natgillin/translations-raw huggingface dataset:
EXULETT skulle udelukkende have været anvendt, når man vidste eller formodede, at infektionen var forårsaget af bakterietyper, der er klassificeret som ‘grampositive', og som ville blive dræbt af lægemidlet.
EXULETT was to be used only when the infection was known or thought to be caused by types of bacteria that are classified as ‘Gram-positive' and that would be killed by the medicine.
På baggrund af gennemgangen af dataene og virksomhedens besvarelse af CHMP's liste med spørgsmål på tidspunktet for tilbagetrækningen af ansøgningen havde CHMP visse betænkeligheder og var af den foreløbige opfattelse, at EXULETT ikke kunne godkendes til behandling af komplicerede hud- og bløddelsinfektioner hos voksne, når de vides eller formodes at være forårsaget af modtagelige grampositive bakterier.
Based on the review of the data and the company's response to the CHMP list of questions at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that EXULETT could not have been approved for the treatment of complicated skin and soft tissue infections in adults when known or suspected to be caused by susceptible Gram-positive bacteria.
Firmaet har til CHMP oplyst, at beslutningen ikke vil få konsekvenser for patienter, der deltager i kliniske undersøgelser med EXULETT.
The company informed the CHMP that there are no consequences for patients currently included in clinical trials of EXULETT.
inden udvalget afgiver en udtalelse, stille eventuelle supplerende spørgsmål til virksomheden på dag 180.
Once the company has supplied responses to the questions, the CHMP reviews them and may, before giving an opinion, ask any remaining questions at day 180.
Stigning af bilirubin var under 3%.
Bilirubin elevation was below 3%.
I resten af denne indlægsseddel, vil vi bruge forkortelserne, når vi omtaler disse sygdomme.
In the rest of this leaflet, we will use the abbreviations when talking about these diseases.
Derudover har børn været behandlet i 2 fase I-studier og et fase II studie.
In addition, children have been treated in two phase I studies and one phase II study.
• Omrør med en ske indtil tabletterne er opløst fuldstændig.
• Stir with a spoon until the tablets have completely dissolved.
% patienter (CI95%)
% of patients (CI95%)
Undersøgelsens primære effektmål er progressionsfri overlevelse.
The primary efficacy endpoint of the study is progression-free survival.
Der inkluderedes et begrænset antal patienter i fase I undersøgelser (n=10).
A limited number of patients were enrolled in phase I studies (n=10).
Molekulær respons**
Molecular response**
PVC/PE/PVdC/PE/PVC//Al blister OPA/Al/PVC//Al blister
PVC/PE/PVdC/PE/PVC//Al blisters OPA/Al/PVC//Al blisters
Responsdata fremgår af Tabel 2.
Response data are shown in Table 2.
meget sjælden (<1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
very rare (<1/10,000), not known (cannot be estimated from the available data).
Andre bivirkninger blev indberettet med lavere eller den samme hyppighed.
Other adverse reactions were reported with lower or equal frequency.
• Risikostyringsplan (RMP)
• Risk Management Plan (RMP) Not applicable.
I alle kliniske undersøgelser var 38-40% af patienterne ≥60 år, og 10-12% af patienterne var ≥70 år.
In all clinical studies 38-40% of patients were ≥ 60 years of age and 10-12% of patients were ≥ 70 years of age.
Et større respons (0-35%) omfatter både fuldstændig og delvis respons.
A major response (0-35%) combines both complete and partial responses.
Mekanismen og betydningen for mennesker af disse resultater i karcinogenicitetsstudiet hos rotter er endnu ikke afklaret.
The mechanism and relevance of these findings in the rat carcinogenicity study for humans are not yet clarified.
Gennemsnitsalderen var 51 år (range 18-70 år), med 21,9% patienter ≥60 år.
Median age was 51 years (range 18-70 years), with 21.9% of patients ≥ 60 years of age.
I alt randomiseredes 1.106 patienter, 553 til hver arm. Baselinekarakteristika var velafbalancerede mellem de to arme.
