FrancophonIA/ELRC3.0 huggingface dataset:
English: It can also be used with cisplatin (another anticancer medicine) in patients who have not yet received any treatment for their cancer;
Danish: Det kan også anvendes i kombination med cisplatin (et andet lægemiddel til behandling af kræft) hos patienter, som ikke tidligere er blevet behandlet for deres kræftsygdom.
English: What is Docefrez?
Danish: Hvad er Docefrez?
English: For more information, see the Summary of Product Characteristics.
Danish: De nærmere oplysninger fremgår af produktresuméet.
English: How has Docefrez been studied?
Danish: Hvordan blev Docefrez undersøgt?
English: What is Docefrez used for?
Danish: Hvad anvendes Docefrez til?
English: Dexamethasone (an anti-inflammatory medicine) should also be given to the patient, starting on the day before the Docefrez infusion.
Danish: Dagen før infusionen af Docefrez gives desuden dexamethason (et antiinflammatorisk lægemiddel) til patienten.
English: How is Docefrez used?
Danish: Hvordan anvendes Docefrez?
English: How does Docefrez work?
Danish: Hvordan virker Docefrez?
English: Submission of final study report.
Danish: Indsendelse af endelig studierapport.
English: Glivec can help you to fight this condition.
Danish: Glivec kan hjælpe dig med at bekæmpe denne tilstand.
English: Date of first authorisation: 07 November 2001 Date of latest renewal: 07 November 2006
Danish: Dato for første markedsføringstilladelse: 7. november 2001 Dato for seneste fornyelse: 7. november 2006
English: Risk criteria
Danish: Risikokriterier
English: They contain a white to yellow powder.
Danish: De indeholder et hvidt til gulligt pulver.
English: 12 months 24 months 36 months 48 months 60 months Survival 36 months 48 months 60 months
Danish: 12 måneder 24 måneder 36 måneder 48 måneder 60 måneder Overlevelse 36 måneder 48 måneder 60 måneder
English: • Do not use this medicine after the expiry date which is stated on the carton after EXP.
Danish: • Brug ikke lægemidlet efter den udløbsdato, der står på pakningen efter EXP.
English: 4 cycles
Danish: 4 cyklus
English: Glivec should not be used during pregnancy unless clearly necessary.
Danish: Glivec bør ikke anvendes under graviditeten, medmindre det er klart nødvendigt.
English: Glivec may do the same to some other medicines.
Danish: Glivec kan gøre det samme ved andre lægemidler.
English: When and how to take Glivec - Take Glivec with a meal.
Danish: Hvornår og hvordan skal du tage Glivec - Tag Glivec sammen med et måltid.
English: Therefore, the use of Glivec in combination requires special precaution.
Danish: Brug af Glivec i denne kombination kræver derfor særlig forsigtighed.
English: Probability of overall survival
Danish: Sandsynlighed for overall survival
English: Survival time in months
Danish: Overlevelsestid i måneder
English: While you are taking Glivec, your doctor will regularly check whether the medicine is working.
Danish: Mens du tager Glivec, vil din læge regelmæssigt kontrollere, om lægemidlet virker.
English: They have “glivec” on one side.
Danish: De er præget med ”glivec” på den ene side.
English: Your doctor has prescribed Glivec because you suffer from a serious condition.
Danish: Din læge har udskrevet Glivec, fordi du lider af en alvorlig sygdom.
English: The Kaplan-Meier estimate for survival after 36-month follow-up is 68%.
Danish: Kaplan-Meier estimatet for overlevelse efter 36 måneders opfølgning er 68%.
English: Complete response Partial response Stable disease Progressive disease Not evaluable Unknown
Danish: Komplet respons Partielt respons Stabil sygdom Progressiv sygdom Kan ikke vurderes Ukendt
English: If you forget to take Glivec - If you forget a dose, take it as soon as you remember.
Danish: Hvis du har glemt at tage Glivec - Hvis du glemmer at tage en dosis, så tag den, så snart du kommer i tanker om det.
English: Glivec can reduce the number of white blood cells, so you might get infections more easily.
Danish: Glivec kan nedsætte antallet af hvide blodlegemer, så du lettere kan få infektioner.
