FrancophonIA/ELRC3.0 huggingface dataset:
English: Application site reaction, Influenzalike illness, Feeling of body temperature change,
Danish: Reaktion på påsætningsstedet, influenzalignende sygdom, følelse af ændringer i kropstemperaturen, overfølsomhed på påsætningsstedet, seponeringssyndrom, pyreksi
English: Do no sunbathe, have long hot baths or saunas.
Danish: Du skal også undgå solbadning, lange, varme bade eller saunaer.
English: • Spinning sensation (vertigo)
Danish: • Følelse af, at det hele drejer rundt (vertigo)
English: • Some medicines used to treat depression or Parkinson's disease called MAOIs (such as isocarboxazid, phenelzine, selegiline, or tranylcypromine).You should not take DUROGESIC
Danish: • Visse lægemidler til behandling af depression eller Parkinsons sygdom, som kaldes MAO-hæmmere (som f.eks. isocarboxazid, phenelzin, selegilin eller tranylcypromin).
English: Do not sunbathe, have long hot baths or saunas or use hot whirlpool spa baths.
Danish: Du skal også undgå solbadning, lange, varme bade eller saunaer og varme boblebade/spabade.
English: • Flu-like illness
Danish: • Influenzalignende sygdom
English: Thursday
Danish: Torsdag
English: The resultant prolongation in gastrointestinal transit time may be responsible for the constipating effect of fentanyl.
Danish: Derved forlænges transporttiden gennem tarmen, hvilket kan være årsagen til, at fentanyl giver obstipation.
English: Tuesday
Danish: Tirsdag
English: 2 In clinical studies these ranges of daily oral morphine doses were used as a basis for conversion to DUROGESIC.
Danish: 2 I kliniske studier blev disse intervaller for døgndoser af oralt morphin brugt som grundlag for omregning til
English: Step 3: Peel and press
Danish: Trin 3: Træk beskyttelsesfilmen af og tryk
English: Sunday
Danish: Søndag
English: 30b pethidine oral parenteral
Danish: Oral Parenteral b
English: Monoamine Oxidase Inhibitors (MAOI)
Danish: Monoaminoxidasehæmmere (MAO-hæmmere)
English: More about using DUROGESIC
Danish: Flere oplysninger om brug af DUROGESIC
English: Somnolence, Dizziness, Headache
Danish: Døsighed, svimmelhed, hovedpine
English: Based on pooled safety data from these 3 clinical studies in paediatric subjects, the most commonly reported (i.e. ≥10% incidence) adverse reactions were vomiting (33.9%), nausea (23.5%), headache
Danish: Baseret på de samlede sikkerhedsdata fra disse 3 kliniske studier hos pædiatriske forsøgspersoner var de hyppigst rapporterede bivirkninger (forekomst ≥10 %): opkastning (33,9 %), kvalme (23,5 %), hovedpine (16,3 % ), obstipation (13,5 %), diarré (12,8 %) og pruritus (12,8 %).
English: Monday
Danish: Mandag
English: If you are not sure, talk to your doctor or pharmacist before using DUROGESIC.
Danish: Tal med lægen eller apotekspersonalet, før du bruger DUROGESIC, hvis du er i tvivl.
English: DUROGESIC is not recommended for use in patients who require the concomitant administration of an MAOI.
Danish: Det frarådes at anvende DUROGESIC til patienter, hvor samtidig behandling med en MAO-hæmmer er nødvendig.
English: The polymer matrix and the diffusion of fentanyl through the layers of the skin ensure that the release rate is relatively constant.The concentration gradient existing between the system and the lower concentration in the skin drives drug release.
Danish: Det er den koncentrationsgradient, der eksisterer mellem plastret og den lavere koncentration i huden, der driver lægemidlets frigivelse.
English: Then they should be safely discarded by putting them back into the original sachet and stored out of sight and reach of other people, especially children, until safely disposed.
