natgillin/translations-raw huggingface dataset:
≥ 10 and < 100 x 109/l
≥ 10 in < 100 x 109/ l
CTC Gr ade 2
SMT 2. stopnja
CTC Grade 3 or 4
SMT 3. ali 4. stopnja
The dose should be reduced or administration discontinued according to Table 3.
Odmerek zmanjšajte ali uporabo ukinite, kot je opisano v preglednici 3.
33 Table 3.
33 Preglednica 3.
TMZ dose reduction or discontinuation during monotherapy treatment
Zmanjšanje odmerka ali ukinitev zdravila Temodal med monoterapijo
CTC Grade 4b
a: b: •
Adult and paediatric patients 3 years of age or older with recurrent or progressive malignant glioma:
Odrasli in pediatrični bolniki, stari 3 leta ali več, s ponavljajočim se ali napredujočim malignim gliomom
Based on the ph armacokinetic properties of TMZ, it is unlikely that dose reductions are required in patients with severe hepatic impairment or any degree of renalimpairment.
Na podlagi farmakokinetičnih lastnosti TMZ obstaja majhna verjetnost, da bo pri bolnikih s hudo jetrno okvaro ali ledvično okvaro katerekoli stopnje potrebno zmanjšanje odmerka zdravila.
Hypersensitivity to the active substanceor to any of the excipients.
34 Preobčutljivost za zdravilno učinkovino ali katerokoli pomožno snov
34 Severe myelosuppression (see section 4.4).
Huda mielosupresija (glejte poglavje 4. 4).
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 carinii pneumonia (PCP).
Pilotno preskušanje podaljšane 42- dnevne sheme zdravljenja je pokazalo, da pri bolnikih, ki so sočasno prejemali TMZ in RT, obstaja, še posebej veliko tveganje za nastanek pljučnice zaradi okužbe s Pneumocystis carinii (PCP).
Patients with recurrent or progressive malignant glioma
Bolniki s ponavljajočim se ali napredujočim malignim gliomom:
Elderly patients (> 70 years of age)
35 Starejši bolniki (stari > 70 let)
Elderly patients appear to be at increased risk of neutropenia and thrombocytopenia, compared with younger patients.
Videti je, da je pri starejših bolnikih tveganje za nevtropenijo ali trombocitopenijo večje, kot pri mlajših.
35 Male patients
Moški bolniki
Women of childbearing potential should be advised to use effective contraception to avoid pregnancy while they are receiving TMZ. pregnancy while they are receiving TMZ.
Ženskam v rodni dobi je treba svetovati, naj med zdravljenjem s TMZ z učinkovitimi kontracepcijskimi sredstvi preprečijo zanositev.
It is not known whether TMZ is excreted in human milk; thus, breast-feeding should be discontinued while receiving treatment with TMZ.
36 Ni znano, ali se TMZ izloča v materino mleko, zato je treba med zdravljenjem s TMZ dojenje prekiniti.
In patients treated with TMZ, whe ther 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.
Pri bolnikih, ki se zdravijo s TMZ, v kombinaciji z RT ali monoterapijo po RT zaradi novo diagnosticiranega multiformnega glioblastoma ali z monoterapijo pri bolnikih s ponavljajočim se ali napredujočim gliomom, so bili zelo pogosti neželeni učinki podobni: slabost, bruhanje, zaprtje, neješčnost, glavobol in utrujenost.
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.
Pogostnosti laboratorijskih izvidov 3. ali 4. stopnje jakosti je navedena pod vsako preglednico.
Infection, Herpes simplex, wound infection, pharyngitis, candidiasis oral
okužba, Hherpes simplex, okužba rane, faringitis, oralna kandidiaza
Respiratory, thoracic and mediastinal disorders Common:
38 Bolezni dihal, prsnega koša in mediastinalnega prostora
38 Common:
Pogosti:
Myelosuppression (neutropenia and thrombocytopenia), which is known dose-limiting toxicity for most cytotoxic agents, including TMZ, was observed.
