FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients receiving Temozolomide Teva in combination with radiotherapy may experience different side effects than patients taking Temozolomide Teva alone.
Slovenian: Temozolomide Teva v zdravljenju na novo diagnosticiranega glioblastoma v kombinaciji z obsevanjem Bolniki, ki se zdravijo z zdravilom Temozolomide Teva v kombinaciji z obsevanjem, lahko doživijo drugačne neželene učinke kot tisti, ki jemljejo samo Temozolomide Teva.
English: After oral administration of 14C-labelled TMZ, mean faecal excretion of 14C over 7 days post-dose was 0.8%
Slovenian: Po peroralnem vnosu 14C-označenega TMZ se je v sedmih dneh po vnosu z blatom izločilo povprečno 0,8 % odmerka, kar kaže na popolno absorpcijo.
English: How to take Temozolomide Teva
Slovenian: Kako jemati zdravilo Temozolomide Teva
English: The excipient sunset yellow FCF (E110) included in the capsules shell may cause allergic reactions.
Slovenian: Sončno rumeno FCF (E110) Ovoj kapsul vsebuje pomožno snov sončno rumeno FCF (E110), ki lahko povzroči alergijske reakcije.
English: Temozolomide Teva 5 mg hard capsules Temozolomide Teva 20 mg hard capsules Temozolomide Teva 100 mg hard capsules Temozolomide Teva 140 mg hard capsules Temozolomide Teva 180 mg hard capsules Temozolomide Teva 250 mg hard capsules
Slovenian: Temozolomide Teva 5 mg trde kapsule Temozolomide Teva 20 mg trde kapsule Temozolomide Teva 100 mg trde kapsule Temozolomide Teva 140 mg trde kapsule Temozolomide Teva 180 mg trde kapsule Temozolomide Teva 250 mg trde kapsule
English: Dermatitis, dry skin, erythema, pruritus
Slovenian: dermatitis, suha koža, eritem, pruritus suha koža, pruritus
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: Uporaba TMZ se lahko nadaljuje skozi celotno 42 dnevno obdobje sočasnega zdravljenja (do 49
English: The primary targets of toxicity included the bone marrow, lymphoreticular system, testes, the gastrointestinal tract and, at higher doses, which were lethal to 60% to 100% of rats and dogs tested, degeneration of the retina occurred.
Slovenian: Med glavnimi tarčnimi tkivi toksičnega delovanja so bili kostni mozeg, limforetikularni sistem, testisi in prebavila, večji odmerki, ki so bili smrtni za 60 do
English: During the monotherapy phase, the dose and way you take Temozolomide Teva will be different.
Slovenian: V obdobju samostojnega zdravljenja boste jemali zdravilo Temozolomide Teva drugače in v drugačnem odmerku.
English: Do not open, crush or chew the capsules.
Slovenian: Kapsul ne smete odpreti, drobiti ali žvečiti.
English: Cerebral haemorrhage, hypertension Embolism pulmonary, oedema, oedema peripheral
Slovenian: možganska krvavitev, hipertenzija pljučna embolija, edem, periferni edem
English: Pneumocystis jirovecii pneumonia (PCP) prophylaxis was required during RT and combined TMZ therapy.
Slovenian: Med zdravljenjem z obsevanjem in TMZ je bila potrebna profilaksa proti pljučnici Pneumocystis jirovecii (PCP).
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: in obsevanjem v 42-dnevnem režimu (največ 49 dni), potrebna profilaksa proti PCP, ne glede na število limfocitov.
English: 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).
Slovenian: Pneumocystis jirovecii) in reaktivacijo okužb (kot sta HBV, CMV) (glejte poglavje 4.8).
English: 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).
Slovenian: ≥ 1,5 x 109/l; število trombocitov ≥ 100 x 109/l; SMT za nehematološko toksičnost ≤ 1. stopnje (z izjemo alopecije, slabosti in bruhanja).
English: The dose should be reduced or administration discontinued according to Table 3.
Slovenian: Zmanjšanje odmerka ali opustitev zdravljenja mora ustrezati priporočilom v razpredelnici 3.
English: The excipient sunset yellow FCF (E110) is also included in the capsule shell of Temozolomide Teva 20 mg hard capsules and may cause allergic reactions.