A total of 1.106 patients were randomised, 553 to each arm. Baseline characteristics were well balanced between the two arms.
• Når tabletten er opløst, så drik hele glassets indhold med det samme.
• Once the tablet has dissolved, drink everything in the glass straight away.
Der inkluderedes 260 patienter med myeloid blastkrise.
260 patients with myeloid blast crisis were enrolled.
Hæmatologiske responskriterier (alle respons skal bekræftes efter ≥4 uger):
1 Haematological response criteria (all responses to be confirmed after ≥ 4 weeks):
Translokationen t(17:22) [(q22:q13)], eller dets gen-produkt, var til stede i næsten alle respons på Imatinib Teva-behandling.
The translocation t(17:22)[(q22:q13)], or its gene product, was present in nearly all responders to imatinib treatment.
Fuldstændigt hæmatologisk respons opnåedes hos 95% af patienterne.
A complete haematological response was achieved in 95% of patients.
Der inkluderedes 235 voksne patienter med accelereret sygdomsfase.
235 adult patients with accelerated phase disease were enrolled.
Plasma AUC for denne metabolit blev kun fundet at være 16% af AUC for imatinib.
The plasma AUC for this metabolite was found to be only 16% of the AUC for imatinib.
Lignende resultater fandtes baseret på analysen efter 18 måneder.
Similar findings were found based on a 18months landmark analysis.
Efter 42 måneders opfølgning fik 11 patienter bekræftet tab (inden for 4 uger) af cytogenetiske respons (inden for 4 uger).
After 42 months of follow-up, 11 patients experienced a confirmed loss (within 4 weeks) of their cytogenetic response.
20 ud af 50 (40%) patienter i kohorte 5 fik hæmatopoietisk stamcelletransplantation.
20 out of the 50 (40%) patients in cohort 5 received haematopoietic stem cell transplant.
Fem patienter responderede, 3 komplet og 2 partielt.
5 patients responded, 3 completely and 2 partially.
Imatinib Teva kan gøre det samme ved andre lægemidler.
Imatinib Teva may do the same to some other medicines.
Din læge har udskrevet Imatinib Teva, fordi du lider af en alvorlig sygdom.
Your doctor has prescribed Imatinib Teva because you suffer from a serious condition.
Den høje rate af CHR er ledsaget af udvikling af komplet cytogenetisk respons (CCyR) hos 65%, hvilket er sammenligneligt med resultater observeret hos voksne.
The high rate of CHR is accompanied by the development of a complete cytogenetic response (CCyR) of 65% which is comparable to the results observed in adults.
Dette skyldes, at Imatinib Teva kan forårsage, at hepatitis B-infektionen bliver aktiv igen, hvilket undertiden kan være dødeligt.
This is because Imatinib Teva could cause hepatitis B to become active again, which can be fatal in some cases.
Mens du tager Imatinib Teva, vil din læge regelmæssigt kontrollere, om lægemidlet virker.
While you are taking Imatinib Teva your doctor will regularly check whether the medicine is working.
Incidensen af hæmatologisk respons var 70% med en varighed på 2-3 måneder.
The rate of haematological response was 70% with a duration of 2-3 months.
ULN = laboratoriets øvre normalgrænse AST = aspartat aminotransferase
ULN = upper limit of normal for the institution AST = aspartate aminotransferase
Den estimerede 4-års OS hos kohorte 5-patienter var 83,6% sammenlignet med 44,8% i den historiske kontrolgruppe.
The estimated 4-year OS in cohort 5-patients was 83.6% compared to 44.8% in the historical controls.
Den gennemsnitlige absolutte biotilgængelighed for imatinib er 98%.
Mean absolute bioavailability for imatinib is 98%.
Imatinib Teva kan hjælpe dig med at bekæmpe denne tilstand.
Imatinib Teva can help you to fight this condition.
Ki værdier i humane levermikrosomer var henholdsvis 27; 7,5 og 7,9 µmol/l.
Ki values in human liver microsomes were 27, 7.5 and 7.9 µmol/l, respectively.
