FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Maltese: MTIC jkun idrolizzat b'mod spontanju għal 5-amino-imidazole-4-carboxamide (AIC), intermedju mgħaruf fil-bijosintesi tal-purini u aċidi nuklejiċi u ta' methylhydrazine, li hu maħsub li jkun l-ispeċi alkylating attiva.
English: Marketing Authorisation Holder Accord Healthcare S.L.U.
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq Accord Healthcare S.L.U.
English: The estimated probability of surviving 2 years or more (26% vs 10%) is higher for the RT + TMZ arm.
Maltese: Il-probabilità stmata li jkun hemm sopravivenza ta' sentejn jew aktar (26 % vs 10 %) hija ogħla għall-fergħa ta' RT + TMZ.
English: In the tables, undesirable effects are classified according to System Organ Class and frequency.
Maltese: Fit-tabelli l-effetti mhux mixtieqa huma kklassifikati skont is-Sistema tal-Klassi tal-Organi u l-frekwenza.
English: Lactose
Maltese: Lattosju
English: Status epilepticus, extrapyramidal disorder, hemiparesis, ataxia, cognition impaired, dysphasia, gait abnormal, hyperesthesia, hypoesthesia, neurological disorder (NOS), peripheral
Maltese: Status epilepticus, disturbi ekstrapiramidali, emipareżi, atassja, għarfien imxekkel, disfażja, andatura mhux normali, iperesteżija, ipoesteżija, disturbi newroloġiċi (NOS), newropatija periferali
English: 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).
Maltese: Ġew osservati infezzjonijiet opportunistiċi (bħal pnewmonja kkawżata minn b'Pneumocystis jirovecii) u attivazzjoni mill-ġdid ta' infezzjonijiet (bħal HBV, CMV) waqt il-kura b'TMZ (ara sezzjoni 4.8).
English: 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.
Maltese: Doża eċċessiva ta' 10,000 mg (doża totali f'ċiklu wieħed, matul 5 ijiem) ittieħdet minn pazjent u r-reazzjonijiet avversi rrappurtati kienu panċitopenja, deni, kollass ta' diversi organi u mewt.
English: Each hard capsule contains 182.5 mg of anhydrous lactose.
Maltese: Kull kapsula iebsa fiha 182.5 mg ta' lattosju anidru.
English: See the package leaflet for further infrmation.
Maltese: Jista' jkun li mhux il-pakketti tad-daqsijiet kollha jkunu fis-suq.
English: Prior to dosing, the following laboratory parameters must be met: ANC ≥1.5 x 109/l and platelet count ≥ 100 x 109/l.
Maltese: ANC ≥ 1.5 x 109/l u għadd tal-plejtlets ≥ 100 x 109/l.
English: * Frequencies estimated based on relevant clinical trials.
Maltese: * Frekwenzi stmati bbażati fuq studji kliniċi rilevanti †
English: How to store Temozolomide Accord
Maltese: Mediċini oħra u Temozolomide Accord
English: The half-life (t1/2) in plasma is approximately 1.8 hours.
Maltese: Il-half-life (t1/2) fil-plażma hija ta' madwar 1.8 sigħat.
English: See footnote b
Maltese: Ara n-nota b ta' taħt
English: Neutropenia, thrombocytopenia, lymphopenia, leukopenia
Maltese: Newtropenija, tromboċitopenija, limfopenija, lewkopenija
English: Anti-emetic therapy may be administered (see section 4.4).
Maltese: Kura antiemetika tista' tingħata (ara sezzjoni 4.4).
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.
Maltese: Pazjenti tfal kellhom AUC ogħla minn dak ta' pazjenti adulti; madankollu, id-doża massima ttollerata (MTD) kienet ta' 1,000 mg/m2 kull ċiklu kemm fit-tfal u kemm fl-adulti.