English: Return to chronic phase (RTC)
Danish: Remission til kronisk fase (RTC)
English: RFS rates (%) 12 month 24 month
Danish: RFS rater (%) 12 måneder 24 måneder
English: The translocation t(17:22)[(q22:q13)], or its gene product, was present in nearly all responders to Glivec treatment.
Danish: Translokationen t(17:22) [(q22:q13)], eller dets gen-produkt, var til stede i næsten alle respons på Glivec-behandling.
English: - Glivec is not recommended during pregnancy unless clearly necessary as it may harm your baby.
Danish: - Glivec anbefales ikke under graviditeten, medmindre det er strengt nødvendigt, da det kan skade din baby.
English: Do not stop taking Glivec unless your doctor tells you to.
Danish: Du må ikke stoppe med at tage Glivec, medmindre din læge fortæller dig det.
English: When needed, discontinuation of Glivec treatment may be considered.
Danish: Om nødvendigt kan det overvejes at ophøre med Glivec-behandling.
English: Table 6 Best tumour response in trial STIB2222 (GIST)
Danish: Tabel 6 Bedste tumorrespons i undersøgelse STIB2222 (GIST)
English: AST: >ULN (can be normal or <ULN if total bilirubin is >ULN)
Danish: ASAT: >ULN (kan være normal eller <ULN hvis total-bilirubin er >ULN)
English: In all clinical studies 38-40% of patients were  60 years of age and 10-12% of patients were  70 years of age.
Danish: I de kliniske undersøgelser var 38-40% af patienterne 60 år, og 10-12% af patienterne var 70 år.
English: Some children and adolescents taking Glivec may have slower than normal growth.
Danish: Nogle børn og unge, der får Glivec, kan vokse langsommere end normalt.
English: Accelerated phase: 235 adult patients with accelerated phase disease were enrolled.
Danish: Accelereret fase: Der inkluderedes 235 voksne patienter med accelereret sygdomsfase.
English: Frequency categories are defined using 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), not known (cannot be estimated from the available data).
Danish: Frekvenskategorier er defineret ved brug af 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), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: The mechanism and relevance of these findings in the rat carcinogenicity study for humans are not yet clarified.
Danish: Mekanismen og betydningen for mennesker af disse resultater i karcinogenicitetsstudie hos rotter er endnu ikke afklaret.
English: IU/week and were all in late chronic phase, with a median time from diagnosis of 32 months.
Danish: IU/uge og var alle i sen kronisk fase med en gennemsnitlig tid siden diagnose på 32 måneder.
English: The results of subgroup analyses according to the United States National Institutes of Health (NIH) and the Armed Forces Institute of Pathology (AFIP) risk classifications are shown in Table 7.
Danish: Resultaterne fra undergruppen-analysen, der blev vurderet ved risikoklassifikationer ifølge the United States National Institutes of Health (NIH) og the Armed Forces Institute of Pathology (AFIP), er vist i Tabel 7.
English: Do not take Glivec: - if you are allergic to imatinib or any of the other ingredients of this medicine (listed in section 6).
Danish: Tag ikke Glivec: - hvis du er allergisk over for imatinib eller et af de øvrige indholdsstoffer i Glivec (angivet i afsnit 6).
English: Results are provided in Table 6.
Danish: Resultaterne er angivet i Tabel 6.
English: You may become more sensitive to the sun while taking Glivec.
Danish: Du kan blive mere følsom overfor sollys, når du tager Glivec.
English: This is because Glivec could cause hepatitis B to become active again, which can be fatal in some cases.
Danish: Dette skyldes, at Glivec kan forårsage, at hepatitis B-infektionen bliver aktiv igen, hvilket undertiden kan være dødeligt.
English: Complete blood counts must be performed regularly during therapy with Glivec.
Danish: Fuldstændige blodtællinger skal foretages jævnligt under behandling med Glivec.
English: See the end of section 4 for how to report side effects
Danish: Se sidst i afsnit 4, hvordan du indberetter bivirkninger.
English: Glivec is indicated for
Danish: Glivec er indiceret til
English: If it is used during pregnancy, the patient must be informed of the potential risk to the foetus.