Slovenian: Zdravilo Temozolomide Teva vsebuje sončno rumeno FCF (E110) Ovoj kapsul zdravila Temozolomide Teva 20 mg trde kapsule vsebuje tudi pomožno snov sončno rumeno FCF (E110), ki lahko povzroči alergijske reakcije.
English: Anxiety, emotional lability, insomnia Anxiety, depression, emotional lability, insomnia
Slovenian: anksioznost, čustvena labilnost, nespečnost anksioznost, depresija, čustvena labilnost, nespečnost
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: TMZ (v odmerku od 150 do 200 mg/m²), ki se je začelo štiri tedne po koncu obsevanja.
English: Hemianopia, visual acuity reduced, vision disorder, visual field defect, eye pain
Slovenian: hemianopija, zmanjšana ostrina vida, motnja vida, nepravilnost vidnega polja, bolečina v očesu zmanjšana ostrina vida, bolečina v očesu, suhe oči
English: Temozolomide Teva 20 mg hard capsules Temozolomide Teva 100 mg hard capsules Temozolomide Teva 140 mg hard capsules Temozolomide Teva 180 mg hard capsules Temozolomide Teva 250 mg hard capsules temozolomide
Slovenian: Temozolomide Teva 20 mg trde kapsule Temozolomide Teva 100 mg trde kapsule Temozolomide Teva 140 mg trde kapsule Temozolomide Teva 180 mg trde kapsule Temozolomide Teva 250 mg trde kapsule temozolomid
English: The active substance is temozolomide.
Slovenian: Zdravilna učinkovina je temozolomid.
English: Adult patients with newly-diagnosed glioblastoma multiforme
Slovenian: Odrasli bolniki z na novo diagnosticiranim multiformnim glioblastomom
English: This led to hospitalisation and/or discontinuation of TMZ in 8% and 4%, respectively.
Slovenian: To je pri 8 % (trombocitopenija) oziroma 4 % (nevtropenija) bolnikov privedlo do hospitalizacije oziroma opustitve zdravljenja s TMZ.
English: At the start of Cycle 2, the dose is escalated to 200 mg/m² if the CTC nonhaematological 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
Slovenian: Na začetku drugega cikla se odmerek poveča na 200 mg/m², če je nehematološka toksičnost po splošnih merilih toksičnosti za prvi cikel stopnja ≤ 2 (razen za alopecijo, navzejo in bruhanje) ter če je absolutno število nevtrofilcev
English: Haemorrhage, oedema, oedema leg Haemorrhage, deep venous thrombosis, oedema leg
Slovenian: krvavitev, edem, edem noge krvavitev, globoka venska tromboza, edem noge
English: Hypokalemia, alkaline phosphatase increased, weight increased
Slovenian: hipokaliemija, povišana raven alkalne fosfataze, povečanje telesne mase hiperglikemija, povečanje telesne mase
English: Hepatic injury, including fatal hepatic failure, has been reportedin patients treated with TMZ (see section 4.8).
Slovenian: Pri bolnikih, zdravljenih s TMZ, so poročali o poškodbah jeter, vključno z odpovedjo jeter s smrtnim izidom (glejte poglavje 4.8).
English: Male fertility
Slovenian: Moška plodnost
English: Patients with newly-diagnosed glioblastoma multiforme If you are a newly-diagnosed patient, treatment will occur in two phases: - treatment together with radiotherapy (concomitant phase) first - followed by treatment with only Temozolomide Teva (monotherapy phase).
Slovenian: Če ste na novo diagnosticiran bolnik, bo zdravljenje potekalo v dveh obdobjih: - najprej jemanje zdravila skupaj z obsevanjem (obdobje sočasnega zdravljenja),
English: There is no clinical experience with use of TMZ in children under the age of 3 years.
Slovenian: Z uporabo TMZ pri otrocih, mlajših od treh let, ni kliničnih izkušenj.
English: If you have been previously treated with chemotherapy, your first dose of Temozolomide Teva will be 150 mg/m² once daily for the first 5 days.
Slovenian: Če ste se že zdravili s kemoterapijo, bo prvih pet dni vaš odmerek zdravila Temozolomide Teva 150 mg/m² enkrat dnevno.
English: Each capsule is approximately 19.5 mm in length.
Slovenian: Ena kapsula je dolga približno 19,5 mm.
