FrancophonIA/ELRC3.0 huggingface dataset:
English: - cisplatin - 80 mg/m every 3 weeks for 6 cycles on day 1 of each cycle.
Danish: - cisplatin - 80 mg/m hver 3. uge i 6 serier på dag 1 i hver serie.
English: In the BCIRG 006 study, trastuzumab was administered either in combination with docetaxel, following AC chemotherapy (AC→DH) or in combination with docetaxel and carboplatin (DCarbH).
Danish: I BCIRG 006-studiet blev trastuzumab administreret enten i kombination med docetaxel efter AC-kemoterapi (AC→DH) eller i kombination med docetaxel og carboplatin (DCarbH).
English: Dedicated pharmacokinetic studies in the elderly and those with renal or hepatic impairment have not been carried out.
Danish: Egentlige farmakokinetiske studier hos æ ldre og hos personer med nedsat nyre- eller leverfunktion er ikke udført.
English: Norge Orion Pharma AS
Danish: Danmark Orion Pharma A/S
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 Herzuma.
Danish: Hos patienter med tidlig brystkræ ft 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 Herzuma.
English: Patients with EBC should be treated with Herzuma for 1 year or until disease recurrence, whichever occurs first; extending treatment in EBC beyond one year is not recommended (see section 5.1).
Danish: Patienter med tidlig brystkræ ft bør behandles med Herzuma i 1 år, eller indtil sygdommen recidiverer afhæ ngigt af, hvad der forekommer først; forlæ ngelse af behandling af tidlig brystkræ ft udover et år anbefales ikke (se pkt.
English: In the BCIRG 006 study, HER2 positive, EBC was defined as either lymph node positive or high risk node negative patients with no (pN0) lymph node involvement, and at least 1 of the following factors: tumour size greater than 2 cm, estrogen receptor and progesterone receptor negative, histological and/or nuclear grade 2 - 3, or age < 35 years.
Danish: I BCIRG 006-studiet var HER2-positiv tidlig brystkræ ft defineret som brystkræ ft hos enten patienter med positive lymfeknuder eller hos højrisiko-patienter med negative lymfeknuder, hvor ingen (pN0) lymfeknude var involveret og mindst 1 af følgende faktorer: tumorstørrelse større end 2 cm, østrogenreceptor- og progesteronreceptor-negative, histologisk og/eller kernegrad 2 - 3 eller alder <35 år.
English: Volume (mL) = Body weight (kg) x dose (8 mg/kg for loading or 6 mg/kg for maintenance) 21 (mg/mL, concentration of reconstituted solution)
Danish: Volumen (ml) = Legemsvæ gt (kg) x dosis (8 mg/kg som støddosis eller 6 mg/kg til vedligeholdelse) 21 (mg/ml, koncentration af rekonstitueret opløsning)
English: Each vial contains 150 mg trastuzumab that has to be dissolved in 7.2 mL of water for injection.
Danish: Hvert hætteglas indeholder 150 mg trastuzumab, som skal opløses i 7,2 ml vand til injektionsvæ sker.
English: Patients who had previously received anthracycline-based adjuvant chemotherapy were treated with paclitaxel (175 mg/m infused over 3 hours) with or without trastuzumab.
Danish: Patienter, som tidligere har fået antracyklinbaseret adjuverende kemoterapi, blev behandlet med paclitaxel (175 mg/m infunderet over
English: The pre-planned final analysis of OS from the joint analysis of studies NSABP B-31 and NCCTG N9831 was performed when 707 deaths had occurred (median follow-up 8.3 years in the AC→PH
Danish: Den på forhånd planlagte endelige analyse af samlet overlevelse fra den samlede analyse af NSABP B-31- og NCCTG N9831-studierne blev udført, da 707 dødsfald var forekommet (median opfølgningstid var 8,3 år i AC→PH-gruppen).
