FrancophonIA/ELRC3.0 huggingface dataset:
English: • in adults with newly-diagnosed glioblastoma multiforme.
Maltese: • f'adulti li jkunu għadhom kif ġew iddijanjostikati bi glioblastoma multiforme.
English: In very rare cases, patients taking temozolomide and medicines like it may have a small risk of developing secondary cancers, including leukaemia.
Maltese: F'każijiet rari ħafna, pazjenti li jieħdu temozolomide u mediċini simili, jista' jkollhom riskju żgħir li jiżviluppaw kanċers sekondarji inkluż lewkimja.
English: Hepatotoxicity
Maltese: Temozolomide
English: When laboratory abnormalities and adverse events were combined across concomitant and monotherapy treatment phases, Grade 3 or Grade 4 neutrophil abnormalities including neutropenic events were observed in 8 % of the patients.
Maltese: Meta l-anormalitajiet tal laboratorju u l-avvenimenti avversi kienu kkombinati tul il-fażijietta' kura konkomittanti u dik bħala monoterapija, kienu osservati anormalitajiet ta' Grad 3 jew ta' Grad 4, fin-newtrofili, inkluż avvenimenti newtropeniċi fi 8% tal-pazjenti.
English: Metabolism and nutrition disorders Very common:
Maltese: Disturbi fil-metaboliżmu u n-nutrizzjoni Komuni ħafna:
English: Uncommon (may affect up to 1 in 100 people):
Maltese: Mhux komuni (jistgħu jaffettwaw sa persuna waħda minn kull 100):
English: You will again take Temozolomide Sandoz once daily for 5 days followed by 23 days without Temozolomide Sandoz.
Maltese: Ser terġa' tieħu Temozolomide Sandoz darba kuljum għal 5 ijiem segwit bi 23 jum mingħajr Temozolomide Sandoz.
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 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: Detailed information on this medicine is available on the website of the European Medicines Agency (EMA) http://www.ema.europa.eu/
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għallMediċini http://www.ema.europa.eu/
English: In vivo, the t1/2 of MTIC was similar to that of TMZ, 1.8 hr. Absorption After oral administration to adult patients, TMZ is absorbed rapidly with peak concentrations reached as early as 20 minutes post-administration (mean time between 0.5 and 1.5 hours).
Maltese: Wara l-għoti orali lil pazjenti adulti, TMZ jiġi assorbit malajr, bl-ogħla konċentrazzjonijiet jintlaħqu anki 20 minuta wara li jkun ingħata (ħin medju 0.5 u 1.5 sigħat).
English: Temozolomide Sandoz 20 mg hard capsules Each capsule contains 20 mg temozolomide.
Maltese: Temozolomide Sandoz 20 mg kapsuli ibsin Kull kapsula fiha 20 mg ta' temozolomide.
English: Adult patients with newly-diagnosed glioblastoma multiforme
Maltese: Pazjenti adulti li jkunu għadhom kif ġew iddijanjostikati bi glioblastoma multiforme
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, kif ukoll bħala monoterapija wara RT għal glioblastoma multiforme li tkun għadha kif ġiet iddijanjostikata, jew bħala monoterapija f'pazjenti bi glijoma rikorrenti jew progressiva, ir-reazzjonijiet avversi komuni ħani ħafna rrapportati kienu simili: tqalligħ, rimettar, stitikezza, anoressija, uġigħ ta' ras u għejja.
English: Oral use Read the package leaflet before use.
Maltese: Jista' jkun li mhux il-pakketti tad-daqsijiet kollha jkunu fis-suq.
English: Plasma clearance, volume of distribution and half-life are independent of dose.
Maltese: It-tneħħija mill-plażma, il-volum tad-distribuzzjoni u l-half-life huma indipendenti mid-doża.
English: Temozolomide Sandoz 5 mg capsules temozolomide
Maltese: Temozolomide Sandoz 5 mg kapsuli ibsin temozolomide
English: A complete blood count should be obtained on Day 22 (21 days after the first dose) or within 48 hours of that day, and weekly until ANC > 1.5 x 109/l and platelet count > 100 x 109/l.
Maltese: Għadd komplet tad-demm għandu jinkiseb fit-22 jum (21 jum wara l-ewwel doża) jew sa 48 siegħa minn dak il-jum, u kull ġimgħa sakemm l-ANC ikun > 1.5 x 109/l u l-għadd tal-plejtlets ikun > 100 x 109/l.
