natgillin/translations-raw huggingface dataset:
• betændelse i øjet eller øget tåredannelse i øjnene
• inflammation of the eye or increased watering of the eyes
Docefrez er uforligelig med PVC-udstyr.
Docefrez is incompatible with PVC equipment or devices.
Brug ikke Docefrez:
Do not use Docefrez
De hyppigste bivirkninger ved Docefrez, når det gives alene, er et fald i antallet af røde blodlegemer eller hvide blodlegemer, hårmangel, kvalme, opkastning, sår i munden, diarré og træthed (alle meget almindelige).
The most frequent side effects of Docefrez, when given alone, are decrease in the number of red blood cells or white blood cells, alopecia, nausea, vomiting, sores in the mouth, diarrhoea and tiredness (all very common).
Fordelingen af fordele/ulemper blev ikke fuldt ud defineret hos patienter med 4 eller flere positive lymfeknuder på dette analysestadie.
The benefit/risk ratio was not defined fully in patients with 4 and more positive nodes at this analysis stage.
TTP-medianen var 37,3 uger (95 % CI: 33,4 - 42,1) i AT-armen og 31,9 uger (95 % CI: 27,4 - 36,0) i AC-armen.
The median TTP was 37.3 weeks (95%CI : 33.4 - 42.1) in AT arm and 31.9 weeks (95%CI : 27.4 - 36.0) in AC arm.
Hvis der opstår alvorlig neutropeni (< 500 celler/mm3) 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.
In the case of severe neutropenia (<500 cells/mm3 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).
• et enkeltdosis-solvenshætteglas med 1 ml solvens til Docefrez
• one single-dose solvent vial with 1 ml solvent for Docefrez
Docefrez må ikke anvendes, hvis du er gravid, med mindre din læge klart har anvist dette.
You must not use Docefrez if you are pregnant unless clearly indicated by your doctor.
Uden primær GCSFprofylakse (n = 111) n (%)
Without primary G-CSF prophylaxis (n = 111) n (%)
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 ciclosporine, terfenadine, ketoconazole, erythromycin and troleandomycin.
Du kan finde yderligere information om Docefrez på Det europæiske Lægemiddelagenturs (EMA) hjemmeside: http://www.ema.europa.eu
Detailed information on this product is available on the website of the European Medicines Agency (EMA): http://www.ema.europa.eu.
Den kombinerede administration af docetaxel, cisplatin og 5-fluorouracil hos 12 patienter med massive tumorer havde ingen indflydelse på farmakokinetikken for hvert af de individuelle lægemidler.
The combined administration of docetaxel, cisplatin and 5-fluorouracil in 12 patients with solid tumours had no influence on the pharmacokinetics of each individual medicinal product.
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.
• fornemmelse af følelsesløshed eller stikkende fornemmelse, smagsforstyrrelser (på grund af nervebeskadigelse)
• feeling of numbness or pins and needles, taste disturbances (due to nerve damage)
Ethanol Lægemidlet indeholder små mængder af ethanol (alkohol) på mindre end 100 mg pr. dosis.
Ethanol This medicinal product contains small amounts of ethanol (alcohol), less than 100 mg per dose.
Den mediane tid indtil progression var 186 dage (docetaxel + capecitabin) vs. 128 dage (docetaxel alene).
The median time to progression was 186 days (docetaxel + capecitabine) vs. 128 days (docetaxel alone).
Patienter, som får grad 3- eller 4-stomatitis, bør have deres dosis reduceret til 60 mg/m2.
Patients who experience Grade 3 or 4 stomatitis should have their dose decreased to 60 mg/m2.
Fordelingen af TACbehandlede patienter ifølge allerede definerede større prognostiske faktorer blev analyseret:
TAC-treated patient subsets according to prospectively defined major prognostic factors were analyzed:
Instruktioner vedrørende rekonstitution
Instructions for reconstitution
• træthed, smerte, influenza-lignende symptomer*
• tiredness, pain, flu-like symptoms*
• 332 patienter som fik docetaxel i kombination med prednison eller prednisolon (klinisk relevante behandlingsrelaterede bivirkninger er medtaget).
• 332 patients who received docetaxel in combination with prednisone or prednisolone (clinically important treatment related adverse events are presented).
I denne undersøgelse blev 358 patienter med inoperabelt, lokalt fremskreden SCCHN og WHO funktionsstatus 0 eller 1, randomiseret i en af to behandlingsarme.
