FrancophonIA/ELRC3.0 huggingface dataset:
English: cytomegalovirus infection, infection reactivation such as cytomegalovirus, hepatitis B virus†, meningoencephalitis herpetic† , sepsis†
Maltese: infezzjoni b'cytomegalovirus, attivazzjoni mill-ġdid ta' infezzjonijiet bħal cytomegalovirus, virus tal epatite B†, meningoenċefalite ħerpetika†, sepsis†
English: 28 August 2014
Maltese: Data tal-aħħar tiġdid: 28 ta' Awissu 2014
English: The other ingredients are: capsule content: lactose, colloidal anhydrous silica, sodium starch glycolate type A, tartaric acid, stearic acid (see section 2 “Temozolomide Teva contains lactose”).
Maltese: Is-sustanzi l-oħra huma: kontenut tal-kapsula: lactose, colloidal anhydrous silica, sodium starch glycolate type A, tartaric acid, stearic acid (ara sezzjoni 2 “Temozolomide Teva fih lactose”). qoxra tal-kapsula:
English: There is limited information in patients over 3 years of age who have taken Temozolomide Teva.
Maltese: Hemm informazzjoni limitata f'pazjenti li għandhom 'l fuq minn 3 snin li ħadu Temozolomide Teva.
English: Pharmacotherapeutic group: Antineoplastic agents-other alkylating agents, ATC code: L01A X03
Maltese: Sustanzi antineoplastiċi-sustanzi alkylating oħra, Kodiċi ATC L01A
English: ≥ 0.5 and < 1.5 x 109/l
Maltese: ≥ 0.5 u < 1.5 x 109/l < 0.5 x 109/l
English: Viale Pasteur, 10 20014 Nerviano (MI) Italy
Maltese: NerPharMa S.r.l. Viale Pasteur, 10 20014
English: Teva Sweden AB Tel: +46 42 12 11 00
Maltese: Tel: +46 42 12 11 00
English: ≥ 10 and < 100 x 109/l
Maltese: ≥ 10 u < 100 x 109/l < 10 x 109/l
English: These reactions were usually Grade 1 or 2 (0 - 5 episodes of vomiting in 24 hours) and were either self-limiting or readily controlled with standard anti-emetic therapy.
Maltese: Dawn ir-reazzjonijet kienu normalment Grad 1 jew 2 (0 - 5 episodji ta' rimettar f'24 siegħa) u jew waqfu waħidhom jew kienu kontrollati b'terapija kontra t-tqalligħ standard.
English: † Including cases with fatal outcome *Frequencies estimated based on relevant clinical trials
Maltese: Inkluż każijiet b'riżultat fatali *Frekwenzi stmati abbażi tal-provi kliniċi relevanti
English: Propylene Glycol Red iron oxide (E172) Yellow iron oxide (E172) Titanium dioxide (E171)
Maltese: Propylene Glycol Iron oxide aħmar (E172) Iron oxide isfar (E172) Titanium dioxide (E171)
English: Vaginal haemorrhage, menorrhagia, amenorrhea, vaginitis, breast pain
Maltese: Emorraġija vaġinali, menorraġja, amenorreja, vaġinite, uġigħ fis-sider
English: How to take Temozolomide Teva
Maltese: Tiħux Temozolomide Teva
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: Temozolomide Teva 5 mg hard capsules Temozolomide Teva 20 mg hard capsules Temozolomide Teva 100 mg hard capsules Temozolomide Teva 140 mg hard capsules Temozolomide Teva 180 mg hard capsules Temozolomide Teva 250 mg hard capsules
Maltese: Temozolomide Teva 5 mg kapsuli ibsin Temozolomide Teva 20 mg kapsuli ibsin Temozolomide Teva 100 mg kapsuli ibsin Temozolomide Teva 140 mg kapsuli ibsin Temozolomide Teva 180 mg kapsuli ibsin Temozolomide Teva 250 mg kapsuli ibsin
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 u astroċitoma anaplastika.
English: Temozolomide Teva 5 mg hard capsules: (including printing ink): gelatin, titanium dioxide (E171), shellac, propylene glycol, Indigo carmine (E132) aluminium lake, yellow iron oxide (E172) Temozolomide Teva 20 mg hard capsules: (including printing ink): gelatine, titanium dioxide (E171), shellac, propylene glycol, Sunset yellow FCF Aluminium Lake (E110) Temozolomide Teva 100 mg hard capsules: (including printing ink): gelatin, titanium dioxide (E171), red iron oxide (E172), shellac, propylene glycol and yellow iron oxide (E172).
