FrancophonIA/ELRC3.0 huggingface dataset:
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 podlagi izkušenj iz kliničnih preskušanj so obdelali podatke 101 žensk in 169 moških, za katere so bili na voljo podatki o najmanjšem številu nevtrofilcev, ter od 110 žensk in 174 moških, za katere so bili na voljo podatki o najmanjšem številu trombocitov.
English: This led to hospitalisation and/or discontinuation of TMZ in 8 % and 4 %, respectively.
Slovenian: Zaradi njiju je bila potrebna hospitalizacija in/ali prekinitev zdravljenja s TMZ pri 8 % in 4 % bolnikov.
English: Very rare cases of severe 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: Poročali so o zelo redkih primerih hudega izpuščaja z otekanjem kože, vključno s kožo na dlaneh in podplatih, ter boleči pordelosti kože in/ali mehurjev po telesu ali v ustih.
English: Post-Marketing experience
Slovenian: Izkušnje v obdobju trženja
English: • cough • infections including pneumonia.
Slovenian: • okužbe, vključno s pljučnico.
English: However, caution should be exercised when TMZ is administered in these patients.
Slovenian: Kljub temu je potrebna previdnost pri uporabi TMZ pri teh bolnikih.
English: In some cases, exposure to concomitant medicinal products associated with aplastic anaemia, including carbamazepine, phenytoin, and sulfamethoxazole/trimethoprim, complicates assessment.
Slovenian: V nekaterih primerih izpostavljenost sočasno jemanim zdravilom, ki jih povezujejo z aplastično anemijo, vključno s karbamazepinom, fenitoinom in sulfametoksazolom/trimetoprimom, otežuje oceno.
English: Figure 1 Kaplan-Meier curves for overall survival (intent-to-treat population)
Slovenian: Kaplan-Meierjeve krivulje skupnega preživetja (populacija, ki naj bi jo zdravili)
English: Your doctor will monitor your blood regularly for any changes, and will decide if any specific treatment is needed.
Slovenian: Zdravnik vas bo redno naročal na krvne preiskave, da bo ugotovil morebitne spremembe, in vam po potrebi predpisal specifično zdravljenje.
English: • partial loss of vision
Slovenian: • delna izguba vida,
English: Contains lactose.
Slovenian: Vsebuje laktozo.
English: Dose-limiting toxicity was haematological and was reported with any dose but is expected to be more severe at higher doses.
Slovenian: Toksični učinki, ki so omejevali odmerek, so bili hematološki in so jih opažali pri vseh odmerkih, vendar je pričakovati, da so hujši pri večjih odmerkih.
English: It is not known whether TMZ is excreted in human milk; thus, breast-feeding should be discontinued while receiving treatment with TMZ.
Slovenian: Ni znano, ali se TMZ izloča v materino mleko, zato je treba med zdravljenjem s TMZ dojenje prekiniti.
English: During treatment a complete blood count should be obtained on Day 22 (21 days after the first dose of TMZ).
Slovenian: Med zdravljenjem morate 22. dan pregledati celotno krvno sliko (21 dni po prvem odmerku TMZ).
English: TMZ administration can be continued throughout the 42 day concomitant period (up to 49 days) if all of the following conditions are met:
Slovenian: TMZ lahko bolnik jemlje ves čas 42-dnevnega obdobja sočasne terapije (do 49 dni), če so izpolnjeni vsi od naslednjih pogojev:
English: Patients with rare hereditary problems of galactose intolerance, the total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Slovenian: Bolniki z redko dedno intoleranco za galaktozo, odsotnostjo encima laktaze ali malabsorpcijo glukoze/galaktoze ne smejo jemati tega zdravila.
English: Temozolomide Sandoz treatment can cause a reduction in certain kinds of blood cells.
Slovenian: Zdravljenje z zdravilom Temozolomid Sandoz lahko povzroči zmanjšanje števila nekaterih vrst krvnih celic.
English: The estimated probability of surviving 2 years or more (26 % vs 10 %) is higher for the RT + TMZ arm.
Slovenian: Ocenjena verjetnost preživetja bolnika 2 leti ali več (26 % v primerjavi z 10 %) je bila večja za del študije z RT + TMZ.