Danish: Derefter kan de bortskaffes sikkert ved at lægge dem tilbage i posen og gemme dem på et sikkert sted uden for børns rækkevidde, indtil de kan kasseres på sikker vis.
English: • Feeling sleepy (somnolence)
Danish: • Søvnighed (døsighed)
English: The manifestations of fentanyl overdose are an extension of its pharmacologic actions, the most serious effect being respiratory depression.
Danish: Ved fentanyloverdosering ses en forlængelse af dets farmakologiske virkning.
English: Saturday
Danish: Lørdag
English: • You have breathing difficulties, with slow or shallow breathing Do not use this medicine if any of the above apply to you or your child.
Danish: Brug ikke dette lægemiddel, hvis noget af ovenstående gælder for dig eller dit barn.
English: <{fax}> <{e-mail}>
Danish: <{Medlemslandets navn}> <{Lægemidlets navn}>
English: Multiplication Factor morphine oral
Danish: Multiplikationsfaktor
English: To guard against accidental ingestion by children, use caution when choosing the application site for DUROGESIC (see sections 4.2 and 6.6) and monitor adhesion of the patch closely.
Danish: For at forhindre at børn utilsigtet indtager plastret, skal der udvises forsigtighed ved valg af påsætningssted for DUROGESIC (se pkt.
English: To remove the patch from the protective sachet, locate the pre-cut notch (indicated by an arrow on the patch label) along the edge of the seal.
Danish: Plastret fjernes fra den beskyttende pose ved at finde hakket (angivet med en pil på posens etiket) langs kanten af forseglingen, folde posen ved hakket og derefter forsigtigt rive posen op. Åbn posen yderligere langs begge sider, så den åbnes som en bog.
English: DUROGESIC may be worn continuously for 72 hours.
Danish: Et DUROGESIC-plaster kan sidde på huden i 72 timer.
English: - Common (may affect up to 1 in 10 people)
Danish: Almindelig (kan forekomme hos op til 1 ud af 10 personer)
English: Elderly patients should be observed carefully for signs of fentanyl toxicity and the dose reduced if necessary (see section 4.4).
Danish: Ældre patienter bør observeres nøje for tegn på fentanyltoksicitet, og om nødvendigt skal dosis reduceres (se pkt.
English: • Stopping breathing from time to time (apnoea)
Danish: • Uregelmæssig vejrtrækning med pauser i vejrtrækningen (apnø)
English: If patients with renal impairment receive DUROGESIC, they should be observed carefully for signs of fentanyl toxicity and the dose reduced if necessary.
Danish: Patienter med nedsat nyrefunktion, som behandles med DUROGESIC, skal observeres nøje for tegn på fentanyltoksicitet, og om nødvendigt skal dosis reduceres.
English: How to use DUROGESIC
Danish: Sådan skal du bruge DUROGESIC
English: Tolerance, physical dependence, and psychological dependence may develop upon repeated administration of opioids.
Danish: Lægemiddelafhængighed og potentialet for misbrug Gentagen administration af opioider kan give anledning til toleransudvikling samt fysisk og psykisk afhængighed.
English: It also crosses the placenta and is excreted in breast milk.
Danish: Fentanyl passerer nemt blod-hjernebarrieren, ligesom det passerer placenta og udskilles i mælk.
English: What DUROGESIC is and what it is used for What you need to know before you use DUROGESIC How to use DUROGESIC
Danish: Det skal du vide, før du begynder at bruge DUROGESIC Sådan skal du bruge DUROGESIC Bivirkninger
English: Therefore, during the first 12 hours after switching to DUROGESIC, the patient should be given the previous regular dose of analgesics.
Danish: Derfor bør patienten fortsætte behandling med normal dosering af det tidligere analgetikum de første 12 timer efter skift til DUROGESIC.
English: If patients with hepatic impairment receive DUROGESIC, they should be observed carefully for signs of fentanyl toxicity and the dose of DUROGESIC reduced if necessary (see section
Danish: Hvis patienter med nedsat leverfunktion får DUROGESIC, skal de observeres nøje for tegn på fentanyltoksicitet, og om nødvendigt skal dosis af DUROGESIC reduceres (se pkt.
