Posology : מינונים

4.2   Posology and method of administration
Posology
For intravenous use. For single use only.
Adults
Initial dose: 10 mL of (300 mg) sodium nitrite (rate of 2.5 to 5 mL/minute) should be administered intravenously, immediately followed by 50 mL 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.
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 30 mg/mL SPC 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. 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.