(For term and preterm neonates, infants and children)
Please read all of this leaflet carefully before you start using this medicine because it contains important information for you.

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

This medicine is called TRACYELT, Concentrate for solution for infusion, but will be referred to as TRACYELT throughout this leaflet.
Contents of this leaflet

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

1. What TRACYELT is and what it is used for

TRACYELT is a concentrate for solution for infusion, specifically designed for term and preterm neonates, infants, and children.
It contains five trace elements (zinc, copper, manganese, iodine, selenium) considered essential because the body is unable to produce them but requires them in small amounts for proper functioning.
Trace elements are normally supplied through a balanced diet.
TRACYELT is used to provide trace elements to term and preterm neonates, infants, and children who are unable to feed normally and require parenteral (intravenous) nutrition.

2. What you should know before using TRACYELT

Your child must not receive TRACYELT if:

he/she is allergic (hypersensitive) to any of the components of TRACYELT (see section 6 of this leaflet).
he/she has Wilson's disease (a hereditary disorder in which copper accumulates in the body).
he/she has abnormally high blood levels of any of the components of this medicine (if in doubt, consult your doctor).

Warnings and precautions
Talk to your doctor before using TRACYELT if your child has:

liver or kidney problems.
thyroid gland disorders.

During treatment, your doctor will regularly monitor the levels of trace elements in the blood and adjust the dosage of TRACYELT accordingly.

Other medicines and TRACYELT
Inform your doctor if your child is taking, has recently taken, or might take any other medicines, including those without a prescription.

TRACYELT contains sodium and potassium
This medicine contains less than 1 µmol (11.6 µg) of sodium per vial and less than 1 µmol (3.1 µg) of potassium per vial, i.e. it is essentially "sodium-free" and "potassium-free".

3. How to use TRACYELT

TRACYELT will be administered to your child intravenously (into a vein) by means of an infusion (intravenous infusion) carried out by a nurse or doctor. They will determine the correct dose for your child.
Dosage
Term and preterm neonates, infants and children (body weight less than or equal to 20 kg):
The basal requirement for the included trace elements is met by 1 ml of TRACYELT per kilogram of body weight per day, up to a maximum daily dose of 20 ml.
Children (body weight greater than 20 kg):
A daily dose of 20 ml of TRACYELT meets the basal requirement for trace elements.
TRACYELT must be supplemented with a single injectable zinc solution when administered to preterm infants in order to achieve a total parenteral zinc intake of 450–500 µg/kg/day.
Daily iron infusion is recommended for preterm infants receiving long-term parenteral nutrition (> 3 weeks), and molybdenum supplementation is recommended when parenteral nutrition lasts > 4 weeks.
TRACYELT must not be administered directly to the patient but must be diluted before use.
If your child receives more TRACYELT than they should
It is extremely unlikely that your child could receive more infusion than required, as they will be monitored by the doctor or nurse during treatment. However, if you suspect that your child has received an excessive amount of TRACYELT, inform the doctor or nurse immediately.
The doctor will discontinue treatment with TRACYELT and carry out the necessary laboratory tests in case of suspected overdose.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, TRACYELT may cause side effects, although not everybody gets them.
Inform your doctor if you experience any of the following symptoms:
Frequency not known (cannot be estimated from the available data): pain at the application site.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You may also report side effects directly through the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store TRACYELT

After dilution, chemical and physical in-use stability has been demonstrated for 48 hours at 25°C.
From a microbiological standpoint, the product should be used immediately after dilution. If not used
immediately, the in-use storage times and 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.
Do not use this medicine if visible signs of deterioration are observed.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of
medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What TRACYELT contains
The active substances are:
Per 10 ml of TRACYELT (1 vial)
Zinc (Zn) 1,000 µg (as Zinc gluconate)
Copper (Cu) 200 µg (as Copper gluconate)
Manganese (Mn) 5 µg (as Manganese gluconate)
Iodine (I) 10 µg (as Potassium iodide)
Selenium (Se) 20 µg (as Sodium selenite)
The other components are hydrochloric acid and water for injections.

Description of the appearance of TRACYELT and contents of the pack
TRACYELT is a clear, colourless concentrate for solution for infusion, supplied in 10 ml vials.
TRACYELT is packaged in boxes containing 10 and 50 vials.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Laboratoire AGUETTANT
1 rue Alexander Fleming
69007 LYON
France

Responsible manufacturer for batch release
Laboratoire AGUETTANT
Lieu-dit « Chantecaille »
07340 CHAMPAGNE
France

The following information is intended exclusively for physicians or healthcare professionals.

Pharmaceutical information
Density: 1.0
pH: from 2.7 to 3.3
Osmolality: 15 mosm/kg
Osmolarity: 15 mosm/l

Incompatibilities:
TRACYELT must not be used as a vehicle for other medicinal products.
This medicinal product must not be mixed with other medicinal products except with 0.9% sodium chloride solution for infusion or 5% glucose solution for infusion.

Shelf life:
24 months
After dilution, chemical and physical in-use stability has been demonstrated for 48 hours at 25°C.
From a microbiological standpoint, the product should be used immediately after dilution. If not used immediately, the storage conditions and duration of in-use storage are the responsibility of the user.

Special precautions for storage:
Do not freeze.

Instructions for use and handling:
Before use, check that the concentrate for solution for infusion is homogeneous and that the vial is intact and free from particles.
TRACYELT is not intended to be administered in its current formulation. TRACYELT must be diluted or mixed with gentle agitation under strict aseptic conditions prior to infusion.
TRACYELT must be diluted to ensure appropriate final osmolarity.
For example:

5 or 10 ml of TRACYELT can be diluted in at least 50 ml of 0.9% sodium chloride solution for infusion or 5% glucose solution for infusion,
10 or 20 ml of TRACYELT can be diluted in at least 100 ml of 0.9% sodium chloride solution for infusion or 5% glucose solution for infusion.

For these dilutions, the pH values vary approximately between 3.5 and 4.5. The reconstituted solution for infusion must be inspected visually before use. Only a clear, particle-free solution should be used. Partially used containers must not be stored; all equipment must be discarded after use. Compatibility with solutions administered simultaneously via a common infusion line must be ensured.

For information on dosage, please refer to section 3 of the package leaflet.