FrancophonIA/ELRC3.0 huggingface dataset:
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: toxic epidermal necrolysis, Stevens-Johnson syndrome
Maltese: Nekrolisi tossika tal-ġilda, sindrome ta' StevensJohnson
English: - The active substance is temozolomide.
Maltese: • Is-sustanza attiva hija temozolomide.
English: Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.
Maltese: Mediċini http://www.ema.europa.eu.
English: There were higher rates of Grade 4 neutropenia (ANC < 0.5 x 109/l), 12 % vs 5 %, and thrombocytopenia (< 20 x 109/l), 9 % vs 3 %, in women vs men in the first cycle of therapy.
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: 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: Neutropenia or lymphopenia (Grade 3 - 4), thrombocytopenia (Grade 3 - 4)
Maltese: Newtropenija jew limfopenija (Grad 3 - 4), tromboċitopenija (Grad 3 - 4)
English: Capsule content anhydrous lactose, sodium starch glycolate Type A, colloidal anhydrous silica, tartaric acid, stearic acid
Maltese: Anhydrous lactose Sodium starch glycolate Type A Colloidal anhydrous silica Tartaric acid
English: LIST OF EXCIPIENTS Contains lactose, sunset yellow FCF (E110).
Maltese: TA' EĊĊIPJENTI Fih lactose u sunset yellow FCF (E110).
English: TMZ is spontaneously hydrolysed at physiologic pH primarily to the active species, 3-methyl-(triazen1-yl)imidazole-4-carboxamide (MTIC).
Maltese: TMZ huwa idrolizzat b'mod spontanju fil-pH fiżjoloġika għall-ispeċi attiva, 3-methyl-(triazen1-yl)imidazole-4-carboxamide (MTIC).
English: Side effects from clinical studies:
Maltese: Effetti sekondarji minn studji kliniċi:
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, u virus talepatite B†, meningoenċefalite ħerpetika†, sepsis†
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 = 1.331.91) b'log rank p < 0.0001 favur il-fergħa ta' TMZ.
English: ≥ 10 and < 100 x 109/l < 10 x 109/l
Maltese: ≥ 10 u < 100 x 109/l
English: CTC Grade 3 or 4
Maltese: CTC Grad 3
English: In the tables undesirable effects are classified according to System Organ Class and frequency.
Maltese: Fit-tabelli l-effetti mhux mixtieqa huma klassifikati skont is- Sistema tal-Klassifika tal-Organi u l frekwenza.
English: diabetes insipidus
Maltese: Dijabete insipidus
English: ≥ 0.5 and < 1.5 x 109/l < 0.5 x 109/l
Maltese: ≥ 0.5 u < 1.5 x 109/l
English: Temomedac contains lactose (a kind of sugar).
Maltese: Temomedac fih lactose (tip ta' zokkor).
English: interstitial pneumonitis/pneumonitis, pulmonary fibrosis, respiratory failure†
Maltese: Pulmonite tal-interstizju/pulmonite, fibrożi talpulmuni, insuffiċjenza respiratorja
English: There is limited information in patients over 3 years of age who have taken Temomedac.
Maltese: Hemm informazzjoni limitata f'pazjenti li għandhom 'l fuq minn 3 snin li ħadu Temomedac.
English: drug reaction with eosinophilia and systemic symptoms (DRESS)
Maltese: Reazzjoni għall-Mediċina b'esinofilja u sintomi sistemiċi (DRESS)
English: MTIC is spontaneously hydrolysed 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-aminoimidazole-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: Temomedac contains lactose
Maltese: Temomedac fih lactose
English: Temomedac 5 mg hard capsules Temomedac 20 mg hard capsules Temomedac 100 mg hard capsules Temomedac 140 mg hard capsules Temomedac 180 mg hard capsules Temomedac 250 mg hard capsules temozolomide
Maltese: Temomedac 5 mg kapsuli ibsin Temomedac 20 mg kapsuli ibsin Temomedac 100 mg kapsuli ibsin Temomedac 140 mg kapsuli ibsin Temomedac 180 mg kapsuli ibsin Temomedac 250 mg kapsuli ibsin
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-aminoimidazole4-carboxamide (AIC) jew metaboliti polari li ma ġewx identifikati.