39 Opažali so mielosupresijo (nevtropenijo in trombocitopenijo), kar so znani toksični učinki večine citotoksičnih snovi, vključno s TMZ, ki tudi omejujejo njihov odmerek.
39 abnormalities including neutropenic events were observed in 8% of the patients.
Ko so sešteli nenormalne laboratorijske izvide in neželene sopojave iz faze sočasne terapije in faze monoterapije, so pri 8% bolnikov opažali anomalije nevtrofilcev 3. ali 4. stopnje, vključno z nevtropeničnimi sopojavi.
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.
Oba učinka sta bila ponavadi 1. ali 2. stopnje (od 0 do 5 epizod bruhanja v 24 urah) in sta prenehala sama, ali pa ju je bilo mogoče hitro obvladati s standardnim antiemetičnim zdravljenjem.
Adverse reactions in patients with recurrent or progressive malignant glioma Infections and infestations
Ponavljajoči ali napredujoči maligni gliom
Very rare:
40 Zelo redki:
This led to hospitalisation and/or discontinuation of TMZ in 8% and 4%, respectively.
Zaradi njiju je bila potrebna hospitalizacija in/ ali prekinitev zdravljenja s TMZ pri 8% in 4% bolnikov.
40 Gender
Spol
Temozolomide is a triazene, which undergoes rapid chemical conversion at physiologic pH to the active monomethyl triazenoimidazole carboxamide (MTIC).
L01A X03 41 Temozolomid je zdravilo iz skupine triazenov, ki se pri fiziološkem pH hitro kemično pretvori v aktivni monometil triazenoimidazol karboksamid (MTIC).
41 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.
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 in RT.
The hazard ratio (H R) for overall survival was 1.59 (9 5% CI for HR=1 .33 -1.91) with a log-rank p < 0.0001 in favour of the TMZ arm.
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.
Recurrent or progressive malignant glioma
Ponavljajoči se ali napredujoči maligni gliom Podatki o klinični učinkovitosti zdravila pri bolnikih z multiformnim glioblastomom (indeks kliničnega stanja po Karnofskyju [KPS – » Karnofsky performance status «] ≥ 70), ki napreduje ali se je
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.
42 ponovil po kirurškem posegu in RT, temeljijo na dveh kliničnih preskušanjih s peroralno uporabo TMZ.
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).
V randomiziranem, z učinkovino nadzorovanem preskušanju je bil PFS po 6 mesecih statistično značilno daljši pri TMZ kot pri prokarbazinu (21% v primerjavi z 8%, hi- kvadrat, p = 0, 008), z mediano vrednostjo PFS 2, 89 meseca za TMZ in 1, 88 meseca za prokarbazin (test log. ranga p = 0, 0063).
42 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).
Mediana vrednost časa do napredovanja bolezni za naštete končne točke je bila za 0, 7 do 2, 1 meseca daljša za TMZ kot za prokarbazin (test log. ranga p = < 0, 01 do 0, 03).
Response rate, based on the central reviewer assessment, was 35% (13 CR and 43 PR) for the intent-to-treat population (ITT) n=162.
Po ugotovitvi osrednjega ocenjevalca je bil delež odziva v populaciji, ki so jo želeli zdraviti (ITT) n=162 35% (13 popolno okrevanje in 43 delno okrevanje).
Oral TMZ has been studied in paediatric patients (age 3-18 years) with recurrent brainstem glioma or recurrent high grade astrocytoma, in a regimen admin istered daily for 5 days every 28 days.
TMZ so dajali 5 dni vsakih 28 dni.
After oral administration to adult patients, TMZ is absorbed rapidely, with peak concentrations reached as early as 20 minutes post-administration (mean time between 0.5 and 1.5 hours).
43 Po peroralnem vnosu se pri odraslih zdravilo TMZ hitro absorbira in doseže največjo koncentracijo že v 20 minutah po zaužitju odmerka (srednja vrednost časa med 0, 5 in 1, 5 ure).
