FrancophonIA/ELRC3.0 huggingface dataset:
English: If this happens, do not drive or use any tools or machines before discussing with your doctor, nurse or hospital pharmacist.
Danish: Hvis dette sker, må du ikke føre motorkøretøj, bruge værktøj eller maskiner, før du har talt med din læge, sundhedspersonalet eller hospitalsfarmaceuten.
English: DFS data were not statistically significant but were still associated with a positive trend in favour of TAC.
Danish: Data for DFS var ikke statistisk signifikante, men blev alligevel forbundet med en positiv tendens til fordel for TAC.
English: The length of a treatment cycle was 3 weeks for the TCF arm and 4 weeks for the CF arm.
Danish: Behandlings cyklus var på 3 uger for TCF-armen og 4 uger for CF-armen.
English: TTP = time to progression; “ne” indicates that it could not be estimated or it was not yet reached.
Danish: ”ne” indikerer at dette ikke kunne estimeres eller ikke blev nået.
English: These symptoms may be the first signs of a serious gastrointestinal toxicity, which could be fatal.
Danish: Disse symptomer kan være de første tegn på en alvorlig mave-tarmforgiftning, som kan være dødelig.
English: However, it did not induce mutagenicity in the Ames test or the CHO/HGPRT gene mutation assay.
Danish: Derimod induceredes ingen mutationer i Ames test eller i en CHO/HGPRT gen mutation assay.
English: DOCETAXEL KABI will be administered to you by a healthcare professional.
Danish: DOCETAXEL KABI vil blive administreret af personale med en sundhedsfaglig uddannelse.
English: • infections, decrease in the number of red (anaemia), or white blood cells (which are important in fighting infection) and platelets
Danish: • Infektioner, fald i antallet af røde blodlegemer (anæmi), eller hvide blodlegemer (som er vigtige for at bekæmpe infektioner) og blodplader
English: A minority of patients were tested using fluorescence in-situ hybridization (FISH).
Danish: En mindre del af patienterne blev testet ved hjælp af fluoroscence in situ hybridization (FISH).
English: Use the vial immediately after its opening.
Danish: Anvend hætteglasset straks efter dets åbning.
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: L01CD 02
English: Pre-Menopausal
Danish: Præ-menopausal
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 rating af livskvalitet med EuroQoL5D, lungekræft-symptom skala, og forandringer i karnosfkys performance status.
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 perifere compartments.
English: Mitoxantrone every 3 weeks
Danish: Mitoxantrone Hver 3.uge
English: Acute leukaemia / Myelodysplastic syndrome
Danish: Akut leukæmi / myelodysplastisk syndrom
English: If you have any further questions on the use of this medicine, ask your doctor, or hospital pharmacist.
Danish: Hvis du har yderligere spørgsmål om anvendelsen af dette lægemiddel, så spørg din læge eller sygehusfarmaceut.
English: Although majority of cases occurred during the first or second cycle of docetaxel containing regimen, enterocolitis could develop at any time, and could lead to death as early as on the first day of onset.
Danish: Selvom et flertal af tilfældene opstod under den første eller anden behandlingsrunde med docetaxel kunne enterocolitis opstå når som helst, og medføre død så tidligt som på den første dag tilstanden indtrådte.
English: You must not become pregnant during treatment with this medicine and must use an effective method of contraception during therapy, because DOCETAXEL KABI 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 KABI kan skade det ufødte barn.
English: In cases of overdose, exacerbation of adverse events may be expected.
Danish: I tilfælde af en overdosis kan der forventes en forværring af bivirkninger.
English: Before each treatment with DOCETAXEL KABI, you will have blood tests to check that you have enough blood cells and sufficient liver function to receive DOCETAXEL KABI.
Danish: Før hver behandling med DOCETAXEL KABI, vil du få taget blodprøver for at få kontrolleret, om du har nok blodceller og den nødvendige leverfunktion til at få DOCETAXEL KABI.
