natgillin/translations-raw huggingface dataset:
Én patient har taget en overdosis på 10.000 mg (total dosis i en enkelt serie over 5 dage), og de rapporterede bivirkninger var pancytopeni, pyreksi, multiorgansvigt og dødsfald. 
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.
• hallucinationer og forringet hukommelse 
• hallucination and memory impairment
Resultaterne af Ames/Salmonellas test og kromosomaberrationstest i humane perifere blodlymfocytter (HPBL) viste en positiv mutagenicitetsrespons. 
Results of the Ames/salmonella and Human Peripheral Blood Lymphocyte (HPBL) chromosome aberration tests showed a positive mutagenicity response.
Dosistrinerne omfatter 100 mg/m2, 150 mg/m2 og 200 mg/m2. 
Dose levels include 100 mg/m2, 150 mg/m2, and 200 mg/m2.
Myelosuppression (neutropeni og trombocytopeni), som er en kendt dosisbegrænsende toksicitet for de fleste cytotoksiske stoffer, herunder TMZ, blev observeret. 
Myelosuppression (neutropenia and thrombocytopenia), which is known dose-limiting toxicity for most cytotoxic agents, including TMZ, was observed.
Indgift af TMZ bør afbrydes midlertidigt eller seponeres permanent under den konkomitante fase i henhold til de hæmatologiske og ikke-hæmatologiske toksicitetskriterier som angivet i Tabel 1. 
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.
Patienter, der er blevet behandlet med TMZ, kan opleve myelosuppression, herunder vedvarende pancytopeni, hvilket kan resultere i aplastisk anæmi, som i visse tilfælde har haft dødeligt udfald. 
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.
Hepatitisreaktivering på grund af hepatitis B-virus (HBV), der i visse tilfælde er resulteret i dødsfald, er blevet rapporteret. 
Hepatitis due to hepatitis B virus (HBV) reactivation, in some cases resulting in death, has been reported.
Når du tager Temozolomide Sandoz, kan du føle dig træt eller søvnig. 
Temozolomide Sandoz may make you feel tired or sleepy.
Svær myelosuppression (se pkt. 
Severe myelosuppression (see section 4.4).
Der er ingen klinisk erfaring med anvendelse af TMZ til børn under 3 år. 
There is no clinical experience with use of TMZ in children under the age of 3 years.
I et observationsmateriale fra farmakokinetisk analyse af kliniske forsøg var erfaringen, at der var 101 kvindelige og 169 mandlige forsøgspersoner, for hvem nadir neutrofiltallet forelå, og 110 kvindelige og 174 mandlige forsøgspersoner, for hvem nadir blodpladetallet forelå. 
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.
monoterapi Dosisniveau TMZ Dosis (mg/m2/dag) 
TMZ Dose (mg/m2/day)
Mandlig fertilitet 
Male fertility
• ændring i hudfarve 
• change in skin colour
Patienter, der får temozolomid i kombination med strålebehandling, kan opleve andre bivirkninger end patienter, der kun får temozolomid. 
Patients receiving temozolomide in combination with radiotherapy may experience different side effects than patients taking temozolomide alone.
Hazard rate (HR) for den totale overlevelse var 1,59 (95 % CI for HR=1,33-1,91) med en log-rank p < 0,0001 til fordel for TMZ-gruppen. 
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.
A. FREMSTILLERE ANSVARLIGE FOR BATCHFRIGIVELSE 
A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
TMZ blev administreret som salvage-behandling i opfølgningsfasen hos 161 patienter af 282 (57 %) i armen med kun strålebehandling, og 62 patienter af 277 (22 %) i armen med TMZ + strålebehandling. 
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.
Behandling med Temozolomide Sandoz kan give et fald i antallet af visse typer blodceller. 
Temozolomide Sandoz treatment can cause a reduction in certain kinds of blood cells.
• lavt kaliumindhold i blodet 
• low potassium level in the blood
Der er set meget sjældne tilfælde af alvorligt udslæt med hævelser i huden, som omfatter håndfladerne og fodsålerne, eller smertefuld rødmen af huden og/eller blærer på kroppen eller i munden. 
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.
Herpes simplex, herpes zoster, influenzalignende symptomer 
Herpes simplex, herpes zoster, influenza-like symptoms
Endokrine lidelser* 
Endocrine disorders*
Nye eller reaktiverede (recidiverende) cytomegalovirus-infektioner og reaktiverede hepatitis Bvirusinfektioner er blevet rapporteret som værende ualmindelige. 
New or reactivated (recurring) cytomegalovirus infections and reactivated hepatitis B virus infections have been uncommonly reported.
