Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Hope Pharmaceuticals, Ltd., 120 Baker Street, London, W1U 6TU, United Kingdom
Sodium Thiosulfate 250 mg/mL Solution for Injection.
| Pharmaceutical Form |
|---|
|
Solution for Injection. The solution for injection is a clear and colourless sterile solution. |
Each 50 mL vial contains 12.5 g of sodium thiosulfate (250 mg/mL).
Excipient of known effect:
3.6 g of sodium in 50 ml of solution for injection.
115 mg of potassium in 50 ml of solution for injection.
140 mg of boric acid in 50 mL of solution for injection.
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 |
Each carton of Sodium Thiosulfate Solution for Injection contains one 50 mL single use glass vial of sodium thiosulfate 250 mg/mL solution for injection (containing 12.5 g of sodium thiosulfate). Each glass vial includes a chlorobutyl stopper and an aluminum cap with a plastic lid.
Hope Pharmaceuticals, Ltd., 120 Baker Street, London, W1U 6TU, United Kingdom
PL 42589/0002
19/06/2015
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