English: • fever: if this happens you must tell your doctor immediately
Danish: • Feber: Hvis dette forekommer, skal du straks fortælle det til din læge
English: Patients should be monitored for symptoms of congestive heart failure during therapy and during the follow up period.
Danish: Patienter bør monitoreres for symptomer på kongestivt hjertesvigt under behandlingen og i opfølgningsperioden.
English: These patients should be closely monitored during initiation of docetaxel therapy.
Danish: Disse patienter skal monitoreres tæt ved initiering af docetaxelbehandling.
English: Elderly treated with TCF should be closely monitored.
Danish: Ældre personer, som behandles med TCF, bør monitoreres nøje.
English: The study population comprised patients with technically unresectable disease, patients with low probability of surgical cure and patients aiming at organ preservation.
Danish: Studiepopulationen bestod af patienter med teknisk uresekterbar sygdom, patienter med lav chance for kirurgisk helbredelse og patienter med bevarelse af organer som mål.
English: • decrease in blood pressure; irregular or rapid heart beat
Danish: • Fald i blodtrykket, uregelmæssig eller hurtig hjerterytme
English: Grade1 (includes grade not assessed)
Danish: Grad 1 (inklusiv grader, der ikke er fastsat)
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 HR på 0,71; 95 % CI 0,56-0,90; log-rank test p =0,004.
English: Docetaxel belongs to the group of anti-cancer medicines called taxoids.
Danish: Docetaxel hører til gruppen af kræftmedicin, der kaldes taxoider.
English: Febrile neutropenia (includes neutropenia associated with fever and antibiotic use) or neutropenic sepsis
Danish: Febril neutropeni (inklusive neutropeni associeret med feber og brug af antibiotika) eller neutropenisk sepsis
English: Docetaxel is metabolised by CYP3A4 and prednisone is known to induce CYP3A4.
Danish: Docetaxel metaboliseres via CYP3A4, og prednison er kendt for at inducere CYP3A4.
English: Gastrointestinal reactions
Danish: Gastrointestinale reaktioner
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: Taget i betragtning af, at docetaxel givet hver uge gav en lidt bedre sikkehedsprofil end docetaxel administreret hver 3. uge, er det en mulighed, at nogle patienter kan have fordel af docetaxel administreret hver uge.
English: Based on a population pharmacokinetic analysis, there are no special instructions for use in the elderly.
Danish: Baseret på de farmakokinetiske studier findes der ingen særlige retningslinjer for ældre.
English: Contraindications for other medicinal products also apply, when combined with docetaxel.
Danish: Kontraindikationer for andre lægemidler gælder også, når disse lægemidler kombineres med docetaxel.
English: As a result, caution should be exercised when treating patients with these medicinal products as concomitant therapy since there is a potential for a significant interaction.
Danish: Man bør derfor udvise forsigtighed ved samtidig medicinering med disse lægemidler på grund af risikoen for en betydelig interaktion.
English: Hormonal receptor status
Danish: Hormonel receptorstatus
English: Symptoms such as early abdominal pain and tenderness, fever, diarrhoea, with or without neutropenia, may be early manifestations of serious gastrointestinal toxicity and should be evaluated and treated promptly.
Danish: Symptomer såsom tidlig abdominal smerte og ømhed, feber, diarré, med eller uden neutropeni, kan være tidlige manifestationer på alvorlig gastrointestinal toksicitet og bør evalueres og behandles med det samme.
English: Therefore, docetaxel must not be used during pregnancy unless clearly indicated.
Danish: Docetaxel må derfor ikke anvendes til gravide, medmindre det er tydeligt indikeret.
English: • change in the colour of your nails, which may detach
Danish: • Ændring af neglenes farve, som også kan løsne sig
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: • if you have a severe liver disease.
Danish: • hvis du har en alvorlig leverlidelse
English: One TAC patient (0.1%) and 1 FAC patient (0.1%) died due to AML during the follow-up period (median follow-up time of 8 years).
