natgillin/translations-raw huggingface dataset:
Den samlede responsrate, tid til sygdomsprogression, progressionsfri overlevelse og samlet overlevelse for patienter, der fik >førstelinjebehandling, er vist nedenfor. 
Results for overall response rate and time to disease progression, and progression-free survival and survival for patients receiving > 1st-line therapy, are shown below.
• Personer med metastatisk brystkræft, der fik Abraxane, efter en anden behandlingsmetode ikke havde hjulpet, havde større sandsynlighed for at opleve en reduktion i tumorstørrelse og levede længere end personer, der fik en anden behandling. 
• People with metastatic breast cancer who received Abraxane where another therapy had failed, were more likely to experience a reduction in tumour size, and lived longer than people who took an alternative therapy.
Hos patienter med ikke-småcellet lungecancer i behandling med Abraxane og carboplatin var mediantiden til første forekomst af behandlingsrelateret grad 3 perifer neuropati 121 dage, og mediantiden til forbedring af behandlingsrelateret grad 3 perifer neuropati til grad 1 var 38 dage. 
For non-small cell lung cancer patients treated with Abraxane and carboplatin, the median time to first occurrence of Grade 3 treatment related peripheral neuropathy was 121 days, and the median time to improvement from Grade 3 treatment related peripheral neuropathy to Grade 1 was 38 days.
• Abraxane anvendes til metastatisk brystkræft, når mindst en anden behandlingsmetode er blevet forsøgt, men ikke har hjulpet, og behandling med en gruppe lægemidler, der kaldes ”antracykliner”, ikke er egnet til dig. 
• Abraxane is used in metastatic breast cancer when at least one other therapy has been tried but has not worked and you are unsuitable for treatments containing a group of medicines called “anthracyclines”.
I et studie med 12 patienter, der fik gentagne doser Abraxane på 260 mg/m2 i.v., var den intraindividuelle variabilitet i AUC 19 % (interval 3,21-37,70 %). 
In a repeat dose study with 12 patients receiving Abraxane administered intravenously at 260 mg/m2, intrapatient variability in AUC was 19% (range = 3.21%-37.70%).
Nadir-ANC < 500/mm3 i > 1 uge 
OR Nadir ANC <500/mm3 for > 1 week
Til behandling af ikke-småcellet lungekræft gives Abraxane én gang ugentligt (dvs. på dag 1, 8 og 15 i hver 21-dages cyklus), hvor carboplatin gives en gang hver tredje uge (dvs. kun på dag 1 i hver 21-dages cyklus), umiddelbart efter Abraxane-dosis er blevet givet. 
For treatment of non-small cell lung cancer Abraxane is given once every week (i.e. on days 1, 8 and 15 of a 21 day cycle), with carboplatin being given once every three weeks (i.e. only on day 1 of each 21-day cycle), immediately after the Abraxane dose has been given.
Det skal du vide, før du begynder at få Abraxane 
What you need to know before you are given Abraxane
Hver ml Abraxane indeholder cirka 4,2 mg natrium. 
Each ml of Abraxane contains approximately 4.2 mg of sodium.
Reducer til det næste lavere dosisniveaua; seponer behandlingen, hvis bivirkningen varer ved 
Reduce to next lower dose levela; discontinue treatment if ADR persists
trøske (svampeinfektion), svær infektion i blodet, som kan være forårsaget af et nedsat antal hvide blodlegemer 
flushing, thrush, severe infection in your blood which may be caused by reduced white blood cells
Hvis suspensionen kommer i kontakt med huden, skal huden straks vaskes grundigt med vand og sæbe. 
If the suspension contacts the skin, the skin should be washed immediately and thoroughly with soap and water.
Paclitaxels proteinbinding efter administration af Abraxane blev vurderet ved ultrafiltrering i et intraindividuelt sammenligningsstudie. 
The protein binding of paclitaxel following Abraxane was evaluated by ultrafiltration in a within-patient comparison study.
>Førstelinjebehandling 26,5 [18,98; 34,05] (n = 132) 13,2 [7,54; 18,93] (n = 136) 0,006a 
26.5 [18.98, 34.05] (n = 132) 13.2 [7.54, 18.93] (n = 136) 0.006a
Abraxane indeholder nanopartikler med en størrelse på ca. 130 nm, der består af humant serumalbumin, hvor paclitaxel findes i en ikke-krystallinsk, amorf tilstand. 
