FrancophonIA/ELRC3.0 huggingface dataset:
English: Other side effects Tell your doctor or nurse if you notice any of the following side effects:
Danish: Andre bivirkninger Fortæl lægen eller sundhedspersonalet hvis du oplever nogen af de følgende bivirkninger:
English: · If you get an infusion related reaction, you may require additional treatment, or the infusion may need to be slowed down or stopped.
Danish: • Hvis du får en infusionsrelateret reaktion, kan du få behov for yderligere behandling eller måske skal infusionen gives langsommere eller stoppes.
English: Size of PVC or non-PVC polyolefin infusion bag
Danish: Størrelse PVC- eller nonPVC-polyolefininfusionspose
English: Patients at acute risk of hypertensive crisis should be evaluated for the benefits and risks of withholding their anti-hypertensive medicine.
Danish: Patienter i akut risiko for hypertensiv krise bør evalueres for fordele og ulemper ved at afbryde deres antihypertensive behandling.
English: The subgroups evaluated included IPI, FLIPI, Bulky Disease, B Symptoms at baseline, Ann Arbor Stage and ECOG at baseline.
Danish: De evaluerede subgrupper inkluderede IPI, FLIPI, bulky sygdom, B-symptomer ved baseline, Ann Arbor stadie og ECOG ved baseline.
English: Any signs of concomitant infection should be treated as appropriate.
Danish: Ethvert symptom på samtidig infektion skal behandles.
English: Patients requiring premedication
Danish: Patienter med behov for præmedicinering Præmedicinering
English: Data during follow up, especially for the chlorambucil alone arm, is limited.
Danish: Data fra opfølgningsperioden, især for den gruppe der kun fik chlorambucil, er begrænset.
English: Gazyvaro is available in a pack containing 1 glass vial.
Danish: Gazyvaro fås i pakker med 1 hætteglas.
English: If there are any modifications of the infusion rate or interruptions during the first 100 mg the second bag must be administered the following day.
Danish: Hvis der er ændringer i infusionshastigheden, eller infusionen afbrydes under de første 100 mg, skal pose nr. 2 administreres den følgende dag.
English: Patients with positive hepatitis B serology should consult liver disease experts before start of treatment and should be monitored and managed following local medical standards to prevent hepatitis reactivation.
Danish: Patienter med positiv hepatitis B-serologi bør vurderes af en ekspert i leversygdomme, inden behandlingen påbegyndes og bør overvåges og behandles i overensstemmelse med lokal klinisk praksis for at forhindre reaktivering af hepatitis.
English: In animal models obinutuzumab mediates potent B-cell depletion and antitumour efficacy.
Danish: I dyremodeller medierer obinutuzumab potent B-celle-depletering og antitumor-effekt.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 23 July 2014
Danish: Dato for første markedsføringstilladelse: 23. juli 2014 Dato for seneste fornyelse:
English: If you miss your appointment, make another one as soon as possible.
Danish: Hvis du ikke kan komme til en behandlingsaftale, skal du lave en ny aftale så hurtigt som muligt.
English: Gazyvaro binds to targets on the surface of the affected “B-lymphocyte” cells and causes them to die.
Danish: Gazyvaro bindes til et bestemt sted på overfladen af de påvirkede B-lymfocytter og forårsager, at de dør.
English: Pharmacotherapeutic group: Antineoplastic agents, monoclonal antibodies, ATC code: L01XC15
Danish: Farmakoterapeutisk klassifikation: Antineoplastiske midler, monoklonale antistoffer, ATC-kode: L01XC15
English: The demographic data and baseline characteristics were well balanced between the treatment arms (median age 63 years, the majority were Caucasian [88%] and male [58%]).
Danish: De demografiske karakteristika og baseline-karakteristiska var velbalancerede mellem behandlingsarmene (medianalder 63 år, størstedelen var kaukasere (88%) og mænd (58%)).
English: Dose modifications during treatment (all indications) No dose reductions of Gazyvaro are recommended.
