देश: ताइवान
भाषा: चीनी
स्रोत: 衛生福利部食品藥物管理署 (Ministry of Health and Welfare, Food And Drug Administration)
ALISKIREN HEMIFUMARATE;;AMLODIPINE BESYLATE
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)
C09XA53
膜衣錠
主成分 () ; ALISKIREN HEMIFUMARATE (2408007010) MG; AMLODIPINE BESYLATE (2412402210) MG
鋁箔盒裝
製 劑
須由醫師處方使用
LEK PHARMACEUTICALS D.D PRODUCTION OF PHARMACEUTICAL INGREDIENTS KOLODVORSKA 27, SLOVENIA - 1234 MENGES SI
aliskiren and amlodipine
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
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
已註銷
2012-05-22
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 पूरा दस्तावेज़ पढ़ें