FrancophonIA/ELRC3.0 huggingface dataset:
English: • Triptans, tramadol and tryptophan used for conditions including depression, generalised anxiety disorder, obsessive compulsive disorder (OCD) and social phobia as well as migraine and pain
Maltese: • triptans, tramadol u tryptophan użati għal kundizzjonijiet li jinkludu depressjoni, disturb ta'
English: Diarrhoea
Maltese: Diplopja
English: The recommended starting dose for Aripiprazole Zentiva is 15 mg administered on a once-a-day schedule without regard to meals as monotherapy or combination therapy (see section 5.1).
Maltese: Id-doża tal-bidu rakkomandata għal Aripiprazole Zentiva hija 15-il mg mogħtija bi skeda ta' darba kuljum mingħajr ma jitqies il-ħin tal-ikel bħala monoterapija jew bħala terapija ta' kombinazzjoni (ara sezzjoni 5.1).
English: The incidence of hypoprolactinaemia or decreased serum prolactin in patients treated with aripiprazole was 0.4%, compared with 0.02% for patients treated with placebo.
Maltese: L-inċidenza ta' ipoprolaktinemija jew tnaqqis ta' prolaktin fis-serum f'pazjenti trattati b'aripiprazole kien ta' 0.4 % meta mqabbel ma' 0.02 % għal pazjenti trattati bi plaċebo.
English: The overall completion rate was significantly higher for patients on aripiprazole (43%) than for haloperidol (30%).
Maltese: Ir-rata globali ta' dawk li spiċċaw il-kors kienet sinifikament ogħla għall-pazjenti fuq aripiprazole (43 %) milli għall-haloperidol (30 %).
English: In the pooled adolescent schizophrenia population (13 - 17 years) with exposure up to 2 years, incidence of low serum prolactin levels in females (< 3 ng/ml) and males (< 2 ng/ml) was 29.5% and 48.3%, respectively.
Maltese: Fil-popolazzjoni miġbura ta' adolexxenti (13-17-il sena) li jbatu bl-iskizofrenja li kellhom espożizzjoni sa sentejn, l-inċidenza ta' livelli baxxi ta' prolactin fis-serum fin-nisa (< 3 ng/ml) u flirġiel (< 2 ng/ml) kienet ta' 29.5 % u ta' 48.3 % respettivament.
English: • tiredness,
Maltese: • tfartis,
English: • Certain medicines to treat HIV infection (such as efavirenz, nevirapine, an protease inhibitors e.g. indinavir, ritonavir)
Maltese: • ċerti mediċini biex jittrattaw infezzjoni ta' HIV (bħal efavirenz, nevirapine, u impedituri ta'
English: This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially “sodium free”.
Maltese: Din il-mediċina fiha inqas minn 1 mmol sodium (23 mg) għal kull pillola, jiġifieri essenzjalment hija “mingħajr sodium”.
English: Each orodispersible tablet contains 10 mg/15 mg/30 mg of aripiprazole.
Maltese: Kull pillola li tinħall fil-ħalq fiha 10 mg/15 mg/30 mg ta' aripiprazole.
English: Prolactin
Maltese: Porjomanija
English: • slower heart beat,
Maltese: • livelli baxxi ta' plejtlits tad-demm,
English: Animal studies could not exclude potential developmental toxicity (see section 5.3).
Maltese: Studji fuq lannimali ma setgħux jeskludu l-potenzjal ta' tossiċità fl-iżvilupp (ara sezzjoni 5.3).
English: If you are taking Aripiprazole Zentiva, your doctor will discuss with you whether you should breast feed considering the benefit to you of your therapy and the benefit to your baby of breast feeding.
Maltese: Fi provi kliniċi ta' aripiprazole, l-inċidenza ta' titwil tal-QT kien komparabbli mal-plaċebo.
English: Hiccups
Maltese: Sinkope
English: • Muscle stiffness, and drowsiness or sleepiness, slower breathing, choking, high or low blood pressure, abnormal rhythms of the heart.
Maltese: • ebusija tal-muskoli, u ħedla jew ngħas, tieħu n-nifs aktar bil-mod, tifga', pressjoni għolja jew baxxa, ritmi mhux normali tal-qalb.
