FrancophonIA/ELRC3.0 huggingface dataset:
English: 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).
Slovenian: 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).
English: 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.
Slovenian: 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.
English: No data are available on the administration of TMZ in patients with severe hepatic impairment (Child's Class C) or with renal impairment.
Slovenian: Podatki o uporabi TMZ pri bolnikih s hudo okvaro jeter (razred C po ChildPughu) ali okvaro ledvic niso na voljo.
English: • mood swings, depression, hallucination and memory loss
Slovenian: • nihanje razpoloženja, depresija, prividi in izguba spomina
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1 hard capsule
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 1 trda kapsula
English: • muscle damage, back pain
Slovenian: • poškodbe mišic, bolečine v hrbtu
English: 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.
Slovenian: 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.
English: Adult and paediatric patients 3 years of age or older with recurrent or progressive malignant glioma:
Slovenian: Odrasli in pediatrični bolniki, stari 3 leta ali več, s ponovljenim ali napredovalim malignim gliomom:
English: 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).
Slovenian: 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).
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Date of first authorisation: 15 March 2010 Date of the latest renewal: 12 January 2015
Slovenian: Datum prve odobritve: 02.2013 Datum zadnjega podaljšanja: 01.2015
English: You may be given other medicines to take before and/or after temozolomide to avoid or control vomiting.
Slovenian: Možno je, da boste pred jemanjem temozolomida ali po njem prejeli še druga zdravila za preprečevanje ali omejevanje bruhanja.
English: 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).
Slovenian: 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).
English: 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.
Slovenian: 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.
English: Take the dose on an empty stomach; for example, at least one hour before you plan to eat breakfast.
Slovenian: Predpisani odmerek zdravila Temozolomid Accord vzemite enkrat na dan. Odmerek zaužijte na prazen želodec, na primer eno uro pred zajtrkom.
English: 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.
Slovenian: 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.
English: Read the package leaflet before use .
Slovenian: Pred uporabo preberite priloženo navodilo.
English: 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.
Slovenian: 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.
English: cytomegalovirus infection, infection reactivation such as cytomegalovirus, hepatitis B virus†, Meningoencephalitis herpetic†, sepsis†
Slovenian: okužba s citomegalovirusom, reaktivacija okužb, kot sta okužbi s citomegalovirusom, z virusom hepatitisa B†, herpetični meningoencefalitis†, sepsa†
English: If you develop fever or symptoms of an infection contact your doctor immediately.
Slovenian: Če dobite vročino ali simptome okužbe, se nemudoma posvetujte s svojim zdravnikom.
English: A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IZDELOVALEC/IZDELOVALCI , ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE
English: Temozolomide is first used together with radiotherapy (concomitant phase of treatment) and after that alone (monotherapy phase of treatment).
Slovenian: Temozolomid se najprej uporablja sočasno z radioterapijo (sočasna faza zdravljenja), nato pa samostojno (samostojna faza zdravljenja (monoterapija)).
English: Temozolomide should only be prescribed by specialists experienced in brain tumours.
Slovenian: Temozolomid smejo predpisovati le specialisti, ki imajo izkušnje z zdravljenjem možganskih tumorjev.
English: 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.
Slovenian: 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.
English: Erythema multiforme, erythroderma, urticaria, exanthema General disorders and administration site conditions Very common:
Slovenian: multiformni eritem, eritrodermija, koprivnica, eksantem Splošne težave in spremembe na mestu aplikacije Zelo pogosti:
English: 5 hard capsules 20 hard capsules
Slovenian: 5 trdih kapsul 20 trdih kapsul
English: The dose should be reduced or administration discontinued according to Table 3.
Slovenian: Odmerek je treba zmanjšati ali prenehati z dajanjem zdravila kot je opisano v preglednici 3.
English: Cases of myelodysplastic syndrome and secondary malignancies, including myeloid leukaemia, have also been reported very rarely (see section 4.8).
Slovenian: Zelo redko so bili opaženi primeri mielodisplastičnega sindroma in sekundarnih malignosti vključno z mieloidno levkemijo (glejte poglavje 4.8).
English: 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.
Slovenian: 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.
English: Pneumocystis jirovecii pneumonia (PCP) prophylaxis was required during RT and combined TMZ therapy.
Slovenian: Profilaksa proti pljučnici, ki jo povzroča pneumocystis carinii (PCP), je bila potrebna med radioterapijo in med kombiniranim zdravljenjem s TMZ.
English: Four weeks after completing the TMZ + RT phase, TMZ is administered for up to 6 cycles of monotherapy treatment.
