FrancophonIA/ELRC3.0 huggingface dataset:
English: Table 3 Adverse drug reactions occurring at 6-months in ≥ 5% of patients receiving rituximab for induction of remission of GPA and MPA, and at a higher frequency than the comparator group.
Danish: Bivirkninger opstået hos ≥ 5 % af patienterne i behandling med rituximab for induktion af remission af granulomatose med polyangiitis (Wegeners granulomatose) og mikroskopisk polyangiitis, og med en højere frekvens end sammenligningsgruppen, ved måned 6.
English: A small number of cases of hepatitis-B reactivation, some with fatal outcome, have been reported in granulomatosis with polyangiitis and microscopic polyangiitis patients receiving rituximab in the postmarketing setting.
Danish: Der er efter markedsføring indberettet få tilfælde af hepatitis B-reaktivering, nogle med dødeligt udfald, blandt patienter med GPA eller MPA behandlet med rituximab.
English: vincristine 1.4 mg/m2 up to a maximum of 2 mg on day 1, and prednisolone 40 mg/m2/day on days 15) every 3 weeks for 8 cycles or rituximab 375 mg/m2 in combination with CVP (R-CVP).
Danish: I et åbent, randomiseret studie blev 322 tidligere ubehandlede patienter med follikulært lymfom randomiseret til enten CVP-kemoterapi (cyklophosphamid 750 mg/m2, vincristin 1,4 mg/m2 op til maksimalt 2 mg på dag 1 og prednisolon 40 mg/m2 på dag 1-5) hver 3. uge i 8 serier eller til rituximab 375 mg/m2 i kombination med CVP (R-CVP).
English: Treatment with Rixathon uses four separate infusions given at weekly intervals.
Danish: Hvert behandlingsforløb består af fire separate infusioner, der gives med én uges mellemrum.
English: Tumour pain, flushing, malaise, cold syndrome, +fatigue, +shivering, +multiorgan failure4
Danish: Almene symptomer og reaktioner på administrationss tedet feber, kulderystelser, asteni, hovedpine tumorsmerter, hedeture, utilpashed, kuldesyndrom, +træthed, +kulderystelser, +multiorgansvigt4
English: Mean change DAS28
Danish: DAS28-ESR
English: Rheumatoid arthritis only
Danish: Kun reumatoid artrit
English: Gastrointestinal perforation in some cases leading to death has been observed in patients receiving rituximab for treatment of non-Hodgkin lymphoma.
Danish: Hos patienter, der er behandlet med rituximab for non-Hodgkin-lymfom, er der i nogle tilfælde set gastrointestinal perforation og i nogle tilfælde med dødelig udgang.
English: Upper respiratory tract infection, urinary tract infections
Danish: Infektioner og parasitære sygdomme øvre luftvejsinfektioner, urinvejsinfektio n bronkitis, sinuitis gastroenteritis, fodsvamp
English: serious brain infection, which has been fatal (Progressive Multifocal Leukoencephalopathy or
Danish: alvorlig virusinfektion2 pneumocys tis jiroveci progressiv multifokal leukoencefa lo pati
English: Bronchospasm4, respiratory disease, chest pain, dyspnoea, increased cough,
Danish: Luftveje, thorax og mediastinum bronkospasmer4, luftvejssygdomm e, brystsmerter, dyspnø, øget hoste, rhinitis astma, bronchiolit is obliterans, lungesygdomme, hypoksi interstitiel lungesygdo m7
English: • loss of hair
Danish: • hårtab.
English: What is in this leaflet:
Danish: Tilberedningen skal:
English: • What you need to know before having
Danish: • Hvad du skal vide, før du får Rixathon
English: collapse
Danish: kollaps.
