freie Kombination

English translation: free combination of ...

GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW)
German term or phrase: freie Kombination
English translation:free combination of ...
Entered by: Marga Shaw

19:57 Jan 7, 2011
German to English translations [PRO]
Medical - Medical: Pharmaceuticals
German term or phrase: freie Kombination
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!
Lirka
Austria
Local time: 19:22
free combination of ...
Explanation:

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...
Selected response from:

Marga Shaw
United Kingdom
Local time: 18:22
Grading comment
Thank you, Marga.
4 KudoZ points were awarded for this answer



Summary of answers provided
4 +1Free Dose Combination
J. Pieter Mielekamp
3 +1free combination of ...
Marga Shaw


  

Answers


25 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): +1
Free Dose Combination


Explanation:
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(s):
  • 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.

    Reference: http://www.ionchannels.org/showabstract.php?pmid=18507275
J. Pieter Mielekamp
United States
Local time: 10:22
Native speaker of: Native in DutchDutch

Peer comments on this answer (and responses from the answerer)
agree  Harald Moelzer (medical-translator): yes, e.g. see here: http://tinyurl.com/26fd9zw
1 day 18 hrs
Login to enter a peer comment (or grade)

5 hrs   confidence: Answerer confidence 3/5Answerer confidence 3/5 peer agreement (net): +1
free combination of ...


Explanation:

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...


Marga Shaw
United Kingdom
Local time: 18:22
Specializes in field
Native speaker of: German
PRO pts in category: 154
Grading comment
Thank you, Marga.

Peer comments on this answer (and responses from the answerer)
agree  Ramey Rieger (X)
10 hrs
  -> Thank you, Ramey!
Login to enter a peer comment (or grade)



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