FrancophonIA/ELRC3.0 huggingface dataset:
English: This daily dose depends on whether or not you have received chemotherapy before.
Danish: Denne daglige dosis afhænger af, om du tidligere har modtaget kemoterapi.
English: Paediatric population Interaction studies have only been performed in adults.
Danish: Interaktionsstudier er kun udført hos voksne.
English: The following additional serious adverse reactions have been identified during post-marketing exposure:
Danish: Følgende yderligere alvorlige bivirkninger er identificeret efter markedsføring:
English: Infection, candidiasis oral
Danish: Infektion, oral candidiasis
English: Tolerance to TMZ is similar to adults.
Danish: Tolerancen over for TMZ er som hos voksne.
English: Žižkova 22B,
Danish: - organizačná zložka Žižkova 22B,
English: TMZ is more toxic to the rat and dog than to humans, and the clinical dose approximates the minimum lethal dose in rats and dogs.
Danish: TMZ er mere toksisk for rotter og hunde end for mennesker, og den kliniske dosis nærmer sig den mindste letale dosis hos rotter og hunde.
English: Do not use this medicine after the expiry date which is stated on the label and carton after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen efter ”Exp”.
English: As it cannot be excluded that the change in Cmax is clinically significant, Temozolomide Sandoz should be administered without food.
Danish: Da det ikke kan udelukkes, at ændringen i Cmax er klinisk signifikant, bør Temozolomide Sandoz indgives uden føde.
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: There are no data in pregnant women.
Danish: Der foreligger ingen data om anvendelse til gravide.
English: Tell your pharmacist if you notice any change in the appearance of the capsules.
Danish: Underret en farmaceut, hvis du bemærker et ændret udseende af kapslerne.
English: • anxiety/depression
Danish: • angst/depression
English: recurs after dose reduction.
Danish: vender tilbage efter dosisreduktion.
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 retinal degeneration.
English: If use during pregnancy must be considered, the patient should be apprised of the potential risk to the foetus.
Danish: Hvis anvendelse under graviditet bør overvejes, skal patienten informeres om den potentielle risiko for fostret.
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 for hændelsesfri overlevelse på 4,6 måneder, hvilket var i lighed med resultaterne for den progressionsfri overlevelse.
English: The median PFS was 5.4 months.
Danish: Medianen for PFS var 5,4 måneder.
English: Your doctor will check your blood to make sure you have enough of these cells before you begin treatment.
Danish: Din læge vil tjekke dit blod for at sikre, at du har nok af disse celler, før behandlingen påbegyndes.
English: Plasma clearance, volume of distribution and half-life are independent of dose.
Danish: Plasmaclearance, fordelingsvolumen og halveringstid er uafhængige af dosis.
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 frekvens.
English: Contact your doctor immediately if you have any of the following:
Danish: Kontakt øjeblikkeligt din læge, hvis du oplever noget af følgende:
English: Side effects from clinical studies:
Danish: Bivirkninger fra kliniske studier:
English: Liver toxicity may occur several weeks or more after the last treatment with temozolomide.
Danish: Levertoksicitet kan forekomme flere uger eller mere efter sidste behandling med temozolomid.
English: ALT increased
Danish: Forhøjet ALT
English: Hard capsule (capsule).
Danish: Hård kapsel (kapsel).
English: • as you should be observed closely for the development of a serious form of chest infection called Pneumocystis jirovecii pneumonia (PCP).
Danish: • da du skal observeres tæt for udviklingen af en alvorlig form for lungebetændelse kaldet Pneumocystis jirovecii pneumoni (PCP).
English: Patients will be carefully checked by their doctor for signs of this infection before treatment is started.
Danish: Patienter vil blive grundigt undersøgt af egen læge for tegn på denne infektionstype før behandlingen påbegyndes.
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: Eksperter i leversygdomme bør konsulteres før behandling påbegyndes af patienter med positiv hepatitis B-serologi (herunder patienter med aktiv sygdom).
