natgillin/translations-raw huggingface dataset:
Baseret på en farmakokinetisk populationsanalyse med 593 patienter med let nedsat nyrefunktion (CLcr 60 til &lt; 90 ml/min), 254 patienter med moderat nedsat nyrefunktion (CLcr 30 til &lt; 60 ml/min), 5 patienter med svært nedsat nyrefunktion (CLcr 15 til &lt; 30 ml/min) og 502 patienter med normal nyrefunktion (CLcr ≥ 90 ml/min) var osimertinibeksponeringerne sammenlignelige.
Based on a population pharmacokinetic analysis of 593 patients with mild renal impairment (CLcr 60 to less than 90 mL/min), 254 patients with moderate renal impairment (CLcr 30 to &lt; than 60 mL/min), 5 patients with severe renal impairment (CLcr 15 to &lt; than 30 mL/min) and 502 patients with normal renal function (greater than or equal to 90 mL/min), osimertinib exposures were similar.
På baggrund af en farmakokinetisk populationsanalyse blev serumalbumin identificeret som en signifikant kovariat med en forventet ændring på &lt; 30 % i osimertinibs AUCss over albuminintervallet på henholdsvis 29 til 46 g/l (95 % til 5 % kvantiler) ved sammenligning med AUCss for den mediane baseline-albumin på 39 g/l.
Based on population PK analysis, serum albumin was identified as a significant covariate with a &lt; 30% change in osimertinib AUCss expected across the albumin range of 29 to 46 g/L respectively (95% to 5% quantiles) when compared to the AUCss for the median baseline albumin of 39 g/L.
Baseret på farmakokinetisk populationsanalyse, er dosisjustering ligeledes ikke nødvendig hos patienter med let nedsat leverfunktion (total-bilirubin ≤ øvre normalgrænse (ULN) og aspartataminotransferase (ASAT) &gt; ULN eller total-bilirubin &gt; 1,0-1,5 x ULN og en hvilken som helst ASAT) eller moderat nedsat leverfunktion (total-bilirubin fra 1,5-3,0 x ULN og en hvilken som helst ASAT).
Similarly, based on population pharmacokinetic analysis, no dose adjustment is recommended in patients with mild hepatic impairment (total bilirubin ≤upper limit of normal (ULN) and aspartate aminotransferase (AST) &gt; ULN or total bilirubin &gt; 1.0 to 1.5x ULN and any AST) or moderate hepatic impairment (total bilirubin between 1.5 to 3 times ULN and any AST).
En populationsfarmakokinetisk analyse indikerede, at legemsvægt var en signifikant kovariat med en forventet ændring på &lt; 20 % i osimertinib-AUCss over et interval på henholdsvis 88 kg til 43 kg (95 % til 5 % fraktiler) i sammenligning med AUCss for den mediane legemsvægt på 61 kg.
Population PK analysis indicated that body weight was a significant covariate with a less than 20% change in osimertinib AUCss expected across a body weight range of 88 kg to 43 kg respectively (95% to 5% quantiles) when compared to the AUCss for the median body weight of 61 kg.
Justeret middelværdi Estimeret forskel (95 %CI) p-værdi p &lt; 0,001
Difference (95%CI) p-value p &lt; 0.001
HR=Hazard ratio; CI=Konfidensinterval, NC=Ikke muligt at beregne En HR &lt; 1 favoriserer TAGRISSO, en oddsratio på &gt; 1 favoriserer TAGRISSO CNS PFS bestemt ved RECIST v1.1 af CNS BICR (målbare og ikke målbare CNS-læsioner ved baseline ved BICR) n=61 for TAGRISSO og n=67 for EGFR TKI-komparator; ubekræftede responser
CNS PFS determined by RECIST v1.1by CNS BICR (CNS measurable and non-measurable lesions at baseline by BICR) n=61 for TAGRISSO and n=67 for EGFR TKI comparator; responses are unconfirmed Nominally statistically significant
Bivirkningerne er opstillet ifølge MedDRA-konventionen om hyppighed: meget almindelig (≥1/10); almindelig (≥1/100 til &lt; 1/10); ikke almindelig (≥1/1.000 til &lt; 1/100); sjælden (≥1/10.000 til &lt; 1/1.000); meget sjælden ( &lt; 1/10.000); ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
The reactions are classified according to MedDRA frequency convention: very common (≥ 1/10); common (≥1/100 to &lt; 1/10); uncommon (≥1/1,000 to &lt; 1/100); rare (≥1/10,000 to &lt; 1/1,000); very rare ( &lt; 1/10,000); not known (cannot be estimated from the available data).
