FrancophonIA/ELRC3.0 huggingface dataset:
English: Package leaflet: Information for the patient Truxima 500 mg concentrate for solution for infusion rituximab This medicine is subject to additional monitoring.
Danish: Indlægsseddel: Information til brugeren Truxima 500 mg koncentrat til infusionsvæske, opløsning rituximab Dette lægemiddel er underlagt supplerende overvågning.
English: Metabolism and hypercholesterolemia
Danish: Metabolisme og ernæring hyperkolesterolæmi
English: CI: confidence interval; FU: follow-up; OS: overall survival; TNLT: time to next anti-lymphoma treatment; TNCT: time to next chemotherapy treatment; NR: not reached at time of clinical cut-off.
Danish: KI: konfidensinterval; TNLT: Tid til næste anti-lymfom-behandling; TNCT: Tid til næste kemoterapibehandling; NR: Ikke opnået ved det kliniske skæringstidspunkt.
English: PATIENT ALERT CARD TEXT FOR NON-ONCOLOGY INDICATIONS Truxima (Rituximab) Alert Card for patients with non-oncology diseases Why have I been given this card?
Danish: TEKST TIL PATIENTKORT FOR IKKE-ONKOLOGISKE INDIKATIONER Truxima (Rituximab)-patientkort for ikkeonkologiske indikationer
English: This is because Truxima can affect the way some other medicines work.
Danish: Det er vigtigt, da Truxima kan påvirke virkningen af anden medicin, og anden medicin kan påvirke virkningen af Truxima.
English: Package leaflet: Information for the patient Truxima 100 mg concentrate for solution for infusion rituximab This medicine is subject to additional monitoring.
Danish: Indlægsseddel: Information til brugeren Truxima 100 mg koncentrat til infusionsvæske, opløsning rituximab Dette lægemiddel er underlagt supplerende overvågning.
English: 1 mg/kg/day (not to exceed 80 mg/day, and tapered as rapidly as possible based on clinical need) during and after the 4 week induction course of Truxima treatment.
Danish: Dette bør efterfølges af prednison oralt, 1 mg/kg/dag (dog højst 80 mg/dag og nedtitreret så hurtigt som muligt afhængigt af det kliniske behov) under og efter de 4 ugers induktionsbehandling med Truxima.
English: You must also do this for 12 months after your last treatment with Truxima.
Danish: I skal fortsætte med sikker prævention i 12 måneder efter din sidste behandling med Truxima.
English: The Physician information about Truxima should contain the following key elements:
Danish: Informationen til lægen om Truxima skal indeholde følgende nøgle-elementer:
English: Truxima is provided in sterile, preservative-free, non-pyrogenic, single use vials.
Danish: Truxima leveres i sterile, pyrogenfri hætteglas uden konserveringsmiddel til engangsbrug.
English: • changes in blood pressure, nausea, rash, fever, feeling itchy, runny or blocked nose and sneezing, shaking, rapid heart beat, and tiredness
Danish: • ændringer i blodtryk, kvalme, udslæt, feber, en følelse af kløe, løbende eller stoppet næse og nysen, rysten, hurtig hjerterytme (puls) og træthed
English: Percentage of Patients with First Major Relapse infusions were administered no sooner than 16 weeks following the previous infusion.
Danish: Patienter med første større recidiv i procent recidivinfusioner blev ikke administreret senere end 16 uger efter den tidligere infusion.
English: Other medicines and Truxima
Danish: Brug af anden medicin sammen med Truxima
English: Adverse drug reactions presented in Table 5 were adverse events which occurred at a rate of ≥ 5% among rituximab-treated PV patients, with a ≥ 2% absolute difference in incidence between the rituximab-treated group and the standard-dose prednisone group up to month 24.
Danish: De bivirkninger, der opsummeres i tabel 5, forekom alle med en hyppighed ≥ 5 % blandt rituximabbehandlede patienter med PV med en ≥ 2 % absolut forskel i forekomst mellem den rituximabbehandlede-gruppe og standarddosis prednison-gruppen op til måned 24.
English: In patients with granulomatosis with polyangiitis (Wegener's) or microscopic polyangiitis, methylprednisolone given intravenously for 1 to 3 days at a dose of 1000 mg per day is recommended prior to the first infusion of Truxima (the last dose of methylprednisolone may be given on the same day as the first infusion of Truxima).