Danish: Hvis Glivec anvendes under graviditet, skal patienten informeres om den potentielle risiko for fostret.
English: Caution should therefore be exercised when using high doses of Glivec and paracetamol concomitantly.
Danish: Der rådes derfor til forsigtighed, når høje doser Glivec og paracetamol anvendes samtidig.
English: When Glivec is co-administered with other medicinal products, there is a potential for drug interactions.
Danish: Når Glivec administreres sammen med andre lægemidler, er der risiko for lægemiddelinteraktioner.
English: Resume treatment with Glivec at previous dose (i.e. before severe adverse reaction).
Danish: Genoptag Glivec-behandlingen ved den tidligere dosis (dvs. før svære bivirkninger).
English: At-risk : Events
Danish: Risiko : Tilfælde
English: They may increase or decrease the effect of Glivec, either leading to increased side effects or making Glivec less effective.
Danish: De kan enten øge eller nedsætte virkningen af Glivec, hvilket kan resultere i enten flere bivirkninger, eller de kan gøre Glivec mindre virksomt.
English: * These types of reactions have been reported mainly from post-marketing experience with Glivec.
Danish: * Denne type bivirkninger er hovedsageligt blevet rapporteret efter markedsføring af Glivec.
English: Probability of recurrence-free survival
Danish: Sandsynlighed for recidivfri overlevelse
English: It is important to cover sun-exposed areas of skin and use sunscreen with high sun protection factor (SPF).
Danish: Det er vigtigt at dække de områder af huden, som udsættes for solen, og at bruge solcreme med høj solbeskyttelsesfaktor (SPF).
English: Patients should be tested for HBV infection before initiating treatment with Glivec.
Danish: Patienten bør testes for HBV-infektion før initiering af behandling med Glivec.
English: Glivec is also a treatment for children with CML.
Danish: Glivec bruges også til behandling af børn med CML.
English: The median time of follow-up was 54 months (from date of randomisation to data cut-off), with a total of 83 months between the first patient randomised and the cut-off date.
Danish: Mediantiden til follow-up var 54 måneder (fra dato for randomisering til data cut-off) med i alt 83 måneder mellem den første randomiserede patient og cut-off datoen.
English: The estimated 4-year OS in cohort 5-patients was 83.6% compared to 44.8% in the historical controls.
Danish: Den estimerede 4-års OS hos kohorte 5patienter var 83,6% sammenlignet med 44,8% i den historiske kontrolgruppe.
English: Table 2 Response in newly diagnosed CML Study (84-month data)
Danish: Tabel 2 Respons i undersøgelsen vedrørende nydiagnosticeret CML (84 måneders data)
English: The risk of recurrence was thus reduced by approximately 89% as compared with placebo (hazard ratio = 0.113
Danish: Risikoen for tilbagefald var således reduceret med ca. 89% sammenlignet med placebo (hazard ratio =
English: Glivec treatment induces a rapid response in newly diagnosed paediatric CML patients with a CHR of 78% after 8 weeks of therapy.
Danish: Glivec-behandling inducerer et hurtigt respons hos nydiagnosticerede pædiatriske CML-patienter med en CHR hos 78% efter 8 ugers behandling.
English: If you have any questions about how Glivec works or why this medicine has been prescribed for you, ask your doctor.
Danish: Hvis du har spørgsmål om, hvordan Glivec virker, eller hvorfor du har fået ordineret dette lægemiddel, kontakt din læge.
English: The degree of cytogenetic response and molecular response had a clear effect on long-term outcomes in patients on Glivec.
Danish: Graden af cytogenisk respons og molekylært respons havde en klar effekt på langtidsudfaldet for patienter i Glivec-behandling.
English: This will help protect you from stomach problems when taking Glivec.
Danish: Dette vil hjælpe med at beskytte dig mod maveproblemer, når du tager Glivec.
English: Glivec will only be prescribed to you by a doctor with experience in medicines to treat blood cancers or solid tumours.
Danish: Glivec vil kun blive ordineret til dig af en læge med erfaring i behandlingen af kræft i blodet eller kræftknuder.
English: They are supplied in packs containing 30 capsules.
