Special Warning : אזהרת שימוש

4.4   Special warnings and precautions for use

Treatment of cyanide poisoning must include immediate attention to airway patency, adequacy of oxygenation and hydration, cardiovascular support, and management of seizures. Consideration must be given to decontamination measures based on the route of exposure.
Sodium thiosulfate does not substitute oxygen therapy and must not delay the set up of the above measures.
The presence and extent of cyanide poisoning are often initially unknown. There is no widely available, rapid, confirmatory cyanide blood test. Treatment decisions must be made on the basis of clinical history and/or signs and symptoms of cyanide intoxication.
Cyanide poisoning may result from exposure to smoke from closed space fires, inhalation, ingestion, or dermal exposure. Sources of cyanide poisoning include hydrogen cyanide and its salts, cyanogens, including cyanogenic plants, aliphatic nitriles, or prolonged exposure to sodium nitroprusside.
Signs and symptoms of cyanide poisoning
Common signs and symptoms of cyanide poisoning include: nausea, vomiting, headache, altered mental status (e.g. confusion, disorientation), chest tightness, dyspnoea, tachypnoea or hyperpnoea (early), bradypnoea or apnoea (late), hypertension (early) or hypotension (late), cardiovascular collapse, seizures or coma, mydriasis, and plasma lactate concentration > 8 mmol/L.
In the setting of multiple casualties such as terrorism or chemical disaster, panic symptoms including tachypnoea and vomiting may mimic early cyanide poisoning signs. The presence of altered mental status (confusion and disorientation) and/or mydriasis is suggestive of true cyanide poisoning.
Smoke inhalation
Not all smoke inhalation victims necessarily will have cyanide poisoning, but may present with burns, trauma, and exposure to additional toxic substances aggravating the clinical picture. Before sodium nitrite is administered, it is recommended to check affected persons for the presence of the following:
• exposure to fire smoke in an enclosed area
• soot present around mouth, nose and/or oropharynx
• altered mental status
In this setting hypotension and/or a plasma lactate concentration ≥ 10 mmol/L (higher than the one mentioned under signs and symptoms due to the fact that carbon monoxide contributes to lactic acidaemia) are highly suggestive of cyanide poisoning. In the presence of the above signs, treatment with sodium nitrite must not be delayed to obtain a plasma lactate concentration.

Sodium thiosulfate drug product may contain trace impurities of sodium sulfite. The presence of a trace amount of sulfites in this product should not deter administration of the drug for treatment of emergency situations, even if the patient is sulfite- sensitive.
Each 12.5 g dose of sodium thiosulfate contains approximately 3.6 g of sodium which is equivalent to 180% of the WHO recommended maximal daily intake of 2 g sodium for an adult.

Each 12.5 g dose of sodium thiosulfate also contains 115 mg of potassium and 140 mg of boric acid.

Effects on Driving

4.7   Effects on ability to drive and use machines
Not relevant.