Adverse reactions : תופעות לוואי

4.8    Undesirable Effects
Mild reactions such as flush, urticaria, fever, and nausea occur rarely. These reactions normally disappear rapidly when the infusion rate is slowed down or the infusion is stopped.
Very rarely, severe reactions such as shock may occur. In case of severe reactions, the infusion should be stopped and an appropriate treatment should be initiated.
The following adverse reactions have been observed for human albumin solutions during the postmarketing phase and can therefore also be expected for Albunorm 5%.


System Organ Class                              Reactions
(frequency not known)*


Immune system disorders                  anaphylactic shock anaphylactic reaction hypersensitivity
Psychiatric disorders                    confusional state
Nervous system disorders                 headache
Cardiac disorders                        tachycardia bradycardia
Vascular disorders                       hypotension hypertension flushing
Respiratory, thoracic and                dyspnoea mediastinal disorders
Gastrointestinal disorders               nausea
Skin and subcutaneous tissue             urticaria disorders                                angioneurotic oedema rash erythematosus hyperhidrosis
General disorders and                    pyrexia administration site conditions           chills
* cannot be estimated from the available data


For safety with respect to transmissible agents, see 4.4.
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 http://forms.gov.il/globaldata/getsequence/getsequence.aspx?formType=AdversEffectMedic @moh.gov.il