Danish: Dosisjustering under behandlingen (begge indikationer) Der er ingen anbefalet dosisreduktion af Gazyvaro.
English: In the population pharmacokinetic analysis, gender was found to be a covariate which explains some of the inter-patient variability, with a 22% greater steady state clearance (CLss) and a 19% greater volume of distribution (V) in males.
Danish: I den farmakokinetiske populationsanalyse fandtes køn at være et kovariat, hvilket forklarer noget af variabiliteten patienterne imellem, med en 22% større steady-state-clearance (CLss) og et 19% større fordelingsvolumen (V) hos mænd.
English: Gazyvaro is given under the supervision of a doctor experienced in such treatment.
Danish: Gazyvaro gives under opsyn af en læge, som har erfaring i denne behandling.
English: Administer at 25 mg/hr over 4 hours.
Danish: Giv 25 mg/time over 4 timer.
English: Gazyvaro should be prepared by a healthcare professional using aseptic technique.
Danish: Gazyvaro skal tilberedes af sundhedspersonalet ved aseptisk teknik.
English: · Store in a refrigerator (2 °C-8 °C).
Danish: • Opbevar medicinen i køleskab (2°C-8°C).
English: A typical schedule is shown below.
Danish: Nedenfor kan du se et typisk skema:
English: · The other ingredients are histidine, histidine hydrochloride monohydrate, trehalose dihydrate, poloxamer 188 and water for injections.
Danish: • Øvrige indholdsstoffer er histidin, histidinhydrochloridmonohydrat, trehalosedihydrat, poloxamerer 188 og vand til injektionsvæsker.
English: Based on the FACT-Lym questionnaire collected during treatment and follow-up phases, patients in both treatment arms experienced clinically meaningful improvements in lymphoma-related symptoms as defined by a ³ 3 point increase from baseline in the Lymphoma subscale, a ³ 6 point increase from baseline in the FACT Lym TOI and a ³ 7 point increase from baseline in the FACT Lym Total score.
Danish: Baseret på FACT-Lym spørgeskema indsamlet under behandlings- og opfølgningsfaser, oplevede patienter i begge behandlings-arme klinisk betydningsfulde forbedringer i lymfom symptomer, som defineret ved et ≥ 3 point stigning fra baseline i Lymfom sub-skala, en ≥ 6 point stigning fra baseline i FACT Lym Trial Outcome Index og en ≥ 7 point stigning fra baseline i FACT-Lym total score.
English: These patients experienced more serious adverse events and adverse events leading to death than those patients < 75 years of age.
Danish: Disse patienter oplevede flere alvorlige bivirkninger og bivirkninger medførende død end patienter <75 år.
English: While fatal haemorrhagic events occurred in less than 1% of patients; none of the fatal adverse events occurred in Cycle 1.
Danish: Mens fatale hæmoragiske bivirkninger forekom hos mindre end 1 % af patienterne; forekom ingen af de fatale bivirkninger under 1. behandlingsserie.
English: Required amount of Gazyvaro concentrate
Danish: Mængde Gazyvaro koncentrat
English: If the first bag is completed without modifications of the infusion rate or interruptions, the second bag may be administered on the same day (no dose delay necessary, no repetition of premedication), provided that appropriate time, conditions and medical supervision are available throughout the infusion.
Danish: Hvis pose nr. 1 administreres uden ændringer i infusionshastighed og uden afbrydelser, kan pose nr. 2 administreres samme dag (dosisforsinkelse ikke nødvendig, ingen gentagelse af præmedicinering) forudsat der er tid, forholdene opfylder kravene og medicinsk overvågning er tilgængelig under hele infusionen.
English: Of these patients, none experienced anaphylactic or hypersensitivity reactions that were considered related to ATA, nor was clinical response affected.
Danish: Ingen af disse patienter oplevede anafylaktiske eller allergiske reaktioner, der vurderedes at være forbundet med ATA, ligesom det kliniske respons heller ikke var påvirket.
English: The median estimated CrCl was 62 mL/min and 66% of all patients had a CrCl < 70 mL/min.
