FrancophonIA/ELRC3.0 huggingface dataset:
English: Parenteral medicinal products should be inspected visually for particulate matter and discoloration prior to administration.
Danish: Parenterale lægemidler skal inspiceres visuelt for partikler og misfarvning inden administration.
English: - in combination with neoadjuvant chemotherapy followed by adjuvant Trazimera therapy, for locally advanced (including inflammatory) disease or tumours > 2 cm in diameter (see sections 4.4 and 5.1).
Danish: i kombination med neoadjuverende kemoterapi efterfulgt af adjuverende Trazimera-behandling for lokalt avanceret (herunder inflammatorisk) sygdom eller tumorer > 2 cm i diameter (se pkt.
English: If LVEF percentage drops ≥10 points from baseline AND to below 50%, treatment should be suspended and a repeat LVEF assessment performed within approximately 3 weeks.
Danish: Ved et fald i LVEF-procenten på ≥ 10 point fra baseline OG til under 50 %, bør behandlingen seponeres, og en ny LVEF-måling udføres inden for ca. 3 uger.
English: In general, SISH or FISH is considered positive if the ratio of the HER2 gene copy number per tumour cell to the chromosome 17 copy number is greater than or equal to 2.
Danish: Generelt anses SISH eller FISH for at være positive, hvis forholdet mellem antallet af HER2genkopier per tumorcelle og antallet af kromosom 17-kopier er større end eller lig med 2.
English: A: doxorubicin; C: cyclophosphamide; P: paclitaxel; H: trastuzumab
Danish: A: doxorubicin; C: cyclophosphamid; P: paclitaxel; H: trastuzumab
English: Patients with EBC should be treated with Trazimera 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 brystkræft bør behandles med Trazimera i 1 år, eller indtil sygdommen recidiverer afhængigt af, hvad der forekommer først; forlængelse af behandling af tidlig brystkræft udover et år anbefales ikke (se pkt.
English: Combination treatment with trastuzumab and anastrozole Trastuzumab has been studied in combination with anastrozole for first line treatment of MBC in HER2 overexpressing, hormone-receptor (i.e. oestrogen-receptor (ER) and/or progesterone-receptor (PR)) positive postmenopausal patients.
Danish: Kombinationsbehandling med trastuzumab og anastrozol Trastuzumab er blevet undersøgt i kombination med anastrozol ved 1. linjebehandling af metastatisk brystkræft hos HER2-positive, hormon-receptor-positive (dvs. østrogen-receptor og/eller progesteronreceptor) postmenopausale patienter.
English: In vitro, trastuzumabmediated ADCC has been shown to be preferentially exerted on HER2 overexpressing cancer cells compared with cancer cells that do not overexpress HER2.
Danish: Det er vist in vitro, at trastuzumab-medieret ADCC fortrinsvis virker på cancerceller med overekspression af HER2 sammenlignet med celler, som ikke har overekspression af HER2.
English: In patients with EBC eligible for neoadjuvant-adjuvant treatment, Trazimera should be used concurrently with anthracyclines only in chemotherapy-naive patients and only with low-dose anthracycline regimens i.e. maximum cumulative doses of doxorubicin 180 mg/m2 or epirubicin
Danish: Hos patienter med tidlig brystkræft, som er egnede til neoadjuverende-adjuverende behandling, bør Trazimera kun bruges samtidig med antracykliner hos kemoterapi-naive patienter og kun i regimer med lave antracyklindoser dvs. maksimale kumulative doser af doxorubicin 180 mg/m2 eller epirubicin 360 mg/m
English: Women of childbearing potential should be advised to use effective contraception during treatment with Trazimera and for 7 months after treatment has concluded (see section 5.2).
Danish: Kvinder i den fertile alder skal rådes til at bruge sikker prævention under behandlingen med Trazimera og i 7 måneder efter afslutning af behandlingen (se pkt.
English: The exploratory analyses of covariates with information in only a subset of patients suggested that patients with greater shed HER2-ECD level had faster nonlinear clearance (lower Km) (P < 0.001).