In this study, 358 patients with inoperable locally advanced SCCHN, and WHO perfomance status 0 or 1, were randomized to one of two treatment arms.
Ved en median opfølgningtid på 77 måneder forekom akut leukæmi hos 1 ud af 532 (0,2%) patienter, som fik docetaxel, doxorubicin og cyclophosphamid i GEICAM 9805-forsøget.
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.
Effekten af docetaxel ved behandling af patienter med gastrisk adenocarcinom
Efficacy of docetaxel in the treatment of patients with gastric adenocarcinoma
Hvis du er en mand, der får behandling med Docefrez, anbefales det, at du ikke bliver far til et barn under behandlingen og op til 6 måneder efter den. Søg vejledning om konservering af sædceller før behandlingen, da docetaxel kan ændre den mandlige fertilitet.
If you are a man being treated with Docefrez 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.
Overfølsomhedsreaktioner er generelt forekommet inden for få minutter at infusionen af dicetaxel er begyndt og var i reglen 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.
4.2.5 Som alle andre parenterale præparater bør Docefrez-præmix-opløsning og infusionsvæske inspiceres visuelt inden brug, og opløsninger med udfældning skal kasseres.
4.2.5 As with all parenteral products, Docefrez reconstituted solution and solution for infusion should be visually inspected prior to use, solutions containing a precipitate should be discarded.
Blandt 300 patienter (221 patienter i fase III-delen af undersøgelsen og 79 patienter i fase II-delen af undersøgelsen), som fik behandling med docetaxel i kombination med cisplatin og 5-fluorouracil i undersøgelsen af gastrisk kræft, var 74 patienter 65 år eller ældre og 4 patienter var 75 år eller ældre.
Among the 300 (221 patients in the phase III part of the study and 79 patients in the phase II part) patients treated with docetaxel in combination with cisplatin and 5-fluorouracil in the gastric cancer study, 74 were 65 years of age or older and 4 patients were 75 years of age or older.
Der blev udført eksplorativ undergruppeanalyse af sygdomsfri overlevelse for patienter, der opfylder kriterierne for kemoterapi ifølge 2009 St. Gallen-kriterierne - (ITT population).
Exploratory subgroup analyses for disease-free survival for patients who meet the 2009 St. Gallen chemotherapy criteria - (ITT population) were performed and presented here
Polysorbat 80 og ethanol, vandfri
Solvent: Polysorbate 80 and ethanol, anhydrous
4.1.4 Fjern sprøjten og kanylen, og ryst grundigt, så pulveret opløses fuldstændigt.
4.1.4 Remove the syringe and needle and shake well for complete solubilisation of powder.
cyster og polypper)
(incl cysts and polyps)
†Stratificeret log rank test *Tærskel for statistisk signifikans =0,0175 **PSA: Prostata-Specific Antigen
Tumour response rate (%) 95% CI p-value* †Stratified log rank test *Threshold for statistical significance=0.0175 **PSA: Prostate-Specific Antigen
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.
Indgives intravenøst efter rekonstitution og fortynding.
Intravenous use, after reconstitution and dilution.
• rødmen og opsvulmen af håndfladerne eller fodsålerne, som kan få huden til at skalle af
• redness and swelling of the palms of your hands or soles of your feet which may cause skin to peel
• Den totale responshyppighed var signifikant højere i AT-armen i forhold til AC-armen, p = 0,009.
• Overall response rate (ORR) was significantly higher in the AT arm versus AC arm, p=0.009.
Antal patienter Median overlevelsestid (måneder)
Median survival (months)
Hvis der kræves en større dosis end 200 mg docetaxel, skal der bruges en større mængde af infusionsvæsken, så en koncentration på 0,74 mg/ml docetaxel ikke overstiges i den færdige infusionsopløsning.
If a dose greater than 200 mg docetaxel is required, a larger volume of the infusion vehicle should be used, so that a concentration of 0.74 mg/ml docetaxel is not exceeded in the final solution for infusion.
Docetaxel bør administreres med forsigtighed til patienter, som er i samtidig behandling med potente CYP3A4-hæmmere (f.eks. protease-hæmmere som ritonavir, azol antimykotika som ketokonazol eller itrakonazol).
Docetaxel should be administered with caution in patients concomitantly receiving potent CYP3A4 inhibitors (e.g. protease inhibitors like ritonavir, azole antifungals like ketoconazole or itraconazole).
