SODIUM THIOSULFATE Solution for injection Ref.[9522] Active ingredients: Thiosulfate

Posology

For intravenous use. For single use only.

Adults

Initial dose: 10 mL (300 mg) of sodium nitrite (rate of 2.5 to 5 mL/minute) should be administered intravenously, immediately followed by 50 mL (12.5 g) of sodium thiosulfate (rate of 5 mL/minute).

Alternatively, an initial dose of 5 g hydroxocobalamin administered as an intravenous infusion over 15 minutes followed by 50 mL (12.5 g) of sodium thiosulfate (rate of 5 mL/minute).

Special populations

Older people

No specific dose adjustment is required in elderly patients (aged >65 years).

Paediatric population

In infants to adolescents (0 to 18 years old), 0.2 mL/kg (6 mg/kg or 6-8 mL/m² BSA) of sodium nitrite (rate of 2.5 to 5 mL/minute) not to exceed 10 mL should be administered intravenously, immediately followed by 1 mL/kg of body weight (250 mg/kg or approximately 30-40 mL/m² of BSA) (rate of 2.5 to 5 mL/minute) not to exceed 50 mL total dose of sodium thiosulfate.

Alternatively, in infants to adolescents (0 to 18 years old), the initial dose of hydroxocobalamin is 70 mg/kg body weight not exceeding 5 g followed by 1 mL/kg of body weight (250 mg/kg or approximately 30-40 mL/m² of BSA) (rate of 2.5 to 5 mL/minute) not to exceed 50 mL total dose of sodium thiosulfate.

NOTE: If no treatment response is observed within 30 to 60 minutes or if signs of poisoning reappear, repeat treatment after 30 minutes of initial administration using one-half the original dose of both sodium nitrite and sodium thiosulfate.

In adult and paediatric patients with known anaemia, it is recommended that the dosage of sodium nitrite should be reduced proportionately to the hemoglobin concentration (see Sodium Nitrite SmPC section 4.4).

Renal and hepatic impairment

Although the safety and efficacy of sodium thiosulfate have not been studied in patients with renal and hepatic impairments, sodium thiosulfate is administered as emergency therapy in an acute, life-threatening situation only and no dose adjustment is required in these patients.

Method of administration

Comprehensive treatment of acute cyanide intoxication requires support of vital functions. Supportive care alone may be sufficient treatment without administration of antidotes for many cases of cyanide intoxication, particularly in conscious patients without signs of severe toxicity. Administration of cyanide antidotes should be considered adjunctive to appropriate supportive therapies such as airway, ventilatory, and circulatory support. Supportive therapies, including oxygen administration, should not be delayed to administer cyanide antidotes.

Sodium nitrite injection and sodium thiosulfate injection are administered by slow intravenous injection. Cyanide antidotes should be given as early as possible after a diagnosis of acute life-threatening cyanide poisoning has been established. Sodium thiosulfate may be administered soon after prior treatment with a fast-acting cyanide antidote such as sodium nitrite or hydroxocobalamin. Blood pressure must be monitored during infusion in both adults and children. The rate of infusion should be decreased if significant hypotension is noted.

All parenteral drug products should be inspected visually for particulate matter and discolouration prior to administration, whenever solution and container permit.

There is limited information about the effects of large doses of sodium thiosulfate in humans. Oral administration of 3 g sodium thiosulfate per day for 1-2 weeks in humans resulted in reductions in room air arterial oxygen saturation to as low as 75%, which was due to a rightward shift in the oxygen hemoglobin dissociation curve. The subjects returned to baseline oxygen saturations 1 week after discontinuation of sodium thiosulfate. A single intravenous administration of 20 mL of 10% sodium thiosulfate reportedly did not change oxygen saturations.

5 years.

From a microbiological point of view, Sodium Thiosulfate Solution for Injection should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user.

Do not store above 25°C.

For storage conditions after first opening of the medicinal product, see Section 6.3.

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.

No special requirements for disposal. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.