FrancophonIA/ELRC3.0 huggingface dataset:
English: Cases of permanent alopecia (frequency not known) have been reported.
Danish: Der er rapporteret tilfælde af permanent alopeci (frekvens ikke kendt).
English: The first interim analysis was planned 3 years after the date when half of study enrolment was done.
Danish: Den første interim-analyse var planlagt til 3 år efter datoen for opnåelse af halvdelen af tilmeldingen til studiet.
English: A total of 1006 patients with KPS ≥ 60 were randomised to the following treatment groups:
Danish: I alt 1006 patienter med KPS  60 blev randomiseret i følgende behandlingsgrupper:
English: Histological grade Grade1 (includes grade not assessed) Grade 2
Danish: Histologisk grad Grad 1 (inklusiv grader, der ikke er fastsat) Grad 2
English: This is because Docetaxel Accord or the other medicine may not work as well as expected and you may be more likely to get a side effect.
Danish: Dette er fordi Docetaxel Accord eller den anden medicin måske ikke virker så godt som forventet, og du måske lettere får bivirkninger.
English: Overall Age category 1 <50 years ≥50 years Age category 2 <35 years ≥35 years
Danish: Alderskategori 2 <35 år ≥35 år
English: Hormonal receptor status
Danish: Hormonel receptorstatus Negativ
English: The amount of alcohol in this medicine may have effects on the central nervous system (the part of the nervous system that includes the brain and spinal cord).
Danish: Mængden af alkohol i dette lægemiddel kan påvirke centralnervesystemet (den del af nervesystemet, der omfatter hjernen og rygmarven).
English: Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from available data).
Danish: Hyppigheder defineres som: meget almindelig ( 1/10); almindelig ( 1/100 til < 1/10); ikke almindelig ( 1/1000 til < 1/100); sjælden ( 1/10.000 til < 1/1000); meget sjælden (< 1/10.000); frekvens ikke kendt (kan ikke estimeres ud fra tilgængelige data).
English: Your doctor may change the dose and frequency of dosing depending on your blood tests, your general condition and your response to Docetaxel Accord.
Danish: Din læge kan ændre dosis og dosisfrekvensen afhængig af dine blodprøver, din almene helbredstilstand og din reaktion på Docetaxel Accord.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 22 May 2012
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN Dato for første markedsføringstilladelse: 22 maj 2012 Dato for seneste fornyelse: 23 februar 2017
English: Docetaxel Accord will be administered to you by a healthcare professional.
Danish: Docetaxel Accord vil blive administreret af personale med en sundhedsfaglig uddannelse.
English: You should usually receive your infusion once every 3 weeks.
Danish: Du vil normalt få en infusion en gang hver 3. uge.
English: • injection site reactions at the site of a previous reaction.
Danish: • Reaktioner på injektionsstedet på stedet for en tidligere reaktion
English: Before each treatment with Docetaxel Accord, you will have blood tests to check that you have enough blood cells and sufficient liver function to receive Docetaxel Accord.
Danish: Før hver behandling med Docetaxel Accord, vil du få taget blodprøver for at få kontrolleret, om du har nok blodceller og den nødvendige leverfunktion til at få Docetaxel Accord.
English: Pharmacotherapeutic group: Antineoplastic agents, plant alkaloids and other natural products, Taxanes, ATC Code: L01CD02
Danish: Farmakoterapeutisk klassifikation : Antineoplastiske stoffer, plantealkaloider og andre naturprodukter, taxaner, ATC kode: L01CD02
English: The safety and efficacy of docetaxel in nasopharyngeal carcinoma in children aged 1 month to less than 18 years have not yet been established.
Danish: Docetaxels sikkerhed og virkning ved nasofaryngealt karcinom hos børn i alderen 1 måned til under 18 år er endnu ikke klarlagt.
English: Use the medicine immediately after it is added into the infusion bag.
Danish: Anvend lægemidlet umiddelbart efter tilsætning til infusionsposen.
