FrancophonIA/ELRC3.0 huggingface dataset:
English: Localised candida infections as well as Herpes zoster were reported at a higher incidence in the rituximab-containing arm of randomised studies.
Danish: I de randomiserede studier var hyppigheden af lokale candidainfektioner og herpes zoster højere i den arm, som indeholdt rituximab.
English: A total of 6/34 (18%) of rituximab treated patients from the maintenance therapy clinical trial developed ADA.
Danish: I alt 6 ud af 34 (18 %) rituximab-behandlede patienter fra det kliniske studie med vedligeholdelsesbehandling udviklede ADA.
English: b) If you are being treated for granulomatosis with polyangiitis or microscopic polyangiitis
Danish: b) Hvis du behandles for granulomatose med polyangiitis eller mikroskopisk polyangiitis
English: Infections were predominately mild to moderate and consisted mostly of upper respiratory tract infections, herpes zoster and urinary tract infections.
Danish: Infektionerne var hovedsageligt lette til moderate og var som regel øvre luftvejsinfektioner, herpes zoster og urinvejsinfektioner.
English: 1 mL contains 10 mg of rituximab.
Danish: 1 ml indeholder 10 mg rituximab.
English: Treatment with Ritemvia uses four separate infusions given at weekly intervals.
Danish: Hvert behandlingsforløb Ritemviabestår af fire separate infusioner, der gives med én uges mellemrum.
English: Mean change in HAQ‐DI
Danish: Gennemsnitsændring i HAQ-DI
English: System Organ Class
Danish: Systemorganklass e
English: In the clinical trial on induction of remission, cardiac events occurred at a rate of approximately 273 per 100 patient years (95% CI 149-470) at the 6-month primary endpoint.
Danish: I det kliniske studie med induktion af remission blev kardielle bivirkninger rapporteret med en hyppighed på ca. 273 pr. 100 patientår (95 % konfidensinterval 149-470) ved det primære endepunkt ved måned 6.
English: • short term increase in the amount of some types of anti-bodies in the blood (called immunoglobulins - IgM), chemical disturbances in the blood caused by break-down of dying cancer cells
Danish: • kortvarig stigning i antallet af bestemte antistoffer kaldet immunglobuliner i blodet (IgM),
English: Infusion-related reactions in the pemphigus vulgaris clinical study were common (58%).
Danish: Infusionsrelaterede reaktioner var almindelige (58 %) i det kliniske studie med PV.
English: In two open-label randomised trials, a total of 817 previously untreated patients and 552 patients with relapsed/refractory CLL were randomised to receive either FC chemotherapy (fludarabine 25 mg/m2, cyclophosphamide 250 mg/m2, days 1-3) every 4 weeks for 6 cycles or rituximab in combination with FC (R-FC).
Danish: I to åbne, randomiserede studier blev 817 tidligere ubehandlede patienter og 552 patienter med relaps/refraktær CLL randomiseret til enten FC-kemoterapi (fludarabin 25 mg/m2, cyclophosphamid 250 mg/m2, på dag 1-3) hver 4. uge i 6 serier eller rituximab i kombination med FC (R-FC).
English: Cases of fatal PML that occurred after disease progression and retreatment have also been reported in clinical trials.
Danish: Også i kliniske studier er der rapporteret om tilfælde af fatal PML, som forekom efter sygdomsprogression og genbehandling.
English: This medicine contains 52.6 mg sodium (main component of cooking/table salt) in each 10 mL vial.
Danish: Dette lægemiddel indeholder 52,6 mg natrium (hoved komponent af madlavnings-/bordsalt) pr. 10 mL hætteglas.
English: late neutropenia2 serum sickness-like reaction
Danish: sen neutropeni2 serumsygelignende reaktion
English: The “primary” statistical test for “response” was the trend test of CR versus PR versus non-response (p < 0.0001) Abbreviations: NA, not available; ORR: overall response rate; CR: complete response; PR: partial response
Danish: Den “primære” statistiske undersøgelse af “respons” var test for trend af CR versus PR versus ingen respons (p< 0,0001).
English: Patients treated with rituximab in combination with methotrexate had a significantly greater reduction in disease activity score (DAS28) than patients treated with methotrexate alone (Table 12).
