Adverse reactions : תופעות לוואי

4.8   Undesirable effects

The following adverse reactions are based on post marketing experience and were observed very rarely (< 1/10,000 including reported single cases):
• General disorders and administration site conditions:
Chills, fever, nausea, vomiting, headache, malaise and flush.
• Immune system disorders:
Hypersensitivity reactions or allergic-anaphylactic reactions such as rash, itching, urticaria, dyspnoea, tachycardia, bradycardia, hypotension. These reactions might in single cases be reaching as far as life-threatening shock.

Mild reactions normally disappear rapidly after the infusion rate has been slowed down or the infusion stopped. In case of severe reactions (e.g. anaphylactic shock) the infusion has to be stopped immediately and appropriate treatment instituted.

For safety with respect to transmissible agents, see section 4.4 "Special warnings and precautions for use".

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