natgillin/translations-raw huggingface dataset:
Farmakoterapeutisk klassifikation: Taxaner, ATC-kode: L01CD 02 
Pharmacotherapeutic group: Taxanes, ATC Code: L01CD 02
Yderligere information om dette lægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/. 
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/.
Tilfælde af vedvarende alopeci er rapporteret. 
Cases of persisting alopecia have been reported.
Median overlevelsestid (måneder) 
Median survival (months)
Hvis du har yderligere spørgsmål om anvendelsen af denne medicin, så spørg din læge eller hosptialsfarmaceut. 
If you have any further questions on the use of this medicine, ask your doctor or hospital pharmacist.
Den samlede overlevelsesrate var 6,8 % i de evaluerbare patienter, og medianvarigheden for respons var 26,1 uge. 
The overall response rate was 6.8% in the evaluable patients, and the median duration of response was 26.1 weeks.
For flere detaljer se produktresumé for trastuzumab. 
For more details see Summary of Product Characteristics of trastuzumab.
Sekundære endepunkter inkluderede forandring i smerter, global rating af livskvalitet med EuroQoL5D, lungekræft-symptomskala, og forandringer i Karnofskys 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.
Din læge kan ændre dosis og dosisfrekvensen afhængig af dine blodprøver, din almene helbredstilstand og din reaktion på Docetaxel Teva Pharma. 
Your doctor may change the dose and frequency of dosing depending on your blood tests, your general condition and your response to Docetaxel Teva Pharma.
Akut leukæmi/myelodysplastisk syndrom 
Acute leukaemia / Myelodysplastic syndrome.
Den sene fase skyldes til dels den relativt langsomme redistribution af docetaxel fra perifere kompartments. 
The late phase is due, in part, to a relatively slow efflux of docetaxel from the peripheral compartment.
Yderligere forsigtighedsregler for anvendelse ved adjuverende behandling af brystkræft Kompliceret neutropeni 
Additional cautions for use in adjuvant treatment of breast cancer Complicated neutropenia
Ved kombination med docetaxel, var carboplatins clearance af carboplatin ca. 50 % højere end de værdier, der tidligere er rapporteret for carboplatin-monoterapi. 
When combined to docetaxel, the clearance of carboplatin was about 50% higher than values previously reported for carboplatin monotherapy.
Ændring af neglenes farve, som også kan løsne sig 
• change in the colour of your nails, which may detach
Spørg din læge eller apoteket til råds, før du tager nogen form for medicin. 
Ask your doctor for advice before being given any medicine.
Docetaxel må derfor ikke anvendes til gravide, medmindre det er tydeligt indiceret. 
Therefore, docetaxel must not be used during pregnancy unless clearly indicated.
†Stratificeret log rank test *Tærskel for statistisk signifikans =0,0175 **PSA: Prostata-Specific Antigen 
95% CI p-value* †Stratified log rank test *Threshold for statistical significance=0.0175 **PSA: Prostate-Specific Antigen
Computerweg 10 3542 DR Utrecht Nederlandene 
3542 DR Utrecht The Netherlands
Tør hud; Afskalning 
Dry skin; Desquamation
Bemærk, at dette sandsynligvis er underestimeret, da docetaxel alene ved en dosis på 100 mg/m er kendt for at resultere i neutropeni hos 97 % af patienterne, 76 % grad 4, baseret på laveste blodtælling. 
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.
Ved slutningen af follow-up perioden blev alopeci fortsat observeret hos 29 TAC-patienter (4,2%) og 16 FAC-patienter (2,4%) 
At the end of the follow-up period, alopecia was observed to be ongoing in 29 TAC patients (4.2%) and 16 FAC patients (2.4%).
Dette lægemiddel må ikke blandes med andre lægemidler end dem, der er anført under pkt. 
This medicinal product must not be mixed with other medicinal products except those mentioned in Section 6.6.
Myelodysplastisk syndrom blev rapporteret hos 2 ud af 744 TAC-patienter og hos 1 ud af 736 FAC-patienter. 
Myelodysplastic syndrome was reported in 2 of 744 TAC patients and in 1 of 736 FAC patients.
