natgillin/translations-raw huggingface dataset:
I tilfælde af UPC-forhold &gt; 2 eller albumin &lt; 0,75 nedre grænse for normalområdet (LLN) skal behandlingen afbrydes, indtil albumin- og UPC-værdierne igen er på grænseværdien (UPCforhold &lt; 2 og albumin &gt; 0,75 LLN).
In case of UPC ratio &gt; 2 or albumin &lt; 0.75 lower limit of normal (LLN), treatment should be interrupted until albumin and UPC values have returned to limit value (UPC ratio &lt; 2 and albumin &gt; 0.75 LLN), treatment can then be continued at the same dose.
Hepatisk toksicitet (forhøjet ALAT eller AST), neutropeni I tilfælde af forhøjet ALAT eller AST &gt; 3 × ULN, nedsat neutrofiltælling &lt; 2000/mm eller en hvilken som helst anden alvorlig bivirkning skal behandlingen justeres som følger:
Hepatic toxicity (ALT or AST elevation), neutropenia In case of an increase of ALT or AST &gt; 3 ULN, decrease of neutrophil count &lt; 2,000/mm or any other severe adverse events, treatment should be modified as follows: At the first occurrence, treatment should be interrupted until resolution, and then resumed at the same dose level;
Albumin &lt; 0,75 LLN eller UPC &gt; 2 (2. gang)
Albumin &lt; 0.75 LLN or UPC &gt; 2
Albumin &lt; 0.75 LLN eller UPC &gt; 2 (1. gang)
Albumin &lt; 0.75 LLN or UPC &gt; 2
&gt; 3ULN (4. gang)
&gt; 3ULN
&lt; 2000 / mm (1. gang)
&lt; 2,000/mm th time)
CHMP godkendte følgende: Der kræves ingen dosisjustering for patienter med en kreatininclearance ≥ 10 ml/min.
The CHMP endorsed following text: No dosage adjustment is required for patients with a creatinine clearance &gt; 10ml/min.
Janumets sikkerhed og virkning hos børn og unge fra fødslen til &lt; 18 år er ikke klarlagt.
The safety and efficacy of Janumet in children and adolescents from birth to &lt; 18 years of age have not been established.
Janumet er kontraindiceret hos patienter med GFR &lt; 30 ml/min, og behandlingen skal afbrydes midlertidigt ved tilstedeværelse af tilstande, der påvirker nyrefunktionen (se pkt.
Janumet is contraindicated in patients with GFR &lt; 30 mL/min and should be temporarily discontinued during conditions with the potential to alter renal function (see section 4.3).
3 og/eller albumin &lt; 3,3 g/dl.
3 and/or albumin &lt; 3.3 g/dl.
Sikkerhed og virkning af INCIVO hos børn i alderen &lt; 18 år er endnu ikke klarlagt.
The safety and efficacy of INCIVO in children aged &lt; 18 years have not yet been established.
Bivirkningerne er opstillet efter systemorganklasse og hyppighed: meget almindelig (≥ 1/10), almindelig (≥ 1/100 til &lt; 1/10), ikke almindelig (≥ 1/1.000 til &lt; 1/100) og sjælden (≥ 1/10.000 til &lt; 1/1.000).
ADRs are listed by system organ class (SOC) and frequency: very common (≥ 1/10), common (≥ 1/100 to &lt; 1/10), uncommon (≥ 1/1,000 to &lt; 1/100) and rare (≥ 1/10,000 to &lt; 1/1,000).
Ved behov for samtidig anvendelse anbefales det ikke at anvende høje doser af itraconazol ( &gt; 200 mg/dag) eller ketoconazol ( &gt; 200 mg/dag).
When co-administration is required, high doses of itraconazole ( &gt; 200 mg/day) or ketoconazole ( &gt; 200 mg/day) are not recommended.
( &lt; 25.000/mm absolut lymfocyttal
( &lt; 25,000/mm absolute lymphocyte count
Eftersom det er højst usandsynligt, at patienter med utilstrækkeligt viralt respons opnår et vedvarende virologisk respons (sustained virologic response, SVR), anbefales det, at patienter med HCV-RNA &gt; 1.000 IE/ml i uge 4 eller uge 12 stopper med behandlingen (se tabel 1).