Abraxane contains human serum albumin-paclitaxel nanoparticles of approximately 130 nm in size, where the paclitaxel is present in a non-crystalline, amorphous state.
Efter infektiøs ætiologi er udelukket og pneumonitis diagnosticeret, seponeres Abraxane og gemcitabin permanent, og passende behandling og støttebehandling påbegyndes straks (se pkt. 
After ruling out infectious etiology and upon making a diagnosis of pneumonitis, permanently discontinue treatment with Abraxane and gemcitabine and promptly initiate appropriate treatment and supportive measures (see section 4.2).
Meget almindelig: Artralgi, myalgi 
Very common: Arthralgia, myalgia.
Denne analyse omfattede patienter med normal leverfunktion (n=130) og let (n=8), moderat (n=7) eller svært (n=5) nedsat leverfunktion (i henhold til kriterierne fra NCI Organ Dysfunction Working Group). 
This analysis included patients with normal hepatic function (n=130), and pre-existing mild (n=8), moderate (n=7), or severe (n=5) hepatic impairment (according to NCI Organ Dysfunction Working Group criteria).
Dosisjusteringer i løbet af behandling af ikke-småcellet lungecancer: 
Dose adjustments during treatment of non-small cell lung cancer:
• Abraxane anvendes sammen med et lægemiddel, der kaldes gemcitabin, hvis du har metastatisk kræft i bugspytkirtlen. 
• Abraxane is used together with a medicine called gemcitabine if you have metastatic cancer of the pancreas.
Da der ikke foreligger et farmakokinetisk lægemiddelinteraktionsstudie, bør der udvises forsigtighed, når paclitaxel indgives samtidigt med lægemidler, der vides at hæmme enten CYP2C8 eller CYP3A4 (f.eks. ketoconazol og andre imidazol-antimykotika, erythromycin, fluoxetin, gemfibrozil, clopidogrel, cimetidin, ritonavir, saquinavir, indinavir og nelfinavir), da paclitaxels toksicitet kan øges på grund af højere eksponering for paclitaxel. 
Therefore, in the absence of a PK drug-drug interaction study, caution should be exercised when administering paclitaxel concomitantly with medicines known to inhibit either CYP2C8 or CYP3A4 (e.g. ketoconazole and other imidazole antifungals, erythromycin, fluoxetine, gemfibrozil, clopidogrel, cimetidine, ritonavir, saquinavir, indinavir, and nelfinavir) because toxicity of paclitaxel may be increased due to higher paclitaxel exposure.
Der blev udført et multicenter, multinationalt, randomiseret, åbent studie hos 861 patienter for at sammenligne Abraxane/gemcitabin med gemcitabin-monoterapi som førstelinjebehandling hos patienter med metastatisk adenokarcinom i pancreas. 
A multicenter, multinational, randomized, open-label study was conducted in 861 patients to compare Abraxane/gemcitabine versus gemcitabine monotherapy as first-line treatment in patients with metastatic adenocarcinoma of the pancreas.
Ud af de 431 patienter med adenokarcinom i pancreas, der blev randomiseret til Abraxane i kombination med gemcitabin, var hovedparten (93 %) hvide, 4 % var sorte og 2 % var asiatiske. 
Of the 431 patients with pancreatic adenocarcinoma who were randomized to receive Abraxane in combination with gemcitabine, the majority (93%) were white, 4% were black and 2% were Asian.
• Svage eller manglende reflekser, ufrivillige bevægelser, smerter langs en nerve, besvimelse, svimmelhed, når du rejser dig, rysten, lammelse af ansigtsnerven 
• Decreased or lack of reflexes, involuntary movements, pain along a nerve, fainting, dizziness when standing up, shaking, facial nerve paralysis
• Infektion, feber med nedsat antal af en type hvide blodlegemer (neutrofiler) i blodet, blussen, 
• Infection, fever with decrease in the number of a type of white blood cell (neutrophils) in the blood,
• hvis du er allergisk (overfølsom) over for paclitaxel eller et af de øvrige indholdsstoffer i 
• if you are allergic (hypersensitive) to paclitaxel or any of the other ingredients of Abraxane (listed in section 6);
Hos patienter på 75 år og ældre blev der ikke demonstreret en fordel af kombinationsbehandling med Abraxane og gemcitabin sammenlignet med monoterapi med gemcitabin. 
