Land: Indonesien
Sprog: indonesisk
Kilde: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
VALSARTAN
NOVARTIS INDONESIA - Indonesia
VALSARTAN
80.00 MG
TABLET SALUT SELAPUT
DUS, 2 BLISTER @ 14 TABLET SALUT SELAPUT
SIEGFRIED BARBERA, S.L. - Spain
2021-10-11
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 Læs hele dokumentet