FrancophonIA/ELRC3.0 huggingface dataset:
English: Rash, pruritus, alopecia
Maltese: Raxx, ħakk, alopeċja
English: Printing ink
Maltese: imnieħer imblukkat
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).
Maltese: 4.4 Twissijiet speċjali u prekawzjonijiet għall-użu Infezzjonijiet opportunistiċi u riattivazzjoni tal-infezzjonijiet Infezzjonijiet opportunistiċi (bħal pnewmonja Pneumocystis jirovecii) u riattivazzjoni tal infezzjonijiet (bħall-HBV, CMV) ġew osservati matul il-kura b'TMZ (ara sezzjoni 4.8).
English: Musculoskeletal and connective tissue disorders Common:
Maltese: Disturbi muskolu-skeletriċi u tat-tessuti konnettivi Komuni:
English: Pneumonia, sinusitis, upper respiratory infection, bronchitis
Maltese: Pulmonite, sinusite, infezzjoni filparti ta' fuq tal-apparat respiratorju, bronkite
English: TMZ was administered as salvage therapy in the follow-up phase in 161 patients of the 282 (57 %) in the RT alone arm, and 62 patients of the 277 (22 %) in the TMZ + RT arm.
Maltese: TMZ ingħata bħala terapija ta' salvataġġ fil-fażi ta' follow-up f'161 pazjent mill-282 (57 %) filfergħa b'RT waħdu, u f'62 pazjent mill-277 (22 %) fil-fergħa ta' TMZ + RT.
English: One was a non-comparative trial in 138 patients (29 % received prior chemotherapy), and the other was a randomised active-controlled trial of TMZ vs procarbazine in a total of 225 patients (67 % received prior treatment with nitrosourea based chemotherapy).
Maltese: Waħda kienet prova mhux komparattiva f'138 pazjent (29 % irċevew kemoterapija qabel), u l-oħra kienet prova randomizzata ikkontrollata b'mod attiv ta' TMZ vs procarbazine f'total ta' 225 pazjent (67 % irċevew trattament qabel bil-kemoterapija bbażata fuq nitrosourea).
English: Each hard capsule contains 73 mg of anhydrous lactose.
Maltese: Kull kapsula iebsa fiha 73 mg ta' anhydrous lactose.
English: TMZ can have genotoxic effects.
Maltese: TMZ jista' jkollu effetti ġenotossiċi.
English: A total of 573 patients were randomised to receive either TMZ + RT (n=287) or RT alone (n=286).
Maltese: Total ta' 573 pazjent intgħażlu b'mod randomizzat sabiex jirċievu jew TMZ + RT (n=287) jew RT waħdu (n=286).
English: Pack-size of 5 or 20 hard capsules individually sealed in sachets.
Maltese: Daqs tal-pakkett ta' 5 jew 20 kapsula iebsa ssiġillati individwalment fi qratas.
English: Anti-emetic therapy may be administered (see section 4.4).
Maltese: Kura anti-emetika tista' tingħata (ara sezzjoni 4.4).
English: ul.
Maltese: A.
English: Elderly patients Based on a population pharmacokinetic analysis in patients 19-78 years of age, clearance of TMZ is not affected by age.
Maltese: Fuq il-bażi ta' analiżi farmakokinetika tal-popolazzjoni f'pazjenti ta' età bejn 19-78 sena, leliminazzjoni ta' TMZ mhijiex affettwata mill-età.
English: positions of guanine.
Maltese: N7 ta' guanine.
English: Visual field defect, vision blurred, diplopia
Maltese: Difett fil-kamp viżiv, vista mċajpra, diplopja
English: Patients with rare hereditary problems of galactose intolerance, the total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Maltese: Pazjenti li għandhom problemi ereditarji rari ta' intolleranza għall-galactose, nuqqas totali ta' lactase jew malassorbiment tal-glucose-galactose m'għandhomx jieħdu din il-mediċina.
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: 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 kinux konsistenti fis-sottogrupp ta' pazjenti bi status baxx ta' prestazzjoni (WHO PS=2, n=70), fejn is-sopravivenza globali u ż-żmien sal-progressjoni tal-marda kienu simili fiż-żewġ gruppi.
