FrancophonIA/ELRC3.0 huggingface dataset:
English: Neutralizing anti-trastuzumab antibodies were detected in post-baseline samples in 2 of 30 patients in the trastuzumab intravenous arm.
Danish: Neutraliserende anti-trastuzumab-antistoffer blev fundet i prøver efter baseline hos 2 ud af 30 patienter i armen behandlet med intravenøst trastuzumab.
English: Trazimera is for intravenous use.
Danish: Trazimera er kun til intravenøs anvendelse.
English: More patients experienced at least one grade 3 or 4 adverse event in the 2-year treatment arm (20.4%) compared with the 1-year treatment arm (16.3%).
Danish: Flere patienter oplevede mindst en grad 3 eller 4 bivirkning i 2-års-behandlings-armen (20,4 %) sammenlignet med 1-års-behandlings-armen (16,3 %).
English: If you receive Trazimera with any other medicine to treat cancer, such as paclitaxel, docetaxel, an aromatase inhibitor, capecitabine, 5-fluorouracil, or cisplatin you should also read the patient information leaflets for these products.
Danish: Hvis du får Trazimera sammen med andre lægemidler til at behandle kræft, såsom paclitaxel, docetaxel, en aromatasehæmmer, capecitabin, 5-fluoruracil eller cisplatin, skal du også læse indlægssedlerne for disse lægemidler.
English: A vial of Trazimera reconstituted with water for injections (not supplied) is stable for 48 hours at 2ºC - 8ºC after reconstitution and must not be frozen.
Danish: Et hætteglas Trazimera rekonstitueret med vand til injektionsvæsker (følger ikke med) er stabilt i 48 timer efter rekonstitueringen ved 2 °C - 8 °C, og det må ikke nedfryses.
English: Trastuzumab binds with high affinity and specificity to sub-domain IV, a juxta-membrane region of HER2's extracellular domain.
Danish: Trastuzumab binder med høj affinitet og specificitet til subdomæne IV, en juxtamembranregion i HER2's ekstracelluære domæne.
English: The MAH shall perform the pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in the RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Danish: Indehaveren af markedsføringstilladelsen skal udføre de påkrævede aktiviteter og foranstaltninger vedrørende lægemiddelovervågning, som er beskrevet i den godkendte RMP, der fremgår af modul 1.8.2 i markedsføringstilladelsen, og enhver efterfølgende godkendt opdatering af RMP.
English: Chemotherapy was administered as follows:
Danish: Kemoterapien blev administreret som følger:
English: - as monotherapy for the treatment of those patients who have received at least two chemotherapy regimens for their metastatic disease.
Danish: - som enkeltstofbehandling til behandling af de patienter, som har fået mindst to kemoterapiregimer for deres metastatiske sygdom.
English: In patients who receive anthracycline-containing chemotherapy further monitoring is recommended, and should occur yearly up to 5 years from the last administration of Trazimera, or longer if a continuous decrease of LVEF is observed.
Danish: Yderligere monitorering anbefales hos patienter, som får antracyklin-baseret kemoterapi, og monitoreringen bør foregå årligt i op til 5 år efter sidste administration af Trazimra eller længere, hvis kontinuerligt fald i LVEF observeres.
English: The results of this substudy suggested that the exposure to the bioactive metabolites (e.g., 5-FU) of capecitabine was not affected by concurrent use of cisplatin or by concurrent use of cisplatin plus trastuzumab.
Danish: Resultaterne af dette substudie tydede på, at eksponeringen for capecitabins biologisk aktive metabolitter (f.eks. 5-FU) ikke blev påvirket af samtidig anvendelse af cisplatin eller cisplatin plus trastuzumab.
English: t1/2 range from Cmax,ss to Cmin,ss (day)
Danish: t1/2-interval fra Cmax,ss til Cmin,ss (dag)
English: It is also used in combination with medicines called aromatase inhibitors with patients with high levels of HER2 and hormone receptor-positive metastatic breast cancer (cancer that is sensitive to the presence of female sex hormones).
