6. Contents of the container and additional information

A mixtureof fat-soluble vitamins that belongs to the group of medications calledadditives for intravenous solutions.

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

Do not administer Vitalipid Infantilto

- If you are allergic to egg protein.

- This medication contains soy oil. Do not use in case of peanut or soy allergy.

- If you are allergic to any of the fat-soluble vitamins it contains or to any of the other components of this medication (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 should not be administered without dilution.

This medication contains soy oil. Do not use in case of peanut or soy allergy.

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

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

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

Other medications and Vitalipid InfantilInfantil

Inform your doctor or pharmacist if you are using, have used recently or may have to use any other medication.

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

Anticoagulant and antiplatelet medications (preventing clot formation) administered at the same time as high doses of vitamin A may increase the risk of bleeding.

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

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

Vitamin K1 interacts with anticoagulants of the coumarinic type (such as acenocoumarol or warfarin).

Pregnancy, breastfeeding and fertility

Not applicable.

Driving and operating machinery

Not applicable.

Vitalipid Infantil contains soy oil and egg phospholipids

This medication contains soy oil. Do not use in case of peanut or soy allergy. Cross-reactive allergic reactions have been observed between soy and peanuts.

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

In case of doubt, consult your doctor or pharmacist.

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

By intravenous route.

The recommended dose is:

- In premature babies and low-weight babies up to 2.5 kg of body weight: 4 ml of solution per kg of body weight/day.

- In babies 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) must be protected from exposure to light until the end of administration (see section 2).

To consult the dilution instructions of the medication before administration, see the section at the end of the prospectus titledInstructions for correct administration.

If you use more Vitalipid Infantil than you should

Vitamin liposoluble overdose may lead to toxicity syndromes, although there is no evidence of toxicity at 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 perfusion with Vitamin D overdose, elevated serum concentrations of Vitamin D metabolites may appear. This can cause osteopenia (decrease in bone mineral density).

Fast perfusion of Vitamin K1 in colloidal aqueous solution may cause hot flashes, bronchospasm, rapid heartbeats (tachycardia), and hypotension. These disorders have not been reported after perfusions with Vitalipid Infantil.

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

Like all medications,this medicationmay cause adverse effects, although not all people will experience them.

No adverse effects related to VitalipidInfantilhave been reported.

Reporting Adverse Effects

If you experienceany type ofadverse effect, consult your doctor, pharmacistor nurse,even if it is apossibleadverse effect not listed in this leaflet.You can also report them directly through theSpanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es.By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

Store below25°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 medication after the expiration date appearing on the packaging after CAD. The expiration date is the last day of the month indicated.

Product packaging shelf life for sale: 24 months.

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

Composition ofVitalipidInfantilconcentrate for infusion solution

• The active principles are: Vitamin A (as retinol palmitate), vitamin K1(fitomenadiona),vitamin D2(ergocalciferol) andvitamin E(all-rac-?-tocoferol).
• The other components are purified soybean oil, purified egg phospholipids, glycerol, 1 M sodium hydroxide andwater for parenteral preparations.

The amount of each active principle in Vitalipid Infantil is:

Amount per ml: Amount per ampoule (10 ml):

Vitamin A (retinol) 69 micrograms (230 UI) 690 micrograms

(as retinol palmitate 135.3 micrograms)

Vitamin K1(fitomenadiona) 20 micrograms 200 micrograms

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

Vitamin E (all-rac-α-tocoferol) 0.64 mg (0.7 UI) 6.4 mg

pH approx. 8

Osmolality: approx. 300 mosm/kg of water.

Appearance of the product and contents of the packaging

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

Package containing 10 ampoules of 10 ml each.

Holder of the marketing authorization:

FRESENIUS KABI ESPAÑA S.A.U

C/ Marina 16-18

08005-Barcelona

Spain

Responsible for manufacturing:

Fresenius Kabi AB

Rapsgatan 7

SE-751 74 Uppsala

Sweden

Date of the last review of this leaflet:September 2019.

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/

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This information is intended solely for healthcare professionals:

Instructions for correct administration

Vitalipid Infantil must not be administered without dilution. All additions must be made in an aseptic manner.

Up to10 ml (1 ampoule) of Vitalipid Infantil must be added to Intralipid200 mg/mlor to other lipid emulsions whose compatibility has been previously studied. To ensure a homogeneous mixture, the bottle must be inverted a couple of times immediately before infusion.

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

In case of dissolution with Soluvit: The contents of one ampoule of Soluvit are dissolved by adding 10 ml of Vitalipid Infantil and are then added to Intralipid, or to 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) must be protected from exposure to light until the end of administration.

Warnings and special precautions for use:

Exposure to light of parenteral nutrition solutions for intravenous administration, especially after mixing them with oligoelements or vitamins, may 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 must be protected from ambient light until the end of administration.

Incompatibilities

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

Stability

The addition of Vitalipid Infantil to Intralipid200 mg/mlmust be made one hour before the start of infusion, and it must be used within 24 hours of preparation to prevent microbial contamination. The remaining contents of the bottles/vials/ampoules must be discarded and cannot be reused.

Special precautions for disposal and other handling:

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