natgillin/translations-raw huggingface dataset:
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%.
faze, v kateri so ocenjevali varnost in učinkovitost peroralne uporabe TMZ pri zdravljenju bolnikov z anaplastičnim astrocitomom ob prvem recidivu, je bil PFS po 6 mesecih 46 %.
Therefore, special care should be taken when TMZ is administered in elderly patients.
Zato je pri uporabi TMZ pri starejših bolnikih potrebna posebna previdnost.
4.2 Posology and method of administration Temozolomide Accord should only be prescribed by physicians experienced in the oncological treatment of brain tumours.
4.2 Odmerjanje in način uporabe Zdravilo Temozolomid Accord smejo predpisati le zdravniki, ki imajo izkušnje z onkološkim zdravljenjem možganskih tumorjev.
• long or repeated fits, tremors or jerking movement, partial paralysis, difficulty with your coordination and balance, changes in sensation of touch
• dolgi ali ponavljajoči se krči/napadi, trepetanje ali trzajoči gibi, delna paraliza, težave s koordinacijo in ravnotežjem, spremembe v občutku tipa
If ANC falls to < 1.0 x 109/l or the platelet count is < 50 x109/l during any cycle, the next cycle should be reduced one dose level (see section 4.2).
Če absolutno število nevtrofilcev pade pod < 1.0 x 109/l ali je število trombocitov < 50 x 109/l v katerem koli ciklu, je treba odmerek za naslednji cikel zmanjšati za eno stopnjo odmerka (glejte poglavje 4.2).
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 korist kraka, ki je prejemal TMZ.
• increased sugar in the blood, loss of weight
• povečana koncentracija sladkorja v krvi, hujšanje
Dose-related reductions in leukocytes and platelets appear to be sensitive indicators of toxicity.
Kaže, da je od odmerka odvisno zmanjšanje števila levkocitov in trombocitov občutljiv kazalec toksičnosti.
TMZ dose(mg/m2 /day)
Odmerek TMZ (mg/m2 /dan)
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 je kot zadnji poskus zdravljenja v fazi spremljanja prejelo 161 od 282 bolnikov (57 %) v kraku z radioterapijo, in 62 bolnikov od 277 (22 %) v kraku TMZ + RT.
Neutropenia or lymphopenia (grade 3-4), thrombocytopenia (grade 3-4)
nevtropenija ali limfopenija (stopnje 3-4), trombocitopenija (stopnje 3-4),
interstitial pneumonitis/pneumonitis, pulmonary fibrosis, respiratory failure†
intersticijski pneumonitis/pneumonitis, pljučna fibroza, odpoved dihanja†
Based on your blood counts and how you tolerate temozolomide, the dose may be delayed or stopped.
Glede na število vaših krvnih celic in odvisno od tega, kako dobro prenašate temozolomid, bo jemanje odmerkov morda treba odložiti ali prekiniti.
How to open sachet Open the sachet by folding and tearing along the fold line with the notch in the corner of the sachet.
Odpiranje vrečke Vrečko odprete tako, da prepognete in pretrgate vrečko vzdolž črte z zarezo v kotu vrečke.
Hepatitis due to hepatitis B virus (HBV) reactivation, in some cases resulting in death, has been reported.
Poročali so o hepatitisu zaradi reaktivacije okužbe z virusom hepatitisa B (HBV), v nekaterih primerih tudi s smrtnim izidom.
Micturition frequency, urinary incontinence
pogosto uriniranje, urinarna inkontinenca urinarna inkontinenca
The hard capsules are dispensed in amber glass bottles containing 5 or 20 capsules.
Trde kapsule so na voljo v stekleničkah iz rjavega stekla po 5 ali 20 kapsul.
myelodysplastic syndrome (MDS), secondary malignancies, including myeloid leukaemia
mielodisplastični sindrom (MDS), sekundarne novotvorbe, vključno z mieloidno levkemijo
Once escalated, the dose remains at 200 mg/m2 per day for the first 5 days of each subsequent cycle except if toxicity occurs.