Maltese: Temozolomide Teva 5 mg kapsuli ibsin: (li tinkudi l-linka tal-istampar): gelatin, titanium dioxide (E171), shellac, propylene glycol, Indigo carmine (E132) aluminium lake, yellow iron oxide (E172) Temozolomide Teva 20 mg kapsuli ibsin: (li tinkudi l-linka tal-istampar): gelatin, titanium dioxide (E171), shellac, propylene glycol, Sunset yellow FCF aluminium lake (E110) Temozolomide Teva 100 mg kapsuli ibsin: (li tinkudi l-linka tal-istampar): gelatin, titanium dioxide (E171), shellac, propylene glycol, yellow iron oxide (E172).
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: MTIC is spontaneously hydrolyzed to 5-amino-imidazole-4carboxamide (AIC), a known intermediate in purine and nucleic acid biosynthesis, and to methylhydrazine, which is believed to be the active alkylating species.
Maltese: MTIC 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: Temozolomide Teva 20 mg hard capsules Sunset yellow FCF (E110)
Maltese: Temozolomide Teva 20 mg kapsuli ibsin Sunset yellow FCF (E110)
English: Musculoskeletal and connective tissue disorders Common:
Maltese: Disturbi muskolu-skelettriċi u tat-tessuti konnettivi Komuni:
English: Dyspnoea
Maltese: diplopja
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: Temozolomide Teva 20 mg hard capsules Temozolomide Teva 100 mg hard capsules Temozolomide Teva 140 mg hard capsules Temozolomide Teva 180 mg hard capsules Temozolomide Teva 250 mg hard capsules temozolomide
Maltese: Temozolomide Teva 20 mg kapsuli ibsin Temozolomide Teva 100 mg kapsuli ibsin Temozolomide Teva 140 mg kapsuli ibsin Temozolomide Teva 180 mg kapsuli ibsin Temozolomide Teva 250 mg kapsuli ibsin temozolomide
English: In a study of 288 subjects with newly-diagnosed glioblastoma multiforme, Grade 4 neutropenia occurred in 3% of female vs 0% of male subjects and Grade 4 thrombocytopenia in 1% of female vs 0% of male subjects in the first cycle of therapy.
Maltese: Fi studju b'288 individwu bi 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: Colour/marking
Maltese: Kulur/immarkar
English: Abdominal distension, fecal incontinence, gastrointestinal disorder (NOS), gastroenteritis, haemorrhoids
Maltese: lippurgar, disturbi gastro-intestinali (NOS), gastroenterite, emorrojdi
English: The excipient sunset yellow FCF (E110) is also included in the capsule shell of Temozolomide Teva 20 mg hard capsules and may cause allergic reactions.
Maltese: Is-sustanza mhix attiva sunset yellow FCF (E110) hija inkluża wkoll fil-qoxra tal-kapsula ta' Temozolomide Teva 20 mg kapsuli iebsin u tista' tikkaġuna reazzjonijiet allerġiċi.
English: Excipient with known effect Each hard capsule contains 117 mg of lactose.
Maltese: Kull kapsula iebsa fiha 117 mg lactose.
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-4carboxamide (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-4carboxamide (AIC) jew metaboliti polari li ma ġewx identifikati.
English: Temozolomide Teva 250 mg hard capsules: (including printing ink): gelatin, titanium dioxide (E171), shellac, propylene glycol, black iron oxide (E172), Ammonium hydroxide (E527).
Maltese: Temozolomide Teva 250 mg kapsuli ibsin: (li tinkudi l-linka tal-istampar): gelatin, titanium dioxide (E171), shellac, propylene glycol, black iron oxide (E172), Ammonium hydroxide (E527).
English: - absolute neutrophil count (ANC) ≥ 1.5 x 109/l - thrombocyte count ≥ 100 x 109/l
Maltese: ANC ≥ 1.5 x 10 9/l u għadd tal-plejtlets ≥ 100 x 10
English: Nervous system disorders Very Common:
Maltese: Disturbi fis-sistema nervuża Komuni ħafna:
English: The excipient sunset yellow FCF (E110) included in the capsules shell may cause allergic reactions.
Maltese: L-eċċipjent sunset yellow FCF (E110) inkluż fil-qoxra tal-kapsuli jista' jikkawża reazzjonijiet allerġiċi.
