FrancophonIA/ELRC3.0 huggingface dataset:
English: In an exploratory subgroup analysis performed in the TOGA (BO18255) trial, there was no apparent benefit on overall survival with the addition of trastuzumab in patients with ECOG PS 2 at baseline [HR 0.96 (95% CI 0.51 - 1.79)], non-measurable [HR 1.78 (95% CI 0.87 - 3.66)] and locally advanced disease [HR 1.20 (95% CI 0.29 - 4.97)].
Danish: En eksploratorisk subgruppeanalyse udført i ToGA (BO18255) studiet viste, at der ikke var tydelig fordel for den samlede overlevelse ved at tilføje trastuzumab hos patienter med ECOG PS 2 ved baseline [hazard ratio 0,96 (95 % konfidensinterval 0,51 - 1,79)], med ikke målbar sygdom [hazard ratio 1,78 (95 % konfidensinterval 0,87 - 3,66)] eller lokalt fremskreden sygdom [hazard ratio 1,20 (95 % konfidensinterval 0,29 - 4,97)].
English: *Co-primary endpoint of DFS of 1 year versus observation met the pre-defined statistical boundary **Final analysis (including crossover of 52% of patients from the observation arm to trastuzumab) *** There is a discrepancy in the overall sample size due to a small number of patients who were randomised after the cut-off date for the 12-month median follow-up analysis
Danish: *Co-primæ re endepunkt for sygdomsfri overlevelse på 1 år versus observation overholdt de præ definerede statistiske græ nser ** Endelig analyse (inkluderende overgang af 52 % af patienterne fra observations-armen til trastuzumab)
English: A study conducted in lactating Cynomolgus monkeys at doses 25 times that of the weekly human maintenance dose of 2 mg/kg trastuzumab intravenous formulation demonstrated that trastuzumab is secreted in the milk.
Danish: Et studie udført på diegivende cynomolgusaber med doser, der er op til 25 gange højere end den humane ugentlige vedligeholdelsesdosis på 2 mg/kg intravenøst formuleret trastuzumab har vist, at trastuzumab udskilles i mæ lken.
English: One vial contains 420 mg of trastuzumab, a humanised IgG1 monoclonal antibody produced by mammalian (Chinese hamster ovary) cell suspension culture and purified by affinity and ion exchange chromatography including specific viral inactivation and removal procedures.
Danish: Et hæ tteglas indeholder 420 mg trastuzumab, et humaniseret IgG1 monoklonalt antistof, produceret af cellekultursuspension fra pattedyr (ovarie fra kinesisk hamster) og oprenset ved affinitets- og ionbytningskromatografi herunder specifikke virale inaktiverings- og oprensningsprocedurer.
English: Median survival (months) (95% CI)
Danish: Median overlevelse (måneder) (95 % konfidensinterval)
English: Comparison of trastuzumab PK data from Study M77004 in which women with HER2-positive MBC were treated concomitantly with trastuzumab, paclitaxel and doxorubicin to trastuzumab PK data in studies where trastuzumab was administered as monotherapy (H0649g) or in combination with anthracycline plus cyclophosphamide or paclitaxel (Study H0648g), suggested no effect of doxorubicin and paclitaxel on the pharmacokinetics of trastuzumab.
Danish: Sammenligning af trastuzumabs farmakokinetiske data fra studie M77004, hvor kvinder med HER2positiv metastatisk brystkræ ft blev behandlet samtidigt med trastuzumab, paclitaxel og doxorubicin, med trastuzumabs farmakokinetiske data i studier, hvor trastuzumab blev administreret som monoterapi (H0649g) eller i kombination med antracykliner plus cyclophosphamid eller paclitaxel (studie H0648g), tydede på, at doxorubicin og paclitaxel ikke påvirker trastuzumabs farmakokinetik.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Danish: Bivirkningerne præ senteres efter faldende alvorlighed inden for hver hyppighedsgruppering.
English: In the BCIRG 006 study for the primary endpoint, DFS, the hazard ratio translates into an absolute benefit, in terms of 3-year disease-free survival rate estimates of 5.8 percentage points (86.7% versus 80.9%) in favour of the AC→DH (trastuzumab) arm and 4.6 percentage points (85.5% versus 80.9%) in favour of the DCarbH (trastuzumab) arm compared to AC→D.
