FrancophonIA/ELRC3.0 huggingface dataset:
English: a: Treatment with concomitant TMZ can be continued when all of the following conditions are met: absolute neutrophil count  1.5 x 10
Danish: a: Behandling med konkomitant TMZ kan fortsættes, når alle de følgende betingelser er opfyldt: Absolut antal neutrofile  1,5 x 10
English: 9/l), 12 % vs 5 %, and thrombocytopenia (< 20 x 10
Danish: 9/l), 12 % vs. 5 %, og thrombocytopeni (< 20 x
English: Always take Temodal exactly as your doctor has told you.
Danish: Tag altid Temodal nøjagtigt efter lægens anvisning.
English: As with other similar chemotherapeutic agents, caution is recommended to avoid extravasation.
Danish: Som for andre lignende kemoterapeutiske lægemidler anbefales det at undgå udsivning.
English: If you vomit after taking your dose, do not take a second dose on the same day.
Danish: Hvis De kaster op efter at have indtaget Deres dosis, skal De ikke tage en anden dosis samme dag.
English: - if you have low counts of red blood cells (anaemia), white blood cells and platelets, or blood clotting problems before starting the treatment, or if you develop them during treatment.
Danish: - hvis De har et lavt antal røde blodlegemer (anæmi), hvide blodlegemer og blodplader eller problemer med blodets størkning før behandling eller udvikler dem under behandling.
English: Results of the Ames/salmonella and Human Peripheral Blood Lymphocyte (HPBL) chromosome aberration tests showed a positive mutagenicity response.
Danish: Resultaterne af Ames/Salmonella og Human Perifer Blod Lymfocyt (HPBL) kromosomaberrationtest viste et positivt mutagenicitetsresultat.
English: Each vial must be reconstituted with 41 ml sterilised water for injections.
Danish: Hvert hætteglas skal rekonstitueres med 41 ml sterilt vand til injektionsvæsker.
English: TMZ dose (mg/m2/day)
Danish: TMZ dosis (mg/m2/dag)
English: PET studies in humans and preclinical data suggest that TMZ crosses the blood-brain barrier rapidly and is present in the CSF.
Danish: PET-undersøgelser hos mennesker samt prækliniske data tyder på, at TMZ hurtigt passerer blodhjernebarrieren og er til stede i CSF.
English: The pump tubing should be attached to the bag, the tubing purged and then capped.
Danish: Slangen fra pumpen bør sættes fast på posen, renses og herefter lukkes.
English: Data on time to worsening of neurological status favoured TMZ over procarbazine as did data on time to worsening of performance status (decrease to a KPS of < 70 or a decrease by at least 30 points).
Danish: Data for tiden til forværring af neurologisk status var bedre for TMZ end for procarbazin, ligesom data for tiden til forværring af performance (reduktion til en KPS på < 70 eller en reduktion på mindst 30 points).
English: Single-cycle (5-day dosing, 23 days non-treatment), 3- and 6-cycle toxicity studies were conducted in rats and dogs.
Danish: Enkelt-serie (5-dages dosering, 23 dages behandlingspause) og 3- og 6-cycli toksicitetsundersøgelser blev udført på rotter og hunde.
English: Store in a refrigerator (2 C - 8 C).
Danish: Opbevar Temodal i køleskab (2C -8C).
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 Deres blod for eventuelle ændringer, og vil afgøre, om det er nødvendigt med specifik behandling.
English: †, CMV infection, CMV reactivation, hepatitis B virus
Danish: †, CMV-infektion, reaktivering af CMV, hepatitis B-virus
English: Most haematologic adverse reactions were reported commonly; the frequency of Grade 3-4 laboratory findings is presented after Table 4.
Danish: De fleste hæmatologiske bivirkninger blev rapporteret som værende almindelige; hyppighed af grad 3-4 laboratoriefund er angivet efter tabel 4.
English: Therefore, special care should be taken when TMZ is administered in elderly patients.
Danish: Derfor bør der udvises speciel omhu, når TMZ gives til ældre patienter.
English: The reconstituted solution should not be used if discolouration or particulate matter is observed.
Danish: Den rekonstituerede opløsning bør ikke anvendes, hvis der observeres misfarvning eller småpartikler.
English: Your doctor may decide to reduce the dose, interrupt, stop or change your treatment.
