natgillin/translations-raw huggingface dataset:
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.
Ethanol (vandfri) Citronsyremonohydrat 
Ethanol (anhydrous) Citric acid monohydrate
• Tiden indtil progression (TTP) var signifikant længere i AT-armen end i AC-armen, p = 0,0138. 
• Time to progression (TTP) was significantly longer in the AT arm versus AC arm, p = 0.0138.
Ud af 333 patienter behandlet med docetaxel hver tredje uge i et prostatakræftstudie var 209 patienter 65 år eller derover, og 68 patienter var ældre end 75 år. 
Of the 333 patients treated with docetaxel every three weeks in a prostate cancer study, 209 patients were 65 years of age or greater and 68 patients were older than 75 years.
Febril neutropeni og neutropenisk infektion forekom hos henholdsvis 12,1 % og 3,4 % af patienterne, når patienterne fik profylaktisk G-CSF, og hos 15,6 % og 12,9 % af patienterne uden profylaktisk G-CSF (se punkt 4.2). 
Febrile neutropenia and neutropenic infection occurred respectively in 12.1% and 3.4 % of patients when patients received prophylactic G-CSF, in 15.6% and 12.9% of patients without prophylactic G-CSF (see section 4.2).
Docetaxel må derfor ikke anvendes til gravide, medmindre det er på tvingende indikation. 
Therefore, docetaxel must not be used during pregnancy unless clearly indicated.
• vægtstigning eller vægttab. 
• weight gain or loss.
Overlevelsesprocenten var 93,7 % i TAC-armen og 91,4 % i FAC-armen ved tidspunktet for 8-års opfølgning, og 91,3 % i TAC-armen og 89 % i FAC-armen ved tidspunktet for 10-års opfølgning. 
The survival rate was 93.7% in the TAC arm and 91.4 % in the FAC arm, at the 8-year follow-up timepoint, and 91.3 % in the TAC arm and 89 % in the FAC arm, at the 10-year follow-up timepoint.
Det skal du vide, før du begynder at bruge Taxespira 
What you need to know before you use Taxespira
• Docetaxel 30 mg/m2 administreret ugentligt i de første 5 uger i en 6-ugers cyklus i 5 cyklusser. 
• Docetaxel 30 mg/m2 administered weekly for the first 5 weeks in a 6 week cycle for 5 cycles.
De patienter, der fik docetaxel hver 3. uge, viste signifikant længere overordnet overlevelse sammenlignet med dem, der fik mitoxantron. 
Patients who received docetaxel every three weeks demonstrated significantly longer OS compared to those treated with mitoxantrone.
Alle 3 behandlingsregimener blev administreret i kombination med prednison eller prednisolon 5 mg to gange dagligt kontinuerligt. 
All 3 regimens were administered in combination with prednisone or prednisolone 5 mg twice daily, continuously.
Det er vigtigt at læse hele indholdet af denne vejledning inden fremstilling af Taxespira koncentrat til infusionsvæske, opløsning. 
It is important that you read the entire contents of this guide prior to the preparation of the Taxespira infusion solution.
Øre og labyrint Der er rapporter om sjældne tilfælde af ototoksicitet, nedsat hørelse og/eller tab af hørelse. 
Ear and labyrinth disorders Rare cases of ototoxicity, hearing impaired and/or hearing loss have been reported.
Efter induktionskemoterapi skulle patienter i begge behandlingsarme have 7 ugers CRT med et minimumsinterval på 3 uger og ikke senere end 8 uger efter påbegyndelse af sidste cyklus (dag 22 til dag 56 af sidste cyklus). 
Patients in both treatment arms were to receive 7 weeks of CRT following induction chemotherapy with a minimum interval of 3 weeks and no later than 8 weeks after start of the last cycle (day 22 to day 56 of last cycle).
- Aktivt stof: docetaxel (som trihydrat). 
- The active substance is docetaxel (as trihydrate).
Taxespira må IKKE anvendes, hvis du er gravid, medmindre din læge udtrykkeligt ønsker det. 
Taxespira must NOT be administered if you are pregnant unless clearly indicated by your doctor.
*En Hazard ratio på mindre end 1 indikerer, at TAC kan associeres med længere sygdomsfri overlevelse og længere total overlevelse sammenlignet med FAC. 
*a hazard ratio of less than 1 indicates that TAC is associated with a longer disease-free survival and OS compared to FAC
Brug ikke lægemidlet efter den udløbsdato, der står på den ydre pakning og hætteglassets etiket efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned. 
Do not use this medicine after the expiry date which is stated on the outer carton and on the label of the vial after EXP.
Taxespira blev administreret som infusion over 1 time, alle andre lægemidler blev givet intravenøst på dag 1 hver 3. uge. 
Taxespira was administered as a 1-hour infusion, all other medicinal products were given intravenously on day 1 every three weeks.
