FrancophonIA/ELRC3.0 huggingface dataset:
English: The clinical significance of these findings is unknown (see section 4.4).
Danish: Den kliniske signifikans for disse data er ikke kendt (se pkt.
English: What do you need to know before you take Nexavar Do not take Nexavar
Danish: Det skal De vide, før De begynder at tage Nexavar Tag ikke Nexavar
English: anaphylactic reaction angioedema
Danish: anafylaktisk reaktion angioødem
English: ** Hand foot skin reaction corresponds to palmar plantar erythrodysaesthesia syndrome in
Danish: ** Hånd-fod-hud-reaktion (HFSR) svarende til palmoplantar erytrodysæstesi-syndrom i MedDRA
English: Children and adolescents have not yet been tested with Nexavar.
Danish: Nexavar er ikke blevet undersøgt på børn og unge.
English: Nexavar is indicated for the treatment of patients with advanced renal cell carcinoma who have failed prior interferon-alpha or interleukin-2 based therapy or are considered unsuitable for such therapy.
Danish: Nexavar er indiceret til behandling af patienter med fremskredent renalcellekarcinom, hvor tidligere interferon-alfa- og interleukin-2-baseret behandling ikke har hjulpet, eller hvor en sådan behandling ikke er blevet vurderet passende.
English: You must not breast-feed your baby during Nexavar treatment, as this medicine may interfere with the growth and development of your baby.
Danish: De må ikke amme Deres barn under behandlingen med Nexavar, da dette lægemiddel kan påvirke
English: Patients with stable disease on therapy with sorafenib were randomised to placebo or continued sorafenib therapy.
Danish: Patienter med stabil sygdom i behandling med sorafenib var randomiseret til placebo eller fortsat behandling med sorafenib.
English: Progression-free survival in patients with RCC was significantly longer in the sorafenib group (163 days) than in the placebo group (41 days) (p = 0.0001, HR = 0.29).
Danish: Progressionsfri overlevelse hos patienter med RCC var signifikant længere i Nexavargruppen (163 dage) end i placebogruppen (41 dage) (p = 0,0001, HR = 0,29).
English: Sorafenib is a multikinase inhibitor that decreases tumour cell proliferation in vitro.
Danish: Sorafenib er en multikinasehæmmer, som nedsætter proliferationen af tumorceller in vitro.
English: Caution is recommended when administering sorafenib with compounds that are metabolised/eliminated predominantly by the UGT1A1 (e.g. irinotecan) or UGT1A9 pathways (see section 4.5).
Danish: Der bør udvises forsigtighed, når sorafenib administreres sammen med lægemidler, der hovedsageligt metaboliseres/elimineres gennem UGT1A1 (f.eks. irinotecan) eller UGT1A9-systemet (se pkt.
English: The HR of progression free survival was 0.39 (95% CI: 0.21 - 0.72) for patients with symptoms at baseline and 0.60 (95% CI: 0.45 - 0.81) for patients without symptoms at baseline.
Danish: HR for progressionsfri overlevelse var 0,39 (95% CI: 0,21-0,72) for patienter med symptomer ved baseline og 0,60 (95% CI: 0,45-1,81) for patienter uden symptomer ved baseline.
English: CTCAE Grade 3 or 4 laboratory abnormalities occurring in ≥ 5 % of sorafenib treated patients included lymphopenia and neutropenia.
Danish: CTCAE Grad 3 eller 4 laboratorieafvigelser forekommer hos ≥ 5 % af sorafenib-behandlede patienter og inkluderer lymfopeni og neutropeni.
English: Study 1 (study 11213) was a Phase III, multi-centre, randomised, double blind, placebo-controlled study in 903 patients.
Danish: Studie 1 (studie 11213) var et fase III, multicenter, randomiseret, dobbeltblind, placebo-kontrolleret studie med 903 patienter.
English: Studies in animals have shown reproductive toxicity including malformations (see section 5.3).
Danish: Dyrestudier har påvist reproduktionstoksicitet inklusive fosterskader (se pkt.
English: Respiratory, thoracic and mediastinal disorders rhinorrhoea dysphonia interstitial lung disease-like events* (pneumonitis, radiation pneumonitis, acute respiratory distress, etc. )
Danish: Luftveje, thorax og mediastinum rinoré dysfoni bivirkninger, der ligner interstitiel lungesygdom* (pneumonitis, strålepneumonitis, akut dyspnø etc.)
