FrancophonIA/ELRC3.0 huggingface dataset:
English: • Do not use this medicine after the expiry date which is stated on the carton and the vial label after EXP.
Danish: · Brug ikke lægemidlet efter den udløbsdato, der står på pakningen og hætteglasset efter EXP.
English: If particulates or discoloration are observed, the solution should not be used.
Danish: Hvis der observeres partikler eller misfarvning, må opløsningen ikke anvendes.
English: The primary efficacy outcome was overall survival.
Danish: Det primære effektresultat var samlet overlevelse.
English: Based on the stratified log-rank test.
Danish: Baseret på stratificeret log-rank test.
English: OS results for each of steps 2 and 3 could be formally tested for statistical significance only if the result in the preceding step was statistically significant.
Danish: Samlet overlevelsesresultater for trin 2 og 3 kunne kun testes formelt for statistisk signifikans, hvis resultatet i det foregående trin var statistisk signifikant.
English: *** Responses were ongoing in 63% of responders in the atezolizumab arm and in 21% of responders in the chemotherapy arm.
Danish: ***Respons var opretholdt hos 63% af responderne i atezolizumabarmen og hos 21% af responderne i kemoterapiarmen.
English: months).
Danish: måneder.
English: There have been no studies performed with other routes of administration.
Danish: Andre administrationsveje er ikke undersøgt.
English: Nederland Roche Nederland B.V.
Danish: Roche Nederland B.V.
English: Tecentriq may cause some side effects that you must tell your doctor about straight away.
Danish: Tecentriq kan give nogle bivirkninger, som du straks skal informere lægen om.
English: A monoclonal antibody is a type of protein designed to recognise and attach to a specific target in the body.
Danish: Monoklonale antistoffer er en type protein, der er designet til at genkende og binde sig til helt bestemte mål i kroppen.
English: For all subgroup analyses, formal statistical testing was not planned.
Danish: Formel statistisk testning var ikke planlagt for alle subgruppeanalyser.
English: A total of 931 patients were enrolled.
Danish: I alt deltog 931 patienter.
English: If you miss an appointment, make another one straight away.
Danish: Hvis du er nødt til at aflyse en aftale, skal du straks lave en ny.
English: No data are available to allow conclusions to be drawn on possible effects of neutralising antibodies.
Danish: Der er ingen data, der gør det muligt at drage en konklusion vedrørende eventuel effekt af neutraliserende antistoffer.
English: The median survival follow-up is 17 months.
Danish: Medianoverlevelsesopfølgning er 17 måneder.
English: • You will not be given Tecentriq if you are pregnant unless your doctor considers it necessary.
Danish: · Du må ikke få Tecentriq, hvis du er gravid, medmindre lægen skønner det er nødvendigt.
English: The prescriber must discuss the risks of Tecentriq therapy with the patient.
Danish: Den ordinerende læge skal diskutere risici ved Tecentriq-behandling med patienten.
English: However, monoclonal antibodies are not expected to alter DNA or chromosomes.
Danish: Monoklonale antistoffer forventes dog ikke at ændre DNA eller kromosomer.
English: Tecentriq will be stored by the healthcare professionals at the hospital or clinic.
Danish: Tecentriq bliver opbevaret af sundhedspersonalet på hospitalet eller klinikken.
English: • Do not use if this medicine is cloudy, discoloured or contains particles
Danish: · Brug ikke lægemidlet, hvis det er uklart, misfarvet eller indeholder partikler
English: Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Danish: Appendiks V. Ved at indrapportere bivirkninger kan du hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
English: The OS rate at 12 month was 37% in all comers.
Danish: Den samlede overlevelsesrate ved 12 måneder var 37% i hele gruppen.
English: Treatment may be resumed when the event is resolved
Danish: Behandlingen kan genoptages, når reaktionen er forvundet.
English: The systemic accumulation in area under the curve, maximum concentration and trough concentration was 1.91, 1.46 and 2.75-fold, respectively.
Danish: Den systemiske akkumulering i arealet under kurven, maksimal koncentration og dal-koncentration var henholdsvis 1,91; 1,46 og 2,75 gange.
English: • followed by adequate storage of the prepared solution for intravenous infusion to ensure maintenance of the aseptic conditions.
Danish: · efterfølges af passende opbevaring af den fortyndet opløsning til intravenøs infusion, for at sikre opretholdelse af de aseptiske betingelser.
English: It is important that you also read the package leaflet for these medicines.
Danish: Det er vigtigt at du også læser indlægssedlerne for disse lægemidler.
English: The safety and efficacy of Tecentriq in children and adolescents aged below 18 years have not been established.
