FrancophonIA/ELRC3.0 huggingface dataset:
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 tar-reazzjonijiet ematoloġiċi avversi kienu rrappurtati b'mod komuni jew komuniħafna fiż-żewġ indikazzjonijiet (Tabelli 4 u 5); il-frekwenza tas-sejbiet tal- laboratorju ta' grad 3-4 tidher wara kull tabella.
English: Pneumocystis jiroveciipneumonia
Maltese: Disturbi psikjatriċi
English: Temozolomide SUN contains lactose
Maltese: Temozolomide SUN fih lactose
English: Endocrine disorders Uncommon:
Maltese: Disturbi fis-sistema endokrinarja* Mhux komuni:
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 avvenimenti 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: 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 % ta' l-irġiel u tromboċitopenija ta' Grad 4 fi 8 % tan-nisa vs 3 % ta' lirġiel fl-ewwel ċiklu tat-terapija.
English: Side effects from clinical studies
Maltese: Effetti sekondarji minn studji kliniċi
English: B. PACKAGE LEAFLET
Maltese: KARTUNA (FOLJA)
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: tikkettat b'-14C, il-medja tal-ammont ta' 14C fl-ippurgar matul is 7 ijiem wara d- doża kienet 0.8% li tindika assorbiment komplet.
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 l-endpoints varja minn 0.7 sa 2.1 xhur aktar għal TMZ milli għal procarbazine (log rank p=< 0.01 sa 0.03).
English: Thw cap is imprinted with ‘892'.
Maltese: L-għatu hu stampat b'‘892'.
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 gastrointestinali, speċifikament tqalligħ (43 %) u rimettar (36 %).
English: CTC Grade 4b a: TMZ dose levels are listed in Table 2. b: TMZ is to be discontinued if: - dose level -1 (100 mg/m2) still results in unacceptable toxicity
Maltese: b: TMZ għandu jitwaqqaf jekk: - Livell tad-doża -1 (100 mg/m2) jibqa jirriżulta f'tossiċità inaċċettabbli
English: Dose in Cycle 1 (monotherapy) is 150 mg/m2 once daily for 5 days followed by 23 days without treatment.
Maltese: Id-doża f'Ċiklu 1 (monoterapija) hija 150 mg/m2 darba kuljum għal 5 ijiem segwit minn 23 jum mingħajr kura.
English: Then you will have 23 days without Temozolomide SUN.
Maltese: Imbagħad se jkollok 23 jum mingħajr Temozolomide SUN.
English: Imprint
Maltese: Stampar
English: Infection, Herpes simplex, wound infection, pharyngitis, candidiasis oral
Maltese: Infezzjoni, Herpes simplex, infezzjoni tal-ġerħa, farinġite, kandidijasi fil-ħalq
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. Pazjenti fil-fergħa tal-kontroll ingħataw RT biss.
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 glijoblastoma multiforme jew astroċitoma anaplastika.
English: Cases of myelodysplastic syndrome and secondary malignancies, including myeloid leukaemia, have also been reported very rarely (see section 4.8).
Maltese: Każijiet ta' sindrome majelodisplastika u tumuri sekondarji, inkluża lewkimija majelojde kienu irrappurtati b'mod rari ħafna (ara sezzjoni 4.8).
English: You will again receive Temozolomide SUN once daily for 5 days, followed by 23 days without Temozolomide SUN.
Maltese: Se tieħu mill-ġdid Temozolomide SUN darba kuljum għal 5 ijiem, segwiti minn 23 jum mingħajr Temozolomide SUN.
English: Other medicines and Temozolomide SUN
Maltese: Mediċini oħra u Temozolomide SUN
English: Haemorrhage, oedema, oedema leg
Maltese: Emorraġija, edima, edima firriġlejn
English: Deafness, vertigo, earache
Maltese: Telf tas-smigħ, vertigo, uġigħ filwidnejn
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: Fi studji ta' qabel l-użu kliniku fuq firien u fniek li kienu qed jirċievu 150 mg/m2, TMZ, kienu murija teratoġeniċità u/jew effett tossiku fuq il-fetu (ara sezzjoni 5.3).
English: Erythema, pigmentation
Maltese: Popolazzjoni pedjatrika
English: Haemorrhage, deep venous thrombosis, oedema leg
Maltese: Emorraġija, deep vein trombosis, edima fir-riġlejn
English: You will again take Temozolomide SUN once daily for 5 days followed by 23 days without Temozolomide SUN.
