natgillin/translations-raw huggingface dataset:
What Temozolomide SUN is and what it is used for
Što je Temozolomid SUN i za što se koristi
TMZ dose (mg/m2/day)
Doza TMZ-a (mg/m2/dan)
If you vomit frequently before or during treatment, ask your doctor about the best time to take Temozolomide SUN until the vomiting is under control.
Ako često povraćate prije ili za vrijeme liječenja, upitajte svog liječnika u koje je vrijeme najbolje uzimati Temozolomid SUN dok povraćanje ne bude pod kontrolom.
- if you develop fever or symptoms of an infection contact your doctor immediately.
- ako dobijete vrućicu ili simptome infekcije, odmah se javite svom liječniku.
common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); Rare (≥1/10,000 to <1/1,000); Very rare (<1/10,000).
< 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000), vrlo rijetko (<1/10 000).
† Including cases with fatal outcome * Frequencies estimated based on relevant clinical trials.
† uključujući slučajeve sa smrtnim ishodom * učestalost procijenjena na temelju relevantnih kliničkih ispitivanja.
Talk to your doctor, pharmacist or nurse before taking Temozolomide SUN,
Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego uzmete Temozolomid SUN,
This is because you must not be treated with Temozolomide SUN during pregnancy unless clearly indicated by your doctor.
To je zbog toga što se ne smijete liječiti Temozolomid SUN-om tijekom trudnoće, osim ako ga Vaš liječnik nije izričito propisao.
If Temozolomide SUN comes into contact with skin or mucosa, it should be washed immediately and thoroughly with soap and water.
Ako Temozolomid SUN dođe u kontakt s kožom ili sluznicom, to područje treba odmah temeljito isprati sapunom i vodom.
Temozolomide SUN treatment can cause a reduction in certain kinds of blood cells.
Liječenje Temozolomid SUN-om može izazvati smanjenje broja nekih vrsta krvnih stanica.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON (BLISTER)
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA (BLISTER)
02-954 Warszawa Polska
Kubickiego 11 02-954 Warszawa
Always take Temozolomide SUN exactly as your doctor has told you.
Uvijek uzmite Temozolomid SUN točno onako kako Vam je rekao liječnik.
A treatment cycle with Temozolomide SUN lasts 28 days.
Ciklus liječenja Temozolomid SUN-om traje 28 dana.
Other medicines and Temozolomide SUN
Drugi lijekovi i Temozolomid SUN
You may be given other medicines (anti-emetics) to take before and/or after taking Temozolomide SUN to prevent or control nausea and vomiting.
Liječnik Vam može dati i neke druge lijekove (antiemetike) koje ćete uzimati prije i/ili nakon što uzmete Temozolomid SUN radi izbjegavanja ili kontrole mučnine i povraćanja.
This is because Temozolomide SUN could cause hepatitis B to become active again, which can be fatal in some cases.
Ovo je zato što Temozolomid SUN može uzrokovati ponovnu aktivaciju hepatitisa B, što u nekim slučajevima može imati smrtni ishod.
- if you have nausea (feeling sick) and/or vomiting which are very common side effects of Temozolomide SUN (see section 4), your doctor may prescribe you a medicine (an anti-emetic) to help prevent vomiting.
- ako imate mučninu i/ili povraćanje što su vrlo česte nuspojave Temozolomid SUN-a (pogledajte dio 4) liječnik Vam može propisati lijek koji sprečava povraćanje (antiemetik).
In clinical trials, the most frequently occurring treatment-related undesirable effects were gastrointestinal disorders, specifically nausea (43 %) and vomiting (36 %).
U kliničkim su ispitivanjima najčešće nuspojave povezane s liječenjem bile poremećaji probavnog sustava, preciznije mučnina (43%) i povraćanje (36%).
In very rare cases, patients taking Temozolomide SUN and medicines like it may have a small risk of developing secondary cancers, including leukaemia.