English: Dose during Cycles 2 - 6 in absence of toxicity
Maltese: Dożi waqt Ċikli 2 - 6 jekk ma jkunx hemm tossiċità
English: capsule shell (including printing ink):
Maltese: qoxra tal-kapsula (li tinkudi l-linka tal-istampar):
English: How to store Temomedac
Maltese: Tieħux Temomedac
English: Pharmacotherapeutic group: Antineoplastic agents - Other alkylating agents, ATC code: L01A X03 Mechanism of action
Maltese: Aġenti antineoplastiċi - alkylating agents oħra, kodiċi ATC:
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: 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, tagħmel awrina ta' spiss, diffikulta' biex iżżomm l-awrina, reazzjoni allerġika, deni, ħsara effett tarraġġi, nefħa fil-wiċċ, uġigħ, togħma anormali, testijiet tal-funzjoni tal-fwied mhux normali.
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: 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 ġimgħat wara li ntemmet r-RT.
English: Then you will have 23 days without Temomedac.
Maltese: Imbagħad ikollok 23 jum mingħajr Temomedac.
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, bħall glijoblastoma multiforme u astroċitoma anaplastika.
English: Micturition frequency, urinary incontinence
Maltese: Żieda fil-frekwenza ta' l-awrinar, inkontinenza ta' l-awrina
English: - The other ingredients are: capsule content: anhydrous lactose, colloidal anhydrous silica, sodium starch glycolate type A, tartaric acid, stearic acid (see section 2 “Temomedac contains lactose”).
Maltese: • Is-sustanzi l-oħrajn huma: kontenut tal-kapsula: anhydrous lactose, colloidal anhydrous silica, sodium starch glycolate type A, tartaric acid,
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: Table 6.
Maltese: Tabella 4.
English: INFORMATION IN BRAILLE Temomedac 5 mg
Maltese: Temomedac 5 mg
English: Temomedac 250 mg hard capsules: Each capsule contains 250 mg temozolomide.
Maltese: Temomedac 250 mg kapsuli ibsin: Kull kapsula fiha 250 mg temozolomide.
English: Infection, herpes simplex, wound infection, pharyngitis, candidiasis oral
Maltese: Infezzjoni, Herpes simplex, infezzjoni talġerħa, farinġite, kandidijasi fil-ħalq
English: INFORMATION IN BRAILLE Temomedac 180 mg
Maltese: Temomedac 180 mg
English: INFORMATION IN BRAILLE Temomedac 250 mg
Maltese: Temomedac 250 mg
English: Each hard capsule contains 117 mg of anhydrous lactose.
Maltese: Temomedac 140 mg kapsuli ibsin Kull kapsula iebsa fiha 117 mg anhydrous lactose.
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 lavvenimenti avversi kienu kkombinati tul il-fażijiet ta' kura konkomitanti u dik bħala monoterapija, kienu osservati anormalitajiet ta' Grad 3 jew ta' Grad 4 fin-newtrofili, inkluż avvenimenti newtropeniċi, fi 8 % tal-pazjenti.
English: INFORMATION IN BRAILLE Temomedac 140 mg
Maltese: Temomedac 140 mg
English: Hypokalaemia, alkaline phosphatase increased, weight increased
Maltese: Ipokalimja, żieda ta' alkaline phosphatase, żieda fil-piż
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, absent or heavy menstrual periods, vaginal irritation, breast pain, hot flushes, shivering, discolouration of your tongue, change in your sense of smell, thirst, tooth disorder.
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, infezzjoni fil-widna minn ġewwa, tisfir fil-widnejn, uġigħ fil-widnejn, palpitazzjonijiet (tferfir ta' qalb), demm magħqud fil-pulmun, pressjoni tad-demm għolja, pulmonite, infjammazzjoni fis-sinuses,
English: INFORMATION IN BRAILLE Temomedac 20 mg
Maltese: Temomedac 20 mg
English: Temomedac 20 mg hard capsules: Each capsule contains 20 mg temozolomide.
Maltese: Temomedac 20 mg kapsuli ibsin: Kull kapsula fiha 20 mg temozolomide.
English: Temomedac 140 mg hard capsules: gelatin, titanium dioxide (E 171), shellac, propylene glycol, indigo carmine (E 132) aluminium lake.
Maltese: Temomedac 140 mg kapsuli ibsin: gelatin, titanium dioxide (E 171), shellac, propylene glycol, Indigo carmine (E 132) aluminium lake.
English: Each hard capsule contains 72 mg of anhydrous lactose and sunset yellow FCF (E110).
Maltese: Temomedac 20 mg kapsuli ibsin Kull kapsula iebsa fiha 72 mg anhydrous lactose u sunset yellow FCF (E 110).
English: Temomedac 140 mg hard capsules: Each capsule contains 140 mg temozolomide.
Maltese: Temomedac 140 mg kapsuli ibsin: Kull kapsula fiha 140 mg temozolomide.
