Pentaglobin Adverse Reactions

Summary of the safety profile: Adverse reactions caused by human normal immunoglobulins (in decreasing frequency) encompass (see also Precautions): 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).
Information on safety with regard to transmissible agents: see Precautions.
Tabulated summary of adverse reactions observed with the use of Pentaglobin: Table 2 shows the adverse reactions from clinical trials of Pentaglobin and Table 3 shows the adverse reactions from post-marketing experience with Pentaglobin.
The assessment of adverse reactions is based on the following frequency categories: 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). (See Tables 2 and 3.)

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Paediatric population: Although the nature and frequency of adverse reactions in the age groups neonates and infants are generally comparable to the adverse reactions in other age groups (e.g. infusion reactions, anaphylactic reactions, hypersensitivity), their clinical presentation in terms of the reported signs and symptoms vary and may additionally include e.g. changes in heart rate (tachycardia or bradycardia), tachypnea, oxygen saturation decreased, skin discolorations including pallor and/or cyanosis, and hypotonia.
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. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system.