FrancophonIA/ELRC3.0 huggingface dataset:
English: The mechanism and relevance of these findings in the rat carcinogenicity study for humans are not yet clarified.
Danish: Mekanismen bag og betydningen for mennesker af disse resultater af carcinogenicitetsstudiet med rotter er endnu ikke afklaret.
English: Myeloid blast crisis: 260 patients with myeloid blast crisis were enrolled.
Danish: Myeloid blastkrise: Der blev inkluderet 260 patienter med myeloid blastkrise.
English: The median duration of therapy in study B2225 was 6.2 months, with a maximum duration of 24.3 months.
Danish: Den mediane varighed af behandlingen i studie B2225 var 6,2 måneder med en maksimum varighed på 24,3 måneder.
English: The liver was a target organ in rats and dogs.
Danish: Leveren var målorganet hos rotter og hunde.
English: If you think you may be allergic but are not sure, ask your doctor for advice.
Danish: Hvis du tror, du er allergisk, men ikke er sikker, skal du kontakte din læge for at få rådgivning.
English: Adverse reactions reported as more than an isolated case are listed below, by system organ class and by frequency.
Danish: Bivirkninger rapporteret med mere end et isoleret tilfælde er listet nedenfor efter organklasse og frekvens.
English: The active substance imatinib demonstrates an environmental risk for sediment organisms.
Danish: Det aktive stof imatinib viser en miljørisiko for sedimentlevende organismer.
English: The plasma AUC for this metabolite was found to be only 16 % of the AUC for imatinib.
Danish: Plasma AUC for denne metabolit blev kun fundet at være 16 % af AUC for imatinib.
English: The effect of stopping treatment after the achievement of a complete cytogenetic response has not been investigated.
Danish: Effekt af seponering af behandling efter opnåelse af komplet cytogenetisk respons er ikke undersøgt.
English: No patient developed grade 4 thrombocytopenia.
Danish: Ingen patienter udviklede grad 4 trombocytopeni.
English: When needed, discontinuation of imatinib treatment may be considered.
Danish: Om nødvendigt kan det overvejes at ophøre med imatinib-behandling.
English: The median duration of therapy in the published literature ranged between 4 weeks and more than 20 months.
Danish: Den mediane behandlingsvarighed i publiceret litteratur varierede mellem 4 uger og mere end 20 måneder.
English: Lymphoid blast crisis: a limited number of patients were enrolled in phase I studies (n = 10).
Danish: Lymfoid blastkrise: der inkluderedes et begrænset antal patienter i fase I undersøgelser (n = 10).
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 5-patienter var 83,6 % sammenlignet med 44,8 % i den historiske kontrolgruppe.
English: 20 out of the 50 (40 %) patients in cohort 5 received haematopoietic stem cell transplant.
Danish: 20 ud af 50 (40 %) patienter i kohorte 5 fik hæmatopoietisk stamcelletransplantation.
English: 11) Fatal cases have been reported in patients with advanced disease, severe infections, severe neutropenia and other serious concomitant conditions.
Danish: 11 Der er blevet rapporteret dødelige tilfælde hos patienter med fremskreden sygdom, alvorlige infektioner, alvorlig neutropeni og andre alvorlige, samtidige tilstande.
English: The first 37 patients were started at 400 mg, the protocol was subsequently amended to allow higher dosing and the remaining 223 patients were started at 600 mg.
Danish: De første 37 patienter startede med 400 mg, protokollen blev efterfølgende ændret og tillod højere doser, hvorefter de resterende 223 patienter startede med 600 mg.
English: SPECIAL STORAGE CONDITIONS Do not store above 30 ºC.
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Må ikke opbevares ved temperaturer over 30 °C.
English: Considering the limited safety database, the adverse events thus far reported in children are consistent with the known safety profile in adult patients with Ph+ ALL.
Danish: Under hensyntagen til den begrænsede sikkerhedsdatabase er de bivirkninger, der hidtil er rapporteret hos børn, i overensstemmelse med den kendte sikkerhedsprofil for voksne patienter med Ph+ ALL.
