FrancophonIA/ELRC3.0 huggingface dataset:
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Danish: Du kan finde yderligere oplysninger om dette lægemiddel på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/
English: The first dose will be 150 mg/m².
Danish: Den første dosis vil være på 150 mg/m2.
English: No dose reductionsare recommended, but delay or discontinuation of TMZ administration should be decided weekly according to haematological and non-haematological toxicity criteria.
Danish: Det anbefales ikke at foretage dosisreduktioner, men udskydelse eller seponering af TMZ-indgift bør overvejes hver uge i henhold til hæmatologiske og ikke-hæmatologiske toksicitetskriterier.
English: During treatment patients should be monitored and managed appropriately.
Danish: Under behandlingen skal patienterne monitoreres og behandles under hensyntagen til deres sygdom.
English: In some cases, your Temozolomide Teva dose will be reduced or treatment stopped.
Danish: I visse tilfælde vil din Temozolomid Teva-dosis nedsættes, eller din behandling vil blive stoppet.
English: Patients receiving Temozolomide Teva in combination with radiotherapy may experience different side effects than patients taking Temozolomide Teva alone.
Danish: Patienter, der modtager Temozolomid Teva i kombination med strålebehandling kan opleve andre bivirkninger end patienter der kun får Temozolomid Teva.
English: If you are a newly-diagnosed patient (glioblastoma multiforme) you may be receiving Temozolomide Teva for 42 days in combination with radiotherapy.
Danish: Er du nydiagnosticeret patient (glioblastoma multiforme) får du muligvis Temozolomid Teva i 42 dage i kombination med strålebehandling.
English: Grade 3 or 4 thrombocytopenia and neutropenia occurred in 19% and 17% respectively, of patients treated for malignant glioma.
Danish: Grad 3- eller 4-trombocytopeni og neutropeni forekom hos henholdsvis 19 % og 17 % af patienterne behandlet for malignt gliom.
English: Patients who received concomitant TMZ and RT in a pilot trial for the prolonged 42-day schedule were shown to be at particular risk for developing Pneumocystis jirovecii pneumonia (PCP).
Danish: Patienter, som fik TMZ og strålebehandling i kombination i en pilotundersøgelse af det længerevarende 42 dages-program, viste sig at have særlig risiko for at udvikle Pneumocystis jirovecii pneumoni (PCP).
English: This is because Temozolomide Teva could cause hepatitis B to become active again, which can be fatal in some cases.
Danish: Dette skyldes, at Temozolomid Teva kan forårsage at hepatitis B bliver aktiv igen.
English: Table 5 includes adverse reactions reported during clinical trials for recurrent or progressive malignant glioma and following the marketing of TMZ.
Danish: Tabel 5 omfatter bivirkninger rapporteret under kliniske undersøgelser ved tilbagevendende eller progressivt malignt gliom samt efter markedsføring af TMZ.
English: Temozolomide Teva should only be prescribed by physicians experienced in the oncological treatment of brain tumours.
Danish: Temozolomid Teva bør kun ordineres af læger, der har erfaring med onkologisk behandling af hjernetumorer.
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.
Danish: Risikoforholdene (HR) for den totale overlevelse var 1,59 (95 % CI for HR=1,33 - 1,91) med en logrank p < 0,0001 til fordel for TMZ-gruppen.
English: - if you have liver or kidney problems, your dose of Temozolomide Teva may need to be adjusted.
Danish: - hvis du har problemer med leveren eller nyrerne, skal din Temozolomid Teva-dosis muligvis justeres.
English: Then you will have 23 days without Temozolomide Teva.
Danish: Derefter vil du have 23 dage uden Temozolomid Teva.
English: Patients will be carefully checked by their doctor for signs of this infection before treatment is started.
Danish: Din læge vil tjekke dig for tegn på denne infektion, før behandlingen startes.
English: The hard capsules are dispensed in amber glass bottles containing 5 or 20 capsules.
Danish: De hårde kapsler udleveres i ravfarvede glasflasker indeholdende 5 eller 20 kapsler.
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 x109/l.
Danish: En fuldstændig blodtælling skal foretages på dag 22 (21 dage efter den første dosis) eller inden for 48 timer herefter, og ugentligt indtil ANC > 1,5 x 109/l og trombocyttallet > 100 x 109/l.
English: During the concomitant phase, your doctor will start Temozolomide Teva at a dose of 75 mg/m² (usual dose).
