natgillin/translations-raw huggingface dataset:
These symptoms might be caused by a sudden decrease of kidney function.
Ti simptomi so morda posledica nenadnega poslabšanja delovanja ledvic.
IC50 values for inhibition of CYP2B6 and CYP2E1 by temsirolimus were 48 and 100 μM, respectively.
Vrednosti IC50 za zaviranje CYP2B6 in CYP2E1 s temsirolimusom sta bili 48 oziroma 100 μM.
Other side effects with Torisel may include:
Drugi neželeni učinki zdravila Torisel so lahko:
However, it is unlikely that whole blood concentrations of temsirolimus after intravenous administration of temsirolimus will inhibit the metabolic clearance of concomitant medicinal products that are substrates of CYP2C9, CYP2C8, CYP2B6 or CYP2E1.
Vendar ni verjetno, da bi koncentracije temsirolimusa v polni krvi po intravenskem dajanju temsirolimusa zavirale presnovni očistek sočasnih zdravil, ki so substrati za CYP2C9, CYP2C8, CYP2B6 ali CYP2E1.
It is unknown whether temsirolimus is excreted in human breast milk.
Ni znano, ali se temsirolimus izloča v materino mleko pri ljudeh.
The excretion of temsirolimus in milk has not been studied in animals.
Izločanja temsirolimusa v mleko pri živalih niso proučevali.
You should also tell your doctor straight away: if you have cough, chest pain, difficulties in breathing.
Prav tako brez odlašanja povejte zdravniku: - če kašljate, imate bolečine v prsih, težko dihate.
Others presented with symptoms such as dyspnoea, cough, and fever.
Pri drugih so se pojavili simptomi, na primer dispneja, kašelj in vročina.
Temsirolimus is not recommended for use in paediatric patients (see sections 4.2, 4.8 and 5.1).
Uporaba temsirolimusa pri pediatričnih bolnikih ni priporočljiva (glejte poglavja 4.2, 4.8 in 5.1).
Torisel may elevate triglycerides and/or cholesterol, and this may require treatment with lipid-lowering agents (medicines used to reduce cholesterol in the blood).
Zdravilo Torisel lahko zviša trigliceride in/ali holesterol, zato bo morda potrebno zdravljenje s hipolipemiki (to so zdravila, ki znižujejo holesterol v krvi).
Secondary endpoints included progression-free survival (PFS), objective response rate (ORR), clinical benefit rate, time to treatment failure (TTF), and quality adjusted survival measurement.
Sekundarni opazovani dogodki so vključevali preživetje brez napredovanja bolezni (PFS - Progression-Free Surival), objektivni odziv na zdravljenje (ORR - Objective Response Rate), stopnjo klinične koristnosti, čas do prenehanja učinkovitosti zdravljenja (TTF - Time to Treatment Failure) in preživetja, popravljenega za kvaliteto življenja.
Torisel may cause non-specific interstitial pneumonitis.
Zdravilo Torisel lahko povzroči nespecifično intersticijsko pljučnico.
The anti-tumour effect of temsirolimus, therefore, may also in part stem from its ability to depress levels of HIF and VEGF in the tumour or tumour microenvironment, thereby impairing vessel development.
Zato lahko protitumorsko delovanje temsirolimusa deloma izvira tudi iz njegove sposobnosti za zniževanje ravni HIF in VEGF v tumorju ali mikrookolju tumorja, s čimer zavira razvoj žilja.
Inhibition of mTOR activity results in a G1 growth delay at nanomolar concentrations and growth arrest at micromolar concentrations in treated tumour cells resulting from selective disruption of translation of cell cycle regulatory proteins, such as D-type cyclins, c-myc, and ornithine decarboxylase.
Zaviranje aktivnosti mTOR povzroči zakasnitev rasti G1 v nanomolarnih koncentracijah in zaustavitev rasti v mikromolarnih koncentracijah v zdravljenih tumorskih celicah, ki je posledica selektivne prekinitve translacije beljakovin, ki uravnavajo celični ciklus, kot so ciklini tipa D, c-myc in ornitinska dekarboksilaza.
The effect on the unbound concentrations of sirolimus has not been determined, but is expected to be larger than the effect on whole-blood concentrations due to the saturable binding to red blood cells.
Učinka na nevezano koncentracijo sirolimusa niso ugotavljali, zaradi nasičene vezave na rdeče krvničke pa je pričakovati, da bo večji kot učinek na koncentracijo v polni krvi.