Since it is highly unlikely that patients with inadequate viral responses will achieve a sustained virologic response (SVR), it is recommended that patients with HCV RNA &gt; 1,000 IU/ml at week 4 or week 12 discontinue therapy (refer to table 1).
Responsraten i Pbo/PR-gruppen var højere end i andre kliniske studier af pegyleret interferon baseret 2-stof behandling (historiske SVR-rater &lt; 36%).
The response rate in the Pbo/PR arm was higher than that seen in other clinical studies of peginterferon bitherapy (historical SVR rates &lt; 36%).
SVR-raten for T8/PR-gruppen var 72% (261/364) (P &lt; 0,0001 sammenlignet med Pbo/PR48gruppen).
The SVR rate for the T8/PR group was 72% (261/364) (P &lt; 0.0001 compared to Pbo/PR48 group).
Et 3-års opfølgningsstudie med patienter, som opnåede SVR med et INCIVO-baseret regime, viste, at &gt; 99% (122/123) af patienterne opretholdt deres SVR-status under den foreliggende opfølgningsperiode (median varighed 22 måneder).
A 3-year follow-up study of patients who achieved SVR with an INCIVO-based regimen showed that &gt; 99% (122/123) of patients maintained their SVR status through the available follow-up period
Der foreligger begrænsede farmakokinetiske data om anvendelse af INCIVO til HCV-patienter i aldersgruppen ≥ 65 år og ingen data om personer &gt; 70 år.
There is limited pharmacokinetic data on the use of INCIVO in HCV patients aged ≥ 65 years and no data in subjects &gt; 70 years of age.
Sikkerhed og virkning er ikke klarlagt hos patienter med moderat eller svært nedsat nyrefunktion (CrCl &lt; 50 ml/min) eller hos patienter i hæmodialyse.
The safety and efficacy have not been established in patients with moderate or severe renal impairment (CrCl &lt; 50 ml/min) or in patients on haemodialysis.
Varianterne V36A/M, T54A/S, R155K/T og A156S medførte lavere niveauer af in vitro-resistens mod telaprevir (en stigning på faktor 3-25 i telaprevirs IC50-værdi), og varianterne A156V/T og V36M+R155K medførte højere niveauer af in vitro-resistens mod telaprevir (en stigning på &gt; faktor 25 i telaprevirs IC50-værdi).
Variants V36A/M, T54A/S, R155K/T, and A156S conferred lower levels of in vitro resistance to telaprevir (3- to 25-fold increase in telaprevir IC50), and the A156V/T and V36M+R155K variants conferred higher levels of in vitro resistance to telaprevir ( &gt; 25-fold increase in telaprevir IC50).
T12(DS)/PR % (n/N) &lt; 1 log10 reduktion i HCVRNA i uge 4
T12(DS)/PR % (n/N) ≥ 1 log10 reduction in HCV RNA at week 4
P &lt; 0,001, T12/PR sammenlignet med Pbo/PR48.
P &lt; 0.001, T12/PR compared to Pbo/PR48.
I tabel 13 vises SVR-raterne ud fra response i uge 4 ( &lt; 1 log10 eller ≥ 1 log10 reduktion i HCV-RNA) for tidligere partial responders og for tidligere null responders i T12(DS)/PR-gruppen.
Table 13 shows the SVR rates by week 4 response ( &lt; 1 log10 or ≥ 1 log10 reduction in HCV RNA) for prior partial responders and for prior null responders in the T12(DS)/PR group.
SVR-raterne var højere (absolut forskel mindst 28%) i T12/PR-gruppen end i Pbo/PR48-gruppen på tværs af undergrupperne fordelt efter køn, alder, race, etnisk afstamning, body mass index, HCV-genotype subtype, baseline HCV-RNA ( &lt; 800.000, ≥ 800.000 IE/ml) og omfanget af leverfibrose.