English: If possible, physicians should avoid anthracycline-based therapy for up to 7 months after stopping Herzuma.
Danish: Antracyklin-baseret behandling bør så vidt muligt undgås i op til 7 måneder efter ophør af Herzuma-behandlingen.
English: - intravenous cyclophosphamide, at 600 mg/m over 30 minutes, given every 3 weeks for
Danish: - intravenøs cyclophosphamid på 600 mg/m over 30 minutter, administreret hver 3. uge i
English: Early breast cancer (adjuvant setting)
Danish: Tidlig brystkræ ft (adjuverende behandling)
English: Chemo only (n=116)
Danish: Kemo alene (n = 116)
English: The non-linear elimination parameter values were 8.81 mg/day for the maximum elimination rate (Vmax) and 8.92 μg/mL for the Michaelis-Menten constant (Km) for the MBC, EBC and AGC patients.
Danish: De ikke-lineæ re 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 brystkræ ft, tidlig brystkræ ft eller fremskreden ventrikelkræ ft.
English: If the patient has missed a dose of Herzuma by one week or less, then the usual maintenance dose (weekly regimen: 2 mg/kg; three-weekly regimen: 6 mg/kg) should be administered as soon as possible.
Danish: Hvis patienten undlader en dosis af Herzuma i en uge eller mindre, bør den sæ dvanlige vedligeholdelsesdosis (ugentligt doseringsregime: 2 mg/kg; 3-ugers doseringsregime: 6 mg/kg) administreres så hurtigt som muligt.
English: Volume (mL) = Body weight (kg) x dose (4 mg/kg for loading or 2 mg/kg for maintenance) 21 (mg/mL, concentration of reconstituted solution)
Danish: Volumen (ml) = Legemsvæ gt (kg) x dosis (4 mg/kg som støddosis eller 2 mg/kg til vedligeholdelse) 21 (mg/ml, koncentration af rekonstitueret opløsning)
English: 150 mg Unopened vial
Danish: 150 mg Uåbnet hæ tteglas
English: Refer to the SmPC for paclitaxel, docetaxel or aromatase inhibitor for information on dose reduction or delays.
Danish: Se produktresuméet for paclitaxel, docetaxel eller aromatasehæ mmer for information om reduktion af dosis eller udsæ ttelse af behandlingen.
English: MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Danish: FREMSTILLER AF DET BIOLOGISK AKTIVE STOF OG FREMSTILLERE ANSVARLIGE FOR BATCHFRIGIVELSE
English: Table 15 Population predicted steady state PK exposure values (median with 5
Danish: Tabel 15: Populationsforudsagte steady-state farmakokinetiske eksponeringsvæ rdier (med
English: L-histidine hydrochloride L-histidine α,α-trehalose dihydrate Polysorbate 20
Danish: L-histidinhydrochlorid L-histidin -trehalosedihydrat polysorbat 20
English: p-value versus AC→P
Danish: p-væ rdi versus AC→P
English: Patients are eligible for Herzuma treatment if they show strong HER2 overexpression as described by a 3+ score by IHC or a positive FISH or CISH result.
Danish: Patienterne er valgbare for behandling med Herzuma, hvis de udviser stæ rk overekspression af HER2, som beskrevet med en 3+ score ved IHC eller et positivt FISH eller CISH resultat.
English: Do not use Herzuma if you notice any particulate matter or discoloration prior to administration.
Danish: Brug ikke Herzuma hvis du bemæ rker nogle partikler eller misfarvning inden brug.
English: In the neoadjuvant setting, the experience of concurrent administration of trastuzumab and low dose anthracycline regimen is limited (see section 4.4).
Danish: Ved neoadjuverende behandling er erfaringen med samtidig administration af trastuzumab og et lavdosis antracyklin-regime begræ nset (se pkt.
English: Herzuma is a biosimilar medicinal product.
