FrancophonIA/ELRC3.0 huggingface dataset:
English: The pharmacokinetics of trastuzumab were evaluated in a population pharmacokinetic model analysis using pooled data from 1,582 subjects, including patients with HER2 positive MBC, EBC, AGC or other tumor types, and healthy volunteers, in 18 Phase I, II and III trials receiving Herceptin IV. A two-compartment model with parallel linear and non-linear elimination from the central compartment described the trastuzumab concentration-time profile.
Danish: Trastuzumabs farmakokinetik blev evalueret i en populationsfarmakokinetisk model-analyse ved brug af puljede data fra 1.582 forsøgspersoner, som fik Herceptin i.v., inkluderende patienter med HER2positiv metastatisk brystkræft, tidlig brystkræft, fremskreden ventrikelkræft eller andre tumortyper, og raske forsøgspersoner, i 18 fase I-, II- og III-studier.
English: • you are allergic to trastuzumab, to murine (mouse) proteins, or to any of the other ingredients of this medicine (listed in section 6).
Danish: • du er allergisk over for trastuzumab, murine proteiner (fra mus) eller et af de øvrige indholdsstoffer i Herceptin (angivet i pkt.
English: - intravenous cyclophosphamide, at 600 mg/ m2 over 30 minutes, given every 3 weeks for 4
Danish: intravenøs cyclophosphamid på 600 mg/m2 over 30 minutter, administreret hver 3. uge i 4 serier.
English: Manufacturer Roche Pharma AG Emil-Barell-Strasse 1
Danish: Indehaver af markedsføringstilladelsen Roche Registration GmbH Emil-Barell-Strasse 1
English: • bladder and skin infections
Danish: • infektion i blæren og huden
English: Patients with history of myocardial infarction (MI), angina pectoris requiring medical treatment, history of or existing CHF (NYHA Class II -IV), LVEF of < 55%, other cardiomyopathy, cardiac arrhythmia requiring medical treatment, clinically significant cardiac valvular disease, poorly controlled hypertension (hypertension controlled by standard medical treatment eligible), and hemodynamic effective pericardial effusion were excluded from adjuvant and neoadjuvant EBC pivotal trials with Herceptin and therefore treatment cannot be recommended in such patients.
Danish: Patienter blev ekskluderet fra de pivotale studier med Herceptin til adjuverende og neoadjuverende tidlig brystkræft, hvis de havde en anamnese med myokardieinfarkt, angina pectoris, der kræver medicinsk behandling, tidligere eller eksisterende kongestiv hjerteinsufficiens (NYHA-klasse II-IV), LVEF < 55 %, anden kardiomyopati, hjertearytmi, der kræver medicinsk behandling, klinisk signifikant hjerteklapsygdom, dårligt kontrolleret hypertension (hvis hypertensionen var kontrolleret på almindelig medicinsk behandling, kunne patienten få præparatet) og hæmodynamisk effektiv perikardie-effusion.
English: What Herceptin is and what it is used for What you need to know before you are given Herceptin How Herceptin is given
Danish: Oversigt over indlægssedlen Virkning og anvendelse Det skal du vide, før du får Herceptin Sådan får du Herceptin Bivirkninger
English: Signs and symptoms of cardiac dysfunction such as dyspnoea, orthopnoea, increased cough, pulmonary oedema, S3 gallop, or reduced ventricular ejection fraction, have been observed in patients treated with Herceptin (see section 4.4).
Danish: Der er observeret symptomer på kardiel dysfunktion såsom dyspnø, ortopnø, tiltagende hoste, lungeødem, S3galoprytme eller nedsat ventrikulær ejektionsfraktion hos patienter behandlet med Herceptin (se pkt.