English: Hearing impairment, tinnitus
Slovenian: vnetje srednjega ušesa, tinitus,
English: If you have not been previously treated with chemotherapy, your first dose of Temozolomide Teva will be 200 mg/m² once daily for the first 5 days.
Slovenian: Če se še nikoli niste zdravili s kemoterapijo, bo prvih pet dni vaš odmerek zdravila Temozolomide Teva 200 mg/m² enkrat dnevno.
English: The other ingredients are: capsule content: lactose, colloidal anhydrous silica, sodium starch glycolate type A, tartaric acid, stearic acid (see section 2 “Temozolomide Teva contains lactose”).
Slovenian: Pomožne snovi so: o vsebina kapsul: laktoza, koloidni brezvodni silicijev dioksid, natrijev karboksimetilškrob vrste A, vinska kislina, stearinska kislina (glejte poglavje 2 "Zdravilo Temozolomide Teva vsebuje laktozo").
English: In clinical trials, the most frequently occurring treatment-related undesirable effects were gastrointestinal disorders, specifically nausea (43%) and vomiting (36%).
Slovenian: prebavne motnje, in sicer navzeja (43 %) in bruhanje (36 %).
English: - if you are older than 70 years of age, you might be more prone to infections, bruising or bleeding.
Slovenian: - če dobite vročino ali simptome okužbe, se takoj obrnite na zdravnika; - če ste starejši od 70 let, ste lahko bolj nagnjeni h okužbam, podplutbam ali krvavitvam; - če imate težave z jetri ali ledvicami, boste morda jemali drugačen odmerek zdravila
English: Abdominal distension, fecal incontinence, gastrointestinal disorder (NOS), gastroenteritis, haemorrhoids
Slovenian: abdominalna distenzija, fekalna inkontinenca, bolezen prebavil, gastroenteritis, hemoroidi
English: Temozolomide Teva 5 mg two stripes in green ink on the cap and “T 5 mg” in green ink on the body
Slovenian: Temozolomide Teva 5 mg dve zeleni progi na kapici in zelen napis “T 5 mg” na telesu
English: Your blood will be tested frequently during treatment to monitor the side effects of Temozolomide Teva on your blood cells.
Slovenian: Med zdravljenjem boste pogosto opravljali preiskave krvi; zdravnik bo tako preverjal neželene učinke zdravila Temozolomide
English: The capsules must be swallowed whole with a glass of water and must not be opened or chewed.
Slovenian: Kapsule je treba pogoltniti cele in popiti kozarec vode.
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: Pred začetkom zdravljenja bo zdravnik bolnike skrbno pregledal glede znakov te okužbe; - če imate pred zdravljenjem majhno število rdečih (anemijo) in belih krvnih celic ter krvnih ploščic ali težave s strjevanjem krvi ali če se to razvije med zdravljenjem, se bo vaš zdravnik morda odločil, da boste jemali manjši odmerek, prekinili ali končali zdravljenje ali ga spremenili.
English: Erythema multiforme, erythroderma, urticaria, exanthema
Slovenian: multiformni eritem, eritrodermija, urtikarija, eksantem
English: Black iron oxide (E172) Propylene Glycol Ammonium hydroxide (E527)
Slovenian: propilenglikol, amonijev hidroksid (E527).
English: Adverse reactions in patients with recurrent or progressive malignant glioma Infections and infestations
Slovenian: Neželeni učinki pri bolnikih s ponavljajočim se ali napredujočim malignim gliomom
English: Common (may affect up to 1 in 10 people): oral infections, wound infection, reduced number of blood cells (neutropenia, thrombocytopenia, lymphopenia, leukopenia), increased sugar in the blood, loss of weight, change in mental status or alertness, anxiety/depression, sleepiness, difficulty speaking, impaired balance, dizziness, confusion, forgetfulness, difficulty concentrating, inability to fall asleep or stay asleep,tingling sensation, bruising, shaking, abnormal or blurry vision, double vision, hearing impairment, shortness of breath, cough, blood clot in the legs, fluid retention, swollen legs, diarrhoea, stomach or abdominal pain, heartburn, upset stomach, difficulty swallowing, dry mouth, skin irritation or redness, dry skin, itching, muscle weakness, painful joints, muscle aches and pains, frequent urination, difficulty with holding your urine, allergic reaction, fever, radiation injury, face swelling, pain, abnormal taste, abnormal liver function tests.
