VITALIPID ADULTS

Introduction

Contents of the Package Leaflet

1. What is Vitalipid Adults and what is it used for
2. What you need to know before you use Vitalipid Adults
3. How to use Vitalipid Adults
4. Possible side effects
5. Storage of Vitalipid Adults
6. Contents of the pack and other information

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

It is a mixture of liposoluble vitamins that belongs to the group of medicines called additives for intravenous solutions.

Vitalipid Adults is indicated in adult patients and children from 11 years of age, as a supplement in intravenous nutrition to cover the needs of liposoluble vitamins A, D2, E, and K1.

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

Vitalipid Adults must not be administered to:

• 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 or pharmacist before Vitalipid Adults is administered to you.

Vitalipid Adults 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.

Other Medicines and Vitalipid Adults

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 increase the risk of benign intracranial hypertension.

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

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

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

No reproduction studies have been performed in animals or humans with Vitalipid Adults during pregnancy.

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

The vitamins in this medicine pass into breast milk.

Driving and Using Machines

No effects on the ability to drive or use machines are expected.

Vitalipid Adults 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 Adults

In case of doubt, consult your doctor or pharmacist.

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

Intravenous route.

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

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

If You Use More Vitalipid Adults 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 Adults 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 colloid solution can cause flushing, bronchial constriction (bronchospasm), faster heart rate (tachycardia), and hypotension. These disorders have not been reported after infusions with Vitalipid Adults.

If you have any further questions on 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 Adults have been reported.

Reporting of Side Effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is 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.

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5. Storage of Vitalipid Adults

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 Adults 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 stated.

Shelf life of the product packaged for sale: 24 months

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6. Contents of the Pack and Other Information

Composition of Vitalipid Adults 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, anhydrous glycerol, sodium hydroxide 1M, and water for injectable preparations.

The amount of each active substance in Vitalipid Adults is:

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

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

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

All-rac-α-Tocopherol (Vit E) ....... 0.91 mg (1 IU) ................................ 9.1 mg

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

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

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. Pack 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:January 2017.

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 Adults must not be administered undiluted. All additions must be made aseptically.

10 ml (1 ampoule) of Vitalipid Adults should be added to 500 ml of Intralipid or 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 contents of one ampoule of Soluvit are dissolved by adding 10 ml of Vitalipid Adults and then adding it 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 be added or mixed only 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 the 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 used again.