The safety and efficacy of intravenous temsirolimus for the treatment of relapsed and/or refractory MCL were studied in the following Phase 3 clinical study.
Varnost in učinkovitost intravenskega temsirolimusa za zdravljenje recidivnega in/ali proti zdravljenju odpornega MCL so proučevali v naslednji klinični študiji 3. faze.
What Torisel looks like and contents of the pack
Izgled zdravila Torisel in vsebina pakiranja
There have been cases of non-specific interstitial pneumonitis, including fatal reports, occurring in patients who received weekly intravenous temsirolimus.
Opisani so bili primeri nespecifične intersticijske pljučnice, tudi smrti, pri bolnikih, ki so vsak teden intravensko dobivali temsirolimus.
6 hours when stored below 25°C and protected from light.
6 ur, če je shranjeno pri temperaturi do 25 C in zaščiteno pred svetlobo
When mTOR activity is inhibited, its ability to phosphorylate, and thereby control the activity of protein translation factors (4E-BP1 and S6K, both downstream of mTOR in the P13 kinase/AKT pathway) that control cell division, is blocked.
Ko je aktivnost mTOR zavrta, je blokirana njegova sposobnost fosforilacije in s tem nadzorovanja aktivnosti faktorjev translacije beljakovin (4E-BP1 in S6K, obe v fazah, ki sledita mTOR v presnovni poti P13 kinaza/AKT), ki nadzirajo celično delitev.
Dose reduction level
Ravni zmanjšanja odmerka
If the patient cannot maintain ANC 1.0 x 109/l and platelets 50 x 109/l on the new dose reduction level, then the next lower dose should be given once the counts have recovered.
Če bolniku ne moremo vzdrževati ANC  1,0 x 9/l in trombocitov  50 x 10 9/l na novi ravni zmanjšanja odmerka, je treba dati naslednji zmanjšani odmerek, potem ko se ANC in koncentracija trombocitov popravita.
P-value
Vrednost p
After 12 weeks of treatment, no response was observed in subjects with rhabdomyosarcoma or high-grade glioma.
Po 12 tednih zdravljenja niso opazili nobenega odziva pri bolnikih z rabdomiosarkomom ali gliomom visoke stopnje.
However, sirolimus, the main metabolite of temsirolimus, is excreted in milk of lactating rats.
Se pa sirolimus, ki je glavni presnovek temsirolimusa, izloča v mleko doječih podgan.
Do not use this medicine after the expiry date, which is stated on the vial label and carton.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki na viali in kartonski škatli poleg oznake ''Uporabno do'' oziroma ''EXP''.
Concomitant use of angiotensin-converting enzyme (ACE) inhibitors and/or calcium channel blockers
Sočasna uporaba zaviralcev angiotenzinske konvertaze (ACE) in/ali zaviralcev kalcijevih kanalčkov
Studies in animals have shown reproductive toxicity.
Študije na živalih so pokazale vpliv na sposobnost razmnoževanja.
There is no relevant use of temsirolimus in the paediatric population for the indications of RCC and MCL.
Pediatrična populacija Temsirolimus ni namenjen za uporabo pri pediatrični populaciji za indikaciji RCC in MCL.
Starting dose 175 mg
Začetni odmerek 175 mg
No specific dose adjustment is necessary in elderly patients.
Starostniki Pri starejših bolnikih posebno prilagajanje odmerka ni potrebno.
Use of temsirolimus in patients with MCL with moderate or severe hepatic impairment.
Uporaba temsirolimusa pri bolnikih z MCL z zmerno ali hudo okvaro jeter.
Torisel is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC) who have at least three of six prognostic risk factors (see section 5.1).
Zdravilo Torisel je indicirano kot zdravilo prvega izbora za zdravljenje odraslih bolnikov z napredovalim karcinomom ledvičnih celic (RCC - Renal Cell Carcinoma), ki imajo vsaj tri od šestih prognostičnih dejavnikov tveganja (glejte poglavje 5.1).
Bleeding into the brain in patients with brain tumours or who are on blood thinners, eye bleeding.
Krvavitev v možgane pri bolnikih z možganskimi tumorji ali pri tistih, ki se zdravijo s sredstvi za preprečevanje strjevanja krvi, krvavitve v očeh.
An in-line polyethersulfone filter with a pore size of not greater than 5 microns is recommended for administration to avoid the possibility of particles bigger than 5 microns being infused.
