natgillin/translations-raw huggingface dataset:
Til prostatakræft er præmedicineringen oral dexamethason 8 mg 12 timer, 3 timer og 1 time før docetaxel-infusionen (se 4.2). 
For prostate cancer, the premedication is oral dexamethasone 8 mg, 12 hours, 3 hours and 1 hour before the docetaxel infusion (see section 4.2).
Patienter med operabel, lymfeknude-positiv brystkræft (TAX 316) Data fra et åbent, randomiseret multicenterstudie understøtter anvendelsen af den adjuverende behandling til patienter med operabel lymfeknude-positiv brystkræft og KPS ≥ 80 % i alderen 18 til 70 år. 
Patients with operable node-positive breast cancer (TAX 316) Data from a multicenter open label randomized study support the use of docetaxel for the adjuvant treatment of patients with operable node-positive breast cancer and KPS ≥80%, between 18 and 70 years of age.
Taxespira indeholder: 
What Taxespira contains
Undergruppeanalyser - adjuverende behandling hos patienter med lymfeknude-negativ brystkræft (intent-to-treat-analyse) 
Subset analyses-adjuvant therapy in patients with node-negative breast cancer study (intent-to-treat analysis)
Begyndelsen af moderat og alvorlig retention var forsinket hos patienter (kumulativ mediandosis: 818,9 mg/m 2) med præmedicinering sammenlignet med patienter uden præmedicinering (kumulativ mediandosis: 489,7 mg/m2). 
The onset of moderate and severe retention is delayed (median cumulative dose: 818.9 mg/m2) in patients with premedication compared with patients without premedication (median cumulative dose: 489.7 mg/m2); however, it has been reported in some patients during the early courses of therapy.
Bivirkningerne af docetaxel kan blive mere alvorlige, når docetaxel gives i kombination med andre kemoterapeutiske midler. 
The severity of adverse events of docetaxel may be increased when docetaxel is given in combination with other chemotherapeutic agents.
Et stort, randomiseret fase III-studie med 429 tidligere ubehandlede patienter med metastatisk sygdom er blevet udført med doxorubicin (50 mg/m²) i kombination med docetaxel (75 mg/²) (AT-arm) vs. doxorubicin (60 mg/m²) i kombination med cyclophosphamid (600 mg/m²) (AC-arm). 
One large randomized phase III study, involving 429 previously untreated patients with metastatic disease, has been performed with doxorubicin (50 mg/m²) in combination with docetaxel (75 mg/m²) (AT arm) versus doxorubicin (60 mg/m²) in combination with cyclophosphamide (600 mg/m²) (AC arm).
I studiet TAX 316 fik 26 patienter (3,5 %) i TAC-armen og 17 patienter (2,3 %) i FAC-armen kongestivt hjertesvigt. 
In study TAX316, 26 patients (3.5%) in the TAC arm and 17 patients (2.3%) in the FAC arm experienced congestive heart failure.
Efter den sidste cyklus af kemoterapi fik patienter i begge arme, der havde positive østrogen- og/eller progesteronreceptorer, tamoxifen 20 mg dagligt i op til 5 år. 
In both arms, after the last cycle of chemotherapy, patients with positive estrogen and/or progesterone receptors received tamoxifen 20 mg daily for up to 5 years.
Begge regimener blev administreret på dag 1 hver 3. uge. 
Both regimens were administered on day 1 every 3 weeks.
Begge regimener blev administreret hver 3. uge. 
Both regimens were administered every 3 weeks.
• 1.276 patienter (744 og 532 i henholdsvis TAX 316 og GEICAM 9805), som fik docetaxel i kombination med doxorubicin og cyclophosphamid (klinisk relevante behandlingsrelaterede 
• 1,276 patients (744 and 532 in TAX 316 and GEICAM 9805 respectively) who received docetaxel in combination with doxorubicin and cyclophosphamide (clinically important treatment related adverse events are presented).
Der foreligger ingen data for patienter med nedsat leverfunktion, der får kombinationsbehandling med docetaxel i de andre indikationer. 
No data are available in patients with hepatic impairment treated by docetaxel in combination in the other indications.