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Danish: Bivirkningerne er præsenteret i faldende alvorlighed inden for hver frekvensgruppering.
English: - Holes in the gut wall (gastrointestinal perforation) may occur during treatment (see section 4:
Danish: - Hul på mave-tarm-kanalen (gastrointestinal perforation) kan forekomme under behandlingen (se også Bivirkninger, punkt 4).
English: Most reports of hypocalcaemia were low grade (CTCAE Grade 1 and 2).
Danish: De fleste indberetninger om hypokalcæmi var hypokalcæmi af lav grad (CTCAE grad 1 og 2).
English: Higher mortality has been reported in patients with squamous cell carcinoma of the lung treated with sorafenib in combination with platinum-based chemotherapies.
Danish: Der er set en højere dødelighed hos patienter med pladecellekarcinom i lungerne, som blev behandlet med sorafenib i kombination med platinbaseret kemoterapi.
English: Management of suspected adverse drug reactions may require temporary interruption or dose reduction of sorafenib therapy.
Danish: Behandling af formodede bivirkninger kan kræve midlertidig afbrydelse eller dosisreduktion af sorafenib.
English: The most common adverse reactions were diarrhoea, fatigue, alopecia, infection, hand foot skin reaction (corresponds to palmar plantar erythrodysaesthesia syndrome in MedDRA) and rash.
Danish: De hyppigste bivirkninger var diarré, træthed, alopeci, infektion, hånd-fod-hud-reaktion (HFSR) (svarende til palmoplantar erytrodysæstesisyndrom i MedDRA) samt udslæt.
English: Table 2: Treatment-emergent laboratory test abnormalities reported in DTC patient (study 5) double blind period
Danish: Tabel 2: Afvigelser i laboratorieanalyser rapporteret hos DTC-patienter i den dobbeltblinde periode (studie 5)
English: Results from animal studies further indicate that sorafenib can impair male and female fertility (see section 5.3).
Danish: Resultater fra dyrestudier indikerer yderligere, at sorafenib kan nedsætte fertiliteten hos hanner og hunner (se pkt.
English: Sorafenib inhibits the activity of targets present in the tumour cell (CRAF, BRAF, V600E BRAF, c-KIT, and FLT-3) and in the tumour vasculature (CRAF, VEGFR-2, VEGFR-3, and PDGFR-ß).
Danish: Sorafenib hæmmer aktiviteten af målfaktorer, som findes i tumorceller (CRAF, BRAF, V600E BRAF, c-KIT og FLT-3) og i tumorens kar (CRAF, VEGFR-2, VEGFR-3 og PDGFR-β).
English: A post-hoc subgroup analysis by maximum tumour size showed a treatment effect for PFS in favour of sorafenib over placebo for patients with maximum tumour size of 1.5 cm or larger (HR 0.54 (95% CI: 0.41 - 0.71)) whereas a numerically lower effect was reported in patients with a maximum tumour size of less than 1.5 cm (HR 0.87 (95% CI: 0.40 - 1.89).
Danish: En post-hoc-undergruppeanalyse i forhold til maksimal tumorstørrelse viste en bedre behandlingseffekt (PFS) for sorafenib i forhold til placebo for patienter med maksimal tumorstørrelse på 1,5 cm eller derover (HR 0,54 (95% CI: 0,41-0,71)), hvorimod en numerisk mindre virkning blev rapporteret hos patienter med en maksimal tumorstørrelse på under 1,5 cm (HR 0,87 (CI: 0,40-1,89)).
English: In study 5 (see section 5.1), 37% of subjects had dose interruption and 35% had dose reduction already in cycle 1 of sorafenib treatment.
Danish: 5.1) fik 37 % af personerne afbrudt dosis, og 35 % fik dosis reduceret allerede i den første cyklus af sorafenib-behandlingen.
English: These data suggest that clinical pharmacokinetic interactions of sorafenib with CYP3A4 inhibitors are unlikely.
Danish: Disse data tyder på, at kliniske farmakokinetiske interaktioner mellem sorafenib og CYP3A4-hæmmere ikke foreligger.
English: No data is available in patients requiring dialysis (see section 5.2).
Danish: Der findes ingen tilgængelige data for patienter, som kræver dialyse (se pkt.
