FrancophonIA/ELRC3.0 huggingface dataset:
English: For docetaxel/carboplatin combination, neither equivalent nor non-inferior efficacy could be proven compared to the reference treatment combination VCis.
Danish: For docetaxel-/carboplatin-kombinationen kunne der hverken bevises en ækvivalent eller noninferior effekt sammenlignet med referencebehandlingen kombinations-VCis.
English: Pharmacotherapeutic group: antineoplastic agents, taxanes, ATC Code: L01CD02
Danish: Farmakoterapeutisk klassifikation: antineoplastiske midler, taxaner, ATC-kode: L01CD02
English: Patients should receive therapeutic G-CSF as soon as possible after discovery of overdose.
Danish: Patienten bør have terapeutisk G-CSF så snart som muligt, efter overdosering er erkendt.
English: If this happens, you must tell your doctor immediately.
Danish: Hvis dette sker, skal du omgående fortælle det til lægen.
English: Overall, quality of life (QoL) and clinical benefit results consistently indicated improvement in favour of the TCF arm.
Danish: Som helhed viste resultaterne af quality of life (QoL) og kliniske fordele konsekvent en forbedring til fordel for TCF-armen.
English: For combination with trastuzumab, adverse events (all grades) reported in ≥10% are displayed.
Danish: For kombinationer med trastuzumab vises de bivirkninger (alle grader), som er rapporteret hos ≥ 10 %.
English: Each box contains 1 vial.
Danish: Hver kasse indeholder 1 hætteglas.
English: In case of vision problems, in particular blurred vision, you should immediately have your eyes and vision examined.
Danish: Hvis du får problemer med synet, særligt sløret syn, skal du straks have dine øjne og dit syn undersøgt.
English: See also section “Taxespira contains ethanol (alcohol)” below.
Danish: Se også afsnittet “Taxespira indeholder ethanol (alkohol)” nedenfor.
English: In the case of severe neutropenia (<500 cells/mm
Danish: Hvis der opstår alvorlig neutropeni (< 500 celler/mm
English: • fever: if this happens you must tell your doctor immediately
Danish: • feber: Hvis det forekommer, skal du straks fortælle det til lægen.
English: Prednisone and dexamethasone
Danish: Prednison og dexamethason
English: Treatment difference: 7.1% [95% CI: 0.7; 13.5] *: Corrected for multiple comparisons and adjusted for stratification factors (stage of disease and region of treatment), based on evaluable patient population.
Danish: Behandlingsforskel: 7,1 % [95 % CI: 0,7; 13,5] *: Korrigeret for multiple sammenligninger og justeret for stratificeringsfaktorer (sygdomsstadie og behandlingsregion), baseret på evaluerbar patientpopulation.
English: In this study, 87% of patients had disease that was IHC 3+, and 95% of patients entered had disease that was IHC 3+ and/or FISH positive.
Danish: I dette studie havde 87 % af patienterne sygdom, som var IHC 3+, og 95 % af de inkluderede patienter havde sygdom, som var IHC3+, og/eller patienterne var FISH-positive.
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Danish: Du eller dine pårørende kan også indberette bivirkninger direkte til Lægemiddelstyrelsen via det nationale rapporteringssystem anført i Appendiks V.Ved at indrapportere bivirkninger kan du hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
English: Cisplatin and 5-fluorouracil
Danish: Cisplatin og 5-fluorouracil
English: You must not become pregnant during treatment with this medicine and must use an effective method of contraception during therapy, because Taxespira may be harmful for the unborn baby.
Danish: Du må ikke blive gravid under behandling med dette lægemiddel, og du skal bruge sikker prævention under behandlingen, da Taxespira kan skade det ufødte barn.
English: • decrease of the sodium, potassium, magnesium, and/or calcium in your blood (electrolyte balance disorders).
Danish: • fald i indholdet af natrium, kalium, magnesium og/eller calcium i blodet (forstyrrelse i elektrolytbalancen).
