Do not use product if it is turbid or cloudy, or contains any sediment or particles. Contact the hospital blood bank or pharmacy.

Transcription

1 octagam 5% and octagam 10% Liquid Human Normal Immunoglobulin Solution for intravenous infusion Information for clinicians and nurses Intravenous Immunoglobulin (IVIg) Infusions The following general information on IVIg infusions has been prepared by Octapharma with the aim of ensuring that IVIg infusions are as safe and convenient to administer as possible. Always refer to the octagam Product Information prior to use.* If you have any queries about octagam 5% or octagam 10%, please contact Octapharma Australia Pty Ltd on * Please note changes in the Product Information. octagam 5% [50mg/mL] and octagam 10% [100mg/mL] General Infusion Information 1, 2 Always refer to the octagam Product Information before prescribing.* The following are some general points to consider prior to infusing octagam 5% and octagam 10%: octagam solutions should be brought to room or body temperature prior to administration. octagam 5% and octagam 10% do not contain antimicrobial agents. The products must therefore be used immediately after opening. Any remaining contents must be discarded. Do not use product if it is turbid or cloudy, or contains any sediment or particles. Contact the hospital blood bank or pharmacy. A volumetric pump may be used to administer octagam 5% and octagam 10%. An in-line filter is not necessary when administering octagam 5% and octagam 10%; however, if there is an in-line filter already in an infusion line it will not pose any problems. Priming and flushing the infusion line normal saline, water for injections or 5% glucose may be used for this purpose. Compatibility with other i.v. fluids has not been evaluated therefore octagam 5% and octagam 10% should not be mixed with other fluids. In the interest of patients, it is recommended that the batch number of the product is recorded before administration. A peel off batch label is provided on every vial. * Please note changes in the Product Information. Potential interference with blood and urinary blood glucose tests Glucose monitoring systems (test strips) using the glucose dehydrogenase pyrroloquinolinequinone (GDH-PQQ) or the glucose-dye-oxidoreductase method will report falsely elevated glucose readings in the presence of maltose. octagam 5% and octagam 10% contain maltose. To reduce the risk of inppropriate administration of insulin due to falsely elevated glucose readings, the following precautions should be taken when patients are receiving maltose containing products: Review the product insert of the glucose monitoring system/test strips, or contact the manufacturer of the testing system to determine which glucose determination method is used. Only use those systems that use glucose oxidase or hexokinase, or glucose dehydrogenase-nad (GDH-NAD) for the method of glucose determination.

2 Administration of octagam 5% and octagam 10% Certain severe adverse drug reactions reported with the administration of IVIg products may be related to the rate of infusion. The recommended infusion rates must be closely followed and patients closely monitored and observed for any symptoms throughout the infusion period, and in line with your hospital s policy. In particular, patients naive to human normal immunoglobulin, patients switched from an alternative IVIg product, or when treatment has been stopped for more than eight weeks these patients should be monitored during the first infusion and for the first hour after the first infusion, in order to detect potential adverse signs. All other patients should be observed for at least 20 minutes after administration. The following are some general points to consider during an infusion of octagam : Infusion rates (ml/kg/hr) Patients judged to be at risk of renal dysfunction Patients judged to be at risk of thromboembolism Elderly patients or patients with preexisting risk factors, or risk factors for renal disease octagam 5% [50mg/mL] 1 octagam 10% [100mg/mL] 2 Infuse intravenously at an initial rate of 1 ml/kg/hr for 30 minutes. If well tolerated, the rate of administration may gradually be increased to a maximum of 5 ml/kg/hr. It may be prudent to reduce the amount of product infused per unit time by infusing at a maximum rate less than 4mL/kg/hr. Infuse intravenously at an initial rate of 0.6 to 1.2 ml/kg/hr for 30 minutes. If well tolerated, the rate of administration may gradually be increased to a maximum of 7.2 ml/kg/hr Product should be administered at the minimum rate of infusion and dose practicable. Product should be administered at the minimum rate of infusion