natgillin/translations-raw huggingface dataset:
5 In a separate phase I study, administration of TMZ with ranitidine did not result in alterations in the extent of absorption of temozolomide or the exposure to its active metabolite monomethyl triazenoimidazole carboxamide (MTIC).
V ločeni študiji 1. faze sočasna uporaba zdravila TMZ in ranitidina ni povzročila spremembe obsega absorpcije temozolomida ali izpostavljenosti aktivnemu presnovku, monometiltriazenoimidazol karboksamidu (MTIC).
Administration of TMZ with food resulted in a 33% decrease in Cmax and a 9% decrease in area under the curve (AUC).
Jemanje TMZ s hrano je povzročilo 33% zmanjšanje Cmax in 9% zmanjšanje površine pod krivuljo (AUC).
As it cannot be excluded that the change in Cmax is clinically significant, Temodal should be administered without food.
Ker ne moremo izključiti možnosti, da bi bila sprememba Cmax lahko klinično pomembna, naj bolniki jemljejo zdravilo Temodal brez hrane.
However, since TMZ does not undergo hepatic metabolism and exhibits low protein binding, it is unlikely that it would affect the pharmacokinetics of other medicinal products (see section 5.2).
Ker pa se TMZ ne presnavlja v jetrih in se na beljakovine veže le v majhni meri, je malo verjetno, da bi vplival na farmakokinetiko drugih zdravil (glejte poglavje 5. 2).
In preclinical studies in rats and rabbits receiving 150 mg/m2 TMZ, teratogenicity and/or foetal toxicity were demonstrated (see section 5.3).
Predklinične študije na podganah in kuncih, ki so prejemali 150 mg/ m2 TMZ, so pokazale teratogenost in/ ali toksičnost za plod (glejte poglavje 5. 3).
Temodal hard capsules should not be administered to pregnant women.
Zdravilo Temodal trde kapsule se ne sme dajati nosečnicam.
Women of childbearing potential should be advised to use effective contraception to avoid pregnancy while they are receiving TMZ.
Ženskam v rodni dobi je treba svetovati, naj med zdravljenjem s TMZ z učinkovitimi kontracepcijskimi sredstvi preprečijo zanositev.
Therefore, men being treated with it should be advised not to father a child up to 6 months after receiving the last dose and to seek advice on cryoconservation of sperm prior to treatment, because of the possibility of irreversible infertility due to therapy with TMZ.
6 TMZ ima lahko genotoksične učinke, zato morate moškim, ki se zdravijo z njim svetovati, da naj ne zaplodijo otroka še šest mesecev po zadnjem vzetem odmerku in naj se zaradi možnosti ireverzibilne neplodnosti zaradi zdravljenja s TMZ pred zdravljenjem posvetujejo o možnostih za shranitev zmrznjene sperme.
The ability to drive and use machines may be impaired in patients treated with TMZ due to fatigue and somnolence.
Pri bolnikih, ki se zdravijo s TMZ, je lahko sposobnost vožnje in upravljanja s stroji zmanjšana zaradi utrujenosti in zaspanosti.
Convulsions were reported very commonly in the newly- diagnosed glioblastoma multiforme patients receiving monotherapy, and rash was reported very
Pri bolnikih z novo diagnosticiranim glioblastomom multiforme na monoterapiji so zelo pogosto poročali o konvulzijah, medtem ko je bil izpuščaj opisan zelo pogosto pri bolnikih z novo diagnosticiranim multiformnim glioblastomom, ki so prejemali TMZ sočasno z RT, ter pri tistih, ki so zdravilo prejemali v obliki monoterapije, pogosto pa pri tistih s ponavljajočim se gliomom.
6 commonly in newly-diagnosed glioblastoma multiforme patients receiving TMZ concurrent with RT and also as monotherapy, and commonly in recurrent glioma.
Pri obeh indikacijah so o večini hematoloških neželenih reakcij poročali pogosto ali zelo pogosto (preglednici 4 in 5).