English: In company sponsored clinical trials congestive heart failure was reported as an adverse event in 1.9% of patients treated with sorafenib (N= 2276).
Danish: I kliniske studier, der var sponsoreret af firmaet, blev der set hjerteinsufficiens som bivirkning hos 1,9 % af de patienter, der blev behandlet med sorafenib (N=2.276).
English: In vitro studies of CYP enzyme induction
Danish: In vivo studier af CYP-enzyminduktion
English: Lipase increased * Common Terminology Criteria for Adverse Events (CTCAE), version 3.0 ** The aetiology of hypophosphatemia associated with sorafenib is not known.
Danish: Adverse Events (CTCAE)), version 3.0 ** Ætiologien af hypofosfatæmi forbundet med sorafenib er ukendt.
English: The recommended dose of Nexavar in adults is 400 mg sorafenib (two tablets of 200 mg) twice daily (equivalent to a total daily dose of 800 mg).
Danish: Den anbefalede dosis til voksne er 400 mg sorafenib (to tabletter a 200 mg) to gange dagligt (ækvivalent med en total daglig dosis på 800 mg).
English: In clinical trials, hypocalcaemia was more frequent and more severe in patients with DTC, especially with a history of hypoparathyroidism, compared to patients with renal cell or hepatocellular carcinoma.
Danish: I kliniske studier opstod hypokalcæmi hyppigere og med større sværhedsgrad hos patienter med DTC, især hvis de tidligere havde haft hypoparatyreoidisme, sammenlignet med patienter med renalcellekarcinom eller hepatocellulært karcinom.
English: - If you have thyroid cancer.
Danish: - Hvis De har kræft i skjoldbruskkirtlen.
English: Clinical pancreatitis was reported in 2 of 451 sorafenib treated patients (CTCAE Grade 4) in study 1, 1 of 297 sorafenib treated patients in study 3 (CTCAE Grade 2), and 1 of 451 patients (CTCAE Grade 2) in the placebo group in study 1.
Danish: Klinisk pankreatitis blev rapporteret hos 2 ud af 451 patienter behandlet med sorafenib (CTCAE Grad 4) i studie 1, 1 ud af 297 patienter behandlet med sorafenib i studie 3 (CTCAE grad 2) og 1 ud af 451 patienter (CTCAE Grad 2) i placebogruppen i studie 1.
English: There is no evidence that sorafenib affects the ability to drive or to operate machinery.
Danish: Der er intet, der tyder på, at sorafenib påvirker evnen til at føre bil og betjene maskiner.
English: However, in clinical pharmacokinetic studies, concomitant administration of sorafenib 400 mg twice daily with cyclophosphamide, a CYP2B6 substrate, or paclitaxel, a CYP2C8 substrate, did not result in a clinically meaningful inhibition.
Danish: I kliniske farmakokinetiske studier medførte samtidig administration af sorafenib 400 mg to gange dagligt og cyclophosphamid, et CYP2B6-substrat, eller paclitaxel, et CYP2C8-substrat, dog ikke en klinisk relevant hæmning.
English: TSH suppression in DTC
Danish: TSH-suppression ved DTC
English: Other medicines and Nexavar
Danish: Brug af anden medicin sammen med Nexavar
English: In four Phase I clinical trials, steady state exposure to sorafenib was similar in patients with mild or moderate renal impairment compared to the exposures in patients with normal renal function.
Danish: I fire fase-I kliniske studier var steady state eksponering af sorafenib ens hos patienter med let til moderat nedsat nyrefunktion sammenlignet med eksponeringen af patienter med normal nyrefunktion.
English: Tablet coating: hypromellose, macrogol, titanium dioxide (E 171), ferric oxide red (E 172).
Danish: Filmovertræk: Hypromellose; macrogol; titandioxid (E 171); jernoxid (E 172).
English: There were no cases of CTCAE Grade 4 hypophosphataemia (< 1 mg/dl) reported in either sorafenib or placebo patients in study 1, and 1 case in the placebo group in study 3.
Danish: Der var ingen rapporterede tilfælde af CTCAE Grad 4 hypofosfatæmi (< 1 mg/dl) hos hverken sorafenib- eller placebopatienter i studie 1, og 1 tilfælde i placebogruppen i studie 3.