U vrlo rijetkim slučajevima, bolesnici koji uzimaju Temozolomid SUN i slične lijekove mogu imati malen rizik od razvoja sekundarnih vrsta raka, uključujući leukemiju.
You will take this dose every day for 42 to 49 days in combination with radiotherapy.
Tu ćete dozu uzimati svakodnevno tijekom 42 dana (najdulje 49 dana) u kombinaciji sa zračenjem.
Temozolomide SUN is used in these tumours if they return or get worse after standard treatment.
U ovom slučaju Temozolomid SUN se koristi ako se tumor ponovno pojavio ili se pogoršava nakon standardne terapije.
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.
Većina hematoloških nuspojava prijavljena je često ili vrlo često u obje indikacije (Tablice 4 i 5); iza svake tablice navedena je učestalost poremećaja laboratorijskih nalaza stupnja 3-4.
What Temozolomide SUN looks like and contents of the pack
Kako Temozolomid SUN izgleda i sadržaj pakiranja
Temozolomide SUN should not be administered to pregnant women.
Temozolomid SUN se ne smije davati trudnicama.
Pharmacotherapeutic group: Antineoplastic agents, other alkylating agents, ATC code: L01A X03.
Farmakoterapijska skupina: Antineoplastici, ostali alkilirajući pripravci, ATK oznaka: L01A X03.
You may have to take different strengths to make up the dose.
Možda ćete morati uzimati kapsule različitih jačina kako bi dobili odgovarajuću dozu.
If you take more Temozolomide SUN than you should
Ako uzmete više Temozolomid SUN kapsula nego što ste trebali
Contents of the pack and other information What Temozolomide SUN contains
Sadržaj pakiranja i druge informacije Što Temozolomid SUN sadrži
Myelosuppression was predictable (usually within the first few cycles, with the nadir between Day 21 and Day 28), and recovery was rapid, usually within 1-2 weeks.
Mijelosupresija se mogla predvidjeti (obično se javljala u prvih nekoliko ciklusa liječenja, a bila je najizraženija između 21. i 28. dana), a oporavak je bio brz, obično u roku od
Before each new treatment cycle, your blood will be tested to see if the Temozolomide SUN dose needs to be adjusted.
Prije svakog novog terapijskog ciklusa napravit će Vam se krvne pretrage kako bi se utvrdilo treba li prilagoditi dozu Temozolomid SUN-a.
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-4carboxamide (AIC) or unidentified polar metabolites.
Nakon peroralne primjene se približno 5 do 10% doze nalazi u mokraći u nepromijenjenom obliku tijekom 24 sata, dok se ostatak izlučuje u obliku temozolomidske kiseline, 5-aminoimidazol-4-karboksamida ili neidentificiranih polarnih metabolita.
drug reaction with eosinophilia and systemic symptoms (DRESS)
reakcija na lijek s eozinofilijom i sistemskim simptomima (DRESS)
- if the numbers of certain kinds of blood cells, such as your white blood cells or platelets are severely reduced (known as myelosuppression).
- ako imate jako smanjen broj određenih vrsta krvnih stanica, primjerice bijelih krvnih stanica ili krvnih pločica (poznato kao mijelosupresija).
In some cases, it may be necessary to stop treatment with Temozolomide SUN. - as you may have a small risk of other changes in blood cells, including leukaemia.
U nekim će slučajevima možda biti neophodno prekinuti liječenje Temozolomid SUN-om. jer može postojati malen rizik od razvoja drugih promjena krvnih stanica, uključujući leukemiju.
Rare (may affect up to 1 in 1,000 people): cough, infections including pneumonia.
Rijetke (mogu se javiti u do 1 na 1000 osoba): kašalj, infekcije uključujući upalu pluća.
The hard capsules are available in blister packs containing 5 capsules.
Tvrde kapsule su dostupne u blister pakovanjima koja sadrže 5 kapsula.
The marking on the capsule is different for each strength (see table below).