English: • diarrhoea
Maltese: • dijarrea
English: Each carton contains 5 or 20 hard capsules.
Maltese: Kull kartuna fiha 5 jew 20 kapsula iebsa..
English: Based on an analysis of population pharmacokinetics in phase II trials, co-administration of dexamethasone, prochlorperazine, phenytoin, carbamazepine, ondansetron, H2 receptor antagonists, or phenobarbital did not alter the clearance of TMZ.
Maltese: II, l-għoti flimkien ta' dexamethasone, prochlorperazine, phenytoin, carbamazepine, ondansetron, antagonisti tar-riċettur ta' H2, jew phenobarbital ma biddilx l-eliminazzjoni ta' Ta' TMZ.
English: The body is imprinted with “140”.
Maltese: Il-parti prinċipali hija ttimbrata b'“140”.
English: • inflammation of your sinuses
Maltese: • infjammazzjoni fis-sinuses
English: Concomitant phase
Maltese: Fażi konkomittanti
English: Deafness, vertigo, earache
Maltese: Truxija, vertigo, uġigħ fil widnejn
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: Qabel id-dożaġġ, għandhom jintlaħqu dawn il-parametri tal-laboratorju li ġejjin: ANC ≥ 1.5 x 109/l u għadd tal-plejtlets ≥ 100 x 109/l.
English: How to store Temozolomide Sandoz
Maltese: Mediċini oħra u Temozolomide Sandoz
English: Haemorrhage, oedema, oedema leg Haemorrhage, deep venous thrombosis, oedema leg
Maltese: Emorraġija, trombożi venuża profonda, edema fir-riġlejn
English: Capsule shell: gelatine, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172), water.
Maltese: Qoxra tal-kapsula: gelatine, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172), ilma.
English: Convulsions, headache
Maltese: Konvulsjonijiet, uġigħ ta' ras
English: Temozolomide Sandoz 140 mg capsules temozolomide
Maltese: Temozolomide Sandoz 140 mg kapsuli ibsin temozolomide
English: Temozolomide Sandoz 20 mg capsules temozolomide
Maltese: Temozolomide Sandoz 20 mg kapsuli ibsin temozolomide
English: Otitis media, tinnitus, hyperacusis, earache
Maltese: Otitis media, tisfir fil-widnejn,
English: prolonged pancytopenia, aplastic anaemia†
Maltese: panċitopenija li tieħu fit-tul, anemija aplastika†
English: • dose level -1 (100 mg/m2) still results in unacceptable toxicity
Maltese: • livell tad-doża -1 (100 mg/m2) xorta waħda jirriżulta f'tossiċità mhux aċċettabbli
English: Temozolomide Sandoz 250 mg capsules temozolomide
Maltese: Temozolomide Sandoz 250 mg kapsuli ibsin temozolomide
English: Convulsions were reported very commonly in the newly-diagnosed 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.
Maltese: Konvulżjonijiet kienu rrapportati b'mod komuni ħafna f'pazjenti bi glioblastoma multiforme li tkun għadha kif ġiet iddijanjostikata, li kienu qed jirċievu monoterapija, u raxx kien irrapportat b'mod komuni ħafna f'pazjenti bi glioblastoma multiforme li tkun għadha kif ġiet iddijanjostikata li kienu qed jirċievu TMZ flimkien ma' RT kif ukoll bħala monoterapija, u b'mod komuni fi glijoma rikorrenti.
English: The lowest recommended dose is 100 mg/m2.
Maltese: L-inqas doża rakkomandata hija ta' 100 mg/m2.
English: Sachet Do not store above 25 °C.
Maltese: Taħżinx f'temperatura 'l fuq minn 25°C.
English: • fever,
Maltese: • deni,
English: Temozolomide Sandoz 180 mg hard capsules Each capsule contains 180 mg temozolomide.
Maltese: Temozolomide Sandoz 180 mg kapsuli ibsin Kull kapsula fiha 180 mg ta' temozolomide.
English: Anti-emetic therapy
Maltese: EFFIKAĊI TAL-PRODOTT MEDIĊINALI
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON CONTAINING SACHETS
Maltese: Kontenut tal-pakkett u informazzjoni oħra
English: Dose level
Maltese: U KWANTITATTIVA
English: Hepatitis due to hepatitis B virus (HBV) reactivation, in some cases resulting in death, has been reported.
