FrancophonIA/ELRC3.0 huggingface dataset:
English: Studies in two breast-feeding women revealed that both imatinib and its active metabolite can be distributed into human milk.
Danish: Studier i to ammende kvinder viste, at både imatinib og dets aktive metabolit kan blive udskilt i modermælk.
English: No significant age-related pharmacokinetic differences have been observed in adult patients in clinical trials which included over 20% of patients age 65 and older.
Danish: Der er ikke set signifikante aldersrelaterede farmakokinetiske forskelle hos voksne patienter i kliniske afprøvninger, hvor mere end 20% patienter af de inkluderede patienter var over 65 år.
English: Additionally, partial cytogenetic response (PCyR) was observed in 16% for a MCyR of 81%.
Danish: Derudover sås partielt cytogetisk respons (PCyR) hos 16 %, dermed MCyR hos 81 %.
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: Name and address of the manufacturer responsible for batch release S.C. Sindan-Pharma S.R.L.
Danish: Navn og adresse på fremstilleren (fremstillerne) ansvarlig(e) for batchfrigivelse S.C. Sindan-Pharma S.R.L.
English: - Numbness of the hands or feet.
Danish: - Følelsesløshed i hænder eller fødder.
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: Imatinib Actavis can help you to fight this condition.
Danish: Imatinib Actavis kan hjælpe dig med at bekæmpe denne tilstand.
English: Patients, who are allergic to peanut or soya, may not use this medicinal product.
Danish: Patienter, der er allergiske over for jordnødder eller soya, må ikke tage dette lægemiddel.
English: 5 patients responded, 3 completely and 2 partially.
Danish: Fem (5) patienter responderede, 3 komplet og 2 partielt.
English: These measures will help protect the environment.
Danish: Dette er en miljømæssig foranstaltning.
English: - Difficulty hearing.
Danish: - Hørebesvær.
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/plasma ratio undersøgt i en enkelt patient blev bestemt til at være 0,5 for imatinib og 0,9 for metabolitten, hvilket tyder på en større fordeling af metabolitten i modermælken.
English: In patients treated with metoprolol clinical monitoring should be considered.
Danish: Hos patienter, der behandles med metoprolol, bør klinisk monitorering overvejes.
English: In adult patients, Imatinib Actavis is intended for use in the most advanced phase of the disease (blast crisis).
Danish: Hos voksne patienter er Imatinib Actavis beregnet til brug i den mest fremskredne fase af sygdommen (blastkrise).
English: Imatinib Actavis may do the same to some other medicines.
Danish: Imatinib Actavis kan gøre det samme ved andre lægemidler.
English: In children and adolescents, Imatinib Actavis can be used in different phases of the disease (chronic, accelerated phase and blast crisis).
Danish: Hos børn og teenagere kan Imatinib Actavis bruges i forskellige sygdomsfaser (kronisk, accelereret fase og blastkrise).
English: Study AJP01
Danish: Studie AJP01
English: Imatinib Actavis can reduce the number of white blood cells, so you might get infections more easily.
Danish: Imatinib Actavis kan nedsætte antallet af hvide blodlegemer, så du lettere kan få infektioner.
English: This is because Imatinib Actavis could cause hepatitis B to become active again, which can be fatal in some cases.
Danish: Dette skyldes, at (Imatinib Actavis) kan forårsage, at hepatitis B-infektionen bliver aktiv igen, hvilket undertiden kan være dødeligt.
English: - If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor 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 til råds, før du tager dette lægemiddel.
English: Haematological response1
Danish: Hæmatologisk respons1
English: Patients should be instructed to use measures such as protective clothing and sunscreen with high sun protection factor (SPF).
Danish: Patienter bør instrueres i at tage forholdsregler såsom at bære beskyttende tøj eller bruge solcreme med en høj solbeskyttelsesfaktor (SPF).
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: Study AAU02
Danish: Studie AAU02
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(0-48h)).
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: Thrombosis/embolism*
Danish: Trombose/emboli*
English: 95 (37%) had received prior chemotherapy for treatment of either accelerated phase or blast crisis (“pretreated patients”) whereas 165 (63%) had not (“untreated patients”).