Danish: Median-CrCl var 62 ml/min, og 66% af alle patienterne havde en CrCl <70 ml/min.
English: · Do not use this medicine after the expiry date which is stated on the carton after EXP.
Danish: • Brug ikke lægemidlet efter udløbsdatoen, der står på pakningen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Transfusion of blood products (i.e. platelet transfusion) according to institutional practice is at the discretion of the treating physician.
Danish: Transfusion af blodprodukter (dvs. transfusion af blodplader), i overensstemmelse med klinisk praksis, kan overvejes af behandlende læge.
English: The majority of the patients in study GAO4753g had FL (81.1%).
Danish: Størstedelen af patienterne i studie GAO4753g havde follikulært lymfom (81,1%).
English: · If you do not have an infusion related reaction following the small part of your first dose, you may be given the rest of your first dose (900 mg) on the same day.
Danish: • Hvis du ikke oplever en reaktion på infusionen på den mindre del af din første dosis, kan du få resten af din første dosis (900 mg) samme dag.
English: In patients treated with Gazyvaro 8 out of 140 patients in the randomised phase and 2 out of 6 in the run in phase tested positive for ATA at 12 months of follow up.
Danish: Blandt patienter behandlet med Gazyvaro var 8 ud af 140 patienter i den randomiserede fase og 2 ud af 6 patienter i indkøringsfasen positive for ATA ved opfølgningen efter 12 måneder.
English: Gazyvaro is not likely to affect your ability to drive, cycle or use any tools or machines.
Danish: Gazyvaro vil sandsynligvis ikke påvirke din evne til at føre motorkøretøj, cykle eller betjene værktøj eller maskiner.
English: · If you do have an infusion related reaction following the small part of your first dose, you will be given the rest of your first dose on Day 2.
Danish: • Hvis du oplever en infusionsrelateret reaktion på den mindre del af din første dosis, får du resten af din første dosis på dag 2.
English: The majority of patients had follicular lymphoma (81%).
Danish: Størstedelen af patienterne havde follikulært lymfon (81%).
English: Gazyvaro contains the active substance obinutuzumab, which belongs to a group of medicines called “monoclonal antibodies”.
Danish: Gazyvaro indeholder det aktive stof obinutuzumab, som tilhører en gruppe af lægemidler, der kaldes monoklonale antistoffer.
English: The symptoms of PML are nonspecific and can vary depending on the affected region of the brain.
Danish: Symptomer på progressiv multifokal leukoencefalopati er uspecifikke og kan variere afhængigt af, hvilken del af hjernen der rammes.
English: Offspring exposure on day 28 post-partum suggests that obinutuzumab can cross the blood-placenta barrier.
Danish: Afkommets værdier på 28. dag postpartum tyder på, at obinutuzumab passerer blod-placenta-barrieren.
English: You may be more likely to get an infection during and after treatment with Gazyvaro.
Danish: Du vil måske lettere få infektioner under og efter behandling med Gazyvaro.
English: Results of subgroup analyses
Danish: Resultater af analyser af subgrupper
English: As treatment continues, the impact of this pathway diminishes and the linear clearance pathway predominates.
Danish: Som behandlingen skrider frem, mindskes betydningen af denne clearancevej, og den lineære clearancevej kommer til at dominere.
English: This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Danish: Dette lægemiddel må ikke blandes med andre lægemidler end dem, der er anført i pkt.
English: Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000
Danish: Hyppigheder defineres som meget almindelig (≥1/10), almindelig (≥1/100 til <1/10), ikke almindelig (≥1/1000 til <1/100), sjælden (≥1/10.000 til <1/1000) og meget sjælden (<1/10.000).
English: Results of subgroup analyses (not adjusted for multiplicity) were, in general, consistent with the results seen in the FL population, supporting the robustness of the overall result.
Danish: Resultaterne frasubgruppe analyser (ikke justeret for multipel testing) var generelt i overensstemmelse med de resultater, der ses i follikulært lymfom populationen, hvilket støtter robustheden af det samlede resultat.