Danish: Under konbinations-fasen vil din læge starte behandlingen med en dosis Temozolomid Teva på 75 mg/m2 (sædvanlig dosis).
English: You will take your new dose of Temozolomide Teva alone once daily for the first 5 days (“dosing days”) of each cycle.
Danish: Du vil tage din nye dosis Temozolomid Teva alene én gang dagligt i de første 5 dage (”doseringsdage”) i hver cyklus.
English: Temozolomide Teva may cause permanent infertility.
Danish: Temozolomid Teva giver muligvis permanent ufrugtbarhed.
English: TMZ + concomitant RT n=288*
Danish: TMZ + samtidig strålebehandling n=288*
English: The Temozolomide Teva dose may be adjusted, delayed or stopped depending on your blood counts and how you tolerate your medicine during each treatment cycle.
Danish: Temozolomid Teva-dosen kan blive justeret, udskudt eller afbrudt afhængig af dit blodtal, og hvordan du tåler din medicin under hver behandlingscyklus.
English: Adult patients with newly-diagnosed glioblastoma multiforme Anti-emetic prophylaxis is recommended prior to the initial dose of concomitant phase and it is strongly recommended during the monotherapy phase.
Danish: Voksne patienter med nydiagnosticeret glioblastoma multiforme Antiemetisk forebyggelse anbefales før den initiale dosis af kombinationsfasen, og det anbefales kraftigt under monoterapifasen.
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.
Danish: Når unormale laboratorieværdier og bivirkninger blev slået sammen på tværs af kombinations- og monoterapi-behandlingsfaser, blev Grad 3- eller Grad 4-neutrofilabnormaliteter inklusive neutropeni-bivirkninger set hos 8 % af patienterne.
English: The active substance is temozolomide.
Danish: - Aktivt stof: Temozolomid.
English: This may cause you to have increased bruising or bleeding, anaemia (a shortage of red blood cells), fever, and reduced resistance to infections.
Danish: Det kan betyde, at du lettere får blå mærker eller blødning, at du får anæmi (blodmangel), feber og nedsat modstandskraft over for infektioner.
English: Temozolomide Teva contains lactose (a kind of sugar).
Danish: Temozolomid Teva indeholder lactose (en form for sukker).
English: If you forget to take Temozolomide Teva
Danish: Hvis du har glemt at tage Temozolomid Teva
English: Temozolomide Teva monotherapy in recurrent or progressive glioma The following side effects may occur, and may require medical attention.
Danish: Temozolomid Teva-monoterapi i tilbagevendende eller progressiv glioma Følgende bivirkninger kan opstå og kan kræve lægebehandling:
English: The excipient sunset yellow FCF (E110) included in the capsules shell may cause allergic reactions.
Danish: Hjælpestoffet Sunset Yellow FCF (E110), der findes i kapselskallen, kan medføre allergiske reaktioner.
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).
Danish: I den randomiserede aktive kontrollerede undersøgelse var 6 måneders PFS signifikant større for TMZ end for procarbazin (henholdsvis 21 % versus 8 % - chi-square p = 0,008) med median PFS på henholdsvis 2,89 og 1,88 måneder (log rank p = 0,0063).
English: Amber glass bottle with white polypropylene child-resistant screw cap equipped with an induction seal of polyethylene containing 5 or 20 capsules.
Danish: Ravfarvet glasflaske med hvidt børnesikret polypropylenskruelåg med en induktionsforsegling af polyethylen, indeholdende 5 eller 20 kapsler.
English: Thus, prophylaxis against PCP is required for all patients receiving concomitant TMZ and RT for the 42-day regimen (with a maximum of 49 days) regardless of lymphocyte count.
Danish: Forebyggende behandling mod PCP er derfor påkrævet for alle patienter, der får kombinations-TMZ og strålebehandling i 42 dages regime (med højst 49 dage) uafhængigt af lymfocyttal.
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: Der var større hyppighed af Grad 4-neutropeni (ANC < 0,5 x 109/l), 12 % vs. 5 %, og trombocytopeni (< 20 x 109/l), 9 % vs. 3 %, hos kvinder vs. mænd i det første terapiforløb.
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.
Danish: Hjælpestoffet sunset yellow FCF (E110) er ligeledes indeholdt i kapselskallerne af Temozolomid Teva 20 mg hårde kapsler og kan forårsage allergiske reaktioner.
English: Temozolomide Teva contains a medicine called temozolomide.
Danish: Temozolomid Teva indeholder en medicin, som kaldes temozolomid.