Maltese: Ġiet irrapportata epatite minħabba riattivazzjoni tal-virus tal-epatite B (HBV), li f'xi każijiet irriżultat f'mewt.
English: New or reactivated (recurring) cytomegalovirus infections and reactivated hepatitis B virus infections have been uncommonly reported.
Maltese: Infezzjonijiet ġodda jew riattivati (rikorrenti) minn cytomegalovirus u infezzjonijiet riattivati b'virus tal-epatite B ġew irrapportati b'mod mhux komuni.
English: Temozolomide Sandoz 100 mg hard capsules Each capsule contains 100 mg temozolomide.
Maltese: Temozolomide Sandoz 100 mg kapsuli ibsin Kull kapsula fiha 100 mg ta' temozolomide.
English: Capsule shell: gelatine, titanium dioxide (E 171), yellow iron oxide (E 172), water.
Maltese: Qoxra tal-kapsula: gelatine, titanium dioxide (E 171), yellow iron oxide (E 172), ilma.
English: Capsule shell: gelatine, titanium dioxide (E 171), red iron oxide (E 172), water.
Maltese: Qoxra tal-kapsula: gelatine, titanium dioxide (E 171), red iron oxide (E 172), ilma.
English: Temozolomide Sandoz 250 mg hard capsules Each capsule contains 250 mg temozolomide.
Maltese: Temozolomide Sandoz 250 mg kapsuli ibsin Kull kapsula fiha 250 mg ta' temozolomide.
English: Convulsions, consciousness decreased, somnolence, aphasia, balance impaired, dizziness, confusion, memory impairment, concentration impaired, neuropathy, paresthesia, speech disorder, tremor
Maltese: Konvulżjonijiet, tnaqqis fil-livell ta' għarfien, ngħas, afażja, telf tal ekwilibriju, sturdament, konfużjoni, indeboliment talmemorja, indeboliment tal konċentrazzjoni, newropatija,
English: • vaginal irriation
Maltese: Fertilità fl-irġiel
English: Administration of TMZ with food resulted in a 33 % decrease in Cmax and a 9 % decrease in area under the curve (AUC).
Maltese: L-għoti ta' TMZ mal-ikel irriżulta fi tnaqqis ta' 33 % fis-Cmax u fi tnaqqis ta' 9 % fl-erja taħt il-kurva
English: Treatment-emergent events during concomitant and monotherapy treatment phases in patients with newly-diagnosed glioblastoma multiforme System organ class
Maltese: Fit-tabelli, l-effetti mhux mixtieqa huma klassifikati skont is-Sistema tal-Klassifika tal-Organi u lfrekwenza.
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: keratokantoma tal-ġilda u basal cell adenoma kienu osservati fi studju ta' 6 ċikli fuq il-firien, filwaqt li l-ebda tumur jew tibdil pre-neoplastiku ma kien evidenti fi studji fuq il-klieb.
English: CZ.Sandoz.Regulatory_ORG_GX_cz@dl.mgd.no vartis.com
Maltese: • dardir (tħoss l-istonku mhux f'postu)
English: Temozolomide Sandoz 140 mg hard capsules Each capsule contains 140 mg temozolomide.
Maltese: Temozolomide Sandoz 140 mg kapsuli ibsin Kull kapsula fiha 140 mg ta' temozolomide.
English: The colour of the capsule cap is different for each strength (see in the table below).
Maltese: Il-kulur tal-għatu talkapsula huwa differenti għal kull qawwa (ara t-tabella hawn taħt).
English: • chills
Maltese: • ngħas
English: reduced blood cell counts (pancytopenia, anaemia, leukopenia).
Maltese: tnaqqis fin-numru tal-għadd ta' ċelloli tad-demm (panċitopenija, anemija, lewkopenija).
English: CTC Grade 4b a: TMZ dose levels are listed in Table 2. b: TMZ is to be discontinued if:
Maltese: Il-livelli tad-doża ta' TMZ huma elenkati fit-Tabella 2.
English: • thirst
Maltese: • tertir
English: The body is imprinted with “250”.
Maltese: Il-parti prinċipali hija ttimbrata b'“250”.