Danish: Det anvendes også i kombination med medicin, som kaldes aromatasehæmmere til patienter med høje koncentrationer af HER2 samt hormonreceptor-positiv metastatisk brystkræft (brystkræft der er følsom over for tilstedeværelsen af kvindelige kønshormoner).
English: Name and address of the manufacturer(s) of the biological active substance(s)
Danish: Navn og adresse på fremstillerne af det biologisk aktive stof
English: During a Trazimera infusion, chills, fever and other flu like symptoms may occur.
Danish: Under en Trazimera-infusion kan der forekomme kulderystelser, feber og andre influenzalignende symptomer.
English: Blood pressure increased
Danish: Forhøjet blodtryk
English: The efficacy results from Study MO16432 are summarized in Table 12.
Danish: Effektresultaterne i studie MO16432 er sammenfattet i tabel 12.
English: It may take up to 7 months for Trazimera to be removed from the body.
Danish: Det kan tage op til 7 måneder at udskille Trazimera fra kroppen.
English: Trazimera intravenous formulation is not intended for subcutaneous administration and should be administered via an intravenous infusion only.
Danish: Trazimera intravenøs formulering er ikke beregnet til subkutan administration og må kun administreres ved intravenøs infusion.
English: If patients have been treated concurrently with a full course of low-dose anthracyclines and Trazimera in the neoadjuvant setting, no additional cytotoxic chemotherapy should be given after surgery.
Danish: Hvis patienterne er blevet behandlet samtidigt med et fuldt forløb af lavdosis-antracykliner og Trazimera i et neoadjuverende behandlingsregime, bør yderligere cytotoksisk kemoterapi ikke gives efter operation.
English: • Tumour lysis syndrome (a group of metabolic complications occurring after cancer treatment characterised by high blood levels of potassium and phosphate, and low blood levels of calcium).
Danish: Tumorlysesyndrom (en gruppe af metaboliske komplikationer, der sker efter behandling mod kræft, som er karakteriseret ved høje blodværdier af kalium og fosfat og lave blodværdier af kalcium).
English: Risk factors for a cardiac event identified in four large adjuvant studies included advanced age (>50 years), low LVEF (<55%) at baseline, prior to or following the initiation of paclitaxel treatment, decline in LVEF by 10-15 points, and prior or concurrent use of anti-hypertensive medicinal products.
Danish: Risikofaktorer for en kardiel bivirkning blev identificeret i fire store adjuverende studier og inkluderede alder (> 50 år), lav LVEF (< 55 %) ved baseline før eller efter initiering af paclitaxelbehandling, fald i LVEF på 10-15 point samt tidligere eller samtidig brug af antihypertensiva.
English: Biopsy specimen - staining pattern
Danish: Biopsi prøve - farvningsmønstre
English: When trastuzumab was administered after completion of adjuvant chemotherapy NYHA Class III-IV heart failure was observed in 0.6% of patients in the one-year arm after a median follow-up of 12 months.
Danish: Når trastuzumab blev administreret efter afslutning af adjuverende kemoterapi, blev NYHA-klasse IIIIV hjerteinsufficiens observeret hos 0,6 % af patienterne i 1-års armen efter en median opfølgning på 12 måneder.
English: In the adjuvant treatment setting, trastuzumab was investigated in 4 large multicentre, randomised, trials.
Danish: Trastuzumab blev undersøgt som adjuverende behandling i 4 store multicenter, randomiserede studier:
English: More patients treated with trastuzumab and paclitaxel progressed in the central nervous system than those treated with paclitaxel alone (12.6% versus 6.5%; p=0.377).
Danish: Flere patienter, som blev behandlet med trastuzumab og paclitaxel, progredierede i centralnervesystemet sammenlignet med dem, som blev behandlet med paclitaxel alene (12,6 % versus 6,5 %, p = 0,377).
English: The presence of anti-trastuzumab antibodies had no impact on the pharmacokinetics, efficacy (determined by pathological Complete Response [pCR] and event free survival [EFS]) and safety determined by occurrence of administration related reactions (ARRs) of trastuzumab intravenous.
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 trastuzumab.
English: The highest rate of cardiac dysfunction was seen in patients receiving trastuzumab concurrently with anthracycline/cyclophosphamide (27%), and was significantly higher than for anthracycline/cyclophosphamide alone (7% - 10%).
Danish: Den største hyppighed af kardiel dysfunktion blev set hos patienter, der fik trastuzumab samtidigt med antracyklin/cyclophosphamid (27 %), og var signifikant højere end ved antracyklin/cyclophophamid alene (7-10 %).
English: An overfill of 4% ensures that the labelled dose of 150 mg can be withdrawn from each vial.
Danish: Et overskud på 4 % sikrer, at den angivne dosis på 150 mg kan trækkes op af hvert hætteglas.
English: 2) Swirl vial gently to aid reconstitution.
Danish: 2) Sving hætteglasset forsigtigt for at understøtte rekonstitueringen.
English: Talk to your doctor, pharmacist or nurse before you are given Trazimera if:
Danish: Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før du får Trazimera, hvis:
English: The efficacy results from the BO16348 trial following 12 months* and 8 years** median follow-up are summarized in Table 6:
Danish: Effektresultaterne fra studie BO16348 efter 12 måneders* og 8 års** median opfølgning er sammenfattet i tabel 6:
English: White lyophilised powder or cake.
Danish: Hvidt frysetørret pulver eller hvidt kompakt pulver.
English: Do not use Trazimera if you notice any particulate matter or discoloration prior to administration.
Danish: Brug ikke Trazimera hvis du bemærker nogle partikler eller misfarvning inden brug.
English: Table 12 Efficacy Results from MO16432 Parameter
Danish: Effektresultater fra MO16432 Parameter
English: • You should use effective contraception during treatment with Trazimera and for at least 7 months after treatment has ended.
Danish: Du skal bruge effektiv prævention under behandlingen med Trazimera og i mindst 7 måneder efter, at behandlingen er stoppet.
English: Instructions for reconstitution
Danish: Instruktioner for rekonstituering
English: In a method comparison study (study D008548) a high degree of concordance (>95%) was observed for SISH and FISH techniques for the detection of HER2 gene amplification in gastric cancer patients.
Danish: I et studie (studie D008548), der sammenlignede metoder, blev der observeret en høj grad af overensstemmelse (> 95 %) mellem SISH- og FISH-teknikker til detektion af HER2-genamplifikation hos patienter med ventrikelkræft.
English: In the pivotal metastatic trials of intravenous trastuzumab, the incidence of cardiac dysfunction varied between 9% and 12% when it was combined with paclitaxel compared with 1% - 4% for paclitaxel alone.
Danish: I de pivotale metastatiske studier med intravenøst trastuzumab varierede incidensen af kardiel dysfunktion mellem 9 % og 12 %, når trastuzumab blev givet i kombination med paclitaxel sammenlignet med 1-4 %, når paclitaxel blev givet alene.
English: What Trazimera contains - The active substance is trastuzumab.
Danish: Trazimera indeholder: Aktivt stof: trastuzumab.
English: Parenteral solutions should be inspected visually for particulates and discoloration prior to administration.
Danish: Parenterale opløsninger bør inspiceres visuelt for partikler og misfarvning før administrationen.
English: Details of risk minimisation measures that are consistent with the EU Risk Management Plan are presented in (section 4.4) Warnings and Precautions.
Danish: Detaljer omkring risikominimeringsaktiviteter, som er i overensstemmelse med EU's risikostyringsprogram, er præsenteret i (pkt.
English: • sleepiness (somnolence)
Danish: •nakkesmerter søvnighed (døsighed)
English: Discard by:
Danish: Bortskaf inden:
English: Trazimera contains the active substance trastuzumab, which is a monoclonal antibody.
Danish: Trazimera indeholder det aktive stof trastuzumab, som er et monoklonalt antistof.
English: Trazimera is indicated for the treatment of adult patients with HER2 positive early breast cancer.
Danish: Trazimera er indiceret til behandling af voksne patienter med HER2-positiv tidlig brystkræft.
English: Malignant neoplasm progression
Danish: Progression af malign neoplasma Ikke kendt Neoplasma progression
English: 5.2 Pharmacokineticproperties
Danish: 5.2 Farmakokinetiske egenskaber
English: Pulmonary fibrosis
Danish: Pulmonal fibrose
English: The bag or bottle should be gently inverted to mix the solution in order to avoid foaming.
Danish: Vend forsigtigt posen eller flasken op og ned for at blande opløsningen og for at undgå skumdannelse.
English: Observed with combination therapy following anthracyclines and combined with taxanes
Danish: * Observeret ved kombinationsbehandling efter antracykliner og kombineret med taxaner.
English: • You have metastatic gastric cancer with high levels of HER2, when it is in combination with the other cancer medicines capecitabine or 5-flououracil and cisplatin.
Danish: du har metastatisk mavekræft med høje koncentrationer af HER2, når det er i kombination med de andre kræftlægemidler, capecitabin eller 5-fluoruracil og cisplatin.
English: If left ventricular ejection fraction (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: Hvis venstre ventrikel ejektionsfraktions (LVEF)-procent falder ≥10 point fra baseline OG til under 50 %, skal behandlingen afbrydes, og LVEF-vurdering gentages inden for ca. 3 uger.
English: If the patient has missed a dose of Trazimera by more than one week, a re-loading dose of Trazimera 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 Trazimera i mere end en uge, bør der administreres en ny støddosis af Trazimera over ca. 90 minutter (ugentligt doseringsregime: 4 mg/kg; 3-ugers doseringsregime: 8 mg/kg) så hurtigt som muligt.
English: The efficacy results from study BO18225 are summarized in Table 13:
Danish: Effektresultaterne fra studie BO18255 er sammenfattet i tabel 13:
English: In patients receiving trastuzumab after completion of adjuvant chemotherapy, the risk of cardiac dysfunction was associated with a higher cumulative dose of anthracycline given prior to initiation of trastuzumab and a body mass index (BMI) >25 kg/m
Danish: Risikoen for kardiel dysfunktion hos patienter, der fik trastuzumab efter afsluttet adjuverende kemoterapi, var associeret med en højere kumulativ antracyklin-dosis, givet før initiering af trastuzumab, og et body mass index (BMI) > 25 kg/m
English: Study WO16229: loading dose 8 mg/kg, followed by 6 mg/kg 3 weekly schedule Study MO16982: loading dose 6 mg/kg weekly x 3; followed by 6 mg/kg 3-weekly schedule Study BO15935
Danish: Studie WO16229: støddosis 8 mg/kg efterfulgt af 6 mg/kg med 3-ugers intervaller Studie MO16982: støddosis 6 mg/kg ugentlig x 3 efterfulgt af 6 mg/kg med 3-ugers intervaller Studie BO15935
English: An overfill of 5% ensures that the labelled dose of 420 mg can be withdrawn from each vial.
Danish: Et overskud på 5 % sikrer, at den angivne dosis på 420 mg kan trækkes op af hvert hætteglas.
English: Trazimera may be prescribed in combination with the chemotherapy medicine paclitaxel or docetaxel as first treatment for metastatic breast cancer or it may be prescribed alone if other treatments have proved unsuccessful.
Danish: Trazimera kan ordineres i kombination med kemoterapilægemidlerne paclitaxel og docetaxel som første behandling for metastatisk brystkræft, eller det kan ordineres alene, hvis andre behandlinger har vist sig ikke at virke.
English: Chemo + Trastuzumab (n=115)
Danish: Kemo + Trastuzu mab (n=115)
English: In addition, caution should be exercised in treating patients with increased cardiac risk, e.g. hypertension, documented coronary artery disease, CHF, LVEF of <55%, older age.
Danish: Herudover skal der udvises forsigtighed ved behandling af patienter med risikofaktorer for hjertesygdom f.eks. hypertension, dokumenteret koronararteriesygdom, kongestiv hjerteinsufficiens, LVEF < 55 %, ældre patienter.
English: If patients have a continued decrease in left ventricular function, but remain asymptomatic, the physician should consider discontinuing therapy if no clinical benefit of trastuzumab therapy has been seen.
Danish: Hvis patienten har vedvarende nedsat venstre ventrikelfunktion, men forbliver asymptomatisk, bør lægen overveje at seponere trastuzumab, hvis der ikke ses nogen klinisk fordel.
English: In order to prevent medication errors it is important to check the vial labels to ensure that the medicine being prepared and given is Trazimera (trastuzumab) and not trastuzumab emtansine.
Danish: For at undgå fejlmedicinering er det også vigtigt at kontrollere hætteglassets etiket for at sikre, at det præparat, som klargøres og gives, er Trazimera (trastuzumab) og ikke trastuzumabemtansin.
English: One vial contains either:
Danish: Hvert hætteglas indeholder enten:
English: No incompatibilities between Trazimera and polyvinylchloride, polyethylene, polypropylene or ethylene vinyl acetate bags or with glass intravenous bottles have been observed.
Danish: Der er ikke set uforligeligheder mellem Trazimera og polyvinylchlorid-, polyethylen, polypropylen eller ethylen vinylacetat poser eller med glasflasker.
English: Trazimera may have a minor influence on the ability to drive or use machines (see section 4.8).
Danish: Trazimera kan have en mindre påvirkning på evnen til at føre motorkøretøj og betjene maskiner (se pkt.
English: Subsequent Trazimera maintenance doses (weekly regimen:2 mg/kg; three-weekly regimen 6 mg/kg respectively) should be administered 7 days or 21 days later according to the weekly or three-weekly schedules respectively.
Danish: Efterfølgende vedligeholdelsesdoser af Trazimera (henholdsvis ugentligt doseringsregime: 2 mg/kg; 3-ugers doseringsregime: 6 mg/kg) bør administreres 7 eller 21 dage senere i henhold til henholdsvis ugentlige eller 3-ugers doseringsregimer.
English: In one of the 3 pivotal studies conducted in which a median follow-up of 5.5 years was available (BCIRG006) a continuous increase in the cumulative rate of symptomatic cardiac or LVEF events was observed in patients who were administered trastuzumab concurrently with a taxane following anthracycline therapy up to 2.37% compared to approximately 1% in the two comparator arms (anthracycline plus cyclophosphamide followed by taxane and taxane, carboplatin and trastuzumab).
Danish: I et af de 3 pivotale studier, hvor en median opfølgningstid på 5,5 år var tilgængelig (BCIRG 006), blev der observeret en kontinuerlig stigning i det samlede antal af symptomatiske kardielle eller LVEF hændelser hos patienter, som fik trastuzumab administreret samtidig med et taxan efter antracyklinbehandling, på op til 2,37 %, sammenlignet med ca. 1 % i de to komparatorarme (antracyklin plus cyclophosphamid efterfulgt af taxan; taxan, carboplatin og trastuzumab).
English: All candidates for treatment with Trazimera, but especially those with prior anthracycline and cyclophosphamide (AC) exposure, should undergo baseline cardiac assessment including history and physical examination, electrocardiogram (ECG), echocardiogram, and/or multigated acquisition (MUGA) scan or magnetic resonance imaging.
Danish: Alle kandidater til behandling med Trazimera, men specielt de som tidligere har fået antracykliner og cyclophosphamid (AC), skal have foretaget en kardiel vurdering ved baseline, inklusive anamnese og objektiv undersøgelse, elektrokardiogram (ekg), ekkokardiografi, og/eller MUGA-scanning eller magnetisk resonansscanning.
English: - in combination with adjuvant chemotherapy consisting of docetaxel and carboplatin.
Danish: i kombination med adjuverende kemoterapi bestående af docetaxel og carboplatin.
English: Negative
Danish: Negativ
English: Table 6 Efficacy Results from Study BO16348 Median follow-up 12 months* Median follow-up 8 years**
Danish: Effektresultater fra studie BO16348 Median opfølgning 12 måneder*
English: Patients with MBC who have previously received anthracyclines are also at risk of cardiac dysfunction with Trazimera treatment, although the risk is lower than with concurrent use of Trazimera and anthracyclines.
Danish: Patienter med metastatisk brystkræft, som tidligere har fået antracykliner, er også i risikogruppe for kardiel dysfunktion ved Trazimera-behandling, selvom risikoen er lavere end ved samtidig brug af Trazimera og antracykliner.
English: Trazimera is a powder for concentrate for solution for infusion, which is supplied in a glass vial with a rubber stopper containing either 150 mg or 420 mg of trastuzumab.
Danish: Trazimera er et pulver til koncentrat til infusionsvæske, opløsning, som bliver leveret i et hætteglas med en gummiprop, og indeholder enten 150 mg eller 420 mg trastuzumab.
English: Risk factors associated with interstitial lung disease include prior or concomitant therapy with other anti-neoplastic therapies known to be associated with it such as taxanes, gemcitabine, vinorelbine and radiation therapy.
Danish: Risikofaktorer for interstitiel lungesygdom omfatter tidligere eller samtidig behandling med andre anti-neoplastiske stoffer, som er kendt for at være forbundet med interstitiel lungesygdom, såsom taxaner, gemcitabin og vinorelbin, og strålebehandling.
English: Overall Survival, Median months Progression-Free Survival, Median months
Danish: Progressionsfri overlevelse Median måneder
English: Patients who receive anthracyclines after stopping trastuzumab may possibly be at increased risk of cardiac dysfunction.
Danish: Patienter, som får antracykliner efter ophør af trastuzumab-behandling, kan muligvis have øget risiko for kardiel dysfunktion.
English: The European Medicines Agency has waived the obligation to submit the results of studies with trastuzumab in all subsets of the paediatric population for breast and gastric cancer (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med trastuzumab i alle undergrupper af den pædiatriske population ved bryst- og ventrikelkræft (se pkt.
English: Total CL range from Cmax,ss to Cmin,ss (L/day)
Danish: Samlet CLinterval fra Cmax,ss til Cmin,ss (l/dag)
English: As a weekly regimen (initial loading dose of 4 mg/kg followed by 2 mg/kg every week) concomitantly with paclitaxel following chemotherapy with doxorubicin and cyclophosphamide.
Danish: I et ugentligt doseringsregime er den initiale støddosis 4 mg/kg efterfulgt af 2 mg/kg hver uge samtidig med paclitaxel efter kemoterapi med doxorubicin og cyclophosphamid.
English: • Hypersensitivity to trastuzumab, murine proteins, or to any of the excipients listed in section
Danish: • Overfølsomhed over for trastuzumab, murine proteiner eller over for et eller flere af hjælpestofferne anført i pkt.
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 brystkræft i HERA-studiet var begrænset til operabel, primær, invasiv adenokarcinom i brystet med positive lymfeknuder i aksillen, eller med negative lymfeknuder i aksillen, hvis tumoren var mindst 1 cm i diameter.
English: A final analysis was performed after a median follow-up of 8 years, which showed that 1 year trastuzumab treatment is associated with a 24% risk reduction compared to observation only (HR=0.76, 95% CI 0.67, 0.86).
Danish: En endelig analyse blev udført efter en median opfølgning på 8 år, hvilket viste, at 1 års trastuzumabbehandling er associeret med 24 % risikoreduktion sammenlignet med observation alene (hazard ratio=0,76; 95 % konfidensinterval 0,67-0,86).
English: - following surgery, chemotherapy (neoadjuvant or adjuvant) and radiotherapy (if applicable) (see section 5.1).
Danish: efter operation, kemoterapi (neoadjuverende eller adjuverende) og strålebehandling (hvis indiceret) (se pkt.