Hypersensitivity and anaphylactic reactions may occur. Aseptic meningitis syndrome reported with intravenous immune globulin administration (rare). Acute renal dysfunction (increased serum creatinine, oliguria, acute renal failure) can rarely occur. Not indicated for use in adults. Not indicated for children ≥1 year of age. As a product of human plasma it may potentially contain infectious agents which could transmit disease (risk of Creutzfeldt-Jakob disease). For I.V. administration exclusively. May facilitate oral candidiasis. Irritability is common. May cause agitation. Rash is common (be mindful if patient is also receiving lamotrigine). Gastrointestinal side-effects are common. Concomitant use with SSRIs, lithium, or valproic acid may produce additive effects. If hypotension or anaphylaxis occurs, BIG-IV should be discontinued immediately.