Danish: Herzuma er et biosimilæ rt læ gemiddel.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Danish: NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØ RINGSTILLADELSEN
English: Disease-free survival No. patients with event (%)
Danish: Sygdomsfri overlevelse - Antal patienter med en hæ ndelse (%)
English: Duration of response, median months
Danish: Responsvarighed Median måneder
English: 420 mg Unopened vial
Danish: 420 mg Uåbnet hæ tteglas
English: Parenteral medicinal products should be inspected visually for particulate matter and discoloration prior to administration.
Danish: Parenterale læ gemidler skal inspiceres visuelt for partikler og misfarvning inden administration.
English: If symptomatic cardiac failure develops during Herzuma therapy, it should be treated with standard medicinal products for CHF.
Danish: Symptomatisk hjerteinsufficiens opstået under behandling med Herzuma bør behandles med standardbehandling af kongestiv hjerteinsufficiens.
English: Early breast cancer in the HERA trial was limited to operable, primary, invasive adenocarcinoma of the breast, with axillary nodes positive or axillary nodes negative if tumours at least 1 cm in diameter.
Danish: Tidlig brystkræ ft i HERA-studiet var begræ nset til operabel, primæ r, invasiv adenokarcinom i brystet med positive lymfeknuder i aksillen, eller med negative lymfeknuder i aksillen, hvis tumoren var mindst 1 cm i diameter.
English: Herzuma is indicated for the treatment of adult patients with HER2 positive early breast cancer (EBC):
Danish: Herzuma er indiceret til behandling af voksne patienter med HER2-positiv tidlig brystkræ ft:
English: After reconstitution, 1 mL concentrate contains 21 mg of trastuzumab.
Danish: Efter rekonstitution indeholder 1 ml koncentrat 21 mg trastuzumab.
English: Death (OS event): No. patients with event (%)
Danish: Død (OS-hæ ndelse): Antal patienter med en hæ ndelse (%)
English: Despite the crossover to trastuzumab in the control arm, the addition of trastuzumab to paclitaxel chemotherapy resulted in a 52% decrease in the risk of disease recurrence.
Danish: På trods af overkrydsning til trastuzumab i kontrolarmen resulterede tilføjelse af trastuzumab til paclitaxel-kemoterapi i en 52 % nedsæ ttelse af risikoen for sygdomstilbagefald.
English: Faint ⁄ barely perceptible membranous reactivity in ≥ 10% of tumour cells; cells are reactive only in part of their membrane
Danish: 1+ En svag/lige akkurat synlig membranøs reaktivitet i ≥10 % af tumorcellerne; cellerne er kun reaktive i dele af deres membran
English: SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
Danish: EVENTUELLE SÆ RLIGE FORHOLDSREGLER VED BORTSKAFFELSE AF IKKE ANVENDT LÆ GEMIDDEL SAMT AFFALD HERAF
English: In the pivotal trials (H0648g, M77001), paclitaxel or docetaxel was administered the day following the first dose of trastuzumab (for dose, see the Summary of Product Characteristics (SmPC) for paclitaxel or docetaxel) and immediately after the subsequent doses of trastuzumab if the preceding dose of trastuzumab was well tolerated.
Danish: I de pivotale studier (H0648g, M77001) blev paclitaxel eller docetaxel administreret dagen efter den første trastuzumab-dosis (se dosis i produktresuméet for paclitaxel eller docetaxel).
English: Metabolism and nutrition disorders
Danish: Metabolisme og ernæring Vægttab
English: If the patient has missed a dose of Herzuma by more than one week, a re-loading dose of Herzuma should be administered over approximately 90 minutes (weekly regimen: 4 mg/kg; three-weekly regimen: 8 mg/kg) as soon as possible.
Danish: Hvis patienten undlader en dosis af Herzuma i mere end en uge, bør der administreres en ny støddosis af Herzuma over ca. 90 minutter (ugentligt doseringsregime: 4 mg/kg; 3-ugers doseringsregime:
English: Do not take Herzuma if:  you are allergic to trastuzumab, to murine (mouse) proteins or 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 Herzuma (angivet i punkt 6).
