Vitalipid N Infant

Leaflet attached to the packaging: information for the user

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

VITALIPID N INFANT (Vitalipid Infant)

Concentrate for preparation of infusion emulsion
VITALIPID N INFANT and Vitalipid Infant are different trade names for the same medicine.

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. It should not be given to others. The medicine may harm another person, even if the symptoms of their disease are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform 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

The medicine should not be used:

• 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 properly preparing the medicine for infusion.

Warnings and precautions

The doctor should be informed about the child's use of all 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

The doctor or pharmacist should be informed about all medicines currently or recently used by the child, as well as any medicines that will be used.
The doctor should be informed if the patient is using medicines that prevent blood clotting (anticoagulants) or medicines containing vitamin A.

The medicine contains soybean oil, egg phospholipids, and sodium

Soybean oil

It should not be used 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 with a body weight over 2.5 kg

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

Children from 11 years old and adults

Vitalipid N Adult is recommended.

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 a low probability 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, the patient should consult their 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, the patient should inform their 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,
Jerozolimskie Avenue 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.
Store at a temperature below 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 given month.
Unused medicine is not suitable for further use.
Medicines should not be disposed of via wastewater or household waste containers. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. 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) 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:
retinol palmitate
1353 µg
(corresponding 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)

• 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 10 pieces in a cardboard box.
For more detailed information, please contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Greece, the country of export:

Fresenius Kabi Hellas A.E.
Mesoghion Avenue 354
153 41 Agia Paraskevi
Athens
Greece

Manufacturer:

Fresenius Kabi AB
Rapsgatan 7
S-751 74 Uppsala
Sweden

Parallel importer:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Marketing authorization number in Greece, the country of export: 38030/10/18-04-2011
77429/11/10-02-2014

Parallel import authorization number: 5/13 Date of approval of the leaflet: 22.12.2022

[Information about the trademark]

Information intended exclusively for healthcare professionals:

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 should 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 with a body weight 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 in the recommended doses.
After a single overdose of fat-soluble vitamins, no side effects are expected to occur. No specific treatment is necessary.
After prolonged infusion of excessive doses of vitamin D, elevated levels of vitamin D metabolites may occur in the serum, which may 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 reactions 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 with a body weight over 10 kg.
The mixture obtained after dissolving SOLUVIT N in Vitalipid N Infant is not recommended for use in children with a 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 the start of the infusion, and the infusion should be completed within 24 hours of preparing the mixture, to avoid microbiological contamination. Unused contents of opened bottles/vials/ampoules should be destroyed; 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 representative of the marketing authorization holder.

Pharmaceutical incompatibilities

The medicine should not be mixed with other medicines, except those listed in the section: Preparation of the medicine for use.

Storage conditions

Store at a temperature below 25°C. Protect from light.

Disposal of unused medicine

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