English: • a cold or the flu
Slovenian: • prehlad ali gripa,
English: • a severe allergic (hypersensitive) reaction (hives, wheezing or other breathing difficulty),
Slovenian: • huda alergijska (preobčutljivostna) reakcija (koprivnica, sopenje ali druge težave pri dihanju).
English: • infection of the middle ear
Slovenian: • okužba srednjega ušesa,
English: • high blood pressure
Slovenian: • zvišan krvni tlak,
English: Anti-emetic therapy may be administered (see section 4.4).
Slovenian: Predpiše se lahko tudi antiemetično zdravljenje (glejte poglavje 4.4).
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: 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 %.
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 stanja bolnika.
English: • frequent urination
Slovenian: • pogosto uriniranje,
English: Grade 3 or 4 thrombocytopenia and neutropenia occurred in 19 % and 17 % respectively, of patients treated for malignant glioma.
Slovenian: Trombocitopenija in nevtropenija 3. in 4. stopnje sta se pojavili pri 19 % in 17 % bolnikov, zdravljenih zaradi malignega glioma.
English: Do not store above 25 °C.
Slovenian: Shranjujte pri temperaturi do 25 °C.
English: During treatment a complete blood count should be obtained weekly.
Slovenian: Med zdravljenjem morate pri bolniku enkrat na teden pregledati celotno krvno sliko.
English: Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2).
Slovenian: Izdaja zdravila je le pod omejenimi pogoji in na recept (glejte Dodatek I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
English: Investigations Common:
Slovenian: Preiskave Pogosti:
English: Patients with tumours that have returned or worsened (malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma) taking Temozolomide Sandoz only
Slovenian: Bolniki s tumorji, ki so se ponovili ali poslabšali (maligni gliomi, kot sta multiformni glioblastom ali anaplastični astrocitom) in jemljejo samo zdravilo Temozolomid Sandoz
English: Tolerance to TMZ is similar to adults.
Slovenian: Bolniki so TMZ prenašali podobno kot odrasli.
English: Review the dose with your doctor each time you start a new cycle, since it may be different from the last cycle.
Slovenian: Vsakič, ko začnete novi cikel, morate preveriti odmerek zdravila z zdravnikom, ker se bo morda razlikoval od tistega v prejšnjem ciklu.
English: Toxicity
Slovenian: Toksičnost
English: • difficulty concentrating
Slovenian: • težave s koncentracijo,
English: liver enzymes elevations
Slovenian: povečane vrednosti jetrnih encimov
English: Thus, prophylaxis against PCP is required for all patients receiving concomitant TMZ and RT for the 42-day regimen (with a maximum of 49 days) regardless of lymphocyte count.
Slovenian: Profilaksa proti PCP je torej potrebna pri vseh bolnikih, ki sočasno prejemajo zdravilo TMZ in RT v okviru 42-dnevne sheme zdravljenja (do največ 49 dni), ne glede na število limfocitov.
English: Anorexia
Slovenian: anoreksija
English: This medicinal product contains lactose.
Slovenian: To zdravilo vsebuje laktozo.
English: 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.
Slovenian: V neprimerjalnem preskušanju je bil PFS po 6 mesecih 19 %, mediana vrednost PFS 2,1 meseca in mediana vrednost celotnega preživetja 5,4 mesecev.
English: Women of childbearing potential 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: indicating complete absorption.
Slovenian: 0,8 %, kar kaže na popolno absorpcijo.
English: Summary of events reported with temozolomide in the post-marketing setting
Slovenian: Povzetek dogodkov, o katerih so poročali pri uporabi temozolomida v obdobju trženja*
English: Manufacturer
Slovenian: Izdelovalca
English: ANNEX III LABELLING AND PACKAGE LEAFLET
Slovenian: PRILOGA III OZNAČEVANJE IN NAVODILA ZA UPORABO
English: Your doctor may decide to reduce the dose, interrupt, stop or change your treatment.
Slovenian: V hudih primerih bo morda moral prekiniti, ustaviti ali spremeniti zdravljenje.
English: If use during pregnancy must be considered, the patient should be apprised of the potential risk to the foetus.
Slovenian: Če pa je uporaba v času nosečnosti nujna, morate bolnico opozoriti na možne nevarnosti zdravila za plod.