For patients of 75 years and older, no benefit for the combination treatment of Abraxane and gemcitabine in comparison to gemcitabine monotherapy has been demonstrated.
CI = konfidensinterval, HRA/T = Hazard ratio af Abraxane/carboplatin til solvensbaseret paclitaxel/carboplatin, pA/pT = responsrate for Abraxane/carboplatin i forhold til solvensbaseret paclitaxel/carboplatin. 
CI = confidence interval; HRA/T = hazard ratio of Abraxane/carboplatin to solvent-based paclitaxel/carboplatin; pA/pT = response rate ratio of Abraxane/carboplatin to solvent-based paclitaxel/carboplatin.
Resultaterne viser, at let nedsat leverfunktion (totalbilirubin > 1 til ≤1,5 x øvre normalværdi) ikke har nogen klinisk vigtig virkning på paclitaxels farmakokinetik. 
The results show that mild hepatic impairment (total bilirubin >1 to ≤1.5 x ULN) has no clinically important effect on pharmacokinetics of paclitaxel.
Febril neutropeni forekom hos fire patienter, som fik Abraxane. 
Febrile neutropenia occurred in four patients on Abraxane.
En populationsfarmakokinetisk analyse af Abraxane inkluderede patienter i aldersintervallet fra 24 til 85 år og viser, at alder ikke har en signifikant indflydelse på paclitaxels maksimale eliminationshastighed og systemiske eksponering (AUC og Cmax). 
Population pharmacokinetic analysis for Abraxane included patients with ages ranging from 24 to 85 years old and shows that age does not significantly influence the maximum elimination rate and systemic exposure (AUC and Cmax) of paclitaxel.
3 Hyppigheden af pneumonitis er beregnet på grundlag af poolede data hos 1.310 patienter i kliniske studier, der fik Abraxane-monoterapi for brystkræft og for andre indikationer, på grundlag af MedDRA, SMQ interstitiel lungesygdom. 
3 The frequency of pneumonitis is calculated based on pooled data in 1310 patients in clinical trials receiving Abraxane monotherapy for breast cancer and for other indications using MedDRA SMQ Interstitial lung disease.
Studiet sammenlignede Abraxane i kombination med carboplatin med solvensbaseret paclitaxel i kombination med carboplatin som førstelinjebehandling hos patienter med fremskreden ikke-småcellet lungecancer. 
The study compared Abraxane in combination with carboplatin versus solvent-based paclitaxel in combination with carboplatin as first-line treatment in patients with advanced non-small cell lung cancer.
14 % af patienterne havde ikke tidligere fået kemoterapi; 27 % havde alene fået kemoterapi som adjuverende behandling, 40 % alene som behandling for metastaserende sygdom og 19 % havde fået både adjuverende behandling og behandling for metastaserende sygdom. 
Fourteen percent of the patients had not received prior chemotherapy; 27% had received chemotherapy in the adjuvant setting only, 40% in the metastatic setting only, and 19% in both metastatic and adjuvant settings.
Hos meget ældre patienter (≥75 år), som fik Abraxane and gemcitabin, var der en højere forekomst af alvorlige bivirkninger, der førte til seponering af behandlingen, herunder hæmatologiske toksiciteter, perifer neuropati, nedsat appetit og dehydrering. 
In the very elderly (≥75 years) who received Abraxane and gemcitabine, there was a higher incidence of serious adverse reactions and adverse reactions that led to treatment discontinuation including haematologic toxicities, peripheral neuropathy, decreased appetite and dehydration.
Efter 30-minutters infusion af Abraxane 260 mg/m2 til patienter med metastatisk brystkræft udgjorde den gennemsnitlige kumulative udskillelse af uomdannet aktivt stof i urinen 4 % af den totale administrerede dosis med under 1 % som metabolitterne 6-hydroxypaclitaxel og 3'-p-hydroxypaclitaxel, hvilket indikerer omfattende ikke-renal clearance. 
