Thioredox

Package leaflet: Information for the user

TIOREDOX 4.8 g/50 ml powder and solvent for solution for infusion, 2.4 g/25 ml powder and solvent for solution for infusion

Glutathione
Please read 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 questions, ask your doctor or pharmacist.
• 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 could be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What TIOREDOX is and what it is used for
2. What you need to know before taking TIOREDOX
3. How to take TIOREDOX
4. Possible side effects
5. How to store TIOREDOX
6. Contents of the pack and other information

1. What TIOREDOX is and what it is used for

TIOREDOX contains the active substance glutathione (GSH), a physiological tripeptide (a compound made up of three amino acids: glutamic acid, cysteine, and glycine) that participates in numerous biological processes and plays an important role in reactions involved in the elimination of toxic substances from the body. Glutathione, administered by intravenous infusion, belongs to the category of antidotes—substances capable of transforming a toxic agent into a harmless or minimally harmful compound.
TIOREDOX is used to prevent neuropathy (a disease of the nervous system) resulting from treatment with chemotherapeutic medicines, such as cisplatin or its analogues, used in the treatment of certain types of cancer.

2. What you should know before taking TIOREDOX

Do not take TIOREDOX

• if you are allergic to glutathione or to any of the other ingredients of this medicine.

Warnings and precautions
TIOREDOX will be administered to you only by experienced personnel and exclusively in a hospital setting.
Children and adolescents
The safety and efficacy of Tioredox in children have not been established.
Other medicines and TIOREDOX
Inform your doctor or nurse if you are taking, have recently taken, or might take any other medicines.
At the recommended doses, TIOREDOX does not interfere with the therapeutic activity of chemotherapy agents.
In the absence of compatibility studies with other medicines, TIOREDOX must not be mixed with other products.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor before taking this medicine.
Available data indicate that glutathione, being a substance physiologically present in cells, does not cause adverse effects in pregnant or breastfeeding women. Animal studies have not shown any direct or indirect harmful effects related to pregnancy, embryofetal development, delivery, or postnatal development.
Driving and using machines
TIOREDOX does not affect, or affects negligibly, the ability to drive vehicles or operate machinery.

3. How to take TIOREDOX

The generally recommended daily dose of TIOREDOX in patients undergoing chemotherapy with cisplatin or its analogues is 1.5 g/m² (corresponding to 2.5 g), administered by slow intravenous infusion.
However, the dosage depends on the patient's age, weight, and clinical condition, and should also be correlated with the dose and regimen of the chemotherapeutic agent.
When administering glutathione in association with chemotherapy, the intravenous infusion of TIOREDOX should be performed within 15–30 minutes before the start of chemotherapy.

Method of administration
The package includes a sterile transfer device, TRANSFERSET, for transferring the solvent into the TIOREDOX lyophilisate vial. Insert the TRANSFERSET into the solvent vial and into the lyophilisate vial, and allow the solvent to flow in by gravity. During the downward flow of the liquid, gently shake intermittently to facilitate penetration of the solvent into the lyophilisate mass. After complete transfer, shake vigorously and check that the resulting solution is perfectly clear; then administer the solution thus obtained by slow intravenous infusion using a standard infusion set.
The reconstituted solution must be used within 1 hour.
The reconstituted solution must be clear and free from visible particles. It is intended for single, uninterrupted administration, and any residual solution must not be reused.

Use in children and adolescents
The safety and efficacy of Tioredox in children have not been established.

If you take more TIOREDOX than you should
Cases of overdose have not been reported. If necessary, symptomatic treatments may be administered.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
As with all parenteral solutions, fever reactions, infections at the injection site, venous thrombosis (blood clotting in the veins), or phlebitis (inflammation of the veins) may occur. Extravasation (leakage of the drug from the veins into surrounding tissues) is also possible.
In case of an immediate adverse reaction during intravenous infusion, stop administration immediately and, if possible, retain the unused fluid for potential testing.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system at:
www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store TIOREDOX

Keep this medicine out of the sight and reach of children.
This medicine requires no special storage conditions.
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.
The reconstituted solution must be used within 1 hour.
Do not use this medicine if you notice the presence of particles, abnormal discoloration, cloudiness, or precipitate.
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 TIOREDOX contains
TIOREDOX 4.8 g/50 ml powder and solvent for solution for infusion

• The active substance is reduced glutathione 4.8 g, equivalent to 5.14 g of sodium glutathione
• The other component is water for injections (50 ml)

TIOREDOX 2.4 g/25 ml powder and solvent for solution for infusion

• The active substance is reduced glutathione 2.4 g, equivalent to 2.57 g of sodium glutathione
• The other component is water for injections (25 ml)

The vial of lyophilized powder contains only the active substance and the solvent vial contains water for injections.
Description of the appearance of TIOREDOX and contents of the pack
The pack contains one vial of lyophilisate and one vial of solvent.
Marketing Authorization Holder
BIOMEDICA FOSCAMA INDUSTRIA CHIMICO-FARMACEUTICA S.p.A.
Via dei Castelli Romani, 22
00071 Pomezia (RM), Italy
Manufacturer
Biomedica Foscama Industria Chimico-Farmaceutica S.p.A.
Manufacturing site: Via Morolense, 87
03013 Ferentino (FR) – (Italy)