FrancophonIA/ELRC3.0 huggingface dataset:
English: In this trial, 2 cohorts (one using subcutaneous formulation in vial and one using subcutaneous formulation in administration system) were investigated using a 2-arm, cross-over design with 488 patients being randomized to one of two different three-weekly Herceptin treatment sequences (IV [Cycles 1-4]→ SC [Cycles 5-8], or SC [Cycles 1-4]→ IV [Cycles 5-8]).
Danish: 2 kohorter (én anvendte subkutan formulering i hætteglas og én anvendte subkutan formulering i injektionssystem) blev i dette studie undersøgt ved et 2-arms overkrydsningsdesign, hvor 488 patienter blev randomiseret til én af to forskellige 3-ugers behandlingsforløb med Herceptin (i.v.
English: • haemorrhoids
Danish: • hæmorider
English: If LVEF has not improved, or has declined further, or if symptomatic congestive heart failure (CHF) has developed, discontinuation of Herceptin should be strongly considered, unless the benefits for the individual patient are deemed to outweigh the risks.
Danish: Hvis LVEF ikke er forbedret eller er faldet yderligere, eller hvis der er udviklet symptomatisk kongestiv hjerteinsufficiens, bør det kraftigt overvejes at afbryde Herceptin-behandlingen, medmindre fordelene for den enkelte patient anses at opveje risiciene.
English: Cardiac assessments, as performed at baseline, should be repeated every 3 months during treatment and every 6 months following discontinuation of treatment until 24 months from the last administration of Herceptin.
Danish: I løbet af behandlingen skal den kardielle vurdering, som udføres ved baseline, gentages hver tredje måned og efter seponering skal den kardielle vurdering gentages hver sjette måned indtil 24 måneder efter sidste administration af Herceptin.
English: +Acute respiratory distress syndrome
Danish: +Akut lungeødem
English: Disease-free survival No. patients with event p=0.0003
Danish: Sygdomsfri overlevelse - Antal patienter med en hændelse p = 0,0003
English: Herceptin is indicated for the treatment of adult patients with HER2 positive metastatic breast cancer (MBC):
Danish: Herceptin er indiceret til behandling af voksne patienter med HER2-positiv metastatisk brystkræft:
English: - following adjuvant chemotherapy with doxorubicin and cyclophosphamide, in combination with paclitaxel or docetaxel.
Danish: i kombination med paclitaxel eller docetaxel efter adjuverende kemoterapi med doxorubicin og cyclophosphamid.
English: Herceptin 600 mg solution for injection in vial Trastuzumab
Danish: Herceptin 600 mg injektionsvæske, opløsning i hætteglas Trastuzumab
English: confidence interval for the difference in pCR rates was -4.0, establishing the non-inferiority of Herceptin subcutaneous for the co-primary endpoint
Danish: Den nedre grænse for ensidigt 97,5 % konfidensinterval for forskel i patologisk fuldstændigt respons-hyppigheder var -4,0, hvilket viser Herceptin subkutans non-inferiøritet for de co-primære endepunkter.
English: CI = confidence interval
Danish: konfidensinterval)
English: Justification for not including Braille accepted
Danish: INFORMATION I BRAILLESKRIFT Fritaget fra krav om brailleskrift
English: Neutralizing antitrastuzumab antibodies were detected in post-baseline samples in 2 of 30 patients in the Herceptin intravenous arm and 3 of 47 in the Herceptin subcutaneous arm. 21.0 % of patients treated with Herceptin subcutaneous formulation developed antibodies against the excipient hyaluronidase (rHuPH20).
Danish: Neutraliserende anti-trastuzumab-antistoffer blev fundet i prøver efter baseline hos 2 ud af 30 patienter i armen behandlet med intravenøst Herceptin og hos 3 ud af 47 patienter i armen behandlet med subkutant Herceptin.
English: Severe pulmonary events have been reported with the use of Herceptin in the post-marketing setting (see section 4.8).