English: 4mg/kg + 2mg/kg qw
Danish: 8 mg/kg +
English: The non-linear elimination parameter values were 8.81 mg/day for the maximum elimination rate (Vmax) and 8.92
Danish: De ikke-lineære eliminations-parametre var 8,81 mg/dag for den maksimale eliminationshastighed (Vmax) og 8,92 mikrogram/ml for Michaelis-Menten kontanten (Km) hos patienter med metastatisk brystkræft, tidlig brystkræft eller fremskreden ventrikelkræft.
English: In the NSABP B-31 and NCCTG N9831 studies Herceptin was administered in combination with paclitaxel, following AC chemotherapy.
Danish: I NSABP B-31- og NCCTG N9831 -studierne blev Herceptin administreret i kombination med paclitaxel efter AC-kemoterapi.
English: In the pivotal trials (H0648g, M77001), paclitaxel or docetaxel was administered the day following the first dose of Herceptin (for dose, see the Summary of Product Characteristics (SmPC) for paclitaxel or docetaxel) and immediately after the subsequent doses of Herceptin if the preceding dose of Herceptin was well tolerated.
Danish: Administration i kombination med paclitaxel eller docetaxel I de pivotale studier (H0648g, M77001) blev paclitaxel eller docetaxel administreret dagen efter den første Herceptin-dosis (se dosis i produktresuméet for paclitaxel eller docetaxel).
English: L-histidine hydrochloride monohydrate α,α-trehalose dihydrate
Danish: L-histidinhydrochloridmonohydrat α,α-trehalosedihydrat
English: • The other ingredients are recombinant human hyaluronidase (rHuPH20), L-histidine, L-histidine hydrochloride monohydrate, α,α-trehalose dihydrate, L-methionine, polysorbate 20, water for injections.
Danish: • Øvrige indholdsstoffer: Rekombinant human hyalorunidase (rHuPH20), L-histidin, Lhistidinhydrochloridmonohydrat, α,α-trehalosedihydrat, L-methionin, polysorbat 20, vand til injektionsvæsker
English: In the post-marketing setting, cases of fetal renal growth and/or function impairment in association with oligohydramnios, some associated with fatal pulmonary hypoplasia of the fetus, have been reported in pregnant women receiving Herceptin.
Danish: Efter markedsføringen er der blevet rapporteret tilfælde af føtal nyrevækstsnedsættelse og/eller nyrefunktionsnedsættelse i forbindelse med oligohydramnion hos gravide kvinder, der får Herceptin.
English: Herceptin should only be used in patients with metastatic or early breast cancer whose tumours have either HER2 overexpression or HER2 gene amplification as determined by an accurate and validated assay (see sections 4.4 and 5.1).
Danish: Herceptin bør kun bruges til patienter med metastatisk eller tidlig brystkræft, som enten har tumorer med overekspression af HER2 eller amplifikation af HER2-genet, bestemt ved en præcis og valideret analyse (se pkt.
English: Study BO22227 was designed to demonstrate non-inferiority of treatment with Herceptin subcutaneous formulation versus Herceptin intravenous formulation based on co-primary PK and efficacy endpoints (trastuzumab Ctrough at pre-dose Cycle 8, and pCR rate at definitive surgery, respectively).
Danish: BO22227-studiet var designet til at demonstrere non-inferioritet af behandling med Herceptin subkutan formulering versus intravenøst formuleret Herceptin baseret på co-primære farmakokinetiske- og virkningsendepunkter (henholdsvis Ctrough af trastuzumab før dosis i serie 8 og patologisk fuldstændigt respons-hyppigheder ved definitiv operation).
English: Herceptin IV is provided in sterile, preservative-free, non-pyrogenic, single use vials.
Danish: leveres i sterile, konserveringsfrie, ikke-pyrogene hætteglas til engangsbrug.
English: • Hypersensitivity to trastuzumab, murine proteins, hyaluronidase or to any of the other excipients listed in section 6.1.
Danish: • Overfølsomhed over for trastuzumab, murine proteiner, hyalorunidase eller over for et af de andre hjælpestoffer anført i pkt.