Most haematologic adverse reactions were reported commonly or very commonly in both indications (Tables 4 and 5);the frequency of grade 3-4 laboratory findings is presented after each table.
Pogostnost laboratorijskih izvidov 3. ali 4. stopnje jakosti je navedena za vsako preglednico.
In the tables undesirable effects are classified according to System Organ Class and frequency.
Neželeni učinki so v preglednicah razvrščeni skladno s telesnim sisetmom in po pogostnosti.
Very common (≥ 1/10); Common (≥ 1/100 to < 1/10); Uncommon (≥ 1/1,000 to < 1/100).
Skupine pogostnosti so opredeljenje skladno s konvencijo: zelo pogosti (≥1/ 10), pogosti (≥1/ 100 do < 1/ 10), občasni (≥1/ 1. 000 do < 1/ 100).
Table 4 provides treatment-emergent adverse events in patients with newly-diagnosed glioblastoma multiforme during the concomitant and monotherapy phases of treatment.
V preglednici 4 so navedeni neželeni učinki, ki so nastopili med zdravljenjem pri bolnikih z novo diagnosticiranim glioblastomom multiforme med fazo sočasne terapije in fazo monoterapije.
Treatment-emergent events during concomitant and monotherapy treatment phases in patients with newly-diagnosed glioblastoma multiforme
Neželeni učinki, ki so nastopili med zdravljenjem med fazo sočasne in monoterapije pri bolnikih z novo diagnosticiranim glioblastomom multiforme Telesni sistem
System Organ Class Infections and infestations
TMZ + sočasna radioterapija n=288 *
monotherapy n=224
TMZ monoterapija n=224
Common:
Infekcijske in parazitske bolezni Pogosti:
Infection, Herpes simplex, wound infection, pharyngitis, candidiasis oral
okužba, Herpes simplex, okužba rane, faringitis, oralna kandidiaza
Metabolism and nutrition
Bolezni endokrinega sistema Občasni:
Cushingoid disorders
cushingoidni sindrom
Very common:
7 Zelo pogosti:
Anorexia Hyperglycaemia, weight decreased Hypokalemia, alkaline phosphatase increased, weight increased
anoreksija hiperglikemija, hujšanje hipokaliemija, zvišanje vrednosti alkalne fosfataze, povečanje telesne mase
Anorexia Weight decreased Hyperglycaemia, weight increased
anoreksija hujšanje hiperglikemija, povečanje telesne mase
Nervous system disorders Very common:
Zelo pogosti:
7 Common:
Pogosti:
Convulsions, consciousness decreased, somnolence, aphasia, balance impaired, dizziness, confusion, memory impairment, concentration impaired, neuropathy, paresthesia, speech disorder, tremor
glavobol konvulzije, motnje zavesti, somnolenca, afazija, motnje ravnotežja, omotica, zmedenost, motnje spomina, zmanjšanje miselne zbranosti, nevropatija, parestezije, motnje govora, tremor
Hemiparesis, aphasia, balance impaired, somnolence, confusion, dizziness, memory impairment, concentration impaired, dysphasia, neurological disorder (NOS), neuropathy, peripheral neuropathy, paresthesia, speech disorder, tremor
konvulzije, glavobol hemipareza, afazija, motnje ravnotežja, somnolenca, zmedenost, omotica, motnje spomina, zmanjšanje miselne zbranosti, disfazija, nevrološke motnje (NOS), nevropatija, periferna nevropatija, parestezije, motnje govora, tremor
Otitis media, tinnitus, hyperacusis, earache
okvara sluha otitis media, tinitus, hiperakuzija, ušesne bolečine
Deafness, vertigo, earache
okvara sluha, tinitus gluhost, vertigo, ušesne bolečine
Cardiac disorders Uncommon:
Občasni:
Gastrointestinal disorders Very common:
Bolezni prebavil
Constipation, nausea, vomiting