Po povečanju odmerka ta ostane 200 mg/m2 na dan v prvih 5 dneh vsakega cikla, razen če se pojavi toksičnost.
Not Known
Neznani:
In patients 3 years of age or older, TMZ is only to be used in recurrent or progressive malignant glioma.
Pri bolnikih, starih 3 leta ali več, se TMZ uporablja le pri ponovljenem ali napredovalem malignem gliomu.
Dose reductions and discontinuations during the monotherapy phase should be applied according to Tables 2 and 3.
V fazi monoterapije je treba zmanjševanje odmerkov in prenehanje dajanja izvajati v skladu s podatki v preglednicah 2 in 3.
Based on the pharmacokinetic properties of TMZ, it is unlikely that dose reductions are required in patients with severe hepatic impairment or any degree of renal impairment.
Na osnovi farmakokinetičnih lastnosti TMZ je malo verjetno, da bi bilo pri bolnikih s hudo okvaro jeter ali okvaro ledvic katerekoli stopnje potrebno zmanjšanje odmerka.
TMZ dose (mg/m2 /day)
Odmerek (mg/m2 /dan)
Myelosuppression (neutropenia and thrombocytopenia), which is known dose-limiting toxicity for most cytotoxic agents, including TMZ, was observed.
Opažena je bila mielosupresija (nevtropenija in trombocitopenija), ki je znan toksični učinek za omejitev odmerka večine citotoksičnih snovi, vključno s TMZ.
No studies have been conducted to determine the effect of TMZ on the metabolism or elimination of other medicinal products.
Študije, ki bi določile učinek TMZ na presnovo ali izločanje drugih zdravil, niso bile izvedene.
Your doctor will check your blood to make sure you have enough of these cells before you begin treatment.
Zdravnik bo odredil krvne preiskave, da se bo pred začetkom zdravljenja prepričal, da je število teh celic pri vas zadostno.
Marketing Authorisation Holder Accord Healthcare S.L.U.
Imetnik dovoljenja za promet z zdravilom Accord Healthcare S.L.U.
In patients treated with TMZ, whether used in combination with RT or as monotherapy following RT for newly-diagnosed glioblastoma multiforme, or as monotherapy in patients with recurrent or progressive glioma, the reported very common adverse reactions were similar: nausea, vomiting, constipation, anorexia, headache and fatigue.
Pri bolnikih, ki so se zdravili s TMZ v kombinaciji z RT ali v monoterapiji po RT za novo diagnosticiran multiformni glioblastom ali pa so prejemali samo temozolomid v primeru ponovljenega ali napredovalega glioma, so zelo pogosto poročali o podobnih neželenih reakcijah: navzea, bruhanje, zaprtje, anoreksija, glavobol in utrujenost.
6 PHARMACEUTICAL PARTICULARS
6 FARMACEVTSKI PODATKI
Based on a population pharmacokinetic analysis in patients 19-78 years of age, clearance of TMZ is not affected by age.
Na osnovi populacijske farmakokinetične analize pri bolnikih, starih od 19 do 78 let, je bilo ugotovljeno, da starost ne vpliva na očistek TMZ.
If abnormal, physicians should assess the benefit/risk prior to initiating temozolomide including the potential for fatal hepatic failure.
V primeru nenormalnih izvidov morajo zdravniki pred uvedbo temozolomida pretehtati razmerje med koristnostjo zdravljenja in tveganjem, vključno z možnim tveganjem za pojav odpovedi jeter s smrtnim izidom.
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 % proti 8 %, hi-kvadrat p = 0,008) z mediano vrednostjo PFS 2,89 meseca za TMZ oziroma 1,88 mesecev za prokarbazin (logrank p = 0,0063).
There are reports of patients who have taken the recommended dose for more than 5 days of treatment (up to 64 days) with adverse reactions reported including bone marrow suppression, with or without infection, in some cases severe and prolonged and resulting in death.