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: Urinary incontinence
Maltese: edima periferali
English: Temomedac 180 mg hard capsules: Each capsule contains 180 mg temozolomide.
Maltese: Temomedac 180 mg kapsuli ibsin: Kull kapsula fiha 180 mg temozolomide.
English: The half-life (t1/2) in plasma is approximately 1.8 hours.
Maltese: Eliminazzjoni Il-half-life (t1/2) fil-plażma hija ta' madwar 1.8 sigħat.
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: Temomedac 5 mg hard capsules: Each capsule contains 5 mg temozolomide.
Maltese: Temomedac 5 mg kapsuli ibsin: Kull kapsula fiha 5 mg temozolomide.
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: Each hard capsule contains 209 mg of anhydrous lactose.
Maltese: Temomedac 250 mg kapsuli ibsin Kull kapsula iebsa fiha 209 mg anhydrous lactose.
English: Each hard capsule contains 84 mg of anhydrous lactose.
Maltese: Temomedac 100 mg kapsuli ibsin Kull kapsula iebsa fiha 84 mg anhydrous lactose.
English: Temomedac 250 mg hard capsules
Maltese: Temomedac 250 mg kapsuli ibsin
English: INFORMATION IN BRAILLE Temomedac 100 mg
Maltese: Temomedac 100 mg
English: This medicine is an antitumour agent.
Maltese: Din il-mediċina hija sustanza li taġixxi kontra t tumuri.
English: Based on a population pharmacokinetic analysis in patients 19 - 78 years of age, clearance of TMZ is not affected by age.
Maltese: Ibbażat fuq analiżi farmakokinetika tal-popolazzjoni f'pazjenti ta' età bejn 19 - 78 sena, it-tneħħija ta' TMZ mhijiex affettwata mill-età.
English: Adult and paediatric patients 3 years of age or older with recurrent or progressive malignant glioma
Maltese: Pazjenti adulti u pedjatriċi minn 3 snin 'il fuq bi glijoma malinna rikorrenti jew progressiva
English: Temomedac 100 mg hard capsules: Each capsule contains 100 mg temozolomide.
Maltese: Temomedac 100 mg kapsuli ibsin: Kull kapsula fiha 100 mg temozolomide.
English: Temomedac 5 mg hard capsules
Maltese: Temomedac 5 mg kapsuli ibsin
English: Additional information for Temomedac 20 mg hard capsules The excipient sunset yellow FCF (E110) included in the capsules shell may cause allergic reactions.
Maltese: Tagħrif addizzjonali għall-Temomedac 20 mg kapsuli ibsin Is-sustanza mhux attiva sunset yellow FCF (E110) inkluża fil-qoxra tal-kapsuli tista' tikkawża reazzjonijiet allerġiċi.
English: - 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, adolexxenti, u pazjenti adulti bi glijoma malinna, bħal glijoblastoma multiforme jew astroċitoma anaplastika, li jerġgħu jirkadu jew ikollhom avvanz talmarda wara li tkun ingħatat terapija standard.
English: Each hard capsule contains 150 mg of anhydrous lactose.
Maltese: Temomedac 180 mg kapsuli ibsin Kull kapsula iebsa fiha 150 mg anhydrous lactose.
English: After oral administration of 14C-labelled TMZ, mean faecal excretion of 14C over 7 days post-dose was 0.8 %
Maltese: tikkettat b'14C, il-medja tal-ammont ta' 14C fl-ippurgar matul is-7 ijiem wara ddoża kienet 0.8 % li tindika assorbiment komplet.
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' infezzjoni fis-sider imsejħa pulmonite bi Pneumocystis jirovecii (PCP).
English: Frequency groupings are defined according to the following convention: very common (≥ 1/10); common (≥ 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: Rari (≥ 1/10,000 sa < 1/1,000);
English: Temomedac 20 mg hard capsules
Maltese: Temomedac 20 mg kapsuli ibsin
English: Each hard capsule contains 87 mg of anhydrous lactose.
Maltese: Temomedac 5 mg kapsuli ibsin Kull kapsula iebsa fiha 87 mg anhydrous lactose.
English: Temomedac 100 mg hard capsules
Maltese: Temomedac 100 mg kapsuli ibsin
English: SPECIAL STORAGE CONDITIONS Do not store above 30 °C.
Maltese: Taħżinx f'temperatura 'l fuq minn 30 °C.
English: Temomedac 100 mg hard capsules: gelatin, titanium dioxide (E 171), red iron oxide (E 172), shellac, propylene glycol and yellow iron oxide (E 172).