Ikke relevant Ikke relevant
Not applicable Not applicable
Om nødvendigt kan det overvejes at ophøre med Imatinib Teva-behandling.
When needed, discontinuation of Imatinib Teva treatment may be considered.
Nogle børn og unge, der får Imatinib Teva, kan vokse langsommere end normalt.
Some children and adolescents taking Imatinib Teva may have slower than normal growth.
Dette lægemiddel kræver ingen specielle opbevaringsforhold.
This medicine does not require any special storage conditions.
Medianvarigheden af andenvalgsbehandling med imatinib var 64 måneder.
The median duration of second-line treatment with imatinib was 64 months.
- Imatinib Teva anbefales ikke under graviditeten, medmindre det er strengt nødvendigt, da det kan skade din baby.
- Imatinib Teva is not recommended during pregnancy unless clearly necessary as it may harm your baby.
Væsentligt er det, at 27,7% af patienterne også opnåede et cytogenetisk hovedrespons, hvilket var fuldstændigt hos 20,4% (bekræftet 16%) af patienterne.
Importantly, 27.7% of patients also achieved a major cytogenetic response, which was complete in 20.4% (confirmed 16%) of patients.
Graden af cytogenisk respons og molekylært respons havde en klar effekt på langtidsudfaldet for patienter i imatinib-behandling.
The degree of cytogenetic response and molecular response had a clear effect on long-term outcomes in patients on imatinib.
De kan enten øge eller nedsætte virkningen af Imatinib Teva, hvilket kan resultere i enten flere bivirkninger, eller de kan gøre Imatinib Teva mindre virksomt.
They may increase or decrease the effect of Imatinib Teva, either leading to increased side effects or making Imatinib Teva less effective.
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).
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).
Den årlige frekvens for progression til fremskreden fase eller blastkrise aftog, jo længere behandlingen stod på, og var mindre end 1% årlig i fjerde og femte år.
The annual rate of progression to accelerated phase or blast crisis decreased with time on therapy and was less than 1% annually in the fourth and fifth years.
For patienter behandlet med 600 mg, var de nuværende estimater for median progressionsfri overlevelse og overlevelse i det hele taget henholdsvis 22,9 og 42,5 måneder.
For the patients treated at 600 mg, the current estimates for median progression-free-survival and overall survival were 22.9 and 42.5 months, respectively.
Bivirkninger Bivirkninger rapporteret med mere end et isoleret tilfælde er listet nedenfor efter organklasse og frekvens.
Adverse reactions reported as more than an isolated case are listed below, by system organ class and by frequency.
Derudover sås partielt cytogetisk respons (PCyR) hos 16%, dermed MCyR hos 81%.
Additionally, partial cytogenetic response (PCyR) was observed in 16% for a MCyR of 81%.
Imatinibs farmakokinetik er ikke specifikt undersøgt hos ældre.
Imatinib pharmacokinetics has not been specifically studied in the elderly.
Du må ikke stoppe med at tage Imatinib Teva, medmindre din læge fortæller dig det.
Do not stop taking Imatinib Teva unless your doctor tells you to.
12 Gy i 8 fraktioner for alle patienter, som er CNS1 og CNS2 ved diagnosticering
12 Gy in 8 fractions for all patients that are CNS1 and CNS2 at diagnosis
For patienter med reduktion i Bcr-Abl transkripter på mindst 3 logaritmer ved 12 måneder, var sandsynligheden for at forblive fri for progression til accelereret fase/blastkrise 99% efter 84 måneder.
For patients with reduction in Bcr-Abl transcripts of at least 3 logarithms at 12 months, the probability of remaining free from progression to accelerated phase/blast crisis was 99% at 84 months.
Der opnåedes konfirmeret hæmatologisk respons hos 71,5% af patienterne (Tabel 3).
A confirmed haematological response was achieved in 71.5% of patients (Table 3).
Varigheden af behandling med Imatinib Teva kan variere med det valgte behandlingsprogram, men generelt har længere eksponering for Imatinib Teva givet de bedste resultater.
