絡舒優適 300/5 毫克膜衣錠

מדינה: טייוואן

שפה: סינית

מקור: 衛生福利部食品藥物管理署 (Ministry of Health and Welfare, Food And Drug Administration)

מרכיב פעיל:

ALISKIREN HEMIFUMARATE;;AMLODIPINE BESYLATE

זמין מ:

台灣諾華股份有限公司 台北市中正區仁愛路二段99號11、12、13樓 (01516589)

קוד ATC:

C09XA53

טופס פרצבטיות:

膜衣錠

הרכב:

主成分 () ; ALISKIREN HEMIFUMARATE (2408007010) MG; AMLODIPINE BESYLATE (2412402210) MG

יחידות באריזה:

鋁箔盒裝

סיווג:

製　劑

סוג מרשם:

須由醫師處方使用

תוצרת:

LEK PHARMACEUTICALS D.D PRODUCTION OF PHARMACEUTICAL INGREDIENTS KOLODVORSKA 27, SLOVENIA - 1234 MENGES SI

איזור תרפויטי:

aliskiren and amlodipine

סממני תרפויטית:

高血壓，適用於無法有效以aliskiren或amlodipine單一療法控制血壓的病患

leaflet_short:

註銷日期: 2017/03/20; 註銷理由: 自請註銷; 有效日期: 2017/05/22; 英文品名: Rasilamlo 300mg/5mg Film-Coated Tablets

מצב אישור:

已註銷

תאריך אישור:

2012-05-22

עלון מידע

RASILAMLO 150/5MG FILM-COATED TABLETS
RASILAMLO 150/10MG FILM-COATED TABLETS
RASILAMLO 300/5MG FILM-COATED TABLETS
RASILAMLO 300/10MG FILM-COATED TABLETS
FULL PRESCRIBING
INFORMATION WARNING: FETAL TOXICITY
• WHEN PREGNANCY IS DETECTED, DISCONTINUE RASILAMLO AS SOON
AS POSSIBLE.
• DRUGS THAT ACT DIRECTLY ON THE RENIN-ANGIOTENSIN SYSTEM CAN
CAUSE INJURY AND DEATH TO THE DEVELOPING FETUS. (5.1)
1 INDICATIONS AND USAGE
Rasilamlo is indicated for the treatment of hypertension, in patients
not adequately controlled with aliskiren or amlodipine monotherapy,
to lower blood pressure. There are no controlled trials demonstrating
risk reduction of cardiovascular disease with Rasilamlo.
Description:
The benefit of Rasilamlo in decreasing cardiovascular disease’s risk
has not been evaluated in any placebo-controlled trial.
Data from the high-dose multifactorial study [see Clinical Studies]
provide estimates of the probability of reaching a target blood
pressure with Rasilamlo compared to aliskiren or amlodipine
monotherapy. The figures below provide estimates of the likelihood
of achieving systolic or diastolic blood pressure control with
Rasilamlo
300 mg/10 mg, based upon baseline systolic or diastolic blood
pressure. The curve of each treatment group was estimated by
logistic regression modeling. The estimated likelihood at the right
tail
of each curve is less reliable because of a small number of subjects
with high baseline blood pressures.
FIGURE 1: PROBABILITY OF ACHIEVING SYSTOLIC BLOOD PRESSURE (SBP)
<140 MMHG
FIGURE 2: PROBABILITY OF ACHIEVING DIASTOLIC BLOOD PRESSURE
(DBP) <90 MMHG
FIGURE 3: PROBABILITY OF ACHIEVING SYSTOLIC BLOOD PRESSURE (SBP)
<130
MMHG
FIGURE 4: PROBABILITY OF ACHIEVING DIASTOLIC BLOOD PRESSURE
(DBP) <80 MMHG
The figures above provide an approximation of the likelihood of
reaching a targeted blood pressure goal (e.g. SBP<140 mmHg or
<130 mmHg) for the high dose groups evaluated in the study. At all
levels of baseline blood pressure, the probability of achieving any
given diastolic or systol