Behring - Model CMV -VF -Human Cytomegalovirus Immunoglobulin

The distribution of the IgG subclasses closely resembles that found in normal human plasma (approximate mean ranges: 52.5-64.9% Igd, 29.0-42.2% IgG2, 3.1-6.8% IgG3, 0.4-1.2%IgG4).

CMV Immunoglobulin-VF contains less than 0.5 mg/mL immunoglobulin A (IgA).

The pH value of the ready-to-use solution is 4.25.

CMV Immunoglobulin-VF is manufactured from human plasma collected by Australian Red Cross Lifeblood. Isotonicity is achieved by the addition of 292 mmol/L maltose.

CLINICAL PARTICULARS

Therapeutic indications

CMV Immunoglobulin-VF is indicated for the prevention of CMV infection following bone marrow and renal transplants. Specifically, the product is indicated when the recipient is seronegative for CMV and receives a graft from a CMV positive donor. CMV Immunoglobulin-VF may also be a helpful adjunct to therapy in patients with established CMV infection, e.g. CMV pneumonitis.

Dose and method of administration

Dosage

Because there is currently no international standard for CMV Immunoglobulin-VF, recommended dosage remains empirical. For prophylactic use it is recommended that patients receive 25,000 units/leg on days -4, -2, on the day of transplantation (intra-operatively) and then weekly for a further two months.

For therapy, 50,000 units/leg should be given initially, repeated after 4 to 5 days and then every 10 to 14 days until clinical improvement occurs.

Refer to Table 1 for dosing requirements. If the calculated quantity of CMV Immunoglobulin-VF required for patients weighing >15 kg includes a fraction of a vial, then the higher whole number of vials should be administered.

Specifically, patients weighing