Adverse reactions : תופעות לוואי

4.8   Undesirable effects

Summary of the Safety Profile
Allergic or anaphylactic-type reactions have been uncommonly observed, including severe anaphylactic reactions (see section 4.4).
Replacement therapy may lead to the formation of circulating antibodies inhibiting one or more of the human prothrombin complex factors. If such inhibitors occur, the condition will manifest itself as a poor clinical response. In such cases, it is recommended to contact a specialised haemophilia center for guidance. Anaphylactic reactions have been observed in patients with antibodies to factors contained in Beriplex.

Increase in body temperature has been commonly observed.

There is a risk of thromboembolic episodes following the administration of human prothrombin complex (see section 4.4).

Tabulated list of adverse drug reactions of Beriplex
The following adverse reactions are based on clinical trial data, post marketing experience as well as scientific literature.

The table presented below is according to the MedDRA system organ classification (SOC and Preferred Term Level). Frequencies have been based on clinical trial data, 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) or not known (cannot be estimated from the available data).

MedDRA Standard              Adverse Drug Reaction by PT       Frequency System Organ Class

Vascular disorders and       Thromboembolic events*            common other SOCs
MedDRA Standard              Adverse Drug Reaction by PT          Frequency System Organ Class

Blood and lymphatic          Disseminated intravascular           not known system disorders             coagulation

Immune system                Hypersensitivity or allergic         uncommon disorders                    reactions

Anaphylactic reactions including     not known anaphylactic shock

Development of antibodies            not known
Nervous system               Headache                             common disorders

General disorders and        Body temperature increased           common administration site conditions

*including cases with fatal outcome

For safety with respect to transmissible agents, see section 4.4.
Paediatric population
No data are available regarding the use of Beriplex in 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/ and emailed to the Registration Holder’s Patient Safety Unit at:
PV-IL@cslbehring.com