Det anbefales ikke at foretage dosisreduktioner, men udskydelse eller seponering af TMZ-indgift bør overvejes hver uge i henhold til hæmatologiske og ikkehæmatologiske toksicitetskriterier. 
No dose reductions are recommended, but delay or discontinuation of TMZ administration should be decided weekly according to haematological and non-haematological toxicity criteria.
Patienter, som fik konkomitant TMZ og strålebehandling i et pilotforsøg af det længerevarende 42 dages-program, viste sig at have særlig risiko for at udvikle Pneumocystis jirovecii pneumonia (PCP). 
Patients who received concomitant TMZ and RT in a pilot trial for the prolonged 42-day schedule were shown to be at particular risk for developing Pneumocystis jirovecii pneumonia (PCP).
Dosis bør reduceres eller indgiften seponeres i henhold til Tabel 3. 
The dose should be reduced or administration discontinued according to Table 3.
Erythema multiforme, erythroderma, urticaria, exantem 
Erythema multiforme, erythroderma, urticaria, exanthema
I alt 573 patienter blev randomiseret til at få enten TMZ + strålebehandling (n=287) eller kun strålebehandling (n=286). 
A total of 573 patients were randomised to receive either TMZ + RT (n=287) or RT alone (n=286).
Hver karton indeholder 5 eller 20 hårde kapsler. 
Each carton contains 5 or 20 hard capsules.
Baseret på TMZ's farmakokinetiske egenskaber er det usandsynligt, at dosisreduktion er påkrævet hos patienter med svær leverinsufficiens eller en hvilken som helst grad af nyreinsufficiens. 
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.
Alle hårde kapsler (kapslerne) er pakket enkeltvist i breve. 
Each hard capsule (capsule) is individually packed in a sachet.
Under monoterapi-fasen vil dosis og måden, du tager Temozolomide Sandoz på, være anderledes. 
During the monotherapy phase, the dose and way you take Temozolomide Sandoz will be different.
Derfor bør der udvises særlig forsigtighed, når TMZ gives til ældre patienter. 
Therefore, special care should be taken when TMZ is administered in elderly patients.
Den første dosis vil være på 150 mg/m2. 
The first dose will be 150 mg/m2.
Der bør imidlertid udvises forsigtighed, når TMZ gives til disse patienter. 
However, caution should be exercised when TMZ is administered in these patients.
De hårde kapsler leveres i brune glasflasker (Type III-glas) med børnesikret polypropylen-låg. 
The hard capsules are dispensed in amber glass bottles (Type 3 glass) with polypropylene childresistant closures.
Patienter bør rådes til at opbevare kapslerne utilgængeligt og ude af syne for børn, helst i et aflåst skab. 
Patients should be advised to keep capsules out of the sight and reach of children, preferably in a locked cupboard.
Lægen har ordineret dette lægemiddel dig personligt. 
- This medicine has been prescribed for you only.
Temozolomide Sandoz bør kun ordineres af læger, der har erfaring med onkologisk behandling af hjernetumorer. 
Temozolomide Sandoz should only be prescribed by physicians experienced in the oncological treatment of brain tumours.
• ukontrolleret blødning 
• uncontrolled bleeding,
Tag altid Temozolomide Sandoz nøjagtigt efter lægens anvisning. 
Always take Temozolomide Sandoz exactly as your doctor has told you.
Den ene var et non-komparativt forsøg hos 138 patienter (29 % fik tidligere kemoterapi), og den anden var et randomiseret aktiv-kontrolleret forsøg med TMZ versus procarbazin hos i alt 225 patienter (67 % fik tidligere behandling med nitrosurea baseret kemoterapi). 
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).
I visse tilfælde vil din dosis af Temozolomide Sandoz blive nedsat, eller din behandling vil blive stoppet. 
In some cases, your Temozolomide Sandoz dose will be reduced or treatment stopped.
Hvis du ofte kaster op før eller under behandlingen, så spørg din læge om, hvornår du helst skal tage Temozolomide Sandoz, indtil opkastningen er under kontrol. 
If you vomit frequently before or during treatment, ask your doctor about the best time to take Temozolomide Sandoz until the vomiting is under control.
Hvis du ved en fejl tager flere kapsler med Temozolomide Sandoz end foreskrevet, skal du straks kontakte din læge, apotekspersonalet eller sundhedspersonalet. 
If you accidentally take more Temozolomide Sandoz capsules than you were told to, contact your doctor, pharmacist or nurse immediately.