English: Table 1 Undesirable effects reported with intravenous trastuzumab monotherapy or in combination with chemotherapy in pivotal clinical trials (N = 8386) and in post-marketing
Danish: Bivirkninger rapporteret med intravenøs trastuzumab-monoterapi eller i kombination med kemoterapi i pivotale kliniske studier (N = 8.386) samt efter markedsføring.
English: Median follow-up 8 years**
Danish: Median opfølgning 12 måneder* Median opfølgning 8 år**
English: In the pivotal trial MO16432, trastuzumab was administered concurrently with neoadjuvant chemotherapy containing three cycles of doxorubicin (cumulative dose 180 mg/m
Danish: I det pivotale studie, MO16432 blev trastuzumab administreret samtidig med neoadjuverende kemoterapi, som indeholdt 3 serier af doxorubicin (kumulativ dosis 180 mg/m
English: If LVEF has not improved, or has declined further, or if symptomatic congestive heart failure (CHF) has developed, discontinuation of Herzuma 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 Herzuma-behandlingen, medmindre fordelene for den enkelte patient anses at opveje risiciene.
English: Trastuzumab has been used in clinical trials as monotherapy for patients with MBC who have tumours that overexpress HER2 and who have failed one or more chemotherapy regimens for their metastatic disease (trastuzumab alone).
Danish: Trastuzumab er blevet anvendt i kliniske studier som monoterapi til patienter med metastatisk brystkræ ft, som har tumorer, som viser overekspression af HER2, og hvis metastatiske sygdom ikke har responderet på et eller flere kemoterapiregimer (trastuzumab alene).
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 tumour types, and healthy volunteers, in 18 Phase I, II and III trials receiving trastuzumab intravenous.
Danish: Trastuzumabs farmakokinetik blev evalueret i en populationsfarmakokinetisk model-analyse ved brug af puljede data fra 1.582 forsøgspersoner, som fik trastuzumab intravenøst, inkluderende patienter med HER2-positiv metastatisk brystkræ ft, tidlig brystkræ ft, fremskreden ventrikelkræ ft eller andre tumortyper, og raske forsøgspersoner, i 18 fase I-, II- og III-studier.
English: Primary tumour type
Danish: Primæ r tumor type
English: Based on the clinical trial results, the beneficial effects were limited to patients with the highest level of HER2 protein overexpression, defined by a 3+ score by IHC, or a 2+ score by IHC and a positive FISH result.
Danish: De gavnlige effekter, baseret på det kliniske studies resultater, var begræ nset til patienter med de højeste niveauer af overekspression af HER2-proteinet, defineret ved et 3+ score ved IHC eller 2+ score ved IHC og et positivt FISH- resultat.
English: CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Danish: BETINGELSER ELLER BEGRÆ NSNINGER MED HENSYN TIL SIKKER OG EFFEKTIV ANVENDELSE AF LÆ GEMIDLET
English: Trastuzumab is a recombinant humanised IgG1 monoclonal antibody against the human epidermal growth factor receptor 2 (HER2).
Danish: Trastuzumab er et rekombinant humant IgG1 monoklonalt antistof mod den humane epidermale væ kstfaktorreceptor 2 (HER2).
English: Herzuma is indicated for the treatment of adult patients with HER2 positive metastatic breast cancer (MBC):
Danish: Herzuma er indiceret til behandling af voksne patienter med HER2-positiv metastatisk brystkræ ft:
English: In the NSABP B-31 and NCCTG N9831 studies, trastuzumab was administered in combination with paclitaxel, following AC chemotherapy.
Danish: I NSABP B-31- og NCCTG N9831 -studierne blev trastuzumab administreret i kombination med paclitaxel efter AC-kemoterapi.
