FrancophonIA/ELRC3.0 huggingface dataset:
English: Cycles 2-6 or 2-8 - this will be just one dose of Gazyvaro in the 28 or 21 days depending on which other cancer medicines are given together with Gazyvaro: · Day 1 - full dose (1,000 mg).
Danish: Dette vil inkludere 3 doser af Gazyvaro i løbet af 28 eller 21 dage afhængigt af hvilke andre lægemidler mod kræft, der gives sammen med Gazyvaro: 1. dag - fuld dosis (1000 mg)
English: Management of IRRs (all indications)
Danish: Håndtering af infusionsrelaterede reaktioner (begge indikationer)
English: Management of IRRs may require temporary interruption, reduction in the rate of infusion, or treatment discontinuations of Gazyvaro as outlined below.
Danish: Håndtering af infusionsrelaterede reaktioner (begge indikationer) Håndtering af infusionsrelaterede reaktioner kan kræve midlertidig afbrydelse, nedsættelse af infusionshastighed eller seponering af Gazyvaro, som beskrevet nedenfor.
English: No studies have been performed to establish the carcinogenic potential of obinutuzumab.
Danish: Obinutuzumabs carcinogene potentiale er ikke undersøgt.
English: · Before each infusion of Gazyvaro, you will be given medicines which help to reduce possible infusion related reactions or “tumour lysis syndrome”.
Danish: • Inden hver infusion af Gazyvaro, vil du få medicin der mindsker risikoen for infusionsrelaterede reaktioner og for en bestemt komplikation, der kan være livstruende som benævnes tumorlysesyndrom.
English: For patients with FL, the recommended dose of Gazyvaro in combination with chemotherapy is shown in Table 3.
Danish: Hos patienter med follikulært lymfom er den anbefalede dosis af Gazyvaro i kombination med kemoterapi angivet i tabel 3.
English: In the pivotal studies (BO21223/GALLIUM, GAO4753g/GADOLIN) in iNHL, 5% (35 out of 698) and 8% (15 out of 194) of patients treated with Gazyvaro, respectively, had moderate renal impairment (CrCL < 50 mL/min).
Danish: Indolent non-Hodgkin lymfom inklusive follikulært lymfom I de pivotale studier (BO21223/GALLIUM og GAO4753g/GADOLIN) med indolent non-Hodgkin lymfom, havde hhv. 5 % (35 ud af 698) og 8% (15 ud af 194) af patienterne, der blev behandlet med Gazyvaro, moderat nedsat nyrefunktion (CrCl <50 ml/min).
English: If the patient experienced an IRR of Grade 2 or higher during the previous infusion administer at 50 mg/hr.
Danish: Hvis patienten har oplevet en infusionsrelateret reaktion af grad 2 eller højere i den forudgående infusion, start med administration på 50 mg/time.
English: PML is a very rare and life-threatening brain infection that has been reported with Gazyvaro.
Danish: Progressiv multifokal leukoencefalopati er en meget sjælden og livstruende hjernebetændelse, der er set ved brug af Gazyvaro.
English: Table 1 Premedication to be administered before Gazyvaro infusion to reduce the risk of IRRs in patients with CLL and FL (see section 4.4)
Danish: Tabel 1 Præmedicinering, der skal gives inden infusion af Gazyvaro med henblik på at reducere risikoen for infusionsrelaterede reaktioner hos patienter med kronisk lymfatisk leukæmi og follikulært lymfom (se pkt.
English: Patients with a high tumour burden and/or high circulating lymphocyte count in CLL [> 25 x 109/L] may be at increased risk of severe IRRs.
Danish: Patienter med kronisk lymfatisk leukæmi og høj tumorbyrde og/eller højt antalcirkulerende lymfocytter ([>25 x 109/l]) kan have øget risiko for svære infusionsrelaterede reaktioner.
English: Indolent Non-Hodgkin Lymphoma including Follicular Lymphoma
Danish: Indolent non-Hodgkin lymfom inklusive follikulært lymfom Incidensen af trombocytopeni var14 %.
English: *pre-specified analyses performed on the intent to treat (ITT) population were repeated on the FL population; analysis of double refractory (i.e. unresponsive to or disease progression during or within 6 months of the last dose of an alkylating agent-based regimen) status was exploratory.
Danish: Analyser af dobbeltrefraktær status (dvs. uden respons eller med sygdomsprogression under eller inden for 6 måneder efter den sidste dosis af et behandlingsregime indeholdende et alkylerende middel), var eksplorative.
English: For management of IRRs see section 4.2 Posology and method of administration.
Danish: 4.2 Dosering og administration.
English: Cycle 1
Danish: 1. serie
English: Results of subgroup analyses were in general consistent with the results seen in the FL population, supporting the robustness of the overall result.
Danish: Resultater fra sub-gruppe analyser var generelt i overensstemmelse med de resultater, der er set hos patienterne med follikulært lymfom.
English: Nasal congestion, rhinorrhoea, oropharyngeal pain
Danish: Nasal kongestion, rhinore orofaryngeal smerte
English: From the population PK model, after the Cycle 6 Day 1 infusion in CLL patients, the estimated median Cmax value was 465.7 μg/mL and AUC(τ) value was 8961 μg•d/mL and in iNHL patients the estimated median Cmax value was
Danish: Fra den farmakokinetiske populationsmodel var den estimerede mediane Cmax og AUC(τ) efter infusion på dag 1 i 6. behandlingsserie henholdsvis 465,7 μg/ml og 8.961 μg•døgn/ml hos patienter med kronisk lymfatisk leukæmi og 539,3 μg/ml og 10.956 μg•døgn/ml hos patienter med indolent non-Hodgkin lymfom.
English: Primary Endpoint in FL population IRC-assessed PFS (PFS-IRC) Number (%) of patients with event Median time to event (months, 95% CI)
Danish: Primært endepunkt Progressionsfri overlevelse vurderet af en uafhængig komité Antal (%) patienter med hændelse Median tid til hændelse (måneder, 95% konfidensinterval)
English: Dose of Gazyvaro to be administered
Danish: Gazyvaro-dosis, der skal gives
English: Do not use other diluents such as glucose (5%) solution (see section 6.2).
Danish: Andre fortyndingsmidler, fx glucose (5%) injektionsvæske må ikke bruges (se pkt.
English: All Grades Gazyvaro + chemotherapy* (CLL, iNHL) followed by Gazyvaro maintenance (iNHL)
Danish: Alle grader Gazyvaro + kemoterapi* (kronisk lymfatisk leukæmi, indolent non-Hodgkin lymfom) efterfulgt af Gazyvarovedligeholdelsesbehandling (indolent non-Hodgkin lymfom)
English: For patients with CLL the recommended dose of Gazyvaro in combination with chlorambucil is shown in Table 2.
Danish: Hos patienter med kronisk lymfatisk leukæmi er den anbefalede dosis af Gazyvaro i kombination med chlorambucil angivet i tabel 2.
English: Chronic lymphocytic leukaemia · You will be given 6 treatment cycles of Gazyvaro in combination with another medicine for cancer called chlorambucil.
Danish: • Du vil få 6 behandlingsserier med Gazyvaro i kombination med chlorambucil, et andet lægemiddel mod kræft.
English: No adverse effects on male and female reproductive organs were observed in repeat-dose toxicity studies in cynomolgus monkeys (see section 5.3).
Danish: Der er i toksicitetsstudier med gentagne doser til cynomolgusaber ikke set negativ påvirkning af de mandlige eller kvindelige forplantningsorganer (se pkt.
English: · Six 21-day cycles in combination with cyclophosphamide, doxorubicin, vincristine, prednisolone (CHOP), followed by 2 additional cycles of Gazyvaro alone or · Eight 21-day cycles in combination with cyclophosphamide, vincristine, and prednisone/prednisolone/methylprednisolone (CVP).
Danish: • Otte 21-dages behandlingsserier i kombination med cyclophosphamid, vincristin og prednison/prednisolon/methylprednisolon (CVP).
English: B-cell counts returned to normal levels in the offspring, and immunologic function was restored within 6 months of birth.
Danish: Afkommets Bcelletal og immunologiske funktion normaliseredes inden for 6 måneder efter fødslen.
English: Patients with a high tumour burden and/or a high circulating lymphocyte count (> 25 x 109/L) and/or renal impairment (CrCl < 70 mL/min) are considered at risk of TLS and should receive prophylaxis.
Danish: Profylakse og præmedicinering for tumorlysesyndrom Patienter med høj tumorbyrde og/eller højt antal cirkulerende lymfocytter (>25 x 109/l) og/eller nedsat nyrefunktion (CrCl <70 ml/min) er anset for at være i risiko for tumorlysesyndrom og bør have profylaktisk behandling.
English: In the pivotal studies (BO21223/GALLIUM, GAO4753g/GADOLIN) in iNHL, patients 65 years or older experienced more serious adverse events and adverse events leading to withdrawal or death than patients < 65 years of age.
Danish: Indolent non-Hodgkin lymfom inklusive follikulært lymfom I de pivotale studier (BO21223/GALLIUM og GAO4753g/GADOLIN) med indolent non-Hodgkin lymfom oplevede patienter, som var 65 år eller derover mere alvorlige bivirkninger og bivirkninger medførende seponering eller død end patienter <65 år.
English: Prophylaxis should consist of adequate hydration and administration of uricostatics (e.g. allopurinol), or suitable alternative such as a urate oxidase (e.g. rasburicase) starting 12-24 hours prior to start of Gazyvaro infusion as per standard practice.
Danish: Profylakse bør bestå af tilstrækkelig hydrering og administration af uratsænkende middel (fx allopurinol) eller anden passende alternativ behandling, som fx uratoxidase (fx rasburikase), indledt 12-24 timer inden infusion af Gazyvaro i henhold til standardpraksis.
English: Patients with renal impairment (CrCl < 50 mL/min) and patients with both Cumulative Illness Rating Scale (CIRS) > 6 and CrCl < 70 mL/min are more at risk of IRRs, including severe IRRs (see section 4.8).
Danish: Patienter med nedsat nyrefunktion (CrCl <50 ml/min) og patienter med en en co-morbiditetsscore >6 på CIRS-skalaen (Cumulative Illness Rating Scale) samt CrCl <70 ml/min har højere risiko for infusionsrelaterede reaktioner, inklusive svære infusionsrelaterede reaktioner (se pkt.
English: Median observation time: 22 months
Danish: 22 månedersmedian observationstid
English: Patients with follicular lymphoma who did not respond or who progressed during or up to 6 months after treatment with rituximab or a rituximab-containing regimen
Danish: Patienter med follikulært lymfom, som ikke responderede eller som fik sygdomsprogression under eller op til 6 måneder efter behandling med rituximab eller en behandling indeholdende rituximab
English: Tumour lysis syndrome, hypokalaemia
Danish: Tumorlysesyndrom, hypokaliæmi
English: Prophylaxis should consist of adequate hydration and administration of uricostatics (e.g. allopurinol), or suitable alternative treatment such as urate oxidase (e.g. rasburicase), starting 12-24 hours prior to start of Gazyvaro infusion as per standard practice (see section 4.4).
Danish: Profylakse bør bestå af tilstrækkelig hydrering og administration af uratsænkende middel (fx allopurinol) eller anden passende alternativ behandling, som fx uratoxidase (fx rasburikase), indledt 12-24 timer inden Gazyvaro infusion i henhold til standardpraksis (se pkt.
English: Primary endpoint Investigator-assessed PFS (PFS-INV)a Number (%) of patients with event Median time to event (months) Hazard ratio (95% CI) p-value (Log-Rank test, stratifiedb) Key secondary endpoints IRC-assessed PFS (PFS-IRC)a Number (%) of patients with event Median time to event (months) Hazard ratio (95% CI) p-value (Log-Rank test, stratifiedb) End of treatment response rate No. of patients included in the analysis Responders (%) Non-responders (%) Difference in response rate, (95% CI) p-value (Chi-squared Test) No. of complete responders c
Danish: Vigtigste sekundære endepunkter Uafhængig komité-vurderet progressionfri overlevelsea Antal (%) patienter med hændelse Median tid til hændelse (måneder) Hazard ratio (95% konfidensinterval) p-værdi (stratificeret log-rank testb) Responsrate ved behandlingsafslutning Antal patienter inkluderet i analysen Respondere (%) Non-respondere (%) Forskel i responsrate, (95% konfidensinterval) p-værdi (Chi-i anden-test) Antal patienter med fuldstændigt responsc (%) Molekylær remission ved behandlingsafslutning Antal patienter inkluderet i analysen MRD-negative (%) MRD-positiv f
English: Medicines should not be disposed of via wastewater or household waste.
