compassionate use

Serbian translation: medicinska upotreba ispitivanog leka, medicinska upotreba neodobrenog leka, upotreba neodobrenog leka van kliničkog ispitivanja

GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW)
English term or phrase:compassionate use
Serbian translation:medicinska upotreba ispitivanog leka, medicinska upotreba neodobrenog leka, upotreba neodobrenog leka van kliničkog ispitivanja
Entered by: RINA LINGUISTIC SERVICES, Katarina Radojevic- Mitrovic

22:04 Apr 19, 2011
English to Serbian translations [PRO]
Medical - Medical: Pharmaceuticals / Instructions
English term or phrase: compassionate use
compassionate drug use

Potreban je termin usklađen s relevantnim pravilnikom Ministarstva zdravlja RS.
RINA LINGUISTIC SERVICES, Katarina Radojevic- Mitrovic
Serbia
Local time: 07:41
upotreba iz samilosti
Explanation:
Mislim da je "iz samilosti" odgovarajući termin, jer, koliko sam ja razumela, "compassionate use" znači da se teško obolelim pacijentima može odobriti upotreba lekova koji su još uvek u fazi ispitivanja.
Ne znam da li se taj termin koristi u pravilnicima min. zdravlja.
Selected response from:

Katarina Delic
Local time: 07:41
Grading comment
Hvala na sugestijama! :)
1 KudoZ points were awarded for this answer



Summary of answers provided
3 +1upotreba iz samilosti
Katarina Delic
4Neodobrena primena leka
Natasa Djurovic
Summary of reference entries provided
milosrdna upotreba
Daniela Slankamenac

Discussion entries: 15





  

Answers


34 mins   confidence: Answerer confidence 3/5Answerer confidence 3/5 peer agreement (net): +1
upotreba iz samilosti


Explanation:
Mislim da je "iz samilosti" odgovarajući termin, jer, koliko sam ja razumela, "compassionate use" znači da se teško obolelim pacijentima može odobriti upotreba lekova koji su još uvek u fazi ispitivanja.
Ne znam da li se taj termin koristi u pravilnicima min. zdravlja.


    Reference: http://www.hendidrustvo.info/forum/index.php?topic=3052.15
Katarina Delic
Local time: 07:41
Specializes in field
Native speaker of: Native in SerbianSerbian
PRO pts in category: 17
Grading comment
Hvala na sugestijama! :)
Notes to answerer
Asker: Vidite gorenavedeni komentar. Hvala na pomoći svakako!

Asker: Moram priznati da je kolega Bukurov zapravo u potpunosti razumeo problematiku.


Peer comments on this answer (and responses from the answerer)
agree  Dinap: tako je, samilosno davanje leka, to je dio proširenog pristupa leku za ososbe koje ne mogu da učestvuju u kliničkim ispitivanjima jer su isuviše bolesne a lek još nije odobren u njihovim zemljama
8 hrs
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7 hrs   confidence: Answerer confidence 4/5Answerer confidence 4/5
Neodobrena primena leka


Explanation:
http://www.med.bg.ac.rs/dloads/studenti/2010/januar/farma/to...

Ja bih to resila na navedeni nacin jer je cesta upotreba kod klinickih ispitivanja.

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Note added at 7 hrs (2011-04-20 05:20:41 GMT)
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http://www.medterms.com/script/main/art.asp?articlekey=30711

Koliko vidim citav program postoji u USD, za pacijente koji nemaju drugu opciju za lecenje, a ne zadovoljavaju kriterijume klinickog ispitivanja.

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Note added at 7 hrs (2011-04-20 05:23:50 GMT)
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http://en.wikipedia.org/wiki/Expanded_access

Evo reference da se compassionate use koristi kolokvijalno, a da se odnosi na Expanded access program-Prosireni Program za primenu neodobrenog leka.

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Note added at 7 hrs (2011-04-20 05:25:58 GMT)
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Poenta jeste da se u klinicko ispitivanje ukljucuje pacijent koji nema drugu alternativu za lecenje i izvestan je smrtni ishod. Cesto za pacijente koji boluju od kancera ili HIV-a.

Natasa Djurovic
Serbia
Local time: 07:41
Works in field
Native speaker of: Native in SerbianSerbian
PRO pts in category: 9
Notes to answerer
Asker: Hvala najlepše na pomoći! Pogledajte moje komentare u okviru diskusije i rešenje koje je zapravo jedino prihvatljivo, a koje je ponudio kolega Bukurov.

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Reference comments


50 mins
Reference: milosrdna upotreba

Reference information:
Hrvatski prevod.

MILOSRDNA UPORABA (eng. compassionate use): Postupak primjene pokusnog lijeka ili proizvoda prije odobrenja državnih tijela za uporabu na ljudima. Ovaj se postupak koristi kod vrlo bolesnih ljudi za koje ne postoje drugi oblici liječenja. Odobrenje za takav postupak najčešće se daje za svaki pojedinačni slučaj milosrdne uporabe lijeka.

http://www.regpok.hr/RegPok/Rjecnik.html

Daniela Slankamenac
Serbia
Native speaker of: Serbian
PRO pts in category: 4
Note to reference poster
Asker: Puno hvala, no vidite moj komentar gore! :)

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