English: Operations
Danish: Administration
English: Patients with hepatic impairment should be observed carefully for signs of fentanyl toxicity and the dose of DUROGESIC should be reduced if necessary (see section 4.4).
Danish: Patienter med nedsat leverfunktion skal observeres nøje for tegn på fentanyltoksicitet, og dosis af DUROGESIC skal om nødvendigt reduceres (se pkt.
English: Rare
Danish: Hyppighed
English: • If you have any further questions, ask your doctor, pharmacist or nurse
Danish: Er du i tvivl, så spørg lægen eller apotekspersonalet.
English: DUROGESIC may interact with these medicines and you may experience changes to mental status such as feeling agitated, seeing, feeling, hearing, or smelling things that are not there (hallucinations) and other effects such as changing blood pressure, fast heart beat, high body temperature, overactive reflexes, lack of coordination, muscle stiffness, nausea, vomitting and diarrhoea.
Danish: Der kan også være andre virkninger som f.eks. ændring i blodtrykket, hurtig puls, forhøjet kropstemperatur, overaktive reflekser, manglende koordination, muskelstivhed, kvalme, opkastning og diarré.
English: • Some medicines used to treat depression called SSRIs or SNRIs (such as citalopram, duloxetine,
Danish: • Visse lægemidler til behandling af depression, som kaldes SSRI'er eller SNRI'er (som f.eks. citalopram, duloxetin, escitalopram, fluoxetin, fluvoxamin, paroxetin, sertralin eller venlafaxin)se herunder for yderligere oplysninger
English: • Dry mouth
Danish: • Muskeltrækninger
English: Putting a patch on
Danish: Hvis du sætter plastret på
English: • Itching, skin rash or redness of the skin
Danish: • Kløe, hududslæt eller hudrødme
English: If elderly patients receive DUROGESIC, they should be observed carefully for signs of fentanyl toxicity and the dose reduced if necessary (see section 5.2).
Danish: Ældre patienter, der bruger DUROGESIC, bør observeres omhyggeligt for tegn på fentanyltoksicitet, og om nødvendigt skal dosis reduceres (se pkt.
English: The potential for serious or life-threatening hypoventilation exists even if the lowest dose of DUROGESIC is used in initiating therapy in opioid-naïve patients (see sections 4.4 and
Danish: Der er risiko for alvorlig eller livstruende hypoventilation ved initiering af behandling hos opioid-naive patienter.
English: Cardiac disease
Danish: Hjertesygdom
English: PHARMACEUTICAL FORM Transdermal patch.
Danish: LÆGEMIDDELFORM Depotplaster.
English: DUROGESIC contains {name the excipient(s)
Danish: DUROGESIC indeholder {nævn de(t) hjælpestof(fer), hvor advarsel er påkrævet}
English: Breastfeeding
Danish: Buprenorphin
English: This may be months from now.
Danish: Dette kan være om flere måneder.
English: Why have I been given this card?
Danish: Hvorfor har jeg fået dette kort?
English: Date of first authorization: 15 June 2017
Danish: Dato for første markedsføringstilladelse: 15. juni 2017
English: • Changes in laboratory tests carried out by your doctor.
Danish: • ændringer i laboratorieundersøgelser udført af din læge.
English: This is usually given every 3 week up to 8 times.
Danish: Det vil sædvanligvis sige hver 3. uge, op til 8 gange.
English: For non-oncology indications:
Danish: For ikke-onkologiske indikationer:
English: The prespecified non-inferiority margin for the treatment difference was 20%.
Danish: Den præspecificerede non-inferioritetsmargin for behandlingsforskel var 20 %.
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: Each cycle has a duration of 28 days.
Danish: Hver serie varer 28 dage.
English: Note: Patients were censored at month 28 if they had no event.
Danish: Note: Patienter blev censureret ved måned 28, hvis ikke de havde et recidiv.