English: Sachet
Maltese: Kundl
English: • allergic reaction
Maltese: • reazzjoni allerġika
English: Temozolomide Sandoz 180 mg capsules temozolomide
Maltese: Temozolomide Sandoz 180 mg kapsuli ibsin temozolomide
English: Temozolomide Sandoz 100 mg capsules temozolomide
Maltese: Temozolomide Sandoz 100 mg kapsuli ibsin temozolomide
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: 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: assorbiment ta' temozolomide jew fl-esponiment għall-metabolit attiv tiegħu monomethyl triazenoimidazole carboxamide (MTIC).
English: Temozolomide Sandoz is administered in combination with focal radiotherapy (concomitant phase) followed by up to 6 cycles of temozolomide (TMZ) monotherapy (monotherapy phase).
Maltese: Temozolomide Sandoz jingħata flimkien ma' radjuterapija fokali (fażi konkomittanti) segwit b'mhux aktar minn 6 cikli ta' monoterapija ta' temozolomide (TMZ) (fażi ta' monoterapija).
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 ħafif sa moderat tal-fwied kienu jixbhu lil dawk osservati f'pazjenti b'funzjoni tal-fwied normali.
English: Dose in Cycle 1 (monotherapy) is 150 mg/m2 once daily for
Maltese: Dan kien segwit b'monoterapija ta' TMZ (150 - 200 mg/m2) f'Jiem 1 - 5 ta' kull ċiklu ta'
English: • hallucination and memory impairment
Maltese: • alluċinazzjoni u indeboliment fil-memorja • paraliżi parzjali
English: Respiratory, thoracic and mediastinal disorders Common:
Maltese: Disturbi respiratorji, toraċiċi u medjastinali Rari ħafna:
English: • stomach or abdominal pain
Maltese: • uġigħ addominali
English: Male fertility
Maltese: Pazjenti rġiel
English: Temozolomide in combination treatment with radiotherapy in newly-diagnosed glioblastoma
Maltese: Għadd assolut ta' newtrofili
English: B-1800 Vilvoorde Tél/Tel: +32 2 738 78 37
Maltese: SI-1526 Ljubljana Tel: +386 1 580
English: Temozolomide Sandoz 140 mg hard capsules blue
Maltese: Temozolomide Sandoz 140 mg kapsuli ibsin blu
English: • muscle weakness
Maltese: • impotenza sesswali
English: • vaginal bleeding
Maltese: • fsada vaġinali
English: Blood and lymphatic system disorders Common:
Maltese: Disturbi fis-sistema riproduttiva u fis-sider Mhux komuni:
English: Strength
Maltese: Fixkun
English: Temozolomide Sandoz 5 mg hard capsules
Maltese: Temozolomide Sandoz 5 mg kapsuli ibsin
English: Temozolomide Sandoz 5 mg hard capsules Each capsule contains 5 mg temozolomide.
Maltese: Temozolomide Sandoz 5 mg kapsuli ibsin Kull kapsula fiha 5 mg ta' temozolomide.
English: CTC non-haematological toxicity (except for alopecia, nausea, vomiting) CTC Grade 2
Maltese: Tossiċità mhux ematoloġika ta' CTC (ħlief għal alopeċja, tqalligħ u rimettar)
English: • deafness
Maltese: • rimettar
English: Dyspnoea, coughing
Maltese: Emipleġja, atassja,
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: The hazard ratio (HR) for overall survival was 1.59 (95 % CI for HR=1.33-1.91) with a log-rank p < 0.0001 in favour of the TMZ arm.
Maltese: Il-proporzjon tal-periklu (HR) għas-sopravivenza ġenerali kien ta' 1.59 (95 % CI għal HR=
English: Temozolomide Sandoz 180 mg hard capsules maroon
Maltese: Temozolomide Sandoz 180 mg kapsuli ibsin
English: Dysuria
Maltese: Diżurja
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: bin-nadir ikun bejn Jum 21 u Jum 28), u l-irkupru kien wieħed mgħaġġel, normalment fi żmien 1-2 ġimgħat.
English: Temozolomide Sandoz 250 mg hard capsules white
Maltese: Temozolomide Sandoz 250 mg kapsuli ibsin
English: In some cases, it may be prolonged and may lead to a very severe form of anaemia (aplastic anaemia).
Maltese: F'xi każijiet, jista' jieħu fit-tul u jista' jwassal għal forma ta' anemija serja ħafna (anemija aplastika).