English: Pack size: 14, 28 or 49 orodispersible tablets
Maltese: Daqs tal-pakkett: 14, 28 jew 49 pillola li jinħallu fil-ħalq
English: Oculogyric crisis
Maltese: TAGĦRIF
English: Aripiprazole Zentiva 30 mg tablets are white to off-white capsule shaped uncoated tablets with ‘30' debossed on one side and snap tab breakline on the other side with dimensions approx. 15.5 x 8 mm.
Maltese: Il-pilloli Aripiprazole Zentiva 30 mg huma pilloli mhux miksija forma ta' kapsula minn bojod sa ofwajt b'‘30' imnaqqxa fuq naħa waħda u b'linja li taqsam il-pillola fuq in-naħa l-oħra b'qies ta' madwar 15.5
English: If aripiprazole is administered concomitantly with medicinal products known to cause QT prolongation or electrolyte imbalance, caution should be used.
Maltese: Is-sinjali u sintomi rappurtati li possibbilment huma medikament importanti kienu jinkludu ħedla ta' rqad, telf temporanju ta' koxjenza u sintomi ekstrapiramidali.
English: In clinical trials with aripiprazole, there were no significant differences in the incidence rates of hyperglycaemia-related adverse reactions (including diabetes) or in abnormal glycaemia laboratory values compared to placebo.
Maltese: Fi provi kliniċi b'aripirazole, ma kienx hemm differenzi sinifikanti fir-rati ta' inċidenza ta' reazzjonijiet avversi assoċjati ma' ipergliċemija (inkluż id-dijabete) jew fil-valuri tal-laboratorju ta' gliċemija annormali mqabbla ma' plaċebo.
English: Aripiprazole Zentiva 10 mg orodispersible tablets White to off-white round tablets debossed ‘10' on one side and snap break line on other side with diameter approx. 7 mm.
Maltese: Pilloli Aripiprazole Zentiva 10 mg li jinħallu fil-ħalq Pilloli tondi minn bojod sa ofwajt b'‘10' imnaqqxa fuq naħa waħda u b'linja li taqsam il-pillola fuq innaħa l-oħra b'dijametru ta' madwar 7 mm.
English: The safety and efficacy of aripiprazole in children and adolescents aged below 18 years have not yet been established.
Maltese: Is-sigurtà u l-effikaċja ta' aripiprazole fit-tfal u adolexxenti b'età taħt it-18-il sena ma ġewx determinati s'issa.
English: Among the patients included in the primary efficacy analysis, 139 patients had a current comorbid diagnosis of ADHD.
Maltese: Fost il-pazjenti inklużi fl-analiżi tal-effikaċja primarja, 139 pazjent kellhom dijanjosi komorbida kurrenti ta' ADHD.
English: Aripiprazole doses ranging from 0.5 to 30 mg administered once a day to healthy subjects for 2 weeks produced a dose-dependent reduction in the binding of 11C-raclopride, a D2/D3 receptor ligand,
Maltese: Dożi ta' aripiprazole li jvarjaw minn 0.5 sa 30 mg mogħtija darba kuljum għal ġimagħtejn lil nies b'saħħithom ipproduċew tnaqqis ta' dipendanza fuq id-droga fl-irbit ta' 11C-raclopride, reċettur li jgħaqqad D2/D3, caudate u l-putamen osservati bit-tomografija bl-emisssjoni positronika.
English: Dysphagia
Maltese: Prijapiżmu
English: Each tablet contains 30 mg of aripiprazole.
Maltese: Kull pillola għandha 30 mg ta' aripiprazole.
English: Aripiprazole Zentiva 30 mg orodispersible tablets
Maltese: Pilloli Aripiprazole Zentiva 30 mg
English: Name and address of the manufacturer responsible for batch release Zentiva SA
Maltese: Isem u indirizz tal-manifattur responsabbli għall-ħruġ tal-lott Zentiva SA
English: The mean weight gain over the stabilisation phase (up to 26 weeks) on aripiprazole was 3.2 kg, and a further mean increase of 2.2 kg for aripiprazole as compared to 0.6 kg for placebo was observed in the second phase (16 weeks) of the trial.
Maltese: Iż-żieda medja fil-piż medju matul il-fażi ta' stabbilizzazzjoni (sa 26 ġimgħa) fuq aripiprazole kienet ta' 3.2 kg, u żieda medja ta' 2.2 kg addizzjonali għal aripiprazole meta mqabbla ma' 0.6 kg għal plaċebo ġiet osservata fit-tieni fażi (16-il ġimgħa) tal-prova.
