Intragam P

Intragam P

human normal immunoglobulin

Manufacturer:

CSL Behring

Distributor:

HKRCBTS
Concise Prescribing Info
Contents
Human Ig
Indications/Uses
Replacement IgG therapy in: Primary immunodeficiency, myeloma & chronic lymphocytic leukaemia w/ severe secondary hypogammaglobulinaemia & recurrent infections; congenital or AIDs w/ recurrent infections. Immunomodulatory therapy in: Idiopathic thrombocytopenic purpura (ITP), allogeneic bone marrow transplantation, Kawasaki disease, Guillain-Barre syndrome (GBS).
Dosage/Direction for Use
Replacement therapy 0.2-0.6 g/kg body wt/mth as single or 2 equal doses. Thereafter, 0.4-0.6 g/kg body wt/mth for several mth. ITP Max: 2 g/kg body wt over 2-5 days. Kawasaki disease 1.6-2 g/kg body wt in divided dose over 2-5 days or 2 g/kg body wt as single dose. Allogeneic bone marrow transplantation Starting dose: 0.5 g/kg body wt wkly. GBS 0.4 g/kg body wt/day for 5 days.
Contraindications
Hypersensitivity to a human IgG prep.
Special Precautions
For IV use only. Anaphylaxis in patients w/ IgA deficiency. Aseptic meningitis syndrome (AMS) in patients w/ high dose. Renal dysfunction in patients w/ pre-existing renal insufficiency, DM, elderly >65 yr, vol depletion, sepsis, paraproteinaemia, concomitant use w/ nephrotoxic drugs. Haemolysis in patients w/ blood group A, B or AB, those who have underlying associated inflammatory conditions & those receiving high cumulative doses of IVIG over the course of several days. Thrombotic events in patients w/ advanced age, immobility, estrogen use, in-dwelling vascular catheters, acquired or hereditary hypercoagulable states, a history of venous or arterial thrombosis, cardiovascular risk factors (including history of atherosclerosis &/or impaired cardiac output) & conditions associated w/ increased plasma viscosity eg, fasting chylomicronemia &/or hypertriglyceridaemia, cryoglobulins & monoclonal gammopathies. Thrombophlebitis at the infusion site in patient w/ prolonged administration (>6 hr). Pregnancy & lactation.
Adverse Reactions
Haemolytic anaemia following high cumulative doses of IVIG over the course of several days in patients of blood group A, B or AB particularly in recipients w/ reduced bone marrow reserve or post haemopoietic stem cell transplant. Malaise, abdominal pain, headache, chest-tightness, facial flushing or pallor, erythema, hot sensations, dyspnoea or resp difficulty, non-urticarial skin rash, cutaneous vasculitis, pompholyx on hands/palms, itching, tissue swelling, change in BP, nausea or vomiting. Rigors, dizziness, aching legs or arthralgia. Mild & moderate elevations of serum transaminases.
Drug Interactions
Live, attenuated vaccines (poliomyelitis or measles).
MIMS Class
Vaccines, Antisera & Immunologicals
ATC Classification
J06BA02 - immunoglobulins, normal human, for intravascular adm. ; Belongs to the class of normal human immunoglobulins. Used in passive immunizations.
Presentation/Packing
Form
Intragam P inj 6 %
Packing/Price
200 mL x 1's;50 mL x 1's
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