Slovenian: Štiri tedne po zaključku faze zdravljenja s TMZ in RT sledi še do 6 ciklov monoterapije s TMZ.
English: Dermatitis, dry skin, erythema, pruritus
Slovenian: dermatitis, suha koža, eritem, srbenje suha koža, srbenje
English: 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)
Slovenian: 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).
English: 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.
Slovenian: Mediana vrednost preživetja brez sopojavov je bila 4,6 mesecev, kar je podobno izsledkom za preživetje brez napredovanja bolezni.
English: Anti-emetic therapy may be administered prior to or following administration of TMZ.
Slovenian: Antiemetično zdravljenje se lahko da pred dajanjem TMZ ali po njem.
English: 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.
Slovenian: 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.
English: Temozolomide comes in different strength capsules (shown on the outer label in mg).
Slovenian: Temozolomid je na voljo v kapsulah različnih jakosti, ki je označena v mg na zunanji ovojnini.
English: Cases of elevations of liver enzymes have been commonly reported.
Slovenian: Pogosto so poročali o povišanih vrednostih jetrnih encimov.
English: Psychiatric disorders Common:
Slovenian: Psihiatrične motnje Pogosti:
English: capsule shell:
Slovenian: Ovojnica kapsule:
English: TMZ is spontaneously hydrolyzed at physiologic pH primarily to the active species, 3-methyl-(triazen1-yl)imidazole-4-carboxamide (MTIC).
Slovenian: TMZ spontano hidrolizira pri fiziološkem pH v glavnem v aktivno snov, 3-metil-(triazen1-il)imidazol-4-karboksamid (MTIC).
English: Ask your doctor for advice before taking any medicine.
Slovenian: Posvetujte se z zdravnikom ali s farmacevtom, preden vzamete katerokoli zdravilo.
English: Infection, Herpes simplex, wound infection, pharyngitis, candidiasis oral
Slovenian: okužba, herpes simplex, okužba rane, faringitis, oralna kandidiaza okužba, oralna kandidiaza
English: Gamma GT increased, AST increased *A patient who was randomised to the RT arm only, received TMZ + RT.
Slovenian: povečane vrednosti jetrnih encimov, povečana vrednost gama GT, povečana vrednost AST *Bolnik, ki je bil randomiziran v RT krak, je prejel TMZ + RT.
English: How to take Temozolomide Accord
Slovenian: Kako uporabljati zdravilo Temozolomid Accord
English: The pharmacokinetics of TMZ were comparable in patients with normal hepatic function and in those with mild or moderate hepatic impairment.
Slovenian: Farmakokinetika TMZ je primerljiva pri bolnikih z normalnim delovanjem jeter in tistih z blago ali zmerno okvaro jeter.
English: • pneumonia, inflammation of your sinuses, bronchitis, blocked nose, a cold or the flu
Slovenian: • pljučnica, vnetje sinusov, bronhitis, zamašen nos, prehlad ali gripa
English: • infection of the middle ear, pain or discomfort in the ears from loud noises, earache, deafness,
Slovenian: • vnetje srednjega ušesa, bolečine ali nelagodje v ušesih zaradi hrupa, bolečina v ušesih, oglušelost,
English: Cases of increased bilirubin, problems with bile flow (cholestasis), hepatitis and injury to the liver, including fatal liver failure, have been uncommonly reported.
Slovenian: Občasno so poročali o povišani vrednosti bilirubina, težavah s pretokom žolča (holestazi), hepatitisu in poškodbah jeter, vključno z odpovedjo jeter s smrtnim izidom.
English: prolonged pancytopenia, aplastic anaemia† Neoplasm benign, malignant and unspecified Very rare:
Slovenian: podaljšana pancitopenija, aplastična anaemija† Benigne, maligne in neopredeljene novotvorbe Zelo redko:
English: However, elderly patients (>70 years of age) appear to be at increased risk of neutropenia and thrombocytopenia (see section 4.4).
Slovenian: Vendar pa se zdi, da obstaja pri starejših bolnikih (>70 let) povečano tveganje za pojav nevtropenije in trombocitopenije (glejte poglavje 4.4).
English: However, elderly patients (> 70 years of age) appear to be at increased risk of neutropenia and thrombocytopenia (see section 4.4).
Slovenian: Vendar pa se zdi, da obstaja pri starejših bolnikih (> 70 let) povečano tveganje za pojav nevtropenije in trombocitopenije (glejte poglavje 4.4).
English: 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.
Slovenian: 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.
English: 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).
