VITALIPID INFANTIL

Introduction

Contents of the Package Leaflet

1. What is Vitalipid Infantil and what is it used for
2. What you need to know before you use Vitalipid Infantil
3. How to use Vitalipid Infantil
4. Possible side effects
5. Storage of Vitalipid Infantil

1. Contents of the Pack and Further Information

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

It is a mixture of liposoluble 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 cover the needs of liposoluble vitamins A, D2, E, and K1.

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

Vitalipid Infantil must not be administered:

• If you are allergic to egg protein.
• This medicine contains soybean oil. It must not be used in case of peanut or soy allergy.
• If you are allergic to any of the liposoluble vitamins it contains or to any of the other components of this medicine (listed in section 6).
• If you have hypervitaminosis of the vitamins it contains (excess of them).

Warnings and Precautions

Consult your doctor, pharmacist, or nurse before Vitalipid Infantil is administered to you.

Vitalipid Infantil must not be administered undiluted.

This medicine contains soybean oil. It must not be used in case of peanut or soy allergy.

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

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

When used in newborns and children under 2 years, the solution (in bags and administration equipment) should be protected from light exposure until administration is completed. Exposure of Vitalipid Infantil to ambient light, especially after mixing with oligoelements or vitamins, generates peroxides and other degradation products that can be reduced by protecting the product from light exposure.

Other Medicines and Vitalipid Infantil

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Rarely, interactions of liposoluble vitamins with other components in parenteral nutrition regimens have been reported.

Anticoagulant and antiplatelet medicines (which prevent clot formation) administered at the same time as vitamin A in high doses may increase the risk of bleeding.

Minocycline (an antibiotic) administered at the same time as vitamin A in high doses and for a prolonged period may have a higher risk of causing benign intracranial hypertension.

The presence of oligoelements (chemical elements needed in small quantities in the body) may cause some degradation of vitamin A.

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

Pregnancy, Breastfeeding, and Fertility

Not applicable.

Driving and Using Machines

Not applicable.

Vitalipid Infantil contains soybean oil and egg phospholipids

This medicine contains soybean oil. It must not be used in case of peanut or soy allergy. Cross-allergic reactions have been observed between soy and peanuts.

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

3. How to use Vitalipid Infantil

In case of doubt, consult your doctor or pharmacist.

The ampoule of Vitalipid Infantil 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 body weight/day.
• In infants and children over 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, the solution (in bags and administration equipment) should be protected from light exposure until administration is completed (see section 2).

To consult the instructions for dilution of the medicine before administration, see the section "Instructions for Correct Administration" at the end of the package leaflet.

If you use more Vitalipid Infantil than you should

Overdose of liposoluble vitamins can lead to toxicity syndromes, although there is no evidence of toxicity at the recommended doses.

If Vitalipid Infantil is administered at the recommended dose in a complete parenteral nutrition regimen, no signs or symptoms of intoxication should appear. No specific treatment is necessary.

After prolonged infusion with overdose of Vitamin D, elevated serum concentrations of Vitamin D metabolites may appear. This can cause osteopenia (decrease in bone mineral density).

Rapid infusion of Vitamin K1 in aqueous colloidal solution can cause flushing, bronchospasm, tachycardia, and hypotension. These disorders have not been reported after infusions with Vitalipid Infantil.

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

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

No side effects related to Vitalipid Infantil have been reported.

Reporting of Side Effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side 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) can break down due to exposure to ultraviolet light.

Vitalipid Infantil must be diluted before use.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date is the last day of the month shown.

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

When used in newborns and children under 2 years, the solution (in bags and administration equipment) should be protected from light exposure until administration is completed (see section 2).

6. Contents of the Pack and Further Information

Composition of Vitalipid Infantil Concentrate for Solution for Infusion

• 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, sodium hydroxide 1 M, and water for injectable preparations.

The amount of each active substance in Vitalipid Infantil is:

Quantity per ml: Quantity per ampoule (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

pH approx. 8

Osmolality: approx. 300 mosm/kg water.

Appearance of the Product and Contents of the Pack

Concentrate for solution for infusion. It is a sterile white homogeneous oil-in-water emulsion.

Package containing 10 ampoules of 10 ml each.

Marketing Authorisation 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 Last Revision of this Leaflet:September 2019.

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

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This information is intended only for healthcare professionals:

Instructions for Correct Administration

Vitalipid Infantil must not be administered undiluted. All additions must be made aseptically.

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

In children over 10 kg body weight, Vitalipid Infantil can be used to dissolve Soluvit. In children under 10 kg body weight, dissolution with Soluvit is not recommended due to differences in dosing regimens.

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

When used in newborns and children under 2 years, the solution (in bags and administration equipment) should be protected from light exposure until administration is completed.

Special Precautions for Use:

Exposure to light of parenteral nutrition solutions for intravenous use, especially after mixing with oligoelements or vitamins, can have adverse effects on the clinical outcome of newborns due to the generation of peroxides and other degradation products. When used in newborns and children under 2 years, Vitalipid Infantil should be protected from ambient light until administration is completed.

Incompatibilities

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

Stability

The addition of Vitalipid Infantil to Intralipid 200 mg/ml should be made one hour before the start of infusion, and it should be used within 24 hours of preparation to prevent microbial contamination. The remaining contents of the bottles/vials/ampoules should be discarded and cannot be used again.

Special Precautions for Disposal and Other Handling:

When used in newborns and children under 2 years, it should be protected from light exposure until administration is completed. Exposure of Vitalipid Infantil to ambient light, especially after mixing with oligoelements or vitamins, generates peroxides and other degradation products that can be reduced by protecting the product from light exposure.