Slovenian: pozabljivost, težave s koncentracijo, nezmožnost zaspati ali pogosto prebujanje, občutek mravljinčenja, podplutbe, tresenje, nenormalen ali meglen vid, dvojni vid, poslabšanje sluha, zasoplost, kašelj, krvni strdek v nogah, zastajanje tekočine, otekle noge, driska, bolečina v želodcu ali trebuhu, zgaga, želodčne težave, oteženo požiranje, suha usta, razdraženost ali pordelost kože, suha koža, srbenje, mišična šibkost, bolečine v sklepih, bolečine v mišicah, pogosto uriniranje, težave z zadrževanjem urina, alergijska reakcija, vročina, poškodba zaradi obsevanja, otekanje obraza, bolečina, nenormalno okušanje, nenormalne vrednosti jetrnih preiskav.
English: Temozolomide Teva is indicated for the treatment of: - adult patients with newly-diagnosed glioblastoma multiforme concomitantly with radiotherapy (RT) and subsequently as monotherapy treatment.
Slovenian: Zdravilo Temozolomide Teva je indicirano za zdravljenje: - odraslih, ki imajo na novo diagnosticiran multiformni glioblastom - sočasno z obsevanjem,
English: Muscle weakness, arthralgia, musculoskeletal pain, myalgia
Slovenian: šibkost mišic, artralgija šibkost mišic, artralgija,
English: TMZ is administered orally at a dose of 75 mg/m² daily for 42 days concomitant with focal radiotherapy (60 Gy administered in 30 fractions).
Slovenian: TMZ se 42 dni uporablja peroralno v odmerku 75 mg/m² dnevno, sočasno s fokalnim obsevanjem
English: Convulsions were reported very commonly in the newlydiagnosed glioblastoma multiforme patients receiving monotherapy, and rash was reported very commonly in newly-diagnosed glioblastoma multiforme patients receiving TMZ concurrent with RT and also as monotherapy, and commonly in recurrent glioma.
Slovenian: O izpuščaju so zelo pogosto poročali pri bolnikih z na novo diagnosticiranim multiformnim glioblastomom, ki so se sočasno zdravili s TMZ in obsevanjem ali s samim TMZ, pogosto pa pri bolnikih s ponavljajočim se gliomom.
English: Table 3.
Slovenian: Razpredelnica 3.
English: 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.
Slovenian: Izrazitost teh učinkov je bila ponavadi stopnje 1 ali 2 (0 do 5 epizod bruhanja v 24 urah).
English: Accidental ingestion can be lethal for children.
Slovenian: Zaužitje zdravila je lahko za otroke smrtno nevarno.
English: Temozolomide Teva should not be administered to pregnant women.
Slovenian: Nosečnice ne smejo jemati zdravila Temozolomide Teva.
English: Status epilepticus, extrapyramidal disorder, hemiparesis, ataxia, cognition impaired, dysphasia, gait abnormal, hyperesthesia, hypoesthesia, neurological disorder (NOS), peripheral neuropathy
Slovenian: epileptični status, ekstrapiramidna motnja, hemipareza, ataksija, poslabšana kognicija, disfazija, nenormalna hoja, hiperestezija, hipoestezija, nevrološka motnja, periferna nevropatija hemiplegija, ataksija, nenormalna koordinacija, nenormalna hoja, hiperestezija,
English: Temozolomide Teva 180 mg two stripes in red ink on the cap and “T 180 mg” in red ink on the body
Slovenian: Temozolomide Teva 180 mg dve rdeči progi na kapici in rdeč napis “T 180 mg” na telesu
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: Kljub temu je bil največji odmerek, ki so ga prenašali, enak pri otrocih in odraslih (1000 mg/m² na cikel).
English: ≥ 0.5 and < 1.5 x 109/l
Slovenian: absolutno število nevtrofilcev ≥ 0,5 in < 1,5 x 109/l
English: Temozolomide Teva contains a medicine called temozolomide.
Slovenian: Zdravilo Temozolomide Teva vsebuje zdravilno učinkovino temozolomid.
English: Table 4 provides treatment-emergent adverse events in patients with newly-diagnosed glioblastoma multiforme during the concomitant and monotherapy phases of treatment.
