Adverse reactions : תופעות לוואי

4.8   Undesirable effects

Side-effects of adrenaline in general are associated with the α- and β-receptor activity of adrenaline.
The following table is based upon experience with the use of adrenaline.
The adverse events were classified according to the following frequencies: Very common (1/10)
Common (1/100, <1/10)
Uncommon (1/1,000, <1/100)
Rare (1/10,000 to <1/1,000)
Very rare (<1/10,000)
Not known (cannot be estimated from the available data).

System organ class         Frequency      Adverse reaction
Metabolic and              Not known      Hyperglycaemia,
nutrition disorders                       hypokalaemia, acidosis
Psychiatric disorders      Not known      Anxiety, hallucination
Nervous system             Not known      Headache, dizziness, tremor, disorders                                 syncope
Cardiac disorders          Not known      Tachycardia, arrhythmia,
palpitations, angina pectoris,
stress cardiomyopathy
Vascular disorders         Not known      Hypertension,
vasoconstriction, peripheral ischaemia
Respiratory, thoracic      Not known      Bronchospasm and mediastinal disorders
Gastrointestinal           Not known      Nausea, vomiting disorders
General disorders and      Not known      Hyperhidrosis, asthenia administration site conditions

Emerade contains sodium metabisulphite, which may rarely cause severe hypersensitivity reactions (see section 4.4).

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/ and emailed to the Registration Holder’s Patient Safety Unit at: drugsafety@neopharmgroup.com