Adverse reactions : תופעות לוואי

8.           ADVERSE REACTIONS
Due to the lack of randomized, controlled clinical trials of epinephrine for the treatment of anaphylaxis, the true incidence of adverse reactions associated with the systemic use of epinephrine is difficult to determine. Adverse reactions reported in observational trials, case reports, and studies are listed below.

Common adverse reactions to systemically administered epinephrine include anxiety; apprehensiveness; restlessness; tremor; weakness; dizziness; sweating; palpitations; pallor; nausea and vomiting; headache; and/or respiratory difficulties. These symptoms occur in some persons receiving therapeutic doses of epinephrine but are more likely to occur in patients with hypertension or hyperthyroidism [see Warnings and Precautions (7.5)].

Cardiovascular Reactions
•   Arrhythmias, including fatal ventricular fibrillation, have been reported, particularly in patients with underlying cardiac disease or those receiving certain drugs [see Warnings and Precautions (7.5) and Drug Interactions (9)].

•    Rapid rises in blood pressure have produced cerebral hemorrhage, particularly in elderly patients with cardiovascular disease [see Warnings and Precautions (7.5)].

•    Angina may occur in patients with coronary artery disease [see Warnings and Precautions (7.5)].

•    Rare cases of stress cardiomyopathy have been reported in patients treated with epinephrine.

Reactions from Accidental Injection and/or Improper Technique
•   Accidental injection into the digits, hands or feet may result in loss of blood flow to the affected area [see Warnings and Precautions (7.2)].

•    Adverse reactions experienced as a result of accidental injections may include increased heart rate, local reactions including injection site pallor, coldness and hypoesthesia or injury at the injection site resulting in bruising, bleeding, discoloration, erythema or skeletal injury.

Lacerations, bent needles, and embedded needles have been reported when Epinephrine Injection Mylan has been injected into the thigh of young children who are uncooperative and kick or move during the injection [see Warning and Precautions (7.2)].

•    Injection into the buttock has resulted in cases of gas gangrene [see Warnings and Precautions (7.2)].
Skin and Soft Tissue Infections
Rare cases of serious skin and soft tissue infections, including necrotizing fasciitis and myonecrosis caused by Clostridia (gas gangrene), have been reported following epinephrine injection, including Epinephrine Injection Mylan, in the thigh [see Warnings and Precautions (7.3)].

Reporting suspected adverse reactions after authorization 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