VALCYTE

Država: Indonezija

Jezik: indonezijščina

Source: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Aktivna sestavina:

VALGANCICLOVIR HYDROCHLORIDE

Dostopno od:

MENARINI INDRIA LABORATORIES - Indonesia

INN (mednarodno ime):

VALGANCICLOVIR HYDROCHLORIDE

Odmerek:

496.3 MG

Farmacevtska oblika:

TABLET SALUT SELAPUT

Enote v paketu:

DUS, 1 BOTOL PLASTIK @ 60 TABLET SALUT SELAPUT

Izdeluje:

Patheon inc - Canada

Datum dovoljenje:

2021-12-14

Lastnosti izdelka

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