Država: Indonezija
Jezik: indonezijščina
Source: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
BAYER INDONESIA - Indonesia -
10.00 MG
TABLET SALUT SELAPUT
VERICIGUAT
DUS, 1 BLISTER @ 14 TABLET SALUT SELAPUT
Obat
BAYER AG - Federal Republic of Germany
Berlakus/d 30-10-2028
2023-10-30
ID/Verquvo/Vericiguat 2.5, 5 & 10 mg - Film Coated Tablet/CCDS#02 1 VERQUVO ® FILM-COATED TABLET NAME OF THE DRUG VERQUVO 2.5 mg (vericiguat 2.5 mg) VERQUVO 5 mg (vericiguat 5 mg) VERQUVO 10 mg (vericiguat 10 mg) PHARMACEUTICAL FORM Film-coated tablets. VERQUVO 2.5 mg film-coated tablets Round, biconvex, white film-coated tablet with a diameter of 7 mm, debossed with “2.5” on one side and “VC” on the other side. VERQUVO 5 mg f ilm-coated tablets Round, biconvex, brown-red film-coated tablet with a diameter of 7 mm, debossed with “5” on one side and “VC” on the other side. VERQUVO 10 mg f ilm-coated tablets Round, biconvex, yellow-orange film-coated tablet with a diameter of 9 mm, debossed with “10” on one side and “VC” on the other side. INDICATIONS AND USAGE Verquvo is indicated for the treatment of symptomatic chronic heart failure in adult patients with reduced ejection fraction less than 45% who are stabilized with IV diuretic therapy after hospitalization for heart failure, occurring on guideline-based medical therapy, including angiotensin-converting enzyme (ACE) inhibitors or angiotensin II receptor blockers (ARB), betablockers, mineralocorticoid receptor antagonists (MRA), and a combination of an angiotensin receptor and neprilysin inhibitor (ARNI). DOSAGE AND ADMINISTRATION ADULTS • The recommended starting dose of VERQUVO is 2.5 mg once daily, taken with food. • Double the dose of VERQUVO approximately every 2 weeks to reach the target maintenance dose of 10 mg once daily, as tolerated by the patient. • If patients experience tolerability issues (symptomatic hypotension or systolic blood pressure [SBP] less than 90 mmHg), temporary down-titration or discontinuation of vericiguat is recommended • For patients who are unable to swallow whole tablets, VERQUVO may be crushed and mixed with water immediately before administration _[see CLINICAL PHARMACOLOGY, Pharmacokinetics]_. Verquvo is administered in conjunction with other heart failure therapies (see Clinical Studies). M Preberite celoten dokument