SVR rates were higher (absolute difference of at least 28%) for the T12/PR group than for the Pbo/PR48 group across subgroups by sex, age, race, ethnicity, body mass index, HCV genotype subtype, baseline HCV RNA ( &lt; 800,000, ≥ 800,000 IU/ml), and extent of liver fibrosis.
HCV-RNA &lt; 25 IE/ml i uge 12 opfølgningsvinduet
HCV RNA &lt; 25 IU/ml in the week 12 follow-up window
( &lt; 350/mm kalium
( &lt; 350/mm potassium
Forsigtighed tilrådes ved anvendelse af INCIVO hos patienter med: - erhvervet QT-forlængelse i anamnesen - klinisk relevant bradykardi (vedvarende hjertefrekvens &lt; 50 slag i minuttet) - hjertesvigt i anamnesen med nedsat ejection fraction i venstre ventrikel - behov for lægemidler, der vides at forlænge QT-intervallet, men hvis metabolisme ikke hovedsageligt beror på CYP3A4 (f.eks. methadon, se pkt.
Use INCIVO with caution in patients with: - a history of acquired QT prolongation; - clinically relevant bradycardia (persistent heart rate &lt; 50 bpm); - a history of heart failure with reduced left-ventricular ejection fraction; - a requirement for medicinal products known to prolong the QT interval but the metabolism of which is not mainly CYP3A4 dependent (e.g. methadone, see section 4.5).
I kliniske fase 2- og fase 3-studier med telaprevir sås sjældne tilfælde af behandlingsnaive patienter samt patienter med tidligere behandlingssvigt med overvejende telaprevir-resistente varianter ved baseline (før behandlingen) (V36M, T54A og R155K &lt; 1% og T54S 2,7%).
In Phase 2 and 3 clinical trials of telaprevir, treatment-naïve and prior treatment-failure patients with predominant telaprevir-resistant variants at baseline (pre-treatment) were rare (V36M, T54A and R155K &lt; 1% and T54S 2.7%).
I fase 3-studier opnåede ingen af patienterne med HCV-RNA &gt; 1.000 IE/ml i enten uge 4 eller uge 12 SVR ved fortsat behandling med pegyleret interferon-alfa og ribavirin.
In the Phase 3 studies, none of the patients with HCV RNA &gt; 1,000 IU/ml at either week 4 or week 12 achieved SVR with continued peginterferon alfa and ribavirin treatment.
4.8 og 5.1) blev der observeret forbigående bilirubin-stigning af grad 3 (2,5 til ≤ 5 X ULN) og grad 4 ( &gt; 5 X ULN) under behandling med INCIVO hos henholdsvis 39% og 22% af de 59 patienter, der fik atazanavir/ritonavir.
In Study HPC3008 (see sections 4.8 and 5.1), transient grade 3 (2.5 to ≤5 X ULN) and grade 4 ( &gt; 5 X ULN) bilirubin increases during INCIVO treatment were seen in 39% and in 22% of the 59 patients on atazanavir/ritonavir, respectively.
Telaprevirs farmakokinetik blev vurderet efter indgift af en enkelt dosis på 750 mg til forsøgspersoner uden hepatitis C med stærkt nedsat nyrefunktion (kreatininclearance &lt; 30 ml/min).
The pharmacokinetics of telaprevir were assessed after administration of a single dose of 750 mg to HCV-negative subjects with severe renal impairment (CrCl &lt; 30 ml/min).
Tabel 13: SVR-rater ud fra response i uge 4 ( &lt; 1 log10 eller ≥ 1 log10 reduktion) i T12(DS)/PR48-gruppen: Studie C216
Table 13: SVR rates by week 4 response ( &lt; 1 log10 or ≥ 1 log10 reduction) in the T12(DS)/PR48
Nævneren ved beregning af relapse-raten er antallet af patienter med respons ved endt behandling (HCV-RNA
The denominator when calculating the relapse rate represents the number of patients with end-of-treatment response (HCV RNA &lt; 25 IU/ml).
Hæmoglobinværdier på &lt; 10 g/dl observeredes hos 34% af de patienter, der fik INCIVO-kombinationsbehandling, og hos 14% af de patienter, der fik pegyleret interferon-alfa og ribavirin.