Slovenian: V razpredelnici 4 so neželeni učinki, ki so se pojavili v obdobjih sočasnega in samostojnega zdravljenja pri bolnikih z na novo diagnosticiranim multiformnim glioblastomom.
English: 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
Slovenian: V drugem ciklu se poveča na 200 mg/m² enkrat dnevno, in sicer za pet dni, če ni hematološke toksičnosti (glejte poglavje 4.4).
English: Each capsule is approximately 22 mm in length.
Slovenian: Ena kapsula je dolga približno 22 mm.
English: TMZ dose reduction or discontinuation during monotherapy treatment Toxicity
Slovenian: Zmanjšanje odmerka ali opustitev TMZ med samostojnim zdravljenjem toksičnost zmanjšanje odmerka TMZ za eno ravena opustitev uporabe TMZ
English: Hemiparesis, aphasia, balance impaired, somnolence, confusion, dizziness, memory impairment, concentration impaired, dysphasia, neurological disorder (NOS), neuropathy, peripheral neuropathy, paresthesia, speech disorder, tremor
Slovenian: zavesti, somnolenca, afazija, poslabšano ravnotežje, omotica, zmedenost, poslabšanje spomina, poslabšanje koncentracije, nevropatija, parestezija, motnja govora, tremor ravnotežje, somnolenca, zmedenost, omotica, poslabšanje spomina, poslabšanje koncentracije, disfazija, nevrološka motnja, nevropatija, periferna nevropatija, parestezija, motnja govora, tremor
English: Diarrhoea, abdominal pain, dyspepsia
Slovenian: diareja, bolečina v trebuhu, dispepsija
English: Response rate, based on the central reviewer assessment, was 35% (13 CR and 43 PR) for the intent-to-treat population (ITT) n=162.
Slovenian: Stopnja odziva v populaciji, ki naj bi jo zdravili (ITT) (n = 162) je bila po oceni glavnega pregledovalca 35
English: - if you have nausea (feeling sick in your stomach) and/or vomiting which are very common side effects of Temozolomide Teva (see section 4), your doctor may prescribe you a medicine (an anti-emetic) to help prevent vomiting.
Slovenian: Temozolomide Teva (glejte poglavje 4), vam bo zdravnik morda predpisal zdravilo, ki preprečuje bruhanje (antiemetik).
English: TMZ is spontaneously hydrolyzed at physiologic pH primarily to the active species, 3-methyl-(triazen1-yl)imidazole-4-carboxamide (MTIC).
Slovenian: 5.2 Farmakokinetične lastnosti TMZ se pri fiziološki vrednosti pH spontano hidrolizira v aktivno različico, 3-metil-(triazen-1
English: Anti-emetic therapy may be administered prior to or following administration of TMZ.
Slovenian: Pred odmerkom TMZ ali po njem se lahko uporabijo antiemetiki.
English: Skin exfoliation, photosensitivity reaction, pigmentation abnormal
Slovenian: luščenje kože, preobčutljivostna reakcija na svetlobo, nenormalna pigmentacija eritem, nenormalna pigmentacija, močnejše potenje
English: CTC Grade 4b a:
Slovenian: stopnja 3 po splošnih merilih toksičnosti stopnja 4b po splošnih merilih toksičnosti a:
English: The median PFS was 5.4 months.
Slovenian: Srednje preživetje brez napredovanja bolezni je bilo 5,4 meseca.
English: Table 2.
Slovenian: Razpredelnica 2.
English: Common (may affect up to 1 in 10 people): loss of weight, tiredness, dizziness, tingling sensation, shortness of breath, diarrhoea, abdominal pain, upset stomach, rash, itching, hair loss, fever, weakness, shivering, feeling unwell, pain, change in taste.
Slovenian: Pogosti (pojavijo se lahko pri največ 1 od 10 bolnikov): zmanjšanje telesne mase, utrujenost, omotica, mravljinčenje, zasoplost, driska, bolečina v trebuhu, želodčne težave, izpuščaj, srbenje, izpadanje las, vročina, šibkost, drgetanje, slabo počutje, bolečina, spremenjeno okušanje.
English: You will take your new dose of Temozolomide Teva alone once daily for the first 5 days (“dosing days”) of each cycle.
Slovenian: Prvih pet dni vsakega cikla zdravljenja (»dnevi odmerjanja«) boste enkrat dnevno vzeli novi odmerek zdravila Temozolomide Teva.
