SUPLIVEN

Package leaflet: Information for the user

Warning! Keep this leaflet! The information on the immediate packaging is in a foreign language.
Supliven (Addamel N New), concentrate for solution for infusion
Combination product
Supliven and Addamel N New are different trade names for the same medicine.
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, please consult your doctor, pharmacist, or nurse.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

1. What Supliven is and what it is 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 Supliven is and what it is used for

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

2. Important information before using the medicine Supliven

When not to use Supliven
Do not use Supliven if:

• the patient is allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6). If the patient develops a rash or any other allergic reaction (itching, swelling of the lips or face, difficulty breathing), inform the doctor immediately.
• the patient has complete biliary obstruction;
• the patient has Wilson's disease (a genetic disorder causing excessive accumulation of copper in the body) or haemochromatosis (excessive accumulation of iron in the body).

Supliven must not be used in children with body weight below 15 kg.
Warnings and precautions
Inform the doctor if the patient has liver and/or kidney problems.
The doctor may recommend regular blood tests to monitor the patient's health. If the patient is taking oral iron at the same time as the infusion, the doctor will ensure that iron does not accumulate excessively in the body.
Iron and iodine administered intravenously may rarely cause allergic reactions.
If the patient experiences an allergic reaction during administration of Supliven, inform the doctor or nurse immediately.
Supliven with other medicines
Tell the doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor before using this medicine.
Supliven may be used in women during pregnancy and while breastfeeding.
Driving and operating machinery
Supliven has no effect on the ability to drive and operate machinery.

3. How to use Supliven

Supliven is administered by medical personnel as an intravenous infusion (in an intravenous drip into a vein).
The dosage is determined individually for each patient by the physician.
The recommended dose for use in adult patients is 10 millilitres (ml) per day.
Patients with impaired liver or kidney function may receive lower doses of the medicine.
Supliven must be mixed with another solution before administration. The doctor or nurse will ensure that this has been done correctly.

Children
The recommended dose for use in children with body weight greater than 15 kg is 0.1 ml/kg body weight/day.

Use of a higher than recommended dose of Supliven
It is highly unlikely that a patient will receive a dose higher than recommended, as the physician or nurse will monitor the patient's health condition during treatment.
However, if the patient thinks they have received a higher than recommended dose of Supliven, this should be reported immediately to the physician or nurse.

If you have any further questions concerning the use of this medicine, consult your physician or pharmacist.

4. Possible adverse reactions

No adverse reactions related to the use of Supliven according to recommendations have been reported.
If any adverse reactions occur, inform your doctor or nurse.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions enables continued monitoring of the medicine's safety and helps to accumulate further information on its safe use.

5. How to store Supliven

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the container. The expiry date refers to the last day of the stated month.
No special storage instructions apply.
The physician or hospital pharmacist is responsible for the correct storage, handling, and disposal of Supliven.

After dilution:
Supliven should be added to an infusion solution immediately before the start of infusion and used within 24 hours.
If the medicine is not used immediately, the user is responsible for storage conditions and in-use shelf life. This period should not normally exceed 24 hours at 2–8°C, unless dilution was carried out under controlled and validated aseptic conditions.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging 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.
• Other ingredients: xylitol, hydrochloric acid concentrated (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 colourless solution of trace elements.
Supliven is available in polypropylene ampoules containing 10 ml of concentrate,
packaged 20 ampoules in a cardboard box.
For more detailed information, please contact the Marketing Authorisation Holder or the Parallel Importer.
Marketing Authorisation Holder in Greece, 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 in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249, 04-458 Warsaw
Marketing Authorisation Number in Greece, country of export: 3660/20-1-2016
Parallel Import Authorisation Number: 62/24