Danish: Cirkulerende shed HER2 ekstracellulære domæne De eksplorative analyser af kovarianter fra en patientundergruppe tydede på, at patienter med forhøjet niveau af shed HER2-ekstracellulære domæne havde en hurtigere ikke-lineær clearance (lavere Km) (p<0,001).
English: The frequency of progression in the liver was significantly reduced in patients treated with the combination of trastuzumab and paclitaxel, compared to paclitaxel alone (21.8% versus 45.7%;
Danish: Hyppigheden af progression i leveren var signifikant lavere hos patienter, som blev behandlet med kombinationen af trastuzumab og paclitaxel sammenlignet med paclitaxel alene (21,8 % versus 45,7 %, p = 0,004).
English: 1) Using a sterile syringe, slowly inject the appropriate volume (as noted above) of sterile water for injections in the vial containing the lyophilised Trazimera.
Danish: 1) Anvend en steril sprøjte og injicer langsomt det passende volumen (som angivet ovenfor) sterilt vand til injektionsvæsker i hætteglasset, som indeholder det frysetørrede Trazimera.
English: In study BCIRG 006, 213/1075 patients in the DCarbH (TCH) arm, 221/1074 patients in the AC→DH (AC→TH) arm, and 217/1073 in the AC→D (AC→T) arm had a Karnofsky performance status ≤90 (either 80 or 90).
Danish: I BCIRG 006-studiet havde 213/1.075 patienter i DCarbH (TCH)-armen, 221/1.074 patienter i AC→DH (AC→TH)-armen og 217/1.073 patienter i AC→D (AC→T)-armen en Karnofsky performance status ≤ 90 (enten 80 eller 90).
English: Event-free survival
Danish: Hændelsesfri overlevelse
English: Trazimera in combination with capecitabine or 5-fluorouracil and cisplatin is indicated for the treatment of adult patients with HER2 positive metastatic adenocarcinoma of the stomach or gastrooesophageal junction who have not received prior anti-cancer treatment for their metastatic disease.
Danish: Trazimera er, i kombination med capecitabin eller 5-fluoruracil og cisplatin, indiceret til behandling af voksne patienter med HER2-positivt metastatisk adenokarcinom i ventriklen eller den gastroøsofageale overgang, som ikke tidligere har fået anticancer-behandling for deres metastatiske sygdom.
English: Discard at the end of this 3-month period or by the expiry date on the vial, whichever occurs first.
Danish: Bortskaf efter perioden på 3 måneder eller efter udløbsdatoen, som er angivet på hætteglasset, alt efter hvad der indtræffer først.
English: In 3 pivotal clinical trials of adjuvant trastuzumab 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 (i.e., did not receive trastuzumab) and in patients who were administered trastuzumab sequentially after a taxane (0.3-0.4%).
Danish: I 3 pivotale kliniske studier, hvor adjuverende trastuzumab 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 trastuzumab), som hos patienter, der fik trastuzumab sekventielt efter et taxan (0,3-0,4 %).
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: Behandling med AC→PH resulterede i en statistisk signifikant forbedring af samlet overlevelse sammenlignet med AC→P (stratificeret hazard ratio = 0,64; 95 % konfidensinterval = 0,55-0,74; log-rank p-værdi < 0,0001).
English: Causing excessive foaming during reconstitution or shaking the reconstituted Trazimera may result in problems with the amount of Trazimera that can be withdrawn from the vial.
Danish: Stærk skumdannelse under rekonstitueringen eller omrysten af det rekonstituerede Trazimera kan medføre problemer med hensyn til den mængde Trazimera, der kan trækkes op af hætteglasset.
English: Patients are eligible for Trazimera 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 Trazimera, hvis de udviser stærk overekspression af HER2, som beskrevet med en 3+ score ved IHC eller et positivt FISH eller CISH resultat.
English: Any remaining reconstituted solution should be discarded.
Danish: Overskydende rekonstitueret opløsning skal bortskaffes.
English: If you develop any signs of heart failure (inadequate pumping of blood by the heart), 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 Trazimera treatment.
Danish: Hvis du udvikler tegn på hjertesvigt (dårlig pumpefunktion af hjertet), kan din hjertefunktion blive undersøgt oftere (hver 6. til 8. uge).