In patients with metastatic breast cancer, after a 30-minute infusion of Abraxane at 260 mg/m2, the mean value for cumulative urinary excretion of unchanged active substance accounted for 4% of the total administered dose with less than 1% as the metabolites 6-hydroxypaclitaxel and 3'-p-hydroxypaclitaxel, indicating extensive non-renal clearance.
Hvis der forekommer skumdannelse eller sammenklumpning, skal suspensionen stå i mindst 15 minutter, indtil skummet lægger sig. 
If foaming or clumping occurs, the suspension should stand for at least 15 minutes until foam subsides.
Det naturlige forløb af perifer neuropati, forårsaget af kumulativ toksicitet af Abraxane efter mere end 6 behandlinger, indtil neuropatien vendte tilbage til baseline, blev ikke evalueret og forbliver ukendt. 
The natural course of peripheral neuropathy to resolution to baseline due to cumulative toxicity of Abraxane after > 6 courses of treatment was not evaluated and remains unknown.
Det er ikke relevant at anvende Abraxane hos den pædiatriske population til indikationerne metastaserende brystkræft, adenokarcinom i pancreas eller ikke-småcellet lungecancer. 
There is no relevant use of Abraxane in the paediatric population in the indication of metastatic breast cancer or pancreatic adenocarcinoma or non-small cell lung cancer.
Brystkræft (Abraxane administreret som monoterapi) 
Breast cancer (Abraxane administered as monotherapy)
Der har været sjældne rapporter om nedsat synsskarphed på grund af cystoidt makulaødem under behandling med Abraxane. 
There have been rare reports of reduced visual acuity due to cystoid macular oedema during treatment with Abraxane.
Perifer neuropati: Grad 3 eller 4 
Peripheral Neuropathy: Grade 3 or 4
Erlotinib bør ikke administreres sammen med Abraxane plus gemcitabin (se pkt. 
Erlotinib should not be coadministered with Abraxane plus gemcitabine (see section 4.5).
Abraxane i kombination med gemcitabin er indiceret til førstelinjebehandling af voksne patienter med metastatisk adenokarcinom i pancreas. 
Abraxane in combination with gemcitabine is indicated for the first-line treatment of adult patients with metastatic adenocarcinoma of the pancreas.
Justering af startdosis af Abraxane er ikke nødvendig for patienter med let til moderat nedsat nyrefunktion (estimeret kreatininclearance ≥ 30 til < 90 ml/min). 
Adjustment of the starting Abraxane dose is not required for patients with mild to moderate renal impairment (estimated creatinine clearance ≥30 to <90 ml/min).
Paclitaxel og/eller dets metabolitter blev udskilt i mælken hos diegivende rotter (se pkt. 
Paclitaxel and/or its metabolites were excreted into the milk of lactating rats (see section 5.3).
En populationsfarmakokinetisk analyse omfattede patienter med normal nyrefunktion (n=65) og let (n=61), moderat (n=23) eller svært (n=l) nedsat nyrefunktion (i henhold til udkastet til kriterierne for FDA-retningslinjerne 2010). 
Population pharmacokinetic analysis included patients with normal renal function (n=65), and pre-existing mild (n=61), moderate (n=23), or severe (n=l) renal impairment (according to draft FDA guidance criteria 2010).
Tabel 6 angiver bivirkninger forbundet med administration af Abraxane til patienter fra studier, hvor Abraxane er blevet administreret som monoterapi i forskellige doseringer til forskellige indikationer (N = 789). 
Table 6 lists adverse reactions associated with the administration of Abraxane to patients from studies in which Abraxane has been administered as monotherapy at any dose in any indication (N = 789).
Patienter med moderat (total bilirubin > 1,5 til ≤ 3 x øvre normalværdi) eller svært (totalbilirubin > 3 til ≤ 5 x øvre normalværdi) nedsat leverfunktion har en 22 % til 26 % reduktion i paclitaxels maksimale eliminationshastighed og en ca. 20 % forhøjet gennemsnitlig paclitaxel-AUC, sammenlignet med patienter med normal leverfunktion. 
Patients with moderate (total bilirubin >1.5 to ≤3 x ULN) or severe (total bilirubin >3 to ≤5 x ULN) hepatic impairment have a 22% to 26% decrease in the maximum elimination rate of paclitaxel and approximately 20% increase in mean paclitaxel AUC compared with patients with normal hepatic function.