English: Status epilepticus, extrapyramidal disorder, hemiparesis, ataxia, cognition impaired, dysphasia, gait abnormal, hyperesthesia, hypoesthesia, neurological disorder (NOS), peripheral neuropathy
Maltese: Status epilepticus, disturbi ekstrapiramidali, emipareżi, atassja, għarfien imxekkel, disfażja, mixja mhux normali, iperesteżija, ipoesteżija, disturbi newroloġiċi (NOS), newropatija periferali
English: • skin irritation or redness
Maltese: • irritazzjoni vaġinali
English: Each hard capsule contains 131.4 mg of anhydrous lactose.
Maltese: Kull kapsula iebsa fiha 131.4 mg ta' anhydrous lactose.
English: Pneumocystis jirovecii pneumonia
Maltese: Pnewmonja bi Pneumocystis jirovecii
English: Temozolomide Sandoz contains lactose
Maltese: Temozolomide Sandoz fih lactose
English: Urinary incontinence
Maltese: Inkontinenza tal-awrina
English: • in children 3 years and older and adult patients with malignant glioma , such as glioblastoma multiforme or anaplastic astrocytoma.
Maltese: • fi tfal li għandhom minn 3 snin 'il fuq u f'pazjenti adulti bi glijoma malinna, bħal glioblastoma multiforme jew astroċitoma anaplastika.
English: In some cases, exposure to concomitant medicinal products associated with aplastic anaemia, including carbamazepine, phenytoin, and sulfamethoxazole/trimethoprim, complicates assessment.
Maltese: F'xi każijiet, esponiment flistess ħin għal prodotti mediċinali assoċjati ma' anemija aplastika, inkluż carbamazepine, phenytoin, u sulfamethoxazole/trimethoprim, jikkumplika l-valutazzjoni.
English: MTIC is spontaneously hydrolyzed to 5-amino-imidazole-4-carboxamide (AIC), a known intermediate in purine and nucleic acid biosynthesis, and to methylhydrazine, which is believed to be the active alkylating species.
Maltese: MTIC huwa idrolizzat b'mod spontanju għal 5-amino imidazole-4-carboxamide (AIC), intermedju magħruf fil-bijosintesi ta' purine u aċidi nuklejiċi u għal methylhydrazine, li huwa maħsub li huwa l-ispeċi attiv li jagħmel l-alkalizzazzjoni.
English: This medicine is an antitumour agent.
Maltese: Din il-mediċina hija sustanza kontra t tumuri.
English: Each hard capsule contains 168 mg of anhydrous lactose.
Maltese: Kull kapsula iebsa fiha 168 mg ta' anhydrous lactose.
English: Each hard capsule contains 14.6 mg of anhydrous lactose.
Maltese: Kull kapsula iebsa fiha 14.6 mg ta' anhydrous lactose.
English: Printing ink: shellac, black iron oxide (E 172), potassium hydroxide.
Maltese: Inka tal-istampar: shellac, black iron oxide (E 172), potassium hydroxide.
English: No data are available.
Maltese: Dejta mhux disponibbli.
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: Intwera li pazjenti li ngħataw TMZ flimkien ma' RT fi prova pilota għall-iskeda mtawwla ta' 42 jum kellhom riskju partikolari li taqbadhom pulmonite b'Pneumocystis jirovecii (PCP).
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 tijiem) ittieħdet minn pazjent u r-reazzjonijiet avversi rrapportati kienu panċitopenja, deni, kollass ta' diversi organi u mewt.
English: Vision blurred
Maltese: Vista mċajpra
English: Very rare (may affect up to 1 in 10,000 people):
Maltese: Rari ħafna (jistgħu jaffettwaw sa persuna waħda minn kull 10,000):
English: Capsule contents Anhydrous lactose Colloidal anhydrous silica Sodium starch glycolate type A Tartaric acid
Maltese: Kontenut tal-kapsula Anhydrous lactose Colloidal anhydrous silica Sodium starch glycolate tip A Tartaric acid
English: {DD/MM/YYYY}
Maltese: {JJ/XX/SSSS}
English: Micturition frequency, urinary incontinence Urinary incontinence
Maltese: Żieda fil-frekwenza ta' mogħdija tal-awrina, inkontinenza talawrina
English: The major route of 14C elimination is renal.
Maltese: Il-mod ewlieni tal-eliminazzjoni ta' 14C huwa dak renali.
English: Haemorrhage, oedema, oedema leg
Maltese: Emorraġija, edema, edema firriġlejn
English: Neutropenia or lymphopenia (grade 3-4), thrombocytopenia (grade 3-4)
Maltese: tromboċitopenija (Grad 3-4)
English: Each hard capsule contains 182.5 mg of anhydrous lactose.
Maltese: Kull kapsula iebsa fiha 182.5 mg ta' anhydrous lactose.
English: Printing ink: contains shellac, black iron oxide (E 172), potassium hydroxide.
Maltese: Inka tal-istampar: fih shellac, black iron oxide (E 172), potassium hydroxide.
English: The cap is imprinted with “TMZ”.
Maltese: L-għatu huwa ttimbrat b'“TMZ”.
English: Each hard capsule contains 102.2 mg of anhydrous lactose.
Maltese: Kull kapsula iebsa fiha 102.2 mg ta' anhydrous lactose.
English: Cases of myelodysplastic syndrome and secondary malignancies, including myeloid leukaemia, have also been reported very rarely (see section 4.8).
Maltese: Każijiet tas-sindromu majelodisplastiku u tumuri malinni sekondarji, inkluż lewkimja majelojde ġew irrapportati b'mod rari ħafna (ara sezzjoni 4.8).
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 fl-eliminazzjoni ta' TMZ.
English: Hypokalemia, alkaline phosphatase increased, weight increased
Maltese: Ipokalimja, żieda ta' alkaline phosphatase, żieda fil-piż
English: See package leaflet for further information.
Maltese: Sorsi oħra ta' informazzjoni
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).
Maltese: F'pazjenti li qabel kienu qegħdin jiġu kkurati bilkimoterapija, id-doża tal-bidu hija 150 mg/m2 darba kuljum, li tiżdied fit-tieni ċiklu għal 200 mg/m2 kuljum, għal 5 ijiem jekk ma jkunx hemm tossiċità ematoloġika (ara sezzjoni 4.4).
English: • impaired sensations
Maltese: • indeboliment fis-sensazzjonijiet
English: Capsule shell: gelatine, titanium dioxide (E 171), indigo carmine (E 132), water.
Maltese: Qoxra tal-kapsula: gelatine, titanium dioxide (E 171), indigo carmine (E 132), ilma.
English: Data on clinical efficacy in patients with glioblastoma multiforme (Karnofsky performance status [KPS] ≥ 70), progressive or recurrent after surgery and RT, were based on two clinical trials with oral TMZ.
Maltese: Karnofsky [KPS] ≥ 70), progressiva jew rikorrenti wara kirurġija u RT, kienet ibbażata fuq żewġ provi kliniċi b'TMZ orali.
English: After oral administration of 14C-labelled TMZ, mean faecal excretion of 14C over 7 days post-dose was 0.8 % indicating complete absorption.
Maltese: TMZ tikkettat b'14C, il-medja tal-ammont ta' 14C fl-ippurgar aktar minn 7 ijiem wara d-doża kienet 0.8% li tindika assorbiment komplet.
English: • shivering
Maltese: • sturdament
English: Capsule content: anhydrous lactose, colloidal anhydrous silica, sodium starch glycolate type A, tartaric acid, stearic acid.
Maltese: Kontenut tal-kapsula: anhydrous lactose, colloidal anhydrous silica, sodium starch glycolate type A, tartaric acid, stearic acid.
English: Titanium dioxide (E 171) Yellow iron oxide (E 172) Indigo carmine (E132) Water
Maltese: Titanium dioxide (E 171) Yellow iron oxide (E 172) Indigo carmine (E 132) Ilma
English: • tooth disorder.
Maltese: • disturbi fis-snien.
English: Stomatitis, diarrhoea, dyspepsia, dysphagia, mouth dry
Maltese: Stomatite, dijarea, dispepsja,
English: In clinical trials, the most frequently occurring treatment-related undesirable effects were gastrointestinal disorders, specifically nausea (43 %) and vomiting (36 %).
Maltese: Fi provi kliniċi, l-aktar effetti mhux mixtieqa relatati mal-kura li seħħew b'mod komuni kienu disturbi gastrointestinali, speċifikament tqalligħ (43 %) u rimettar (36 %).
English: • abdominal pain
Maltese: • emboli fil-pulmun
English: 2 years.
Maltese: 28 jum.
English: Each hard capsule contains 20 mg temozolomide.
Maltese: Kull kapsula iebsa fiha 20 mg ta' temozolomide.
English: Renal and urinary disorders Common:
Maltese: Disturbi fil-kliewi u fis-sistema urinarja Komuni:
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe wieћed mill-eċċipjenti elenkati fis sezzjoni 6.1..
English: Newly-diagnosed glioblastoma multiforme
Maltese: Dejta dwar l-effikaċja klinika f'pazjenti bi glioblastoma multiforme (Status tal-prestazzjoni ta'
English: Capsule shell: gelatine, titanium dioxide (E 171), water.
Maltese: Qoxra tal-kapsula: gelatine, titanium dioxide (E 171), ilma.
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: Il-biċċa l-kbira tarreazzjonijiet emetoloġiċi avversi ġew irrapportati b'mod komuni jew komuni ħafna fiż-żewġ indikazzjonijiet (Tabelli 4 u 5); il-frekwenza tas-sejbiet tal-laboratorju ta' grad 3-4 tidher wara kull tabella.
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 il-punti ta' tmiem varja minn 0.7 sa 2.1 xhur aktar għal TMZ milli għal procarbazine (log rank p = < 0.01 sa 0.03).
English: Recurrent or progressive malignant glioma
Maltese: Glijoma malinna rikorrenti jew progressiva
English: The objective response rate (ORR) based on MRI scans was 8 %.
Maltese: Ir-rata ta' rispons oġġettiv (ORR) ibbażata fuq skens tal-MRI kienet ta' 8 %.
English: Swallow the capsule(s) whole with a glass of water.
Maltese: Ibla' l-kapsula(i) sħiħa/sħaħ ma' tazza ilma.
English: There were higher rates of Grade 4 neutropenia (ANC < 0.5 x 109/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: Each capsule is approximately 11.4 mm in length.
Maltese: Kull kapsula iebsa hija twila madwar 11.4 mm.
English: Each hard capsule contains 180 mg temozolomide.
Maltese: Kull kapsula iebsa fiha 180 mg ta' temozolomide.
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: B'mod mhux komuni ġew irrapportati każijiet ta' żjieda fil-bilirubin, problemi bil-fluss tal-bila (kolestasi) u epatite u ħsara filfwied, inkluż insuffiċjenza fatali tal-fwied.
English: Grade 3 or Grade 4 thrombocyte abnormalities, including thrombocytopenic events were observed in 14 % of the patients who received TMZ.
Maltese: Anormalitajiet ta' Grad 3 jew ta' Grad 4 fit-tromboċiti , inkluż effetti tromboċitopeniċi dehru f'14 % tal-pazjenti li ngħataw TMZ.
English: Each hard capsule contains 250 mg temozolomide.
Maltese: Kull kapsula iebsa fiha 250 mg ta' temozolomide.
English: • allergic reactions.
Maltese: • reazzjonijiet allerġiċi.
English: • dizziness
Maltese: • uġigħ
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: Studji għal glijoma rikorrenti b'288 suġġett, newtropenija ta' Grad 4 seħħet fi 1 % tan-nisa vs 0 % tas-suġġetti rġiel u tromboċitopenija ta' Grad 4 fi 8 % tan nisa vs 3 % tas-suġġetti rġiel fl-ewwel ċiklu tat-terapija.
