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 the preparation of infusion emulsion

Read the 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 you need to.
• In case of any doubts, consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for this person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, tell the 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 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 proper preparation of the medicine for infusion.

Warnings and precautions

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

The medicine contains purified soybean oil, purified egg yolk phospholipids, and sodium

Purified soybean oil

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

Purified egg yolk phospholipids

The medicine contains purified egg yolk phospholipids, which may 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 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 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 little likelihood of administering a higher dose than recommended. However, if the patient thinks 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 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 the doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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 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 in a temperature below 25°C. Protect from light. Do not freeze. 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:
retinyl 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:
retinyl 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

• Other ingredients (excipients) are: purified soybean oil, purified egg yolk 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 what the packaging contains

Vitalipid N Infant is a sterile concentrate for the 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 (type I glass), 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 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:

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 Spain, the country of export:680397.4
Parallel import authorization number:32/20

Date of approval of the leaflet: 19.11.2024

[Information about the trademark]

Information intended exclusively for healthcare professionals:

Warnings and precautions for use

Vitalipid N Infant contains purified soybean oil and purified egg yolk phospholipids, which may 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 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 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 diluting 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 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 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 principles must be observed. 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: 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 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 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

Store in a temperature below 25°C. Protect from light. Do not freeze.

Disposal of unused medicine

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