English: Symptoms may include kidney problems (weakness, shortness of breath, fatigue and confusion), heart problems (fluttering of the heart or a faster or slower heartbeat), seizures, vomiting or diarrhoea and tingling in the mouth, hands or feet
Danish: Symptomerne kan væ re nyreproblemer (svaghed, åndenød, træ thed og forvirring), hjerteproblemer (hjerteflagren eller en hurtigere eller langsommere hjerterytme), krampeanfald, opkast eller diarré, og prikkende fornemmelse i munden, på hæ nderne eller fødderne.
English: Herzuma is a powder for concentrate for solution for intravenous infusion, which is supplied in a glass vial with a rubber stopper containing 150 mg of trastuzumab.
Danish: Herzuma er et pulver til koncentrat til intravenøs infusionsvæ ske, opløsning, som bliver leveret i et hæ tteglas med en gummiprop, og indeholder 150 mg trastuzumab.
English: In the post-marketing setting, cases of foetal renal growth and/or function impairment in association with oligohydramnios, some associated with fatal pulmonary hypoplasia of the foetus, have been reported in pregnant women receiving trastuzumab.
Danish: Efter markedsføringen er der blevet rapporteret tilfæ lde af føtal nyrevæ kstsnedsæ ttelse og/eller nyrefunktionsnedsæ ttelse i forbindelse med oligohydramnion hos gravide kvinder, der får trastuzumab.
English: The median overall survival for the high HER2 expressing group was 11.8 months versus 16 months, HR 0.65 (95% CI 0.51 - 0.83) and the median progression free survival was 5.5 months versus 7.6 months, HR 0.64 (95% CI 0.51 - 0.79) for FP versus FP + H, respectively.
Danish: Den mediane samlede overlevelse for den høje HER2-ekspressionsgruppe var 11,8 måneder versus 16 måneder, hazard ratio 0,65 (95 % konfidensinterval 0,51 - 0,83), og den mediane progressionsfri overlevelse var 5,5 måneder versus 7,6 måneder, hazard ratio 0,64 (95 % konfidensinterval 0,51 - 0,79) for henholdsvis FP og FP+H.
English: A: doxorubicin; C: cyclophosphamide; P: paclitaxel; H: trastuzumab * 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: A: doxorubicin; C: cyclophosphamid; P: paclitaxel; H: trastuzumab * Ved median opfølgningstid, som var 1,8 år for patienterne i AC→P-armen og 2,0 år for patienterne i AC→PH- armen.
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 Herzuma.
Danish: Under 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 Herzuma.
English: Patients experiencing dyspnoea at rest due to complications of advanced malignancy and comorbidities may be at increased risk of a fatal infusion reaction.
Danish: Patienter, som oplever hviledyspnø på grund af komplikationer fra avanceret malignitet og comorbiditet, har muligvis forhøjet risiko for letale infusionsreaktioner.
English: Pharmacokinetic data from studies BO15935 and M77004 in women with HER2-positive MBC suggested that exposure to paclitaxel and doxorubicin (and their major metabolites 6-α hydroxyl-paclitaxel, POH, and doxorubicinol, DOL) was not altered in the presence of trastuzumab (8 mg/kg or 4 mg/kg intravenous loading dose followed by 6 mg/kg q3w or 2 mg/kg q1w intravenous, respectively).
Danish: Farmakokinetiske data fra BO15935- og M77004-studierne udført med kvinder med HER2-positiv metastatisk brystkræ ft tydede på, at eksponeringen for paclitaxel og doxorubicin (og hovedmetabolitterne 6-α-hydroxyl-paclitaxel, POH og doxorubicinol, DOL) ikke blev æ ndret ved tilstedevæ relse af trastuzumab (henholdsvis 8 mg/kg eller 4 mg/kg intravenøs støddosis efterfulgt af 6 mg/kg hver 3. uge eller 2 mg/kg intravenøst hver uge).