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 jiġu applikati skont it-Tabelli 2 u 3.
English: Temozolomide Sandoz 250 mg hard capsules Capsule content: anhydrous lactose, colloidal anhydrous silica, sodium starch glycolate type A, tartaric acid, stearic acid.
Maltese: Temozolomide Sandoz 250 mg kapsuli ibsin Kontenut tal-kapsula: anhydrous lactose, colloidal anhydrous silica, sodium starch glycolate type A, tartaric acid, stearic acid.
English: • pain
Maltese: • deni
English: Industriestr.
Maltese: KLINIKU
English: Psychiatric disorders Common:
Maltese: Kategorija farmakoterapewtika:
English: Pharmacotherapeutic group: Antineoplastic agents - Other alkylating agents, ATC code: L01AX03 Mechanism of action
Maltese: Aġenti antineoplastiċi - Sustanzi ta' alkalizzazzjoni oħrajn, Kodiċi
English: Temozolomide Sandoz 20 mg hard capsules
Maltese: Temozolomide Sandoz 20 mg kapsuli ibsin
English: a: Treatment with concomitant TMZ can be continued when all of the following conditions are met: absolute neutrophil count ≥ 1.5 x 109/l; thrombocyte count ≥ 100 x 109/l; CTC non-haematological toxicity ≤ Grade 1 (except for alopecia, nausea, vomiting).
Maltese: Il-kura b'TMZ mogħti b'mod konkomittanti tista' titkompla meta jiġu sodisfatti dawn il-kondizzjonijiet kollha li ġejjin: għadd assolut tan-newtrofili ≥ 1.5 x 109/l; għadd tat-tromboċiti ≥ 100 x 109/l; tossiċità mhux ematoloġika ta' CTC ta' ≤ Grad 1 (ħlief għal alopeċja, tqalligħ, rimettar).
English: The body is imprinted with “180”.
Maltese: Il-parti prinċipali hija ttimbrata b'“180”.
English: Temozolomide Sandoz 140 mg hard capsules Capsule content: anhydrous lactose, colloidal anhydrous silica, sodium starch glycolate type A, tartaric acid, stearic acid.
Maltese: Temozolomide Sandoz 140 mg kapsuli ibsin Kontenut tal-kapsula: anhydrous lactose, colloidal anhydrous silica, sodium starch glycolate type A, tartaric acid, stearic acid.
English: Temozolomide Sandoz 140 mg hard capsules
Maltese: Temozolomide Sandoz 140 mg kapsuli ibsin
English: Novartis (Hellas) S.A.C.I 18, Kifisias Ave. & Gyzi, 151 25 Marousi, Athens Τηλ: +30 216 6005011 regulatory.greece@sandoz.com
Maltese: Sandoz s.r.o. Na Pankráci 1724/129 CZ-140 00, Praha 4 Tel: +420 225 755 111 CZ.Sandoz.Regulatory_ORG_GX_cz@dl.mgd.no vartis.com
English: Temozolomide Sandoz 100 mg hard capsules Capsule content: anhydrous lactose, colloidal anhydrous silica, sodium starch glycolate type A, tartaric acid, stearic acid.
Maltese: Temozolomide Sandoz 100 mg kapsuli ibsin Kontenut tal-kapsula: anhydrous lactose, colloidal anhydrous silica, sodium starch glycolate type A, tartaric acid, stearic acid.
English: Table 5 includes adverse reactions reported during clinical trials for recurrent or progressive malignant glioma and following the marketing of TMZ.
Maltese: Tabella 5 tinkludi reazzjonjiet avversi li ġew irrapportati fi provi kliniċi għall-glijoma malinna rikorrenti jew progressiva u wara t-tqegħid fis-suq ta' TMZ.
English: Temozolomide Sandoz 100 mg hard capsules
Maltese: Temozolomide Sandoz 100 mg kapsuli ibsin
English: TMZ.
Maltese: Sess
English: Temozolomide Sandoz 180 mg hard capsules Capsule content: anhydrous lactose, colloidal anhydrous silica, sodium starch glycolate type A, tartaric acid, stearic acid.
Maltese: Temozolomide Sandoz 180 mg kapsuli ibsin Kontenut tal-kapsula: anhydrous lactose, colloidal anhydrous silica, sodium starch glycolate type A, tartaric acid, stearic acid.