English: If possible, physicians should avoid anthracycline-based therapy for up to 7 months after stopping trastuzumab.
Danish: Antracyklin-baseret behandling bør så vidt muligt undgås i op til 7 måneder efter ophør af trastuzumab-behandlingen.
English: Trazimera intravenous formulation is not for subcutaneous use and should be given as an intravenous infusion only.
Danish: Trazimera-intravenøs formulering er ikke beregnet til subkutan brug og må kun gives som en intravenøs infusion.
English: In the joint analysis of the NSABP B-31 and NCCTG N9831 studies, EBC was limited to women with operable breast cancer at high risk, defined as HER2-positive and axillary lymph node positive or HER2 positive and lymph node negative with high risk features (tumour size > 1 cm and ER negative or tumour size >2 cm, regardless of hormonal status).
Danish: I den samlede analyse af NSABP B-31- og NCCTG N9831-studierne var tidlig brystkræft begrænset til kvinder med operabel brystkræft med høj risiko, defineret som HER2-positiv og med positive lymfeknuder i aksillen eller HER2-positiv og med negative lymfeknuder i aksillen med høje risikofaktorer (tumorstørrelse > 1 cm og ER-negativ eller tumorstørrelse > 2 cm, uanset hormonstatus).
English: • dry eyes
Danish: Tørre øjne
English: In order to prevent medication errors it is important to check the vial labels to ensure that the drug being prepared and administered is Trazimera (trastuzumab) and not Kadcyla (trastuzumab emtansine).
Danish: For at forebygge fejlmedicinering er det vigtigt at kontrollere hætteglassets etiket for at sikre, at det lægemiddel, der klargøres og administreres, er Trazimera (trastuzumab) og ikke Kadcyla (trastuzumabemtansin).
English: Causing excessive foaming during reconstitution or shaking the reconstituted solution may result in problems with the amount of Trazimera that can be withdrawn from the vial.
Danish: Stærk skumning under rekonstitueringen eller omrysten af den rekonstituerede opløsning kan medføre problemer med hensyn til den mængde Trazimera, der kan trækkes ud af hætteglasset.
English: Reproduction studies have been conducted in Cynomolgus monkeys at doses up to 25 times that of the weekly human maintenance dose of 2 mg/kg trastuzumab intravenous formulation and have revealed no evidence of impaired fertility or harm to the foetus.
Danish: Reproduktionsstudier er blevet udført på cynomolgusaber med doser, der er op til 25 gange højere end den humane ugentlige vedligeholdelsesdosis på 2 mg/kg intravenøst formuleret trastuzumab, og har ikke vist tegn på nedsat fertilitet eller skader på fostret.
English: In study BO16348, after a median follow-up of 8 years the incidence of severe CHF (NYHA Class III & IV) in the trastuzumab 1 year treatment arm was 0.8%, and the rate of mild symptomatic and asymptomatic left ventricular dysfunction was 4.6%.
Danish: I studie BO16348 var incidensen af svær kongestiv hjerteinsufficiens (NYHA III & IV) efter 1 års trastuzumab-behandling 0,8 % efter en median opfølgning på 8 år, og hyppigheden af let symptomatisk og asymptomatisk dysfunktion af venstre ventrikel var 4,6 %.
English: For overall survival, the HR was 0.75 (95% CI 0.51-1.11) in the IHC 2+/FISH+ group and the HR was 0.58 (95% CI 0.41-0.81) in the IHC 3+/FISH+ group.
Danish: For den samlede overlevelse var hazard ratio 0,75 (95 % konfidensinterval 0,51-1,11) i IHC2+/FISH+ gruppen og 0,58 (95 % konfidensinterval 0,41-0,81) i ICH3+/FISH+ gruppen.
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-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: No reactivity or membranous reactivity in <10% of tumour cells
Danish: Ingen reaktivitet eller membranøs reaktivitet i < 10 % af tumorcellerne
English: - capecitabine - 1000 mg/m 2 orally twice daily for 14 days every 3 weeks for 6 cycles (evening of day 1 to morning of day 15 of each cycle)
Danish: - capecitabin - 1.000 mg/m 2 oralt 2 gange dagligt i 14 dage hver 3. uge i 6 serier (aften på dag 1 til morgen på dag 15 i hver serie)
English: The median duration of follow up was 2.9 years in the AC→D arm and 3.0 years in each of the AC→DH and DCarbH arms.