English: Aripiprazole also exhibited moderate binding affinity for the serotonin reuptake site and no appreciable affinity for muscarinic receptors.
Maltese: Madankollu, ġew irrappurtati wkoll żidiet ta' ‘creatine phosphokinase' u rabdomajoliżi, mhux neċessarjemant assoċjati ma' NMS.
English: Each tablet contains 10 mg of aripiprazole.
Maltese: Kull pillola għandha 10 mg ta' aripiprazole.
English: • accidental inhalation of food with risk of pneumonia (lung infection),
Maltese: • bligħ aċċidentali ta' ikel b'riskju ta' pnewmonja (infezzjoni tal-pulmun)
English: Hyperprolactinaemia Diabetic hyperosmolar coma Diabetic ketoacidosis
Maltese: Logħob tal-ażżard patoloġiku Disturbi tal-kontroll tal-impuls
English: Enhanced efficacy at doses higher than a daily dose of 10 mg has not been demonstrated, and a daily dose of 30 mg is associated with a substantially higher incidence of significant adverse reactions including EPS related events, somnolence, fatigue and weight gain (see section 4.8).
Maltese: Ma ntweriex titjib fl-effikaċja b'dożi ogħla minn doża ta' kuljum ta' 10 mg, u doża ta' kuljum ta' 30 mg hija assoċjata ma' inċidenza ogħla b'mod sinifikanti ta' reazzjonijiet avversi marbuta ma' sindromu ekstrapiramidali, ħedla, għeja u żieda fil-piż (ara sezzjoni 4.8).
English: • prolonged and/or painful erection,
Maltese: • aktar bżieq fil-ħalq mis-soltu,
English: • Unusual movements (especially of the face or tongue) and reduced level of consciousness.
Maltese: • movimenti mhux tas-soltu (speċjalment tal-wiċċ jew l-ilsien) u livell mnaqqas ta' koxjenza.
English: Aripiprazole also demonstrated a comparable proportion of patients in symptomatic remission from mania as lithium or haloperidol at week 12.
Maltese: Aripiprazole wera wkoll proporzjon komparabbli ta' pazjenti b'remissjoni sintomatika minn manija bħal litju jew haloperidol f'ġimgħa 12.
English: Aripiprazole Zentiva 10 mg tablets are white to off-white round uncoated tablets with ‘10' debossed on one side and snap tab breakline on the other side with diameter approx. 8 mm.
Maltese: Il-pilloli Aripiprazole Zentiva 10 mg huma pilloli tondi mhux miksija minn bojod sa ofwajt b'‘10' imnaqqxa fuq naħa waħda u b'linja li taqsam il-pillola fuq in-naħa l-oħra b'dijametru ta' madwar 8 mm.
English: • life-threatening irregular heart beat,
Maltese: • il-qalb tħabbat aktar bil-mod,
English: Each tablet contains 15 mg of aripiprazole.
Maltese: Kull pillola għandha 15 mg ta' aripiprazole.
English: Compulsive shopping Poriomania
Maltese: Xiri kompulsiv
English: Thus, aripiprazole is unlikely to cause clinically important medicinal product interactions mediated by these enzymes.
Maltese: Għaldaqstant m'huwiex probabbli li aripiprazole jikkawża interazzjonijiet importanti b'mod kliniku bejn prodotti mediċinali effettwati minn dawn lenzimi.
English: Manufacturer: SP Labo N.V., Industriepark 30, B-2220 Heist-op-den-Berg, Belgium
Maltese: SP Labo N.V., Industriepark 30, B-2220 Heist-op-den-Berg, Il-Belġju
English: Cushingoid
Maltese: Cushingoidc
English: Temodal may cause permanent infertility.
Maltese: Temodal jista' jikkawża infertilità permanenti.
English: Myelodysplastic syndrome (MDS), secondary malignancies, including myeloid leukaemia
Maltese: Sindrome mijelodisplastiku (MDS - myelodysplastic syndrome), tumuri malinni sekondarji, inkluża lewkimja mijelojd
English: In vivo, the t1/2 of MTIC was similar to that of TMZ, 1.8 hr.
Maltese: In vivo it-t1/2 ta' MTIC kien simili għal dak ta' TMZ, 1.8 hr.
