Adverse reactions : תופעות לוואי

4.8   Undesirable effects
Summary of safety profile

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 these cases, the infusion should be stopped and an appropriate treatment should be initiated.

Tabulated list of adverse reactions

The table presented below is according to the MedDRA System Organ Classification (SOC) and Preferred Term Level (PT) and it includes undesirable effects occurring with the use of human albumin solutions.

Frequencies have been evaluated according to the following convention: 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); very rare (<1/10,000), not known (cannot be estimated from the available data).
There are no robust data on the frequency of undesirable effects from clinical trials.
The following data is in line with the safety profile of human albumin solutions, and confirmed by the post marketing experience; as the post marketing reporting of adverse reactions is voluntary and from a population of uncertain size, it is not possible to reliably estimate the frequency of these reactions:

MedDRA System Organ                Adverse reactions               Frequency Class (SOC)                   (MedDRA Preferred
Term)

Hypotension                   Not known
Vascular disorders

Nervous system disorder            Tremor                        Not known Respiratory, thoracic and          Dyspnea                       Not known mediastinal disorder

Erythema                      Not known

Skin and subcutaneous tissue disorder
Urticaria                     Not known
Pruritus                      Not known

Chills                        Not known
General disorders and administration site conditions
Pyrexia                       Not known


For safety information with respect to transmissible agents, see section 4.4.

Paediatric population
No specific data are available on paediatric population.
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
Additionally, you should also report to Kamada Ltd. to email address: pharmacovigilance@kamada.com