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ta opredelitev bi morala določiti način delovanja, ki ga zdravilo lahko ima na fiziološke funkcije.
this definition should specify the type of action that the medicinal product may exert on physiological functions.
Last Update: 2014-11-21
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holna kislina je ena od primarnih žolčnih kislin pri človeku, od katere so odvisne esencialne fiziološke funkcije.
cholic acid is one of the primary bile acids in man on which essential physiological functions depend.
Last Update: 2017-04-26
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„receptorji“ pomenijo biološke makromolekularne strukture, ki so sposobne vezati ligande in katerih vezava vpliva na fiziološke funkcije.
”receptors” means biological macromolecular structures capable of binding ligands, the binding of which affects physiological functions.
Last Update: 2014-11-21
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kompleks faktorja viii in von willebrandovega faktorja je sestavljen iz dveh molekul (faktorja viii in von willebrandovega faktorja), ki imata različne fiziološke funkcije.
the factor viii/von willebrand factor complex consists of two molecules (factor viii and von willebrand factor) with different physiological functions.
Last Update: 2017-04-26
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za zdravilo se šteje tudi vsaka snov ali kombinacija snovi, ki se lahko daje ljudem z namenom, da se določi diagnoza ali ponovno vzpostavijo, izboljšajo ali spremenijo fiziološke funkcije.
any substance or combination of substances which may be administered to human beings with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in human beings is likewise considered a medicinal product.
preskus o zgornjih in spodnjih mejnih vrednostih je obvezen za konzervanse ter preskus o zgornjih mejnih vrednostih za vsako drugo pomožno snov, ki bi morda lahko imele neželen vpliv na fiziološke funkcije;
an upper and lower limit test shall be obligatory in respect of preserving agents and an upper limit test for any other excipient component liable to affect adversely physiological functions;
v ta namen je neželen učinek zdravila učinek, ki je škodljiv in nenameren in se pojavlja pri odmerkih, ki se običajno dajejo ljudem za preventivo, diagnostiko ali terapijo bolezni ali za spremembo fiziološke funkcije.
for this purpose, an adverse drug reaction is a reaction which is noxious and unintended and which occurs at doses normally used in man for prophylaxis, diagnosis or therapy of disease or for the modification of physiological function.
cox-1 je običajno konstitutivni encim, izražen v tkivih, ki sintetizirajo produkte odgovorne za normalne fiziološke funkcije (npr. v gastrointestinalnem traktu in ledvicah).
cox-1 is usually a constitutive enzyme expressed in tissues, which synthesize products responsible for normal physiologic functions (e.g. in the gastro-intestinal tract and kidneys).
neželen škodljiv učinek: škodljiva in nenamerna reakcija, do katere prihaja v odmerkih, ki jih normalno uporabljamo pri živalih za preprečevanje, diagnozo ali zdravljenje bolezni, ali za spreminjanje fiziološke funkcije.
adverse reaction: a reaction which is harmful and unintended and which occurs at doses normally used in animals for the prophylaxis, diagnosis or treatment of disease or the modification of physiological function.
neželen učinek zdravila je škodljiva in nenamerna reakcija, ki se pojavi pri odmerkih, ki se običajno uporabljajo pri ljudeh za preprečevanje, diagnosticiranje ali zdravljenje bolezni, ali za ponovno vzpostavitev, izboljšanje ali spremembo fiziološke funkcije.
a response to a medicinal product which is noxious and unintended and which occurs at doses normally used in man for the prophylaxis, diagnosis or therapy of disease or for the restoration, correction or modification of physiological function.
(1) celice ali tkiva so bili predmet bistvene manipulacije, s čimer so bile spremenjene njihove biološke značilnosti, fiziološke funkcije ali lastnosti sestave, pomembne za nameravano regeneracijo, obnovitev ali nadomestitev.
(1) the cells or tissues have been subject to substantial manipulation, so that their original biological characteristics, physiological functions or structural properties relevant for the intended regeneration, repair or replacement, are altered.
škodljiva in nenamerna reakcija na zdravilo za uporabo v veterinarski medicini, ki se pojavi v odmerkih, ki jih običajno uporabljamo pri živalih bodisi za preprečevanje, diagnozo ali zdravljenje bolezni ali da bi se ponovno vzpostavile, izboljšale ali spremenile fiziološke funkcije."
a reaction to a veterinary medicinal product which is harmful and unintended and which occurs at doses normally used in animals for the prophylaxis, diagnosis or treatment of disease or to restore, correct or modify a physiological function.";
neželen učinek: neželen učinek zdravila je škodljiva in nenamerna reakcija, ki se pojavi pri odmerkih, ki se običajno uporabljajo pri ljudeh za preprečevanje, diagnosticiranje ali zdravljenje bolezni, ali za ponovno vzpostavitev, izboljšanje ali spremembo fiziološke funkcije.
adverse reaction: a response to a medicinal product which is noxious and unintended and which occurs at doses normally used in man for the prophylaxis, diagnosis or therapy of disease or for the restoration, correction or modification of physiological function.
vsaka snov ali mešanica snovi, namenjena uporabi v proizvodnji zdravil, ki z uporabo v proizvodnji zdravila postane njegova zdravilna učinkovina, katere namen je farmakološko, imunološko ali presnovno delovanje, da bi se ponovno vzpostavile, izboljšale ali spremenile fiziološke funkcije ali da bi se določila diagnoza.
any substance or mixture of substances intended to be used in the manufacture of a medicinal product and that, when used in its production, becomes an active ingredient of that product intended to exert a pharmacological, immunological or metabolic action with a view to restoring, correcting or modifying physiological functions or to make a medical diagnosis.
vsebuje ali je sestavljeno iz celic ali tkiv, ki so bila podvržena bistveni manipulaciji, s čimer so se spremenile njihove biološke značilnosti, fiziološke funkcije ali strukturne lastnosti, pomembne za predvideno klinično uporabo, ali iz celic ali tkiv, ki niso predvidena za uporabo za enake bistvene funkcije v prejemniku in darovalcu;
contains or consists of cells or tissues that have been subject to substantial manipulation so that biological characteristics, physiological functions or structural properties relevant for the intended clinical use have been altered, or of cells or tissues that are not intended to be used for the same essential function(s) in the recipient and the donor;
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