Obstajajo poročila o bolnikih, ki so jemali priporočen odmerek več kot 5 dni zdravljenja (do 64 dni), neželene reakcije pa so vključevale supresijo kostnega mozga z okužbo ali brez nje, ki je bila v nekaterih primerih huda in dolgotrajna ter je povzročila smrt.
No data are available on the administration of TMZ in patients with severe hepatic impairment (Child's Class C) or with renal impairment.
Podatki o uporabi TMZ pri bolnikih s hudo okvaro jeter (razred C po ChildPughu) ali okvaro ledvic niso na voljo.
• mood swings, depression, hallucination and memory loss
• nihanje razpoloženja, depresija, prividi in izguba spomina
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1 hard capsule
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 1 trda kapsula
• muscle damage, back pain
• poškodbe mišic, bolečine v hrbtu
The following side effects may occur if you are a newly diagnosed patient taking Temozolomide Accord for a specific brain tumour (glioblastoma multiforme) in combination treatment with radiotherapy and then later taking temozolomide on its own.
Naslednji neželeni učinki se lahko pojavijo, če ste na novo diagnosticiran bolnik, ki jemlje zdravilo Temozolomid Accord zaradi določenega možganskega tumorja (multiformni glioblastom) v kombinaciji z radioterapijo in nato še samostojno.
Adult and paediatric patients 3 years of age or older with recurrent or progressive malignant glioma:
Odrasli in pediatrični bolniki, stari 3 leta ali več, s ponovljenim ali napredovalim malignim gliomom:
Men being treated with TMZ 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 (see section 4.6).
Moškim, ki se zdravijo s TMZ, je treba svetovati naj ne spočnejo otroka še 6 mesecev po zadnjem odmerku in naj se pred zdravljenjem posvetujejo glede kriokonzervacije sperme (glejte poglavje 4.6).
CSF penetration was confirmed in one patient; CSF exposure based on AUC of TMZ was approximately 30% of that in plasma, which is consistent with animal data.
Izpostavljenost TMZ v cerebrospinalni tekočini, določena na podlagi vrednosti AUC temozolomida, je bila približno 30 % izpostavljenosti v plazmi, kar je v skladu s podatki, pridobljenimi na živalih.
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.
Peroralno uporabo TMZ so preučevali pri pediatričnih bolnikih (starost 3-18 let) s ponavljajočim se gliomom možganskega debla ali ponavljajočim se astrocitomom visoke stopnje, in sicer v režimu, ki je vključeval 5-dnevno uporabo vsakih 28 dni.
Date of first authorisation: 15 March 2010 Date of the latest renewal: 12 January 2015
Datum prve odobritve: 02.2013 Datum zadnjega podaljšanja: 01.2015
You may be given other medicines to take before and/or after temozolomide to avoid or control vomiting.
Možno je, da boste pred jemanjem temozolomida ali po njem prejeli še druga zdravila za preprečevanje ali omejevanje bruhanja.
Opportunistic infections (such as Pneumocystis jirovecii pneumonia) and reactivation of infections (such as HBV, CMV) have been observed during the treatment with TMZ (see section 4.8).
Med zdravljenjem s TMZ so opazili oportunistične okužbe (kot je pljučnica, ki jo povzroča Pneumocystis jirovecii) in reaktivacijo okužb (kot sta HBV, CMV) (glejte poglavje 4.8).
children from the age of three years, adolescents and adult patients with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy.
otrok, starejših od treh let, mladostnikov in odraslih bolnikov z malignim gliomom, na primer multiformnim glioblastomom ali anaplastičnim astrocitomom, ki se po standardnem zdravljenju ponovi ali napreduje.
Take the dose on an empty stomach; for example, at least one hour before you plan to eat breakfast.
Predpisani odmerek zdravila Temozolomid Accord vzemite enkrat na dan. Odmerek zaužijte na prazen želodec, na primer eno uro pred zajtrkom.
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.