Slovenian: TMZ se jemlje peroralno v odmerkih 75 mg/m2 na dan, in sicer 42 dni sočasno s fokalno radioterapijo (60 Gy v 30 frakcijah).
English: TMZ dose reduction or discontinuation during monotherapy treatment Toxicity
Slovenian: Zmanjšanje odmerka TMZ ali prenehanje dajanja med monoterapijo Toksičnost
English: 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).
Slovenian: Enako velja za podatke o času do poslabšanja telesne zmogljivosti (zmanjšanje KPS do < 70 oziroma padec zmogljivosti za vsaj 30 točk).
English: Date of first authorisation:15 March 2010 Date of latest renewal: 12 January 2015
Slovenian: Datum prve odobritve: 02.2013 Datum zadnejga podaljšanja: 01.2015
English: Table 5 includes adverse reactions reported during clinical trials for recurrent or progressive malignant glioma and following the marketing of TMZ.
Slovenian: Preglednica 5 vključuje neželene učinke, o katerih so poročali med kliničnimi preskušanji pri ponovljenem ali napredovalem malignem gliomu po začetku trženja TMZ.
English: 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).
Slovenian: 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).
English: Doses of 500, 750, 1,000, and 1,250 mg/m2 (total dose per cycle over 5 days) have been evaluated clinically in patients.
Slovenian: Pri bolnikih so bili klinično preverjeni odmerki 500, 750, 1.000 in 1.250 mg/m2 (celokupni odmerek v
English: Temozolomide is a triazene, which undergoes rapid chemical conversion at physiologic pH to the active monomethyl triazenoimidazole carboxamide (MTIC).
Slovenian: Temozolomid je triazen, ki se pri fiziološki vrednosti pH hitro kemično pretvori v aktivni monometil triazenoimidazol karboksamid (MTIC).
English: Hypokalemia, alkaline phosphatase increased, weight increased
Slovenian: hipokaliemija, povečana vrednost alkalne fosfataze, povečana telesna masa hiperglikemija, povečana telesna masa
English: 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).
Slovenian: 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).
English: Grade 3 or 4 thrombocytopenia and neutropenia occurred in 19 % and 17 % respectively, of patients treated for malignant glioma.
Slovenian: Trombocitopenija in nevtropenija stopnje 3 ali 4 sta se pojavili pri 19 % oziroma 17 % bolnikov, ki so se zdravili zaradi malignega glioma.
English: If you accidentally get some in your eyes or nose, flush the area with water.
Slovenian: Če pride prašek po nesreči v stik z vašimi očmi ali v nos, izperite z vodo.
English: The median survival was 7.34 and 5.66 months for TMZ and procarbazine, respectively (log rank p = 0.33).
Slovenian: Mediana vrednost časa preživetja je bila 7,34 mesecev za TMZ oziroma 5,66 mesecev za prokarbazin (logrank p = 0,33).
English: Rash, alopecia
Slovenian: izpuščaj, alopecija
English: See package leaflet for further information PHARMACEUTICAL FORM AND CONTENTS 5 hard capsules 20 hard capsules METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use .
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA 5 trdih kapsul 20 trdih kapsul POSTOPEK IN POT(I) UPORABE ZDRAVILA Pred uporabo preberite priloženo navodilo.
English: a severe allergic reaction (rash which might be itchy, wheezing or other breathing difficulty), - uncontrolled bleeding, - Seizures (convulsions), - fever, - chills, - severe headache that does not go away.
Slovenian: Nemudoma se obrnite na svojega zdravnika, če se pri vas pojavi kar koli od naslednjega: - huda alergijska (preobčutljivostna) reakcija (koprivnica, piskanje ali druge težave pri dihanju), - neobvladljivo krvavitev, - epileptični napadi (konvulzije), - zvišana telesna temperatura, - mrzlica, - hud neprekinjen glavobol.
English: Newly diagnosed glioblastoma multiforme
Slovenian: Novo diagnosticiran multiformni glioblastom
English: Pregnancy,breast-feeding and fertility
Slovenian: Nosečnost, dojenje in plodnost
English: After oral administration to adult patients, TMZ is absorbed rapidly, with peak concentrations reached as early as 20 minutes post administration (mean times between 0.5 and 1.5 hours).
Slovenian: Po peroralnem dajanju se pri odraslih bolnikih TMZ zelo hitro absorbira in doseže največjo koncentracijo že v 20 minutah po zaužitju (povprečen čas se giblje med 0,5 in 1,5 ure).
