EZERO

국가: 인도네시아

언어: 인도네시아어

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

유효 성분:

ROSUVASTATIN CALCIUM, EZETIMIBE

제공처:

MEIJI INDONESIAN PHARMACEUTICAL INDUSTRIES - Indonesia

INN (International Name):

ROSUVASTATIN CALCIUM, EZETIMIBE

복용량:

20.00 MG /10.00 MG

약제 형태:

TABLET SALUT SELAPUT

패키지 단위:

DUS, 3 BLISTER @ 10 TABLET SALUT SELAPUT

Manufactured by:

MEDREICH LIMITED - India

승인 날짜:

2022-02-06

제품 특성 요약

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