Megalotect CP

Prophylaxis of clinical manifestations of cytomegalovirus (CMV) infection in patients subjected to immunosuppressive therapy, particularly in transplant recipients.

IV Single dose of 1 mL/kg infused at initial rate of 0.08 mL/kg/hr for 10 min. May gradually be increased to max of 0.8 mL/kg/hr for the remainder of infusion if well tolerated. Initiate administration on day of transplantation. Prophylaxis in bone marrow transplantation Initiate up to 10 days before transplantation, particularly in CMV sero +ve patients. A total of at least 6 single doses at 2-3 wk intervals should be given.

Hypersensitivity. Patients w/ selective IgA deficiency who developed Abs to IgA.

Hypersensitivity. May develop anaphylaxis in patients w/ undetectable IgA who have anti-IgA Abs; tolerance to previous human Ig treatment. Stop infusion or reduce administration rate in case of adverse reaction. Stop infusion immediately in case of pulmonary adverse reactions. Consider discontinuation in case of renal impairment. Infusion-related adverse reactions (eg, headache, flushing, chills, myalgia, wheezing, tachycardia, lower back pain, nausea, & hypotension). Thromboembolic events eg, MI, CVA (including stroke), pulmonary embolism & DVT; acute renal failure; aseptic meningitis syndrome [more frequently w/ high-dose (2 g/kg) IVIg treatment] haemolytic anaemia; transient decrease in neutrophil count &/or episodes of neutropenia; acute non-cardiogenic pulmonary oedema. Possible transmission of infective agents. Pre-existing renal insufficiency, DM, hypovolemia, overwt. Patients who receive human Ig for the 1st time or, in rare cases, when human Ig product is switched or when there has been a long interval since previous infusion; w/ untreated infection or underlying chronic inflammation; w/ pre-existing risk factors for thrombotic events (eg, advanced age, HTN, DM & history of vascular disease or thrombotic episodes, patients w/ acquired or inherited thrombophilic disorders, prolonged periods of immobilisation, diseases which increase blood viscosity & severely hypovolemic patients). Obese patients. Assess renal parameters prior to infusion & at appropriate intervals, particularly in patients w/ potential for increased risk of developing acute renal failure. Ensure patients are not sensitive to human Ig by initially injecting the product slowly (0.08 mL/kg/hr); adequate hydration prior to initiation. Observe patients for at least 20 min after administration & carefully monitor for any symptoms throughout infusion period. Monitor patients naive to human Ig, switched from IVIg product or when there has been long interval since previous infusion, during the first infusion & for the 1st hr after 1st infusion. Monitor urine output & serum creatine levels; clinical signs & symptoms of haemolysis. Administer IVIg at min infusion rate & dose practicable in patients at risk for thromboembolic adverse reactions &/or acute renal failure. Consider concomitant use of adequate virostatic agents for CMV-prophylaxis. Avoid concomitant use of loop diuretics. Concomitant nephrotoxic medicinal products. May result in misleading +ve results in serological testing. Minor influence on ability to drive & use machines. Pregnancy & lactation. Elderly >65 yr.

Chills, headache, dizziness, fever, vomiting, allergic reactions, nausea, arthralgia, low BP & moderate low back pain; reversible haemolytic reactions; reversible aseptic meningitis; increased serum creatinine level &/or occurrence of acute renal failure; transfusion-related acute lung injury.

May impair efficacy of live attenuated virus vaccines eg, measles, rubella, mumps & varicella for a period of at least 6 wk up to 3 mth; may persist for up to 1 yr in the case of measles vaccine. Avoid concomitant use of loop diuretics.

Vaccines, Antisera & Immunologicals

J06BB09 - cytomegalovirus immunoglobulin ; Belongs to the class of specific immunoglobulins. Used in passive immunizations.

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