FrancophonIA/ELRC3.0 huggingface dataset:
English: Direct healthcare professional communication were agreed, together with the timelines for distribution and that a postauthorisation safety study as well as a drug utilisation study should be conducted.
Danish: Der blev truffet bestemmelse om udsendelse af en direkte meddelelse til fagfolk i sundhedssektoren og om en tidsplan for udsendelsen samt om gennemførelse af en sikkerhedsundersøgelse efter markedsføring og en undersøgelse af lægemiddelanvendelse konkluderede PRAC, at risk/benefit-forholdet for produkter indeholdende flupirtin til behandling af kroniske smerter ikke positivt i henhold til artikel 116 i direktiv 2001/83/EF.
English: You should make sure you fully understand and remember the following:
Danish: Du bør sikre dig, at du præcis forstår og kan huske følgende:
English: • which days are your dosing days.
Danish: • hvilke dage der er dine doseringsdage.
English: • how many capsules you need to take every dosing day.
Danish: • hvor mange kapsler du skal tage hver doseringsdag.
English: The colour and marking of the capsule is different for each strength (see table below).
Danish: Farven og mærkningen af kapslen er forskellig for hver styrke (se tabellen nedenfor).
English: Ask your doctor or pharmacist to write it down (including the colour).
Danish: Bed din læge eller apotek om at skrive det ned (inklusive farve).
English: - if you have ever had or might now have a hepatitis B infection.
Danish: - hvis du nogensinde har haft eller ved at du kan have hepatitis B infektion.
English: Review the dose with your doctor each time you start a new cycle, since it may be different from the last cycle.
Danish: Gennemgå doseringen med din læge hver gang du starter på en ny cyklus, da det kan være forskelligt fra den sidste cyklus.
English: Tell your doctor immediately if this occurs.
Danish: Kontakt straks din læge, hvis dette forekommer.
English: In this case, your doctor will also prescribe medicine to help you prevent this type of pneumonia (PCP).
Danish: I dette tilfælde vil din læge også udskrive medicin, der kan hjælpe med at forebygge denne form for lungebetændelse (PCP).
English: The objective response rate (ORR) based on MRI scans was 8%.
Danish: Den objektive responsrate (ORR) baseret på MRI-scanninger var 8 %.
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 undersøge dit blod for eventuelle ændringer og vil afgøre, om det er nødvendigt med specifik behandling.
English: Administration of TMZ with food resulted in a 33% decrease in Cmax and a 9% decrease in area under the curve (AUC).
Danish: Indtagelse af TMZ med føde resulterede i et 33 % fald i Cmax og et 9 % fald i arealet under kurven (AUC).
English: You will take this dose every day for 42 days (up to 49 days) in combination with radiotherapy.
Danish: Du vil tage denne dosis hver dag i 42 dage (op til 49 dage) i kombination med strålebehandling.
English: - as you may have a small risk of other changes in blood cells, including leukaemia.
Danish: - da du kan have en lille risiko for andre ændringer i blodcellerne, inklusive leukæmi.
English: TMZ Dose (mg/m²/day)
Danish: TMZ-dosis (mg/m²/dag)
English: The following side effects may occur, and may require medical attention.
Danish: Følgende bivirkninger kan forekomme og kan kræve lægebehandling.
English: Hypersensitivity to dacarbazine (DTIC).
Danish: Overfølsomhed over for dacarbazin (DTIC).
English: As it cannot be excluded that the change in Cmax is clinically significant, Temozolomide Teva should be administered without food.
Danish: Da det ikke kan udelukkes, at ændringen i Cmax er klinisk signifikant, bør Temozolomid Teva indgives uden føde.
English: This is bedcause you must not be treated with Temozolomide Teva during pregnancy unless clearly indicated by your doctor.
Danish: Det skyldes, at du ikke må tage Temozolomid Teva under graviditet, medmindre det er klart angivet af din læge.
English: No studies have been conducted to determine the effect of TMZ on the metabolism or elimination of other medicinal products.
Danish: Ingen undersøgelser er udført for at bestemme effekten af TMZ på metabolisering eller elimination af andre lægemidler.
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: In the tables undesirable effects are classified according to System Organ Class and frequency.
Danish: I tabellerne er bivirkningerne klassificeret i henhold til Systemorganklasse og hyppighed.
English: Then, you will start the monotherapy phase.
Danish: Derefter vil du påbegynde monoterapi-fasen.