Za dajanje zdravila priporočajo polietersulfonski filter v infuzijskem sistemu s porami, ki niso večje od 5 mikronov, da se izognete možnosti, da bi infundirali delce, večje od 5 mikronov.
In the 25 mg arm (n = 36), all patients had metastatic disease; 4 (11%) had no prior chemo- or immunotherapy; 17 (47%) had one prior treatment, and 15 (42%) had 2 or more prior treatments for RCC. Twenty-seven (27, 75%) had undergone a nephrectomy.
V kraku s 25 mg (n = 36) so imeli vsi bolniki metastatsko bolezen; 4 (11 %) kemoterapije ali imunoterapije prej niso imeli; 17 (47 %) jih je imelo po eno predhodno zdravljenje, 15 (42 %) pa po 2 ali več predhodnih zdravljenj zaradi RCC. Sedemindvajset (27, 75 %) jih je imelo nefrektomijo.
a Based on log-rank test stratified by prior nephrectomy and region.
Na podlagi testa log-rank, stratificiranega po predhodni nefrektomiji in regiji.
Hypersensitivity to temsirolimus, its metabolites (including sirolimus), polysorbate 80, or to any of the excipients listed in section 6.1.
Preobčutljivost na temsirolimus, njegove presnovke (med drugim sirolimus), polisorbat 80 ali katerokoli pomožno snov, navedeno v poglavju 6.1.
Manufacturer Wyeth Lederle S.r.l.
Izdelovalec Wyeth Lederle S.r.l.
Temsirolimus distribution is dose-dependent with mean (10th, 90th percentiles) maximal specific binding in blood cells of 1.4 mg (0.47 to 2.5 mg).
Porazdelitev temsirolimusa je odvisna od odmerka s povprečno (10., 90. percentila) maksimalno specifično vezavo v krvničkah 1,4 mg (od 0,47 do 2,5 mg).
In population pharmacokinetic-based data analysis, increased body weight (between 38.6 and 158.9 kg) was associated with a two-fold range of trough concentration of sirolimus in whole blood.
Na podlagi analize podatkov s populacijsko farmakokinetiko je bila zvečana telesna masa (med 38,6 in 158,9 kg) povezana z dvakrat večjim razponom najmanjših koncentracij sirolimusa v polni krvi.
At the discretion of the physician, treatment may be resumed after the administration of an H1-receptor antagonist (diphenhydramine or similar antihistamine) and a H2-receptor antagonist (intravenous famotidine 20 mg or intravenous ranitidine 50 mg) approximately 30 minutes before restarting the temsirolimus infusion.
Po zdravnikovi presoji se lahko zdravljenje nadaljuje potem, ko bolnik prejme antagonist receptorjev H1 (difenhidramin ali podoben antihistaminik) in antagonist receptorjev H2 (famotidin 20 mg intravensko ali ranitidin 50 mg intravensko) približno 30 minut pred ponovnim začetkom infuzije temsirolimusa.
Torisel can decrease the number of blood cells that help in clotting and resisting infection.
- zdravilo Torisel lahko zmanjša število krvnih celic, ki sodelujejo pri strjevanju krvi ter premagovanju okužb.
In preparing the solution, the following two-step process must be carried out in an aseptic manner according to local standards for handling cytotoxic/cytostatic medicinal products:
Pri pripravi raztopine je treba na aseptičen način in v skladu z lokalnimi standardi za ravnanje s citotoksičnimi/citostatičnimi zdravili izvesti naslednji dvostopenjski postopek:
In the paediatric population, clearance of temsirolimus was lower and exposure (AUC) was higher than in adults.
Pri pediatrični populaciji je bil očistek temsirolimusa iz organizma manjši, izpostavljenost (AUC) pa večja kot pri odraslih.
The primary endpoint of the study was PFS, as assessed by an independent radiologist and oncology review.
Primarni opazovani dogodek je bil PFS, ugotovljen s pregledom neodvisnega radiolog in onkologa.
The mean ±standard deviation (SD) dissociation constant (Kd) of binding was 5.1 ± 3.0 ng/ml, denoting the concentration at which 50% of binding sites in blood cells were occupied.
Povprečje ± standardna deviacija (SD) disociacijske konstante (Kd) vezave je bilo 5,1 ± 3,0 ng/ml, kar pomeni koncentracijo, pri kateri je bilo zasedenih 50 % vezavnih mest v krvničkah.
Secondary efficacy endpoints included OS and ORR.