Reversibilitetsdata tilgængelige hos 35,3 % af de patienter, som udviklede neurotoksicitet efter docetaxelbehandling med 100 mg/m som enkelt stof. 
Reversibility data are available among 35.3% of patients who developed neurotoxicity following docetaxel treatment at 100 mg/m² as single agent.
Ikke anvendt lægemiddel samt affald heraf bør destrueres i overensstemmelse med lokale retningslinjer. 
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Patienter bør monitoreres for symptomer på kongestivt hjertesvigt under behandlingen og under follow-up-perioden. 
Patients should be monitored for symptoms of congestive heart failure during therapy and during the follow up period.
Der er rapporter om sjælden forekomst af dehydrering som en konsekvens af gastrointestinale lidelser, gastrointestinal perforation, iskæmisk colitis, colitis og neutropenisk enterocolitis. 
Rare occurrences of dehydration as a consequence of gastrointestinal events, gastrointestinal perforation, colitis ischaemic, colitis and neutropenic enterocolitis have been reported.
Febril neutropeni og neutropenisk infektion forekom respektivt hos 12,1 % og 3,4 % af patienterne, når patienterne modtog profylaktisk G-CSF, 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).
Der er rapporter om dissemineret intravaskulær koagulation (DIC), ofte i forbindelse med sepsis eller multiorgansvigt. 
Disseminated intravascular coagulation (DIC), often in association with sepsis or multiorgan failure, has been reported.
Det er påvist, at docetaxel er både embryo- og føtotoksisk hos kaniner og rotter, samt 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.
De farmakokinetiske parametre i modellen lå tæt på det, der blev observeret i fase I-studier. 
Pharmacokinetic parameters estimated by the model were very close to those estimated from Phase I studies.
Hvis patienten fortsætter med at få disse reaktioner ved 60 mg/m 
If the patient continues to experience these reactions at 60 mg/m², the treatment should be discontinued.
Derimod induceredes ingen mutationer 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.
G-CSF kan anvendes profylaktisk for at formindske risikoen for hæmatologisk toksicitet. 
Prophylactic G-CSF may be used to mitigate the risk of haematological toxicities.
Taget i betragtning 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.
Docetaxel fandtes ydermere at være aktivt over for nogle, men ikke alle cellelinjer, der udviste overekspression af pglycoprotein, hvis tilstedeværelse er bestemt af "multidrug resistance"-genet (MDR-genet). 
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.
Der er rapporteret om meget sjældne tilfælde af hepatitis, nogle gange fatale, hovedsageligt hos patienter med præeksisterende leversygdomme. 
Very rare cases of hepatitis, sometimes fatal primarily in patients with pre-existing liver disorders, have been reported.
Carcinogeniciteten af docetaxel er ikke undersøgt. 
The carcinogenic potential of docetaxel has not been studied.
Det er vigtigt at læse hele indholdet af denne vejledning inden fremstilling af enten Docetaxel Teva Pharma præmixopløsningen eller Docetaxel Teva Pharma infusionsvæske. 
It is important that you read the entire contents of this guide prior to the preparation of either the Docetaxel Teva Pharma premix solution or the Docetaxel Teva Pharma infusion solution
Uden primær G-CSF-profylakse (n = 111) n (%) 
Without primary G-CSF prophylaxis (n = 111) n (%)
Da fordelene hos patienter med 4+ lymfeknuder ikke var statistisk signifikante for sygdoms-fri overlevelse (DFS) og total overlevelse (OS), blev det positive fordel/risiko forhold for TAC-patienter med 4+ lymfeknuder ikke fuldt demonstreret i den endelige analyse. 
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).
Før hver behandling med Docetaxel Teva Pharma vil du få taget blodprøver for at få kontrolleret, om du har nok blodceller og den nødvendige leverfunktion til at få Docetaxel Teva Pharma. 
Before each treatment with Docetaxel Teva Pharma, you will have blood tests to check that you have enough blood cells and sufficient liver function to receive Docetaxel Teva Pharma.
Latvija UAB Sicor Biotech filiāle Latvijā 
Teva Eesti esindus UAB Sicor Biotech Eesti filiaal
Hazard ratio 95 % CI p-værdi†* 
Hazard ratio 95% CI p-value†*
Docetaxels kinetiske profil er dosis-uafhængig og i overensstemmelse med en 3kompartment farmakokinetisk model, med halveringstider for α-, β- og γ-faserne på henholdsvis 4 min., 36 min. og 11,1 time. 
