FrancophonIA/ELRC3.0 huggingface dataset:
English: If you vomit after your dose, do not take a second dose on the same day.
Slovenian: Če bruhate po zaužitju odmerka, v istem dnevu ne vzemite drugega odmerka.
English: • loss of hearing, ringing noise in the ear
Slovenian: • izguba sluha, zvonjenje v ušesu
English: Very rare cases of rash with skin swelling, including on the palms of the hands and soles of the feet, or painful reddening of the skin and/or blisters on the body or in the mouth have been observed.
Slovenian: Zelo redko so opazili izpuščaj z oteklinami na koži, ki zajema tudi dlani in podplate, ali pa bolečo pordelost kože in/ali mehurje na telesu oziroma v ustih.
English: A treatment cycle with Temozolomide Accord comprises 28 days.
Slovenian: Cikel zdravljenja z zdravilom Temozolomid Accord traja 28 dni.
English: Temozolomide Accord capsules are taken to treat specific forms of brain tumours: - adults with newly diagnosed specific form of brain tumour (glioblastoma multiforme).
Slovenian: Kapsule Temozolomid Accord se uporabljajo za zdravljenje posebnih oblik možganskih tumorjev: - Odraslih bolnikov s posebno obliko novo diagnosticiranega možganskega tumorja (multiformni glioblastom).
English: In a population pharmacokinetics analysis of clinical trial experience there were 101 female and 169 male subjects for whom nadir neutrophil counts were available and 110 female and 174 male subjects for whom nadir platelet counts were available.
Slovenian: V analizi populacijske farmakokinetike, na osnovi izkušenj iz kliničnih preskušanj, so bili zajeti podatki 101 bolnice in 169 bolnikov, pri katerih je bil na voljo podatek o najmanjšem številu nevtrofilcev, ter podatki 110 bolnic in 174 bolnikov, pri katerih je bil na voljo podatek o najmanjšem številu trombocitov.
English: If you are a newly-diagnosed patient (glioblastoma multiforme) you may be receiving temozolomide for 42 days in combination with radiotherapy.
Slovenian: Če ste na novo odkrit bolnik (multiformni glioblastom), boste temozolomid morda prejemali 42 dni v kombinaciji z radioterapijo.
English: Liver toxicity may occur several weeks or more after the last treatment with temozolomide.
Slovenian: Hepatotoksičnost se lahko pojavi nekaj tednov po zadnjem zdravljenju s temozolomidom ali še pozneje.
English: Pack-size of 5 or 20 hard capsules individually sealed in sachets.
Slovenian: Pakiranja po 5 ali 20 trdih kapsul, posamezno zaprtih v vrečkah.
English: However, caution should be exercised when TMZ is administered in these patients.
Slovenian: Vendar pa je pri uporabi TMZ pri teh bolnikih potrebna previdnost.
English: Changes in blood cells
Slovenian: Spremembe krvnih celic.
English: Allergic reactions, including anaphylaxis, angioedema
Slovenian: alergijske reakcije, vključno z anafilakso in angioedemom
English: Pancytopenia, anaemia (grade 3-4), leukopenia
Slovenian: pancitopenija, anemija (stopnje 3-4), levkopenija,
English: Keep the bottle tightly closed in order to protect from moisture.
Slovenian: Steklenico shranjujte tesno zaprto za zagotovitev zaščite pred vlago.
English: Patients treated with TMZ may experience myelosuppression, including prolonged pancytopenia, which may result in aplastic anaemia, which in some cases has resulted in a fatal outcome.
Slovenian: Pri bolnikih, zdravljenih s TMZ lahko pride do mielosupresije , vključno s podaljšano pancotopenijo, kar lahko povzroči aplastično anemijo, ki se je v nekaterih primerih končala s smrtnim izidom.
English: If use during pregnancy must be considered, the patient should be apprised of the potential risk to the foetus.
Slovenian: Če je treba pretehtati možnost o uporabi zdravila med nosečnostjo, je treba bolnico obvestiti o morebitnih tveganjih za plod.
English: MTIC is spontaneously hydrolyzed to 5-amino-imidazole-4carboxamide (AIC), a known intermediate in purine and nucleic acid biosynthesis, and to methylhydrazine, which is believed to be the active alkylating species.
Slovenian: MTIC spontano hidrolizira v 5-amino-imidazol-4-karboksamid (AIC), ki je znan intermediat v biosintezi purinov in nukleinskih kislin, in v metilhidrazin, za katerega se domneva, da je aktivni alkilirajoči presnovek.