Til patienter, som i SCCHN pivotalstudiet udviklede kompliceret neutropeni (inklusive prolongeret neutropeni, febril neutropeni eller infektion), blev G-CSF anbefalet som profylakse (f.eks. dag 6-15) i alle efterfølgende cyklusser. 
In the pivotal SCCHN studies patients who experienced complicated neutropenia (including prolonged neutropenia, febrile neutropenia, or infection), it was recommended to use G-CSF to provide prophylactic coverage (e.g., day 6-15) in all subsequent cycles.
Da fordelene hos patienter med 4+ lymfeknuder ikke var statistisk signifikante for sygdomsfri overlevelse (DFS) og total overlevelse (OS), blev det positive fordels-/risikoforhold for TAC-patienter med 4+ lymfeknuder ikke fuldt demonstreret i den endelige analyse (se pkt. 
As the benefit observed in patient with 4+ nodes was not statistically significant on disease-free survival (DFS) and overall survival (OS), the positive benefit/risk ratio for TAC in patients with 4+ nodes was not fully demonstrated at the final analysis (see section 5.1).
Almene symptomer og reaktioner på administrationsstedet Undersøgelser 
General disorders and administration site conditions Investigations
Der var mindre brug af smertestillende morfika (p < 0,01), smertestillende ikke-morfika (p < 0,01), anden sygdomsrelateret medicin (p = 0,06) og strålebehandling (p < 0,01) hos de patienter, der fik behandling med docetaxel ved doseringen 75 mg/m² end hos patienterne, der fik bedste palliative behandling. 
There was less use of morphinic analgesic (p <0.01), non-morphinic analgesics (p <0.01), other disease-related medicinal products (p = 0.06) and radiotherapy (p <0.01) in patients treated with docetaxel at 75 mg/m² compared to those with BSC.
Hjertesvigt er observeret hos patienter, som fik docetaxel i kombination med trastuzumab, specielt efter kemoterapi med anthracyklin (doxorubicin eller epirubicin). 
Heart failure has been observed in patients receiving docetaxel in combination with trastuzumab, particularly following anthracycline (doxorubicin or epirubicin)-containing chemotherapy.
In vivo er docetaxels aktivitet uafhængig af behandlingsregimenet og har eksperimentelt vist et bredt spektrum af antineoplastisk aktivitet over for murine og transplanterede humane tumorer. 
In vivo, docetaxel is schedule independent and has a broad spectrum of experimental antitumour activity against advanced murine and human grafted tumours.
På grund af risikoen for skadelige påvirkninger af barnet skal amning derfor ophøre under behandling med docetaxel. 
Consequently, because of the potential for adverse reactions in nursing infants, breast feeding must be discontinued for the duration of docetaxel therapy.
Der kan også opstå betændelse i lungerne, når behandling med docetaxel bruges sammen med strålebehandling 
Inflammation of the lungs can also develop when docetaxel therapy is used with radiotherapy)
Taxespira i kombination med doxorubicin 
Taxespira in combination with doxorubicin
Begge regimener blev administreret én gang hver 3. uge i 6 cyklusser. 
Both regimens were administered once every 3 weeks for 6 cycles.
Uden at påvirke overlevelsestiden (docetaxel 15 måneder vs. doxorubicin 14 måneder, p = 0,38) eller tiden indtil progression (docetaxel 27 uger vs. doxorubicin 23 uger, p = 0,54) øgede docetaxel responsraten (52 % vs. 37 %, p = 0,01) og gav hurtigere respons (12 uger vs. 23 uger, p = 0,007). 
Without affecting OS time (docetaxel 15 months vs. doxorubicin 14 months, p = 0.38) or time to progression (docetaxel 27 weeks vs. doxorubicin 23 weeks, p = 0.54), docetaxel increased response rate (52% vs. 37%, p = 0.01) and shortened time to response (12 weeks vs. 23 weeks, p = 0.007).
Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med Taxespira i alle undergrupper af den pædiatriske population ved brystkræft, ikke-småcellet lungekræft, prostatakræft, gastrisk adenokarcinom og hoved- og halskræft med undtagelse af type II og type III lavt differentieret nasofaryngealt karcinom (se pkt. 