Danish: Hos patienter med GPA eller MPA anbefales det at give methylprednisolon intravenøst i 1-3 dage i en dosis på 1000 mg pr. dag inden den første Truxima-infusion (sidste dosis methylprednisolon kan gives samme dag som første Truxima-infusion).
English: Truxima monotherapy is indicated for treatment of patients with stage III-IV follicular lymphoma who are chemo-resistant or are in their second or subsequent relapse after chemotherapy.
Danish: Truxima monoterapi er indiceret til behandling af patienter med grad III-IV follikulært lymfom, som er resistente overfor kemoterapi eller som er i deres andet eller efterfølgende relaps efter kemoterapi.
English: Contents of the pack and other information What Truxima contains
Danish: Pakningsstørrelse og yderligere oplysninger Truxima indeholder:
English: If you are not sure, talk to your doctor, pharmacist or nurse before you are given Truxima.
Danish: Hvis du er i tvivl, skal du kontakte lægen, apotekspersonalet eller sundhedspersonalet, inden du får Truxima.
English: during and after the 4 week induction course of Truxima treatment.
Danish: 4 ugers induktions behandling med Truxima.
English: Corticosteroids will usually be given by injection before the start of Truxima treatment.
Danish: Du vil som regel få en indsprøjtning med binyrebarkhormon, inden behandlingen med Truxima påbegyndes.
English: Efficacy Parameter
Danish: Effektparametre
English: Talk to your doctor, pharmacist or nurse before you are given this medicine if you, or your child, are under 18 years of age.
Danish: Da der er begrænset viden om brug af Truxima til børn og unge, skal du kontakte lægen, apotekspersonalet eller sundhedspersonalet inden medicinen gives, hvis du eller dit barn er under 18 år.
English: Truxima has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function, when given in combination with methotrexate.
Danish: Det er vist, at Truxima i kombination med methotrexat reducerer hastigheden af ledskadeprogression, målt ved hjælp af røntgen, samt forbedrer fysisk funktionsevne.
English: If you are being treated for rheumatoid arthritis
Danish: c) Hvis du behandles for reumatoid artrit
English: A course of Truxima consists of two 1000 mg intravenous infusions.
Danish: En behandlingsserie med Truxima består af to intravenøse infusioner a 1.000 mg.
English: • pain in the tummy, back, muscles and/or joints
Danish: • smerter i maven, ryg, muskler og/eller led
English: • infections such as bronchial tube inflammation (bronchitis)
Danish: • infektioner som f.eks. inflammation i bronkierne (bronkitis)
English: What Truxima is and what it is used for What you need to know before you use Truxima How to use Truxima
Danish: Virkning og anvendelse Det skal du vide, før du begynder at få Truxima Sådan får du Truxima
English: You might get infections more easily during your treatment with Truxima.
Danish: Risikoen for infektioner kan øges under behandling med Truxima.
English: INFORMATION IN BRAILLE truxima 500 mg
Danish: truxima 500 mg
English: This is because in a few cases, Truxima could cause hepatitis B to become active again, which can be fatal in very rare cases.
Danish: Det er vigtigt, fordi Truxima i enkelte tilfælde har forårsaget, at en tidligere leverbetændelse (hepatitis B) er blevet aktiv igen.
English: The recommended dosage of Truxima for the treatment of pemphigus vulgaris is 1000 mg administered as an IV infusion followed two weeks later by a second 1000 mg IV infusion in combination with a tapering course of glucocorticoids.
Danish: Den anbefalede dosis af Truxima til behandling af PV er 1.000 mg administreret som en intravenøs infusion efterfulgt af endnu en 1.000 mg intravenøs infusion 2 uger senere i kombination med nedtitrerende glukokortikoider.
English: Repeated treatment courses with
Danish: Gentagne behandlingsserier
English: Truxima in combination with chemotherapy is indicated for the treatment of patients with previously untreated and relapsed/refractory CLL.
Danish: Truxima er i kombination med kemoterapi indiceret til behandling af kronisk lymfatisk leukæmi (CLL) hos patienter, som ikke tidligere er behandlet, og til patienter med relaps/refraktær CLL.
English: Truxima can be given alone or with other medicines called “chemotherapy”.
Danish: Truxima kan anvendes alene eller sammen med kemoterapi.