Danish: I BCIRG 006-studiet kan hazard ratio for det primæ re endepunkt, sygdomsfri overlevelse, overføres til en absolut gavnlig effekt udtrykt i en 3-års sygdomsfri estimeret overlevelse på 5,8 procentpoint (86,7 % versus 80,9 %) til fordel for AC→DH (trastuzumab)-armen og 4,6 procentpoint (85,5 % versus 80,9 %) til fordel for DCarbH (trastuzumab)-armen sammenlignet med AC→D.
English: Most patients who developed CHF or asymptomatic cardiac dysfunction in pivotal trials improved with standard CHF treatment consisting of an angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) and a beta-blocker.
Danish: De fleste patienter, som udviklede kongestiv hjerteinsufficiens eller asymptomatisk kardiel dysfunktion i de pivotale studier, opnåede en bedring med standardbehandling af kongestiv hjerteinsufficiens bestående af en ACE-hæ mmer eller angiotensin II receptor-antagonist og en betablokker.
English: The reconstituted Herzuma solution contains 21 mg/mL of trastuzumab.
Danish: Den rekonstituerede Herzuma-opløsning indeholder 21 mg/ml trastuzumab.
English:  Doxorubicin 60mg/m and paclitaxel 150 mg/m 2, administered 3-weekly for 3 cycles,
Danish: • Doxorubicin 60 mg/m og paclitaxel 150 mg/m administreret hver 3. uge i 3 serier,
English: In rare cases, a reduction in the amount of (amniotic) fluid that surrounds the developing baby within the womb has been observed in pregnant women receiving Herzuma.
Danish: I sjældne tilfæ lde er der hos gravide kvinder, der får Herzuma, blevet observeret en nedsat mæ ngde fostervand (den væ ske, der omgiver barnet i livmoderen).
English: The hazard ratio translates into an absolute benefit, in terms of 3-year disease-free survival rate estimates of 11.8 percentage points (87.2% versus 75.4%) in favour of the AC→PH (trastuzumab) arm.
Danish: Hazard ratio kan overføres til en absolut gavnlig effekt udtrykt i en 3-års sygdomsfri estimeret overlevelse på 11,8 procentpoint (87,2 % versus 75,4 %) til fordel for AC→PH (trastuzumab)-armen.
English: Comparison of PK results from two Phase II studies (BO15935 and M77004) and one Phase III study (H0648g) in which patients were treated concomitantly with trastuzumab and paclitaxel and two Phase II studies in which trastuzumab was administered as monotherapy (W016229 and MO16982), in women with HER2-positive MBC indicates that individual and mean trastuzumab trough serum concentrations varied within and across studies but there was no clear effect of the concomitant administration of paclitaxel on the pharmacokinetics of trastuzumab.
Danish: Sammenligning af farmakokinetiske resultater fra to fase II-studier (BO15935 og M77004) og et fase III-studie (H0648g), hvor patienter blev behandlet med trastuzumab og paclitaxel samtidigt, og 2 fase II-studier, hvor trastuzumab blev administeret som monoterapi (W016229 og MO16982) til kvinder med HER2-positiv metastatisk brystkræ ft, indikerer, at individuel og gennemsnitlig dalvæ rdi af trastuzumab-serumkoncentration varierede inden for og imellem studier.
English: Each vial contains 420 mg trastuzumab that has to be dissolved in 20 mL of water for injection.
Danish: Hvert hætteglas indeholder 420 mg trastuzumab, som skal opløses i 20 ml vand til injektionsvæ sker.
English: The recommended initial loading dose of Herzuma is 4 mg/kg body weight.
Danish: Den anbefalede initiale støddosis af Herzuma er 4 mg/kg legemsvæ gt.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION
Danish: LÆ GEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E)
English: Cmin,ss* (μg/mL)
Danish: Cmin,ss* (mikrogram/ml)
English: At 8 years, the disease-free survival rate was estimated to be 77.2% (95% CI: 75.4, 79.1) in the AC→PH arm, an absolute benefit of 11.8% compared with the AC→P arm.
Danish: Den sygdomsfrie overlevelsesrate blev efter 8 år estimeret til at væ re 77,2 % (95 % konfidensinterval: 75,4-79,1) i AC→PH armen, en absolut gavnlig effekt på 11,8 % sammenlignet med AC→P armen.
English: Data from a single-arm study JP16003 of trastuzumab (4 mg/kg intravenous loading dose and 2 mg/kg intravenous weekly) and docetaxel (60 mg/m intravenous) in Japanese women with HER2-positive MBC, suggested that concomitant administration of trastuzumab had no effect on the single dose pharmacokinetics of docetaxel.
