FrancophonIA/ELRC3.0 huggingface dataset:
English: PET studies in humans and preclinical data suggest that TMZ crosses rapidly the blood-brain barrier and is present in the CSF.
Danish: PET-undersøgelser hos mennesker og prækliniske data tyder på, at TMZ passerer blodhjernebarrieren hurtigt og er til stede i CSF.
English: • changes in blood cells,
Danish: • ændringer i blodets celler
English: Keep the bottle tightly closed in order to protect from moisture.
Danish: Hold flasken tæt tillukket for at beskytte mod fugtighed.
English: • abnormal or blurred vision, double-vision
Danish: • unormalt eller sløret syn, dobbeltsyn
English: The hard capsules are dispensed in amber glass bottles containing 5 or 20 capsules.
Danish: De hårde kapsler udleveres i brune glas, som indeholder 5 eller 20 kapsler.
English: The hard capsules are dispensed in sachet containing 1 capsule.
Danish: De hårde kapsler udleveres i breve indeholdende 1 kapsel.
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 prospektiv multicenterundersøgelse i fase II, der vurderede sikkerhed og effekt af oral TMZ i behandlingen af patienter med anaplastisk astrocytom efter første relaps, var 6 måneders PFS 46 %.
English: Temozolomide Accord 5 mg hard capsules Temozolomide Accord 20 mg hard capsules Temozolomide Accord 100 mg hard capsules Temozolomide Accord 140 mg hard capsules Temozolomide Accord 180 mg hard capsules Temozolomide Accord 250 mg hard capsules temozolomide
Danish: Temozolomide Accord 5 mg hårde kapsler Temozolomide Accord 20 mg hårde kapsler Temozolomide Accord 100 mg hårde kapsler Temozolomide Accord 140 mg hårde kapsler Temozolomide Accord 180 mg hårde kapsler Temozolomide Accord 250 mg hårde kapsler temozolomid
English: Other medicines and Temozolomide Accord Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicin sammen med Temozolomide Accord Fortæl lægen eller apotekspersonalet, hvis De bruger anden medicin, gjort det for nylig eller måske skal gøre det.
English: Nausea and vomiting are very commonly associated with TMZ.
Danish: Kvalme og opkastning forekommer meget almindeligt i forbindelse med TMZ.
English: - if you have a reduced number of blood cells, such as your white blood cell count and platelet count.
Danish: - hvis De har et nedsat antal blodceller, for eksempel hvide blodceller og blodplader.
English: Do not open, crush or chew the capsules.
Danish: De må ikke åbne, knuse eller tygge kapslerne.
English: If you are a newly-diagnosed patient (glioblastoma multiforme) you may be receiving temozolomide for 42 days in combination with radiotherapy.
Danish: Hvis De er diagnosticeret for nylig (glioblastoma multiforme), skal De muligvis have temozolomid i 42 dage i kombination med strålebehandling.
English: Cases of elevations of liver enzymes have been commonly reported.
Danish: Tilfælde af forhøjede leverenzymer er almindelig rapporteret.
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: Den mediane tid til progression af disse endepunkter spændte fra 0,7 til 2,1 måneder længere for TMZ end for procarbazin (log rank p = < 0,01 til 0,03).
English: Table 5 includes adverse reactions reported during clinical trials for recurrent or progressive malignant glioma and following the marketing of TMZ.
Danish: Af tabel 5 fremgår de bivirkninger, som blev rapporteret under de kliniske undersøgelser ved recidiverende eller progressivt malignt gliom og efter markedsføring af TMZ.
English: Frequency groupings are defined according to the following convention: Very Common (≥1/10); 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: 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: What Temozolomide Accord contains
Danish: Temozolomide Accord indeholder
English: After day 28, the next cycle will begin, in which you will again take this medicine once daily for five days followed by 23 days without temozolomide.
Danish: Efter dag 28 begynder den næste serie, hvor De igen skal tage medicinen en gang om dagen i fem dage efterfulgt af 23 dage uden behandling med temozolomid.
English: You will take this dose every day for 42 days (up to 49 days) in combination with radiotherapy.
Danish: 42 dage (op til 49 dage) sammen med strålebehandlingen.
