Adverse reactions : תופעות לוואי

4.8   Undesirable effects
Summary of the safety profile
Adverse reactions caused by human normal immunoglobulins (in decreasing frequency) encompass (see also section 4.4):
• chills, headache, dizziness, fever, vomiting, allergic reactions, nausea, arthralgia, low blood pressure and moderate low back pain
• reversible haemolytic reactions; especially in those patients with blood groups A, B, and AB and (rarely) haemolytic anaemia requiring transfusion
• (rarely) a sudden fall in blood pressure and, in isolated cases, anaphylactic shock, even when the patient has shown no hypersensitivity to previous administration
• (rarely) transient cutaneous reactions (including cutaneous lupus erythematosus – frequency unknown)
• (very rarely) thromboembolic reactions such as myocardial infarction, stroke, pulmonary embolism, deep vein thromboses
• cases of reversible aseptic meningitis
• cases of increased serum creatinine level and/or occurrence of acute renal failure • cases of Transfusion Related Acute Lung Injury (TRALI)
For safety information with respect to transmissible agents, see section 4.4.

Tabulated list of adverse reactions
The table presented below is according to the MedDRA system organ classification (SOC) and Preferred Term (PT) 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 <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).Within each frequency grouping, the adverse reactions are presented in the order of decreasing seriousness.

Adverse reactions from clinical trials:
In the clinical trial program (3 clinical trials, single dose) conducted with Biotest CMVIG preparations involving 33 patients in total, no adverse drug reactions related to Biotest CMVIG products have been identified.

Adverse reactions from post-marketing experience (frequencies not known - cannot be estimated from the available data):

MedDRA System Organ Class                 Adverse reactions
Blood and lymphatic system disorders      Haemolytic anaemia

Immune system disorders                   Anaphylactic shock,
anaphylactic reaction, anaphylactoid reaction,
hypersensitivity
Nervous system disorders                  Headache, dizziness
Gastrointestinal disorders                Vomiting
Skin and subcutaneous tissue disorders Rash, erythema, drug eruption, pruritus 
Musculoskeletal and connective tissue     Arthralgia disorders

Renal and urinary disorders               Acute renal failure
General disorders and administration      Chills, pyrexia, fatigue site conditions
Investigations                            Blood creatinine increased

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