Danish: En TAC patient (0,1 %) og 1 FAC patient (0,1 %) døde på grund af AML i løbet af opfølgningsperioden (median opfølgningstid på 8 år).
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 personer i forhold til gruppen med de yngre patienter.
English: Contraceptive measures must be taken by both men and women during treatment and for men at least 6 months after cessation of therapy (see section 4.6).
Danish: Svangerskabsforebyggende midler skal anvendes af både mænd og kvinder under behandlingen og for mænd i mindst 6 måneder efter seponering (se pkt.
English: Median time to progression (weeks):
Danish: Gennemsnitlig tid til progression (uger)
English: Rare cases of myocardial infarction have been reported.
Danish: Sjældne tilfælde af myokardieinfarkt er rapporteret.
English: All patients on the docetaxel-containing arm of the TAX 323 and TAX 324 studies, received prophylactic antibiotics.
Danish: Alle patienter på den docetaxel-indeholdende arm af TAX 323 og TAX 324 studierne modtog profylaktisk antibiotika.
English: Therefore, patients should be warned of the potential impact of the amount of alcohol and the side effects of this medicinal product on the ability to drive or use machines, and be advised not to drive or use machines if they experience these side effects during treatment.
Danish: Patienter bør derfor advares om den potentielle indvirkning, som mængden af alkohol og bivirkningerne af dette lægemiddel kan have på evnen til at føre motorkøretøj eller betjene maskiner, samt frarådes at føre motorkøretøj og betjene maskiner, hvis de oplever disse bivirkninger under behandlingen.
English: In about 20% of these cases there were no risk factors for acute renal failure such as concomitant nephrotoxic medicinal products and gastrointestinal disorders.
Danish: I ca. 20% af tilfældene var der ingen risikofaktorer for akut nyresvigt såsom samtidig behandling med nefrotoksiske lægemidler og gastrointestinale sygdomme.
English: Efficacy results are summarized in the following table:
Danish: Resultaterne af effekten er opsummeret i den følgende tabel:
English: Preparation for the intravenous administration
Danish: Forberedelse til intravenøs administration
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 flere end 1 ud af 10 patienter):
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 er kendt for at resultere i neutropeni hos 97 % af patienterne, 76 % grad 4, baseret på laveste blodtælling.
English: Age category 2 <35 years ≥35 years
Danish: Alderskategori 2 <35 år ≥35 år
English: In addition, physical and chemical in-use stability of the infusion solution prepared as recommended has been demonstrated in non-PVC bags up to 48 hours when stored between 2 to 8°C.
Danish: Fysisk og kemisk i-brug stabilitet af infusionsopløsningen fremstillet som anbefalet er endvidere påvist i op til 48 timer, når opbevaret mellem 2⁰C til 8⁰C i ikke-PVC poser.
English: Overall, quality of life (QoL) and clinical benefit results consistently indicated improvement in favour of the TCF arm.
Danish: Som helhed viste livskvalitet (LK) og kliniske fordele resultater i overensstemmelse med fremgang til fordel for TCF-armen.
English: The adverse reactions considered to be possibly or probably related to the administration of docetaxel have been obtained in:
Danish: De bivirkninger, som muligvis eller sandsynligvis er relateret til anvendelsen af docetaxel, er set hos:
English: Patients who received docetaxel every three weeks demonstrated significantly longer overall survival compared to those treated with mitoxantrone.
Danish: De patienter, der fik docetaxel hver 3. uge, viste signifikant længere total overlevelsese sammenlignet med dem, der fik mitoxantrone.
English: Subgroup analyses across age, gender and race consistently favoured the TCF arm compared to the CF arm.
Danish: Undergruppe-analyser på tværs af alder, køn og race favoriserede samstemmende TCF-armen sammenlignet med CF-armen.
English: • swelling of the hands, feet, legs
Danish: • Hævelse af hænder, fødder eller ben
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); hyppighed ikke kendt (kan ikke estimeres ud fra tilgængelige data).
English: The safety and efficacy of DOCETAXEL KABI in nasopharyngeal carcinoma in children aged 1 month to less than 18 years have not yet been established.
Danish: DOCETAXEL KABIS sikkerhed og virkning ved nasofaryngealt karcinom hos børn i alderen 1 måned til under 18 år er endnu ikke klarlagt.
English: Docetaxel is highly protein bound (> 95%).
Danish: Docetaxel er i udstrakt grad proteinbundet (> 95 %).
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: Gastric adenocarcinoma
Danish: Gastrisk adenokarcinom
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: • redness and swelling of the palms of your hands or soles of your feet which may cause your skin to peel (this may also occur on the arms, face, or body)
Danish: • Rødme og hævelse af håndflader eller fodsåler, hvilket kan få huden til at skalle af (dette kan også forekomme på arme, ansigt eller krop)
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 den ikke anvendes straks, er brugeren ansvarlig for i-brug opbevaringstid- og betingelser, som normalt ikke vil være længere end 6 timer under 25˚C inklusive 1 times infusion.
English: Surgical resection was allowed following chemotherapy, before or after radiotherapy.
Danish: Kirurgisk resektion blev tilladt efter kemoterapi, før eller efter strålebehandling.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Ready to add to infusion solution.
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Klar til at tilsætte infusionsvæske.
English: Disseminated intravascular coagulation (DIC), often in association with sepsis or multi-organ failure, has been reported.
Danish: Der er rapporteret om dissemineret intravaskulær koagulation (DIC), ofte i forbindelse med sepsis eller multiorgan-svigt.
English: The primary anticipated complications of overdose would consist of bone marrow suppression, peripheral neurotoxicity and mucositis.
Danish: De forventede komplikationer ved overdosis vil være knoglemarvsuppression, perifer neurotoksicitet og mucositis.
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 studium 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: This regimen was administered every three weeks for 4 cycles in case at least a minor response (≥ 25% reduction in bidimensionally measured tumour size) was observed after 2 cycles.
Danish: Dette regime blev administreret hver 3. uge i 4 cyklusser i tilfælde hvor der som mindstemål blev observeret mindre respons (> 25% reduktion i den bidimensionelt målte tumorstørrelse) efter 2 cyklusser.
English: Docetaxel is a lipophilic substance but it is not known whether it is excreted in human milk.
Danish: Docetaxel er lipofilt, men det vides ikke, om det udskilles i human mælk.
English: Patients who have developed severe hypersensitivity reactions should not be re-challenged with docetaxel.
Danish: Patienter, som har udviklet svære overfølsomhedsreaktioner, bør ikke genbehandles med docetaxel.
English: These results are consistent with the pharmacological activity of docetaxel.
Danish: Disse resultater er i overensstemmelse med docetaxels farmakologiske aktivitet.
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 letale, hovedsageligt hos patienter med præ-eksisterende leversygdomme.
English: Disease-free survival (DFS) was the primary efficacy endpoint and Overall survival (OS) was the secondary efficacy endpoint.
Danish: DFS var det primære effekt-endepunkt, og total overlevelse (OS) var det sekundære effekt-endepunkt.
English: The pharmacokinetics of docetaxel were not altered by the age or sex of the patient.
Danish: Docetaxels farmakokinetik varierede ikke med patientens alder eller køn.
English: Method of administration For instructions on preparation and administration of the product, see section 6.6.
Danish: Administration For instruktioner om forberedelse og administration af lægemidlet, se pkt.
English: Docetaxel every week
Danish: Docetaxel hver uge
English: • decrease of the sodium, potassium, magnesium, and/or calcium in your blood (electrolyte balance disorders).
Danish: • Nedsat indhold af natrium, kalium, magnesium og/eller calcium i blodet (forstyrrelse i elektrolytbalancen).