English: • Abnormal liver function tests,
Maltese: • Testijiet anormali tal-funzjoni tal-fwied
English: Psychiatric disorders Common:
Maltese: Disturbi psikjatriċi Komuni:
English: The median PFS was 5.4 months.
Maltese: Il-PFS medjana kienet ta' 5.4 xhur.
English: Grade 3 or 4 thrombocytopenia and neutropenia occurred in 19 % and 17 % respectively, of patients treated for malignant glioma.
Maltese: Tromboċitopenija u newtropenija ta' Grad 3 jew 4 seħħew f'19 % u 17 % tal-pazjenti rispettivament, f'pazjenti kkurati għal glijoma malinna.
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.
Maltese: Dawn ir-reazzjonijet kienu normalment ta'Grad 1 jew 2 (0 - 5 episodji ta' rimettar f'24 siegħa) li jew waqfu waħidhom jew kienu kontrollati b'terapija standard kontra d-dardir.
English: Infection, Herpes simplex, wound infection, pharyngitis, candidiasis oral
Maltese: Infezzjoni, Herpes simplex, infezzjoni tal-ferita, farinġite, kandidijasi fil-ħalq
English: Pack-size of 5 or 20 hard capsules individually sealed in sachets.
Maltese: Daqs tal-pakkett ta' 5 jew 20 kapsula iebsa ssiġillati b'mod individwali fi qratas.
English: Titanium dioxide (E171) Iron oxide yellow (E172) Indigo carmine (E132)
Maltese: Titanium dioxide (E171) Iron oxide yellow (E172) Indigo carmin (E132)
English: • hair loss
Maltese: Tnaqqis tal-piż
English: Each hard capsule contains 102.2 mg of anhydrous lactose.
Maltese: Kull kapsula iebsa fiha 102.2 mg ta' lattosju anidru.
English: Very rare cases of lung side effects have been observed with temozolomide.
Maltese: Każijiet rari ħafna ta' effetti sekondarji fil-pulmun ġew osservati b'temozolomide.
English: 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.
Maltese: Ħafna mir-reazzjonijet ematoloġiċi avversi kienu rrappurtati b'mod komuni jew komuni ħafna fiż-żewġ indikazzjonijiet (Tabelli 4 u 5); il-frekwenzi ta' grad 3-4 tar-riżultati tal-laboratorju huma preżentati wara kull tabella.
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Maltese: B'mod mhux komuni ġew irrappurtati każijiet ta' dijabete insipidus.
English: Swallow the capsule(s) whole with a glass of water.
Maltese: Ibla' l-kapsula(/i) sħiħa b'tazza ilma.
English: Pneumocystis jirovecii pneumonia
Maltese: Pnewmonja b'Pneumocystis jirovecii
English: 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).
Maltese: Iż-żminijiet medjani għall-progressjoni f'dawn l-endpoints varja minn 0.7 sa 2.1 xhur aktar għal TMZ milli għal procarbazine (log rank p = < 0.01 sa 0.03).
English: Grade 3 or Grade 4 thrombocyte abnormalities, including thrombocytopenic reactions were observed in 14% of the patients who received TMZ.
Maltese: Anormalitajiet fit-tromboċiti ta' Grad 3 jew Grad 4, li jinkludu reazzjonijiet tromboċitopeniċi kienu osservati f'14 % tal-pazjenti li ngħataw TMZ.
English: Each carton contains 1 bottle.
Maltese: Kull kartuna fiha flixkun 1.
English: INFORMATION IN BRAILLE Temozolomide 250mg
Maltese: INFORMAZZJONI BIL-BRAILLE Temozolomide 250 mg
English: • loss of appetite
Maltese: • telf t'aptit
English: INFORMATION IN BRAILLE Temozolomide 5mg
Maltese: INFORMAZZJONI BIL-BRAILLE Temozolomide 5 mg
English: In a study of 288 subjects with newly diagnosed glioblastoma multiforme, Grade 4 neutropenia occurred in 3% of female vs 0% of male subjects and Grade 4 thrombocytopenia in 1% of female vs 0% of male subjects in the first cycle of therapy.
