FrancophonIA/ELRC3.0 huggingface dataset:
English: Includes pharyngitis, nasopharyngeal pharyngitis, pharyngitis Streptococcal Includes gastroenteritis, gastroenteritis viral Includes cushingoid, Cushing syndrome Includes neuropathy, peripheral neuropathy, polyneuropathy, peripheral sensory neuropathy, peripheral motor neuropathy Includes visual impairment, eye disorder Includes deafness, deafness bilateral, deafness neurosensory, deafness unilateral Includes earache, ear discomfort Includes abdominal pain, abdominal pain lower, abdominal pain upper, abdominal discomfort Includes oedema peripheral, peripheral swelling Includes liver function test increased, alanine aminotransferase increased, aspartate aminotransferase increased, hepatic enzymes increased Includes radiation injury, radiation skin injury Including cases with fatal outcome
Maltese: Korriment ikkawżat minn radjazzjonik a Tinkludi farniġite, farinġite tal-imnieħer u l-farinġi, farinġite kkawżata minn Streptokokki b Tinkludi gastroenterite, gastroenterite kkawżata minn virus c Jinkludi cushingoid, sindrome ta' Cushing d Tinkludi newropatija, newropatija periferali, polinewropatija, newropatija periferali tas-sensi, newropatija periferali motorja e Jinkludi indeboliment fil-vista, disturb fl-għajnejn f Tinkludi truxija, truxija bilaterali, truxija newrosensorja, truxija unilaterali g Jinkludi uġigħ fil-widna, skumdità fil-widna h Jinkludi uġigħ fl-addome, uġigħ fil-parti t'isfel tal-addome, uġigħ fin-naħa ta' fuq tal-addome,
English: Dysuria
Maltese: Disurja
English: Temodal 180 mg hard capsules: gelatin, titanium dioxide (E 171), sodium lauril sulfate, yellow iron oxide (E 172), and red iron oxide (E 172),
Maltese: Temodal 180 mg kapsuli ibsin: gelatin, titanium dioxide (E 171), sodium lauril sulfate, yellow iron oxide (E 172), red iron oxide (E 172),
English: EU/1/98/096/001 EU/1/98/096/002 EU/1/98/096/024 EU/1/98/096/025
Maltese: EU/1/98/096/001 EU/1/98/096/002 EU/1/98/096/024
English: 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.
Maltese: Majelosuppressjoni setgħet tkun imbassra (normalment fl-ewwel ftit ċikli, bl-aktar punt baxx ma' jum 21 u jum 28), u l-irkupru kien mg ħaġġel, normalment fi żmien 1-2 ġimgħat.
English: Temodal 2.5 mg/ml powder for solution for infusion delivers equivalent TMZ dose and exposure to both TMZ and its active metabolite MTIC as the corresponding Temodal hard capsules (see section 5.2).
Maltese: Temodal 2.5 mg/ml trab għal soluzzjoni għall-infużjoni jipprovdi doża ta' TMZ ekwivalenti għallesponiment kemm ta' TMZ kif ukoll tal-metabolu attiv tiegħu MTIC, bħal dik ta' Temodal kapsuli ibsin (ara sezzjoni 5.2).
English: Temodal 20 mg hard capsules: gelatin, titanium dioxide (E 171), sodium lauril sulfate, yellow iron oxide (E 172),
Maltese: Temodal 20 mg kapsuli ibsin: gelatin, titanium dioxide (E 171), sodium lauril sulfate, yellow iron oxide (E 172),
English: Temodal 140 mg hard capsules: gelatin, titanium dioxide (E 171), sodium lauril sulfate, indigo carmine (E 132),
Maltese: Temodal 140 mg kapsuli ibsin: gelatin, titanium dioxide (E 171), sodium lauril sulfate, indigo carmin
English: A variety of neoplasms, including mammary carcinomas, keratocanthoma of the skin and basal cell adenoma were observed in the 6-cycle rat study while no tumours or pre-neoplastic changes were evident in dog studies.