Danish: Data fra et enkelt-arm-studie, JP16003, med trastuzumab (4 mg/kg intravenøs støddosis og 2 mg/kg intravenøst ugentligt) og docetaxel (60 mg/m intravenøst) hos japanske kvinder med HER2-positiv metastisk brystkræ ft, tydede på, at samtidig administration af trastuzumab ikke påvirkede docetaxels enkeltdosis-farmakokinetik.
English: A 50 mL clear glass type I vial with butyl rubber stopper containing 420 mg of trastuzumab.
Danish: Et 50 ml klart type I hæ tteglas med butylgummiprop, som indeholder 420 mg trastuzumab.
English: Herzuma is a powder for concentrate for solution for intravenous infusion, which is supplied in a glass vial with a rubber stopper containing 420 mg of trastuzumab.
Danish: Herzuma er et pulver til koncentrat til infusionsvæ ske, opløsning, som bliver leveret i et hæ tteglas med en gummiprop, og indeholder 420 mg trastuzumab.
English: The updated DFS analysis results (stratified HR = 0.61; 95% CI [0.54, 0.69]) showed a similar DFS benefit compared to the definitive primary DFS analysis, despite 24.8% patients in the AC→P arm who crossed over to receive trastuzumab.
Danish: Resultatet af den opdaterede analyse af sygdomsfri overlevelse (stratificeret hazard ratio = 0,61; 95 % konfidensinterval [0,54-0,69]) viste lignende gavnlig effekt med hensyn til sygdomsfri overlevelse sammenlignet med den endelige primæ re analyse af sygdomsfri overlevelse på trods af, at 24,8 % af patienterne i AC→P armen skiftede til at få trastuzumab.
English: Patients with MBC or MGC should be treated with Herzuma until progression of disease.
Danish: Patienter med metastatisk brystkræ ft eller metastatisk ventrikelkræ ft bør behandles med Herzuma, indtil sygdommen progredierer.
English: Cmax,ss** (μg/mL)
Danish: Cmax,ss** (mikrogram/ml)
English: In this final analysis, extending trastuzumab treatment for a duration of two years did not show additional benefit over treatment for 1 year [DFS HR in the intent to treat (ITT) population of 2 years versus 1 year=0.99 (95% CI: 0.87, 1.13), p-value=0.90 and OS HR=0.98 (0.83, 1.15); p-value=0.78].
Danish: I denne endelige analyse viste forlæ ngelse af trastuzumab-behandling til en varighed af 2 år ikke yderligere fordel over behandling i 1 år [Sygdomsfri overlevelse hazard ratio i intent-to-treat- (ITT) populaionen 2 år versus 1 år = 0,99 (95 % konfidensinterval: 0,87-1,13), p-væ rdi = 0,90 og samlet overlevelse hazard ratio = 0,98 (0,83-1,15); p-væ rdi = 0,78].
English: Excipients: L-histidine hydrochloride, L-histidine, polysorbate 20, α,α-trehalose dihydrate.
Danish: Hjæ lpestoffer: L-histidinhydrochlorid, L-histidin, polysorbat 20, -trehalosedihydrat.
English: Post-hoc exploratory analysis with DFS and symptomatic cardiac events Long term follow-up hazard ratios (95% CI)
Danish: Post-hoc eksplorativ analyse med sygdomsfri overlevelse og symptomatiske kardielle hæ ndelser læ ngerevarende opfølgning** hazard ratio 95 % konfidensinterval
English: How to use Herzuma
Danish: Sådan skal du bruge Herzuma
English: Early breast cancer (neoadjuvant-adjuvant setting)
Danish: Tidlig brystkræ ft (neoadjuverende-adjuverende behandling)
English: Causing excessive foaming during reconstitution or shaking the reconstituted solution may result in problems with the amount of Herzuma that can be withdrawn from the vial.
Danish: Stæ rk skumning under rekonstitutionen eller omrysten af den rekonstituerede opløsning kan medføre problemer med hensyn til den mæ ngde opløsning af Herzuma, der kan træ kkes ud af hæ tteglasset.
English: As a three-weekly regimen the recommended initial loading dose of Herzuma is 8 mg/kg body weight.
Danish: I et 3 ugers doseringsregime er den anbefalede initiale støddosis af Herzuma 8 mg/kg legemsvæ gt.
English: Linear clearance was 0.136 L/day for MBC, 0.112 L/day for EBC and 0.176 L/day for AGC.
Danish: Lineæ r clearance var 0,136 l/dag ved metastatisk brystkræ ft, 0,112 l/dag ved tidlig brystkræ ft og 0,176 l/dag ved fremskreden ventrikelkræ ft.
English: Patients experiencing dyspnoea at rest due to complications of advanced malignancy and comorbidities may be at increased risk of pulmonary events.
Danish: Patienter, som oplever hviledyspnø på grund af komplikationer fra avanceret malignitet og co-morbiditet, har muligvis forhøjet risiko for pulmonale hæ ndelser.
English: - intravenous 5-fluorouracil - 800 mg/m 2/day as a continuous intravenous infusion over 5 days, given every 3 weeks for 6 cycles (days 1 to 5 of each cycle)
Danish: - intravenøs 5-fluoruracil - 800 mg/m 2/dag som en kontinuerlig intravenøs-infusion over 5 dage, administreret hver 3. uge i 6 serier (dag 1 til 5 af hver serie)
English: In patients with EBC an increase in the incidence of symptomatic and asymptomatic cardiac events was observed when trastuzumab was administered after anthracycline-containing chemotherapy compared to administration with a non-anthracycline regimen of docetaxel and carboplatin and was more marked when trastuzumab was administered concurrently with taxanes than when administered sequentially to taxanes.
Danish: Hos patienter med tidlig brystkræ ft er der blevet observeret øget hyppighed af symptomatiske og asymptomatiske kardielle hæ ndelser, når trastuzumab blev administreret efter antracyklin-baseret kemoterapi sammenlignet med administration af et ikke-antracyklin-baseret regime med docetaxel og carboplatin.
English: The recommended weekly maintenance dose of Herzuma is 2 mg/kg body weight, beginning one week after the loading dose.
Danish: Den anbefalede ugentlige vedligeholdelsesdosis af Herzuma er 2 mg/kg legemsvæ gt og påbegyndes én uge efter støddosis.
English: The European Medicines Agency has waived the obligation to submit the results of studies with trastuzumab in all subsets of the paediatric population for breast and gastric cancer (see section 4.2 for information on paediatric use).
Danish: Det Europæ iske Læ gemiddelagentur har dispenseret fra kravet om at fremlæ gge resultaterne af studier med trastuzumab i alle undergrupper af den pæ diatriske population ved bryst- og ventrikelkræ ft (se pkt.
English: LABELLING AND PACKAGE LEAFLET
Danish: ETIKETTERING OG INDLÆ GSSEDDEL
English: The final OS results from the joint analysis of studies NSABP B-31 and NCCTG N9831 are summarised in Table 8 below:
Danish: De endelige resultater for samlet overlevelse fra den samlede analyse af NSABP B-31- og NCCTG N9831-studierne er opsummeret i tabel 8 nedenfor:
English: Herzuma treatment should only be initiated by a physician experienced in the administration of cytotoxic chemotherapy (see section 4.4), and should be administered by a healthcare professional only.
Danish: Behandling med Herzuma må kun påbegyndes af en læ ge med erfaring i administration af cytotoksisk kemoterapi (se pkt.
English: Circulating shed HER2 ECD
Danish: Cirkulerende shed HER2 ekstracellulæ re domæ ne
English: SCIENTIFIC CONCLUSIONS AND GROUNDS FOR THE VARIATION TO THE TERMS OF THE MARKETING AUTHORISATION(S)
Danish: VIDENSKABELIGE KONKLUSIONER OG BEGRUNDELSER FOR Æ NDRING AF BETINGELSERNE FOR MARKEDSFØ RINGSTILLADELSEN/-TILLADELSERNE
English: Other infusion-related symptoms are: feeling sick (nausea), vomiting, pain, increased muscle tension and shaking, headache, dizziness, breathing difficulties, wheezing, high or low blood pressure, heart rhythm disturbances (palpitations, heart fluttering or irregular heart beat), swelling of the face and lips, rash and feeling tired.
Danish: Andre symptomer som har forbindelse med infusionen er: kvalme, opkastning, smerter, forøget muskelspæ nding og rystelser, hovedpine, svimmelhed, besvæ r med at træ kke vejret, hiven efter vejret, forhøjet eller for lavt blodtryk, forstyrrelser i hjerterytmen (hjertebanken, flakkende hjerte eller uregelmæ ssig hjerterytme), hæ velse i ansigtet og læ berne, udslæ t og træ thedsfølelse.