Danish: Den mediane opfølgningstid var 2,9 år i AC→D-armen og 3,0 år i hver af AC→DH og DCarbH-armene.
English: Disease-free survival No. patients with event (%)
Danish: Sygdomsfri overlevelse - Antal patienter med en hændelse (%)
English: Duration of Response, Median months
Danish: Responsvarighed Median måneder
English: Once the infusion is prepared it should be administered immediately.
Danish: Når infusionsvæsken først er fremstillet skal den anvendes med det samme.
English: In the neoadjuvant-adjuvant EBC study (BO22227), at a median follow-up exceeding 70 months, 10.1% (30/296) of patients treated with trastuzumab 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 trastuzumab antistoffer mod trastuzumab ved en median opfølgningstid på mere end 70 måneder.
English: A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLERE AF DET BIOLOGISK AKTIVE STOF OG FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE
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→P H group).
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: Studies of HER2-positivity rates in gastric cancer (GC) using immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH) or chromogenic in situ hybridization (CISH) have shown that there is a broad variation of HER2-positivity ranging from 6.8% to 34.0% for IHC
Danish: Studier af HER2-positivitetsrater ved ventrikelkræft ved brug af immunhistokemi (IHC) og fluorescens in situ hybridisering (FISH) eller kromogen in situ hybridisering (CISH) har vist, at der er udstrakt variation af HER2-positivitet, som rækker fra 6,8 % til 34,0 % for IHC og 7,1 % til 42,6 % for FISH.
English: Solutions of Trazimera for intravenous infusion are physically and chemically stable in polyvinylchloride, polyethylene, polypropylene or ethylene vinyl acetate bags, or glass intravenous bottles, containing sodium chloride 9 mg/mL (0.9%) solution for injection for 24 hours at temperatures not exceeding 30°C.
Danish: Trazimera-opløsninger til infusion er fysisk og kemisk stabile i polyvinylchlorid-, polyethylen-, polypropylen- eller etylen-vinylacetatposer eller glasflasker, som indeholder natriumchlorid 9 mg/ml (0,9 %) injektionsvæske, opløsning, i 24 timer ved temperaturer, som ikke overstiger 30 °C.
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 ACkemoterapi (AC→DH) eller i kombination med docetaxel og carboplatin (DCarbH).
English: - Study BO16348 was designed to compare one and two years of three-weekly trastuzumab treatment versus observation in patients with HER2 positive EBC following surgery, established chemotherapy and radiotherapy (if applicable).
Danish: Studie BO16348 var designet til at sammenligne 1 og 2-års trastuzumab-behandling hver 3. uge versus observation hos patienter med HER2-positiv tidlig brystkræft efter operation, standardkemoterapi og strålebehandling (hvis indiceret).
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: Tag ikkeTrazimera, hvis: du er allergisk over for trastuzumab, murine proteiner (fra mus) eller etaf de øvrige indholdsstofferi medicinen (angivet i punkt 6).
English: AUC0-21days (µg.day/mL)
Danish: AUC0-21 dage (mikrogram.dag/ml)
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 Trazimera.
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 Trazimera.
English: Patients were recruited to the trial who were previously untreated for HER2-positive inoperable locally advanced or recurrent and/or metastatic adenocarcinoma of the stomach or gastrooesophageal junction not amenable to curative therapy.
Danish: Patienterne, som blev inkluderet i studiet, var tidligere ubehandlet for HER2-positiv, inoperabel, lokalt fremskreden eller tilbagevendende og/eller metastatisk adenokarcinom i ventriklen eller den gastroøsofageale overgang, som ikke kunne underkastes en kurativ behandling.
English: Chemo only (n=116)
Danish: Kemo alene (n=116)
English: For early breast cancer, metastatic breast cancer and metastatic gastric cancer, Trazimera is given every 3 weeks.