Danish: 95 (37 %) havde tidligere modtaget kemoterapi til behandling af enten accelereret fase eller blastkrise (”tidligere behandlede patienter”), hvorimod 165 (63 %) ikke havde (”ubehandlede patienter”).
English: Based on population pharmacokinetic analysis in CML patients, there was a small effect of age on the volume of distribution (12% increase in patients > 65 years old).
Danish: Populationsfarmakokinetiske analyser hos CML-patienter har vist, at alder har en lille effekt på fordelingsvolumen (12 % stigning hos patienter > 65 år).
English: If you have any questions about how Imatinib Actavis works or why this medicine has been prescribed for you, ask your doctor.
Danish: Hvis du har spørgsmål om, hvordan Imatinib Actavis virker, eller hvorfor du har fået ordineret dette lægemiddel, kontakt din læge.
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: 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: 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: * These types of reactions have been reported mainly from post-marketing experience with imatinib.
Danish: * Denne type bivirkningerreaktioner er hovedsageligt blevet rapporteret fra erfaring med imatinib efter markedsføring af imatinib.
English: In this study, 31% of patients achieved a haematological response (36% in previously untreated patients and 22% in previously treated patients) (Table 2).
Danish: I denne undersøgelse opnåede 31 % af patienterne et hæmatologisk respons (36 % af de tidligere ”ubehandlede patienter” og 22 % af de ”tidligere behandlede patienter”) (Tabel 2).
English: In addition, mortality was observed in juvenile animals (around weaning phase) at approximately 2 times the average paediatric exposure at the highest recommended dose of 340 mg/m2.
Danish: Derudover blev der set mortalitet hos juvenile dyr (omkring fravænningsfase) ved ca. 2 gange den gennemsnitlige pædiatriske eksponering ved den højst anbefalede dosis på 340 mg/m2.
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- fold, svarende til en 1,5-gangs stigning af plasma AGP som imatinib binder stærkt til.
English: - Swallow the capsules whole with a large glass of water.
Danish: - Synk kapslerne hele med et stort glas vand.
English: monthly for 13 months; prednisolone 200 mg oral, 5 days per month for 13 months
Danish: månedligt i 13 måneder; prednisolon 200 mg oral, 5 dag per måned i 13 måneder
English: - Eye pain or deterioration in vision, bleeding in the eyes.
Danish: - Øjensmerter eller svækkelse af dit syn, blødning i øjnene.
English: Do not stop taking Imatinib Actavis unless your doctor tells you to.
Danish: Du må ikke stoppe med at tage Imatinib Actavis, medmindre din læge fortæller dig det.
English: The score line is not intended for breaking the tablet.
Danish: Delekærven skal ikke bruges til at brække tabletten.
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: - Painful and/or blistering skin lesions.
Danish: - Smertefulde og/eller blæredannende hudlæsioner.
English: Imatinib Actavis will only be prescribed to you by a doctor with experience in medicines to treat blood cancers or solid tumours.
Danish: Imatinib Actavis vil kun blive ordineret til dig af en læge med erfaring i behandlingen af kræft i blodet eller kræftknuder.
English: There was no change in the kinetics of imatinib on repeated dosing, and accumulation was 1.5-2.5-fold at steady state when dosed once daily.
Danish: Der var ingen ændringer i imatinibs kinetik ved gentagen dosering, og akkumulering var 1,5-2,5 gange ved steady-state ved dosering 1 gang daglig.
English: - adult patients with Ph+ CML in blast crisis.
Danish: - voksne med Ph+ CML i blastkrise.
English: This Ki value is far higher than the expected plasma levels of imatinib in patients, consequently no interaction is expected upon coadministration of either 5-fluorouracil or paclitaxel and imatinib.
Danish: Denne Ki værdi er langt højere end de forventede plasmaniveauer af imatinib hos patienter, og der forventes derfor ingen interaktion i forbindelse med samtidig administration af hverken 5-fluorouracil eller paclitaxel og imatinib.
English: If anti-ADAMTS13-antibody is elevated in conjunction with low ADAMTS13 activity, treatment with Imatinib Actavis should not be resumed.
