DIOVAN

Valsts: Indonēzija

Valoda: indonēziešu

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

Aktīvā sastāvdaļa:

VALSARTAN

Pieejams no:

NOVARTIS INDONESIA - Indonesia

SNN (starptautisko nepatentēto nosaukumu):

VALSARTAN

Deva:

160.0 MG

Zāļu forma:

TABLET SALUT SELAPUT

Vienības iepakojumā:

DUS, 2 BLISTER @ 14 TABLET SALUT SELAPUT

Ražojis:

SIEGFRIED BARBERA, S.L. - Spain

Autorizācija datums:

2021-10-11

Produkta apraksts

NAME OF THE MEDICINAL PRODUCT
Diovan
®
DESCRIPTION AND COMPOSITION
ACTIVE SUBSTANCE
One tablet contains 40 mg, 80 mg or 160 mg valsartan.
PHARMACEUTICAL FORM(S)
Film-coated tablet.
Diovan 40 mg: yellow, ovaloid, scored on one side, slightly convex,
with bevelled edges,
debossed on one side with DO and with NVR on the other side.
Diovan 80 mg: pale red, round, scored on one side, slightly convex,
with bevelled edges,
debossed on one side with D/V and NVR on the other side.
Diovan 160 mg: grey-orange, ovaloid, scored on one side, convex,
debossed on one side with
DX/DX and NVR on the other side.
EXCIPIENTS
Microcrystalline cellulose, crospovidone, colloidal anhydrous silica,
magnesium stearate,
hypromellose, titanium dioxide (E171), Macrogol 8000, red iron oxide
(E172), yellow iron
oxide (E172), black iron oxide (E172; 40 mg and 160 mg only).
INDICATIONS
HYPERTENSION
Diovan
®
(valsartan) is indicated for the treatment of hypertension. It may be
used alone or in
combination with other antihypertensive agents.
HEART FAILURE
Diovan is indicated for the treatment of heart failure (NYHA class
II-IV) in patients who are
intolerant of angiotensin converting enzyme inhibitors. In a
controlled clinical trial, Diovan
®
significantly reduced hospitalizations for heart failure. There is no
evidence that Diovan
®
provides added benefits when it is used with an adequate dose of an
ACE inhibitor (see
sections Clinical pharmacology, Pharmacodynamics and Clinical Studies,
Heart Failure for
details).
POST-MYOCARDIAL INFARCTION
Diovan is indicated to improve survival following myocardial
infarction in clinically stable
patients with signs, symptoms or radiological evidence of left
ventricular failure and/or with
left ventricular systolic dysfunction (see section Clinical
pharmacology).
DISETUJUI OLEH BPOM : 16/09/2021
ID : EREG100005VR12100159
EREG100005VR12100160
EREG100005VR12100161
2
DOSAGE AND ADMINISTRATION
DOSAGE
HYPERTENSION
The recommended dose of Diovan is 80 mg film-coated tablet once daily,
irrespective of race,
age, o