English: Overall survival (Primary end-point): Median survival (months) 1-year Survival (%) 2-year Survival (%)
Danish: Total overlevelse (Primær endepunkt) Median overlevelsestid (måneder) 1-års overlevelse (%)
English: You must not become pregnant during treatment with this medicine and must use an effective method of contraception during therapy, because docetaxel may be harmful for the unborn baby.
Danish: Du må ikke blive gravid under behandling med dette lægemiddel, og du skal bruge effektiv prævention under behandlingen, fordi docetaxel kan skade det ufødte barn.
English: Elderly treated with TCF should be closely monitored.
Danish: Ældre, som behandles med TCF, bør monitores nøje.
English: It is important that you read the entire contents of this guide prior to the preparation of the Docetaxel Accord infusion solution.
Danish: Det er vigtigt at læse hele denne vejledning inden fremstilling af Docetaxel Accord infusionsvæske.
English: Disease-free survival (DFS) was the primary efficacy endpoint and Overall survival (OS) was the secondary efficacy endpoint.
Danish: Sygdomsfri overlevelse (DFS) var det primære effektendepunkt og total overlevelse (OS) var det sekundære effektendepunkt.
English: D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND
Danish: BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL SIKKER OG
English: The incidence of serious adverse events was higher in elderly compared to younger patients.
Danish: Forekomsten af alvorlige bivirkninger var højere i gruppen med ældre i forhold til gruppen med yngre patienter.
English: If not used immediately, in-use storage times and conditions are the responsibility of the user and would normally not be longer than 6 hours below 25°C including the one hour infusion.
Danish: Hvis det ikke anvendes straks, er opbevaringstid og -forhold brugerens ansvar og vil normalt ikke være længere end 6 timer ved opbevaring under 25 °C inklusive den time, patienten får infusionen.
English: Overall, the study results demonstrate a positive benefit risk ratio for TAC compared to FAC.
Danish: Overordnet demonstrerer resultaterne fra studierne en positiv benefit/risiko fordeling for TAC sammenlignet med FAC.
English: Docetaxel Accord contains alcohol.
Danish: Docetaxel Accord indeholder alkohol.
English: 2-year estimate (%)
Danish: 2-års overlevelse (%)
English: If you had an allergic reaction to paclitaxel, you may also experience an allergic reaction to docetaxel, which may be more severe.
Danish: Hvis du har haft en allergisk reaktion over for paclitaxel, kan du også få en allergisk reaktion over for docetaxel, som kan være mere alvorlig.
English: You must not breast-feed while you are treated with docetaxel.
Danish: Du må IKKE amme, mens du behandles med docetaxel.
English: When combined to docetaxel, the clearance of carboplatin was about 50% higher than values previously reported for carboplatin monotherapy.
Danish: Ved kombination med docetaxel var carboplatins clearence ca. 50 % højere end de værdier, der tidligere er rapporteret for carboplatin-monoterapi.
English: OTHER CYTOTOXIC
Danish: ANDET CYTOTOKSISK
English: TAC = docetaxel, doxorubicin and cyclophosphamide FAC = 5-fluorouracil, doxorubicin and cyclophospamide CI = confidence interval; ER = oestrogen receptor PR = progesterone receptor a ER/PR-negative or Grade 3 or tumour size >5 cm
Danish: TAC = docetaxel, doxorubicin og cyclophosphamid FAC = 5-fluoruracil, doxorubicin and cyclophosphamid CI = Konfidensinterval; ER = østrogenreceptor PR = progesteronreceptor a ER/PR-negativ eller grad 3 eller tumorstørrelse >5 cm
English: *a hazard ratio (TAC/FAC) of less than 1 indicates that TAC is associated with a longer disease free survival compared to FAC.
Danish: * Hazard ratio (TAC/FAC) på mindre end 1 indikerer, at der er en sammenhæng mellem TAC og en længere sygdoms-fri overlevelse, sammenlignet med FAC.
English: What Docetaxel Accord contains - The active substance is docetaxel.
Danish: Docetaxel Accord indeholder: - Aktivt stof: docetaxel.
English: 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 (< 500 cells/mm3) was 7 days), anaemia, alopecia, nausea, vomiting, stomatitis, diarrhoea and asthenia.