English: • if you are taking the medicine levothyroxine because your thyroid has been removed.
Danish: • hvis du tager medicin indeholdende levothyroxin, fordi din skjoldbruskkirtel er blevet fjernet.
English: No new target organs were identified in the rat juvenile development toxicology study (day 10 to 70 postpartum) with respect to the known target organs in adult rats.
Danish: Der blev ikke identificeret nye målorganer i i tokxikologistudiet af udviklingen hos unge rotter (dag 10-70 postpartum) vedrørende de kendte målorganer hos voksne rotter.
English: The preclinical safety profile of imatinib was assessed in rats, dogs, monkeys and rabbits.
Danish: Imatinibs prækliniske sikkerhedsprofil blev vurderet hos rotter, hunde, aber og kaniner.
English: The rate of haematological response was 70 % with a duration of 2-3 months.
Danish: Incidensen af hæmatologisk respons var 70 % med en varighed på 2-3 måneder.
English: 5, pharyngolaryngeal pain, pharyngitis
Danish: 5, faryngolaryngeale smerter, pharyngitis
English: Studies in two breast-feeding women revealed that both imatinib and its active metabolite can be distributed into human milk.
Danish: Studier med to ammende kvinder viste, at både imatinib og dets aktive metabolit kan udskilles i human mælk.
English: Non-neoplastic lesions not identified in earlier preclinical studies were the cardiovascular system, pancreas, endocrine organs and teeth.
Danish: Non-neoplastiske læsioner, som ikke er identificeret ved tidligere prækliniske studier, er i det kardiovaskulære system, pankreas, endokrine organer og tænder.
English: Total bilirubin: = 1.5 ULN AST: >ULN (can be normal or < ULN if total bilirubin is >ULN)
Danish: Total bilirubin = 1,5 ULN ASAT: > ULN (kan være normal eller < ULN, hvis total bilirubin er > ULN)
English: • Imatinib medac is not recommended during pregnancy unless clearly necessary as it may harm your baby.
Danish: • Imatinib medac anbefales ikke under graviditeten, medmindre det er strengt nødvendigt, da det kan skade din baby.
English: • if you have ever had or might now have a hepatitis B infection.
Danish: • hvis du nogensinde har været eller måske er smittet med hepatitis B-virus.
English: Leukaemia is a cancer of white blood cells.
Danish: Leukæmi er kræft i de hvide blodlegemer.
English: Patients will be carefully checked by their doctor for signs of this infection before treatment is started.
Danish: Lægen vil omhyggeligt kontrollere dig for tegn på denne infektion, før behandlingen påbegyndes.
English: Consolidation therapy I, III, V
Danish: Konsoliderende behandling I, III, V
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: This medicine works by inhibiting the growth of abnormal cells in the diseases listed below.
Danish: Dette lægemiddel virker ved at hæmme væksten af unormale celler ved de sygdomme, der er nævnt nedenfor.
English: Resume treatment with imatinib at previous dose (i.e. before severe adverse reaction).
Danish: Genoptag imatinib-behandlingen ved den tidligere dosis (dvs. før svære bivirkninger).
English: Out of the 12 patients enrolled, 9 responded, one completely and 8 partially.
Danish: Af de 12 inkluderede patienter responderede 9, en komplet og 8 partielt.
English: The rate of response was also higher in the patients treated at 600 mg (33 %) as compared to the patients treated at 400 mg (16 %, p = 0.0220).
Danish: Hovedresponsniveauet var også større hos patienter behandlet med 600 mg (33 %) sammenlignet med patienter behandlet med 400 mg (16 %, p = 0,0220).
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 25 September 2013
Danish: Dato for første markedsføringstilladelse: 25 september 2013.
English: • if you have or have ever had a liver, kidney or heart problem.
Danish: • hvis du har eller har haft lever-, nyre- eller hjerteproblemer.
English: The adverse reactions were similar in all indications, with two exceptions.
Danish: Bivirkningsmønstret var, med 2 undtagelser, det samme ved alle indikationer.