English: Heart failure4and 6
Danish: Nyre- og urinveje nyresvigt4
English: Infusion site pain
Danish: smerter på infusionsst edet
English: (CLL):
Danish: CR,
English: 300 mg Concentrate for solution for infusion
Danish: 300 mg Koncentrat til infusionsvæske, opløsning
English: MA (EU)-number (Invented) Name Strength Pharmaceutical Form
Danish: MF (EU)-nummer (Særnavn) Navn Styrke
English: Route of Administration
Danish: Lægemiddelform Administration
English: 30 ml (10 mg/ml) 1 vial
Danish: Til intravenøs anvendelse hætteglas (glas) 30 ml (10 mg/ml) 1 hætteglas
English: EU number
Danish: EU nummer
English: It was to be available as prolonged-release tablets (50, 100 and 200 mg).
Danish: Det skulle være tilgængeligt som depottabletter (50, 100 og 200 mg).
English: What is Ellefore?
Danish: Hvad er Ellefore?
English: International non-proprietary name (INN): desvenlafaxine
Danish: Internationalt fællesnavn (INN): desvenlafaxin
English: The effects of Ellefore were first tested in experimental models before being studied in humans.
Danish: Virkningerne af Ellefore blev først afprøvet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
English: The application was at day 166 when the company withdrew.
Danish: Ansøgningsproceduren var ved dag 166, da virksomheden trak sin ansøgning tilbage.
English: Questions and answers on the withdrawal of the marketing application for Ellefore
Danish: Spørgsmål og svar i forbindelse med tilbagetrækning af ansøgningen om markedsføringstilladelse for Ellefore
English: Two of the flexible-dose studies also included venlafaxine (however, the studies were not designed to compare the two medicines).
Danish: To af undersøgelserne med fleksible doser omfattede også venlafaxin (undersøgelserne var dog ikke udformet med henblik på en sammenligning af de to lægemidler).
English: On 13 October 2008, Wyeth Europa Ltd. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Ellefore, for the treatment of major depressive disorder.
Danish: Den 13. oktober 2008 meddelte Wyeth Europa Ltd. officielt Udvalget for Humanmedicinske Lægemidler (CHMP), at det ønsker at tilbagetrække sin ansøgning om markedsføringstilladelse for Ellefore til behandling af svære depressive forstyrrelser.
English: ‘Prolonged release' means that the active substance is released from the tablets over a few hours.
Danish: "Depottablet" betyder, at det aktive stof frigives fra tabletterne over nogle timer.
English: Ellefore was compared with placebo (a dummy treatment) in nine main studies involving a total of over 3,000 adults with major depression.
Danish: Ellefore blev sammenlignet med placebo (en virkningsløs behandling) i ni hovedundersøgelser, der samlet omfattede over 3 000 voksne med svær depression.
English: The letter from the company notifying the EMEA of the withdrawal of the application is available here.
Danish: Brevet, hvori virksomheden meddeler EMEA, at den ønsker at tilbagetrække sin ansøgning, findes her.
English: In all of the studies, the effectiveness of the medicine was measured using standard questionnaires for depression.
Danish: I alle undersøgelserne blev lægemidlets virkning målt ved hjælp af standardspørgeskemaer om depression.
English: Ellefore is a medicine that contains the active substance desvenlafaxine.
Danish: Ellefore er et lægemiddel, der indeholder det aktive stof desvenlafaxin.
English: Desvenlafaxine is derived from venlafaxine, an SNRI that has been used as an antidepressant since the 1990s.
Danish: Desvenlafaxin er et derivat af venlafaxin, et SNRI, der har været anvendt som antidepressivt middel siden 1990'erne.
English: Four of the studies involving 1,814 patients used a fixed dose of Ellefore, and another four involving 1,229 patients used doses of Ellefore that could be adjusted.
Danish: Fire af undersøgelserne omfattede 1 814 patienter, der fik faste doser af Ellefore, og yderligere fire, som omfattede 1 229 patienter, der fik justerbare doser af Ellefore.
English: Information on the short and long-term effectiveness of Ellefore was also considered to be insufficient, because too few patients in the studies took the doses of Ellefore that were intended for use and because the studies' results were inconsistent.