Danish: Deres læge kan i disse tilfælde være nødsaget til at mindske dosis af Deres medicin, afbryde, stoppe eller ændre Deres behandling.
English: If you accidentally get some in your eyes or nose, flush the area with water.
Danish: Hvis De ved et uheld får noget på huden, i øjnene eller næsen, skal området skylles med vand.
English: Adverse reactions observed in clinical studies and reported from post-marketing use of TMZ are listed in Table 4.
Danish: Bivirkninger, som er set i kliniske studier og rapporteret i forbindelse med brug efter markedsføring, er anført i tabel 4.
English: Temodal contains lactose (a kind of sugar).
Danish: Temodal indeholder lactose (en form for sukker).
English: Simi: +354 535 7000
Danish: Sími: + 354 535 7000
English: In some cases, your Temodal dose will be reduced or treatment stopped.
Danish: I visse tilfælde vil Deres Temodal dosis nedsættes, eller Deres behandling vil blive stoppet.
English: Myelosuppression (neutropenia and thrombocytopenia), which is known dose-limiting toxicity for most cytotoxic agents, including TMZ, was observed.
Danish: Myelosuppression (neutropeni og trombocytopeni), som er en kendt dosisbegrænsende toksicitet for de fleste cytotoksiske stoffer, inklusive TMZ, blev observeret.
English: Erythema, dry skin, pruritus
Danish: Erytem, tør hud, pruritus
English: In a population pharmacokinetics analysis of clinical trial experience there were 101 female and 169 male subjects for whom nadir neutrophil counts were available and 110 female and 174 male subjects for whom nadir platelet counts were available.
Danish: I et observationsmateriale fra farmakokinetisk analyse af kliniske undersøgelser var erfaringen, at der var 101 kvindelige og 169 mandlige forsøgspersoner, for hvem nadir neutrophiltallet forelå, og 110 kvindelige og 174 mandlige forsøgspersoner, for hvem nadir blodpladetallet forelå.
English: For patients with recurrent or progressive glioma, nausea (43 %) and vomiting (36 %) were usually Grade 1 or 2 (0 - 5 episodes of vomiting in 24 hours) and were either self-limiting or readily controlled with standard anti-emetic therapy.
Danish: Hos patienter med tilbagevendende eller progressivt gliom var kvalme (43 %) og opkastning (36 %) oftest grad 1 eller 2, (0-5 opkastningsepisoder inden for 24 timer) og ophørte enten af sig selv eller kunne let kontrolleres med kvalmestillende standardbehandling.
English: Clinical trial experience with IV
Danish: Erfaringer fra kliniske undersøgelser med IV
English: Temodal contains a medicine called temozolomide.
Danish: Temodal indeholder en medicin, som kaldes temozolomid.
English: Based on the pharmacokinetic properties of TMZ, it is unlikely that dose reductions are required in patients with severe hepatic impairment or any degree of renal impairment.
Danish: Baseret på TMZ's farmakokinetiske egenskaber er det usandsynligt, at dosisreduktion er påkrævet hos patienter med svær leverinsufficiens eller hvilken som helst grad af nyreinsufficiens.
English: Absolute neutrophil count
Danish: Absolut antal neutrofile
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Danish: Hvis Deres læge har fortalt Dem, at De ikke tåler visse sukkerstoffer, skal De kontakte Deres læge, før De tager dette lægemiddel.
English: TMZ was administered as salvage therapy in the follow-up phase in 161 patients of the 282 (57 %) in the RT alone arm, and 62 patients of the 277 (22 %) in the TMZ + RT arm.
Danish: TMZ blev givet som salvage-behandling i opfølgningsfasen hos 161 patienter af 282 (57 %) i armen med strålebehandling alene, og 62 patienter af 277 (22 %) i armen med TMZ + strålebehandling.
English: Temodal should only be prescribed by physicians experienced in the oncological treatment of brain tumours.
Danish: Temodal bør kun ordineres af læger, der har erfaring med onkologisk behandling af hjernetumorer.
English: Gamma-glutamyltransferase increased Injury, poisoning and procedural complications Common:
Danish: Forhøjet gamma-glutamyltransferase Traumer, forgiftninger og behandlingskomplikationer Almindelig:
English: Patients will be carefully checked by their doctor for signs of this infection before treatment is started.
