.

2. Important 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, to the active substances or to any of the other ingredients of this medicine (listed in section 6),
in undiluted form. Vitalipid N Infant must be added to another solution, e.g. 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 if the child is taking any other medicines containing vitamin A.
The doctor may order regular blood tests for patients receiving Vitalipid N Infant to monitor their 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 medicines that prevent blood clotting (anticoagulants) or medicines containing vitamin A.

The medicine contains soy oil, egg phospholipids and sodium

Soy 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
The 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 drip).
The dose for each patient is determined 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 adults
Use of Vitalipid N Adult is recommended.
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 administering a higher than recommended dose is small. 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 there are any further doubts regarding the use of this medicinal product, consult the 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 the 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 enables continuous monitoring of the benefit-risk balance of the medicinal product and helps to improve its safety.

5. How to store Vitalipid N Infant

Keep this medicine out of the sight and reach of children.
The doctor or nurse is responsible for ensuring appropriate storage, use and disposal of Vitalipid N Infant.
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 medicinal product or waste material must not be used subsequently.
Medicines must not be disposed of via the sewage system 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 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
which corresponds to:
vitamin A 69 µg (230 IU)
vitamin K 20 µg
vitamin D 1.0 µg (40 IU)
vitamin E 0.64 mg (0.7 IU)

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
which corresponds to:
vitamin A 690 µg (2300 IU)
vitamin K 200 µg
vitamin D 10 µg (400 IU)
vitamin E 6.4 mg (7 IU)

Other components (excipients) are: purified soybean oil, purified egg phospholipids, glycerol, sodium hydroxide 1 M, 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 an oil-in-water emulsion for infusion, containing fat-soluble vitamins in the oil phase.
Each vial contains 10 ml of concentrate for preparing an emulsion for infusion.
Vitalipid N Infant is available in glass vials (Type I glass), packed in cardboard boxes of 10 vials.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing Authorisation Holder in Spain, country of export:
FRESENIUS KABI ESPAÑA S.A.U.
C/ Marina 16-18
08005-Barcelona
Spain
Manufacturer:
Fresenius Kabi AB
Rapsgatan 7
SE-751 74 Uppsala
Sweden
Parallel Importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Poland
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Poland
Spanish marketing authorisation number, country of export: 680397.4
Parallel import authorisation number: 219/16

Information intended exclusively for healthcare professionals:

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

Dosage and administration
Dosage
The recommended dose to meet 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 to meet requirements in newborns and children up to 11 years of age and with body weight above 2.5 kg is 10 ml/day.

Administration
For instructions on dilution of the medicinal product 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 Infant at recommended doses.
Following 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 Infant.

Preparation of the medicinal product for use
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
The 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 portion of opened vials/ampoules/bottles 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 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.