Država: Indonezija
Jezik: indonezijski
Izvor: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
MENARINI INDRIA LABORATORIES - Indonesia -
496.3 MG
TABLET SALUT SELAPUT
VALGANCICLOVIR HYDROCHLORIDE
DUS, 1 BOTOL PLASTIK @ 60 TABLET SALUT SELAPUT
Obat
Patheon inc - Canada
Berlakus/d 14-12-2026
2023-03-25
Draft_Valcyte_PI_MAT_CDS9.0_EN_v1 Page 1 of 18 VALCYTE ® Valganciclovir Antiviral 1. DESCRIPTION 1.1 Therapeutic/Pharmacologic Class of Drug Antiviral ATC code: J05AB14 1.2 Type of Dosage Form Film-coated tablet 1.3 Route of Administration Oral 1.4 Sterile/Radioactive Statement Not applicable. 1.5 Qualitative and Quantitative Composition Active ingredient: valganciclovir (as valganciclovir hydrochloride). Film-coated tablets: 450 mg. 2. CLINICAL PARTICULARS 2.1 Therapeutic Indication(s) Valcyte tablets are indicated for the induction and maintenance treatment of cytomegalovirus (CMV) retinitis in patients with acquired immunodeficiency syndrome (AIDS). Valcyte tablets are indicated for the prevention of CMV disease in CMV–negative patients who have received a solid organ transplant from a CMV-positive donor. 2.2 Dosage and Administration Caution – strict adherence to dosage recommendations is essential to avoid overdose. Standard dosage Valcyte is administered orally, and should be taken with food (see sections 3.2.5 Pharmacokinetics in Special Populations and 3.2.1 Absorption). Valcyte is rapidly and extensively converted into ganciclovir. The bioavailability of ganciclovir from Valcyte is 10-fold higher than from ganciclovir capsules, therefore the dosage and administration of Valcyte tablets as described below should be closely followed (see sections 2.4 Warnings and Precautions and 2.7 Overdose). Treatment of CMV Retinitis in AIDS Induction treatment For patients with active CMV retinitis, the recommended dose is 900 mg (two 450 mg tablets) twice a day for 21 days, whenever possible, taken with food. Prolonged induction treatment may increase the risk of bone marrow toxicity (see section 2.4 Warnings and Precautions). Maintenance treatment For immunocompromised patients at risk of relapse of CMV retinitis the recommended dosage is 900 mg (two 450 mg tablets) once daily with food. Patients whose retinitis worsens may repeat induction treatment (see Induction Treatment). The duration of maintenance treatme Pročitajte cijeli dokument