I begge studier var esomeprazol 20 mg betydeligt bedre, sammenlignet med placebo, til opnåelse af det primære mål, fuldstændigt ophør af halsbrand defineret som ingen halsbrand i de seneste 7 dage før det sidste besøg (33,9 - 41,6 % versus placebo 11,9 - 13,7 % (p &lt; 0,001).
In both studies esomeprazole 20 mg was significantly better compared to placebo for the primary endpoint, complete resolution of heartburn, defined as no heartburn episodes during the last 7 days prior to the final visit (33.9% - 41.6% vs. placebo 11.9 - 13.7%, (p &lt; 0.001).
Det sekundære mål, fuldstændigt ophør af halsbrand, defineret som ingen halsbrand på patientens dagbogskort i 7 på hinanden følgende dage, var statistisk signifikant både i uge 1 (10,0 - 15,2 % versus placebo 0,9 - 2,4 %; p = 0,014 henholdsvis p &lt; 0,001 i de 2 studier) og i uge 2 (25,2 - 35,7 % versus placebo 3,4 - 9,0 %, p &lt; 0,001).
The secondary endpoint of complete resolution of heartburn, defined as no heartburn on the patient's diary card for 7 consecutive days, was statistically significant at both week 1 (10.0% - 15.2% vs placebo 0.9% - 2.4%, p = 0.014, p &lt; 0.001) and week 2 (25.2% - 35.7% vs placebo 3.4% - 9.0%, p &lt; 0.001).
Hverken levetiracetam eller den primære metabolit bindes i signifikant grad til plasmaproteiner ( &lt; 10 %).
Neither levetiracetam nor its primary metabolite are significantly bound to plasma proteins ( &lt; 10 %).
Bivirkningerne er præsenteret i rækkefølge efter faldende alvorlighed, og deres hyppighed er defineret på følgende måde: meget almindelig (≥1/10); almindelig (≥ 1/100 til &lt; 1/10); ikke almindelig (≥1/1.000 til &lt; 1/100); sjælden (≥1/10.000 til &lt; 1/1.000); meget sjælden ( &lt; 1/10.000).
Adverse reactions are presented in the order of decreasing seriousness and their frequency is defined as follows: very common (≥1/10); common (≥ 1/100 to &lt; 1/10); uncommon: (≥ 1/1,000 to &lt; 1/100); rare (≥ 1/10,000 to &lt; 1/1,000) and very rare ( &lt; 1/10,000).
Derfor anbefales en reduktion på 50 % af den daglige vedligeholdelsesdosis, når kreatininclearance er &lt; 60 ml/min/1,73 m2.
Therefore a 50 % reduction of the daily maintenance dose is recommended when the creatinine clearance is &lt; 60 ml/min/1.73 m2.
Bivirkninger rapporteret fra kliniske studier (voksne, unge, børn og spædbørn &gt; 1 måned)) og efter markedsføring er angivet i nedenstående tabel i henhold til systemorganklasse og hyppighed.
Adverse reactions reported in clinical studies (adults, adolescents, children and infants &gt; 1 month) and from post-marketing experience are listed in the following table per System Organ Class and per frequency.
