FrancophonIA/ELRC3.0 huggingface dataset:
English: The addition of concomitant TMZ to RT, followed by TMZ monotherapy in the treatment of patients with newly diagnosed glioblastoma multiforme demonstrated a statistically significant improvement in overall survival (OS) compared with RT alone (Figure 1).
Danish: Supplerende behandling til RTen i form af konkomitant behandling med TMZ, efterfulgt af monoterapi med TMZ, til patienter med nydiagnosticeret glioblastoma multiforme medførte en statistisk signifikant forbedring af samlet overlevelse (OS), sammenlignet med RT alene (figur 1).
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.
Danish: Den maksimalt tolererede dosis (MTD) var dog 1.000 mg/m2 pr. serie for både børn og voksne.
English: • increased sugar in the blood, loss of weight
Danish: • øget sukkerindhold i blodet, vægttab
English: Dose during Cycle 1
Danish: Dosis i serie 1
English: • the same Grade 3 non-haematological toxicity (except for alopecia, nausea, vomiting) recurs after dose reduction.
Danish: • den samme ikke-hæmatologisk toksicitet af grad 3 (undtagen alopeci, kvalme og opkastning) vender tilbage efter dosisreduktion.
English: Temozolomide Accord is administered in combination with focal radiotherapy (concomitant phase) followed by up to 6 cycles of temozolomide (TMZ) monotherapy (monotherapy phase).
Danish: Temozolomide Accord anvendes i kombination med lokal strålebehandling (konkomitant fase) efterfulgt af op til 6 serier af temozolomide (TMZ) monoterapi (monoterapi fase).
English: Abdominal distension, faecal incontinence, gastrointestinal disorder (NOS), gastroenteritis, haemorrhoids
Danish: Udspilet abdomen, fækal inkontinens, gastrointestinal sygdom (NOS), gastroenteritis, hæmorider
English: Anxiety, depression, emotional lability, insomnia
Danish: Angst, depression, emotionel labilitet, insomni
English: Marketing Authorisation Holder and Manufacturer
Danish: Indehaver af markedsføringstilladelsen og fremstiller:
English: Date of first authorisation:15 March 2010 Date of latest renewal: 12 January 2015
Danish: Dato for første markedsføringstilladelse: 15. marts 2010 Dato for seneste fornyelse: 12. januar 2015
English: Anxiety, emotional lability, insomnia
Danish: Angst, emotionel labilitet, insomni
English: Clinical trial experience
Danish: Erfaringer fra kliniske undersøgelser
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1 hard capsule
Danish: INDHOLDSMÆNGDE ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 1 hård kapsel
English: Gamma GT increased, AST increased *A patient who was randomised to the RT arm only, received TMZ + RT.
Danish: Træthed *En patient, som kun var randomiseret til RTsarmen, fik TMZ + RT.
English: Abnormal blood values, headache, feeling or being sick, constipation, loss of appetite, tiredness
Danish: Unormale blodværdier, hovedpine, kvalme, forstoppelse, tab af appetit, træthed
English: Table 4 provides treatment-emergent adverse reactions in patients with newly-diagnosed glioblastoma multiforme during the concomitant and monotherapy phases of treatment.
Danish: Tabel 4 anfører bivirkninger fremkommet hos patienter med nydiagnosticeret glioblastoma multiforme under konkomitant- og monoterapi behandlingsfaserne.
English: - The active substance is temozolomide.
Danish: - Aktivt stof: temozolomid
English: Vaginal haemorrhage, menorrhagia, amenorrhea, vaginitis, breast pain
Danish: Vaginalblødning, menorrhagi, amenorrhea, vaginitis, brystsmerter
English: Infections and infestations* Uncommon:
Danish: Infektioner og parasitære sygdomme* Ikke almindelig:
English: Grade 3 or Grade 4 thrombocyte abnormalities, including thrombocytopenic reactions were observed in 14% of the patients who received TMZ.
Danish: Der blev set trombocytabnormaliteter af grad 3 eller 4, inklusive trombocytopeniske bivirkninger, hos 14 % af patienterne, der fik TMZ.
