FrancophonIA/ELRC3.0 huggingface dataset:
English: Gastrointestin al disorders nausea vomiting , diarrhoea, abdominal pain, dysphagia, stomatitis, constipation, dyspepsia, anorexia, throat irritation abdominal enlargement gastro-intesti nal perforation7
Danish: Mave-tarmkanalen Kvalme opkastning, diarre, mavesmerter, dysfagi, stomatitis, obstipation, dyspepsi, anoreksi, halsirritation forstørret abdomen gastrointestinal perforation7
English: Musculoskelet al, connective tissue and bone disorders hypertonia, myalgia, arthralgia, back pain, neck pain, pain
Danish: Knogler, led, muskler og bindevæv hypertoni, myalgier, artralgier, rygsmerter, nakkesmerter, smerter
English: 1 vial contains 500 mg of rituximab.
Danish: 1 hætteglas indeholder 500 mg rituximab.
English: The pharmacokinetic (PK) parameters in the anti-TNF inadequate responder population, following the same dosage regimen (2 × 1000 mg, IV, 2 weeks apart), were similar with a mean maximum serum concentration of 369 μg/mL and a mean terminal half-life of 19.2 days.
Danish: De farmakokinetiske parametre hos patienter i populationen, der responderer utilstrækkeligt på antiTNF-behandling, var efter den samme dosis (2 x 1.000 mg, i.v.
English: Laboratory abnormalities
Danish: Abnorme laboratorieværdier
English: Ritemvia 100 mg concentrate for solution for infusion
Danish: Ritemvia 100 mg koncentrat til infusionsvæske, opløsning
English: Immunisations
Danish: Vaccinationer
English: Other side effects include: a) If you are being treated for non-Hodgkin's Lymphoma
Danish: a) Hvis du behandles for non-Hodgkin-lymfom
English: Table 4 Adverse drug reactions occurring in ≥ 5% of patients receiving rituximab for maintenance treatment of GPA and MPA, and at a higher frequency than the comparator group.
Danish: Tabel 4 Bivirkninger opstået hos ≥ 5 % af patienterne i vedligeholdelsesbehandling med rituximab for granulomatose med polyangiitis (Wegeners granulomatose) og mikroskopisk polyangiitis, og ved en højere frekvens end sammenligningsgruppen.
English: Hazard Ratio (95% CI)
Danish: (95 % CI)
English: Headache Dizziness
Danish: Sen neutropeni
English: Due to the long retention time of rituximab in B cell depleted patients, women of childbearing potential should use effective contraceptive methods during and for 12 months following treatment with rituximab.
Danish: Kvinder i den fertile alder skal anvende sikker prævention under behandlingen og i 12 måneder efter behandlingen med rituximab på grund af den lange retentionstid for rituximab hos B-celle-depleterede patienter.
English: • severe blistering skin conditions that can be life-threatening.
Danish: • alvorlige, eventuelt livstruende hudsygdomme med blærer.
English: • a reduction in white blood cells which does not happen straight away
Danish: • forsinket fald i de hvide blodlegemer
English: The infections were predominately mild to moderate and consisted mostly of upper respiratory tract infections and urinary tract infections.
Danish: Infektionerne var hovedsageligt lette til moderate og var som regel lokaliseret i de øvre luftveje eller urinvejene.
English: The incidence of IRR decreased with subsequent courses (see section 4.8).
Danish: Forekomsten af infusionsrelaterede reaktioner faldt i efterfølgende behandlingsserier (se pkt.
English: Rate
Danish: niveauer
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, in the pivotal clinical study.
Danish: Tabel 3 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: n=98 n=48 n=50
Danish: n = 48
English: The most frequent reported or observed serious adverse drug reactions were:  IRRs (including cytokine-release syndrome, tumour-lysis syndrome), see section 4.4.
Danish: • Infusionsrelaterede reaktioner (herunder cytokinfrigivelsessyndrom, tumorlysesyndrom), se pkt.
