Negara: Indonesia
Bahasa: Bahasa Indonesia
Sumber: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
ROSUVASTATIN CALCIUM, EZETIMIBE
MEIJI INDONESIAN PHARMACEUTICAL INDUSTRIES - Indonesia
ROSUVASTATIN CALCIUM, EZETIMIBE
10.00 MG /10.00 MG
TABLET SALUT SELAPUT
DUS, 3 BLISTER @ 10 TABLET SALUT SELAPUT
MEDREICH LIMITED - India
2022-02-06
ROSUVASTATIN/EZETIMIBE fixed dose combination is indicated as adjunct to diet for treatment of primary hypercholesterolemia as substitution therapy in adult patients adequately controlled with the individual substances given concurrently at the same dose level as in the fixed dose combination, but as separate products. ROSUVASTATIN/ EZETIMIBE fixed dose combination should not be used as initial therapy. Co-administration with bile acid sequestrants Treatment initiation or dose adjustment if necessary should only be done with the monocomponents and after setting the appropriate doses the switch to the fixed dose combination of the appropriate strength is possible. Patient should use the strength corresponding to their previous treatment. Treatment initiation or dose adjustment if necessary should only be done with the mono- components and after setting the appropriate doses the switch to the fixed dose combination of the appropriate strength is possible. Monocomponent preparations should be used to start the treatment or to modify the dose. It is recommended that liver function tests be carried out prior to, and 3 months following, the initiation of treatment. Rosuvastatin should be discontinued or the dose reduced if the level of serum transaminase is greater than 3 times the upper limit of normal. The reporting rate for serious hepatic events (consisting mainly of increased hepatic transaminases) in post-marketing use is higher at the 40 mg dose. The reporting rate for serious renal events in post-marketing use is higher at the 40 mg dose. An assessment of renal function should be considered during routine follow-up of patients treated with a dose of 40 mg. film-coated tablets Rosuvastatin Rosuvastatin Rosuvastatin Rosuvastatin Rosuvastatin Rosuvastatin Rosuvastatin Rosuvastatin Rosuvastatin (Rosuvastatin, Ezetimibe) Ezetimibe Rosuvastatin, Ezetimibe Rosuvastatin Ezetimibe Ezetimibe, Ezetimibe Ezetimibe, Rosuvastatin-treated DISETUJUI BPOM 21 JANUARI 2022 EREG10025312000033; EREG10025312000034 Rosuvastatin ADVER Baca dokumen lengkapnya