万赛维药品说明书

[Common name]: (Valganciclovir hydrochloride tablets)

[Product name]: valcyte

[All names]: Valcyte, Valganciclovir hydrochloride tablets, valcyte, Valganciclovir, valgansiklovir

[Indications]:

Prevention of cytomegalovirus (CMV) in high-risk adult kidney, heart, and pancreas transplant patients (donor CMV seropositive/recipient CMV seronegative). 

Prevention of cytomegalovirus (CMV) in high-risk children with kidney transplantation (4 months to 16 years old) and heart transplantation (1 month to 16 years old). 

Cytomegalovirus Retinitis, Treatment (AIDS-Related): Treatment of cytomegalovirus (CMV) retinitis in patients with acquired immunodeficiency syndrome (AIDS). 

[Usage and Dosage]:

Adult patients should use Vancevir tablets rather than Vancevir oral solution.

Oral solutions and tablets should be taken with food.

Vancevir tablets should not be broken or crushed.

Before dispensing medication to patients, pharmacists must prepare oral solution (50 mg/ml) with Vancevi. 

Treatment of induction of cytomegalovirus retinitis: The recommended dose is 900 mg (two 450 mg tablets) twice daily for 21 days.

Maintenance: After induction therapy, or in adult patients with inactive cytomegalovirus retinitis, the recommended dose is 900 mg orally once daily.

Cytomegalovirus prophylaxis: For adult patients who have received a heart or kidney-pancreas transplant, the recommended dose is 900 mg orally once daily starting within 10 days of transplantation and continuing until 100 days after transplantation.

For adult patients who have received a kidney transplant, the recommended dose is 900 mg taken orally once daily starting within 10 days after transplantation and until 200 days after transplantation.

[Adverse reactions]:

Cardiovascular: Hypertension (12% to 18%)

Central nervous system: headache (6%-22%), insomnia (6%-20%)

Gastrointestinal tract: diarrhea (16%-41%), nausea (8%-30%), vomiting (3%-21%), abdominal pain (15%)

Hematology and tumors: anemia (<31%), thrombocytopenia (<22%), neutropenia (3%-19%)

Immunity: Graft rejection (24%)

Neuromuscular and skeletal: Tremor (12% to 28%)

Ophthalmology: Retinal detachment (15%)

Kidney: Elevated serum creatinine (Scr>1.5-2.5mg/dL: 12%-50%; Scr>2.5: 3%-17%)

Other: Fever (9% to 31%)

【Storage】：

Vancevir oral solution: Store dry powder at a temperature of 20°C to 25°C (68°F to 77°F); allowable deviation of 15°C to 30°C (59°F to 86°F). Store reconstituted oral solution at 2°C to 8°C (36°F to 46°F); do not freeze. Throw away any unused medication after 49 days.

Tablets: Store at 20°C to 25°C (68°F to 77°F); tolerance allowed 15°C to 30°C (59°F to 86°F).