English: The mean Cmax (N=15) was 408 µg/mL (range, 97 - 764 µg/mL) after the fifth 500 mg/m2
Danish: Den gennemsnitlige Cmax efter den 4. infusion var 486 µg/ml (spændvidde 77,5 µg/ml - 996,6 µg/ml).
English: 1 vial contains 100 mg of rituximab.
Danish: 1 hætteglas indeholder 100 mg rituximab.
English: The vial contains 500 mg of rituximab.
Danish: Hætteglasset indeholder 500 mg rituximab.
English: This includes rheumatoid arthritis and off-label autoimmune diseases, including Systemic Lupus Erythematosus (SLE) and vasculitis.
Danish: Tilfælde af progressiv multifokal leukoencefalopati med dødelig udgang er rapporteret efter anvendelse af rituximab i forbindelse med behandling for autoimmune sygdomme, som inkluderer reumatoid artrit og ikke-godkendte indikationer som systemisk lupus erythematosus (SLE) og vaskulitis.
English: You may be asked not to take these other medicines 12 hours before you are given Ritemvia.
Danish: 12 timer inden, du får Ritemvia.
English: Cardiac disorders
Danish: Kardiovaskulære bivirkninger
English: Non-Hodgkin's lymphoma and chronic lymphocytic leukaemia
Danish: Non-Hodgkin-lymfom og kronisk lymfatisk leukæmi
English: The vial contains 100 mg of rituximab.
Danish: Hætteglasset indeholder 100 mg rituximab.
English: Decreased haemoglobin
Danish: Nedsat hæmoglobin
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: In a multicentre, single-arm trial, 37 patients with relapsed or chemoresistant, low grade or follicular B cell NHL received 375 mg/m2 of rituximab as intravenous infusion weekly for eight doses.
Danish: Induktionsbehandling, 1 dosis ugentligt til i alt 8 doser I et enkelt-arms multicenterstudie fik 37 patienter med recidiveret elle kemoterapi-resistent lavmalignt eller follikulært B-celle NHL 375 mg/m2 rituximab som intravenøs infusion ugentligt i otte doser.
English: Also do not breast-feed for 12 months after your last treatment with Ritemvia.
Danish: Da Ritemvia udskilles i mælken, må du ikke amme, mens du er i behandling med Ritemvia samt i 12 måneder efter din sidste dosis af Ritemvia.
English: Adverse drug reaction1
Danish: Infusionsrelaterede reaktioner2
English: • feeling dizzy or anxious
Danish: • svimmelhed, nervøsitet
English: Malignancy
Danish: Hudpapillom
English: Skin reactions
Danish: Hudsygdomme
English: Ritemvia
Danish: Rygsmerter
English: Body system Adverse Event
Danish: Legemssystem Bivirkning
English: Gastrointestinal perforation in some cases leading to death has been observed in patients receiving rituximab for treatment of non-Hodgkin's 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: Progression‐free Survival (PFS)
Danish: Progressionsfri overlevelse (PFS)
English: Abdominal pain upper
Danish: Smerter i den øvre del af abdomen
English: Infections and infestations upper respiratory tract infection, urinary tract infections bronchitis, sinusitis, gastroenteritis, tinea pedis
Danish: Systemorgan-klasser Meget almindelig Almindelig Ikke almindelig Sjælden Meget sjælden Infektioner og parasitære sygdomme øvre luftvejsinfektioner, urinvejsinfektion bronkitis, sinuitis gastroenteritis, fodsvamp
English: Immunisation
Danish: Vaccination
English: Infusion related reactions
Danish: For det meste forbundet med infusionsrelaterede reaktioner
English: Date of first infusion:
Danish: Oversigt over indlægssedlen:
English: Each vial contains 500 mg of rituximab.
Danish: Et hætteglas indeholder 500 mg rituximab.