Maltese: Se tieħu mill-ġdid Temozolomide SUN darba kuljum għal 5 ijiem segwiti minn 23 jum mingħajr Temozolomide SUN.
English: Otitis media, tinnitus, hyperacusis, earache
Maltese: Otitis media, tisfir fil-widnejn, iperakużis, uġigħ fil-widnejn
English: disorder, depression, hallucination
Maltese: konfużjoni, indeboliment talmemorja, indeboliment tal
English: Febrile neutropenia, thrombocytopenia, anaemia, leukopenia
Maltese: Newtropinja bid-deni, tromboċitopenija, anemija, lewkopenija
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: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Maltese: DATA TA' L-EWWEL AWTORIZZAZZJONI/TIĠDID TA' LAWTORIZZAZZJONI
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 l- medjan tas-sopravivenza totali kien ta' 5.4 xhur.
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' żieda fil-bilirubin, problemi bil-fluss tal-bila (kolestasi), epatite u ħsara fil-fwied, inkluż insuffiċjenza fatali tal-fwied kienu rrappurtati b'mod mhux komuni.
English: Temozolomide SUN 140 mg hard capsules have a white opaque body and cap, imprinted in blue ink.
Maltese: Temozolomide SUN 140 mg kapsuli ibsin tal-ġelatina, b'għatu u korp opaki bojod, stampati b'linka blu.
English: Pneumocystis jiroveciipneumonia (PCP) prophylaxis was required during RT and combined TMZ therapy.
Maltese: Terapija biex tilqa għall-pulmonite b'Pneumocystis jirovecii (PCP) kienet meħtieġa waqt it-terapija bl-RT u b'dik ikkombinata ma' TMZ.
English: Table 4 provides treatment-emergent adverse events in patients with newly-diagnosed glioblastoma multiforme during the concomitant and monotherapy phases of treatment.
Maltese: 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 konkomitanti u monoterapija.
English: Propylene glycol Black iron oxide (E172)
Maltese: Black iron oxide (E172)
English: Temozolomide SUN is administered in combination with focal radiotherapy (concomitant phase) followed by up to 6 cycles of temozolomide (TMZ) monotherapy (monotherapy phase).
Maltese: Temozolomide SUN jingħata flimkien ma' radjuterapija fokali (fażi konkomitanti) segwit b'mhux aktar minn 6 ċikli b'monoterapiji ta' temozolomide (TMZ) (fażi ta' monoterapija).
English: CTC Grade 4b a: TMZ dose levels are listed in Table 2. b: TMZ is to be discontinued if: - dose level -1 (100 mg/m2) still results in unacceptable toxicity - the same Grade 3 non-haematological toxicity (except for alopecia, nausea, vomiting) recurs after dose reduction.
Maltese: b: TMZ għandu jitwaqqaf jekk: - Livell tad-doża -1 (100 mg/m2) jibqa jirriżulta f'tossiċità inaċċettabbli - L-istess tossiċità mhux ematoloġika ta' Grad 3 (ħlief għal alopeċja, tqalligħ, rimettar) terġa tiġri wara.tnaqqis fid-doża
English: After oral administration to adult patients, TMZ is absorbed rapidly, with peak concentrations reached as early as 20 minutes post-administration (mean time between 0.5 and 1.5 hours).
Maltese: Wara għoti orali lil-pazjenti adulti, TMZ jiġi assorbit malajr, bl-ogħla konċentrazzjonijiet jintlaħqu anki 20 minuta wara li jkun ingħata (ħin medju bejn 0.5 u 1.5 sigħat).
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 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: Sintomi bħal dawk talinfluwenza, tikek ħomor taħt il-ġilda, livell baxx ta' potassium fid-demm, żieda fil-piż, tibdil filburdata, alluċinazzjonijiet u indeboliment fil-memorja, paralisi parzjali, indeboliment filkoordinazzjoni, indeboliment fis-sensazzjonijiet, telf parzjali tal-vista, għajnejn xotti jew bl-uġigħ, tittarrax, infezzjoni fil-parti tan-nofs tal-widna, tisfir fil-widnejn, uġigħ fil-widnejn, palpitazzjonijiet (meta tkun tista' tisma' t-taħbit ta' qalbek), embolu tad-demm fil-pulmun, pressjoni tad-demm għolja, pnewmonja, infjammazzjoni tas-sinuses, bronkite, riħ jew influwenza, stonku minfuħ, diffikultà biex tikkontrolla l-ippurgar, murliti, il-ġilda titqaxxar, żieda fis-sensittività tal-ġilda għad-dawl tax-xemx, tibdil fil-kulur tal-ġilda, żieda fl-għaraq, ħsara fil-muskoli, uġigħ fid-dahar, diffikultà biex tagħmel lawrina, ħruġ ta' demm mill-vaġina, impotenza sesswali, assenza ta' mestrwazzjoni jew mestrwazzjoni b'ħafna ħruġ ta' demm, irritazzjoni vaġinali, uġigħ fis-sider, fwawar, rogħda, tibdil fil-kulur ta' lsienek, tibdil fis-sens tax-xamm, għatx, disturbi fis-snien.