dispneja, kašelj pljučnica, okužba zgornjih dihal, kongestija nosne sluznice
Stomatitis, diarrhoea, abdominal pain, dyspepsia, dysphagia
dispneja, kašelj pljučnica, sinusitis, okužba zgornjih dihal, bronhitis
8 Very common:
8 Zelo pogosti:
Rash, alopecia
zaprtje, slabost, bruhanje
Dermatitis, dry skin, erythema, pruritus
stomatitis, driska, trebušne bolečine, dispepsija, disfagija
Dry skin, pruritus
stomatitis, driska, dispepsija, disfagija, suha usta napihnjenost trebuha, inkontinenca blata, bolezni prebavil (NOS), gastroenteritis, hemoroidi
Skin exfoliation, photosensitivity reaction, pigmentation abnormal
izpuščaj, alopecija dermatitis, suha koža, eritem, pruritus luščenje kože, preobčutljivostne reakcije na svetlobo, nenormalna pigmentacija
Erythema, pigmentation abnormal, sweating increased
izpuščaj, alopecija suha koža, pruritus eritem, nenormalna pigmentacija, povečano znojenje
Musculoskeletal and connective tissue disorders Common:
Bolezni mišično- skeletnega sistema in vezivnega tkiva Pogosti:
Renal and urinary disorders Common:
Občasni:
Urinary incontinence
inkontinenca seča disurija
General disorders and administration site conditions Very common:
Splošne težave in spremembe
Fatigue
na mestu aplikacije
Fatigue
Zelo pogosti:
Allergic reaction, fever, radiation injury, face oedema, pain, taste perversion
utrujenost alergijska reakcija, zvišana telesna temperatura, radiacijske poškodbe, edem obraza, bolečine, motnje okusa
Allergic reaction, fever, radiation injury, pain, taste perversion
utrujenost alergijska reakcija, zvišana telesna temperatura, radiacijske poškodbe, bolečine, motnje okusa
Asthenia, flushing, hot flushes, condition aggravated, rigors, tongue discolouration, parosmia, thirst
alergijska reakcija, zvišana telesna temperatura, radiacijske poškodbe, edem obraza, bolečine, motnje okusa
Asthenia, face oedema, pain, condition aggravated, rigors, tooth disorder, taste perversion
alergijska reakcija, zvišana telesna temperatura, radiacijske poškodbe, bolečine, motnje okusa
ALT increased
zvišana vrednost ALT zvišane vrednosti jetrnih encimov, zvišana vrednost gama- GT, zvišana vrednost AST
*A patient who was randomised to the RT arm only, received TMZ + RT.
* Bolnik, ki je bil randomiziran v skupino, ki je prejemala samo RT, je prejemal TMZ in RT.
When laboratory abnormalities and adverse events were combined across concomitant and monotherapy treatment phases, Grade 3 or Grade 4 neutrophil abnormalities including neutropenic events were observed in 8% of the patients.
Ko so sešteli nenormalne laboratorijske izvide in neželene sopojave iz faze sočasne terapije in faze monoterapije, so pri 8% bolnikov opažali anomalije nevtrofilcev 3. ali 4. stopnje, vključno z nevtropeničnimi sopojavi.
Grade 3 or Grade 4 thrombocyte abnormalities, including thrombocytopenic events were observed in 14% of the patients who received TMZ.
Anomalije trombocitov 3. ali 4. stopnje, vključno s trombocitopeničnimi sopojavi, so opažali pri 14% bolnikov, ki so prejeli zdravilo TMZ.
Recurrent or progressive malignant glioma
9 Ponavljajoči se ali napredujoči maligni gliom
These reactions were usually
V kliničnih preskušanjih so bili najpogostnejši neželeni učinki, povezani z zdravljenjem, prebavne motnje, natančneje slabost (43%) in bruhanje (36%).
9 Grade 1 or 2 (0 – 5 episodes of vomiting in 24 hours) and were either self-limiting or readily controlled with standard anti-emetic therapy.
Oba učinka sta bila ponavadi 1. ali 2. stopnje (od 0 do 5 epizod bruhanja v 24 urah) in sta prenehala sama ali pa ju je bilo mogoče hitro obvladati s standardnim antiemetičnim zdravljenjem.
The incidence of severe nausea and vomiting was 4%.
Incidenca hude slabosti in bruhanja je bila 4%.
Adverse reactions in patients with recurrent or progressive malignant glioma Infections and infestations
Neželene reakcije pri bolnikih s ponavljajočim se ali napredujočim malignim gliomom
Rare:
Infekcijske in parazitske bolezni Redki:
Anorexia Weight decrease
anoreksija hujšanje
Headache Somnolence, dizziness, paresthesia
Bolezni dihal, prsnega koša in mediastinalnega prostora
Respiratory, thoracic and mediastinal disorders
glavobol zaspanost, omotica, parestezije
Vomiting, nausea, constipation Diarrhoea, abdominal pain, dyspepsia
bruhanje, slabost, zaprtje driska, trebušne bolečine, dispepsija
Rash, pruritus, alopecia Erythema multiforme, erythroderma, urticaria, exanthema
Splošne težave in spremembe na mestu aplikacije
General disorders and administration site conditions
izpuščaj, pruritus, alopecija multiformni eritem, eritroderma, urtikarija, eksantem
Fatigue Fever, asthenia, rigors, malaise, pain, taste perversion Allergic reactions, including anaphylaxis, angioedema
alergijske reakcije, vključno z anafilaksijo, angioedem
Grade 3 or 4 thrombocytopenia and neutropenia occurred in 19% and 17% respectively, of patients treated for malignant glioma.
17% bolnikov, zdravljenih zaradi malignega glioma.
This led to hospitalisation and/or discontinuation of TMZ in 8% and 4%, respectively.
Zaradi njiju je bila potrebna hospitalizacija in/ ali prekinitev
There were higher rates of Grade 4 neutropenia (ANC < 0.5 x 109/l), 12% vs 5%, and thrombocytopenia (< 20 x 109/l), 9% vs 3%, in women vs men in the first cycle of therapy.
Pri ženskah so ugotovili 12% pogostnost nevtropenije 4. stopnje (absolutno število nevtrofilcev (ANC) < 0, 5 x 109/ l), v primerjavi s 5% pri moških, medtem ko je pogostnost trombocitopenije (< 20 x 109/ l) pri ženskah znašala 9%, v primerjavi s 3% pri moških, torej so bile v prvem ciklu terapije pri ženskah te pogostnosti večje kot pri moških.
In a 400 subject recurrent glioma data set, Grade 4 neutropenia occurred in 8% of female vs 4% of male subjects and Grade 4 thrombocytopenia in 8% of female vs 3% of male
Po podatkih o ponavljajočem se gliomu pri 400 preiskovancih se je v prvem ciklu terapije nevtropenija 4. stopnje pojavila pri 8% žensk in pri 4% moških preiskovancev, trombocitopenija 4. stopnje pa pri 8% žensk in 3% moških preiskovancev.
In a study of 288 subjects with newly-diagnosed glioblastoma multiforme, Grade 4 neutropenia occurred in 3% of female vs 0% of male subjects and Grade 4 thrombocytopenia in 1% of female vs 0% of male subjects in the first cycle of therapy.
V študiji pri 288 preiskovancih z novo diagnosticiranim glioblastomom multiforme se je v prvem ciklu terapije nevtropenija 4. stopnje pojavila pri 3% žensk in 0% moških, trombocitopenija 4. stopnje pa pri 1% žensk in 0% moških.
Post-Marketing Experience
Postmarketinške izkušnje
Antineoplastic agents, and notably alkylating agents, have been associated with a potential risk of myelodysplastic syndrome (MDS) and secondary malignancies, including leukaemia.
Uporaba antineoplastičnih sredstev, še posebej alkilirajočih snovi, je bila povezana z možnim tveganjem za nastanek mielodisplastičnega sindroma (MDS) in sekundarnih malignomov, vključno z levkemijo.