English: • abnormal sensations of the skin, such as numbness, tingling, pricking or burning,
Danish: • unormal fornemmelse i huden, såsom følelsesløshed, snurren, prikken eller brænden, iskias,
English: INFORMATION IN BRAILLE truxima 100 mg
Danish: truxima 100 mg
English: • inflammation, irritation and / or tightness of the lungs and throat, coughing
Danish: • vævsirritation, irritation og/eller tæthed i lunger og hals, hoste
English: The recommended dosage of Truxima in combination with chemotherapy for previously untreated and relapsed/refractory patients is 375 mg/m2 body surface area administered on day 0 of the first treatment cycle followed by 500 mg/m2 body surface area administered on day 1 of each subsequent cycle for 6 cycles in total.
Danish: Den anbefalede dosis af Truxima i kombination med kemoterapi til tidligere ubehandlede patienter og til relaps/refraktære patienter er 375 mg/m2 legemsoverflade, som gives på dag 0 af første behandlingsserie, efterfulgt af 500 mg/m2 legemsoverflade på dag 1 af hver af de følgende serier, i alt 6 serier.
English: • indigestion, diarrhoea, acid reflux, irritation and /or ulceration of the throat and the mouth
Danish: • fordøjelsesbesvær, diarré, sure opstød, irritation og/eller sårdannelse i halsen og munden
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: Truxima is used for the treatment of granulomatosis with polyangiitis (formerly called Wegener's granulomatosis) or microscopic polyangiitis, taken in combination with corticosteroids.
Danish: Truxima gives i kombination med binyrebarkhormon, for at behandle sygdommen granulomatose med polyangiitis (blev tidligere kaldt Wegeners granulomatose) og mikroskopisk polyangiitis.
English: The recommended dose of Truxima 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 Truxima 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: The recommended dose of Truxima used as a maintenance treatment for patients with relapsed/refractory follicular lymphoma who have responded to induction treatment is: 375 mg/m2 body surface area once every 3 months (starting 3 months after the last dose of induction therapy) until disease progression or for a maximum period of two years (8 infusions in total).
Danish: Den anbefalede dosis af Truxima til vedligeholdelsesbehandling hos patienter med recidiveret/ refraktært follikulært lymfom, som har responderet på induktionsbehandling, er 375 mg/m2 legemsoverfladeareal én gang hver 3. måned (startende 3 måneder efter den sidste dosis i induktionsbehandlingen) indtil sygdomsprogression eller i maksimalt 2 år (8 infusioner i alt).
English: If you have rheumatoid arthritis, granulomatosis with polyangiitis, microscopic polyangiitis or pemphigus vulgaris also tell your doctor
Danish: Hvis du har reumatoid artrit, granulomatose med polyangiitis, mikroskopisk polyangiitis fortæl da også din læge eller pemfigus vulgaris
English: The recommended dosage of Truxima 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 Truxima 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: Truxima 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: Truxima 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: Treatment with Truxima uses four separate infusions given at weekly intervals.
Danish: Hvert behandlingsforløb består af fire separate infusioner, der gives med én uges mellemrum.
English: The recommended dose of Truxima 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 Truxima 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: • a feeling of fullness or a throbbing pain behind the nose, cheeks and eyes (sinusitis), pain in the abdomen, vomiting and diarrhoea, breathing problems
Danish: • en trykkende følelse eller en dunkende smerte bag næse, kinder og øjne (bihulebetændelse),
English: For retreatment with Truxima monotherapy for patients who have responded to previous treatment with Truxima monotherapy for relapsed/refractory follicular lymphoma, the recommended dose is: 375 mg/m2 body surface area, administered as an intravenous infusion once weekly for four weeks (see section 5.1).
Danish: Til genbehandling med Truxima monoterapi til patienter, som har responderet på tidligere behandling med Truxima monoterapi for recidiveret/refraktært follikulært lymfom, er den anbefalede dosis: 375 mg/m2 legemsoverfladeareal, givet som en intravenøs infusion én gang ugentligt i 4 uger (se pkt.
English: Psychiatric depression, anxiety
Danish: Psykiske forstyrrelser depression, angst
English: p-value a
Danish: p-værdi a konfidensintervalb
English: You may be asked not to take these other medicines 12 hours before you are given Truxima.