Sekundarni opazovani dogodek je bila ocena učinkovitosti, ki je vključevala OS in ORR.
Temsirolimus and sirolimus were demonstrated to be substrates for P-gp in vitro.
Dokazali so, da sta temsirolimus in sirolimus substrata za P-gp in vitro.
Pharmacotherapeutic group: Antineoplastic agents, protein kinase inhibitors; ATC code: L01X E09
Farmakoterapevtska skupina: zdravila z delovanjem na novotvorbe, zaviralci proteinske kinaze; oznaka ATC: L01XE09
One-year survival rate % (97.5% CI) a Compared with inv choice based on Cox proportional hazard model.
Celokupno preživetje meseci (95 % IZ) Enoletno preživetje % (97,5 % IZ) V primerjavi z inv choice (= zdravljenje po izbiri raziskovalca) na podlagi Coxovega modela proporcionalnega tveganja.
In an in vitro study, temsirolimus inhibited the transport of P-glycoprotein (P-gp) substrates with an IC50 value of 2 µM.
V študiji in vitro je temsirolimus zaviral transport substratov P-glikoproteina (P-gp) z vrednostjo IC50 2 µM.
Cases of anaemia have been reported in RCC and MCL (see section 4.8).
Pri RCC in MCL so poročali o primerih anemije (glejte poglavje 4.8).
For patients with MCL, it is recommended that coadministration of CYP3A4/5 inducers should be avoided due to the higher dose of temsirolimus (see section 4.5).
Pri bolnikih z MCL je priporočljivo izogibanje sočasni uporabi induktorjev CYP3A4/5, zaradi večjega odmerka temsirolimusa (glejte poglavje 4.5).
Temsirolimus has been associated with phospholipidosis in rats.
Temsirolimus povezujejo s fosfolipidozo pri podganah.
c Compared with inv choice based on log-rank test. d Compared with inv choice alone based on Fisher's exact test.
V primerjavi z inv choice samo na podlagi Fisherjevega eksaktnega testa.
In vivo, the effect of P-gp inhibition has not been investigated in a clinical drugdrug interaction study, however, recent preliminary data from a Phase 1 study of combined lenalidomide (dose of 25 mg) and temsirolimus (dose of 20 mg) seem to support the in vitro findings and suggest an increased risk of adverse events.
In vivo učinka zaviranja P-gp v kliničnih študijah medsebojnega delovanja niso raziskali, vendar pa nedavni preliminarni podatki iz študije 1. faze kažejo, da uporaba kombinacije lenalidomida (odmerek 25 mg) in temsirolimusa (odmerek 20 mg) podpira ugotovitve in vitro in kaže na povečano tveganje za pojav neželenih učinkov.
c Based on Cochran-Mantel-Hansel test stratified by prior nephrectomy and region.
Na podlagi Cochran-Mantel-Haenszelovega testa, stratificiranega po predhodni nefrektomiji in regiji.
In vitro, at high concentrations (10-20 M), temsirolimus can bind and inhibit mTOR in the absence of FKBP-12.
In vitro lahko temsirolimus v velikih koncentracijah (10-20 M) veže in zavre mTOR v odsotnosti FKBP-12.
Tell your doctor if you develop any of the following signs and symptoms of liver problems during Torisel treatment: itching, yellow eyes or skin, dark urine, and pain or discomfort in the right upper stomach area.
Povejte zdravniku, če se vam med zdravljenjem z zdravilom Torisel pojavi katerikoli od naslednjih znakov in simptomov težav z jetri: srbenje, porumenelost oči in kože, temen urin, bolečina ali nelagodje v zgornjem desnem predelu trebuha.
Treatment with Torisel should continue until the patient is no longer clinically benefiting from therapy or until unacceptable toxicity occurs.
Zdravljenje z zdravilom Torisel je treba nadaljevati, dokler pri bolniku ne preneha klinična korist ali dokler se ne pojavi nesprejemljiva toksičnost.
Intestinal puncture, tear or holes
Predrtje črevesa, raztrganine ali luknje
Carcinogenicity studies have not been conducted with temsirolimus; however, sirolimus, the major metabolite of temsirolimus in humans, was carcinogenic in mice and rats.
Raziskav kancerogenosti s temsirolimusom niso izvedli; je pa bil sirolimus, ki je glavni presnovek temsirolimusa pri človeku, kancerogen pri miših in podganah.
The diluted solution must be administered by intravenous infusion.
Razredčeno raztopino je treba dajati v obliki intravenske infuzije.
Summary of efficacy results in temsirolimus MCL clinical trial
Povzetek rezultatov učinkovitosti temsirolimusa v kliničnem preskušanju MCL
In contrast, exposure to sirolimus was commensurately reduced in paediatric patients, such that the net exposure as measured by the sum of temsirolimus and sirolimus AUCs (AUCsum) was comparable to that for adults.
Nasprotno pa je bila izpostavljenost sirolimusu pri pediatričnih bolnikih sorazmerno manjša, tako da je bila neto izpostavljenost, merjena z vsoto vrednosti AUC temsirolimusa in sirolimusa (AUCvsota), primerljiva z izpostavljenostjo, ugotovljeno pri odraslih.
Torisel may increase the risk of problems with wound healing.
Zdravilo Torisel lahko poveča tveganje za težave pri celjenju ran.
The following effects were reported in mice and/or rats in the carcinogenicity studies conducted: granulocytic leukaemia, lymphoma, hepatocellular adenoma and carcinoma, and testicular adenoma.
Pri miših in/ali podganah so v opravljenih raziskavah kancerogenosti poročali o naslednjih učinkih: granulocitna levkemija, limfom, hepatocelularni adenom in karcinom ter testikularni adenom.
In an open-label, dose-escalation Phase 1 study in 110 subjects with advanced malignancies and either normal or impaired hepatic function, concentrations of temsirolimus and its metabolite sirolimus were increased in patients with elevated aspartate aminotransferase (AST) or bilirubin levels.
V odprti študiji večanja odmerka 1. faze pri 110 bolnikih z napredovalimi malignimi tumorji in bodisi normalnim bodisi okvarjenim delovanjem jeter so bile koncentracije temsirolimusa in njegovega presnovka sirolimusa povečane pri bolnikih s povečanimi ravnmi aspartat-aminotransferaze (AST) ali bilirubina.
If clinically significant respiratory symptoms develop, temsirolimus administration may be withheld until after recovery of symptoms and improvement of radiographic findings related to pneumonitis.
Če se pojavijo klinično pomembni respiratorni simptomi, lahko zdravljenje s temsirolimusom odložimo, dokler se simptomi ne izboljšajo in na rentgenski sliki ni več videti znakov pljučnice.
Temsirolimus also was associated with statistically significant advantages over investigator's choice in the secondary endpoint of ORR.
Temsirolimus je bil povezan tudi s statistično pomembnimi prednostmi pred zdravljenjem, ki ga je izbral raziskovalec, in sicer v sekundarnem opazovanem dogodku ORR.
For patients receiving the higher dose of Torisel for the treatment of mantle cell lymphoma, the amount of alcohol in this medicine may impair your ability to drive or use machines (see section below “Torisel contains ethanol [alcohol]”).
Pri bolnikih, ki za zdravljenje limfoma plaščnih celic prejemajo večje odmerke zdravila Torisel, lahko količina alkohola v tem zdravilu vpliva na njihovo sposobnost vožnje in upravljanja strojev (glejte spodnje poglavje “Zdravilo Torisel vsebuje etanol (alkohol)”).
In a Phase 1/2 safety and exploratory efficacy study, 71 patients (59 patients, aged from 1 to 17 years, and 12 patients, aged from 18 to 21 years) received temsirolimus as a 60-minute intravenous infusion once weekly in three-week cycles.
faze o varnosti in raziskovalni učinkovitosti, je 71 bolnikov (59 bolnikov, starih od 1 do 17 let, in 12 bolnikov, starih od 18 do 21 let) prejemalo temsirolimus v 60-minutni intravenski infuziji enkrat tedensko v tri tedne trajajočih ciklusih.
Unexplained muscle pain, tenderness or weakness which could indicate muscle damage
Nepojasnjena bolečina, občutljivost ali šibkost mišic, ki bi lahko kazala na okvaro mišic (rabdomioliza).
Torisel is indicated for the treatment of adult patients with relapsed and/or refractory mantle cell lymphoma (MCL) (see section 5.1).
Zdravilo Torisel je indicirano za zdravljenje odraslih bolnikov z recidivnim in/ali proti zdravljenju odpornim limfomom plaščnih celic (MCL - Mantle Cell Lymphoma) (glejte poglavje 5.1).
Population PK analysis based on sparse sampling indicated no clinically significant interaction effect on AUC and Cmax of the CYP2D6 substrate desipramine.