English: Once escalated, the dose remains at 200 mg/m² per day for the first 5 days of each subsequent cycle except if toxicity occurs.
Danish: Når dosis en gang er steget, bibeholdes den på 200 mg/m2 pr. dag i de første 5 dage af hver følgende serie, undtagen hvis der forekommer toksicitet.
English: Based on an analysis of population pharmacokinetics in phase II trials, co-administration of dexamethasone, prochlorperazine, phenytoin, carbamazepine, ondansetron, H2 receptor antagonists, or phenobarbital did not alter the clearance of TMZ.
Danish: På basis af en analyse af populationsfarmakokinetik i fase II-undersøgelser, ændrede samtidig anvendelse af dexamethason, prochlorperazin, phenytoin, carbamazepin, ondansetron, H2receptorantagonister eller phenobarbital ikke udskillelsen af TMZ.
English: Themedian 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).
Danish: Median-tiden til progression af disse endpoints varierede fra at være 0,7 til 2,1 måneder længere for TMZ end for procarbazin (log rank p = < 0,01 til 0,03).
English: You should stop breast-feeding while receiving treatment with Temozolomide Teva.
Danish: Du skal stoppe med at amme, mens du behandles med Temozolomid Teva.
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: Supplement med kombinations-TMZ til strålebehandling, efterfulgt af TMZ-monoterapi i behandlingen af patienter med nydiagnosticeret glioblastoma multiforme viste en statistisk signifikant forbedret total overlevelse sammenlignet med strålebehandling alene (Figur 1).
English: If you accidentally take more Temozolomide Teva capsules than you were told to, contact your doctor, pharmacist or nurse immediately.
Danish: Hvis du ved en fejl tager flere Temozolomid Teva-kapsler end foreskrevet, skal du straks kontakte din læge, apotekspersonalet eller sundhedspersonalet.
English: At 6 months, the fraction of surviving patients was significantly higher in the TMZ arm (60 %) compared with the procarbazine arm (44%) (chi-square p = 0.019).
Danish: Efter 6 måneder var andelen af overlevende patienter signifikant større i TMZ-gruppen (60 %) sammenlignet med procarbazingruppen (44 %) (chi-square p = 0,019).
English: What you need to know before you take Temozolomide Teva Do not take Temozolomide Teva
Danish: Det skal du vide, før du begynder at tage Temozolomid Teva Tag ikke Temozolomid Teva
English: Rare (may affect up to 1 in 1,000 people): cough, infections including pneumonia.
Danish: Sjælden (kan påfirke op til 1 ud af 1.000): Hoste, infektioner inklusive lungebetændelse.
English: Temozolomide Teva is used for the treatment of specific forms of brain tumours: - in adults with newly-diagnosed glioblastoma multiforme.
Danish: Temozolomid Teva anvendes til behandling af specifikke former for hjernesvulster: - hos voksne med nydiagnosticeret glioblastoma multiforme.
English: The Temozolomide Teva dose may be delayed or stopped, depending on your blood counts and how you tolerate your medicine during the concomitant phase.
Danish: Temozolomid Teva-dosen kan udskydes eller afbrydes afhængig af dit blodtal og hvordan du tåler din medicin under kombinationsfasen.
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).
Danish: Opportunistiske infektioner og reaktivering af infektioner Opportunistiske infektioner (såsom Pneumocystis jirovecii pneumoni) og reaktivering af infektioner (såsom hepatitis B virus og cytomegalovirus) er blevet observeret under behandling med TMZ (se pkt.
English: You will take Temozolomide Teva alone once daily for the first 5 days.
Danish: Du vil tage Temozolomid Teva alene én gang dagligt i de første 5 dage.
English: 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.
Danish: TMZ skal seponeres, hvis: dosistrin -1 (100 mg/m²) fortsat resulterer i uacceptabel toksicitet den samme Grad 3 ikke-hæmatologisk toksicitet (undtaget alopeci, kvalme, opkastning) vender tilbage efter dosisreduktion.
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.
Danish: Resultaterne fra undersøgelsen var ikke konsistente i undergruppen af patienter med dårlig præstationsstatus (WHO PS=2, n=70), hvor total overlevelse og tid til progression var ens for de to grupper.
English: Temozolomide Teva hard capsules should be administered in the fasting state.
Danish: Temozolomid Teva hårde kapsler bør indtages fastende.
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.
Danish: Dette blev efterfulgt af monoterapi med TMZ (150 - 200 mg/m2) på dag 1 - 5 i hver 28-dags-serie i op til 6 serier, startende 4 uger efter afsluttet strålebehandling.