til hunde (1,3-2,5 kg) til hunde ( &gt; 2,5-5,5 kg) til hunde ( &gt; 5,5-11 kg) til hunde ( &gt; 11-22 kg) til hunde ( &gt; 22-45 kg)
for dogs (1.3-2.5 kg) for dogs ( &gt; 2.5-5.5 kg) for dogs ( &gt; 5.5-11 kg) for dogs ( &gt; 11-22 kg) for dogs ( &gt; 22-45 kg)
til katte (0,5-2,0 kg) til katte ( &gt; 2-8,0 kg)
for cats (0.5-2.0 kg) for cats ( &gt; 2-8.0 kg)
til katte (0,5-2,0 kg) til katte ( &gt; 2,0-8,0 kg)
for cats (0.5-2.0 kg) for cats ( &gt; 2.0-8.0 kg)
10 DATO FOR ÆNDRING AF TEKSTEN {DD måned ÅÅÅÅ}
10 DATE OF REVISION OF THE TEXT &lt; {DD/MM/YYYY} &gt;
VETERINÆRLÆGEMIDLETS NAVN Credelio 12 mg, tyggetabletter, til katte (0,5-2,0 kg) Credelio 48 mg, tyggetabletter, til katte ( &gt; 2,0-8.0 kg)
NAME OF THE VETERINARY MEDICINAL PRODUCT Credelio 12 mg chewable tablets for cats (0.5-2.0 kg) Credelio 48 mg chewable tablets for cats ( &gt; 2.0-8.0 kg)
INDLÆGSSEDDEL: Credelio 12 mg, tyggetabletter, til katte (0,5-2,0 kg) Credelio 48 mg, tyggetabletter, til katte ( &gt; 2,0-8,0 kg)
PACKAGE LEAFLET: Credelio 12 mg chewable tablets for cats (0.5-2.0 kg) Credelio 48 mg chewable tablets for cats ( &gt; 2.0-8.0 kg)
INDLÆGSSEDDEL: Credelio 56 mg, tyggetabletter, til hunde (1,3-2,5 kg) Credelio 112 mg, tyggetabletter, til hunde ( &gt; 2,5-5,5 kg) Credelio 225 mg, tyggetabletter, til hunde ( &gt; 5,5-11 kg) Credelio 450 mg, tyggetabletter, til hunde ( &gt; 11-22 kg) Credelio 900 mg, tyggetabletter, til hunde ( &gt; 22-45 kg)
PACKAGE LEAFLET: Credelio 56 mg chewable tablets for dogs (1.3-2.5 kg) Credelio 112 mg chewable tablets for dogs ( &gt; 2.5-5.5 kg) Credelio 225 mg chewable tablets for dogs ( &gt; 5.5-11 kg) Credelio 450 mg chewable tablets for dogs ( &gt; 11-22 kg) Credelio 900 mg chewable tablets for dogs ( &gt; 22-45 kg)
Credelio 56 mg, tyggetabletter, til hunde (1,3-2,5 kg) Credelio 112 mg, tyggetabletter, til hunde ( &gt; 2,5-5,5 kg) Credelio 225 mg, tyggetabletter, til hunde ( &gt; 5,5-11 kg) Credelio 450 mg, tyggetabletter, til hunde ( &gt; 11-22 kg) Credelio 900 mg, tyggetabletter, til hunde ( &gt; 22-45 kg)
Credelio 56 mg chewable tablets for dogs (1.3-2.5 kg) Credelio 112 mg chewable tablets for dogs ( &gt; 2.5-5.5 kg) Credelio 225 mg chewable tablets for dogs ( &gt; 5.5-11 kg) Credelio 450 mg chewable tablets for dogs ( &gt; 11-22 kg) Credelio 900 mg chewable tablets for dogs ( &gt; 22-45 kg)
I et randomiseret, dobbeltblindt, placebokontrolleret undersøgelse med 426 patienter (TRIMPOL-II) forbedrede trimetazidin (60 mg/dag) tilsat metoprolol 100 mg/dag (50 mg bid) i 12 uger signifikant statistiske parametre for arbejds-EKG samt kliniske symptomer sammenlignet med placebo: samlet arbejdsvarighed +20,1 s, p=0,023, samlet arbejdsbelastning +0,54 METs, p=0,001, tid til 1-mm ST-segment-depression +33,4 s, p=0,003, tid til fremkomst af angina +33,9 s, p &lt; 0,001, anginaanfald/uge -0,73, p=0,014 og forbrug af korttidsvirkende nitrater/uge, -0,63, p=0,032, uden hæmodynamiske ændringer.