English: The duration of imatinib therapy can vary with the treatment program selected, but generally longer exposures to imatinib have yielded better results.
Danish: Varigheden af behandling med imatinib kan variere med det valgte behandlingsprogram, men generelt har længere eksponering for imatinib givet de bedste resultater.
English: Ki values in human liver microsomes were 27, 7.5 and 7.9 μmol/l, respectively.
Danish: Ki værdier i humane levermikrosomer var henholdsvis 27; 7,5 og 7,9 µmol/l.
English: Because these reactions are reported from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to imatinib exposure.
Danish: Eftersom disse bivirkninger er rapporteret fra en population af ukendt størrelse, er det ikke altid muligt at bestemme frekvensen pålideligt eller at fastlægge en kausal sammenhæng med eksponering for imatinib.
English: Complete cytogenetic response confirmed by a second bone marrow cytogenetic evaluation performed at least one month after the initial bone marrow study.
Danish: Fuldstændigt cytogenetisk respons bekræftet ved endnu en cytogenetisk knoglemarvsundersøgelse udført mindst 1 måned efter den initiale knoglemarvsundersøgelse.
English: Safety data from this study seem to be in line with the safety profile of imatinib in Ph+ ALL patients.
Danish: Sikkerhedsdata fra dette studie synes at være i overensstemmelse med sikkersprofilen for imatinib hos Ph+ ALLpatienter.
English: RTC: < 15 % blasts BM and PB, < 30 % blasts+promyelocytes in BM and PB, < 20 % basophils in PB, no extramedullary disease other than spleen and liver.
Danish: RTC: < 15 % blaster I BM og PB, <30 % blaster + promyelocytter in BM og PB, <20 % basofilocytter i PB, ingen ekstramedullær sygdom andet end milt og lever.
English: Considering the combined concentration of imatinib and the metabolite and the maximum daily milk intake by infants, the total exposure would be expected to be low (~10 % of a therapeutic dose).
Danish: Den totale koncentration af imatinib og metabolitten og spædbørns maksimale daglige indtagelse af mælk taget i betragtning forventes det, at den totale eksponering er lav (~10 % af den terapeutiske dosis).
English: ANC = absolute neutrophil count a occurring after at least 1 month of treatment
Danish: ANC = fuldstændigt antal neutrofilocytter opstået efter mindst 1 måneds behandling
English: GI and tumoural bleeding may be serious and sometimes fatal.
Danish: Gastrointestinal og tumoral blødning kan være alvorlig og i visse tilfælde fatal.
English: Within each frequency grouping, undesirable effects are presented in order of frequency, the most frequent first.
Danish: Inden for hver enkelt frekvensgruppe er bivirkningerne opstillet efter frekvens med de hyppigste først.
English: As in adult patients, imatinib was rapidly absorbed after oral administration in paediatric patients in both phase I and phase II studies.
Danish: Ligesom hos voksne absorberedes imatinib hurtigt hos pædiatriske patienter efter oral administration i både fase I- og fase II-undersøgelser.
English: Teratogenic effects included exencephaly or encephalocele, absent/reduced frontal and absent parietal bones.
Danish: Teratogene virkninger inkluderede exencephali eller encephalocele, manglende/reducerede frontale knogler og manglende parietalknogler.
English: Table 1 Tabulated summary of adverse reactions Infections and infestations
Danish: Tabel 1 Opsummering af bivirkninger Infektioner og parasitære sygdomme
English: This is because Imatinib medac could cause hepatitis B to become active again, which can be fatal in some cases.
Danish: Dette skyldes, at Imatinib medac kan forårsage, at hepatitis B-infektionen bliver aktiv igen, hvilket undertiden kan være dødeligt.
English: No evidence of leukaemia (NEL) Return to chronic phase (RTC) Major cytogenetic response Complete (Confirmed
Danish: Intet tegn på leukæmi (NEL) Remission til kronisk fase (RTC) Cytogenetisk hovedrespons Fuldstændigt (Bekræftet
English: There is no experience in children or adolescents with HES/CEL.