English: Temozolomide Teva in combination treatment with radiotherapy in newly-diagnosed glioblastoma
Danish: Temozolomid Teva i kombination med strålebehandling i nydiagnosticeret glioblastoma
English: D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Danish: D. BETINGELSE ELLER BEGRÆNSNINGER MED HENSYN TIL SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET
English: Concomitant phase
Danish: Kombinationsfase
English: Pneumocystis jirovecii pneumonia (PCP) prophylaxis was required during RT and combined TMZ therapy.
Danish: Pneumocystis jirovecii -pneumoni (PCP) forebyggende behandling var påkrævet under strålebehandling og TMZ-kombinationsbehandling.
English: Patients with newly-diagnosed glioblastoma multiforme If you are a newly-diagnosed patient, treatment will occur in two phases: - treatment together with radiotherapy (concomitant phase) first - followed by treatment with only Temozolomide Teva (monotherapy phase).
Danish: Patienter med nydiagnosticeret glioblastoma multiforme Hvis du er nydiagnosticeret patient vil behandlingen ske i to faser: - behandling sammen med strålebehandling (kombinationsfasen) først - efterfulgt af behandling kun med Temozolomid Teva (monoterapi-fasen).
English: Prior to dosing, the following laboratory parameters must be met: ANC ≥ 1.5 x 109/l and platelet count ≥ 100 x 109/l.
Danish: Forud for dosering skal følgende laboratorieparametre være opfyldte: ANC ≥ 1,5 x 109/l og trombocyttal ≥ 100 x 109/l.
English: After oral administration of 14C-labelled TMZ, mean faecal excretion of 14C over 7 days post-dose was 0.8%
Danish: Efter peroral administration af 14C-mærket TMZ var den gennemsnitlige fækale udskillelse af 14C over 7 dage 0,8 %, hvilket tyder på fuldstændig absorption.
English: CTC Non-haematological Toxicity (except for alopecia, nausea, vomiting)
Danish: CTC ikke-hæmatologisk toksicitet (undtaget alopeci, kvalme, opkastning)
English: Symptoms of diabetes insipidus include passing a lot of urine and feeling thirsty.
Danish: Symptomer på sukkersygeinkluderer øget vandladning og tørst.
English: Uncommon (may affect up to 1 in 100 people): reduced number of blood cell counts (pancytopenia, anaemia, leukopenia).
Danish: Ikke almindelig (kan påvirke op til 1 ud af 100): Reduceret antal blodceller (pancytopeni, anæmi,
English: Hypokalemia, alkaline phosphatase increased, weight increased
Danish: Hypokalæmi, forhøjet alkalisk fosfatase, vægtøgning
English: Hepatic enzymes increased, Gamma GT increased, AST increased
Danish: Forhøjede leverenzymtal, forhøjet gamma GT, forhøjet AST
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 nyligt diagnosticeret multiform glioblastom forekom Grad 4-neutropeni hos 3 % af de kvindelige vs. 0 % af de mandlige forsøgspersoner og Grad 4-trombocytopeni hos 1 % af de kvindelige vs. 0 % af de mandlige forsøgspersoner i det første terapiforløb.
English: TMZ dose reduction or discontinuation during monotherapy treatment Toxicity
Danish: TMZ-dosisreduktion eller -seponering under monoterapi-behandling Toksicitet
English: Your doctor will work out your dose of Temozolomide Teva.
Danish: Din læge vil fastsætte den rigtige dosis Temozolomid Teva for dig.
English: Summary of events reported with temozolomide in the post-marketing setting* Infections and infestations*
Danish: Opsummering af bivirkninger, der er indberettet med temozolomid efter markedsføring*
English: Grade 3 or Grade 4 thrombocyte abnormalities, including thrombocytopenic events were observed in 14% of the patients who received TMZ.
Danish: Grad 3- eller Grad 4-trombocytabnormaliteter, inklusive trombocytopeni-bivirkninger blev set hos 14 % af patienterne, der fik TMZ.
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 i kombination med fokal strålebehandling (60 Gy indgivet i 30 fraktioner).
English: Hepatitis due to hepatitis B virus (HBV) reactivation, in some cases resulting in death, has been reported.
Danish: Tilfælde af hepatitis grundet reactivering af hepatitis B virus og i nogle tilfælde med dødelig udgang er blevet rapporteret.