Ikke-småcellet lungecancer (Abraxane administreret i kombination med carboplatin) 
Non-small cell lung cancer (Abraxane administered in combination with carboplatin)
Genoptag Abraxane med reduceret dosis, når perifer neuropati forbedres til grad 0 eller 1(se pkt. 
Resume Abraxane at reduced dose when peripheral neuropathy improves to Grade 0 or 1 (see section 4.2).
Det er ikke nødvendigt at anvende specielle di(2-ethylhexyl)phthalat (DEHP)-frie infusionsbeholdere eller administrationssæt til at klargøre eller indgive Abraxane-infusioner. 
The use of specialized di(2-ethylhexyl)phthalate (DEHP)-free solution containers or administration sets is not necessary to prepare or administer Abraxane infusions.
Pulver til infusionvæske, suspension. 
Powder for suspension for infusion.
Patienter i alderen 75 år og ældre med adenokarcinom i pancreas bør nøje vurderes for deres evne til at tolerere Abraxane i kombination med gemcitabin med særlig opmærksomhed på præstationsstatus, komorbiditeter og øget infektionsrisiko (se pkt. 
Patients with pancreatic adenocarcinoma aged 75 years and older should be carefully assessed for their ability to tolerate Abraxane in combination with gemcitabine with special consideration to performance status, co-morbidities and increased risk of infections (see section 4.2 and 4.8).
Følgende bivirkninger er de hyppigste og klinisk mest relevante bivirkninger relateret til 229 patienter med metastatisk brystkræft, som blev behandlet med 260 mg/m2 Abraxane én gang hver 3. uge i det pivotale kliniske fase III-studie. 
The following are the most common and clinically relevant adverse reactions related to 229 patients with metastatic breast cancer who were treated with 260 mg/m2 Abraxane once every three weeks in the pivotal phase III clinical study.
I et studie af patienter med fremskredne, solide tumorer blev de farmakokinetiske karakteristika af paclitaxel efter intravenøs indgift af 260 mg/m2 Abraxane over 30 minutter sammenlignet med karakteristikaene efter 175 mg/m2 af den solvensbaserede paclitaxelindsprøjtning givet over tre timer. 
In a study in patients with advanced solid tumours, the pharmacokinetic characteristics of paclitaxel following Abraxane administered intravenously at 260 mg/m2 over 30 minutes were compared with those following 175 mg/m2 of the solvent-based paclitaxel injection administered over 3 hours.
Mænd anbefales at anvende sikker prævention samt at undgå at gøre kvinder gravide under og i op til seks måneder efter behandlingen, og de bør søge rådgivning om opbevaring af sæd forud for behandlingen på grund af risikoen for permanent sterilitet efter behandling med Abraxane. 
Male patients are advised to use effective contraception and to avoid fathering a child during and up to six months after treatment and should seek advice on conservation of sperm prior to treatment because of the possibility of irreversible infertility due to therapy with Abraxane.
Abraxane (100 mg/m2/uge) + carboplatin (N = 521) 
Abraxane (100 mg/m2/week) + carboplatin (N=521)
Ikke-småcellet lungecancer: 
Non-small cell lung cancer:
hudskjolder, flere svedeture, natlige svedeture, hvide områder på huden, sår, opsvulmet ansigt 
skin discolouration, increased sweating, night sweats, white areas on the skin, sores, swollen face
Mandlige patienter bør søge rådgivning om opbevaring af sæd forud for behandling på grund af risikoen for permanent sterilitet som følge af behandling med Abraxane. 
Male patients should seek advice on conservation of sperm prior to treatment because of the possibility of irreversible infertility due to therapy with Abraxane.
Det skyldes, at Abraxane kan påvirke virkningen af andre lægemidler, og andre lægemidler kan påvirke virkningen af Abraxane. 
This is because Abraxane can affect the way some other medicines work.
(10 g/dl)) blev observeret hos 46 % af patienterne, der fik Abraxane, og var udtalt (Hb < 5 µmol/l (8 g/dl)) i tre tilfælde. 
Anaemia (Hb < 10 g/dl) was observed in 46% of patients on Abraxane, and was severe (Hb < 8 g/dl) in three cases.
