Adverse reactions : תופעות לוואי

4.8   Undesirable effects
Summary of the safety profile
Most adverse drug reactions (ADRs) were mild to moderate in nature. In isolated cases human normal immunoglobulins may cause an anaphylactic shock.

Tabulated list of adverse reactions
The following adverse reactions have been reported in the context of 4,810 subcutaneous applications of Zutectra during four completed clinical trials and 1,006 applications during a non-interventional post marketing safety study (PASS).
The ADRs reported in four trials are summarised and categorised according to the MedDRA system organ class and frequency below. Frequency per injection has been evaluated using 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 decreasing seriousness.

MedDRA System                      Adverse reactions                   Frequency Organ Class
Infections and infestations        Nasopharyngitis                     Rare* Immune system disorders            Hypersensitivity                    Rare* Nervous system disorders           Headache                            Uncommon Cardiac disorders                  Palpitations, cardiac discomfort    Rare* Vascular disorders                 Hypertension                        Rare* Respiratory, thoracic and          Oropharyngeal pain                  Rare* mediastinal disorders
Gastrointestinal disorders         Upper abdominal pain                Uncommon Skin and subcutaneous tissue       Pruritus, rash                      Rare* disorders
Musculoskeletal and connective     Muscle spams                        Rare* tissue disorders

General disorders and               Injection site pain, injection site   Common administration site conditions      urticaria, injection site haematoma, injection site erythema
Fatigue, tiredness                    Rare*
* single case reports


Adverse reactions observed with other human immunoglobulin preparations With normal immunoglobulins 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 normal 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.

Injection site reactions
Swelling, soreness, redness, induration, local heat, itching, bruising and 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.il Additionally, you should also report to Kamada LTD to email address: pharmacovigilance@kamada.com