natgillin/translations-raw huggingface dataset:
33 sædvanligvis behandlet ved midlertidigt at tilbageholde behandling med Glivec, og behandle med diuretika og andre relevante, understøttende tiltag.
These reactions can usually be managed by withholding Glivec temporarily and with diuretics and other appropriate supportive care measures.
Meget almindelig (> 1/ 10), almindelig (> 1/ 100 ≤1/ 10) og usædvanlig (> 1/ 1. 000 ≤1/ 100), sjælden (≤1/ 1. 000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data.
Frequencies are defined as: very common (> 1/ 10), common (> 1/ 100, ≤ 1/ 10), uncommon (> 1/ 1,000, ≤ 1/ 100), rare (≤ 1/ 1,000), not known (cannot be estimated from the available data).
Kvalme, diarré, opkast, dyspepsi, abdominalsmerter4 Flatulens, abdominal udspilling, gastrooesophageal refluks, obstipation,
Nausea, diarrhoea, vomiting, dyspepsia, abdominal pain4 Flatulence, abdominal distension, gastro-oesophageal reflux, constipation, dry mouth, gastritis
Herpes zoster, herpes simplex, næsesvælgsrumskatar, pneumoni7, bihulebetændelse, cellulitis, infektioner i øvre luftveje, influenza, urinvejsinfektion, gastroenteritis, sepsis
Herpes zoster, herpes simplex, nasopharyngitis, pneumonia7, sinusitis, cellulites, upper respiratory tract infection, influenza, urinary tract infection, gastroenteritis, sepsis
35 1 På patientårsbasis blev kardielle hændelser, herunder hjertesvigt, observeret oftere hos patienter med transformeret CML i forhold til patienter med kronisk CML.
1 On a patient-year basis, cardiac events including congestive heart failure were more commonly observed in patients with transformed CML than in patients with chronic CML.
Hæmatologi Cytopeni hos CML- patienter, særligt neutropeni og thrombocytopeni, har været gennemgående fund i alle undersøgelser med tegn på større hyppighed ved doser ≥750 mg (fase I undersøgelse).
36 Laboratory test abnormalities Haematology In CML, cytopenias, particularly neutropenia and thrombocytopenia, have been a consistent finding in all studies, with the suggestion of a higher frequency at high doses ≥ 750 mg (phase I study).
Incidensen af cytopeni hang imidlertid også tydeligt sammen med sygdomsstadiet, idet hyppigheden af 3. eller 4. grads neutropeni (ANC < 1, 0 x 109/ l) og thrombocytopeni (thrombocyttal < 50 x 109/ l) var 4– 6 gange højere ved blastkrise og accelereret fase (59– 64% og 44– 63% for henholdsvis neutropeni og
However, the occurrence of cytopenias was also clearly dependent on the stage of the disease, the frequency of grade 3 or 4 neutropenias (ANC < 1.0 x 109/ l) and thrombocytopenias (platelet count < 50 x 109/ l) being between 4 and 6 times higher in blast crisis and accelerated phase (59– 64% and 44– 63% for neutropenia and thrombocytopenia, respectively) as compared to newly diagnosed patients in chronic phase CML (16.7% neutropenia and 8.9% thrombocytopenia).
Hos GIST- patienter rapporteredes anæmi grad 3 og 4 hos henholdsvis 5, 4% og 0, 7% af patienterne, hvilket kan hænge sammen med gastrointestinal eller intra- tumoral blødning, i hvert fald hos enkelte af patienterne.
In patients with GIST, grade 3 and 4 anaemia was reported in 5.4% and 0.7% of patients, respectively, and may have been related to gastrointestinal or intra-tumoural bleeding in at least some of these patients.
Der er ingen kontrollerede undersøgelser undtagen hos nyligt diagnosticerede kronisk fase CML- patienter, der har vist klinisk bedring såsom forbedring af sygdomsrelaterede symptomer eller øget overlevelse.
Except in newly diagnosed chronic phase CML, there are no controlled trials demonstrating a clinical benefit, such as improvement in disease-related symptoms or increased survival.
Større cytogenetisk respons, hæmatologisk respons, molekylær respons (evaluering af minimal tilbageværende sygdom), tid til accellereret fase eller blastkrise samt overlevelse er de sekundære hovedeffektmål.
Major cytogenetic response, haematological response, molecular response (evaluation of minimal residual disease), time to accelerated phase or blast crisis and survival are main secondary endpoints.
490 (88, 6%) * 38
490 (88.6%)*
Lignende resultater fandtes baseret 39 på analysen efter 18 måneder.
Similar findings were found based on a 18-months landmark analysis.
Hovedresponsniveauet var også større hos patienter behandlet med 600 mg (33%) sammenlignet med patienter behandlet med 400 mg (16%, p=0, 0220).
40 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).
40 Tabel 4
Table 4
Det var en population af patienter, der i udtalt omfang 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.
Glivecbehandling inducerer et hurtigt respons hos nydiagnosticerede pædiatriske CML- patienter med en CHR hos 78% efter 8 ugers behandling.
Glivec treatment induces a rapid response in newly diagnosed paediatric CML patients with a CHR of 78% after 8 weeks of therapy.
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.
41 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.
41 (96, 3% versus 50%, p=0, 0001).
50%; p=0.0001).
42 dag 1- 3; vinkistin 1, 3 mg/ m2 i. v., dag 1, 8, 15, 21; prednisolon 60 mg/ m2/ dag oral
(1 h), days 1-3; vincristine 1.3 mg/ m2 i. v., days 1, 8, 15, 21; prednisolone 60 mg/ m2/ day oral
43 PDGFR- proteintyrosinkinaser.
43 or disappearance of fusion transcripts as measured by RT-PCR.
I to kliniske undersøgelser (studie B2222 og et mellemgruppe studie S0033) blev den daglige dosis optrappet til 800 mg hos patienter, hvis sygdom fremskrider ved de lavere daglige doser på 400 mg eller 600 mg.
44 In two clinical studies (study B2222 and an intergroup study S0033) the daily dose of Glivec was escalated to 800 mg in patients progressing at the lower daily doses of 400 mg or 600 mg.
44 Kliniske studier ved DFSP Der er udført et åbent multicenter fase II- klinisk forsøg (studie B2225) med inklusion af 12 patienter med DFSP, som blev behandlet med Glivec 800 mg daglig.
Clinical studies in DFSP One phase II, open label, multicentre clinical trial (study B2225) was conducted including 12 patients with DFSP treated with Glivec 800 mg daily.
Imatinib blev in vitro vist at være en kompetitiv hæmmer af markørsubstrater for CYP2C9, CYP2D6 og CYP3A4/ 5.
45 Imatinib was shown in vitro to be a competitive inhibitor of marker substrates for CYP2C9, CYP2D6 and CYP3A4/ 5.
45 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.
5. 3 Prækliniske sikkerhedsdata
46 5.3 Preclinical safety data
46 Toksicitetsundersøgelser med gentagen dosering viste milde til moderate hæmatologiske forandringer hos rotter, hunde og aber, ledsaget af knoglemarvsændringer hos rotter og hunde.
Multiple dose toxicity studies revealed mild to moderate haematological changes in rats, dogs and monkeys, accompanied by bone marrow changes in rats and dogs.
I et 2- års carcinogen studie i rotter resulterede administration af imatinib på 15, 30 og 60 mg/ kg/ dag i en signifikant reduktion i levetiden ved 60 mg/ kg/ dag for hanner og for hunner ved ≥30 mg/ kg/ dag.
47 In the 2-year rat carcinogenicity study administration of imatinib at 15, 30 and 60 mg/ kg/ day resulted in a statistically significant reduction in the longevity of males at 60 mg/ kg/ day and females at ≥ 30 mg/ kg/ day.
Dette svarer til 0, 4 gange den daglige eksponering (baseret på AUC) hos børn på 340 mg/ m2/ dag.
Papilloma/ carcinoma of the preputial/ clitoral gland were noted from 30mg/ kg/ day onwards, representing approximately 0.5 or 0.3 times the human daily exposure (based on AUC) at 400 mg/ day or 800 mg/ day, respectively, and 0.4 times the daily exposure in children (based on AUC) at 340 mg/ m2/ day.
Gelatine Jernoxid, rød (E 172) Jernoxid, gul (E 172) Titandioxid (E 171)
Gelatin Iron oxide, red (E172) Iron oxide, yellow (E172) Titanium dioxide (E171)
6. 4 Særlige opbevaringsforhold
48 6.4 Special precautions for storage
48 Pakninger indeholdende 24, 48, 96, 120 og 180 kapsler.
Packs containing 24, 48, 96, 120 and 180 capsules.
Meget mørk gul til brunlig- orange filmovertrukken tablet, rund med ” NVR ” på den ene side og ” SA ” samt delekærv på den anden side.
Very dark yellow to brownish-orange film-coated tablet, round with “ NVR” on one side and “ SA” and score on the other side.
50 4. 2 Dosering og indgivelsesmåde
50 4.2 Posology and method of administration
Behandlingen bør initieres af en læge med erfaring i behandling af patienter med maligne hæmatologiske lidelser og/ eller maligne sarkomer eller som passende.
Therapy should be initiated by a physician experienced in the treatment of patients with haematological malignancies and malignant sarcomas, as appropriate.
Patienter, der ikke er i stand til at synke de filmovertrukne tabletter, kan dispergere tabletterne i et glas almindeligt vand eller æblejuice.
For patients unable to swallow the film-coated tablets, the tablets may be dispersed in a glass of mineral water or apple juice.
50 ml til en 100 mg tablet og 200 ml til en 400 mg tablet) og omrøres med en ske.
The required number of tablets should be placed in the appropriate volume of beverage (approximately 50 ml for a 100 mg tablet, and 200 ml for a 400 mg tablet) and stirred with a spoon.
Suspensionen skal administreres straks efter fuldstændig opløsning af tabletten/ tabletterne.
The suspension should be administered immediately after complete disintegration of the tablet(s).
Dosisøgning fra 340 mg/ m2 daglig til 570 mg/ m2 daglig (uden at overstige total dosis på 800 mg) kan overvejes hos børn ved fravær af alvorlige bivirkninger og svær ikke- leukæmirelateret neutropeni eller thrombocytopeni ved følgende omstændigheder: sygdomsprogression (på ethvert tidspunkt); hvis der ikke er opnået tilfredsstillende hæmatologisk respons efter mindst 3 måneders behandling; hvis der ikke er opnået cytogenetisk respons efter 12 måneders behandling; eller ved tab af tidligere opnået hæmatologisk og/ eller cytogenetisk respons.
Dose increases from 340 mg/ m2 daily to 570 mg/ m2 daily (not to exceed the total dose of 800 mg) may be considered in children in the absence of severe adverse drug reaction and severe non-leukaemia- related neutropenia or thrombocytopenia in the following circumstances: disease progression (at any 51 time); failure to achieve a satisfactory haematological response after at least 3 months of treatment; failure to achieve a cytogenetic response after 12 months of treatment; or loss of a previously achieved haematological and/ or cytogenetic response.
Patienterne bør monitoreres tæt under dosiseskaleringen, 51 da der er mulighed for øget forekomst af bivirkninger ved højere doseringer.
Patients should be monitored closely following dose escalation given the potential for an increased incidence of adverse reactions at higher dosages.
Dosisøgning fra 100 mg til 400 mg kan overvejes, hvis der ikke er observeret bivirkninger, og respons på behandlingen vurderes som værende utilstrækkeligt
Dose increase from 100 mg to 400 mg may be considered in the absence of adverse drug reactions if assessments demonstrate an insufficient response to therapy.
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
52 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.
I tilfælde af svær neutropeni og thrombocytopeni anbefales dosisreduktion eller seponering af behandlingen, som angivet i nedenstående tabel:
Haematological adverse reactions Dose reduction or treatment interruption for severe neutropenia and thrombocytopenia are recommended as indicated in the table below.
Hvis cytopeni vedvarer i 4 uger og stadig ikke er leukæmirelateret, seponér Glivec - behandlingen indtil ANC ≥1, 0 x 109l og thrombocytter ≥20 x 109l og genoptag
If cytopenia persists for 4 weeks and is still unrelated to leukaemia, stop Glivec until ANC ≥ 1 x 109/ l and platelets ≥ 20 x 109/ l, then resume treatment at
behandling med 200 mg/ m2.
200 mg/ m2.
ANC < 1, 0 x 10 / l og/ eller thrombocytter < 50 x 109/ l
ANC < 1.0 x 109/ l and/ or platelets < 50 x 109/ l
Stop Glivec indtil ANC ≥1, 5 x 109/ l og thrombocytter ≥75 x 109/ l.
Stop Glivec until ANC ≥ 1.5 x 109/ l and platelets ≥ 75 x 109/ l.
Når Glivec administreres sammen med andre lægemidler, er der risiko for lægemiddelinteraktioner (se pkt.
When Glivec is co-administered with other medicinal products, there is a potential for drug interactions (see section 4.5).
4. 5).
Concomitant use of imatinib and medicinal products that induce CYP3A4 (e. g. dexamethasone,
54 Samtidig anvendelse af imatinib og lægemidler, der inducerer CYP3A4 (f. eks. dexamethason, phenytoin, carbamazepin, rifampicin, phenobarbital eller hypericum perforatum, også kendt som prikbladet perikum) kan signifikant reducere følsomheden over for Glivec, og dermed potientielt øge risikoen for terapeutisk svigt.
John’ s Wort) may significantly reduce exposure to Glivec, potentially increasing the risk of therapeutic failure.
Disse cytopenier opstår imidlertid sandsynligvis relateret til det sygdomsstadie, der behandles, og er hyppigere hos patienter med CML i accelereret fase eller blastkrise end hos patienter med CML i kronisk fase.
However, the occurrence of these cytopenias is likely to be related to the stage of the disease being treated and they were more frequent in patients with accelerated phase CML or blast crisis as compared to patients with
55 i Glivec- behandling.
55 chronic phase CML.
Plasmaeksponeringen synes at være højere hos patienter med nedsat nyrefunktion end hos patienter med normal nyrefunktion, formentlig på grund af forhøjede plasmaniveauer af alpha- acid glucoprotein (AGP), et imatinib- bindende protein, hos disse patienter.
In patients with impaired renal function, imatinib plasma exposure seems to be higher than that in patients with normal renal function, probably due to an elevated plasma level of alpha-acid glycoprotein (AGP), an imatinib-binding protein, in these patients.
Stoffer, der hæmmer cytochrom P450 isoenzym CYP3A4- aktivitet (f. eks. ketoconazol, itraconazol, erythromycin, clarithromycin), kan nedsætte metabolismen og øge koncentrationen af imatinib.
Substances that inhibit the cytochrome P450 isoenzyme CYP3A4 activity (e. g. ketoconazole, itraconazole, erythromycin, clarithromycin) could decrease metabolism and increase imatinib concentrations.
Samtidig behandling med CYP3A4- inducerende stoffer (f. eks. dexamethason, phenytoin, carbamazepin, rifampicin, phenobarbital, fosphenytoin, primidon eller hypericum perforatum, også kendt som prikbladet perikum) kan signifikant reducere følsomheden overfor Glivec, og dermed potentielt øge risikoen for terapeutisk svigt.
John’ s Wort) may significantly reduce exposure to Glivec, potentially increasing the risk of therapeutic failure.
Der tilrådes forsigtighed, når Glivec anvendes sammen med paracetamol, især ved høje doser af paracetamol.
56 Caution should therefore be exercised when using Glivec and paracetamol concomitantly, especially with high doses of paracetamol.
Mekanismen for den observerede interaktion er dog endnu ukendt
However, the mechanism of the observed interaction is presently unknown.
57 Når imatinib blev kombineret med højdosis kemoterapi hos Ph+ ALL patienter, sås forbigående levertoksicitet i form af forhøjet transaminase og hyperbilirubinæmi.
57 When imatinib was combined with high dose chemotherapy in Ph+ ALL patients, transient liver toxicity in the form of transaminase elevation and hyperbilirubinaemia were observed.
Diverse bivirkninger, som for eksempel pleuraeksudat, ascites, lungeødem og hurtig vægtstigning med eller uden overfladiske ødemer, kan kollektivt betegnes som ” væskeretention ”.
Miscellaneous adverse reactions such as pleural effusion, ascites, pulmonary oedema and rapid weight gain with or without superficial oedema may be collectively described as “ fluid retention”.
58 Ikke almindelig:
Uncommon:
Pleuraekssudat3, faryngolaryngeale smerter, pharyngitis Pleuralgi, pulmonær fibrose, pulmonær hypertension, pulmonær blødning
Dyspnoea, epistaxis, cough Pleural effusion3, pharyngolaryngeal pain, pharyngitis Pleuritic pain, pulmonary fibrosis, pulmonary hypertension, pulmonary haemorrhage
Forhøjede leverenzymer Hyperbilirubinæmi, hepatitis, gulsot Leversvigt9, levernekrose og mammae Gynæcomasti, erektil dysfunktion, menorrhagi, uregelmæssig menstruation, seksuel dysfunktion, smerter i brystvorterne, brystforstørrelse, scrotalt ødem
Increased hepatic enzymes Hyperbilirubinaemia, hepatitis, jaundice Hepatic failure9, hepatic necrosis
Hæmatologi Cytopeni hos CML- patienter, særligt neutropeni og thrombocytopeni, har været gennemgående fund i alle undersøgelser med tegn på større hyppighed ved doser ≥750 mg (fase I undersøgelse).
60 Laboratory test abnormalities Haematology In CML, cytopenias, particularly neutropenia and thrombocytopenia, have been a consistent finding in all studies, with the suggestion of a higher frequency at high doses ≥ 750 mg (phase I study).
Incidensen
The median duration of the neutropenic and thrombocytopenic episodes usually ranged from 2 to 3 weeks, and from 3 to 4 weeks, respectively.
Stoffet hæmmer selektivt proliferationen og inducerer apoptosis i Bcr - Abl- positive cellelinier såvel som i friske leukæmiceller fra Philadelphia- kromosompositiv (Ph+) CML
The compound selectively inhibits proliferation and induces apoptosis in Bcr-Abl positive cell lines as well as fresh leukaemic cells from Philadelphia chromosome positive CML and acute lymphoblastic leukaemia (ALL) patients.
I dyremodeller, hvor der anvendes Bcr- Abl- positive tumorceller, har stoffet som enkeltstof in vivo antitumoraktivitet.
In vivo the compound shows anti-tumour activity as a single agent in animal models using Bcr-Abl positive tumour cells.
Der er udført 3 store, internationale, åbne, ikke- kontrollerede fase II undersøgelser med patienter med Philadelphia- kromosompositiv (Ph+) CML i fremskreden blastkrise eller accelereret fase, andre Ph+ - leukæmier eller med CML i kronisk fase men tidligere behandlet med alfa- interferonbehandling (IFN) uden effekt. Der er gennemført en større, åben, international, randomiseret, fase III multicenterundersøgelse med patienter med nydiagnosticeret Ph+ CML.
One large, open-label, multicentre, international randomised phase III study has been conducted in patients with newly diagnosed Ph+ CML.
Respons i undersøgelsen vedrørende nydiagnosticeret CML (60 måneders data)
Response in newly diagnosed CML Study (60-month data)
Glivec IFN+Ara- C
IFN+Ara-C
[94, 7%, 97, 9%] 62
[94.7%, 97.9%]
Hvor estimeret 97% (93%) af patienterne med CCyR (PCyR) ved 12 måneder var fri for progression til accelereret fase/ blastkrise ved 60 måneder, var kun 81% af patienterne uden CCyR ved 12 måneder fri for progression til fremskreden CML ved 60 måneder 63 (p < 0, 001 samlet, p=0, 20 mellem CCyR og PCyR).
Whereas an estimated 97% (93%) of patients with CCyR (PCyR) at 12 months were free of progression to accelerated phase/ blast crisis at 60 months, only 81% of patients without MCyR at 12 months were free of progression to advanced CML at 60 months (p < 0.001 overall, p=0.20 between CCyR and PCyR).
Hovedresponsniveauet var også større hos patienter behandlet med 600 mg (33%) sammenlignet med patienter behandlet med 400 mg (16%, p=0, 0220).
64 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).
64 Lymfoid blastkrise: der inkluderedes et begrænset antal patienter i fase I undersøgelser (n=10).
Lymphoid blast crisis: a limited number of patients were enrolled in phase I studies (n=10).
Hæmatologisk respons Fuldstændigt hæmatologisk respons (CHR)
% of patients (CI95%) 1 Haematological response Complete haematological response (CHR)
95% (92, 3- 96, 3) 95%
95% (92.3– 96.3) 95%
71% (65, 3- 77, 2) 42%
71% (65.3– 77.2) 42%
Intet tegn på leukæmi (NEL) Remission til kronisk fase (RTC) Cytogenetisk hovedrespons2 Fuldstændigt
No evidence of leukaemia (NEL)
Ikke relevant Ikke relevant 65% (61, 2- 69, 5) 53%
Not applicable
12% 17% 28% (22, 0- 33, 9) 20%
12%
5% 18% 15% (11, 2– 20, 4) 7%
Return to chronic phase (RTC) 2
1
17%
(Bekræftet3) [95% CI] Delvist
18%
(43%) [38, 6- 47, 2] 12%
Major cytogenetic response Complete
(16%) [11, 3- 21, 0] 7%
65% (61.2– 69.5) 53%
(2%)
28% (22.0– 33.9) 20%
[0, 6- 4, 4] 8%
15% (11.2– 20.4) 7%
BM = Knoglemarv; PB = Perifert blod.
1
2 Cytogenetiske responskriterier:
Haematological response criteria (all responses to be confirmed after ≥ 4 weeks):
Et hovedrespons kombinerer både fuldstændig og partiel respons:
BM = bone marrow, PB = peripheral blood 2 Cytogenetic response criteria:
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.
65 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.
65 Kliniske studier ved Ph+ ALL Nydiagnostiseret Ph+ ALL:
Clinical studies in Ph+ ALL Newly diagnosed Ph+ ALL:
I et kontrolleret studie (ADE10) hvor imatinib blev sammenlignet med kemoterapi- induktion hos 55 nydiagnostiserede patienter i alderen 55 år og derover, gav imatinib brugt som monoterapi anledning til en signifikant højere ratio af hæmalogisk respons end kemopterapi (96, 3% versus 50%, p=0, 0001).
50%; p=0.0001).
Induktionsbehandling I Induktionsbehandling II Konsoliderende
Induction therapy I
behandling Studie AJP01
Consolidation therapy Study AJP01
1, 5 g/ m2 i. v.
DEX 10 mg/ m2 oral, days 1-5; vindesine 3 mg/ m2 i. v., day 1; MTX 1.5 g/ m2 i. v.
(1 time), dag 1- 3; vinkistin 1, 3 mg/ m2 i. v., dag 1, 8, 15, 21; prednisolon 60 mg/ m2/ dag oral
(1 h), days 1-3; vincristine 1.3 mg/ m2 i. v., days 1, 8, 15, 21; prednisolone 60 mg/ m2/ day oral
67 genetisk translokation.
67 or disappearance of fusion transcripts as measured by RT-PCR.
Kliniske undersøgelser vedrørende HES/ CEL Der er udført en åben, multicenter fase II- undersøgelse (studie B2225) med henblik på at vurdere Glivec hos en blandet patientpopulation med livstruende sygdomme forbundet med Abl -, Kit - eller PDGFR- proteintyrosinkinaser.
Clinical studies in HES/ CEL One open-label, multicentre, phase II clinical trial (study B2225) was conducted testing Glivec in diverse populations of patients suffering from life-threatening diseases associated with Abl, Kit or PDGFR protein tyrosine kinases.
I dette studie blev 14 patienter med HES/ CEL behandlet med 100 mg - 1. 000 mg Glivec daglig.
In this study, 14 patients with HES/ CEL were treated with 100 mg to 1,000 mg of Glivec daily.
betydelig gruppe patienter, længere behandling
A significant number of
(median opfølgningstid på 31 måneder).
patients who had stable disease at the time of the interim analysis achieved a partial response with longer treatment (median follow-up 31 months).
I to kliniske undersøgelser (studie B2222 og et mellemgruppe studie S0033) blev den daglige dosis optrappet til 800 mg hos patienter, hvis sygdom fremskrider ved de lavere daglige doser på 400 mg eller 600 mg.
68 In two clinical studies (study B2222 and an intergroup study S0033) the daily dose of Glivec was escalated to 800 mg in patients progressing at the lower daily doses of 400 mg or 600 mg.