In a 426-patients randomised, double blind, placebo-controlled study (TRIMPOL-II), trimetazidine (60mg/day) added to metoprolol 100mg daily (50 mg b.i.d) for 12 weeks significantly improved statistically exercise tests parameters and clinical symptoms as compared to placebo: total exercise duration +20.1s, p= 0.023, total workload +0.54 METs, p=0.001, time to 1-mm ST-segment depression +33.4s, p=0.003, time to onset of angina +33.9s, p &lt; 0.001, angina attacks/week -0.73, p=0.014 and short acting nitrates consumption/week, -0.63, p=0.032, without hemodynamic changes.
Ved betragtning af alle aktuelt tilgængelige data konkluderede CHMP, at lægemidler, der indeholder trimetazidin, bør være kontraindiceret til patienter med svær nyreinsufficiens (creatininclearance &lt; 30 ml/min).
Considering all currently available data, the CHMP concluded that trimetazidine-containing medicinal products should be contraindicated in patients with severe renal impairment (creatinine clearance &lt; 30ml/min).
• Ved betragtning af alle aktuelt tilgængelige sikkerhedsdata konkluderede udvalget, at trimetazidin bør være kontraindiceret til patienter med Parkinsons sygdom, parkinsonsymptomer, tremor, »Restless Legs Syndrome« og andre beslægtede bevægelsesforstyrrelser samt til patienter med svært nedsat nyrefunktion (creatinineclearance &lt; 30ml/min).
• Considering all the currently available safety data the Committee concluded that trimetazidine should be contraindicated in patients with Parkinson disease, parkinsonian symptoms, tremors, restless leg syndrome, and other related movement disorders as well as in patients with severe renal impairment (creatinine clearance &lt; 30ml/min).
Denne analyse viste, at hos patienter med kronisk, stabil angina forbedrede trimetazidin, givet som supplement til atenolol,
This analysis showed that in patients with chronic stable angina trimetazidine given as add-on to atenolol significantly improved exercise tolerance (p &lt; 0.01), time to 1 mm ST segment depression and time to angina.
[Særnavn] indeholder &lt; mængde &gt; biotin pr. &lt; dosisenhed &gt; .
[Product name] contains &lt; quantity &gt; biotin per &lt; dose unit &gt; .
CVMP accepterer fuldt ud den videnskabelige validitet af kravet om kontrolgrupper i kliniske forsøg, men mener, at en signifikant andel af placebokontrolkatte, der lider af moderat til svær hypertension (dvs. systolisk blodtryk &gt; 180 mm Hg), ville have risiko for at udvikle skader i målorganer, hvis de forblev ubehandlede i en periode på op til 63 dage.
Whilst fully accepting the scientific validity of requiring control groups in clinical studies, the CVMP is of the opinion that a significant proportion of placebo-control cats suffering from moderate-tosevere hypertension (i.e. systolic blood pressure &gt; 180 mm Hg) would be at risk of developing target organ damage if left untreated over a potential period of 63 days.
Af de 43 katte, der tilhørte den svært påvirkede gruppe på dag 0, blev i alt 26 katte (60,5 %) normotensive eller havde et fald på &gt; 20 mm Hg i det systoliske blodtryk på dag 63.
From the 43 cats belonging to the severe group at Day 0, 26 cats in total (60.5 %) became normotensive or had a &gt; 20 mm Hg decrease in systolic blood pressure at Day 63.
De andre 12 katte havde et fald på &gt; 20 mm Hg i det systoliske blodtryk på dag 63 (gennemsnitligt fald: 36,6 mm Hg, interval: 20 mm Hg til 57,8 mm Hg), men var stadig over grænsen for normotension på 160 mm Hg.
The other 12 cats had a &gt; 20 mm Hg decrease in systolic blood pressure at Day 63 (mean decrease of 36.6 mm Hg, range 20 mm Hg to 57.8 mm Hg) but were still above the normotensive limit of 160 mm Hg.
Indehaveren af markedsføringstilladelsen blev endvidere anmodet om yderligere afklarende oplysninger om procentdelen af svært hypertensive katte (dvs. systolisk blodtryk &gt; 180 mm Hg), der efterfølgende blev normotensive eller havde et fald på &gt; 20 mm Hg i det systoliske blodtryk efter behandling.