English: If a full day has gone by, check with your doctor.
Danish: Hvis der er gået en hel dag, skal du kontakte din læge.
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 dette lægemiddel (angivet i punkt 6).
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 (en medicin mod kræft, som også kaldes DTIC).
English: - if you develop fever or symptoms of an infection, contact your doctor immediately.
Danish: - hvis du udvikler feber eller infektionssymptomer, skal du straks kontakte din læge.
English: A treatment cycle with Temozolomide Teva lasts 28 days.
Danish: En behandlingscyklus med Temozolomid Teva varer 28 dage.
English: Temozolomide Teva may make you feel tired or sleepy.
Danish: Når du tager Temozolomid Teva, kan du føle dig træt eller søvnig.
English: Depending on the prescribed dose, you may have to take more than one capsule together, eventually with different strengths (content of active substance, in mg).
Danish: Afhængig af den ordinerede dosis, kan det blive nødvendigt at tage mere end én kapsel ad gangennogle gange vil det også være nødvendigt at tage kapsler af forskellig styrke (indhold af aktivt stof i mg).
English: Temozolomide Teva treatment can cause a reduction in certain kinds of blood cells.
Danish: Behandling med Temozolomid Teva kan give et fald i antallet af visse typer blodceller.
English: However, because the doses implicated in retinal degeneration were in the lethal dose range, and no comparable effect has been observed in clinical studies, this finding was not considered to have clinical relevance.
Danish: Da de pågældende doser for retina-degenerationen imidlertid lå i området for de dødelige doser, og ingen lignende effekt er set i kliniske undersøgelser, blev dette fund ikke betragtet som værende klinisk relevant.
English: drug reaction with eosinophilia and systemic symptons (DRESS)
Danish: Lægemiddelreaktion med eosinofili og systemiske symptomer (DRESS)
English: This led to hospitalisation and/or discontinuation of TMZ in 8% and 4%, respectively.
Danish: Dette medførte hospitalsindlæggelse og/eller seponering af TMZ hos henholdsvis 8 % and 4 %.
English: Response rate, based on the central reviewer assessment, was 35% (13 CR and 43 PR) for the intent-to-treat population (ITT) n=162.
Danish: Responsrate, baseret på den centrale reviewers vurdering, var 35 % (13 CR og 43 PR) for intent-to-treat populationen (ITT) n=162.
English: Most of the toxicity showed evidence of reversibility, except for adverse events on the male reproductive system and retinal degeneration.
Danish: Størstedelen af toksiciteten viste tegn på at være reversibel med undtagelse af bivirkningerne på det mandlige reproduktionssystem og retina-degenerationen.
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 dig til den lokale repræsentant af indehaveren af markedsføringstilladelsen:
English: CTC Grade 4b a:
Danish: CTC Grad 4b a:
English: Temozolomide Teva should not be administered to pregnant women.
Danish: Temozolomid Teva bør ikke anvendes til gravide kvinder.
English: Myelosuppression was predictable (usually within the first few cycles, with the nadir between Day 21 and Day 28), and recovery was rapid, usually within 1-2 weeks.
Danish: Myelosuppression var forudsigelig (sædvanligvis inden for de første få serier med nadir mellem dag 21 og dag 28), og bedring indtraf hurtigt, sædvanligvis inden for 12 uger.
English: Colour/marking
Danish: Farve/mærkning
English: Pneumocystis jirovecii pneumonia
Danish: Pneumocystis jirovecii pneumoni
English: Depending on your blood test results, your doctor may adjust your dose for the next cycle.
Danish: Afhængig af resultaterne af undersøgelsen af dit blod vil din læge justere dosen til næste cyklus.
English: Relative to the AUC of TMZ, the exposure to MTIC and AIC is ~ 2.4% and 23%, respectively.
Danish: I forhold til AUC af TMZ er eksponeringen til MTIC og AIC henholdsvis ~ 2,4 % og 23 %.
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: Børn havde en højere AUC end voksne patienter, men den maksimalt tolererede dosis (MTD) var 1.000 mg/m2 pr. serie for både børn og voksne.
English: If Temozolomide Teva comes into contact with skin or mucosa, it should be washed immediately and thoroughly with soap and water.
Danish: Hvis Temozolomid Teva kommer i kontakt med hud eller slimhinder bør området straks vaskes grundigt med sæbe og vand.
