FrancophonIA/ELRC3.0 huggingface dataset:
English: Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Danish: Læs denne indlægsseddel grundigt, inden De begynder at tage dette lægemiddel, da den indeholder vigtige oplysninger
English: These blood cells are important for fighting infection and for proper blood clotting.
Danish: Disse blodlegemer er vigtige for at bekæmpe infektioner og for korrekt blodkoagulation.
English: - if you are older than 70 years of age, you might be more prone to infection, bruising or bleeding.
Danish: - hvis du er over 70 år, kan du være mere udsat for infektion, blå mærker eller blødning.
English: Always take Temozolomide SUN exactly as your doctor has told you.
Danish: Tag altid Temozolomide SUN nøjagtig, som lægen har fortalt dig.
English: Frequency not known:
Danish: Hyppighed ikke kendt:
English: - if you have had an allergic reaction to dacarbazine (an anticancer medicine sometimes called DTIC).
Danish: - hvis du har haft en allergisk reaktion over for dacarbazin (et anticancermiddel, som af og til kaldes DTIC).
English: As it cannot be excluded that the change in Cmax is clinically significant, Temozolomide SUN should be administered without food.
Danish: Da det ikke kan udelukkes, at ændringen i Cmax er klinisk signifikant, bør Temozolomid SUN indgives uden føde.
English: † Including cases with fatal outcome * Frequencies estimated based on relevant clinical trials.
Danish: †Inklusive tilfælde med dødelig udgang * Hyppigheden er estimeret på basis af relevante kliniske undersøgelser.
English: Your doctor will monitor your blood regularly for any changes, and will decide if any specific treatment is needed.
Danish: Din læge vil regelmæssigt kontrollere dit blod for forandringer og vil beslutte, hvis der er brug for en specifik behandling.
English: You will take this dose every day for 42 to 49 days in combination with radiotherapy.
Danish: Du skal tage denne dosis hver dag i 42 til 49 dage kombineret med strålebehandling.
English: Depending on your blood test results, your doctor may adjust your dose for the next cycle.
Danish: Afhængigt af resultatet af din blodundersøgelse kan lægen justere din dosis til den næste cyklus.
English: - if you develop fever or symptoms of an infection contact your doctor immediately.
Danish: - hvis du får feber eller symptomer på en infektion, skal du straks kontakte din læge.
English: A treatment cycle with Temozolomide SUN lasts 28 days.
Danish: En behandlingscyklus med Temozolomide SUN varer 28 dage.
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Danish: Sundhedspersoner anmodes om at indberette alle mistænkte bivirkninger via det nationale rapporteringssystem anført i Appendiks V.
English: If a full day has gone by, check with your doctor.
Danish: Hvis der er gået en hel dag, skal du spørge din læge.
English: In some cases, it may be prolonged and may lead to a very severe form of anaemia (aplastic anaemia).
Danish: I nogle tilfælde kan det være længerevarende samt medføre en meget alvorlig form for anæmi (aplastisk anæmi).
English: Then, you will start the monotherapy phase.
Danish: Derefter starter du på monoterapifasen.
English: This is because Temozolomide SUN could cause hepatitis B to become active again, which can be fatal in some cases.
Danish: Dette skyldes, at Temozolomide SUN kan forårsage at hepatitis B bliver aktiv igen, hvilket kan være dødeligt i nogle tilfælde.
English: You may have to take different strengths to make up the dose.
Danish: Du skal muligvis tage kapsler af forskellig styrke for at opnå den korrekte dosis.
English: Temozolomide SUN should not be administered to pregnant women.
Danish: Temozolomide SUN bør ikke anvendes til gravide kvinder.
English: - The active substance is temozolomide.
Danish: - Det aktive stof er temozolomid.
English: This daily dose depends on whether or not you have received chemotherapy before.
Danish: Denne daglige dosis afhænger af, om du tidligere har været i kemoterapi.
English: Side effects from clinical studies
Danish: Bivirkninger fra kliniske undersøgelser
English: If Temozolomide SUN comes into contact with skin or mucosa, it should be washed immediately and thoroughly with soap and water.
Danish: Hvis Temozolomide SUN kommer i kontakt med hud eller slimhinder, skal det øjeblikkeligt vaskes grundigt med vand og sæbe.