En bolnik je zaužil prevelik odmerek v količini 10.000 mg (celokupni odmerek v 5-dnevnem ciklu), pri katerem so nato poročali o pancitopeniji, pireksiji, odpovedi več organov in smrti.
Read the package leaflet before use .
Pred uporabo preberite priloženo navodilo.
CLINICAL PARTICULARS 4.1 Therapeutic indications Temozolomide Accord is indicated for the treatment of: adult patients with newly-diagnosed glioblastoma multiforme concomitantly with radiotherapy (RT) and subsequently as monotherapy treatment.
KLINIČNI PODATKI 4.1 Terapevtske indikacije Zdravilo Temozolomid Accord je indicirano za zdravljenje: odraslih bolnikov z novo diagnosticiranim multiformnim glioblastomom ob sočasni radioterapiji (RT) in nato kot monoterapija.
cytomegalovirus infection, infection reactivation such as cytomegalovirus, hepatitis B virus†, Meningoencephalitis herpetic†, sepsis†
okužba s citomegalovirusom, reaktivacija okužb, kot sta okužbi s citomegalovirusom, z virusom hepatitisa B†, herpetični meningoencefalitis†, sepsa†
If you develop fever or symptoms of an infection contact your doctor immediately.
Če dobite vročino ali simptome okužbe, se nemudoma posvetujte s svojim zdravnikom.
A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
A. IZDELOVALEC/IZDELOVALCI , ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE
Temozolomide is first used together with radiotherapy (concomitant phase of treatment) and after that alone (monotherapy phase of treatment).
Temozolomid se najprej uporablja sočasno z radioterapijo (sočasna faza zdravljenja), nato pa samostojno (samostojna faza zdravljenja (monoterapija)).
Temozolomide should only be prescribed by specialists experienced in brain tumours.
Temozolomid smejo predpisovati le specialisti, ki imajo izkušnje z zdravljenjem možganskih tumorjev.
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 monoterapija s TMZ (150 - 200 mg/m2) od 1. do 5. dne vsakega 28-dnevnega cikla, in sicer do največ 6 ciklov, kar se začne 4 tedne po zaključku radioterapije.
Erythema multiforme, erythroderma, urticaria, exanthema General disorders and administration site conditions Very common:
multiformni eritem, eritrodermija, koprivnica, eksantem Splošne težave in spremembe na mestu aplikacije Zelo pogosti:
5 hard capsules 20 hard capsules
5 trdih kapsul 20 trdih kapsul
The dose should be reduced or administration discontinued according to Table 3.
Odmerek je treba zmanjšati ali prenehati z dajanjem zdravila kot je opisano v preglednici 3.
Cases of myelodysplastic syndrome and secondary malignancies, including myeloid leukaemia, have also been reported very rarely (see section 4.8).
Zelo redko so bili opaženi primeri mielodisplastičnega sindroma in sekundarnih malignosti vključno z mieloidno levkemijo (glejte poglavje 4.8).
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.
Zaradi tega je treba moškim, ki se zdravijo s TMZ, svetovati naj ne spočnejo otroka še 6 mesecev po zadnjem odmerku in naj se pred zdravljenjem posvetujejo glede kriokonzervacije sperme, zaradi možnost ireverzibilne neplodnosti po zdravljenju s TMZ.
Pneumocystis jirovecii pneumonia (PCP) prophylaxis was required during RT and combined TMZ therapy.
Profilaksa proti pljučnici, ki jo povzroča pneumocystis carinii (PCP), je bila potrebna med radioterapijo in med kombiniranim zdravljenjem s TMZ.
Four weeks after completing the TMZ + RT phase, TMZ is administered for up to 6 cycles of monotherapy treatment.
Štiri tedne po zaključku faze zdravljenja s TMZ in RT sledi še do 6 ciklov monoterapije s TMZ.
