natgillin/translations-raw huggingface dataset:
Smerteintensitets-scoren blev forbedret under behandling i begge grupper, hvilket indikerer en god smertekontrol.
Pain intensity score improved during treatment in both groups indicating adequate pain management.
Anden episode: Stop kun 5-FU i alle efterfølgende cyklusser.
Second episode: stop 5-FU only, at all subsequent cycles.
Kontraception til mænd og kvinder Der skal anvendes effektiv kontraception under behandlingen.
Contraception in males and females An effective method of contraception should be used during treatment.
Docetaxel er et lipofilt stof, men det vides ikke, om det udskilles i human mælk.
Docetaxel is a lipophilic substance but it is not known whether it is excreted in human milk.
Primær G-CSF-profylakse blev gjort obligatorisk i TAC-armen, efter 230 patienter var blevet randomiseret.
Primary prophylactic G-CSF was made mandatory in TAC arm after 230 patients were randomized.
Taxespira vil blive indgivet til dig af sundhedspersonalet.
Taxespira will be administered to you by a healthcare professional.
Dette regimen blev administreret hver 3. uge i 4 cyklusser i tilfælde, hvor der som et minimum blev observeret en mindre respons (> 25 % reduktion i den todimensionelt målte tumorstørrelse) efter 2 cyklusser.
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.
Behandlingscyklussens længde var 3 uger for TCF-armen og 4 uger for CF-armen.
The length of a treatment cycle was 3 weeks for the TCF arm and 4 weeks for the CF arm.
For docetaxel-/carboplatin-kombinationen kunne der hverken bevises en ækvivalent eller noninferior effekt sammenlignet med referencebehandlingen kombinations-VCis.
For docetaxel/carboplatin combination, neither equivalent nor non-inferior efficacy could be proven compared to the reference treatment combination VCis.
Farmakoterapeutisk klassifikation: antineoplastiske midler, taxaner, ATC-kode: L01CD02
Pharmacotherapeutic group: antineoplastic agents, taxanes, ATC Code: L01CD02
Patienten bør have terapeutisk G-CSF så snart som muligt, efter overdosering er erkendt.
Patients should receive therapeutic G-CSF as soon as possible after discovery of overdose.
Hvis dette sker, skal du omgående fortælle det til lægen.
If this happens, you must tell your doctor immediately.
Som helhed viste resultaterne af quality of life (QoL) og kliniske fordele konsekvent en forbedring til fordel for TCF-armen.
Overall, quality of life (QoL) and clinical benefit results consistently indicated improvement in favour of the TCF arm.
For kombinationer med trastuzumab vises de bivirkninger (alle grader), som er rapporteret hos ≥ 10 %.
For combination with trastuzumab, adverse events (all grades) reported in ≥10% are displayed.
Hver kasse indeholder 1 hætteglas.
Each box contains 1 vial.
Hvis du får problemer med synet, særligt sløret syn, skal du straks have dine øjne og dit syn undersøgt.
In case of vision problems, in particular blurred vision, you should immediately have your eyes and vision examined.
Se også afsnittet “Taxespira indeholder ethanol (alkohol)” nedenfor.
See also section “Taxespira contains ethanol (alcohol)” below.
Hvis der opstår alvorlig neutropeni (< 500 celler/mm
In the case of severe neutropenia (<500 cells/mm
• feber: Hvis det forekommer, skal du straks fortælle det til lægen.
• fever: if this happens you must tell your doctor immediately
Prednison og dexamethason
Prednisone and dexamethasone
Behandlingsforskel: 7,1 % [95 % CI: 0,7; 13,5] *: Korrigeret for multiple sammenligninger og justeret for stratificeringsfaktorer (sygdomsstadie og behandlingsregion), baseret på evaluerbar patientpopulation.
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.
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.
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.
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.
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.
Cisplatin og 5-fluorouracil
Cisplatin and 5-fluorouracil
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.
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.
• fald i indholdet af natrium, kalium, magnesium og/eller calcium i blodet (forstyrrelse i elektrolytbalancen).
• decrease of the sodium, potassium, magnesium, and/or calcium in your blood (electrolyte balance disorders).
• 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)
• 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)
Lægen vil muligvis afbryde din behandling med det samme.
Your doctor may stop your treatment immediately.
Akut leukæmi/myelodysplastisk syndrom
Acute leukaemia /Myelodysplastic syndrome
Opfylder relativ indikation for kemoterapi Nej
Meeting relative indication for chemotherapy No
Ældre patienter, som behandles med TCF, bør monitoreres nøje.
Older people treated with TCF should be closely monitored.
Det positive benefit/risk-forhold for TAC sammenlignet med FAC forblev uændret.
The positive benefit risk ratio for TAC compared to FAC remained unchanged.