English: Middlesex, HA1 4HF, United Kingdom
Slovenian: Middlesex, HA1 4HF,
English: Plasma clearance, volume of distribution and half-life are independent of dose.
Slovenian: Plazemski očistek, porazdelitveni volumen in razpolovni čas so odvisni od odmerka.
English: The results from the trial were not consistent in the subgroup of patients with a poor performance status (WHO PS=2, n=70), where overall survival and time to progression were similar in both arms.
Slovenian: Rezultati preskušanja niso bili konsistentni v podskupini bolnikov s slabo telesno zmogljivostjo (WHO PS - »performance status« =2, n=70), kjer sta bila skupno preživetje in čas do napredovanja podobna v obeh krakih.
English: Patients taking temozolomide in combination with radiation therapy may experience different side effects than patients taking temozolomide alone.
Slovenian: Bolniki, ki jemljejo temozolomid v kombinaciji z radioterapijo, imajo lahko drugačne neželene učinke kot tisti, ki jemljejo samo temozolomid.
English: Most of the toxicity showed evidence of reversibility, except for adverse reactions on the male reproductive system and retinal degeneration.
Slovenian: Pri večini toksičnih učinkov je bila opažena reverzibilnost, z izjemo neželenih reakcij na moške reproduktivne organe in degeneracijo mrežnice.
English: In both trials, the primary endpoint was progression-free survival (PFS) defined by MRI scans or neurological worsening.
Slovenian: 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.
English: Reduce TMZ by 1 dose levela
Slovenian: Zmanjšajte odmerek TMZ za 1 raven odmerkaa
English: 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.
Slovenian: Podatki o klinični učinkovitosti pri bolnikih z multiformnim glioblastomom (stanje telesne zmogljivosti po lestvici Karnofsky [KPS] ≥70), ki je napredoval ali se je ponovil po operaciji in RT, so bili pridobljeni iz dveh kliničnih preskušanj o peroralni uporabi TMZ.
English: The estimated probability of surviving 2 years or more (26% vs 10%) is higher for the RT + TMZ arm.
Slovenian: Ocenjena verjetnost preživetja 2 let ali več je večja za krak TMZ + RT (26 % proti 10 %).
English: Patients in the control arm received RT only.
Slovenian: Bolniki v kontrolnem kraku so prejeli samo radioterapije.
English: How to store Temozolomide Accord Contents of the pack and other information
Slovenian: Shranjevanje zdravila Temozolomid Accord Vsebina pakiranja in dodatne informacije
English: During treatment a complete blood count should be obtained on Day 22 (21 days after the first dose of TMZ).
Slovenian: Med zdravljenjem je treba 22. dan cikla preveriti celotno krvno sliko (21 dni po prvem odmerku TMZ).
English: In vivo, the t1/2 of MTIC was similar to that of TMZ, 1.8 hr.
Slovenian: In vivo je t1/2 MTIC podoben kot pri TMZ, t. j. 1,8 ur.
English: Dose level
Slovenian: Stopnja odmerka
English: Infections including agents causing pneumonia.
Slovenian: Okužbe, ki vključujejo povzročitelje pljučnice.
English: - if you feel sick or vomit, which are very common side effects of Temozolomide (see section 4).
Slovenian: - Če vam je slabo ali bruhate, kar je zelo pogost neželeni učinek temozolomida (glejte poglavje 4).
English: • flu-like symptoms, red spots under the skin
Slovenian: • gripi podobni simptomi, rdeče lise pod kožo
English: - if you have anaemia, low blood count (such as white blood cell count and platelet count), or blood clotting problems before treatment, or develop them during treatment.
Slovenian: - Če imate anemijo, majhno število krvnih celic (npr. majhno število belih krvničk ali krvnih ploščic) ali težave s strjevanjem krvi že pred začetkom zdravljenja ali pa se pojavijo med njim.
English: Herpes simplex, Herpes zoster, influenza-like symptoms
Slovenian: herpes simplex, herpes zoster, gripi podobni simptomi
English: Analysis of population-based pharmacokinetics of TMZ revealed that plasma TMZ clearance was independent of age, renal function or tobacco use.
Slovenian: Analiza populacijske farmakokinetike TMZ je pokazala, da je plazemski očistek TMZ neodvisen od starosti, delovanja ledvic ali uporabe tobaka.
English: Experts in liver disease should be consulted before treatment is initiated in patients with positive hepatitis B serology (including those with active disease).