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 aktivt kontrollerede undersøgelse var PFS efter 6 måneder signifikant længere for TMZ end for procarbazin (hhv. 21 % versus 8 % - chi-square p = 0,008) med en median PFS på henholdsvis 2,89 og 1,88 måneder (log rank p = 0,0063).
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 nedsat nyrefunktion.
English: • peeling skin, increased skin sensitivity to sunlight, change in skin colour, increased sweating
Danish: • skællende hud, øget lysfølsomhed af huden, ændring i hudfarve, øget svedtendens
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 populationsfarmakokinetisk analyse af fase II-undersøgelser, ændrede samtidig anvendelse af dexamethason, prochlorperazin, phenytoin, carbamazepin, ondansetron, H2receptorantagonister eller phenobarbital ikke TMZs clearance.
English: Therefore, special care should be taken when TMZ is administered in elderly patients.
Danish: Der skal derfor iagttages forsigtighed, når TMZ gives til ældre patienter.
English: A variety of neoplasms, including mammary carcinomas, keratocanthoma of the skin and basal cell adenoma were observed in the 6-cycle rat study while no tumours or pre-neoplastic changes were evident in dog studies.
Danish: Der blev set forskellige neoplasier hos rotter, herunder brystcancer, keratoacanthom i huden og basalcelleadenom i en undersøgelse, som omfattede 6 serier, mens der ikke blev set tumorer eller præneoplastiske forandringer i undersøgelser på hunde.
English: A treatment cycle comprises 28 days.
Danish: En behandlingsserie varer således 28 dage.
English: In a separate pharmacokinetic study, plasma pharmacokinetic profiles in patients with mild to moderate hepatic impairment were similar to those observed in patients with normal hepatic function.
Danish: I en separat farmakokinetisk undersøgelse var den farmakokinetiske profil i plasma hos patienter med let til moderat leverinsufficiens sammenlignelig med profilen for patienter med normal leverfunktion.
English: 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: Der er set opportunistiske infektioner (såsom Pneumocystis jirovecii lungebetændelse) og reaktivering af infektioner (såsom HBV, CMV) under behandling med TMZ (se pkt.
English: TMZ is spontaneously hydrolyzed at physiologic pH primarily to the active species, 3-methyl-(triazen1-yl)imidazole-4-carboxamide (MTIC).
Danish: TMZ hydrolyseres spontant ved fysiologisk pH, primært til det aktive stof, 3-methyl-(triazen-1yl)imidazol-4-carboxamid (MTIC).
English: Pancytopenia, anaemia (grade 3-4), leukopenia
Danish: Pancytopeni, anæmi (grad 3-4), leukopeni,
English: Herpes simplex, Herpes zoster, influenza-like symptoms
Danish: Herpes simplex, herpes zoster, influenzalignende symptomer
English: See package leaflet for further information.
Danish: Indlægssedlen indeholder flere oplysninger.
English: Printing ink Shellac
Danish: Påtrykt blæk Shellak
English: Oral TMZ has been studied in paediatric patients (age 3-18 years) with recurrent brainstem glioma or recurrent high grade astrocytoma, in a regimen administered daily for 5 days every 28 days.
Danish: Oral TMZ er undersøgt hos pædiatriske patienter (i alderen 3-18 år) med recidiverende hjernestamme gliom eller recidiverende astrocytom af høj grad i et regime, der administreres dagligt i 5 dage hver 28. dag.
English: If you forget to take Temozolomide Accord
Danish: Hvis De har glemt at tage Temozolomide Accord
English: - if you have anaemia, low blood count (such as white blood cell count and platelet count), or blood clotting problems before treatment, or develop them during treatment.
Danish: - hvis De har blodmangel (anæmi), lave blodtal (som fx et lavt antal hvide blodlegemer eller et lavt antal blodplader), eller har haft problemer med blodpropper før behandlingen påbegyndes eller får blodpropper under behandlingen.
