Flebogamma 5% DIF

Flebogamma 5% DIF

human normal immunoglobulin

Manufacturer:

Grifols

Distributor:

DKSH
Concise Prescribing Info
Contents
Human normal Ig
Indications/Uses
Replacement therapy in primary immunodeficiency syndromes eg, congenital agammaglobulinaemia & hypogammaglobulinaemia, common variable immunodeficiency, severe combined immunodeficiency & Wiskott-Aldrich syndrome; myeloma or chronic lymphocytic leukaemia w/ severe secondary hypogammaglobulinaemia & recurrent infections; childn w/ congenital AIDS & recurrent infections. Immunomodulation in idiopathic thrombocytopenic purpura (ITP), Guillain-Barré syndrome, Kawasaki disease. Allogenic bone marrow transplantation.
Dosage/Direction for Use
Primary immunodeficiency Initially 0.4-0.8 g/kg followed by at least 0.2 g/kg every 3 wk; thereafter 0.2-0.8 g/kg/mth every 2-4 wk. Secondary immunodeficiency & childn w/ AIDS 0.2-0.4 g/kg every 3-4 wk. ITP 0.8-1 g/kg on day 1, possibly repeated once w/in 3 days or 0.4 g/kg/day for 2-5 days. Guillain-Barré syndrome 0.4 g/kg/day for 3-7 days. Kawasaki disease In association w/ acetylsalicylic acid, 1.6-2 g/kg in several doses for 2-5 days or 2 g/kg in 1 dose. Allogenic bone marrow transplantation Treatment of infection & prophylaxis of graft versus host disease 0.5 g/kg every wk from day-7 up to 3 mth after transplant. Persistent lack of Ab production: 0.5 g/kg every mth. Infuse IV at an initial rate of 0.01-0.02 mL/kg/min for 1st 30 min; may be gradually increased to max 0.1 mL/kg/min.
Contraindications
Hypersensitivity to homologous Ig. Fructose intolerance.
Special Precautions
Patients naive to human normal Ig. MI, stroke, pulmonary embolism, DVT, obese patients, advanced age, HTN, DM, history of vascular disease or thrombotic episodes, acquired or inherited thrombophilic disorders, prolonged periods of immobilisation, severe hypovolaemia, diseases which increase blood viscosity. Ensure adequate hydration. Monitor urine output & serum creatinine. Avoid concomitant loop diuretics. Use w/ caution when driving or operating machinery. Infant & young childn due to possible fructose intolerance. Pregnancy, lactation.
Adverse Reactions
Occasionally, chills, headache, fever, vomiting, allergic reactions, nausea, arthralgia, low BP & moderate low back pain. Aseptic meningitis, reversible haemolytic anaemia/haemolysis, increased serum creatinine, acute renal failure.
Drug Interactions
ATC Classification
J06BA - Immunoglobulins, normal human ; Used in passive immunizations.
Presentation/Packing
Form
Flebogamma 5% DIF soln for infusion 2.5 g/50 mL
Packing/Price
1's
Form
Flebogamma 5% DIF soln for infusion 5 g/100 mL
Packing/Price
1's
Form
Flebogamma 5% DIF soln for infusion 10 g/200 mL
Packing/Price
1's
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