Vitalipid N Infant

Package Leaflet: Information for the User

WARNING! Keep the package leaflet. Information on the immediate packaging 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 medicinal product.

Read the package leaflet carefully before using the medicinal product, as it contains important information for the patient.

• Keep this package leaflet, you may need to read it again.
• In case of any doubts, consult a doctor, pharmacist, or nurse.
• This medicinal product has been prescribed to you by a doctor. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any not listed in this package leaflet, tell the doctor, pharmacist, or nurse. See section 4.

Package Leaflet Contents

• 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. Package contents and other information

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

Vitalipid N Infant is a medicinal product 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 medicinal product:

• if the patient is allergic to egg protein, soy, peanuts, active substances, or any of the other ingredients of this medicinal product (listed in section 6),
• in an undiluted form. Vitalipid N Infant must be added to another medicinal product, e.g., Intralipid 10% or Intralipid 20%, before administration to the patient. The doctor or nurse is responsible for the proper preparation of the medicinal product for infusion.

Warnings and precautions

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

Vitalipid N Infant and other medicinal products

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

The medicinal product contains soybean oil, egg phospholipids, and sodium

Soybean oil

Do not use in case of known hypersensitivity to peanuts or soy. Cross-allergic reactions between soy and peanuts have been observed.

Egg phospholipids

The medicinal product contains egg phospholipids, which may rarely cause allergic reactions.

Sodium

The medicinal product contains less than 1 mmol (23 mg) of sodium per 10 ml, which means the medicinal product is considered "sodium-free".

3. How to use Vitalipid N Infant

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

Dosage

Preterm 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 a body weight over 2.5 kg

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

Children from 11 years of age 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 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 the doctor or nurse. Symptoms of overdose may include headache, nausea, vomiting, and drowsiness.
In case of any further doubts about the use of this medicinal product, 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 not listed in the package leaflet, tell the doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Post-Marketing Surveillance 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 side effects will help gather more information on the safety of the medicinal product.

5. How to store Vitalipid N Infant

Store the medicinal product out of sight and reach of children.

The doctor or nurse is responsible for ensuring the proper storage, use, and disposal of Vitalipid N Infant.
Store at a temperature below 25°C. Do not freeze.
Store in the original packaging to protect from light.
Do not use this medicinal product after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.
Any unused portion of the medicinal product is not suitable for further use.
Medicinal products should not be disposed of via wastewater or household waste. Ask a pharmacist how to dispose of medicinal products that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Vitalipid N Infant contains

• The active substances of the medicinal product 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 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)
phylloquinone
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 ingredients (excipients) are: purified soybean oil, purified egg phospholipids, glycerol, sodium hydroxide 1 M, and water for injection.

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

What Vitalipid N Infant looks like and what the package contains

Vitalipid N Infant is a sterile concentrate for solution for infusion of the oil-in-water type containing fat-soluble vitamins in the oil phase.
Each ampoule contains 10 ml of the concentrate for solution for infusion.
Vitalipid N Infant is available in glass ampoules (type I glass), packaged in 10 units per carton.
For more detailed information, consult the marketing authorization holder or parallel importer.

Marketing authorization holder in Spain, the 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

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Spanish export authorization number: 680397.4

Parallel import authorization number: 219/16

Date of package leaflet approval: 28.02.2024

[Information on the trademark]

Information intended for healthcare professionals only:

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 an undiluted form.

Dosage and administration

Dosage
The recommended dose to meet the requirements for preterm infants and newborns with low birth weight (up to 2.5 kg) is 4 ml/kg body weight/day.
The recommended dose to meet the requirements for newborns and children up to 11 years of age and with a body weight over 2.5 kg is 10 ml/day.
Administration
Instructions for dilution of the medicinal product before administration, see section: Preparation of the medicinal product 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 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 effects have not been reported after infusion of Vitalipid N Infant.

Preparation of the medicinal product for use

Pharmaceutical compatibility and instructions for preparation for use
During mixing with other medicinal products, aseptic principles must 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 resulting from 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 1 hour before the start of the infusion, and the infusion should be completed within 24 hours of preparation of the mixture to avoid microbiological contamination. Any 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 medicinal products used for parenteral nutrition are available on 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 at a temperature below 25°C. Do not freeze.
Store in the original packaging to protect from light.

Disposal of unused medicinal product

Any unused medicinal product or waste should be disposed of in accordance with local requirements.