Megalotect CP

Megalotect CP

cytomegalovirus immunoglobulin, human

Manufacturer:

Biotest

Distributor:

Chong Lap
Concise Prescribing Info
Contents
Human cytomegalovirus Ig
Indications/Uses
Prophylaxis of clinical manifestations of cytomegalovirus (CMV) infection in patients subjected to immunosuppressive therapy, particularly in transplant recipients.
Dosage/Direction for Use
IV Single dose of 1 mL/kg infused at an initial rate of 0.08 mL/kg/hr for 10 min, may be gradually increased to max 0.8 mL/kg/hr for the remainder of the infusion if well tolerated. Reduce rate of administration or stop infusion in case of adverse reaction. Initiate on day of transplantation. Prophylaxis in bone marrow transplantation Initiate up to 10 days before transplantation, particularly in CMV sero-positive patients. Total of at least 6 single doses at 2-3 wk intervals should be given.
Contraindications
Hypersensitivity. Patients w/ selective IgA deficiency who developed Abs to IgA.
Special Precautions
Anaphylaxis can develop in patients w/ undetectable IgA who have anti-IgA Abs; in patients w/ tolerance to previous human Ig treatment. Adverse reactions may occur more frequently in patients who receive human Ig for the 1st time or, in rare cases, when switching human Ig product or when there has been a long interval since the previous infusion; in patients w/ an untreated infection or underlying chronic inflammation. IVIg administration requires adequate hydration prior to initiation, monitoring of urine output & serum creatinine levels, & avoidance of concomitant loop diuretics. Thromboembolic events eg, MI, CVA (including stroke), pulmonary embolism & DVT; acute renal failure; aseptic meningitis syndrome occuring more frequently w/ high-dose (2 g/kg) IVIg treatment; haemolytic anaemia; neutropenia; acute non-cardiogenic pulmonary oedema (transfusion-related acute lung injury). Administer IVIg products at min infusion rate & dose practicable in patients at risk for thromboembolic adverse reactions &/or acute renal failure. Consider discontinuation in case of renal impairment. Monitor for clinical signs & symptoms of haemolysis. May result in misleading positive results in serological testing. Possibility of transmitting infective agents. Minor influence on the ability to drive & use machines. Pregnancy & lactation.
Adverse Reactions
Chills, headache, dizziness, fever, vomiting, allergic reactions, nausea, arthralgia, low BP, moderate low back pain; reversible haemolytic reactions; cases of reversible aseptic meningitis; cases of increased serum creatinine level &/or occurrence of acute renal failure; cases of transfusion-related acute lung injury.
Drug Interactions
May impair efficacy of live attenuated virus vaccines eg, measles, rubella, mumps & varicella for at least 6 wk to 3 mth. Impaired efficacy may persist for up to 1 yr in measles vaccine. Avoid concomitant use of loop diuretics.
ATC Classification
J06BB09 - cytomegalovirus immunoglobulin ; Belongs to the class of specific immunoglobulins. Used in passive immunizations.
Presentation/Packing
Form
Megalotect CP soln for infusion 5,000 U/50 mL
Packing/Price
1's
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