Maltese: Varjetà ta' neoplażmi, li jinkudu karċinomi mammarji, keratokantoma tal-ġilda u basal cell adenoma kienu osservati fi studju ta' 6-ċikli fuq il-firien, filwaqt li l-ebda tumuri jew tibdil pri-neoplastiku ma kien evidenti fi studji fuq il-klieb.
English: The body is imprinted with "180 mg", the Schering-Plough logo and two stripes.
Maltese: In-naħa l-oħra hija ttimbrata b'“180 mg”, il-logo ta' Schering-Plough u żewġ strixxi.
English: Convulsions, hemiparesis, aphasia/dysphasia, headache
Maltese: Konvulżjonijiet, emiparesi, afasja/disfasja, uġigħ ta' ras
English: However, elderly patients (> 70 years of age) appear to be at increased risk of neutropenia and thrombocytopenia (see section 4.4).
Maltese: Madankollu, jidher li pazjenti anzjani (>70 sena) għandhom riskju akbar li jkollhom newtropenija u tromboċitopenija (ara sezzjoni 4.4).
English: C elimination is renal.
Maltese: Il-mod ewlieni ta' l-eliminazzjoni ta' 14C huwa dak renali.
English: Hepatic failure
Maltese: Disturbi vaskulari
English: a: TMZ dose levels are listed in Table 2. b: TMZ is to be discontinued if:
Maltese: CTC Grad 4b a: Livelli tad-doża ta' TMZ huma elenkati f'Tabella 2.
English: 9/l), 12 % vs 5 %, and thrombocytopenia (< 20 x 10
Maltese: Kien hemm rati ogħla ta' newtropenija ta' Grad 4 (ANC < 0.5 x 109/l), 12 % vs 5 %, u tromboċitopenija (< 20 x 109/l), 9 % vs 3 % fin-nisa vs l-irġiel fl-ewwel ċiklu tat-terapija.
English: After reconstitution, 1 ml solution for infusion contains 2.5 mg temozolomide.
Maltese: Wara r-rikostituzzjoni, ml 1 ta' soluzzjoni għall-infużjoni jkun fih 2.5 mg temozolomide.
English: A volume up to 40 ml reconstituted solution should be withdrawn, according to the total prescribed dose and transferred into an empty 250 ml infusion bag (PVC or polyolefin).
Maltese: Volum sa 40 ml tas-soluzzjoni mħallta għandu jinġibed, skond id-doża totali ordnata u ttrasferit ġo borża ta' l-infużjoni vojta ta' 250 ml (PVC jew poljolefin).
English: Patients with tumours that have returned or worsened (malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma) taking Temodal only:
Maltese: Pazjenti b'tumuri li reġgħu ħarġu jew aggravaw (glijoma malinna, bħal glioblastoma multiforme jew astroċitoma anaplastika) li qed jieħdu Temodal biss:
English: CTC non-haematological Toxicity (except for alopecia, nausea, vomiting)
Maltese: Tossiċità mhux ematoloġika ta' CTC (ħlief għal alopeċja, tqalligħ, rimettar)
English: Stomatitis, abdominal pain h, dyspepsia, dysphagia
Maltese: Stomatite, uġigħ fl-addomeh, dispepsja, disfaġja
English: Capsule shell: gelatin, titanium dioxide (E 171), sodium lauril sulfate , indigo carmine (E 132),
Maltese: titanium dioxide (E 171), sodium lauril sulfate, indigo carmin (E 132).
English: 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).
Maltese: Fi studju separat ta' fażi I, l-għoti ta' TMZ ma' ranitidine ma bidilx il-grad ta' assorbiment ta' temozolomide jew l-esponiment għall-metabolit attiv tiegħu monomethyl triazenoimidazole carboxamide (MTIC).
English: EU/1/98/096/005 EU/1/98/096/006 EU/1/98/096/015 EU/1/98/096/016
Maltese: EU/1/98/096/005 EU/1/98/096/006 EU/1/98/096/015
English: Malignancies
Maltese: Anafilassi
English: 9/l - common toxicity criteria (CTC) non-haematological toxicity ≤ Grade 1 (except for alopecia,
Maltese: - tossiċità mhux ematoloġika ta' kriterju komuni tat-tossiċità (CTC) ta' ≤ Grad 1 (ħlief għal alopeċja, tqalligħ u rimettar).
