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Human normal Ig

Replacement therapy in primary immunodeficiency syndromes (PID) eg, congenital hypo- & agammaglobulinaemia, common variable & severe combined immunodeficiency, Wiskott-Aldrich syndrome; myeloma or chronic lymphocytic leukaemia w/ severe secondary hypogammaglobulinaemia & recurrent infections; childn w/ congenital AIDS & recurrent infections. Immune thrombocytopenic purpura (ITP) in childn or adults at high risk of bleeding or prior to surgical interventions to correct platelet count; Guillain-Barré syndrome, Kawasaki disease, chronic inflammatory demyelinating polyneuropathy (CIDP). Allogeneic bone marrow transplantation.

Replacement therapy in PID Initially 0.4-0.8 g/kg followed by at least 0.2 g/kg every 3-4 wk. Replacement therapy in myelomas or chronic lymphocytic leukaemia w/ severe secondary hypogammaglobulinaemia & recurrent infections; replacement therapy in childn w/ congenital AIDS & recurrent infections 0.2-0.4 g/kg every 3-4 wk. Acute ITP 0.8-1 g/kg on day 1, may be repeated once w/in 3 days or 0.4 g/kg daily for 2-5 days. Guillain-Barré syndrome 0.4 g/kg daily over 5 days. Kawasaki disease 1.6-2 g/kg in divided doses over 2-5 days or 2 g/kg as single dose. CIDP Initially 2 g/kg divided over 2-5 consecutive days followed by 1 g/kg maintenance dose given on 1 day or divided over 2 consecutive days every 3 wk. Allogeneic bone marrow transplantation Initially 0.5 g/kg wkly commencing 7 days pre-transplant & continued 3 mth post-transplant. Persistent lack of Ab production 0.5 g/kg mthly until normal Ab levels.

Hypersensitivity to human Ig particularly in IgA deficiency where patient has anti-IgA Ab. Hyperprolinaemia.

Hypersensitivity. Not indicated in patients w/ selective IgA deficiency. High rate of infusion; patients w/ hypo- or agammaglobulinaemia w/ or w/o IgA deficiency, 1st time receiving human normal Ig therapy, or when human normal Ig is switched or long interval since previous infusion. Haemolytic anaemia; aseptic meningitis syndrome; obese patients, preexisting risk factors for thrombotic events eg, HTN, DM, history of vascular disease or thrombotic episodes, acquired or inherited thrombophilic disorders, prolonged periods of immobilisation, severe hypovolaemia, diseases which increases blood viscosity; risk factors for acute renal failure eg, preexisting renal insufficiency, overwt; transfusion-related acute lung injury. Possibility of transmitting infective agents. Monitor for any symptoms throughout therapy. Ensure adequate hydration prior to infusion. False +ve results in serological tests. Concomitant use w/ nephrotoxic medicinal products. May affect ability to drive & use machines. Discontinue use in case of renal impairment. Pregnancy & lactation. Paed. Elderly >65 yr.

Headache, sinus & tension headache, migraine, head discomfort; pain, back, neck & facial pain, pain in extremity, arthralgia, pyrexia, chills, flu-like illness, nasopharyngitis, pharyngolaryngeal pain, oropharyngeal blistering, throat tightness. Anaemia, haemolysis, haemolytic anaemia, leukopenia; hypersensitivity; dizziness, vertigo; HTN, flushing, hot flush, hyperaemia, hypotension; dyspnoea, chest pain & discomfort, painful respiration; nausea, vomiting, diarrhoea, abdominal pain; hyperbilirubinaemia; skin disorder & exfoliation, rash, pruritus, urticaria, maculopapular rash, erythema; myalgia, muscle spasms, musculoskeletal stiffness & pain; fatigue, asthenia, muscular weakness; decreased Hb, RBC count & haematocrit, +ve direct Coombs' test, increased ALT, AST & blood LDH.

Impaired efficacy of live attenuated virus vaccines eg, MMR, chickenpox. Not to be mixed w/ other medicinal products or physiological saline.

Vaccines, Antisera & Immunologicals

J06BA02 - immunoglobulins, normal human, for intravascular adm. ; Belongs to the class of normal human immunoglobulins. Used in passive immunizations.

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