English: Temozolomide SUN is used in these tumours if they return or get worse after standard treatment.
Danish: Temozolomide SUN bruges til disse tumorer, hvis de vender tilbage eller forværres efter almindelig behandling.
English: You may be given other medicines (anti-emetics) to take before and/or after taking Temozolomide SUN to prevent or control nausea and vomiting.
Danish: Du har måske fået andre lægemidler (antiemetikum), der skal tages før og/eller efter indtagelse af Temozolomide SUN for at forhindre eller kontrollere kvalme og opkastning.
English: It is very important to check with your doctor or pharmacist if you are not sure.
Danish: Det er meget vigtigt at spørge lægen eller apotekeren, hvis du ikke er sikker.
English: In clinical trials, the most frequently occurring treatment-related undesirable effects were gastrointestinal disorders, specifically nausea (43 %) and vomiting (36 %).
Danish: I kliniske forsøg var de hyppigst forekommende behandlingsrelaterede bivirkninger gastrointestinale forstyrrelser, særligt kvalme (43 %) og opkastninger (36 %).
English: Temozolomide SUN treatment can cause a reduction in certain kinds of blood cells.
Danish: Behandling med Temozolomide SUN kan medføre en reduction i bestemte typer blodlegemer.
English: - if you have nausea (feeling sick) and/or vomiting which are very common side effects of Temozolomide SUN (see section 4), your doctor may prescribe you a medicine (an anti-emetic) to help prevent vomiting.
Danish: - hvis du får kvalme (utilpashed) og/eller kaster op, hvilke er meget almindelige bivirkninger ved Temozolomide SUN (se afsnit 4), kan din læge ordinere et lægemiddel (et antiemetikum), som hjælper med at forhindre opkastning.
English: 5x1 hard capsule 20x1 hard capsule
Danish: 5x1 hårde kapsel 20x1 hårde kapsel
English: If you have been newly-diagnosed with glioblastoma multiforme you may be receiving Temozolomide SUN for 42 days in combination with radiotherapy.
Danish: Hvis du for nyligt er diagnosticeret med glioblastoma multiforme, skal du muligvis tage Temozolomide SUN i 42 dage kombineret med strålebehandling.
English: There is limited information in patients over 3 years of age who have taken Temozolomide SUN.
Danish: Der foreligger begrænset information om børn over 3 år, der har fået Temozolomide SUN.
English: allergic reactions.
Danish: hududslæt, allergiske reaktioner.
English: Reduce TMZ by 1 dose levela
Danish: Reducer TMZ med 1 dosistrina
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: This is based on your size (height and weight) and whether you have a recurrent tumour and have had chemotherapy treatment in the past.
Danish: Dosis fastlægges ud fra din størrelse (højde og vægt), og om du har en tilbagevendende tumor og tidligere har været i kemoterapi.
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 hæmatologiske bivirkninger blev rapporteret som værende almindelige eller meget almindelige for begge indikationer (Tabel 4 og 5); hyppighed af grad 3-4 laboratoriefund er angivet efter hver tabel.
English: This medicine is an antitumour agent.
Danish: Denne medicin er et antitumormiddel.
English: Pack size: blisters are packed in cartons containing 5 or 20 hard capsules.
Danish: Pakkestørrelse: Blisterpakker pakkes i kartoner indeholdende 5 eller 20 hårde kapsler.
English: - if the numbers of certain kinds of blood cells, such as your white blood cells or platelets are severely reduced (known as myelosuppression).
Danish: - hvis antallet af bestemte typer blodlegemer, f.eks. hvide blodlegemer eller trombocytter er væsentligt reduceret (kaldet myelosuppression).
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 du har et reduceret antal røde blodlegemer (anæmi), hvide blodlegemer og trombocytter eller problemer med blodkoagulation, inden du starter behandlingen, eller hvis du udvikler dem under behandlingen.
English: Your doctor will check your blood to make sure you have enough of these cells before you begin treatment.
Danish: Din læge vil kontrollere dit blod for at sikre, at du har tilstrækkeligt af disse blodlegemer, inden du påbegynder behandlingen.
English: If you vomit after taking your dose, do not take a second dose on the same day.
Danish: Hvis du kaster op efter at have taget din dosis, skal du ikke tage en dosis mere samme dag.
English: For the 20 capsules packs, 4 blisters of 5 capsules will be included in a carton.
Danish: For pakker med 20 kapsler vil 4 blisterpakker med 5 kapsler være inkluderet i et karton.
English: - as you should be observed closely for the development of a serious form of chest infection called Pneumocystis jirovecii pneumonia (PCP).
Danish: - du vil blive overvåget nøje for udvikling af en alvorlig form for lungebetændelse kaldet Pneumocystis jirovecii pneumoni (PCP).
English: In some cases, it may be necessary to stop treatment with Temozolomide SUN. - as you may have a small risk of other changes in blood cells, including leukaemia.
Danish: I nogle tilfælde kan det være nødvendigt at standse behandlingen med Temozolomide SUN. - du kan have en lille risiko for andre ændringer i blodlegemer, inklusive leukæmi.
English: Temozolomide SUN may make you feel tired or sleepy.
Danish: Når De tager Temozolomide SUN, kan De føle Dem træt eller søvnig.
English: Very rare cases of lung side effects have been observed with Temozolomide SUN.
Danish: Der er observeret meget sjældne tilfælde af lungebivirkninger med Temozolomide SUN.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON (BLISTER)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE ÆSKE (BLISTER)
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.
Danish: I den ikke-randomiserede undersøgelse var PFS efter 6 måneder 19 %, median progressiv overlevelse var 2,1 måneder, og median samlet overlevelse 5,4 måneder.
English: Take your prescribed dose of Temozolomide SUN once a day, preferably at the same time each day.
Danish: Tag den ordinerede dosis af Temozolomide SUN én gang dagligt, helst samme tidspunkt hver dag.
English: In some cases, your Temozolomide SUN dose will be reduced or treatment stopped.
Danish: I nogle tilfælde kan din Temozolomide SUNdosis blive reduceret eller behandlingen helt stoppes.
English: common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); Rare (≥1/10,000 to <1/1,000); Very rare (<1/10,000).
Danish: < 1/10); ikke almindelig (≥ 1/1.000 til < 1/100); sjælden (≥1/10.000 til <1/1.000); meget sjælden
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Danish: Hvis du ønsker yderligere oplysninger om dette lægemiddel, skal du henvende Dem til den lokale repræsentant for indehaveren af markedsføringstilladelsen:
English: In very rare cases, patients taking Temozolomide SUN and medicines like it may have a small risk of developing secondary cancers, including leukaemia.
Danish: I meget sjældne tilfælde kan patienter, der tager Temozolomide SUN og lignende lægemidler, have en lille risiko for at udvikle sekundær cancer, herunder leukæmi.
English: The cytotoxicity of MTIC is thought to be primarily due to alkylation of DNA mainly at the O6 and N7 positions of guanine.
Danish: Cytotoksiciteten af MTIC menes primært at skyldes alkyleringen af DNA hovedsageligt ved O6 og N7 positionerne i guanin.
English: Effective contraceptive precautions must be taken by both male and female patients who are taking Temozolomide SUN (see also “Male fertility” below).
Danish: Både mandlige og kvindelige patienter skal anvende sikre præventionsmidler, mens de tager Temozolomide SUN (se også ”Frugtbarhed hos mænd” nedenfor).
English: If you vomit frequently before or during treatment, ask your doctor about the best time to take Temozolomide SUN until the vomiting is under control.
Danish: Hvis du kaster op ofte før eller under behandling, skal du spørge din læge, hvornår det er bedst at tage Temozolomide SUN, indtil opkastningen er under kontrol.
English: Your blood will be tested frequently during treatment to monitor the side effects of Temozolomide SUN on your blood cells.
Danish: Dit blod vil blive kontrolleret regelmæssigt under behandlingen for at overvåge bivirkningerne af Temozolomide SUN på dine blodlegemer.
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: Dette kan give dig flere blå mærker eller forøget blødning, anæmi (mangel på røde blodlegemer), feber og reduceret modstandsdygtighed mod infektioner.
English: drug reaction with eosinophilia and systemic symptoms (DRESS)
Danish: lægemiddelreaktion med eosinofili og systemiske symptomer (DRESS)
English: The Temozolomide SUN dose may be delayed or stopped, depending on your blood counts and how you tolerate your medicine during the concomitant phase.
Danish: Temozolomide SUN-dosen kan blive forsinket eller stoppet, afhængigt af din blodtælling, samt hvordan du tåler lægemidlet under den konkomiterende fase.
English: cytomegalovirus infection, infection reactivation such as cytomegalovirus, hepatitis B virus†, meningoencephalitis herpetic†, sepsis†
Danish: Cytomegalovirusinfektion, reaktivering af infektion såsom cytomegalovirus, hepatitis B-virus†, meningoencephalitis herpetica†, sepsis†
English: Very rare cases of severe rash with skin swelling, including on the palms of the hands and soles of the feet, or painful reddening of the skin and/or blisters on the body or in the mouth have been observed.
Danish: Der er observeret meget sjældne tilfælde af alvorlig udslæt med hævelse i huden, herunder på håndflader og fodsåler, eller smertende rødme i huden og/eller blærer på kroppen eller i muden.
English: Following oral administration, approximately 5 % to 10 % of the dose is recovered unchanged in the urine over 24 hours, and the remainder excreted as temozolomide acid, 5-aminoimidazole-4carboxamide (AIC) or unidentified polar metabolites.
Danish: Efter peroral administration genfindes cirka 5 % til 10 % af dosis uomdannet i urinen over 24 timer, og resten udskilles som temozolomidsyre, 5-aminoimidazol-4-carboxamid (AIC) eller uidentificerede polære metabolitter.
English: These reactions 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: Disse bivirkninger var oftest grad 1 eller 2, (0-5 opkastninger inden for 24 timer) og ophørte af sig selv eller kunne let kontrolleres med kvalmestillende standard-behandling.
English: Before each new treatment cycle, your blood will be tested to see if the Temozolomide SUN dose needs to be adjusted.
Danish: Inden hver ny behandlingscyklus kontrolleres dit blod for at se, om Temozolomide SUN-dosen skal justeres.
English: The first dose will be 150 mg/m2.
Danish: Den første dosis vil være 150 mg/m2.
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, multiorgan 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: Pharmacotherapeutic group: Antineoplastic agents, other alkylating agents, ATC code: L01A X03.
Danish: Farmakoterapeutisk klassifikation: Antineoplastiske midler, andre alkylerende midler, ATC-kode: L01A X03.
English: Contact your doctor immediately if you have any of the following: - a severe allergic (hypersensitive) reaction (hives, wheezing or other breathing difficulty) - uncontrolled bleeding - seizures (convulsions) - fever - chills - severe headache that does not go away.
Danish: Kontakt din læge øjeblikkeligt, hvis du får nogen af følgende: - en alvorlige allergisk (overfølsom) reaktion (nældefeber, hvæsende vejtrækning eller anden åndedrætsbesvær) - ukontrolleret blødning - krampeanfald (krampetrækninger) - feber - kulderystelser - voldsom hovedpine, som ikke forsvinder.
English: After oral administration of 14C-labelled TMZ, mean faecal excretion of 14C over 7 days post-dose was 0.8 % indicating complete absorption.
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: Your doctor will work out your dose of Temozolomide SUN.
Danish: Din læge vil fastlægge din dosis af Temozolomide SUN.
English: No dose reductions are 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: Dose during Cycles 2-6 in absence of toxicity
Danish: Dosis under serie 2-6 ved fravær af toksicitet Tabel 3.
English: The hard capsules are available in blister packs containing 5 capsules.
Danish: De hårde kapsler forefindes i blisterpakninger, som indeholder 5 kapsler.
English: Aluminium/aluminium unit dose blisters, consisting of an OPA [Oriented Poly Amide] / Aluminium / PVC [Polyvinyl chloride] forming film and peelable Aluminium lidding foil with heat seal laquer.
Danish: Enhedsdoser i aluminium/aluminium-blisterpakker, bestående af en OPA-dannende [orienteret polyamid]/Aluminium/PVC [Polyvinylchlorid] film og et aftageligt låg af aluminiumsfolie med varmeforseglende lak.
English: Blue #1/Brilliant Blue FCF Aluminium Lake (E133)
Danish: Blå 1/Brilliant Blue FCF aluminium lake (E 133)
English: Table 5 includes adverse reactions reported during clinical trials for recurrent or progressive malignant glioma and following the marketing of Temozolomide SUN.
Danish: Tabel 5 omfatter bivirkninger rapporteret under kliniske undersøgelser ved tilbagevendende eller progressivt malignt gliom samt efter markedsføring af Temozolomid SUN.
English: Talk to your doctor, pharmacist or nurse before taking Temozolomide SUN,
Danish: Kontakt lægen, apoteketspersonalet eller sygeplejersken, før De tager Temozolomide SUN
English: - if you are allergic to temozolomide or any of the other ingredients of this medicine (listed in section 6).
Danish: - hvis du er allergisk over for temozolomid eller et af de øvrige indholdsstoffer i Temozolomide SUN (angivet i punkt 6).
English: However, all patients receiving TMZ, particularly patients receiving steroids, should be observed closely for the development of PCP, regardless of the regimen.
Danish: Uanset regime bør alle patienter, der får TMZ, især patienter der får steroider, følges nøje for udvikling af PCP.
English: During the monotherapy phase, the dose and way you take Temozolomide SUN can vary.
Danish: Under monoterapifasen kan dosis og den måde, du tager Temozolomide SUN, variere.
English: Frequency groupings are defined according to the following convention: very common (≥ 1/10);
Danish: Hyppigheden er defineret i henhold til følgende konvention: Meget almindelig (≥ 1/10); almindelig (≥ 1/100 til
English: Then you will have 23 days without Temozolomide SUN.
Danish: Derefter har du 23 dage uden Temozolomide SUN.
English: In preclinical studies in rats and rabbits receiving 150 mg/m2 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: MTIC is spontaneously hydrolyzed to 5-amino-imidazole-4carboxamide (AIC), a known intermediate in purine and nucleic acid biosynthesis, and to methylhydrazine, which is believed to be the active alkylating species.
Danish: MTIC hydrolyseres spontant til 5-amino-imidazol-4-carboxamid (AIC), et kendt mellemprodukt i purin- og nucleinsyrebiosyntesen, og til methylhydrazin, som menes at være det aktive alkylerende stof.
English: Analysis of population-based pharmacokinetics of TMZ revealed that plasma TMZ clearance was independent of age, renal function or tobacco use.
Danish: Ved analyse af populationsbaseret farmakokinetik for TMZ blev det fundet, at plasma-TMZ-clearance var uafhængig af alder, nyrefunktion og tobaksforbrug.
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: Temozolomide SUN should only be prescribed by physicians experienced in the oncological treatment of brain tumours.
Danish: Temozolomide SUN bør kun ordineres af læger, der har erfaring med onkologisk behandling af hjernetumorer.
English: If you accidentally take more Temozolomide SUN capsules than you were told to, contact your doctor, pharmacist or nurse immediately.
Danish: Hvis du kommer til at tage flere Temozolomide SUN-kapsler, end du har fået besked på, skal du straks kontakte din læge, apotekspersonalet eller sundhedspersonalet.
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: 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.
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: The median survival was 7.34 and 5.66 months for TMZ and procarbazine, respectively (log rank p=0.33).
Danish: Den mediane overlevelse var 7,34 og 5,66 måneder for henholdsvis TMZ og procarbazin (log rank p = 0,33).
English: Temozolomide SUN contains lactose (a kind of sugar).
Danish: Temozolomide SUN indeholder lactose (en form for sukker).
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 thrombocytopeni (< 20 x 109/l), 9 % vs. 3 %, hos kvinder vs. mænd i det første terapiforløb.
English: If you are a newly-diagnosed patient, treatment will occur in two phases: - treatment together with radiotherapy (concomitant phase) first - followed by treatment with Temozolomide SUN only (monotherapy phase).
Danish: Hvis du er en nyligt diagnosticeret patient, vil behandlingen foregå i to faser: - først behandling sammen med strålebehandling (konkomiterende fase) - efterfulgt af behandling med kun Temozolomide SUN (monoterapifase).