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: Doser på 500, 750, 1.000 og 1.250 mg/m2 (total dosis pr. serie over 5 dage) er blevet vurderet klinisk hos patienter.
English: TMZ monotherapy n=224
Danish: TMZ-monoterapi n=224
English: Experts in liver disease should be consulted before treatment is initiated in patients with positive hepatitis B serology (including those with active disease).
Danish: Specialister inden for leversygdomme skal konsulteres inden behandling opstartes hos patienter med hepatitis B serologi (inklusive patienter med aktiv sygdom).
English: Tell your pharmacist if you notice any change in the appearance of the capsules.
Danish: Kontakt apoteket, hvis du bemærker et ændret udseende af kapslerne.
English: During the monotherapy phase, the dose and way you take Temozolomide Teva will be different.
Danish: Under monoterapi-fasen vil dosis og måden, du tager Temozolomid Teva på være anderledes.
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: Take your prescribed dose of Temozolomide Teva once a day, preferably at the same time each day.
Danish: Tag din ordinerede dosis af Temozolomid Teva hver dag, helst på samme tidspunkt hver dag.
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: - if you are older than 70 years of age, you might be more prone to infections, bruising or bleeding.
Danish: - hvis du er ældre end 70 år, kan du være mere modtagelig over for infektion eller have øget tendens til at få blå mærker og bløde.
English: Your doctor may decide to reduce the dose, interrupt, stop or change your treatment.
Danish: Din læge kan i disse tilfælde være nødsaget til at mindske dosis af din medicin, afbryde, stoppe eller ændre din behandling.
English: Doserelated reductions in leukocytes and platelets appear to be sensitive indicators of toxicity.
Danish: Det dosisrelaterede fald i leukocyt- og trombocyttal synes at være følsomme markører for toksicitet.
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: 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-penetration blev bekræftet hos en patient; CSFeksponering baseret på AUC for TMZ var cirka 30 % i forhold til plasma, hvilket er konsistent med data fra dyr.
English: It is not known whether TMZ is excreted in human milk; thus, breast-feeding should be discontinued while receiving treatment with TMZ.
Danish: Det vides ikke, om TMZ udskilles i modermælk; amning bør derfor afbrydes, mens behandling med TMZ modtages.
English: The estimated probability of surviving 2 years or more (26% vs 10%) is higher for the RT + TMZ arm.
Danish: Den estimerede sandsynlighed for at overleve 2 år eller mere (26 % vs. 10 %) er højere for gruppen med strålebehandling + TMZ.
English: The lowest recommended dose is 100 mg/m².
Danish: Den lavest anbefalede dosis er 100 mg/m2.
English: There is limited information in patients over 3 years of age who have taken Temozolomide Teva.
Danish: Der foreligger begrænset information om børn over 3 år, der har fået Temozolomid Teva.
English: Haupt Pharma Amareg GmbH Donaustaufer Straβe 378 93055 Regensburg Germany
Danish: Haupt Pharma Amareg GmbH Donaustaufer Straβe 378 93055 Regensburg Tyskland
English: TMZ dose levels are listed in Table 2.
Danish: TMZ-dosistrin er anført i tabel 2.
English: Capsule shell Gelatin
Danish: Kapselskal Gelatin
English: toxic epidermal necrolysis, Stevens-Johnson syndrome
Danish: Toksisk epidermal nekrolyse, Stevens-Johnsons syndrom
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 progressionsfri overlevelse var 2,1 måneder, og median samlet overlevelse 5,4 måneder.
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 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: 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: Temozolomide Teva is used in these tumours if they return or get worse after standard treatment.
Danish: Temozolomid Teva bruges til behandling af disse svulster, hvis der er tegn på, at de vender tilbage eller bliver værre efter standardbehandling.
English: If you vomit frequently before or during treatment, ask your doctor about the best time to take Temozolomide Teva until the vomiting is under control.
Danish: Hvis du ofte kaster op før eller under behandlingen, så spørg din læge om, hvornår du helst skal tage Temozolomid Teva, indtil opkastningerne er under kontrol.
English: Common (≥ 1/100 to < 1/10); Uncommon (≥ 1/1,000 to < 1/100) ); Rare (≥1/10,000 to <1/1,000);
Danish: Hyppigheden er defineret i henhold til følgende konvention: Meget almindelig (≥ 1/10); almindelig (≥ 1/100 til < 1/10); ikke almindelig (≥ 1/1.000 til <1/100); sjælden (≥1/10.000 til <1/1.000); meget sjælden (<1/10.000).
