Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Fennec Pharmaceuticals (EU) Limited, Block A, 5th Floor, The Atrium, Blackthorn Road, Sandyford, Dublin 18, Ireland
Pedmarqsi 80 mg/mL solution for infusion.
| Pharmaceutical Form |
|---|
|
Solution for infusion. The solution for infusion is a clear, colourless solution essentially free of particulate matter, with a pH of 7.7 – 9.0 and an osmolality of 980 – 1 200 mOsm/kg. |
Each vial of 100 mL contains 8 g of sodium thiosulfate as an anhydrous salt. Each mL of solution for infusion contains 80 mg sodium thiosulfate.
Excipient(s) with known effect: Each mL of solution for infusion contains 0.25 mg boric acid and 23 mg sodium.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Thiosulfate |
Sodium thiosulfate is indicated for sequential use with sodium nitrite for the treatment of acute cyanide poisoning that is judged to be life-threatening. The primary route of endogenous cyanide detoxification is by enzymatic transulfuration to thiocyanate (SCN-), which is relatively nontoxic and readily excreted in the urine. Sodium thiosulfate is also indicated for the prevention of ototoxicity induced by cisplatin chemotherapy. The mechanism of protection against ototoxicity may include increasing levels of endogenous antioxidants, inhibition of intracellular oxidative stress, and direct interaction between cisplatin and the thiol group in sodium thiosulfate to produce inactive platinum species. |
| List of Excipients |
|---|
|
Boric acid |
Type I, 100 mL, clear glass vials sealed with a chlorinated butyl rubber stopper and an aluminium flipoff overseal. Each vial contains 100 mL of solution for infusion.
Vials are supplied in cartons of 1 vial pack.
Fennec Pharmaceuticals (EU) Limited, Block A, 5th Floor, The Atrium, Blackthorn Road, Sandyford, Dublin 18, Ireland
EU/1/23/1734/001
| Drug | Countries | |
|---|---|---|
| PEDMARQSI | Austria, Croatia, Ireland, Italy, Lithuania |
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