Maltese: Fi studju b'288 individwu bi glijoblastoma multiforme li għadha kif ġiet dijanjostikata, newtropenija ta' Grad 4 seħħet f'3 % tan-nisa vs 0 % tal-irġiel u tromboċitopenija ta' Grad 4 seħħet f'1 % tan-nisa vs 0 % tal-irġiel fl-ewwel ċiklu tat-terapija.
English: † Including cases with fatal outcome
Maltese: Inkluż każijiet b'riżultat fatali
English: - as you should be observed closely for the development of a serious form of chest infectioncalled Pneumocystis jirovecii pneumonia (PCP).
Maltese: peress li inti trid tinżamm taħt osservazzjoni stretta għall-iżvilupp ta' forma serja ta' infezzjoni fis-sider imsejħa Pulmonite bi Pneumocystis jirovecii (PCP).
English: Temozolomide Accord 5 mg hard capsules: gelatine, titanium dioxide (E 171), yellow iron oxide (E 172), indigo carmine (E 132), water.
Maltese: Temozolomide Accord 5 mg kapsuli ibsin: gelatine, titanium dioxide (E171), yellow iron oxide (E172), indigo carmine (E 132), ilma.
English: INFORMATION IN BRAILLE Temozolomide 20mg
Maltese: INFORMAZZJONI BIL-BRAILLE Temozolomide 20 mg
English: - absolute neutrophil count (ANC) ≥ 1.5 x 109/l - thrombocyte count ≥ 100 x 109/l - common toxicity criteria (CTC) non-haematological toxicity ≤ Grade 1 (except for alopecia, nausea and vomiting).
Maltese: - għadd assolut tan-newtrofili (ANC) ≥ 1.5 x 109/l - għadd tat-tromboċiti ≥ 100 x 109/l - kriterji tossiċi komuni (CTC), tossiċità mhix ematoloġika ≤ Grad 1 (ħlief għal alopeċja, dardir u rimettar).
English: The capsules contain lactose (a kind of sugar).
Maltese: Il-kapsuli fihom lattosju (tip ta' zokkor).
English: Headache
Maltese: FEJN
English: Temozolomide Accord 250 mg hard capsules: gelatine, titanium dioxide (E 171), water.
Maltese: Temozolomide Accord 250 mg kapsuli ibsin: gelatine, titanium dioxide (E171), ilma.
English: Results of the Ames/salmonella and Human Peripheral Blood Lymphocyte (HPBL) chromosome aberration tests showed a positive mutagenicity response.
Maltese: Ir-riżultati ta' testijiet ta' aberazzjoni kromosomali tal-Ames/salmonella u l-Limfoċit tad-Demm Periferali Uman (HPBL) urew rispons pożittiv għall-mutaġeniċità.
English: Patients in the TMZ + RT arm received concomitant TMZ (75 mg/m2) once daily, starting the first day of RT until the last day of RT, for 42 days (with a maximum of 49 days).
Maltese: Il-pazjenti fil-fergħa ta' TMZ + RT ngħataw TMZ (75 mg/m2) darba kuljum fl-istess waqt, bdew fl-ewwel jum ta' RT sa l-aħħar jum ta' RT għal 42 jum (sa mhux aktar minn 49 jum).
English: Stomatitis, diarrhoea, dyspepsia, dysphagia, mouth dry
Maltese: Stomatite, dijarea, uġigħ ta' żaqq, dispepsja, disfaġja
English: Cases of increased bilirubin, problems with bile flow (cholestasis), hepatitis and injury to the liver, including fatal liver failure, have been uncommonly reported.
Maltese: Każijiet ta'żieda fil-bilirubin, problemi bil-fluss tal-bila (kolestasi), epatite u ħsara fil-fwied, inkluż insuffiċjenza fatali tal-fwied ġew irrappurtati mhux komunament.