Danish: Efter markedsføringen er der rapporteret om alvorlige pulmonale bivirkninger ved anvendelse af Herceptin (se pkt.
English: 1 Heart beat irregular
Danish: 1Uregelmæssig hjerteslag
English: A population PK model with parallel linear and nonlinear elimination from the central compartment was constructed using pooled Herceptin SC and Herceptin IV PK data from the phase III study BO22227 to describe the observed PK concentrations following Herceptin IV and Herceptin SC administration in EBC patients.
Danish: En populationsfarmakokinetisk model med parallel lineær og ikke-lineær elimination fra det centrale kompartment blev konstrueret ved brug af samlede farmakokinetiske data fra Herceptin subkutan og Herceptin i.v.
English: Weekly dosing in metatstatic breast cancer The efficacy results from the monotherapy and combination therapy studies are summarised in Table
Danish: Ugentligt doseringsregime ved metastatisk brystkræft Effektresultaterne fra monoterapi og kombinationsterapi studierne er sammenfattet i tabel 3:
English: Serious IRRs to Herceptin infusion including dyspnoea, hypotension, wheezing, hypertension, bronchospasm, supraventricular tachyarrhythmia, reduced oxygen saturation, anaphylaxis, respiratory distress, urticaria and angioedema have been reported (see section 4.8).
Danish: Alvorlige infusionsrelaterede reaktioner, som er rapporteret efter infusion med Herceptin, omfatter dyspnø, hypotension, hvæsende vejrtrækning, hypertension, bronkospasmer, supraventrikulær takyarytmi, nedsat iltmætning, anafylaksi, åndedrætsbesvær, urticaria og angioødem (se pkt.
English: Table 7: Final Overall Survival Analysis from the joint analysis of trials NSABP B-31 and NCCTG N9831
Danish: Tabel 7: Endelig analyse af samlet overlevelse (OS) fra den samlede analyse af NSABP B-31- og NCCTG N9831-studierne
English: Herceptin subcutaneous formulation is not intended for intravenous administration and should be administered via a subcutaneous injection only.
Danish: Herceptin subkutan formulering er ikke beregnet til intravenøs administration og må kun administreres ved subkutan injektion.
English: Instructions for aseptic dilution of the reconstituted solution
Danish: Instruktioner for aseptisk fortynding af den rekonstituerede opløsning: Beregn det nødvendige volumen af opløsningen:
English: Table 12 Efficacy Results from MO16432
Danish: Effektresultater fra MO16432 Parameter
English: Table 4: Efficacy results from the non-comparative monotherapy and combination therapy studies Parameter
Danish: Tabel 4: Effektresultater fra ikke-komparative studier med monoterapi- og kombinationsterapi Parameter
English: Hypertensive events
Danish: Hypertensive bivirkninger
English: Table 1 Undesirable Effects Reported with Intravenous Herceptin Monotherapy or in Combination with Chemotherapy in Pivotal Clinical Trials (N = 8386) and in Post-Marketing
Danish: Bivirkninger rapporteret med intravenøs Herceptin-monoterapi eller i kombination med kemoterapi i pivotale kliniske studier (N=8.386) samt efter markedsføring.
English: STATEMENT OF ACTIVE SUBSTANCE(S) One vial contains 600 mg/5 mL trastuzumab.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Et hætteglas indeholder 600 mg trastuzumab/5 ml.
English: Duration of Response, Median months
Danish: Median måneder
English: Herceptin subcutaneous fixed dose formulation is not for intravenous use and should be given as a subcutaneous injection only.
Danish: Herceptin subkutan fast-dosis formulering er ikke beregnet til intravenøs brug og må kun gives som en subkutan injektion.
English: Herceptin intravenous formulation is not intended for subcutaneous administration and should be administered via an intravenous infusion only.
Danish: Herceptin intravenøs formulering er ikke beregnet til subkutan administration og må kun administreres ved intravenøs infusion.