English: Elderly patients (≥ 65 years)
Danish: Ældre (≥ 65 år)
English: Some infections may be severe (please see information on Infections within this section).
Danish: Nogle infektioner kan være alvorlige (se venligst information om Infektioner i dette afsnit).
English: Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Danish: Læs denne indlægsseddel grundigt, inden du begynder at få dette lægemiddel, da den indeholder vigtige oplysninger.
English: As the Patient Alert Card is part of the product information in the outer packaging, the content will be centrally approved for all EU/EEA languages without need of further approval by National Authorities.
Danish: Da patientkortet er en del af produktinformationen i den ydre emballage, vil indholdet blive godkendt centralt for alle EU-/EØSsprog, og der er ikke behov for yderligere godkendelse fra de nationale myndigheder.
English: Currently, there are limited data on possible interactions with other medicinal products and rituximab.
Danish: På nuværende tidspunkt er der begrænsede data om mulige interaktioner med andre lægemidler og rituximab.
English: • you have a severe active infection at the moment
Danish: • du i øjeblikket har en aktiv svær infektion.
English: When should I not have Rixathon?
Danish: Hvornår må jeg ikke få Rixathon?
English: • you have a weak immune system.
Danish: • du har et svagt immunforsvar.
English: It is important to check the medicinal product labels to ensure that the appropriate formulation is being given to the patient, as prescribed.
Danish: Det er vigtigt at kontrollere lægemidlets etiket for at sikre, at den formulering, der gives til patienten, er korrekt i henhold til ordinationen.
English: 95.1%b CI (-3.2%, 24.3%)a
Danish: 95,1 %b konfidensinterval (-3,2 %; 24,3 %) a
English: These findings were replicated at week 48, where autoantibody seropositivity also significantly increased the probability of achieving ACR70.
Danish: Disse resultater blev gentaget ved uge 48, hvor autoantistof-seropositivitet også signifikant øgede sandsynligheden for at opnå ACR70.
English: • Rixathon will be given to you once a week for 4 weeks.
Danish: • Rixathon gives en gang ugentligt i 4 uger.
English: Continued therapy should be carefully reconsidered in patients who show no evidence of therapeutic benefit within this time period.
Danish: Fortsat behandling bør nøje overvejes hos patienter, som ikke viser tegn på terapeutisk fordel inden for denne tidsperiode.
English: When rituximab sticks to the surface of this cell, the cell dies.
Danish: Når rituximab bindes til overfladen af denne celle, dør cellen.
English: Do not have Rixathon if you have an active infection or a serious problem with your immune system.
Danish: Du må ikke få Rixathon, hvis du har en aktiv infektion eller alvorlige problemer med dit immunsystem.
English: If the more rapid infusion is tolerated, this infusion schedule can be used when administering subsequent infusions.
Danish: Hvis denne hurtigere infusion tolereres, kan denne infusionstid anvendes ved administration af efterfølgende infusioner.
English: Retreatment should be given at that time if residual disease activity remains, otherwise retreatment should be delayed until disease activity returns.
Danish: Genbehandling bør gives på dette tidspunkt, hvis residual sygdomsaktivitet vedbliver, ellers bør genbehandling udsættes, til sygdomsaktivitet vender tilbage.
English: − * Worst case imputation a Non-inferiority was demonstrated since the lower bound (− 3.2%) was higher than the predetermined 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 non inferioritetsmargin (-20 %).
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C - 8°C, unless dilution has taken place in controlled and validated aseptic conditions.
Danish: Hvis den ikke anvendes straks, er opbevaringstid og -forhold inden anvendelse brugerens ansvar og vil normalt ikke være længere end 24 timer ved 2 °C - 8 °C, med mindre opløsningen har fundet sted under kontrollerede og validerede aseptiske forhold.
English: Tell the person giving you the infusion immediately if you develop any of these symptoms, as the infusion may need to be slowed down or stopped.
Danish: Fortæl det straks til den person, der giver dig infusionen, hvis du oplever nogle af disse symptomer, da infusionshastigheden måske skal nedsættes eller stoppes.
English: Rixathon is indicated in adults for the following indications:
Danish: Rixathon er indiceret hos voksne til følgende indikationer:
English: For these reasons Rixathon should not be administered to pregnant women unless the possible benefit outweighs the potential risk.
Danish: Derfor bør Rixathon ikke gives til gravide kvinder, medmindre den potentielle gevinst opvejer den potentielle risiko.
English: Do not have Rixathon if any of the above apply to you.
Danish: Du må ikke få Rixathon, hvis ét eller flere af ovenstående punkter gælder for dig.
English: Available data suggest that clinical response is usually achieved within 16 to 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: Abbreviation: NS, non-significant
Danish: Forkortelser: NS = ikke signifikant
English: Your doctor may decide to treat you longer with Rixathon (up to 5 years), depending on how you respond to the medicine.
Danish: Din læge kan beslutte at behandle dig i længere tid med Rixathon (op til 5 år), alt efter hvor godt du reagerer på medicinen.
English: Both tests are commonly positive in rheumatoid arthritis and aid in confirming the diagnosis.
Danish: Begge prøver er almindeligvis positive ved reumatoid artrit og hjælper med at bekræfte diagnosen.
English: See the Rixathon package leaflet for more information.
Danish: Se indlægssedlen i Rixathon-pakken for mere information.
English: Complete remission All patients Newly diagnosed Relapsing
Danish: Fuldstændig remission Alle patienter Nyligt diagnosticerede Patienter med recidiv
English: Aseptic preparation
Danish: Aseptisk tilberedning
English: Patients were followed beyond week 24 for long term endpoints, including radiographic assessment at 56 weeks and at 104 weeks.
Danish: Patienterne blev fulgt efter uge 24 for langtidsendepunkter, inklusive en radiologisk vurdering i uge 56 og i uge 104.
English: Aseptic handling must be ensured when preparing the infusion.
Danish: Aseptisk håndtering skal sikres ved tilberedning af infusionen.
English: • High cholesterol levels in the blood
Danish: • høje kolesterolniveauer i blodet
English: Binet stage A Binet stage B Binet stage C CI: Confidence Interval
Danish: Binet stadium A Binet stadium B Binet stadium C CI: Konfidensinterval
English: Tell your doctor immediately if you experience any of these symptoms.
Danish: Fortæl det øjeblikkeligt til lægen, hvis du oplever nogen af disse symptomer.
English: Unopened vial 3 years.
Danish: Uåbnet hætteglas 3 år
English: Significance levels were defined as * p <0.05, ** p < 0.001, *** p < 0.0001.
Danish: Signifikante niveauer var defineret som * p< 0,05 **p< 0,001, ***p< 0,0001.
English: Your doctor will decide if you should receive concomitant supportive therapy.
Danish: Din læge vil tage stilling til, om du samtidig skal have understøttende behandling.
English: Table 14 Physical Function and Quality of Life outcomes at week 24 in Trial 1
Danish: Tabel 14 Resultater for fysisk funktion og livskvalitet ved uge 24 i studie 1
English: Rixathon may be used for the treatment of several different conditions in adults.
Danish: Rixathon kan anvendes til behandling af flere forskellige tilstande hos voksne.
English: If you feel dizzy, do not drive or use any tools or machines.
Danish: Hvis du føler dig svimmel, må du ikke føre motorkøretøj eller arbejde med maskiner.
English: 1 Events were considered ADRs only after thorough assessment and where a causal relationship between the medicinal product and the adverse event was at least a reasonable possibility.
Danish: 1 Hændelser blev kun betragtet som bivirkninger efter grundig vurdering og hvor en årsagssammenhæng mellem lægemidlet og bivirkningen var en rimelig mulighed.
English: Patients should receive Rixathon for at least 24 months after achievement of remission (absence of clinical signs and symptoms).
Danish: Patienter skal gives Rixathon i mindst 24 måneder efter opnåelse af remission (fravær af kliniske symptomer).
English: Before you are given Rixathon you will be given other medicines (premedication) to prevent or reduce possible side effects.
Danish: Inden du får Rixathon, vil du få anden medicin (præmedicin), der forebygger eller mindsker mulige bivirkninger.
English: Some vaccines should not be given at the same time as Rixathon or in the months after you receive Rixathon.
Danish: Nogle vaccinationer bør ikke gives på samme tid som Rixathon eller i månederne efter du har fået Rixathon.
English: Rixathon in combination with chemotherapy destroys these cells which are gradually removed from the body by biological processes.
Danish: Rixathon anvendt sammen med kemoterapi ødelægger disse celler, som gradvis fjernes fra kroppen ved biologiske processer.
English: • you are allergic to rituximab, other proteins which are like rituximab, or any of the other ingredients of this medicine (listed in section 6).
Danish: • du er allergisk over for rituximab, andre proteiner, der ligner rituximab eller et af de øvrige indholdsstoffer i Rixathon (angivet i punkt 6).
English: Treatment difference (rituximabcyclophosphamide)
Danish: Behandlingsforskel (Rituximabcyclophosphamid)
English: This antigen does not internalise upon antibody binding and is not shed from the cell surface.
Danish: Dette antigen ændres ikke efter antistof binding og fjernes ikke fra celleoverfladen.
English: The proportion of patients experiencing an infusionrelated reaction was 29% (11 patients), 40% (15 patients), 13% (5 patients), and 10% (4 patients) following the first, second, third, and fourth infusions, respectively.
Danish: Andelen af patienter, der oplevede en infusionsrelateret reaktion var henholdsvis 29 % (11 patienter), 40 % (15 patienter), 13 % (5 patienter) og 10 % (4 patienter) efter den første, anden, tredje og fjerde infusion.
English: Final analysis (median FU:9.0 years)
Danish: Final analyse (median opfølgning: 9,0 år)
English: • heart beating faster than normal
Danish: • hjertet slår hurtigere end normalt.
English: Rixathon slows down the damage to your joints caused by rheumatoid arthritis and improves your ability to do normal daily activities.
Danish: Rixathon bremser beskadigelsen af dine led forårsaget af reumatoid artrit og forbedrer din evne til at udføre normale daglige aktiviteter.
English: Rixathon is a biosimilar medicinal product.
Danish: Rixathon er et biosimilært lægemiddel.
English: EFS - Event Free Survival TTP - Time to progression or death PFS - Progression-Free Survival TTF - Time to Treatment Failure OS rates - survival rates at the time of the analyses
Danish: EFS - Hændelsesfri overlevelse TTP - Tid til progression eller død PFS - Progressionsfri overlevelse TTF - Tid til behandlingssvigt OS rates - Overlevelsesrater ved analysetiden
English: Rituximab was detectable in the serum of patients 3 to 6 months after completion of last treatment.
Danish: Rituximab kunne detekteres i patienternes serum i op til 3 til 6 måneder efter færdiggørelse af den sidste behandling.
English: Depending on the signs and symptoms of your disease, your doctor will decide when you should receive more Rixathon.
Danish: Afhængigt af kliniske fund og symptomer på din sygdom, vil din læge bedømme, om du skal have mere Rixathon.
English: Following reconstitution of the immune system in immunocompromised patients with PML, stabilisation or improved outcome has been seen.
Danish: Efter rekonstituering af immunsystemet hos immunkomprimerede patienter med PML er der set stabilisering eller forbedret tilstand.
English: ACR20 ACR50 ACR70 EULAR response (good/moderate) Mean change in DAS
Danish: ACR20 ACR50 ACR70 EULAR respons (god/moderat) Gennemsnits-ændring i DAS
English: B lymphocytes are involved in the cause of these conditions.
Danish: B-lymfocytter er involveret i årsagen til disse tilstande.
English: You should also tell them about your Rixathon treatment.
Danish: Du skal også fortælle dem om din Rixathon-behandling.