practicable and patients should be monitored closely for signs and symptoms of thromboembolism, particularly during the infusion and for up to 72 hours after the infusion. Refer to the octagam product information for full details of risk factors for thrombembolic events. Consideration should be given to a lower rate of infusion. Refer to the octagam product information for full details of risk factors and precautions. If an adverse drug reaction occurs, either the rate of administration must be reduced or the infusion stopped. Consult the treating doctor. Adverse events must be reported to Octapharma by calling Product Characteristics octagam 5% 1 octagam 10% 2 Concentration 50mg/mL 100mg/mL Presentations 1g (20mL) 2g (20mL) Storage Conditions 2.5g (50mL) 5g (100mL) 10g (200mL) Store below 25 C. Do not freeze. Protect from light. 5g (50mL) 10g (100mL 20g (200mL) Store at 2 C to 8 C (Refrigerate. Do not freeze). Protect from light. Once removed from refrigeration, the product may be stored below 25 C for a single period of 3 months. In this case the product expires at the end of the 3 month period. The product may not be returned to refrigerated storage after storage below 25 C. Shelf life 2 years 2 years 1. octagam 5% approved Product Information 2. octagam 10% approved Product Information Octapharma Australia Pty Ltd Jones Bay Whard, 42/26-32 Pirrama Road Pyrmont NSW 2009 Australia ABN Medical Enquiries: AUDE002/2 Issue Date: Nov 2011

3 OCTAGAM 5% [50 mg/ml] - Abbreviated product information Please review the approved Product Information before prescribing. INDICATIONS: Replacement therapy in primary immunodeficiency (PID) syndromes (congenital agammaglobulinaemia & hypogammaglobulinaemia, common variable immunodeficiency, severe combined immunodeficiencies, Wiskott Aldrich syndrome), myeloma or chronic lymphocytic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections, and in children with congenital AIDS who have repeated bacterial infections. As an immunomodulator in idiopathic thrombocytopenic purpura (in adults or children with a high risk of bleeding or prior to surgery to correct the platelet count), Guillain Barré syndrome and Kawasaki disease. Allogeneic bone marrow transplantation. CONTRAINDICATIONS: Hypersensitivity to homologous immunoglobulins (Ig), especially in very rare cases of IgA deficiency, when the patient has antibodies against IgA. Allergies to any human Ig preparation or constituents of OCTAGAM. WARNINGS: When medicinal products prepared from human blood/plasma are administered, infectious diseases due to transmission of infective agents cannot be totally excluded. This also applies to pathogens of unknown nature and theoretically to Creutzfeld-Jacob Disease (CJD) agents. The risk of transmission of infective agents is reduced by; selection of donors by medical interview, screening of donations for the 3 major pathogenic viruses (HIV, HCV, HBV), testing of plasma pools for HCV genomic material, and validated removal/inactivation procedures in the production process that are considered effective for HIV, HCV and HBV but may be of limited value against non-enveloped viruses (i.e. HAV or parvovirus B19). The manufacturing process for OCTAGAM has also been shown to decrease the amount of an experimental agent of transmissible spongiform encephalopathy (TSE), considered a model for the vcjd and CJD agents. Vaccination for patients in receipt of medicinal products made from human plasma should be considered where appropriate. PRECAUTIONS: Severe adverse drug reactions may be related to the rate of infusion. Patients must be monitored and observed for symptoms during the infusion. Adverse reactions may occur more frequently; with high infusion rates, in patients with hypo/ agammaglobulinemia with or without IgA deficiency, and in patients receiving human normal Ig for the first time or, in rare cases, when the product is switched or when treatment has stopped for more than 8 weeks. True hypersensitivity reactions are rare. They can occur in cases of IgA deficiency with anti-iga antibodies. Rarely, human normal Ig can induce a fall in blood pressure with an anaphylactic reaction, even in patients who have tolerated previous treatment with human normal Ig. Complications can often be avoided by ensuring; patients are not sensitive to human normal Ig by first injecting the product slowly (1 ml/kg/hr), and carefully monitoring patients for any symptoms during the infusion. Patients naive to human normal Ig, patients switched from an alternative intravenous Ig (IVIg) product or when treatment has stopped for more than 8 weeks, should be monitored during the first infusion and for the first