English: 17 February 2012
Danish: 17 februar 2012
English: The European Commission issued a decision on 17 February 2012.
Danish: Europa-Kommissionen offentliggjorde afgørelsen den 17. februar 2012.
English: What are the recommendations for patients and healthcare professionals?
Danish: Hvad er anbefalingerne til patienter og plejepersonale?
English: Pholcodine-containing medicines are currently approved in the EU in Belgium, France, Ireland, Lithuania, Luxembourg, Malta, Slovenia, Spain and the United Kingdom, either subject to medical prescription or as over-the-counter medicines.
Danish: Pholcodin-indeholdende lægemidler er for øjeblikket godkendt i EU i Belgien, Frankrig, Irland, Litauen, Luxembourg, Malta, Slovenien, Spanien og Storbritannien, enten som receptpligtigt lægemiddel eller som håndkøbsmedicin.
English: Therefore, it recommended that all marketing authorisations for medicines containing pholcodine should be maintained throughout the European Union (EU).
Danish: Det anbefales derfor, at alle markedsføringstilladelser for lægemidler indeholdende pholcodin opretholdes i hele Den Europæiske Union (EU).
English: At the time of the review, pholcodine-containing medicines had been withdrawn from the markets in Sweden (in the 1980s) and Norway (in 2007).
Danish: Pholcodin-indeholdende lægemidler var på tidspunktet for revurderingen trukket tilbage fra markederne i Sverige (i 1980'erne) og Norge (i 2007).
English: • Patients taking pholcodine-containing medicines can continue to do so, and should contact their doctor or pharmacist if they have any questions about their treatment.
Danish: • Patienter, der tager lægemidler indeholdende pholcodin, kan fortsat gøre dette og bør kontakte deres læge eller apotek, hvis de har spørgsmål til deres behandling.
English: What is pholcodine?
Danish: Hvad er pholcodin?
English: A group of experts in immunology and anaesthesia was also convened to provide advice.
Danish: Der blev også nedsat en gruppe eksperter inden for immunologi og anæstesi, der fremsatte anbefalinger.
English: No new risks have been identified with pholcodine.
Danish: Der er ikke identificeret nye risici ved pholcodin.
English: Pholcodine has been used as a cough suppressant since the 1950s.
Danish: Pholcodin har været anvendt som hostemiddel siden 1950'erne.
English: They may be available as syrups, oral solutions, suppositories, tablets and capsules under various trade names and as generics.
Danish: Det findes som sirup, orale opløsninger, suppositorier, tabletter og kapsler under forskellige handelsnavne og som generiske lægemidler.
English: Which data has the CHMP reviewed?
Danish: Hvilke data har CHMP revurderet?
English: Why was pholcodine reviewed?
Danish: Hvorfor blev pholcodin revurderet?
English: Pholcodine is an opioid medicine that is used for the treatment of non-productive (dry) cough in children and adults.
Danish: Pholcodin er et opioid, der anvendes til behandling af uproduktiv (tør) hoste hos børn og voksne.
English: To assess its safety, the Committee reviewed the results from preclinical and clinical studies, postmarketing data, epidemiological studies and data from the published literature.
Danish: For at vurdere dets sikkerhed gennemgik udvalget resultaterne af prækliniske og kliniske undersøgelser, data fra efter markedsføring, epidemiologiske undersøgelser og data fra offentliggjorte kilder.
English: • Patients and healthcare professionals are reminded that the benefits of pholcodine continue to outweigh its risks for the treatment of non-productive cough.
Danish: • Patienter og plejepersonale indskærpes, at fordelene ved pholcodin fortsat opvejer risiciene ved behandling af uproduktiv hoste.
English: Consequently, the French medicines regulatory agency changed the prescription status for these medicines in France from over-the-counter to prescription-only, and asked the CHMP to carry out a full assessment of the benefit-risk balance of pholcodine and to issue an opinion on whether the marketing authorisations for pholcodine-containing products should be maintained, varied, suspended or withdrawn across the EU.