• Den overordnede responsrate (ORR) var signifikant højere i AT-armen end i AC-armen, p = 0,009. 
• Overall response rate (ORR) was significantly higher in the AT arm versus AC arm, p = 0.009.
• Ved ethvert efterfølgende tegn på toksicitet eller grad 4-toksiciteter seponeres docetaxelbehandlingen. 
• For any subsequent appearances of toxicities, or any Grade 4 toxicities, discontinue the docetaxel dose.
Toksisk dødsfald forekom hos 1 patient i AT-armen (kongestivt hjertesvigt) og hos 4 patienter i AC-armen (1 på grund af septisk shock og 3 på grund af kongestivt hjertesvigt). 
Toxic deaths occurred in 1 patient in the AT arm (congestive heart failure) and in 4 patients in the AC arm (1 due to septic shock and 3 due to congestive heart failure).
Der er observeret lokaliseret erythem på ekstremiteterne (håndflader og fodsåler) med ødem efterfulgt af afskalning. 
Localised skin erythema of the extremities (palms of the hands and soles of the feet) with oedema followed by desquamation has been observed.
De patienter, der fik behandling med TPF, fik signifikant mindre forværring af deres globale helbredsscore i forhold til patienter i behandling med PF (p = 0,01, med anvendelse af EORTC QLQC30-skalaen). 
Patients treated with TPF experienced significantly less deterioration of their Global health score compared to those treated with PF (p = 0.01, using the EORTC QLQ-C30 scale).
Hætteglasset skal bruges umiddelbart efter åbning. 
Use the vial immediately after its opening.
Sygdomsfri overlevelse Hazard ratio* 
Disease free survival Hazard ratio*
Overordnet responsrate (CR+PR) (%) p-værdi 
Overall response rate (CR+PR) (%) p-value
Den endelige analyse blev udført, da alle patienter havde nået deres 10-års opfølgningsbesøg (medmindre de havde DFS eller udgik tidligere fra opfølgning). 
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).
Hvis det er nødvendigt at anvende en dosis på mere end 190 mg docetaxel, skal der anvendes en større mængde af infusionsopløsningen, så man ikke overstiger en koncentration på 0,74 mg docetaxel/ml. 
If a dose greater than 190 mg of docetaxel is required, use a larger volume of the infusion vehicle so that a concentration of 0.74 mg/ml docetaxel is not exceeded.
Hvis hætteglassene opbevares i køleskab, skal det nødvendige antal pakninger med Taxespira koncentrat til infusionsvæske, opløsning, stå ved under 25° C i 5 minutter før brug. 
If the vials are stored under refrigeration, allow the required number of boxes of Taxespira concentrate for solution for infusion to stand below 25°C for 5 minutes before use.
Blod og lymfesystem Sjælden: Blødningsepisoder forbundet med trombocytopeni grad 3/4. 
Blood and lymphatic system disorders Rare: bleeding episodes associated with grade 3/4 thrombocytopenia.
Kan være skadeligt for alkoholikere. 
Harmful for those suffering from alcoholism.
Forekomsten af følgende bivirkninger (alle grader): letargi, stomatitis, neutropenisk infektion var ≥ 10 % højere end hos de patienter, som var 65 år eller derover, end hos de yngre patienter. 
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.
De patienter, der blev behandlet i TCF-armen, havde længere tid indtil 5 % definitiv forværring af global helbredsstatus på QLQ-C30-spørgeskemaet (p = 0,0121) og en længere tid indtil definitiv forværring af Karnofskys performance status (p = 0,0088) sammenlignet med patienterne, som fik behandling med CF. 
Patients treated with TCF had a longer time to 5% definitive deterioration of global health status on the QLQ-C30 questionnaire (p = 0.0121) and a longer time to definitive worsening of Karnofsky performance status (p = 0.0088) compared to patients treated with CF.
3) i mere end 7 dage i løbet af en docetaxelbehandling, anbefales det at reducere dosis i de efterfølgende cyklusser eller at tage passende symptomatiske forholdsregler (se pkt. 
3 for seven days or more) during a course of docetaxel therapy, a reduction in dose for subsequent courses of therapy or the use of appropriate symptomatic measures are recommended (see section 4.2).
Alvorlige negleforandringer er karakteriseret ved hypo- eller hyperpigmentering og sommetider smerter og onykolyse. 
Severe nail disorders are characterised by hypo- or hyperpigmentation and sometimes pain and onycholysis.
D. BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL EN SIKKER OG EFFEKTIV ANVENDELSE AF 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
C-mærket docetaxel på tre kræftpatienter. 
C-docetaxel has been conducted in three cancer patients.
Stråling blev udført med megavolt-udstyr med én fraktionering dagligt (2 Gy pr. dag, 5 dage om ugen i 7 uger, dosis i alt 70-72 Gy). 