Haemoglobin values of &lt; 10 g/dl were observed in 34% of patients who received INCIVO combination treatment and in 14% of patients who received peginterferon alfa and ribavirin.
Hvis HCV-RNA-koncentrationen er &gt; 1.000 IE/ml, bør behandling med INCIVO, pegyleret interferon-alfa og ribavirin seponeres.
If the HCV RNA concentration is &gt; 1,000 IU/ml, INCIVO, peginterferon alfa, and ribavirin should be discontinued.
HCV-RNA &gt; 1.000 IE/ml i uge 4 af behandlingen
HCV RNA &gt; 1,000 IU/ml at week 4 of treatment
Patienterne skulle have hiv-1-RNA &lt; 50 kopier/ml og CD4-celletal &gt; 300 celler/mm
Patients were required to have an HIV-1 RNA &lt; 50 copies/ml
HCV-RNA &lt; 25 IE/ml efter endt behandling
HCV RNA &lt; 25 IU/ml at End of Treatment
Alvorligt udslæt: Udslættets omfang &gt; 50% af legemsoverfladen eller associeret med vesikler, bullae og ulcerationer andre end
Severe rash: Extent of rash &gt; 50% of body surface area or associated with vesicles,
Se også produktresuméet for ribavirin vedrørende patienter med CrCl &lt; 50 ml/min.
Refer also to the Summary of Product Characteristics for ribavirin for patients with CrCl &lt; 50 ml/min.
Populationen af non-responders omfattede 2 undergrupper: patienter med tidligere partial response (≥ 2 log10 reduktion i HCV-RNA i uge 12, men uden ikkedetekterbart HCV-RNA ved afsluttet behandlingen med et pegyleret interferon og ribavirin) og patienter med tidligere null response ( &lt; 2 log10 reduktion i HCV-RNA i uge 12 af den tidligere behandling med pegyleret interferon og ribavirin).
The non-responder-population was comprised of 2 subgroups: prior partial responders (greater than or equal to 2 log10 reduction in HCV RNA at week 12, but not achieving HCV RNA undetectable at end of treatment with a peginterferon and ribavirin) and prior null responders (less than 2 log10 reduction in HCV RNA at week 12 of prior treatment with peginterferon and ribavirin).
Nævneren er antallet af patienter med HCV RNA &lt; 25 IE/ml på det planlagte tidspunkt for behandlingsafslutning eller manglende vurdering af HCV RNA på det planlagte tidspunkt for behandlingsafslutning og HCV RNA &lt; 25 IE/ml i opfølgningsperioden fra det planlagte tidspunkt for behandlingsafslutning og fremefter.
The denominator is the number of patients with HCV RNA &lt; 25 IU/ml at planned end of treatment or a missing HCV RNA assessment at planned end of treatment and HCV RNA &lt; 25 IU/ml during follow-up from planned end of treatment onwards.
Der henvises også til produktresuméet for ribavirin vedrørende patienter med CrCl &lt; 50 ml/min (se også
Refer also to the Summary of Product Characteristics for ribavirin for patients with CrCL &lt; 50 ml/min
Relaps blev defineret som havende detekterbart plasma-HCV RNA fra det planlagte tidspunkt for behandlingsafslutning og fremefter efter tidligere at have haft HCV RNA &lt; 25 IE/ml på det planlagte tidspunkt for HCV-behandlingsafslutning og manglende opnåelse af SVR12.
Relapse was defined as having detectable plasma HCV RNA from planned end of treatment onwards after previous HCV RNA &lt; 25 IU/ml at planned end of HCV treatment, and not achieving SVR12.
Patienterne i disse studier, 108, 111 og C216, havde kompenseret leversygdom, påviseligt HCV-RNA, og lever-histopatologi svarende til kronisk hepatitis C. Med mindre andet angives, blev INCIVO givet i en dosis på 750 mg hver 8. time.