hour after the first infusion (to detect potential adverse signs). All other patients should be observed for at least 20 minutes after administration. Cases of renal dysfunction, acute renal failure, osmotic nephrosis and death have been reported in patients receiving IVIg therapy identified risk factors include pre-existing renal insufficiency, diabetes mellitus, hypovolemia, sepsis, overweight, concomitant nephrotoxic medicinal products or age over 65. Where there is a risk for developing renal dysfunction, it may be prudent to reduce the amount of product infused per unit time by infusing OCTAGAM at a maximum rate less than 0.2 g/kg/hr. In all patients, IVIg administration requires; adequate hydration prior to infusion, monitoring of urine output and serum creatinine levels, and avoidance of concomitant use of loop diuretics. In case of renal impairment, IVIg discontinuation should be considered. Renal dysfunction and acute renal failure have been associated with the use of IVIg products; however, those containing sucrose as a stabiliser accounted for a disproportionate share. In patients at risk, the use of IVIg products that do not contain sucrose may be considered. OCTAGAM should be administered at the minimum concentration and infusion-rate practicable. In case of adverse reaction, the rate of infusion must be reduced or the infusion stopped. Arterial and venous thromboembolic events (TEEs) have been reported in association with OCTAGAM, particularly in those with known risk factors. While the pathogenesis of TEEs associated with IVIg s is assumed to be multifactorial, a relative increase in blood viscosity from the high influx of Ig and/ or the presence of procoagulant factors in the Ig solution are possible mechanisms. There was an increased rate of TEEs reported in 2010 associated with OCTAGAM. The unexpected presence of factor XIa appeared to be the main cause for the TEEs. Corrective measures in the manufacturing process of OCTAGAM have been implemented. Arterial TEEs (included myocardial infarction and stroke) occurred mostly during OCTAGAM infusion or within the first 24 hours post infusion. Venous TEEs (included deep vein thromboses and pulmonary embolism) occurred mostly within 72 hours post OCTAGAM infusion. Caution should be exercised in prescribing and infusing IVIg in patients with pre-existing risk factors for arterial and venous TEEs such as obesity, smoking, a history of atherosclerosis/vascular disease or thrombotic events, hypertension, diabetes, hyperlipidaemia, multiple cardiovascular risk factors, advanced age, impaired cardiac output, pregnancy and the puerperium, oestrogen-containing hormone replacement therapy or oral contraceptive, acquired or inhertited thrombophilic disorders, prolonged periods of immobilisation, hypovolemia, surgery, central venous catheterisation, active malignancy and/or known or suspected hyperviscosity. Potential risks and benefits of IVIg s, including OCTAGAM should be weighed against those of alternative therapies for all patients for whom IVIg administration is being considered. Baseline assessment of blood viscosity should be considered in patients at risk for hyperviscosity, including those with cryoglobulins, fasting chylomicronaemia/markedly high triglycerides, or monoclonal gammopathies. Patients should be monitored closely for signs and symptoms of thromboembolism, particularly during and for 72 hours after OCTAGAM infusion. Rapid rates of IVIg infusion may be a risk factor for TEEs. The recommended infusion rate should not be exceeded. For patients judged to be at risk of developing TEEs, administer OCTAGAM at the minimum rate of infusion practible. The decision to take antithrombotic prophylactic measures is a clinical decision that requires an assessment of the patients underlying risk factors. Aseptic meningitis syndrome (AMS) can occur infrequently in association with IVIg treatment. Discontinuation of IVIg treatment has resulted in remission of AMS within several days without sequelae. AMS usually begins within several hours to two days following treatment and is characterised by severe headache, nuchal rigidity, drowsiness, fever, photophobia, painful eye movements, nausea and vomiting. Cerebrospinal fluid (CSF) studies are frequently positive with pleocytosis, predominantly from the granulocytic series, and elevated protein levels up to several g/l. Patients exhibiting symptoms and signs should receive a neurological examination, including CSF studies, to rule out other causes of meningitis. Patients with a history of migraine may be more susceptible. IVIg products can contain blood group antibodies which may act as haemolysins and