43 Special populations
Posebne skupine bolnikov
Results of the Ames/salmonella and Human Peripheral Blood Lymphocyte (HPBL) chromosome aberration tests showed a positive mutagenicity response.
44 Rezultati testa Ames/ Salmonella in testa kromosomskih aberacij v človeških limfocitih iz periferne krvi (HPBL – » Human Peripheral Blood Lymphocyte «) so pokazali pozitiven mutageni odziv.
Capsule shell: gelatin, titanium dioxide (E 171), sodium lauril sulfate, red iron oxide (E172).
Ovojnica kapsule: želatina, titanov dioksid (E 171), natrijev lavrilsulfat, rdeči železov oksid (E172).
Printing ink: shellac, propylene glycol, purified water, ammonium hydroxide, potassium hydroxide, black iron oxide (E 172).
Napis: šelak, propilenglikol, prečiščena vodoa, amonijev hidroksid, kalijev hidroksid, črni železov oksid (E 172).
44 6.2 Incompatibilities
6. 2 Inkompatibilnosti
6.3 Shelf life
45 6. 3 Rok uporabnosti
Patients should be advised to keep capsules out of the reach and sight of children, preferably in a locked cupboard.
Bolnikom je treba svetovati, naj zdravilo shranjujte nedosegljivo otrokom, po možnosti v zaklenjeni omari.
EU/1/98/096/005 EU/1/98/096/006 EU/1/98/096/015 EU/1/98/096/016
1 EU/ 1/ 98/ 096/ 006 EU/ 1/ 98/ 096/ 015 EU/ 1/ 98/ 096/ 016
46 1.
2 1.
Each hard capsule contains 246 mg of anhydrous lactose.
Pomožna snov: ena trda kapsula vsebuje 246 mg brezvodne laktoze.
Hard capsule The hard capsules have an opaque white body, a blue cap, and are imprinted with black ink.
Trde kapsule imajo neprozorno belo telo, modro kapico in tiskan napis s farmacevtskim črnilom.
The body is imprinted with "140 mg", the Schering-Plough logo and two stripes.
Na kapici je napis “ Temodal ”, na telesu kapsule pa so natisnjeni oznaka "140 mg", znak družbe Schering - Plough in dve črti.
Temodal hard capsules is indicated for the treatment of:
Zdravilo Temodal trde kapsuleje indicirano za zdravljenje:
- adult patients with newly-diagnosed gliobl astoma multiforme concomitantly with radiotherapy
- odraslih bolnikov z novo diagnosticiranim multiformnim glioblastomom, sočasno z
Temodal hard capsules is administered in combination with focal radiotherapy (concomitant phase) followed by up to 6 cycles of temozolomide (TMZ) monotherapy (monotherapy phase).
Zdravilo Temodal trde kapsule se uporabljajo v kombinaciji z žariščno radioterapijo (faza sočasne terapije), temu pa sledi do 6 ciklov monoterapije (monoterapijska faza) s temozolomidom (TMZ).
TMZ administration can be continued throughout the 42 day concomitant period (up to 49 days) if all of the following conditions are met:
TMZ lahko bolnik uporablja ves čas 42- dnevnega obdobja sočasne terapije (do 49 dni), če so izpolnjeni vsi od naslednjih pogojev:
47 During treatment a complete blood count should be obtained weekly.
Med zdravljenjem morate pri bolniku enkrat na teden pregledati celotno krvno sliko.
48 Table 3.
4 Preglednica 3.
In patients previously untreated with chemotherapy, TMZ is administered orally at a dose of 200 mg/m2 once daily for the first 5 days followed by a 2 3 day treatment interruption (total of 28 days).
Bolniki, ki še niso bili zdravljeni s kemoterapijo, naj jemljejo TMZ peroralno v odmerku 200 mg/ m2 enkrat na dan prvih 5 dni, temu pa naj sledi 23- dnevni premor (skupaj 28 dni).