The kinetic profile of docetaxel is dose independent and consistent with a three-compartment pharmacokinetic model with half lives for the α, β and γ phases of 4 min, 36 min and 11.1 h, respectively.
Et åbent multicenter randomiseret fase III-studie blev udført for at sammenligne docetaxel monoterapi 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.
Der blev ikke set nogen tilfælde hos patienter, der fik fluoruracil, doxorubicin og cyclofosfamid. 
No cases were reported in patients who received fluorouracil, doxorubicin and cyclophosphamide.
To patienter i TAC-armen og 4 patienter i FAC-armen døde hjertesvigt. 
Two patients in the TAC arm and 4 patients in the FAC arm died because of cardiac failure.
Der er observeret lokaliseret erytem 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.
Prednison eller prednisolon oralt 5 mg 2 gange daglig gives kontinuerligt (se pkt. 
Prednisone or prednisolone 5 mg orally twice daily is administered continuously (see section 5.1).
Koncentratet er en klar viskøs, gul til gulbrun opløsning. 
The concentrate is a clear viscous, yellow to brown-yellow solution.
Du må ikke blive gravid under behandling med denne medicin og skal bruge effektiv prævention under behandlingen, fordi Docetaxel Teva Pharma 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 Docetaxel Teva Pharma may be harmful for the unborn baby.
CYTOTOKSISK. 
CYTOTOXIC.
Prednisons virkning på farmakokinetikken for docetaxel administreret med standard dexamethasonpræmedicinering 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.
Overfølsomhedsreaktioner opstod generelt inden for få minutter efter starten af docetaxelinfusionen og reaktionerne var ofte milde til moderate. 
Hypersensitivity reactions have generally occurred within a few minutes following the start of the infusion of docetaxel and were usually mild to moderate.
3 patienter (2 %), der fik docetaxel, ophørte med behandlingen grundet væskeretention, hvorimod 15 patienter (9 %), der fik doxorubicin, stoppede behandlingen grundet hjertetoksicitet (3 tilfælde af fatal hjerteinsufficiens). 
Three docetaxel patients (2%) discontinued the treatment due to fluid retention, whereas 15 doxorubicin patients (9%) discontinued due to cardiac toxicity (three cases of fatal congestive heart failure).
Amenorré fortsatte under opfølgning hos 121 patienter ud af de 202 patienter med amenorré ved slutningen af kemoterapien i studiet TAX 316. 
Amenorrhoea was observed to be ongoing during follow-up in 121 patients out of the 202 patients with amenorrhoea at the end of the chemotherapy in study TAX316.
Docetaxel Teva Pharma vil blive administreret af personale med en sundhedsfaglig uddannelse. 
Docetaxel Teva Pharma will be administered to you by a healthcare professional.
In vitro-studier har vist, at docetaxels metabolisme kan ændres ved samtidig medicinering med stoffer, som inducerer, hæmmer eller metaboliseres (og således hæmmer enzymet kompetitivt) af cytochrom P450-3A, f.eks. ciclosporin, terfenadin, ketokonazol, erythromycin og troleandromycin. 
In vitro studies have shown that the metabolism of docetaxel may be modified by the concomitant administration of compounds which induce, inhibit or are metabolised by (and thus may inhibit the enzyme competitively) cytochrome P450-3A such as cyclosporine, terfenadine, ketoconazole, erythromycin and troleandomycin.
Reaktioner på infusionsstedet; Smerter 
Infusion site reaction; Pain
Behandlingsforskel: 7,1 % [95 % CI: 0,7; 13,5] *: rettet for multiple sammenligninger og justeret for stratification-faktorer (stadie af sygdommen og behandlingsregion), baseret på beregnelig 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.
Svære 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.
Mekanismen bag denne interaktion er ritonavirs hæmning af CYP3A4, der er det primære isoensym i metaboliseringen af docetaxel. 
The mechanism behind this interaction is a CYP3A4 inhibition, the main isoenzyme involved in docetaxel metabolism by ritonavir.