English: • infections, decrease in the number of red blood cells (anaemia), or white blood cells (which are important in fighting infection) and platelets (important in blood clotting)
Danish: • infektioner, fald i antallet af røde blodlegemer (anæmi) eller hvide blodlegemer (som er vigtige i bekæmpelsen af infektioner) og blodplader (vigtige for størkning af blodet)
English: Your doctor may stop your treatment immediately.
Danish: Lægen vil muligvis afbryde din behandling med det samme.
English: Acute leukaemia /Myelodysplastic syndrome
Danish: Akut leukæmi/myelodysplastisk syndrom
English: Meeting relative indication for chemotherapy No
Danish: Opfylder relativ indikation for kemoterapi Nej
English: Older people treated with TCF should be closely monitored.
Danish: Ældre patienter, som behandles med TCF, bør monitoreres nøje.
English: The positive benefit risk ratio for TAC compared to FAC remained unchanged.
Danish: Det positive benefit/risk-forhold for TAC sammenlignet med FAC forblev uændret.
English: Progressive disease as best overall response (%) *Unstratified logrank test
Danish: Progressiv sygdom som bedste overordnede respons (%) *Ikke-stratificeret log-rank-test
English: The performance status scale, for head and neck (PSS-HN) subscales designed to measure understandability of speech, ability to eat in public, and normalcy of diet, was significantly in favour of TPF as compared to PF.
Danish: Performance status-skalaen (underskalaerne for hoved og hals [PSS-HN]), som blev udformet med henblik på at måle forståeligheden af tale, evnen til at spise offentligt samt kostens normalitet, var signifikant til fordel for TPF sammenlignet med PF.
English: Dry skin; Desquamation
Danish: Tør hud; afskalning
English: Given the fact that docetaxel every week presented a slightly better safety profile than docetaxel every 3 weeks, it is possible that certain patients may benefit from docetaxel every week.
Danish: I lyset af, at docetaxel givet hver uge gav en lidt bedre sikkerhedsprofil end docetaxel administreret hver 3. uge, er det en mulighed, at nogle patienter kan have fordel af docetaxel administreret hver uge.
English: Mitoxantrone every 3 weeks
Danish: Mitoxantron hver 3. uge
English: Clinical benefit parameters
Danish: Parametre for klinisk fordel
English: Secondary end-points included change of pain, global rating of quality of life by EuroQoL-5D, Lung Cancer Symptom Scale, and changes in Karnosfky performance status.
Danish: Sekundære endepunkter inkluderede forandring i smerter, global vurdering af livskvalitet med EuroQoL-5D, lungekræftsymptom-skala og forandringer i Karnosfkys performance status.
English: Docetaxel is highly protein bound (>95%).
Danish: Docetaxel er i udstrakt grad proteinbundet (> 95 %).
English: G-CSF was used for secondary prophylaxis in 19.3% of patients (10.7 % of the cycles).
Danish: G-CSF blev anvendt som sekundær profylakse hos 19,3 % af patienterne (10,7 % af cyklusserne).
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 -betingelser efter anbrud brugerens eget ansvar og vil normalt ikke overstige 6 timer ved temperaturer på under 25 °C, inklusive 1 times infusion.
English: TAC-treated patient subsets according to prospectively defined major prognostic factors were analysed in the primary analysis (at the median follow-up time of 77 months) (see table below):
Danish: Undergrupper af TAC-behandlede patienter efter prospektivt definerede betydningsfulde prognostiske faktorer blev analyseret i den primære analyse (ved den mediane opfølgningsperiode på 77 måneder) (se tabel nedenfor):
English: Efficacy results are summarized in the following table:
Danish: Effektresultaterne er opsummeret i nedenstående tabel:
English: Overall response rate (%):
Danish: Overordnet responsrate (%):
English: Pharmacokinetic parameters estimated by the model were very close to those estimated from phase I studies.
Danish: De farmakokinetiske parametre i modellen lå tæt på det, der blev estimeret i fase I-studier.