Very rare cases of MDS and secondary malignancies, including myeloid leukaemia have been reported in patients treated with regimens that included TMZ.
Pri bolnikih, zdravljenih po shemah, ki vključujejo TMZ, so poročali o zelo redkih primerih MDS in sekundarnih malignomov, vključno z mieloidno levkemijo.
Prolonged pancytopenia, which may result in aplastic anaemia has been reported very rarely.
Zelo redko so poročali o daljši pancitopeniji, ki lahko povzroči aplastično anemijo.
Cases of toxic epidermal necrolysis and Stevens-Johnson syndrome have been reported very rarely.
Zelo redko so poročali o primerih toksične epidermalne nekrolize in Stevens- Johnsonovega sindroma.
Cases of interstitial pneumonitis/pneumonitis have been reported very rarely.
Zelo redko so poročali o primerih intersticijskega pnevmonitisa oz. pnevmonitisa.
Doses of 500, 750, 1,000, and 1,250 mg/m2 (total dose per cycle over 5 days) have been evaluated clinically in patients.
Pri bolnikih so klinično ovrednotili odmerke 500, 750, 1. 000 in 1. 250 mg/ m2 (skupni odmerek na 5 - dnevni cikel).
An overdose of 10,000 mg (total dose in a single cycle, over 5 days) was taken by one patient and the adverse reactions reported were pancytopenia, pyrexia, multi- organ failure and death.
Med prijavljenimi neželenimi učinki so bili pancitopenija, pireksija, odpoved več organov in smrt.
There are reports of patients who have taken the recommended dose for more than 5 days of treatment (up to 64 days) with adverse events reported including bone marrow suppression, with or without infection, in some cases severe and prolonged and resulting in death.
Med neželenimi učinki je bila supresija kostnega mozga, z ali brez okužbe, ki je bila v nekaterih primerih huda in dolgotrajna in je povzročila smrt.
Antineoplastic agents - Other alkylating agents, ATC code:
Antineoplastična zdravila – Drugi alkilirajoči citostatiki, oznaka ATC:
Newly-diagnosed glioblastoma multiforme
11 Novo diagnosticiran glioblastoma multiforme
This was followed by monotherapy TMZ (150 - 200 mg/m2) on Days 1 - 5 of every 28-day cycle for up to 6 cycles, starting 4 weeks after the end of RT.
Temu je sledila faza monoterapije s TMZ (od 150 do 200 mg/ m2) od 1. do 5. dne vsakega 28- dnevnega cikla, do največ 6 ciklov, ki se je začela 4 tedne po koncu RT.
Pneumocystis carinii pneumonia (PCP) prophylaxis was required during RT and combined TMZ therapy.
Med RT sta bili potrebni profilaksa proti pljučnici zaradi okužbe s Pneumocystis carinii (PCP) in kombinirana terapija s TMZ.
TMZ was administered as salvage therapy in the follow-up phase in 161 patients of the 282 (57%) in the RT alone arm, and 62 patients of the 277 (22%) in the TMZ + RT arm.
TMZ so bolniki jemali kot zadnji poskus terapije v fazi spremljanja pri 161 bolnikih od 282 (57%) v delu študije samo z RT in pri 62 bolnikih od 277 (22%) v delu študije s TMZ + RT.
11 The hazard ratio (HR) for overall survival was 1.59 (95% CI for HR=1.33 -1.91) with a log-rank p < 0.0001 in favour of the TMZ arm.
Količnik tveganja (KT) za skupno preživetje je bil 1, 59 (95% IZ za KT=1, 33 - 1, 91) z logaritmičnim rangom p < 0, 0001 v prid delu študije s TMZ.
The estimated probability of surviving 2 years or more (26% vs 10%) is higher for the RT + TMZ arm.
Ocenjena verjetnost preživetja bolnika 2 leti ali več (26% v primerjavi z 10%) je bila večja za del študije z RT + TMZ.