Danish: 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 ( 500 celler/mm3) var 7 dage), anæmi, alopeci, kvalme, opkastning, stomatitis, diarré og asteni.
English: The final analysis was performed when all patients had reached their 10-year follow-up visit (unless they had a DFS event or were lost to follow-up before).
Danish: Den endelige analyse blev udført, da alle patienter havde nået deres 10 års opfølgningsbesøg (medmindre de havde en DFS hændelse eller tidligere udgik af opfølgning).
English: A study of 14C-docetaxel has been conducted in three cancer patients.
Danish: Der er gennemført et studie med 14C-mærket docetaxel på 3 kræftpatienter.
English: General disorders and administration site conditions The median cumulative dose to treatment discontinuation was more than 1,000 mg/m2 and the median time to fluid retention reversibility was 16.4 weeks (range 0 to 42 weeks).
Danish: Almene symptomer og reaktioner på administrationsstedet Den mediane kumulative dosis til behandlingsophør var mere end 1000 mg/m2 og median-tiden til reversibilitet af væskeretention var 16,4 uger (range 0 til 42 uger).
English: The kinetic profile of docetaxel is dose independent and consistent with a three-compartment pharmacokinetic model with half lives for the α, β and γ phases of 4 min, 36 min and 11.1 h, respectively.
Danish: Docetaxels kinetiske profil er dosis-uafhængig og i overensstemmelse med en 3compartment farmakokinetisk model, med halveringstider for ,  og  faserne på henholdsvis 4 min., 36 min. og 11,1 time.
English: Patients who have previously experienced a hypersensitivity reaction to paclitaxel may be at risk to develop hypersensitivity reaction to docetaxel, including more severe hypersensitivity reaction.
Danish: Patienter, som tidligere har haft en overfølsomhedsreaktion over for paclitaxel, kan være i risiko for at udvikle overfølsomhedsreaktion over for docetaxel, inklusive mere alvorlige overfølsomhedsreaktioner.
English: FAC (n=521)
Danish: (n=521)
English: Hypersensitivity reactions (frequency not known) have been reported with docetaxel in patients who previously experienced hypersensitivity reactions to paclitaxel.
Danish: Overfølsomhedsreaktioner (hyppighed ikke kendt) er rapporteret for docetaxel hos patienter, der tidligere har haft overfølsomhedsreaktioner over for paclitaxel.
English: Neutropenia (Grade 4) Febrile neutropenia Neutropenic infection Neutropenic infection (Grade 3-4)
Danish: Neutropeni (grad 4) Febril neutropeni Neutropenisk infektion Neutropenisk infektion (grad 3
English: • if you are allergic (hypersensitive) to docetaxel or any of the other ingredients of Docetaxel
Danish: • hvis du er allergisk (overfølsom) overfor docetaxel eller nogle af de andre indholdsstoffer i Docetaxel Accord (angivet i punkt 6),
English: Hazard Ratio: 1.122 [97.2% CI: 0.937; 1.342]* Treatment difference: 5.4% [95% CI: -1.1; 12.0] Treatment difference: 6.2% [95% CI: 0.2; 12.3]
Danish: Hazard ratio: 1,122 (97,2 %CI:0.937;1,342)* Behandlingsforskel 5,4 % (95 %CI:-1,1;12,0) Behandlingsforskel 6,2 % (95 %CI:0,2;12,3)
English: To be taken into account in pregnant or breast-feeding, in children and high-risk groups such as patients with liver disease, or epilepsy.
Danish: Dette skal tages i betragtning hos gravide eller ammende, hos børn samt hos patienter i højrisikogrupper såsom patienter med leversygdomme samt epilepsi.
English: Docetaxel Accord will be given by infusion into one of your veins (intravenous use).
Danish: Docetaxel Accord gives som infusion i en blodåre (intravenøs anvendelse).
English: The incidence of the following adverse events (all grades): lethargy, stomatitis, neutropenic infection occurred at rates ≥ 10% higher in patients who were 65 years of age or older compared to younger patients.
Danish: Forekomsten af de følgende bivirkninger (alle grader): Letargi, stomatitis, neutropenisk infektion opstod  10 % oftere hos de patienter, som var 65 år eller derover end hos de yngre patienter.
English: Prepare the infusion solution as recommended.
Danish: Præparer infusionsopløsningen efter retningslinjerne.
English: SPECIAL STORAGE CONDITIONS Do not store above 25°C.
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Må ikke opbevares ved temperaturer over 25C.
English: In vitro studies have shown that the metabolism of docetaxel may be modified by the concomitant administration of compounds which induce, inhibit or are metabolised by (and thus may inhibit the enzyme competitively) cytochrome P450-3A such as ciclosporine, ketoconazole, erythromycin.
Danish: In vitro-studier har vist, at docetaxels metabolisme kan ændres ved samtidig medicinering med stoffer, som inducerer, hæmmer eller metaboliseres (og således hæmmer enzymet kompetitivt) af CYP3A, f.eks ciclosporin, ketoconazol og erythromycin.
English: See also section “Docetaxel Accord contains ethanol (alcohol)” below.
Danish: Se også punktet ”Docetaxel Accord indeholder ætanol (alkohol)” nedenfor.
English: The amount of alcohol in this medicinal product may impair your ability to drive or use machines.
Danish: Den mængde alkohol, som dette lægemiddel indeholder, kan nedsætte din evne til at køre bil eller betjene maskiner.
English: In a phase III study, in previously treated patients, time to progression (12.3 weeks versus 7 weeks) and overall survival were significantly longer for docetaxel at 75 mg/m2 compared to Best Supportive
Danish: I et fase III-studie med tidligere behandlede patienter var tid til progression (12,3 uger vs. 7 uger) og den samlede overlevelse signifikant længere for docetaxel ved doseringen 75 mg/m2 end for bedste palliative behandling.
English: However, it did not induce mutagenicity in the Ames test or the CHO/HGPRT gene mutation assay.
Danish: Ames test eller i en CHO/HGPRT gen mutation assay.
English: The incidence of related fever, diarrhoea, anorexia, and peripheral oedema occurred at rates ≥ 10% higher in patients who were 75 years of age or greater versus less than 65 years.
Danish: Hyppigheden af relateret feber, diarré, anoreksi og perifere ødemer var  10 % højere hos patienter som var 75 år eller ældre end hos patienter under 65 år.
English: The median TTP was 37.3 weeks (95% CI: 33.4 - 42.1) in AT arm and 31.9 weeks (95% CI: 27.4-36.0) in AC arm.
Danish: TTP-medianen var 37,3 uger (95 %CI: 33,4 - 42,1) i AT-armen og 31,9 uger (95 %CI: 27,4 - 36,0) i AC-armen.
English: In this study, 358 patients with inoperable locally advanced SCCHN, and WHO perfomance status 0 or 1, were randomised to one of two treatment arms.
Danish: I denne studie blev 358 patienter med inoperabelt, lokalt fremskreden SCCHN og WHO funktionsstatus 0 eller 1, randomiseret i en af to behandlingsarme.
English: • ventricular arrhythmia or ventricular tachycardia (manifested as irregular and/or rapid heartbeat,
Danish: • Ventrikulær arytmi eller ventrikulær takykardi (manifesteret som uregelmæssig og / eller hurtig hjerterytme, alvorlig åndenød, svimmelhed og / eller besvimelse).
English: If you are a man being treated with Docetaxel Accord you are advised not to father a child during and up to 6 months after treatment and to seek advice on conservation of sperm prior to treatment because docetaxel may alter male fertility.
Danish: Hvis du er mand og i behandling med docetaxel, rådes du til ikke at avle et barn under og 6 måneder efter behandling samt til at søge vejledning om opbevaring af sæd inden behandling, fordi docetaxel kan nedsætte den mandlige fertilitet.
English: Name and address of the manufacturer responsible for batch release
Danish: Navn og adresse på de fremstilleren, der er ansvarlige for batchfrigivelse
English: FAC arm), as adjuvant treatment of operable node-negative breast cancer patients with high risk of relapse according to 1998 St. Gallen criteria (tumour size >2 cm and/or negative ER and PR and/or high histological/nuclear grade (grade 2 to 3) and /or age <35 years).).