Danish: Tecentriqs sikkerhed og virkning hos børn og unge under 18 år er endnu ikke klarlagt.
English: As a consequence, no formal tests of statistical significance could be performed for OS in the IC1/2/3 or all comer populations, and results of those analyses would be considered exploratory.
Danish: Der kunne derfor ikke gennemføres formelle test med statistisk signifikans for samlet overlevelse i IC1/2/3- eller ITTpopulationerne, og resultatet af disse analyser vil blive betragtet som eksploratoriske.
English: 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
Danish: Følgende hyppighedskategorier er anvendt: meget almindelig (≥1/10), almindelig (≥1/100 til <1/10), ikke almindelig (≥1/1000 til <1/100), sjælden (≥1/10.000 til <1/1000), meget sjælden (<1/10.000).
English: The patient alert card shall contain the following key messages:
Danish: · Patientkortet skal indeholde følgende hovedbudskaber:
English: No dose adjustments are recommended.
Danish: Ingen andre ændringer blev anbefalet.
English: A risk to the newborns/infants cannot be excluded.
Danish: Det kan ikke udelukkes, at dette indebærer en risiko for den nyfødte/spædbarnet.
English: Atezolizumab should not be used during pregnancy unless the clinical condition of the woman requires treatment with atezolizumab.
Danish: Atezolizumab bør ikke anvendes under graviditet medmindre kvindens kliniske tilstand kræver behandling med atezolizumab.
English: It belongs to a group of medicines called monoclonal antibodies.
Danish: Det tilhører den gruppe af lægemidler, der kaldes monoklonale antistoffer.
English: This regimen is administered every three weeks for four cycles.
Danish: Dette doseringsregime administreres hver 3. uge i fire serier.
English: This protein suppresses the body's immune (defense) system, thereby protecting cancer cells from being attacked by the immune cells.
Danish: Dette protein hæmmer kroppens immunforsvar og beskytter dermed kræftcellerne mod at blive angrebet af immuncellerne.
English: Reduce infusion rate or interrupt.
Danish: Reducér infusionshastigheden eller afbryd infusionen.
English: Unstratified HR for other exploratory subgroups.
Danish: Ikke-stratificeret hazardratio for andre subgrupper.
English: This is because the effects of Tecentriq in this age group are not known.
Danish: Det er fordi, det ikke vides hvordan Tecentriq virker hos denne aldersgruppe.
English: The primary analysis of Cohort 2 was performed when all patients had at least 24 weeks of follow-up.
Danish: Den primære analyse af kohorte 2 blev udført da alle patienter havde mindst 24 ugers opfølgning.
English: Patients received treatment until radiographic disease progression per RECIST v1.1, or unacceptable toxicity.
Danish: Patienterne modtog behandling indtil radiografisk sygdomsprogression defineret ved RECIST v1.1 eller uacceptabel toksicitet.
English: The paclitaxel starting dose for patients of Asian race/ethnicity was 175 mg/m due to higher overall level of haematologic toxicities in patients from Asian countries compared with those from non-Asian countries c
Danish: b Startdosis for paclitaxel til patienter med asiatisk race/etnicitet var 175 mg/m2 på grund af højere overordnede niveauer af hæmatologiske toksiciteter hos patienter fra asiatiske lande sammenlignet med patienter fra ikke-asiatiske lande.
English: Isolated hypothyroidism may be managed with replacement therapy and without corticosteroids.
Danish: Isoleret hypothyroidisme kan behandles med substitutionsbehandling og uden kortikosteroider.
English: The time to onset was 1.2 months.
Danish: Tid til hændelse var 1,2 måneder.
English: These results should be interpreted with caution due to the open-label design of the study.
Danish: Disse resultater skal vurderes med forsigtighed på grund af at studiet er åbent.
English: Atezolizumab is a monoclonal antibody and is expected to be present in the first milk and at low levels afterwards.
Danish: Atezolizumab er et monoklonalt antistof og forventes at udskilles i den tidlige mælk samt i lave niveauer efterfølgende.
English: Antibodies are cleared principally by catabolism.
Danish: Antistoffer udskilles principielt ved katabolisme.
English: No dose reduction was allowed.
Danish: Dosisreduktion var ikke tilladt.
English: If the first infusion is well tolerated, all subsequent infusions may be administered over 30 minutes.
Danish: Hvis første infusion er veltolereret, kan alle efterfølgende infusioner administreres over 30 minutter.
English: Body weight, gender, positive ADA status, albumin levels and tumour burden have a statistically significant, but not clinically relevant effect on atezolizumab pharmacokinetics.