English: Pharmacotherapeutic group: Antineoplastic agents - Other alkylating agents, ATC code: L01A X03
Maltese: Aġenti antineoplastiċi - alkylating agents oħra, kodiċi ATC L01A X03
English: Agitation, amnesia, depression, anxiety, confusion, insomnia
Maltese: Aġitazzjoni, amnesija, depressjoni, ansjetà, konfużjoni, insomnja
English: CTC Grade 2
Maltese: CTC Grad 2
English: Response rate, based on the central reviewer assessment, was 35 % (13 CR and 43 PR) for the intent-to-treat population (ITT) n=162.
Maltese: Ir-rata ta' rispons, ibbażata fuq il-valutazzjoni tal-verifikatur ċentrali, kienet ta' 35 % (13 CR u 43 PR) għallpopolazzjoni intent-to-treat (ITT) n=162 .
English:  0.5 and < 1.5 x 10
Maltese: ≥ 0.5 u < 1.5 x 109/l
English: Relative to the AUC of TMZ, the exposure to MTIC and AIC is ~ 2.4 % and 23 %, respectively.
Maltese: L-esponiment għal MTIC u AIC relattiv għall-AUC ta' TMZ huwa ~ 2.4 % u 23 %, rispettivament.
English: TMZ demonstrates low protein binding (10 % to 20 %), and thus it is not expected to interact with highly protein-bound substances.
Maltese: TMZ jeħel b'mod ħafif mal-proteini (10% sa 20%), u għalhekk mhux mistenni li jinteraġixxi ma' sustanzi li jeħlu ħafna mal-proteini.
English: Drug reaction with eosinophilia and systemic symptoms (DRESS)
Maltese: Reazzjoni għall-mediċina b'eosinofilja u sintomi sistemiċi (DRESS - Drug reaction with eosinophilia and systemic symptoms)
English: If
Maltese: JIS
English: Capsule content: anhydrous lactose, colloidal anhydrous silica, sodium starch glycolate type A, tartaric acid, stearic acid.
Maltese: anhydrous lactose, colloidal anhydrous silica, sodium starch glycolate tip A, tartaric acid, stearic acid.
English: It is incompatible with dextrose solutions.
Maltese: Mhux kompatibbli ma' soluzzjonijiet ta' dextrose.
English: Dose levels include 100 mg/m 2, 150 mg/m 2, and
Maltese: Il-livelli tad-doża jinkludu 100 mg/m2, 150 mg/m2, u 200 mg/m2.
English: Mannitol (E421), threonine, polysorbate 80, sodium citrate and hydrochloric acid.
Maltese: Mannitol (E421), threonine, polysorbate 80, sodium citrate u hydrochloric acid.
English: • dose level -1 (100 mg/m2) still results in unacceptable toxicity
Maltese: • Livell tad-doża -1 (100 mg/m2) jibqa jirriżulta f'tossiċità inaċċettabbli
English: The active substance is temozolomide.
Maltese: Is-sustanza attiva hija temozolomide.
English: Elderly patients (> 70 years of age)
Maltese: Pazjenti anzjani (> 70 sena)
English: Merck Sharp & Dohme, Lda.
Maltese: Portugal Merck Sharp & Dohme, Lda.
English: In the randomised active-controlled trial, the PFS at 6 months was significantly greater for TMZ than for procarbazine (21 % vs 8 %, respectively - chi-square p = 0.008) with median PFS of 2.89 and 1.88 months respectively (log rank p = 0.0063).
Maltese: Fil-prova randomised ikkontrollata b'mod attiv, l-PFS ma' 6 xhur kien akbar b'mod sinifikanti għal TMZ milli għal procarbazine (21 % vs 8 %, rispettivament - chi-square p = 0.008) bil-PFS medjan ta' 2.89 u 1.88 xhur rispettivament (log rank p = 0.0063).
English: Micturition frequency, urinary incontinence
Maltese: Żieda fil-frekwenza tal-awrina, inkontinenza tal-awrina
English: < 1.0 x 10
Maltese: < 1.0 x 109/l
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 ġew randomised biex jirċievu jew TMZ + RT (n=287) jew RT waħdu (n=286).
English: Tolerance to TMZ is similar to adults.
Maltese: Ittolleranza għal TMZ hija simili għal dik tal-adulti.
English: Doses of 500, 750, 1,000, and 1,250 mg/m
Maltese: Dożi ta' 500, 750, 1,000, u 1,250 mg/m2 (doża totali kull ċiklu matul 5 ijiem) ġew evalwati klinikament f'pazjenti.