Dermatitis, dry skin, erythema, pruritus
dermatitis, suha koža, eritem, srbenje suha koža, srbenje
In patients previously treated with chemotherapy, the initial dose is 150 mg/m2 once daily, to be increased in the second cycle to 200 mg/m2 once daily, for 5 days if there is no haematological toxicity (see section 4.4)
Pri bolnikih, ki so bili zdravljeni s kemoterapijo, je začetni odmerek 150 mg/m2 enkrat na dan, v drugem ciklu pa se poveča na 200 mg/m2 enkrat na dan prvih 5 dni, če ni hematološke toksičnosti (glejte poglavje 4.4).
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.
Anti-emetic therapy may be administered prior to or following administration of TMZ.
Antiemetično zdravljenje se lahko da pred dajanjem TMZ ali po njem.
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.
Večina hematoloških neželenih reakcij je bila poročana pogosto ali zelo pogosto pri obeh indikacijah (preglednici 4 in 5); za vsako preglednico so po pogostnosti razvrščeni laboratorijski izidi stopnje 3-4.
Temozolomide comes in different strength capsules (shown on the outer label in mg).
Temozolomid je na voljo v kapsulah različnih jakosti, ki je označena v mg na zunanji ovojnini.
Cases of elevations of liver enzymes have been commonly reported.
Pogosto so poročali o povišanih vrednostih jetrnih encimov.
Psychiatric disorders Common:
Psihiatrične motnje Pogosti:
TMZ is spontaneously hydrolyzed at physiologic pH primarily to the active species, 3-methyl-(triazen1-yl)imidazole-4-carboxamide (MTIC).
TMZ spontano hidrolizira pri fiziološkem pH v glavnem v aktivno snov, 3-metil-(triazen1-il)imidazol-4-karboksamid (MTIC).
Ask your doctor for advice before taking any medicine.
Posvetujte se z zdravnikom ali s farmacevtom, preden vzamete katerokoli zdravilo.
Infection, Herpes simplex, wound infection, pharyngitis, candidiasis oral
okužba, herpes simplex, okužba rane, faringitis, oralna kandidiaza okužba, oralna kandidiaza
Gamma GT increased, AST increased *A patient who was randomised to the RT arm only, received TMZ + RT.
povečane vrednosti jetrnih encimov, povečana vrednost gama GT, povečana vrednost AST *Bolnik, ki je bil randomiziran v RT krak, je prejel TMZ + RT.
How to take Temozolomide Accord
Kako uporabljati zdravilo Temozolomid Accord
The pharmacokinetics of TMZ were comparable in patients with normal hepatic function and in those with mild or moderate hepatic impairment.
Farmakokinetika TMZ je primerljiva pri bolnikih z normalnim delovanjem jeter in tistih z blago ali zmerno okvaro jeter.
• pneumonia, inflammation of your sinuses, bronchitis, blocked nose, a cold or the flu
• pljučnica, vnetje sinusov, bronhitis, zamašen nos, prehlad ali gripa
• infection of the middle ear, pain or discomfort in the ears from loud noises, earache, deafness,
• vnetje srednjega ušesa, bolečine ali nelagodje v ušesih zaradi hrupa, bolečina v ušesih, oglušelost,
Cases of increased bilirubin, problems with bile flow (cholestasis), hepatitis and injury to the liver, including fatal liver failure, have been uncommonly reported.
Občasno so poročali o povišani vrednosti bilirubina, težavah s pretokom žolča (holestazi), hepatitisu in poškodbah jeter, vključno z odpovedjo jeter s smrtnim izidom.
prolonged pancytopenia, aplastic anaemia† Neoplasm benign, malignant and unspecified Very rare:
podaljšana pancitopenija, aplastična anaemija† Benigne, maligne in neopredeljene novotvorbe Zelo redko:
However, elderly patients (>70 years of age) appear to be at increased risk of neutropenia and thrombocytopenia (see section 4.4).
Vendar pa se zdi, da obstaja pri starejših bolnikih (>70 let) povečano tveganje za pojav nevtropenije in trombocitopenije (glejte poglavje 4.4).