Maltese: Temomedac 100 mg kapsuli ibsin: gelatin, titanium dioxide (E 171), red iron oxide (E 172), shellac, propylene glycol, yellow iron oxide (E 172).
English: Other medicines and Temomedac
Maltese: Mediċini oħra u Temomedac
English: Temomedac 140 mg hard capsules
Maltese: Temomedac 140 mg kapsuli ibsin
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 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: NAME OF THE MEDICINAL PRODUCT Temomedac 5 mg hard capsules temozolomide
Maltese: Temomedac 5 mg kapsuli ibsin temozolomide
English: Temomedac 180 mg hard capsules
Maltese: Temomedac 180 mg kapsuli ibsin
English: Convulsions, consciousness decreased, somnolence, aphasia, balance impaired, dizziness, confusion, memory impairment, concentration impaired, neuropathy, paraesthesia, speech disorder, tremor
Maltese: Konvulżjonijiet, tnaqqis tal-konxjetà, ngħas, afażja, telf ta' l-ekwilibriju, sturdament, konfużjoni, indeboliment tal-memorja, indeboliment talkonċentrazzjoni, newropatija, parasteżija, ma jitkellmux tajjeb, tregħid
English: Temomedac 250 mg hard capsules: gelatin, titanium dioxide (E 171), shellac, propylene glycol, black iron oxide (E 172).
Maltese: Temomedac 250 mg kapsuli ibsin: gelatin, titanium dioxide (E 171), shellac, propylene glycol, black iron oxide (E 172).
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: Pneumonia, sinusitis, upper respiratory infection, bronchitis
Maltese: Pulmonite, sinusite, infezzjoni filparti ta' fuq tal-apparat respiratorju,
English: Very rare (may affect up to 1 in 10,000 people): skin redness, urticaria (hives), skin eruption, allergic reactions.
Maltese: Rari ħafna (jistgħu jaffettwaw sa persuna waħda minn kull 10,000): ħmura tal-ġilda, urtikarja (ħobżħobz), ponot fil-ġilda, reazzjonijiet allerġiċi.
English: At the start of Cycle 2, the dose is escalated to 200 mg/m² if the CTC non-haematological toxicity for Cycle 1 is Grade ≤ 2 (except for alopecia, nausea and vomiting), absolute neutrophil count (ANC) is ≥ 1.5 x 109/l, and the thrombocyte count is ≥ 100 x 109/l.
Maltese: Fil-bidu ta' Ċiklu 2, id-doża tiżdied għal 200 mg/m² jekk ittossiċità mhux ematoloġika CTC għal Ċiklu 1 huwa Grad ≤ 2 (ħlief għal alopeċja, tqalligħ u rimettar), jekk l-għadd assolut tan-newtrofili (ANC) jkun ≥ 1.5 x 109/l, u l-għadd tat-tromboċiti jkun ≥ 100 x 109/l.
English: NAME OF THE MEDICINAL PRODUCT Temomedac 250 mg hard capsules temozolomide
Maltese: Temomedac 250 mg kapsuli ibsin temozolomide
English: NAME OF THE MEDICINAL PRODUCT Temomedac 140 mg hard capsules temozolomide
Maltese: Temomedac 140 mg kapsuli ibsin temozolomide
English: Temomedac 180 mg hard capsules: gelatin, titanium dioxide (E 171), shellac, propylene glycol, red iron oxide (E 172)
Maltese: Temomedac 180 mg kapsuli ibsin: gelatin, titanium dioxide (E 171), shellac, propylene glycol, red iron oxide (E 172).
English: A variety of neoplasms, including mammary carcinomas, keratocanthoma of the skin and basal cell adenoma were observed in the 6-cycle rat study while no tumours or pre-neoplastic changes were evident in dog studies.
Maltese: Varjetà ta' neoplażmi, li jinkudu karċinomi mammarji, keratokantoma tal-ġilda u basal cell adenoma kienu osservati fi studju ta' 6 ċikli fuq il-firien, filwaqt li l-ebda tumuri jew tibdil pri-neoplastiku ma kien evidenti fi studji fuq il-klieb.
English: Temomedac monotherapy in recurrent or progressive glioma
Maltese: Monoterapija b'Temomedac fi glijoma rikurrenti jew progressiva
English: NAME OF THE MEDICINAL PRODUCT Temomedac 20 mg hard capsules temozolomide
Maltese: Temomedac 20 mg kapsuli ibsin temozolomide
English: NAME OF THE MEDICINAL PRODUCT Temomedac 180 mg hard capsules temozolomide
Maltese: Temomedac 180 mg kapsuli ibsin temozolomide