induce in vivo coating of red blood cells (RBC) with Ig, causing a positive direct antiglobulin reaction and, rarely, haemolysis. Haemolytic anaemia can develop following IVIg therapy due to enhanced RBC sequestration. Patients should be monitored for signs and symptoms of haemolysis. In patients with limited or compromised acid base compensatory mechanisms including neonates, consideration should be given to the effect of the additional acid load that the preparation might present. Children: safety has not been established in newborns. Pregnancy & Lactation: safety has not been established in human pregnancy thus OCTAGAM should only be given with caution to pregnant woman and breast-feeding mothers. Clinical experience with Igs suggests no harmful effects on the course of pregnancy, or on the foetus and the neonate are to be expected. INTERACTIONS: May impair for a period of at least 6 weeks and up to 3 months the efficacy of live attenuated virus vaccines such as measles, rubella, mumps and varicella. Interference with serological testing: passive transmission of antibodies to erythrocyte antigens, e.g. A, B or D may interfere with some serological tests for red cell allo-antibodies (e.g. Coombs Test), reticulocyte count and haptoglobin. OCTAGAM contains maltose, which could interfere with blood and urinary glucose tests. ADVERSE REACTIONS: Common (>1% - <10%): chills, fatigue, fever, injection site reaction, headache, nausea, vomiting,

4 hypersensitivity, tachycardia, hypertension, eczema, hepatic enzyme increase. Uncommon (>0.1% - <1%): dizziness, chest pain, hypotension, hot flushes, back pain. Other reactions: a fall in blood pressure (rarely), isolated cases of anaphylactic shock, reversible aseptic meningitis, isolated cases of reversible haemolytic anaemia/ haemolysis, transient cutaneous reactions, increases in serum creatinine levels and/or acute renal failure. The following reactions have also been identified during post-approval use of OCTAGAM : Leucopoenia, haemolytic anaemia, anaphylactic shock, anaphylactic reaction, anaphylactoid reaction, angioneurotic oedema, facial oedema, fluid overload, agitation, cerebrovascular accident, meningitis aseptic, migraine, paraesthesia, seizures, myocardial infarction, palpitations, cyanosis, cardiac arrest, thromboembolism, peripheral circulatory failure, respiratory failure, pulmonary embolism, pulmonary oedema, bronchospasm, dyspnoea, cough, diarrhoea, abdominal pain, urticaria, rash, rash erythematous, dermatitis, pruritus, alopecia, arthralgia, myalgia, pain in extremity, acute renal failure, flushing, hyperhidrosis, malaise, blood glucose false positive. OVERDOSE: May lead to fluid overload and hyperviscosity, particularly in patients at risk, including the elderly or patients with renal impairment. DOSAGE & ADMINISTRATION: Dosing is dependent on the indication and should be individually tailored. Replacement therapy in PID: a plasma trough level of IgG of at least 4-6 g/l should be achieved. Recommended starting dose is g/kg followed by 0.2 g/kg every 3 weeks. The dose required to achieve a trough level of 6 g/l is of the order of g/kg/month. The dosage interval in steady state varies from 2-4 weeks. Replacement therapy in myeloma or chronic lymphocytic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections; replacement therapy in children with AIDS and recurrent infections: recommended dose is g/kg every 3-4 weeks. Idiopathic Thrombocytopenic Purpura: for an acute episode, g/kg on day 1, repeated on day 3 if necessary, or 0.4 g/kg daily for 2-5 days. Treatment can be repeated if relapse occurs. Guillain Barré Syndrome: 0.4 g/kg/day for 3-7 days. Experience in children is limited. Kawasaki Disease: g/kg should be administered in divided doses over 2-5 days. Patients should receive concomitant treatment with acetylsalicylic acid. Allogeneic Bone Marrow Transplantation: For the treatment of infections and prophylaxis of graft versus host disease, dosage is individually tailored. Starting dose is normally 0.5 g/kg/wk, starting 7 days before transplantation and for up to 3 months after transplantation. Method of Administration: OCTAGAM should be infused intravenously at an initial rate of 1 ml/ kg/hr for 30 minutes and if well tolerated may be gradually increased to a maximum of 5 ml/kg/hr. OCTAGAM 10% [100 mg/ml] - Abbreviated product information Please review the approved Product Information before prescribing. INDICATIONS: Replacment therapy in primary immunodeficiency (PID) syndromes (congenital agammaglobulinaemia & hypogammaglobulinaemia, common variable immunodeficiency, severe combined immunodeficiencies, Wiskott Aldrich syndrome), myeloma or