English: Very common (may affect more than 1 in 10 people): reduced number of blood cells (neutropenia or lymphopenia, thrombocytopenia), loss of appetite, headache, vomiting, nausea (feeling sick in your stomach), constipation (difficulty passing stools).
Danish: Meget almindelig (kan påvirke flere end 1 ud af 10): Reduceret antal blodceller (neutropeni eller lymfopeni, trombocytopeni), tab af appetit, hovedpine, opkastning, kvalme (følelse af ubehag i maven), forstoppelse (besvær med afføring).
English: You will again receive Temozolomide Teva once daily for 5 days, followed by 23 days without Temozolomide Teva.
Danish: Du vil igen modtage Temozolomid Teva én gang dagligt i 5 dage, efterfulgt af 23 dage uden Temozolomid Teva.
English: Very common (may affect more than 1 in 10 people): loss of appetite, headache, constipation
Danish: Meget almindelig (kan påvirke flere end 1 ud af 10): appetitløshed, hovedpine, forstoppelse
English: Patients with tumours that have returned or worsened (malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma) taking Temozolomide Teva only
Danish: Patienter med tilbagevendende eller forværrede svulster (malignt gliom såsom glioblastoma multiforme eller anaplastisk astrocytoma), som kun tager Temozolomid Teva
English: CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Danish: D BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET
English: cytomegalovirus infection, infection reactivation such as cytomegalovirus, hepatitis B virus†, meningoencephalitis herpetic† , sepsis†
Danish: Cytomegalovirus infektion, reaktivering af infektioner såsom cytomegalovirus, hepatitis B virus†
English: Adult and paediatric patients 3 years of age or older with recurrent or progressive malignant glioma A treatment cycle comprises 28 days.
Danish: Voksne og børn fra 3 år med tilbagevendende eller progressivt malignt gliom En behandlingsserie består af 28 dage.
English: Patients in the TMZ + RT arm received concomitant TMZ (75 mg/m²) once daily, starting the first day of RT until the last day of RT, for 42 days (with a maximum of 49 days).
Danish: Patienter, der var i den gruppe, der modtog TMZ + strålebehandling, fik kombinations-TMZ (75 mg/m2) én gang dagligt, begyndende den første strålebehandlingsdag, indtil den sidste strålebehandlingsdag, i 42 dage (med højst 49 dage).
English: Signs of allergic reaction include feeling itchy, breathlessness or wheezing, swelling of the face, lips, tongue or throat.
Danish: Tegn på allergisk reaktion inkluderer kløende fornemmelse, åndenød eller hvæsende åndedræt, hævelser i ansigtet, læber, tunge eller svælg.
English: TMZ dosing interruption or discontinuation during concomitant radiotherapy and TMZ
Danish: TMZ-doseringsafbrydelse eller -seponering under kombinationsstrålebehandling og TMZ
English: You will again take Temozolomide Teva once daily for 5 days followed by 23 days without Temozolomide Teva.
Danish: Du vil igen tage Temozolomid Teva én gang dagligt i 5 dage, efterfulgt af 23 dage uden Temozolomid Teva.
English: (difficulty passing stools), nausea (feeling sick in your stomach), vomiting, rash, hair loss, tiredness.
Danish: (besvær med afføring), kvalme (følelse af ubehag i maven), opkastning, udslæt, hårtab, træthed.
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, indgives TMZ oralt i en dosis på 200 mg/m2 én gang dagligt i de første 5 dage efterfulgt af en 23dages behandlingspause (i alt 28 dage).
English: At the start of Cycle 2, the dose is escalated to 200 mg/m² if the CTC nonhaematological 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
Danish: Ved begyndelsen af serie 2 øges dosis til 200 mg/m2, hvis CTC ikke hæmatologisk toksicitet for serie 1 er Grad ≤ 2 (undtagen alopeci, kvalme og opkastning), absolut antal neutrofile (ANC) er ≥ 1,5 x 109/l og trombocyttal er ≥ 100 x 109/l.
English: New or reactivated (recurring) cytomegalovirus infections and reactivated hepatitis B virus infections have been uncommonly reported.
Danish: Der er rapporteret nye eller tilbagevendende cytomegalovirus infektioner og tilbagevendende hepatitis B virus infektioner med hyppigheden ”ikke almindelig”.
English: If a capsule is damaged, avoid contact of the powder with your skin, eyes or nose.
Danish: Hvis en kapsel bliver ødelagt, skal du undgå at pulveret kommer i kontakt med hud, øjne og næse.