English: The demographic data and baseline characteristics of the patient population were well balanced between the treatment arms; median age was 59 years, 81% were Caucasian, 53% were female, 79% had a FLIPI score of ≥ 2 and 7% had Stage II (bulky), 35% had Stage III and 57% had Stage IV disease, 44% had bulky disease (> 7 cm), 34% had at least one B-symptom at baseline and 97% had an ECOG performance status of 0-1 at baseline.
Danish: De demografiske data og baseline-karakteristika af patientpopulationen var velafbalancerede mellem behandlingsarmene; median alder var 59 år, 81 % var kaukasere, 53 % var kvinder, 79% havde en FLIPI score på ≥ 2 og 7 % havde stadie II (bulky), 35 % havde stadie III og 57 % havde stadie IV sygdom, 44 % havde bulky sygdom (> 7 cm), 34% havde mindst et B-symptom ved baseline og 97% havde en ECOG performancestatus på 0-1 ved baseline.
English: Antiviral and antifungal prophylaxis should also be considered (see section 4.2).
Danish: Antiviral og antimykotisk profylakse bør også overvejes (se pkt.
English: Obinutuzumab is not a substrate, inhibitor, or inducer of cytochrome P450 (CYP450), uridine diphosphate glucuronyltransferase (UGT) enzymes and transporters such as P-glycoprotein.
Danish: Obinutuzumab er ikke et substrat, en hæmmer eller en induktor af cytokrom P450 (CYP450), uridindiphosphatglucuronyltransferase (UGT)-enzymer og -transportere som P-glykoprotein.
English: This includes medicines obtained without a prescription and herbal medicines.
Danish: Dette gælder også anden medicin, der kan købes uden recept, samt naturmedicin.
English: The safety and efficacy of Gazyvaro in patients with impaired hepatic function has not been established.
Danish: Sikkerhed og virkning af Gazyvaro hos patienter med nedsat leverfunktion er ikke klarlagt.
English: It specifically targets the extracellular loop of the CD20 transmembrane antigen on the surface of non-malignant and malignant pre-B and mature B-lymphocytes, but not on haematopoietic stem cells, pro-B-cells, normal plasma cells or other normal tissue.
Danish: Det er specifikt målrettet mod det ekstracellulære loop i CD20transmembran-antigenet på overfladen af non-maligne og maligne præ-B- og modne B-lymfocytter, men ikke mod hæmatopoietiske stamceller, pro-B-celler, normale plasmaceller eller andet normalt væv.
English: However, if you get an infusion related reaction, (see section 4), do not drive, cycle or use any tools or machines until the reaction stops.
Danish: Hvis du oplever en reaktion på infusionen (se afsnit 4), mådu ikke køre motorkøretøj, cykle eller betjene værktøj og/eller maskiner, før reaktionen er forsvundet.
English: Patients with FL Grade 3b were excluded from the study.
Danish: Patienter med follikulært lymfom grad 3b blev ekskluderet fra studiet.
English: Gazyvaro should be administered under the close supervision of an experienced physician and in an environment where full resuscitation facilities are immediately available.
Danish: Gazyvaro skal administreres under omhyggelig overvågning af en erfaren læge og i et miljø, hvor alle genoplivningsfaciliteter er umiddelbart tilgængelige.
English: Intravenous corticosteroid1 (mandatory)
Danish: Intravenøst kortikosteroid1 (obligatorisk)
English: The safety and timing of vaccination should be discussed with the infant's physician (see section 4.6).
Danish: Sikkerhed ved vaccination og tidspunkt herfor, skal diskuteres med barnets læge (se pkt.
English: The median comorbidity score was 8 and 76% of the patients enrolled had a comorbidity score above 6.
Danish: Medianværdien for co-morbiditetscore var 8, og 76% af de inkluderede patienter havde en comorbiditetsscore over 6.
English: However, once the majority of CD20 cells are bound with obinutuzumab, the impact of TMDD on PK is minimised.
Danish: Når størstedelen af CD20-cellerne er bundet til obinutuzumab, mindskes dog TMDD betydning for farmakokinetikken.