English: In 3 pivotal EBC clinical trials of adjuvant intravenous Herceptin given in combination with chemotherapy, the incidence of grade 3/4 cardiac dysfunction (specifically symptomatic congestive heart failure) was similar in patients who were administered chemotherapy alone (ie did not receive Herceptin) and in patients who were administered Herceptin sequentially after a taxane (0.3-0.4 %).
Danish: I tre pivotale kliniske studier med tidlig brystkræft, hvor intravenøst Herceptin i kombination med kemoterapi blev givet adjuverende, var incidensen af grad 3 og 4 kardiel dysfunktion (især symptomatisk kongestiv hjerteinsufficiens) sammenlignelig med patienter, som fik administreret kemoterapi alene (dvs. de modtog ikke Herceptin), og med patienter, som fik administreret Herceptin sekventielt efter et taxan (0,3-0,4 %).
English: A final analysis was performed after a median follow-up of 8 years, which showed that 1 year Herceptin treatment is associated with a 24 % risk reduction compared to observation only (HR=0.76,
Danish: En endelig analyse blev udført efter en median opfølgning på 8 år, hvilket viste, at 1 års Herceptinbehandling er associeret med 24 % risikoreduktion sammenlignet med observation alene (hazard ratio=0,76; 95 % konfidensinterval 0,67-0,86).
English: Pre-switching rates (Cycles 1-4) for serious adverse events, grade 3 adverse events and treatment discontinuations due to adverse events were low (<5%) and similar to post-switching rates (Cycles 58).
Danish: Hyppigheden af alvorlige bivirkninger, grad 3 bivirkninger og seponering på grund af bivirkninger før skiftet (serie 1-4) var lav (<5 %) og sammenlignelig med hyppigheden efter skiftet (serie 5-8).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One vial of 5 mL contains 600 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 hætteglas med 5 ml indeholder 600 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: In 3 pivotal clinical trials of adjuvant Herceptin given in combination with chemotherapy, the incidence of grade 3/4 cardiac dysfunction (specifically symptomatic Congestive Heart Failure) was similar in patients who were administered chemotherapy alone (ie did not receive Herceptin) and in patients who were administered Herceptin sequentially after a taxane (0.3-0.4 %).
Danish: I 3 pivotale kliniske studier, hvor adjuverende Herceptin blev administreret i kombination med kemoterapi, var hyppigheden af kardiel dysfunktion af grad 3/4 (især symptomatisk kongestiv hjerteinsufficiens) tilsvarende hos patienter, der fik administreret kemoterapi alene (dvs. som ikke fik Herceptin), som hos patienter, der fik Herceptin sekventielt efter et taxan (0,3-0,4 %).
English: Strong complete membrane staining is detected in > 10 % of the tumour cells.
Danish: Stærk, fuldstændig membranfarvning detekteres i > 10 % af tumorcellerne.
English: In the neoadjuvant-adjuvant EBC study (BO22227), at a median follow-up exceeding 70 months, 10.1% (30/296) of patients treated with Herceptin intravenous and 15.9 % (47/295) of patients receiving Herceptin subcutaneous vial developed antibodies against trastuzumab.
Danish: I det neoadjuverende-adjuverende studie af tidlig brystkræft (BO22227) udviklede 10,1 % (30/296) af patienterne behandlet med intravenøst Herceptin og 15,9 % (47/295) af patienterne, der fik Herceptin subkutant antistoffer mod trastuzumab ved en median opfølgningstid på mere end 70 måneder.
English: For patients with EBC, 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: Hos patienter med tidlig brystkræft bør de kardiologiske vurderinger, som er udført ved baseline, gentages hver 3. måned under behandlingen og hver 6. måned efter behandlingsophør indtil 24 måneder efter sidste administration af Herceptin.
English: • feeling weak and unwell
Danish: • svagheds- og utilpashedsfølelse
English: SPECIAL STORAGE CONDITIONS Store in a refrigerator (2ºC - 8ºC).