Danish: I alle studier havde patienter behandlet med rituximab i kombination med methotrexat en signifikant større reduktion i sygdomsaktivitetsscore (DAS28) end patienter behandlet med methotrexat alene (tabel 12).
English: Immune system disorders infusion related reactions4, angioedema hypersensitivit y anaphylaxi s tumour lysis syndrome, cytokine release syndrome4, serum sickness infusion-related acute reversible thrombocytope nia4
Danish: Immunsystemet infusionsrelaterede reaktioner, angioødem hypersensitivitet anafylaksi tumorlysesyndrom, cytokinfrigivelsessyndrom4, serumsygdom infusionsrelateret akut, reversibel trombocytopen i4
English: The ORR was 57% (95% Confidence interval (CI); 41% - 73%; CR 14%, PR 43%) with a projected median TTP for responding patients of 19.4 months (range 5.3 to 38.9 months).
Danish: Den samlede responsrate var 57 % (95 % konfidensinterval: 41 % - 73 %; CR 14 % og PR 43 %) med en median tid indtil progression, for responderende patienter, på 19,4 måneder (interval: 5,3-38,9 måneder).
English: The most frequent adverse reactions considered due to receipt of rituximab were IRRs.
Danish: De mest almindelige bivirkninger, der blev anset for at være relateret til administration af rituximab, var infusionsrelaterede reaktioner.
English: Closely monitor patients with pre-existing cardiac conditions and those who experienced prior cardiopulmonary adverse reactions.
Danish: Patienter med præ-eksisterende hjertelidelser, og patienter, som tidligere har oplevet kardiopulmonære bivirkninger, skal overvåges nøje.
English: % HAQ‐DI MCID Mean change in FACIT‐T
Danish: % HAQ-DI MCID Gennemsnitsændring i FACIT-T
English: Relapsed/Refractory follicular lymphoma
Danish: Recidiveret/ refraktært follikulært lymfom
English: Initial treatment, bulky disease, weekly for 4 doses In pooled data from three trials, 39 patients with relapsed or chemoresistant, bulky disease (single lesion ≥ 10 cm in diameter), low grade or follicular B cell NHL received 375 mg/m2 of rituximab as intravenous infusion weekly for four doses.
Danish: Induktionsbehandling, udbredt sygdom, 1 dosis ugentligt til i alt 4 doser I data sammenlagt fra tre studier fik 39 patienter med recidiveret eller kemoterapi-resistent, udbredt sygdom (enkeltlæsion ≥ 10 cm i diameter), lavmalignt eller follikulært B-celle NHL 375 mg/m2 rituximab som intravenøs infusion ugentligt i fire doser.
English: Each mL of concentrate contains 10 mg of rituximab.
Danish: Hver ml koncentrat indeholder 10 mg rituximab.
English: In the clinical trial on induction of remission, the incidence of malignancy in rituximab-treated patients in the granulomatosis with polyangiitis and microscopic polyangiitis clinical study was 2.00 per 100 patient years at the study common closing date (when the final patient had completed the follow-up period).
Danish: I det kliniske studie med induktion af remission var malignitetshyppigheden blandt rituximabbehandlede patienter i det kliniske studie med patienter med GPA eller MPA var 2,00 pr. 100 patientår ved studiets slutning (da sidste patient havde gennemført opfølgningsperioden).
English: The available data indicate that the rate of clinically relevant infection is unchanged when such therapies are used in patients previously treated with rituximab, however patients should be closely observed for signs of infection if biologic agents and/or DMARDs are used following rituximab therapy.
Danish: Tilgængelige data indikerer, at hyppigheden af kliniske relevante infektioner er uændret, når disse terapier anvendes hos patienter, som tidligere er blevet behandlet med rituximab.
English: This medicine contains 263.2 mg sodium (main component of cooking/table salt) in each 50 mL vial.
Danish: Dette lægemiddel indeholder 263,2 mg natrium (hoved komponent af madlavnings-/bordsalt) pr. 50 mL hætteglas.
English: This variability in V1 (27.1% and 19.0%) contributed by the range in BSA (1.53 to 2.32 m2) and concurrent CHOP therapy, respectively, were relatively small.
Danish: Forskellen i kroppens overfladeareal (1,53-2,32 m2) og samtidig behandling med CHOP kemoterapi, bidrog til den relativt ringe variation i V1 (27,1 % og 19,0 %).