En fuldstændig blodtælling skal foretages på dag 22 (21 dage efter den første dosis) eller inden for 48 timer herefter, og ugentligt indtil ANC > 1,5 x 109/l og trombocyttallet > 100 x 109/l. 
A complete blood count should be obtained on Day 22 (21 days after the first dose) or within 48 hours of that day, and weekly until ANC > 1.5 x 109/l and platelet count > 100 x 109/l.
Der er rapporteret tilfælde af sepsis (blodforgiftning - når bakterier og deres toksiner (giftstoffer) er kommet ind i blodet og begynder at skade kroppens organer) med hyppigheden ”ikke almindelig”. 
Cases of sepsis (when bacteria and their toxins circulate in the blood and start to damage the organs) have been uncommonly reported.
• forvirring 
• confusion
Laboratorieresultater 
Laboratory results
CTC Grad 3 
CTC Grade 3
Opportunistiske infektioner (såsom Pneumocystis jirovecii-pneumonia) og reaktivering af infektioner (såsom HBV, CMV) er blevet observeret under behandling med TMZ (se afsnit 4.8). 
Opportunistic infections and reactivation of infections 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).
Du vil eventuelt få ordineret anden medicin (kvalmestillende), der skal tages før og/eller efter, at du har taget Temozolomide Sandoz for at undgå eller regulere kvalme og opkastning. 
You may be given other medicines (anti-emetics) to take before and/or after taking Temozolomide Sandoz to prevent or control nausea and vomiting.
I et separat fase I-studie resulterede indtagelse af TMZ sammen med ranitidin ikke i ændringer i absorptionsgraden af temozolomid eller eksponeringen over for dets aktive metabolit monomethyltriazenoimidazolcarboxamid (MTIC). 
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).
• delvis lammelse 
• partial paralysis
Hvert brev indeholder 1 hård kapsel. 
Each sachet contains 1 hard capsule.
Kvalme og opkastning er meget almindeligt i forbindelse med TMZ. 
Nausea and vomiting are very commonly associated with TMZ.
EVENTUELLE ANDRE SÆRLIGE ADVARSLER Cytotoksisk . 
OTHER SPECIAL WARNING, IF NECESSARY Cytotoxic
MTIC hydrolyseres spontant til 5-amino-imidazol-4-carboxamid (AIC), et kendt mellemprodukt i purin- og nucleinsyrebiosyntesen, og til methylhydrazin, som menes at være det aktive alkyleringsmiddel. 
MTIC is spontaneously hydrolyzed to 5-amino-imidazole-4-carboxamide (AIC), a known intermediate in purine and nucleic acid biosynthesis, and to methylhydrazine, which is believed to be the active alkylating species.
Temozolomide Sandoz indeholder lactose (en form for sukker). 
Temozolomide Sandoz contains lactose (a kind of sugar).
Den mediane overlevelse var 7,34 og 5,66 måneder for henholdsvis TMZ og procarbazin (log rank p = 0,33). 
The median survival was 7.34 and 5.66 months for TMZ and procarbazine, respectively (log rank p = 0.33).
Allergiske reaktioner, herunder anafylaksi, angioødem 
Allergic reactions, including anaphylaxis, angioedema
Læger og sundhedspersonale anmodes om at indberette alle formodede bivirkninger via det nationale rapporteringssystem anført i Appendiks V*. 
Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Myelodysplastisk syndrom (MDS), sekundære maligne lidelser, inklusive myeloid leukæmi 
myelodysplastic syndrome (MDS), secondary malignancies, including myeloid leukaemia
• allergiske reaktioner 
• allergic reaction
Ved analyse af populationsbaseret farmakokinetik for TMZ blev det fundet, at plasmaclearance af TMZ var uafhængig af alder, nyrefunktion og tobaksforbrug. 
Analysis of population-based pharmacokinetics of TMZ revealed that plasma TMZ clearance was independent of age, renal function or tobacco use.
Mandlige patienter 
Male patients
Forebyggende behandling mod PCP er derfor påkrævet for alle patienter, der får konkomitant TMZ og strålebehandling i 42 dages regimen (med højst 49 dage) uafhængigt af lymfocyttal. 
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.
• forkølelse eller influenza 
• a cold or the flu
• udeblivende eller kraftige menstruationer 
• absent or heavy menstrual periods,
Hvis disse er unormale, bør lægen vurdere fordel/risiko-forholdet før initiering af temozolid-behandling herunder risikoen for letalt leversvigt. 
If abnormal, physicians should assess the benefit/risk prior to initiating temozolomide including the potential for fatal hepatic failure.
Kvinder i den fertile alder skal anbefales at anvende sikker kontraception for at undgå graviditet under behandling med TMZ. 
Women of childbearing potential should be advised to use effective contraception to avoid pregnancy while they are receiving TMZ.
TMZ + konkomitant strålebehandling n=288* 
TMZ + concomitant RT n=288*
Meget sjældent kan patienter, som tager Temozolomide Sandoz eller lignende medicin, have en lille risiko for at udvikle en sekundær kræftform, herunder leukæmi. 
In very rare cases, patients taking temozolomide and medicines like it may have a small risk of developing secondary cancers, including leukaemia.
Reduktion på grund af tidligere toksicitet Dosis under serie 1 
Reduction for prior toxicity Dose during Cycle 1
På basis af en analyse af populationsfarmakokinetik i fase II-forsøg, ændrede samtidig administration af dexamethason, prochlorperazin, phenytoin, carbamazepin, ondansetron, H2-receptorantagonister eller phenobarbital ikke clearance af TMZ. 
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.
Temozolomide Sandoz anvendes til behandling af specifikke former for hjernesvulster: 
Temozolomide Sandoz is used for the treatment of specific forms of brain tumours:
Du vil regelmæssigt få undersøgt dit blod under behandlingen for at følge bivirkningerne af Temozolomide Sandoz på dine blodceller. 
Your blood will be tested frequently during treatment to monitor the side effects of Temozolomide Sandoz on your blood cells.
Toksicitet 
Toxicity
I prækliniske forsøg udført på rotter og kaniner med doser på 150 mg/m2 TMZ blev teratogenicitet og/eller føtal toksicitet påvist (se pkt. 
In preclinical studies in rats and rabbits receiving 150 mg/m2 TMZ, teratogenicity and/or foetal toxicity were demonstrated (see section 5.3).
Der er ingen tilgængelige data vedrørende indgift af TMZ til patienter med svær leverinsufficiens (Child's Class C) eller med nedsat nyrefunktion. 
No data are available on the administration of TMZ in patients with severe hepatic impairment (Child's Class C) or with renal impairment.
I nogle tilfælde vanskeliggøres vurderingen af samtidig eksponering for lægemidler, der er associeret med aplastisk anæmi, herunder carbamazepin, phenytoin og sulfamethoxazol/trimethoprim. 
In some cases, exposure to concomitant medicinal products associated with aplastic anaemia, including carbamazepine, phenytoin, and sulfamethoxazole/trimethoprim, complicates assessment.
Tilfælde af dødeligt åndedrætssvigt er set hos patienter, som fik TMZ, især i kombination med dexamethason eller andre steroider. 
Cases of fatal respiratory failure have been reported in patients using TMZ, in particular in combination with dexamethasone or other steroids.
• vaginal irritation 
• vaginal irriation
• øget lysfølsomhed i huden 
• increased skin sensitivity to sunlight
Det anbefales at søge råd med hensyn til nedfrysning af sædvæske før behandling. 
It is recommended to seek advice on conservation of sperm prior to treatment.
Indlægsseddel: Information til brugeren Temozolomide Sandoz 5 mg hårde kapsler Temozolomide Sandoz 20 mg hårde kapsler Temozolomide Sandoz 100 mg hårde kapsler Temozolomide Sandoz 140 mg hårde kapsler Temozolomide Sandoz 180 mg hårde kapsler Temozolomide Sandoz 250 mg hårde kapsler temozolomid 
Package leaflet: information for the user Temozolomide Sandoz 5 mg hard capsules Temozolomide Sandoz 20 mg hard capsules Temozolomide Sandoz 100 mg hard capsules Temozolomide Sandoz 140 mg hard capsules Temozolomide Sandoz 180 mg hard capsules Temozolomide Sandoz 250 mg hard capsules temozolomide
Symptomer på diabetes insipidus omfatter hyppige vandladninger og tørstighed. 
Symptoms of diabetes insipidus include passing a lot of urine and feeling thirsty.
Efter peroral administration af 14C-mærket TMZ var den gennemsnitlige fækale udskillelse af 14C over 7 dage post dosis 0,8 %, hvilket tyder på fuldstændig absorption. 
After oral administration of 14C-labelled TMZ, mean faecal excretion of 14C over 7 days post-dose was 0.8 % indicating complete absorption.
Pancytopeni, anæmi (grad 3-4), leukopeni 
Pancytopenia, anaemia (grade 3-4), leukopenia
Fortæl det altid til lægen eller apotekpersonalet, hvis du bruger anden medicin eller har gjort det for nylig. 
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Antiemetisk behandling kan anvendes (se pkt. 
Anti-emetic therapy may be administered (see section 4.4).
Dette medførte hospitalisering og/eller seponering af TMZ hos henholdsvis 8 % and 4 % af patienter med gliom. 
This led to hospitalisation and/or discontinuation of TMZ in 8 % and 4 %, respectively.
• hvis antallet af visse former for blodceller er svært nedsat (myelosuppression), såsom antallet af hvide blodlegemer og antallet af blodplader. 
• if certain kinds of blood cells are severely reduced (myelosuppression), such as your white blood cell count and platelet count.
I det randomiserede, aktiv-kontrollerede forsøg var PFS efter 6 måneder signifikant større for TMZ end for procarbazin (henholdsvis 21 % versus 8 % - chi-square p = 0,008) med median PFS på henholdsvis 2,89 og 1,88 måneder (log rank p = 0,33). 
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).
Cytomegalovirusinfektion, infektionsreaktivering såsom cytomegalovirus, hepatitis B-virus†, meningoencephalitis herpetica†, sepsis† 
cytomegalovirus infection, infection reactivation such as cytomegalovirus, hepatitis B virus†, meningoencephalitis herpetic†, sepsis†
Efter 6 måneder var andelen af overlevende patienter signifikant større i TMZ-gruppen (60 %) sammenlignet med procarbazingruppen (44 %) (chi-square p = 0,019). 
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).
Disse bivirkninger var oftest grad 1 eller 2, (0 - 5 opkastninger inden for 24 timer) og ophørte af sig selv eller kunne let kontrolleres med kvalmestillende standard-behandling. 
These reactions were usually Grade 1 or 2 (0 - 5 episodes of vomiting in 24 hours) and were either self-limiting or readily controlled with standard anti-emetic therapy.
Neutropeni eller lymfopeni (grad 3-4), trombocytopeni (grad 3-4) 
Neutropenia or lymphopenia (grade 3-4), thrombocytopenia (grade 3-4)
• en kraftig allergisk (overfølsomheds)reaktion (kløende udslæt, hvæsende vejrtrækning eller anden form for åndedrætsbesvær 
• a severe allergic (hypersensitive) reaction (hives, wheezing or other breathing difficulty),
• ringen for ørerne 
• ringing in the ears
Før hver ny behandlingscyklus vil dit blod blive undersøgt for, om dosen af Temozolomide Sandoz skal justeres. 
Before each new treatment cycle, your blood will be tested to see if the Temozolomide dose needs to be adjusted.
• diarré 
• diarrhoea
Tilfælde af hjerneinfektioner forårsaget af herpesvirus (meningoencephalitis herpetica), herunder tilfælde med dødelig udgang, er indberettet som ikke almindelige. 
Cases of brain infections caused by herpes virus (meningoencephalitis herpetic), including fatal cases, have been uncommonly reported.
Metabolisme og ernæring Meget almindelig 
Metabolism and nutrition disorders Very common:
Trombocytopeni og neutropeni af Grad 3 eller 4 forekom hos henholdsvis 19 % og 17 % af de patienter, som blev behandlet for malignt gliom. 
Grade 3 or 4 thrombocytopenia and neutropenia occurred in 19 % and 17 % respectively, of patients treated for malignant glioma.
TMZ hydrolyseres spontant ved fysiologisk pH primært til det aktive stof, 3-methyl-(triazen-1yl)imidazol-4-carboxamid (MTIC). 
TMZ is spontaneously hydrolyzed at physiologic pH primarily to the active species, 3-methyl-(triazen-1-yl)imidazole-4-carboxamide (MTIC).
• koncentrationsbesvær 
• difficulty concentrating
Patienter med tilbagevendende eller forværrede svulster (malignt gliom såsom glioblastoma multiform eller anaplastisk astrocytoma) som kun tager Temozolomide Sandoz: 
Patients with tumours that have returned or worsened (malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma) taking Temozolomide Sandoz only
Medianen for tiden til progression for disse endpoints varierede fra at være 0,7 til 2,1 måneder længere for TMZ end for procarbazin (log rank p = < 0,01 til 
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).
Supplement med konkomitant TMZ til strålebehandling, efterfulgt af TMZ monoterapi i behandlingen af patienter med nydiagnosticeret glioblastoma multiforme viste en statistisk signifikant forbedret total overlevelse sammenlignet med kun strålebehandling (Figur 1). 
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).
Dosen af Temozolomide Sandoz kan blive justeret, udskudt eller afbrudt afhængig af dit blodtal, og hvordan du tåler din medicin under hver behandlingscyklus. 
The Temozolomide Sandoz dose may be adjusted, delayed or stopped depending on your blood counts and how you tolerate your medicine during each treatment cycle.