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 renalimpairment.
Na podlagi farmakokinetičnih lastnosti TMZ obstaja majhna verjetnost, da bo pri bolnikih s hudo jetrno okvaro ali ledvičo okvaro katerekoli stopnje potrebno zmanjšanje odmerka zdravila.
Hypersensitivity to the active substanceor to any of the excipients.
5 Preobčutljivost za zdravilno učinkovino ali katerokoli pomožno snov.
49 Severe myelosuppression (see section 4.4).
Huda mielosupresija (glejte poglavje 4. 4).
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.
Profilaksa proti PCP je torej potrebna pri vseh bolnikih, ki sočasno prejemajo TMZ in RT v okviru 42- dnevne sheme zdravljenja (do največ 49 dni), ne glede na število limfocitov.
Elderly patients appear to be at increased risk of neutropenia and thrombocytopenia, compared with younger patients.
6 Videti je, da je pri starejših bolnikih tveganje za nevtropenijo ali trombocitopenijo večje, kot pri mlajših.
50 Male patients
Moški bolniki
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).
V ločeni študiji 1. faze sočasna uporaba TMZ in ranitidina ni povzročila spremembe obsega absorpcije temozolomida ali izpostavljenosti aktivnemu presnovku, monometiltriazenoimidazol karboksamidu (MTIC).
No studies have been conducted to determine the effect of TMZ on the metabolism or elimination of other medicinal products.
Ni bilo študij za določitev učinka TMZna presnovo ali izločanje drugih zdravil.
In preclinical studies in rats and rabbits receiving 150 mg/m2 TMZ, teratogenicity and/or foetal toxicity were demonstrated (see section 5.3).
Predklinične študije na podganah in kuncih, ki so prejemali 150 mg/ m2 TMZ so pokazale teratogenost in/ ali toksičnost za plod (glejte poglavje 5. 3).
It is not known whether TMZ is excreted in human milk; thus, breast-feeding should be discontinued while receiving treatment with TMZ.
Dojenje Ni znano, ali se TMZ izloča v materino mleko, zato je treba med zdravljenjem s TMZ dojenje prekiniti.
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.
7 TMZ ima lahko genotoksične učinke, zato morate moškim, ki se zdravijo z njim svetovati, da naj ne zaplodijo otroka še šest mesecev po zadnjem vzetem odmerku in naj se zaradi možnosti ireverzibilne neplodnosti zaradi zdravljenja s TMZ pred zdravljenjem posvetujejo o možnostih za shranitev zmrznjene sperme.
51 4.7 Effects on ability to drive and use machines
4. 7 Vpliv na sposobnost vožnje in upravljanja s stroji
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.
Pri bolnikih, ki se zdravijo s TMZ v kombinaciji z RT ali monoterapijo po RT zaradi novo diagnosticiranega multiformnega glioblastoma ali z monoterapijo pri bolnikih s ponavljajočim se ali napredujočim gliomom, so bili zelo pogosti neželeni učinki podobni: slabost, bruhanje, zaprtje, neješčnost, glavobol in utrujenost.
Very common:
8 Presnovne in prehranske motnje Zelo pogosti:
52 Psychiatric disorders Common:
Pogosti:
53 Common:
Pogosti:
Musculoskeletal and connective tissue disorders Common:
Bolezni mišično- skeletnega
Renal and urinary disorders Common:
Bolezni sečil
Micturition frequency, urinary incontinence
Občasni:
Urinary incontinence
pogosto uriniranje, inkontinenca seča
Uncommon:
inkontinenca seča disurija
When laboratory abnormalities and adverse events were combined across concomitant and monotherapy treatment phases, Grade 3 or Grade 4 neutrophil
Ko so sešteli nenormalne laboratorijske izvide in neželene sopojave iz faze sočasne terapije in faze monoterapije, so pri 8% bolnikov opažali anomalije nevtrofilcev 3. ali 4. stopnje, vključno z nevtropeničnimi sopojavi.