Danish: Du kan blive bedt om ikke at tage denne medicin i
English: sciatica, migraine, dizziness
Danish: migræne, svimmelhed
English: Truxima 500 mg concentrate for solution for infusion Rituximab
Danish: Truxima 500 mg, koncentrat til infusionsvæske, opløsning Rituximab
English: Truxima 100 mg concentrate for solution for infusion Rituximab
Danish: Truxima 100 mg, koncentrat til infusionsvæske, opløsning Rituximab
English: Data from extended follow-up of patients in the study (median follow-up 9 years) confirmed the long-term benefit of rituximab maintenance therapy in terms of PFS, EFS, TNLT and TNCT (Table
Danish: Resultaterne af forlænget opfølgning af patienterne i studiet (median observationstid 9 år) bekræftede langtidseffekterne af rituximab vedligeholdelsesbehandling i forhold til progressionsfri overlevelse, hændelsesfri overlevelse, tid til næste anti-lymfom-behandling og tid til næste kemoterapibehandling
English: The recommended dose of Truxima monotherapy used as induction treatment for adult patients with stage III-IV follicular lymphoma who are chemoresistant or are in their second or subsequent relapse after chemotherapy is: 375 mg/m2 body surface area, administered as an intravenous infusion once weekly for 4 weeks.
Danish: Den anbefalede dosis af Truxima monoterapi til induktionsbehandling hos voksne patienter med grad III-IV follikulært lymfom, som er resistente over for behandling med kemoterapi eller som er i deres anden eller efterfølgende recidiv efter kemoterapi, er 375 mg/m2 legemsoverfladeareal, givet som intravenøs infusion én gang ugentligt i 4 uger.
English: Your doctor may decide to stop your Truxima treatment if these reactions are serious.
Danish: Hvis disse reaktioner er alvorlige, kan lægen vælge at stoppe behandlingen med Truxima.
English: Adverse drug reaction rituximab + low-dose prednisone (n = 38)
Danish: Rituximab + lavdosis prednison (n = 38)
English: Truxima 500 mg concentrate for solution for infusion
Danish: Truxima 500 mg koncentrat til infusionsvæske, opløsning
English: In patients with rheumatoid arthritis, granulomatosis with polyangiitis (Wegener's) or microscopic polyangiitis in disease remission or pemphigus vulgaris, premedication with 100 mg intravenous methylprednisolone should be completed 30 minutes prior to Truxima infusions to decrease the incidence and severity of infusion related reactions (IRRs).
Danish: Hos patienter med reumatoid artrit, GPA eller MPA i sygdomsremission eller PV, bør præmedicinering i form af 100 mg methylprednisolon i.v.
English: Truxima 100 mg concentrate for solution for infusion
Danish: Truxima 100 mg koncentrat til infusionsvæske, opløsning
English: Hazard ratio (95% CI)
Danish: (95 % CI)
English: Experience from granulomatosis with polyangiitis and microscopic polyangiitis Induction of remission
Danish: Erfaring fra granulomatose med polyangiitis og mikroskopisk polyangiitis
English: 1 vial contains 500 mg of rituximab.
Danish: Et hætteglas indeholder 500 mg rituximab.
English: Also do not breast-feed for 12 months after your last treatment with Truxima.
Danish: Da Truxima udskilles i mælken, må du ikke amme, mens du er i behandling med Truxima samt i 12 måneder efter din sidste dosis af Truxima.
English: Maintenance and relapse
Danish: Vedligeholdelses- og
English: • skin reactions including hives, itching and rash
Danish: • hudreaktioner herunder nældefeber, kløe og udslæt
English: Truxima
Danish: Hoste
English: Other side effects include: a) If you are being treated for non-Hodgkin's Lymphoma or chronic lymphocytic leukaemia
Danish: Hvis du behandles for non-Hodgkin-lymfom eller kronisk lymfatisk leukæmi
English: Tomas Salmonson (Sweden)
Danish: Tomas Salmonson (Sverige)
English: Pierre Demolis (France)
Danish: Pierre Demolis (Frankrig)
English: Treatment should be evaluated after six to 12 months.
Danish: Behandlingen evalueres efter 6-12 måneder.
English: What is Valtrex?
Danish: Hvad er Valtrex?
English: For first episodes, which can be more severe, treatment may be extended to ten days.
Danish: Ved primær infektion, som kan være mere alvorlig, kan behandlingen forlænges til 10 dage.
English: Valtrex was authorised in the EU via national procedures.
Danish: Valtrex er godkendt i EU efter nationale procedurer.
English: 20 November 2008 Company responses provided on: 2 March 2009, 22 September 2009, 19 January 2010, 24 March
Danish: 2. marts 2009, 22. september 2009, 19. januar 2010, 24. marts
English: 13 July 2010
Danish: 13. juli 2010
English: Why was Valtrex reviewed?
Danish: Hvorfor blev Valtrex vurderet igen?