Danish: Hvis niveauet af ADAMTS13-antistoffer er forøget samtidig med lav ADAMTS13-aktivitet, må behandlingen med Imatinib Actavis ikke genoptages.
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: I et juvenilt udviklingstoksikologisk rottestudie blev der ikke identificeret nye målorganer (dag 10 til 70 postpartum) med hensyn til kendte målorganer hos voksne rotter.
English: CML in blast crisis and Ph+ ALL (starting dose 600 mg)
Danish: CML i blastkrise og Ph+ ALL (startdosis 600 mg)
English: - Blood clots in small blood vessels (thrombotic microangiopathy).
Danish: - Blodpropper i små blodkar (trombotisk mikroangiopati).
English: - Swallow the tablets whole with a large glass of water.
Danish: - Synk tabletterne hele med et stort glas vand.
English: This was a population of heavily pretreated patients, as 46% had received prior BMT and 73% a prior multi-agent chemotherapy.
Danish: Det var en population af patienter, der i udtalt grad tidligere havde modtaget anden behandling, eftersom 46 % tidligere havde modtaget BMT, og 73 % tidligere havde modtaget multi-stof kemoterapi.
English: Your doctor may prescribe a higher or lower dose depending on how you respond to the treatment.
Danish: Din læge kan foreskrive højere eller lavere dosis afhængigt af, hvordan du reagerer på behandlingen.
English: This may be a sign of damage to blood vessels known as thrombotic microangiopathy (TMA).
Danish: Dette kan være tegn på beskadigelse af dine blodkar, hvilket kaldes trombotisk mikroangiopati (TMA).
English: Following oral administration in healthy volunteers, the t½ was approximately 18 h, suggesting that once-daily dosing is appropriate.
Danish: Efter oral administration til raske frivillige var t½ ca. 18 timer, hvilket indikerer, at dosering 1 gang daglig er passende.
English: The effect of bodyweight on the clearance of imatinib is such that for a patient weighing 50 kg the mean clearance is expected to be 8.5 L/h, while for a patient weighing 100 kg the clearance will rise to 11.8 L/h.
Danish: Kropsvægtens betydning for clearance af imatinib er således, at for patienter, der vejer 50 kg, forventes den gennemsnitlige clearance at være 8,5 l/t, mens den for patienter, der vejer 100 kg, vil stige til 11,8 l/t.
English: no extramedullary disease other than spleen and liver.
Danish: PB, ingen ekstramedullær sygdom andet end milt og lever.
English: However, some of these reactions may be serious or lifethreatening and several patients with blast crisis died with a complex clinical history of pleural effusion, congestive heart failure and renal failure.
Danish: I nogle tilfælde kan disse tilstande dog være alvorlige eller livstruende, og flere patienter med blastkrise døde med en kompleks anamnese af pleuraeksudat, kongestivt hjerteinsufficiens og nyresvigt.
English: - If you are being treated for MDS/MPD:
Danish: - Hvis du behandles for MDS/MPD:
English: approximately equal to the maximum clinical dose of 800 mg/day, based on body surface area.
Danish: svarende til den maksimale kliniske dosis på 800 mg/dag, baseret på legemsoverfladeareal.
English: The most important changes included cardiac hypertrophy and dilatation, leading to signs of cardiac insufficiency in some animals.
Danish: Den vigtigste ændring er hjertehypertrofi og dilation, som i nogle dyr kan føre til tegn på hjerteinsufficiens.
English: 21 patients were treated with imatinib 400 mg daily, while the other 3 patients received lower doses.
Danish: 21 patienter blev behandlet med 400 mg imatinib daglig, mens 3 patienter fik en lavere dosis.
English: The in vitro results showed that CYP3A4 was the major human P450 enzyme catalysing the biotransformation of imatinib.
Danish: In vitro resultater viste, at CYP3A4 var det primære P450 enzym i katalyseringen af biotransformationen af imatinib.
English: Patients should be tested for HBV infection before initiating treatment with Imatinib Actavis.
Danish: Patienten bør testes for HBV-infektion før initiering af behandling med (Imatinib Actavis).
English: Study AUS01
Danish: Studie AUS01
English: Imatinib Actavis is also a treatment for children with CML.