The European Medicines Agency has waived the obligation to submit the results of studies with Taxespira in all subsets of the paediatric population in breast cancer, non-small cell lung cancer, prostate cancer, gastric carcinoma and head and neck cancer, not including type II and III less differentiated nasopharyngeal carcinoma (see section 4.2 for information on paediatric use).
Fra et mikrobiologisk synspunkt skal rekonstitution/fortynding foretages under kontrollerede og aseptiske forhold, og lægemidlet bør anvendes umiddelbart herefter. 
From a microbiological point of view, reconstitution/dilution must take place in controlled and aseptic conditions and the medicinal product should be used immediately.
Lægemidlet skal bruges, straks efter at det er tilsat i infusionsposen. 
Use immediately the medicine once added into the infusion bag.
• hævelse på grund af mangelfuld drænage af lymfe 
• swelling caused by faulty lymphatic drainage
For kombinationer med capecitabin vises de mest almindelige behandlingsrelaterede bivirkninger (≥ 5 %), som blev rapporteret i et fase III-studie med brystkræftpatienter, hvor anthracyclinbehandling ikke havde haft effekt (se produktresuméet for capecitabin). 
For combination with capecitabine, the most frequent treatment-related undesirable effects (≥5%) reported in a phase III study in breast cancer patients failing anthracycline treatment are presented (see capecitabine summary of product characteristics).
Der er i sjældne tilfælde rapporteret tåreflåd med eller uden konjunktivitis som tilfælde af obstruktion af tårekanalerne, der resulterede i usædvanlig kraftigt tåreflåd. 
Cases of lacrimation with or without conjunctivitis, as cases of lacrimal duct obstruction resulting in excessive tearing have been rarely reported.
• Ved behandling af tidlig brystkræft med eller uden spredning til lymfeknuder kan Taxespira indgives i kombination med doxorubicin og cyclophosphamid. 
• For the treatment of early breast cancer with or without lymph node involvement, Taxespira could be administered in combination with doxorubicin and cyclophosphamide.
Hætteglas af klart glas (type I) med chlorobutyl-gummiprop og aluminiumsforsegling med vippelåg. 
Clear glass (type I) vial with a chlorobutyl rubber stopper and an aluminium seal with a flip-off cap.
Fra et mikrobiologisk synspunkt skal rekonstitution/fortynding foretages under kontrollerede og aseptiske forhold, og infusionsopløsningen bør anvendes umiddelbart herefter. 
From a microbiological point of view, reconstitution /dilution must take place in controlled and aseptic conditions and the infusion solution should be used immediately.
Patienter med svær væskeretention i form af pleuraekssudat og perikardieekssudat samt ascites skal observeres nøje. 
Patients with severe fluid retention such as pleural effusion, pericardial effusion and ascites should be monitored closely.
Taxespira i kombination med prednison eller prednisolon er indiceret til behandling af patienter med hormonrefraktær metastatisk prostatakræft. 
Taxespira in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer.
En opfølgende analyse af overlevelse efter en median opfølgningstid på 41,6 måneder viste ikke længere signifikant forskel, selv om TCF-regimenet altid gav bedre resultater. 
A survival update analysis conducted with a median follow-up time of 41.6 months no longer showed a statistically significant difference although always in favour of the TCF regimen and showed that the benefit of TCF over CF is clearly observed between 18 and 30 months of follow up.
Efter den anbefalede tilsætning til infusionsposen er docetaxel infusionsvæske, opløsning, stabil i 6 timer, hvis den opbevares ved temperaturer under 25 °C. 
Once added as recommended into the infusion bag, the docetaxel infusion solution, if stored below 25°C, is stable for 6 hours.
Taxespira koncentrat til infusionsvæske, opløsning, er en svagt gul til brun-gul opløsning i hætteglas. 
Taxespira concentrate for solution for infusion is a pale yellow to brownish-yellow solution provided in glass vials.
Som førstebehandling indgives 75 mg/m 2 doxetaxel i kombinationsbehandling med doxorubicin (50 mg/m 
In first-line treatment, docetaxel 75 mg/m is given in combination therapy with doxorubicin (50 mg/m
Blandt de patienter, der fik docetaxel hver tredje uge, var hyppigheden af relaterede negleforandringer ≥ 10 % højere i patientgruppen på 65 år og derover end i gruppen af yngre patienter. 
In patients treated with docetaxel every three weeks, the incidence of related nail changes occurred at a rate ≥ 10 % higher in patients who were 65 years of age or greater compared to younger patients.
• næseflåd, betændelse i hals og næse, hoste 
• nasal drainage; inflammation of the throat and nose; cough
Den fysiske og kemiske stabilitet efter åbning af infusionsopløsningen, der er tilberedt efter anbefalingerne, er påvist i poser uden indhold af PVC i op til 48 timer, når den opbevares ved mellem 2° C og 8° C. 
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°C to 8°C.
G-CSF blev administreret som sekundær profylakse til patienter, som fik kompliceret neutropeni (febril neutropeni, forlænget neutropeni eller infektion). 
G-CSF was administered as secondary prophylaxis to patients who experienced complicated neutropenia (febrile neutropenia, prolonged neutropenia, or infection).
Den nødvendige mængde Taxespira koncentrat til infusionsvæske, opløsning, skal via en enkelt injektion (et skud) injiceres i en 250 ml infusionspose eller -flaske indeholdende enten en 5 % glucoseinfusionsopløsning eller en 9 mg/ml (0,9 %) natriumchloridinfusionsopløsning. 
The required volume of Taxespira concentrate for solution for infusion must be injected via a single infusion (one shot) into a 250 ml infusion bag or bottle containing either 5% glucose solution or sodium chloride 9 mg/ml (0.9%) solution for infusion.
Ventrikulær arytmi inklusive ventrikulær takykardi (hyppighed ikke kendt), undertiden dødelig, er rapporteret hos patienter behandlet med docetaxel i kombinationsregimer, herunder doxorubicin, 5fluorouracil og/eller cyclofosfamid. 
Ventricular arrhythmia including ventricular tachycardia (frequency not known), sometimes fatal, has been reported in patients treated with docetaxel in combination regimens including doxorubicin, 5fluorouracil and/ or cyclophosphamide.
Som ved alle andre parenterale lægemidler skal infusionsopløsningen med docetaxel kontrolleres visuelt inden brug, og opløsninger med udfældning skal kasseres. 
As with all parenteral products, docetaxel infusion solution should be visually inspected prior to use, solutions containing a precipitate should be discarded.
Gennemsnitsværdierne for den totale clearence og steady state-distributionsvolumen var henholdsvis 21 l/h/m2 og 113 l. Den interindividuelle variation i samlet clearance var ca. 50 %. 
Mean values for total body clearance and steady-state volume of distribution were 21 l/h/m2 and 113 l, respectively.
Som ved alle andre parenterale lægemidler skal infusionsopløsningen kontrolleres visuelt inden brug, og opløsninger med udfældning skal kasseres. 
As with all parenteral products, infusion solution should be visually inspected prior to use, solutions containing a precipitate should be discarded.
Bivirkningerne af Taxespira kan blive mere alvorlige, når det gives i kombination med andre kemoterapeutiske midler. 
The severity of adverse events of Taxespira may be increased when Taxespira is given in combination with other chemotherapeutic agents.
Sådan skal du bruge Taxespira 4. 
How to store Taxespira 6.
445 patienter med KPS > 70 blev behandlet med enten docetaxel (T) (75 mg/m på dag 1) i kombination med cisplatin (C) (75 mg/m2 på dag 1) og 5-fluoruracil (F) (750 mg/m2 pr. 
A total of 445 patients with KPS >70 were treated with either docetaxel (T) (75 mg/m2 on day 1) in combination with cisplatin (C) (75 mg/m2 on day 1) and 5-fluorouracil (F)
Der er begrænsede tilgængelige data vedrørende anvendelse af docetaxel i kombination med doxorubicin og cyclophosphamid til patienter over 70 år. 
There are limited data available in patients >70 years of age on docetaxel use in combination with doxorubicin and cyclophosphamide.