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 priporočeno, vendar se boste vsak teden odločili o morebitni odložitvi jemanja TMZ ali njegovi ukinitvi na podlagi kriterijev hematološke in nehematološke toksičnosti.
English: • change in your sense of smell
Slovenian: • sprememba čuta za vonj,
English: Patients receiving temozolomide in combination with radiotherapy may experience different side effects than patients taking temozolomide alone.
Slovenian: Pri bolnikih, ki prejemajo temozolomid v kombinaciji z radioterapijo, se lahko pojavijo drugačni neželeni učinki kot pri bolnikih, ki prejemajo samo temozolomid.
English: For patients on a 42 day treatment cycle liver function tests should be repeated midway during this cycle.
Slovenian: 42-dnevnem ciklu zdravljenja, je treba teste jetrne funkcije ponoviti na polovici cikla.
English: Pack-size of 5 or 20 hard capsules individually sealed in sachets.
Slovenian: Velikosti pakiranj po 5 ali 20 trdih kapsul, posamezno zatesnjenih v vrečice.
English: The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.
Slovenian: V natisnjenem navodilu za uporabo zdravila mora biti navedeno ime in naslov izdelovalca,
English: TMZ demonstrates low protein binding (10 % to 20 %), and thus it is not expected to interact with highly protein-bound substances.
Slovenian: TMZ se v majhni meri veže na beljakovine (10 % do 20 %), zato ni pričakovati, da bi medsebojno deloval z zdravili z učinkovinami, ki se dobro vežejo na beljakovine.
English: Other side effects:
Slovenian: Drugi neželeni učinki:
English: Effective contraceptive precautions must be taken by both male and female patients who are taking Temozolomide Sandoz (see also “Male fertility” below).
Slovenian: Bolnice in bolniki, ki jemljejo zdravilo Temozolomid Sandoz, morajo uporabljati učinkovito kontracepcijsko metodo (glejte tudi ″Plodnost pri moških″ spodaj).
English: Pancytopenia, anaemia (grade 3-4), leukopenia
Slovenian: pancitopenija, anemija (3. do 4. stopnje), levkopenija
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
Slovenian: VSEBINA IZRAŽENA Z MASO; PROSTORNINO ALI ŠTEVILOM ENOT
English: Experience in these children is very limited (see sections 4.4 and 5.1).
Slovenian: Izkušenj z uporabo tega zdravila pri teh otrocih je malo (glejte poglavji 4.4 in 5.1).
English: Each sachet contains 1 hard capsule.
Slovenian: Ena vrečica vsebuje 1 trdo kapsulo.
English: • The active substance is temozolomide.
Slovenian: • Zdravilna učinkovina je temozolomid.
English: Following oral administration, approximately 5 % to 10 % of the dose is recovered unchanged in the urine over 24 hours, and the remainder excreted as temozolomide acid, 5-aminoimidazole-4-carboxamide (AIC) or unidentified polar metabolites.
Slovenian: Po peroralni uporabi se v 24 urah s sečem v nespremenjeni obliki izloči približno 5 % do 10 % odmerka, preostanek pa se izloči v obliki temozolomidske kisline, 5-aminoimidazol-4-karboksamida (AIC) ali neopredeljenih polarnih presnovkov.
English: • if you have low counts of red blood cells (anaemia), white blood cells and platelets, or blood clotting problems before starting the treatment, or if you develop them during treatment.
Slovenian: • če imate majhno število eritrocitov (anemija), levkocitov in trombocitov, če imate težave s strjevanjem krvi pred začetkom zdravljenja, ali če se takšne težave pojavijo med zdravljenjem.
English: • difficulty speaking
Slovenian: • težave z govorom,
English: In some cases, your Temozolomide Sandoz dose will be reduced or treatment stopped.
Slovenian: V nekaterih primerih bo odmerek zdravila Temozolomid Sandoz zmanjšal ali zdravljenje prekinil.
English: It is recommended to seek advice on conservation of sperm prior to treatment.
Slovenian: Priporočamo, da se pred zdravljenjem pozanimate glede možnosti shranitve sperme.
English: Take your prescribed dose of Temozolomide Sandoz once a day, preferably at the same time each day.
Slovenian: Predpisani odmerek zdravila Temozolomid Sandoz vzemite enkrat dnevno, najbolje vsak dan ob istem času.