Progressiv sygdom som bedste overordnede respons (%) *Ikke-stratificeret log-rank-test
Progressive disease as best overall response (%) *Unstratified logrank test
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.
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.
Tør hud; afskalning
Dry skin; Desquamation
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.
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.
Mitoxantron hver 3. uge
Mitoxantrone every 3 weeks
Parametre for klinisk fordel
Clinical benefit parameters
Sekundære endepunkter inkluderede forandring i smerter, global vurdering af livskvalitet med EuroQoL-5D, lungekræftsymptom-skala og forandringer i Karnosfkys performance status.
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.
Docetaxel er i udstrakt grad proteinbundet (> 95 %).
Docetaxel is highly protein bound (>95%).
G-CSF blev anvendt som sekundær profylakse hos 19,3 % af patienterne (10,7 % af cyklusserne).
G-CSF was used for secondary prophylaxis in 19.3% of patients (10.7 % of the cycles).
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.
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.
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):
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):
Effektresultaterne er opsummeret i nedenstående tabel:
Efficacy results are summarized in the following table:
Overordnet responsrate (%):
Overall response rate (%):
De farmakokinetiske parametre i modellen lå tæt på det, der blev estimeret i fase I-studier.
Pharmacokinetic parameters estimated by the model were very close to those estimated from phase I studies.
• fald i blodtrykket, uregelmæssig eller hurtig hjerterytme
• decrease in blood pressure; irregular or rapid heart beat
Du må ikke amme, mens du er i behandling med Taxespira.
You must not breast-feed while you are treated with Taxespira.
Disse reaktioner er også set under infusion af lægemidlet.
These reactions sometimes appear during the infusion of the medicinal product.
Den bør anvendes inden for 6 timer (inklusive 1 times intravenøs infusion).
It should be used within 6 hours (including the one hour infusion intravenous administration).
Nedenstående bivirkninger kan opstå mellem infusionerne af Taxespira, og hyppigheden kan variere alt efter kombinationen af de lægemidler, du får:
Between infusions of Taxespira the following may occur, and the frequency may vary with the combinations of medicines that are received:
Stratificeret log-rank-test *Tærskel for statistisk signifikans = 0,0175 **PSA: prostataspecifikt antigen
Stratified log rank test *Threshold for statistical significance = 0.0175 **PSA: Prostate-Specific Antigen
• ændrede eller udeblevne menstruationer
• change or absence of menstrual periods
Hjertesvigtet kan være moderat til alvorligt og har været associeret med dødsfald (se 4.8).
This may be moderate to severe and has been associated with death (see section 4.8).
2-års estimat (%)
2-year estimate (%)
• manglende appetit (anoreksi)
• loss of appetite (anorexia)
Toksicitet Diarré grad 3
Toxicity Diarrhoea grade 3
Docetaxel ugentligt
Docetaxel every week
Der findes ingen data vedrørende anvendelse af docetaxel til gravide kvinder.
There is no information on the use of docetaxel in pregnant women.
Den sene fase skyldes til dels den relativt langsomme redistribution af docetaxel fra det perifere kammer.
The late phase is due, in part, to a relatively slow efflux of docetaxel from the peripheral compartment.
• hvis du er allergisk over for docetaxel eller et af de øvrige indholdsstoffer i Taxespira (angivet i punkt 6)
• if you are allergic (hypersensitive) to docetaxel or any of the other ingredients of Taxespira (listed in section 6).
Følgende bivirkninger er hyppigt observeret med docetaxel:
The following adverse reactions are frequently observed with docetaxel:
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.
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.
• hævelse på hænder, fødder eller ben
• swelling of the hands, feet, legs
De primære forventede komplikationer ved overdosis vil være knoglemarvsuppression, perifer neurotoksicitet og mucositis.
The primary anticipated complications of overdose would consist of bone marrow suppression, peripheral neurotoxicity and mucositis.
Der er rapporter om sjælden forekomst af dehydrering som en konsekvens af gastrointestinale hændelser, herunder enterocolitis og gastrointestinal perforation.
Rare occurrences of dehydration have been reported as a consequence of gastrointestinal events including enterocolitis and gastrointestinal perforation.
Dette var også statistisk signifikant med en hazard ratio på 0,71; 95 % CI 0,56-0,90; log-rank-test p = 0,004.
This was also statistically significant with an HR of 0.71; 95% CI 0.56-0.90; log-rank test p = 0.004.
Estimeret medianoverlevelse
Estimated median survival
Taxespira indeholder ethanol (alkohol)
Taxespira contains ethanol (alcohol)
Der er rapporteret om meget sjældne tilfælde af hepatitis, nogle gange fatale, hovedsageligt hos patienter med eksisterende leversygdomme.
Very rare cases of hepatitis, sometimes fatal primarily in patients with pre-existing liver disorders, have been reported.