Danish: Oplysningerne om Ellefores virkning på kortere og længere sigt blev også anset for utilstrækkelige, fordi for få patienter i undersøgelserne fik Ellefore i de doser, det var meningen skulle anvendes, og fordi undersøgelsesresultaterne ikke var konsekvente.
English: One long-term study looked at how long it took for symptoms to return in a total of 376 patients who had already shown a response to an initial 12 weeks of Ellefore treatment.
Danish: En langsigtet undersøgelse så på, hvor længe det tog, før symptomerne vendte tilbage hos i alt 376 patienter, som allerede havde vist respons på de første 12 ugers behandling med Ellefore.
English: Ellefore was expected to be used to treat major depression in adults.
Danish: Ellefore forventedes anvendt til behandling af svære depressive forstyrrelser hos voksne.
English: The substance has been slightly modified with the aim of reducing side effects in patients who have problems breaking venlafaxine down.
Danish: Stoffet er ændret let for at reducere bivirkningerne hos patienter, der har vanskeligt ved at nedbryde venlafaxin.
English: What was Ellefore expected to be used for?
Danish: Hvad forventedes Ellefore anvendt til?
English: How is Ellefore expected to work?
Danish: Hvordan forventes Ellefore at virke?
English: In relation to its parent substance, venlafaxine, desvenlafaxine seemed to be less effective with no advantages in terms of safety and tolerability.
Danish: I forhold til dets moderstof, venlafaxin, syntes desvenlafaxin at have en ringere virkning og viste ikke fordele med hensyn til sikkerhed og tolerans.
English: In these short-term studies, the main measure of effectiveness was the change in depressive symptoms over the eight weeks of treatment.
Danish: I de kortvarige undersøgelser var det primære mål for virkningen ændringen i symptomerne på depression i løbet af de 8 ugers behandling.
English: Since these neurotransmitters are involved in the control of mood, blocking their re-uptake into nerve cells is expected to improve the symptoms of major depression.
Danish: Da disse neurotransmittere medvirker til at styre sindstilstanden, forventes blokeringen af genoptagelsen af disse i nervecellerne at forbedre symptomerne på svær depression.
English: By blocking their re-uptake, desvenlafaxine increases the amount of these neurotransmitters in the spaces between certain nerve cells, increasing the level of communication between the cells.
Danish: Ved at blokere for genoptagelsen af disse stoffer øger desvenlafaxin mængden af disse neurotransmittere i mellemrummene mellem visse nerveceller og øger derved kommunikationen mellem disse celler.
English: Based on the review of the data, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Ellefore could not have been approved for the treatment of major depressive disorder.
Danish: På baggrund af gennemgangen af dataene på tidspunktet for tilbagetrækningen af ansøgningen havde CHMP visse betænkeligheder og var af den foreløbige opfattelse, at Ellefore ikke kunne være blevet godkendt til behandling af svære depressive forstyrrelser.
English: What are the consequences of the withdrawal for patients undergoing clinical trials or compassionate use programmes with Ellefore?
Danish: Hvilke konsekvenser har tilbagetrækningen for patienter, der deltager i kliniske undersøgelser med Ellefore eller i programmer for anvendelse af Ellefore med særlig udleveringstilladelse?
English: Therefore, at the time of the withdrawal, the CHMP's view was that a benefit of Ellefore had not been sufficiently demonstrated and any benefits did not outweigh the identified risks.
Danish: På tidspunktet for tilbagetrækningen var CHMP således af den opfattelse, at fordelene ved Ellefore ikke var blevet tilstrækkeligt påvist, og at eventuelle fordele ikke opvejede de påviste risici.
English: The active substance in Ellefore, desvenlafaxine, is a ‘serotonin-noradrenaline re-uptake inhibitor' (SNRI).
Danish: Det aktive stof i Ellefore, desvenlafaxin, er en "selektiv serotonin-noradrenalin genoptagelseshæmmer" (SNRI).