chronic lymphocytic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections, and in children with congenital Acquired Immune Deficiency Syndrome (AIDS) who have repeated bacterial infections. As an immunomodulator in idiopathic thrombocytopenic purpura (ITP, in adults or children with a high risk of bleeding or prior to surgery to correct the platelet count), Guillain Barré syndrome and Kawasaki disease. Allogeneic bone marrow transplantation. CONTRAINDICATIONS: Hypersensitivity to homologous Igs, especially in very rare cases of IgA deficiency, when the patient has antibodies against IgA. Allergies to any human Ig preparation or to any constituent of OCTAGAM 10% [100 mg/ml]. WARNINGS: When medicinal products prepared from human blood/plasma are administered, infectious diseases due to transmission of infective agents cannot be totally excluded. This also applies to pathogens of unknown nature and theoretically to Creutzfeld-Jacob Disease (CJD) agents. Risk of transmission of infective agents is reduced by; selection of donors by medical interview, screening of donations for the 3 major pathogenic viruses (HIV, HCV, HBV), testing of plasma pools for HCV genomic material, and validated removal/inactivation procedures in the production process that are considered effective for HIV, HCV and HBV but may be of limited value against non-enveloped viruses (i.e. HAV or parvovirus B19). Parvovirus B19 infection may be serious for pregnant women (foetal infection) and for individuals with immunodeficiency or increased erythropoiesis (e.g. haemolytic anaemia). There is a reassuring clinical experience regarding the lack of hepatitis A or parvovirus B19 transmission with Igs and it is also assumed that the antibody content makes an important contribution to the viral safety. Vaccination for patients in receipt of medicinal products made from human plasma should be considered where appropriate. It is strongly recommended that every time OCTAGAM 10% [100 mg/ml] is administered, the name and batch number of the product are recorded in order to maintain a link between the patient and batch of the product. PRECAUTIONS: If allergic or anaphylactic-type reactions occur, the infusion should be stopped immediately and appropriate treatment instituted. In case of shock, the current medical standards for shocktreatment should be observed. Certain severe adverse reactions may be related to the rate of infusion. The recommended infusion rate must be closely followed and patients closely monitored and observed for any symptoms throughout the infusion period. Certain adverse reactions may occur more frequently; in cases of high rate of infusion, in patients with hypo- or agammaglobulinaemia, with or without IgA deficiency, and in patients receiving human normal Ig for the first time or, in rare cases, when the human normal Ig product is switched or when there has been a long interval since the previous infusion. True hypersensitivity reactions are rare. They can occur in very seldom cases of IgA deficiency with anti- IgA antibodies. Rarely, human normal Ig can induce a fall in blood pressure with anaphylactic reaction, even in patients who had tolerated previous treatments. Potential complications can often be avoided by ensuring; that patients are not sensitive to human normal Ig by initially injecting the product slowly (0.6 to 1.2 ml/kg/hr), and that patients are carefully monitored for any symptoms throughout the infusion period; in particular, patients naive to human normal Ig, patients switched from an alternative IVIg product or when there has been a long interval since the previous infusion, should be monitored during the first infusion and for the first hour after the first infusion, in order to detect potential adverse signs. All other patients should be observed for at least 20 minutes after administration. Arterial and venous thromboembolic events (TEEs) have been reported in association with OCTAGAM, particularly in those with known risk factors. The pathogenesis of TEEs associated with IVIg s is assumed to be multifactorial. A relative increase in blood viscosity from the high influx of Ig and/or the presence of procoagulant factors in the Ig solution are two possible mechanisms. There was an increased rate of TEEs reported in 2010 associated with OCTAGAM. The unexpected presence of factor XIa appeared to be the main cause for the TEEs. Corrective measures in the manufacturing process of OCTAGAM have been implemented. Arterial TEEs included myocardial infarction and stroke. Most arterial TEEs occurred during OCTAGAM infusion or within the first 24 hours post infusion. Venous TEEs included deep vein thromboses (DVT) and