Adverse reactions : תופעות לוואי

4.8   Undesirable effects

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).

Very           Common         Uncommon            Rare          Very rare Common
Immune system disorders                                                                           anaphylactic shock
Gastrointestinal disorders                                                         nausea 
Skin and subcutaneous tissue                                                    flushing, skin disorders                                                                            rash General disorders and                                                               fever 
administration site conditions

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 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