Svaka jačina ima drugu oznaku otisnutu na kapsuli (vidjeti tablicu u nastavku).
Ranbaxy UK Ltd a Sun Pharma Company Millington Road 11
United Kingdom Ranbaxy UK Ltd a Sun Pharma Company
If you have been newly-diagnosed with glioblastoma multiforme you may be receiving Temozolomide SUN for 42 days in combination with radiotherapy.
Ako ste bolesnik s novodijagnosticiranim multiformnim glioblastomom, uzimat ćete Temozolomid SUN u kombinaciji sa zračenjem tijekom 42 dana.
For the 20 capsules packs, 4 blisters of 5 capsules will be included in a carton.
Za pakovanja od 20 kapsula, u kutiji će biti sadržana 4 blistera s 5 kapsula.
Signs of allergic reaction include itchiness, breathlessness or wheezing, or swelling of the face, lips, tongue or throat.
Znakovi alergijske reakcije obuhvaćaju svrbež, nedostatak daha ili piskanje pri disanju ili oticanje lica, usana, jezika ili grla.
Patients receiving Temozolomide SUN in combination with radiotherapy may experience different side effects from patients taking Temozolomide SUN alone.
Bolesnici koji uzimaju Temozolomid SUN u kombinaciji sa zračenjem mogu imati drugačije nuspojave od bolesnika koji uzimaju samo Temozolomid SUN.
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.
Vrlo rijetko su zabilježeni slučajevi ozbiljnog osipa s oticanjem kože, uključujući dlanove i tabane, ili bolno crvenilo kože i/ili mjehurići po tijelu ili u ustima.
Frequency groupings are defined according to the following convention: very common (≥ 1/10);
Učestalost pojavljivanja razvrstana je prema sljedećoj konvenciji: vrlo često (≥ 1/10), često ≥1 /100 i
If you accidentally take more Temozolomide SUN capsules than you were told to, contact your doctor, pharmacist or nurse immediately.
Ako uzmete više Temozolomid SUN kapsula nego što ste trebali, odmah se javite liječniku, ljekarniku ili medicinskoj sestri.
Take your prescribed dose of Temozolomide SUN once a day, preferably at the same time each day.
Uzmite propisanu dozu Temozolomid SUN-a jedanput na dan, po mogućnosti svakoga dana u isto vrijeme.
- 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.
ako imate smanjen broj crvenih krvnih stanica (anemiju), bijelih krvnih stanica i trombocita ili problema sa zgrušavanjem krvi prije početka liječenja, ili se ti poremećaji razviju tijekom liječenja.
If you forget to take Temozolomide SUN
Ako ste zaboravili uzeti Temozolomid SUN
The Temozolomide SUN dose may be delayed or stopped, depending on your blood counts and how you tolerate your medicine during the concomitant phase.
Uzimanje Temozolomid SUN-a može se odgoditi ili prekinuti ovisno o broju Vaših krvnih stanica i o tome kako podnosite lijek tijekom faze istodobnog liječenja.
OTHER SPECIAL WARNING(S), IF NECESSARY
DRUGO(A) POSEBNO(A) UPOZORENJE(A), AKO JE POTREBNO Citotoksično.
Patients with tumours that have returned or worsened (malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma) taking Temozolomide SUN only
Bolesnici s tumorom koji se ponovno pojavio ili pogoršao (malignim gliomom, poput multiformnog glioblastoma ili anaplastičnog astrocitoma) koji uzimaju samo Temozolomid SUN:
You should stop breast-feeding while receiving treatment with Temozolomide SUN.
Morate prekinuti dojenje dok se liječite Temozolomid SUN-om.
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).
Muškarcima koji se liječe TMZ-om treba savjetovati da ne začinju dijete do 6 mjeseci nakon primanja posljednje doze lijeka te da se prije početka liječenja posavjetuju oko kriokonzerviranja sperme zamrzavanjem (vidjeti dio 4.6).