pulmonary embolism. Most venous TEEs occurred within 72 hours post OCTAGAM infusion. Caution should be exercised in prescribing and infusing IVIg in patients with pre-existing risk factors for arterial and venous TEEs such as obesity, smoking, advanced age, hypertension, diabetes, a history of atherosclerosis/vascular disease or thrombotic events, hyperlipidaemia, multiple cardiovascular risk factors, impaired cardiac output, pregnancy and the puerperium, oestrogen-containing hormone replacement therapy or oral contraceptive, acquired or inherited thrombophilic disorders, prolonged periods of immobilisation, hypovolemia, surgery, central venous catheterisation, active malignancy and/or known or suspected hyperviscosity. The potential risks and benefits of IVIg s, including OCTAGAM should be weighed against those of alternative therapies for all patients for whom IVIg administration is being considered. Baseline assessment of blood viscosity should be considered in patients at risk for hyperviscosity, including those with cryoglobulins, fasting chylomicronaemia/markedly high triglycerides, or

5 monoclonal gammopathies. Patients should be monitored closely for signs and symptoms of thromboembolism, particularly during and for 72 hours after OCTAGAM infusion. Rapid rates of IVIg infusion may be a risk factor for TEEs. The recommended infusion rate should not be exceeded. For patients judged to be a risk of developing TEEs, administer OCTAGAM at the minimum rate of infusion practicable. The decision to take antithrombotic prophylactic measures is a clinical decision that requires a careful assessment of individual patients underlying risk factors. Cases of renal dysfunction, acute renal failure, osmotic nephrosis and death have been reported in patients receiving IVIg therapy. In most cases, risk factors have been identified, such as pre-existing renal insufficiency, diabetes mellitus, hypovolemia, sepsis, overweight, concomitant nephrotoxic medicinal products or age over 65. In patients at risk of acute renal failure or thromboembolic adverse reactions, IVIg products should be administered at the minimum rate of infusion and dose practicable. In case of renal impairment, IVIg discontinuation should be considered. While reports of renal dysfunction and acute renal failure have been associated with the use of many IVIg products containing various excipients such as sucrose, glucose and maltose, those containing sucrose as a stabiliser accounted for a disproportionate share of the total number. In patients at risk, the use of IVIg products not containing sucrose may be considered. In all patients, IVIg administration requires; adequate hydration prior to infusion, monitoring of urine output and serum creatinine levels and avoidance of concomitant use of loop diuretics. Aseptic meningitis syndrome (AMS) has been reported infrequently in association with IVIg treatment. Discontinuation of IVIg treatment has resulted in remission of AMS within several days without sequelae. AMS usually begins within several hours to 2 days following IVIg treatment and is characterised by symptoms and signs including severe headache, nuchal rigidity, drowsiness, fever, photophobia, painful eye movements, nausea and vomiting. Cerebrospinal fluid (CSF) studies are frequently positive with pleocytosis up to several thousand cells per cu.mm., predominantly from the granulocytic series, and elevated protein levels up to several g/l. Patients exhibiting such symptoms and signs should receive a thorough neurological examination, including CSF studies, to rule out other causes of meningitis. Patients with a history of migraine may be more susceptible. IVIg products can contain blood group antibodies which may act as haemolysins and induce in vivo coating of red blood cells (RBC) with Ig, causing a positive direct antiglobulin reaction and, rarely, haemolysis. Haemolytic anaemia can develop subsequent to IVIg therapy due to enhanced RBC sequestration. IVIg recipients should be monitored for clinical signs and symptoms of haemolysis. In patients with a normal acid base compensatory mechanism, the acid load delivered by the largest dose of the preparation would be neutralised by the buffering capacity of whole blood alone, even if the dose were to be infused instantaneously. In patients with limited or compromised acid base compensatory mechanisms including neonates, consideration should be given to the effect of the additional acid load that the preparation might present. Pregnancy & Lactation: Safety of OCTAGAM 10% [100 mg/ml] for use in human pregnancy has not been established and therefore should only be given with caution to pregnant