English: • pain in the muscles • heart beating faster than normal
Danish: • hjertet slår hurtigere end normalt
English: In a multicentre, single-arm trial, 58 patients with relapsed or chemoresistant low grade or follicular B cell NHL, who had achieved an objective clinical response to a prior course of rituximab, were re-treated with 375 mg/m2 of rituximab as intravenous infusion weekly for four doses.
Danish: I et enkelt-arms multicenterstudie blev 58 patienter med recidiveret elle kemoterapi-resistent lavmalignt eller follikulært B-celle NHL, som havde opnået et objektivt klinisk respons efter en tidligere serie med rituximab, genbehandlet med 375 mg/m2 rituximab som intravenøs infusion ugentligt i fire doser.
English: The incidence of ADRs of all grades and grade 3/4 ADR was similar in elderly patients compared to younger patients (< 65 years).
Danish: Hyppigheden af bivirkninger, uanset sværhedsgrad, og hyppigheden af grad 3/4 bivirkninger var ens hos ældre, sammenlignet med yngre (< 65 år).
English: Metabolism and nutrition disorders hyperglycaemia , weight decrease, peripheral oedema, face oedema, increased LDH, hypocalcaemia
Danish: Metabolisme og ernæring hyperglykæmi, vægttab, perifert ødem, ansigtsødem, øget LD, hypocalcæmi
English: however transient B-cell depletion and lymphocytopenia have been reported in some infants born to mothers exposed to rituximab during pregnancy.
Danish: Der foreligger ingen adækvate og velkontrollerede data fra studier hos gravide kvinder, men der er dog beskrevet forbigående B-celle depletion og lymfocytopeni hos børn af mødre, som har været eksponeret for rituximab under graviditeten.
English: Hypogammaglobulinaemia (IgG or IgM below the lower limit of normal) has been observed in RA patients treated with rituximab.
Danish: Der er observeret hypogammaglobulinæmi (IgA, IgG eller IgM under den nedre normalgrænse) hos patienter med GPA eller MPA behandlet med rituximab.
English: Severe IRRs with fatal outcome have been reported in the post-marketing setting.
Danish: Alvorlige infusionsrelaterede reaktioner med dødelig udgang er rapporteret efter markedsføring.
English: Muscle weakness Musculoskeletal pain Pain in extremities
Danish: Muskelsvaghed Muskuloskeletale smerter Ekstremitetssmerter
English: Rituximab maintenance treatment consisted of a single infusion of rituximab at 375 mg/m2 body surface area given every 2 months until disease progression or for a maximum period of two years.
Danish: Rituximab-vedligeholdelsesbehandling bestod af en enkelt rituximab-infusion på 375 mg/m2 legemsoverfladeareal hver 2. måned indtil sygdomsprogression eller i maksimalt 2 år.
English: Clinical laboratory finding
Danish: Kliniske laboratoriefund
English: • pain in the tummy
Danish: • smerter i maven
English: In the pivotal trial, 166 patients with relapsed or chemoresistant low-grade or follicular B cell NHL received 375 mg/m2 of rituximab as an intravenous infusion once weekly for four weeks.
Danish: I det pivotale studie fik 166 patienter med recidiverende eller kemoterapi-resistent lavmalignt eller follikulært B-celle NHL 375 mg/m2 rituximab som intravenøs infusion én gang om ugen i fire uger.
English: The recommended dose of Ritemvia used as a maintenance treatment for patients with previously untreated follicular lymphoma who have responded to induction treatment is: 375 mg/m2 body surface area once every 2 months (starting 2 months after the last dose of induction therapy) until disease progression or for a maximum period of two years (12 infusions in total).
Danish: Den anbefalede dosis af Ritemvia til vedligeholdelsesbehandling hos tidligere ubehandlede patienter med follikulært lymfom, som har responderet på induktionsbehandling, er 375 mg/m2 legemsoverfladeareal én gang hver 2. måned (startende 2 måneder efter den sidste dosis i induktionsbehandlingen) indtil sygdomsprogression eller i maksimalt 2 år (12 infusioner i alt).