In addition the MAH was requested to submit a further clarification in relation to the percentage of severely hypertensive cats (i.e. systolic blood pressure &gt; 180 mm Hg) that subsequently became normotensive or had a &gt; 20 mm Hg decrease in systolic blood pressure following treatment.
Indehaveren af markedsføringstilladelsen præciserede, at den gennemsnitlige reduktion i den svært påvirkede gruppe (systolisk blodtryk &gt; 180 mm Hg) var på -25,5 mm Hg (mens den var på -18,3 mm Hg i den moderat påvirkede gruppe (systolisk blodtryk mellem 160 mm Hg og 180 mm Hg).
The MAH clarified that the mean decrease in the severely affected group (systolic blood pressure &gt; 180 mm Hg) was of -25.5 mm Hg (while it was of -18.3 mm Hg in the moderately affected group (systolic blood pressure between 160 mm Hg and 180 mm Hg).
Resultatet, at 63 % af de svært påvirkede katte blev normotensive eller havde en reduktion &gt; 20 mm Hg i det systoliske blodtryk efter behandling med Vasotop P, bemærkes derfor.
Thus, the finding that 63 % of severely affected cats became normotensive or had a &gt; 20 mm Hg reduction in systolic blood pressure following treatment with Vasotop P is noted; whilst it is accepted that 12/26 cats did not become normotensive, a mean reduction of 37 mm Hg in systolic blood pressure in severely hypertensive cats has also been noted.
Frekvenskategorier er defineret ved brug af følgende konvention: Meget almindelig (≥1/10), almindelig (≥1/100 til &lt; 1/10), ikke almindelig (≥1/1.000 til &lt; 1/100), sjælden (≥1/10.000 til &lt; 1/1.000), meget sjælden ( &lt; 1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
Frequency categories are defined using the following convention: very common (≥ 1/10), common (≥ 1/100 to &lt; 1/10), uncommon (≥ 1/1,000 to &lt; 1/100), rare (≥ 1/10,000 to &lt; 1/1,000), very rare ( &lt; 1/10,000), not known (cannot be estimated from the available data).
I de 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 &gt; 60 years of age and 10-12% of patients were &gt; 70 years of age.
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 &gt; 65 years old).
Total bilirubin: &gt; 3-10 ULN ASAT: alt ULN = laboratoriets øvre normalgrænse ASAT = aspartataminotransferase
Total bilirubin: &gt; 3-10 ULN AST: any ULN = upper limit of normal for the institution AST = aspartate aminotransferase
Total bilirubin: &gt; 1,5-3,0 ULN ASAT: alt
Total bilirubin: &gt; 1.5-3.0 ULN AST: any
Den estimerede progressionsfri overlevelse efter 84 måneder var 81,2 % i Imatinib-armen og 60,6 % i kontrolarmen (p &lt; 0,001).
The estimated rate of progression-free survival at 84 months was 81.2% in the Imatinib arm and 60.6% in the control arm (p &lt; 0.001).
ASAT: &gt; ULN (kan være normal eller &lt; ULN hvis total bilirubin er &gt; ULN)
Total bilirubin: = 1.5 ULN AST: &gt; ULN (can be normal or &lt; ULN if total bilirubin is &gt; ULN)
Hvor estimeret 96 % (93 %) af patienterne med CCyR (PCyR) ved 12 måneder var fri for progression til accelereret fase/blastkrise ved 84 måneder, var kun 81 % af patienterne uden CCyR ved 12 måneder fri for progression til fremskreden CML ved 84 måneder (p &lt; 0,001 samlet, p=0,25 mellem CCyR og PCyR).
Whereas an estimated 96% (93%) of patients with CCyR (PCyR) at 12 months were free of progression to accelerated phase/blast crisis at 84 months, only 81% of patients without MCyR at 12 months were free of progression to advanced CML at 84 months (p &lt; 0.001 overall, p=0.25 between CCyR and PCyR).
I denne retrospektive analyse af total overlevelse blev Imatinibs overlegenhed vist i forhold til IFN+AraC (p &lt; 0,001); inden for 42 måneder var 47 (8,5 %) Imatinib-patienter og 63 (19,4 %) IFN+Ara-Cpatienter døde.