- Øvrige indholdsstoffer: Polysorbat 80 og 25,1 % (w/w) vandfri ethanol. 
- The other ingredients are polysorbate 80 and 25.1% (w/w) anhydrous ethanol.
Sikkerheden og effekten af docetaxel i kombination med prednison eller prednisolon hos patienter med hormonrefraktær metastatisk prostatakræft blev undersøgt i et randomiseret multicenter fase IIIstudie. 
The safety and efficacy of docetaxel in combination with prednisone or prednisolone in patients with hormone refractory metastatic prostate cancer were evaluated in a randomized multicenter Phase III study.
Docetaxels Teva Pharmas sikkerhed og virkning ved nasofaryngealt karcinom hos børn i alderen 1 måned til under 18 år er endnu ikke klarlagt. 
The safety and efficacy of Docetaxel Teva Pharma in nasopharyngeal carcinoma in children aged 1 month to less than 18 years have not yet been established.
Reaktionerne var karakteriseret ved udslæt inklusive lokale udbrud, hovedsagelig på fødder og hænder (inklusive svært hånd- og fodsyndrom), men også 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.
In vitro-forsøg har vist, at docetaxel ødelægger det mikrotubulære netværk i celler, som er essentielle for mitosen og cellulære funktioner i interfasen. 
Docetaxel has been shown in vitro to disrupt the microtubular network in cells which is essential for vital mitotic and interphase cellular functions.
Docetaxel Teva Pharma må ikke anvendes efter udløbsdatoen, som er anført på karton og hætteglas. 
Docetaxel Teva Pharma should not be used after the expiry date shown on the carton and vials.
I docetaxel - plus trastuzumabarmen havde 64 % modtaget en tidligere behandling med antracyklin som adjuverende behandling sammenlignet med 55 % i docetaxel-armen alene. 
In the docetaxel plus trastuzumab arm, 64% had received a prior anthracycline as adjuvant therapy compared with 55% in the docetaxel arm alone.
Hypotension; Hypertension; Hæmoragi 
Hypotension; Hypertension Haemorrhage
Forekomsten af de følgende bivirkninger (alle grader): letargi, stomatitis, neutropenisk infektion opstod ≥ 10 % oftere 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.
Neutropenisk infektion 
Neutropenic infection;
Fald i blodtrykket, uregelmæssig eller hurtig hjerterytme 
• decrease in blood pressure; irregular or rapid heart beat
I studiet TAX 316 oplevede 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.
Derimod kræver svære overfølsomhedsreaktioner såsom svær hypotension, bronkospasme eller generaliseret udslæt/erytem øjeblikkelig afbrydelse af docetaxelinfusion og passende terapi. 
However, severe reactions, such as severe hypotension, bronchospasm or generalised rash/erythema require immediate discontinuation of docetaxel and appropriate therapy.
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.
Symptomatisk hjertesvigt blev rapporteret hos 2,2 % af patienterne, som modtog docetaxel plus trastuzumab i forhold til 0 % af de patienter, som fik docetaxel alene. 
Symptomatic cardiac failure was reported in 2.2% of the patients who received docetaxel plus trastuzumab compared to 0% of patients given docetaxel alone.
Ikke almindelige (kan forekomme hos op til 1 ud af 100 patienter) 
Uncommon (may affect up to 1 in 100 people):
Docetaxel fandtes in vitro at være cytotoksisk over for forskellige murine og humane tumorcellelinjer samt over for humane tumorceller fra frisk udtagne humane tumorer i klonogene assays. 
Docetaxel was found to be cytotoxic in vitro against various murine and human tumour cell lines and against freshly excised human tumour cells in clonogenic assays.
Docetaxel Teva Pharma må IKKE anvendes, hvis du er gravid, medmindre det klart er anvist af din 
Docetaxel Teva Pharma must NOT be administered if you are pregnant unless clearly indicated by your doctor.
Docetaxel Teva Pharma er ordineret af din læge til behandling af fremskreden brystkræft, specielle former for lungekræft (ikke-småcellet lungekræft) og prostatakræft: - Ved behandling af fremskreden brystkræft kan Docetaxel Teva Pharma indgives alene. 
