Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor, pharmacist or nurse.
This medicine has been prescribed for you only. Do not pass it on to other people, even if their symptoms are the same as yours, as it may be harmful to them.
If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

What is in this leaflet

What SUPPLYELT is and what it is used for
What you need to know before using SUPPLYELT
How to use SUPPLYELT
Possible side effects
How to store SUPPLYELT
Contents of the pack and other information

1. What SUPPLYELT is and what it is used for

SUPPLYELT is a concentrate for solution for infusion.
It contains 9 essential trace elements (iron, copper, manganese, zinc, fluorine, iodine, selenium, chromium,
molybdenum).
These trace elements are considered essential because the body cannot produce them, but needs them in very small amounts for proper functioning.
SUPPLYELT is used to provide trace elements in adults who require parenteral nutrition (intravenous feeding).

2. What you need to know before using SUPPLYELT

Do not use SUPPLYELT:

If you are allergic (hypersensitive) to any of the components of SUPPLYELT (see section 6 of this leaflet).
If blood levels of one of the components of the medicine are abnormally high. (If you have any doubts, consult your doctor.)
If you have severe cholestasis (yellowing of the skin or whites of the eyes caused by liver or blood disorders).
If you have excess copper (Wilson's disease) or iron (hemochromatosis) in the body.

Warnings and precautions
Talk to your doctor or pharmacist before taking SUPPLYELT if:

you have kidney problems,
you have liver problems, for example mild cholestasis (reduced liver function with yellowing of the skin or whites of the eyes),
you receive repeated blood transfusions,
you have diabetes and are undergoing insulin therapy,
you have thyroid disorders, or if you are taking medicines containing iodine (e.g. iodine-based antiseptics).

Your doctor will regularly monitor the levels of trace elements in your blood during treatment and will adjust the dose of SUPPLYELT accordingly.
Children
SUPPLYELT must not be used in children and adolescents.
Other medicines and SUPPLYELT
Inform your doctor if you are taking, have recently taken, or might take any other medicines. Especially oral iron salts.
SUPPLYELT and alcohol
Not applicable
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or are breastfeeding, ask your doctor or nurse for advice before using this medicine.
SUPPLYELT must not be used during pregnancy or breastfeeding unless your doctor considers it absolutely necessary.
Driving and using machines
Not applicable
SUPPLYELT contains sodium
and potassium
This medicine contains less than 1 mmol of sodium (23 mg) per vial, i.e. it is practically "sodium-free".
This medicine contains less than 1 mmol of potassium (39 mg) per vial, i.e. essentially "potassium-free".
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

3. How to use SUPPLYELT

SUPPLYELT is intended for adult patients only.
SUPPLYELT will be administered intravenously (into a vein) by a nurse or doctor. Use this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Instructions for dilution of SUPPLYELT prior to administration
SUPPLYELT is not intended to be administered in its original formulation as supplied.
SUPPLYELT must be diluted or mixed with gentle agitation during preparation under strict aseptic conditions before infusion.
SUPPLYELT must be diluted to achieve an appropriate final osmolarity. For example:

10 to 20 ml of SUPPLYELT may be diluted in at least 250 ml of Sodium Chloride 0.9% solution for infusion,
10 to 20 ml of SUPPLYELT may be diluted in at least 250 ml of Glucose 5% solution for infusion. The pH after reconstitution of 20 ml of SUPPLYELT with 250 ml of 0.9% sodium chloride will be 3.3, or 3.3–3.4 with 5% glucose.

The reconstituted solution for infusion must be visually inspected before use. Only a clear solution free of particles should be used.
Do not store partially used containers and dispose of all equipment after use.
Compatibility with solutions administered simultaneously via a common infusion line must be ensured.
Degradation of ascorbic acid in parenteral nutrition mixtures is accelerated by trace elements.
This medicine must not be mixed with other medicines except those mentioned in this section.
SUPPLYELT must not be used as a vehicle for other drugs.
Dosage
Your doctor will determine the correct dose for you.
The recommended daily dose is one vial (10 ml) of SUPPLYELT. Your doctor may administer up to 2 vials per day.
SUPPLYELT will be diluted before use.
Use in children
SUPPLYELT must not be used in children and adolescents.
Use a specific product to provide trace elements to children and adolescents when parenteral (intravenous) nutrition is required.
If you use more SUPPLYELT than you should
Your doctor will discontinue treatment with SUPPLYELT and carry out the necessary laboratory tests in case of suspected overdose.
If you stop treatment with SUPPLYELT
Not applicable

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Inform your doctor if you notice any of the following:
Frequency not known (frequency cannot be estimated from the available data): Pain at the site of administration.

Cases of hypersensitivity reactions, including fatal anaphylactic reactions, have been reported in patients receiving intravenous iron-containing medicines.

If you experience any side effect, including those not listed in this leaflet, please consult your doctor, pharmacist or nurse. You may also report side effects directly through the national reporting system at the following website:
www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa .

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store SUPPLYELT

After dilution, chemical and physical in-use stability has been demonstrated for 48 hours at 25°C, protected from light.
From a microbiological standpoint, the medicinal product should be used immediately after dilution. If not used immediately, the duration of storage and the conditions prior to use are the responsibility of the user.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label after "Exp". The expiry date refers to the last day of that month.
Do not freeze.
Keep the container in the outer packaging to protect the medicine from light.
Do not use this medicine if you notice any visible signs of deterioration.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What SUPPLYELT contains
The active substances are:
Per 10 ml of SUPPLYELT
Zinc (Zn) 10000 µg (as Zinc gluconate)
Copper (Cu) 300 µg (as Copper gluconate)
Manganese (Mn) 55 µg (as Manganese gluconate)
Fluoride (F) 950 µg (as Sodium fluoride)
Iodine (I) 130 µg (as Potassium iodide)
Selenium (Se) 70 µg (as Sodium selenite)
Molybdenum (Mo) 20 µg (as Sodium molybdate)
Chromium (Cr) 10 µg (as Chromium chloride)
Iron (Fe) 1000 µg (as Iron gluconate)
The other components are hydrochloric acid and water for injections.

Description of the appearance of SUPPLYELT and contents of the pack
SUPPLYELT is a clear, transparent, slightly yellow concentrate for solution for infusion in a 10 ml vial.
SUPPLYELT is packaged in boxes containing 10, 25 or 50 vials.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Laboratoire Aguettant
1 rue Alexander Fleming
69007 LYON
France

Manufacturer responsible for batch release
Laboratoire AGUETTANT
Lieu-dit Chantecaille
07340 CHAMPAGNE
France