English: When dose reduction is necessary during the treatment of hepatocellular carcinoma (HCC) and advanced renal cell carcinoma (RCC), the Nexavar dose should be reduced to two tablets of 200 mg sorafenib once daily (see section 4.4).
Danish: Når dosisreduktion er nødvendig under behandling af hepatocellulært karcinom (HCC) og fremskredent renalcellekarcinom (RCC), bør dosis af Nexavar reduceres til to tabletter a 200 mg sorafenib én gang dagligt (se pkt.
English: CYP3A4, CYP2D6 and CYP2C19 substrates
Danish: CYP3A4-, CYP2D6- og CYP2C19-substrater
English: Hypocalcaemia was reported in 35.7% of sorafenib treated patients compared to 11.0% of placebo patients.
Danish: Hypokalcæmi blev rapporteret hos 35,7 % af de sorafenibbehandlede patienter sammenlignet med hos 11,0 % af placebopatienterne.
English: Co-administration of neomycin or other antibiotics that cause major ecological disturbances of the gastrointestinal microflora may lead to a decrease in sorafenib bioavailability (see section 4.5).
Danish: Samtidig indgift af neomycin eller andre antibiotika, der forårsager større forstyrrelser i mikrofloraen i mave og tarm, kan medføre en nedsat biotilgængelighed af sorafenib (se pkt.
English: Decreases in blood glucose, in some cases clinically symptomatic and requiring hospitalization due to loss of consciousness, have been reported during sorafenib treatment.
Danish: Fald i blodglukoseniveau er blevet rapporteret under behandling med sorafenib, og det har i nogle tilfælde været klinisk symptomatisk og krævet hospitalsindlæggelse på grund af bevidstløshed.
English: CYP2B6, CYP2C8 and CYP2C9 substrates
Danish: CYP2B6-, CYP2C8- og CYP2C9-substrater
English: No dose adjustment is required in patients with Child Pugh A or B (mild to moderate) hepatic impairment.
Danish: Dosisreduktion er ikke nødvendig hos patienter med Child Pugh A eller B (let til moderat) nedsat leverfunktion.
English: Most reports of hypokalaemia were low grade (CTCAE Grade 1).
Danish: De fleste rapporter af hypokaliæmi var af lav grad (CTCAE grad 1).
English: The European Medicines Agency has waived the obligation to submit the results of studies, in all subsets of the paediatric population, in kidney and renal pelvis carcinoma (excluding nephroblastoma, nephroblastomatosis, clear cell sarcoma, mesoblastic nephroma, renal medullary carcinoma and rhabdoid tumour of the kidney) and liver and intrahepatic bile duct carcinoma (excluding hepatoblastoma) and differentiated thyroid carcinoma (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med sorafenib i alle undergrupper af den pædiatriske population med nyre- og nyre-bækken-karcinom (undtagen nefroblastom, nefroblastomatose, clear cell-sarkom, mesoblastisk nefrom, renal medullært karcinom og rabdoid tumor i nyrerne) og lever- og intrahepatisk galdegangskarcinom (undtagen hepatoblastom) og differentieret thyreoideacancer (se pkt.
English: How to take Nexavar The recommended dose of Nexavar in adults is 2 x 200 mg tablets, twice daily.
Danish: Den anbefalede dosis af Nexavar til voksne er 2 x 200 mg tabletter to gange dagligt.
English: If additional dose reduction is necessary, Nexavar may be reduced to 400 mg sorafenib daily in divided doses (two tablets of 200 mg twelve hours apart), and if necessary further reduced to one tablet of 200 mg once daily.
Danish: Hvis yderligere dosisreduktion er nødvendig, kan Nexavar reduceres til 400 mg sorafenib dagligt i delte doser (en tablet a 200 mg 2 gange dagligt med 12 timers mellemrum), og om nødvendigt reduceres ydereligere til én tablet a 200 mg én gang dagligt.
English: Hand foot skin reaction (palmar-plantar erythrodysaesthesia) and rash represent the most common adverse drug reactions with sorafenib.
Danish: Hånd-fod-hud-reaktion (HFSR) (palmoplantar erytrodysæstesi) og hududslæt er de hyppigste bivirkninger med sorafenib.
English: If you could become pregnant use adequate contraception during treatment.
Danish: Hvis De er en kvinde i den fødedygtige alder, skal De bruge effektiv prævention, mens De er under behandling.