English: Oral TMZ has been studied in paediatric patients (age 3-18 years) with recurrent brainstem glioma or recurrent high grade astrocytoma, in a regimen administered daily for 5 days every 28 days.
Maltese: TMZ orali kien studjat f'pazjenti tfal (età 3-18-il sena) bi brainstem glijoma rikurrenti jew astroċitoma rikurrenti ta' grad għoli, fi programm ta' kura mogħti kuljum għal 5t ijiem kull 28 jum.
English: Temozolomide Accord 140 mg hard capsules: gelatine, titanium dioxide (E 171), indigo carmine (E 132), water.
Maltese: Temozolomide Accord 140 mg kapsuli ibsin: gelatine, titanium dioxide (E171) u indigo carmine (E132), ilma.
English: Each hard capsule contains 168 mg of anhydrous lactose.
Maltese: Kull kapsla iebsa fiha 168 mg ta' lattosju anidru.
English: Febrile neutropenia, thrombocytopenia, anaemia, leukopenia
Maltese: Newtropenija bid-deni, tromboċitopenija, anemija, lewkopenija
English: 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.
Maltese: F'pazjenti kkurati b'TMZ, kemm ikkombinat ma' RT jew bħala monoterapija wara r-RT għal glijoblastoma multiforme li tkun għadha kif ġiet dijanjostikata, jew bħala monoterapija f'pazjenti bi glijoma rikurrenti jew progressiva, l-effetti avversi komuni ħafna rrappurtati kienu simili: dardir, rimettar, stitikezza, anoressija, uġigħ ta' ras u għeja.
English: Drug reaction with eosinophilia and systemic symptoms (DRESS)
Maltese: Mhux magħrufa reazzjoni għall-Mediċina b'esinofilja u sintomi sistemiċi (DRESS)
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.
Maltese: F'sett ta' dejta għal glijoma b'400 individwu, newtropenija ta' Grad 4 seħħet fi 8 % tan-nisa vs 4 % tal-irġiel u tromboċitopenija ta' Grad 4 fi 8 % tan-nisa vs 3 % talirġiel fl-ewwel ċiklu tat-terapija.
English: Figure 1 Kaplan-Meier curves for overall survival (intent-to-treat population) The results from the trial were not consistent in the subgroup of patients with a poor performance status (WHO PS=2, n=70), where overall survival and time to progression were similar in both arms.
Maltese: Ir-riżultati mill-prova ma kienux konsistenti fis-sottogrupp ta' pazjenti bi stat ta' prestazzjoni dgħajjef (WHO PS=2, n=70), fejn is-sopravivenza ġenerali u ż-żmien biex javvanzaw kienu simili fiż-żewġ fergħat.
English: INFORMATION IN BRAILLE Temozolomide 140mg
Maltese: INFORMAZZJONI BIL-BRAILLE Temozolomide 140 mg
English: Experience in older children and adolescents is very limited (see sections 4.2 and 5.1).
Maltese: Esperjenza fi tfal akbar u adolexxenti hija limitata ħafna (ara sezzjonijiet 4.2 u 5.1).
English: Each hard capsule contains 250 mg of temozolomide.
Maltese: Kull kapsula iebsa fiha 250 mg temozolomide.
English: INFORMATION IN BRAILLE Temozolomide 180mg
Maltese: INFORMAZZJONI BIL-BRAILLE Temozolomide 180 mg
English: Temozolomide Accord 5 mg hard capsules temozolomide
Maltese: Temozolomide Accord 5 mg kapsuli ibsin Temozolomide
English: 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).
Maltese: F'pazjenti li ngħataw Temozolomide flimkien ma' RT fi prova pilota għall-iskeda mtawla ta' 42 jum instab li kellhom riskju partikolari li taqbadhom pulmonite b'Pneumocystis jirovecii (PCP).