women and breastfeeding mothers. Clinical experience with Igs suggests that no harmful effects on the course of pregnancy, or on the foetus and the neonate are to be expected. Igs are excreted into the milk and may contribute to the transfer of protective antibodies to the neonate. Paediatric use: safety has not been established in controlled clinical trials. INTERACTIONS: May impair for a period of at least 6 weeks and up to 3 months the efficacy of live attenuated virus vaccines such as measles, rubella, mumps and varicella. Interference with serological testing: passive transmission of antibodies to erythrocyte antigens, e.g. A, B or D may interfere with some serological tests for red cell allo-antibodies, for example the antiglobulin test (e.g. Coombs Test), reticulocyte count and haptoglobin. Blood Glucose Testing: some testing systems falsely interpret the maltose contained in OCTAGAM 10% [100 mg/ml] as glucose. This may result in falsely elevated glucose readings and, consequently in the inappropriate administration of insulin, resulting in life-threatening or even fatal hypoglycemia. ADVERSE EFFECTS: Reactions to IVIg tend to be related to the dose and rate of infusion. Common (>1% - <10%): hypersensitivity, headache, tachycardia, hypertension, nausea, vomiting, eczema, fever, fatigue, chills, injection site reaction, hepatic enzyme increase. Uncommon (>0.1% - <1%): dizziness, hypotension, back pain, chest pain, hot flushes. Other reactions: cases of reversible aseptic meningitis, isolated cases of reversible haemolytic anaemia/ haemolysis and rare cases of transient cutaneous reactions, increase in serum creatinine level and/or acute renal failure, very rarely thromboembolic reactions (such as myocardial infarction, stroke, pulmonary embolism, DVT), a sudden fall in blood pressure (rarely) and isolated cases of anaphylactic shock. The following reactions have been identified during postapproval use of Octagam: leucopenia, haemolytic anaemia, hypersensitivity, anaphylactic shock, anaphylactic reaction, anaphylactoid reaction, angioneurotic edema, face edema, fluid overlaod, agitation, headache, cerebrovascular accident, meningitis aseptic, migraine, dizziness, paraesthesia, myocardial infarction, tachycardia, palpitations, cyanosis, hypotension, thrombosis, peripheral circulatory failure, hypertension, respiratory failure, pulmonary embolism, pulmonary oedema, bronchospasm, dyspnea, cough, nausea, vomiting, diarrhea, abdominal pain, eczema, urticaria, rash, rash erythematous, dermatitis, pruritus, alopecia, back pain, arthralgia, myalgia, pain in extremity, acute renal failure, fatigue, injection site reaction, pyrexia, chills, chest pain, hot flush, flushing, hyperhidrosis, malaise, hepatic enzymes increased, blood glucose false positive. OVERDOSE: May lead to fluid overload and hyperviscosity, particularly in patients at risk, including the elderly or patients with renal impairment. DOSAGE & ADMINISTRATION: Dosing is dependent on the indication and may need to be individualised for each patient. Replacement therapy in PID: dosing should achieve a trough level of IgG of at least 4 6 g/l. Recommended starting dose is g/kg, followed by at least 0.2 g/kg every 3 weeks. The dose required to achieve a trough level of 6 g/l is of the order of g/kg/month. The dosage interval when steady state has been reached varies from 2-4 weeks. Replacement therapy in myeloma or chronic lymphatic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections; replacement therapy in children with AIDS and recurrent infections: recommended dose is g/kg every 3-4 weeks. ITP: for an acute episode, g/ kg on day 1, which may be repeated once within 3 days, or 0.4 g/kg daily for 2-5 days. The treatment can be repeated if relapse occurs. Guillain Barré syndrome: 0.4 g/kg/day for 3-7 days. Experience in children is limited. Kawasaki disease: g/kg administered in divided doses over 2-5 days or 2 g/kg as a single dose. Patients should receive concomitant treatment with acetylsalicylic acid. Allogeneic Bone Marrow Transplantation: For the treatment of infections and prophylaxis of graft versus host disease, dosage is individually tailored. Starting dose is normally 0.5 g/kg/week, starting 7 days before transplantation and for up to 3 months after transplantation. In the case of persistent lack of antibody production, dosage of 0.5 g/kg/month is recommended until antibody level returns to normal. MetHod of Administration: OCTAGAM 10% [100 mg/ml] should be infused intravenously at an initial rate of 0.6 to 1.2 ml/kg/hr for 30 minutes. If well tolerated, the rate of administration may gradually be increased to a maximum of 7.2 ml/kg/hr.