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

Vitalipid Adultos is indicated in adult patients and children aged 11 years and above, as a supplement in intravenous nutrition to cover the needs of fat-soluble vitamins A, D2, E, and K1.

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Do not administer Vitalipid Adultos:

- 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 or pharmacist before Vitalipid Adultos is administered to you.

Vitalipid Adultos should not be administered without dilution.

This medication contains soy oil. Do notuse 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.

Other medications and Vitalipid AdultosAdultos

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

In rare cases, 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 and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

No studies of reproduction in animals or humans have been conducted with Vitalipid Adultos during pregnancy.

Human experience suggests that high doses of retinol (vitamin A) (more than 6,000 IU per day) may cause alterations in the newborn.

The vitamins in this medication pass into breast milk.

Driving and operating machinery

No effects on the ability to drive or operate machinery are expected.

Vitalipid Adultos containssoy 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 Adultos ampoule must be diluted before administration (see below).

By intravenous route.

The recommended normal dose in adult patients and children over 11 years old is 10 ml (one ampoule) per day.

To consult the dilution instructions of the medication before administration, see the sectionInstructions for correct administrationat the end of the prospectus.

If you use more Vitalipid Adultos than you should

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

If Vitalipid Adultos 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 overdosing of Vitamin D, elevated serum concentrations of Vitamin D metabolites may appear. This may cause osteopenia (decrease in bone mineral density).

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

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

Like all medications, this medication may produce adverse effects, although not all people will experience them.

No adverse effects related to Vitalipid Adultos have 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.

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

Store below25°C. Protect from light.

Do not freeze.

Retinol (Vitamin A) may break down upon exposure to ultraviolet light.

Vitalipid Adults 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

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Composition of Vitalipid Adults concentrated solution for infusion

• 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, anhydrous glycerol, 1 M sodium hydroxide andwater for injectable preparations.

The amount of each active principle in Vitalipid Adults is:

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

Retinol (Vit A)............................ 99 micrograms(330 UI)..............990 micrograms

(as Retinol palmitate .......... 194.1 micrograms)

All-rac-?-Tocoferol (Vit E) ....... 0.91 mg (1 UI) ................................ 9.1 mg

Ergocalciferol (Vit D2) .................. 0.5 micrograms (20 UI) ............... 5 micrograms

Fitomenadiona (Vit K1) ............... 15 micrograms ............................ 150 micrograms

pH approx. 8

Osmolality: approx. 300 mosm/kg water

Appearance of the product and contents of the package

Concentrated solution for infusion. 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:January 2017.

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 Adults should not be administered without dilution. All additions must be made in aseptic conditions.

10 ml (1 ampoule) of Vitalipid Adults should be added to 500 ml of Intralipidor to 500 ml of 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.

Vitalipid Adults can be used to dissolve Soluvit. The content of a Soluvit ampoule is dissolved by adding 10 ml of Vitalipid Adults and is then added to Intralipid, or to the lipid emulsion whose compatibility has been previously studied.

Vitalipid Adults can also be used as a complement in Total Parenteral Nutrition (TPN) mixtures in plastic bags.

Incompatibilities

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

Stability

The addition of Vitalipid Adults to the infusion solution should be made up to one hour before the start of infusion, and it should be used within 24 hours after preparation to prevent microbial contamination. The remaining contents of the bottles/vials/ampoules should be discarded and cannot be reused.