Danish: Ved tidlig brystkræft, metastatisk brystkræft og metastatisk mavekræft gives Trazimera hver 3. uge.Trazimera kan også gives én gang om ugen ved metastatisk brystkræft.
English: - cisplatin - 80 mg/m 2 every 3 weeks for 6 cycles on day 1 of each cycle.
Danish: - cisplatin - 80 mg/m 2 hver 3. uge i 6 serier på dag 1 i hver serie.
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, oestrogen 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 brystkræft defineret som brystkræft 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: Glomerulonephritis membranous
Danish: Membranøs glomerulonephritis
English: The recommended scoring system to evaluate the IHC staining patterns is as stated in Table 2:
Danish: Det anbefalede scoringssystem til evaluering af de IHC-farvede mønstre er som angivet i tabel 2:
English: Do not use with glucose-containing solutions (see section 6.2).
Danish: Der må ikke anvendes glucoseopløsninger (se pkt.
English: Infections and infestations Infection
Danish: Infektioner og parasitære sygdomme
English: Patients who had previously received anthracycline-based adjuvant chemotherapy were treated with paclitaxel (175 mg/m2 infused over 3 hours) with or without trastuzumab.
Danish: Patienter, som tidligere har fået antracyklinbaseret adjuverende kemoterapi, blev behandlet med paclitaxel (175 mg/m2 infunderet over
English: 8mg/kg + 6mg/kg q3w
Danish: 8 mg/kg + 6 mg/kg 3-ugers doseringsregime
English: The recommended scoring system to evaluate the IHC staining patterns is as stated in Table 3:
Danish: Det anbefalede scoringsystem til evaluering af de IHC-farvede mønstre er som angivet i tabel 3:
English: Death (OS event): No. patients with event (%)
Danish: Død (OS-hændelse): Antal patienter med en hændelse (%)
English: use after reconstitution and dilution
Danish: anvendelse efter rekonstituering og fortynding
English: HER2 gene amplification should be detected using fluorescence in situ hybridisation (FISH) or chromogenic in situ hybridisation (CISH) of fixed tumour blocks.
Danish: Amplifikation_af HER2-genet bør detekteres ved brug af flourescens in situ hybridisering (FISH) eller kromogen in situ hybridisering (CISH) af fikserede tumorblokke.
English: Faint ⁄ barely perceptible membranous reactivity in ≥10% of tumour cells; cells are reactive only in part of their membrane
Danish: En svag/lige akkurat synlig membranøs reaktivitet i ≥ 10 % af tumorcellerne; cellerne er kun reaktive i dele af deres membran
English: Three -weekly dosing in metastatic breast cancer 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:
English: • infections
Danish: Infektioner
English: Supraventricular tachyarrhythmia
Danish: Supraventrikulær takyarytmi
English: L-histidine hydrochloride monohydrate L-histidine sucrose polysorbate 20
Danish: L-histidinhydrochloridmonohydrat L-histidin saccharose polysorbat 20
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ
English: - intravenous cyclophosphamide, at 600 mg/m 2 over 30 minutes, given every 3 weeks for
Danish: - intravenøs cyclophosphamid på 600 mg/m 2 over 30 minutter, administreret hver 3. uge i
English: If LVEF has not improved, or has declined further, or if symptomatic congestive heart failure (CHF) has developed, discontinuation of Trazimera 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 trastuzumab-behandlingen, medmindre fordelene for den enkelte patient anses at opveje risiciene.
English: The reconstituted Trazimera results in a colourless to pale brownish-yellow transparent solution and should be essentially free of visible particulates.
Danish: Det rekonstituerede Trazimera resulterer i en farveløs til svagt brunlig-gul klar opløsning, som hovedsaglig skal være fri for synlige partikler.
English: 1) Using a sterile syringe, slowly inject the appropriate volume (as noted above) of sterile water for injections in the vial containing the lyophilised Trazimera, directing the stream into the lyophilised cake.
Danish: 1) Anvend en steril sprøjte, og injicer langsomt det passende volumen (som anført ovenfor) sterilt vand til injektionsvæsker i hætteglasset, som indeholder det frysetørrede Trazimera, idet strålen rettes mod det frysetørrede kompakte pulver.