Total responshyppighed var 59,3 % (95 % CI: 52,8 - 65,9) I AT armen i forhold til 46,5 % (95 % CI: 39,8 - 53,2) i AC armen.
The ORR was 59.3% (95%CI : 52.8 - 65.9) in AT arm versus 46.5% (95%CI : 39.8 - 53.2) in AC arm.
Det primære endepunkt i denne undersøgelse, progression-fri overlevelse (PFS), var signifikant længere i TPF-armen sammenlignet med PF-armen, p = 0,0042 (median PFS: 11,4 vs. 8,3 måneder respektivt) med en samlet median-opfølgningstid på 33,7 måneder.
The primary endpoint in this study, progression-free survival (PFS), was significantly longer in the TPF arm compared to the PF arm, p=0.0042 (median PFS: 11.4 vs. 8.3 months respectively) with an overall median follow up time of 33.7 months.
De anbefalede dosismodifikasjoner for gastrointestinal toksicitet hos patienter behandlet med docetaxel i kombination med cisplatin og 5-fluorouracil (5-FU):
Recommended dose modifications for toxicities in patients treated with docetaxel in combination with cisplatin and 5-fluorouracil (5-FU):
De mest almindeligt rapporterede bivirkninger med docetaxel var: neutropeni (som var reversibel og ikke kumulativ, median-dagen til nadir var 7 dage og median-varigheden af alvorlig neutropeni (< 500 celler/mm 3) var 7 dage), anæmi, alopeci, kvalme, opkastning, stomatitis, diarré og asteni.
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/mm3) was 7 days), anaemia, alopecia, nausea, vomiting, stomatitis, diarrhoea and asthenia.
Der er sjældne rapporter om akut respiratorisk åndedrætsbesvær, interstitial pneumoni og pulmonar fibrosis.
Acute respiratory distress syndrome, interstitial pneumonia and pulmonary fibrosis have rarely been reported.
Overlevelsen var bedre i kombinationsarmen med docetaxel + capecitabin (p = 0,0126).
Survival was superior in the docetaxel +capecitabine combination arm (p=0.0126).
Lokoregional behandling med stråling blev givet enten med en konventionel fraktion (1,8 Gy-2,0 Gy en gang daglig, 5 dage om ugen til en total dosis på 66 til 70 Gy), eller accelererede/hyperfraktionerede regimer af strålebehandling (to gange daglig, med et minimum interfraktion-interval på 6 timer, 5 dage pr. uge).
Locoregional therapy with radiation was delivered either with a conventional fraction (1.8 Gy-2.0 Gy once a day, 5 days per week for a total dose of 66 to 70 Gy), or accelerated/hyperfractionated regimens of radiation therapy (twice a day, with a minimum interfraction interval of 6 hours, 5 days per week).
Overlevelse i alt var også signifikant længere (p = 0,0201) til fordel for TCFarmen med en nedsættelse af risikoen for død på 22,7 %.
Overall survival was also significantly longer (p=0.0201) in favor of the TCF arm with a risk reduction of mortality of 22.7%.
Med primær GCSFprofylakse (n = 421) n (%)
With primary G-CSF prophylaxis (n = 421) n (%)
36 min. og 11,1 time.
11.1 h, respectively.
1 hætteglas med solvens
1 vial of solvent
Man bør anvende profylaktisk G-CSF for at nedsætte risikoen for hæmatologisk toksicitet (se også Dosisjustering under behandling).
Prophylactic G-CSF should be used to mitigate the risk of haematological toxicities (see also Dose adjustments during treatment).
Perifert ødem fortsatte under opfølgning hos 18 patienter ud af de 112 patienter med perifert ødem ved slutningen af kemoterapien i TAX 316-forsøget, mens lymfødem fortsatte hos 4 ud af 5 patienter med lymfødem ved slutningen af kemoterapien i GEICAM 9805-forsøget.
Peripheral oedema was observed to be ongoing during follow-up time in 18 patients out of the 112 patients with peripheral oedema at the end of the chemotherapy in study TAX 316, whereas lymphoedema was observed to be ongoing in 4 of the 5 patients with lymphoedema at the end of the chemotherapy in the study GEICAM 9805.
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/m2in all subsequent cycles
De hyppigst rapporterede symptomer er rødme, udslæt med eller uden pruritus, stramhed for brystet, rygsmerter, dyspnø og feber eller kuldegysninger.
