Vitalipid Infantil

Package leaflet: Information for the user

Introduction

Package leaflet contents

1. What Vitalipid Infantil is and what it is used for

2. What you need to know before starting to use Vitalipid Infantil

3. How to use Vitalipid Infantil

4. Possible side effects

5. Storage of Vitalipid Infantil

6. Contents of the pack and additional information

1. What Vitalipid Infantil is and what it is used for

It is a mixture of fat-soluble vitamins belonging to the group of medicines called additives for intravenous solutions.

Vitalipid Infantil is indicated in infants and children up to 11 years of age as a supplement in parenteral nutrition to meet the requirements of fat-soluble vitamins A, D2, E, and K1.

2. What you need to know before starting to use Vitalipid Infantil

Do not administer Vitalipid Infantil:

• If you are allergic to egg protein.
• This medicine contains soybean oil. It should not be used if you are allergic to peanuts or soybeans.
• If you are allergic to any of the fat-soluble vitamins it contains, or to any of the other ingredients of this medicine (listed in section 6).
• If you have hypervitaminosis of the vitamins it contains (excess levels of these vitamins).

Warnings and precautions

Consult your doctor, pharmacist, or nurse before being administered Vitalipid Infantil.

Vitalipid Infantil must not be administered without prior dilution.

This medicine contains soybean oil. It should not be used if you are allergic to peanuts or soybeans.

Cross-allergic reactions between soybeans and peanuts have been observed.

It also contains egg phospholipids, which very rarely may cause allergic reactions.

When used in newborns and children under 2 years of age, the solution (in bags and administration sets) must be protected from light exposure until administration is complete. Exposure of Vitalipid Infantil to ambient light, especially after mixing with trace elements or vitamins, may generate peroxides and other degradation products. These can be minimized by protecting the product from light.

Other medicines and Vitalipid Infantil

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Rarely, interactions between fat-soluble vitamins and other components in parenteral nutrition regimens have been reported.

Anticoagulant and antiplatelet medicines (which prevent blood clotting), when administered concomitantly with high-dose vitamin A, may increase the risk of bleeding.

Minocycline (an antibiotic), when given together with high-dose vitamin A over a prolonged period, may increase the risk of benign intracranial hypertension.

The presence of trace elements (chemical elements required by the body in small amounts) may cause some degradation of vitamin A.

Vitamin K1 interacts with coumarin-type anticoagulants (such as acenocumarol or warfarin).

Pregnancy, breastfeeding and fertility

Not applicable.

Driving and use of machines

Not applicable.

Vitalipid Infantil contains soybean oil and egg phospholipids

This medicine contains soybean oil. It should not be used if you are allergic to peanuts or soybeans. Cross-allergic reactions between soybeans and peanuts have been observed.

It also contains egg phospholipids, which very rarely may cause allergic reactions.

3. How to use Vitalipid Infantil

If in doubt, consult your doctor or pharmacist.

The Vitalipid Infantil ampoule must be diluted before administration (see below).

Intravenous route.

The recommended dose is:

• In premature infants and low-birth-weight infants up to 2.5 kg body weight: 4 ml of solution per kg of body weight/day.
• In infants and children above 2.5 kg and up to 11 years of age: 10 ml of solution/day. The daily dose should not exceed 10 ml (1 ampoule of Vitalipid).

When used in newborns and children under 2 years of age, the solution (in bags and administration sets) must be protected from exposure to light until administration is complete (see section 2).

For instructions on how to dilute the medicine before administration, see the section at the end of the leaflet entitled Instructions for proper administration.

If you use more Vitalipid Infantil than you should

Overdose of fat-soluble vitamins may lead to toxicity syndromes, although there is no evidence of toxicity at the recommended doses.

If Vitalipid Infantil is administered at the recommended dose as part of a complete parenteral nutrition regimen, signs or symptoms of intoxication should not occur. No specific treatment needs to be initiated.

After prolonged infusion with overdose of Vitamin D, elevated serum concentrations of Vitamin D metabolites may occur. This may cause osteopenia (decreased bone mineral density).

Rapid infusion of Vitamin K1 in an aqueous colloidal solution may cause flushing, bronchial constriction (bronchospasm), faster heartbeat (tachycardia), and hypotension. These disorders have not been reported following infusions with Vitalipid Infantil.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.

