Oropharyngeal swelling
Uncommon
Gastrointestinal disorders
Nausea
Very common
Diarrhoea, vomiting, abdominal pain, dyspepsia
Common
Abdominal distension
Uncommon
Skin and subcutaneous tissue disorders
Rash
Very common
Contusion, pruritus, urticaria, dermatitis, erythema
Common
Angioedema, acute urticaria, cold sweat, photosensitivity reaction, night sweats, hyperhidrosis
Uncommon
Musculoskeletal and connective tissue disorders
Back pain, arthralgia, pain in extremity, myalgia, muscle spasms, muscular weakness
Common
Muscle twitching
Uncommon
Renal and urinary disorders
Proteinuria
Uncommon
General disorders and administration site conditions
Local reactions (e.g. infusion site pain/swelling/reaction/pruritus), pyrexia, fatigue
Very common
Chills, edema, influenza-like illness, chest discomfort, chest pain, asthenia, malaise, rigors
Common
Chest tightness, feeling hot, burning sensation, swelling
Uncommon
Investigations
Blood cholesterol increased, blood creatinine increased, blood urea increased, white blood cell count decreased, alanine aminotransferase increased, haematocrit decreased, red blood cell count decreased, respiratory rate increased
Uncommon
Tabe 2
Post-Marketing Adverse Reactions (ARs)
MedDRA
System Organ Class (SOC)
Adverse reaction
Frequency
Blood and lymphatic system disorders
Hemolysis
Not known
Immune system disorders
Anaphylactic shock
Not known
Nervous system disorders
Transient ischemic attack, cerebral vascular accident
Not known
Cardiac disorders
Myocardial infarction
Not known
Vascular disorders
Hypotension, deep vein thrombosis
Not known
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism, pulmonary edema
Not known
Investigations
Coombs direct test positive, oxygen saturation decreased
Not known
Injury, poisoning and procedural complications
Transfusion-related acute lung injury
Not known
Description of selected adverse reactions
Muscle twitching and weakness were reported only in patients with MMN.
Paediatric population
Frequency, type and severity of adverse reactions in children are the same as in adlts.
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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
For safety with respect to transmissible agents, see section 4.4.
4.9 Overdose
Overdose may lead to fluid overload and hyperviscosity, particularly in patients at risk, including elderly patients or patients with cardiac or renal impairment.
Paediatric population
Smaller children below the age of 5 years may be particularly susceptible to volume overload. Therefore, dosing should be carefully calculated for this population. In addition, children with Kawasaki Disease are at especially high risk due to underlying cardiac compromise so dose and rate of administration should be carefully controlled.
5. Pharmacological properties
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: immune sera and immunoglobulins: immunoglobulins, normal human, for intravascular administration, ATC code: J06BA02
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