English: Male patients
Slovenian: Moški bolniki
English: Paediatric patients had a higher AUC than adult patients; however, the maximum tolerated dose (MTD) was 1,000 mg/m2 per cycle both in children and in adults.
Slovenian: Pri otrocih je bila vrednost AUC večja kot pri odraslih, medtem ko je bil največji odmerek, ki so ga bolniki še prenašali (MTD - »maximum tolerated dose«), pri obojih 1.000 mg/m2 na cikel.
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 virusa hepatitisa B (HBV), v nekaterih primerih s smrtnim izidom.
English: Severe myelosuppression (see section 4.4).
Slovenian: Huda mielosupresija (glejte poglavje 4.4).
English: For all patients, liver function tests should be checked after each treatment cycle.
Slovenian: Teste jetrne funkcije je potrebno pri vseh bolnikih opraviti po vsakem ciklu zdravljenja.
English: Polyester/aluminium/polyethylene (PET/alu/PE) sachet.
Slovenian: Vrečica iz poliestra/aluminija/polietilena (PET/alu/PE).
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: V fazi sočasne terapije odmerjanje TMZ začasno prekinite ali stalno ukinite glede na merila hematološke in nehematološke toksičnosti, kot je navedeno v preglednici 1.
English: There is no clinical experience with use of TMZ in children under the age of 3 years.
Slovenian: Kliničnih izkušenj z uporabo TMZ pri otrocih, mlajših od 3 let, ni.
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 prid delu študije s TMZ.
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 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.
English: The presence of thrombocytopenia may increase the risk of bleeding, and the presence of neutropenia or leukopenia may increase the risk of infection.
Slovenian: Trombocitopenija lahko poveča tveganje za pojav krvavitev, nevtropenija ali levkopenija pa tveganje za okužbe.
English: Discontinue TMZ
Slovenian: Ukinite TMZ
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: 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 nitrozouree).
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: Izsledki glede časa do poslabšanja nevrološkega stanja so bili v prid TMZ v primerjavi s prokarbazinom, kar velja tudi za izsledke glede časa do poslabšanja stanja zmogljivosti bolnika po Karnofskyju (upad na KPS < 70 ali zmanjšanje za najmanj 30 točk).
English: Blood and lymphatic system disorders
Slovenian: Bolezni krvi in limfatičnega sistema
English: Endocrine disorders*
Slovenian: Bolezni endokrinega sistema*
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 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.
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients
Slovenian: FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi
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 zaplodijo otroka še šest mesecev po prejetem zadnjem odmerku in naj se pred zdravljenjem posvetujejo o možnostih shranjevanja zamrznjene sperme (glejte poglavje 4.6).
English: If ANC falls to < 1.0 x 109/l or the platelet count is < 50 x 109/l during any cycle, the next cycle should be reduced one dose level (see section 4.2).
Slovenian: Če med katerimkoli ciklom ANC pade na < 1,0 x 109/l ali število trombocitov na < 50 x 109/l, morate odmerek zdravila v naslednjem ciklu zmanjšati za eno stopnjo (glejte poglavje 4.2).
English: TMZ Dose (mg/m2/day)
Slovenian: Odmerek TMZ (mg/m2/dan)
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 za hepatitis B (vključno s tistimi z aktivno boleznijo) se je treba posvetovati s specialisti za bolezni jeter.
English: Allergic reactions, including anaphylaxis, angioedema
Slovenian: alergijske reakcije, vključno z anafilaksijo,
English: Elderly patients appear to be at increased risk of neutropenia and thrombocytopenia, compared with younger patients.
Slovenian: Videti je, da je pri starejših bolnikih tveganje za nevtropenijo ali trombocitopenijo večje kot pri mlajših.
English: TMZ is an embryotoxic, teratogenic and genotoxic alkylating agent.
Slovenian: TMZ je embriotoksična, teratogena in genotoksična alkilirajoča snov.
English: During the monotherapy phase, the dose and way you take Temozolomide Sandoz will be different.
Slovenian: Med fazo zdravljenja z enim zdravilom bosta odmerek in način odmerjanja zdravila Temozolomid Sandoz drugačna.
English: The hard capsules are dispensed in amber glass bottles (Type 3 glass) with polypropylene childresistant closures.