English: • decrease in blood pressure; irregular or rapid heart beat
Danish: • fald i blodtrykket, uregelmæssig eller hurtig hjerterytme
English: You must not breast-feed while you are treated with Taxespira.
Danish: Du må ikke amme, mens du er i behandling med Taxespira.
English: These reactions sometimes appear during the infusion of the medicinal product.
Danish: Disse reaktioner er også set under infusion af lægemidlet.
English: It should be used within 6 hours (including the one hour infusion intravenous administration).
Danish: Den bør anvendes inden for 6 timer (inklusive 1 times intravenøs infusion).
English: Between infusions of Taxespira the following may occur, and the frequency may vary with the combinations of medicines that are received:
Danish: Nedenstående bivirkninger kan opstå mellem infusionerne af Taxespira, og hyppigheden kan variere alt efter kombinationen af de lægemidler, du får:
English: Stratified log rank test *Threshold for statistical significance = 0.0175 **PSA: Prostate-Specific Antigen
Danish: Stratificeret log-rank-test *Tærskel for statistisk signifikans = 0,0175 **PSA: prostataspecifikt antigen
English: • change or absence of menstrual periods
Danish: • ændrede eller udeblevne menstruationer
English: This may be moderate to severe and has been associated with death (see section 4.8).
Danish: Hjertesvigtet kan være moderat til alvorligt og har været associeret med dødsfald (se 4.8).
English: 2-year estimate (%)
Danish: 2-års estimat (%)
English: • loss of appetite (anorexia)
Danish: • manglende appetit (anoreksi)
English: Toxicity Diarrhoea grade 3
Danish: Toksicitet Diarré grad 3
English: Docetaxel every week
Danish: Docetaxel ugentligt
English: There is no information on the use of docetaxel in pregnant women.
Danish: Der findes ingen data vedrørende anvendelse af docetaxel til gravide kvinder.
English: The late phase is due, in part, to a relatively slow efflux of docetaxel from the peripheral compartment.
Danish: Den sene fase skyldes til dels den relativt langsomme redistribution af docetaxel fra det perifere kammer.
English: • if you are allergic (hypersensitive) to docetaxel or any of the other ingredients of Taxespira (listed in section 6).
Danish: • hvis du er allergisk over for docetaxel eller et af de øvrige indholdsstoffer i Taxespira (angivet i punkt 6)
English: The following adverse reactions are frequently observed with docetaxel:
Danish: Følgende bivirkninger er hyppigt observeret med docetaxel:
English: About 80% of the radioactivity recovered in faeces is excreted during the first 48 hours as one major inactive metabolite and 3 minor inactive metabolites and very low amounts of unchanged medicinal product.
Danish: Ca. 80 % af radioaktiviteten i fæces er udskilt efter 48 timer i form af en større inaktiv og tre mindre inaktive metabolitter samt meget lave koncentrationer af uomdannet lægemiddel.
English: • swelling of the hands, feet, legs
Danish: • hævelse på hænder, fødder eller ben
English: The primary anticipated complications of overdose would consist of bone marrow suppression, peripheral neurotoxicity and mucositis.
Danish: De primære forventede komplikationer ved overdosis vil være knoglemarvsuppression, perifer neurotoksicitet og mucositis.
English: Rare occurrences of dehydration have been reported as a consequence of gastrointestinal events including enterocolitis and gastrointestinal perforation.
Danish: Der er rapporter om sjælden forekomst af dehydrering som en konsekvens af gastrointestinale hændelser, herunder enterocolitis og gastrointestinal perforation.
English: This was also statistically significant with an HR of 0.71; 95% CI 0.56-0.90; log-rank test p = 0.004.
Danish: Dette var også statistisk signifikant med en hazard ratio på 0,71; 95 % CI 0,56-0,90; log-rank-test p = 0,004.
English: Estimated median survival
Danish: Estimeret medianoverlevelse
English: Taxespira contains ethanol (alcohol)
Danish: Taxespira indeholder ethanol (alkohol)
English: Very rare cases of hepatitis, sometimes fatal primarily in patients with pre-existing liver disorders, have been reported.