English: Table 10a First-line treatment of chronic lymphocytic leukaemia Overview of efficacy results for rituximab plus FC vs. FC alone - 48.1 months median observation time Efficacy Parameter
Danish: Tabel 10a Førstelinjebehandling af kronisk lymfatisk leukæmi - sammenfatning af resultaterne for effekt for rituximab plus FC versus FC alene - median observationstid: 48,1 måneder Effektparameter
English: Contraindications for use in rheumatoid arthritis, granulomatosis with polyangiitis, microscopic polyangiitis and pemphigus vulgaris
Danish: Kontraindikationer for anvendelse til reumatoid artrit, granulomatose med polyangiitis, mikroskopisk polyangiitis og pemfigus vulgaris
English: In a non-randomised study, patients with relapsed low-grade NHL who received rituximab monotherapy when compared to healthy untreated controls had a lower rate of response to vaccination with tetanus recall antigen (16% vs. 81%) and Keyhole Limpet Haemocyanin (KLH) neoantigen (4% vs. 76% when assessed for >2-fold increase in antibody titer).
Danish: Patienterne havde en lavere responsrate over for vaccination med tetanus recall antigen (16 % versus 81 %) og Keyhole Limet Haemocyanin (KLH) neoantigen (4 % versus 76 %, når vurderet for > 2-fold stigning i antistof -titeren).
English: Rituximab maintenance treatment consisted of a single infusion of rituximab at 375 mg/m2 body surface area given every 3 months until disease progression or for a maximum period of two years.
Danish: Rituximab vedligeholdelsesbehandling bestod af en enkelt infusion med rituximab på 375 mg/m2 legemsoverflade administreret hver tredje måned indtil sygdomsprogression eller i en periode på højst to år.
English: The pre-specified primary analysis was conducted at a median observation time of 25 months from randomisation, maintenance therapy with rituximab resulted in a clinically relevant and statistically significant improvement in the primary endpoint of investigator assessed progressionfree survival (PFS) as compared to observation in patients with previously untreated follicular lymphoma (Table 7).
Danish: Vedligeholdelsesbehandling med rituximab resulterede i en klinisk relevant og statistisk signifikant forbedring af det primære endepunkt investigatorbedømt progressionsfri overlevelse, sammenlignet med observation hos patienter med tidligere ubehandlet follikulært lymfom (tabel 7).
English: • What you need to know before having
Danish: • Hvad du skal vide, før du får Ritemvia
English: The ADRs listed in Table 3 were all adverse events which occurred at an incidence of ≥ 5% in the rituximab group and at a higher frequency than the comparator group.
Danish: De bivirkninger, der opsummeres i tabel 3, forekom alle med en hyppighed ≥ 5 % i rituximab-gruppen og med en højere frekvens end sammenligningsgruppen.
English: • being sick (vomiting), diarrhoea, pain in the stomach, irritation or ulcers in the throat and mouth, problems swallowing, constipation, indigestion
Danish: • opkastning, diarré, mavesmerter, irritation eller sår i svælg eller mund, synkebesvær,
English: Very rare side effects (may affect up to 1 in 10,000 people):
Danish: Meget sjældne bivirkninger (kan forekomme hos op til 1 ud af 10.000 patienter):
English: • skin disorders such as itching, hives, and benign lumps
Danish: • hudsygdomme såsom kløe, nældefeber og godartede knuder
English: Respiratory, thoracic and mediastinal disorders bronchospasm4, respiratory disease, chest pain, dyspnoea, increased cough, rhinitis asthma, bronchiolitis obliterans, lung disorder, hypoxia interstitial lung disease7
Danish: Luftveje, thorax og mediastinum bronkospasmer4, luftvejssygdom me, brystsmerter, dyspnø, øget hoste, rhinitis astma, bronchiolitis obliterans, lungesygdomme, hypoksi interstitiel lungesygdom7
English: The recommended dose of Ritemvia in combination with chemotherapy for induction treatment of previously untreated or relapsed/refractory patients with follicular lymphoma is: 375 mg/m2 body surface area per cycle, for up to 8 cycles.
Danish: Den anbefalede dosis af Ritemvia i kombination med kemoterapi til induktionsbehandling hos tidligere ubehandlede patienter eller patienter med recidiveret/ refraktært follikulært lymfom er 375 mg/m2 legemsoverfladeareal pr. behandlingsserie i op til 8 serier.
English: In the clinical trial studying induction of remission with severe active GPA and MPA, IRRs were defined as any adverse event occurring within 24 hours of an infusion and considered to be infusion-related by investigators in the safety population.
Danish: Infusionsrelaterede reaktioner (IRR) i det kliniske studie, hvor man så på induktion af remission hos patienter med svær, aktiv GPA eller MPA blev defineret som enhver bivirkning, der opstod inden for 24 timer efter en infusion i sikkerhedspopulationen, og som af investigator blev anset som værende infusionsrelateret.
English: The recommended dosage of Ritemvia for induction of remission therapy of granulomatosis with polyangiitis and microscopic polyangiitis is 375 mg/m2 body surface area, administered as an intravenous infusion once weekly for 4 weeks (four infusions in total).
Danish: Den anbefalede dosis af Ritemvia til induktion af remission af GPA og MPA er 375 mg/m2 legemsoverfladeareal, administreret som intravenøs infusion, én gang ugentligt i 4 uger (4 infusioner i alt).
English: The ORR was 36% (CI95% 21% - 51%; CR 3%, PR 33%) with a median TTP for responding patients of 9.6 months (range 4.5 to 26.8 months).
Danish: Den samlede responsrate var 36 % (95 % konfidensinterval: 21 % - 51 %; CR 3 % og PR 33 % med en median tid indtil progression, for responderende patienter, på 9,6 måneder (interval: 4,5-26,8 måneder).
English: Musculo-skeletal disorders arthralgia / musculoskeletal pain, osteoarthritis, bursitis
Danish: Knogler, led, muskler og bindevæv artralgier / muskulo-skeletale smerter, osteoartrit, bursitis
English: Observation N=513
Danish: Observation Rituximab N=513
English: Granulomatosis with polyangiitis and microscopic polyangiitis are two forms of inflammation of the blood vessels which mainly affects the lungs and kidneys, but may affect other organs as well.
Danish: Granulomatose med polyangiitis og mikroskopisk polyangiitis er to former for inflammation (betændelse) i blodkarrene.
English: Follicular non-Hodgkin's lymphoma
Danish: Follikulær non-Hodgkin-lymfom
English: R‐CHOP
Danish: R-CHOP NR
English: In patients with non-Hodgkin's lymphoma receiving rituximab in combination with cytotoxic chemotherapy, cases of hepatitis B reactivation have been reported (see non-Hodgkin's lymphoma).
Danish: Der er rapporteret hepatitis B-reaktivering hos patienter med non-Hodgkins lymfom, som fik rituximab i kombination med cytotoksisk kemoterapi (se non-Hodgkins lymfom).
English: The two treatment groups were well balanced with regards to baseline characteristics and disease status.
Danish: De to behandlingsgrupper var ligeligt fordelt med hensyn til baseline-karakteristika og sygdomsstatus.
English: Infections and infestations bacterial infections, viral infections, +bronchitis sepsis, +pneumonia, +febrile infection, +herpes zoster, +respiratory tract infection, fungal infections, infections of unknown aetiology, +acute bronchitis, +sinusitis, hepatitis B1
Danish: Infektioner og parasitære sygdomme bakterielle og virale infektioner +bronkitis sepsis, +pneumoni, +febril infektion, +herpes zoster, +luftvejsinfektioner, svampeinfektioner, infektioner af ukendt ætiologi, +akut bronkitis, +sinusitis, hepatitis B1
English: For the 60 re-treatments on study, the ORR was 38% (CI95% 26% - 51%; 10% CR, 28% PR) with a projected median TTP for responding patients of 17.8 months (range 5.4 - 26.6).
Danish: Den samlede responsrate for de 60 genbehandlinger i studiet var 38 % (95 % konfidensinterval: 26 % - 51 %, CR 10 % og PR 28 %) med en median tid indtil progression, for responderende patienter, på 17,8 måneder (spændvidde: 5,4 måneder - 26,6 måneder).
English: Mild or moderate infusion-related reactions (IRRs) (section 4.8) usually respond to a reduction in the rate of infusion.
Danish: 4.8) responderer sædvanligvis på en reduktion af infusionshastigheden.
English: Following second infusion, mean Cmax ranged from 183 to 198 μg/mL for the 2 × 500 mg dose and ranged from 355 to 404 μg/mL for the 2 × 1000 mg dose.
Danish: Efter den anden infusion varierede gennemsnittet for Cmax fra 183 til 198 μg/ml for doseringen på 2 x 500 mg og fra 355 til 404 μg/ml for doseringen på 2 x 1.000 mg.
English: 99 patients were treated for induction of remission of GPA and MPA in a clinical trial with rituximab (375 mg/m2, once weekly for 4 weeks) and glucocorticoids (see section 5.1).
Danish: I et klinisk studie blev 99 patienter behandlet med rituximab (375 mg/m2, én gang ugentligt i 4 uger) og glukokortikoider for induktion af remission af GPA og MPA (se pkt.
English: General disorders and administration site conditions
Danish: Almene symptomer og reaktioner på administrations-stedet
English: Clinical experience in granulomatosis with polyangiitis (Wegener's) and microscopic polyangiitis
Danish: Klinisk erfaring ved granulomatose med polyangiitis (Wegeners granulomatose) og mikroskopisk polyangiitis.
English: Late neutropenia
Danish: Perifert ødem
English:  Cardiovascular events, see section 4.4.
Danish: • Kardiovaskulære hændelser, se pkt.
English: Ritemvia is indicated for the treatment of patients with CD20 positive diffuse large B cell non-Hodgkin's lymphoma in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone) chemotherapy.
Danish: Ritemvia er, i kombination med CHOP-kemoterapi (cyclophosphamid, doxorubicin, vincristin og prednisolon), indiceret til behandling af patienter med CD20 positivt, diffust storcellet B-celle nonHodgkin-lymfom.
English: Ritemvia is used for the treatment of granulomatosis with polyangiitis (formerly called Wegener's granulomatosis) or microscopic polyangiitis, taken in combination with corticosteroids.
Danish: Ritemvia gives i kombination med binyrebarkhormon, for at behandle sygdommen granulomatose med polyangiitis (blev tidligere kaldt Wegeners granulomatose) og mikroskopisk polyangiitis.
English: • muscle problems - such as tight muscles, joint or muscle pain, back and neck pain
Danish: • muskelproblemer, f.eks. muskelkramper, led-eller muskelsmerter, ryg-og nakkesmerter
English: Blood and lymphatic system disorders neutropenia, leucopenia, +febrile neutropenia, +thrombocytope nia anaemia, +pancytopenia, +granulocytope nia coagulation disorders, aplastic anaemia, haemolytic anaemia, lymphadenopa thy transient increase in serum IgM levels3
Danish: Blod og lymfesystem neutropeni, leukopeni, +febril neutropeni, +trombocytope ni anæmi, +pancytopeni, +granulocytopeni koagulations sygdomme, aplastisk anæmi, hæmolytisk anæmi, lymfadenopat i forbigående stigning i serum IgM3
English: Muscle spasms Arthralgia
Danish: Muskelkramper Artralgi
English: In a randomised, open-label trial, a total of 399 previously untreated elderly patients (age 60 to 80 years) with diffuse large B cell lymphoma received standard CHOP chemotherapy (cyclophosphamide 750 mg/m2, doxorubicin 50 mg/m2, vincristine 1.4 mg/m2 up to a maximum of 2 mg on day 1, and prednisolone 40 mg/m2/day on days 1-5) every 3 weeks for eight cycles, or rituximab 375 mg/m2 plus CHOP (R-CHOP).
Danish: I et åbent, randomiseret studie fik 399 tidligere ubehandlede, ældre patienter (60-80 år) med diffust storcellet B-celle lymfom standard-CHOP kemoterapi (cyklophosphamid 750 mg/m2, doxorubicin 50 mg/m2, vinkristin 1,4 mg/m2 op til maksimalt 2 mg på dag 1 og prednison 40 mg/m2 på dag 1-5) hver 3. uge i 8 serier eller rituximab 375 mg/m2 plus CHOP (R-CHOP).
English: Cases of posterior reversible encephalopathy syndrome (PRES) / reversible posterior leukoencephalopathy syndrome (RPLS) have been reported.
Danish: Tilfælde af posterior reversibel encefalopati syndrom (PRES)/reversibel posterior leukoencefalopati syndrom (RPLS) er blevet rapporteret.
English: Bulky disease
Danish: Udbredt sygdom