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 kienet ta' 1.59 (95 % CI għal HR=1.33 - 1.91) b'log rank p < 0.0001 favur il-fergħa ta' TMZ.
English: The other ingredients are: capsule content: anhydrous lactose, colloidal anhydrous silica, sodium starch glycolate type A, tartaric acid, stearic acid (see section 2 "Temodal contains lactose").
Maltese: anhydrous lactose, colloidal anhydrous silica, sodium starch glycolate type A, tartaric acid, stearic acid (ara sezzjoni 2 “Temodal fih lactose”).
English:  10 and < 100 x 10
Maltese: ≥ 10 u < 100 x 109/l
English: Temodal contains lactose
Maltese: Temodal fih lactose
English: Temodal 5 mg hard capsules Temodal 20 mg hard capsules Temodal 100 mg hard capsules Temodal 140 mg hard capsules Temodal 180 mg hard capsules Temodal 250 mg hard capsules temozolomide
Maltese: Temodal 20 mg kapsuli ibsin Temodal 100 mg kapsuli ibsin Temodal 140 mg kapsuli ibsin Temodal 180 mg kapsuli ibsin Temodal 250 mg kapsuli ibsin temozolomide
English: Hypokalaemia, alkaline phosphatase increased
Maltese: Ipokalimja, żieda fl-alkaline phosphatase
English: Status epilepticus, hemiplegia, extrapyramidal disorder, parosmia, gait abnormality, hyperaesthesia, sensory disturbance, coordination abnormal
Maltese: Status epilepticus, emipleġja, disturb ekstrapiramidali, parożmija, mixja mhux normali, iperestesija, disturb fis-sensi, koordinazzjoni mhux normali
English: capsule shell:
Maltese: qoxra tal-kapsula:
English: Each one lasts 28 days.
Maltese: Ċiklu ta' kura jikkonsisti fi 28 jum.
English: (≥ 1/100 to < 1/10); Uncommon (≥ 1/1,000 to < 1/100); Rare (≥1/10,000 to <1/1,000); Very rare (<1/10,000); Not known (cannot be estimated from the available data).
Maltese: Mhux komuni (≥ 1/1,000 sa < 1/100); Rari (≥1/10,000 sa <1/1,000);
English: Infections, herpes zoster, pharyngitis a, candidiasis oral
Maltese: Infezzjonijiet, herpes zoster, farinġitea, kandidjażi fil ħalq
English: < 0.5 x 10
Maltese: < 0.5 x 109/l
English: Mean Cmax values for TMZ and MTIC were 7.4 µg/ml and 320 ng/ml, respectively, following 90 minute intravenous infusion.
Maltese: Il-medja tal-valuri ta' Cmax għal TMZ u MTIC kienu 7.4 μg/ml u 320 ng/ml, rispettivament, wara infużjoni għal ġol-vina ta' 90 minuta.
English: Temodal contains sodium
Maltese: Temodal fih sodium
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 kien mogħti bħala terapija tas-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: Printing ink: shellac, propylene glycol, purified water, ammonium hydroxide,
Maltese: Linka tal-istampar:shellac, propylene glycol, ilma purifikat, ammonium hydroxide,
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 (AUC).
English: 1 capsule
Maltese: 20 kapsula.
English: Temodal contains lactose (a kind of sugar).
Maltese: Temodal fih lactose (tip ta' zokkor).
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 %, rispettivament, tal-pazjenti kkurati għal glijoma malinna.
English: Sachets are composed of linear low density polyethylene (innermost layer), aluminium and polyethylene terephthalate.
Maltese: Il-qratas huma magħmula minn polyethylene lineari ta' densità baxxa (saff ta' ġewwa nett), aluminju u polyethylene terephthalate.
English: Mean AUC (0  ) values for TMZ and MTIC were 25 µg•h/ml and 1,004 ng•h/ml, respectively.
Maltese: Il-medja tal-valuri ta' l-AUC (0 → ∞) għal TMZ u MTIC kienu 25 µg•h/ml u 1,004 ng•h/ml, rispettivament.
English: †, interstitial pneumonitis/pneumonitis, pulmonary fibrosis, nasal congestion
Maltese: Insuffiċjenza respiratorja†, pulmonite talinterstizju/pulmonite, fibrożi fil-pulmun, konġestjoni fl-imnieħer
English: TMZ is spontaneously hydrolyzed at physiologic pH primarily to the active species, 3-methyl(triazen-1-yl)imidazole-4-carboxamide (MTIC).