Danish: Deres læge vil tjekke Dem for tegn på denne infektion, før behandlingen startes.
English: You should stop breast-feeding while receiving treatment with Temodal.
Danish: De skal stoppe med at amme, mens De behandles med Temodal.
English: ANC falls to < 1.0 x 10
Danish: Hvis ANC falder til < 1,0 x 10
English: A total of 573 patients were randomised to receive either TMZ + RT (n=287) or RT alone (n=286).
Danish: Et samlet antal patienter på 573 blev randomiseret til at få enten TMZ + strålebehandling (n=287) eller strålebehandling alene (n=286).
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).
Danish: Den ene var en ikke-sammenlignende undersøgelse hos 138 patienter (29 % fik tidligere kemoterapi), og den anden var en randomiseret aktiv-kontrolleret undersøgelse med TMZ versus procarbazin hos i alt 225 patienter (67 % fik tidligere behandling med nitrosurea baseret kemoterapi).
English: Temodal is used in these tumours if they return or get worse after standard treatment.
Danish: Temodal bruges til behandling af disse svulster, hvis der er tegn på, at de vender tilbage eller bliver værre efter standardbehandlingen.
English: - if certain kinds of blood cells are severely reduced (myelosuppression), such as your white blood cell count and platelet count.
Danish: - hvis antallet af visse former for blodceller er svært nedsat (myelosuppression), såsom antallet af de hvide blodlegemer og antallet af blodplader.
English: Each sachet contains 1 hard capsule and is dispensed in a cardboard carton.
Danish: Hvert brev indeholder 1 hård kapsel og er pakket i en pap karton.
English: Before each new treatment cycle, your blood will be tested to see if the Temodal dose needs to be adjusted.
Danish: Før hver ny behandlingscyklus vil Deres blod blive undersøgt for, om Temodal-dosen skal justeres.
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 De lettere får blå mærker eller blødning, at De får anæmi (blodmangel), feber og nedsat modstandskraft over for infektioner.
English: Hypokalaemia, alkaline phosphatase increased
Danish: Hypokaliæmi, forhøjet alkalisk fosfatase
English: Adverse reactions reported during the two studies with the intravenous formulation (n=35) but not in studies using hard capsules, were infusion site reactions: pain, irritation, pruritus, warmth, swelling, and erythema, as well as haematoma.
Danish: De bivirkninger, der blev rapporterede under de to studier med den intravenøse formulering (n=35) men ikke i studier med de hårde kapsler, var reaktioner i forbindelse med infusionsstedet: smerte, irritation, pruritus, varme, hævelse og erythema såvel som hæmatom.
English: Clinical trial experience with hard capsules
Danish: Erfaringer fra kliniske undersøgelser med hårde kapsler
English: 9/l during any cycle, the next cycle should be reduced one dose level (see section 4.2).
Danish: 9/l i en behandlingsserie, skal næste behandlingsserie reduceres med et dosisniveau (se pkt.
English: During the monotherapy phase, the dose and way you take Temodal will be different.
Danish: Under monoterapi-fasen vil dosis og måden, De tager Temodal på være anderledes.
English: In patients with prior chemotherapy a benefit was indicated in those with a KPS ≥ 80.
Danish: Hos patienter med tidligere kemoterapi, blev en forbedring registreret hos patienter med en KPS ≥ 80.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Fortæl altid lægen eller apotekspersonalet, hvis De bruger anden medicin, for nylig har brugt anden medicin eller planlægger at bruge anden medicin.
English: The 6-month event-free survival for the ITT population was 44 % with a median event-free survival of 4.6 months, which was similar to the results for the progression-free survival.
Danish: Den 6-måneders hændelses-frie overlevelse for ITT populationen var 44 % med en median event-fri overlevelse på 4,6 måneder, hvilket var i lighed med resultaterne for den progressionsfri overlevelse.
English: Myelodysplastic syndrome (MDS), secondary malignancies, including myeloid leukaemia
Danish: Myelodysplastisk syndrom (MDS), sekundære maligne lidelser, inklusive myeloid leukæmi
English: Data on clinical efficacy in patients with glioblastoma multiforme (Karnofsky performance status [KPS]  70), progressive or recurrent after surgery and RT, were based on two clinical trials with oral TMZ.
