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MEGALOTECT CP SOLUTION FOR INFUSION 100 U/ML [SIN14452P]
Active ingredients: MEGALOTECT CP SOLUTION FOR INFUSION 100 U/ML
Last updated 26 October 2025
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Product Info
MEGALOTECT CP SOLUTION FOR INFUSION 100 U/ML
[SIN14452P]
Product information
Active Ingredient and Strength | HUMAN CYTOMEGALOVIRUS IMMUNOGLOBULIN IN 50 MG/ML HUMAN PLASMA PROTEIN (IGG ≥ 96%) - 100 UNITS/ML |
Dosage Form | INJECTION |
Manufacturer and Country | BIOTEST AG - GERMANY |
Registration Number | SIN14452P |
Licence Holder | GRIFOLS ASIA PACIFIC PTE. LTD. |
Forensic Classification | PRESCRIPTION ONLY MEDICINES |
Anatomical Therapeutic Chemical (ATC) code | J06BB09 |
Indications
Prophylaxis of clinical manifestations of cytomegalovirus infection in patients receiving immunosuppressive therapy, particularly in transplant recipients.
The concomitant use of adequate virostatic agents should be considered for CMV-prophylaxis.
Posology and method of administration
Posology
The single dose is 1 ml per kg body weight. Administration should be initiated on the day of transplantation. In case of bone marrow transplantation an initiation of prophylaxis up to 10 days before transplantation can also be envisaged, particularly in CMV zero-positive patients. A total of at least 6 single doses at 2 to 3 weeks' intervals should be given.
Hepatic impairment
No evidence is available to require a dose adjustment.
Renal impairment
No dose adjustment unless clinically warranted, see section ‘Special warnings and precautions for use’ – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.
Elderly
No dose adjustment unless clinically warranted, see section "special warings and precautions for use" – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.
Method of administration
Intravenous use
Megalotect CP should be infused intravenously at an initial rate of 0.08 ml/kg BW/hr for the first 10 minutes. See section Special warnings and precautions for use – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information. In case of adverse reaction, either the rate of administration must be reduced or the infusion stopped. If well tolerated, the rate of administration may gradually be increased to a maximum of 0.8 ml/kg BW/hr for the remainder of the infusion.
Contraindications
Hypersensitivity to the active substance (human cytomegalovirus immunoglobulin) or to any of the excipients listed above – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.
Patients with selective IgA deficiency who developed antibodies to IgA, as administering an IgA-containing product can result in anaphylaxis.