English: The company informed the CHMP that there are no consequences for patients currently included in clinical trials with Ellefore and that there are no compassionate use programmes ongoing.
Danish: Virksomheden har informeret CHMP om, at tilbagetrækningen ikke vil få nogen konsekvenser for patienter, som i øjeblikket deltager i kliniske undersøgelser med Ellefore, og at der ikke er nogen igangværende programmer med særlig udleveringstilladelse.
English: The CHMP was concerned that, overall, the effectiveness of Ellefore had not been shown convincingly.
Danish: CHMP var betænkelig ved, at virkningen af Ellefore generelt set ikke var blevet tilstrækkeligt påvist.
English: Ref. EMEA/544525/2008
Danish: London, den 23. oktober 2008 Referencedokument: EMEA/180883/2009
English: Date of most recent infusion: ____________ Date of first infusion: ___________________ Patient's Name:________________________ Doctor's Name:________________________ Doctor's contact details:_________________
Danish: Dato for seneste infusion:_______________ Dato for første infusion:________________ Patientens navn: ______________________ Lægens navn: ________________________ Lægens tlf. nr.: _______________________
English: Distribution/Elimination
Danish: Fordeling/elimination
English: • Keep this card with you all the time - such as in your wallet or purse.
Danish: • Opbevar altid dette kort på dig - f.eks. i din tegnebog eller pung
English: and 6
Danish: og 6
English: Note: Patients were censored at month 28 if they had no event.
Danish: Note: Patienter blev censoreret ved måned 28, hvis ikke de havde et recidiv.
English: When should I not have MabThera?
Danish: Hvornår må jeg ikke få MabThera?
English: In-use storage times and conditions prior to use are the responsibility of the user.
Danish: Opbevaringstid og -forhold efter åbning inden anvendelse er brugerens ansvar.
English: The prespecified non-inferiority margin for the treatment difference was 20%.
Danish: Den præspecificerede non-inferioritetsmargin for behandlingsforskel var 20%.
English: • hearing loss, loss of other senses.
Danish: • høretab og tab af andre sanser.
English: Treatment, N
Danish: Behandling, N
English: UNIQUE IDENTIFIER -- HUMAN READABLE DATA PC:
Danish: ENTYDIG IDENTIFIKATOR - MENNESKELIGT LÆSBARE DATA PC:
English: • Needles and syringes should never be reused
Danish: • Nåle og sprøjter må aldrig genbruges
English: If not used immediately, preparation should take place in controlled and validated aseptic conditions.
Danish: Hvis det ikke anvendes straks, bør klargøring finde sted under kontrollerede og validerede aseptiske forhold.
English: They are not specifically related to the route of administration of MabThera and can be observed with both formulations.
Danish: De er ikke specifikt forbundne med administrationsvejen for MabThera og kan ses med begge formuleringer.
English: The corresponding AUCτ ratios were 1.66, 1.17 and 1.32.
Danish: De tilsvarende AUCτ ratio var 1,66; 1,17 og 1,32.
English: Following subcutaneous administration, the absorption of rituximab is slow, reaching maximal concentrations about 3 days after administration.
Danish: Efter subkutan administration er absorptionen af rituximab langsom og når maksimal koncentration ca. 3 dage efter administration.
English: b The 95.1% confidence level reflects an additional 0.001 alpha to account for an interim efficacy analysis.
Danish: b Konfidensintervallet på 95,1% afspejler et yderligere 0,001 alfa for at tage højde for en interims-effektanalyse.
English: Also please tell your doctor if you had a lot of infections in the past or suffer from severe infections.
Danish: Fortæl også lægen, hvis du tidligere har haft mange infektioner eller lider af alvorlige infektioner.
English: If an injection is interrupted it can be resumed at the same site or another location may be used, if appropriate.
Danish: Hvis en injektion afbrydes, kan den genoptages samme sted eller på andet sted, hvis dette ønskes.
English: Take this into account if you are on a low-sodium diet.
Danish: Dette skal tages i betragtning hvis du er på en natriumfattig kost.