Danish: Data for klinisk effekt hos patienter med glioblastoma multiforme (Karnofsky performance status KPS  70), der progredierer eller recidiverer efter kirurgi og strålebehandling, var baseret på to kliniske undersøgelser med oral TMZ.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Danish: Patienter med sjældne arvelige sygdomme med galaktose intolerance, total laktase-mangel eller glukose-galaktose-malabsorption bør derfor ikke anvende dette lægemiddel.
English: If you are a newly-diagnosed patient (glioblastoma multiforme) you may be receiving Temodal for 42 days in combination with radiotherapy.
Danish: Er De nydiagnostiseret patient (glioblastoma multiform) får De muligvis Temodal i 42 dage i kombination med strålebehandling.
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 konkomitant 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: 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 10
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), absolut antal neutrofile (ANC) er ≥ 1,5 x 10
English: Sachets are composed of linear low density polyethylene (innermost layer), aluminium and polyethylene terephthalate.
Danish: Brevene består af lineære lav-densitet polyethylen (inderste lag), aluminium og polyethylen terephtalat.
English: There is limited information in patients over 3 years of age who have used Temodal.
Danish: Der foreligger begrænset information om børn over 3 år, der har brugt Temodal.
English: You will take this dose every day for 42 days (up to 49 days) in combination with radiotherapy.
Danish: De vil tage denne dosis hver dag i 42 dage (op til 49 dage) i kombination med strålebehandling.
English: Patients in the control arm received RT only.
Danish: Patienter i kontrolgruppen fik strålebehandling alene.
English: It is therefore unlikely that you will receive more Temodal than you should.
Danish: Det er derfor usandsynligt, at De vil modtage mere Temodal end nødvendigt.
English: If Temodal comes into contact with skin or mucosa, it should be washed immediately and thoroughly with soap and water.
Danish: Hvis Temodal kommer i kontakt med hud eller slimhinder bør området straks vaskes grundigt med sæbe og vand.
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: Risiko forholdene (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: In a multicentre, prospective phase II trial evaluating the safety and efficacy of oral TMZ in the treatment of patients with anaplastic astrocytoma at first relapse, the 6 month PFS was 46 %.
Danish: I en multicenter, prospektiv fase II undersøgelse, der vurderede sikkerhed og effekt af oral TMZ i behandlingen af patienter med anaplastisk astrocytoma ved første relaps, var 6 måneders PFS 46 %.
English: - if you are older than 70 years of age, you might be more prone to infections, bruising or bleeding.
Danish: - hvis De er ældre end 70 år, kan De være mere modtagelig over for infektion eller have øget tendens til at få blå mærker og bløde.
English: Temodal is available in a glass vial, with a butyl rubber stopper and aluminium seal with a flip-off bonnet.
Danish: Temodal er tilgængelig i et hætteglas med en butyl-gummiprop og aluminium-forsegling med en flip-off hætte.
English: Temodal may cause permanent infertility.
Danish: Temodal giver muligvis permanent ufrugtbarhed.
English: Then you will have 23 days without Temodal.
Danish: Derefter vil De have 23 dage uden Temodal.
English: You will receive this dose every day for 42 days (up to 49 days) in combination with radiotherapy.
Danish: De vil modtage denne dosis hver dag i 42 dage (op til 49 dage) i kombination med strålebehandling.
English: 9/l), 9 % vs 3 %, in women vs men in the first cycle of therapy.
Danish: 9/l), 9 % vs. 3 %, hos kvinder vs. mænd i det første terapiforløb.
English: Deafness f, vertigo, tinnitus, earache
Danish: Døvhed f, vertigo, tinnitus, ørepine
English: Local injection site adverse reactions, which were mostly mild and short-lived were reported in patients receiving Temodal 2.5 mg/ml powder for solution for infusion.
Danish: Bivirkninger relateret til det lokale injektionssted, som for det meste var milde og kortvarige, blev rapporterede hos patienter, der modtog Temodal 2,5 mg/ml pulver til infusionsvæske, opløsning.
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).
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: In preclinical studies in rats and rabbits receiving 150 mg/m TMZ, teratogenicity and/or foetal toxicity were demonstrated (see section 5.3).