Danish: Kropsvægt, køn, positiv ADA-status, albuminniveauer og tumorbyrde har en statistisk signifikant, men ikke klinisk relevant effekt på atezolizumabs farmakokinetik.
English: • If you could become pregnant, you must use effective contraception; while you are being treated with Tecentriq and for 5 months after the last dose.
Danish: · Hvis du er i stand til at blive gravid, skal du bruge sikker prævention mens du er i behandling med Tecentriq og i 5 måneder efter sidste dosis.
English: For instructions on dilution and handling of the medicinal product before administration, see section 6.6.
Danish: For instruktioner om fortynding og håndtering af lægemidlet før administration, se pkt.
English: Based on limited data from clinical studies in patients whose immune-related adverse reactions could not be controlled with systemic corticosteroid use, administration of other systemic immunosuppressants may be considered.
Danish: På baggrund af begrænsede data fra kliniske studier med patienter, hvis immunrelaterede bivirkninger ikke kunne kontrolleres med systemisk kortikosteroidbehandling, kan administration af andet systemisk immunsupprimerende middel overvejes.
English: The time to deterioration (a sustained ≥ 10-point decline from baseline score) of patient-reported global health status/health-related quality of life as measured by the EORTC QLQ-C30 was similar in each treatment group indicating that all patients maintained their baseline HRQoL for a comparable duration of time.
Danish: Tiden til forværring (et vedvarende ≥ 10-point fald fra baseline score) af patientrapporterede globale sundhedsstatus/sundhedsrelateret livskvalitet (HRQoL) målt ved EORTC QLQ-C30 var ens i hver behandlingsgruppe, hvilket indikerer, at alle patienter opretholdt deres baseline HRQoL i en sammenligelig tidsperiode.
English: From a microbiological point of view, the prepared solution for infusion should be used immediately.
Danish: Af mikrobiologiske hensyn bør den fortyndet opløsning til infusion anvendes straks.
English: There are no data from the use of atezolizumab in pregnant women.
Danish: Der foreligger ingen data vedrørende brug af atezolizumab til gravide kvinder.
English: Reminder to educate patients/caregivers about the symptoms of immune-related adverse reactions and of the need to report them immediately to the physician.
Danish: Påmindelse om at uddanne patienter/omsorgspersoner om symptomerne for immunrelaterede bivirkninger og nødvendigheden af at rapportere bivirkninger omgående til lægen.
English: It is important that you also read the package leaflet for nab-paclitaxel.
Danish: Det er vigtigt, at du også læser indlægssedlen for nab-paclitaxel.
English: There were no effects on the male reproductive organs.
Danish: Der sås ingen påvirkning af mandlige reproduktionsorganer.
English: The schedule of administration must be adjusted to maintain a 3-week interval between doses.
Danish: Planlægning af behandlingen kan herefter justeres for at opretholde et 3-ugers interval mellem doseringerne.
English: The primary analysis was performed when all patients had at least 24 weeks of follow-up.
Danish: Den primære analyse blev udført da alle patienter havde mindst 24 ugers opfølgning.
English: Ask your doctor if you should stop breast-feeding or if you should stop treatment with Tecentriq.
Danish: Spørg lægen om du skal holde op med at amme, eller om du skal holde op med at få Tecentriq.
English: The patient will be provided with the patient alert card and instructed to carry the card at all times.
Danish: Patienten vil få udleveret et patientkort og vil blive vejledt i altid at have kortet på sig.
English: Parenteral medicinal products should be inspected visually for particulates and discolouration prior to administration.
Danish: Parenterale lægemidler skal efterses for partikler og misfarvning inden administration.
English: Tell your doctor straight away if you notice any of the side effects below or if they get worse.
Danish: Kontakt straks lægen, hvis du bemærker nedenstående bivirkninger eller hvis de forværres.
English: Metabolism and nutrition disorders Very common decreased appetite decreased appetite
Danish: Metabolisme og ernæring Meget almindelig Nedsat appetit
English: This is because stopping treatment may stop the effect of the medicine.
Danish: Hvis du stopper behandlingen, kan det påvirke virkningen af medicinen.
English: Your first infusion will be given over 60 minutes.
Danish: Din første infusion vil tage 60 minutter.
English: Do not stop treatment with Tecentriq unless you have discussed this with your doctor.
Danish: Fortsæt behandlingen med Tecentriq medmindre du har aftalt noget andet med lægen.
English: Patients who met established criteria and who agreed to be treated beyond disease progression had tumour assessments conducted every 6 weeks until treatment discontinuation.
Danish: De patienter, der opfyldte de opsatte kriterier og indvilligede i at blive behandlet efter sygdomsprogression, fik udført tumoranalyser hver 6. uge indtil behandlingsophør.
