Adverse reactions : תופעות לוואי

4.8   Undesirable effects
There have been no controlled clinical trials conducted to systematically assess the adverse events profile of Nithiodote.
The medical literature has reported the following adverse events in association with sodium nitrite administration. These adverse events were not reported in the context of controlled trials or with consistent monitoring and reporting methodologies for adverse events. Therefore, frequency of occurrence of these adverse events cannot be assessed.
Sodium Nitrite

System organ class                 Frequency              Undesirable effect 

Cardiac and vascular               Not known              Syncope, hypotension*, disorders                                                 tachycardia, palpitations, dysrhythmia*
Blood and lymphatic                Not known              Methemoglobinemia* system disorders
Nervous system                     Not known              Headache, dizziness, blurred disorders                                                 vision, seizures, confusion, coma*
Gastrointestinal                   Not known              Nausea, vomiting, abdominal disorders                                                 pain


Respiratory, thoracic             Not known             Tachypnea, dyspnea and mediastinal disorders
Skin disorders                    Not known             Urticaria General disorders and             Not known             Anxiety, diaphoresis, administration site                                     lightheadedness, injection site conditions                                              tingling, cyanosis, acidosis, fatigue, weakness,
generalized numbness and tingling
*Description of selected adverse reactions
Severe hypotension, methemoglobinemia, cardiac dysrhythmias, coma and death have been reported in patients without life-threatening cyanide poisoning but who were treated with injection of sodium nitrite at doses less than twice those recommended for the treatment of cyanide poisoning.
Sodium Thiosulfate
System organ class               Frequency               Undesirable effect Cardiac and vascular             Not known               Hypotension disorders
Nervous system                   Not known               Headache, disorientation disorders
Gastrointestinal                 Not known               Nausea*, vomiting* disorders
Blood and lymphatic              Not known               Prolonged bleeding time* system disorders
General disorders and            Not known               Salty taste in mouth, warm administration site                                      sensation over body conditions
*Description of selected adverse reactions
Nausea and vomiting
In humans, rapid administration of concentrated solutions or solutions not freshly prepared, and administration of large doses of sodium thiosulfate have been associated with a higher incidence of nausea and vomiting. However, administration of 0.045 g sodium thiosulfate per kilogram up to a maximum of 15 g in a 10-15% solution over 10-15 minutes was associated with nausea and vomiting in 7 of 26 patients without concomitant cyanide intoxication.
Prolonged bleeding time
In a series of 11 human subjects, a single intravenous infusion of 50 mL of 50% sodium thiosulfate was associated with increases in clotting time 1-3 days after administration. However, no significant changes were observed in other hematological parameters.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form: /https://sideeffects.health.gov.il