Radiation was delivered with megavoltage equipment using once daily fractionation (2 Gy per day, 5 days per week for 7 weeks, for a total dose of 70-72 Gy).
Docetaxel er et antineoplastisk stof, som virker ved at fremme polymerisering af tubulin til stabile mikrotubuli og hæmme depolymerisering af mikrotubuli til tubulin, hvilket medfører et udtalt fald i koncentrationen af frit tubulin. 
Docetaxel is an antineoplastic agent which acts by promoting the assembly of tubulin into stable microtubules and inhibits their disassembly which leads to a marked decrease of free tubulin.
Med en hazard ratio på under 1 kan docetaxel + cisplatin + fluorouracil anvendes med fordel *ikke-justeret log-rank-test **ikke-justeret log-rank-test, ikke justeret for multiple sammenligninger ***Chi-kvadrat-test, ikke justeret for multiple sammenligninger NA - not applicable (ikke relevant) 
A hazard ratio of less than 1 favours docetaxel + cisplatin + fluorouracil *un-adjusted log-rank test **un-adjusted log-rank test, not adjusted for multiple comparisons ***Chi square test, not adjusted for multiple comparisons NA-not applicable
Mænd, som er i behandling med docetaxel, tilrådes derfor ikke at få børn under og op til 6 måneder efter behandling samt til at søge vejledning vedrørende opbevaring af sæd inden behandling. 
Therefore, men being treated with docetaxel 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
Vaskulære sygdomme Venøse tromboemboliske hændelser er rapporteret i sjældne tilfælde. 
Vascular disorders Venous thromboembolic events have rarely been reported.
Alle patienter i studiets docetaxel-arm fik profylaktisk antibiotika. 
All patients on the docetaxel-containing arm of the study received prophylactic antibiotics.
Reaktionerne var karakteriseret ved udslæt inklusive lokale udbrud, hovedsagelig på fødder og hænder (inklusive alvorligt hånd-/fodsyndrom), men også på arme, ansigt og thorax. 
Reactions were characterised by a rash including localised eruptions mainly on the feet and hands (including severe hand and foot syndrome), but also on the arms, face or thorax, and frequently associated with pruritus.
Prednisons virkning på farmakokinetikken for docetaxel administreret med standardpræmedicinering med prednison er undersøgt hos 42 patienter. 
The effect of prednisone on the pharmacokinetics of docetaxel administered with standard dexamethasone premedication has been studied in 42 patients.
Taxespira er ordineret af din læge til behandling af brystkræft, specielle former for lungekræft (ikkesmåcellet lungekræft), prostatakræft, mavekræft eller hoved- og halskræft: 
Taxespira has been prescribed by your doctor for the treatment of breast cancer, special forms of lung cancer (non-small cell lung cancer), prostate cancer, gastric cancer or head and neck cancer:
Skønt mulige in vivo-interaktioner mellem docetaxel og andre samtidigt administrerede lægemidler ikke er undersøgt formelt, har in vitrointeraktioner med kraftigt proteinbundne stoffer såsom erythromycin, diphenhydramin, propranolol, propafenon, phenytoin, salicylat, sulfamethoxazol og natriumvalproat ikke påvirket docetaxels proteinbinding. 
Although the possible in vivo interaction of docetaxel with concomitantly administered medicinal product has not been investigated formally, in vitro interactions with tightly protein-bound agents such as erythromycin, diphenhydramine, propranolol, propafenone, phenytoin, salicylate, sulfamethoxazole and sodium valproate did not affect protein binding of docetaxel.
Hvis du får akutte problemer med lungerne (feber, åndenød eller hoste), eller de bliver værre, skal du straks fortælle det til lægen, apotekspersonalet på hospitalet eller sundhedspersonalet. 
If you develop acute or worsening problems with your lungs (fever, shortness of breath or cough), please tell your doctor, hospital pharmacist or nurse immediately.
De anbefalede dosismodifikationer ved toksiciteter hos patienter, der er behandlet med docetaxel i kombination med cisplatin og 5-fluoruracil (5-FU): 
Recommended dose modifications for toxicities in patients treated with docetaxel in combination with cisplatin and 5-fluorouracil (5-FU):
Hvis du er mand, og du er i behandling med Taxespira, frarådes du at få børn under og op til 6 måneder efter behandlingen samt til at søge vejledning vedrørende opbevaring af sæd inden behandlingen, da docetaxel kan ændre mandens frugtbarhed. 
If you are a man being treated with Taxespira 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.
Docetaxels clearance var ikke påvirket hos patienter med let til moderat væskeretention, og der findes ingen data for clearancen hos patienter med svær væskeretention. 
Docetaxel clearance was not modified in patients with mild to moderate fluid retention and there are no data available in patients with severe fluid retention.