Fortæl det straks til hospitalspersonalet, hvis du får nogle af disse bivirkninger.
Tell them immediately if you notice any of these effects.
Yderligere forsigtighedsregler for anvendelse ved adjuverende behandling af brystkræft
Additional cautions for use in adjuvant treatment of breast cancer
Dette lægemiddel hedder Taxespira.
The name of this medicine is Taxespira.
Følgende allergiske reaktioner kan optræde under infusionen på hospitalet (kan forekomme hos mere end 1 ud af 10 patienter):
During the infusion at the hospital the following allergic reactions may occur (may affect more than 1 in 10 people):
Neutrofil-lavpunkt sås efter gennemsnitligt 7 dage, men intervallet kan være kortere hos patienter, der tidligere har fået en kraftigt virkende behandling.
Neutrophil nadirs occurred at a median of 7 days but this interval may be shorter in heavily pre-treated patients.
I cirka 20 % af tilfældene var der ingen risikofaktorer for akut nyresvigt såsom samtidig behandling med nefrotoksiske lægemidler og gastrointestinale sygdomme.
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.
Hvis du har haft en allergisk reaktion overfor paclitaxel kan du også få en allergisk reaktion overfor docetaxel, som kan være mere alvorlig.
If you had an allergic reaction to paclitaxel, you may also experience an allergic reaction to docetaxel, which may be more severe.
Forekomsten af alvorlige bivirkninger var højere i gruppen med de ældre patienter i forhold til gruppen med de yngre patienter.
The incidence of serious adverse events was higher in older people compared to younger patients.
Taxespira koncentrat til infusionsvæske, opløsning, kræver INGEN forudgående fortynding med en solvens, men er klar til tilsætning til infusionsopløsningen.
Taxespira concentrate for solution for infusion requires NO prior dilution with a solvent and is ready to add to the infusion solution.
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
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
DFS var det primære effektendepunkt, og total overlevelse (OS) var det sekundære effektendepunkt.
Disease-free survival (DFS) was the primary efficacy endpoint and OS was the secondary efficacy endpoint.
Det skal der tages højde for hos gravide og ammende kvinder, børn og patienter i højrisikogrupper såsom patienter med leversygdom eller epilepsi.
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.
Væskeretention (alvorlig/livstruende: 1 %)
Fluid retention (severe/life-threatening: 1%)
Derimod inducerede det ingen mutagenicitet i Ames' test eller i en CHO/HGPRT-genmutationsassay.
However, it did not induce mutagenicity in the Ames test or the CHO/HGPRT gene mutation assay.
Det skal du vide, før du begynder at bruge Taxespira 3.
What you need to know before you use Taxespira 3.
Hypotension; Hypertension; Blødning
Hypotension; Hypertension; Haemorrhage
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.
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.
Behandlingen skal afbrydes, hvis disse toksiciteter varer ved (se pkt.
Treatment must be discontinued if these toxicities persist (see section 4.4).
Med primær G-CSF-profylakse (n = 421) n (%)
With primary G-CSF prophylaxis (n = 421) n (%)
Tilberedning af infusionsopløsningen
Preparation of the infusion solution
Forsøgspopulationen bestod af patienter med teknisk uresekterbar sygdom, patienter med lav sandsynlighed for kirurgisk helbredelse og patienter med bevarelse af organer som mål.
The study population comprised patients with technically unresectable disease, patients with low probability of surgical cure and patients aiming at organ preservation.
Det er påvist, at docetaxel er både embryo- og føtotoksisk hos kaniner og rotter, og at det nedsætter fertiliteten hos rotter.
Docetaxel has been shown to be both embryotoxic and foetotoxic in rabbits and rats, and to reduce fertility in rats.
Ældre Baseret på de farmakokinetiske studier findes der ingen særlige retningslinjer for ældre personer.
Based on a population pharmacokinetic analysis, there are no special instructions for use in the elderly.
Median tid indtil første forværring af WHO performance status var signifikant længere i TPF-armen end i PF-armen.
Median time to first deterioration of WHO performance status was significantly longer in the TPF arm compared to PF.
Febril neutropeni og neutropenisk infektion forekom hos henholdsvis 17,2 % og 13,5 % af patienterne, uanset anvendelse af G-CSF.
Febrile neutropenia and neutropenic infection occurred in 17.2% and 13.5% of patients respectively, regardless of G-CSF use.
Stomatitis/mucositis grad 4 Første episode: Stop kun 5-FU i alle efterfølgende cyklusser.
Stomatitis/mucositis grade 4 First episode: stop 5-FU only, at all subsequent cycles.
Der er observeret sjældne tilfælde af kramper eller forbigående tab af bevidsthed under administration af docetaxel.
Rare cases of convulsion or transient loss of consciousness have been observed with docetaxel administration.