English: Valtrex is also available in the EU under other trade names: Talavir, Valaciclovir Allen, Valaciclovir Biogaran, Valaciclovir GSK, Valaciclovir Sandoz, Valaciclovir Winthrop, Valavir, Valherpes, Valtrex S, Virval and Zelitrex.
Danish: Valtrex markedsføres ligeledes i EU under andre særnavne: Talavir, Valaciclovir Allen, Valaciclovir Biogaran, Valaciclovir GSK, Valaciclovir Sandoz, Valaciclovir Winthrop, Valavir, Valherpes, Valtrex S, Virval og Zelitrex.
English: The areas harmonised include: 4.1 Therapeutic indications The CHMP recommended that Valtrex should be used for:
Danish: De harmoniserede områder omfatter: 4.1 Terapeutiske indikationer CHMP anbefalede, at Valtrex bør anvendes til:
English: Valtrex is also used to prevent infection with cytomegalovirus.
Danish: Valtrex anvendes også til at forebygge infektion med cytomegalovirus.
English: Immunocompromised patients should be treated for a further two days after the crusting of their lesions.
Danish: Immunkompromitterede patienter bør behandles i yderligere to dage efter skorpedannelse på deres læsioner.
English: The Committee also harmonised other sections of the SmPC, including the sections on special warnings and side effects.
Danish: Udvalget harmoniserede ligeledes andre punkter i produktresuméet, herunder punkterne om særlige advarsler og bivirkninger.
English: The company that markets these medicines is GlaxoSmithKline.
Danish: Disse lægemidler markedsføres af virksomheden GlaxoSmithKline.
English: For recurrent episodes treatment should be for three to five days.
Danish: Behandling af recidivudbrud bør vare 3-5 dage.
English: Cytomegalovirus can cause harmful effects in high-risk populations such as infants and patients who have had a solid organ transplant.
Danish: Cytomegalovirus kan have skadevirkninger hos højrisikogrupper som spædbørn og patienter, der har fået transplanteret et organ.
English: The CHMP recommended that Valtrex should only be used in pregnancy if the potential benefits of treatment outweigh the risks.
Danish: CHMP anbefalede, at Valtrex kun bør anvendes under graviditet, hvis den gavnlige virkning ved behandling opvejer risikoen.
English: On 22 October 2008, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Valtrex and associated names in the EU.
Danish: Den 22. oktober 2008 henviste Europa-Kommissionen sagen til CHMP med henblik på harmonisering af markedsføringstilladelserne for Valtrex og relaterede navne i EU.
English: The European Medicines Agency has completed a review of Valtrex and associated names.
Danish: Det Europæiske Lægemiddelagentur (EMA) har foretaget en revurdering af Valtrex og relaterede navne.
English: Aciclovir is an antiviral that works by blocking an enzyme that the viruses need to produce DNA.
Danish: Aciclovir er et antiviralt lægemiddel, der virker ved at blokere et enzym, som virus har brug for for at producere dna.
English: • the prevention of cytomegalovirus infection and disease following solid organ transplantation in adults and adolescents.
Danish: • forebyggelse af cytomegalovirusinfektion og sygdom efter organtransplantation hos voksne og unge.
English: The Committee recommended that the doses of Valtrex should be reduced in patients with impaired kidney function.
Danish: Udvalget anbefalede, at Valtex-dosis nedsættes hos patienter med nedsat nyrefunktion.
English: The active substance in Valtrex, valaciclovir, is broken down in the body into two substances, aciclovir and valine (an amino-acid).
Danish: Det aktive stof i Valtrex, valaciclovir, nedbrydes i kroppen til to stoffer, aciclovir og valin (en aminosyre).
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that there is a need to harmonise the prescribing information for Valtrex in the European Union (EU).
Danish: EMA's Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at der er behov for at harmonisere ordinationsoplysningerne for Valtrex i Den Europæiske Union (EU).
English: 2,000 mg twice a day for one day for treating patients with herpes labialis.
Danish: 2 000 mg to gange dagligt i én dag til behandling af patienter med herpes labialis.
English: The blocking of the production of DNA leads to the viruses being unable to multiply.
Danish: Når dna-produktionen blokeres, kan virus ikke formere sig.
English: It is used to treat infections with herpes, including varicella zoster which causes shingles and herpes simplex viruses (HSV) which can cause cold sores or genital herpes.
Danish: Det anvendes til behandling af infektioner med herpesvirus, herunder varicella zoster, som forårsager helvedesild, og herpes simplex (HSV), som kan forårsage forkølelsessår eller genital herpes.