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 cyklus).
English: Neutrophil nadirs occurred at a median of 7 days but this interval may be shorter in heavily pre-treated patients.
Danish: Neutrocyt-lavpunkt sås efter gennemsnitligt 7 dage, men intervallet kan være kortere hos patienter, der tidligere har fået en kraftigt virkende behandling.
English: Overall response rate (%):
Danish: Total response rate (%)
English: Lion Court, Farnham Road, Bordon Hampshire, GU35 0NF United Kingdom
Danish: Lion Court, Farnham Road, Bordon Hampshire, GU35 0NF Storbritannien
English: Reversibility data are available among 35.3% of patients who developed neurotoxicity following docetaxel treatment at 100 mg/m² as single agent.
Danish: Reversibilitets-data tilgængelige hos 35,3 % af de patienter, som udviklede neurotoksicitet efter docetaxel-behandling med 100 mg/m2 som enkelt stof.
English: DOCETAXEL KABI contains alcohol.
Danish: DOCETAXEL KABI indeholder alkohol.
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: Patients receiving TAC should be closely monitored (see sections 4.2 and 4.8).
Danish: Patienter, som får TAC, bør monitoreres omhyggeligt (se pkt 4.2 og 4.8).
English: Neutropenic complications
Danish: Neutropeniske komplikationer
English: In addition, docetaxel was found to be active on some but not all cell lines over expressing the p-glycoprotein which is encoded by the multidrug resistance gene.
Danish: Docetaxel fandtes ydermere at være aktivt over for nogle, men ikke alle cellelinjer, der udviste overekspression af p-glycoprotein, hvis tilstedeværelse er bestemt af "multidrug resistance"-genet (MDR-genet).
English: If pregnancy occurs during your treatment, you must immediately inform your doctor.
Danish: Hvis du bliver gravid under behandlingen, skal du straks fortælle det til din læge.
English: In case of combination with CYP3A4 inhibitors, the occurrence of docetaxel adverse reactions may increase, as a result of reduced metabolism.
Danish: I tilfælde af kombination med CYP3A4-hæmmere kan forekomsten af docetaxelrelaterede bivirkninger stige som et resultat af reduceret metabolisering.
English: Do not store above 25°C.
Danish: Må ikke opbevares over 25˚C.
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 henholdsvist 17,2 % og 13,5 % af patienterne, uanset anvendelse af G-CSF.
English: Primary prophylactic G-CSF was made mandatory in TAC arm after 230 patients were randomised.
Danish: Primær G-CSF-profylakse blev gjort obligatorisk i TAC-armen, efter 230 patienter var blevet randomiseret.
English: The benefit of resuming docetaxel treatment must be carefully evaluated.
Danish: Fordelene ved at genoptage behandlingen med docetaxel skal overvejes nøje.
English: You may experience side effects of this medicine that may impair your ability to drive, use tools or operate machines (see section 4 Possible side effects).
Danish: Du kan opleve bivirkninger af dette lægemiddel, som kan påvirke din evne til at føre motorkøretøj, bruge værktøj eller betjene maskiner (se punkt 4 ”Bivirkninger”).
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 bevidstheden under administration af docetaxel.
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 observeret i fase I-studier.
English: Interruption of docetaxel therapy is recommended until diagnosis is available.
Danish: Det anbefales at afbryde behandlingen med docetaxel, indtil der foreligger en diagnose.
English: After opening of the vial
Danish: Efter åbning af hætteglasset
English: Patients with impaired vision should undergo a prompt and complete ophthalmologic examination.
Danish: Patienter med påvirket syn bør omgående gennemgå en fuldstændig oftalmologisk undersøgelse.
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 af carboplatin ca. 50 % højere end de værdier, der tidligere er rapporteret for carboplatin monoterapi.
English: In combination with cisplatin
Danish: I kombination med cisplatin