English: allergic reactions.
Slovenian: alergijska reakcija, vročina,
English: Temozolomide Teva 250 mg hard capsules: (including printing ink): gelatin, titanium dioxide (E171), shellac, propylene glycol, black iron oxide (E172), Ammonium hydroxide (E527).
Slovenian: Temozolomide Teva 250 mg trde kapsule: (vključno s tiskarskim črnilom): želatina, titanov dioksid (E171), šelak, propilenglikol, črni železov oksid (E172), amonijev hidroksid (E527).
English: Patients usually present with shortness of breath and cough.
Slovenian: Ponavadi sta to zasoplost in kašelj.
English: Each capsule is approximately 16 mm in length.
Slovenian: Ena kapsula je dolga približno 16 mm.
English: Myopathy, back pain, musculoskeletal pain, myalgia
Slovenian: miopatija, bolečine v hrbtu, bolečine v mišicah in kosteh, mialgija miopatija, bolečina v hrbtu
English: There were higher rates of Grade 4 neutropenia (ANC < 0.5 x 109/l), 12% vs 5%, and thrombocytopenia (< 20 x 109/l), 9% vs 3%, in women vs men in the first cycle of therapy.
Slovenian: Enako velja za trombocitopenijo (< 20 x 109/l ) - 9 % pri ženskah in 3 % pri moških.
English: In a 400 subject recurrent glioma data set, Grade 4 neutropenia occurred in 8% of female vs 4% of male subjects and Grade 4 thrombocytopenia in 8% of female vs 3% of male subjects in the first cycle of therapy.
Slovenian: pojavila pri 8 % žensk in 4 % moških, trombocitopenija stopnje 4 pa pri 8 % žensk in 3 % moških.
English: Excipient with known effect Each hard capsule contains 117 mg of lactose.
Slovenian: Ena trda kapsula vsebuje 117 mg laktoze.
English: Propylene Glycol Red iron oxide (E172) Yellow iron oxide (E172) Titanium dioxide (E171)
Slovenian: rumeni železov oksid (E172), titanov dioksid (E171).
English: Each capsule is approximately 18 mm in length.
Slovenian: Ena kapsula je dolga približno 18 mm.
English: The following additional serious adverse reactions have been identified during post-marketing exposure:
Slovenian: V obdobju trženja zdravila so ugotovili dodatne resne neželene učinke, in sicer: Razpredelnica 6.
English: Concomitant phase
Slovenian: Obdobje sočasnega zdravljenja
English: Dose in Cycle 1 (monotherapy) is 150 mg/m² once daily for 5 days followed by 23 days without treatment.
Slovenian: Odmerek v prvem ciklu (samostojno zdravljenje) je 150 mg/m² enkrat dnevno.
English: Excipient with known effect Each hard capsule contains 209 mg of lactose.
Slovenian: Ena trda kapsula vsebuje 209 mg laktoze.
English: There are reports of patients who have taken the recommended dose for more than 5 days of treatment (up to 64 days) with adverse events reported including bone marrow suppression, with or without infection, in some cases severe and prolonged and resulting in death.
Slovenian: Med neželenimi učinki je bila supresija kostnega mozga z okužbo ali brez nje, v nekaterih primerih huda in dolgotrajna, ki je privedla do smrti.
English: - absolute neutrophil count (ANC) ≥ 1.5 x 109/l - thrombocyte count ≥ 100 x 109/l
Slovenian: ≥ 1,5 x 109/l in število trombocitov ≥ 100 x 109/l.
English: Teva Nederland B.V. Tel: +31 0 800 0228 400
Slovenian: Tel: +31 0 800 0228 400
English: Discontinue TMZ
Slovenian: TMZ.
English: Temozolomide Teva 5 mg hard capsules
Slovenian: Temozolomide Teva 5 mg trde kapsule
English: Tel.: +36 1 288 64 00
Slovenian: Teva Gyógyszergyár Zrt Tel.: +36 1 288 64 00
English: Adult and paediatric patients 3 years of age or older with recurrent or progressive malignant glioma A treatment cycle comprises 28 days.
Slovenian: Odrasli in pediatrični bolniki, stari tri leta ali več, s ponavljajočim se ali napredujočim malignim gliomom
English: Titanium dioxide (E171)
Slovenian: Ovoj kapsul želatina, titanov dioksid (E171).