English: NAME OF THE MEDICINAL PRODUCT Herceptin 600 mg solution for injection in vial
Danish: LÆGEMIDLETS NAVN Herceptin 600 mg injektionsvæske, opløsning i hætteglas
English: • The other ingredient(s) are L-histidine hydrochloride monohydrate, L-histidine, α,α-trehalose dihydrate, polysorbate 20.
Danish: • Øvrige indholdsstoffer: L-histidinhydrochlorid monohydrat, L-histidin, α,α-trehalosedihydrat og polysorbat 20.
English: Patients with MBC or MGC should be treated with Herceptin until progression of disease.
Danish: Patienter med metastatisk brystkræft eller metastatisk ventrikelkræft bør behandles med Herceptin, indtil sygdommen progredierer.
English: Due to the significant impact of body weight on trastuzumab clearance and the use of a fixed dose for the subcutaneous administration the difference in exposure between subcutaneous and intravenous administration was dependent on body weight: in patients with a body weight < 51 kg, mean steady state AUC of trastuzumab was about 80% higher after subcutaneous than after intravenous treatment whereas in the highest BW group (> 90 kg) AUC was 20% lower after subcutaneous than after intravenous treatment.
Danish: Hos patienter med en kropsvægt < 51 kg var trastuzumabs gennemsnitlige steady-state AUC omkring 80 % højere efter subkutan behandling sammenlignet med efter intravenøs behandling.
English: • inflammation of the breast
Danish: • betændelse i brystet
English: Herceptin intravenous formulation is not for subcutaneous use and should be given as an intravenous infusion only.
Danish: Herceptin intravenøs formulering er ikke beregnet til subkutan brug og må kun gives som en intravenøs infusion.
English: weekly) and docetaxel (60 mg/m2 IV) in Japanese women with HER2- positive MBC, suggested that concomitant administration of Herceptin had no effect on the single dose pharmacokinetics of docetaxel.
Danish: hos japanske kvinder med HER2-positiv metastisk brystkræft, tydede på, at samtidig administration af Herceptin ikke påvirkede docetaxels enkeltdosisfarmakokinetik.
English: Table 3: Efficacy results from the monotherapy and combination therapy studies Parameter
Danish: Tabel 3: Effektresultater fra studier med monoterapi og kombinationsterapi Parameter
English: Rare side effects of Herceptin: may affect up to 1 in 1,000 people
Danish: Sjældne bivirkninger af Herceptin: kan forekomme hos op til 1 ud af 1.000 patienter
English: • Keep this medicine out of the sight and reach of children.
Danish: • Opbevar lægemidlet utilgængeligt for børn
English: For the sequence IV→SC (SC vial and SC formulation in administration system cohorts combined), adverse event rates (all grades) were described preswitching (Cycles 1-4) and post-switching (Cycles 5-8) as 53.8% vs. 56.4%, respectively; for the sequence SC→IV (SC vial and SC formulation in administration system cohorts combined), adverse event rates (all grades) were described pre- and post-switching as 65.4% vs. 48.7%, respectively.
Danish: → s.c. (s.c. hætteglas og s.c. formulering i injektionssystem, kohorter kombineret) var bivirkningsraterne (alle grader) før skiftet (serie 1-4) og efter skiftet (serie 5-8) henholdsvis 53,8 % versus 56,4 %.
English: Paclitaxel, in combination with Herceptin, was administered as follows: - intravenous paclitaxel - 80 mg/m2 as a continuous intravenous infusion, given every week for 12 weeks.
Danish: - intravenøs paclitaxel - 80 mg/m2 som kontinuerlig intravenøs-infusion, administreret hver uge i 12 uger.