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: De primære målorganer for toksicitet omfattede knoglemarven, det lymforetikulære system, testes, mave-tarm-kanalen og ved højere doser, der var dødelige hos 60 % til 100 % af de undersøgte rotter og hunde, forekom degeneration af retina.
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 neutrofiltallet forelå, og 110 kvindelige og 174 mandlige forsøgspersoner, for hvem nadir blodpladetallet forelå.
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: TMZ administration should be temporarily interrupted or permanently discontinued during the concomitant phase according to the haematological and non-haematological toxicity criteria as noted in Table 1.
Danish: Indgift af TMZ bør afbrydes midlertidigt eller seponeres permanent under kombinationsfasen i henhold til de hæmatologiske og ikke-hæmatologiske toksicitetskriterier som angivet i Tabel 1.
English: Always take Temozolomide Teva exactly as your doctor has told you.
Danish: Tag altid Temozolomid Teva nøjagtigt efter lægens anvisning.
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 Teva (see also “Male fertility” below).
Danish: Både mandlige og kvindelige patienter skal anvende sikre præventionsmidler, mens de tager Temozolomid Teva (se også ”Frugtbarhed hos mænd” nedenfor).
English: Before each new treatment cycle, your blood will be tested to see if the Temozolomide Teva dose needs to be adjusted.
Danish: Før hver ny behandlingscyklus vil dit blod blive undersøgt for, om Temozolomid Teva-dosen skal justeres.
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: In very rare cases, patients taking Temozolomide Teva and medicines like it may have a small risk of developing secondary cancers, including leukaemia.
Danish: Meget sjældent kan patienter, som tager Temozolomid Teva eller lignende medicin, have en lille risiko for at udvikle en sekundær kræftform, inklusive leukæmi.
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 de farmakokinetiske egenskaber for TMZ er det usandsynligt, at dosisreduktion er påkrævet hos patienter med svær leverinsufficiens eller hvilken som helst grad af nyreinsufficiens.
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: Dose levels include 100 mg/m², 150 mg/m², and 200 mg/m².
Danish: Dosisniveauerne omfatter 100 mg/m2, 150 mg/m2 og 200 mg/m2.
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: Meget sjældne tilfælde af alvorligt udslæt med hævelser i huden, som inkluderer håndfladerne og fodsålerne, eller smertefuld rødmen af huden og/eller blærer på kroppen eller i munden er set.
English: Warnings and precations
Danish: Advarsler og forsigtighedsregler
English: Absolute Neutrophil Count
Danish: Absolut antal neutrofile
English: You may be given other medicines (anti-emetics) to take before and/or after taking Temozolomide Teva to prevent or control nausea and vomiting.
Danish: Du vil eventuelt få ordineret anden medicin (kvalmestillende), der skal tages før og/eller efter, du har taget Temozolomid Teva, for at undgå eller regulere kvalme og opkastning.
English: Very rare cases of lung side effects have been observed with Temozolomide Teva.
Danish: Der er set meget sjældne tilfælde af lungebivirkninger med Temozolomid Teva.
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 gruppen med strålebehandling alene, og 62 patienter af 277 (22 %) i gruppen med TMZ + strålebehandling.
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 øjeblikkeligt din læge, hvis du oplever noget af følgende: - en kraftig allergisk (overfølsomheds) reaktion (kløende udslæt, hvæsende vejrtrækning eller anden form for åndedrætsbesvær) - ukontrolleret blødning - anfald (kramper) - feber - kulderystelser - kraftig hovedpine, som ikke går væk.
English: *A patient who was randomised to the RT arm only, received TMZ + RT.
Danish: *En patient, der kun var randomiseret til strålebehandlingsgruppen, fik TMZ + strålebehandling.
English: Teva UK Limited Tel: +44 1977 628 500
Danish: United Kingdom Teva UK Limited Tel: +44 1977 628 500
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: Patients with recurrent or progressive malignant glioma Patients who have experienced severe (Grade 3 or 4) vomiting in previous treatment cycles may require anti-emetic therapy.
Danish: Patienter med tilbagevendende eller progressivt malignt gliom Patienter, der har haft alvorlige (grad 3 eller 4) opkastninger i tidligere behandlingsserier, kan have behov for antiemetisk behandling.