Grade 3 or Grade 4 thrombocyte abnormalities, including thrombocytopenic events were observed in 14% of the patients who received TMZ.
10 Anomalije trombocitov 3. ali 4. stopnje, vključno s trombocitopeničnimi sopojavi, so opažali pri 14% bolnikov, ki so prejeli TMZ.
55 Gender
Spol
A total of 573 patients were randomised to receive either TMZ + RT (n=287) or RT alone (n=286).
12 Novo diagnosticiran glioblastoma multiforme Skupaj 573 bolnikov so randomizirali v dve skupini, od katerih je ena prejemala TMZ in RT (n=287), druga pa samo RT (n=286).
56 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.
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 in RT.
The estimated probability of surviving 2 years or more (26% vs 10%) is higher for the R T + TMZ arm.
Ocenjena verjetnost preživetja bolnika 2 leti ali več (26% v primerjavi z 10%) je bila večja za del študije z RT in TMZ.
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.
Ponavljajoči se ali napredujoči maligni gliom Podatki o klinični učinkovitosti zdravila pri bolnikih z multiformnim glioblastomom (indeks kliničnega stanja po Karnofskyju [KPS – » Karnofsky performance status «] ≥ 70), ki napreduje ali se je ponovil po kirurškem posegu in RT, temeljijo na dveh kliničnih preskušanjih s peroralno uporabo TMZ.
In both trials, the primary endpoint was progression-free survival (PFS) defined by MRI scans or neurological worsening.
V obeh preskušanjih je bila primarna končna točka preskušanja čas preživetja brez napredovanja bolezni (PFS – » progression- free survival «), ugotovljen na podlagi NMR posnetkov, ali
57 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).
Mediana vrednost časa do napredovanja bolezni za naštete končne točke je bila za 0, 7 do 2, 1 meseca daljša za TMZ kot za prokarbazin (test log. ranga p = < 0, 01 do 0, 03).
After oral administration to adult patients, TMZ is absorbed rapidely, with peak concentrations reached as early as 20 minutes post-administration (mean time between 0.5 and 1.5 hours).
Po peroralnem vnosu se pri odraslih zdravilo TMZ hitro absorbira in doseže največjo koncentracijo že v 20 minutah po zaužitju odmerka (srednja vrednost časa med 0, 5 in 1, 5 ure).
Distribution
14 Porazdelitev
58 Special populations
Posebne skupine bolnikov
6.1 List of excipients
15 6. 1 Seznam pomožnih snovi
Capsule shell: gelatin, titanium dioxide (E 171), sodium lauril sulfate, indigo carmine (E 132),
Ovojnica kapsule želatina, titanov dioksid (E 171), natrijev lavrilsulfat, indigotin (E 132).
Type I amber glass bottles with polypropylene child-resistant closures containing 5 -or 20 hard capsules.
Steklenice iz rjavega stekla tip I s polipropilensko, za otroke varno zaporko, ki vsebujejo po 5 ali 20 kapsul.
The carton contains 5 or 20 hard capsules, individually sealed in sachets.
16 Kartonasta škatla vsebuje 5 ali 20 trdih kapsul, posamezno zavarjenih v vrečke.
61 1.
17 1.
Each hard capsule contains 316.3 mg of anhydrous lactose.
Pomožna snov:: ena trda kapsula vsebuje 316, 3 mg brezvodne laktoze.
Hard capsule The hard capsules have an opaque white body, an opaque orange cap, and are imprinted with black ink.
Trde kapsule imajo neprozorno belo telo, neprozorno oranžno kapico in tiskan napis s farmacevtskim črnilom.
The body is imprinted with "180 mg", the Schering-Plough logo and two stripes.
Na kapici je napis “ Temodal ”, na telesu kapsule pa so natisnjeni oznaka "180 mg", znak družbe Schering- Plough in dve črti.