English: • If you become pregnant while you are being treated with Tecentriq tell your doctor.
Danish: · Hvis du bliver gravid mens du er i behandling med Tecentriq, skal du kontakte lægen.
English: In the absence of data, atezolizumab should be used with caution in these populations after careful evaluation of the balance of benefits and risks for the patient.
Danish: På grund af manglende data, bør atezolizumab anvendes med forsigtighed til disse populationer og efter omhyggelig afvejning af fordele og risici for patienten.
English: The schedule of administration must be adjusted to maintain the appropriate interval between doses.
Danish: Planlægning af behandlingen kan herefter justeres for at opretholde et passende interval mellem doseringerne.
English: In addition, nab-paclitaxel is administered on days 8 and 15.
Danish: Nab-paclitaxel administreres også på dag 8 og dag 15.
English: Physicians should consult the nab-paclitaxel summary of product characteristics (SmPC) for specific precautions and contraindications of this medicine.
Danish: Læger bør læse nab-paclitaxels produktresumé for specifikke forholdsregler og kontraindikationer for dette lægemiddel.
English: Tecentriq must be initiated and supervised by physicians experienced in the treatment of cancer.
Danish: Behandling med Tecentriq skal påbegyndes og superviseres af læge med erfaring i behandling af cancer.
English: Etoposide is also administered by intravenous infusion on days 2 and 3.
Danish: Etoposid administreres også som intravenøs infusion på dag 2 og 3.
English: The Marketing Authorisation Holder shall submit the first periodic safety update report for this product within 6 months following authorisation.
Danish: Indehaveren af markedsføringstilladelsen skal fremsende den første PSUR for dette præparat inden for 6 måneder efter godkendelsen.
English: Healthcare professionals are asked to report any suspected adverse reactions the national reporting system listed in Appendix V.
Danish: Læger og sundhedspersonale anmodes om at indberette alle formodede bivirkninger via det nationale rapporteringssystem anført i Appendiks V.
English: ** Based on Kaplan-Meier estimate
Danish: ** Baseret på Kaplan-Meier estimat.
English: Due to increased haematologic toxicities observed in Asian patients in IMpower150, it is recommended that the starting dose of paclitaxel should be 175 mg/m2 every three weeks.
Danish: På grund af øget hæmatologisk toksicitet observeret i asiatiske patienter i studiet IMpower150, anbefales det, at startdosis for paclitaxel er 175 mg/m2 hver tredje uge for denne population.
English: Tecentriq is an anti-cancer medicine that contains the active substance atezolizumab.
Danish: Tecentriq er kræftmedicin, der indeholder det aktive stof atezolizumab.
English: Best supportive care or pemetrexed a
Danish: Bedste understøttende behandling eller pemetrexed a
English: Thyroid function should be monitored prior to and periodically during treatment with atezolizumab.
Danish: Thyroideafunktionen bør monitoreres inden og periodisk under behandling med atezolizumab.
English: • performed under aseptic conditions by trained personnel in accordance with good practice rules especially with respect to the aseptic preparation of parenteral products.
Danish: Klargøringen skal: · udføres under aseptiske betingelser af uddannet personale i overensstemmelse med reglerne for god praksis, især hvad angår aseptisk fortynding af parenterale produkter.
English: • prepared in a laminar flow hood or biological safety cabinet using standard precautions for the safe handling of intravenous agents.
Danish: · foregå i et aftræksskab med laminar strømning eller et biologisk sikkerhedsskab med anvendelse af standardforholdsreglerne for sikker håndtering af intravenøse midler.
English: The metabolism of atezolizumab has not been directly studied.
Danish: Atezolizumabs metabolisme er ikke direkte undersøgt.
English: • If you do not have an infusion reaction during the first infusion, the next infusions will be given to you over a period of 30 minutes.
Danish: · Hvis du ikke oplever reaktioner på den første infusion, vil de næste infusioner tage 30 minutter.
English: Grade 4 Diarrhoea or Colitis (life threatening; urgent intervention indicated)
Danish: Grad 4 diarré eller colitis (livstruende; akut intervention indiceret)
English: For suspected immune-related adverse reactions, thorough evaluation to confirm aetiology or exclude other causes should be performed.
Danish: Hvis der er formodning om immunrelaterede bivirkninger, skal der udføres grundig evaluering for at bekræfte ætiologi og udelukke andre årsager.
English: Polska Roche Polska Sp.z o.o.
Danish: Roche Polska Sp.z o.o.
English: These results indicate a potential risk, based on its mechanism of action, that administration of atezolizumab during pregnancy could cause foetal harm, including increased rates of abortion or stillbirth.