Danish: Den franske lægemiddelstyrelse har som følge heraf ændret ordineringsstatus for disse lægemidler i Frankrig fra håndkøbsmedicin til udelukkende receptpligtig medicin, og har bedt CHMP om at gennemføre en fuld vurdering af benefit/risk-forholdet for pholcodin og fremkomme med en udtalelse om, hvorvidt markedsføringstilladelserne for pholcodin-indeholdende produkter bør opretholdes, ændres, suspenderes eller tilbagetrækkes i hele EU.
English: Cross-sensitisation has also been observed in countries where pholcodine is not on the market, suggesting that other substances may also trigger cross-sensitisation and that the observed changes in reporting rates may be explained by other factors.
Danish: Der er også blevet observeret krydssensibilisering i lande, hvor pholcodin ikke er markedsført, hvilket tyder på, at andre midler muligvis også udløser krydssensibilisering, og at de observerede ændringer i indberetningshyppigheden kan skyldes andre faktorer.
English: It works directly in the brain, depressing the cough reflex by reducing the nerve signals that are sent to the muscles involved in coughing.
Danish: Det påvirker hjernen direkte ved at hæmme hosterefleksen gennem en reduktion af de nervesignaler, der sendes til de muskler, der aktiveres ved hoste.
English: Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the benefits of pholcodine-containing medicines continue to outweigh their risks, and therefore recommended that all marketing authorisations for these medicines should be maintained.
Danish: På baggrund af vurderingen af de nu foreliggende data og den videnskabelige drøftelse i udvalget konkluderede CHMP, at fordelene ved lægemidler indeholdende pholcodin fortsat opvejer risiciene, og anbefalede derfor opretholdelse af alle markedsføringstilladelser for disse lægemidler .
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the existing evidence of the risk is weak, and that the benefits of pholcodine continue to outweigh its risks.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at de foreliggende beviser for risikoen er svage, og at fordelene ved pholcodin opvejer dets risici.
English: The CHMP considered that, although this is biologically plausible, the available data are weak and not fully consistent.
Danish: CHMP's overvejelser er, at selvom dette biologisk er muligt, er de foreliggende data ikke overbevisende og stemmer ikke altid overens.
English: Regarding pholcodine's safety, the majority of adverse effects reported with pholcodine are those commonly seen with opioid medicines.
Danish: Og hvad angår pholcodins sikkerhed, er størstedelen af de bivirkninger, der blev indberettet ved pholcodin, de bivirkninger, der almindeligvis optræder ved opioidlægemidler.
English: Further publications in 2010 and 2011 from the same authors supported the hypothesis that pholcodine use may increase the likelihood of patients having an anaphylactic reaction if they are exposed to an NMBA.
Danish: Andre publikationer i 2010 og 2011 fra samme forfattere understøttede hypotesen om, at anvendelsen af pholcodin kan øge sandsynligheden for, at patienter
English: In 2009, a study was published indicating that the reduction in pholcodine consumption in these countries was associated with a decrease in reports of anaphylactic reactions to neuromuscular blocking agents (NMBAs).
Danish: Der blev i 2009 offentliggjort en undersøgelse, der tydede på, at en reduktion i anvendelsen af pholcodin i disse lande var associeret med en reduktion i rapporter om anafylaktiske reaktioner over for neuromuskulære blokkere.
English: The CHMP reviewed all the available data on the effects of pholcodine as a cough suppressant.
Danish: CHMP revurderede alle foreliggende data om virkningen af pholcodin som hostemiddel.
English: NMBAs are used in emergency hospital procedures to prevent spontaneous muscle movements during surgery.
Danish: Neuromuskulære blokkere anvendes i forbindelse med akutte hospitalsprocedurer til forebyggelse af spontane muskelbevægelser/reflekser under operation.