English: The requirements for submission of PSURs for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: • Rapporti perjodiċi aġġornati dwar is-sigurtà (PSURs) Id-rekwiżiti biex jiġu ppreżentat għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikati fuq il-portal elettroniku Ewropew tal-mediċini.
English: Headache
Maltese: Kummenti
English: Abdominal distension, fecal
Maltese: Tqala, treddigħ u fertilità
English: If you have been newly-diagnosed with glioblastoma multiforme you may be receiving Temozolomide SUN for 42 days in combination with radiotherapy.
Maltese: Jekk tkun ġejt iddijanjostikat għall-ewwel darba bi glijoblastoma multiforme, hu possibbli li se tirċievi Temozolomide SUN għal 42 jum flimkien ma' radjuterapija.
English: - common toxicity criteria (CTC) non-haematological toxicity ≤ Grade 1 (except for alopecia, nausea and vomiting).
Maltese: - tossiċità mhux ematoloġika ta' kriterju komuni tat-tossiċità (CTC), ta' ≤ Grad 1 (ħlief għal alopeċja, tqalligħ u rimettar).
English: Temozolomide SUN 20 mg hard capsules temozolomide
Maltese: Temozolomide SUN 20 mg kapsuli ibsin Temozolomide
English: Hard gelatin capsules, with white opaque cap and body, imprinted in blue ink.
Maltese: Kapsuli ibsin tal-ġelatina, b'għatu u korp opaki bojod, stampati b'linka blu.
English: The hard capsules are available in blister packs containing 5 capsules.
Maltese: Il-kapsuli ibsin huma formuti f'pakketti bil-folji li fihom 5 kapsuli.
English: The cap is imprinted with ‘929'.
Maltese: L-għatu hu stampat b'‘929'.
English: Temozolomide SUN 5 mg hard capsules temozolomide
Maltese: Temozolomide SUN 5 mg kapsuli ibsin temozolomide
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: Anti-emetic therapy
Maltese: Terapia S.A.
English: Temozolomide SUN 250 mg hard capsules
Maltese: Temozolomide SUN 250 mg kapsuli ibsin
English: Temozolomide SUN 5 mg hard capsules
Maltese: Temozolomide SUN 5 mg kapsuli ibsin
English: Uncommon (may affect up to 1 in 100 people): reduced blood cell counts (pancytopenia, anaemia, leukopenia).
Maltese: Mhux komuni (jistgħu jaffettwaw sa persuna waħda minn kull 100): tnaqqis fl-għadd tan-numru ta' ċelluli tad-demm (panċitopenija, anemija, lewkopenija).
English: Myelosuppression (neutropenia and thrombocytopenia), which is known dose-limiting toxicity for most cytotoxic agents, including TMZ, was observed.
Maltese: Majelosuppressjoni (newtropenija u tromboċitopenija), li hija magħrufa bħala tossiċità li tillimita ddoża għal ħafna sustanzi ċitotossiċi, inkluż TMZ, seħħet.
English: Infections and infestations Common:
Maltese: Infezzjonijiet u infestazzjonijiet
English: Temozolomide SUN 250 mg hard capsules temozolomide
Maltese: Temozolomide SUN 250 mg kapsuli ibsin Temozolomide
English: Temozolomide SUN 250 mg hard capsules have a white opaque body and cap, imprinted in black ink.
Maltese: Temozolomide SUN 250 mg kapsuli ibsin tal-ġelatina, b'għatu u korp opaki bojod, stampati b'linka sewda.
English: Temozolomide SUN 140 mg hard capsules
Maltese: Temozolomide SUN 140 mg kapsuli ibsin
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 blurred 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: sensazzjoni ta' tnemnim, tbenġil, rogħda, vista mhux normali jew vista mċajpra, tara doppju, indeboliment fis-smigħ, qtugħ ta' nifs, sogħla, embolu tad-demm fir-riġlejn, żamma ta' fluwidu, riġlejn minfuħin, dijarea, uġigħ fl-istonku jew uġigħ ta' żaqq, qrusa fl-istonku, stonku mqalleb, diffikultà biex tibla', ħalq xott, irritazzjoni jew ħmura tal-ġilda, ġilda xotta, ħakk, dgħufija fil-muskoli, uġigħ fil-ġogi, uġigħ u dulur fil-muskoli, tagħmel l-awrina ta' spiss, diffikultà biex iżżomm l-awrina, reazzjoni allerġika, deni, feriti minħabba r-radjazzjoni, nefħa fil-wiċċ, uġigħ, togħma mhux normali, testijiet tal-funzjoni tal-fwied b'riżultat mhux normali.
English: A complete blood count should be obtained on Day 22 (21 days after the first dose) or within 48 hours of that day, and weekly until ANC > 1.5 x 109/l and platelet count > 100 x 109/l.
Maltese: Għadd komplet tad-demm għandu jinkiseb fit-22 jum (21 jum wara l-ewwel doża) jew sa 48 siegħa minn dak il-jum, u kull ġimgħa sakemm l-ANC ikun > 1.5 x 109/l u l-għadd tal- plejtlets ikun > 100 x 109/l.
English: The cap is imprinted with ‘891'.
Maltese: L-għatu hu stampat b'‘891'.
English: Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu/.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għallMediċini http://www.ema.europa.eu/.
English: Temozolomide SUN 100 mg hard capsules
Maltese: Temozolomide SUN 100 mg kapsuli ibsin
English: The cap is imprinted with ‘890'.
Maltese: L-għatu hu stampat b'‘890'.
English: prolonged pancytopenia, aplastic anaemia†
Maltese: Newtropenija bid-deni, anemija Limfopenija, petekje
English: Temozolomide SUN 100 mg hard capsules temozolomide
Maltese: Temozolomide SUN 100 mg kapsuli ibsin Temozolomide
English: Propylene glycol Yellow iron oxide (E172)
Maltese: Isfar iron oxide (E172)
English: Medicinal product subject to medical prescription.
Maltese: Din il-mediċina hija sustanza.
English: Temozolomide SUN 180 mg hard capsules temozolomide
Maltese: Temozolomide SUN 180 mg kapsuli ibsin Temozolomide
English: The cap is imprinted with ‘930'.
Maltese: L-għatu hu stampat b'‘930'.
English: Temozolomide SUN 180 mg hard capsules
Maltese: Temozolomide SUN 180 mg kapsuli ibsin
English: Stomatitis, diarrhoea, dyspepsia, dysphagia, mouth dry
Maltese: Stomatite, dijarea, uġigħ addominali, dispepsja, disfaġja
English: a: Treatment with concomitant TMZ can be continued when all of the following conditions are met: absolute neutrophil count ≥ 1.5 x 109/l; thrombocyte count ≥ 100 x 109/l; CTC non-haematological toxicity ≤ Grade 1 (except for alopecia, nausea, vomiting).
Maltese: Il-kura b'TMZ mogħti b'mod konkomitanti tista' titkompla meta jintlaħqu dawn ilkondizzjonijiet kollha li ġejjin:għadd assolut tan-newtrofili ≥ 1.5 x 109/l; għadd tat-tromboċiti ≥ 100 x 109/l; tossiċità mhux ematoloġika ta'CTC ta' ≤ Grad 1 (ħlief għal alopeċja, tqalligħ, rimettar).
English: In patients treated with TMZ, whether used in combination with RT or as monotherapy following RT for newly-diagnosed glioblastoma multiforme, or as monotherapy in patients with recurrent or progressive glioma, the reported very common adverse reactions were similar: nausea, vomiting, constipation, anorexia, headache and fatigue.
Maltese: F'pazjenti kkurati b'TMZ, kemm kombinat ma' RT, kif ukoll bħala monoterapija wara RT għal glioblastoma multiforme li tkun għadha kif ġiet iddijanjostikata, jew bħala monoterapija f'pazjenti bi glijoma rikorrenti jew progressiva, reazzjonijiet avversi komuni ħafna rappurtati kienu simili: tqalligħ, rimettar, stitikezza, anoressija, uġigħ ta' ras u għejja.
English: Ear and labyrinth disorders Common:
Maltese: Disturbi tad-demm u tas-sistema limfatika Komuni:
English: Temozolomide SUN contains a medicine called temozolomide.
