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izdelek tkivnega inženirstva
tissue engineered product

posebne zahteve za izdelke tkivnega inženirstva
specific requirements for tissue engineered products

vrednosti tkivnega utežnega faktorja, wt [1]
values of tissue weighting factor, wt (1*)

„izdelek tkivnega inženirstva“ pomeni izdelek, ki:
‘tissue engineered product’ means a product that:

2.3 opredelitev izdelka tkivnega inženirstva je bolj zapletena.
2.3 the definition of a tissue engineered product seems more complex however.

(b) izdelek tkivnega inženirstva pomeni izdelek, ki:
(b) tissue engineered product means a product that:

zdravilo za somatsko celično zdravljenje ali izdelek tkivnega inženirstva in
a somatic cell therapy medicinal product or a tissue engineered product, and

izdelek tkivnega inženirstva, kakor je opredeljen v točki (b);
a tissue engineered product as defined in point (b);

posebne zahteve za zdravila za somatsko celično zdravljenje in izdelke tkivnega inženirstva
specific requirements for somatic cell therapy medicinal products and tissue engineered products

izdelek tkivnega inženirstva, kakor je opredeljen v točki (b).
a tissue engineered product as defined in point (b).

posledica je pretvorba protrombina v veliko količino trombina, neodvisno od tkivnega faktorja.
this results in the conversion of prothrombin into large amounts of thrombin independently of tissue factor.

izdelek tkivnega inženirstva lahko vsebuje celice ali tkiva človeškega ali živalskega izvora ali oboje.
a tissue engineered product may contain cells or tissues of human or animal origin, or both.

Študije o farmakodinamiki obravnavajo posebne lastnosti izdelkov tkivnega inženirstva, katerim so te študije tudi prilagojene.
pharmacodynamic studies shall be designed and tailored to the specificities of tissue engineered products.

previdnost pri opredelitvah in tudi pri uvedbi izdelkov tkivnega inženirstva jasno poudarja, da ta etična razprava še ni zaključena.
the caution exercised with regard to both definitions and the use of the products of tissue engineering clearly shows that the ethical debate is not yet resolved.

faktor ix aktivirata faktor xia v intrinzični poti koagulacije in kompleks faktorja vii/tkivnega faktorja v ekstrinzični poti.
factor ix is activated by factor xia in the intrinsic coagulation pathway and by the factor vii/tissue factor complex in the extrinsic pathway.

faktor ix se aktivira s kompleksom faktorja vii/tkivnega faktorja v ekstrinzični poti in s faktorjem xia v intrinzični koagulacijski poti.
factor ix is activated by factor vii/tissue factor complex in the extrinsic pathway as well as factor xia in the intrinsic coagulation pathway.

pokazali so, da zdravljenje z doksazosinom zmanjša hipertrofijo levega prekata, zavira agregacijo trombocitov in poveča zmogljivost tkivnega aktivatorja plazminogena.
treatment with doxazosin has been shown to result in regression of left ventricular hypertrophy, inhibition of platelet aggregation as well as enhanced capacity of tissue plasminogen-activator.

farmakološki odmerki zdravila novoseven aktivirajo faktor x neposredno na površini aktiviranih trombocitov, ki se nahajajo na mestu poškodbe, neodvisno od tkivnega faktorja.
pharmacological doses of novoseven activate factor x directly on the surface of activated platelets, localized to the site of injury, independently of tissue factor.

kadar običajne študije o farmakokinetiki niso pomembne za izdelke tkivnega inženirstva, se med kliničnim razvojem obravnavajo biološka porazdelitev, obstojnost in razgradnja sestavin izdelkov tkivnega inženirstva.
where conventional pharmacokinetic studies are not relevant for tissue engineered products, the biodistribution, persistence and degradation of the tissue engineered product components shall be addressed during the clinical development.

poleg tega je treba določiti podrobne znanstvene in tehnične zahteve za izdelke tkivnega inženirstva, zdravila za napredno zdravljenje, ki vključujejo pripomočke ter kombinirana zdravila za napredno zdravljenje.
moreover, detailed scientific and technical requirements should be established for tissue engineered products, as well as for advanced therapy medicinal product containing devices and combined advanced therapy medicinal products.