English: Neutropenia or lymphopenia (grade 3-4), thrombocytopenia (grade 3-4)
Maltese: tromboċitopenija (grad 3-4)
English: drug reaction with eosinophilia and systemic symptons (DRESS)
Maltese: Mhux magħruf reazzjoni għall-mediċina b'esinofilja u sintomi sistemiċi (DRESS)
English: Muscle weakness, arthralgia, musculoskeletal pain, myalgia
Maltese: Dgħjufija fil-muskoli, artralġja, uġigħ muskolu-skeletrali, mijalġja
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: Ελλάδα Teva Ελλάς Α.Ε.
Maltese: M'hemmx dejta dwar nisa tqal.
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: 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% kienu rċevew ilkemoterapija qabel), u l-oħra kienet prova randomized kontrollata b'mod attiv ta' TMZ vs procarbazine f'total ta' 225 pazjent (67% kienu rċivew trattament qabel bil-kemoterapija bbażata fuq nitrosourea).
English: Temozolomide Teva contains sunset yellow FCF (E110)
Maltese: Temozolomide Teva fih sunset yellow FCF (E110)
English: Contains lactose, sunset yellow FCF (E110).
Maltese: Fih lactose u sunset yellow FCF (E110).
English: capsule shell:
Maltese: Kontenut tal-kapsula:
English: Then you will have 23 days without Temozolomide Teva.
Maltese: Imbagħad ikollok 23 jum mingħajr Temozolomide Teva.
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'set ta' dejta għal glijoma b'400 individwu, newtropenija ta' Grad 4 seħħet fi 8% tan-nisa vs 4% tal-irġiel u tromboċitopenija ta' Grad 4 fi 8% tan-nisa vs 3% tal-irġiel flewwel ċiklu tat-terapija.
English: How to store Temozolomide Teva Contents of the pack and other information
Maltese: Kontenut tal-pakkett u informazzjoni oħra
English: Agitation, apathy, behaviour disorder, depression, hallucination
Maltese: Aġitazzjoni, apatija, disturbi fl-imġiba, dipressjoni, alluċinazzjoni
English: Common (may affect up to 1 in 10 people): oral infections, wound infection, reduced number of blood cells (neutropenia, thrombocytopenia, lymphopenia, leukopenia), increased sugar in the blood, loss of weight, change in mental status or alertness, anxiety/depression, sleepiness, difficulty speaking, impaired balance, dizziness, confusion, forgetfulness, difficulty concentrating, inability to fall asleep or stay asleep,tingling sensation, bruising, shaking, abnormal or blurry vision, double vision, hearing impairment, shortness of breath, cough, blood clot in the legs, fluid retention, swollen legs, diarrhoea, stomach or abdominal pain, heartburn, upset stomach, difficulty swallowing, dry mouth, skin irritation or redness, dry skin, itching, muscle weakness, painful joints, muscle aches and pains, frequent urination, difficulty with holding your urine, allergic reaction, fever, radiation injury, face swelling, pain, abnormal taste, abnormal liver function tests.
Maltese: Komuni (jistgħu jaffettwaw sa persuna waħda minn kull 10): infezzjonijiet fil-ħalq, infezzjoni talferita, jonqos l-għadd taċ-ċelluli tad-demm (newtropenija, tromboċitopenija, limfopenija, lewkopenija), jogħla z-zokkor fid-demm, titlef il-piż, bidla fl-istat mentali jew viġilanza, ansjetà/dipressjoni, ngħas, diffikultajiet biex titkellem, l-ekwilibriju jiddgħajjef, sturdament, konfużjoni, tinsa ħafna, tbati biex tikkonċentra, ma tkunx tista' torqod jew tibqa rieqed, tingiż, titbenġel, rogħda, vista mhux normali jew imċajpra, tara doppju, problemi fissmigħ, qtugħ ta' nifs, sogħla, demm magħqud fir-riġlejn, jiżdied l-ilma fil-ġisem, nefħa fir-riġlejn, dijarea, uġigħ fl-istonku jew fl-addome, ħruq ta' stonku, stonku mqalla, diffikulta' biex tibla', ħalq xott, irritazzjoni jew ħmura tal-ġilda, ġilda xotta, ħakk, dgħjufija fil-muskoli, uġigħ fil-ġogi, uġigħ fil-muskoli jew weġgħat,
English: Excipient with known effect Each hard capsule contains 209 mg of lactose.
Maltese: Kull kapsula iebsa fiha 209 mg lactose.
English: The first dose will be 150 mg/m².
Maltese: L-ewwel doża se tkun ta' 150 mg/m².
English: Dose Level
Maltese: U KWANTITATTIVA
English: A total of 573 patients were randomised to receive either TMZ + RT (n=287) or RT alone (n=286).
