Vitalipid N Infant

Leaflet attached to the packaging: information for the user

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Vitalipid N Infant

Concentrate for preparation of infusion emulsion

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor, pharmacist or nurse.
• This medicine has been prescribed to a specific person. Do not pass it on to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Vitalipid N Infant and what is it 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 packaging and other information

1. What is Vitalipid N Infant and what is it 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 for use as a component of clinical parenteral nutrition, together with proteins, fats, carbohydrates, salts, 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, or any of the other ingredients of this medicine (listed in section 6);
• in an undiluted form. Vitalipid N Infant should be added to another medicine, e.g. Intralipid 10% or Intralipid 20%, before administration to the patient. The doctor or nurse is responsible for proper preparation of the medicine for infusion.

Warnings and precautions

Tell your doctor if your child is taking any medicines containing vitamin A. In patients using Vitalipid N Infant, the doctor may order regular blood tests to check the patient's health.

Vitalipid N Infant and other medicines

Tell your doctor or pharmacist about all medicines your child is currently taking or has recently taken, as well as any medicines they will be taking. Inform your doctor if the patient is taking medicines that prevent blood clotting (anticoagulants) or medicines containing vitamin A.

The medicine contains soybean oil, egg phospholipids, and sodium

Soybean oil
Do not use in case of known hypersensitivity to peanuts or soy. Cross-allergic reactions have been observed between soy and peanuts.
Egg phospholipids
The medicine contains egg phospholipids, which can rarely cause allergic reactions.
Sodium
The medicine contains less than 1 mmol (23 mg) of sodium per 10 ml, which means the medicine is considered "sodium-free".

3. How to use Vitalipid N Infant

Vitalipid N Infant is administered by intravenous infusion (drip). The dosage for each patient is determined by the doctor.

Dosage

Preterm and low birth weight infants (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 old and weighing over 2.5 kg

The usual daily dose of Vitalipid N Infant is 10 ml.

Children over 11 years old and adults

Vitalipid N Adult is recommended for use.

Using a higher dose of Vitalipid N Infant than recommended

The doctor or nurse will monitor the patient's health during the infusion, so there is little likelihood of administering a higher dose than recommended. However, if the patient believes they have received a higher dose of Vitalipid N Infant than recommended, they should immediately inform their doctor or nurse. Symptoms of overdose may include headache, nausea, vomiting, and drowsiness.
In case of any further doubts about the use of this medicine, consult a doctor or nurse.

4. Possible side effects

No side effects have been reported with the use of Vitalipid N Infant.

Reporting side effects

If any side effects occur, including any side effects not listed in this leaflet, tell your doctor, pharmacist or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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 side effects can help gather more information on the safety of the medicine.

5. How to store Vitalipid N Infant

The medicine should be stored out of sight and reach of children.

The doctor or nurse is responsible for ensuring proper 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 packaging. The expiry date refers to the last day of the month stated.
Unused medicine is not suitable for further use.
Medicines should 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 packaging and other information

What Vitalipid N Infant contains

• The active substances of the medicine are:

1 ml contains:
retinol palmitate
135.3 μg
(corresponding to retinol)
(69 μg)
phylloquinone
20 μg
ergocalciferol
1.0 μg
all-rac-α-tocopherol
0.64 mg
which corresponds 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:
retinol palmitate
1353 μg
(corresponding to retinol)
(690 μg)
phylloquinone
200 μg
ergocalciferol
10 μg
all-rac-α-tocopherol
6.4 mg
which corresponds to:
vitamin A
690 μg
(2300 IU)
vitamin D
10 μg
(400 IU)
vitamin E
6.4 mg
(7 IU)
vitamin K
200 μg

• The other ingredients (excipients) are: purified soybean oil, purified egg phospholipids, glycerol, sodium hydroxide 1M, and water for injection.

Osmolality: approximately 300 mOsm/kg water, pH: approximately 8.

What Vitalipid N Infant looks like and what the packaging contains

Vitalipid N Infant is a sterile concentrate for preparation of infusion emulsion of the oil-in-water type, containing fat-soluble vitamins in the oil phase.
Each ampoule contains 10 ml of the concentrate for infusion emulsion.
Vitalipid N Infant is available in glass ampoules, packaged in cartons of 10.
For more detailed information, please contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Greece, the 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 by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249, 04-458 Warsaw
Marketing authorization number in Greece, the country of export:38030/10/18-04-2011
77429/11/10-02-2014

Parallel import authorization number: 354/22 Date of approval of the leaflet: 26.09.2022

[Information about the trademark]

Information intended for healthcare professionals only:

Warnings and precautions for use

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

Dosage and administration

Dosage
The recommended dose to meet the needs of preterm and low birth weight infants (up to 2.5 kg) is 4 ml/kg body weight/day.
The recommended dose to meet the needs of newborns and children up to 11 years old and weighing over 2.5 kg is 10 ml/day.
Administration
Instructions for dilution of the medicine before administration, see section: Preparation of the medicine for use.

Overdose

Overdose of fat-soluble vitamins may cause toxicity symptoms, but there are no data on toxicity during the use of Vitalipid N Infant at the recommended doses.
After a single overdose of fat-soluble vitamins, no side effects should occur. No specific treatment is necessary.
After prolonged infusion of excessive doses of vitamin D, elevated levels of vitamin D metabolites in serum may occur, which can cause osteopenia.
Infusion of vitamin K in a colloidal aqueous solution at a rate greater than recommended may cause flushing, bronchospasm, tachycardia, and hypotension. Such effects have not been reported after infusion of Vitalipid N Infant.

Preparation of the medicine for use

Pharmaceutical compatibility and instructions for preparation of the medicine for use
During mixing with other medicines, aseptic rules should be followed.
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 turned several times immediately before infusion.
Vitalipid N Infant can be dissolved in SOLUVIT N and used in children weighing over 10 kg.
The mixture resulting from dissolving SOLUVIT N in Vitalipid N Infant is not recommended for use in children weighing less than 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 1 hour before the start of infusion, and the infusion should be completed within 24 hours of preparation of the mixture to avoid microbiological contamination. Unused contents of opened bottles/vials/ampoules should be discarded; they should not be stored for further use.
Data on stability and pharmaceutical compatibility with medicines used for parenteral nutrition are available on request from the marketing authorization holder.

Pharmaceutical incompatibilities

Do not mix the medicine with other medicines, except those listed in the section: Preparation of the medicine for use.

Storage conditions

Do not store above 25°C. Protect from light.

Disposal of unused medicine

Any unused medicine or waste should be disposed of in accordance with local regulations.