English: EU/1/10/615/021 EU/1/10/615/022 EU/1/10/615/035 EU/1/10/615/036
Maltese: EU/1/10/615/021 EU/1/10/615/022 EU/1/10/615/035
English: In a multicentre, prospective phase II trial evaluating the safety and efficacy of oral TMZ in the treatment of patients with anaplastic astrocytoma at first relapse, the 6 month PFS was 46%.
Maltese: II li evalwat is-sigurtà u l-effikaċja ta' TMZ orali fittrattament ta' pazjenti b'astroċitoma anaplastika wara l-ewwel rikaduta, wara 6 xhur il-PFS kienet ta' 46 %.
English: Adult and paediatric patients 3 years of age or older with recurrent or progressive malignant glioma:
Maltese: Pazjenti adulti u tfal minn 3 snin ‘l fuq bi glijoma malinna rikurrenti jew progressiva:
English: When laboratory abnormalities and adverse reactions were combined across concomitant and monotherapy treatment phases, Grade 3 or Grade 4 neutrophil abnormalities including neutropenic reactions were observed in 8% of the patients.
Maltese: Meta anormalitajiet tal-laboratorju u reazzjonijiet avversi kienu kkumbinati bejn il-fażijiet ta' trattament b'kura konkomitanti u monoterapija, anormalitajiet tan-newtrofili ta' Grad 3 jew Grad 4, inklużi reazzjonijiet newtropeniċi dehru f'8% tal-pazjenti.
English: No data are available on the administration of TMZ in patients with severe hepatic impairment (Child's Class C) or with renal impairment.
Maltese: M'hemmx informazzjoni disponibbli dwar l-għoti ta' TMZ f'pazjenti b'indeboliment epatiku serju (Kategorija ta' Child C) jew b'indeboliment renali.
English: The lowest recommended dose is 100 mg/m2.
Maltese: L-inqas doża rakkomandata hi ta'100 mg/m2.
English: In a separate pharmacokinetic study, plasma pharmacokinetic profiles in patients with mild to moderate hepatic impairment were similar to those observed in patients with normal hepatic function.
Maltese: Fi studju farmakokinetiku separat, il-profili farmakokinetiċi tal-plażma f'pazjenti b'indeboliment tal-fwied minn ħafif sa moderat kienu jixbhu lil dawk osservati f'pazjenti b'funzjoni tal-fwied normali.
English: Anti-emetic therapy
Maltese: Terapija kontra d-dardir
English: Date of first authorisation:15 March 2010 Date of latest renewal: 12 January 2015
Maltese: Data tal-ewwel awtorizzazzjoni:15 ta' Marzu 2010
English: See package leaflet for further information.
Maltese: Ara l-fuljett ta' tagħrif aħal aktar informazzjoni.
English: Temozolomide Accord 250 mg hard capsules temozolomide
Maltese: Temozolomide Accord 250 mg kapsuli ibsin Temozolomide
English: In preclinical studies in rats and rabbits receiving 150 mg/m2, teratogenicity and/or foetal toxicity were demonstrated (see section 5.3).
Maltese: Fi studji ta' qabel l-użu kliniku fuq firien u fniek li kienu qed jingħataw 150 mg/m2, deher li kien hemm teratoġeniċità u/jew tossiċità tal-fetu (ara sezzjoni 5.3).
English: Based on a population pharmacokinetic analysis in patients 19-78 years of age, clearance of TMZ is not affected by age.
Maltese: Skont l-analiżi farmakokinetika tal-popolazzjoni f'pazjenti ta' bejn 19-78 sena, it-tneħħija ta' TMZ mhix affettwata mill-età.
English: Each hard capsule contains 180 mg of temozolomide.
Maltese: Kull kapsula iebsa fiha 180 mg temozolomide.
English: Each hard capsule contains 140 mg of temozolomide.
Maltese: Kull kapsula iebsa fiha 140 mg temozolomide.
