Convenient Infusion therapy

The maximum recommended total dosage per infusion is 150 mg/kg, administered according to the following schedule:

The Cytogam^® Dosing Calculator will help you find the right dosage for your patient.

Preparation for administration. Remove the tab portion of the vial cap and clean the rubber stopper with 70% alcohol or equivalent. DO NOT SHAKE VIAL; AVOID FOAMING.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Infuse the solution only if it is colorless, free of particulate matter and not turbid.

Infusion. Infusion should begin within 6 hours after entering the vial and should be complete within 12 hours of entering the vial. Vital signs should be taken preinfusion, mid-way and postinfusion as well as before any rate increase. Cytogam^® should be administered through an intravenous line using an administration set that contains an inline filter (pore size 15μ) and a constant infusion pump (ie, IVAC pump or equivalent). A smaller in-line filter (0.2μ) is also acceptable. Predilution of Cytogam^® before infusion is not recommended.

For full details of dosing and administration of Cytogam^® click here to see the full Prescribing Information.

Cytogam^® is supplied in one single-dose vial form:

NDC Number	Total Quantity of Immunoglobulin	Volume	Concentration

44206-3101-1	2500 ± 500 mg	50 ml	50 ± 10 mg/ml

© 2008 CSL Behring

Important Safety Information

Cytogam^® is indicated for the prophylaxis of cytomegalovirus disease associated with transplantation of kidney, lung, liver, pancreas, and heart.

Cytogam^® is contraindicated in individuals with a history of a prior severe reaction associated with the administration of this or other human immunoglobulin preparations and in persons with selective immunoglobulin A deficiency who have known antibodies to IgA.

Immune Globulin Intravenous (Human) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis and death. Patients predisposed to acute renal failure include patients with any degree of preexisting renal insufficiency, diabetes mellitus, age greater than 65, volume depletion, sepsis, paraproteinemia or patients receiving known nephrotoxic drugs. Especially in such patients, IGIV products should be administered at the minimum concentrations available and the minimum rate of infusion practicable.

Increases in serum creatinine and blood urea nitrogen (BUN) have been observed as soon as one to two days following IGIV infusion. Progression to oliguria or anuria requiring dialysis has been observed.

Cytogam^® is derived from human plasma. As with all plasma-derived products, the risk of transmission of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent, cannot be completely eliminated.

Minor reactions, such as flushing, chills, muscle cramps, back pain, fever, nausea, vomiting, arthralgia, and wheezing, were the most frequent adverse reactions observed during the clinical trials for Cytogam^®.

For more information about Cytogam^®, please see the full prescribing information.

Cytogam^® is a registered trademark of CSL Behring AG.