Sodium thiosulfate Monico
ItalyPatient Information Leaflet: Information for the User
SODIUM THIOSULFATE MONICO
1 g/10 ml concentrate for solution for infusion
Sodium Thiosulfate
Equivalent medicine
Please read all of this leaflet carefully before you start using this medicine, as 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 they have the same symptoms as you, because 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.
Contents of this leaflet:
- What SODIUM THIOSULFATE MONICO is and what it is used for
- What you need to know before using SODIUM THIOSULFATE MONICO
- How to use SODIUM THIOSULFATE MONICO
- Possible side effects
- How to store SODIUM THIOSULFATE MONICO
- Contents of the pack and other information
1. What SODIO TIOSOLFATO MONICO is and what it is used for
SODIO TIOSOLFATO MONICO contains the active substance sodium thiosulfate, also known as sodium hyposulfite, which belongs to a group of medicines called antidotes—substances that counteract poisoning.
This medicine is used:
- as an antidote in cyanide poisoning, because it promotes the conversion of these toxic compounds into relatively non-toxic compounds, thiocyanates, which are eliminated in the urine;
- to prevent kidney damage (nephropathy) caused by cisplatin, a medicine used in cancer treatment, because it forms a non-toxic thiosulfate-cisplatin complex;
- to prevent damage (desensitizing effect) due to leakage of chemotherapeutic medicines from the injection site (extravasation).
2. What you need to know before using SODIO TIOSOLFATO MONICO
Do not use SODIO TIOSOLFATO MONICO
- if you are allergic to sodium thiosulfate or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using SODIO TIOSOLFATO MONICO.
This medicine must be administered only under strict medical supervision.
Exercise particular caution, as this medicine may cause a decrease in blood volume (hypovolemia) due to increased urine excretion (osmotic diuretic effect).
Other medicines and SODIO TIOSOLFATO MONICO
Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines.
This medicine may interact with metals or other ions because it is capable of binding to them (chelating action).
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before using this medicine.
If you are pregnant or breastfeeding, use this medicine only when strictly necessary and under direct medical supervision, after carefully weighing the benefits to the mother against the potential risks to the fetus or infant.
Driving and using machines
This medicine does not affect the ability to drive or operate machinery.
SODIO TIOSOLFATO MONICO contains sodium
This medicine contains 202 mg of sodium per vial, which should be taken into account in patients with impaired renal function or those on a low-sodium diet.
3. How to use SODIO TIOSOLFATO MONICO
Use this medicine exactly as directed by your doctor, pharmacist, or nurse. If you have any doubts, consult your doctor, pharmacist, or nurse.
SODIO TIOSOLFATO MONICO will be administered to you as a very slow intravenous injection (intravenous infusion), after dilution in an appropriate amount of 0.9% sodium chloride solution or 5% glucose solution.
Antidote in cyanide poisoning: In case of suspected cyanide poisoning (by inhalation or ingestion), the medicine must be used promptly.
The recommended dose in adults is 12.5 g, suitably diluted in 250 ml of 0.9% sodium chloride solution or 5% glucose, administered by slow intravenous infusion over 10–30 minutes following 300 mg of sodium nitrite.
You will be kept under observation for 24–48 hours after the infusion. In case of recurrence of poisoning symptoms, repeat administration of half the dose of both sodium thiosulfate and sodium nitrite is recommended.
This medicine may be administered simultaneously with a hydroxocobalamin solution, but through a different administration site, at a dosage of 5 g suitably diluted in 250 ml of 0.9% sodium chloride solution or 5% glucose.
If necessary, in the event of recurrent poisoning, administration of sodium thiosulfate and hydroxocobalamin may be repeated.
Use in children
The recommended dose is 412.5 mg per kg of body weight (0.7 g per m² of body surface area), suitably diluted in 100 ml of 0.9% sodium chloride solution or 5% glucose, administered by slow intravenous infusion (0.625–1.25 g/min).
It is recommended not to exceed 12.5 g.
The doctor may adjust the initial treatment dose based on blood hemoglobin levels.
This medicine may be administered simultaneously with a hydroxocobalamin solution, but through a different administration site, at a dosage of 50–100 mg/kg, suitably diluted.
If necessary, in the event of recurrent poisoning, administration of sodium thiosulfate and hydroxocobalamin may be repeated.
The following table shows the recommended dose of sodium thiosulfate according to the child's hemoglobin level:
- 8 g hemoglobin: 275.0 mg sodium thiosulfate per kg body weight
- 10 g hemoglobin: 337.5 mg sodium thiosulfate per kg body weight
- 12 g hemoglobin: 412.5 mg sodium thiosulfate per kg body weight
- 14 g hemoglobin: 487.5 mg sodium thiosulfate per kg body weight
Prevention of cisplatin-induced nephropathy
The recommended dose in adults is 9 g/m² as a bolus, followed by continuous intravenous infusion of 1.2 g/m² per hour for 6 hours.
Desensitization in extravasation of chemotherapeutic agents
You will be injected directly at the site of extravasation with a solution containing 400 mg/10 ml (corresponding to 4 ml of 1 g/10 ml sodium thiosulfate solution added to 6 ml of water for injections).
A possible chemical interaction with hydroxocobalamin has been reported; therefore, when necessary, the two medicines must be administered at different sites.
If you use more SODIO TIOSOLFATO MONICO than you should
This medicine will be administered by trained healthcare professionals; therefore, overdose is unlikely.
In case of overdose (blood concentration of 20 mg per 100 ml), life-threatening effects may occur. Trained medical personnel may perform mechanical blood filtration (hemodialysis) to remove the drug from the body.
In case of accidental ingestion or overdose of SODIO TIOSOLFATO MONICO, contact your doctor immediately or go to the nearest poison control center.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur:
Not known ( frequency cannot be estimated from the available data):
- allergic skin inflammations such as contact dermatitis;
- nausea, vomiting, diarrhoea;
- low blood pressure (hypotension), if infused too rapidly, and reduced blood volume (hypovolemia);
- burning and allergic irritation at the injection site.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at http://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 SODIUM THIOSULFATE MONICO
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "EXP.".
The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from light. Do not freeze.
The medicine should be used immediately after opening the container. The solution must be clear, colourless, and free from precipitate and visible particles.
The contents of the vial are intended for a single, uninterrupted administration; any remaining medicine must not be reused.
Do not dispose of medicines 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 SODIO TIOSOLFATO MONICO contains
SODIO TIOSOLFATO MONICO 1 g/10 ml concentrate for solution for infusion
- The active substance is sodium thiosulfate (sodium hyposulfite). Each vial contains 1 g of sodium thiosulfate.
- The other components are: sodium bicarbonate, water for injections.
Description of the appearance of SODIO TIOSOLFATO MONICO and pack contents
Carton containing 5 glass vials of 10 ml concentrate for solution for infusion.
Marketing Authorization Holder and Manufacturer
MONICO SPA – Via Ponte di Pietra 7, 30173 – VENEZIA/MESTRE – Italy