English: A reproduction study in cynomolgus monkeys showed no evidence of embryofoetal toxicity or teratogenic effects but resulted in a complete depletion of B-lymphocytes in offspring.
Danish: Et reproduktionsstudie med cynomolgusaber viste ingen tegn på embryoføtal toksicitet eller teratogen virkning, men medførte fuldstændig depletering af B-lymfocytter hos afkommet.
English: The bag should be gently inverted to mix the solution in order to avoid excessive foaming.
Danish: Posen vendes forsigtigt for at blande opløsningen og for at undgå, at der dannes skum.
English: Patients who have pre-existing cardiac or pulmonary conditions should be monitored carefully throughout the infusion and the post-infusion period.
Danish: Patienter med hjerte- eller lungesygdom skal omhyggeligt overvåges under hele infusionen og i perioden efter infusionen.
English: The incidence of IRRs with subsequent infusions was 3% with the second 1,000 mg dose and 1% thereafter.
Danish: Incidensen af infusionsrelaterede reaktioner ved efterfølgende infusioner var 3% ved infusion af 2. dosis på 1000 mg og herefter 1%.
English: EQ-5D utility scores were similar at baseline, during treatment and follow-up.
Danish: EQ5D nytteværdi score var både under behandling og opfølgning ens ved baseline.
English: Gazyvaro should not be administered in the presence of an active infection and caution should be exercised when considering the use of Gazyvaro in patients with a history of recurring or chronic infections.
Danish: Gazyvaro bør ikke administreres hvis patienten har en aktiv infektion, og der bør udvises forsigtighed når det overvejes at anvende Gazyvaro til patienter med recidiverende og kroniske infektioner i anamnesen.
English: If a hypersensitivity reaction is suspected during or after an infusion, the infusion must be stopped and treatment permanently discontinued.
Danish: Hvis en overfølsomhedsreaktion mistænkes under eller efter en infusion, skal infusionen afbrydes, og behandlingen permanent seponeres.
English: In study GAO4753g/GADOLIN, patients in the bendamustine arm received 6 months of induction treatment only, whereas after the induction period, patients in the Gazyvaro plus bendamustine arm continued with Gazyvaro maintenance treatment.
Danish: I studie GAO4753g/GADOLIN fik patienterne i bendamustin-armen kun 6 måneder med induktionsbehandling, hvorimod patienterne i Gazyvaro plus bendamustin-armen fortsatte med Gazyvaro vedligeholdelsesbehandling efter induktionsperioden.
English: In order to improve the traceability of biological medicinal products, the trade name and batch number of the administered product should be clearly recorded (or stated) in the patient file.
Danish: Handelsnavnet og batchnummeret på det administrerede præparat skal registreres (eller anføres) tydeligt i patientens journal for at sikre sporbarheden af biologiske lægemidler.
English: 2See section 5.1 for information on bendamustine dose
Danish: 5.1 for information om bendamustin dosis
English: During the follow-up phase, Grade 3-5 infections are observed more in patients who received Gazyvaro plus bendamustine in the induction phase.
Danish: Under opfølgningsfasen er grad 3-5 infektioner observeret mere hos patienter, der fik Gazyvaro plus bendamustin i induktionsfasen.
English: · Full dose (1,000 mg) once every 2 months for up to 2 years as long as your disease does not progress.
Danish: Vedligeholdelsesfase Fuld dosis (1000 mg) en gang hver anden måned i op til 2 år, så længe din sygdom ikke bliver værre.
English: Injury, poisoning and procedural complications Very common
Danish: Traumer, forgiftninger og behandlingskomplikationer Meget almindelig
English: Gazyvaro can then be used on its own for up to 2 years as a “maintenance treatment”.
Danish: - Gazyvaro kan derefter bruges alene i op til 2 år.
English: Every 2 months for 2 years or until disease progression (whichever occurs first)
Danish: Hver 2. måned i 2 år eller indtil sygdomsprogression (hvad end, der opstår først)
English: In study BO21223/GALLIUM, 1/565 patient (0.2% of patients with a post-baseline assessment) developed HAHA at induction completion.
Danish: I BO21223 / GALLIUM studiet udviklede 1/565 patienter (0,2 % af patienterne med en post-baseline vurdering) HAHA ved endt induktion.
English: With a median observation time of 24.1 months for FL patients, 48 patients (28.1%) in the B arm and 30 patients (18.3%) in the G+B arm had died.
Danish: Med en median observationstid på 24,1 måned for patienter med follikulært lymfom, var 48 patienter (28,1%) i bendamustin-armen og 30 patienter (18,3%) i Gazyvaro + bendamustin armen døde.
English: Gazyvaro has no or negligible influence on the ability to drive and use machines.
Danish: Gazyvaro påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maksiner.
English: 40 mL concentrate in a 50 mL vial (clear Type I glass) with stopper (butyl rubber).
Danish: 40 ml koncentrat i 50 ml hætteglas (klart type I-glas) med prop (butylgummi).
English: Patients who received G-CSF prophylaxis had a lower rate of Grade 3-5 infections (see section 4.4).
Danish: Patienter, som fik G-CSF-profylakse havde en lavere incidens af grad 3-5 infektioner (se pkt.
English: In clinical studies with Gazyvaro, doses ranging from 50 mg up to and including 2,000 mg per infusion have been administered.
Danish: Der er i kliniske studier med Gazyvaro givet doser fra 50 mg til og med 2000 mg per infusion.
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 brug.
English: The combination of obinutuzumab with chlorambucil, bendamustine, CHOP or CVP may increase the risk of neutropenia (see section 4.4).
Danish: Kombinationen af obinutuzumab og chlorambucil,bendamustin, CHOP eller CVP kan øge risikoen for neutropeni (se pkt.
English: No specific studies in animals have been performed to evaluate the effect of obinutuzumab on fertility.
Danish: Der er ikke gennemført specifikke dyrestudier for at evaluere obinutuzumabs effekt på fertilitet.
English: 11.6% of the patients had marginal zone lymphoma (MZL) and 7.1% had small lymphocytic lymphoma (SLL).
Danish: 11,6 % af patienterne havde marginal zone lymfom og 7,1 % havde småcellet lymfocytært lymfom.
English: In the majority of patients, irrespective of indication, IRRs were mild to moderate and could be managed by the slowing or temporary halting of the first infusion, but severe and life-threatening IRRs requiring symptomatic treatment have also been reported.
Danish: Hos de fleste patienter, uafhængigt af indikationen, var infusionsrelaterede reaktioner lettetil moderate og kunne håndteres ved at nedsætte infusionshastigheden eller midlertidigt afbryde den første infusion, men der er også rapporteret svære og livstruende infusionsrelaterede reaktioner med behov for symptomatisk behandling.
English: Use of any concomitant therapies which could possibly worsen thrombocytopenia-related events, such as platelet inhibitors and anticoagulants, should also be taken into consideration, especially during the first cycle.
Danish: Brug af enhver samtidig behandling, der kan forværre trombocytopenirelaterede hændelser, fx trombocythæmmere og antikoagulantia, bør også tages i betragtning, særligt under den første behandlingsserie.
English: An enhanced pre and postnatal development (ePPND) toxicity study in pregnant cynomolgus monkeys showed no evidence of teratogenic effects.
Danish: Et styrket præ- og postnatalt udviklingstoksicitetsstudie (ePPND) med drægtige cynomolgusaber viste ingen tegn på teratogen virkning.
English: · Grade 1-2 (mild to moderate): The infusion rate must be reduced and symptoms treated.
Danish: • Grad 1-2 (mild til moderat): Infusionshastigheden skal reduceres og symptomerne behandles.
English: Patients with previously untreated follicular lymphoma
Danish: Patienter med tidligere ubehandlet follikulært lymfom
English: Duration of treatment Six treatment cycles, each of 28 day duration.
Danish: Varighed af behandling Seks behandlingsserier, hver af 28 dages varighed.