Patients in these studies, 108, 111 and C216, had compensated liver disease, detectable HCV RNA, and liver histopathology consistent with chronic hepatitis C. Unless otherwise indicated, INCIVO was administered at a dosage of 750 mg every 8 hours (q8h); the peginterferon alfa-2a dose was 180 µg/week, and the ribavirin dose was 1,000 mg/day (patients weighing &lt; 75 kg) or 1,200 mg/day (patients weighing ≥ 75 kg).
Relaps blev defineret som havende HCV RNA ≥ 25 IE/ml i opfølgningsperioden efter tidligere at have haft HCV RNA &lt; 25 IE/ml på det planlagte tidspunkt for behandlingsafslutning og manglende opnåelse af SVR12.
Relapse was defined as having HCV RNA ≥ 25 IU/ml during the follow-up period after previous HCV RNA &lt; 25 IU/ml at planned end of treatment and not achieving SVR12.
HCV-RNA &gt; 1.000 IE/ml i uge 12 af behandlingen Behandling med INCIVO gennemført
HCV RNA &gt; 1,000 IU/ml at week 12 of treatment
Anvendelse af INCIVO i kombination med peginterferon og ribavirin anbefales ikke til patienter med
INCIVO in combination with peginterferon and ribavirin is not recommended in patients with platelets &lt; 90,000/mm
60% af patienterne var mænd, 32% havde et body mass index ≥ 30 kg/m2, 14% var sorte, 10% var af latinamerikansk afstamning, 82% havde HCV-RNA ≥ 800.000 IE/ml ved baseline, 16% havde brofibrose, 11% havde cirrose, 72% havde HCV af genotype 1a og 27% havde HCV af genotype 1b.
The 540 enrolled patients had a median age of 51 years (range: 19 to 70); 60% of the patients were male; 32% had a body mass index ≥ 30 kg/m2; 14% were Black; 10% were Hispanic or Latino; 82% had baseline HCV RNA levels &gt; 800,000 IU/ml; 16% had bridging fibrosis; 11% had cirrhosis; 72% had HCV genotype 1a; and 27% had HCV genotype 1b.
Hæmoglobinværdier &lt; 8,5 g/dl blev observeret hos 8%, der fik INCIVO
Haemoglobin values of &lt; 8.5 g/dl were observed in 8% of INCIVO combination treatment compared to 2% of patients receiving peginterferon alfa and ribavirin.
2, 5% var sorte, 11% var af latinamerikansk afstamning, 89% havde HCV-RNA ≥ 800.000 IE/ml ved baseline, 22% havde brofibrose, 26% havde cirrose, 54% havde HCV af genotype 1a og 46% havde HCV af genotype 1b.
The 662 enrolled patients had a median age of 51 years (range: 21 to 70); 70% of the patients were male; 26% had a body mass index ≥ 30 kg/m2; 5% were Black; 11% were Hispanic or Latino; 89% had baseline HCV RNA levels &gt; 800,000 IU/ml; 22% had bridging fibrosis; 26% had cirrhosis; 54% had HCV genotype 1a; and 46% had HCV genotype 1b.
3), eller de havde stabil, kontrolleret hiv (hiv-RNA &lt; 50 kopier/ml, CD4
3), or had stable controlled HIV
Infusionen skal vare mellem en og to timer og skal gives i et omrÃ¥de, hvor der ikke har vÃ¦ret ekstravasation.
The infusion should last between one and two hours, and be given at a site other than where the extravasation happened.
• hæmoglobin &lt; 9 g/dl
• haemoglobin &lt; 9 g/dL
Infusionshastigheden mÃ¥ ikke overstige 10 mg/min.
The infusion rate must not exceed 10 mg/min.
• absolut neutrofiltal &lt; 1.500/mm³
• absolute neutrophil count &lt; 1500/mm³
• leukocyttal &lt; 3.000/mm³
• leukocyte count &lt; 3000/mm³
• trombocyttal &lt; 100.000/mm³
• platelet count &lt; 100000/mm³
Almindelig (≥ 1/100 til &lt; 1/10)
Common ( 1/100 to &lt; 1/10)
Sjælden (≥ 1/10.000 til &lt; 1/1.000)
Rare ( 1/10,000 to &lt; 1/1,000)
Ikke almindelig (≥ 1/1.000 til &lt; 1/100)
Uncommon ( 1/1,000 to &lt; 1/100)
Baseret på forskellige anerkendte sammensatte MACE-endepunkter i Qsiva-programmet viste udfaldene ingen øget risiko for nogen af disse endepunkter ved sammenligning med placebo (alle risikoforhold &lt; 1,0).
