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).


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 <1/1,000); Very rare (<1/10,000); Not known (cannot be estimated from the available data).

Adverse reactions from clinical trials:
In four clinical trials no adverse reactions with Hepatect CP were identified.
Adverse reactions from post-marketing experience and non-interventional studies (frequencies not known - cannot be estimated from the available data): 

MedDRA Standard System             Adverse reactions
Organ Class
Immune system disorders            Anaphylactic shock,
hypersensitivity
Nervous system disorders           Headache, dizziness

Cardiac disorders                  Tachycardia

Vascular disorders                 Hypotension
Gastrointestinal disorders         Nausea

Skin and subcutaneous tissue       Skin reaction, rash, pruritus disorders
General disorders and              Pyrexia, malaise administration site conditions

For safety information with respect to transmissible agents, see section 4.4 
Paediatric population
Adverse reactions in children are expected to be the same as in adults.

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