Maltese: TMZ huwa idrolizzat b'mod spontanju fil-pH fiżjoloġika għall-ispeċi attiva, 3-methyl-(triazen-1-yl)imidazole-4-carboxamide (MTIC).
English: For storage conditions of the reconstituted medicinal product, see section 6.3.
Maltese: Għall-kondizzjonijiet ta' ħażna wara r-rikostituzzjoni tal-prodott mediċinali, ara sezzjoni 6.3. 6.5
English: Store in a refrigerator (2 C - 8 C).
Maltese: Aħżen fi friġġ (2ºC - 8ºC).
English: potassium hydroxide, black iron oxide (E 172).
Maltese: black iron oxide (E 172).
English: Figure 1 Kaplan-Meier curves for overall survival (Intent to treat population)
Maltese: Kaplan-Meier għas-sopravivenza ġenerali (popolazzjoni intent-to-treat)
English: In a study of 288 subjects with newlydiagnosed 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 glioblastoma multiforme li għadha kif ġiet iddijanjostikata, newtropenija ta' Grad 4 seħħet fi 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: This medicine contains 2.4 mmol sodium per vial.
Maltese: Kull kunjett fih 2.4 mmol sodium.
English: Temozolomide is a triazene, which undergoes rapid chemical conversion at physiologic pH to the active monomethyl triazenoimidazole carboxamide (MTIC).
Maltese: Temozolomide huwa triazene, li fil-pH fiżjoloġiku jinbidel malajr f'sustanza attiva monomethyl triazenoimidazole carboxamide (MTIC).
English: Musculoskeletal and connective tissue disorders Common:
Maltese: Disturbi muskoluskeletriċi u tat-tessuti konnettivi
English: The colour of the capsule cap is different for each strength (see in the table below).
Maltese: Il-kulur tal-qoxra tal-kapsula huwa differenti għal kull qawwa (ara t-tabella hawn taħt).
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: Dejta dwar l-effikaċja klinika f'pazjenti bi glioblastoma multiforme (Status ta' prestazzjoni ta' Karnofsky [KPS] ≥ 70), progressiva jew rikorrenti wara operazzjoni u RT, kienet ibbażata fuq żewġ provi kliniċi b'TMZ orali.
English: Temodal 2.5 mg/ml powder for solution for infusion may be administered in the same IV line with 0.9% Sodium Chloride injection.
Maltese: Temodal 2.5 mg/ml trab għal soluzzjoni għall-infużjoni jista' jingħata fl-istess pajp tal-IV ma' injezzjoni ta' 0.9% Sodium Chloride.
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, inklużi effetti tromboċitopeniċi, dehru f'14 % tal-pazjenti li ngħataw 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 fiżżewġ gruppi.
English: Myopathy, muscle weakness, arthralgia, back pain, musculoskeletal pain, myalgia
Maltese: Mijopatija, dgħufija fil-muskoli, artralġja, uġigħ fiddahar, uġigħ muskoluskeletriku, mijalġja
English: < 50 x 10
Maltese: < 50 x 109/l
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 fl-awrina fuq medda ta' 24 siegħa, u l-bqija tiġi eliminata bħala aċidu temozolomide, 5-aminoimidazole-4-carboxamide (AIC) jew metaboliti polari li ma ġewx identifikati.
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 rreazzjonijiet avversi rrappurtati kienu panċitopenija, deni, kollass ta' diversi organi u mewt.
English: MTIC is spontaneously hydrolyzed to 5-aminoimidazole-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 hu maħsub li jkun l-ispeċi alkylating attiva.
English: Toxic epidermal necrolysis, Stevens-Johnson syndrome, angioedema, erythema multiforme, erythroderma, skin exfoliation, photosensitivity reaction, urticaria, exanthema, dermatitis, sweating increased, pigmentation abnormal
Maltese: Nekrolisi tossika tal-epidermide, sindrome ta' StevensJohnson, anġjoedima, eritema multiforme, eritroderma, il-ġilda taqa' qxur qxur, reazzjoni ta' sensittività eċċessiva għad-dawl, urtikarja, eksantema, dermatite, żieda fil-ħruġ tal-għaraq, pigmentazzjoni mhux normali