English: Temozolomide Accord 140 mg hard capsules temozolomide
Maltese: Temozolomide Accord 140 mg kapsuli ibsin Temozolomide
English: Respiratory, thoracic and mediastinal disorders Common:
Maltese: Disturbi respiratorji, toraċiċi u medjastinali Komuni:
English: Temozolomide Accord 20 mg hard capsules temozolomide
Maltese: Temozolomide Accord 20 mg kapsuli ibsin Temozolomide
English: Pneumonia, sinusitis, upper respiratory infection, bronchitis
Maltese: Pulmonite, sinusite, infezzjoni respiratorja tal-parti ta' fuq,
English: EU/1/10/615/001 EU/1/10/615/002 EU/1/10/615/025 EU/1/10/615/026
Maltese: EU/1/10/615/001 EU/1/10/615/002 EU/1/10/615/025
English: Pregnancy,breast-feeding and fertility
Maltese: Tqala, treddigħ u fertilità
English: Myelosuppression (neutropenia and thrombocytopenia), which is known dose-limiting toxicity for most cytotoxic agents, including TMZ, was observed.
Maltese: Ġiet osservata l-majelosuppressjoni (newtropenija u tromboċitopenja), li hija magħrufa bħala tossiċità li tillimita d-doża għal biċċa l-kbira tas-sustanzi ċitotossiċi, inkluż TMZ.
English: Male patients
Maltese: TA' EĊĊIPJENTI
English: Meningoencephalitis herpetic
Maltese: Tossiċità fil-fwied
English: Each hard capsule contains 5 mg of temozolomide.
Maltese: Kull kapsula iebsa fiha 5 mg temozolomide.
English: In the non-comparative trial, the PFS at 6 months was 19%, the median progression-free survival was 2.1 months, and the median overall survival 5.4 months.
Maltese: Fl-istudju mhux komparattiv, il-PFS wara 6 xhur kien ta' 19 %, is-sopravivenza mingħajr progressjoni medjana kienet ta' 2.1. xhur, u l-medjan tas-sopravivenza totali kien ta' 5.4 xhur.
English: Temozolomide Accord 140 mg hard capsules have a white body, a blue cap, and are imprinted ‘TMZ' on cap and ‘140' on body with black ink.
Maltese: Temozolomide Accord 140 mg kapsuli ibsin għandhom korp abjad, ras blu u fuqhom hemm stampat b'linka sewda ‘TMZ' fuq ir-ras u ‘140' fuq il-korp.
English: Each hard capsule contains 20 mg of temozolomide.
Maltese: Kull kapsula iebsa fiha 20 mg temozolomide.
English: Opportunistic infections and reactivation of infections
Maltese: Infezzjonijiet opportunistiċi u attivazzjoni mill-ġdid ta' infezzjonijiet
English: Sleepiness, dizziness, tingling sensation, diarrhoea, stomach pain, indigestion, rash, itching, hair loss, weight loss, fever, weakness, shivering, feeling unwell, pain, change in taste, shortness of breath
Maltese: Ħedla, sturdament, sensazzjoni ta' tingiż, dijarea, uġigħ fl-istonku, indiġestjoni, raxx, ħakk, telf ta' xagħar, deni, dgħufija, tregħid, tħossok ma tiflaħx, uġigħ, bidla fit-togħma, qtugħ ta' nifs.
English: Myopathy, back pain, musculoskeletal pain, myalgia
Maltese: Mijopatija, uġigħ fid-dahar, uġigħ muskolu-skeletrali, mijalġja
English: Batch
Maltese: Flixkun
English: Temozolomide Accord 180 mg hard capsules: gelatine, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172), water.
Maltese: Temozolomide Accord 180 mg kapsuli ibsin: gelatine, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), ilma.
English: exanthema
Maltese: Pożoloġija
English: Co-administration with valproic acid was associated with a small but statistically significant decrease in clearance of TMZ.
Maltese: L-għoti flimkien ma' valproic acid kien assoċjat ma' tnaqqis żgħir iżda statistikament rilevanti fit-tneħħija ta' TMZ.