English: EU/1/98/096/017 (5 hard capsules) EU/1/98/096/018 (20 hard capsules)
Maltese: EU/1/98/096/017 (5 kapsuli ibsin) EU/1/98/096/018(20 kapsula iebsa)
English: For sodium, see leaflet for further information.
Maltese: Aqra l-fuljett ta' tagħrif għal aktar informazzjoni.
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 pedjatriċi (età ta' 3-18-il sena) bi glijoma rikorrenti taz-zokk ċentrali tal-moħħ jew b'astroċitoma rikorrenti ta' grad għoli, f'kors mogħti kuljum għal 5 ijiem kull 28 jum.
English: Powder for solution for infusion 1 vial 100 mg
Maltese: U KONTENUT Trab għal soluzzjoni għall-infużjoni Kunjett wieħed ta' 100 mg
English: Temodal 20 mg hard capsules
Maltese: Temodal 20 mg kapsuli ibsin
English: Dose reductions and discontinuations during the monotherapy phase should be applied according to Tables 2 and 3.
Maltese: It-tnaqqis u t-twaqqif tad-dożi waqt il-fażi ta' monoterapija għandhom isiru skond f'Tabelli 2 u 3.
English: EU/1/98/096/005 (5 hard capsules) EU/1/98/096/006 (20 hard capsules)
Maltese: EU/1/98/096/005 (5 kapsuli ibsin) EU/1/98/096/006 (20 kapsula iebsa)
English: After reconstitution, 1 ml of solution for infusion contains 2.5 mg.
Maltese: Wara r-rikostituzzjoni, 1 ml ta' soluzzjoni għall-infużjoni jkun fih 2.5 mg.
English: Very Common side effects (may affect more than 1 in 10 people) are: - loss of appetite, difficulty speaking, headache - vomiting, nausea, diarrhoea, constipation - rash, hair loss - tiredness
Maltese: Effetti sekondarji komuni ħafna (jistgħu jaffettwaw aktar minn persuna 1 minn kull 10 ) huma: - telf t'aptit, diffikultà biex titkellem, uġigħ ta' ras - rimettar, dardir, dijarea, stitikezza
English: Capsule shell: gelatin, titanium dioxide (E 171), sodium lauril sulfate, yellow iron oxide (E 172), red iron oxide (E 172)
Maltese: titanium dioxide (E 171), sodium lauril sulfate, yellow iron oxide (E 172), red iron oxide (E 172).
English: Temodal 5 mg hard capsules
Maltese: Temodal 5 mg kapsuli ibsin
English: EU/1/98/096/011 (5 hard capsules) EU/1/98/096/012 (20 hard capsules)
Maltese: EU/1/98/096/011 (5 kapsuli ibsin) EU/1/98/096/012 (20 kapsula iebsa)
English: Temodal 140 mg hard capsules
Maltese: Temodal 140 mg kapsuli ibsin
English: The body is imprinted with "100 mg", the Schering-Plough logo and two stripes.
Maltese: In-naħa l-oħra hija ttimbrata b'“100 mg”, il-logo ta' Schering-Plough u żewġ strixxi.
English: Temodal 250 mg hard capsules white
Maltese: Temodal 250 mg kapsuli ibsin
English: Temodal 100 mg hard capsules
Maltese: Temodal 100 mg kapsuli ibsin
English: EU/1/98/096/013 (5 hard capsules) EU/1/98/096/014 (20 hard capsules)
Maltese: EU/1/98/096/013 (5 kapsuli ibsin) EU/1/98/096/014 (20 kapsula iebsa)
English: In patients previously treated with chemotherapy, the initial dose is 150 mg/m 2 once daily, to be increased in the second cycle to 200 mg/m 2 once daily, for 5 days if there is no haematological toxicity (see section 4.4)
Maltese: F'pazjenti li qabel kienu kkurati bil-kimoterapija, id-doża tal-bidu hija 150 mg/m2 darba kuljum, li tkun miżjuda fit-tieni ċiklu għal 200 mg/m2 kuljum, għal 5 ijiem jekk ma jkunx hemm tossiċità ematoloġika (ara sezzjoni 4.4).
