Je was op zoek naar: orathecin (Deens - Engels)

hvad er orathecin?
what is orathecin?

hvad forventedes orathecin anvendt til?
what was orathecin expected to be used for?

hvordan forventes orathecin at virke?
how is orathecin expected to work?

orathecin er en kapsel, der indtages oralt.
orathecin is a capsule to be taken orally.

orathecin er blevet undersøgt i to kliniske hovedundersøgelser.
orathecin has been investigated in two main clinical studies.

orathecin tilhører en gruppe af alkaloider, der kaldes camptotheciner.
orathecin belongs to a group of alkaloids called camptothecins.

spØrgsmÅl og svar vedrØrende tilbagetrÆkning af ansØgningen om markedsfØringstilladelse for orathecin
questions and answers on withdrawal of marketing application for orathecin

ved at blokere dette protein forventes orathecin at beskadige kræftcellerne.
by blocking this protein, orathecin is expected to damage the cancer cells.

orathecin blev udpeget som lægemiddel til sjældne sygdomme den 10. juni 2003.
orathecin was designated as an orphan medicinal product on 10 june 2003.

orathecin indeholder 0, 5 mg eller 1, 25 mg af det aktive stof rubitecan.
orathecin contains 0.5 or 1.25 of the active substance rubitecan.

desuden kom patienter behandlet med orathecin ud for mange bivirkninger, nogle af dem alvorlige.
moreover, patients treated with orathecin experienced many side effects, including serious ones.

virkningerne af orathecin er først testet i forsøgsmodeller, inden de er blevet undersøgt på mennesker.
the effects of orathecin were first tested in experimental models before being studied in humans.

patienterne fik orathecin, indtil deres kræftsygdom udviklede sig videre, eller indtil de ikke tålte behandlingen længere.
orathecin was given to the patients until their cancer progressed or they could not tolerate the treatment anymore.

hvilke konsekvenser har tilbagetrækningen for patienter, der deltager i kliniske undersøgelser med orathecin eller i programmer for anvendelse med særlig udleveringstilladelse?
what are the consequences of the withdrawal for patients undergoing clinical trials / compassionate use programmes with orathecin?

i de undersøgelser, firmaet havde fremlagt, kunne det ikke påvises, at orathecin forlænger patienternes liv eller giver dem bedre livskvalitet.
in the studies presented by the company, it could not be shown that orathecin extends the life of patients nor improves their quality of life.

efter gennemgang af de foreliggende oplysninger og firmaets besvarelse af chmp' s spørgsmål var der i chmp betænkelighed, og udvalgets foreløbige standpunkt var, at orathecin ikke kunne godkendes til behandling af patienter med fremskreden eller metastaserende pancreascancer.
based on the review of the data and the company’ s response to the chmp list of questions, at the time the withdrawal, the chmp had concerns and was of the provisional opinion that orathecin could not be approved for treatment of patients with advanced or metastatic pancretic cancer.

den 19. januar 2006 underrettede eurogen pharmaceuticals ltd. officielt udvalget for humanmedicinske lægemidler (chmp) om, at firmaet havde besluttet at trække sin ansøgning om markedsføringstilladelse for lægemidlet orathecin (rubitecan) tilbage.
on 19 january 2006, eurogen pharmaceuticals ltd officially notified the agency’ s committee for medicinal products for human use (chmp) of its decision to withdraw its application for marketing authorisation for the medicinal product orathecin (rubitecan).