English: Table 11 Post-Hoc Exploratory Analysis Results from the Joint Analysis NSABP B-31/NCCTG N9831* and BCIRG006 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: Docetaxel was administered as follows:
Danish: Paclitaxel i kombination med Herceptin blev administreret som følger:
English: weeks for 6 cycles (day 2 of cycle 1, then day 1 of each subsequent cycle) which was followed by: - carboplatin - at target AUC = 6 mg/mL/min administered by intravenous infusion over 3060 minutes repeated every 3 weeks for a total of six cycles
Danish: som blev efterfulgt af: - carboplatin - ved tilsigtet AUC = 6 mg/ml/min administreret som intravenøs infusion over 30-60 minutter gentaget hver 3. uge i samlet 6 serier.
English: Disease-free survival - No. patients with event - No. patients without event P-value versus Observation Hazard Ratio versus Observation Recurrence-free survival - No. patients with event - No. patients without event P-value versus Observation Hazard Ratio versus Observation
Danish: Tilbagefaldsfri overlevelse - Antal patienter med en hændelse - Antal patienter uden en hændelse p-værdi versus observation
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, kan have forhøjet risiko for pulmonale hændelser.
English: Table 16 Population Predicted PK Parameter Values at Steady State for Herceptin IV Dosing
Danish: Tabel 16: Populationsforudsagte farmakokinetiske parameter værdier ved steady state for Herceptin i.v.-doseringsregimer hos patienter med metastatisk brystkræft, tidlig brystkræft og fremskreden ventrikelkræft.
English: Single doses of Herceptin alone greater than 10 mg/kg have not been administered in the clinical trials; a maintenance dose of 10 mg/kg q3w following a loading dose of 8 mg/kg has been studied in a clinical trial with metastatic gastric cancer patients.
Danish: I et klinisk studie med patienter der havde metastatisk ventrikelkræft blev en vedligeholdelsesdosis på 10 mg/kg i 3-ugers intervaller efter en støddosis på 8 mg/kg undersøgt.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Herceptin 600 mg solution for injection
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Herceptin 600 mg injektionsvæske, opløsning i hætteglas Trastuzumab
English: Disease-free survival No. patients with event p<0.0001
Danish: Sygdomsfri overlevelse - Antal patienter med en hændelse p < 0,0001
English: Herceptin and anthracyclines should not be given concurrently in combination in the adjuvant treatment setting.
Danish: Herceptin og antracykliner bør ikke anvendes i kombination hos patienter, som får adjuverende behandling.
English: Pharmacokinetic Properties.
Danish: 5.2 Farmakokinetiske egenskaber.
English: The final OS results from the joint analysis of studies NSABP B-31 and NCCTG N9831 are summarized in Table 7:
Danish: De endelige resultater for samlet overlevelse fra den samlede analyse af NSABP B-31- og NCCTG N9831-studierne er opsummeret i tabel 7 nedenfor:
English: which was followed by - CMF on day 1 and 8 every 4 weeks for 3 cycles which was followed after surgery by - additional cycles of adjuvant Herceptin (to complete 1 year of treatment)
Danish: som efter operation blev efterfulgt af: - Yderligere serier af adjuverende Herceptin (indtil 1 års behandling var fuldført).
English: 80.9 %) in favour of the AC→DH (Herceptin) arm and 4.6 percentage points (85.5 % versus 80.9 %) in favour of the DCarbH (Herceptin) arm compared to AC→D.
Danish: I BCIRG 006-studiet kan hazard ratioen for det primære 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 (Herceptin)-armen og 4,6 procentpoint (85,5 % versus 80,9 %) til fordel for DCarbH (Herceptin)-armen sammenlignet med AC→D.
English: The efficacy results from the joint analysis of the NSABP B-31 and NCCTG 9831 trials at the time of the definitive analysis of DFS* are summarized in Table 6.
Danish: Effektresultaterne fra den samlede analyse af NSABP B-31 og NCCTG 9831-studierne efter den endelige analyse af sygdomsfri overlevelse* er sammenfattet i tabel 6.