Tabellen nedenfor viser, at hyppigheden af grad 4-neutropeni, febril neutropeni og neutropenisk infektion var lavere hos patienter, der fik G-CSF profylaktisk, efter det blev gjort obligatorisk i TACarmen i GEICAM-studiet. 
Table below shows that the incidence of Grade 4 neutropenia, febrile neutropenia and neutropenic infection was decreased in patients who received primary G-CSF prophylaxis after it was made mandatory in the TAC arm - GEICAM study.
For patienter, behandlet med docetaxel, doxorubicin og cyclophosphamid (TAC), kræver risikoen for forsinket myelodysplasi eller myolid leukæmi hæmatologisk opfølgning. 
In the docetaxel, doxorubicin and cyclophosphamide (TAC) treated patients, the risk of delayed myelodysplasia or myeloid leukaemia requires haematological follow-up.
Antal positive lymfeknuder I alt 
No of positive nodes Overall
449 patienter blev randomiseret til enten at få monoterapi med docetaxel 100 mg/m² givet som 1 times infusion eller paclitaxel 175 mg/m² givet som en infusion over 3 timer. 
A total of 449 patients were randomized to receive either docetaxel monotherapy 100 mg/m² as a 1 hour infusion or paclitaxel 175 mg/m² as a 3 hour infusion.
Meget almindelige (kan forekomme hos mere end 1 ud af 10 patienter): 
Very common (may affect more than 1 in 10 people):
• Ved behandling af fremskreden brystkræft kan Taxespira enten indgives alene eller i kombination med doxorubicin, trastuzumab eller capecitabin. 
• For the treatment of advanced breast cancer, Taxespira could be administered either alone or in combination with doxorubicin, or trastuzumab, or capecitabine.
• 300 patienter med gastrisk adenokarcinom (221 patienter i studiets fase III-del og 79 patienter i fase II-delen), som fik docetaxel i kombination med cisplatin og 5-fluorouracil (klinisk relevante behandlingsrelaterede bivirkninger er medtaget). 
• 300 gastric adenocarcinoma patients (221 patients in the phase III part of the study and 79 patients in the phase II part) who received docetaxel in combination with cisplatin and 5-fluorouracil (clinically important treatment related adverse events are presented).
Desuden er den fysiske og kemiske stabilitet efter åbning af infusionsopløsningen, der er tilberedt med natriumchlorid 9 mg/ml (0,9 %) eller 5 % glucoseopløsning i poser uden indhold af PVC eller med 5 % glucose i glasflasker, påvist i op til 48 timer, når den opbevares ved mellem 2° C og 8° C og i op til 6 timer ved opbevaring under 25 °C. 
In addition, physical and chemical in-use stability of the infusion solution prepared with sodium chloride 9 mg/ml (0.9%) or 5% glucose infused solution in non-PVC bags or with 5% glucose in glass bottles has been demonstrated for up to 48 hours when stored between 2°C to 8°C and for up to
Der var en øget forekomst af meget alvorlige bivirkninger (40 % mod 31 %) og grad 4 alvorlige bivirkninger (34 % mod 23 %) i kombinationsarmen trastuzumab sammenlignet med docetaxel som monoterapi. 
There was an increased incidence of SAEs (40% vs. 31%) and Grade 4 AEs (34% vs. 23%) in the trastuzumab combination arm compared to docetaxel monotherapy.
Almene symptomer og reaktioner på administrationsstedet Der er sjældne rapporter om radiation recall-fænomen. 
General disorders and administration site conditions Radiation recall phenomena have rarely been reported.
10, DATO FOR ÆNDRING AF TEKSTEN Yderligere information om dette lægemiddel findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu 
Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Infektion forbundet med G4-neutropeni (G3/4: 4,6 %) 
Infection associated with G4 neutropenia (G3/4: 4.6%)
Effektresultaterne vises i nedenstående tabel: 
Efficacy results are presented in the table below:
Med docetaxel er der rapporter om meget sjældne tilfælde af kutan lupus erythematosus og bulløst udslæt, såsom erythema multiforme, Stevens-Johnson syndrom og toksisk epidermal nekrolyse. 
Very rare cases of cutaneous lupus erythematosus and bullous eruptions such as erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, have been reported with docetaxel.