Danish: lymfeknude-negativ brystkræft med høj risiko for tilbagefald ifølge 1998 St. Gallen-kriterierne (tumorstørrelse > 2 cm og/eller negative østrogenreceptorer (ER) og progesteronreceptorer (PR) og/eller høj histologisk/nukleær grad (grad 2 til 3) og/eller alder < 35 år).
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Danish: BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING OG ANVENDELSE Lægemidlet må kun udleveres efter ordination på en recept udstedt af en begrænset lægegruppe (se bilag I: Produktresumé; pkt.
English: From a microbiological point of view, dilution must take place in controlled and aseptic conditions and the medicinal product should be used immediately.
Danish: Fra et mikrobiologisk synspunkt skal fortynding foretages under kontrollerede og aseptiske forhold, og lægemidlet bør anvendes umiddelbart herefter.
English: The severity of adverse events of docetaxel may be increased when docetaxel is given in combination with other chemotherapeutic agents.
Danish: Alvorligheden af bivirkningerne ved docetaxel kan forøges, når docetaxel gives i kombination med andre kemoterapeutiske lægemidler.
English: Docetaxel was administered as a 1-hour infusion, all other medicinal products were given intravenously on day 1 every three weeks.
Danish: Docetaxel blev administreret som infusion over 1 time, alle andre lægemidler blev givet intravenøst på dag 1 hver 3. uge.
English: Mild to moderate neuro-sensory signs are characterised by paraesthesia, dysesthesia or pain including burning.
Danish: Milde til moderate neurosensoriske symptomer er karakteriseret ved paræstesi, dysæstesi eller smerter inklusiv brændende fornemmelser.
English: In particular, please inform your doctor in case of diarrhoea, sores in the mouth, feeling of numbness or pins and needles, fever and give any results of your blood tests to your doctor.
Danish: Vær særlig opmærksom på at informere din læge, hvis du får diarré, sår i munden, følelsesløshed, stikkende og prikkende fornemmelser eller feber, og giv lægen resultatet af dine blodprøver.
English: At the median follow-up time of 77 months significantly longer disease-free survival for the TAC arm compared to the FAC arm was demonstrated.
Danish: Ved den mediane opfølgningsperiode på 77 måneder blev der vist signifikant længere sygdoms-fri overlevelse (DFS) i TAC-armen sammenlignet med FAC-armen.
English: Docetaxel as single agent
Danish: Docetaxel som enkeltstof
English: Docetaxel Accord in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with:
Danish: Docetaxel Accord i kombination med doxorubicin og cyclophosphamid er indiceret til adjuverende behandling af patienter med:
English: In both arms, after the last cycle of chemotherapy, patients with positive oestrogen and/or progesterone receptors received tamoxifen 20 mg daily for up to 5 years.
Danish: Efter den sidste cyklus af kemoterapi, fik patienter i begge arme, der havde positive østrogen- og/eller progesteron-receptorer tamoxifen 20 mg daglig i op til 5 år.
English: OTHER SPECIAL WARNING(S), IF NECESSARY CYTOTOXIC
Danish: EVENTUELLE ANDRE SÆRLIGE ADVARSLER CYTOTOKSISK
English: Eye disorders Very rare cases of transient visual disturbances (flashes, flashing lights, scotomata) typically occurring during infusion of the medicinal product and in association with hypersensitivity reactions have been reported.
Danish: Der er observeret meget sjældne tilfælde af forbigående synsforstyrrelser (glimt, lysglimt, pletter i synsfeltet) typisk forekommende under infusion med lægemidlet og i forbindelse med overfølsomheds-reaktioner.
English: Subset analyses-adjuvant therapy in patients with node-negative breast cancer study (Intent-to-treat analysis)
Danish: Undergruppeanalyser - adjuverende behandling hos patienter med lymfeknude-negativ brystkræft (intent-to-treat-analyse)
English: • Docetaxel 30 mg/m2 administered weekly for the first 5 weeks in a 6 week cycle for 5 cycles.