English: Overall survival (death) - No. patients with event - No. patients without event
Danish: Samlet overlevelse (død) - Antal patienter med en hændelse - Antal patienter uden en hændelse p-værdi versus observation
English: Herceptin SC 600 mg Q3W Dosing Regimen in EBC patients
Danish: Tidlig brystkræft 600 mg Herceptin subkutan 3-ugers doseringsregime
English: Amongst the most serious and/or common adverse reactions reported in Herceptin usage (intravenous and subcutaneous formulations) to date are cardiac dysfunction, administration-related reactions, haematotoxicity (in particular neutropenia), infections and pulmonary adverse reactions.
Danish: Kardiel dysfunktion, administrationsrelaterede reaktioner, hæmatotoksicitet (specielt neutropeni) infektioner og pulmonale bivirkninger er til dato blandt de mest alvorlige og/eller almindelige bivirkninger rapporteret ved anvendelse af Herceptin (intravenøs og subkutan formuleringer).
English: Amongst the most serious and/or common adverse reactions reported in Herceptin usage (intravenous and subcutaneous formulations) to date are cardiac dysfunction, infusion-related reactions, haematotoxicity (in particular neutropenia), infections and pulmonary adverse reactions.
Danish: Kardiel dysfunktion, infusionsrelaterede reaktioner, hæmatotoksicitet (specielt neutropeni), infektioner og pulmonale bivirkninger er til dato blandt de mest alvorlige og/eller almindelige bivirkninger rapporteret ved anvendelse af Herceptin (intravenøs og subkutan formulering).
English: - intravenous push doxorubicin, at 60 mg/ m2, given every 3 weeks for 4 cycles.
Danish: intravenøs bolus doxorubicin på 60 mg/m2, administreret hver 3. uge i 4 serier.
English: - intravenous docetaxel - 75 mg/m2 as an intravenous infusion over 1 hour, given every 3
Danish: Docetaxel blev administreret som følger: - intravenøs docetaxel - 100 mg/m2 som intravenøs infusion over 1 time, administreret hver
English: - Study BO16348 was designed to compare one and two years of three-weekly Herceptin treatment versus observation in patients with HER2 positive EBC following surgery, established chemotherapy and radiotherapy (if applicable).
Danish: Herceptin blev undersøgt som adjuverende behandling i 4 store multicenter, randomiserede studier: - Studie BO16348 var designet til at sammenligne 1 og 2-års Herceptin-behandling hver 3. uge versus observation hos patienter med HER2-positiv tidlig brystkræft efter operation, standardkemoterapi og strålebehandling (hvis indiceret).
English: - intravenous docetaxel - 100 mg/m2 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 - 75 mg/m2 som intravenøs infusion over 1 time, administreret hver 3. uge i 6 serier (dag 2 i serie 1, derefter dag 1 i hver af de efterfølgende serier)
English: which was followed by • CMF on day 1 and 8 every 4 weeks for 3 cycles which was followed after surgery by • additional cycles of adjuvant Herceptin (to complete 1 year of treatment)
Danish: som efter operation blev efterfulgt af: • Yderligere serier af adjuverende Herceptin (indtil 1 års behandling var fuldført).
English: • throat infections
Danish: • lungeinfektioner
English: Median duration of follow up was 1.8 years in the AC→P arm and 2.0 years in the AC→PH arm Median duration of long term follow-up for the Joint Analysis clinical studies was 8.3 years (range: 0.1 to 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) arm and the
Danish: ** Den mediane varighed af længerevarende opfølgning i den samlede analyse af de kliniske studier var 8,3 år (interval: 0,1-12,1) i AC→PH-armen og 7,9 år (interval: 0,0-12,2) i AC→P-armen.
English: In addition a post-hoc exploratory analysis was performed on the data sets from the joint analysis (JA) NSABP B-31/NCCTG N9831* and BCIRG006 clinical studies combining DFS events and symptomatic cardiac events and summarised in Table 10: Table 10: Post-hoc exploratory analysis results from the joint analysis NSABP B-31/NCCTG N9831*
Danish: Desuden blev en post-hoc eksplorativ analyse udført på datasættene fra den samlede analyse fra studierne NSABP B-31/NCCTG N9831* og BCIRG 006, hvor sygdomsfri overlevelse og symptomatiske kardielle hændelser blev kombineret.
