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in amlodipine single formulation

Russian translation: монопрепарат амлодипина

06:00 Jun 27, 2017
English to Russian translations [PRO]
Medical - Medical: Pharmaceuticals
English term or phrase: in amlodipine single formulation
The MAH reviewed the results from the clinical PK study in healthy volunteers showing increased mTOR inhibitor exposure during concomitant treatment with a strong CYP3A inhibitor, and also reviewed the 4 publications reporting 17 cases of angioedema in patients treated with mTOR inhibitors while on concomitant medications.
The latter included 2 cases reporting concomitant treatment with amlodipine.
The MAH concluded that a potential exists to augment the exposure of the sirolimus metabolite if treatment of temsirolimus is accompanied by treatment with amlodipine, a weak CYP3A4 inhibitor.
In doing so, the potential exists to enhance the risk for angioedema when these agents are administered in combination19.
This potential interaction is considered to exist when temsirolimus is administered with amlodipine in any of its formulations: either **in amlodipine single formulation**, or amlodipine in dual formulations (amlodipine/ramipril, or amlodipine/atorvastatin).
This information on potential DDI has been added to temsirolimus label.
The following sections of the temsirolimus CDS and of the respective local labels were updated (text newly added to the temsirolimus CDS is represented by underlined font below).
Maxim Polukhin
Local time: 01:16
Russian translation:монопрепарат амлодипина
Explanation:
т.е. лекарственный препарат с одним только действующим веществом, в отличие от комбинированных препаратов, которые перечисляются далее (amlodipine/ramipril, or amlodipine/atorvastatin).
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Leila Usmanova
Local time: 01:16
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Спасибо!
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4монопрепарат амлодипина
Leila Usmanova


  

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53 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5
монопрепарат амлодипина


Explanation:
т.е. лекарственный препарат с одним только действующим веществом, в отличие от комбинированных препаратов, которые перечисляются далее (amlodipine/ramipril, or amlodipine/atorvastatin).


Leila Usmanova
Local time: 01:16
Specializes in field
Native speaker of: Russian
PRO pts in category: 2661
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Спасибо!
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