SUPLIVEN CONCENTRADO FOR PERFUSION SOLUTION

Introduction

Package Leaflet: Information for the User

Supliven Concentrate for Solution for Infusion

Oligoelements

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

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

1. What Supliven is and what it is used for

Supliven is a medicine that contains oligoelements. Oligoelements are small amounts of chemical substances that your body needs to function properly. Supliven is administered intravenously (in a vein) if you are an adult or a child with a weight of 15 kg or more, who cannot eat normally.

This medicine is usually used as part of a balanced intravenous diet, along with proteins, fats, carbohydrates, salts, and vitamins.

2. What you need to know before you use Supliven

Do not use Supliven:

• if you are allergic to the active substances or to any of the other components of this medicine (listed in section 6). If a rash or other allergic reactions appear (such as itching, swelling of the lips or face, or difficulty breathing), inform your doctor immediately.
• if you have blocked bile ducts
• if you have Wilson's disease (a genetic disease that causes copper accumulation in the liver) or hemochromatosis (iron accumulation in the body)

Supliven should not be administered to children weighing less than 15 kg.

Warnings and precautions

Tell your doctor if you have liver or kidney problems.

Your doctor may perform periodic blood tests to monitor your condition. If you are taking oral iron in parallel with the infusion, your doctor may want to ensure that you do not accumulate iron in your body.

Iron and iodine can cause allergic reactions in rare cases when administered as a drip. Inform your doctor or nurse if you have allergic reactions when Supliven is administered.

Tell your doctor or pharmacist if you have problems with your thyroid gland (hyperthyroidism).

Using Supliven with other medicines

Tell your doctor or pharmacist that you are using, have recently used, or may need to use any other medicine.

Pregnancy and breastfeeding

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

Although the need for oligoelements is slightly increased in pregnant women, there are no safety data for the administration of Supliven during pregnancy. Therefore, Supliven should not be administered during pregnancy, unless it is absolutely necessary.

The active substances of Supliven are excreted in breast milk, and effects have been observed in infants whose mothers were treated with this medicine. Supliven should only be administered to breastfeeding women if they need to obtain oligoelements through parenteral nutrition.

Driving and using machines

Supliven has no effect on driving or using machines.

3. How to use Supliven

This medicine will be administered by healthcare personnel.

You will receive the medicine through an intravenous drip directly into a vein.

Your doctor will decide the appropriate dose for you to receive.

The recommended dose for adults is 10 ml (one ampoule) per day. If you have liver or kidney problems, you may be given a lower dose.

Before administration, Supliven must be added to another solution. Your doctor or nurse will ensure that the medicine is prepared correctly before administering it to you.

Use in children

The recommended dose for children weighing more than 15 kg is 0.1 ml per kg of body weight per day.

If you are given too much Supliven

It is unlikely that you will receive more medicine than you should, as your doctor or nurse will monitor you during treatment. However, if you think you are being given too much Supliven, inform your doctor or nurse immediately.

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

4. Possible side effects

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

No side effects have been observed due to the use of Supliven according to the recommended instructions.

Some cases of superficial thrombophlebitis have been observed after the administration of glucose-containing Addamel. However, it has been impossible to confirm whether this reaction was caused by the oligoelements.

Reporting of side effects

If you experience any side effects, talk to your doctor or nurse, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Supliven

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

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.

This medicine does not require any special storage conditions.

The hospital doctor and pharmacist are responsible for the correct storage, use, and disposal of Supliven.

After dilution: The addition of Supliven should be performed immediately before the start of the infusion and should be used within 24 hours. If not used immediately, the storage times and conditions before use are the responsibility of the user and should not normally exceed 24 hours at 2-8°C, unless the mixture has been prepared in controlled and validated aseptic conditions.

Any remaining solution after treatment should be disposed of according to the standard hospital procedures.

6. Contents of the pack and other information

Composition of Supliven concentrate for solution for infusion

• The active substances contained in one ampoule (10 ml) are:

Chromium chloride hexahydrate 53.3 μg

Copper chloride dihydrate 1.02 mg

Iron chloride hexahydrate 5.40 mg

Manganese chloride tetrahydrate 198 μg

Potassium iodide 166 μg

Sodium fluoride 2.10 mg

Sodium molybdate dihydrate 48.5 μg

Sodium selenite anhydrous 173 μg

Zinc chloride 10.5 mg

• The other components are: xylitol, hydrochloric acid, water for injections.

This product contains 0.052 mmol of sodium (1.2 mg) per dose (10 ml).

Appearance and pack size

Supliven is a clear, almost colorless solution of oligoelements presented in polypropylene ampoules containing 10 ml of concentrate. The pack size is 20 ampoules of 10 ml.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

FRESENIUS KABI ESPAÑA S.A.U

Calle Marina 16-18

08005-Barcelona

Manufacturer

HP Halden Pharma AS

Svinesundsveien 80

1788 Halden

Norway

Revision date of this leaflet:June 2016

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