Danish: Der er rapporteret om meget sjældne tilfælde af hepatitis, nogle gange fatale, hovedsageligt hos patienter med eksisterende leversygdomme.
English: Tell them immediately if you notice any of these effects.
Danish: Fortæl det straks til hospitalspersonalet, hvis du får nogle af disse bivirkninger.
English: Additional cautions for use in adjuvant treatment of breast cancer
Danish: Yderligere forsigtighedsregler for anvendelse ved adjuverende behandling af brystkræft
English: The name of this medicine is Taxespira.
Danish: Dette lægemiddel hedder Taxespira.
English: During the infusion at the hospital the following allergic reactions may occur (may affect more than 1 in 10 people):
Danish: Følgende allergiske reaktioner kan optræde under infusionen på hospitalet (kan forekomme hos mere end 1 ud af 10 patienter):
English: Neutrophil nadirs occurred at a median of 7 days but this interval may be shorter in heavily pre-treated patients.
Danish: Neutrofil-lavpunkt sås efter gennemsnitligt 7 dage, men intervallet kan være kortere hos patienter, der tidligere har fået en kraftigt virkende behandling.
English: In about 20% of these cases there were no risk factors for acute renal failure such as concomitant nephrotoxic medicinal products and gastro-intestinal disorders.
Danish: I cirka 20 % af tilfældene var der ingen risikofaktorer for akut nyresvigt såsom samtidig behandling med nefrotoksiske lægemidler og gastrointestinale sygdomme.
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 overfor paclitaxel kan du også få en allergisk reaktion overfor docetaxel, som kan være mere alvorlig.
English: The incidence of serious adverse events was higher in older people compared to younger patients.
Danish: Forekomsten af alvorlige bivirkninger var højere i gruppen med de ældre patienter i forhold til gruppen med de yngre patienter.
English: Taxespira concentrate for solution for infusion requires NO prior dilution with a solvent and is ready to add to the infusion solution.
Danish: Taxespira koncentrat til infusionsvæske, opløsning, kræver INGEN forudgående fortynding med en solvens, men er klar til tilsætning til infusionsopløsningen.
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/mm
Danish: De mest almindeligt rapporterede bivirkninger med docetaxel alene var: Neutropeni (som var reversibel og ikke kumulativ, median-dage til nadir var 7 dage og median-varigheden af alvorlig neutropeni (< 500 celler/mm
English: Disease-free survival (DFS) was the primary efficacy endpoint and OS was the secondary efficacy endpoint.
Danish: DFS var det primære effektendepunkt, og total overlevelse (OS) var det sekundære effektendepunkt.
English: To be taken into account in pregnant or breast-feeding women, in children and in high-risk groups such as patients with liver disease, or epilepsy.
Danish: Det skal der tages højde for hos gravide og ammende kvinder, børn og patienter i højrisikogrupper såsom patienter med leversygdom eller epilepsi.
English: Fluid retention (severe/life-threatening: 1%)
Danish: Væskeretention (alvorlig/livstruende: 1 %)
English: However, it did not induce mutagenicity in the Ames test or the CHO/HGPRT gene mutation assay.
Danish: Derimod inducerede det ingen mutagenicitet i Ames' test eller i en CHO/HGPRT-genmutationsassay.
English: What you need to know before you use Taxespira 3.
Danish: Det skal du vide, før du begynder at bruge Taxespira 3.
English: Hypotension; Hypertension; Haemorrhage
Danish: Hypotension; Hypertension; Blødning
English: Note that this is likely to be an underestimate since docetaxel alone at a dose of 100 mg/m2 is known to result in neutropenia in 97% of patients, 76% grade 4, based on nadir blood counts.
Danish: Bemærk, at dette sandsynligvis er underestimeret, da docetaxel alene ved en dosis på 100 mg/m2 vides at medføre neutropeni hos 97 % af patienterne, 76 % grad 4, baseret på laveste blodtællinger.