English: Talk to your doctor, pharmacist or nurse before taking Temodal, - as you should be observed closely for the development of a serious form of chest infection called 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: You will again receive Temodal once daily for 5 days followed by 23 days without Temodal.
Maltese: Ser terġa' tirċievi Temodal darba kuljum għal 5 ijiem segwit bi 23 jum mingħajr Temodal.
English: 9/l and platelet count > 100 x 10
Maltese: ANC ≥ 1.5 x 109/l u għadd tal-plejtlets ≥ 100 x 109/l.
English: Tel.: +420 233 010 111 dpoc_czechslovak@merck.com
Maltese: +32(0)27766211 dpoc_belux@merck.com
English: After reconstitution, use the solution within 14 hours at 25 C, including infusion time.
Maltese: Wara r-rikostituzzjoni, uża s-soluzzjoni fi żmien 14-il siegħa f'temperatura ta' 25ºC, inkluż il-ħin talinfużjoni.
English: Hepatobiliary disorders Uncommon:
Maltese: Soluzzjoni imħallta:
English: Temodal 180 mg hard capsules have an opaque white body, an opaque orange cap, and are imprinted with black ink.
Maltese: Temodal 180 mg kapsuli ibsin għandhom parti opaka bajda, għatu opak oranġjo, u huma stampati b'inka sewda.
English: Haemorrhage, embolism pulmonary, deep vein thrombosis, hypertension
Maltese: Emorraġija, emboliżmu fil-pulmun, trombożi fil-vini tal-fond, pressjoni għolja
English: Local injection site adverse reactions, which were mostly mild and short-lived were reported in patients receiving Temodal 2.5 mg/ml powder for solution for infusion.
Maltese: Reazzjonijiet avversi fis-sit mnejn tingħata l-injezzjoni, li kienu fil-parti l-kbira ħfief u ma damux, kienu rrappurtati f'pazjenti li kienu qed jirċievu Temodal 2.5 mg/ml trab għal soluzzjoni għallinfużjoni.
English: Temodal 180 mg hard capsules
Maltese: Temodal 180 mg kapsuli ibsin
English: EU/1/98/096/021 (5 hard capsules) EU/1/98/096/022 (20 hard capsules)
Maltese: EU/1/98/096/021 (5 kapsuli ibsin) EU/1/98/096/022 (20 kapsula iebsa)
English: Results of the Ames/salmonella and Human Peripheral Blood Lymphocyte (HPBL) chromosome aberration tests showed a positive mutagenicity response.
Maltese: Ir-riżultati ta' chromosome aberration tests ta' l-Ames/salmonella u l-Limfoċit tad-Demm Periferali
English: Temodal 100 mg hard capsules have an opaque white body, an opaque pink cap, and are imprinted with black ink.
Maltese: Temodal 100 mg kapsuli ibsin għandhom parti opaka bajda, għatu opak roża, u huma stampati b'inka sewda.
English: MSD Polska Sp. z o.o.
Maltese: Danmark MSD Danmark ApS
English: A treatment cycle with Temodal lasts 28 days.
Maltese: Kull wieħed idum 28 jum.
English: EU/1/98/096/019 (5 hard capsules) EU/1/98/096/020 (20 hard capsules)
Maltese: EU/1/98/096/019 (5 kapsuli ibsin) EU/1/98/096/020 (20 kapsula iebsa)
English: EU/1/98/096/009 (5 hard capsules) EU/1/98/096/010 (20 hard capsules)
Maltese: EU/1/98/096/009 (5 kapsuli ibsin) EU/1/98/096/0010 (20 kapsula iebsa)
English: 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 10
Maltese: Fil-bidu ta' Ċiklu 2, id-doża tiżdied għal 200 mg/m2 jekk ittossiċità mhux ematoloġika CTC għal Ċiklu 1 huwa Grad ≤ 2 (ħlief għal alopeċja, tqalligħ u rimettar), jekk l-għadd assolut tan-newtrofili (ANC) jkun ≥ 1.5 x 109/l, u l-għadd tat-tromboċiti jkun ≥ 100 x 109/l.