In this retrospective analysis, the superiority of Imatinib over IFN+Ara-C in overall survival was demonstrated (p &lt; 0.001); within 42 months, 47 (8.5%) Imatinib patients and 63 (19.4%) IFN+Ara-C patients had died.
Pædiatriske patienter: Ialt 26 pædiatriske patienter i alderen &lt; 18 år med enten CML i kronisk fase (n=11) eller CML i blastkrise eller Ph+ akut leukæmi (n=15) blev inkluderet i en fase I undersøgelse med dosis-eskalering.
A total of 26 paediatric patients of age &lt; 18 years with either chronic phase CML (n=11) or CML in blast crisis or Ph+ acute leukaemias (n=15) were enrolled in a dose-escalation phase I trial.
CLM i kronisk fase defineres ved, at alle følgende kriterier er opfyldt: blaster &lt; 15 % i blod og knoglemarv, perifere blodbasofiltal &lt; 20%, trombocyttal &gt; 100 x 109 /l.
Chronic phase CML is defined when all of the following criteria are met: blasts &lt; 15% in blood and bone marrow, peripheral blood basophils &lt; 20%, platelets &gt; 100 x 109/l.
Incidensen af cytopeni hang imidlertid også tydeligt sammen med sygdomsstadiet, idet hyppighed af 3. eller 4. grads neutropeni (ANC &lt; 1,0 x 109/l) og trombocytopeni (trombocyttal &lt; 50 x 109/l) var 4-6 gange højere ved blastkrise og accelereret fase (59-64% og 44-63% for henholdsvis neutropeni og trombopeni) end ved sammenligning med nydiagnosticerede patienter med kronisk fase CML (16,7% neutropeni og 8,9% trombocytopeni).
However, the occurrence of cytopenias was also clearly dependent on the stage of the disease, the frequency of grade 3 or 4 neutropenias (ANC &lt; 1.0x109/1) and thrombocytopenias (platelet count &lt; 50x109/1) 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).
Den estimerede frekvens af patienter fri for progression til fremskreden fase eller blastkrise efter 84 måneder var signifikant højere i Imatinib-armen end i IFN-armen (92,5 % vs. 85,1 %, p &lt; 0,001.
The estimated rate of patients free of progression to accelerated phase or blast crisis at 84 months was significantly higher in the Imatinib arm compared to the IFN arm (92.5% versus 85.1%, p &lt; 0.001).
Accelereret fase defineres som tilstedeværelse af én eller flere af følgende: blaster 15 %, men &lt; 30 % i blod eller knoglemarv, blaster plus promyelocytter 30 % i blod eller knoglemarv (hvilket giver &lt; 30 % blaster), perifere blodbasofiltal 20 %, trombocyttal &lt; 100 x 109/l uafhængigt af behandlingen.
Accelerated phase is defined by the presence of any of the following: blasts ≥ 15% but &lt; 30% in blood or bone marrow, blasts plus promyelocytes ≥ 30% in blood or bone marrow (providing &lt; 30% blasts), peripheral blood basophils ≥ 20%, platelets &lt; 100 x 109/l unrelated to therapy.
= intramuskulær, ARA-C = cytarabin, CPM = cyclophosphamid, VCR = vinkristin, DEX = dexamethason, DAUN = daunorubicin, 6-MP = 6-mercaptopurin, E.Coli L-ASP = L-asparaginase, PEG-ASP = PEG asparaginase, MESNA= 2mercaptoethan-natriumsulfonat, iii= eller indtil MTX-niveauet er &lt; 0,1 µM, Gy= Gray
G-CSF = granulocyte colony stimulating factor, VP-16 = etoposide, MTX = methotrexate, IV = intravenous, SC = subcutaneous, IT = intrathecal, PO = oral, IM = intramuscular, ARA-C = cytarabine, CPM = cyclophosphamide, VCR = vincristine, DEX = dexamethasone, DAUN = daunorubicin, 6-MP = 6-mercaptopurine, E.Coli L-ASP = L-asparaginase, PEG-ASP = PEG asparaginase, MESNA= 2-mercaptoethane sulfonate sodium, iii= or until MTX level is &lt; 0.1 μM, q6h = every 6 hours, Gy= Gray
ingen blaster og promyelocytter i blod, basofile &lt; 20%, ingen ekstramedullær påvirkning Cytogenetiske responskriterier: fuldstændig (0 % Ph+ metafaser), delvis (1-35 %), mindre (36- 65 %) eller minimal (66-95 %).
Cytogenetic response criteria: complete (0% Ph+ metaphases), partial (1-35%), minor (36-65%) or minimal (66-95%).
Fuldstændigt (Bekræftet3) [95% CI] Delvist 1Hæmatologiske responskriterier (hvert respons skal bekræftes ≥ 4 uger): CHR: Undersøgelse 0110 [leukocytter &lt; 10 x 109/l, trombocytter &lt; 450 x 109/l, myelocyt + metamyelocyt &lt; 5% i blodet, ingen blaster eller promyelocytter i blodet, basophiler &lt; 20%, ingen ekstramedullær involvering] og i undersøgelse 0102 and 0109 [ANC 1,5 x 109/l, trombocytter 100 x 109/l, ingen blaster i blodet, BM-blaster &lt; 5 % og ingen ekstramedullær sygdom].
Partial Haematological response criteria (all responses to be confirmed after ≥ 4 weeks): CHR: Study 0110 [WBC &lt; 10 x 109/l, platelets &lt; 450 x 109/l, myelocyte+metamyelocyte &lt; 5% in blood, no blasts and promyelocytes in blood, basophils &lt; 20%, no extramedullary involvement] and in studies 0102 and 0109 [ANC ≥ 1.5 x 109/l, platelets ≥ 100 x 109/l, no blood blasts, BM blasts &lt; 5% and no extramedullary disease] NEL Same criteria as for CHR but ANC ≥ 1 x 109/l and platelets ≥ 20 x 109/l (0102 and 0109 only) RTC &lt; 15% blasts BM and PB, &lt; 30% blasts+promyelocytes in BM and PB, &lt; 20% basophils in PB, no extramedullary disease other than spleen and liver (only for 0102 and 0109).
Der sås 4. grads neutropeni (ANC &lt; 0,5 x 109/l) og trombopeni (trombocyttal &lt; 10 x 109/l) hos henholdsvis 3,6% og 1% af patienterne med nydiagnosticeret CML i kronisk fase.
In newly diagnosed chronic phase CML grade 4neutropenia (ANC &lt; 0.5x109/1) and thrombocytopenia (platelet count &lt; 10x109/1) were observed in 3.6% and &lt; 1% of patients, respectively.
I tilfælde af recidiverende ANC &lt; 1,0 x 109/l og/eller trombocytter &lt; 50 x 109/l, gentag trin 1 og genoptag behandling med Imatinib Accord i en reduceret dosis på 260 mg/m2.
In the event of recurrence of ANC &lt; 1.0 x 109/1 and/or platelets &lt; 50 x 109/1, repeat step 1 and resume Imatinib Accord at reduced dose of 260 mg/m2.
I tilfælde af recidiverende ANC &lt; 1,0 x 109/l og/eller trombocytter &lt; 50 x 109/l, gentag trin 1 og genoptag behandling med Imatinib Accord i en reduceret dosis på 300 mg.
In the event of recurrence of ANC &lt; 1.0 x 109/l and/or platelets &lt; 50 x 109/l, repeat step 1 and resume Imatinib Accord at reduced dose of 300 mg.
ANC &lt; 1,0 x 109/l og/eller trombocytter &lt; 50 x 109/l
ANC &lt; 1.0x109/l and/or platelets &lt; 50 x 109/l
I tilfælde af tilbagevenden af ANC &lt; 1,0 x 109/l og/eller trombocytter &lt; 50 x 109/l, gentages trin 1 og Imatinib Accord reintroduceres med nedsat dosering på 400 mg.
In the event of recurrence of ANC &lt; 1.0x109/1 and/or platelets &lt; 50x109/1, repeat step1 and resume Imatinib Accordat reduced dose of 400 mg.
aANC &lt; 0,5 x 109/l og/eller trombocytter &lt; 10 x 109/l
aANC &lt; 0.5x109/1 and/or platelets &lt; 10 x 109/1