English: Embolism pulmonary, oedema, oedema peripheral
Maltese: Emorraġija ċerebrali, pressjoni għolja Emboliżmu fil-pulmun, edima, edima periferali
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.
Maltese: Dan kien segwit b'monoterapija ta' TMZ (150 - 200 mg/m2) f'jiem 1 - 5 ta' kull ċiklu ta' 28 jum sa 6 ċikli, li bdew 4 ġimgħat wara li ntemmet ir-RT. Pazjenti fil-fergħa tal-kontroll ingħataw RT biss.
English: Pneumocystis jirovecii pneumonia (PCP) prophylaxis was required during RT and combined TMZ therapy.
Maltese: Terapija biex tilqa' għall-pulmonite b'Pneumocystis jirovecii (PCP) kienet meħtieġa waqt it terapija bir-radjuterapija u b'dik ikkombinata ma' TMZ.
English: In a population pharmacokinetics analysis of clinical trial experience there were 101 female and 169 male subjects for whom nadir neutrophil counts were available and 110 female and 174 male subjects for whom nadir platelet counts were available.
Maltese: F'analiżi farmakokinetika ta'popolazzjoni b'esperjenza bi prova klinika kien hemm 101 mara u 169 raġel li l-valuri l-aktar baxxi tan-newtrofili għalihom kienu disponibbli u 110 mara u 174 raġel li għalihom il-valuri l-aktar baxxi tal-plejtlets kienu disponibbli.
English: Each hard capsule contains 100 mg of temozolomide.
Maltese: Kull kapsula iebsa fiha 100 mg temozolomide.
English: TMZ administration can be continued throughout the 42 day concomitant period (up to 49 days) if all of the following conditions are met: - absolute neutrophil count (ANC) ≥ 1.5 x 109/l - thrombocyte count ≥ 100 x 109/l - common toxicity criteria (CTC) non-haematological toxicity ≤ Grade 1 (except for alopecia, nausea and vomiting).
Maltese: TMZ jista' jitkompla fil-perijodu ta' 42 jum meta jkunu qed jingħataw flimkien (sa 49 jum) jekk ilkundizzjonijiet kollha li ġejjin ikunu sodisfaċenti: - għadd assolut tan-newtrofili (ANC) ≥ 1.5 x 109/l - għadd tat-tromboċiti ≥ 100 x 109/l - kriterji tossiċi komuni (CTC), tossiċità mhix ematoloġika ≤ Grad 1 (ħlief għal alopeċja, dardir u rimettar).
English: Temozolomide Accord 180 mg hard capsules have a white body, a maroon cap, and are imprinted ‘TMZ' on cap and ‘180' on body with black ink.
Maltese: Temozolomide Accord 180 mg kapsuli ibsin għandhom korp abjad, ras marun ħamrani u fuqhom hemm stampat b'linka sewda ‘TMZ' fuq ir-ras u ‘180' fuq il-korp.
English: Temozolomide Accord 100 mg hard capsules temozolomide
Maltese: Temozolomide Accord 100 mg kapsuli ibsin Temozolomide
English: Respiratory, thoracic and mediastinal disorders Very rare:
Maltese: Disturbi respiratorji, toraċiċi u medjastinali Rari ħafna:
English: Febrile neutropenia, anaemia Lymphopenia, petechiae
Maltese: Reazzjonijiet allerġiċi, li jinkludu anafilassi, anġjoedima
English: Temozolomide Accord 180 mg hard capsules temozolomide
Maltese: Temozolomide Accord 180 mg kapsuli ibsin Temozolomide
English: Temozolomide Accord 20 mg hard capsules: gelatine, titanium dioxide (E 171), yellow iron oxide (E 172), water.
Maltese: Temozolomide Accord 20 mg kapsuli ibsin: gelatine, titanium dioxide (E171) u yellow iron oxide (E172), ilma.