The most frequently reported symptoms were flushing, rash with or without pruritus, chest tightness, back pain, dyspnoea and fever or chills.
Efter den sidste cyklus af kemoterapi, fik patienter i begge arme, der havde positive østrogen- og/eller progesteron receptorer tamoxifen 20 mg daglig 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.
Gennemsnitsværdierne for den totale clearence og steady-state distributionsvolumen var henholdsvis 21 l/h/m2 og 113 l. Den interindividuelle variation i totalclearance var ca. 50 %.
Mean values for total body clearance and steady-state volume of distribution were 21 l/h/m2 and 113 l, respectively.
Skønt mulige in vivo-interaktioner mellem docetaxel og anden samtidig administreret medicin ikke er undersøgt formelt, har in vitrointeraktions-studier med kraftigt proteinbundne stoffer såsom erythromycin, difenhydramin, propranolol, propafenon, fenytoin, 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.
Infektioner (G3/4:5,7 %; inklusive sepsis og pneumoni, fatal hos
Infections (G3/4;5.7%; including sepsis and pneumonia, fatal in
Den rekonstituerede opløsning indeholder ca. 24 mg/ml docetaxel, hvilket svarer til en udtagelig volumen på ca. 20 mg/0,84 ml og 80 mg/3,36 ml.
The reconstituted solution contains ~ 24 mg/ml docetaxel, corresponding with an extractable volume of approximately 20 mg/0.84 ml and 80 mg/3.36 ml.
I lymfeknudepositivforsøget (TAX 316) døde 1 patient i hver behandlingsarm af hjertesvigt.
In the node positive study (TAX316) one patient in each treatment arm died because of cardiac failure.
Docetaxel er et antineoplastisk stof, og som med andre potentielt cytotoksiske forbindelser skal der udvises forsigtighed ved tilberedning af docetaxelopløsninger.
Docetaxel is an antineosplastic agent and, as with other potentially cytotoxic compounds, caution should be exercised when preparing docetaxel solutions.
Docefrez må ikke anvendes efter den udløbsdato, der er anført på pakningen og hætteglassene.
Docefrez should not be used after the expiry date shown on the carton and vials.
TAC = docetaxel, doxorubicin og cyclophosphamid FAC = 5-fluoruracil, doxorubicin and cyclophosphamid CI = Konfidensinterval; ER = østrogenreceptor PR = progesteronreceptor a ER/PR-negativ eller grad 3 eller tumorstørrelse >5 cm
TAC = docetaxel, doxorubicin and cyclophosphamide FAC = 5-fluorouracil, doxorubicin and cyclophospamide CI = confidence interval; ER = estrogen receptor PR = progesterone receptor aER/PR-negative or Grade 3 or tumor size >5 cm
Det primære endepunkt for effektivitet i dette studie, overlevelse i alt (OS), var signifikant længere (logrank-test, p=0,0058) i det regime, der indeholdt docetaxel sammenlignet med PF (median OS: 70,6 mod 30,1 måneder, respektivt), med en 30 % nedsat risiko i mortalitet sammenlignet med PF (hazard ratio (HR) = 0,70; 95 % konfidensinterval (CI) = 0,54-0,90) med en samlet median opfølgningstid på 41,9 måneder.
The primary efficacy endpoint in this study, overall survival (OS) was significantly longer (log-rank test, p = 0.0058) with the docetaxelcontaining regimen compared to PF (median OS: 70.6 versus 30.1 months respectively), with a 30% risk reduction in mortality compared to PF (hazard ratio (HR) = 0.70, 95% confidence interval (CI) = 0.54-0.90) with an overall median follow up time of 41.9 months.
Disse reaktioner blev beskrevet under brug af NCI Common Toxicity Criteria (grad 3 = G3; grad 3-4 = G3/4; grad 4 = G4) og COSTART-termerne og MEdDRA-termerne.
These reactions were described using the NCI Common Toxicity Criteria (grade 3 = G3; grade 3-4 = G3/4; grade 4 = G4) and the COSTART terms and the MedDRA terms.
Statusskalaen for hoved- og halsunderskalaer (PSS-HN) var designet til at måle sprogforståelse, evnen til at indtage føde offentligt samt en normal kost.
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 favor of TPF as compared to PF.