English: PHARMACEUTICAL FORM AND CONTENTS 5 hard capsules
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) 5 hårde kapsler
English: Agitation, apathy, behaviour disorder, depression, hallucination
Danish: Agitation, apati, adfærdsforstyrrelse, depression, hallucination
English: Cerebral haemorrhage, hypertension
Danish: Hjerneblødning, hypertension
English: • raised liver enzymes (your doctor will check this)
Danish: • forhøjede leverenzymer (tjekkes af lægen)
English: • mood swings, depression, hallucination and memory loss
Danish: • humørsvingninger, depression, hallucinationer og hukommelsestab
English: Temozolomide Accord capsules are taken to treat specific forms of brain tumours: - adults with newly diagnosed specific form of brain tumour (glioblastoma multiforme).
Danish: Temozolomide Accord kapsler bruges til behandling af bestemte typer hjernesvulster: hos voksne med nyligt diagnosticeret glioblastoma multiforme (en særlig form for hjernesvulster).
English: Erythema, pigmentation abnormal, sweating increased
Danish: Erytem, abnorm pigmentering, øget svedtendens
English: Anti-emetic therapy may be administered prior to or following administration of TMZ.
Danish: Der kan anvendes antiemetisk behandling før eller efter indgift af TMZ.
English: Skin redness, an itchy rash with raised yellow or white lumps that are surrounded by red inflammation, skin eruption, allergic reactions.
Danish: Rødme af huden, kløende udslæt med hævede, gule eller hvide knuder, som er omgivet af rød og hævet hud, hududslæt, overfølsomhedsreaktioner.
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: Der skal foretages en fuldstændig blodtælling på dag 22 (21 dage efter første dosis) eller senest 48 timer efter, og derefter ugentligt indtil ANC > 1,5 x 109/l og trombocyttallet > 100 x 109/l.
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, følges nøje for udvikling af PCP, især patienter, der får steroider.
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 først er øget, bibeholdes den på 200 mg/m2 om dagen i de første 5 dage af hver efterfølgende serie, undtagen hvis der forekommer toksicitet.
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 reducere dosis, men det bør overvejes at udskyde eller stoppe behandlingen med TMZ hver uge i henhold til hæmatologiske og ikkehæmatologiske toksicitetskriterier.
English: Special populations Paediatric population
Danish: Særlige patientgrupper Pædiatrisk population
English: Four weeks after completing the TMZ + RT phase, TMZ is administered for up to 6 cycles of monotherapy treatment.
Danish: Fire uger efter fuldført TMZ + RT gives TMZ i op til 6 serier som monoterapi.
English: The following side effects may occur if you are a newly diagnosed patient taking Temozolomide Accord for a specific brain tumour (glioblastoma multiforme) in combination treatment with radiotherapy and then later taking temozolomide on its own.
Danish: Der kan forekomme følgende bivirkninger, hvis De er en nydiagnosticeret patient, som tager Temozolomide Accord for en speciel hjernesvulst (glioblastoma multiforme) i kombination med strålebehandling og senere kun tager temozolomid.
English: Type III amber glass bottles with polypropylene child-resistant closures and a desiccant, containing 5 or 20 capsules.
Danish: Brune glasflasker af type III med børnesikret polypropylen-lukning og et tørremiddel, indeholdende 5 eller 20 kapsler.
English: - Once you take the medicine home, if you are confused or unsure about how to take your dose, call for re-instruction before beginning the treatment cycle.
Danish: - Hvis De bliver forvirret eller usikker på, hvordan De skal tage medicinen, når De begynder at tage medicinen hjemme, skal De ringe og bede om at få doseringen gentaget, før De begynder på en ny serie.
English: After oral administration to adult patients, TMZ is absorbed rapidly, with peak concentrations reached as early as 20 minutes post administration (mean times between 0.5 and 1.5 hours).
Danish: Efter oral administration til voksne absorberes TMZ hurtigt, og der opnås maksimale koncentrationer allerede efter 20 minutter (gennemsnitstider mellem 0,5 og 1,5 time).
English: See package leaflet for further information PHARMACEUTICAL FORM AND CONTENTS 5 hard capsules 20 hard capsules METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use .
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) 5 hårde kapsler 20 hårde kapsler ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Læs indlægssedlen inden brug.
English: If ANC falls to < 1.0 x 109/l or the platelet count is < 50 x109/l during any cycle, the next cycle should be reduced one dose level (see section 4.2).
Danish: Hvis ANC falder til < 1,0 x 109/l, eller trombocyttallet er < 50 x 109/l i en behandlingsserie, skal dosis i næste behandlingsserie reduceres med et dosisniveau (se pkt.
English: In patients treated with TMZ, whether used in combination with RT or as monotherapy following RT for newly-diagnosed glioblastoma multiforme, or as monotherapy in patients with recurrent or progressive glioma, the reported very common adverse reactions were similar: nausea, vomiting, constipation, anorexia, headache and fatigue.
Danish: Uanset om patienterne behandles med TMZ i kombination med RT, eller om de er i monoterapi efter RT for nydiagnosticeret glioblastoma multiforme eller behandles med TMZ hos patienter med recidiveret eller progressivt gliom, var de meget almindelige bivirkninger, som blev indberettet, de samme: kvalme, opkastning, obstipation, anoreksi, hovedpine og træthed.
English: Grade 3 or 4 thrombocytopenia and neutropenia occurred in 19 % and 17 % respectively, of patients treated for malignant glioma.
Danish: Der forekom trombocytopeni og neutropeni af grad 3 eller 4 hos henholdsvis 19 % og 17 % af de patienter, som blev behandlet for malignt gliom.
English: Temozolomide is a triazene, which undergoes rapid chemical conversion at physiologic pH to the active monomethyl triazenoimidazole carboxamide (MTIC).
Danish: TMZ er et triazen, der hurtigt omdannes kemisk ved fysiologisk pH til det aktive monomethyltriazenoimidazolcarboxamid (MTIC).
English: Dry skin, pruritus
Danish: Tør hud, pruritus
English: - Be sure you review the dose with your health care provider each time you start a new cycle.
Danish: - Vær sikker på, at De er klar over hvilke dage, der er behandlingsdage - Husk at gennemgå dosis med lægen hver gang, De starter på en ny serie.
English: Cases of increased bilirubin, problems with bile flow (cholestasis), hepatitis and injury to the liver, including fatal liver failure, have been uncommonly reported.
Danish: Tilfælde af forhøjet bilirubin, problemer med ophobning af galde (kolestase), hepatitis (leverbetændelse) og leverskade, herunder dødelig leversvigt, er ikke almindeligt rapporteret.
English: If you take more Temozolomide Accord than you should If you accidentally take more capsules than you were told to, contact your doctor, pharmacist or nurse immediately.
Danish: Hvis De ved en fejltagelse tager flere kapsler, end De har fået besked på, skal De omgående kontakte lægen, apoteket eller sundhedspersonalet.
English: children from the age of three years, adolescents and adult patients with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy.
Danish: - børn fra 3 år, unge og voksne patienter med malignt gliom, såsom glioblastoma multiforme eller anaplastisk astrocytoma, der får recidiv eller progression efter standardbehandling.
English: Skin exfoliation, photosensitivity reaction, pigmentation abnormal
Danish: Hudeksfoliering, lysoverfølsomhedsreaktion, abnorm pigmentering
English: What you need to know before you take Temozolomide Accord
Danish: Det skal de vide, før De begynder at tage Temozolomide Accord
English: SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
Danish: EVENTUELLE SÆRLIGE FORHOLDSREGLER VED BORTSKAFFELSE AF IKKE ANVENDT LÆGEMIDDEL ELLER AFFALD FRA HERAF
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: Før behandlingen skal følgende krav til laboratorieparametre være opfyldt: ANC ≥ 1,5 x 109/l og trombocyttal ≥ 100 x 109/l.
English: • long or repeated fits, tremors or jerking movement, partial paralysis, difficulty with your coordination and balance, changes in sensation of touch
Danish: • langvarige eller gentagne kramper, rysten eller kastende bevægelser, delvis lammelse (partiel paralyse), koordinations- og balanceproblemer, forringet følefornemmelse
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: Det blev efterfulgt af monoterapi med TMZ (150 - 200 mg/m2) på dag 1 - 5 i hver 28-dags-serie i op til 6 serier, som startede 4 uger efter afsluttet RT.
English: If abnormal, physicians should assess the benefit/risk prior to initiating temozolomide including the potential for fatal hepatic failure.
Danish: Hvis disse er unormale, bør lægen vurdere fordel/risiko-forholdet før initiering af temozolomid-behandling herunder risikoen for letalt leversvigt.
English: Dermatitis, dry skin, erythema, pruritus
Danish: Dermatitis, tør hud, erytem, pruritus
English: Signs of allergic reaction include feeling itchy, breathlessness or wheezing, swelling of the face, lips, tongue or throat.
Danish: Tegnene på en allergisk reaktion kan være kløe, stakåndethed eller hvæsende vejrtrækning, hævelse i ansigtet, på læberne, tungen eller i halsen.
English: Do not take Temozolomide Accord - if you are allergic to temozolomide or any of the other ingredients of this medicine (listed in section 6).
Danish: - hvis De er allergisk over for temozolomideller et af de øvrige indholdsstoffer i denne medicin (angivet i pkt.
English: • infection of the middle ear, pain or discomfort in the ears from loud noises, earache, deafness,
Danish: • mellemørebetændelse, smerte eller ubehag i ørerne på grund af kraftig støj, øresmerter, døvhed,
English: New or reactivated (recurring) cytomegalovirus infections and reactivated hepatitis B virus infections have been uncommonly reported.
Danish: Der er rapporteret nye eller tilbagevendende cytomegalovirusinfektioner og tilbagevendende hepatitis B-virusinfektioner med hyppigheden ”ikke almindelig”.
English: • sexual impotence, vaginal bleeding, absent or heavy menstrual periods, vaginal irritation, breast pain,
Danish: • impotens, blødning fra skeden, udeblivende eller kraftige menstruationer, irritation af skeden,
English: Temozolomide is first used together with radiotherapy (concomitant phase of treatment) and after that alone (monotherapy phase of treatment).
Danish: Temozolomid bruges først sammen med strålebehandling (behandlingsfase med samtidig behandling) og derefter alene (behandlingsfase med monoterapi).
English: Infections including agents causing pneumonia.
Danish: Infektioner, herunder infektioner, som skyldes bakterier eller virus, som kan forårsage lungebetændelse.
English: Do not use this medicine after the expiry date which is stated on the label and carton.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Pneumonia, sinusitis, upper respiratory infection, bronchitis
Danish: Pneumoni, sinusitis, øvre luftvejsinfektion, bronchitis
English: Errors in how you take this medicine may have serious health consequences.
Danish: Det kan få alvorlige følger for Deres helbred, hvis De tager medicinen forkert.
English: Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Danish: Ikke anvendt lægemiddel samt affald heraf skal bortskaffes i henhold til lokale retningslinier.
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 eventfri overlevelse efter 6 måneder for intent to treat (ITT)-populationen var 44 % med en median eventfri overlevelse på 4,6 måneder.
English: Ear and labyrinth disorders Common:
Danish: Øre og labyrint Almindelig:
English: Temozolomide is an anti-cancer medicine.
Danish: Denne medicin er et middel mod kræftsvulster.
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 %) end i procarbazingruppen (44 %) (chisquare p = 0,019).
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: Patienterne, der var i den gruppe, der modtog TMZ + RT, fik konkomitant TMZ (75 mg/m2) én gang dagligt i 42 dage fra den første indtil den sidste RTsdag (højst i 49 dage).
English: • change in your sense of smell
Danish: • ændringer i lugtesansen
English: After oral administration of 14C-labelled TMZ, mean faecal excretion of 14C over 7 days post-dose was 0.8%
Danish: Efter oral administration af 14Cmærket TMZ var den gennemsnitlige, fækale udskillelse af 14C-mærket TMZ 7 dage efter indgiften
English: If vomiting occurs after the dose is administered, a second dose should not be administered that day.
Danish: Hvis der forekommer opkastning efter dosis er taget, må næste dosis ikke tages samme dag.
English: Dose in Cycle 1 (monotherapy) is 150 mg/m2 once daily for 5 days followed by 23 days without treatment.
Danish: Dosis i serie 1 (monoterapi) er 150 mg/m2 én gang dagligt i 5 dage efterfulgt af 23 dage uden behandling.
English: The pharmacokinetics of TMZ were comparable in patients with normal hepatic function and in those with mild or moderate hepatic impairment.
Danish: TMZs farmakokinetik var sammenlignelig for patienter med normal leverfunktion og patienter med let til moderat leverinsufficiens.