Vitalipid N Infant

Package Leaflet: Information for the User

Vitalipid N Infant

Concentrate for solution for infusion

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

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this package leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Package 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 pack 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 its undiluted form. Vitalipid N Infant must 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

Tell your doctor if your child is taking any medicines containing vitamin A. 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 taking or has recently taken, as well as any medicines they will be taking. Inform your doctor if your child 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 if you are hypersensitive to peanuts or soy. Cross-allergic reactions between soy and peanuts have been observed.

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 it 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.

Overdose of Vitalipid N Infant

The doctor or nurse will monitor the patient's health during the infusion, so there is little chance of an overdose. However, if the patient thinks they have received an overdose of Vitalipid N Infant, they should immediately inform their doctor or nurse. Symptoms of overdose may include headache, nausea, vomiting, and drowsiness. If you have any further questions about the use of this medicine, ask your doctor or nurse.

4. Possible side effects

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

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, 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. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Vitalipid N Infant

Store the medicine 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 in a temperature 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 packaging. The expiry date refers to the last day of the month stated. Any unused medicine or waste material should be disposed of in accordance with local regulations. Ask your pharmacist how to dispose of medicines that are no longer needed. 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 (equivalent to retinol) 135.3 μg (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 D 1.0 μg (40 IU), vitamin E 0.64 mg (0.7 IU), vitamin K 20 μg. 10 ml contains: retinyl palmitate (equivalent to retinol) 1353 μg (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 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, anhydrous 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 contents of the pack

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 concentrate for solution for infusion. Vitalipid N Infant is available in glass ampoules (type I glass), packaged in cartons of 10.

Marketing authorization holder and manufacturer:

Fresenius Kabi AB, S-751 74 Uppsala, Sweden. For further information, contact the representative of the marketing authorization holder: Fresenius Kabi Polska Sp. z o.o., Al. Jerozolimskie 134, 02-305 Warsaw, tel.: +48 22 345 67 89.

Date of last revision of the package leaflet:

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 between soy and peanuts have been observed. Vitalipid N Infant must not be used in its undiluted form.

Dosage and administration

Dosage: The recommended dose for preterm and low birth weight infants (up to 2.5 kg) is 4 ml/kg/day. The recommended dose for 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 in the recommended doses. After a single overdose of fat-soluble vitamins, no side effects are expected. 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 medicine for use

Pharmaceutical compatibility and instructions for preparation for use: During mixing with other medicines, 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 weighing over 10 kg. The mixture resulting from the dissolution of 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 the infusion, and the infusion should be completed within 24 hours of preparation of the mixture to avoid microbial 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 other parenteral nutrition products are available on request from the representative of the marketing authorization holder.

Pharmaceutical incompatibilities

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

Storage conditions

Store in a temperature below 25°C. Do not freeze. Store in the original packaging to protect from light.

Disposal of unused medicine

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