English: Median PFS time was 10.8 months in the sorafenib group compared to 5.8 months in the placebo group (HR=0.587; 95% Confidence Interval (CI): 0.454, 0.758; one-sided p <0.0001).
Danish: Den mediane PFS-tid var 10,8 måneder i sorafenib-gruppen sammenlignet med 5,8 måneder i placebogruppen (HR =0,587, 95 % konfidensinterval (CI): 0,454-0,758, ensidet p < 0,0001).
English: Study 5 (study 14295) was a Phase III, international, multi-centre, randomised, double blind, placebocontrolled trial in 417 patients with locally advanced or metastatic DTC refractory to radioactive iodine.
Danish: Studie 5 (studie 14295) var et fase III, internationalt, randomiseret, dobbeltblindet, placebokontrolleret multicenterstudie med 417 patienter med lokalt fremskreden eller metastatisk DTC refraktær over for radioaktivt iod.
English: No subject showed a QTcB or QTcF >500 msec during the post-treatment ECG monitoring (see section 4.4).
Danish: Ingen af patienterne viste et QTcB eller QTcF på >500 msek.
English: Disease specific warnings
Danish: Sygdomsspecifikke advarsler
English: Hypophosphataemia was a very common laboratory finding, observed in 45 % and 35 % of sorafenib treated patients compared to 12 % and 11 % of placebo patients in study 1 and study 3, respectively.
Danish: Hypofosfatæmi var et meget almindeligt laboratoriefund, som blev observeret hos 45 % og 35 % af patienterne, der blev behandlet med sorafenib sammenlignet med 12 % og 11 % hos placebopatienter i henholdsvis studie 1 og studie 3.
English: Patients taking concomitant warfarin or phenprocoumon should be monitored regularly for changes in prothrombin time, INR or clinical bleeding episodes (see sections 4.5 and 4.8).
Danish: Patienter, der samtidigt tager warfarin eller phenprocoumon, bør følges regelmæssigt med hensyn til ændringer i protrombin tid, INR eller kliniske blødningstilfælde (se pkt.
English: Cardiac disorders congestive heart failure* myocardial ischaemia and infarction*
Danish: Hjerteinsufficiens* Myokardieiskæmi og myokardieinfarkt*
English: The median survival was 19.3 months for patients randomised to sorafenib compared to 15.9 months for placebo patients (HR = 0.77; 95 % CI: 0.63 - 0.95; p = 0.015).
Danish: Den gennemsnitlige overlevelse var 19,3 måneder for patienter randomiseret til sorafenib sammenlignet med 15,9 måneder for placebopatienterne (HR = 0,77; 95 % CI: 0,63 - 0,95; p = 0,015).
English: Temporary or permanent discontinuation of sorafenib should be considered in patients who develop cardiac ischaemia and/or infarction (see section 4.8).
Danish: Midlertidig eller permanent seponering af sorafenib bør overvejes hos patienter, som udvikler hjerteiskæmi og/eller infarkt (se pkt.
English: Hypocalcaemia was reported in 12% and 26.5% of sorafenib treated patients compared to 7.5% and 14.8% of placebo patients in study 1 and study 3, respectively.
Danish: Hypokalcæmi blev indberettet hos 12% og 26,5% af de patienter, der blev behandlet med sorafenib, sammenlignet med hos 7,5% og 14,8% af placebo-patienterne i henholdsvis studie 1 og 3.
English: Caution is recommended when sorafenib is co-administered with docetaxel (see section 4.4).
Danish: Der bør udvises forsigtighed, når sorafenib administreres sammen med docetaxel (se pkt.
English: Since sorafenib is mainly eliminated via the hepatic route exposure might be increased in patients with severe hepatic impairment (see sections 4.2 and 5.2).
Danish: Da sorafenib hovedsageligt elimineres via leveren, kan belastningen hos patienter med svært nedsat leverfunktion være øget (se pkt.
English: Nexavar is used to treat thyroid cancer (differentiated thyroid carcinoma).
Danish: Nexavar anvendes til at behandle kræft i skjoldbruskkirtlen (differentieret thyreoideacancer).
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Danish: De kan finde yderligere oplysninger om Nexavar på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/.
English: In studies 1 and 3 decreased potassium was observed in 5.4% and 9.5% of sorafenib-treated patients compared to 0.7% and 5.9% of placebo patients, respectively.