The duration of imatinib therapy can vary with the treatment programme selected, but generally longer exposures to imatinib have yielded better results.
Merckle GmbH Graf-Arco-Str. 3, 89079 Ulm Tyskland
Merckle GmbH Graf-Arco-Str. 3, 89079 Ulm Germany
DFSP (ved 800 mg dosis)
DFSP (at dose 800 mg)
• Genopblussen (reaktivering) af hepatitis B-infektion, hvis du tidligere har haft hepatitis B (leverbetændelse type B).
• Recurrence (reactivation) of hepatitis B infection when you have had hepatitis B in the past (a liver infection).
Imatinib Teva kan nedsætte antallet af hvide blodlegemer, så du lettere kan få infektioner.
Imatinib Teva can reduce the number of white blood cells, so you might get infections more easily.
Polyvinylalkohol (delvist hydrolyseret) Macrogol
Polyvinyl alcohol partially hydrolysed Macrogol
Imatinib-behandling inducerer et hurtigt respons hos nydiagnosticerede pædiatriske CML-patienter med en CHR hos 78% efter 8 ugers behandling.
Imatinib treatment induces a rapid response in newly diagnosed paediatric CML patients with a CHR of 78% after 8 weeks of therapy.
532 voksne patienter blev behandlet med en startdosis på 400 mg.
532 adult patients were treated at a starting dose of 400 mg.
Dato for første markedsføringstilladelse: 8. januar 2013 Dato for seneste fornyelse: 18. september 2017
Date of latest renewal: 18 September 2017
Til sammenligning var der 165 (29,8%) hændelser i IFN+Ara-C-armen, af hvilke 130 opstod under førstevalgsbehandling med IFN+Ara-C.
In contrast, there were 165 (29.8%) events in the IFN+Ara-C arm, of which 130 occurred during first-line treatment with IFN+Ara-C.
Tabel 2 Respons i undersøgelsen vedrørende nydiagnosticeret CML (84 måneders data) (Bedste respons)
Table 2 Response in newly diagnosed CML Study (84-month data)
Det aktive stof imatinib udgør en miljørisiko for organismer i sedimenter.
The active substance imatinib demonstrates an environmental risk for sediment organisms.
• Blodpropper i små blodkar (trombotisk mikroangiopati).
• Blood clots in small blood vessels (thrombotic microangiopathy).
Specifik dosisjustering er ikke nødvendig til ældre.
No specific dose recommendation is necessary in the elderly.
Plasma AUC for imatinib blev reduceret med 73% sammenlignet med patienter som ikke blev behandlet med EIAEDs.
The plasma AUC for imatinib decreased by 73% compared to patients not on EIAEDs.
59% var mænd, 41% kvinder; 89,9% var af kaukatisk afstamning og 4,7% af negroid afstamning.
There were 59% males and 41% females; 89.9% caucasian and 4.7% black patients.
Undersøgelse 0109 40,5 måneders data Accelereret fase (n=235)
Study 0109 40.5-month data Accelerated phase (n=235)
Blastkrise defineres som ≥ 30% blaster i blod eller knoglemarv eller ekstramedullær sygdom ud over hepatosplenomegali.
Blast crisis is defined as blasts ≥ 30% in blood or bone marrow or extramedullary disease other than hepatosplenomegaly.
Hvis du har spørgsmål om, hvordan Imatinib Teva virker, eller hvorfor du har fået ordineret dette lægemiddel, kontakt din læge.
If you have any questions about how Imatinib Teva works or why this medicine has been prescribed for you, ask your doctor.
Molekylær major responskriterier: I det perifere blod reduktion på ≥3 logariter i antallet af Bcr-Abl-transkriptioner (målt ved real-time kvantitativ reverse transkriptase PCR assay) over for en standardiseret baseline.
Major molecular response criteria: in the peripheral blood reduction of ≥ 3 logarithms in the amount of Bcr-Abl transcripts (measured by real-time quantitative reverse transcriptase PCR assay) over a standardised baseline.
I denne undersøgelse opnåede 65% af patienterne et cytogenetisk hovedrespons, som var fuldstændigt hos 53% (bekræftet 43%) af patienterne (Tabel 3).