The addition of concomitant TMZ to RT, followed by TMZ monotherapy in the treatment of patients with newly-diagnosed glioblastoma multiforme demonstrated a statistically significant improvement in overall survival (OS) compared with RT alone (Figure 1).
Pri dodatku sočasne terapije s TMZ k radioterapiji, ki ji sledi monoterapija s TMZ, med zdravljenjem bolnikov z novo diagnosticiranim glioblastomom multiforme so ugotovili statistično značilno izboljšanje skupnega preživetja (OS) v primerjavi s samo RT (Slika 1).
Kaplan-Meier curves for overall survival (intent-to-treat population)
Kaplan- Meierjeve krivulje skupnega preživetja (populacija, ki naj bi jo zdravili)
Data on clinical efficacy in patients with glioblastoma multiforme (Karnofsky performance status [KPS] ≥ 70), progressive or recurrent after surgery and RT, were based on two clinical trials with oral TMZ.
Podatki o klinični učinkovitosti zdravila pri bolnikih z multiformnim glioblastomom (indeks kliničnega stanja po Karnofskyju [KPS – » Karnofsky performance status «] ≥ 70), ki napreduje ali se je ponovil po kirurškem posegu in RT, temeljijo na dveh kliničnih preskušanjih s peroralno uporabo TMZ.
One was a non-comparative trial in 138 patients (29% received prior chemotherapy), and the other was a randomised active-controlled trial of TMZ vs procarbazine in a total of 225 patients (67% received prior treatment with nitrosourea based chemotherapy).
Eno je bilo neprimerjalno preskušanje pri 138 bolnikih (29% jih je pred tem že prejemalo kemoterapijo), drugo pa randomizirano, z učinkovino nadzorovano kontrolirano preskušanje TMZ in prokarbazina pri skupaj 225 bolnikih (67% jih je pred tem že prejemalo kemoterapijo na osnovi
In both trials, the primary endpoint was progression-free survival (PFS) defined by MRI scans or neurological worsening.
V obeh preskušanjih je bila primarna končna točka preskušanja čas preživetja brez napredovanja bolezni (PFS – » progression- free survival «), ugotovljen na podlagi NMR posnetkov, ali poslabšanje nevrološkega statusa bolnika.
In the non- comparative trial, the PFS at 6 months was 19%, the median progression-free survival was 2.1 months, and the median overall survival 5.4 months.
V neprimerjalnem preskušanju je bil PFS po 6 mesecih 19%, mediana vrednost PFS 2, 1 meseca in mediana vrednost celotnega preživetja 5, 4 mesecev.
The objective response rate (ORR) based on MRI scans was 8%.
Objektivno ugotovljena stopnja odzivanja bolnikov na zdravljenje določena na podlagi NMR posnetkov, je bila 8%.
In the randomised active-controlled trial, the PFS at 6 months was significantly greater for TMZ than for procarbazine (21% vs 8%, respectively – chi-square p = 0.008) with median PFS of 2.89 and 1.88 months respectively (log rank p = 0.0063).
V randomiziranem, z učinkovino nadzorovanem preskušanju je bil PFS po 6 mesecih statistično značilno daljši pri TMZ kot pri prokarbazinu (21% v primerjavi z 8%, hi- kvadrat, p = 0, 008), z mediano vrednostjo PFS 2, 89 meseca za temozolomid in 1, 88 meseca za prokarbazin (test log. ranga p = 0, 0063).
The median survival was 7.34 and 5.66 months for TMZ and procarbazine, respectively (log rank p = 0.33).
Mediana vrednost časa preživetja je bila 7, 34 mesecev za TMZ in 5, 66 mesecev za prokarbazin (test log. ranga p = 0, 33).
At 6 months, the fraction of surviving patients was significantly higher in the TMZ arm (60%) compared with the procarbazine arm (44%) (chi-square p = 0.019).