Taxespira vil blive givet som en infusion i en vene (intravenøs indgivelse).
Taxespira will be given by infusion into one of your veins (intravenous use).
Reversibilitetsdata tilgængelige hos 35,3 % af de patienter, som udviklede neurotoksicitet efter docetaxel-behandling med 100 mg/m2 som enkeltstof.
Reversibility data are available among 35.3% of patients who developed neurotoxicity following docetaxel treatment at 100 mg/m² as single agent.
Hvert hætteglas er til engangsbrug og bør anvendes straks.
Each vial is of single use and should be used immediately.
Der er rapporter om dissemineret intravaskulær koagulation (DIC), ofte i forbindelse med sepsis eller multiorgan-svigt.
Disseminated intravascular coagulation (DIC), often in association with sepsis or multiorgan failure, has been reported.
TAC = docetaxel, doxorubicin og cyclophosphamid FAC = 5-fluorouracil, doxorubicin og cyclophosphamid CI = konfidensinterval; ER = østrogenreceptor PR = progesteronreceptor
TAC = docetaxel, doxorubicin and cyclophosphamide FAC = 5-fluorouracil, doxorubicin and cyclophosphamide CI = confidence interval; ER = estrogen receptor PR = progesterone receptor
Patienter, som får grad 3- eller 4-stomatitis, bør have deres dosis reduceret til 60 mg/m
Patients who experience Grade 3 or 4 stomatitis should have their dose decreased to 60 mg/m
Under strålebehandlingsforløbet blev der givet carboplatin (AUC 1,5) ugentligt som en 1-times intravenøs infusion med maksimalt 7 doser.
During radiotherapy, carboplatin (AUC 1.5) was given weekly as a one-hour intravenous infusion for a maximum of 7 doses.
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.
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.
3) var 7 dage), anæmi, alopeci, kvalme, opkastning, stomatitis, diarré og asteni.
3) was 7 days), anaemia, alopecia, nausea, vomiting, stomatitis, diarrhoea and asthenia.
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).
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).
Total overlevelse
Overall survival
• smerter i led eller muskler
• pain in the joints or muscles
Klar til tilsætning i infusionsopløsning.
Ready to add to infusion solution.
Den anden interimanalyse blev udført efter registrering af i alt 400 sygdomsfri overlevelser (DFS), hvilket førte til en median opfølgningstid på 55 måneder.
The second interim analysis was done after 400 DFS events had been recorded overall, which led to a median follow-up of 55 months.
Ved kombination med docetaxel var carboplatins clearence ca. 50 % højere end de værdier, der tidligere er rapporteret for monoterapi med carboplatin.
When combined to docetaxel, the clearance of carboplatin was about 50% higher than values previously reported for carboplatin monotherapy.
De overordnede objektive responsrater i den randomiserede population (investigators vurdering) var 41,6 % (docetaxel+capecitabin) vs. 29,7 % (docetaxel alene); p = 0,0058.
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.
Udbruddene opstod ofte inden for en uge efter docetaxel-infusion.
Eruptions generally occurred within one week after the docetaxel infusion.
I tilfælde af CMO-diagnose skal docetaxel seponeres, og passende behandling initieres (se pkt.
In case CMO is diagnosed, docetaxel treatment should be discontinued and appropriate treatment initiated (see section
Prednison eller prednisolon 5 mg 2 gange dagligt gives kontinuerligt (se pkt.5.1).
Prednisone or prednisolone 5 mg orally twice daily is administered continuously (see section 5.1).
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
Rare (may affect up to 1 in 1,000 people): inflammation of the colon, small intestine, which could be fatal (frequency not known);
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.
Women of childbearing age receiving docetaxel should be advised to avoid becoming pregnant, and to inform the treating physician immediately should this occur.
• 1.312 og 121 patienter, som fik henholdsvis 100 mg/m2 og 75 mg/m2 docetaxel som enkeltstof.
• 1,312 and 121 patients who received 100 mg/m2 and 75 mg/m2 of docetaxel as a single agent
Posen med infusionsopløsningen skal bruges inden for 6 timer ved opbevaring under 25° C inklusive den time, patienten får infusionen.
The infusion bag solution should be used within 6 hours below 25°C including the one hour infusion to the patient.
Docetaxel infusionsvæske, opløsning, er overmættet og kan derfor krystallisere over tid.
Docetaxel infusion solution is supersaturated, therefore may crystallize over time.
Postmenopausal *En hazard ratio (TAC/FAC) på mindre end 1 indikerer, at der er en sammenhæng mellem TAC og en længere sygdomsfri overlevelse, sammenlignet med FAC.
Post-Menopausal *a hazard ratio (TAC/FAC) of less than 1 indicates that TAC is associated with a longer disease free survival compared to FAC.