Leaflet: information for the user

Concentrated solution for perfusion

Oligoelements

Read this leaflet carefully before you start using this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What is Supliven and what it is used for

2. What you need to know before starting to use Supliven

3. How to use Supliven

4. Possible side effects

5. Storage of Supliven

6. Contents of the pack and additional information

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

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

Do not administer Supliven:

• if you are allergic to the active ingredients or to any of the other components of this medication (listed in section 6).If you experience an eruption or other allergic reactions (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 disorder that produces 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

Inform your doctor if you have problems with liver or kidney function.

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

Iron and iodine may cause allergic reactions in rare cases when administered in the form of drops. Inform your doctor or nurse if you experience allergic reactions when Supliven is administered.

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

Use of Supliven with other medications

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

Pregnancy and breastfeeding

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

Although the needs for oligoelements are 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 absolutely necessary.

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

Driving and operating machines

Supliven has no effect on driving or operating machines.

This medication will be administered by healthcare personnel.

You will receive the medication through direct infusion into a vein (intravenous infusion).

Your doctor will decide on the appropriate dose you should receive.

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

Before administration, Supliven must be added to another solution. Your doctor or nurse will ensure that the medication 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 more Supliven than you should

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

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

Like all medications, Supliven may cause adverse effects, although not everyone will experience them.

No adverse effects have been observed due to the use of Supliven in accordance with the recommendations described.

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

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or nurse, even if it is about possible adverse effects that do not appear in this prospectus. You can also report them directly through the Spanish 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.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

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

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

Any remaining solution after treatment should be disposed of in accordance with the hospital's standard procedures.

Composition of Supliven concentrated solution for infusion

- The active principles 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 injection preparations.

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

Appearance of the product and contents of the packaging

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

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

FRESENIUS KABI ESPAÑA S.A.U

Calle Marina 16-18

08005-Barcelona

Responsible for manufacturing

HP Halden Pharma AS

Svinesundsveien 80

1788 Halden

Norway

Review date of this leaflet:June 2016

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