English: Agitation, apathy, behaviour disorder, depression, hallucination
Maltese: Aġitazzjoni, apatija, disturbi flimġiba, dipressjoni, alluċinazzjoni
English: Uncommon:
Maltese: Mhux komuni:
English: Lymphopenia, petechiae
Maltese: limfopenija, lewkopenja
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 pedjatriċi kellhom AUC ogħla minn dak ta' pazjenti adulti; madankollu, id-doza massima ttollerata (MTD) kienet ta' 1,000 mg/m2 kull ċiklu kemm fit-tfal kif ukoll fl-adulti.
English: Sandoz Bulgaria Branch Office 55 Nikola Vaptzarov blvd. Building 4, floor 4
Maltese: Sandoz Bulgaria Branch Office 55
English: Pregnancy
Maltese: Kurvi
English: • if you have had an allergic reaction to dacarbazine (an anticancer medicine sometimes called DTIC).
Maltese: • jekk kellek reazzjoni allerġika għal dacarbazine (mediċina kontra l-kanċer, kultant imsejħa DTIC).
English: • loss of appetite
Maltese: • telf ta' aptit
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 tat-tromboċiti ≥ 100 x 109/l - tossiċità mhux ematoloġika ta' kriterju komuni tat-tossiċità (CTC) ta' ≤ ≤ Grad 1 (ħlief għal alopeċja, tqalligħ u rimettar).
English: Shellac
Maltese: Qawwa
English: Each hard capsule contains 140 mg temozolomide.
Maltese: Kull kapsula iebsa fiha 140 mg ta' temozolomide.
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 rikorrenti b'400 suġġett, newtropenija ta' Grad 4 seħħet fi 8 % tan-nisa vs 4 % tas-suġġetti rġiel u tromboċitopenija ta' Grad 4 fi 8 % tan nisa vs 3 % tas-suġġetti rġiel fl-ewwel ċiklu tat-terapija.
English: Muscle weakness, arthralgia, musculoskeletal pain, myalgia
Maltese: Dgħjufija fil-muskoli, artralġija Dgħjufija fil-muskoli, artralġija, uġigħ muskolu-skeletriċi, mijalġija
English: Each capsule is approximately 21.4 mm in length.
Maltese: Kull kapsula iebsa hija twila madwar 21.4 mm.
English: Titanium dioxide (E 171) Red iron oxide (E 172) Water
Maltese: Titanium dioxide (E 171) Red iron oxide (E 172) Ilma
English: Then you will have 23 days without Temozolomide Sandoz.
Maltese: Imbagħad ikollok 23 jum mingħajr Temozolomide Sandoz.
English: Results of the Ames/salmonella and Human Peripheral Blood Lymphocyte (HPBL) chromosome aberration tests showed a positive mutagenicity response.
Maltese: Periferali Uman (HPBL) urew rispons pożittiv għall-mutaġeniċità.
English: Capsule shell: gelatine, titanium dioxide (E 171), yellow iron oxide (E 172), indigo carmine (E 132), water.
Maltese: Qoxra tal-kapsula: gelatine, titanium dioxide (E 171), yellow iron oxide (E 172), indigo carmine (E 132), ilma.
English: • wound infection
Maltese: • infezzjoni tal-ferita
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: f'pazjenti b'indeboliment epatiku serju (Child's Class C) jew b'indeboliment renali.
English: Titanium dioxide (E 171) Yellow iron oxide (E 172) Red iron oxide (E 172) Water
Maltese: Titanium dioxide (E 171) Yellow iron oxide (E 172) Red iron oxide (E 172) Ilma
English: Following oral administration, approximately 5 % to 10 % of the dose is recovered unchanged in the urine over 24 hours, and the remainder excreted as temozolomide acid, 5-aminoimidazole-4-carboxamide (AIC) or unidentified polar metabolites.
Maltese: Wara għoti orali, madwar 5 % sa 10 % tad-doża tiġi rkuprata mhux mibdula mill-awrina fi żmien 24 siegħa, u l-bqija tiġi eliminata bħala aċidu temozolomide, 5-aminoimidazole-4-carboxamide
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 TMZ (75 mg/m2) darba kuljum b'mod konkomittanti, sa mill-ewwel jum ta' RT sal-aħħar jum ta' RT għal 42 jum (sa mhux aktar minn 49 jum).
English: If you are a newly-diagnosed patient (glioblastoma multiforme) you may be receiving Temozolomide Sandoz for 42 days in combination with radiotherapy.