English: Treatment must be discontinued if these toxicities persist (see section 4.4).
Danish: Behandlingen skal afbrydes, hvis disse toksiciteter varer ved (se pkt.
English: With primary G-CSF prophylaxis (n = 421) n (%)
Danish: Med primær G-CSF-profylakse (n = 421) n (%)
English: Preparation of the infusion solution
Danish: Tilberedning af infusionsopløsningen
English: The study population comprised patients with technically unresectable disease, patients with low probability of surgical cure and patients aiming at organ preservation.
Danish: Forsøgspopulationen bestod af patienter med teknisk uresekterbar sygdom, patienter med lav sandsynlighed for kirurgisk helbredelse og patienter med bevarelse af organer som mål.
English: Docetaxel has been shown to be both embryotoxic and foetotoxic in rabbits and rats, and to reduce fertility in rats.
Danish: Det er påvist, at docetaxel er både embryo- og føtotoksisk hos kaniner og rotter, og at det nedsætter fertiliteten hos rotter.
English: Based on a population pharmacokinetic analysis, there are no special instructions for use in the elderly.
Danish: Ældre Baseret på de farmakokinetiske studier findes der ingen særlige retningslinjer for ældre personer.
English: Median time to first deterioration of WHO performance status was significantly longer in the TPF arm compared to PF.
Danish: Median tid indtil første forværring af WHO performance status var signifikant længere i TPF-armen end i PF-armen.
English: Febrile neutropenia and neutropenic infection occurred in 17.2% and 13.5% of patients respectively, regardless of G-CSF use.
Danish: Febril neutropeni og neutropenisk infektion forekom hos henholdsvis 17,2 % og 13,5 % af patienterne, uanset anvendelse af G-CSF.
English: Stomatitis/mucositis grade 4 First episode: stop 5-FU only, at all subsequent cycles.
Danish: Stomatitis/mucositis grad 4 Første episode: Stop kun 5-FU i alle efterfølgende cyklusser.
English: Rare cases of convulsion or transient loss of consciousness have been observed with docetaxel administration.
Danish: Der er observeret sjældne tilfælde af kramper eller forbigående tab af bevidsthed under administration af docetaxel.
English: Taxespira will be given by infusion into one of your veins (intravenous use).
Danish: Taxespira vil blive givet som en infusion i en vene (intravenøs indgivelse).
English: Reversibility data are available among 35.3% of patients who developed neurotoxicity following docetaxel treatment at 100 mg/m² as single agent.
Danish: Reversibilitetsdata tilgængelige hos 35,3 % af de patienter, som udviklede neurotoksicitet efter docetaxel-behandling med 100 mg/m2 som enkeltstof.
English: Each vial is of single use and should be used immediately.
Danish: Hvert hætteglas er til engangsbrug og bør anvendes straks.
English: Disseminated intravascular coagulation (DIC), often in association with sepsis or multiorgan failure, has been reported.
Danish: Der er rapporter om dissemineret intravaskulær koagulation (DIC), ofte i forbindelse med sepsis eller multiorgan-svigt.
English: TAC = docetaxel, doxorubicin and cyclophosphamide FAC = 5-fluorouracil, doxorubicin and cyclophosphamide CI = confidence interval; ER = estrogen receptor PR = progesterone receptor
Danish: TAC = docetaxel, doxorubicin og cyclophosphamid FAC = 5-fluorouracil, doxorubicin og cyclophosphamid CI = konfidensinterval; ER = østrogenreceptor PR = progesteronreceptor
English: Patients who experience Grade 3 or 4 stomatitis should have their dose decreased to 60 mg/m
Danish: Patienter, som får grad 3- eller 4-stomatitis, bør have deres dosis reduceret til 60 mg/m
English: During radiotherapy, carboplatin (AUC 1.5) was given weekly as a one-hour intravenous infusion for a maximum of 7 doses.
Danish: Under strålebehandlingsforløbet blev der givet carboplatin (AUC 1,5) ugentligt som en 1-times intravenøs infusion med maksimalt 7 doser.