Slovenian: Pred začetkom zdravljenja bolnikov s pozitivno serologijo na hepatitis B (vključno s tistimi, ki imajo aktivno bolezen) se je treba posvetovati s strokovnjaki za jetrne bolezni.
English: Signs of allergic reaction include feeling itchy, breathlessness or wheezing, swelling of the face, lips, tongue or throat.
Slovenian: Znaki alergijske reakcije vključujejo občutek srbenja, sopenje ali piskajoče dihanje, otekanje obraza, ustnic, jezika ali žrela.
English: The cytotoxicity of MTIC is thought to be primarily due to alkylation of DNA mainly at the O6 and N7 positions of guanine.
Slovenian: Domneva se, da je cititoksičnost MTIC večinoma posledica alkilacije DNA, predvsem gvanina na položajih O6 in N7 gvanina.
English: - Be sure you understand exactly how many capsules you need to take of each strength.
Slovenian: - Prepričajte se, da res razumete, koliko kapsul kakšne jakosti morate vzeti.
English: Skin redness, an itchy rash with raised yellow or white lumps that are surrounded by red inflammation, skin eruption, allergic reactions.
Slovenian: Rdečica kože, srbeč izpuščaj z rumenimi ali belimi izboklinami, ki jih obdaja rdeče vneto območje, izpuščaj na koži, alergijske reakcije.
English: • abnormal or blurred vision, double-vision
Slovenian: • nenormalen ali zamegljen vid, dvojni vid
English: 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).
Slovenian: Prvo je bilo neprimerjalno preskušanje pri 138 bolnikih (29 % jih je prej prejelo kemoterapijo), drugo pa je bilo randomizirano, z učinkovino nadzorovano preskušanje TMZ in prokarbazina pri skupaj 225 bolnikih (67 % jih je prej prejelo kemoterapijo na osnovi nitrozouree.)
English: 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).
Slovenian: V ločeni študiji I. faze dajanje TMZ z ranitidinom ni povzročilo sprememb v obsegu absorpcije temozolomida ali izpostavljenosti njegovemu aktivnemu presnovku monometil triazenoimidazol karboksamidu (MTIC).
English: TMZ administration should be temporarily interrupted or permanently discontinued during the concomitant phase according to the haematological and non-haematological toxicity criteria as noted in Table 1.
Slovenian: Jemanje TMZ je treba začasno prekiniti ali popolnoma prenehati med fazo sočasnega zdravljenja v skladu s hematološkimi in nehematološkimi kriteriji toksičnosti, kot je prikazano v preglednici 1.
English: • feeling and/or being sick
Slovenian: • občutek slabosti in/ali bruhanje
English: - as you should be observed closely for the development of a serious form of chest infectioncalled Pneumocystis jirovecii pneumonia (PCP).
Slovenian: - Pozorni morajo biti na morebiten pojav resne oblike okužbe dihal, imenovane pljučnica Pneumocystis jirovecii (PCP- Pneumocystis jirovecii pneumonia).
English: Anti-emetic prophylaxis is recommended prior to the initial dose of concomitant phase and it is strongly recommended during the monotherapy phase.
Slovenian: Antiemetična profilaksa je priporočljiva pred prvim odmerkom temozolomida v sočasnem zdravljenju in je zelo priporočljiva med fazo monoterapije.
English: Depending on the dose of temozolomide that your doctor prescribes, you may have to take several capsules on each dosing day of the treatment cycle.
Slovenian: Odvisno od odmerka, ki ga bo predpisal vaš zdravnik, boste morda morali vsak dan jemanja v ciklu zdravljenja vzeti več kapsul naenkrat.
English: Clinical trial experience
Slovenian: Izkušnje iz kliničnih preskušanj
English: Cases of sepsis (when bacteria and their toxins circulate in the blood and start to damage the organs) have been uncommonly reported.
Slovenian: Občasno so poročali o primerih sepse (kadar so v krvi prisotne bakterije in njihovi toksini in pričnejo povzročati poškodbe na organih).
English: The hard capsules are dispensed in sachet containing 1 capsule.
Slovenian: Trde kapsule so na voljo v vrečkah, ki vsebujejo po 1 kapsulo.
English: Do not take Temozolomide Accord - if you are allergic to temozolomide or any of the other ingredients of this medicine (listed in section 6).
Slovenian: - če ste alergični na temozolomid ali katero koli sestavino zdravila (navedeno v poglavju 6).