In this study 65% of the patients achieved a major cytogenetic response that was complete in 53% (confirmed 43%) of patients (Table 3).
Populationsfarmakokinetiske analyser hos CML-patienter har vist, at alder har en lille effekt på fordelingsvolumen (12% stigning hos patienter >65 år).
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).
* Denne type bivirkninger er hovedsageligt blevet rapporteret efter markedsføring af imatinib.
* These types of reactions have been reported mainly from post-marketing experience with imatinib.
Hovedresponsniveauet var også større hos patienter behandlet med 600 mg (33%) sammenlignet med patienter behandlet med 400 mg (16%, p=0,0220).
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).
Eksponeringen er ca. 1,5- til 2- fold, svarende til en 1,5-gangs stigning af plasma AGP som imatinib binder stærkt til.
The increase is approximately 1.5 to 2-fold, corresponding to a 1.5-fold elevation of plasma AGP, to which imatinib binds strongly.
Mogilska 80, 31-546 Krakow Polen
Mogilska 80, 31-546 Krakow Poland
Myeloid blastkrise
Myeloid blast crisis
Der sås også en let til moderat reduktion i spermatogenesen hos hunde ved orale doser >30 mg/kg.
A slight to moderate reduction in spermatogenesis was also observed in the dog at oral doses ≥ 30 mg/kg.
Imatinib og N-demethylmetabolitten udgjorde tilsammen ca. 65% af den cirkulerende radioaktivitet (AUC(0-48t)).
Imatinib and the N-demethyl metabolite together accounted for about 65% of the circulating radioactivity (AUC(0-48h)).
Procentdelen af nogle bivirkninger var højere hos de 40 patienter, hvor dosis blev øget til 800 mg daglig sammenlignet med patientpopulationen inden dosisstigning (n=551).
The percentage of some adverse reactions was higher in the 40 patients in whom the dose was increased to 800 mg daily compared to the population of patients before dose increase (n=551).
Imatinib Teva vil kun blive ordineret til dig af en læge med erfaring i behandlingen af kræft i blodet eller kræftknuder.
Imatinib Teva will only be prescribed to you by a doctor with experience in medicines to treat blood cancers or solid tumours.
I denne undersøgelse opnåede 31% af patienterne et hæmatologisk respons (36% af de tidligere ”ubehandlede patienter” og 22% af de ”tidligere behandlede patienter”).
In this study, 31% of patients achieved a haematological response (36% in previously untreated patients and 22% in previously treated patients).
Bivirkningsmønstret var, med 2 undtagelser, det sammme ved alle indikationer.
The adverse reactions were similar in all indications, with two exceptions.
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.
This was a population of heavily pretreated patients, as 46% had received prior BMT and 73% a prior multi-agent chemotherapy.
Progression blev defineret som enhver af følgende hændelser: progression til accelereret fase eller blastkrise, død, tab af CHR eller MCyR, eller patienter der ikke opnår CHR eller øget leukocyttal på trods af relevant terapeutisk behandling.
Progression was defined as any of the following events: progression to accelerated phase or blast crisis, death, loss of CHR or MCyR, or in patients not achieving a CHR an increasing WBC despite appropriate therapeutic management.
Din læge vil fortælle dig om de mulige risici, der er forbundet med brug af Imatinib Teva under graviditeten.
Your doctor will discuss with you the possible risks of taking Imatinib Teva during pregnancy.
• Smertefulde og/eller blæredannende hudlæsioner.
• Painful and/or blistering skin lesions.
Imatinib Teva er et lægemiddel, der indeholder et aktivt stof kaldet imatinib.
Imatinib Teva is a medicine containing an active substance called imatinib.
Patienterne blev fordelt i 3 hovedkategorier: Manglende hæmatologisk effekt (29%), manglende cytogenetisk effekt (35%) eller interferonintolerans (36%).
The patients were distributed in three main categories: haematological failure (29%), cytogenetic failure (35%), or intolerance to interferon (36%).
Total bilirubin: = 1,5 ULN AST: >ULN (kan være normal or < ULN hvis total bilirubin er > ULN)
Total bilirubin: = 1.5 ULN AST: >ULN (can be normal or < ULN if total bilirubin is > ULN)
En specialist i leversygdomme og i behandling af hepatitis B skal konsulteres, før behandling initieres hos patienter med positiv hepatitis B-serologi (herunder patienter med aktiv sygdom), og hvis patienten testes HBVpositiv under behandlingen.
Experts in liver disease and in the treatment of hepatitis B should be consulted before treatment is initiated in patients with positive hepatitis B serology (including those with active disease) and for patients who test positive for HBV infection during treatment.
95 (37%) havde tidligere modtaget kemoterapi til behandling af enten accelereret fase eller blastkrise (”tidligere behandlede patienter”), hvorimod 165 (63%) ikke havde (”ubehandlede patienter”).
95 (37%) had received prior chemotherapy for treatment of either accelerated phase or blast crisis (“pretreated patients”) whereas 165 (63%) had not (“untreated patients”).
Der er meget begrænset erfaring med Imatinib Teva ved denne indikation, og den er baseret på hæmatologiske og cytogenetiske responsrater.
Experience with imatinib in this indication is very limited and is based on haematological and cytogenetic response rates.
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.
This Ki value is far higher than the expected plasma levels of imatinib in patients; consequently no interaction is expected upon co-administration of either 5-fluorouracil or paclitaxel and imatinib.
Imatinib interfererede ikke med biotransformationen af 5-fluorouracil, men hæmmede paclitaxelmetabolismen på grund af kompetitiv hæmning af CYP2C8 (Ki = 34,7 μm).
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).
Ved 84 måneder var den estimerede samlede overlevelse 86,4% (83, 90) vs. 83,3% (80, 87) i henholdsvis de randomiserede imatinib- og IFN+Ara-C-grupper (p=0,073, log-rank test).
At 84 months the estimated overall survival is 86.4% (83, 90) vs. 83.3% (80, 87) in the randomised imatinib and the IFN+Ara-C groups, respectively (p=0.073, log-rank test).
Der blev hos GIST patienter (studie B2222) observeret stigning i grad 3 eller 4 ALT (alaninaminotransferase) hos 6,8% og stigning i grad 3 eller 4 AST (aspartat aminotransferase) hos 4,8%.
In GIST patients (study B2222), 6.8% of grade 3 or 4 ALT (alanine aminotransferase) elevations and 4.8% of grade 3 or 4 AST (aspartate aminotransferase) elevations were observed.
Major respons ved 12 måneder (%)
Major response at 12 months (%)
Genoptag Imatinib Tevabehandlingen ved den tidligere dosis (dvs. før svære bivirkninger).
Resume treatment with imatinib at previous dose (i.e. before severe adverse reaction).
Hvis niveauet af ADAMTS13antistoffer er forøget samtidig med lav ADAMTS13-aktivitet, må behandlingen med Imatinib Teva ikke genoptages.
If anti-ADAMTS13-antibody is elevated in conjunction with low ADAMTS13 activity, treatment with Imatinib Teva should not be resumed.
a ANC < 0.5 x 10
ANC < 0.5 x 10
ANC = fuldstændigt antal neutrofilocytter aopstået efter mindst 1 måneds behandling
ANC = absolute neutrophil count a occurring at least after one month of treatment
Tabletterne er ca. 9 mm i diameter.
The tablets are approximately 9 mm in diameter.
Patienterne havde i gennemsnit tidligere modtaget 14 måneders IFNbehandling med doser ≥2 x 106 IE/uge og var alle i sen kronisk fase med en gennemsnitlig tid siden diagnose på 32 måneder.
Patients had received a median of 14 months of prior IFN therapy at doses ≥ 25 x 106 IU/week and were all in late chronic phase, with a median time from diagnosis of 32 months.
• Øjensmerter eller svækkelse af dit syn, blødning i øjnene.
• Eye pain or deterioration in vision, bleeding in the eyes.