English: Tel: +43 (0) 1 26 044 msd-medizin@merck.com
Maltese: +372 6144 200 msdeesti@merck.com
English: During the concomitant phase, your doctor will start Temodal at a dose of 75 mg/m2 (usual dose).
Maltese: Waqt il-fażi konkomitanti, it-tabib tiegħek ser jibdielek Temodal b'doża ta' 75 mg/m2 (doża tas-soltu).
English: Analysis of population-based pharmacokinetics of TMZ revealed that plasma TMZ clearance was independent of age, renal function or tobacco use.
Maltese: Analiżi tal-farmakokinetika ta' TMZ ibbażata fuq il-popolazzjoni wrew li t-tneħħija mill-plażma ta' TMZ kienet indipendenti mill-età, funzjoni tal-kliewi jew l-użu tat-tabakk.
English: Other side effects that have been reported are listed below:
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq:
English: Patients with hepatic or renal impairment
Maltese: Pazjenti b'indeboliment epatiku jew renali
English: Liver enzymes elevation j, weight decreased, weight increased
Maltese: Taħżinx f'temperatura 'l fuq minn 30°C
English: Slovenská republika Merck Sharp & Dohme, s. r. o. Tel.: +421 2 58282010 dpoc_czechslovak@merck.com
Maltese: Slovenija Merck Sharp & Dohme, inovativna zdravila d.o.o. Tel: +386 1 5204 201
English: Capsule shell: gelatin, titanium dioxide (E 171), sodium lauril sulfate, yellow iron oxide (E 172)
Maltese: titanium dioxide (E 171), sodium lauril sulfate, yellow iron oxide (E 172)
English: OTHER
Maltese: Limited
English: EU/1/98/096/015 (5 hard capsules) EU/1/98/096/016 (20 hard capsules
Maltese: EU/1/98/096/015 (5 kapsuli ibsin) EU/1/98/096/016 (20 kapsula iebsa)
English: • which days are your dosing days.
Maltese: • liema ġranet huma l-jiem tad-doża.
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Maltese: Għalhekk mhux probabbli li ser tirċievi aktar Temodal milli suppost.
English: EU/1/98/096/009 EU/1/98/096/010 EU/1/98/096/017 EU/1/98/096/018
Maltese: EU/1/98/096/017 EU/1/98/096/018
English: For patients on a 42 day treatment cycle liver function tests should be repeated midway during this cycle.
Maltese: Għall-pazjenti fuq ċiklu ta' kura ta' 42 jum it-testijiet tal-funzjoni tal-fwied għandhom jiġu ripetuti f'nofs dan iċ-ċiklu.
English: EU/1/98/096/003 EU/1/98/096/004 EU/1/98/096/013 EU/1/98/096/014
Maltese: EU/1/98/096/003 EU/1/98/096/004
English: Dose-related reductions in leukocytes and platelets appear to be sensitive indicators of toxicity.
Maltese: It-tnaqqis fil-lewkoċiti u fil-plejtlets relatat mad-doża jidher li huwa indikatur sensittiv tat-tossiċità.
English: Single-cycle (5-day dosing, 23 days non-treatment), 3- and 6-cycle toxicity studies were conducted in rats and dogs.
Maltese: Studi dwar l-effett tossiku minn ċiklu wieħed (dożaġġ ta' 5 ijiem, 23 jum mingħajr trattament), 3- u 6-ċikli kienu magħmula fuq firien u klieb.
English: Hepatitis due to hepatitis B virus (HBV) reactivation, in some cases resulting in death, has been reported.
Maltese: Kienet irrappurtata epatite minħabba l-attivazzjoni mill-ġdid tal-virus tal-epatite B (HBV - hepatitis B virus), li f'xi każijiet wasslet għall-mewt.
English: The carton contains 5 or 20 hard capsules, individually sealed in sachets.
Maltese: Il-kartuna fiha 5 jew 20 kapsula iebsa, issiġillati b'mod individwali fi qratas.
English: C-labelled TMZ, mean faecal excretion of
Maltese: Il-Ġustifikazzjoni biex ma jkunx inkluż il-Braille hija aċċettata
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 irċevew flimkien TMZ (75 mg/m2) darba kuljum, bdew fl-ewwel jum ta' RT sa l-aħħar jum ta' RT għal 42 jum (sa mhux aktar minn 49 jum).
English: RT+TM Z
Maltese: FULJETT TA' TAGĦRIF
English: Ιtalia
Maltese: U LUŻU
English: Temodal is administered in combination with focal radiotherapy (concomitant phase) followed by up to 6 cycles of temozolomide (TMZ) monotherapy (monotherapy phase).
Maltese: Temodal jingħata flimkien ma' radjuterapija fokali (fażi konkomitanti) segwit b'mhux aktar minn 6 ċikli b'monoterapiji ta' temozolomide (TMZ) (fażi ta' monoterapija).
English: The addition of concomitant TMZ to RT, followed by TMZ monotherapy in the treatment of patients with newly-diagnosed glioblastoma multiforme demonstrated a statistically significant improvement in overall survival (OS) compared with RT alone (Figure 1).
Maltese: Fiż-żewġ provi, il-fini primarju kien is-sopravivenza mingħajr progressjoni (PFS) kif definita minn skans ta' MRI jew mis-sistema newroloġika li tmur għall-agħar.
English: In patients previously untreated with chemotherapy, TMZ is administered orally at a dose of 200 mg/m 2 once daily for the first 5 days followed by a 23 day treatment interruption (total of 28 days).
Maltese: F'pazjenti li qabel ma kinux ikkurati bil-kimoterapija, TMZ jittieħed f'doża ta' 200 mg/m2 darba kuljum għall-ewwel 5 ijiem, segwiti minn 23 jum ta' waqfien mill-kura (total ta' 28 jum).
English: Behaviour disorder, emotional lability, hallucination, apathy
Maltese: Disturb fl-imġiba, burdata tinbidel malajr, alluċinazzjoni, apatija
English: Hearing impairment, hyperacusis, otitis media
Maltese: disturb gastrointestinali, murliti, ħalq xott
English: In preclinical studies in rats and rabbits receiving 150 mg/m TMZ, 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 jirċievu 150 mg/m2 TMZ, intwerew teratoġeniċità u/jew effett tossiku fuq il-fetu (ara sezzjoni 5.3). Temodal m'għandux jingħata lil nisa tqal.
English: Newly-diagnosed glioblastoma multiforme
Maltese: GĦAMLA KWALITATTIVA
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.
Maltese: Għalhekk, hija meħtieġa profilassi kontra PCP għall-pazjenti kollha li jkunu qegħdin jirċievu TMZ flimkien ma' RT għall-kors ta' 42 jum (b'massimu ta' 49 jum), irrispettivament mill-għadd tal-limfoċiti.
English: Temodal powder for solution for infusion
Maltese: Temodal trab għal soluzzjoni għall-infużjoni
English: Fever, influenza-like symptoms, asthenia, malaise, pain, oedema, oedema peripheral i
Maltese: Deni, sintomi bħal tal-influwenza, astenja, telqa tal ġisem mingħajr sinjali ta' mard, uġigħ, edima, edima periferalii
English: EU/1/98/096/024 (5 hard capsules) EU/1/98/096/025 (20 hard capsules)
Maltese: EU/1/98/096/07 (5 kapsuli ibsin) EU/1/98/096/08 (20 kapsula iebsa)
English: NN
Maltese: D.
English: TMZ discontinuation
Maltese: TMZ a
English: Temodal 5 mg hard capsules have an opaque white body, an opaque green cap, and are imprinted with black ink.
Maltese: Temodal 5 mg kapsuli ibsin għandhom parti opaka bajda, għatu opak aħdar, u huma stampati b'inka sewda.
English: The median survival was 7.34 and 5.66 months for TMZ and procarbazine, respectively (log rank p = 0.33).