Populacijska farmakokinetična analiza na podlagi razpršenega vzorčenja ni pokazala klinično pomembnega vpliva na AUC in Cmax desipramina, ki je substrat CYP2D6.
The use of both an in-line and end-filter is not recommended.
Uporaba obeh filtrov, zaporedno vključenega in končnega, ni priporočljiva.
Examples of live vaccines are: measles, mumps, rubella, oral polio, Bacillus CalmetteGuérin (BCG), yellow fever, varicella, and TY21a typhoid vaccines.
Primeri živih cepiv so: cepiva za ošpice, mumps, rdečke, peroralni polio, Calmette-Guérinov bacil (BCG), rumeno mrzlico, norice in cepivo za tifus TY21a.
if you are receiving Torisel, you may be at increased risk of cancers such as skin cancers and lymph node cancers (lymphoma).
- če prejemate zdravilo Torisel, ste lahko izpostavljeni povečanemu tveganju za vrste raka, kot so kožni raki in raki bezgavk (limfomi).
Diarrhoea with mixed cell inflammation of the caecum or colon was observed in monkeys and was associated with an inflammatory response, and may have been due to a disruption of the normal intestinal flora.
Pri opicah so opazili drisko z vnetjem cekuma ali kolona z mešanimi celicami, ki je bila povezana z vnetnim odzivom in bi lahko bila posledica uničenja normalne črevesne flore.
No relevant differences in exposure were apparent when data from the Caucasian population was compared with either the Japanese or Black population.
Pri primerjavi podatkov, pridobljenih na populaciji belcev, s populacijo Japoncev ali črncev se niso pokazale pomembne razlike pri izpostavljenosti.
See the package leaflet for further information.
Za dodatne informacije glejte navodilo za uporabo.
Inhibition of CYP isoforms
Zaviranje izoform CYP
This medicine contains ethanol (alcohol), equivalent to 17.6 ml beer, 7.3 ml wine per 25 mg dose.
To zdravilo vsebuje etanol (alkohol), ki ustreza 17,6 ml piva oziroma 7,3 ml vina na 25 mg odmerek.
MCL clinical trial
Klinično preskušanje MCL
Pharmacokinetic/pharmacodynamic relationship(s)
Farmakokinetično/farmakodinamično razmerje
If a suspected reaction is not manageable with dose delays, then temsirolimus may be reduced by 5 mg/week decrements.
Če neželenih učinkov ne moremo obvladati z zakasnitvijo odmerkov, lahko odmerek temsirolimusa zmanjšamo v korakih po 5 mg/teden.
Age does not appear to affect temsirolimus and sirolimus pharmacokinetics significantly.
Zdi se, da starost ne vpliva pomembno na farmakokinetiko temsirolimusa in sirolimusa.
In male rats, decreased fertility and partly reversible reductions in sperm counts were reported (see section 5.3).
Pri podganjih samcih so poročali o zmanjšani plodnosti in delno reverzibilnem zmanjšanju števila semenčic (glejte poglavje 5.3).
In in vitro studies in human liver microsomes, temsirolimus inhibited CYP3A4/5, CYP2D6, CYP2C9 and CYP2C8 catalytic activity with Ki values of 3.1, 1.5, 14 and 27 μM, respectively.
V študijah na mikrosomih človeških jeter in vitro je temsirolimus zavrl katalitično aktivnost CYP3A4/5, CYP2D6, CYP2C9 in CYP2C8 z vrednostmi Ki 3,1; 1,5; 14 oziroma 27 μM.
During in vitro temsirolimus metabolism studies, sirolimus, seco-temsirolimus and seco-sirolimus were observed; additional metabolic pathways were hydroxylation, reduction and demethylation.
Med raziskavami presnove temsirolimusa in vitro so našli sirolimus, seko-temsirolimus in seko-sirolimus; druge presnovne poti so bile hidroksilacija, redukcija in demetilacija.
25 mg a In the MCL clinical trial, up to two dose level reductions were allowed per patient.
V kliničnem preskušanju MCL sta bili dovoljeni do dve ravni zmanjšanja odmerka na bolnika.
Based on the results of a Phase 3 study in RCC, elderly patients (65 years of age) may be more likely to experience certain adverse reactions, including oedema, diarrhoea, and pneumonia.
Rezultati študije 3. faze RCC so pokazali, da so pri starejših bolnikih ( 65 let starosti) verjetnejši nekateri neželeni učinki, med drugim edemi, diareja in pljučnica.