Valcyte tablets are manufactured by Patheon Inc., Mississauga, Ontario, Canada L5N 7K9Distributed by:27899120Copyright © 2001-2006 by Roche Laboratories Inc.
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Valcyte tablets are indicated for the treatment of cytomegalovirus (CMV) retinitis in patients with acquired immunodeficiency syndrome (AIDS) (see CLINICAL TRIALS).Valcyte is indicated for the prevention of cytomegalovirus (CMV) disease in kidney, heart, and kidney-pancreas transplant patients at high risk (Donor CMV seropositive/Recipient CMV seronegative [(D+/R-)]).Valcyte is not indicated for use in liver transplant patients (see CLINICAL TRIALS and WARNINGS).The safety and efficacy of Valcyte for the prevention of CMV disease in other solid organ transplant patients such as lung transplant patients have not been established.
-- Infection of the retina by cytomegalovirus characterized by retinal necrosis, hemorrhage, vessel sheathing, and retinal edema. Cytomegalovirus retinitis is a major opportunistic infection in AIDS patients and can cause blindness.
Acquired Immunodeficiency Syndrome
-- An acquired defect of cellular immunity associated with infection by the human immunodeficiency virus (HIV), a CD4-positive T-lymphocyte count under 200 cells/microliter or less than 14% of total lymphocytes, and increased susceptibility to opportunistic infections and malignant neoplasms. Clinical manifestations also include emaciation (wasting) and dementia. These elements reflect criteria for AIDS as defined by the CDC in 1993.
-- A definite pathologic process with a characteristic set of signs and symptoms. It may affect the whole body or any of its parts, and its etiology, pathology, and prognosis may be known or unknown.
Valcyte tablets are contraindicated in patients with hypersensitivity to valganciclovir or ganciclovir.
-- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.
THE CLINICAL TOXICITY OF VALCYTE, WHICH IS METABOLIZED TO GANCICLOVIR, INCLUDES GRANULOCYTOPENIA, ANEMIA AND THROMBOCYTOPENIA.
IN ANIMAL STUDIES GANCICLOVIR WAS CARCINOGENIC, TERATOGENIC AND CAUSED ASPERMATOGENESIS.
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