Docetaxel Teva Pharma has been prescribed by your doctor for the treatment of advanced breast cancer, special forms of lung cancer (non-small cell lung cancer) and prostate cancer: - For the treatment of advanced breast cancer, Docetaxel Teva Pharma could be administered alone.
I de 2 her nævnte fase III-studier viste docetaxel den samme sikkerhedsprofil, som tidligere blev set i fase II-studierne (se pkt. 
During these two phase III studies, the safety profile of docetaxel was consistent with the safety profile observed in phase II studies (see section 4.8).
Docetaxel Teva Pharma gives som infusion i en vene (intravenøs anvendelse). 
Docetaxel Teva Pharma will be given by infusion into one of your veins (intravenous use).
Tilfælde af tåresekretion med eller uden konjunktivitis, da der er sjældne rapporter om tilfælde af obstruktion af tårekanalerne, som resulterede i usædvanlig kraftigt tåreflod. 
Cases of lacrimation with or without conjunctivitis, as cases of lachrymal duct obstruction resulting in excessive tearing have been rarely reported.
Almene symptomer og reaktioner på administrationsstedet Den mediane kumulative dosis til behandlingsophør var mere end 1000 mg/m og mediantiden til reversibilitet af væskeretention var 16,4 uger (interval 0 til 42 uger). 
General disorders and administration site conditions The median cumulative dose to treatment discontinuation was more than 1,000 mg/m2 and the median time to fluid retention reversibility was 16.4 weeks (range 0 to 42 weeks).
Almene symptomer og reaktioner på administrationsstedet I studiet TAX 316 fortsatte perifert ødem hos 19 patienter ud af de 119 patienter med perifert ødem i TAC-armen og hos 4 patienter ud af de 23 patienter med perifert ødem i FAC-armen. 
General disorders and administration site conditions In study TAX316, peripheral oedema was observed to be ongoing in 19 patients out of the 119 patients with peripheral oedema in the TAC arm and 4 patients out of the 23 patients with peripheral oedema in the FAC arm.
Immunsystemet Der er rapporter om anafylaktisk shock, i nogle tilfælde fatale. 
Immune system disorders Some cases of anaphylactic shock, sometimes fatal, have been reported.
Efter 10 års follow-up i TAX 316-studiet blev akut leukæmi rapporteret hos 4 ud af 744 TACpatienter og hos 1 ud af 736 FAC-patienter. 
After 10 years of follow up in study TAX316, acute leukaemia was reported in 4 of 744 TAC patients and in 1 of 736 FAC patients.
Ældre personer 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 older people.
In vivo er docetaxels aktivitet uafhængig af behandlingsregimet og har eksperimentelt vist et bredt spektrum af antitumoraktivitet over for fremskredne 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.
Ved en median opfølgningtid på 77 måneder forekom akut leukæmi hos 1 ud af 532 (0,2 %) patienter, som fik docetaxel, doxorubicin og cyclofosfamid i GEICAM 9805-studiet. 
At a median follow-up time of 77 months, acute leukaemia occurred in 1 of 532 (0.2%) patients who received docetaxel, doxorubicin, and cyclophosphamide in the GEICAM 9805 study.
Hjerte Sjældne tilfælde af myokardieinfarkt er rapporteret. 
Cardiac disorders Rare cases of myocardial infarction have been reported.
I studiet TAX 316 blev alopecia, der persisterede ind i follow-up perioden efter endt kemoterapi, rapporteret hos hos 687 TAC-patienter og 645 FAC-patienter. 
In study TAX316, alopecia persisting into the follow-up period after the end of chemotherapy was reported in 687 TAC patients and 645 FAC patients.
Docetaxels clearance i kombinationsterapi med cisplatin var sammenlignelig med det observerede ved monoterapi. 
Clearance of docetaxel in combination therapy with cisplatin was similar to that observed following monotherapy.
Docetaxel har vist sig at være mutagent in vitro i mikronucleus- og kromosom-aberrationstesten i CHO-K1-celler, samt in vivo i mikronucleustesten i mus. 
Docetaxel has been shown to be mutagenic in the in vitro micronucleus and chromosome aberration test in CHO-K1 cells and in the in vivo micronucleus test in the mouse.