Package Leaflet: Information for the User

Introduction

Package Leaflet: Information for the User

Supliven Concentrate for Solution for Infusion

Oligoelements

Read this entire 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 adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet Contents:

What Supliven is and what it is used for
What you need to know before using Supliven
How to use Supliven
Possible adverse effects
How to store Supliven
Contents of the pack and other information

1. What Supliven is and what it is used for

Supliven is a medicine containing trace elements. Trace elements are small amounts of chemical substances your body needs to function properly. Supliven is administered intravenously (into a vein) in adults or children weighing 15 kg or more who cannot eat normally.

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

2. What you need to know before starting to 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 you develop a rash 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 causing copper accumulation in the liver) or hemochromatosis (accumulation of iron in the body)

Supliven must 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 carry out periodic blood tests to monitor your condition. If you are taking oral iron at the same time as the infusion, your doctor may want to ensure that iron is not accumulating in your body.

Iron and iodine may rarely cause allergic reactions when administered intravenously. Inform your doctor or nurse if you experience allergic reactions while receiving Supliven.

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

Use of Supliven with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Pregnancy and breastfeeding

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

Although the requirements for trace elements are slightly increased in pregnant women, there are no safety data available on the use of Supliven during pregnancy. Therefore, Supliven should not be administered during pregnancy unless absolutely necessary.

The active substances in Supliven are excreted in breast milk, and effects in infants have been observed in mothers treated with this medicine. Supliven should only be administered to women who are breastfeeding if they require trace elements via parenteral nutrition.

Driving and using machines

Supliven has no effect on driving or operating machinery.

3. How to use Supliven

This medicine will be administered by healthcare professionals.

You will receive the medicine by intravenous infusion (intravenous drip) directly into a vein.

Your doctor will decide the appropriate dose you should receive.

The recommended dose for adults is 10 ml (one ampoule) 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 medicine is properly prepared before it is given 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 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 adverse effects

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

No adverse effects have been observed due to the use of Supliven according to the recommendations described.

There have been some cases of superficial thrombophlebitis following administration of glucose containing Addamel. However, it has been impossible to confirm whether this reaction was caused by the trace elements.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or nurse, even if it concerns possible adverse effects not listed in this leaflet. You may also report them directly through 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 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 packaging after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

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

After dilution: Supliven should be added immediately before the start of infusion and must be used within 24 hours. If not used immediately, the storage times and conditions prior to use are the responsibility of the user and normally should not exceed 24 hours at 2–8 °C, unless the mixture has been prepared under controlled and validated aseptic conditions.

Any unused solution remaining after treatment must be disposed of according to 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
Ferric 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

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 of the medicine and contents of the pack

Supliven is a clear, almost colourless oligoelement solution supplied in polypropylene ampoules containing 10 ml of concentrate. Pack size: 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
Spain

Manufacturer

HP Halden Pharma AS
Svinesundsveien 80
1788 Halden
Norway

Date of revision of this leaflet: June 2016

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