Danish: Der er ingen erfaring med børn eller unge med HES/CEL.
English: Additionally, partial cytogenetic response (PCyR) was observed in 16 % for a MCyR of 81 %.
Danish: Derudover sås partielt cytogenetisk respons (PCyR) hos 16 %, dermed MCyR hos 81 %.
English: They may increase or decrease the effect of Imatinib medac, either leading to increased side effects or making Imatinib medac less effective.
Danish: De kan enten øge eller nedsætte virkningen af Imatinib medac, hvilket kan resultere i enten flere bivirkninger, eller de kan gøre Imatinib medac mindre virksomt.
English: F1 fertility was not affected, while an increased number of resorptions and a decreased number of viable foetuses was noted at 45 mg/kg/day.
Danish: F1 fertilitet var ikke påvirket, mens der sås et øget antal resorptioner og et nedsat antal levende fostre ved 45 mg/kg/dag.
English: Clinical studies in DFSP
Danish: Kliniske studier ved DFSP
English: Some children and adolescents taking Imatinib medac may have slower than normal growth.
Danish: Nogle børn og unge, der får Imatinib medac, kan vokse langsommere end normalt.
English: If renal dysfunction is observed, appropriate management and treatment should be prescribed in accordance with standard treatment guidelines.
Danish: Hvis nedsat nyrefunktion observeres, skal passende håndtering og behandling i overensstemmelse med standard behandlingsguidelines iværksættes.
English: In a recent publication updated information from 6 of these 11 patients revealed that all these patients remained in cytogenetic remission (range 32 - 38 months).
Danish: Opdaterede oplysninger om 6 af disse 11 patienter, som er publiceret for nylig, viste, at alle disse patienter forblev i cytogenetisk remission (32-38 måneder).
English: Your doctor has prescribed Imatinib medac because you suffer from a serious condition.
Danish: Din læge har udskrevet Imatinib medac, fordi du lider af en alvorlig sygdom.
English: A slight to moderate reduction in spermatogenesis was also observed in the dog at oral doses ≥ 30 mg/kg.
Danish: Der sås også en let til moderat reduktion i spermatogenesen hos hunde ved orale doser ≥ 30 mg/kg.
English: Severe elevation of transaminases (< 5 %) or bilirubin (< 1 %) was seen in CML patients and was usually managed with dose reduction or interruption (the median duration of these episodes was approximately one week).
Danish: Svære stigninger i transaminaser (<5 %) eller bilirubin (<1 %) blev observeret hos CML-patienterne og blev sædvanligvis behandlet med dosisreduktion eller seponering (den gennemsnitlige varighed af disse episoder var ca. 1 uge).
English: The majority of patients who achieved a CCyR developed the CCyR between months 3 and 10 with a median time to response based on the Kaplan-Meier estimate of 5.6 months.
Danish: Hovedparten af patienterne, som opnåede CCyR, udviklede dette mellem 3. og 10. måned med en mediantid til respons på 5,6 måneder baseret på et Kaplan-Meier estimat.
English: As reported in a recent publication 21 of these 65 patients also achieved complete molecular remission with a median follow-up of 28 months (range 13-67 months).
Danish: Som beskrevet i en nylig publikation opnåede 21 af disse 65 patienter også komplet molekylær remission med en median opfølgningstid på 28 måneder (varierende fra 13-67 måneder).
English: • Numbness of the hands or feet.
Danish: • Følelsesløshed i hænder eller fødder.
English: After correcting for the BSA effect, other demographics such as age, body weight and body mass index did not have clinically significant effects on the exposure of imatinib.
Danish: Efter korrigering for legemsoverflade-effekten havde andre demografiske faktorer som alder, kropsvægt og kropsmasseindeks (body mass index) ikke klinisk signifikant effekt på imatinib-eksponeringen.
English: The results observed in a population of 211 newly diagnosed Ph+ ALL patients in four uncontrolled clinical studies (AAU02, ADE04, AJP01 and AUS01) are consistent with the results described above.
Danish: Resultaterne, som blev opnået i en population af 211 nydiagnosticerede Ph+ ALL patienter i fire ikke kontrollerede studier (AAU02, ADE04, AJP01 og AUS01), er i overensstemmelse med resultaterne beskrevet ovenfor.
English: In addition, paediatric patients have been treated in two phase I studies and one phase II study.
Danish: Derudover er der behandlet børn i 2 fase I-undersøgelser og en fase II-undersøgelse.
English: The milk/plasma ratio studied in a single patient was determined to be 0.5 for imatinib and 0.9 for the metabolite, suggesting greater distribution of the metabolite into the milk.
Danish: Mælk/plasmaratio undersøgt i en enkelt patient blev bestemt til at være 0,5 for imatinib og 0,9 for metabolitten, hvilket tyder på en større udskillelse af metabolitten i mælk.
English: Due to the observational nature of this registry, haematologic, cytogenetic and molecular assessment data were available for 22, 9 and 17 of the 23 enrolled patients, respectively.
Danish: På grund af studiets observationelle karakter var data for hæmatologisk, cytogenetisk og molekylær vurdering tilgængelige for henholdvis 22, 9 og 17 af de 23 inkluderede patienter.
English: The increase is approximately 1.5- to 2-fold, corresponding to a 1.5-fold elevation of plasma AGP, to which imatinib binds strongly.
Danish: Eksponeringen er ca. 1,5 til 2 gange, svarende til en stigning på 1,5 gangs stigning af plasma AGP, som imatinib binder stærkt til.
English: The amount of Imatinib medac given will depend on your child's condition, body weight and height.
Danish: Antallet af Imatinib medac-kapsler afhænger af barnets tilstand, kropsvægt og højde.
English: Treatment resulted in worsening of normally suppressed malarial infections in these animals.
Danish: Behandlingen resulterede hos disse dyr i en forværring af normalt kontrollerede malariainfektioner.
English: No significant age-related pharmacokinetic differences have been observed in patients in clinical trials which included over 20 % of patients aged 65 and older.
Danish: Der er ikke set signifikante aldersrelaterede farmakokinetiske forskelle hos patienter i kliniske afprøvninger, hvor mere end 20 % patienter af de inkluderede patienter var i alderen 65 år og derover.
English: Three patients presented a complete haematological response (CHR) and one patient experienced a partial haematological response (PHR).
Danish: Tre patienter viste komplet hæmatologisk respons (CHR) og en patient viste partiel hæmatologisk respons (PHR).
English: imatinib treatment induces a rapid response in newly diagnosed paediatric CML patients with a CHR of 78 % after 8 weeks of therapy.
Danish: Imatinib-behandling inducerer et hurtigt respons hos nydiagnosticerede pædiatriske CML-patienter med en CHR hos 78 % efter 8 ugers behandling.
English: • Numb or cold toes and fingers (signs of Raynaud's syndrome).
Danish: • Følelsesløse eller kolde tæer og fingre (tegn på Raynaud´s syndrom).
English: The most important changes included cardiac hypertrophy and dilatation, leading to signs of cardiac insufficiency in some animals.
Danish: De vigtigste ændringer er bl.a. hjertehypertrofi og dilation, som hos nogle dyr førte til tegn på hjerteinsufficiens.
English: • Pain in your hips or difficulty walking.
Danish: • Smerte i hoften eller svært ved at gå.
English: The doctor will tell you how many capsules of Imatinib medac to give to your child.
Danish: Lægen vil fortælle dig, hvor mange Imatinib medac-kapsler, du skal give dit barn.
English: Caution should therefore be exercised when using high doses of imatinib and paracetamol concomitantly.
Danish: Der rådes derfor til forsigtighed, når høje doser imatinib og paracetamol anvendes samtidig.
English: • Then continue with your normal schedule.
Danish: • Fortsæt derefter med den planlagte dosering.
English: As expected on the basis of the study design, no difference was observed in remission duration, disease-free survival or overall survival, although patients with complete molecular response and remaining in minimal residual disease had a better outcome in terms of both remission duration (p = 0.01) and disease-free survival (p = 0.02).
Danish: Som det var forventet på basis af studiedesignet, sås ingen forskel i varighed af remission, sygdomsfri overlevelse eller generel overlevelse, skønt patienter med komplet molekylær respons og forblivende i minimal residual sygdom havde større udbytte af behandlingen i form af både varighed af remission (p = 0,01) og sygdomsfri overlevelse (p = 0,02).
English: • Dry mouth, dry skin or dry eye.
Danish: • Mundtørhed, tør hud eller tørre øjne.
English: Name and address of the manufacturers responsible for batch release medac Gesellschaft für klinische Spezialpräparate mbH Theaterstr.
Danish: Navn og adresse på de fremstillere, der er ansvarlige for batchfrigivelse medac Gesellschaft für klinische Spezialpräparate mbH Theaterstr.
English: Therefore, the use of imatinib in combination with other chemotherapeutic agents requires special precaution.
Danish: Brug af imatinib i kombination med andre kemoterapeutika kræver derfor særlig forsigtighed.
English: Complete blood counts must be performed regularly during therapy with imatinib.
Danish: Fuldstændige blodtællinger skal foretages jævnligt under behandling med imatinib.
English: If you have any questions about how Imatinib medac works or why this medicine has been prescribed for you, ask your doctor.
Danish: Hvis du har spørgsmål om, hvordan Imatinib medac virker, eller hvorfor du har fået ordineret dette lægemiddel, kontakt din læge.
English: Older people: Imatinib pharmacokinetics have not been studied in older people.
Danish: Ældre patienter: Imatinibs farmakokinetik er ikke undersøgt hos ældre.
English: If it is used during pregnancy, the patient must be informed of the potential risk to the foetus.
Danish: Hvis imatinib anvendes under graviditet, skal patienten informeres om den potentielle risiko for fostret.
English: Table 4 Chemotherapy regimen used in combination with imatinib in study I2301
Danish: Tabel 4 Kemoterapi-regime anvendt i kombination med imatinib i studie I2301
English: Disease-free survival (DFS) and overall survival (OS) constantly exceeded 1 year and were superior to historical control (DFS p < 0.001; OS p < 0.0001) in two studies (AJP01 and AUS01).
Danish: Sygdomsfri overlevelse (disease-free survival DFS) og overordnede overlevelse (overall survival OS) var konstant mere end 1 år og var superior til historiske kontroller (DFS p<0,001; OS p<0,0001) i to studier (AJp01 og AUS01).
English: • Sudden swelling and redness of the skin (signs of a skin infection called cellulitis).
Danish: • Pludselig hævelse og rødme af huden (tegn på en hudinfektion kaldet cellulitis).
English: Patients should be tested for HBV infection before initiating treatment with imatinib.
Danish: Patienten bør testes for HBV-infektion før initiering af behandling med imatinib.
English: Haematological response Complete haematological response (CHR)
Danish: Hæmatologisk respons Fuldstændigt hæmatologisk respons (CHR)
English: There have been cases of cytolytic and cholestatic hepatitis and hepatic failure; in some of them outcome was fatal, including one patient on high dose paracetamol.
Danish: Der har været tilfælde af cytolytisk og cholestatisk hepatitis samt leversvigt, i nogle tilfælde var udfaldet letalt, inkluderende én patient, der fik højdosis paracetamol.
English: Experience with imatinib in this indication is very limited and is based on haematological and cytogenetic response rates.
Danish: Der er meget begrænset erfaring med imatinib ved denne indikation, og den er baseret på hæmatologiske og cytogenetiske responsrater.
English: Imatinib and the N-demethyl metabolite together accounted for about 65 % of the circulating radioactivity (AUC(0-48h)).
Danish: Imatinib og N-demethylmetabolitten udgjorde tilsammen ca. 65 % af den cirkulerende radioaktivitet (AUC(0-48t)).