Supliven

Package Leaflet: Information for the User

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Supliven (Addamel N New), Concentrate for Solution for Infusion

Combined Product
Supliven and Addamel N New are different trade names for the same medicinal product.

Read the Leaflet Carefully Before Using the Medicinal Product, as it Contains Important Information for the Patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Supliven and what is it used for
• 2. Important information before using Supliven
• 3. How to use Supliven
• 4. Possible side effects
• 5. How to store Supliven
• 6. Contents of the pack and other information

1. What is Supliven and what is it used for

Supliven is a medicinal product containing trace elements. Trace elements are chemical substances required in small amounts for the proper functioning of the body.
Supliven is administered intravenously (in a drip into a vein) when oral nutrition is impossible, insufficient, or contraindicated.
This medicinal product is usually used as a component of clinical intravenous nutrition, together with proteins, fats, carbohydrates, salts, and vitamins.

2. Important information before using Supliven

When not to use Supliven

Do not use Supliven if:

• the patient is allergic to the active substances or any of the other ingredients of this medicinal product (listed in section 6). If the patient experiences a rash or other allergic reaction (itching, swelling of the face, lips, tongue, or throat, shortness of breath), tell the doctor immediately.
• the patient has complete bile flow obstruction;
• the patient has Wilson's disease (a genetic disorder characterized by excessive accumulation of copper in the body) or hemochromatosis (excessive accumulation of iron in the body).

Supliven must not be used in children with a body weight below 15 kg.

Warnings and precautions

If the patient has liver and/or kidney disorders, inform the doctor.
The doctor may order regular blood tests to check the patient's health. If the patient is taking iron orally at the same time as the infusion, the doctor will ensure that there is no excessive accumulation of iron in the body.
Iron and iodine administered in a drip can, in rare cases, cause allergic reactions.
If an allergic reaction occurs in the patient during the administration of Supliven, tell the doctor or nurse.

Supliven and other medicinal products

Tell the doctor or pharmacist about all medicinal products the patient is taking or has recently taken, as well as any medicinal products the patient plans to take.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult her doctor before using this medicinal product.
Supliven can be used in pregnant and breastfeeding women.

Driving and using machines

Supliven has no influence on the ability to drive and use machines.

3. How to use Supliven

The medicinal product is administered by medical personnel in an intravenous infusion (in a drip into a vein).
The dosage is determined individually by the doctor for each patient.
The recommended dose for adults is 10 milliliters (ml) per day.
Patients with liver or kidney disorders may receive smaller doses of the medicinal product.
Supliven must be mixed with another solution before administration. The doctor or nurse will ensure that this is done correctly.

Children

The recommended dose for children with a body weight over 15 kg is 0.1 ml/kg body weight per day.

Overdose of Supliven

It is very unlikely that the patient will receive a dose higher than recommended, as the doctor or nurse will monitor the patient's health during treatment.
If, however, the patient thinks they have received a higher dose of Supliven than recommended, tell the doctor or nurse immediately.
If you have any further questions about the use of this medicinal product, ask your doctor or pharmacist.

4. Possible side effects

No side effects have been reported in connection with the use of Supliven according to the recommendations.
If any side effects occur, tell the doctor or nurse.

Reporting side effects

If any side effects occur, including those not listed in the leaflet, tell the doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting side effects will help to gather more information on the safety of the medicinal product.

5. How to store Supliven

Keep the medicinal product out of the sight and reach of children.
Do not use this medicinal product after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.
There are no special precautions for storage.
The doctor or hospital pharmacist is responsible for the proper storage, use, and disposal of Supliven.
After dilution:
Supliven should be added to the solution immediately before the start of the infusion and used within 24 hours.
If the medicinal product is not used immediately, the user is responsible for the storage period during use and the conditions before use. This period should not normally exceed 24 hours at a temperature of 2-8°C, unless the dilution was performed under controlled and validated aseptic conditions.
Medicinal products should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicinal products that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Supliven contains

• 1 ampoule (10 ml) contains the active substances: chromium(III) chloride hexahydrate 53.3 μg copper(II) chloride dihydrate 1.02 mg iron(III) chloride hexahydrate 5.40 mg manganese(II) chloride tetrahydrate 198 μg potassium iodide 166 μg sodium fluoride 2.10 mg sodium molybdate(VI) dihydrate 48.5 μg sodium selenite 173 μg zinc chloride 10.5 mg
• The other ingredients are: xylitol, hydrochloric acid (for pH adjustment), water for injections.

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

What Supliven looks like and contents of the pack

Supliven is a clear, almost colorless solution of trace elements.
Supliven is available in polypropylene ampoules containing 10 ml of concentrate, packed in cartons of 20.
For more detailed information, contact the marketing authorization holder or the parallel importer .

Marketing authorization holder in Greece, the country of export:

Fresenius Kabi Hellas A.E.
Kifisias Ave. 64A, 15125 Marousi, Attica, Greece

Manufacturer:

Fresenius Kabi Norge AS
Svinesundsveien 80, NO-1788 Halden, Norway

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11, 03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249, 04-458 Warsaw
Marketing authorization number in Greece, the country of export:3660/20-1-2016

Parallel import authorization number: 62/24

Date of leaflet approval: 12.02.2024

[Information about the trademark]