Danish: Af hensyn til miljøet må du ikke smide medicinrester i afløbet eller i skraldespanden.
English: Day 1 (1,000 mg)
Danish: 1. dag (1000 mg)
English: If the patient experienced an IRR during the previous infusion, start with administration at 25 mg/hr.
Danish: Hvis patienten har oplevet en infusionsrelateret reaktion i den forudgående infusion, start med administration på 25 mg/time.
English: Mitigation measures to reduce IRRs should be followed (see section 4.2).
Danish: Forebyggende tiltag til reduktion af infusionsrelaterede reaktioner bør initieres (se pkt.
English: Therefore, in order to provide the most comprehensive safety information, the analysis of ADRs presented in the following has been performed on the entire study population (i.e. iNHL).
Danish: Nedenstående analyse af bivirkninger er derfor blevet udført på hele studiepopulationen (dvs. indolent non-Hodgkin lymfom) for at give den mest omfattende information om sikkerheden.
English: Table 8 Summary of efficacy in patients with previously untreated FL from BO21223/ GALLIUM study
Danish: Tabel 8 Resumé af effektresultater hos patienter med tidligere ubehandlet follikulært lymfom i BO21223 (GALLIUM) studiet Rituximab + Kemoterapi efterfulgt af rituximab vedligeholdelsesbehandling N=601
English: · You will be given 6 or 8 treatment cycles of Gazyvaro in combination with other medicines for cancer - each cycle lasts 28 or 21 days depending on which other cancer medicines are given together with Gazyvaro.
Danish: Hver serie varer 28 eller 21 dage afhængigt af hvilke andre lægemidler mod kræft, der gives sammen med Gazyvaro.
English: Patients who achieve a complete or partial response to induction treatment with Gazyvaro in combination with chemotherapy (CHOP or CVP or bendamustine) should continue to receive Gazyvaro 1,000 mg as single agent maintenance therapy once every 2 months for 2 years or until disease progression (whichever occurs first).
Danish: Patienter, der opnår et komplet eller partielt respons på induktionsbehandling med Gazyvaro i kombination med kemoterapi (CHOP, CVP eller bendamustin), skal fortsætte vedligeholdelsesbehandling med Gazyvaro 1000 mg som monoterapi én gang hver 2. måned i 2 år eller indtil sygdomsprogression (hvad end, der opstår først).
English: For CLL patients receiving the Day 1 (Cycle 1) dose split over two days, the Day 1 infusion rate may be increased back up to 25 mg/hr after 1 hour, but not increased further.
Danish: For patienter med kronisk lymfatisk leukæmi, som får 1. dags (1. behandlingsserie) dosis over 2 dage, kan infusionshastigheden på 1. dag øges til 25 mg/time efter 1 time, men må ikke øges yderligere.
English: Dose of Gazyvaro
Danish: Gazyvaro-dosis
English: Chronic Lymphocytic Leukaemia Table 4 Chronic lymphocytic leukaemia: Standard infusion rate in the absence of IRRs/hypersensitivity and recommendations in case an IRR occurred with previous infusion
Danish: Kronisk lymfatisk leukæmi Tabel 4 Kronisk lymfatisk leukæmi: Standard-infusionshastigheder hvis der ikke ses infusionsrelaterede reaktioner/overfølsomhed og anbefalinger i tilfælde af infusionsrelaterede reaktioner opstået under forudgående infusion
English: In patients receiving Gazyvaro plus chemotherapy, the incidence of IRRs was highest on Day 1 and gradually decreased with subsequent infusions.
Danish: I 1. behandlingsserie var den overordnede incidens af infusionsrelaterede reaktioner højere hos patienter, der fik Gazyvaro plus kemoterapi sammenlignet med patienter i komparator armenHos patienter, der fik Gazyvaro plus kemoterapi, var incidensen af infusionsrelaterede reaktioner højst på 1. behandlingsdag og faldt gradvist med efterfølgende infusioner.
English: Cycle
Danish: Serie
English: Cycles 2-6 or
Danish: 2.- 6. eller 2.- 8. serie
English: Talk to your doctor or nurse before you are given Gazyvaro if: · you have an infection, or have had an infection in the past which lasted a long time or keeps coming back · you have ever taken, or been given, medicines which affect your immune system (such as chemotherapy or immunosuppressants) · you are taking medicines for high blood pressure or medicines used to thin your blood - your doctor might need to alter how you take these · you have ever had heart problems · you have ever had brain problems (such as memory problems, difficulty moving or feeling sensations in your body, eyesight problems) · you have ever had breathing problems or lung problems · you have ever had “hepatitis B” - a type of liver disease · you are due to have a vaccine or you know you may need to have one in the near future.
Danish: Almindelige (kan påvirke op til 1 ud af 10 patienter) røde øjne forkølelsessår depression, angst nattesved influenza vægtøgning smerter i lymfeknuder løbende eller stoppet næse eksem betændelseslignende tilstand (inflammation) i næsen eller svælget smerter i mund eller svælg muskel- og knoglesmerter i brystet hudkræft (planocellulært karcinom i huden) knogler, arme og ben uregelmæssige hjerteslag (atrieflimren), hjertesvigt problemer med vandladningen, urininkontinens forhøjet blodtryk problemer med fordøjelsen (fx halsbrand eller sure opstød), betændelse i tarmene, hæmorider ændringer i blodprøve-resultater: - lavt antal af lymfocytter (en type hvide blodlegemer) - forhøjet niveau af kalium, fosfat eller urinsyre, som kan give nyreproblemer (del af tumorlyse-syndrom) reduceret niveau af kalium
English: (INV-assessed, CT) Responders (%) (CR, PR) Difference in response rate (%) [95% CI] p-value (Cochran-Mantel-Haenszel test) Complete Response (CR) Partial Response (PR)
Danish: (komplet respons/partielt respons) Forskel i responsrate (%)(95% konfidensinterval) p-værdi
English: Patients who achieved a complete or partial response to induction treatment (i.e. the initial 6 treatment cycles) with Gazyvaro in combination with bendamustine or have stable disease should continue to receive Gazyvaro 1,000 mg as single agent maintenance therapy once every 2 months for 2 years or until disease progression (whichever occurs first).
Danish: Patienter, som opnåede et komplet eller partiel respons på induktionsbehandlingen (dvs. de initiale 6 behandlingsserier) med Gazyvaro i kombination med bendamustin eller som har stabil sygdom, skal fortsætte i vedligeholdelsesbehandling med Gazyvaro 1000 mg som monoterapi én gang hver 2. måned i 2 år eller indtil sygdomsprogression (hvad end der opstår først).
English: Day of treatment cycle
Danish: Dag i behandlingsserien
English: Hepatic impairment
Danish: • smertefuldt udslæt
English: Nasopharyngitis, rhinitis, influenza, oral herpes
Danish: Nasofaryngitis, rinitis, influenza, oral herpes Benigne, maligne og uspecificerede tumorer (inkl.
English: Squamous cell carcinoma of skin Squamous cell carcinoma of skin Blood and lymphatic system disorders Very common
Danish: Planocellulært carcinom i huden Planocellulært carcinom i huden
English: METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use For intravenous use after dilution Do not shake the vial
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Læs indlægssedlen inden brug
English: If no IRR occurred during the previous infusion, administer at 50 mg/hr.
Danish: Hvis ingen infusionsrelateret reaktion opstod under den forudgående infusion, gives 50 mg/time.
English: Patients who achieve a complete or partial response to induction treatment with Gazyvaro in combination with chemotherapy should continue to receive Gazyvaro 1,000 mg as single agent maintenance therapy once every 2 months for 2 years or until disease progression (whichever occurs first).
Danish: Patienter som opnåede et komplet eller partielt respons på induktionsbehandling med Gazyvaro i kombination med kemoterapi skal fortsætte i vedligeholdelsesbehandling med Gazyvaro 1000 mg som monoterapi én gang hver 2. måned i 2 år eller indtil sygdomsprogression (hvad end, der opstår først).