Danish: Imatinib Actavis bruges også til behandling af børn med CML.
English: - if you experience bruising, bleeding, fever, fatigue and confusion when taking Imatinib Actavis, contact your doctor.
Danish: - hvis du får blå mærker, blødninger, feber, træthed og oplever forvirring, mens du tager Imatinib Actavis, skal du kontakte din læge.
English: Pancytopenia, febrile neutropenia
Danish: Pancytopeni, febril neutropeni
English: Out of 9 patients with chronic phase CML and cytogenetic data available, 4 (44%) and 3 (33%) achieved a complete and partial cytogenetic response, respectively, for a rate of MCyR of 77%.
Danish: Af 9 patienter med kronisk fase CML og tilgængelige cytogenetiske data opnåede henholdsvis 4 (44 %) og 3 (33 %) fuldstændigt og delvist cytogenetisk respons, med en McyR-rate på 77 %.
English: Your doctor will discuss with you the possible risks of taking Imatinib Actavis during pregnancy.
Danish: Din læge vil fortælle dig om de mulige risici, der er forbundet med brug af Imatinib Actavis under graviditeten.
English: The plasma protein binding of the N-demethylated metabolite is similar to that of the parent compound.
Danish: Plasmaproteinbindingen af den N-demethylerede metabolit er sammenlignlig med den for hovedkomponenten.
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: One blister contains either 8 or 10 capsules.
Danish: En blister indeholder enten 8 eller 10 kapsler.
English: All 65 FIP1L1-PDGFRα fusion kinase positive patients achieved a CHR sustained for months (range from 1+ to 44+ months censored at the time of the reporting).
Danish: Alle 65 FIP1L1-PDGFRα fusionkinase-positive patienter opnåede CHR, som vedvarede i måneder (varighed fra 1+ til 44+ måneder censureret på opgørelsestidpunktet).
English: 6+7 Abdominal pain and gastrointestinal haemorrhage were most commonly observed in GIST patients.
Danish: 6+7 Abdominalsmerter og gastrointestinalblødning blev oftest observeret hos patienter med GIST.
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 reaktionerbivirkninger 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 formed imatinib.
English: S.C. Sindan-Pharma S.R.L.
Danish: S.C. SindanPharma S.R.L.
English: - If you are being treated for HES/CEL:
Danish: - Hvis du behandles for HES/CEL:
English: When the response rate is calculated from patients with at least one valid assessment, the response rate for CHR, CCyR and MR was 20/22 (90.9%), 9/9 (100%) and 11/17 (64.7%), respectively.
Danish: Hvis responsraten beregnes ud fra patienter med mindst en valid parametervurdering er reponsraten for CHR, CCyr og MR henholdvis 20/22 (90,9 %), 9/9 (100 %) og 11/17 (64,7 %).
English: This leaflet was last revised in Other sources of information
Danish: Denne indlægsseddel blev senest ændret <DATO> Andre informationskilder
English: Reykjavíkurvegur 76-78 IS-220 Hafnarfjörður Iceland
Danish: Reykjavíkurvegur 76-78 IS-220 Hafnarfjörður Island
English: - if you are allergic to imatinib or any of the other ingredients of this medicine (listed in section 6).
Danish: - hvis du er allergisk over for imatinib eller et af de øvrige indholdsstoffer i lægemidlet (angivet i punkt 6).
English: The amount of Imatinib Actavis given will depend on your child's condition, body weight and height.
Danish: Antallet af Imatinib Actavis-kapsler afhænger af barnets tilstand, kropsvægt og højde.
English: Patients concerned about their fertility on imatinib treatment should consult with their physician.
Danish: Patienter, der bekymrer sig om deres fertilitet under imatinib-behandling, bør konsultere deres læge.
English: In adults the dose should be reduced from 400 to 300 mg or from 600 to 400 mg, or from 800 mg to 600 mg, and in children from 340 to 260 mg/m2/day.
Danish: Hos voksne bør dosis reduceres fra 400 til 300 mg, eller fra 600 til 400 mg, eller fra 800 mg til 600 mg, og hos børn fra 340 til 260 mg/m2/dag.