However, elderly patients (> 70 years of age) appear to be at increased risk of neutropenia and thrombocytopenia (see section 4.4).
Vendar pa se zdi, da obstaja pri starejših bolnikih (> 70 let) povečano tveganje za pojav nevtropenije in trombocitopenije (glejte poglavje 4.4).
When laboratory abnormalities and adverse reactions were combined across concomitant and monotherapy treatment phases, Grade 3 or Grade 4 neutrophil abnormalities including neutropenic reactions were observed in 8% of the patients.
Ko so bile laboratorijske nenormalnosti in neželeni učinki združeni po fazi sočasnega zdravljenja in fazi monoterapije, so bile pri 8 % bolnikov opažene anomalije nevtrofilcev stopnje 3 ali 4, vključno z nevtropeničnimi učinki.
TMZ is administered orally at a dose of 75 mg/m2 daily for 42 days concomitant with focal radiotherapy (60 Gy administered in 30 fractions).
TMZ se jemlje peroralno v odmerkih 75 mg/m2 na dan, in sicer 42 dni sočasno s fokalno radioterapijo (60 Gy v 30 frakcijah).
TMZ dose reduction or discontinuation during monotherapy treatment Toxicity
Zmanjšanje odmerka TMZ ali prenehanje dajanja med monoterapijo Toksičnost
Data on time to worsening of neurological status favoured TMZ over procarbazine as did data on time to worsening of performance status (decrease to a KPS of < 70 or a decrease by at least 30 points).
Enako velja za podatke o času do poslabšanja telesne zmogljivosti (zmanjšanje KPS do < 70 oziroma padec zmogljivosti za vsaj 30 točk).
Date of first authorisation:15 March 2010 Date of latest renewal: 12 January 2015
Datum prve odobritve: 02.2013 Datum zadnejga podaljšanja: 01.2015
Table 5 includes adverse reactions reported during clinical trials for recurrent or progressive malignant glioma and following the marketing of TMZ.
Preglednica 5 vključuje neželene učinke, o katerih so poročali med kliničnimi preskušanji pri ponovljenem ali napredovalem malignem gliomu po začetku trženja TMZ.
Patients in the TMZ + RT arm received concomitant TMZ (75 mg/m2) once daily, starting the first day of RT until the last day of RT, for 42 days (with a maximum of 49 days).
Bolniki v kraku TMZ + RT so sočasno prejemali TMZ (75 mg/m2) enkrat na dan, začetek jemanja je bil prvi dan radioterapije in so ga nato jemali do zadnjega dneva radioterapije, torej 42 dni (do največ 49 dni).
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 bili klinično preverjeni odmerki 500, 750, 1.000 in 1.250 mg/m2 (celokupni odmerek v
Temozolomide is a triazene, which undergoes rapid chemical conversion at physiologic pH to the active monomethyl triazenoimidazole carboxamide (MTIC).
Temozolomid je triazen, ki se pri fiziološki vrednosti pH hitro kemično pretvori v aktivni monometil triazenoimidazol karboksamid (MTIC).
Hypokalemia, alkaline phosphatase increased, weight increased
hipokaliemija, povečana vrednost alkalne fosfataze, povečana telesna masa hiperglikemija, povečana telesna masa
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 je bila za naštete končne točke od 0,7 do 2,1 mesecev daljša pri TMZ kot pri prokarbazinu (logrank p = < 0,01 do 0,03).
Grade 3 or 4 thrombocytopenia and neutropenia occurred in 19 % and 17 % respectively, of patients treated for malignant glioma.
Trombocitopenija in nevtropenija stopnje 3 ali 4 sta se pojavili pri 19 % oziroma 17 % bolnikov, ki so se zdravili zaradi malignega glioma.
If you accidentally get some in your eyes or nose, flush the area with water.
Če pride prašek po nesreči v stik z vašimi očmi ali v nos, izperite z vodo.
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 oziroma 5,66 mesecev za prokarbazin (logrank p = 0,33).
Rash, alopecia
izpuščaj, alopecija