Maltese: Glioblastoma multiforme li tkun għadha kif ġiet iddijanjostikata Total ta' 573 pazjent ġew randomised biex jirċievu jew TMZ + RT (n=287) jew RT waħdu (n=286).
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: TMZ milli għal procarbazine (21% vs 8%, rispettivament - chi-square p = 0.008) bil-PFS medjan ta'
English: Figure 1 Kaplan-Meier curves for overall survival (intent-to-treat population) The results from the trial were not consistent in the subgroup of patients with a poor performance status (WHO PS=2, n=70), where overall survival and time to progression were similar in both arms.
Maltese: Ir-riżultati mill-prova ma kinux konsistenti fis-sottogrupp ta' pazjenti bi status baxx ta' prestazzjoni dgħajjef (WHO PS=2, n=70), fejn is-sopravivenza globali u ż-żmien sal-progressjoni tal-marda kienu simili fiż-żewġ gruppi.
English: - 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: 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 ta' spiss kienu disturbi gastro-intestinali, speċifikament tqalligħ (43%) u rimettar (36%).
English: Excipient with known effect Each hard capsule contains 87 mg of lactose.
Maltese: Kull kapsula iebsa fiha 87 mg lactose.
English: In the noncomparative trial, the PFS at 6 months was 19%, the median progression-free survival was 2.1 months, and the median overall survival 5.4 months.
Maltese: Fl-istudju mhux komparattiv, il-PFS wara 6 xhur kien ta' 19%, is-sopravivenza mingħajr progressjoni medjana kienet ta' 2.1. xhur, u lmedjan tas-sopravivenza totali kien ta' 5.4 xhur.
English: This was followed by monotherapy TMZ (150 - 200 mg/m²) on Days 1 - 5 of every 28-day cycle for up to 6 cycles, starting 4 weeks after the end of RT.
Maltese: Dan kien segwit b'monoterapija ta' TMZ (150 - 200 mg/m²) f'Jiem 1 - 5 ta' kull ċiklu ta' 28 jum sa 6 ċikli, bdew 4
English: Temozolomide Teva contains a medicine called temozolomide.
Maltese: Temozolomide Teva fih mediċina msejħa temozolamide.
English: Haemorrhage, oedema, oedema leg Haemorrhage, deep venous thrombosis, oedema leg
Maltese: Emorraġija, edima, edima fir-riġlejn Emorraġija, deep vein trombosis,
English: Excipient with known effect Each hard capsule contains 84 mg of lactose.
Maltese: Kull kapsula iebsa fiha 84 mg lactose.
English: Excipients with known effect Each hard capsule contains 72 mg of lactose and sunset yellow FCF (E110).
Maltese: Kull kapsula iebsa fiha 72 mg lactose u sunset yellow FCF (E110).
English: Temozolomide Teva 5 mg hard capsules
Maltese: Temozolomide Teva 5 mg kapsuli ibsin
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: HR=1.33 -1.91) b'log rank p < 0.0001 favur il-fergħa ta' TMZ.
English: Temozolomide Teva 250 mg hard capsules
Maltese: Temozolomide Teva 250 mg kapsuli ibsin
English: The primary targets of toxicity included the bone marrow, lymphoreticular system, testes, the gastrointestinal tract and, at higher doses, which were lethal to 60% to 100% of rats and dogs tested, degeneration of the retina occurred.
Maltese: It-targits primarji tat-tossiċità inkludew il-mudullun, is sistema limforetikulari, it-testikoli u l-apparat gastro-intestinali u, f'dożi aktar qawwija, li kkaġunaw il-mewt lil 60% sa 100% tal-firien u l-klieb ittestjati, seħħet deġenerazzjoni tar-retina.
English: Temozolomide Teva 5 mg hard capsules Temozolomide
Maltese: Temozolomide Teva 5 mg kapsuli ibsin Temozolomide
English: Temozolomide Teva 140 mg hard capsules
Maltese: Temozolomide Teva 140 mg kapsuli ibsin
English: Temozolomide Teva 250 mg hard capsules Temozolomide
Maltese: Temozolomide Teva 250 mg kapsuli ibsin Temozolomide
English: Excipient with known effect Each hard capsule contains 150 mg of lactose.
Maltese: Kull kapsula iebsa fiha 150 mg lactose.