English: Do not have MabThera if any of the above apply to you.
Danish: Du må ikke få MabThera, hvis ét eller flere af ovenstående punkter gælder for dig.
English: 2) Last tumour response as assessed by the investigator.
Danish: 2) Seneste tumorrespons vurderet af investigator.
English: Do not have MabThera if you have an active infection or a serious problem with your immune system.
Danish: Du må ikke få MabThera, hvis du har en aktiv infektion eller alvorlige problemer med dit immunsystem.
English: Binet stage A Binet stage B Binet stage C
Danish: Binet stadium A Binet stadium B Binet stadium C
English: Treatment Difference (MabTheraCyclophosphamide)
Danish: Behandlingsforskel (MabTheracyclophosphamid)
English: The gender- related pharmacokinetic differences are not considered to be clinically relevant and dose adjustment is not required.
Danish: Den kønsrelaterede farmakokinetiske forskel anses ikke for at være klinisk relevant, og dosisjustering er ikke nødvendig.
English: Available data suggest that clinical response is usually achieved within 16 - 24 weeks of an initial treatment course.
Danish: Tilgængelige data indikerer, at klinisk respons almindeligvis opnås inden for 16-24 uger af den initiale behandlingsserie.
English: Your doctor may decide to treat you longer with MabThera (up to 5 years), depending on how you respond to the medicine.
Danish: Din læge kan beslutte at behandle dig i længere tid med MabThera (op til 5 år), alt efter hvor godt du reagerer på medicinen.
English: In addition, central volume was slightly (9%) lower in females compared to males.
Danish: Yderligere, var det centrale volumen en smule lavere hos kvinder (9 %) end hos mænd.
English: − * Worst case imputation a Non-inferiority was demonstrated since the lower bound ( − 3.2%) was higher than the pre-determined non-inferiority margin ( − 20%).
Danish: *Værst tænkelige ekstrapolering a Der blev vist non-inferioritet, idet den nedre grænse (−3,2%) var højere end den forud fastsatte noninferioritetsmargin (−20%).
English: • you are allergic to hyaluronidase (an enzyme that helps to increase the absorption of injected active substance)
Danish: • du er allergisk over for hyaluronidase (et enzym, der hjælper med at øge optagelsen af det indsprøjtede lægemiddel)
English: Date of latest renewal: 2 June 2008
Danish: Dato for første markedsføringstilladelse: 2. juni 1998 Dato for seneste fornyelse: 2. juni 2008
English: • heart beating faster than normal
Danish: • hjertet slår hurtigere end normalt
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached
Danish: • når risikostyringssystemet ændres, særlig som følge af, at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i risk/benefit-forholdet, eller som følge af, at en vigtig milepæl (lægemiddelovervågning eller risikominimering) er nået.
English: All patients n=99
Danish: Alle patienter n=99
English: You must tell your doctor or nurse if you are pregnant, think that you might be pregnant or are planning to become pregnant.
Danish: Du skal kontakte lægen eller sundhedspersonalet, hvis du er gravid, tror, du måske kan være gravid, eller planlægger at blive gravid.
English: Your doctor or nurse will place the sticker on the syringe before injection.
Danish: Lægen eller sygeplejersken vil sætte klistermærket på sprøjten inden indsprøjtningen.
English: Risk Reduction
Danish: Risikoreduktion
English: MabThera may be used for the treatment of several different conditions in adults.
Danish: MabThera kan anvendes til behandling af flere forskellige tilstande hos voksne.
English: Complete remission All Patients Newly diagnosed Relapsing
Danish: Fuldstændig remission Alle patienter Nyligt diagnosticerede Patienter med recidiv
English: No data are available on performing the injection in other sites of the body, therefore injections should be restricted to the abdominal wall.
Danish: Der er ingen data tilgængelig, om injektionen kan gives andre steder på kroppen, og injektioner bør derfor begrænses til abdominalvæggen.
