Regulatory Information
ESHCOL PHARMACEUTICAL GROUP SINGAPORE PTE LTD
GRIFOLS ASIA PACIFIC PTE. LTD.
Therapeutic
Prescription Only
Formulation Information
INJECTION
**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_. 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.
INTRAVENOUS
Medical Information
**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.
**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.
J06BB09
cytomegalovirus immunoglobulin
Manufacturer Information
GRIFOLS ASIA PACIFIC PTE. LTD.
Biotest AG
Active Ingredients
Human Cytomegalovirus Immunoglobulin in 50mg/ml Human Plasma Protein (IgG ≥ 96%)
100 U/ml
Documents
Package Inserts
Megalotect CP Solution For Infusion PI.pdf
Approved: November 18, 2020