English: Temozolomide Teva 20 mg hard capsules
Maltese: Temozolomide Teva 20 mg kapsuli ibsin
English: Temozolomide Teva 140 mg hard capsules Temozolomide
Maltese: Temozolomide Teva 140 mg kapsuli ibsin Temozolomide
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-doża massima ttollerata (MTD) kienet ta' 1,000 mg/m² kull ċiklu kemm fit-tfal u kemm fl-adulti.
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: (Tabelli 4 u 5); il-frekwenza tas-sejbiet tal-laboratorju ta' grad 3-4 tidher wara kull tabella.
English: Temozolomide Teva 20 mg hard capsules Temozolomide
Maltese: Temozolomide Teva 20 mg kapsuli ibsin Temozolomide
English: In preclinical studies in rats and rabbits receiving 150 mg/m² TMZ, teratogenicity and/or foetal toxicity were demonstrated (see section 5.3).
Maltese: 150 mg/m² TMZ, kienu murija teratoġeniċità u/jew effett tossiku fuq il-fetu (ara sezzjoni 5.3).
English: Temozolomide Teva 100 mg hard capsules Each hard capsule contains 100 mg temozolomide.
Maltese: Temozolomide Teva 100 mg kapsuli ibsin Kull kapsula iebsa fiha 100 mg temozolomide.
English: Male fertility
Maltese: Ċitotossiku.
English: Temozolomide Teva 180 mg hard capsules
Maltese: Temozolomide Teva 180 mg kapsuli ibsin
English: Temozolomide Teva 20 mg hard capsules Each hard capsule contains 20 mg temozolomide.
Maltese: Temozolomide Teva 20 mg kapsuli ibsin Kull kapsula iebsa fiha 20 mg 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: Każijiet ta' bilirubin miżjud, problemi bil-fluss biljari (kolestażi), epatite u korriment għall-fwied, inkluż ħsara fatali fil-fwied, ġew irrapportati b'mod mhux komuni.
English: Temozolomide Teva 180 mg hard capsules Temozolomide
Maltese: Temozolomide Teva 180 mg kapsuli ibsin Temozolomide
English: Temozolomide Teva 20 mg two stripes in orange ink on the cap and “T 20 mg” in orange ink on the body
Maltese: Temozolomide Teva 20 mg żewġ strixxi b'linka oranġjo fuq lgħatu u “T 20 mg” b'linka oranġjo fuq il-korp
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 attivazzjoni mill-ġdid ta' infezzjonijiet Ġew osservati infezzjonijiet opportunistiċi (bħal pnewmonja kkawżata minn Pneumocystis jirovecii) u attivazzjoni mill-ġdid ta' infezzjonijiet (bħal HBV, CMV) matul il-kura b'TMZ (ara sezzjoni 4.8).
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 brainstem 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: 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) Special populations
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: Temozolomide Teva 100 mg hard capsules
Maltese: Temozolomide Teva 100 mg kapsuli ibsin
English: Uncommon (may affect up to 1 in 100 people): flu-like symptoms, red spots under the skin, low potassium level in the blood, weight gain, mood swings, hallucination and memory impairment, partial paralysis, impaired coordination, impaired sensations, partial loss of vision, dry or painful eyes, deafness, infection of the middle ear, ringing in the ears, earache, palpitations (when you can feel your heart beat), blood clot in the lung, high blood pressure, pneumonia, inflammation of your sinuses, bronchitis, a cold or the flu, swollen stomach, difficulty controlling your bowel movements, haemorrhoids, peeling skin, increased skin sensitivity to sunlight, change in skin colour, increased sweating, muscle damage, back pain, difficulty in urinating, vaginal bleeding, sexual impotence,
Maltese: Mhux komuni (jistgħu jaffettwaw sa persuna waħda minn kull 100): sintomi li jixbhu linfluwenza, dbabar ħomor taħt il-ġilda, livell baxx ta' potassium fid-demm, żieda fil-piż, bidla filburdati, alluċinazzjoni u memorja mhux eżatta, paraliżi parzjali, koordinazzjoni mxekkla, sensazzjonijiet imxekkla, telf parzjali tal-vista, għajnejn xotti jew bl-uġigħ, nuqqas ta' smigħ,
English: Deafness, vertigo, earache
Maltese: Telf tas-smigħ, vertigo, uġigħ fil widnejn
English: The objective response rate (ORR) based on MRI scans was 8%.
Maltese: ibbażata fuq skans ta' MRI kienet ta' 8%.
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: kienu osservati anormalitajiet ta' Grad 3 jew ta' Grad 4 fin-newtrofili, inkluż avvenimenti newtropeniċi, fi 8% tal-pazjenti.