English: Causing excessive foaming during reconstitution or shaking the reconstituted Herzuma may result in problems with the amount of Herzuma that can be withdrawn from the vial.
Danish: Stæ rk skumdannelse under rekonstitutionen eller omrysten af det rekonstituerede Herzuma kan medføre problemer med hensyn til den mæ ngde Herzuma, der kan træ kkes op af hæ tteglasset.
English: METHOD AND ROUTE(S) OF ADMINISTRATION
Danish: ANVENDELSESMÅ DE OG ADMINISTRATIONSVEJ(E)
English: (week)
Danish: - 8. uge).
English: A weak to moderate complete membrane staining is detected in > 10% of the tumour cells.
Danish: En svag til moderat fuldstæ ndig membranfarvning detekteres i >10 % af tumorcellerne.
English: In addition, cases of interstitial lung disease including lung infiltrates, acute respiratory distress syndrome, pneumonia, pneumonitis, pleural effusion, respiratory distress, acute pulmonary oedema and respiratory insufficiency have been reported.
Danish: Desuden er der rapporteret om tilfæ lde af interstitiel lungesygdom inklusive lungeinfiltrater, akut respiratorisk distress syndrom, pneumoni, pleuraeffusion, åndedræ tsbesvæ r, akut lungeødem og respirationsinsufficiens.
English: C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
Danish: C. ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØ RINGSTILLADELSEN
English: The vial contains 150 mg trastuzumab.
Danish: Hæ tteglasset indeholder 150 mg trastuzumab.
English: Herzuma and anthracyclines should not be given concurrently in combination in the adjuvant treatment setting.
Danish: Herzuma og antracykliner bør ikke anvendes i kombination hos patienter, som får adjuverende behandling.
English: Early breast cancer
Danish: Tidlig brystkræ ft
English: Herzuma should only be used in patients with metastatic gastric cancer (MGC) whose tumours have HER2 overexpression as defined by IHC2+ and a confirmatory SISH or FISH result, or by an IHC 3+ result.
Danish: Herzuma bør kun bruges til patienter med metastatisk ventrikelkræ ft, som har tumorer med overekspression af HER2 defineret ved IHC2+ og et bekræ ftende SISH- eller FISH-resultat, alternativt ved et IHC3+ resultat.
English: Cmax (μg/mL)
Danish: Cmax (mikrogram/ml)
English: The vial contains 420 mg trastuzumab.
Danish: Hæ tteglasset indeholder 420 mg trastuzumab.
English: - intravenous docetaxel - 100 mg/m as an intravenous infusion over 1 hour, given every 3 weeks for 4 cycles (day 2 of first docetaxel cycle, then day 1 of each subsequent cycle)
Danish: - intravenøs docetaxel - 100 mg/m som intravenøs-infusion over 1 time, administreret hver 3. uge i 4 serier (dag 2 i første docetaxel serie, derefter dag 1 i hver af de efterfølgende serier)
English: Detection of HER2 overexpression or HER2 gene amplification in breast cancer
Danish: Detektion af HER2-overekspression eller amplifikation af HER2-genet i brystkræ ft
English: Trastuzumab washout
Danish: Å ndedræ tsbesvæ r
English: Table 11 Post-hoc exploratory analysis results from the joint analysis NSABP B-31/NCCTG N9831 and BCIRG 006 clinical studies combining DFS events and symptomatic cardiac events
Danish: Resultater for post-hoc eksplorativ analyse fra den samlede analyse fra de kliniske studier NSABP B-31/NCCTG N9831 og BCIRG006, hvor sygdomsfri overlevelse og symptomatiske kardielle bivirkninger blev kombineret
English: Table 2 Recommended scoring system to evaluate the IHC staining patterns in breast cancer
Danish: Anbefalet scoringssystem til evaluering af de IHC-farvede mønstre ved brystkræ ft
English: 1) Using a sterile syringe, slowly inject the appropriate volume (as noted above) of sterile water for injection in the vial containing the lyophilised Herzuma, directing the stream into the lyophilised cake.
Danish: 1) Anvend en steril sprøjte og injicer langsomt den beregnede mængde (som angivet ovenfor) sterilt vand til injektionsvæ sker i hæ tteglasset, som indeholder det frysetørrede Herzuma, idet strålen rettes mod det frysetørrede kompakte pulver.
English: By comparison of simulated serum trastuzumab concentrations after trastuzumab monotherapy (4 mg/kg loading/2 mg/kg q1w intravenous) and observed serum concentrations in Japanese women with HER2-positive MBC (study JP16003) no evidence of a PK effect of concurrent administration of docetaxel on the pharmacokinetics of trastuzumab was found.
Danish: Ved sammenligning af simulerede trastuzumab-serumkoncentrationer efter trastuzumab-monoterapi (4 mg/kg støddosis/2 mg/kg ugentlig intravenøst) og observerede serumkoncentrationer hos japanske kvinder med HER2-positiv metastatisk brystkræ ft (studie JP16003) blev der ikke fundet evidens for, at samtidig administration af docetaxel påvirkede trastuzumabs farmakokinetik.
English: No. patients with event
Danish: Antal patienter med en hæ ndelse
English: Powder for concentrate for solution for infusion.
Danish: Pulver til koncentrat til infusionsvæ ske, opløsning.
English: The appropriate amount of solution should be withdrawn from the vial and added to a polyvinylchloride, polyethylene or polypropylene infusion bag containing 250 mL of 0.9% sodium chloride solution.
Danish: Træ k den beregnede volumenmæ ngde af opløsningen ud af hæ tteglasset og tilsæ t den til en polyvinylchlorid-, polyethylen- eller polypropylen-infusionspose indeholdende 250 ml 0,9 % natriumchloridopløsning.
English:  Paclitaxel 175 mg/m administered 3-weekly for 4 cycles,
Danish: • Paclitaxel 175 mg/m 2, administreret hver 3. uge i 4 serier,
English: For the primary endpoint, DFS, the addition of trastuzumab to paclitaxel chemotherapy resulted in a 52% decrease in the risk of disease recurrence.
Danish: For det primæ re endepunkt, sygdomsfri overlevelse, resulterede tilføjelse af trastuzumab til paclitaxelkemoterapi i en 52 % nedsæ ttelse af risikoen for sygdomstilbagefald.
English: INSTRUCTIONS ON USE
Danish: INSTRUKTIONER VEDRØ RENDE ANVENDELSEN
English: Malignant neoplasm progression Not known Neoplasm progression
Danish: Progression af malign neoplasma
English: 12.1) for the AC→PH arm and 7.9 years (range: 0.0 to 12.2) for the AC→P arm; Median duration of long term follow-up for the BCIRG 006 study was 10.3 years in both the AC→D arm (range: 0.0 to 12.6) and the DCarbH arm (range: 0.0 to 13.1), and was 10.4 years (range: 0.0 to 12.7) in the AC→DH arm
Danish: Den mediane varighed af læ ngerevarende opfølgning i for BCIRG 006-studiet var 10,3 år i både AC→D-armen (interval: 0,0-12,6) og DCarbH-armen (interval: 0,0-13,1), og 10,4 år (interval: 0,0-12,7) i AC→DH-armen.
English: The efficacy results from the joint analysis of the NSABP B-31 and NCCTG N9831 trials at the time of the definitive analysis of DFS* are summarised in Table 7.
Danish: Virkningsresultaterne fra den samlede analyse af NSABP B-31- og NCCTG N9831-studierne efter den endelige analyse af sygdomsfri overlevelse* er sammenfattet i tabel 7.
English: 6.4 Special precautions for storage
Danish: 6.4 Sæ rlige opbevaringsforhold
English: - intravenous paclitaxel - 175 mg/m as a continuous intravenous infusion, given every 3 weeks for 4 cycles (day 1 of each cycle).
Danish: - intravenøs paclitaxel - 175 mg/m2 som kontinuerlig intravenøs-infusion, administreret hver 3. uge i 4 serier (dag 1 i hver serie).
English: The efficacy results from the monotherapy and combination therapy studies are summarised in Table
Danish: Virkningsresultaterne fra monoterapi og kombinationsterapi studierne er sammenfattet i tabel 4:
English: Powder for concentrate for solution for infusion 1 vial
Danish: Pulver til koncentrat til infusionsvæ ske, opløsning 1 hæ tteglas
English: Table 5 Efficacy results from the non-comparative monotherapy and combination therapy studies
Danish: Virkningsresultater fra ikke-komparative studier med monoterapi og kombinationsterapi
English: Paediatric population
Danish: Pæ diatrisk population
English: Tell your doctor, pharmacist or nurse if you are taking, have recently taken or may take any other medicines.
Danish: Fortæ l det altid til læ gen, apotekspersonalet eller sundhedspersonalet, hvis du tager anden medicin eller har gjort det for nylig.