FrancophonIA/ELRC3.0 huggingface dataset:
English: Women of childbearing potential should have a pregnancy test prior to starting treatment with Abraxane.
Danish: Fertile kvinder skal have foretaget en graviditetstest, inden behandling med Abraxane indledes.
English: Cutaneous Toxicity: Grade 2 or 3
Danish: Kutan toksicitet: Grad 2 eller 3
English: Abraxane was administered to patients (N = 431) as an intravenous infusion over 30-40 minutes at a dose of 125 mg/m2 followed by gemcitabine as an intravenous infusion over 30-40 minutes at a dose of 1000 mg/m2 given on Days 1, 8 and 15 of each 28-day cycle.
Danish: Abraxane blev administreret til patienter (N = 431) som intravenøs infusion i løbet af 30-40 minutter ved en dosis på 125 mg/m2, efterfulgt af gemcitabin som intravenøs infusion i løbet af 30-40 minutter ved en dosis på 1.000 mg/m2, givet på Dag 1, 8 og 15 i hver 28-dages cyklus.
English: Abraxane 5 mg/ml powder for suspension for infusion paclitaxel
Danish: Abraxane5 mg/ml pulver til infusionsvæske, suspension paclitaxel
English: Table 7 lists adverse reactions assessed in patients with pancreatic adenocarcinoma treated with Abraxane in combination with gemcitabine.
Danish: Tabel 7 angiver bivirkninger vurderet hos patienter med adenokarcinom i pancreas i behandling med Abraxane i kombination med gemcitabin.
English: For metastatic breast cancer patients and non-small cell lung cancer patients with moderate to severe hepatic impairment (total bilirubin > 1.5 to ≤ 5 x ULN and AST ≤ 10 x ULN), a 20% reduction in dose is recommended.
Danish: For patienter med metastatisk brystkræft og for patienter med ikke-småcellet lungecancer med moderat til svært nedsat leverfunktion (totalbilirubin > 1,5 til ≤ 5 x øvre normalværdi og ASAT ≤ 10 x øvre normalværdi) anbefales 20 % dosisreduktion.
English: Abraxane is indicated as monotherapy for breast cancer, in combination with gemcitabine for pancreatic adenocarcinoma, or in combination with carboplatin for non-small cell lung cancer (see section 4.1).
Danish: Abraxane er indiceret som monoterapi ved brystkræft, i kombination med gemcitabin ved adenokarcinom i pancreas og i kombination med carboplatin ved ikke-småcellet lungecancer (se pkt.
English: Reconstituted Abraxane suspension is administered intravenously using an infusion set incorporating a 15 µm filter.
Danish: Administrer den rekonstituerede Abraxane-suspension intravenøst via et infusionssæt med et indsat 15 µm filter.
English: Table 8: Haematologic laboratory-detected abnormalities in pancreatic adenocarcinoma trial
Danish: Tabel 8: Hæmatologiske laboratoriedetekterede anomalier i studiet af adenokarcinom i pancreas
English: Treatment effects on OS favoured the Abraxane/gemcitabine arm across the majority of pre-specified subgroups (including gender, KPS, geographic region, primary location of pancreatic cancer, stage at diagnosis, presence of liver metastases, presence of peritoneal carcinomatosis, prior Whipple procedure, presence of biliary stent at baseline, presence of pulmonary metastases, and number of metastatic sites).
Danish: Behandlingens virkning på OS favoriserede Abraxane/gemcitabin-armen i flertallet af de præspecificerede undergrupper (herunder køn, KPS, geografisk region, primær lokalitet af pancreascancer, stadie ved diagnosticering, tilstedeværelse af levermetastaser, tilstedeværelse af peritoneal karcinomatose, tidligere Whipple-procedure, tilstedeværelse af galdevejsstent ved baseline, tilstedeværelse af lungemetastaser og antallet af metastasesteder).For patienter ≥ 75 år i Abraxane/gemcitabin- og gemcitabin-armene var hazard ratio (HR) for overlevelse 1,08 (95% CI 0,653; 1,797).
English: There are insufficient data available to recommend dose modifications of Abraxane in patients with severe renal impairment or end stage renal disease (estimated creatinine clearance <30 ml/min) (see section 5.2).
Danish: Data er utilstrækkelige til at anbefale justering af Abraxanedosis til patienter med svært nedsat nyrefunktion eller nyresygdom i slutstadiet (estimeret kreatininclearance < 30 ml/min) (se pkt.