English: Patients should be advised that they may experience undesirable effects such as dizziness,blurred vision or somnolence during treatment with imatinib.
Danish: Patienter skal advares om, at de kan opleve bivirkninger som svimmelhed, sløret syn eller døsighed under behandling med imatinib.
English: Anaphylactic shock*
Danish: Anafylaktisk shock*
English: Patients were treated at doses of imatinib of 260 mg/m2/day (n=5), 340 mg/m2/day (n=9), 440 mg/m2/day (n=7) and 570 mg/m2/day (n=5).
Danish: Patienterne blev behandlet med imatinib-doser på 260 mg/m2/dag (n=5), 340 mg/m2/dag (n=9), 440 mg/m2/dag (n=7) og 570 mg/m2/dag (n=5).
English: In addition, children and adolescents have been treated in two phase I studies (in patients with CML or Ph+ acute leukaemia) and one phase II study.
Danish: Derudover er der behandlet børn i 2 fase I undersøgelser (hos patienter med CML eller Ph+ akut leukæmi) og et fase II studie.
English: - if you are allergic to imatinib, soya, peanut or any of the other ingredients of this medicine (listed in section 6).
Danish: - hvis du er allergisk over for imatinib, soya, jordnødder eller et af de øvrige indholdsstoffer i lægemidlet (angivet i punkt 6).
English: 1800 to 3200 mg (as high as 3200 mg daily for 6 days): Weakness, myalgia, increased creatine phosphokinase, increased bilirubin, gastrointestinal pain.
Danish: 1800 til 3200 mg (så høj som 3200 mg daglig i 6 dage): Svaghed, myalgi, øget kreatininfosfokinase, øget bilirubin, gastrointestinale smerter.
English: The primary efficacy variable was the rate of haematological response, reported as either complete haematological response, no evidence of leukaemia (i.e. clearance of blasts from the marrow and the blood, but without a full peripheral blood recovery as for complete responses), or return to chronic phase CML.
Danish: Den primære effektvariable var graden af hæmatologisk hovedrespons, rapporteret enten som fuldstændigt hæmatologisk respons, intet tegn på leukæmi (det vil sige clearance af blaster fra knoglemarven og blod, men uden en fuldstændig resitution i perifert blod som ved fuldstændigt respons) eller remission til CML i kronisk fase.
English: - Unusual hair loss or thinning.
Danish: - Usædvanligt hårtab eller udtyndning af håret.
English: Study ADE04
Danish: Studie ADE04
English: Keep taking Imatinib Actavis every day for as long as your doctor tells you.
Danish: Bliv ved med at tage Imatinib Actavis hver dag, så længe som din læge har foreskevet det.
English: This will help protect you from stomach problems when taking Imatinib Actavis.
Danish: Dette vil hjælpe med at beskytte dig mod maveproblemer, når du tager Imatinib Actavis.
English: 9 Musculoskeletal pain during treatment with imatinib or after discontinuation has been observed in post-marketing.
Danish: 9 Muskuloskeletale smerter under behandling med imatinib, eller efter seponering, er blevet observeret efter markedsføring.
English: In clinical trials, there was an increased incidence of these events in elderly patients and those with a prior history of cardiac disease.
Danish: Der er i kliniske undersøgelser set øget incidens af disse hændelser hos ældre patienter og hos patienter med hjertesygdom i anamnesen.
English: An observational registry (study L2401) was conducted to collect long-term safety and efficacy data in patients suffering from myeloproliferative neoplasms with PDGFR- β rearrangement and who were treated with imatinib.
Danish: Et observationelt registerstudie (studie L2401) blev udført for at indsamle langsigtede sikkerheds- og effektdata for patienter, som lider af myeloproliferative neoplasier med PDGFR- β rearrangement og som blev behandlet med imatinib.
English: Haematological and cytogenetic responses have been sustained for a median of 49 months (range 19-60) and 47 months (range 16-59),
Danish: Hæmatologisk og cytogenetisk respons er bibeholdt i en periode varende fra henholdsvis 19-60 måneder (median 49 måneder) og 16-59 måneder (median 47 måneder).
English: Hepatitis B reactivation*
Danish: Reaktivering af hepatitis B*