English: Temozolomide Sandoz 100 mg hard capsules pink
Maltese: Temozolomide Sandoz 100 mg kapsuli ibsin roża
English: The body is imprinted with “20”.
Maltese: Il-parti prinċipali hija ttimbrata b'“20”.
English: Analysis of population-based pharmacokinetics of TMZ revealed that plasma TMZ clearance was independent of age, renal function or tobacco use.
Maltese: TMZ kienet indipendenti mill-età, funzjoni tal-kliewi jew l-użu tat-tabakk.
English: You will again receive Temozolomide Sandoz once daily for 5 days, followed by 23 days without Temozolomide Sandoz.
Maltese: Imbagħad terġa' tibda tingħata Temozolomide Sandoz darba kuljum għal ħamest ijiem, segwiti minn 23 jum mingħajr Temozolomide Sandoz.
English: Meningoencephalitis herpetic
Maltese: • nefħa fil-wiċċ
English: CZ-140 00, Praha 4
Maltese: L01AX03
English: • earache
Maltese: • truxija
English: Method of administration Temozolomide Sandoz hard capsules should be administered in the fasting state.
Maltese: Temozolomide Sandoz kapsuli ibsin għandhom jittieħdu meta wieħed ikun fi stat sajjem.
English: Hepatic injury, including fatal hepatic failure, has been reported in patients treated with TMZ (see section 4.8).
Maltese: Ħsara fil-fwied, li tinkludi insuffiċjenza fatali tal-fwied, kienet irrappurtata f'pazjenti kkurati b'TMZ (ara sezzjoni 4.8).
English: Malignancies
Maltese: FARMAĊEWTIKU
English: Common (may affect up to 1 in 10 people):
Maltese: Komuni (jistgħu jaffettwaw sa persuna waħda minn kull 10):
English: • Skin redness
Maltese: disturbi fis-snien
English: Special populations Paediatric population In patients 3 years of age or older, TMZ is only to be used in recurrent or progressive malignant glioma.
Maltese: Pazjenti adulti u pedjatriċi minn 3 snin ' il fuq bi glijoma malinna rikorrenti jew progressiva
English: Infection, Herpes simplex, wound infection, pharyngitis, candidiasis oral
Maltese: Infezzjoni, Herpes simplex,
English: Dose during Cycles 2-6 in absence of toxicity
Maltese: Dożi waqt Ċikli 2-6 jekk ma jkunx hemm tossiċità
English: • flu-like symptoms
Maltese: • indeboliment fl-ekwilibriju
English: The bottles contain a desiccant pouch.
Maltese: Il-kartuna fiha flixkun wieħed.
English: Constipation, nausea, vomiting Constipation, nausea, vomiting
Maltese: Aġitazzjoni, apatija, disturbi fl imġiba, dipressjoni, alluċinazzjoni
English: This latency period is very short even for an alkylating agent.
Maltese: Il-perijodu ta' latency huwa qasir ħafna, anke għal sustanzi ta' alkalizzazzjoni.
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: Id-doża f'Ċiklu 1 (monoterapija) hija 150 mg/m2 darba kuljum għal 5 ijiem segwiti minn 23 jum mingħajr kura.
English: Somnolence, dizziness, paresthesia
Maltese: Dijarea, uġigħ addominali, dispepsija
English: (≥1/10,000 to <1/1,000); Very rare (<1/10,000), Not known: frequency cannot be estimated from the available data.
Maltese: (≥1/10,000 sa <1/1,000);
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: TMZ flimkien ma' RT, segwit b'monoterapija ta' TMZ fil-kura ta' pazjenti bi glioblastoma multiforme li kienet għadha kif ġiet iddijanjostikata wasslet għal titjib statistikament sinifikanti fissopravivenza ġenerali (OS) meta mqabbel ma' RT waħedha (Figura 1).
English: Bottle
Maltese: Treddigħ
English: What you need to know before you take Temozolomide Sandoz Do not take Temozolomide Sandoz
Maltese: F'ċerti każi, jista' jkun hemm bżonn li t-trattament b'Temozolomide Sandoz jitwaqqaf.
English: Kύπρος Γ.Α.Σταμάτης & Σια Λτδ.
Maltese: Γ.Α.Σταμάτης & Σια Λτδ.