English: Gemcitabine Dose (mg/m2)
Danish: Gemcitabin-dosis (mg/m2)
English: Table 5: Dose reductions for non-haematologic toxicities in patients with non-small cell lung cancer Non-haematologic Toxicity
Danish: Tabel 5: Dosisreduktioner ved ikke-hæmatologiske toksiciteter hos patienter med ikke-småcellet lungecancer
English: Abraxane should be administered under the supervision of a qualified oncologist in units specialised in the administration of cytotoxic agents.
Danish: Abraxane bør gives under overvågning af en kvalificeret onkolog på afdelinger, der er specialiseret i administration af cytotoksiske midler.
English: For febrile neutropenia, withhold Abraxane and gemcitabine until fever resolves and ANC ≥ 1500 cells/mm3, then resume treatment at reduced dose levels (see section 4.2).
Danish: Ved febril neutropeni skal Abraxane og gemcitabin afbrydes, indtil feberen går væk, og ANC ≥ 1.500 celler/mm3, hvorefter behandlingen genoptages med reducerede dosisniveauer (se pkt.
English: If Abraxane suspension contacts the skin, the skin should be washed immediately and thoroughly with soap and water.
Danish: Hvis Abraxanesuspensionen kommer i kontakt med huden, skal du straks vaske huden grundigt med vand og sæbe.
English: Overall Survival Number of deaths, n (%) Median OS (95% CI) (months) HRA/T (95.1% CI)
Danish: Samlet overlevelse Antal dødsfald, n (%) Median OS (95 % CI) (måneder) HRA/T (95,1 % CI)
English: • Decreased phosphorus in the blood, fluid retention, low albumin in the blood, increased thirst,
Danish: • Nedsat fosfor i blodet, væskeansamling, lavt albumin i blodet, øget tørst, nedsat kalcium i blodet,
English: There have been reports of tumour lysis syndrome during treatment with Abraxane.
Danish: Der har været rapporter om tumorlysesyndrom under behandling med Abraxane.
English: Common: Tachycardia, arrhythmia, supraventricular tachycardia Rare: bradycardia, cardiac arrest, left ventricular dysfunction, congestive heart failure, atrioventricular block2
Danish: Almindelig: Takykardi, arytmi, supraventrikulær takykardi Sjælden: Bradykardi, hjertestop, nedsat venstre ventrikelfunktion, kronisk hjerteinsufficiens, atrioventrikulært blok2
English: Abraxane is not recommended in patients that have total bilirubin > 5 x ULN or AST > 10 x ULN.
Danish: Abraxane anbefales ikke hos patienter, der har totalbilirubin >5 x øvre normalværdi eller ASAT > 10 x øvre normalværdi.
English: Table 9: Adverse reactions reported with Abraxane in combination with carboplatin (N = 514) Infections and infestations
Danish: Tabel 9: Bivirkninger rapporteret med Abraxane i kombination med carboplatin (N = 514) Infektioner og parasitære sygdomme
English: There was a statistically significant improvement in PFS for patients treated with Abraxane/gemcitabine versus gemcitabine alone, with 1.8 months increase in median PFS.
Danish: Der var en statistisk signifikant forbedring i PFS med 1,8 måneders forbedring i median PFS hos patienter, der blev behandlet med Abraxane/gemcitabin versus gemcitabin alene.
English: Other medicines and Abraxane
Danish: Brug af anden medicin sammen med Abraxane
English: Of the 421 patients with pancreatic adenocarcinoma in the randomized study who received Abraxane in combination with gemcitabine, 41% were 65 years and older and 10% were 75 years and older.
Danish: Ud af de 421 patienter med adenokarcinom i pancreas i det randomiserede studie, hvor Abraxane blev givet i kombination med gemcitabin, var 41% 65 år og ældre, og 10% var 75 år og ældre.
English: Common: Dehydration, decreased appetite, hypokalaemia Uncommon: Hypophosphataemia, fluid retention, hypoalbuminaemia, polydipsia, hyperglycaemia, hypocalcaemia, hypoglycaemia, hyponatraemia
Danish: Almindelig: Dehydrering, nedsat appetit, hypokalæmi Ikke almindelig: Hypofosfatæmi, væskeretention, hypoalbuminæmi, polydipsi, hyperglykæmi, hypokalcæmi, hypoglykæmi, hyponatræmi
English: Gemcitabine Dose
Danish: Gemcitabin-dosis
English: Very common: Dyspnoea, epistaxis, cough Common: Pneumonitis2, nasal congestion Uncommon: Dry throat, nasal dryness
Danish: Meget almindelig:Dyspnø, epistaxis, hoste Almindelig: Pneumonitis2, nasal tilstopning Ikke almindelig: Tør hals, nasal tørhed
English: Uncommon: Contusion
Danish: Ikke almindelig: Kontusion
English: Reconstituted suspension: It can be stored refrigerated at 2°C to 8°C for up to 24 hours in either the vial or an infusion bag, protected from light.
Danish: Rekonstitueret suspension: Den kan opbevares i køleskab ved temperaturer på 2 °C til 8 °C i op til 24 timer enten i hætteglasset eller i en infusionspose, beskyttet mod lys.
English: The second trial utilised a dose of 300 mg/m2 as a 30 minute infusion in 63
Danish: Det andet studie anvendte en dosis på 300 mg/m2 som en
English: Overall Survival Number of deaths (%) Median Overall Survival, months (95% CI) HRA+G/G (95% CI)a P-valueb
Danish: Samlet overlevelse Antal dødsfald (%) Median samlet overlevelse, måneder (95% CI) HRA+G/G (95% CI)a P-værdib
English: Table 12: Overall response rate in randomized non-small cell lung cancer trial (intent-to-treat population)
Danish: Tabel 12: Samlet responsrate i et randomiseret studie af ikke-småcellet lungecancer (intent-totreat-population)
English: 56.4 [45.1, 76.9] (n = 131)
Danish: >Førstelinjebehandling 56,4 [45,1; 76,9] (n = 131)
English: Table 7: Adverse reactions reported with Abraxane in combination with gemcitabine (N =421) Infections and infestations
Danish: Tabel 7: Bivirkninger rapporteret med Abraxane i kombination med gemcitabin (N =421) Infektioner og parasitære sygdomme
English: *Median progression free survival [95% CI] (weeks)
Danish: *Median progressionsfri overlevelse [95 % CI] (uger)
English: On Days 8 or 15 of the 21-day cycle reduce the dose of Abraxane; reduce the dose of carboplatin in the subsequent cycle.
Danish: På Dag 8 eller 15 i 21-dages cyklussen reduceres dosis af Abraxane.
English: When Abraxane is used as monotherapy, if Grade 3 sensory neuropathy develops, treatment should be withheld until resolution to Grade 1 or 2 followed by a dose reduction for all subsequent courses of Abraxane is recommended (see section 4.2).
Danish: Når Abraxane anvendes som monoterapi, og hvis der udvikles grad 3 sensorisk neuropati, anbefales det at stoppe behandlingen indtil stigning til grad 1 eller 2, hvorefter dosis reduceres i alle efterfølgende Abraxane-behandlingsserier (se pkt.
English: Upon diagnosis of cystoid macular oedema, treatment with Abraxane should be discontinued.
Danish: Hvis cystoidt makulaødem diagnosticeres, skal Abraxane seponeres.
English: For treatment of advanced pancreatic cancer, Abraxane is given on days 1, 8 and 15 of each 28-day treatment cycle with gemcitabine being given immediately after the Abraxane.
Danish: Til behandling af fremskreden kræft i bugspytkirtlen gives Abraxane på dag 1, 8 og 15 i hver 28-dages behandlingscyklus.
English: Women of childbearing potential should use effective contraception during treatment and up to 1 month after receiving treatment with Abraxane.
Danish: Kvinder i den fertile alder bør anvende sikker kontraception under behandlingen og i en måned efter behandlingen med Abraxane.
English: Day 15: If Day 8 doses were given without modification: Day 15 ≥ 500 but < 1000 OR ≥ 50,000 but < 75,000
Danish: Dag 15: Hvis Dag 8 doser blev givet uden modifikation: Dag 15 ≥ 500 men <
English: For combination use of Abraxane and carboplatin, if Grade 3 or higher peripheral neuropathy develops, treatment should be withheld until improvement to Grade 0 or 1 followed by a dose reduction for all subsequent courses of Abraxane and carboplatin (see section 4.2).
Danish: Hvis der udvikles perifer neuropati af grad 3 eller højere ved kombinationsbehandling med Abraxane og carboplatin, bør behandlingen afbrydes indtil bedring til grad 0 eller 1, og dosis reduceres ved alle efterfølgende behandlingsforløb med Abraxane og carboplatin (se pkt.
English: Patients should not be retreated with subsequent cycles of Abraxane until neutrophils recover to >1500 cells/mm3 and platelets recover to >100,000 cells/mm3 (see section
Danish: Patienter bør ikke genoptage behandlingen med efterfølgende serier Abraxane, før neutrofiltallet atter er >1.500 celler/mm3 og trombocyttallet atter er >100.000 celler/mm3 (se pkt.
English: Return to Day 1 dose levels and follow with WBC Growth Factors
Danish: Vend tilbage til Dag 1 dosisniveau og følg op med vækstfaktorer for WBC
English: Abraxane should only be administered under the supervision of a qualified oncologist in units specialised in the administration of cytotoxic agents.
Danish: Abraxane bør kun anvendes under supervision af en erfaren onkolog på afdelinger specialiseret i anvendelse af cytotoksiske lægemidler.
English: Rare reports of congestive heart failure and left ventricular dysfunction have been observed among individuals receiving Abraxane.
Danish: Der er i sjældne tilfælde observeret kongestiv hjerteinsufficiens og nedsat venstre ventrikelfunktion hos patienter i behandling med Abraxane.
English: There was a significant difference in overall response rate in the Abraxane/carboplatin arm compared to the control arm in patients with non-small cell lung cancer of squamous histology (N=450, 41% vs. 24%, p<0.001), however this difference did not translate into a difference in PFS or OS.
Danish: Der var en signifikant forskel i den samlede responsrate til fordel for Abraxane/carboplatin-armen sammenlignet med kontrolarmen hos patienter med ikke-småcellet lungecancer med pladecellehistologi (N=450, 41 % versus 24 %, p<0,001), denne forskel førte imidlertid ikke til en forskel i PFS eller OS. Der var ingen forskel i samlet responsrate mellem de 2 behandlingsarme for patienter med ikke-pladecellehistologi (N=602, 26 % versus 25 %, p=0,808).
English: For each subsequent weekly dose of Abraxane, patients must have an ANC ≥500 cells/mm3 and platelets >50,000 cells/mm3 or the dose is to be withheld until counts recover.
Danish: Ved hver efterfølgende ugentlige dosis af Abraxane skal patienterne have ANC ≥ 500 celler/mm3 og trombocytter > 50.000 celler/mm3,
English: Very common: Neutropenia1, thrombocytopenia1, anaemia1, leukopenia1 Common: Febrile neutropenia, lymphopenia Uncommon: Pancytopenia
Danish: Meget almindelig: Neutropeni1, trombocytopeni1, anæmi1, leukopeni1 Almindelig: Febril neutropeni, lymfopeni
English: Common: Decreased weight, increased alanine aminotransferase, increased aspartate aminotransferase, decreased haematocrit, decreased red blood cell count, increased body temperature, increased gamma-glutamyltransferase, increased blood alkaline phosphatase
Danish: Almindelig: Nedsat vægt, forhøjet alaninaminotransferase (ALAT), forhøjet aspartataminotransferase (ASAT), nedsat hæmatokrit, nedsat antal røde blodlegemer, øget legemstemperatur, forhøjet gamma-glutamyltransferase, forhøjet serum-alkalisk fosfatase
English: How to use Abraxane
Danish: Sådan skal du bruge Abraxane
English: Albumin is known to mediate endothelial caveolar transcytosis of plasma constituents, and in vitro studies demonstrated that the presence of albumin in Abraxane enhances transport of paclitaxel across endothelial cells.
Danish: Under intravenøs administration dissocierer nanopartiklerne hurtigt til opløselige, albuminbundne paclitaxel-komplekser med en størrelse på ca. 10 nm. Albumin vides at formidle caveolae-endoteltranscytose af plasmabestanddele, og in vitro-studier har vist, at tilstedeværelsen af albumin i Abraxane øger transporten af paclitaxel gennem endotelceller.
English: The usual dose for non-small cell lung cancer is 100 mg/m2 of body surface area given over a 30 minute period.
Danish: Den anbefalede dosis ved ikke-småcellet lungekræft er 100 mg/m2 legemsoverflade, givet i løbet af
English: Very common: Peripheral neuropathy1, dysgeusia, headache, dizziness Uncommon: VIIth nerve paralysis
Danish: Meget almindelig: Perifer neuropati1, dysgeusi, hovedpine, svimmelhed Ikke almindelig: parese af 7. nerve
English: If Abraxane contacts mucous membranes, the membranes should be flushed thoroughly with water.
Danish: Hvis Abraxane kommer i kontakt med slimhinder, skal du skylle grundigt med vand.
English: Abraxane is available in glass vials containing 100 mg or 250 mg of paclitaxel formulated as albumin bound nanoparticles.
Danish: Abraxane fås i hætteglas, der indeholder 100 mg eller 250 mg paclitaxel formuleret som albuminbundne nanopartikler.
English: Unopened vials: Keep the vial in the outer carton in order to protect from light.
Danish: Uåbnede hætteglas: Opbevar hætteglasset i den ydre karton for at beskytte mod lys.
English: In some patients previously exposed to capecitabine, reports of palmar-plantar erythrodysaesthesiae have been reported as part of the continuing surveillance of Abraxane.
Danish: I forbindelse med den løbende overvågning af Abraxane har der været rapporteringer om palmar-plantar erytrodysæstesi hos nogle patienter, der tidligere havde været eksponeret for capecitabin.
English: Patients received a median treatment duration of 3.9 months in the Abraxane/gemcitabine arm and 2.8 months in the gemcitabine arm. 32% of patients in the Abraxane/gemcitabine arm compared with 15% of patients in the gemcitabine arm received 6 or more months of treatment.
Danish: 32% af patienterne i Abraxane/gemcitabin-armen, sammenlignet med 15% af patienterne i gemcitabin-armen fik behandling i 6 måneder eller mere.
English: 20.9 [15.7, 25.9] (n = 131)
Danish: >Førstelinjebehandling 20,9 [15,7; 25,9] (n = 131)
English: Very common: Pain in extremity, arthralgia, myalgia Common: Muscular weakness, bone pain
Danish: Meget almindelig:Ekstremitetssmerter, artralgi, myalgi Almindelig: Muskelsvaghed, knoglesmerter
English: What Abraxane looks like and contents of the pack Abraxane is a white to yellow powder for suspension for infusion.
Danish: Abraxane er et hvidt til gult pulver til infusionsvæske, suspension.
English: 20.6 [15.6, 25.9] (n = 131)
Danish: >Førstelinjebehandling 20,6 [15,6; 25,9] (n = 131)
English: If foaming or clumping occurs, the solution must stand for at least 15 minutes until foam subsides.
Danish: Hvis der forekommer skumdannelse eller sammenklumpning, skal infusionsvæsken stå i mindst 15 minutter, indtil skummet lægger sig.
English: Common: Flushing, hot flushes, hypertension, lymphoedema Uncommon: Hypotension, peripheral coldness, orthostatic hypotension Rare: Thrombosis
Danish: Almindelig: Flushing, hedeture, hypertension, lymfødem Ikke almindelig: Hypotension, perifer kuldefornemmelse, ortostatisk hypotension
English: Treat with Day 8 dose level and follow with WBC Growth Factors
Danish: Behandl med Dag 8 dosisniveau og følg op med vækstfaktorer for WBC
English: The usual dose is for breast cancer is 260 mg/m2 of body surface area given over a 30 minute period.
Danish: Den anbefalede dosis for brystkræft er 260 mg/m2 legemsoverflade, givet i løbet af 30 minutter.
English: Very common: Insomnia, depression Common: Anxiety
Danish: Meget almindelig: Søvnløshed, depression
English: *Survival [95% CI] (weeks)
Danish: *Samlet overlevelse [95 % CI] (uger)
English: Very common: Neutropenia, anaemia, leukopenia, thrombocytopenia, lymphopenia, bone marrow suppression Common: Febrile neutropenia
Danish: Meget almindelig: Neutropeni, anæmi, leukopeni, trombocytopeni, lymfopeni, knoglemarvssuppression Almindelig: Febril neutropeni
English: The use of medical devices containing silicone oil as a lubricant (i.e. syringes and IV bags) to reconstitute and administer Abraxane may result in the formation of proteinaceous strands.
Danish: infusionsposer) til at rekonstituere og administrere Abraxane kan føre til dannelse af proteinholdige tråde.
English: The recommended dose of Abraxane is 100 mg/m2 administered as an intravenous infusion over 30 minutes on Days 1, 8 and 15 of each 21-day cycle.
Danish: Den anbefalede dosis af Abraxane er 100 mg/m2 administreret som intravenøs infusion i løbet af 30 minutter på Dag 1, 8 og 15 i hver 21-dages cyklus.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 100 mg of paclitaxel formulated as albumin bound nanoparticles.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hvert hætteglas indeholder 100 mg paclitaxel formuleret som albuminbundne nanopartikler.
English: Abraxane induced infertility in male rats (see section 5.3).
Danish: Abraxane forårsagede infertilitet hos hanrotter (se pkt.
English: This multi-centre trial was conducted in patients with metastatic breast cancer, who were treated every 3 weeks with single-agent paclitaxel, either as solvent-based paclitaxel 175 mg/m2 given as a 3-hour infusion with premedication to prevent hypersensitivity (N = 225), or as Abraxane 260 mg/m2 given as a
Danish: Dette multicenterstudie blev gennemført hos patienter med metastaserende brystkræft, der blev behandlet hver 3. uge med paclitaxel som enkeltstof, enten som solvensbaseret paclitaxel 175 mg/m2
English: After reconstitution, each ml of suspension contains 5 mg of paclitaxel formulated as albumin bound nanoparticles.
Danish: Efter rekonstituering indeholder hver ml suspension 5 mg paclitaxel formuleret som albuminbundne nanopartikler.
English: Table 6: Adverse reactions reported with Abraxane monotherapy at any dose in clinical studies Infections and infestations
Danish: Tabel 6: Bivirkninger rapporteret med Abraxane-monoterapi i forskellige doser i kliniske studier
English: Hepatobiliary disorders Uncommon: Hepatomegaly
Danish: Ikke almindelig: Hepatomegali
English: NAME OF THE MEDICINAL PRODUCT Abraxane 5 mg/ml powder for suspension for infusion.
Danish: LÆGEMIDLETS NAVN Abraxane 5 mg/ml pulver til infusionsvæske, suspension.
English: Human albumin solution (containing sodium, sodium caprylate and N-acetyl DL tryptophanate).
Danish: Humant albumin (indeholdende natrium, natriumcaprylat og D/L-N-acetyl-tryptophan).
English: The concurrent recommended dose of gemcitabine is 1000 mg/m2 administered intravenously over 30 minutes immediately after the completion of Abraxane administration on Days 1, 8 and 15 of each 28-day cycle.
Danish: Den anbefalede samtidige dosis af gemcitabin er 1.000 mg/m2 administreret intravenøst i løbet af 30 minutter, umiddelbart efter administrationen af Abraxane er gennemført på Dag 1, 8 og 15 i hver 28-dages cyklus.
English: Common: Vision blurred
Danish: Almindelig: Sløret syn
English: The other ingredient is human albumin (containing sodium, sodium caprylate and N-acetyl DL tryptophanate).
Danish: Øvrige indholdsstoffer: Humant albumin (indeholder natrium, natriumcaprylat og D/L-N-acetyltryptophan).
English: Abraxane Dose
Danish: Abraxane-dosis
English: Reduce doses 1 dose level
Danish: Reducer dosis med 1 dosisniveau
English: Lung Cancer
Danish: Lungekræft
English: Stability of the reconstituted suspension in the infusion bag Chemical and physical in-use stability has been demonstrated for 24 hours at 2°C-8°C followed by 4 hours at 25°C, protected from light.
Danish: Stabilitet af den rekonstituerede suspension i infusionsposen Kemisk og fysisk stabilitet under brug er blevet påvist i 24 timer ved 2 °C-8 °C efterfulgt af 4 timer ved 25 °C, beskyttet mod lys.
English: For patients with mild hepatic impairment (total bilirubin > 1 to ≤ 1.5 x ULN and aspartate aminotransferase [AST] ≤ 10 x ULN), no dose adjustments are required, regardless of indication.
Danish: Dosisjustering er ikke nødvendig hos patienter med let nedsat leverfunktion (totalbilirubin > 1 til ≤ 1,5 x øvre normalværdi og aspartataminotransferase [ASAT] ≤ 10 x øvre normalværdi) uanset indikation.
English: The recommended dose of Abraxane in combination with gemcitabine is 125 mg/m2 administered intravenously over 30 minutes on Days 1, 8 and 15 of each 28-day cycle.
Danish: Den anbefalede dosis af Abraxane i kombination med gemcitabin er 125 mg/m2 administreret intravenøst i løbet af 30 minutter på Dag 1, 8 og 15 i hver 28-dages cyklus.
English: Abraxane(125 mg/m2)/
Danish: Abraxane (125 mg/m2)/ gemcitabin
English: Reduce doses 1 dose level from Day 8 doses
Danish: Reducer dosis 1 dosisniveau fra Dag 8 dosis
English: Abraxane Dose (mg/m2)
Danish: Abraxane-dosis (mg/m2)
English: Very common: Diarrhoea, vomiting, nausea, constipation
Danish: Meget almindelig: Kvalme, diarré, opkastning, forstoppelse, stomatit