Danish: I prækliniske undersøgelser udført på rotter og kaniner med doser på 150 mg/m2 TMZ blev teratogenicitet og/eller føtal toksicitet påvist (se pkt.
English: Reduce TMZ by 1 dose level
Danish: Reducer TMZ med 1 dosistrin
English: During the concomitant phase, your doctor will start Temodal at a dose of 75 mg/m2 (usual dose).
Danish: Under konkomitant-fasen vil Deres læge starte behandlingen med en dosis Temodal på 75 mg/m (sædvanlig dosis).
English: Errors in how you take this medicine may have serious health consequences.
Danish: Det kan have alvorlige konsekvenser for helbredet, hvis der sker fejl i måden, hvorpå De tager denne medicin.
English: There is limited information in patients over 3 years of age who have taken Temodal.
Danish: Der foreligger begrænset information om børn over 3 år, der har fået Temodal.
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).
Danish: Efter peroral administration til voksne absorberes TMZ hurtigt, og maksimalkoncentrationerne opnås allerede efter 20 minutter (gennemsnitstider mellem 0,5 og 1,5 time).
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8C, unless reconstitution has taken place in controlled and validated aseptic conditions.
Danish: Hvis præparatet ikke anvendes straks, er brugeren ansvarlig for opbevaringstiden og forholdene før anvendelsen, som normalt ikke bør overstige 24 timer ved 2-8
English: Agitation, amnesia, depression, anxiety, confusion, insomnia
Danish: Agitation, amnesi, depression, angst, forvirring, insomni
English: In the absence of additional data, this medicinal product must not be mixed with other medicinal products or infused simultaneously through the same intravenous line.
Danish: Da der ikke foreligger yderligere oplysninger, bør dette præparat ikke blandes med andre præparater eller infunderes samtidigt gennem samme iv sæt.
English: No data are available on the administration of TMZ in patients with severe hepatic impairment (Child's Class C) or with renal impairment.
Danish: Der er ingen data for indgift af TMZ til patienter med svær leverinsufficiens (Child's Class C) eller med nedsat nyrefunktion.
English: Figure 1 Kaplan-Meier curves for overall survival (intent-to-treat population)
Danish: Figur 1 Kaplan-Meier kurver for total overlevelse (intent-to-treat population)
English: If you forget to take Temodal
Danish: Hvis De har glemt at tage Temodal
English: Mean AUC (0  ) values for TMZ and MTIC were 25 µg•h/ml and 1,004 ng•h/ml, respectively.
Danish: Gennemsnits AUC-værdier (0 → ∞) for TMZ og MTIC var henholdsvis 25 µg•h/ml og 1.004 ng•h/ml.
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 per dag i de første 5 dage af hver følgende serie, undtagen hvis der forekommer toksicitet.
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 = 0,33).
English: The cytotoxicity of MTIC is thought to be primarily due to alkylation of DNA mainly at the O
Danish: Cytotoksiciteten af MTIC menes primært at skyldes alkyleringen af DNA hovedsageligt ved O
English: Once your medicine is prepared for infusion (reconstituted), the solution may be stored at room temperature (25°C) for up to 14 hours, including infusion time.
Danish: Når Deres medicin er klargjort til infusion (rekonstitueret), kan opløsningen opbevares ved stuetemperatur (25C) i op til 14 timer inklusive infusionstid.
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: An overdose of 10,000 mg (total dose in a single cycle, over 5 days) was taken by one patient and the adverse reactions reported were pancytopenia, pyrexia, multi-organ failure and death.
Danish: Én patient har taget en overdosis på 10.000 mg (total dosis i en enkelt serie over 5 dage) og de rapporterede bivirkninger var pancytopeni, pyreksi, multiorgansvigt og dødsfald.
English: You may be given other medicines (anti-emetics) to take before and/or after taking Temodal to prevent or control nausea and vomiting.
Danish: De vil eventuelt få ordineret anden medicin (kvalmestillende), der skal tages før og/eller efter, De har taget Temodal, for at undgå eller regulere kvalme og opkastning.
English: Do not use Temodal - if you are allergic to temozolomide or any of the other ingredients of this medicine (listed in section 6).
Danish: Brug ikke Temodal - hvis De er allergisk over for temozolomid eller et af de øvrige indholdsstoffer i Temodal (angivet i punkt 6).