Maltese: Jekk int pazjent li għadek kif ġejt dijanjostikat (glioblastoma multiforme) tista' tingħata Temozolomide Sandoz għal 42 jum flimkien ma' radjuterapija.
English: • followed by treatment with only Temozolomide Sandoz (monotherapy phase).
Maltese: • segwita minn kura b'Temozolomide Sandoz biss (fażi ta' monoterapija).
English: Ear and labyrinth disorders Common:
Maltese: Disturbi fil-widnejn u fis-sistema labirintika Komuni:
English: There may be up to 6 treatment periods (cycles).
Maltese: Jista' jkun hemm sa 6 perijodi ta'
English: However, since TMZ does not undergo hepatic metabolism and exhibits low protein binding, it is unlikely that it would affect the pharmacokinetics of other medicinal products (see section 5.2).
Maltese: Madankollu, billi TMZ ma jgħaddix minn metabolizmu tal-fwied u ma tantx jeħel mal-proteini, mhuwiex probabbli li jaffettwa l-farmakokinetiċi ta' prodotti mediċinali oħrajn (ara sezzjoni 5.2).
English: Temozolomide monotherapy in recurrent or progressive glioma
Maltese: Monoterapija b'Temozolomide fi glijoma rikurrenti jew progressiva
English: No evidence of cumulative myelosuppression was observed.
Maltese: Ma ġiet osservata ebda evidenza ta' majelosuppressjoni kumulattiva.
English: The half-life (t1/2) in plasma is approximately 1.8 hours.
Maltese: Il-half-life (t1/2) fil-plażma huwa ta' madwar 1.8 sigħat.
English: Each sachet contains 1 hard capsule.
Maltese: Kull qartas fih 1 kapsula iebsa.
English: Myopathy, back pain, musculoskeletal pain, myalgia
Maltese: Mijopatija, uġigħ fid-dahar, uġigħ muskolu-skeletriċi, mijalġja
English: Each hard capsule contains 5 mg temozolomide.
Maltese: Kull kapsula iebsa fiha 5 mg ta' temozolomide.
English: Titanium dioxide (E 171) Yellow iron oxide (E 172) Water
Maltese: Titanium dioxide (E 171) Yellow iron oxide (E 172) Ilma
English: Each hard capsule contains 100 mg temozolomide.
Maltese: Kull kapsula iebsa fiha 100 mg ta' temozolomide.
English: Median overall survival was 14.6 months.
Maltese: Il-medjan tas-sopravivenza totali kien ta' 14.6 xhur.
English: Newly-diagnosed glioblastoma multiforme Table 4 provides treatment-emergent adverse events in patients with newly-diagnosed glioblastoma multiforme during the concomitant and monotherapy phases of treatment.
Maltese: It-Tabella 4 turi effetti avversi li ħarġu mal-kura f'pazjenti li jkunu għadhom kif ġew iddijanjostikati bi glioblastoma multiforme waqt il-fażijiet ta' terapija konkomittanti u monoterapija.
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 bil-farmakokinetiċi tal-popolazzjoni, ta' esperjenza bi prova klinika kien hemm 101 mara u 169 raġel li għalihom, il-valuri l-aktar baxxi tan-newtrofili kienu disponibbli u 110 nisa u 174 raġel li għalihom kien disponibbli l-għadd nadir tal-plejtlits.
English: Temozolomide Sandoz is indicated for the treatment of: adult patients with newly-diagnosed glioblastoma multiforme concomitantly with radiotherapy (RT) and subsequently as monotherapy treatment, children from the age of three years, adolescents and adult patients with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy.
Maltese: tfal b'età minn tliet snin ‘il fuq, adoloxxenti u pazjenti adulti bi glijoma malinna, bħal glioblastoma multiforme jew astroċitoma anaplastika, li jerġgħu jirkadu jew li jkollhom avvanz tal-marda wara terapija ta' livell normali.
English: Hemiplegia, ataxia, coordination abnormal, gait abnormal, hyperesthesia, sensory disturbance
Maltese: Emipleġja, atassja, koordinament anormali, mixja mhux normali,