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Opbevares i køleskab (2 °C - 8 °C)
English: Median Survival (months) (95 %CI)
Danish: Median overlevelse (måneder) (95 % konfidensinterval)
English: • Doxorubicin 60mg/m2 and paclitaxel 150 mg/m2, administered 3-weekly for 3 cycles,
Danish: • Doxorubicin 60 mg/m2 og paclitaxel 150 mg/m2 administreret hver 3. uge i 3 serier,
English: Patients with MBC should be treated with Herceptin until progression of disease.
Danish: Patienter med metastatisk brystkræft bør behandles med Herceptin, indtil sygdommen progredierer.
English: Study MO28048 investigating the safety and tolerability of Herceptin subcutaneous formulation as adjuvant therapy in HER2 positive EBC patients who were enrolled in either a Herceptin subcutaneous vial cohort (N=1868 patients, including 20 patients receiving neoadjuvant therapy) or a Herceptin subcutaneous administration system cohort (N=710 patients, including 21 patients receiving neoadjuvant therapy) resulted in no new safety signals.
Danish: Patienterne blev enten inkluderet i en Herceptin subkutan i hætteglas-kohorte (N = 1868 patienter, inklusive 20 patienter, der modtog neoadjuverende behandling) eller i en Herceptin subkutan i injektionssystem-kohorte (N = 710 patienter, inklusive 21 patienter, der modtog neoadjuverende behandling).
English: Herceptin is indicated for the treatment of adult patients with HER2 positive early breast cancer.
Danish: Herceptin er indiceret til behandling af voksne patienter med HER2-positiv tidlig brystkræft.
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: Tabel 1: Uønskede bivirkninger rapporteret med intravenøs Herceptin-moneterapi eller i kombination med kemoterapi i pivotale kliniske studier (N=8.386) og efter markedsføring Systemorganklasse
English: No. patients with event p=0.0275
Danish: Antal patienter med en hændelse p=0,0275
English: - Doxorubicin 60mg/m2 and paclitaxel 150 mg/m2, administered 3-weekly for 3 cycles,
Danish: - Doxorubicin 60 mg/m2 og paclitaxel 150 mg/m2 administreret hver 3. uge i 3 serier,
English: - The BCIRG 006 study was designed to investigate combining Herceptin treatment with docetaxel either following AC chemotherapy or in combination with docetaxel and carboplatin in patients with HER2 positive EBC following surgery.
Danish: - BCIRG 006-studiet var designet til at undersøge kombinationen af Herceptin-behandling med docetaxel efter AC-kemoterapi eller i kombination med docetaxel og carboplatin hos patienter med HER2-positiv tidlig brystkræft efter operation.
English: Weak to moderate complete, basolateral or lateral membranous reactivity in ≥ 10 % of tumour cells
Danish: En svag til moderat komplet, basolateral eller lateral membranøs reaktivitet i ≥ 10 % af tumorcellerne
English: In the neoadjuvant-adjuvant EBC study (BO22227), at a median follow-up exceeding 70 months, 10.1 % (30/296) of patients treated with Herceptin intravenous developed antibodies against trastuzumab.
Danish: I det neoadjuverende-adjuverende studie af tidlig brystkræft (BO22227) udviklede 10,1 % (30/296) af patienterne behandlet med intravenøst Herceptin antistoffer mod trastuzumab ved en median opfølgningstid på mere end 70 måneder.
English: How Herceptin is given
Danish: Sådan får du Herceptin
English: Very common side effects of Herceptin: may affect more than 1 in 10 people
Danish: Meget almindelige bivirkninger af Herceptin: kan forekomme hos flere end 1 ud af 10 patienter
English: which was followed by - Paclitaxel 175 mg/m2 administered 3-weekly for 4 cycles,
Danish: som blev efterfulgt af: - Paclitaxel 175 mg/m2, administreret hver 3. uge i 4 serier,
English: Febrile neutropenia, leukopenia, anaemia, thrombocytopenia and neutropenia occurred very commonly.