English: # Patients with FL who did not respond or who progressed during or up to 6 months after treatment with rituximab or a rituximab-containing regimen
Danish: # Patienter med follikulært lymfom, som ikke responderede eller som fik sygdomsprogression under eller op til 6 måneder efter behandling med rituximab eller en behandling indeholdende rituximab
English: Figure 7 Kaplan-Meier curve of OS in patients with FL # (Study GAO4753g/GADOLIN)
Danish: Kaplan-Meier-kurve over samlet overlevelse hos patienter med follikulært lymfom# (GAO4753g /GADOLIN-studiet)
English: NAME OF THE MEDICINAL PRODUCT Gazyvaro 1,000 mg concentrate for solution for infusion obinutuzumab
Danish: LÆGEMIDLETS NAVN Gazyvaro 1000 mg koncentrat til infusionsvæske, opløsning
English: Renal and Urinary Disorders Common
Danish: Nyre og urinveje Almindelige
English: Best Overall Response (BOR) (IRC-assessed) No. of patients included in the analysis Responders (%) (CR/PR) Difference in response rate (95% CI) p-value (Cochran-Mantel-Haenszel test) Complete Responders (%) Partial Responders (%) Stable Disease (%) Duration of response (DOR) (IRCassessed) No of patients included in the analysis No. (%) of patients with event Median duration (months) of DOR (95% CI)
Danish: Hazard ratio (95% konfidensinterval) p-værdi (stratificeret log-rank test,*) Sekundære endepunkter Investigator-vurderet progressionsfri overlevelse Antal (%) patienter med hændelse Median til til hændelse (måneder, 95% konfidensinterval) Hazard ratio (95% konfidensinterval) p-værdi (stratificeret log-rank test,*) Bedste samlede respons (vurderet af en uafhængig komité)§ Antal patienter inkluderet i analysen Respondere (%) (komplet respons/partielt respons) Forskel i responsrate (95% konfidensinterval) p-værdi (Cochran-Mantel-Haenszel test) Komplet respons (%) Partielt respons (%) Stabil sygdom (%) Responsvarighed (vurderet af en uafhængig komité) Antal patienter inkluderet i analysen Antal (%) patienter med hændelse Median (måneder) responsvarighed (95% konfidensinterval)
English: Withdraw 40 mL of concentrate from the vial and dilute in polyvinyl chloride (PVC) or non-PVC polyolefin infusion bags containing sodium chloride 9 mg/mL (0.9%) solution for injection.
Danish: 2.- 6. behandlingsserie ved kronisk lymfatisk leukæmi og alle behandlingsserier ved follikulært lymfom Træk 40 ml koncentrat op af hætteglasset og fortynd i polyvinylchlorid (PVC)- eller non-PVC polyolefininfusionspose indeholdende natriumchlorid 9 mg/ml (0,9%) opløsning til injektion.
English: · Keep this leaflet.
Danish: Gem indlægssedlen.
English: Your doctor/nurse will monitor you carefully for infusion related reactions.
Danish: Du vil få 100 mg Gazyvaro meget langsomt, mens lægen/sundhedspersonalet overvåger dig for infusionsrelaterede reaktioner.
English: IRC: Independent Review Committee; PFS: progression-free survival; HR: Hazard Ratio; CI: Confidence Intervals, MRD: Minimal Residual Disease, NR = Not reached a Defined as the time from randomisation to the first occurrence of progression, relapse or death from any cause as assessed by the investigator b stratified by Binet stage at baseline c Includes 11 patients in the GClb arm with a complete response with incomplete marrow recovery d Blood and bone marrow combined e MRD negativity is defined as a result below 0.0001 f Includes MRD positive patients and patients who progressed or died before the end of treatment g Median observation time for overall survival (OS) data corresponds to 62.5 months median observation time in Stage 1a and to 59.4 months median observation time in Stage 2.
Danish: MRD-negativitet defineres som et resultat under 0,0001 f Inkluderer MRD-positive patienter og patienter, der har oplevet progression eller er døde inden behandlingen er afsluttet gMedian observationstid for samlet overlevelse svarer til 62,5 måneders median observationstid i stadie 1a og til 59,4 måneders median observationstid i stadie 2
English: Arthralgia, back pain, musculoskeletal chest pain, bone pain
Danish: Artralgi, rygsmerter, muskuloskeletale brystsmerter, knoglesmerter