Temodal hard capsules is indicated for the treatment of:
Zdravilo Temodal trde kapsule je indicirano za zdravljenje bolnikov z:
Temodal hard capsules is administered in combination with focal radiotherapy (concomitant phase) followed by up to 6 cycles of temozolomide (TMZ) monotherapy (monotherapy phase).
Zdravilo Temodal trde kapsule se uporablja v kombinaciji z žariščno radioterapijo (faza sočasne terapije), temu pa sledi do 6 ciklov monoterapije (monoterapijska faza) s z temozolomidom (TMZ).
62 During treatment a complete blood count should be obtained weekly.
Med zdravljenjem morate pri bolniku enkrat na teden pregledati celotno krvno sliko.
At the start of Cycle 2, the dose is escalated to 200 mg/m2 if the CTC non- haematological toxicity for Cycle 1 is Grade ≤ 2 (except for alopecia, nausea and vomiting), absolute neutrophil count (ANC) is ≥ 1.5 x 109/l, and the thrombocyte count is ≥ 100 x 109/l.
Na začetku 2. cikla odmerek povečajte na 200 mg/ m2, če je SKT za nehematološko toksičnost za 1. cikel stopnje ≤ 2 (z izjemo alopecije, slabosti in bruhanja), absolutno število nevtrofilcev (ANC) ≥ 1, 5 x 109/ l in število trombocitov ≥ 100 x 109/ l.
During treatment a complete blood count should be obtained on Day 22 (21 days after the first dose of TMZ).
Med zdravljenjem morate 22. dan pregledati celotno krvno sliko (21 dni po prvem odmerku zdravila TMZ).
TMZ dose levels for monotherapy treatment Remarks
Odmerek
63 Table 3.
19 Preglednica 3.
Absolute neutrophil count Thrombocyte count CTC non-haematological Toxicity
Absolutno število nevtrofilcev Število trombocitov
< 1.0 x 109/l < 50 x 109/l
< 50 x 10
See footnote b See footnote b
glejte opombo b SMT stopnja 4b
(except for alopecia, nausea, vomiting) a:
izjemo alopecije, slabosti in bruhanja) SMT 3. stopnja
Hypersensitivity to the active substanceor to any of the excipients.
20 Preobčutljivost za zdravilno učinkovino ali katerokoli pomožno snov
64 Severe myelosuppression (see section 4.4).
Huda mielosupresija (glejte poglavje 4. 4).
Elderly patients appear to be at increased risk of neutropenia and thrombocytopenia, compared with younger patients.
21 Videti je, da je pri starejših bolnikih tveganje za nevtropenijo ali trombocitopenijo večje, kot pri mlajših.
65 Male patients
Moški bolniki
Male fertility
Plodnost pri moških in kontracepcija
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.
22 TMZ ima lahko genotoksične učinke, zato morate moškim, ki se zdravijo z njim svetovati, da naj ne zaplodijo otroka še šest mesecev po zadnjem vzetem odmerku in naj se zaradi možnosti ireverzibilne neplodnosti zaradi zdravljenja s TMZ pred zdravljenjem posvetujejo o možnostih za shranitev zmrznjene sperme.
66 4.7 Effects on ability to drive and use machines
4. 7 Vpliv na sposobnost vožnje in upravljanja s stroji
Very common:
23 Presnovne in prehranske motnje Zelo pogosti:
67 Psychiatric disorders Common:
Pogosti:
68 Common:
Pogosti:
Grade 3 or Grade 4 thrombocyte abnormalities, including thrombocytopenic events were observed in 14% of the patients who received TMZ.
25 Anomalije trombocitov 3. ali 4. stopnje, vključno s trombocitopeničnimi sopojavi, so opažali pri 14% bolnikov, ki so prejeli TMZ.
70 Gender
Spol
Newly-diagnosed glioblastoma multiforme
27 Novo diagnosticiran glioblastoma multiforme
71 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.
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 in RT.