Supliven

Package Leaflet: Information for the User

Supliven

Concentrate for solution for infusion
Complex product

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this package 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 any not listed in this package leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Package 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 medicine 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 medicine 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 medicine (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 your 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 your doctor.
Your doctor may order regular blood tests to check the patient's health status. 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 rarely cause allergic reactions. If an allergic reaction occurs in the patient during the administration of Supliven, tell your doctor or nurse.

Supliven and other medicines

Tell your doctor or pharmacist about all medicines the patient is 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, thinks she may be pregnant, or plans to have a child, she should consult her doctor before using this medicine.
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 medicine 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 adult patients is 10 milliliters (ml) per day.
Patients with liver or kidney function disorders may receive smaller doses of the medicine.
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.

Using more than the recommended dose 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 status during treatment.
If, however, the patient thinks they have received a higher dose of Supliven than recommended, tell your doctor or nurse immediately.
If you have any further questions about the use of this medicine, 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 your doctor or nurse.

Reporting side effects

If any side effects occur, including any not listed in this package leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Supliven

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and ampoule. The expiry date refers to the last day of the month.
There are no special storage instructions for this medicine.
The hospital doctor or 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 medicine 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 2-8°C, unless the dilution is performed under controlled and validated aseptic conditions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. 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 anhydrous 173 μg, zinc chloride 10.5 mg
• The other ingredients are: xylitol, hydrochloric acid (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 colorless solution of trace elements.
Supliven is available in polypropylene (PP) ampoules containing 10 ml of concentrate, packed in cartons of 20.

Marketing authorization holder and manufacturer

Marketing authorization holder

Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw

Manufacturer

HP Halden Pharma AS
Svinesundsveien 80
1788 Halden
Norway
For further information, please contact the marketing authorization holder: Fresenius Kabi Polska Sp. z o.o., Al. Jerozolimskie 134, 02-305 Warsaw, tel.: +48 22 345 67 89
Date of last revision of the package leaflet:01.03.2024