Den anbefalede dosis af carboplatin er AUC = 6 mg•min/ml kun på Dag 1 i hver 21-dages cyklus umiddelbart efter, administrationen af Abraxane er gennemført. 
The recommended dose of carboplatin is AUC = 6 mg•min/mL on Day 1 only of each 21-day cycle, beginning immediately after the end of Abraxane administration.
Efter rekonstituering indeholder hver ml suspension 5 mg paclitaxel. 
After reconstitution, each ml of suspension contains 5 mg of paclitaxel.
Knoglemarvssuppression (primært neutropeni) forekommer hyppigt ved behandling med paclitaxel. 
Bone marrow suppression (primarily neutropenia) occurs frequently with Abraxane.
Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med Abraxane i alle undergrupper af den pædiatriske population ved behandling af metastaserende brystkræft, adenokarcinom i pancreas og ikke-småcellet lungecancer (se pkt. 
The European Medicines Agency has waived the obligation to submit the results of studies with Abraxane in all subsets of the paediatric population in the treatment of metastatic breast cancer, pancreatic adenocarcinoma and non-small cell lung cancer (see section 4.2 for information on paediatric use).
Almindelig: Kronisk hjerteinsufficiens, takykardi 
Common: Cardiac failure congestive, tachycardia
Der blev udført et farmakokinetisk studie med Abraxane og carboplatin hos patienter med ikkesmåcellet lungecancer. 
A pharmacokinetic study was conducted with Abraxane and carboplatin in non-small cell lung cancer patients.
CI = konfidensinterval, HRA+G/G = hazard ratio for Abraxane+gemcitabin/gemcitabin, pA+G/pG=responsrate-forhold af Abraxane+gemcitabin/gemcitabin a stratificeret Cox proportionel hazard-model b stratificeret log-rank-test, stratificeret ved geografisk region (Nordamerika versus andre), KPS (70 til 
CI = confidence interval, HRA+G/G = hazard ratio of Abraxane+gemcitabine/gemcitabine, pA+G/pG=response rate ratio of Abraxane+gemcitabine/gemcitabine a stratified Cox proportional hazard model b stratified log-rank test, stratified by geographic region (North America versus others), KPS (70 to 80 versus 90 to 100), and presence of liver metastasis (yes versus no).
(AUC) øgedes lineært fra 2.653 til 16.736 ng∙t/ml efter dosering fra 80 til 300 mg/m2. 
The paclitaxel exposure (AUC) increased linearly from 2653 to 16736 ng.hr/ml following dosing from 80 to 300 mg/m2.
Tabel 9 angiver bivirkninger forbundet med administration af Abraxane i kombination med carboplatin. 
Table 9 lists adverse reactions associated with the administration of Abraxane in combination with carboplatin.
Tabel 10: Resultater for samlet responsrate, mediantid til sygdomsprogression og progressionsfri og samlet overlevelse, baseret på investigators vurderinger. 
Table 10: Results for overall response rate, median time to disease progression, and progression-free survival as assessed by the investigator Efficacy variable
Patienter, der får Abraxane, bør derfor kontrolleres nøje for udvikling af hjertesymptomer. 
Thus patients receiving Abraxane should be vigilantly monitored by physicians for the occurrence of cardiac events.
LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Pulver til infusionsvæske, suspension. 
PHARMACEUTICAL FORM AND CONTENTS Powder for suspension for infusion.
Pneumonitis opstod hos 1% af patienterne, når Abraxane blev anvendt til monoterapi, og hos 4% af patienterne, når Abraxane blev anvendt i kombination med gemcitabin. 
Pneumonitis occurred in 1% of patients when Abraxane was used as monotherapy and in 4% of patients when Abraxane was used in combination with gemcitabine.
Der blev vurderet bivirkninger hos 421 patienter, behandlet med Abraxane i kombination med gemcitabin, og hos 402 patienter, behandlet med gemcitabin-monoterapi, der fik systemisk førstelinjebehandling mod metastatisk adenokarcinom i pancreas i et randomiseret, kontrolleret, åbent fase III-studie. 
Adverse reactions were assessed in 421 patients treated with Abraxane in combination with gemcitabine and 402 gemcitabine monotherapy-treated patients receiving first-line systemic treatment for metastatic adenocarcinoma of the pancreas in a phase III randomized, controlled, open-label trial.