Adverse reactions : תופעות לוואי

4.8.        Undesirable effects
Summary of the safety profile
Adverse reactions such as chills, headache, dizziness, fever, vomiting, allergic reactions, nausea, arthralgia, low blood pressure and moderate low back pain may occur occasionally.
Rarely human immunoglobulins may cause a sudden fall in blood pressure and, in isolated cases, anaphylactic shock, even when the patient has shown no hypersensitivity to previous administration.
Local reactions at administration sites: swelling, soreness, redness, induration, local heat, itching, bruising and rash. The following adverse reactions have been reported from post-marketing experience.
Tabulated list of adverse reactions
The table presented below is according to the MedDRA system organ classification (SOC and Preferred Term Level). 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 <1,1000); very rare (<1/10,000), not known (cannot be estimated from the available data).
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.

MedDRA System Organ Class Adverse reaction                            Frequency Immune system disorders             Hypersensitivity, anaphylactic
Not known shock

Nervous system disorders            Headache                         Not known 
Cardiac disorders                   Tachycardia                      Not known 
Vascular disorders                  Hypotension                      Not known 
Gastrointestinal disorders          Nausea, vomiting                 Not known 
Skin and subcutaneous tissue        Skin reaction, erythema,         Not known disorders                           pruritus

Musculoskeletal and connective      Arthralgia, back pain            Not known tissue disorders

MedDRA System Organ Class Adverse reaction                          Frequency General disorders and            Pyrexia, malaise, chills administration site conditions
At the injection site: swelling,   Not known pain, erythema, induration,
warmth, pruritus, rash


For safety information with respect to transmissible agents, see section 4.4.
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.
Additionally, you should also report to Kamada LTD to email address: pharmacovigilance@kamada.com