Supliven

Poland
Brand name Supliven
Form solution for infusion, concentrate
Active substance / Dosage
Ferric chloride hexahydrate · 540 mcg
Copper chloride dihydrate · 102.3 mcg
Zinc chloride · 1050 mcg
Manganese chloride tetrahydrate · 19.79 mcg
Anhydrous sodium selenite · 17.29 mcg
Sodium molybdate dihydrate · 4.85 mcg
Potassium iodide · 16.6 mcg
Chromium chloride hexahydrate · 5.33 mcg
Sodium fluoride · 210 mcg
Prescription type Prescription only
ATC code
B05XA31
Registration number 100330349
Manufacturer HP Halden Pharma AS
Supliven solution for infusion, concentrate

Table of Contents

Package leaflet: Information for the user

Supliven
concentrate for solution for infusion
combination product
Please read all of this leaflet carefully before using this medicine because it contains
important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor, pharmacist, or nurse.
  • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the leaflet

  1. What Supliven is and what it is used for
  2. What you need to know before you are given 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 not possible, 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 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 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 copper accumulation in the body) or haemochromatosis (excessive iron accumulation 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. 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.
Intravenous iron and iodine may rarely cause allergic reactions. If an allergic reaction occurs during administration of Supliven, inform the doctor or nurse immediately.
Supliven and other medicines
Tell the doctor or pharmacist about all medicines the patient is currently using, has recently used, or plans to use.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor before using this medicine.
Supliven may be used during pregnancy and while 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 IV drip into a vein).
The dosage is determined individually by the doctor for each patient.
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 very unlikely that a patient will receive a higher than recommended dose, as the doctor 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 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 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, 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
tel.: +48 22 49 21 301
fax: +48 22 49 21 309
website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Supliven

Keep this medicine out of 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 stated month.
There are no special storage requirements for this medicine.
The physician or hospital pharmacist is responsible for the correct storage, handling, 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 storage conditions prior to use. This period should not generally 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 dispose of medicines no longer required. Doing so helps protect the environment.

6. Contents of the pack and other information

What Supliven contains

  • 1 ampoule (10 ml) contains the following 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.
  • 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, packed 20 ampoules in a cardboard box.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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 Authorisation Holder:
Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw
tel.: +48 22 345 67 89