Danish: De findes i pakninger med 30 kapsler.
English: Table 8 12-month and 36-month Glivec treatment (SSGXVIII/AIO Trial)
Danish: Tabel 8 12 måneders og 36 måneders Glivec-behandling (SSGXVIII/AIO forsøg)
English: Some medicines can interfere with the effect of Glivec when taken together.
Danish: Nogle lægemidler kan påvirke virkningen af Glivec, når de bruges samtidigt.
English: Treatment with Glivec may then be continued at a reduced daily dose.
Danish: Behandling med Glivec kan da genoptages ved reduceret daglig dosis.
English: Overall hazard ratio (95%CI)*
Danish: Samlet hazard ratio (95%CI)*
English: They have “NVR” on one side and “SA” and a score line on the other side.
Danish: De er præget med ”NVR” på den ene side og ”SA” og en delekærv på den anden side.
English: The median duration of second-line treatment with Glivec was 64 months.
Danish: Medianvarigheden af andenlinjebehandling med Glivec var 64 måneder.
English: The duration of Glivec therapy can vary with the treatment programme selected, but generally longer exposures to Glivec have yielded better results.
Danish: Varigheden af behandling med Glivec kan variere med det valgte behandlingsprogram, men generelt har længere eksponering for Glivec givet de bedste resultater.
English: Blast crisis is defined as blasts  30% in blood or bone marrow or extramedullary disease other than hepatosplenomegaly.
Danish: Blastkrise defineres som 30% blaster i blod eller knoglemarv eller ekstramedullær sygdom ud over hepatosplenomegali.
English: Glivec is a medicine containing an active substance called imatinib.
Danish: Glivec er et lægemiddel, der indeholder et aktivt stof kaldet imatinib.
English: Chronic phase, Interferon failure: 532 adult patients were treated at a starting dose of 400 mg.
Danish: Kronisk fase; manglende effekt med Interferon: 532 voksne patienter blev behandlet med en startdosis på 400 mg.
English: Cytogenetic response Major response n (%) [95% CI]
Danish: Cytogenetisk respons Major respons n (%) [95% CI]
English: (1 h), days 28-31, 35-38, 42-45;
Danish: (1 time), dag 28-31, 35-38, 42-45;
English: Table 7 Summary of Z9001 trial RFS analyses by NIH and AFIP risk classifications
Danish: Tabel 7 Resumé af RFS-analyse for det kliniske forsøg Z9001 ved NIH og AFIP risikoklassifikationer
English: If anti-ADAMTS13-antibody is elevated in conjunction with low ADAMTS13 activity, treatment with Glivec should not be resumed.
Danish: Hvis niveauet af ADAMTS13-antistoffer er forøget samtidig med lav ADAMTS13-aktivitet, må behandlingen med Glivec ikke genoptages.
English: The amount of Glivec given will depend on your child's condition, body weight and height.
Danish: Antallet af Glivec-kapsler afhænger af barnets tilstand, kropsvægt og højde.
English: - if you experience bruising, bleeding, fever, fatigue and confusion when taking Glivec, contact your doctor.
Danish: - hvis du får blå mærker, blødninger, feber, træthed og oplever forvirring, mens du tager Glivec, skal du kontakte din læge.
English: 24 hard capsules 48 hard capsules 96 hard capsules 120 hard capsules 180 hard capsules
Danish: 24 hårde kapsler 48 hårde kapsler 96 hårde kapsler 120 hårde kapsler 180 hårde kapsler
English: Liver function (transaminases, bilirubin, alkaline phosphatase) should be monitored regularly in patients receiving Glivec.
Danish: Leverfunktionen (transaminaser, bilirubin og alkalisk fosfatase) bør monitoreres jævnligt hos patienter i Glivec-behandling.
English: Major cytogenetic response Complete (Confirmed
Danish: Cytogenetisk hovedrespons Fuldstændigt (Bekræftet
English: Experience with Glivec in this indication is very limited and is based on haematological and cytogenetic response rates.
Danish: Der er meget begrænset erfaring med Glivec ved denne indikation, og den er baseret på hæmatologiske og cytogenetiske responsrater.