Slovenian: Trde kapsule so na voljo v rjavih steklenicah (steklo tipa III) z za otroke varno zaporko iz polipropilena.
English: • low potassium level in the blood
Slovenian: • nizka koncentracija kalija v krvi,
English: Table 5 includes adverse reactions reported during clinical trials for recurrent or progressive malignant glioma and following the marketing of TMZ.
Slovenian: V preglednici 5 so navedeni neželeni učinki, ki so jih prijavili v kliničnih preskušanjih pri ponavljajočem ali napredujočem malignem gliomu in po trženju TMZ.
English: Cases of diabetes insipidus have been uncommonly reported.
Slovenian: Občasno so poročali o primerih diabetesa insipidusa.
English: • followed by treatment with only Temozolomide Sandoz (monotherapy phase).
Slovenian: • nato sledi zdravljenje samo z zdravilom Temozolomid Sandoz (faza samostojnega zdravljenja).
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: Ko pa odmerek enkrat povečate, naj ostane na ravni 200 mg/m2 na dan v prvih 5 dneh vsakega naslednjega cikla, razen če nastopi toksičnost.
English: Accidental ingestion can be lethal for children.
Slovenian: Nenamerno zaužitje je lahko za otroke smrtno.
English: See package leaflet for further information.
Slovenian: Dodatne informacije so v navodilu za uporabo.
English: Relative to the AUC of TMZ, the exposure to MTIC and AIC is ~ 2.4 % and 23 %, respectively.
Slovenian: Glede na vrednost AUC za temozolomid sta izpostavljenosti MTIK-u in AIK-u ~ 2,4 % in 23 %.
English: myelodysplastic syndrome (MDS), secondary malignancies, including myeloid leukaemia
Slovenian: mielodisplastični sindrom (MDS), sekundarni malignomi, vključno z mieloidno levkemijo
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: Citotoksičnost MTIC je verjetno v prvi vrsti posledica alkiliranja gvanina na položaju O6, z dodatnim alkiliranjem na položaju N7.
English: Dose-related reductions in leukocytes and platelets appear to be sensitive indicators of toxicity.
Slovenian: Kaže, da je od odmerka odvisen upad števila levkocitov in trombocitov občutljiv kazalec toksičnosti zdravila.
English: There is limited information in patients over 3 years of age who have taken Temozolomide Sandoz.
Slovenian: Število podatkov pri bolnikih, starejših od 3 let, ki so jemali zdravilo Temozolomid Sandoz, je omejeno.
English: Patients who have experienced severe (Grade 3 or 4) vomiting in previous treatment cycles may require anti-emetic therapy.
Slovenian: Pri bolnikih, ki so močno bruhali (stopnja 3 ali 4) v prejšnjih ciklih zdravljenja je potrebno antiemetično zdravljenje.
English: Pneumocystis jirovecii pneumonia
Slovenian: Pljučnica, ki jo povzroča Pneumocystis jirovecii
English: Temozolomide Sandoz may make you feel tired or sleepy.
Slovenian: Zdravilo Temozolomid Sandoz lahko povzroči utrujenost ali zaspanost.
English: The safety and efficacy of TMZ in children under the age of 3 years have not been established.
Slovenian: Varnost in učinkovitost TMZ pri otrocih, mlajših od 3 let, nista bili dokazani.
English: • impaired balance
Slovenian: • motnje ravnotežja,
English: If you vomit after taking your dose, do not take a second dose on the same day.
Slovenian: Če ste po zaužitju odmerka bruhali, ne smete še isti dan vzeti drugega odmerka.
English: ANNEX II
Slovenian: PRILOGA I
English: TMZ + concomitant RT n=288*
Slovenian: Organski sistem TMZ + sočasna radioterapija n=288*
English: Temozolomide Sandoz should only be prescribed by physicians experienced in the oncological treatment of brain tumours.
Slovenian: Temozolomid Sandoz smejo predpisati le zdravniki, ki imajo izkušnje z zdravljenjem možganskih tumorjev.
English: If abnormal, physicians should assess the benefit/risk prior to initiating temozolomide including the potential for fatal hepatic failure.
Slovenian: Če vrednosti odstopajo od normalnih, mora zdravnik pred uvedbo temozolomida oceniti razmerje korist/tveganje, vključno z možnostjo odpovedi jeter s smrtnim izidom.