English: These reactions were described using the NCI Common Toxicity Criteria (grade 3 = G3; grade 3-4 = G3/4; grade 4 = G4), the COSTART and the MedDRA terms.
Danish: Disse reaktioner blev beskrevet med anvendelse af NCI Common Toxicity Criteria (grad 3 = G3; grad 3-4 = G3/4; grad 4 = G4), COSTART- og MedDRA-termerne.
English: 3) was 7 days), anaemia, alopecia, nausea, vomiting, stomatitis, diarrhoea and asthenia.
Danish: 3) var 7 dage), anæmi, alopeci, kvalme, opkastning, stomatitis, diarré og asteni.
English: The secondary endpoint, PFS, demonstrated a 29% risk reduction of progression or death and a 22 month improvement in median PFS (35.5 months for TPF and 13.1 for PF).
Danish: Det sekundære endepunkt, progressionsfri overlevelse (PFS), viste en reduktion af risikoen for progression eller dødsfald på 29 % og en 22 måneders forbedring i median PFS (35,5 måneder for TPF og 13,1 måneder for PF).
English: Overall survival
Danish: Total overlevelse
English: • pain in the joints or muscles
Danish: • smerter i led eller muskler
English: Ready to add to infusion solution.
Danish: Klar til tilsætning i infusionsopløsning.
English: The second interim analysis was done after 400 DFS events had been recorded overall, which led to a median follow-up of 55 months.
Danish: Den anden interimanalyse blev udført efter registrering af i alt 400 sygdomsfri overlevelser (DFS), hvilket førte til en median opfølgningstid på 55 måneder.
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 monoterapi med carboplatin.
English: The overall objective response rates in the all-randomised population (investigator assessment) were 41.6% (docetaxel + capecitabine) vs. 29.7% (docetaxel alone); p = 0.0058.
Danish: De overordnede objektive responsrater i den randomiserede population (investigators vurdering) var 41,6 % (docetaxel+capecitabin) vs. 29,7 % (docetaxel alene); p = 0,0058.
English: Eruptions generally occurred within one week after the docetaxel infusion.
Danish: Udbruddene opstod ofte inden for en uge efter docetaxel-infusion.
English: In case CMO is diagnosed, docetaxel treatment should be discontinued and appropriate treatment initiated (see section
Danish: I tilfælde af CMO-diagnose skal docetaxel seponeres, og passende behandling initieres (se pkt.
English: Prednisone or prednisolone 5 mg orally twice daily is administered continuously (see section 5.1).
Danish: Prednison eller prednisolon 5 mg 2 gange dagligt gives kontinuerligt (se pkt.5.1).
English: Rare (may affect up to 1 in 1,000 people): inflammation of the colon, small intestine, which could be fatal (frequency not known);
Danish: Sjældne (kan forekomme hos op til 1 ud af 1.000 patienter): • Betændelse i tyktarm, tyndtarm, som kan være dødelig (hyppighed ikke kendt); perforering af
English: Women of childbearing age receiving docetaxel should be advised to avoid becoming pregnant, and to inform the treating physician immediately should this occur.
Danish: Kvinder i den fertile alder, som behandles med docetaxel, skal rådes til at undgå graviditet og til straks at informere den behandlende læge, hvis graviditet indtræder.
English: • 1,312 and 121 patients who received 100 mg/m2 and 75 mg/m2 of docetaxel as a single agent
Danish: • 1.312 og 121 patienter, som fik henholdsvis 100 mg/m2 og 75 mg/m2 docetaxel som enkeltstof.
English: The infusion bag solution should be used within 6 hours below 25°C including the one hour infusion to the patient.
Danish: Posen med infusionsopløsningen skal bruges inden for 6 timer ved opbevaring under 25° C inklusive den time, patienten får infusionen.
English: Docetaxel infusion solution is supersaturated, therefore may crystallize over time.
Danish: Docetaxel infusionsvæske, opløsning, er overmættet og kan derfor krystallisere over tid.