natgillin/translations-raw huggingface dataset:
G3/4 Forhøjet alkalisk fosfatase i blodet
G3/4 Blood alkaline phosphatase increased
Væskeretention er kumulativ i forekomst og sværhedsgrad (se pkt.
Fluid retention is cumulative in incidence and severity (see section 4.4).
Den anbefalede dosis af docetaxel er 75 mg/m2.
The recommended dose of docetaxel is 75 mg/m2.
• Betændelse i øjet eller øget tåreflåd
• inflammation of the eye or increased tearing of the eyes
Dehydrering og pulmonar ødem er sjældent rapporteret.
Dehydration and pulmonary oedema have rarely been reported.
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.
• Opstød fra maven inklusive kvalme, opkastning og diarré, forstoppelse
• stomach upsets including nausea, vomiting and diarrhoea, constipation
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.
For flere detaljer, se produktresumé for trastuzumab.
For more details see summary of product characteristics of trastuzumab.
2-års overlevelse (%)
2 year Survival (%)
Undergruppe
Subgroups
Milde til moderate neurosensoriske symptomer er karakteriseret ved paræstesi, dysæstesi eller smerter inklusive brændende fornemmelser.
Mild to moderate neuro-sensory signs are characterised by paraesthesia, dysesthesia or pain including burning.
TAC = docetaxel, doxorubicin og cyclophosphamid FAC = 5-fluoruracil, doxorubicin and cyclophosphamid CI = Konfidensinterval; ER = østrogenreceptor PR = progesteronreceptor a
TAC = docetaxel, doxorubicin and cyclophosphamide FAC = 5-fluorouracil, doxorubicin and cyclophosphamide CI = confidence interval
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-fluoruracil 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.
Kun til engangsbrug.
Single-use vial.
Hos patienter, som får kompliceret neutropeni (forlænget neutropeni, febril neutropeni eller infektion), bør G-CSF og dosisreduktion overvejes (se pkt.
For patients who experience complicated neutropenia (prolonged neutropenia, febrile neutropenia or infection), G-CSF and dose reduction should be considered (see section 4.2).
Tilfælde af elektrolytforstyrrelser er rapporteret.
Cases of electrolyte imbalance have been reported.
Alvorlige reaktioner blev karakteriseret ved hypotension og/eller bronkospasmer eller generaliseret udslæt/erytem (se pkt.
Severe reactions were characterised by hypotension and/or bronchospasm or generalized rash/erythema (see section 4.4).
256 patienter blev randomiseret til behandling med docetaxel alene (100 mg/ m2 som 1 times intravøs infusion hver 3. uge).
256 patients were randomised to treatment with docetaxel alone (100 mg/m2 as a 1 hour intravenous infusion every 3 weeks).
Adjuverende stråleterapi blev givet i henhold til eksisterende vejledninger på de deltagende centre og blev givet til 69 % af patienterne, som fik TAC, og 72 % af patienterne som fik FAC.
Adjuvant radiation therapy was prescribed according to guidelines in place at participating institutions and was given to 69% of patients who received TAC and 72% of patients who received FAC.
Der er rapporteret tilfælde af hyponatriæmi, typisk forbundet med dehydrering, opkastning og pneumoni.
Cases of hyponatraemia have been reported, mostly associated with dehydration, vomiting and pneumonia.
• Træthed eller influenza-lignende symptomer
• tiredness; or flu-like symptoms
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).
Undergrupper af TAC-behandlede patienter efter prospektivt definerede betydningsfulde prognostiske faktorer blev analyseret i den primære analyse (ved median opfølgningsperiode på 77 måneder) (se tabel nedenfor):
TAC-treated patient subsets according to prospectively defined major prognostic factors were analysed in the primary analysis (at the median follow-up time of 77 months) (see table below):
Der er gennemført en undersøgelse med 14C-mærket docetaxel på 3 kræftpatienter.
A study of 14C-docetaxel has been conducted in three cancer patients.
Adjuverende strålebehandling blev administreret i henhold til guidelines på de deltagende behandlingssteder og blev givet til 57,3 % af de patienter, der fik TAC, og til 51,2 % af de patienter, der fik FAC.
Adjuvant radiation therapy was administered according to guidelines in place at participating institutions and was given to 57.3% of patients who received TAC and 51.2% of patients who received FAC.
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.
Overfølsomhed (ikke alvorlig)
Hypersensitivity (no severe)
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 time point, and 91.3 % in the TAC arm and 89 % in the FAC arm, at the 10-year follow-up time point.
Hypokaliæmi, hypomagnesiæmi og hypocalcæmi er observeret, sædvanligvis i forbindelse med lidelser i mave-tarmkanalen og især med diarré.
Hypokalaemia, hypomagnesaemia, and hypocalcaemia were observed, usually in association with gastrointestinal disorders and in particular with diarrhoea.
For eksempel, en dosis på 140 mg docetaxel vil kræve 7 ml docetaxel koncentrat til infusionsvæske, opløsning.
For example, a dose of 140 mg docetaxel would require 7 ml docetaxel concentrate for solution.
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)
Patienter, der er kandidater til behandling med docetaxel i kombination med trastuzumab, bør få foretaget rutinemæssige hjerteundersøgelser.
When patients are candidates for treatment with docetaxel in combination with trastuzumab, they should undergo baseline cardiac assessment.
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 letal 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).
Hjertesvigtet kan være moderat til alvorligt og har været associeret med død (se pkt.
This may be moderate to severe and has been associated with death (see section 4.8).
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, ketoconazol og erythromycin.
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, ketoconazole and erythromycin.
Alle patienter uden forværret sygdom skulle ifølge protokollen modtage CRT (PF/CRT).
All patients who did not have progressive disease were to receive CRT as per protocol (PF/CRT).
I et farmakokinetisk studie med 7 patienter resulterede samtidig administration af docetaxel og den potente CYP3A4-hæmmer ketoconazol i et signifikant fald i docetaxel-clearance på 49 %.
In a pharmacokinetic study with 7 patients, the co-administration of docetaxel with the strong CYP3A4 inhibitor ketoconazole leads to a significant decrease in docetaxel clearance by
Docetaxel hver 3. uge
Docetaxel every 3 weeks
Patienter bør ikke genbehandles med efterfølgende cyklusser af docetaxel indtil neutrofil-antallet gendannes til et niveau > 1.500 celler/mm3 og blodplader gendannes til et niveau > 100.000 celler/mm3.
Patients should not be retreated with subsequent cycles of docetaxel until neutrophils recover to a level >1,500 cells/mm3 and platelets recover to a level >100,000 cells/mm3.
Docetaxels clearence 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.
Alopeci; Neglesygdomme (ikke alvorlig)
Alopecia; Nail disorders (no severe)
Mere end 1 hætteglas af DOCETAXEL KABI koncentrat til infusionsvæske, opløsning kan blive nødvendigt for at opnå den påkrævede dosis til patienten.
More than one vial of DOCETAXEL KABI concentrate for solution for infusion may be necessary to obtain the required dose for the patient.
Nervesystemet
Nervous system
Docetaxels kinetiske profil er dosis-uafhængig og i overensstemmelse med en 3compartment 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.
• Non-Hodgkin lymfom (en kræftform, som påvirker immunsystemet) og andre kræftformer kan forekomme hos patienter, der behandles med docetaxel sammen med visse andre behandlinger mod kræft.
• non-Hodgkin lymphoma (a cancer affecting the immune system) and other cancers may occur in patients who are treated with docetaxel together with certain other anticancer treatments.
Overlevelsen var bedre i kombinationsarmen med docetaxel + capecitabin (p = 0,0126).
Survival was superior in the docetaxel + capecitabine combination arm (p = 0.0126).
I kombination med trastuzumab er den anbefalede dosis af docetaxel 100 mg/m2 hver 3. uge med en ugentlig administration af trastuzumab.
In combination with trastuzumab the recommended dose of docetaxel is 100 mg/m2 every three weeks, with trastuzumab administered weekly.
I dette studie blev 501 patienter med lokalt fremskredent SCCHN og en WHO funktionsstatus på 0 eller 1, randomiseret i en af to arme.
In this study, 501 patients, with locally advanced SCCHN, and a WHO performance status of 0 or 1, were randomised to one of two arms.
NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Fresenius Kabi Deutschland GmbH
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Fresenius Kabi Deutschland GmbH
Post-menopausal * Hazard ratio (TAC/FAC) på mindre end 1 indikerer, at der er en sammenhæng mellem TAC og en længere sygdoms-fri 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.
Statusskalaen for hoved- og hals underskalaer (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 favour of TPF as compared to PF.
Til behandling af patienter med lokalt fremskreden eller metastatisk brystkræft er den anbefalede dosis docetaxel i monoterapi 100 mg/m2.
For the treatment of patients with locally advanced or metastatic breast cancer, the recommended dose of docetaxel is 100 mg/m2 in monotherapy.
Efter endt kemoterapi, med et minimum interval på 4 uger og et maksimum interval på 7 uger, blev de patienter, hvis sygdom ikke forværredes, strålebehandlet (RT) i 7 uger i henhold til de fastlagte retningslinier (PF/RT).
At the end of chemotherapy, with a minimal interval of 4 weeks and a maximal interval of 7 weeks, patients whose disease did not progress received radiotherapy (RT) according to institutional guidelines for 7 weeks (PF/RT).
Efter administration af docetaxel 100 mg/m2 givet som infusion over 1 time, fandtes den gennemsnitlige maksimale plasmakoncentration at være 3,7 mg/ml med et AUC på 4,6 h.μg/ml.
Following the administration of a 100 mg/m2 dose given as a one-hour infusion a mean peak plasma level of 3.7 μg/ml was obtained with a corresponding AUC of 4.6 h.μg/ml.
Patienter med operabel, lymfeknude-negativ brystkræft, egnet til behandling med kemoterapi (GEICAM 9805)
Patients with operable node-negative breast cancer eligible to receive chemotherapy (GEICAM 9805)
Effektresultaterne er vist i tabellen nedenfor:
Efficacy results are presented in the table below:
Forhøjet lakrimation
Lacrimation increased
Akut respiratorisk distress syndrom og tilfælde af interstitiel pneumoni/pneumonitis, interstitiel lungesygdom, lungefibrose og respirationssvigt, sommetider letale, er rapporteret sjældent.
Acute respiratory distress syndrome and cases of interstitial pneumonia/ pneumonitis, interstitial lung disease, pulmonary fibrosis and respiratory failure sometimes fatal have rarely been reported.
Tidligere behandling skal have omfattet et anthracyklin
Previous therapy should have included an anthracycline.
• 1.276 patienter (744 i TAX 316 og 532 i GEICAM 9805), som fik docetaxel i kombination med doxorubicin og cyclophosphamid (klinisk vigtige behandlingsrelaterede bivirkninger er nævnt).
• 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).
Hvis samtidig anvendelse af en potent CYP3A4-hæmmer (f.eks. ketoconazol, itraconazol, clarithromycin, indinavir, nefazodon, nelfinavir, ritonavir, saquinavir, telithromycin og voriconazol) ikke kan undgås, er tæt klinisk overvågning nødvendig, og justering af docetaxeldosis kan være hensigtsmæssig under behandling med potente CYP3A4-hæmmere (se pkt.
If the concomitant use of a strong CYP3A4 inhibitor (e.g., ketoconazole, itraconazole, clarithromycin, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin and voriconazole) cannot be avoided, a close clinical surveillance is warranted and a dose-adjustment of docetaxel may be suitable during the treatment with the strong CYP3A4 inhibitor (see section 4.4).
Kontakt straks lægen, hospitalsfarmaceuten eller sundhedspersonalet, hvis du oplever mavesmerter eller -ømhed, diaré, endetarmsblødning, blodig afførring eller feber.
Tell your doctor, hospital pharmacist, or nurse immediately if you have abdominal pain or tenderness, diarrhoea, rectal haemorrhage, blood in stool or fever.
Hos patienter i behandling med TAC-regimet for lymfeknude-positiv brystkræft har risikoen for CHF vist sig at være højere i det første år efter behandling (se pkt.
In patients treated with the TAC regimen for node positive breast cancer, the risk of CHF has been shown to be higher during the first year after treatment (see sections 4.8 and 5.1).
Medicinen hedder DOCETAXEL KABI.
The name of this medicine is DOCETAXEL KABI.
Begyndelsen af moderat og alvorlig retention var forsinket hos patienter (median kumulativ dosis: 818,9 mg/m2) med præmedicinering set i forhold til patienter uden præmedicinering (median kumulativ dosis: 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.
DOCETAXEL KABI må IKKE anvendes, hvis du er gravid eller planlægger at blive gravid, medmindre din læge udtrykkelig ønsker det.
DOCETAXEL KABI must NOT be administered if you are pregnant unless clearly indicated by your doctor.
• Docetaxel 30 mg/m2 administreret ugentlig i de første 5 uger i en 6 ugers behandlingsrunde i 5 behandlingsrunder.
• Docetaxel 30 mg/m2 administered weekly for the first 5 weeks in a 6 week cycle for 5 cycles.
Cisplatins farmakokinetiske profil, når det administreres kort efter infusion med docetaxel, er sammenlignelig med profilen for cisplatin, når det administreres alene.
The pharmacokinetic profile of cisplatin administered shortly after docetaxel infusion is similar to that observed with cisplatin alone.
De mest almindelige bivirkninger af DOCETAXEL KABI givet alene er: Fald i antallet af røde og hvide blodlegemer , hårtab, kvalme, opkastning, sår i munden, diarré og træthed.
The most commonly reported adverse reactions of DOCETAXEL KABI alone are: decrease in the number of red blood cells or white blood cells, alopecia, nausea, vomiting, sores in the mouth, diarrhoea and tiredness.
Disse cyklusser blev gentaget hver 3. uge i 3 cyklusser.
The cycles were repeated every 3 weeks for 3 cycles.
• Følelsesløshed eller stikkende og prikkende fornemmelse eller smerte i led eller muskler
• feeling of numbness or pins and needles or pain in the joints or muscles
I kombination med capecitabin
In combination with capecitabine
Docetaxel indgives som en 1-times infusion hver 3. uge.