Po 6 mesecih je bil delež preživelih bolnikov statistično značilno večji v skupini, ki je prejemala TMZ (60%), kot v tisti, ki je prejemala prokarbazin (44%) (hi- kvadrat, p = 0, 019).
In patients with prior chemotherapy a benefit was indicated in those with a KPS ≥ 80.
Pri bolnikih, ki so že prejemali kemoterapijo, so ugotavljali koristne učinke zdravila pri bolnikih z indeksom kliničnega stanja po po Karnofskyju ≥ 80.
The median times to progression in these endpoints ranged from 0.7 to 2.1 months longer for TMZ than for procarbazine (log rank p = < 0.01 to 0.03).
Mediana vrednost časa do napredovanja bolezni za naštete končne točke je bila za 0, 7 do 2, 1 meseca daljša za TMZ kot za prokarbazin (test log. ranga p = < 0, 01 do 0, 03).
12 Recurrent anaplastic astrocytoma
Ponavljajoči se anaplastični astrocitom
In a multicentre, prospective phase II trial evaluating the safety and efficacy of oral TMZ in the treatment of patients with anaplastic astrocytoma at first relapse, the 6 month PFS was 46%.
V multicentričnem, prospektivnem preskušanju 2. faze za oceno varnosti in učinkovitosti peroralnega TMZ pri zdravljenju bolnikov z anaplastičnim astrocitomom ob prvem recidivu je bila 6- mesečna vrednost PFS (preživetje brez napredovanja bolezni) 46%.
The median PFS was 5.4 months.
Mediana vrednost časa brez napredovanja bolezni je bila 5, 4 mesece.
Median overall survival was 14.6 months.
Mediana vrednost celotnega preživetja je bila 14, 6 mesecev.
Response rate, based on the central reviewer assessment, was 35% (13 CR and 43 PR) for the intent-to-treat population (ITT) n=162.
Po ugotovitvi osrednjega ocenjevalca je bil delež odziva v populaciji, ki so jo želeli zdraviti (ITT, n=162) 35% (13 popolno okrevanje in 43 delno okrevanje).
The 6-month event-free survival for the ITT population was 44% with a median event-free survival of 4.6 months, which was similar to the results for the progression-free survival.
Mediana vrednost preživetja brez sopojavov je bila 4, 6 mesecev, kar je podobno izsledkom za preživetje brez napredovanja bolezni.
Oral TMZ has been studied in paediatric patients (age 3-18 years) with recurrent brainstem glioma or recurrent high grade astrocytoma, in a regimen administered daily for 5 days every 28 days.
TMZ so dajali 5 dni vsakih 28 dni.
TMZ is spontaneously hydrolyzed at physiologic pH primarily to the active species, 3-methyl-(triazen- 1-yl)imidazole-4-carboxamide (MTIC).
TMZ spontano hidrolizira pri fiziološki vrednosti pH predvsem do aktivnih presnovkov, 3- metil - (triazen- 1- il) imidazol- 4- karboksamida (MTIK).
MTIC is spontaneously hydrolyzed to 5-amino-imidazole-4- carboxamide (AIC), a known intermediate in purine and nucleic acid biosynthesis, and to methylhydrazine, which is believed to be the active alkylating species.
MTIK pa spontano hidrolizira do 5- amino- imidazol- 4 - karboksamida (AIK), znanega intermediata v biosintezi purinov in nukleinskih kislin, ter metilhidrazina, za katerega menijo, da je aktivni alkilirajoči presnovek.
Relative to the AUC of TMZ, the exposure to MTIC and AIC is ~ 2.4% and 23%, respectively.
Glede na vrednost AUC za temozolomid sta izpostavljenosti MTIK- u in AIK- u ~ 2, 4% in 23%.
In vivo, the t1/2 of MTIC was similar to that of TMZ, 1.8 hr.
1, 8 ure.
After oral administration to adult patients, TMZ is absorbed rapidely, with peak concentrations reached as early as 20 minutes post-administration (mean time between 0.5 and 1.5 hours).
Po peroralnem jemanju