No adverse effects related to Vitalipid Infantil have been reported.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Vitalipid Infantil

Keep this medicine out of the sight and reach of children.

Store below 25°C. Protect from light.

Do not freeze.

Retinol (vitamin A) may degrade upon exposure to ultraviolet light.

Vitalipid Infantil must be diluted before use.

Do not use this medicine after the expiry date stated on the container after "EXP". The expiry date refers to the last day of the month indicated.

Shelf life of the product as packaged for sale: 24 months.

When used in newborns and children under 2 years of age, the solution (in bags and administration sets) must be protected from light exposure until administration is complete (see section 2).

6. Contents of the pack and other information

Composition of Vitalipid Infantil, concentrate for infusion solution

• The active substances are: Vitamin A (as retinol palmitate), vitamin K1 (phytomenadione), vitamin D2 (ergocalciferol), and vitamin E (all-rac-α-tocopherol).
• The other components are purified soybean oil, purified egg phospholipids, glycerol, 1 M sodium hydroxide, and water for injections.

Amount of each active substance in Vitalipid Infantil:

Amount per ml: Amount per vial (10 ml):

Vitamin A (retinol) 69 micrograms (230 IU) 690 micrograms
(as retinol palmitate 135.3 micrograms)

Vitamin K1 (phytomenadione) 20 micrograms 200 micrograms

Vitamin D2 (ergocalciferol) 1 microgram (40 IU) 10 micrograms

Vitamin E (all-rac-α-tocopherol) 0.64 mg (0.7 IU) 6.4 mg

Approximate pH: 8

Osmolality: approx. 300 mosm/kg water.

Appearance of the product and pack contents

Concentrate for infusion solution. A sterile, homogeneous, white oil-in-water emulsion.

Pack containing 10 vials of 10 ml each.

Marketing Authorization Holder:

FRESENIUS KABI ESPAÑA S.A.U
C/ Marina 16-18
08005-Barcelona
Spain

Manufacturer:

Fresenius Kabi AB
Rapsgatan 7
SE-751 74 Uppsala
Sweden

Date of the most recent revision of this leaflet: September 2019

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

This information is intended for healthcare professionals only:

Instructions for correct administration

Vitalipid Infantil must not be administered without prior dilution. All additions must be carried out aseptically.

Up to 10 ml (1 vial) of Vitalipid Infantil should be added to Intralipid 200 mg/ml or to other lipid emulsions whose compatibility has been previously studied. To ensure a homogeneous mixture, the bottle should be inverted several times immediately before infusion.

In children weighing more than 10 kg, Vitalipid Infantil may be used to dissolve Soluvit. In children weighing less than 10 kg body weight, dissolution with Soluvit is not recommended due to differences in dosage regimens.

In case of dissolution with Soluvit: The contents of one vial of Soluvit are dissolved by adding 10 ml of Vitalipid Infantil, and then added to Intralipid or to the lipid emulsion whose compatibility has been previously studied.

When used in neonates and children under 2 years of age, the solution (in bags and administration sets) must be protected from exposure to light until administration is complete.

Warnings and special precautions for use:

Exposure to light of intravenous parenteral nutrition solutions, especially after mixing with trace elements or vitamins, may have adverse effects on clinical outcomes in neonates due to the formation of peroxides and other degradation products. When used in neonates and children under 2 years of age, Vitalipid Infantil must be protected from ambient light until administration is complete.

Incompatibilities

Vitalipid Infantil may only be added or mixed with medicinal products whose compatibility has been documented.

Stability

The addition of Vitalipid Infantil to Intralipid 200 mg/ml should be performed one hour before starting the infusion, and the mixture must be used within 24 hours after preparation to prevent microbial contamination. Any remaining contents of bottles/vials/ampoules must be discarded and not reused.

Special precautions for disposal and other handling:

When used in neonates and children under 2 years of age, the product must be protected from exposure to light until administration is complete. Exposure of Vitalipid Infantil to ambient light, particularly after mixing with trace elements or vitamins, generates peroxides and other degradation products, which can be reduced by protecting the product from light.