Pack size: blisters are packed in cartons containing 5 or 20 hard capsules.
Veličina pakovanja: blisteri su dostupni u kutijama koje sadrže 5 ili 20 tvrdih kapsula.
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, multiorgan failure and death.
10 000 mg (ukupna doza tijekom 5 dana u jednom ciklusu), a prijavljene nuspojave bile su pancitopenija, pireksija, višeorgansko zatajenje i smrt.
During the concomitant phase, your doctor will start Temozolomide SUN at a dose of 75 mg/m2 (usual dose).
U fazi istodobnog liječenja liječnik će započeti primjenu Temozolomid SUN-a u dozi od 75 mg/m2 (uobičajena doza).
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).
U zasebnom ispitivanju faze I primjena TMZ-a s ranitidinom nije izazvala promjene u opsegu apsorpcije temozolomida niti u izloženosti njegovu aktivnom metabolitu monometil-triazenoimidazol karboksamidu (MTIC).
Contact your doctor immediately if you have any of the following: - a severe allergic (hypersensitive) reaction (hives, wheezing or other breathing difficulty) - uncontrolled bleeding - seizures (convulsions) - fever - chills - severe headache that does not go away.
Odmah se obratite liječniku ako imate neki od sljedećih simptoma: - jaku alergijsku reakciju (reakciju preosjetljivosti) (koprivnjača, piskanje pri disanju ili druge tegobe s disanjem), - nekontrolirano krvarenje, - napadaje (konvulzije),
You will again receive Temozolomide SUN once daily for 5 days, followed by 23 days without Temozolomide SUN.
Ponovno ćete uzimati Temozolomid SUN jedanput na dan tijekom 5 dana, nakon čega slijede 23 dana bez Temozolomid SUN-a.
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).
U randomiziranom ispitivanju s aktivnom kontrolom je PFS nakon 6 mjeseci bio značajno veći u skupini koja je primala TMZ nego u skupini koja je primala prokarbazin (21% naspram 8%; hi-kvadrat p = 0,008), uz medijan PFS-a od 2,89 mjeseci u prvoj odnosno 1,88 mjeseci u drugoj skupini (log rang p = 0,0063).
Aluminium/aluminium unit dose blisters, consisting of an OPA [Oriented Poly Amide] / Aluminium / PVC [Polyvinyl chloride] forming film and peelable Aluminium lidding foil with heat seal laquer.
Aluminij/aluminij blisterima djeljivima na jedinične doze, koji se sastoje od OPA [orijentirani poliamida] / aluminij / PVC [polivinil klorid] filma i toplinski zalijepljene odvojive aluminijske zaštitne folije.
- if you have liver or kidney problems, your dose of Temozolomide SUN may need to be adjusted.
- ako imate problema s jetrom ili bubrezima, možda će biti potrebno prilagoditi dozu Temozolomid SUN-a.
Stearic acid
tartaratna kiselina stearatna kiselina
Tell your doctor immediately if this occurs.
Dogodi li se to, odmah obavijestite liječnika.
Temozolomide SUN contains lactose
Temozolomid SUN sadrži laktozu
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.
MTIC se spontano hidrolizira u 5-amino-imidazol-4karboksamid (AIC), poznati međuspoj u biosintezi purina i nukleinskih kiselina te u metilhidrazin, za koji se vjeruje da je aktivan alkilirajući spoj.
In some cases, your Temozolomide SUN dose will be reduced or treatment stopped.
U nekim će slučajevima smanjiti dozu Temozolomid SUN-a ili prekinuti liječenje ovim lijekom.
- if you have had an allergic reaction to dacarbazine (an anticancer medicine sometimes called DTIC).
- ako ste imali alergijsku reakciju na dakarbazin (antitumorski lijek).
The estimated probability of surviving 2 years or more (26 % vs 10 %) is higher for the RT + TMZ arm.
Procijenjena vjerojatnost preživljenja od 2 godine ili dulje veća je za skupinu koja je primala RT + TMZ (26%
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.
Stoga, muškarcima koji se liječe ovim lijekom treba savjetovati da ne začinju dijete do 6 mjeseci nakon primanja posljednje doze lijeka te da se prije početka liječenja posavjetuju oko kriokonzerviranja sperme zamrzavanjem, jer postoji mogućnost da terapija TMZ-om dovede do trajne neplodnosti.
If you are a newly-diagnosed patient, treatment will occur in two phases: - treatment together with radiotherapy (concomitant phase) first - followed by treatment with Temozolomide SUN only (monotherapy phase).
Ako ste novodijagnosticirani bolesnik, liječenje će se odvijati u dvije faze: - prvo liječenje zajedno sa zračenjem (faza istodobnog liječenja) - zatim liječenje samo Temozolomid SUN-om (faza monoterapije).
Herpes simplex, herpes zoster, influenza-like symptoms
Herpes simplex, herpes zoster,
cytomegalovirus infection, infection reactivation such as cytomegalovirus, hepatitis B virus†, meningoencephalitis herpetic†, sepsis†
infekcija citomegalovirusom, reaktivacija infekcija poput infekcije citomegalovirusom, virusom hepatitisa B†, herpesni meningoencefalitis†, sepsa†
You will take your new dose of Temozolomide SUN once daily for the first 5 days (“dosing days”) of each cycle.
Uzimat ćete novu dozu Temozolomid SUN-a jedanput na dan prvih 5 dana svakog ciklusa ("dani doziranja").
Temozolomide SUN is used for the treatment of specific forms of brain tumours: - in adults with newly-diagnosed glioblastoma multiforme.
Temozolomid SUN se koristi za liječenje određenih vrsta tumora mozga: - u odraslih bolesnika s novodijagnosticiranim multiformnim glioblastomom.
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.
(0-5 epizoda povraćanja u 24 sata) i prestale bi same od sebe ili su se mogle lako kontrolirati standardnim antiemeticima.
- absolute neutrophil count (ANC) ≥ 1.5 x 109/l
- apsolutni broj neutrofila (ABN) ≥ 1,5 x 109/l
Terapia S.A. Str. Fabricii nr 124
Fabricii nr 124
You will take Temozolomide SUN only once daily for the first 5 days.
Uzimat ćete samo Temozolomid SUN jedanput na dan prvih 5 dana.
Your blood will be tested frequently during treatment to monitor the side effects of Temozolomide SUN on your blood cells.
Tijekom liječenja će se često provoditi krvne pretrage radi praćenja nuspojava Temozolomid SUN-a na krvne stanice.
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) Special populations
U bolesnika koji su prethodno liječeni kemoterapijom početna doza iznosi 150 mg/m2 jedanput na dan, a u drugom ciklusu se povećava na 200 mg/m2 jedanput na dan tijekom 5 dana ako nema znakova hematološke toksičnosti (vidjeti dio 4.4).
Table 5 includes adverse reactions reported during clinical trials for recurrent or progressive malignant glioma and following the marketing of Temozolomide SUN.
U Tablici 5 obuhvaćene su nuspojave prijavljene tijekom kliničkih ispitivanja recidivirajućeg ili progresivnog malignog glioma te nakon stavljanja u promet lijeka Temozolomid SUN-a.
Gamma GT increased, AST increased *A patient who was randomised to the RT arm only, received TMZ + RT.
povišene vrijednosti AST-a *Jedan bolesnik koji je bio randomiziran u skupinu koja je primala samo RT, primio je TMZ + RT.
a: Treatment with concomitant TMZ can be continued when all of the following conditions are met: absolute neutrophil count ≥ 1.5 x 109/l; thrombocyte count ≥ 100 x 109/l; CTC non-haematological toxicity ≤ Grade 1 (except for alopecia, nausea, vomiting).
a: Istodobno liječenje temozolomidom može se nastaviti kada su zadovoljeni svi sljedeći uvjeti: apsolutni broj neutrofila ≥ 1,5 x 109/l; broj trombocita ≥ 100 x 109/l; nehematološka toksičnost prema CTC ≤ stupnju 1 (osim alopecije, mučnine i povraćanja).
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.
Karnofsky performance status, KPS] ≥ 70) koji napreduje ili je recidivirao nakon kirurškog zahvata i radioterapije temelje se na dva klinička ispitivanja peroralno primijenjenog
After oral administration of 14C-labelled TMZ, mean faecal excretion of 14C over 7 days post-dose was 0.8 % indicating complete absorption.
Nakon peroralne primjene temozolomida označenog radioizotopom 14C, u fecesu je tijekom 7 dana nakon primjene doze izlučeno prosječno 0,8% radioizotopa 14C, što ukazuje na potpunu apsorpciju.
Effective contraceptive precautions must be taken by both male and female patients who are taking Temozolomide SUN (see also “Male fertility” below).
I bolesnice i bolesnici koji uzimaju Temozolomid SUN moraju primjenjivati učinkovite mjere kontracepcije (pogledajte i dio "Plodnost muškaraca" u daljnjem tekstu).
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
nedostatka Lapp laktaze ili malapsorpcije glukoze i galaktoze ne bi trebali uzimati ovaj lijek.
In post-marketing cases, meningoencephalitis herpetic (including fatal cases) has been observed in patients receiving TMZ in combination with radiotherapy, including cases of concomitant steroids administration.
U slučajevima nakon stavljanja lijeka u promet, herpesni meningoencefalitis (uključujući slučajeve sa smrtnim ishodom) opažen je kod bolesnika koji primaju terapiju TMZ-om u kombinaciji s radioterapijom, uključujući slučajeve istodobne primjene steroida.
Hyde Park, Hayes 3
Millington Road 11 Hyde Park, Hayes 3 5th Floor
If use during pregnancy must be considered, the patient should be apprised of the potential risk to the foetus.
Ako je nužno razmatrati mogućnost primjene Temozolomid SUN-a tijekom trudnoće, bolesnicu se mora upoznati s potencijalnim rizikom za plod.
929 & 140 mg
929 i 140 mg
5x1 hard capsule 20x1 hard capsule
20x1 tvrdih kapsula
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.
U bolesnika koji uzimaju TMZ za liječenje novodijagnosticiranog multiformnog glioblastoma, bilo u kombinaciji s RT-om ili u monoterapiji nakon RT-a te u bolesnika koji uzimaju TMZ u monoterapiji za liječenje recidivirajućeg ili progresivnog malignog glioma prijavljene su slične vrlo česte nuspojave: mučnina, povraćanje, konstipacija, anoreksija, glavobolja i umor.
In the noncomparative 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.
19%, medijan preživljenja bez progresije bolesti bio je 2,1 mjesec, a medijan ukupnog preživljenja 5,4 mjeseca.
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.
Nakon toga slijedila je monoterapija TMZ-om (150-200 mg/m2) od 1. do 5. dana svakog ciklusa od 28 dana.
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).
mjeseci je udio bolesnika koji su preživjeli bio značajno veći u skupini bolesnika koji su primali TMZ (60%) nego u skupini bolesnika koji su primali prokarbazin (44%) (hi-kvadrat p = 0,019).
What you need to know before you take Temozolomide SUN Do not take Temozolomide SUN
Što morate znati prije nego počnete uzimati Temozolomid SUN
Temozolomide SUN is indicated for the treatment of: - adult patients with newly-diagnosed glioblastoma multiforme concomitantly with radiotherapy (RT) and subsequently as monotherapy treatment.
Temozolomid SUN je indiciran za liječenje: - odraslih bolesnika s novodijagnosticiranim multiformnim glioblastomom, istodobno s radioterapijom (RT), a zatim kao monoterapija.