Outcomes using various accepted MACE composite endpoints in the Qsiva programme showed no increase in risk for any of these endpoints compared to placebo (hazard ratios &lt; 1.0).
CHMP fandt, at den gennemsnitlige hjertefrekvens ikke nødvendigvis er den mest relevante parameter (i forhold til f.eks. stigning i hjertefrekvensen i den højeste percentil eller stigning i andelen af personer med &gt; 10 slag/min).
Estimates of the mean heart rate were considered by CHMP not to be necessarily the most relevant parameter (compared to e.g. increase in heart rate in the highest percentile or increased proportion of subjects with &gt; 10 bpm) The consequence of the sympathomimetic mechanism of action of Qsiva for CV outcome in long-term use remains a principle concern for CHMP in the absence of long-term CV outcome trial data.
Infusionen tager ca. en time, mens du er pÃ¥ hospitalet.
The infusion will last approximately one hour during which you will be in the hospital.
Hyppigheder defineres som: meget almindelig (≥ 1/10); almindelig (≥ 1/100 til &lt; 1/10); ikke almindelig (≥ 1/1000 til &lt; 1/100); sjælden (≥ 1/10.000 til &lt; 1/1000); meget sjælden ( &lt; 1/10.000); frekvens ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
Frequencies are defined as: 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).
Docetaxel øgede responsraten (33 % mod 12 %, p &lt; 0,0001), forlængede tiden til progression (19 uger mod 11 uger, p = 0,0004), samt forlængede overlevelsen (11 måneder mod 9 måneder, p = 0,01).
Docetaxel increased response rate (33% vs. 12%, p &lt; 0.0001), prolonged time to progression (19 weeks vs. 11 weeks, p=0.0004) and prolonged overall survival (11 months vs. 9 months, p=0.01).
Docetaxel må ikke anvendes hos patienter med en udgangsværdi for neutrofile granulocytter på &lt; 1.500 celler/mm
Docetaxel must not be used in patients with baseline neutrophil count of &lt; 1,500 cells/mm3.
Der er begrænsede tilgængelige data vedrørende anvendelse af docetaxel i kombination med doxorubicin og cyclofosfamid til patienter over 70 år.
There are limited data available in patients &gt; 70 years of age on docetaxel use in combination with doxorubicin and cyclophosphamide.
Der var mindre brug af smertestillende morfika (p &lt; 0,01), smertestillende ikke-morfika (p &lt; 0,01), anden sygdomsrelateret medicin (p = 0,06) og strålebehandling (p &lt; 0,01) hos de patienter, der fik behandling med docetaxel ved doseringen 75 mg/m end hos patienterne, der fik bedste palliative behandling.
There was less use of morphinic analgesic (p &lt; 0.01), non-morphinic analgesics (p &lt; 0.01), other disease related medications (p=0.06) and radiotherapy (p &lt; 0.01) in patients treated with docetaxel at 75 mg/m² compared to those with BSC.
InfusionsoplÃ¸sning: Kemisk og fysisk stabilitet under brug er pÃ¥vist i 4 timer ved stuetemperatur (under 25 Â°C).
• Infusion solution: Chemical and physical in-use stability has been demonstrated for 4 hours at room temperature (below 25°C).
InfusionsvÃ¦sken skal bruges inden for 4 timer ved stuetemperatur (under 25 ÂºC).
The infusion solution should be used within 4 hours at room temperature (below 25°C).
I kombination med cisplatin Hos patienter med en initialdosis på 75 mg/m i kombination med cisplatin med en minimum blodpladeværdi under den tidligere behandlingsrunde på &lt; 25.000 celler/mm eller hos patienter, der får febril neutropeni, eller hos patienter med alvorlig, ikke-hæmatologisk toksicitet bør docetaxeldosis reduceres til 65 mg/m i de følgende behandlingsrunder.