English: The Committee noted that the study in Sweden and Norway looked at changes in reporting rates of adverse reactions to NMBAs following the withdrawal of these medicines, without convincingly establishing a causal link with pholcodine use.
Danish: Udvalget bemærkede, at undersøgelsen i Sverige og Norge fokuserede på ændringer i indberetningshyppigheden af bivirkninger som følge neuromuskulære blokkere efter tilbagetrækningen af disse lægemidler, uden klart at kunne bevise en kausal forbindelse i forhold til anvendelsen af pholcodin.
English: Regarding pholcodine's benefits, the CHMP noted that there is a large body of data demonstrating the effectiveness of opioids in the management of non-productive cough and that pholcodine has been in use for several decades.
Danish: CHMP bemærkede, at der med hensyn til fordelene ved pholcodin foreligger en stor datasamling, der påviser effekten af opioider til behandling af uproduktiv hoste, og at pholcodin har været anvendt i flere årtier.
English: The Committee nevertheless recommended that a new post-marketing study investigating the possibility of an association between pholcodine and anaphylactic reactions to NMBAs should be carried out.
Danish: Udvalget anbefalede ikke desto mindre, at der bør gennemføres en ny efter markedsføringsundersøgelse, der undersøger muligheden for en forbindelse mellem pholcodin og anafylaktikse reaktioner over for neuromuskulære blokkere.
English: from spontaneous reports also suggested a 25% increase in anaphylactic reactions to NMBAs coinciding with a 9% increase in pholcodine use.
Danish: Spontant indberettede data fra Frankrig viser også en 25 % stigning i anafylaktiske reaktioner over for neuromuskulære blokkere koinciderende med en 9 % stigning ved anvendelse af pholcodin.
English: The European Medicines Agency has completed a review of the safety and effectiveness of pholcodine, following concerns that its use may put people at risk of developing anaphylactic (severe allergic) reactions to neuromuscular blocking agents used during surgery.
Danish: Det Europæiske Lægemiddelagentur har afsluttet en revurdering af sikkerheden og virkningen af pholcodin efter betænkeligheder om, hvorvidt brugen kan øge patientens risiko for at udvikle anafylaktiske (alvorlige allergiske) reaktioner over for neuromuskulære blokkere, der anvendes under operation.
English: The hypothesis that pholcodine use could trigger anaphylactic reactions to NMBAs is based on the body producing antibodies against pholcodine, which eventually trigger reactions to NMBAs (‘crosssensitisation').
Danish: Hypotesen om, at anvendelse af pholcodin kan udløse anafylaktiske reaktioner over for neuromuskulære blokkere, bygger på, at kroppen danner antistoffer mod pholcodin, hvilket senere udløser reaktioner over for neuromuskulære blokkere ('krydsallergi').
English: Therefore, the CHMP concluded that the existing evidence does not support the conclusion that the use of pholcodine-containing medicines presents a risk of developing anaphylactic reactions to NMBAs.
Danish: CHMP konkluderede derfor, at de foreliggende beviser ikke understøtter konklusionen om, at anvendelsen af pholcodinindeholdende lægemidler udgør en risiko for udvikling af anafylaktiske reaktioner over for neuromuskulære blokkere.
English: • The patient has acknowledged the aforementioned conditions.
Danish: • Patienten har anerkendt ovennævnte betingelser.
English: When this happens, it is called ‘response'.
Danish: Når dette forekommer, kaldes det en 'remission'.
English: • Difficulty in falling asleep or staying asleep.
Danish: • Problemer med at falde i søvn eller blive ved med at sove.
English: Carcinogenicity studies have not been conducted.
Danish: Der er ikke blevet udført karcinogenicitetsstudier.
English: The following can be considered to be examples of suitable methods of contraception:
Danish: Følgende kan betragtes som eksempler på velegnede kontraceptionsmetoder:
English: *In case of neutropenia, the physician should consider the use of growth factors.
Danish: *I tilfælde af neutropeni bør lægen overveje at anvende vækstfaktorer.