English: 20 hard capsules
Slovenian: 20 trdih kapsul
English: CTC Grade 3
Slovenian: SMT stopnje 3
English: While the radiotherapy is ongoing your doctor will start temozolomide at a dose of 75 mg/m² and the actual daily dose you take will depend on your height and weight.
Slovenian: Med radioterapijo vam bo zdravnik predpisal začetni odmerek 75 mg/m² temozolomida, dejanski dnevni odmerek pa bo odvisen od vaše višine in telesne mase.
English: PET studies in humans and preclinical data suggest that TMZ crosses rapidly the blood-brain barrier and is present in the CSF.
Slovenian: Študije z uporabo PET pri ljudeh in predklinični podatki nakazujejo, da TMZ hitro prehaja krvnomožgansko pregrado in je prisoten v cerebrospinalni tekočini.
English: The cytotoxicity of MTIC is thought to be due primarily to alkylation at the O6 position of guanine with additional alkylation also occurring at the N7 position.
Slovenian: Cititoksičnost MTIC je verjetno večinoma posledica alkiliranja gvanina na položaju O6, z dodatnim alkiliranjem na položaju N7.
English: Cases of fatal respiratory failure have been reported in patients using TMZ, in particular in combination with dexamethasone or other steroids.
Slovenian: Poročali so o respiratorni odpovedi s smrtnim izidom pri bolnikih, ki so jemali TMZ, zlasti v kombinaciji z deksametazonom ali drugimi steroidi.
English: - if you have a reduced number of blood cells, such as your white blood cell count and platelet count.
Slovenian: - če imate zmanjšano število krvnih celic, na primer belih krvnih celic ali krvnih ploščic.
English: For patients on a 42 day treatment cycle liver function tests should be repeated midway during this cycle.
Slovenian: Pri bolnikih, ki se zdravijo z 42-dnevnim ciklom jemanja zdravila, je treba funkcijske preiskave delovanja jeter opraviti sredi tega cikla.
English: Rash, pruritus, alopecia
Slovenian: izpuščaj, pruritus, alopecija,
English: Effective contraceptive precautions must be taken by both male and female patients who are taking Temozolomide Accord (see also “Male fertility” below).
Slovenian: Bolnice in bolniki, ki jemljejo zdravilo Temozolomid Accord, morajo uporabljati učinkovito kontracepcijsko metodo (glejte tudi poglavje »Plodnost pri moških«).
English: No dose reductions are recommended, but delay or discontinuation of TMZ administration should be decided weekly according to haematological and non-haematological toxicity criteria.
Slovenian: Zmanjševanje odmerka ni priporočljivo, vendar je treba zamik ali prenehanje jemanja TMZ odločati tedensko, glede na hematološke in nehematološke kriterije toksičnosti.
English: In a separate pharmacokinetic study, plasma pharmacokinetic profiles in patients with mild to moderate hepatic impairment were similar to those observed in patients with normal hepatic function.
Slovenian: V ločeni farmakokinetični študiji so bili plazemski farmakokinetični profili pri bolnikih z blago do zmerno okvaro jeter podobni kot pri bolnikih z normalnim delovanjem jeter.
English: 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%.
Slovenian: 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 %.
English: Therefore, special care should be taken when TMZ is administered in elderly patients.
Slovenian: Zato je pri uporabi TMZ pri starejših bolnikih potrebna posebna previdnost.
English: 4.2 Posology and method of administration Temozolomide Accord should only be prescribed by physicians experienced in the oncological treatment of brain tumours.
Slovenian: 4.2 Odmerjanje in način uporabe Zdravilo Temozolomid Accord smejo predpisati le zdravniki, ki imajo izkušnje z onkološkim zdravljenjem možganskih tumorjev.
English: • long or repeated fits, tremors or jerking movement, partial paralysis, difficulty with your coordination and balance, changes in sensation of touch
Slovenian: • dolgi ali ponavljajoči se krči/napadi, trepetanje ali trzajoči gibi, delna paraliza, težave s koordinacijo in ravnotežjem, spremembe v občutku tipa
English: 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).
Slovenian: 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).
English: 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.
Slovenian: 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.
English: • increased sugar in the blood, loss of weight
Slovenian: • povečana koncentracija sladkorja v krvi, hujšanje
English: Dose-related reductions in leukocytes and platelets appear to be sensitive indicators of toxicity.
Slovenian: Kaže, da je od odmerka odvisno zmanjšanje števila levkocitov in trombocitov občutljiv kazalec toksičnosti.
English: TMZ dose(mg/m2 /day)
Slovenian: Odmerek TMZ (mg/m2 /dan)
English: 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.