In combination with cisplatin For patients who are dosed initially at docetaxel 75 mg/m2 in combination with cisplatin and whose nadir of platelet count during the previous course of therapy is &lt; 25,000 cells/mm3, or in patients who experience febrile neutropenia, or in patients with serious non-haematologic toxicities, the docetaxel dose in subsequent cycles should be reduced to 65 mg/m2.
De mest almindeligt rapporterede bivirkninger med docetaxel var: neutropeni (som var reversibel og ikke kumulativ, median-dagen til nadir var 7 dage og median-varigheden af alvorlig neutropeni ( &lt; 500 celler/mm
The most commonly reported adverse reactions of docetaxel alone are: neutropenia (which was reversible and not cumulative; the median day to nadir was 7 days and the median duration of severe neutropenia ( &lt; 500 cells/mm3) was 7 days), anaemia, alopecia, nausea, vomiting, stomatitis, diarrhoea and asthenia.
3) i mere end 7 dage i løbet af en docetaxelbehandling, anbefales det at reducere dosis i de efterfølgende cyklusser eller at tage passende symptomatiske forholdsregler (se pkt.
In the case of severe neutropenia ( &lt; 500 cells/mm3 for seven days or more) during a course of docetaxel therapy, a reduction in dose for subsequent courses of therapy or the use of appropriate symptomatic measures are recommended (see section 4.2).
I kombinationsbehandling med cisplatin og 5-fluoruracil til behandling af patienter med gastrisk adenocarcinom ekskluderede det kliniske pivotalstudie patienter med ALAT og/eller ASAT &gt; 1,5 gange øvre normalværdi associeret med alkalisk fosfatase &gt; 2,5 gange øvre normalværdi, og bilirubin &gt; 1 gange øvre normalværdi.
In combination with cisplatin and 5-fluorouracil for the treatment of patients with gastric adenocarcinoma, the pivotal clinical study excluded patients with ALT and/or AST &gt; 1.5 × ULN associated with alkaline phosphatase &gt; 2.5 × ULN, and bilirubin &gt; 1 x UNL; for these patients, no dose-reductions can be recommended and docetaxel should not be used unless strictly indicated.
For de patienter med serum-bilirubin &gt; øvre normalværdi og/eller ALAT og ASAT &gt; 3,5 gange øvre normalværdi og basiske fosfataser &gt; 6 gange øvre normalværdi, kan det ikke anbefales at reducere dosis.
For patients with serum bilirubin levels &gt; ULN and/or ALT and AST &gt; 3.5 times the ULN concurrent with serum alkaline phosphatase levels &gt; 6 times the ULN, no dose-reduction can be recommended and docetaxel should not be used unless strictly indicated.
Dyspnø (G3/4: 1 %); Hoste (G3/4: &lt; 1 %); Epistaxis (G3/4:
Dyspnoea (G3/4: 1%); Cough (G3/4: &lt; 1%);
75 mg/m2: Hos patienter, som under docetaxel-behandling har haft enten febril neutropeni, neutrofile leukocytter &lt; 500 celler/mm i mere end en uge, alvorlige eller kumulative reaktioner eller alvorlig perifer neuropati.
In patients who experienced either febrile neutropenia, neutrophil count &lt; 500 cells/mm3 for more than one week, severe or cumulative cutaneous reactions or severe peripheral neuropathy during docetaxel therapy, the dose of docetaxel should be reduced from 100 mg/m2 to 75 mg/m2 and/or from
InfusionsvÃ¦sken og prÃ¦mix opblandes ved manuel rotation af infusionsposen.
Mix the infusion bag or bottle manually using a rocking motion.
G3/4 Forhøjet bilirubin i blodet ( &lt; 5 %); G3/4 forhøjet alkalisk fosfatase i blodet ( &lt; 4 %);
G3/4 AST increased G3/4 Blood alkaline phosphatase increased