English: Day (of 21-day cycle)
Danish: Dag (af en 21-dages cyklus)
English: • at least every month after that for as long as you are taking Imnovid.
Danish: • mindst hver måned derefter, så længe du tager Imnovid.
English: Treatment continued until patients had disease progression.
Danish: Behandlingen fortsatte, indtil patienterne havde sygdomsprogression.
English: System Organ Class/ Preferred Term
Danish: Systemorganklasse/ foretrukken term
English: Your doctor should ask you to have a blood test:
Danish: Din læge vil bede dig om at få taget en blodprøve:
English: Follow CBC*** weekly.
Danish: Kontrollér CBC*** ugentligt.
English: There was no maternal toxicity observed in this study.
Danish: Der blev ikke observeret maternal toksicitet i dette studie.
English: • You can take the capsules either with or without food.
Danish: • Du kan tage kapslerne enten sammen med eller uden mad.
English: The difference in OS between the two treatment arms was statistically significant (p < 0.001).
Danish: Forskellen i OS mellem de to behandlingsarme var statistisk signifikant (p < 0,001).
English: Imnovid hard capsules should be taken orally at the same time each day.
Danish: Imnovid hårde kapsler bør tages oralt på samme tidspunkt hver dag.
English: • Lack of energy.
Danish: • Manglende energi.
English: 95% CI about the median.
Danish: 95 % CI omkring medianen.
English: Your partner should also tell her doctor straight away.
Danish: Din partner skal også straks fortælle det til sin læge.
English: Patients may require use of blood product support and /or growth factors.
Danish: Patienterne kan have behov for støttende behandling med blodprodukter og/eller vækstfaktorer.
English: However, treatment can reduce the signs and symptoms of the disease, or make them disappear for a period of time.
Danish: Behandling kan imidlertid nedsætte tegn og symptomer, eller få dem til at forsvinde i en periode.
English: Children and adolescents Imnovid is not recommended for use in children and young people under 18 years.
Danish: Børn og unge Imnovid bør ikke anvendes til børn og unge mennesker under 18 år.
English: • you have ever had blood clots in the past.
Danish: • hvis du tidligere har haft blodpropper.
English: Pomalidomide should only be resumed after a thorough evaluation of the benefits and the risks.
Danish: Pomalidomid må kun genoptages efter en grundig evaluering af fordele og risici.
English: Talk to your doctor about the best method of contraception for you.
Danish: Tal med lægen om den bedste præventionsmetode for dig.
English: CONCLUSIONS ON THE REQUEST FOR ONE-YEAR MARKETING PROTECTION PRESENTED BY THE EUROPEAN MEDICINES AGENCY
Danish: KONKLUSIONER VEDRØRENDE ANMODNING OM MARKEDSFØRINGSBESKYTTELSE I ET ÅR FREMLAGT AF DET EUROPÆISKE LÆGEMIDDELAGENTUR
English: Based on Cox proportional hazards model.
Danish: Baseret på Cox proportionale hazards model.
English: Imnovid works in a number of different ways:
Danish: Imnovid virker på flere forskellige måder:
English: Blood donation and blood tests
Danish: Bloddonation og blodprøver
English: • Take Imnovid at about the same time each day.
Danish: • Tag Imnovid på cirka samme tidspunkt hver dag.
English: Therefore, pomalidomide can be administered without regard to food intake.
Danish: Derfor kan pomalidomid administreres uden hensyntagen til fødevareindtagelse.
English: • High blood levels of sugar.
Danish: • Højt blodsukkerniveau.
English: Your doctor should check whether you have ever had hepatitis B infection.
Danish: Din læge bør teste, om du nogensinde har haft hepatitis B-infektion.
English: • A spinning feeling in your head, making it difficult to stand up and move normally.
Danish: • En snurrende fornemmelse i hovedet, som gør det besværligt at stå op og bevæge sig normalt.