Glossary entry

German term or phrase:

freie Kombination

English translation:

free combination of ...

Added to glossary by Marga Shaw
Jan 7, 2011 19:57
13 yrs ago
3 viewers *
German term

freie Kombination

German to English Medical Medical: Pharmaceuticals
SPCs-- an antihypertensive drug.

"Bei eingeschränkter Nierenfunktion (Creatinin-Clearance zwischen 10-30 ml/Min.) kann eine freie Kombination aus Gopten 0,5 mg und Isoptin retard (120 mg) eingesetzt werden."

Is there a special phrama-related term for it?

Thanks!
Change log

Apr 15, 2011 08:24: Marga Shaw Created KOG entry

Proposed translations

+1
5 hrs
Selected

free combination of ...


a free combination of trandolapril and isoptin

e.g.:
The combination contains known active substances and it is a substitution indication (i.e. use in patients adequately controlled with the individual products given concurrently, at the same dose level as in the combination, but as separate tablets) or the new fixed combination contains known active ingredients that have not been used in combination before. In these cases bioequivalence should be demonstrated between the free combination of the recognised reference formulations of the individual monocomponents and the marketing formulation (fixed combination).
http://www.tga.gov.au/docs/pdf/euguide/ewp/024095enfin.pdf

(a) Comparison of blood pressure goal achievement between
patients receiving valsartan-based single pill combinations and those receiving angiotensin receptor-blocker-based free combinations.
(b) Comparison of blood pressure goal achievement between patients receiving single pill combination of valsartan/amlodipine and those receiving free combination of angiotensin receptor blocker þ calcium channel blocker.
(c) Comparison of blood pressure goal achievement
between patients receiving single-pill combination of valsartan/
hydrochlorothiazide and those receiving free combinations of angiotensin receptor blocker þ hydrochlorothiazide.
http://docs.google.com/viewer?a=v&q=cache:JLenw8NLKFAJ:www.i...

Bioequivalence studies [CP-study 2303 and CP-study 2309] compared the fixed combination valsartan/amlodipine
tablet against the free combination of clinical service forms (CSFs) of valsartan and amlodipine. The amlodipine CSF was an encapsulated US-sourced amlodipine tablet.
http://docs.google.com/viewer?a=v&q=cache:I-vF9Vx9lFkJ:www.e...
Peer comment(s):

agree Ramey Rieger (X)
10 hrs
Thank you, Ramey!
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4 KudoZ points awarded for this answer. Comment: "Thank you, Marga."
+1
25 mins

Free Dose Combination

Some examples:

"Janumet, a fixed dose combination of sitagliptin/metformin HCL manufactured by Merck Pharmaceuticals, has received US Food and Drug Administration approval for treatment of patients with type 2 diabetes, that are inadequately controlled, either by sitagliptin or metformin alone or together in free-dose combination form"


Racial differences in medication compliance and healthcare utilization among hypertensive medicaid recipients: fixed-dose vs free dose combination treatment.

German:
"In der Regel ist die freie Kombination der Wirkstoffe kostengünstiger als die feste Kombination"
Example sentence:

Determining Optimal Free Dose Combination of Tiotropium Bromide and BI 1744 CL in Chronic Obstructive Pulmonary Disease (COPD)

The <b>fixed-dose</b> combination drug is the test formulation and <b>free combination</b> is the reference formulation.

Peer comment(s):

agree Harald Moelzer (medical-translator) : yes, e.g. see here: http://tinyurl.com/26fd9zw
1 day 18 hrs
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