• 174 og 251 patienter med hoved- og halskræft, der fik docetaxel i kombination med cisplatin og 5-fluorouracil (klinisk relevante behandlingsrelaterede bivirkninger er medtaget). 
• 174 and 251 head and neck cancer patients who received docetaxel in combination with cisplatin and 5-fluorouracil (clinically important treatment related adverse events are presented).
Fase I-studier har undersøgt docetaxels farmakokinetiske egenskaber hos kræftpatienter efter indgift af 20-115 mg/m2. 
The pharmacokinetics of docetaxel have been evaluated in cancer patients after administration of 20-115 mg/m2 in phase I studies.
Evalueringen af effekt og sikkerhed blev foretaget udelukkende ud fra kriterier om overlevelse. 
The efficacy and safety evaluation solely addressed survival endpoints and the success of organ preservation was not formally addressed.
Tilfælde af cystoidt makulaødem (CMO) er blevet rapporteret hos patienter, der blev behandlet med docetaxel. 
Cases of cystoid macular oedema (CMO) have been reported in patients treated with docetaxel.
Et åbent, randomiseret fase III-multicenterstudie blev udført for at sammenligne monoterapi med docetaxel med paclitaxel i behandlingen af fremskreden brystkræft hos patienter, hvis tidligere behandling havde inkluderet et antracyklin. 
An open-label, multicenter, randomized phase III study was conducted to compare docetaxel monotherapy and paclitaxel in the treatment of advanced breast cancer in patients whose previous therapy should have included an anthracycline.
Almene symptomer og reaktioner på administrationsstedet Reaktionerne ved infusionsstedet var almindeligvis milde og bestod af hyperpigmentering, inflammation, rødmen eller tørhed i huden, flebitis eller blodudtrækninger og hævelse af venen. 
General disorders and administration site conditions Infusion site reactions were generally mild and consisted of hyper pigmentation, inflammation, redness or dryness of the skin, phlebitis or extravasation and swelling of the vein.
I nogle tilfælde (frekvens ikke kendt) er permanent hårtab blevet observeret 
In some cases (frequency not known)
Trombocytopeni (G3/4: 0,6 %); febril neutropeni 
Thrombocytopenia (G3/4: 0.6%); Febrile neutropenia
For patienter der ikke tidligere er behandlet med kemoterapi, der behandles for ikke-småcellet lungekræft, er den anbefalede dosis af docetaxel 75 mg/m2, straks efterfulgt af cisplatin 75 mg/m givet over 30-60 minutter. 
In chemotherapy naïve patients treated for non-small cell lung cancer, the recommended dose regimen is docetaxel 75 mg/m immediately followed by cisplatin 75 mg/m over 30-60 minutes.
Svimmelhed; hovedpine (G3/4: <1 %); perifer neuropati 
Dizziness; Headache (G3/4: <1%); Neuropathy peripheral
hos patienter med en initialdosis på 75 mg/m2 docetaxel i kombination med cisplatin, som har en minimumsblodpladeværdi under den tidligere behandlingsrunde på < 25000 celler/mm 
For patients who are dosed initially at docetaxel 75 mg/m2 in combination with cisplatin and whose nadir of platelet count during the previous course of therapy is <25,000 cells/mm
Patienter, som får febril neutropeni og/eller neutropenisk infektion, bør have deres docetaxel-dosis reduceret til 60 mg/m2 i alle efterfølgende cykler (se pkt. 
Patients who experience febrile neutropenia and/or neutropenic infection should have their docetaxel dose reduced to 60 mg/m2 in all subsequent cycles (see sections 4.4 and 4.8).
Samtidig administration af docetaxel, doxorubicin og cyclophosphamid påvirkede ikke deres farmakokinetik. 
The pharmacokinetics of docetaxel, doxorubicin and cyclophosphamide were not influenced by their co-administration.
Udtag aseptisk den ønskede mængde koncentrat til infusionsvæske, opløsning, med en kalibreret sprøjte påsat en 21G-kanyle. 
Aseptically withdraw the required amount of concentrate for solution for infusion with a calibrated syringe fitted with a 21G needle.