English: How much and how often you will receive your treatment
Danish: Hvor meget medicin skal du have og hvor ofte?
English: Table 17 Complete remission at 6-months by disease status MabThera
Danish: Tabel 17 Fuldstændig remission ved måned 6 opgjort efter sygdomsstatus MabThera
English: Anti-rituximab antibodies were detected in only 13 patients and did not result in any clinically relevant increase in steady-state clearance.
Danish: Anti-rituximab-antistoffer blev kun påvist hos 13 patienter og medførte ingen klinisk relevant stigning i steady-state clearance.
English: Premedication with glucocorticoids should also be considered.
Danish: Præmedicinering med glukokortikoid bør ligeledes overvejes.
English: MabThera will be given to you once a week for 4 weeks.
Danish: MabThera gives en gang ugentligt i 4 uger.
English: Some vaccines should not be given at the same time as MabThera or in the months after you receive MabThera.
Danish: Nogle vaccinationer bør ikke gives på samme tid som MabThera eller i månederne efter du har fået MabThera.
English: • Show this card to any doctor, nurse or dentist you see - not just the specialist who prescribes your MabThera.
Danish: • Vis dette kort til enhver læge, sygeplejerske eller tandlæge, som er involveret i din behandling - og ikke kun til den læge, der udskriver MabThera til dig
English: See Section 4.2 for information on paediatric use.
Danish: 4.2 for oplysninger om pædiatrisk anvendelse.
English: Names and addresses of the manufacturers of the biological active substance
Danish: Navne og adresser på fremstillerne af det biologisk aktive stof
English: serious viral infection2
Danish: alvorlig virusinfektion2
English: Subcutaneous formulation:
Danish: Subkutan formulering:
English: Patients should receive MabThera for at least 24 months after achievement of remission (absence of clinical signs and symptoms).
Danish: Patienter skal gives MabThera i mindst 24 måneder efter opnåelse af remission (fravær af kliniske symptomer).
English: Newly diagnosed n=48
Danish: Nyligt diagnosticerede n=48
English: MabThera is not indicated for these patients, since the safety data about long-term MabThera treatment are insufficient, in particular concerning the risk of development of malignancies and PML.
Danish: MabThera er ikke indiceret til disse patienter, da sikkerhedsdata for langvarig MabThera-behandling er utilstrækkelig, specielt angående risikoen for udvikling af maligniteter og PML.
English: The overall trial design was identical among both stages and patients were randomized into the following two treatment groups:
Danish: Det overordnede studiedesign var identisk i begge stadier, og patienterne blev randomiseret til en af følgende to behandlingsgrupper:
English: Higher time-dependenet clearance in subjects with higher disease burden would lead to lower initial exposure and longer time needed to achieve the same exposure as in subjects with lower burden of the disease.
Danish: Højere tids-afhængig clearence hos patienter med højere sygdoms-byrde vil medføre en lavere initial eksponering og behov for længere tid til at opnå den samme eksponering, som hos patienter med en lavere sygdoms-byrde.
English: • The need to monitor patients for infections, especially PML, during and after MabThera treatment
Danish: • Nødvendigheden af at overvåge patienterne for infektioner, især PML, under og efter behandling med MabThera
English: 95.1%b CI (−3.2%, 24.3%) a
Danish: 95,1%b konfidensinterval (−3,2%; 24,3%) a
English: MabThera is indicated in adults for the following indications:
Danish: MabThera er indiceret hos voksne til følgende indikationer:
English: See the MabThera package leaflet for more information.
Danish: Se indlægssedlen i MabThera-pakken for mere information.
English: The response rates for the analysis of 176 patients in SAWYER Part 2 are shown in Table 2.
Danish: Responsraterne for analysen af 176 patienter i 2. del af SAWYER er vist i tabel 2.
English: Depending on the signs and symptoms of your disease, your doctor will decide when you should receive more MabThera.
Danish: Afhængigt af kliniske fund og symptomer på din sygdom, vil din læge bedømme, om du skal have mere MabThera.