Danish: • Docetaxel 30 mg/m2 administreret ugentlig i de første 5 uger i en 6 ugers behandlingsrunde i 5
English: Heart failure has been observed in patients receiving docetaxel in combination with trastuzumab, particularly following anthracycline (doxorubicin or epirubicin) -containing chemotherapy.
Danish: Hjertesvigt er observeret hos patienter, som fik docetaxel i kombination med trastuzumab, specielt efter kemoterapi med anthracycline (doxorubicin eller epirubicin).
English: 95% CI p-value†*
Danish: 95 %CI p-værdi†*
English: • 1,276 patients (744 and 532 in TAX 316 and GEICAM 9,805 respectively) who received docetaxel in combination with doxorubicin and cyclophosphamide (clinically important treatment related adverse events are presented).
Danish: • 1.276 patienter (744 i TAX 316 og 532 i GEICAM 9805), som fik docetaxel i kombination med doxorubicin og cyclophosphamid (bivirkninger til klinisk vigtig behandling er præsenteret).
English: From a microbiological point of view, dilution must take place in controlled and aseptic conditions.
Danish: Fra et mikrobiologisk synspunkt skal rekonstitution/fortynding foretages under kontrollerede og aseptiske forhold.
English: TAC (n=539)
Danish: (n=539)
English: Tumour response rate (%) 95% CI p-value* †Stratified log-rank test *Threshold for statistical significance = 0.0175 **PSA: Prostate-Specific Antigen
Danish: †Stratificeret log rank test *Tærskel for statististiskl signifikans =0,0175 **PSA: Prostata-Specific Antigen
English: Following the administration of a 100 mg/m2 dose given as a one-hour infusion a mean peak plasma level of 3.7 µg/ml was obtained with a corresponding AUC of 4.6 h.µg/ml.
Danish: Efter administration af docetaxel 100 mg/m2 givet som infusion over 1 time, fandtes den gennemsnitlige maksimale plasmakoncentration at være 3,7 mg/ml med et AUC på 4,6 h.g/ml.
English: There was less use of morphinic analgesic (p < 0.01), non-morphinic analgesics (p < 0.01), other disease-related medicinal products (p = 0.06) and radiotherapy (p < 0.01) in patients treated with docetaxel at 75 mg/m2 compared to those with BSC.
Danish: Der var mindre brug af smertestillende morfika (p < 0,01), smertestillende ikke-morfika (p < 0,01), anden ikke-sygdomsrelateret medicin (p = 0,06) og strålebehandling (p < 0,01) hos de patienter, der fik behandling med docetaxel ved doseringen 75 mg/m2 end hos patienterne, der fik bedste palliative behandling.
English: Excipients: polysorbate 80, ethanol anhydrous (see leaflet for further information) and citric acid anhydrous.
Danish: Hjælpestoffer: Polysorbat 80, vandfri ætanol (se indlægssedlen for yderligere information) og vandfri citronsyre.
English: Docetaxel Accord concentrate for solution for infusion requires NO prior dilution with a solvent and is ready to add to the infusion solution.
Danish: Docetaxel Accord koncentrat til infusionsvæske, opløsning kræver INGEN forudgående fortynding med en solvens, men er klar til tilsætning til infusionsvæske.
English: Docetaxel Accord contains ethanol (alcohol)
Danish: Docetaxel Accord indeholder ætanol (alkohol)
English: Myelodysplastic syndrome was reported in 2 of 744 TAC patients (0.3%) and in 1 of 736 FAC patients (0.1%).
Danish: Myelodysplastisk syndrom blev rapporteret hos 2 ud af 744 TAC-patienter (0,3 %) og hos 1 ud af 735 FAC-patienter (0,1 %).
English: For treatment after failure of prior platinum-based chemotherapy, the recommended dose is 75 mg/m2 as a single agent.
Danish: For behandling efter forudgående svigt af platinbaseret kemoterapi, er den anbefalede dosis 75 mg/m2 givet som enkeltstof.