Frequency has been evaluated using the following criteria: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), and very rare (<1/10,000), not known (cannot be estimated from the available data). (See table.)
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In cases of severe reactions, the infusion should be stopped and an appropriate treatment should be initiated.
In post-marketing surveillance the following adverse events have been reported. These events are listed by MedDRA System Organ Class, then by Preferred Term in order of severity.
Immune System Disorders: Anaphylactic reaction, Hypersensitivity/Allergic reactions.
Nervous System Disorders: Headache, Dysguesia.
Cardiac Disorders: Myocardial infarction, Atrial fibrillation, Tachycardia.
Vascular Disorders: Hypotension.
Respiratory, Thoracic, and Mediastinal Disorders: Pulmonary edema, Dyspnea.
Gastrointestinal Disorders: Vomiting.
Skin and Subcutaneous Tissue Disorders: Urticaria, Pruritis.
General Disorders and Administration Site Conditions: Chills.
There are no data available on adverse reactions from company-sponsored clinical trials conducted with Albumin (Human).
For safety with respect to transmissible agents, see Precautions.
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. Healthcare professionals are asked to report any suspected adverse reactions.