Danish: I studie 1 og 3 blev der observeret nedsat kalium hos hhv. 5,4 % og 9,5 % af de sorafenib-behandlede patienter sammenlignet med hos hhv. 0,7 % og 5,9 % af de placebo-patienterne.
English: Study 3 (study 100554) was a Phase III, international, multi-centre, randomised, double blind, placebo-controlled study in 602 patients with hepatocellular carcinoma.
Danish: Studie 3 (studie 100554) var et fase III, internationalt, multicenter, randomiseret, dobbeltblindt, placebo-kontrolleret studie med 602 patienter med hepatocellulært karcinom.
English: - If you are taking Neomycin or other antibiotics.
Danish: - hvis De tager neomycin eller andre antibiotika, kan Nexavars virkning blive nedsat.
English: After one 28-day treatment cycle, at the time of maximum concentration of sorafenib, QTcB was prolonged by 4 ±19 msec and QTcF by 9 ±18 msec, as compared to placebo treatment at baseline.
Danish: Efter én 28 dages behandlingscyklus, hvor koncentrationen af sorafenib er højest, var QTcB forlænget med 4 ±19 msek.
English: Combination with other agents
Danish: Kombination med andre lægemidler
English: In clinical trials, certain adverse drug reactions such as hand foot skin reaction, diarrhoea, alopecia, weight decrease, hypertension, hypocalcaemia, and keratoacanthoma/squamous cell carcinoma of skin occurred at a substantially higher frequency in patients with differentiated thyroid compared to patients in the renal cell or hepatocellular carcinoma studies.
Danish: Yderligere information om specielle populationer I kliniske studier opstod visse bivirkninger, såsom hånd-fod-hud-reaktion(HFSR), diaré, alopeci, vægttab, hypertension, hypokalcæmi og keratoakantom/spinocellulært karcinom i huden med betydeligt større hyppighed hos patienter med differentieret thyreoideacancer sammenlignet med patienter med renalcellekarcinom og hepatocellulært karcinom.
English: Package Leaflet: Information for the user Nexavar 200 mg film-coated tablets sorafenib
Danish: Indlægsseddel: Information til brugeren Nexavar 200 mg filmovertrukne tabletter sorafenib
English: Nexavar is used to treat liver cancer (hepatocellular carcinoma).
Danish: Nexavar bruges til behandling af levercancer (hepatocellulært karcinom).
English: Endocrine disorders hypothyroidism hyperthyroidism
Danish: Det endokrine system hypotyreoidisme hypertyreoidisme
English: In study 5 (see section 5.1), increases in TSH levels above 0.5mU/L were observed in sorafenib treated patients.
Danish: 5.1) blev der observeret forhøjede TSH-niveauer over 0,5 mE/l hos sorafenibbehandlede patienter.
English: When dose reduction is necessary during the treatment of differentiated thyroid carcinoma (DTC), the Nexavar dose should be reduced to 600 mg sorafenib daily in divided doses (two tablets of 200 mg and one tablet of 200 mg twelve hours apart).
Danish: Når dosisreduktion er nødvendig under behandling af differentieret thyreoideacancer (DTC), bør dosis af Nexavar reduceres til 600 mg sorafenib dagligt i delte doser (to tabletter a 200 mg og en tablet a 200 mg med 12 timers mellemrum).
English: Docetaxel (75 or 100 mg/m2 administered once every 21 days) when co-administered with sorafenib (200 mg twice daily or 400 mg twice daily administered on Days 2 through 19 of a 21-day cycle with a 3-day break in dosing around administration of docetaxel) resulted in a 36-80 % increase in docetaxel AUC and a 16-32 % increase in docetaxel Cmax.
Danish: Samtidig administration af docetaxel (75 eller 100 mg/m2 administreret en gang hver 21. dag) og sorafenib (200 mg to gange daglig eller 400 mg to gange daglig på dag 2 til og med 19 i en 21-dags cyklus med en 3 dages pause i doseringen omkring administrationen af docetaxel) resulterede i en 36 - 80 % stigning i AUC for docetaxel og en 16 - 32 % øgning af Cmax for docetaxel.
English: Adverse reactions reported in multiple clinical trials or through post-marketing use are listed below in table 1, by system organ class (in MedDRA) and frequency.
Danish: Bivirkninger set under multiple kliniske studier eller under brug efter markedsføringen er opført nedenfor i tabel 1.