English: • the adjuvant treatment of adult patients who are at significant risk of relapse following resection of Kit (CD117)-positive GIST.
Danish: • adjuverende behandling af voksne patienter, som har signifikant risiko for tilbagefald efter resektion af Kit (CD117)-positiv GIST.
English: Glivec 100 mg hard capsules Packs containing 24, 48, 96, 120 and 180 capsules.
Danish: Glivec 100 mg hårde kapsler Pakninger indeholdende 24, 48, 96, 120 og 180 kapsler.
English: The daily dose was escalated to 800 mg in a total of 103 patients; 6 patients achieved a partial response and 21 stabilisation of their disease after dose escalation for an overall clinical benefit of 26%.
Danish: Den daglige dosis blev optrappet til 800 mg hos et total på 103 patienter; 6 patienter opnåede delvist respons og 21 patienter opnåede stabilisering af deres sygdom efter optrapning af dosis med et overordnede klinisk fordel på 26%.
English: These events can usually be managed with either a reduction of the dose or an interruption of treatment with Glivec, but can in rare cases lead to permanent discontinuation of treatment.
Danish: Disse episoder kan sædvanligvis behandles med enten dosisreduktion eller seponering af Glivec, men kan i sjældne tilfælde medføre permanent seponering af behandlingen.
English: There have been post-marketing reports of spontaneous abortions and infant congenital anomalies from women who have taken Glivec.
Danish: Der har efter markedsføring været rapporter om spontane aborter og medfødte abnormaliteter hos spædbørn født af kvinder, som har taget Glivec.
English: However, these oedemas were rarely severe and may be managed with diuretics, other supportive measures, or by reducing the dose of Glivec.
Danish: Disse ødemer var dog sjældent svære og kunne behandles med diuretika, andre understøttende tiltag eller ved at reducere dosis af Glivec.
English: The yearly rates of progression of any type for Glivec also decreased over time.
Danish: Årlige frekvenser af enhver type progression blev reduceret over tid med Glivec.
English: If elevations in bilirubin > 3 x institutional upper limit of normal (IULN) or in liver transaminases > 5 x IULN occur, Glivec should be withheld until bilirubin levels have returned to < 1.5 x IULN and transaminase levels to < 2.5 x IULN.
Danish: Hvis der opstår stigninger i bilirubin >3 x IULN (institutional upper limit of normal) eller i levertransaminaser >5 x IULN, skal Glivec seponeres indtil bilirubinniveauerne er faldet til <1,5 x IULN og transaminaseniveauer til <2,5 x IULN.
English: Isolated cases of Glivec overdose have been reported spontaneously and in the literature.
Danish: Enkelte tilfælde af overdosering med Glivec er blevet spontant rapporteret i literaturen.
English: Glivec inhibits the growth of these cells.
Danish: Glivec hæmmer væksten af disse celler.
English: Imatinib did not interfere with the biotransformation of 5-fluorouracil, but it inhibited paclitaxel metabolism as a result of competitive inhibition of CYP2C8 (Ki = 34.7 µM).
Danish: Imatinib interfererede ikke med biotransformationen af 5-fluorouracil, men hæmmede paclitaxelmetabolismen på grund af kompetitiv hæmning af CYP2C8 (Ki = 34,7 µm).
English: Pharmacotherapeutic group: protein-tyrosine kinase inhibitor, ATC code: L01XE01
Danish: Farmakoterapeutisk klassifikation: Protein-tyrosinkinasehæmmer, ATC-kode: L01XE01
English: A further 6 DFSP patients treated with Glivec were reported in 5 published case reports, their ages ranging from 18 months to 49 years.
Danish: Yderligere seks patienter, behandlet med Glivec, er blevet beskrevet i 5 publicerede kasuistikker, alderen varierede fra 18 måneder til 49 år.
English: The effect of Glivec on the outcome of bone marrow transplantation has not been determined.
Danish: Glivecs effekt på resultatet af knoglemarvstransplantation er ikke blevet bestemt.
English: How long to take Glivec Keep taking Glivec every day for as long as your doctor tells you.
Danish: Hvor længe skal du tage Glivec Bliv ved med at tage Glivec hver dag, så længe som din læge har foreskevet det.
English: Studies on patients receiving Glivec and its effect on fertility and gametogenesis have not been performed.
Danish: Der er ikke udført studier med patienter, der fik Glivec, og dets virkning på fertilitet og gametogenese.
English: The primary evidence of efficacy was based on objective response rates.
Danish: Tegn på effekt baseredes primært på objektive responsrater.
English: However, since the effects of low-dose exposure of the infant to imatinib are unknown, women taking imatinib should not breastfeed.
Danish: Da effekten af lavdosiseksponering af imatinib hos spædbarnet er ukendt, bør kvinder, der tager imatinib, ikke amme.
English: Patients concerned about their fertility on Glivec treatment should consult with their physician.
Danish: Patienter, der bekymrer sig om deres fertilitet under Glivec-behandling, bør konsultere deres læge.
English: 21 patients were treated with Glivec 400 mg daily, while the other 3 patients received lower doses.
Danish: 21 patienter blev behandlet med 400 mg Glivec daglig, mens 3 patienter fik en lavere dosis.
English: Metabolism of Glivec is mainly hepatic, and only 13% of excretion is through the kidneys.
Danish: Glivec metaboliseres primært i leveren, og kun 13% udskilles via nyrerne.
English: Similar results were observed in patients with malignant gliomas treated with Glivec while taking enzyme-inducing anti-epileptic drugs (EIAEDs) such as carbamazepine, oxcarbazepine and phenytoin.
Danish: Lignende resultater blev observeret hos patienter med maligne gliomer behandlet med Glivec samtidig med indtagelse af enzyminducerende antiepileptiske lægemidler (EIAEDs) som carbamazepin, oxcarbazepin og phenytoin.
English: PVC/aluminium blisters
Danish: PVC/aluminium blister.
English: -- (1) Imatinib 12 MO:
Danish: -- (1) Imatinib 12 mdr.
English: 9/l (0102 and 0109
Danish: 9/l (kun 0102 og
English: If laboratory or clinical findings associated with TMA occur in a patient receiving Glivec, treatment should be discontinued and thorough evaluation for TMA, including ADAMTS13 activity and anti-ADAMTS13-antibody determination, should be completed.
Danish: Hvis laboratorie- eller kliniske fund associeret med TMA forekommer hos en patient, som er i behandling med Glivec, skal behandlingen seponeres og der skal foretages en grundig undersøgelse for TMA, inklusiv ADAMTS13-aktivitet og anti-ADAMTS13-antistofbestemmelse.
English: Glivec is indicated for the treatment of
Danish: Glivec er indiceret til behandling af
English: At 84 months the estimated overall survival is 86.4% (83, 90) vs. 83.3% (80, 87) in the randomised Glivec and the IFN+Ara-C groups, respectively (p=0.073, log-rank test).
Danish: Ved 84 måneder var den estimerede samlede overlevelse 86,4% (83, 90) vs. 83,3% (80, 87) i henholdsvis de randomiserede Glivec- og IFN+Ara-C-grupper (p=0,073, log-rank test).
English: The adult patients reported in the published literature were treated with either 400 mg (4 cases) or 800 mg (1 case) Glivec daily.
Danish: De voksne patienter, som er beskrevet i publiceret litteratur blev behandlet med enten 400 mg (fire tilfælde) eller 800 mg (et tilfælde) Glivec daglig.
English: The effect of Glivec treatment on survival in chronic phase, newly diagnosed CML has been further examined in a retrospective analysis of the above reported Glivec data with the primary data from another Phase III study using IFN+Ara-C (n=325) in an identical regimen.
Danish: Effekten af Glivec-behandling på overlevelse i kronisk fase, nyligt diagnostiseret CML er blevet yderligere undersøgt i en retrospektiv analyse af ovenstående rapporterede Glivec-data med primærdata fra et andet fase III-studie hvor IFN+Ara-C (n=325) blev anvendt i et tilsvarende behandlingsregime.
English: Figure 2 Kaplan-Meier estimates for overall survival (ITT population)
Danish: Figur 2 Kaplan-Meier-estimater for total overlevelse (ITT-population)