Adverse reactions : תופעות לוואי

4.8.    Undesirable effects
Immediate hypersensitivity reactions can occur. These reactions may comprise one or more of the following effects, either concomitantly or successively: skin, respiratory and/or cardiovascular reactions. Each of these effects can be a precursor sign of anaphylactic shock. The most frequently reported effects in a context of hypersensitivity reaction include rash, pruritus, erythema, urticaria, angioedema (such as face oedema or laryngeal oedema), bronchospasm, tachycardia, hypotension, and circulatory collapse.


A bluish discoloration of the integuments is observed after injection, which resolves over the following 24 to 48 hours. The discoloration can persist for longer in the event of lymph stasis or circulatory disorders.
Undesirable effects are given in the table below by System Organ Class and by frequency, using the following classifications: very commom (≥1/10), common (≥1/100 to 1<1/10), uncommon (≥1/1,000 to 1<1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), unknown (cannot be estimated from available data).
System Organ Class                                       Frequency: adverse event Immune system disorders                                  Unknown frequency: anaphylactic shock, hypersensitivity
Cardiac disorders                                        Unknown frequency: tachycardia Vascular disorders                                       Unknown frequency: circulatory collapse, hypotension
Respiratory, thoracic and mediastinal disorders           Unknown frequency: bronchospasm 
Skin and subcutaneous tissue disorders                    Unkown frequency: angio-oedema, urticaria, rash, pruritus, erythema, blue discolouration of the skin
General disorders and administration site conditions      Unknown frequency: discolouration of the administration site


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: drugsafety@neopharmgroup.com