Docetaxel is administered as a one-hour infusion every three weeks.
Efter den sidste cyklus af kemoterapi, fik patienter i begge arme, der havde positive østrogen- og/eller progesteronreceptorer tamoxifen 20 mg daglig i op til 5 år.
In both arms, after the last cycle of chemotherapy, patients with positive oestrogen and/or progesterone receptors received tamoxifen 20 mg daily for up to 5 years.
Din læge bør straks igangsætte behandling.
Your doctor should address them immediately.
Hjertesvigt er observeret hos patienter, som fik docetaxel i kombination med trastuzumab, specielt efter kemoterapi med anthracyclin (doxorubicin eller epirubicin).
Heart failure has been observed in patients receiving docetaxel in combination with trastuzumab, particularly following anthracycline (doxorubicin or epirubicin)-containing chemotherapy.
Der findes ingen data på administration af docetaxel til gravide.
There is no information on the use of docetaxel in pregnant women.
MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Yderkarton
PARTICULARS TO APPEAR ON OUTER PACKAGING OUTER CARTON
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 (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).
Der var mindre brug af smertestillende morfika (p < 0,01), smertestillende ikke-morfika (p < 0,01), anden ikke-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.
Alvorligheden af bivirkningerne ved DOCETAXEL KABI kan forøges, når DOCETAXEL KABI gives i kombination med andre kemoterapeutiske lægemidler.
The severity of adverse events of DOCETAXEL KABI may be increased when DOCETAXEL KABI is given in combination with other chemotherapeutic agents.
docetaxel + trastuzumab var effektivt til patienterne, uanset om de havde fået adjuverende anthracyclin eller ikke.
Docetaxel plus trastuzumab was efficacious in patients whether or not they had received prior adjuvant anthracyclines.
Hvis DOCETAXEL KABI koncentrat eller infusionsvæske skulle komme på huden, så vask omgående og grundigt med sæbe og vand.
If DOCETAXEL KABI concentrate or infusion solution should come into contact with skin, wash immediately and thoroughly with soap and water.
Flere grad 3/4 bivirkninger blev observeret for DOCETAXEL KABI monoterapi (55,4 %) sammenlignet med paclitaxel (23,0 %).
More grade 3/4 adverse events were observed for docetaxel monotherapy (55.4%) compared to paclitaxel (23.0%).
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.
I studiet TAX 316 oplevede 26 patienter (3,5%) i TAC-armen og 17 patienter (2,3%) i FACarmen 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.
Docetaxel øgede responsraten (33 % mod 12 %, p < 0,0001), forlængede tiden til progression (19 uger mod 11 uger, p = 0,0004), samt forlængede overlevelsen (11 måneder mod 9 måneder, p = 0,01).
Docetaxel increased response rate (33% vs. 12%, p < 0.0001), prolonged time to progression (19 weeks vs. 11 weeks, p= 0.0004) and prolonged overall survival (11 months vs. 9 months, p= 0.01).
Den 1-årige overlevelsesrate var signifikant længere med docetaxel (40 %) end for bedste palliative behandling (16 %).
The 1-year survival rate was also significantly longer in docetaxel (40%) versus BSC (16%).
Vær særlig opmærksom på at informere din læge, hvis du får diarré, sår i munden, følelsesløshed, stikkende og prikkende fornemmelser eller feber, og giv lægen resultatet af dine blodprøver.
In particular, please inform your doctor in case of diarrhoea, sores in the mouth, feeling of numbness or pins and needles, fever and give her/him results of your blood tests.
Der er rapporteret om alvorlige symptomer såsom udslæt efterfulgt af afskalning, som har ført til afbrydelse eller ophør med docetaxel-behandlingen (se pkt.
Severe symptoms such as eruptions followed by desquamation which lead to interruption or discontinuation of docetaxel treatment were reported (see section 4.2).
I tidligere kemoterapi skal anthracyclin eller et alkylerende stof have været anvendt.
Previous chemotherapy should have included an anthracycline or an alkylating agent.
DOCETAXEL KABI i kombination med doxorubicin og cyclophosphamid er indiceret til adjuverende behandling af patienter med:
DOCETAXEL KABI in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with:
Fra et mikrobiologisk synspunkt skal rekonstituering/fortynding ske under kontrollerede og aseptiske forhold, og lægemidlet skal anvendes straks.
From a microbiological point of view, reconstitution/dilution must take place in controlled and aseptic conditions and the medicinal product should be used immediately.
Patienter med 4+lymfeknuder
Patients with 4+ nodes
Begge regimer blev indgivet på dag 1 hver 3. uge.
Both regimens were administered on day 1 every 3 weeks.
Adjuverende behandling til brystkræft
Adjuvant therapy for breast cancer