Vitalipid Adultos

Patient Information Leaflet

Introduction

Contents of the leaflet

1. What Vitalipid Adults is and what it is used for
2. What you need to know before starting to use Vitalipid Adults
3. How to use Vitalipid Adults
4. Possible side effects
5. Storage of Vitalipid Adults
6. Package contents and additional information

1. What Vitalipid Adults 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 Adults is indicated in adult patients and children from the age of 11 years 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 Adult

Do not administer Vitalipid Adult 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.
• You are allergic to any of the fat-soluble vitamins contained in this medicine or to any of the other ingredients of this medicine (listed in section 6).
• You have hypervitaminosis of the vitamins contained in this product (excess of these vitamins).

Warnings and precautions

Consult your doctor or pharmacist before Vitalipid Adult is administered to you.

Vitalipid Adult 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.

Other medicines and Vitalipid Adult

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) administered concomitantly with high-dose vitamin A may increase the risk of bleeding.

Minocycline (an antibiotic), when administered 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 and lactation

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

No animal or human reproductive studies have been conducted with Vitalipid Adults during pregnancy.

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

The vitamins in this medicine are excreted into breast milk.

Driving and use of machines

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

Vitalipid Adults contains soybean oil and egg phospholipids

This medicine contains soybean oil. It must 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 may very rarely cause allergic reactions.

3. How to use VITALIPID ADULTOS

If in doubt, consult your doctor or pharmacist.

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

For intravenous use.

The recommended normal dose in adult and pediatric patients aged 11 years and older is 10 ml (one ampoule) per day.

For instructions on dilution of the medicine prior to administration, see the section Instructions for correct administration at the end of the leaflet.

If you use more Vitalipid Adult than you should

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

If Vitalipid Adult 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 excessive doses of Vitamin D, elevated serum concentrations of Vitamin D metabolites may occur. This may cause osteopenia (reduced bone mineral density).

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

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 Adultos have been reported.

Reporting of adverse effects

If you experience any 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 via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Vitalipid Adult

Keep this medicine out of 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 Adult must be diluted before use.

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

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

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-?-tocopherol).
• The other components are purified soybean oil, purified egg phospholipids, anhydrous glycerol, sodium hydroxide 1 M, and water for injections.

Amount of each active substance in Vitalipid Adults:

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-?-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

Approx. pH 8
Osmolality: approx. 300 mOsm/kg water

Nature of the product and pack contents

Concentrate for solution for infusion. A sterile, homogeneous, white oil-in-water emulsion. Pack containing 10 ampoules 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: January 2017.

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

This information is intended exclusively for healthcare professionals:

Instructions for correct administration

Vitalipid Adults must not be administered without prior dilution. All additions must be carried out 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 several times immediately before infusion.

Vitalipid Adults may also be used to dissolve Soluvit. The contents of one ampoule of Soluvit are dissolved by adding 10 ml of Vitalipid Adults, and then added to Intralipid or to the lipid emulsion whose compatibility has been previously studied.

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

Incompatibilities

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

Stability

Vitalipid Adults should be added to the infusion solution up to one hour before the start of infusion, and the solution must be used within 24 hours after preparation to prevent microbial contamination. Any remaining contents of bottles/vials/ampoules must be discarded and must not be reused.