English: Temozolomide Accord is administered in combination with focal radiotherapy (concomitant phase) followed by up to 6 cycles of temozolomide (TMZ) monotherapy (monotherapy phase).
Slovenian: Zdravilo Temozolomid Accord se uporablja v kombinaciji s fokalno radioterapijo (faza sočasnega zdravljenja), čemur sledi do 6 ciklov monoterapije s temozolomidom (TMZ) - faza monoterapije.
English: Women of child bearing should be advised to use effective contraception to avoid pregnancy while they are receiving TMZ.
Slovenian: Ženskam v rodni dobi je treba svetovati, naj med zdravljenjem s TMZ uporabljajo učinkovito kontracepcijo, da preprečijo zanositev.
English: Based on an analysis of population pharmacokinetics in phase II trials, co-administration of dexamethasone, prochlorperazine, phenytoin, carbamazepine, ondansetron, H2 receptor antagonists, or phenobarbital did not alter the clearance of TMZ.
Slovenian: faze sočasno jemanje deksametazona, proklorperazina, fenitoina, karbamazepina, ondansetrona, antagonistov receptorjev H2 ali fenobarbitala ni spremenilo očistka TMZ.
English: Dose in Cycle 1 (monotherapy) is 150 mg/m2 once daily for 5 days followed by 23 days without treatment.
Slovenian: V 1. ciklu (monoterapije) je odmerek 150 mg/m2 enkrat na dan 5 dni, čemur sledi 23 dni brez jemanja zdravila.
English: 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).
Slovenian: Dodatna sočasna uporaba TMZ ob RT, ki ji sledi monoterapija s TMZ, je pri bolnikih z novo diagnosticiranim multiformnim glioblastomom pokazala statistično pomembno izboljšanje skupnega preživetja v primerjavi s samo RT (Slika 1).
English: This led to hospitalisation and/or discontinuation of TMZ in 8 % and 4 %, respectively.
Slovenian: To je pri 8 % oziroma 4 % bolnikov privedlo do hospitalizacije in/ali prekinitve zdravljenja s TMZ.
English: 5 PHARMACOLOGICAL PROPERTIES
Slovenian: 5 FARMAKOLOŠKE LASTNOSTI
English: Abnormal blood values, headache, feeling or being sick, constipation, loss of appetite, tiredness
Slovenian: Nenormalne krvne vrednosti, glavobol, občutek slabosti ali bruhanje, zaprtje, izguba apetita, utrujenost
English: The objective response rate (ORR) based on MRI scans was 8%.
Slovenian: Objektivno ugotovljena stopnja odzivanja bolnikov na zdravljenje, določena na podlagi NMR posnetkov, je bila 8 %.
English: Temozolomide Accord contains lactose
Slovenian: Zdravilo Temozolomid Accord vsebuje laktozo.
English: Table 1.TMZ dosing interruption or discontinuation during concomitant radiotherapy and TMZ
Slovenian: Prekinitev ali prenehanje jemanja TMZ med sočasno radioterapijo in zdravljenjem s TMZ
English: Agitation, apathy, behaviour disorder, depression, hallucination
Slovenian: agitacija, apatija, vedenjske motnje, depresija, halucinacije halucinacije, amnezija
English: Marketing Authorisation Holder and Manufacturer
Slovenian: Imetnik dovoljenja za promet z zdravilom in izdelovalec,
English: • weakness, swollen face, shivering, change in your sense of taste, tooth disorder
Slovenian: • šibkost, otečen obraz, drgetanje, spremembe okusa, težave z zobmi
English: • sexual impotence, vaginal bleeding, absent or heavy menstrual periods, vaginal irritation, breast pain,
Slovenian: • impotenca, krvavitev iz nožnice, odsotnost menstruacije, zelo močna menstruacija, razdraženost nožnice, bolečina v dojkah,
English: • fits, change in mental status or alertness, sleepiness, difficulty with your balance, dizziness,
Slovenian: • krči/napadi, spremembe duševnega stanja ali budnosti, zaspanost, težave z ravnotežjem, omotica,
English: 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).
Slovenian: 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).
English: Prior to dosing, the following laboratory parameters must be met: ANC ≥1.5 x 109/l and platelet count ≥ 100 x 109/l.
Slovenian: Pred odmerjanjem morajo biti doseženi naslednji laboratorijski parametri: absolutno število nevtrofilcev ≥ 1,5 x 109/l in število trombocitov ≥ 100 x 109/l.
English: • bleeding within the brain, high blood pressure, blood clot in the lung, swelling
Slovenian: • možganske krvavitve, visok krvni tlak, krvni strdki v pljučih, otekline