Slovenian: 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.
English: Neutropenia or lymphopenia (grade 3-4), thrombocytopenia (grade 3-4)
Slovenian: nevtropenija ali limfopenija (stopnje 3-4), trombocitopenija (stopnje 3-4),
English: interstitial pneumonitis/pneumonitis, pulmonary fibrosis, respiratory failure†
Slovenian: intersticijski pneumonitis/pneumonitis, pljučna fibroza, odpoved dihanja†
English: Based on your blood counts and how you tolerate temozolomide, the dose may be delayed or stopped.
Slovenian: Glede na število vaših krvnih celic in odvisno od tega, kako dobro prenašate temozolomid, bo jemanje odmerkov morda treba odložiti ali prekiniti.
English: How to open sachet Open the sachet by folding and tearing along the fold line with the notch in the corner of the sachet.
Slovenian: Odpiranje vrečke Vrečko odprete tako, da prepognete in pretrgate vrečko vzdolž črte z zarezo v kotu vrečke.
English: Hepatitis due to hepatitis B virus (HBV) reactivation, in some cases resulting in death, has been reported.
Slovenian: Poročali so o hepatitisu zaradi reaktivacije okužbe z virusom hepatitisa B (HBV), v nekaterih primerih tudi s smrtnim izidom.
English: Micturition frequency, urinary incontinence
Slovenian: pogosto uriniranje, urinarna inkontinenca urinarna inkontinenca
English: The hard capsules are dispensed in amber glass bottles containing 5 or 20 capsules.
Slovenian: Trde kapsule so na voljo v stekleničkah iz rjavega stekla po 5 ali 20 kapsul.
English: myelodysplastic syndrome (MDS), secondary malignancies, including myeloid leukaemia
Slovenian: mielodisplastični sindrom (MDS), sekundarne novotvorbe, vključno z mieloidno levkemijo
English: Once escalated, the dose remains at 200 mg/m2 per day for the first 5 days of each subsequent cycle except if toxicity occurs.
Slovenian: Po povečanju odmerka ta ostane 200 mg/m2 na dan v prvih 5 dneh vsakega cikla, razen če se pojavi toksičnost.
English: Not Known
Slovenian: Neznani:
English: In patients 3 years of age or older, TMZ is only to be used in recurrent or progressive malignant glioma.
Slovenian: Pri bolnikih, starih 3 leta ali več, se TMZ uporablja le pri ponovljenem ali napredovalem malignem gliomu.
English: Dose reductions and discontinuations during the monotherapy phase should be applied according to Tables 2 and 3.
Slovenian: V fazi monoterapije je treba zmanjševanje odmerkov in prenehanje dajanja izvajati v skladu s podatki v preglednicah 2 in 3.
English: 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.
Slovenian: 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.
English: TMZ dose (mg/m2 /day)
Slovenian: Odmerek (mg/m2 /dan)
English: Myelosuppression (neutropenia and thrombocytopenia), which is known dose-limiting toxicity for most cytotoxic agents, including TMZ, was observed.
Slovenian: Opažena je bila mielosupresija (nevtropenija in trombocitopenija), ki je znan toksični učinek za omejitev odmerka večine citotoksičnih snovi, vključno s TMZ.
English: No studies have been conducted to determine the effect of TMZ on the metabolism or elimination of other medicinal products.
Slovenian: Študije, ki bi določile učinek TMZ na presnovo ali izločanje drugih zdravil, niso bile izvedene.
English: Your doctor will check your blood to make sure you have enough of these cells before you begin treatment.
Slovenian: Zdravnik bo odredil krvne preiskave, da se bo pred začetkom zdravljenja prepričal, da je število teh celic pri vas zadostno.
English: Marketing Authorisation Holder Accord Healthcare S.L.U.
Slovenian: Imetnik dovoljenja za promet z zdravilom Accord Healthcare S.L.U.
English: 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.
Slovenian: 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.
English: 6 PHARMACEUTICAL PARTICULARS
Slovenian: 6 FARMACEVTSKI PODATKI
English: Based on a population pharmacokinetic analysis in patients 19-78 years of age, clearance of TMZ is not affected by age.
Slovenian: Na osnovi populacijske farmakokinetične analize pri bolnikih, starih od 19 do 78 let, je bilo ugotovljeno, da starost ne vpliva na očistek TMZ.
English: If abnormal, physicians should assess the benefit/risk prior to initiating temozolomide including the potential for fatal hepatic failure.
Slovenian: 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.