Maltese: Is-sopravivenza medjana kienet ta' 7.34 u 5.66 xhur għal TMZ u procarbazine, rispettivament (log rank p = 0.33). Mas-6 xhur, il-porzjon talpazjenti li baqgħu ħajjin kien ogħla b'mod sinifikanti fil-fergħa ta' TMZ (60 %) meta mqabbel malfergħa ta' procarbazine (44 %) (chi-square p = 0.019).
English: Adverse reactions reported during the two studies with the intravenous formulation (n=35) but not in studies using hard capsules, were infusion site reactions: pain, irritation, pruritus, warmth, swelling, and erythema, as well as haematoma.
Maltese: Reazzjonijiet avversi rrappurtati waqt iż-żewġ studji bil-mod li jingħata minn ġolvini (n=35) iżda li ma seħħewx bil-kapsuli ibsin, kienu reazzjonijiet tas-sit mnejn tingħata l-injezzjoni: uġigħ, irritazzjoni, ħakk, ħruq, nefħa u ħmura kif ukoll ematoma.
English: Elderly patients appear to be at increased risk of neutropenia and thrombocytopenia, compared with younger patients.
Maltese: It-tromboċitopenija żżid irriskju ta' emorraġija, u meta jkun hemm newtropenija jew lewkopenija jkun hemm riskju akbar ta' infezzjoni.
English: Uncommon side effects (may affect up to 1 in 100 people) are: - brain infections (meningoencephalitis herpetic) including fatal cases - new or reactivated cytomegalovirus infections - reactivated hepatitis B virus infections - secondary cancers including leukaemia - reduced blood cell counts (pancytopenia, anaemia, leukopenia) - red spots under the skin
Maltese: Effetti sekondarji mhux komuni (jistgħu jaffettwaw sa persuna 1 minn kull 100 ) huma: - infezzjonijiet fil-moħħ (meningoenċefalite erpetika) inklużi każijiet fatali - infezzjonijiet ġodda jew attivati mill-ġdid ta' ċitomegalovirus - infezzjonijiet attivati mill-ġdid tal-virus tal-epatite B - kanċers sekondarji inkluża lewkimja - għadd imnaqqas ta' ċelluli tad-demm (panċitopenija, anemija, lewkopenija) - dbabar ħomor taħt il-ġilda - dijabete insipidus (sintomi jinkludu żieda fl-għamil tal-awrina u tħossok bil-għatx), livell baxx ta' potassium fid-demm
English: Adverse reactions in patients treated with temozolomide Infections and infestations
Maltese: Reazzjonijiet avvesris f'pazjenti ttrattati b'temozolomide Infezzjonijiet u infestazzjonijiet
English: TMZ dosing interruption or discontinuation during concomitant radiotherapy and TMZ
Maltese: TWISSIJA SPEĊJALI LI L-PRODOTT MEDIĊINALI GĦANDU JINŻAMM
English: Disodium phosphate dodecahydrate Concentrated hydrochloric acid Purified water
Maltese: Disodium phosphate dodecahydrate Concentrated hydrochloric acid Ilma ppurifikat
English: Fertility No data is available
Maltese: Fertilità Ebda dejta disponibbli
English: The relative bioavailability of tocofersolan tended to be higher (Frel of 1.01 ± 1.74) with AUC0-t of 0.383 ± 0.203µM.h/mg, Cmax of 0.013 ± 0.006, tmax of 6.0 h (6.0 - 24.0), and t1/2 of 29.7 h (16.0 - 59.5).
Maltese: Il-bijodisponibbiltà relattiva ta' tocofersolan kellha t-tendenza li tkun ogħla (Frel ta' 1.01 ± 1.74) b'AUC0-t ta' 0.383 ± 0.203µM.h/mg, Cmax ta' 0.013 ± 0.006, tmax ta' 6.0 h (6.0 - 24.0), u t1/2 ta' 29.7 h (16.0 - 59.5).
English: Oral solution volume (ml)
Maltese: Volum tas-soluzzjoni orali (ml)
English: 10 ml 20 ml 60 ml
Maltese: Soluzzjoni orali 10 ml 20 ml 60 ml