English: Common side effects of Herceptin: may affect up to 1 in 10 people
Danish: Almindelige bivirkninger af Herceptin: kan forekomme hos op til 1 ud af 10 patienter
English: Presented in Table 1 are adverse reactions that have been reported in association with the use of intravenous Herceptin alone or in combination with chemotherapy in pivotal clinical trials and in the post-marketing setting.
Danish: Bivirkninger, som er blevet rapporteret i forbindelse med anvendelse af intravenøst Herceptin alene eller i kombination med kemoterapi i pivotale kliniske studier og efter markedsføringen, er præsenteret i tabel 1.
English: The efficacy results from the joint analysis of the NSABP B-31 and NCCTG 9831 trials at the time of the definitive analysis of DFS* are summarized in Table 7.
Danish: Effektresultaterne 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: Adverse reaction
Danish: Responsvarighed
English: No staining is observed or membrane staining is observed in < 10 % of the tumour cells
Danish: Der ses ingen farvning eller membranfarvning ses i < 10 % af tumorcellerne.
English: * At median duration of follow up of 1.8 years for the patients in the AC→P arm and 2.0 years for patients in the AC→PH arm ** p value for OS did not cross the pre-specified statistical boundary for comparison of AC→PH vs. AC→P
Danish: * Ved median opfølgningstid, som var 1,8 år for patienterne i AC→P-armen og 2,0 år for patienterne i AC→PH
English: • inflammation or scarring of the lungs.
Danish: • gulsot • betændelse (betændelseslignende reaktion) eller arvæv i lungerne.
English: Treatment with AC→PH resulted in a statistically significant improvement in OS compared with AC→P (stratified HR=0.64; 95% CI [0.55, 0.74]; log-rank p-value < 0.0001).
Danish: 0,64; 95 % konfidensinterval = 0,55-0,74; log-rank p-værdi < 0,0001).
English: Uncommon side effects of Herceptin: may affect up to 1 in 100 people
Danish: Ikke almindelige bivirkninger af Herceptin: kan forekomme hos op til 1 ud af 100 patienter
English: Difference in pCR (SC minus IV arm)
Danish: Forskel i patologisk fuldstændigt respons (subkutan- minus intravenøsarm)
English: By comparison of simulated serum trastuzumab concentrations after Herceptin monotherapy (4 mg/kg loading/2 mg/kg q1w IV) 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: og observerede serumkoncentrationer hos japanske kvinder med HER2-positiv metastatisk brystkræft (studie JP16003) blev der ikke fundet evidens for, at samtidig administration af docetaxel påvirkede trastuzumabs farmakokinetik.
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 %)
Danish: hvilket overføres til en absolut gavnlig effekt udtrykt i en 2-års sygdomsfri overlevelsesrate på 7,6 procentpoint (85,8 % versus 78,2 %) til fordel for Herceptin-armen.
English: Table 10 Overview of Efficacy Analyses BCIRG 006 AC→D versus DCarbH Parameter
Danish: Tabel 9: Oversigt over effektanalyserne af AC→D versus DCarbH fra BCIRG 006-studiet
English: No. patients with event p=0.0182
Danish: Død (OS hændelse) - Antal patienter med en hændelse p = 0,0182
English: your heart function may be checked more frequently (every six to eight weeks), you may receive treatment for heart failure or you may have to stop Herceptin treatment.
Danish: Derfor skal din hjertefunktion kontrolleres før, under (hver tredje måned) og efter behandlingen med Herceptin (op til to til fem år).
English: The efficacy results from the non-comparative monotherapy and combination therapy studies are summarised in Table 5:
Danish: 3-ugers doseringsregime ved metastatisk brystkræft Effektresultaterne fra ikke-komparative monoterapi og kombinationsterapi studier er sammenfattet i tabel 5: