FrancophonIA/ELRC3.0 huggingface dataset:
English: The product is not intended to be stored after reconstitution and dilution unless this has taken place under controlled and validated aseptic conditions.
Danish: Produktet er ikke beregnet til at opbevares efter rekonstituering og fortynding, medmindre dette har fundet sted under kontrollerede og validerede aseptiske betingelser.
English: Trazimera can cause breathing difficulties, especially when it is first given.
Danish: Trazimera kan forårsage vejrtrækningsproblemer, specielt når det gives første gang.
English: The clinical relevance of these antibodies is not known.
Danish: Den kliniske relevans af disse antistoffer er kendes ikke.
English: Trazimera should only be given by a doctor or nurse.
Danish: Trazimera må kun gives af en læge eller sygeplejerske.
English: • Heart problems can sometimes occur during treatment and occasionally after treatment has stopped and can be serious.
Danish: Hjerteproblemer kan nogle gange forekomme under behandlingen og lejlighedsvis efter, at behandlingen er stoppet, og kan være alvorlige.
English: • Your doctor will advise you of the risks and benefits of taking Trazimera during pregnancy.
Danish: Lægen vil rådgive dig om risiko og fordele ved at tage Trazimera under graviditet.
English: If you stop using Trazimera
Danish: Hvis du holder op med at få Trazimera
English: Only patients with a large amount of HER2 will be treated with Trazimera.
Danish: Kun patienter med store mængder HER2 vil blive behandlet med Trazimera.
English: Due to nonlinear elimination, total clearance increased with decreasing concentration.
Danish: Grundet ikkelineær elimination steg den totale clearance ved faldende koncentration.
English: The primary endpoint was overall survival which was defined as the time from the date of randomization to the date of death from any cause.
Danish: Det primære endepunkt var samlet overlevelse, som blev defineret som tiden fra datoen for randomiseringen til datoen for dødsfald uanset årsag.
English: If not used immediately, in-use storage times and conditions are the responsibility of the user.
Danish: Hvis produktet ikke anvendes med det samme, er opbevaringstiderne og opbevaringsbetingelserne inden ibrugtagen brugerens ansvar.
English: Some of the side-effects you experience may be due to your underlying cancer.
Danish: Nogle af de bivirkninger, som du oplever, kan skyldes din underliggende kræftsygdom.
English: The effects may be moderate to severe and could cause death.
Danish: Påvirkningerne kan være moderate til alvorlige og kan forårsage død.
English: In this section, the following categories of frequency have been used: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
Danish: I dette punkt er følgende kategorier for hyppighed blevet anvendt: Meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100), sjælden (≥ 1/10.000 til < 1/1.000), meget sjælden (< 1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Your doctor will monitor your heart regularly during and after treatment but you should tell your doctor immediately if you notice any of the above symptoms.
Danish: Lægen vil kontrollere dit hjerte regelmæssigt under og efter behandlingen, men du skal øjeblikkeligt fortælle lægen, hvis du får nogle af ovenstående symptomer.
English: There is no relevant use of Trazimera in the paediatric population.
Danish: Det er ikke relevant at bruge Trazimera hos den pædiatriske population.
English: Other side effects can occur at any time during treatment with Trazimera, not just related to an infusion.
Danish: Andre bivirkninger kan indtræffe på ethvert tidspunkt under behandlingen med Trazimera, som ikke kun er relateret til en infusion.
English: Your doctor will closely supervise your therapy.
Danish: Din læge vil nøje overvåge din behandling.
English: The loading dose should be administered as a 90-minute intravenous infusion.
Danish: En støddosis bør administreres som en 90 minutters intravenøs infusion.
English: When Trazimera binds to HER2 it stops the growth of such cells and causes them to die.
Danish: Når Trazimera bindes til HER2 stopper det væksten af sådanne celler, hvilket resulterer i, at de dør.
English: Patients who develop asymptomatic cardiac dysfunction may benefit from more frequent monitoring (e.g., every 6 - 8 weeks).
Danish: Patienter, som udvikler asymptomatisk kardiel dysfunktion, kan have gavn af hyppigere monitorering (f.eks. hver 6.-8. uge).
English: Trazimera may affect your ability to drive a car or operate machines.
Danish: Trazimera kan påvirke din evne til at køre bil eller betjene maskiner.
English: Some of these symptoms can be serious and some patients have died (see section 2 under “Warnings and precautions”).
Danish: Nogle af disse sympomer kan være alvorlige, og nogle patienter er døde (se punkt 2 under punktet ” Advarsler og forsigtighedsregler”).
English: As animal reproduction studies are not always predictive of human response, trastuzumab should be avoided during pregnancy unless the potential benefit for the mother outweighs the potential risk to the foetus.
Danish: Da reproduktionsstudier på dyr ikke altid er prædiktive for mennesker, bør trastuzumab undgås under graviditet med mindre den potentielle fordel for moderen opvejer den potentielle risiko for fostret.
English: From a microbiological point of view, the reconstituted solution and Trazimera infusion solution should be used immediately.
Danish: Set fra et mikrobiologisk synspunkt skal den rekonstituerede opløsning og infusionsopløsningen med Trazimera anvendes med det samme.
English: The results of these simulations indicate that at least 95% of patients will reach concentrations that are <1 μg/mL (approximately 3% of the population predicted Cmin,ss, or about 97% washout) by 7 months.
Danish: Resultaterne af disse simuleringer indikerer, at mindst 95 % af patienterne vil nå koncentrationer < 1 mikrogram/ml (ca. 3 % af den populationsforudsagte Cmin,ss, eller omkring 97 % udvaskning) i løbet af 7 måneder.
English: Time to Disease Progression, Median months
Danish: Tid til sygdomsprogression, Median måneder
English: The dose of Trazimera depends on your body weight.
Danish: Trazimeradosis afhænger af din legemsvægt.
English: If you experience any of the above symptoms when your treatment with Trazimera has finished, you should see your doctor and tell them that you have previously been treated with Trazimera.
Danish: Hvis du får nogle af ovenstående symptomer, når behandlingen med Trazimera er stoppet, skal du kontakte din læge og fortælle, at du tidligere er blevet behandlet med Trazimera.
English: Instructions for Reconstitution:
Danish: Instruktioner for rekonstituering:
English: Infusion reactions, allergic-like reactions and hypersensitivity It is estimated that approximately 40% of patients who are treated with trastuzumab will experience some form of infusion-related reaction.
Danish: Infusionsreaktioner, allergilignende reaktioner og overfølsomhed Det estimeres, at ca. 40 % af patienterne, som bliver behandlet med trastuzumab, vil opleve infusionsrelaterede reaktioner i en eller anden form.
English: These medicines (or any other anthracyclines) can damage heart muscle and increase the risk of heart problems with Trazimera.
Danish: Disse lægemidler (og ethvert andet antracyklin) kan skade hjertet og øge risikoen for hjerteproblemer sammen med Trazimera.
English: Trazimera should be carefully handled during reconstitution.
Danish: Trazimera skal behandles forsigtigt under rekonstitueringen.
English: If a pregnant woman is treated with trastuzumab, or if a patient becomes pregnant while receiving trastuzumab or within 7 months following the last dose of trastuzumab, close monitoring by a multidisciplinary team is desirable.
Danish: Hvis en gravid kvinde behandles med trastuzumab, eller hvis en patient bliver gravid under behandlingen med trastuzumab eller indenfor 7 måneder efter den sidste dosis trastuzumab, anbefales tæt monitorering af et tværfagligt hold.
English: Therefore, these patients should not be treated with trastuzumab (see section
Danish: Disse patienter bør derfor ikke behandles med trastuzumab (se pkt.
English: clearance (CL), the central compartment volume (Vc)) and population-predicted steady-state exposures (Cmin, Cmax and AUC).
Danish: clearance, distributionsvolumen for det centrale kompartment (Vc)) og populations-forudsagte steady-state eksponeringer (Cmin, Cmax og AUC).
English: For instructions on reconstitution of Trazimera intravenous formulation before administration, see section 6.6.
Danish: For instruktioner om rekonstitution af Trazimera intravenøs formulering før administration, se pkt.
English: If the initial loading dose was well tolerated, the subsequent doses can be administered as a 30minute infusion.
Danish: Hvis den initiale støddosis er veltolereret, kan de efterfølgende doser administreres som en 30 minutters infusion.
English: Serious reactions have been treated successfully with supportive therapy such as oxygen, beta- agonists, and corticosteroids.
Danish: Alvorlige reaktioner er blevet behandlet succesfuldt med understøttende behandling såsom ilt, beta-agonister og kortikosteroider.
English: defined as absence of any invasive cancer both in the breast and axillary nodes
Danish: * defineret som fravær af hvilken som helst invasiv kræft både i bryst og aksilknuder
English: The efficacy results from the BCIRG 006 are summarized in Tables 9 and 10.
Danish: Effektresultaterne fra BCIRG 006-studiet er sammenfattet i tabel 9 og 10.
English: Trazimera is a biosimilar medicinal product.
Danish: Trazimera er et biosimilært lægemiddel.
English: Treatment with Trazimera alone or with a taxane may affect the heart, especially if you have ever used an anthracycline (taxanes and anthracyclines are two other kinds of medicine used to treat cancer).
Danish: Behandling med Trazimera alene eller sammen med et taxan kan påvirke hjertet, især hvis du tidligere har fået antracykliner (taxaner og antracykliner er to andre slags lægemidler, der anvendes til at behandle kræft).
English: Therefore you should tell your doctor, pharmacist or nurse that you have had Trazimera if you start any new medicine in the 7 months after stopping treatment.
Danish: Du bør derfor fortælle din læge, apotekspersonalet eller sundhedspersonalet, at du har fået Trazimera, hvis du begynder at anvende enhver form for nyt lægemiddel indenfor 7 måneder efter ophør med Trazimera-behandlingen.
English: Like all medicines, Trazimera can cause side effects, although not everybody gets them.
Danish: Dette lægemiddel kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: However, trastuzumab may elevate the overall exposure of one doxorubicin metabolite, (7-deoxy-13 dihydro-doxorubicinone, D7D).
Danish: Trastuzumab kan dog øge den samlede eksponering for en af doxorubicins metabolitter (7-deoxy-13- dihydro-doxorubicinon, D7D).
English: Paclitaxel, in combination with trastuzumab, was administered as follows:
Danish: Paclitaxel i kombination med trastuzumab blev administreret som følger:
English: *Co-primary endpoint of DFS of 1 year versus observation met the pre-defined statistical boundary **Final analysis (including crossover of 52% of patients from the observation arm to trastuzumab) ***There is a discrepancy in the overall sample size due to a small number of patients who were randomized after the cut-off date for the 12-month median follow-up analysis
Danish: *Co-primære endepunkt for sygdomsfri overlevelse på 1 år versus observation overholdt de prædefinerede statistiske grænser **Endelig analyse (inkluderende overgang af 52 % af patienterne fra observations-armen til trastuzumab) ***Der er diskrepans i den samlede prøvestørrelse grundet et lille antal patienter, der blev randomiseret efter skæringsdatoen for analysen for 12 måneders median opfølgning.
English: Cmin,ss = Cmin at steady state Cmax,ss = Cmax at steady state time to 90% of steady-state
Danish: ved steady state **Cmax,ss = Cmax ved steady state ***Tid til 90 % af steady state
English: Denotes adverse reactions that are reported largely in association with Infusion-related reactions.
Danish: Angiver bivirkninger, som er rapporteret i stor udstrækning i forbindelse med infusionsrelaterede reaktioner.
English: Trazimera intravenous formulation is given as an intravenous infusion (“drip”) directly into your veins.
Danish: Trazimera intravenøs formulering gives som en intravenøs infusion (drop) direkte ind i dine blodårer.
English: Ask your doctor or pharmacist for advice before taking any medicine.
Danish: Spørg din læge eller apotek til råds, inden du tager nogen form for medicin.
English: After reconstitution with sterile water for injections the reconstituted solution is physically and chemically stable for 48 hours at 2°C - 8°C.
Danish: Efter rekonstituering med vand til injektionsvæsker er den rekonstituerede opløsning fysisk og kemisk stabil i 48 timer ved 2 °C - 8 °C.
English: Early breast cancer is defined as non-metastatic primary invasive carcinoma of the breast.
Danish: Tidlig brystkræft er defineret som et ikke-metastatisk, primær, invasiv karcinom i brystet.
English: Trastuzumab may persist in the circulation for up to 7 months after stopping treatment based on population pharmacokinetic analysis of all available data (see section 5.2).
Danish: Trastuzumab kan fortsat være i cirkulationen i op til 7 måneder efter ophør af behandlingen, baseret på populationsfarmakokinetiske analyser af alle tilgængelige data (se pkt.
English: Very rarely, patients with severe breathing difficulties before treatment have died when they were given Trazimera.
Danish: I meget sjældne tilfælde er det sket, at patienter, som havde alvorlige vejrtrækningsproblemer inden behandlingsstart døde, da de fik Trazimera.
English: FP + H: Fluoropyrimidine/cisplatin + trastuzumab FP: Fluoropyrimidine/cisplatin Odds ratio
Danish: FP+H: Fluoropyrimidin/cisplatin + trastuzumab FP: Fluoropyrimidin/cisplatin Sandsynslighedsratio
English: It must not be diluted with glucose solutions.
Danish: Det må ikke fortyndes med glucoseopløsninger.
English: Volume of sterile water for injections
Danish: Volumen sterilt vand til injektionsvæske
English: Patients treated with Trazimera are at increased risk for developing CHF (New York Heart Association [NYHA] Class II-IV) or asymptomatic cardiac dysfunction.
Danish: Patienter, som behandles med Trazimera, har en øget risiko for at udvikle kongestiv hjerteinsufficiens (New York Heart Association [NYHA] klasse II-IV) eller asymptomatisk kardiel dysfunktion.
English: This translates into an absolute benefit in terms of an 8 year disease free survival rate of 6.4 percentage points in favour of 1 year trastuzumab treatment.
Danish: Dette overføres til en absolut gavnlig effekt udtrykt i en 8 års sygdomsfri overlevelsesrate på 6,4 procentpoint til fordel for 1 års trastuzumab-behandling.
English: Hormone receptor positive patients must also have failed hormonal therapy, unless patients are unsuitable for these treatments.
Danish: Hormon-receptor-positive patienter må heller ikke have responderet på hormonbehandling, medmindre patienterne er uegnede til behandlingen.
English: If during treatment you experience symptoms, such as chills or fever, you should not drive or use machines until these symptoms disappear.
Danish: Hvis du under behandlingen får symptomer såsom kulderystelser eller feber, må du ikke køre bil eller betjene maskiner før, symptomerne er forsvundet.
English: Table 13 Efficacy Results from BO18225 Parameter
Danish: Effektresultater fra BO18225 Parameter
English: Your doctor may prescribe Trazimera for the treatment of breast and gastric cancer when: • You have early breast cancer, with high levels of a protein called HER2.
Danish: Din læge kan ordinere Trazimera til behandling af bryst- og mavekræft, hvis: du har tidlig brystkræft med høje koncentrationer af et protein, som kaldes HER2.
English: At the time of a safety update after a median of 3.5-3.8 years follow up, an analysis of DFS reconfirms the magnitude of the benefit shown in the definitive analysis of DFS.
Danish: På tidspunktet for en sikkerhedsopdatering efter en median opfølgningstid på 3,5-3,8 år genbekræfter en analyse af sygdomsfri overlevelse størrelsen af den gavnlige effekt vist i den endelige analyse af sygdomsfri overlevelse.
English: • You have metastatic breast cancer (breast cancer that has spread beyond the original tumour) with high levels of HER2.
Danish: du har metastatisk brystkræft (brystkræft, som har spredt sig ud over den oprindelige tumor) med høje koncentrationer af HER2.
English: Cardiac failure (congestive)
Danish: Hjerteinsufficiens (kongestiv)
English: Do not breast-feed your baby during Trazimera therapy and for 7 months after the last dose of Trazimera as Trazimera may pass to your baby through your breast milk.
Danish: Du må ikke amme dit barn under behandling med Trazimera og i de første 7 måneder efter, du har fået den sidste dosis Trazimera, da Trazimera kan overføres til dit barn gennem modermælken.
English: • pain in the arms and/or legs
Danish: •lungesygdomme smerter i armene og/eller benene
English: Concentration after reconstitution - 21 mg/mL
Danish: Koncentration efter rekonstituering - 21 mg/ml
English: Experience of concurrent administration of trastuzumab with low dose anthracycline regimens is currently limited to two trials (MO16432 and BO22227).
Danish: Erfaring med samtidig administration af trastuzumab og regimer med lavdosis-antracyklin er på nuværende tidspunkt begrænset til to studier (MO16432 og BO22227).
English: • If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor, pharmacist or nurse for advice before taking this medicine.
Danish: Hvis du er gravid, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge, apotekspersonalet eller sundhedspersonalet til råds, før du tagerdette lægemiddel.
English: If you receive Trazimera in combination with chemotherapy, some of them may also be due to the chemotherapy.
Danish: Hvis du får Trazimera i kombination med kemoterapi, kan nogle af bivirkningerne skyldes kemoterapien.
English: Trastuzumab was administered weekly with chemotherapy and 3 weekly thereafter for a total of 52 weeks.
Danish: Trastuzumab blev administreret ugentligt med kemoterapi og derefter hver 3. uge i ialt 52 uger.
English: Trastuzumab 1 Year N=1693
Danish: Trastuzumab 1 år N=1.693
English: There are no immunogenicity data available for trastuzumab in gastric cancer.
Danish: Der er ikke tilgængelige immunogenicitetsdata for trastuzumab i ventrikelkræft.
English: • you have severe breathing problems at rest due to your cancer or if you need oxygen treatment.
Danish: du har alvorlige problemer med at trække vejret på grund af din kræft eller hvis du har behov for behandling med ilt.
English: At the time of the analysis a total of 349 randomized patients had died: 182 patients (62.8%) in the control arm and 167 patients (56.8%) in the treatment arm.
Danish: På det tidspunkt, analysen blev foretaget, var i alt 349 randomiserede patienter døde: 182 patienter (62,8 %) i kontrolarmen og 167 patienter (56,8 %) i behandlingsarmen.
English: Reversibility of severe CHF (defined as a sequence of at least two consecutive LVEF values ≥50% after the event) was evident for 71.4% of trastuzumab-treated patients.
Danish: Reversibiliteten af svær kongestiv hjerteinsufficiens (defineret som en sekvens på mindst to på hinanden følgende LVEF- værdier ≥50 % efter hændelsen) var evident hos 71,4 % af de trastuzumabbehandlede patienter.
English: As human IgG1 is secreted into human milk, and the potential for harm to the infant is unknown, women should not breast-feed during Trazimera therapy and for 7 months after the last dose.
Danish: Da humant IgG udskilles i human mælk, og da den potentielle skade på spædbørn er ukendt, må kvinder ikke amme under behandling med Trazimera og i de første 7 måneder efter sidste dosis.
English: If diluted aseptically, it may be stored for 24 hours (do not store above 30°C).
Danish: Hvis den er fortyndet aseptisk, kan den opbevares i 24 timer (må ikke opbevares ved temperaturer over 30 °C).
English: No. patients with event
Danish: - Antal patienter med en hændelse
English: Do not administer as an intravenous push or bolus.
Danish: Den må ikke administreres som intravenøs bolus.
English: For intravenous use only after reconstitution and dilution.
Danish: Kun til intravenøs anvendelse efter rekonstituering og fortynding.
English: An absolute benefit of 13 percentage points in favour of the trastuzumab arm was estimated in terms of 3-year event-free survival rate (65% versus 52%).
Danish: En absolut gavnlig effekt på 13 procentpoint til fordel for trastuzumab-armen blev estimeret, udtrykt i 3- års hændelsesfri overlevelse (65 % versus 52 %).
English: Median follow-up 12 months* Median follow-up 8 years**
Danish: Median opfølgning 8 år**
English: 4 cycles.
Danish: 4 serier.
English: Tell a doctor or nurse straight away, if you notice any of the following side effects:
Danish: Fortæl det straks til lægen eller sygeplejersken, hvis du får en af de følgende bivirkninger:
English: Trazimera intravenous infusion should be administered by a health-care provider prepared to manage anaphylaxis and an emergency kit should be available.
Danish: Intravenøs infusion af Trazimera bør administreres af sundhedspersonale, som er forberedt på at håndtere anafylaksi, og nødudstyr skal være tilgængeligt.
English: IHC is recommended as the first testing modality and in cases where HER2 gene amplification status is also required, either a silver-enhanced in situ hybridization (SISH) or a FISH technique must be applied.
Danish: IHC anbefales som den første testmetode, og i tilfælde, hvor HER2genamplifikationsstatus også er påkrævet, skal enten sølvforstærket in situ hybridisering (SISH) eller en FISH-teknik anvendes.
English: Trazimera is for single-use only, as the product contains no preservatives.
Danish: Trazimera er kun til enkeltdosisbrug, idet lægemidlet ikke indeholder konserveringsmidler.
English: Severe anaphylactic reactions requiring immediate additional intervention can occur usually during either the first or second infusion of trastuzumab(see section 4.4) and have been associated with a fatal outcome.
Danish: Alvorlige anafylaktiske reaktioner, som kræver øjeblikkelig yderligere intervention, kan forekomme normalt under enten den første eller anden infusion af trastuzumab (se pkt 4.4) og er blevet forbundet med letal udgang.
English: In the final population PK model, in addition to primary tumour type, body-weight, serum aspartate aminotransferase and albumin were identified as a statistically significant covariates affecting the exposure of trastuzumab.
Danish: I den endelige populationsfarmakokinetiske model blev udover primær tumortype, kropsvægt, serumaspartat-aminotransferase og -albumin identificeret som statistisk signifikante kovarianter med indvirkning på trastuzumabs eksponering.
English: Formal cardiological assessment should be considered in patients in whom there are cardiovascular concerns following baseline screening.
Danish: Formel kardiologisk vurdering bør overvejes hos patienter, hos hvem der er mistanke om kardiologisk sygdom efter baselinescreening.
English: Therefore, your heart function will be checked before, during (every three months) and after (up to two to five years) treatment with Trazimera.
Danish: (12,3-ne) (18,6-33,7) (11,2-23,8) (27,3-40,8) (19,1-30,8)
English: Congestive heart failure (NYHA Class II-IV) is a common adverse reaction associated with the use of trastuzumab and has been associated with a fatal outcome (see section 4.4).
Danish: Kongestiv hjerteinsufficiens, (NYHA-klasse II-IV) er en almindelig bivirkning forbundet med anvendelse af trastuzumab og er blevet forbundet med letal udgang (se pkt 4.4).
English: • abnormally low oxygen levels in the blood
Danish: • unormalt lave iltkoncentrationer i blodet
English: Doxorubicin and cyclophosphamide were administered concurrently as follows:
Danish: Doxorubicin og cyclophosphamid blev administreret samtidig som følger: