Package leaflet: Information for the user

Warning! Keep the leaflet. Information on the immediate packaging in a foreign language.
Supliven, concentrate for solution for infusion
Composite product
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

Keep this leaflet, so that you can read it again if necessary.
If you have any questions, please consult your doctor, pharmacist, or nurse.
If the patient experiences any adverse reactions, including those not listed in this leaflet, inform the doctor or pharmacist. See section 4.

Table of contents of the leaflet

What Supliven is and what it is used for
Important information before using Supliven
How to use Supliven
Possible side 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 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 (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, electrolytes, 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 to any of the other ingredients of this medicine (listed in section 6). If the patient develops a rash or 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 hemochromatosis (excessive accumulation of iron in the body).

Supliven must not be used in children with 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 monitor the patient's health status. If the patient
is receiving oral iron at the same time as the infusion, the doctor will ensure that excessive
accumulation of iron in the body does not occur.
Intravenous iron and iodine 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 or has recently taken, as well as any medicines the patient plans to take.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a
child, she should consult the doctor before using this medicine.
Supliven may be used in women during pregnancy and breastfeeding.
Driving and operating machinery
Supliven has no influence on the ability to drive or operate machinery.

3. How to use Supliven

The medicine is administered by medical personnel as an intravenous infusion (via an intravenous drip into the 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 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 very unlikely that a patient will receive a higher than recommended dose, as the patient's health status will be monitored by the doctor or nurse during treatment.
However, if the patient thinks they have received a higher than recommended dose of Supliven, this should be reported immediately to the doctor or nurse.

If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

No adverse reactions related to the use of Supliven according to the recommendations have been reported.
If any adverse symptoms occur, inform your doctor or nurse.
Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed
in this leaflet, inform your doctor, pharmacist, or nurse. 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 allows further information on the safety of the medicinal product to be collected.

5. How to store Supliven

Keep this medicine out of sight and reach of children.
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Do not use this medicine after the expiry date stated on the packaging. 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 proper storage, use, and disposal of Supliven.
After dilution:
Supliven should be added to the solution immediately before starting the infusion and used within 24 hours. If the medicine is not used immediately, the user is responsible for the storage period during use and the conditions prior to administration. This period should not normally exceed 24 hours at 2-8°C, unless the 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 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 medicine 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 (PP) ampoules containing 10 ml of concentrate,
packaged in cardboard boxes containing 20 units.
For further information, please contact the responsible entity or the parallel importer.

Responsible entity in Greece, country of export:
Fresenius Kabi Hellas A.E.
L. Kifisias 64A, 151 25 Marousi, Greece

Manufacturer:
Fresenius Kabi Norge AS
Svinesundsveien 80
NO-1753 Halden, Norway

Parallel importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Poland

Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Poland

Marketing authorisation number in Greece, country of export: 3660/20-1-2016
Parallel import authorisation number: 299/23
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