Kongestivt hjertesvigt
Congestive heart failure
Primær G-CSF-profylakse bør overvejes til patienter, som får docetaxel-, doxorubicin- og cyclophosphamid- (TAC)-adjuverende behandling for brystkræft.
Primary G-CSF prophylaxis should be considered in patients who receive docetaxel, doxorubicin and cyclophosphamide (TAC)adjuvant therapy for breast cancer.
Sikkerheden og effekten af docetaxel i kombination med prednison eller prednisolon hos patienter med hormonrefraktær prostatakræft blev undersøgt i et randomiseret multicenter fase III-forsøg.
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.
TAC-behandlede patienter havde 32 % lavere risiko for tilbagefald sammenlignet med de patienter, der blev behandlet med FAC (hazard-ratio = 0,68; 95 % CI (0,49-0,93); p = 0,01).
TAC-treated patients had a 32% reduction in the risk of relapse compared to those treated with FAC (hazard ratio = 0.68, 95% CI (0.49-0.93), p = 0.01).
Hjælpestoffer: solvensen indeholder 35,4 % (w/w) ethanol.
Excipients: the solvent contains 35.4% (w/w) ethanol.
• Docetaxel 30 mg/m2 administreret ugentlig i de første 5 uger i en 6 ugers behandlingsrunde i
• Docetaxel 30 mg/m2 administered weekly for the first 5 weeks in a 6 week cycle for 5 cycles.
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.
Du må IKKE amme, mens du behandles med Docefrez.
You must not breast-feed while using Docefrez.
BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN
CONDITIONS OF THE MARKETING AUTHORISATION
Den rekonstituerede opløsning indeholder ca. 24 mg/ml docetaxel og skal bruges straks efter tilberedning.
The reconstituted solution contains approximately 24 mg/ml docetaxel and should be used immediately after preparation.
Med en hazard ratio < 1 kan docetaxel + cisplatin+5-FU anvendes med fordel *Cox model (tilpasning til primær tumor, T og N kliniske stadier og PSWHO) **Logrank test *** Chi-square-test
A hazard ratio of less than 1 favors Docetaxel +Cisplatin+5-FU *Cox model (adjustment for Primary tumour site, T and N clinical stages and PSWHO) **Logrank test *** Chi-square test
Kraftige reaktioner var karakteriseret ved hypotension og/eller astma eller generelt udslæt/erythem (se pkt.
Severe reactions were characterised by hypotension and/or bronchospasm or generalized rash/erythema (see section 4.4).
In vivo er docetaxels aktivitet uafhængig af behandlingsregimet 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.
Meget almindelig: hæmatologisk toksicitet var forhøjet hos de patienter, som modtog trastuzumab og docetaxel, i forhold til de patienter som fik behandling med docetaxel alene (32 % grad 3/4 neutropeni versus 22 %, under anvendelse af NCI-CTC kriterierne).
Very common: Haematological toxicity was increased in patients receiving trastuzumab and docetaxel, compared with docetaxel alone (32% grade 3/4 neutropenia versus 22%, using NCI-CTC criteria).
Tid indtil progressiv sygdom var længere i kombinationsarmen med Xeloda + docetaxel (p < 0,0001).
Time to progressive disease was superior in the docetaxel + capecitabine combination arm (p<0.0001).
Som førstebehandling indgives 75 mg/m2 docetaxel i kombinationsbehandling med doxorubicin (50 mg/m2).
In first-line treatment, docetaxel 75 mg/m2 is given in combination therapy with doxorubicin (50 mg/m2).
• 300 gastrisk adenocarcinoma-patienter (221 patienter i fase III-delen af undersøgelsen og 79 patienter i fase II-delen af undersøgelsen), som blev behandlet med docetaxel i kombination med cisplatin og 5-fluorouracil (klinisk vigtige behandlingsrelaterede bivirkninger er nævnt).
• 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).
BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL EN SIKKER OG
• CONDITIONS OF RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
4.4 og 4.8).
(see sections 4.4 and 4.8).
Der er rapporter om meget sjældne tilfælde af akut myeloid leukemi og myelodyplasisk syndrom, når docetaxel blev administreret i kombination med andre kemoterapeutiske stoffer og/eller radioterapi.
Very rare cases of acute myeloid leukaemia and myelodysplastic syndrome have been reported in association with docetaxel when used in combination with other chemoterapy agents and/or radiotherapy.
Docefrez i kombination med doxorubicin
Docetaxel in combination with doxorubicin