English: The recommended initial loading dose is 8 mg/kg body weight.
Danish: Den anbefalede initiale støddosis er 8 mg/kg legemsvæ gt.
English: Febrile neutropenia, leukopenia, anaemia, thrombocytopenia and neutropenia occurred very commonly.
Danish: Febril neutropeni, leukopeni, anæ mi, trombocytopeni og neutropeni forekom med hyppigheden ”meget almindelig”.
English: A: doxorubicin; C: cyclophosphamide; P: paclitaxel; D: docetaxel; Carb: carboplatin; H: trastuzumab; CI = confidence interval * At the time of the definitive analysis of DFS.
Danish: A: doxorubicin; C: cyclophosphamid; P: paclitaxel; D: docetaxel; Carb: carboplatin; H: trastuzumab * På tidspunktet for den endelige analyse af sygdomsfri overlevelse.
English: No disease-free survival (DFS) benefit was noticed in this subgroup of patients (hazard ratio = 1.16, 95% CI [0.73, 1.83] for DCarbH (TCH) versus AC→D (AC→T); hazard ratio = 0.97, 95% CI [0.60, 1.55] for AC→DH (AC→TH) versus AC→D).
Danish: Der blev ikke set nogen gavnlig effekt mht. sygdomsfri overlevelse i denne undergruppe af patienter (hazard ratio = 1,16, 95 % konfidenceinterval [0,73-1,83] for DCarbH (TCH) versus AC→D (AC→T); hazard ratio = 0,97, 95 % konfidenceinterval [0,60-1,55] for AC→DH (AC→TH) versus AC→D).
English: A 20 mL clear glass type I vial with fluroTec-coated butyl rubber stopper containing 150 mg of trastuzumab.
Danish: Et 20 ml klart type I hæ tteglas med fluroTec-belagt butylgummiprop, som indeholder 150 mg trastuzumab.
English: This can lead to symptoms such as breathlessness (including breathlessness at night), cough, fluid retention (swelling) in the legs or arms, palpitations (heart fluttering or irregular heart beat) (see 2.
Danish: Dette kan medføre symptomer som åndenød (herunder åndenød om natten), hoste, væ skeretention (hæ velser) i ben eller arme, og hjertebanken (hjerteflagren eller uregelmæ ssig hjerterytme) (se afsnit 2 ”Kontrol af hjertet”).
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 trastuzumab (see section 4.4).
Danish: Der er observeret symptomer på kardiel dysfunktion såsom dyspnø, ortopnø, tiltagende hoste, lungeødem, S3-galoprytme eller nedsat ventrikulæ r ejektionsfraktion hos patienter behandlet med trastuzumab (se pkt.
English: One vial contains 150 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 150 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: - The BCIRG 006 study was designed to investigate combining trastuzumab 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 trastuzumab-behandling med docetaxel efter AC-kemoterapi eller i kombination med docetaxel og carboplatin hos patienter med HER2-positiv tidlig brystkræ ft efter operation.
English: Weekly dosing in metastatic breast cancer
Danish: Ugentligt doseringsregime ved metastatisk brystkræ ft
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 trastuzumab and therefore treatment cannot be recommended in such patients.
Danish: Patienter blev ekskluderet fra de pivotale studier med trastuzumab til adjuverende og neoadjuverende tidlig brystkræ ft, hvis de havde en anamnese med myokardieinfarkt, angina pectoris, der kræ vede medicinsk behandling, tidligere eller eksisterende kongestiv hjerteinsufficiens (NYHA-klasse II-IV), LVEF <55 %, anden kardiomyopati, hjertearytmi, der kræ ver medicinsk behandling, klinisk signifikant hjerteklapsygdom, dårligt kontrolleret hypertension (hvis hypertensionen var kontrolleret på almindelig medicinsk behandling, kunne patienten få præ paratet) og hæ modynamisk effektiv perikardie-effusion.