Danish: Febril neutropeni, leukopeni, anæmi, trombocytopeni og neutropeni forekom med hyppigheden ”meget almindelig”., Hyppigheden af hypoprotrombinæmi er ikke kendt.
English: which was followed by • Paclitaxel 175 mg/m2 administered 3-weekly for 4 cycles,
Danish: som blev efterfulgt af: • Paclitaxel 175 mg/m2, administreret hver 3. uge i 4 serier,
English: What Herceptin contains
Danish: Herceptin indeholder:
English: What Herceptin looks like and contents of the pack Herceptin is a solution for injection that is supplied in a glass vial with a butyl rubber stopper containing 5 mL (600 mg) of trastuzumab.
Danish: Herceptin er en injektionsvæske, opløsning der leveres i et hætteglas af glas med en butylgummiprop og indeholder 5 mL (600 mg) trastuzumab.
English: The clinical relevance of these antibodies is not known.The presence of anti-trastuzumab antibodies had no impact on pharmacokinetics, efficacy (determined by pathological Complete Response [pCR] and event free survival [EFS]) and safety determined by occurrence of administration related reactions (ARRs) of Herceptin intravenous and Herceptin subcutaneous.
Danish: Tilstedeværelsen af anti-trastuzumabantistoffer havde ingen indvirkning på farmakokinetikken, effekten (bestemt ved patologisk fuldstændigt respons og hændelsesfri overlevelse) og sikkerheden, bestemt ved forekomst af administrationsrelaterede reaktioner, af intravenøst Herceptin og Herceptin subkutan.
English: L-histidine hydrochloride monohydrate L-histidine α,α-trehalose dihydrate polysorbate 20
Danish: L-histidinhydrochlorid monohydrat L-histidin α,α-trehalosedihydrat polysorbat 20
English: Patients experiencing administration-related symptoms (see section 4.4) should be advised not to drive and use machines until symptoms abate.
Danish: 4.4), skal rådes til ikke at køre bil og betjene maskiner, før symptomerne er aftaget.
English: The recommended maintenance dose of Herceptin at three-weekly intervals is 6 mg/kg body weight, beginning three weeks after the loading dose.
Danish: Den anbefalede vedligeholdelsesdosis af Herceptin ved 3-ugers intervaller er 6 mg/kg legemsvægt og den påbegyndes 3 uger efter støddosis.
English: In patients with EBC an increase in the incidence of symptomatic and asymptomatic cardiac events was observed when Herceptin was administered after anthracycline-containing chemotherapy compared to administration with a non-anthracycline regimen of docetaxel and carboplatin and was more marked when Herceptin was administered concurrently with taxanes than when administered sequentially to taxanes.
Danish: Hos patienter med tidlig brystkræft er der blevet observeret øget hyppighed af symptomatiske og asymptomatiske kardielle hændelser, når Herceptin blev administreret efter antracyklin-baseret kemoterapi sammenlignet med administration af et ikke-antracyklin-baseret regime med docetaxel og carboplatin.
English: Table 8: Overview of efficacy analyses BCIRG 006 AC→D versus AC→DH Parameter
Danish: Tabel 8: Oversigt over effektanalyserne af AC→D versus AC→DH fra BCIRG 006-studiet
English: No. patients with event p=0.014**
Danish: Død (OS hændelse) - Antal patienter med en hændelse p = 0,014**
English: Distant recurrence No. patients with event p<0.0001
Danish: Distant tilbagefald - Antal patienter med en hændelse p < 0,0001
English: Lower bound one-sided 97.5% CI for the difference in pCR** *Confidence interval for one sample binomial using Pearson-Clopper method **Continuity correction of Anderson and Hauck (1986) has been used in this calculation
Danish: Nedre grænse for ensidigt 97,5 % konfidensinterval for forskel i patologisk fuldstændigt respons** *Konfidensinterval for en-test-binomial beregnet efter Pearson-Clopper-metoden.