Maltese: Temozolomide SUN fih mediċina msejħa temozolamide.
English: Myelosuppression was predictable (usually within the first few cycles, with the nadir between Day 21 and Day 28), and recovery was rapid, usually within 1-2 weeks.
Maltese: Majelosuppressjoni setgħet tkun imbassra (normalment fl-ewwel ftit ċikli, bl-aktar punt baxx ma' Jum 21 u Jum 28), u l-irkupru kien mgħaġġel, normalment fi żmien 1-2 ġimgħat.
English: The cap is imprinted with ‘893'.
Maltese: L-għatu hu stampat b'‘893'.
English: Single-cycle (5-day dosing, 23 days non-treatment), 3- and 6-cycle toxicity studies were conducted in rats and dogs.
Maltese: Studi dwar l-effett tossiku minn ċiklu wieħed (dożaġġ ta' 5 ijiem, 23 jum mingħajr trattament), 3- u 6ċikli kienu magħmula fuq firien u klieb.
English: Contents of the pack and other information What Temozolomide SUN contains
Maltese: Kontenut tal-pakkett u informazzjoni oħra X'fih Temozolomide SUN
English: - The other ingredients are: capsule content: lactose, sodium starch glycolate (Type B), tartaric acid, stearic acid (see section 2 "Temozolomide SUN contains lactose") capsule shell: gelatin, titanium dioxide (E171), sodium laurilsulfate printing ink: shellac, propylene glycol, titanium dioxide (E171), blue #1/Brilliant Blue FCF Aluminium Lake (E133).
Maltese: kontenut tal-kapsula: lactose, sodium starch glycolate (Tip B), tartaric acid, stearic acid (ara sezzjoni 2 “Temozolomide SUN fih lactose”) qoxra tal-kapsula: gelatin, titanium dioxide (E171), sodium laurilsulfate linka tal-istampar: shellac, propylene glycol, titanium dioxide (E171), Blue #1/Brilliant Blue FCF Aluminium Lake (E133).
English: Hemiparesis, aphasia, balance impaired, somnolence, confusion, dizziness, memory impairment, concentration impaired, dysphasia,
Maltese: sturdament, indeboliment talmemorja, indeboliment tal konċentrazzjoni, disfażja,
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 blurred vision, double vision, hearing impairment, shortness of breath, cough, blood clot in the legs, fluid retention, swollen legs, diarrhoea,
Maltese: Komuni (jistgħu jaffettwaw sa persuna waħda minn kull 10): infezzjonijiet orali, infezzjonijiet filferiti, tnaqqis fin-numru ta' ċelluli tad-demm (newtropenija, tromboċitopenija, limfopenija, lewkopenija), żieda fil-livell ta' zokkor fid-demm, telf ta' piż, tibdil fl-istat mentali jew fl-attenzjoni ta' dak li jkun, ansjetà/dipressjoni, irqad, diffikultà biex titkellem, indeboliment fil-bilanċ, sturdament, konfużjoni, tinsa, diffikultà biex tikkonċentra, ma tkunx tista' torqod jew ma tkunx tista' tibqa' rieqed,
English: Temozolomide SUN 20 mg hard capsules have a white opaque body and cap, imprinted in yellow ink.
Maltese: Temozolomide SUN 20 mg kapsuli ibsin tal-ġelatina, b'għatu u korp opaki bojod, stampati b'linka safra.
English: PEEL
Maltese: FOLJA
English: EU/1/11/697/017 (5 capsules in blister) EU/1/11/697/018 (20 capsules in blister)
Maltese: EU/1/11/697/017 (5 kapsuli ibsin) EU/1/11/697/018 (20 kapsuli ibsin)
English: - The other ingredients are: capsule content: lactose, sodium starch glycolate (Type B), tartaric acid, stearic acid (see section 2 "Temozolomide SUN contains lactose") capsule shell: gelatin, titanium dioxide (E171), sodium laurilsulfate printing ink: shellac, propylene glycol, yellow iron oxide (E172), blue #1/Brilliant Blue FCF Aluminium Lake (E133).
Maltese: kontenut tal-kapsula: lactose, sodium starch glycolate (Tip B), tartaric acid, stearic acid (ara sezzjoni 2 “Temozolomide SUN fih lactose”) qoxra tal-kapsula: gelatin, titanium dioxide (E171), sodium laurilsulfate linka tal-istampar: shellac, propylene glycol, isfar iron oxide (E172), Blue #1/Brilliant Blue FCF Aluminium Lake (E133).