English: In both trials, the primary endpoint was progression-free survival (PFS) defined by MRI scans or neurological worsening.
Danish: I begge forsøg var det primære endpoint progressionsfri overlevelse (PFS) defineret ved MRI-scanning eller neurologisk forværring.
English: Dose-limiting toxicity was haematological and was reported with any dose but is expected to be more severe at higher doses.
Danish: Den dosisbegrænsende toksicitet var hæmatologisk og blev rapporteret med en hvilken som helst dosis, men forventes at være alvorligere ved højere doser.
English: Oral use Read the package leaflet before use.
Danish: Oral anvendelse Læs indlægssedlen inden brug.
English: Each one lasts 28 days.
Danish: Hver kan vare op til 28 dage.
English: • if you have ever had or might now have a hepatitis B infection.
Danish: • hvis du nogensinde har fået konstateret eller på nuværende tidspunkt har en hepatitis Binfektion.
English: Depending on your blood test results, your doctor may adjust your dose for the next cycle.
Danish: Afhængig af resultaterne af blodprøverne vil din læge justere dosen til næste cyklus.
English: See package leaflet for further information.
Danish: Se indlægssedlen for yderligere oplysninger.
English: This medicinal product contains lactose.
Danish: Dette lægemiddel indeholder lactose.
English: Baseline liver function tests should be performed prior to treatment initiation.
Danish: Der bør foretages baseline-leverfunktionsprøver før initiering af behandling.
English: In this case, do not drive or use any tools or machines or cycle until you see how this medicine affects you (see section 4).
Danish: I så fald må du ikke køre bil/motorcykel eller cykle eller arbejde med værktøj eller maskiner, før du ved, hvordan dette lægemiddel påvirker dig (se pkt.
English: This leaflet was last revised in <{MM/YYYY}>.
Danish: Denne indlægsseddel blev senest ændret <{MM/ÅÅÅÅ}>.
English: • allergic reactions.
Danish: • allergiske reaktioner.
English: Then, you will start the monotherapy phase.
Danish: Derefter skal du påbegynde monoterapi-fasen.
English: The incidence of severe nausea and vomiting was 4 %.
Danish: Hyppigheden af alvorlig kvalme og opkastning var 4 %.
English: Hearing impairment, tinnitus
Danish: Nedsat hørelse, tinnitus
English: Median overall survival was 14.6 months.
Danish: Medianen for den samlede overlevelse var 14,6 måneder.
English: The following side effects may occur, and may require medical attention.
Danish: Følgende bivirkninger kan opstå og kan kræve lægebehandling.
English: • increased sugar in the blood
Danish: • øget sukkerindhold i blodet
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: Responsraten, baseret på den centrale reviewers vurdering, var 35 % (13 CR og 43 PR) for intent-totreat populationen (ITT) n=162.
English: Meningoencephalitis herpetic
Danish: Meningoencephalitis herpetica
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 1-2 uger.
English: No studies have been conducted to determine the effect of TMZ on the metabolism or elimination of other medicinal products.
Danish: Der er ikke udført forsøg til bestemmelse af TMZ's effekt på metabolisering eller elimination af andre lægemidler.
English: This includes any possible side effects not listed in this leaflet.
Danish: Dette gælder også mulige bivirkninger, som ikke fremgår af denne indlægsseddel.
English: Store in the original package.
Danish: Opbevares i den originale yderpakning.
English: For patients on a 42 day treatment cycle liver function tests should be repeated midway during this cycle.
Danish: Hos patienter, der behandles med en 42-dages cyklus, bør leverfunktionsprøverne gentages midtvejs i denne cyklus.
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 hvis du udvikler dem under behandlingen.
English: • red spots under the skin
Danish: • røde pletter under huden
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: 1 capsule
Danish: 1 kapsel
English: Hallucination, amnesia
Danish: Hallucination, amnesi
English: The presence of thrombocytopenia may increase the risk of bleeding, and the presence of neutropenia or leukopenia may increase the risk of infection.
Danish: Tilstedeværelsen af trombocytopeni kan øge risiko for blødning, og tilstedeværelsen af neutropeni eller leukopeni kan øge risiko for infektion.
English: In this case, your doctor will also prescribe medicine to help you prevent this type of pneumonia (PCP).
Danish: I så fald vil din læge også udskrive medicin, der kan hjælpe med at forebygge denne form for lungebetændelse.
English: Dose-related 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: Patients who have experienced severe (Grade 3 or 4) vomiting in previous treatment cycles may require anti-emetic therapy.
Danish: Patienter, der har haft alvorlige (grad 3 eller 4) opkastninger i tidligere behandlingsserier, kan have behov for antiemetisk behandling.
English: Hypersensitivity to dacarbazine (DTIC).
Danish: Overfølsomhed over for decarbazin (DTIC).
English: This is because you must not be treated with Temozolomide Sandoz during pregnancy unless clearly indicated by your doctor.
Danish: Det skyldes, at du ikke må tage Temozolomide Sandoz under graviditet, medmindre det er klart angivet af din læge.
English: There may be a higher occurrence of PCP when TMZ is administered during a longer dosing regimen.
Danish: Der kan være en højere forekomst af PCP, når TMZ anvendes i et længere dosisregimen.
English: There are reports of patients who have taken the recommended dose for more than 5 days of treatment (up to 64 days) with adverse events reported including bone marrow suppression, with or without infection, in some cases severe and prolonged and resulting in death.
Danish: Der er rapporteret om patienter, som har taget den anbefalede dosis i mere end de 5 behandlingsdage (op til 64 dage) med rapporterede bivirkninger, som inkluderede knoglemarvssuppression med eller uden infektion, i nogle tilfælde alvorlige og langvarige og resulterende i dødsfald.
English: TMZ demonstrates low protein binding (10 % to 20 %), and thus it is not expected to interact with highly protein-bound substances.
Danish: TMZ har en lav proteinbinding (10 % til 20 %) og forventes derfor ikke at interagere med stærkt proteinbundne stoffer.
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) ) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines webportal.
Danish: Indehaveren af markedsføringstilladelsen skal fremsende (PSUR'er) for dette lægemiddel i overensstemmelse med kravene på listen over EU-referencedatoer (EURD list) som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF og offentliggjort på den europæiske webportal for lægemidler.
English: Concomitant phase
Danish: Konkomitant fase
English: Recurrent anaplastic astrocytoma
Danish: Tilbagevendende anaplastisk astrocytom
English: For any information about this medicinal product, 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 for indehaveren af markedsføringstilladelsen:
English: • The active substance is temozolomide.
Danish: • Aktivt stof: temozolomid.
English: Rats appear to be particularly sensitive to oncogenic effects of TMZ, with the occurrence of first tumours within 3 months of initiating dosing.
Danish: Rotter synes at være særligt følsomme over for de onkogene virkninger af TMZ med forekomst af de første tumorer inden for 3 måneder efter dosisstart.
English: TMZ administration can be continued throughout the 42 day concomitant period (up to 49 days) if all of the following conditions are met:
Danish: Indgift af TMZ kan fortsættes under den konkomitante periode på 42 dage (i op til 49 dage), hvis alle de følgende betingelser er opfyldt:
English: toxic epidermal necrolysis, Stevens-Johnson syndrome
Danish: Toksisk epidermal nekrolyse, Stevens-Johnson syndrom
English: If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge eller apotekspersonalet til råds, før du tager dette lægemiddel.
English: If lymphopenia occurs, they are to continue the prophylaxis until recovery of lymphopenia to grade ≤ 1.
Danish: Hvis der forekommer lymfopeni, skal de fortsætte den forebyggende behandling, indtil bedring af lymfopeni til grad ≤ 1.
English: • sexual impotence
Danish: • seksuel impotens
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; CSF-eksponering baseret på AUC for TMZ var cirka 30 % i forhold til plasma, hvilket er konsistent med data fra dyr.
English: Your doctor may decide to reduce the dose, interrupt, stop or change your treatment.
Danish: Din læge kan i alvorlige tilfælde være nødsaget til at mindske dosis af din medicin, afbryde, stoppe eller ændre din behandling.
English: • high blood pressure
Danish: • højt blodtryk
English: Dose during Cycles 2-6 in absence of toxicity
Danish: Dosis under serie 2-6 ved fravær af toksicitet
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: If Temozolomid Sandoz comes into contact with skin or mucosa, it should be washed immediately and thoroughly with soap and water.
Danish: Hvis Temozolomide Sandoz kommer i kontakt med hud eller slimhinder bør området straks vaskes grundigt med sæbe og vand.
English: TMZ monotherapy n=224
Danish: TMZ monoterapi n=224
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 indtaget din dosis, skal du ikke tage en anden dosis samme dag.
English: • cough • infections including pneumonia.
Danish: • hoste • infektioner herunder lungebetændelse.
English: Not known drug reaction with eosinophilia and systemic symptoms (DRESS)
Danish: Lægemiddelfremkaldt reaktion med eosinofili og systemiske symptomer (DRESS)
English: TMZ is an embryotoxic, teratogenic and genotoxic alkylating agent.
Danish: TMZ er et embryotoksisk, teratogent og genotoksisk alkyleringsmiddel.
English: Post-Marketing experience
Danish: Erfaring efter markedsføring
English: Cytotoxic lesions that develop subsequently are thought to involve aberrant repair of the methyl adduct.
Danish: Cytotoksiske læsioner, der udvikles efterfølgende, synes at involvere aberrant reparation af methyladduktet.
English: If the dose was not escalated at Cycle 2, escalation should not be done in subsequent cycles.
Danish: Hvis dosen ikke blev forøget ved serie 2, bør stigning ikke ske i de følgende serier.
English: During treatment a complete blood count should be obtained on Day 22 (21 days after the first dose of TMZ).
Danish: Under behandlingen bør en komplet blodundersøgelse foretages på dag 22 (21 dage efter den første dosis af TMZ).
English: If you accidentally get some in your eyes or nose, flush the area with water.
Danish: Hvis du ved et uheld får noget på huden, i øjnene eller næsen, skal området skylles med vand.
English: For patients with significant liver function abnormalities, physicians should assess the benefit/risk of continuing treatment.
Danish: Hos patienter med signifikant unormal leverfunktion bør lægen vurdere fordel/risiko-forholdet ved fortsat behandling.
English: A treatment cycle with Temozolomide Sandoz lasts 28 days.
Danish: En behandlingscyklus med Temozolomide Sandoz varer 28 dage.
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: Anti-emetic prophylaxis is recommended prior to the initial dose of concomitant phase and it is strongly recommended during the monotherapy phase.
Danish: Antiemetisk forebyggelse anbefales før den initiale dosis i den konkomitante fase, og det anbefales kraftigt under monoterapifasen.
English: Temozolomide Sandoz should not be administered to pregnant women.
Danish: Temozolomide Sandoz bør ikke anvendes til gravide kvinder.
English: The lowest recommended dose is 100 mg/m2.
Danish: Den lavest anbefalede dosis er 100 mg/m2.
English: Use of TMZ in combination with other myelosuppressive agents may increase the likelihood of myelosuppression.
Danish: Anvendelse af TMZ i kombination med andre myelosuppresserende lægemidler kan øge risikoen for myelosuppresion.
English: Anti-emetic therapy may be administered prior to or following administration of TMZ.
Danish: Antiemetisk behandling kan anvendes før eller efter administration af TMZ.
English: Other side effects:
Danish: Andre bivirkninger:
English: (usual dose).You will take this dose every day for 42 days (up to 49 days) in combination with radiotherapy.
Danish: Du skal tage denne dosis hver dag i 42 dage (i op til 49 dage) i kombination med strålebehandling.
English: Elderly patients appear to be at increased risk of neutropenia and thrombocytopenia, compared with younger patients.
Danish: Ældre patienter synes at have større risiko for at udvikle neutropeni og trombocytopeni sammenlignet med yngre patienter.
English: This may cause you to have increased bruising or bleeding, anaemia (a shortage of red blood cells), fever, and reduced resistance to infections.
Danish: Det kan betyde, at du lettere får blå mærker eller blødning, anæmi (mangel på rødeblodlegemer), feber og nedsat modstandskraft over for infektioner.
English: If you are a newly-diagnosed patient (glioblastoma multiforme) you may be receiving Temozolomide Sandoz for 42 days in combination with radiotherapy.
Danish: Hvis du er en nydiagnosticeret patient (glioblastoma multiforme), får du muligvis Temozolomide Sandoz i 42 dage i kombination med strålebehandling.
English: Reduce TMZ by 1 dose levela
Danish: Reducer TMZ med 1 dosisniveaua
English: Type III amber glass bottle with polypropylene child-resistant closure containing 5 or 20 hard capsules.
Danish: Type III-flasker af brunt glas med børnesikret polypropylen-låg indeholdende 5 eller 20 hårde kapsler.
English: In the non-comparative 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 det non-komparative forsøg var PFS efter 6 måneder 19 %, median progressiv overlevelse var 2,1 måneder, og median samlet overlevelse 5,4 måneder.
English: This is because temozolomide could cause hepatitis B to become active again, which can be fatal in some cases.
Danish: Dette skyldes, at temozolomid kan forårsage reaktivering af hepatitis B, hvilket i visse tilfælde kan være dødeligt.
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 retinal degeneration imidlertid lå i området for de dødelige doser, og ingen sammenlignelig effekt er set i kliniske undersøgelser, blev dette fund ikke betragtet som værende klinisk relevant.
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: Dataene vedrørende tiden til forværring af neurologisk status var bedre for TMZ end for procarbazin, ligesom dataene vedrørende tiden til forværring af performance status (reduktion til en KPS på < 70 eller en reduktion på mindst 30 point).
English: Cases of diabetes insipidus have been uncommonly reported.
Danish: Tilfælde af diabetes insipidus er blevet rapporteret som værende ualmindelige.
English: Infections and infestations*
Danish: Infektioner og infestationer*
English: In some cases, it may be necessary to stop treatment with Temozolomide Sandoz.
Danish: I nogle tilfælde kan det være nødvendigt at stoppe behandlingen med Temozolomide Sandoz.
English: Temozolomide Sandoz is used in these tumours if they return or get worse after standard treatment.
Danish: Temozolomide Sandoz bruges til behandling af disse svulster, hvis de vender tilbage eller bliver værre efter standardbehandlingen.
English: There is limited information in patients over 3 years of age who have taken Temozolomide Sandoz.
Danish: Der foreligger begrænset information om børn over 3 år, der har fået Temozolomide Sandoz.
English: • palpitations (when you can feel your heart beat)
Danish: • hjertebanken (du kan mærke dit hjerte slå)
English: However, since TMZ does not undergo hepatic metabolism and exhibits low protein binding, it is unlikely that it would affect the pharmacokinetics of other medicinal products (see section 5.2).
Danish: Da TMZ imidlertid ikke metaboliseres i leveren samt udviser lav proteinbinding, er det usandsynligt, at det vil påvirke andre lægemidlers farmakokinetik (se pkt.
English: Salutas Pharma GmbH Otto-von-Guericke-Allee 1 D-39179 Barleben Germany
Danish: Salutas Pharma GmbH Otto-von-Guericke-Allee 1 D-39179 Barleben Tyskland
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 mave-tarmkanalen, særligt kvalme (43 %) og opkastninger (36 %).
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-forsøg hos mennesker samt prækliniske data tyder på, at TMZ hurtigt passerer blod-hjernebarrieren og er til stede i CSF.