English: - intravenous paclitaxel - 175 mg/m2 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: Administration-related reactions (ARRs)/hypersensitivity reactions such as chills and/or fever, dyspnoea, hypotension, wheezing, bronchospasm, tachycardia, reduced oxygen saturation, respiratory distress, rash, nausea, vomiting and headache were seen in Herceptin clinical trials (see section 4.4).
Danish: Der er set administrationsrelaterede reaktioner/overfølsomhedsreaktioner såsom kulderystelser og/eller feber, dyspnø, hypotension, hvæsende vejrtrækning, bronkospasmer, takykardi, nedsat iltmætning, åndedrætsbesvær, udslæt, kvalme, opkast og hovedpine i kliniske studier med Herceptin (se pkt.
English: LIST OF EXCIPIENTS L-histidine hydrochloride monohydrate, L-histidine, polysorbate 20, α,α-trehalose dihydrate.
Danish: LISTE OVER HJÆLPESTOFFER L-histidinhydrochlorid monohydrat, L-histidin, polysorbat 20, α,α-trehalosedihydrat.
English: Table 5: Efficacy results from study BO16348
Danish: Tabel 5: Effektresultater fra BO16348-studiet Median opfølgning 12 måneder*
English: The pivotal trial BO22227 was designed to demonstrate non-inferiority of treatment with Herceptin subcutaneous formulation versus treatment with Herceptin intravenous formulation based on coprimary PK and efficacy endpoints (trastuzumab Ctrough at pre-dose Cycle 8, and pCR rate at definitive surgery, respectively) (See Section 5.1. of Herceptin subcutaneous formulation SmPC).
Danish: Det pivotale studie BO22227 var designet til at vise non-inferioritet af behandling med Herceptin subkutan formulering versus Herceptin intravenøs formulering baseret på co-primære farmakokinetiske- og virkningsendepunkter (henholdsvis Ctrough af trastuzumab før dosis i serie 8 og hyppigheden af patologisk fuldstændigt respons ved definitiv operation) (se pkt.
English: NAME OF THE MEDICINAL PRODUCT Herceptin 150 mg powder for concentrate for solution for infusion
Danish: LÆGEMIDLETS NAVN Herceptin 150 mg pulver til koncentrat til infusionsvæske, opløsning
English: A faint/barely perceptible membrane staining is detected in > 10 % of the tumour cells.
Danish: Svag/lige akkurat synlig membranfarvning detekteres i > 10 % af tumorcellerne.
English: 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) 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 længerevarende 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: In patients with EBC an increase in the incidence of symptomatic and asymptomatic cardiac events was observed when Herceptin (intravenous formulation) was administered after anthracyclinecontaining chemotherapy compared to administration with a non-anthracycline regimen of docetaxel and carboplatin and was more marked when Herceptin (intravenous formulation) was administered concurrently with taxanes than when administered sequentially to taxanes.
Danish: Hos patienter med tidlig brystkræft er der blevet observeret øget hyppighed af symptomatiske og asymptomatiske kardielle bivirkninger, når Herceptin (intravenøs formulering) blev administreret efter antracyklin-baseret kemoterapi sammenlignet med administration af et ikke-antracyklin-baseret regime med docetaxel og carboplatin.
English: Other 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 er: Utilpashedsfølelse (kvalme), opkastning, smerter, forøget muskelspænding og rystelser, hovedpine, svimmelhed, besvær med at trække vejret, hiven efter vejret, forhøjet eller for lavt blodtryk, forstyrrelser i hjerterytmen (hjertebanken, flakkende hjerte eller uregelmæssig hjerterytme), hævelse i ansigtet og læberne, udslæt og træthedsfølelse.