English: Endocrine disorders* Uncommon:
Danish: Det endokrine system* Ikke almindelig:
English: TMZ dose(mg/m2 /day)
Danish: Dosisniveau TMZ-dosis (mg/m2
English: a severe allergic reaction (rash which might be itchy, wheezing or other breathing difficulty), - uncontrolled bleeding, - Seizures (convulsions), - fever, - chills, - severe headache that does not go away.
Danish: Kontakt straks lægen, hvis De får et eller flere af følgende symptomer: en overfølsomhedsreaktion (udslæt, som kan være kløende, hiven efter vejret eller andre åndedrætsproblemer), ukontrolleret blødning, anfald (kramper), feber, kulderystelser, eller svær hovedpine, som ikke forsvinder.
English: • pneumonia, inflammation of your sinuses, bronchitis, blocked nose, a cold or the flu
Danish: • lungebetændelse, bihulebetændelse, bronkitis, tilstoppet næse, forkølelse eller influenza
English: Your doctor will decide the correct dose of temozolomide for you to take, based on your size (height and weight) and whether you have had chemotherapy treatment.
Danish: Den er baseret på Deres størrelse (højde og vægt), og på om De tidligere har fået kemoterapi.
English: Rash, pruritus, alopecia
Danish: Udslæt, pruritus, alopeci,
English: • fits, change in mental status or alertness, sleepiness, difficulty with your balance, dizziness,
Danish: • kramper, ændringer i mental status eller årvågenhed, søvnighed, problemer med at holde balancen,
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.
Danish: De fleste rapporteringer om hæmatologiske bivirkninger var almindelige eller meget almindelige for begge indikationer (tabel 4 og 5).
English: Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, Section 4.2).
Danish: Lægemidlet må kun udleveres efter ordination på en recept udstedt af en begrænset lægegruppe (se bilag I: Produktresumé; pkt.
English: Each hard capsule contains 73 mg of anhydrous lactose.
Danish: Hver hårde kapsel indeholder 73 mg vandfrit lactose.
English: Psychiatric disorders Common:
Danish: Psykiske forstyrrelser Almindelig:
English: TMZ dose (mg/m2 /day)
Danish: Dosisniveau Dosis (mg/m2 /dag) Bemærkninger
English: MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Danish: FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE
English: Reproductive system and breast disorders Uncommon:
Danish: Det reproduktive system og mammae Ualmindelig:
English: prolonged pancytopenia, aplastic anaemia† Neoplasm benign, malignant and unspecified Very rare:
Danish: Længerevarende pancytopeni, aplastisk anæmi† Benigne, maligne og uspecificerede tumorer Meget sjælden:
English: • infections, wound infection, sore throat, fungal infections in the mouth, cold sores
Danish: • infektioner, sårinfektion, ondt i halsen, svampeinfektion i munden, forkølelsessår
English: Renal and urinary disorders Common:
Danish: Nyrer og urinveje Almindelig:
English: Infection, Herpes simplex, wound infection, pharyngitis, candidiasis oral
Danish: sårinfektion, pharyngitis, oral candidiasis
English: In some cases, exposure to concomitant medicinal products associated with aplastic anaemia, including carbamazepine, phenytoin, and sulfamethoxazole/trimethoprim, complicates assessment.
Danish: I nogle tilfælde vanskeliggøres vurderingen af samtidig eksponering for lægemidler, der er associeret med aplastisk anæmi, herunder carbamazepin, phenytoin, og sulfamethoxazole/ trimethoprim.
English: • bloated stomach, difficulty controlling your bowel movements, haemorrhoids (piles)
Danish: • oppustet mave, besvær med at kontrollere afføringen, hæmorider
English: Experience in these children is very limited (see sections 4.4 and 5.1).
Danish: Erfaringerne hos disse børn er meget begrænset (se pkt.
English: Women of child bearing should be advised to use effective contraception to avoid pregnancy while they are receiving TMZ.
Danish: Kvinder i den fertile alder skal anbefales at anvende sikker kontraception for at undgå graviditet under behandling med temozolomid (TMZ).
English: • Abnormal liver function tests,
Danish: • unormale leverprøver
English: Response rate, based on the central reviewer assessment, was 35% (13 CR and 43 PR) for the intent-to-treat-populations (ITT) n=162.
Danish: Baseret på den centrale bedømmers vurdering var responsraten 35 % (13 CR og 43 PR) for intent-to-treat-populationen (ITT, n=162).
English: Cases of diabetes insipidus have been uncommonly reported.
Danish: Der er rapporteret tilfælde af diabetes insipidus med hyppigheden ”ikke almindelig”.
English: Table 1.TMZ dosing interruption or discontinuation during concomitant radiotherapy and TMZ
Danish: Tabel 1.Afbrydelse eller seponering af behandlingen med TMZ under konkomitant RT og behandling med TMZ
English: Hypokalemia, alkaline phosphatase increased, weight increased
Danish: Hypokalæmi, forhøjet basisk fosfatase, vægtøgning
English: OTHER SPECIAL WARNING(S), IF NECESSARY Cytotoxic.
Danish: EVENTUELLE ANDRE SÆRLIGE ADVARSLER Cytostatikum
English: printing ink: shellac, propylene glycol, black iron oxide (E172) and potassium hydroxide.
Danish: Påtrykt blæk: shellac, propylenglycol, sort jernoxid (E172) og kaliumhydroxid.
English: For the eligible histology population, the efficacy results were similar.
Danish: Det samme gjaldt for effekt for den population, som kunne vurderes med hensyn til histologi.
English: TMZ dose reduction or discontinuation during monotherapy treatment Toxicity
Danish: Reduktion af dosis eller seponering af TMZ under monoterapi Toksicitet
English: In patients previously untreated with chemotherapy, TMZ is administered orally at a dose of 200 mg/m2 once daily for the first 5 days followed by a 23 day treatment interruption (total of 28 days).
Danish: Til patienter, som ikke tidligere er behandlet med kemoterapi, gives TMZ oralt i en dosis på 200 mg/m2 én gang dagligt i de første 5 dage efterfulgt af en 23-dages behandlingspause (i alt 28 dage).
English: • bleeding within the brain, high blood pressure, blood clot in the lung, swelling
Danish: • hjerneblødning, for højt blodtryk, blodprop i lungerne, hævelser
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Danish: Yderligere oplysninger om dette lægemiddel findes på Det europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: Visual acuity reduced, eye pain, eyes dry
Danish: Nedsat synsskarphed, øjensmerter, tørre øjne
English: • skin irritation or redness, dry skin, itching
Danish: • irritation eller rødme af huden, tør hud, kløen
English: 4.2 Posology and method of administration Temozolomide Accord should only be prescribed by physicians experienced in the oncological treatment of brain tumours.
Danish: Temozolomide Accord bør kun ordineres af læger, der har erfaring med onkologisk behandling af hjernetumorer.
English: Single-cycle (5-day dosing, 23 days non-treatment), 3- and 6-cycle toxicity studies were conducted in rats and dogs.
Danish: Der blev udført toksicitetsundersøgelser på rotter og hunde efter en enkelt serie (5 dages behandling, 23 dages behandlingspause) og efter 3 og 6 serier.
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.
Danish: I en undersøgelse med 288 forsøgspersoner med nydiagnosticeret multiform glioblastom forekom neutropeni af grad 4 hos 3 % af de kvindelige vs. 0 % af de mandlige forsøgspersoner og trombocytopeni af grad 4 hos 1 % af de kvindelige vs. 0 % af de mandlige forsøgspersoner i den første behandlingsserie.
English: Cases of myelodysplastic syndrome and secondary malignancies, including myeloid leukaemia, have also been reported very rarely (see section 4.8).
Danish: I meget sjældne tilfælde er der rapporteret om myelodysplastisk syndrom og sekundær malignitet, herunder myeloid leukæmi (se pkt.
English: • low potassium level in the blood, weight gain
Danish: • lavt kaliumindhold i blodet, vægtøgning
English: If a capsule is damaged, avoid contact of the powder with your skin, eyes or nose.
Danish: Hvis en kapsel bliver ødelagt, skal De undgå, at pulveret kommer i kontakt med hud, øjne og næse.
English: While the radiotherapy is ongoing your doctor will start temozolomide at a dose of 75 mg/m² and the actual daily dose you take will depend on your height and weight.
Danish: Mens De får strålebehandling, vil Deres læge påbegynde behandling med temozolomid med en dosis på 75 mg/m².
English: ≥ 10 and < 100 x 109/l
Danish: ≥10 og < 100 x 109 /l
English: Pneumocystis jirovecii pneumonia (PCP) prophylaxis was required during RT and combined TMZ therapy.
Danish: Patienterne i kontrolgruppen fik kun RT. Profylaktisk behandling for Pneumocystis jirovecii pneumoni (PCP) var påkrævet under RTen og under kombinationsbehandlingen med TMZ.
English: You will take the capsules once daily for the first five days (“dosing days”) followed by 23 days without temozolomide, adding up to the 28 day treatment cycle.
Danish: De skal tage kapslerne en gang daglig i de første fem dage (”behandlingsdage”) efterfulgt af 23 dage uden behandling med temozolomid.
English: Sleepiness, dizziness, tingling sensation, diarrhoea, stomach pain, indigestion, rash, itching, hair loss, weight loss, fever, weakness, shivering, feeling unwell, pain, change in taste, shortness of breath
Danish: Søvnighed, svimmelhed, prikkende fornemmelser, diarre, mavesmerter, fordøjelsesbesvær, udslæt, kløen, hårtab, vægttab, feber, slaphed, kulderystelser, følelse af utilpashed, smerter, smagsændringer, kortåndethed
English: Experience in older children and adolescents is very limited (see sections 4.2 and 5.1).
Danish: Erfaringerne hos ældre børn er meget begrænset (se pkt.
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.
Danish: I et gentaget gliom-datasæt med 400 forsøgspersoner forekom neutropeni af grad 4 hos 8 % af de kvindelige vs. hos 4 % af de mandlige forsøgspersoner og trombocytopeni af grad 4 hos 8 % af de kvindelige vs. hos 3 % af de mandlige forsøgspersoner i den første behandlingsserie.
English: In patients 3 years of age or older, TMZ is only to be used in recurrent or progressive malignant glioma.
Danish: Ved tilbagevendende eller progressivt malignt gliom bør TMZ kun bruges til patienter på 3 år eller ældre.
English: TMZ discontinuation
Danish: TMZ seponering
English: ≥ 0.5 and < 1.5 x 109/l
Danish: ≥0,5 og < 1,5 x 109 /l
English: Pneumonia, upper respiratory infection, nasal congestion
Danish: Pneumoni, øvre luftvejsinfektion, næsetæthed
English: CTC non-haematological Toxicity (except for alopecia, nausea, vomiting)
Danish: CTC ikke-hæmatologisk toksicitet (undtagen for alopeci, kvalme og opkastning)
English: SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN Keep out of the sight and reach of children, preferably in a locked cupboard.
Danish: SÆRLIG ADVARSEL OM, AT LÆGEMIDLET SKAL OPBEVARES UTILGÆNGELIGT FOR BØRN Opbevares utilgængeligt for børn, helst i et aflåst skab.
English: Blood and lymphatic system disorders Very rare:
Danish: Blod og lymfesystem Meget sjælden:
English: - common toxicity criteria (CTC) non-haematological toxicity ≤ Grade 1 (except for alopecia, nausea and vomiting).
Danish: - common toxicity criteria (CTC, kriterium for gradering af bivirkninger) for ikke-hæmatologisk toksicitet ≤ grad 1 (undtagen for alopeci, kvalme og opkastning)
English: CSF penetration was confirmed in one patient; CSF exposure based on AUC of TMZ was approximately 30% of that in plasma, which is consistent with animal data.
Danish: CSF-eksponeringen var cirka 30 % sammenlignet med plasma, baseret på AUC for TMZ.
English: Status epilepticus, extrapyramidal disorder, hemiparesis, ataxia, cognition impaired, dysphasia, gait abnormal, hyperesthesia, hypoesthesia, neurological disorder (NOS), peripheral neuropathy
Danish: Status epilepticus, extrapyramidale symptomer, hemiparese, ataksi, kognitive forstyrrelser, dysfasi, unormal gang, hyperæstesi, hypoæstesi, neurologisk sygdom (NOS), perifer neuropati
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 5 hard capsules
Danish: INDHOLDSMÆNGDE ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 5 hårde kapsler
English: Endocrine disorders Uncommon:
Danish: Det endokrine system Ualmindelig:
English: Hemianopia, visual acuity reduced, vision disorder, visual field defect, eye pain
Danish: Hemianopi, nedsat synsskarphed, synssygdom, synsfeltdefekt, øjensmerter
English: Recurrent or progressive malignant glioma
Danish: Recidiverende eller progressiv malignt gliom
English: Your doctor will monitor your blood regularly for any changes, and will decide if any specific treatment is needed.
Danish: Deres læge vil regelmæssigt undersøge blodet for eventuelle.
English: Newly diagnosed glioblastoma multiforme
Danish: Nydiagnosticeret glioblastoma multiforme
English: Myopathy, back pain, musculoskeletal pain, myalgia
Danish: Myopati, rygsmerter, muskuloskeletale smerter, myalgier
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.
Danish: Efter højere doser, der var dødelige hos 60 % til 100 % af de undersøgte rotter og hunde, forekom degeneration af retina.
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.
Danish: I den første behandlingsserie var hyppigheden af neutropeni af grad 4 (ANC < 0,5 x 109/l) og af trombocytopeni af grad 4 (< 20 x 109/l) højere hos kvinder end hos mænd, hhv. 12 % vs. 5 %, og 9 % vs. 3 %.
English: If a capsule is damaged, avoid contact with your skin, eyes or nose.
Danish: Hvis en kapsel er beskadiget, må indholdet ikke komme i kontakt med hud, øjne og næse.
English: Based on a population pharmacokinetic analysis in patients 19-78 years of age, clearance of TMZ is not affected by age.
Danish: På baggrund af en populationsfarmakokinetisk analyse af patienter mellem 19-78 år er clearance af TMZ ikke afhængig af alder. Ældre patienter (> 70 år) ser dog ud til at have øget risiko for udviklingen af neutropeni og trombocytopeni (se pkt.
English: CTC Grade 3 or 4 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 nonhaematological toxicity ≤ Grade 1 (except for alopecia, nausea, vomiting).
Danish: CTC grad 3 eller 4 a : Behandlingen med konkomitant TMZ kan fortsættes, når alle de følgende betingelser er opfyldt: absolut neutrofiltal ≥1,5 x 109 /l , trombocyttal ≥100 x 109 /l og CTC ikkehæmatologisk toksicitet ≤ grad 1 (undtagen for alopeci, kvalme og opkastning).
English: If you have any further questions, ask your doctor, pharmacist or nurse.
Danish: Er De i tvivl, så spørg lægen eller på apoteket.
English: Skin and subcutaneous tissue disorders Very rare:
Danish: Hud og subkutane væv Meget sjælden:
English: Propylene glycol Black iron oxide (E172) Potassium hydroxide
Danish: Propylenglycol Jernoxid, sort (E172) Kaliumhydroxid
English: Adult and paediatric patients 3 years of age or older with recurrent or progressive malignant glioma:
Danish: Voksne og børn fra 3 år med tilbagevendende eller progressivt malignt gliom:
English: TMZ has minor influence on the ability to drive and use machines due to fatigue and somnolence (see section 4.8) .
Danish: På grund af træthed og søvnighed påvirker TMZ i mindre grad evnen til at føre motorkøretøj og betjene maskiner (se pkt.
English: hyperbilirubinemia, cholestasis, hepatitis hepatic injury, hepatic failure†
Danish: Hyperbilirubinæmi, kolestase, hepatitis, leverskade, leversvigt†
English: • sores or ulcers in the mouth, diarrhoea, stomach pain, heartburn, difficulty swallowing, dry mouth
Danish: • sår i munden, diarre, mavesmerter, halsbrand, synkevanskeligheder, mundtørhed
English: How to take Temozolomide Accord
Danish: Sådan skal De tage Temozolomide Accord
English: TMZ is administered orally at a dose of 75 mg/m2 daily for 42 days concomitant with focal radiotherapy (60 Gy administered in 30 fractions).
Danish: TMZ indgives oralt i en dosis på 75 mg/m2 dagligt i 42 dage konkomitant med lokal strålebehandling
English: If a capsule becomes damaged, contact of the powder contents with skin or mucous membrane must be avoided.
Danish: Hvis en kapsel ødelægges, skal det undgås, at det indeholdte pulver kommer i kontakt med hud og slimhinder.
English: Asthenia, face oedema, pain, condition aggravated, rigors, tooth disorder
Danish: Asteni, ansigtsødem, smerter, forværret tilstand, rigor, tandlidelse
English: TMZ administration can be continued throughout the 42 day concomitant period (up to 49 days) if all of the following conditions are met: - absolute neutrophil count (ANC) ≥ 1.5 x 109/l - thrombocyte count ≥ 100 x 109/l - common toxicity criteria (CTC) non-haematological toxicity ≤ Grade 1 (except for alopecia, nausea and vomiting).
Danish: Behandlingen med TMZ kan fortsættes under den konkomitante periode på 42 dage (i op til 49 dage), hvis alle de følgende betingelser er opfyldt: - absolut neutrofiltal (ANC) ≥ 1,5 x 109/l - trombocyttal ≥ 100 x 109/l - common toxicity criteria (CTC, kriterium for gradering af bivirkninger) for ikke-hæmatologisk toksicitet ≤ grad 1 (undtagen for alopeci, kvalme og opkastning)
English: Men being treated with TMZ should be advised not to father a child up to 6 months after receiving the last dose and to seek advice on cryoconservation of sperm prior to treatment (see section 4.6).
Danish: Mænd, som behandles med TMZ, bør ikke få børn op til 6 måneder efter, de har fået den sidste dosis og de tilrådes at søge råd med hensyn til kryokonservering af sædvæske før behandlingen (se pkt.
English: Deafness, vertigo, earache
Danish: Døvhed, vertigo, øresmerter
English: Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.
Danish: De kan finde yderligere oplysninger om temozolomid på Det Europæiske Lægemiddelagenturs (EMAs) hjemmeside: http://www.ema.europa.eu.p
English: CLINICAL PARTICULARS 4.1 Therapeutic indications Temozolomide Accord is indicated for the treatment of: adult patients with newly-diagnosed glioblastoma multiforme concomitantly with radiotherapy (RT) and subsequently as monotherapy treatment.
Danish: Temozolomide Accord er indiceret til behandling af: - voksne patienter med nydiagnosticeret glioblastoma multiforme konkomitant med strålebehandling (RT) og herefter som monoterapi-behandling.
English: 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.
Danish: Ved begyndelsen af serie 2 øges dosis til 200 mg/m2, hvis CTC ikke-hæmatologisk toksicitet for serie 1 er ≤ grad 2 (undtagen for alopeci, kvalme og opkastning), det absolutte neutrofiltal (ANC) er ≥ 1,5 x 109/l, og trombocyttallet er ≥ 100 x 109/l.
English: Pregnancy,breast-feeding and fertility
Danish: Graviditet, amning og frugtbarhed
English: - The other ingredients are: capsule content: anhydrous lactose, colloidal anhydrous silica, sodium starch glycolate type A, tartaric acid, stearic acid.
Danish: Kapsel: vandfrit lactose, kolloidalt vandfrit silica, natriumglykolatstivelse type A, vinsyre og stearinsyre Kapselskal:
English: • weakness, swollen face, shivering, change in your sense of taste, tooth disorder
Danish: • slaphed, hævet ansigt, kulderystelser, smagsændringer, tandsygdom
English: INFORMATION IN BRAILLE Temozolomide 250mg
Danish: Temozolomide 250 mg
English: Doses of 500, 750, 1,000, and 1,250 mg/m2 (total dose per cycle over 5 days) have been evaluated clinically in patients.
Danish: Der er foretaget en klinisk vurdering af patienter efter doser på 500, 750, 1.000 og 1.250 mg/m2