Danish: Disse resultater indikerer en potentiel risiko for, at administration af atezolizumab under graviditet, på grund af virkningsmekanismen, kan forårsage fosterskader, inklusive øget frekvens af abort og dødfødsel.
English: Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness.
Danish: Bivirkninger angives, inden for hver frekvensgruppe, efter alvorlighedsgrad, i faldende rækkefølge.
English: Seventy-five percent of patients received only one prior platinum-based therapeutic regimen.
Danish: 75% af patienterne havde kun haft ét tidligere platinholdig regime.
English: A total of 1,225 patients were enrolled and per the analysis plan the first 850 randomised patients were included in the primary efficacy analysis.
Danish: Der blev i alt inkluderet 1225 patienter, hvoraf de første 850 randomiserede patienter blev inkluderet i den primære effektanalyse jævnfør analyseplanen.
English: Store in a refrigerator (2 °C - 8 °C).
Danish: Opbevares i køleskab (2°C-8°C).
English: • loss of appetite
Danish: Nedsat appetit
English: • Store in a refrigerator (2 °C - 8 °C).
Danish: · Opbevares i køleskab (2°C til 8°C).
English: Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines.
Danish: Fortæl det altid til lægen eller apotekspersonalet, hvis du tager anden medicin eller har gjort det for nylig.
English: Among 107 Arm B patients who had a response status of stable disease, partial response, or complete response after induction therapy, 40 received pemetrexed switch maintenance therapy.
Danish: Af de 107 patienter i behandlingsarm B, som havde en responsstatus for stabil sygdom, patiel respons eller komplet respons efter induktionsbehandlingen, skiftede 40 patienter over til vedligeholdelsesbehandling med pemetrexed.
English: There were 24.2% of patients who received only prior platinum-containing adjuvant or neoadjuvant therapy and progressed within 12 months.
Danish: 24,2% af patienterne fik kun forudgående platinholdig adjuverende eller neoadjuverende behandling og oplevede progression inden for 12 måneder.
English: Patients excluded from clinical trials
Danish: Patienter, der ikke kunne inkluderes i kliniske studier
English: * An analysis of OS in the all comer population was performed based on the stratified log-rank test and the result is provided for descriptive purposes only (p = 0.0378); according to the pre-specified analysis hierarchy, the p-value for the OS analysis in the all comer population cannot be considered statistically significant.
Danish: * Analyse af samlet overlevelse hos ITT-population blev udført på basis af den stratificerede log-rank-test; og resultaterne medtages udelukkende med et deskriptivt formål (p=0,0378); i overensstemmelse med det præspecificerede analysehierarki, kan p-værdien for samlet overlevelsesanalysen i ITT-populationen ikke betragtes som statistisk signifikant.
English: • Obligation to conduct post-authorisation measures
Danish: · Forpligtelse til at gennemføre foranstaltninger efter udstedelse af markedsføringstilladelse
English: Seven (0.2%) patients required the use of corticosteroids.
Danish: Syv (0,2%) patienter havde behov for kortikosteroidbehandling.
English: The initial dose of Tecentriq must be administered over 60 minutes.
Danish: Startdosis af Tecentriq skal administreres over 60 minutter.
English: Includes report of nephritis, Henoch-Schonlein Purpura nephritis.
Danish: Inkluderer indberetninger om nefritis, Henoch-Schonlein Purpura nefritis.
English: By attaching to the protein, Tecentriq helps your immune system to fight your cancer.
Danish: Ved at binde sig til proteinet, hjælper Tecentriq immunforsvaret med at bekæmpe kræften.
English: However, patients who had prior anti-CTLA-4 treatment could be enrolled, as long as the last dose was received at least 6 weeks prior to randomization, and there was no history of severe immunerelated adverse effects from anti-CTLA-4 (NCI CTCAE Grades 3 and 4).
Danish: Patienter, der tidligere havde fået anti-CTLA4 behandling, kunne imidlertid inkluderes, hvis den sidste dosis var administreret mindst 6 uger inden randomisering, og såfremt der ikke var alvorlige immunrelaterede bivirkninger fra behandling med anti-CTLA-4 (NCI CTCAE grad 3 og 4) i anamnesen.
English: The physician educational material should contain:
Danish: Uddannelsesmaterialet for sundhedspersonalet skal indeholde:
English: The median number of treatment cycles was 7 for atezolizumab and 6 for nab-paclitaxel in each treatment arm.
Danish: Medianen af antal behandlingsserier var 7 for atezolizumab og 6 for nab-paclitaxel for hver behandlingsarm.