FrancophonIA/ELRC3.0 huggingface dataset:
English: Treatment with LIFMIOR should continue until remission is achieved, for up to 24 weeks.
Danish: Behandlingen med LIFMIOR bør fortsættes indtil remission er nået, i op til 24 uger.
English: Dose proportionality has not been formally evaluated, but there is no apparent saturation of clearance across the dosing range.
Danish: Dosisproportionalitet er ikke blevet evalueret formelt, men der er tilsyneladende ingen mætning af clearance hen over dosisområdet.
English: The following list of adverse reactions is based on experience from clinical trials in adults and on postmarketing experience.
Danish: Følgende liste over bivirkninger er baseret på erfaringer fra kliniske forsøg på voksne og på postmarketing erfaring.
English: The central volume of distribution of etanercept is 7.6 l, while the volume of distribution at steady-state is 10.4 l.
Danish: Den centrale distributionsvolumen for etanercept er 7,6 l, mens distributionsvolumen ved steady-state er 10,4 l.
English: These reactions were generally transient and did not recur with treatment.
Danish: Disse reaktioner var generelt forbigående og opstod ikke igen efter behandling.
English: The clinical significance of this interaction is unknown.
Danish: Den kliniske betydning af denne interaktion er ukendt.
English: Your doctor will help you to decide whether the benefits of treatment outweigh the potential risk to your baby.
Danish: Din læge vil hjælpe dig med at afgøre, om fordelene ved behandlingen opvejer den mulige risiko for dit barn.
English: Reactions at the injection site (these do not occur as often after the first month of treatment).
Danish: Reaktioner på injektionsstedet (optræder ikke så ofte efter den første måneds behandling).
English: Worsening of symptoms of dermatomyositis
Danish: Forværring af symptomer på dermatomyositis
English: Patients had previously been treated with NSAIDs (86%), DMARDs (80%), and corticosteroids (24%).
Danish: Patienterne var tidligere blevet behandlet med NSAID (86 %), DMARD (80 %) og kortikosteroider (24 %).
English: Use only the items listed.
Danish: Brug kun de ting, der er angivet.
English: Dosing for adult patients (aged 18 years or over)
Danish: Dosering til voksne patienter (18 år og derover)
English: c: Remission is defined as DAS <1.6.
Danish: c: remission er defineret som DAS<1,6
English: Long-term experience with LIFMIOR was generally comparable to the original 48-week study and did not reveal any new safety findings.
Danish: Erfaringerne fra langtidsstudiet med LIFMIOR var generelt sammenlignelige med det oprindelige 48-ugers studie og gav ingen nye sikkerhedsresultater.
English: The safety profile was consistent with that observed in other JIA studies.
Danish: Sikkerhedsprofilen var i overensstemmelse med observationer fra andre JIA-studier.
English: LIFMIOR is a medicine that is made from two human proteins.
Danish: LIFMIOR er et lægemiddel fremstillet af to proteiner, som findes naturligt hos mennesker.
English: This new expiry date should not exceed the expiry date recorded on the outer carton.
Danish: Den nye udløbsdato må ikke overskride udløbsdatoen noteret på den ydre karton.
English: In addition, use of an immunoglobulin Fc region as a fusion element in the construction of a dimeric receptor imparts a longer serum half-life.
Danish: Derudover bibringer brugen af en immunoglobulin Fc-region som et fusionselement i opbyggelsen af en dimerisk receptor en længere serum-halveringstid.
English: The powder must be dissolved before use.
Danish: Pulveret skal opløses før brug.
English: LIFMIOR has not been studied in children aged less than 2 years.
Danish: LIFMIOR er ikke undersøgt hos børn under 2 år.
English: However, it cannot be excluded that the combination of LIFMIOR with methotrexate could be associated with an increase in the rate of infections.
Danish: Det kan dog ikke udelukkes, at kombinationen LIFMIOR og methotrexat kan være forbundet med en stigning i infektionsraten.
English: For all of the above indications, available data suggest that a clinical response is usually achieved within 12 weeks of treatment.
Danish: For de ovenfor nævnte indikationer tyder tilgængelige data på, at klinisk respons normalt opnås i løbet af 12 uger.
English: With the other hand, hold the syringe like a pencil.
Danish: Med den anden hånd holdes sprøjten som en blyant.
English: Continuous therapy beyond 24 weeks may be appropriate for some adult patients (see section 5.1).
Danish: Fortsat behandling ud over 24 uger kan være relevant for visse voksne patienter (se pkt.
English: Hepatitis B reactivation, listeria
Danish: Hepatitis B reaktivering, listeria
English: Etanercept is cleared slowly from the body.
Danish: Etanercept udskilles langsomt fra kroppen.
English: The dosage of LIFMIOR is based on body weight for paediatric patients.
Danish: Doseringen af LIFMIOR er baseret på legemsvægt for pædiatriske patienter.
English: If not used immediately, storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 6 hours at temperatures of up to 25°C, unless reconstitution has taken place in controlled and validated aseptic conditions.
Danish: Hvis det ikke anvendes umiddelbart, er opbevaringstid og -forhold inden brug brugerens ansvar og bør normalt ikke være mere end 6 timer ved temperaturer op til 25 °C, medmindre opblandingen har fundet sted under kontrollerede og validerede aseptiske forhold.
English: If you have used more LIFMIOR than you should (either by injecting too much on a single occasion or by using it too frequently), talk to a doctor or pharmacist immediately.
Danish: Hvis du har anvendt mere LIFMIOR, end du bør (enten ved at injicere for meget en enkelt gang eller ved at anvende det for ofte), bør du straks tale med lægen eller apoteket.
English: Date of first authorisation: 13 February 2017 Date of last renewal: {DD month YYYY}
Danish: Dato for første tilladelse: 13. februar 2017 Dato for sidste fornyelse: {DD month YYYY}
English: Study 4 evaluated 142 patients and had similar inclusion criteria to studies 2 and 3.
Danish: Studie 4 evaluerede 142 patienter og havde samme inklusionskriterier som studie 2 og 3.
English: There have also been rare (< 0.1%) reports of new onset CHF, including CHF in patients without known pre-existing cardiovascular disease.
Danish: Der har også været sjældne (< 0,1 %) rapporter om nyopstået CHF, herunder CHF hos patienter uden kendt forudeksisterende hjerte-kar-sygdom.
English: The needle will remain protected inside the pen until the pen is activated.
Danish: Nålen vil forblive beskyttet inde i pennen, indtil pennen aktiveres.
English: Concurrent treatment with abatacept
Danish: Samtidig behandling med abatacept
English: Posology and administration are the same as for adults 18-64 years of age.
Danish: Dosering og indgivelse er den samme som hos voksne på 18-64 år.
English: Two large clinical trials evaluating the use of LIFMIOR in the treatment of CHF were terminated early due to lack of efficacy.
Danish: To store kliniske forsøg, der evaluerede brugen af LIFMIOR i behandlingen af CHF, blev afsluttet før tiden på grund af manglende effektivitet.
English: LIFMIOR N=103 to 105*
Danish: LIFMIOR N=103 til 105*
English: Patients receiving DMARDs, NSAIDS, or corticosteroids could continue them on stable doses.
Danish: Patienter i behandling med DMARD, NSAID eller kortikosteroider kunne fortsætte med disse på stabile doser.
English: Invasive fungal infections accounted for more than half of the fatalities amongst patients who developed opportunistic infections.
Danish: Invasive svampeinfektioner stod for mere end halvdelen af dødsfaldene blandt patienter, som udviklede opportunistiske infektioner.
English: Do NOT remove the grey stopper or aluminium ring around the top of the vial.
Danish: Fjern IKKE den grå prop eller aluminiumsringen rundt om hætteglassets top.
English: In postmarketing experience, approximately half of all of the case reports of opportunistic infections worldwide were invasive fungal infections.
Danish: Erfaringer efter markedsføring viser, at cirka halvdelen af alle indberetninger om opportunistiske infektioner på verdensplan var invasive svampeinfektioner.
English: There is no apparent pharmacokinetic difference between males and females.
Danish: Der er ingen klar farmakokinetisk forskel mellem mænd og kvinder.
English: The other cases represented a variety of different malignancies and included rare malignancies typically associated with immunosuppression.
Danish: De resterende tilfælde omfattede en række andre maligniteter, herunder sjældne maligniteter, der typisk bliver forbundet med immunsuppresion.
English: Do not attempt to administer an injection until you are sure that you understand how to use the MYCLIC pen properly.
Danish: Forsøg ikke at injicere før du er sikker på, at du er klar over, hvordan MYCLIC pennen bruges korrekt.
English: Reports have included fatal and life-threatening infections and sepsis.
Danish: Rapporterne har omfattet fatale og livstruende infektioner og sepsis.
English: • The pen should be used once only - it should never be re-used.
Danish: • Pennen er kun til engangsbrug - den må ALDRIG genbruges.
English: Both TNFRs exist naturally in membrane-bound and soluble forms.
Danish: Begge TNF-receptorer eksisterer naturligt i membranbundne og opløselige former.
English: Step 4: Disposing of the used MYCLIC pen
Danish: Trin 4: Bortskaffelse af den brugte MYCLIC pen
English: 1 Vial adaptor
Danish: 1 adapter
English: If you received LIFMIOR during pregnancy, your baby may have a higher risk of getting an infection.
Danish: Hvis du har taget LIFMIOR under graviditeten, kan dit spædbarn have en øget risiko for at få en infektion.
English: Gather the items that you will need for your injection, and place them on the chosen surface:
Danish: • Saml de ting du skal bruge til injektionen og læg dem på den valgte arbejdsflade:
English: The clinical impact of this is unknown, however, infants may be at increased risk of infection.
Danish: Den kliniske effekt af dette er ikke kendt, men spædbørnene kan have en øget risiko for infektioner.
English: Do not try to use the pen again, and do not try to use another pen without agreement from your nurse or pharmacist.
Danish: Lad være med at bruge pennen igen, og brug ikke en anden pen uden at aftale det med lægen, sygeplejersken eller apoteket.
English: • Once the solvent is added to the LIFMIOR, the plunger may move up by itself.
Danish: • Når solvensen er tilsat til LIFMIOR, kan stemplet bevæge sig opad af sig selv.
English: Always have the outer carton of the medicine with you, even if it is empty.
Danish: Medbring altid medicinæsken også selv om den er tom.
English: After discontinuation of LIFMIOR, symptoms of arthritis generally returned within a month.
Danish: Efter ophør med LIFMIOR vendte symptomerne på arthritis almindeligvis tilbage inden for en måned.
English: See the end of section 4 for how to report side effects.
Danish: Se sidst i afsnit 4, hvordan du indberetter bivirkninger.
English: Administration of LIFMIOR should be discontinued if a patient develops a serious infection.
Danish: Indgivelse af LIFMIOR skal ophøre, hvis en patient udvikler en alvorlig infektion.
English: The exposure-adjusted rate was 0.06 events per 100 patient-years.
Danish: Den eksponeringsjusterede hyppighed var 0,06 tilfælde per 100 patientår.
English: HAQ Baseline Week 52
Danish: HAQ Baseline Uge 52
English: No data are available on the secondary transmission of infection by live vaccines in patients receiving LIFMIOR.
Danish: Der er ingen data til rådighed om sekundær transmission af infektion via levende vacciner hos patienter, som får LIFMIOR.
English: Etanercept is slowly absorbed from the site of subcutaneous injection, reaching maximum concentration approximately 48 hours after a single dose.
Danish: Etanercept absorberes langsomt fra det sted, hvor den subkutane injektion foretages, og når op på den maksimale koncentration ca. 48 timer efter en enkelt dosis.
English: When you remove the needle cover, there may be a drop of liquid at the end of the needle; this is normal.
Danish: Når du trækker nålehætten af, kan der være en væskedråbe for enden af nålen; det er normalt.
English: Package leaflet: information for the user
Danish: Indlægsseddel: Information til brugeren
English: The types of major birth defects were consistent with those most commonly reported in the general population and no particular pattern of abnormalities was identified.
Danish: Typerne af de alvorlige medførte misdannelser svarede til dem, der hyppigst blev rapporteret i den almene befolkning, og der blev ikke fundet et bestemt mønster i abnormiteterne.
English: Worsening of hepatitis C
Danish: Forværring af hepatitis C
English: • Vaccinations: If possible, children should be up to date with all vaccinations before using LIFMIOR.
Danish: • Vaccinationer: Hvis det er muligt, skal børn være ajour med alle vaccinationer, før du får LIFMIOR.
English: Start again with another dose tray.
Danish: Begynd igen med en anden dosisbakke.
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLERE AF DET BIOLOGISK AKTIVE STOF OG FREMSTILLERE ANSVARLIGE FOR BATCHFRIGIVELSE
English: Starting from one of the top corners, pull back the paper cover from the top and sides of the tray.
Danish: Start ved et af de øverste hjørner og træk papiret væk fra toppen og siderne af bakken.
English: The recommended injection site is the middle of the front of the thighs.
Danish: • Det anbefalede injektionssted er foran midt på lårene.
English: It is important that you tell the baby's doctors and other healthcare professionals about the use of LIFMIOR during pregnancy before the baby receives any vaccine (for more information see section 2, “Vaccinations”).
Danish: Det er vigtigt, at du fortæller læger og andre sundhedspersoner, at du har taget LIFMIOR under graviditeten, inden dit spædbarn vaccineres (for mere information, se afsnit 2 ”Vaccinationer”).
English: Frequency Not Known (Cannot be Estimated from Available Data)
Danish: Ikke kendt (kan ikke estimeres ud fra forhåndenvær ende data)
English: You should consult your doctor if you become pregnant, think you may be pregnant, or are planning to have a baby.
Danish: Kontakt din læge, hvis du bliver gravid, har mistanke om, at du er gravid, eller planlægger at blive gravid.
English: Serious infections affect fewer than 1 in 100 patients treated with LIFMIOR.
Danish: Alvorlige infektioner påvirker færre end 1 ud af 100 patienter, der behandles med LIFMIOR.
English: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Danish: Da der ikke er foretaget forligelighedsstudier, må dette medicinske produkt ikke blandes med andre medicinske produkter.
English: There have been postmarketing reports of worsening of CHF, with and without identifiable precipitating factors, in patients taking LIFMIOR.
Danish: Der har været postmarketingrapporter om forværring af CHF, med og uden identificerbare fremskyndende faktorer hos patienter der tager LIFMIOR.
English: Rare ≥ 1/10,000 to
Danish: Sjælden ≥ 1/10.000 to
English: A biexponential curve is required to describe the concentration time curve of etanercept.
Danish: Der kræves en bieksponentiel kurve for at beskrive koncentrationstidskurven for etanercept.
English: Patients who develop a new infection while undergoing treatment with LIFMIOR should be monitored closely.
Danish: Patienter, som udvikler en ny infektion, mens de gennemgår behandling med LIFMIOR, bør overvåges nøje.
English: Improvements in health-related quality of life and physical function were also maintained through 2 years of therapy.
Danish: Forbedringer i helbredsrelaterede vurderinger af livskvalitet og fysisk funktion blev også opretholdt gennem 2 års behandling.
English: The modified TSS at 12 months is presented in the table below.
Danish: Den modificerede TSS ved 12 måneder vises i tabellen nedenfor.
English: The other ingredients in LIFMIOR are:
Danish: De andre indholdsstoffer i LIFMIOR er:
English: The solvent is a clear, colourless liquid.
Danish: Solvensen er en klar, farveløs væske.
English: ASAS 50 and 70 responses used the same criteria with a 50% improvement or a 70% improvement, respectively.
Danish: De samme responskriterier blev anvendt ved ASAS 50 og 70 med henholdsvis 50 % forbedring eller 70 % forbedring.
English: • Very rare (may affect up to 1 in 10,000 people): failure of the bone marrow to produce crucial blood cells.
Danish: • Meget sjælden (forekommer hos færre end 1 ud af 10.000 personer): Knoglemarvens manglende evne til at danne vigtige blodceller.
English: • Do not use the syringe if this perforation is already broken.
Danish: • Brug ikke sprøjten, hvis denne perforering allerede er brudt.
English: In evaluating patients for infections, the patient's risk for relevant opportunistic infections (e.g., exposure to endemic mycoses) should be considered.
Danish: Når patienterne bliver vurderet med hensyn til infektioner, bør patientens risiko for relevante opportunistiske infektioner (f.eks. eksponering for endemisk mykose) tages med i overvejelserne.
English: • To open the plastic container, hold the short, wide end in one hand.
Danish: • For at åbne plastikbeholderen holdes den korte, brede ende i én hånd.
English: • Once the seal has been broken, remove the short, wide end of the plastic container.
Danish: • Når forseglingen er brudt, fjernes den korte, brede ende af plastikbeholderen.
English: These patients should be monitored for signs and symptoms of active HBV infection throughout therapy and for several weeks following termination of therapy.
Danish: Disse patienter bør monitoreres for tegn og symptomer på aktiv HBV-infektion gennem hele behandlingsforløbet og i flere uger efter, at behandlingen er afsluttet.
English: Responses of Patients with Psoriasis in Studies 2, 3 and 4
Danish: RESPONS HOS PATIENTER MED PSORIASIS I STUDIE 2, 3 OG 4
English: Note - If you are unable to start the injection as described, press the pen more firmly against your skin, then press the green button again.
Danish: Bemærk: Hvis du ikke kan injicere som beskrevet, skal du presse pennen fastere mod huden og trykke på den grønne knap igen.
English: In some cases, particular fungal and other opportunistic infections have not been recognised, resulting in delay of appropriate treatment and sometimes death.
Danish: I visse tilfælde blev især svampe- og andre opportunistiske infektioner ikke diagnosticeret, hvilket resulterede i forsinket instituering af relevant behandling og i visse tilfælde død.
English: The 10 mg vial strength may be more appropriate for administration to children with JIA below the weight of 25 kg.
Danish: Hætteglasset med 10 mg kan være bedre egnet til administration til børn med JIA, der vejer mindre end 25 kg.
English: • Use a new alcohol swab to clean the grey stopper on the LIFMIOR vial.
Danish: • Brug en ny alkoholserviet til at rense den grå prop på LIFMIOR-hætteglasset.
English: Talk to your doctor before taking LIFMIOR.
Danish: Kontakt lægen, før du tager LIFMIOR.
English: LIFMIOR works by reducing the inflammation associated with certain diseases.
Danish: LIFMIOR virker ved at reducere inflammationen i forbindelse med visse sygdomme.
English: Similar results were obtained in the 2 smaller ankylosing spondylitis trials.
Danish: Lignende resultater blev opnået i de 2 mindre studier af ankyloserende spondylitis.
English: If this occurs, you should stop using LIFMIOR.
Danish: Hvis dette sker, skal du ophøre med at bruge LIFMIOR.
English: Patients should be evaluated for infections before, during, and after treatment with LIFMIOR, taking into consideration that the mean elimination half-life of etanercept is approximately 70 hours (range 7 to 300 hours).
Danish: Patienterne bør undersøges for infektioner før, under og efter behandling med LIFMIOR, under hensyntagen til at middeleliminationshalveringstiden for etanercept er ca. 70 timer (spændende fra 7 til 300 timer).
English: Each new injection should be given at least 3 cm from an old site.
Danish: Hver ny injektion skal gives mindst 3 cm fra et tidligere anvendt sted.
English: Patients with complete ankylosis of the spine were not included in the study.
Danish: Patienter med total spinal ankylose blev ikke inkluderet i studiet.
English: A total of 401 patients were enrolled, from which 203 were treated with LIFMIOR.
Danish: Ialt 401 patienter blev inkluderet, af hvilke 203 blev behandlet med LIFMIOR.
English: LIFMIOR contains no antibacterial preservative, and therefore solutions prepared with water for injections should be administered as soon as possible and within 6 hours following reconstitution.
Danish: LIFMIOR indeholder ikke noget antibakterielt konserveringsmiddel, og derfor skal injektionsvæsker, som er tilberedt med vand til injektionsvæsker, indgives så hurtigt som muligt og i løbet af seks timer efter rekonstitution.
English: Please read the instructions carefully, and follow them step by step.
Danish: Læs vejledningen grundigt, og følg den trin for trin.
English: The appropriate dose and frequency of dosing for the child or adolescent will depend on body weight and disease.
Danish: Den dosis og doseringshyppighed, der er passende til barnet eller den unge, vil variere afhængigt af barnets vægt og sygdom.
English: Concurrent treatment with anakinra
Danish: Samtidig behandling med anakinra
English: The incidence of non-cutaneous malignancies of various types was significantly higher in patients treated with LIFMIOR than in the control group.
Danish: Hyppigheden af ikke-kutane maligniteter af forskellig type var signifikant højere hos patienter behandlet med LIFMIOR end i kontrolgruppen.
English: Before starting treatment with LIFMIOR, all patients must be evaluated for both active and inactive (‘latent') tuberculosis.
Danish: Før behandling med LIFMIOR påbegyndes, skal alle patienter undersøges for både aktiv og inaktiv (latent) tuberkulose.
English: Hampshire, PO9 2NG United Kingdom
Danish: Hampshire, PO9 2NG Storbritannien
English: Do not use this medicine if you notice the solution is not clear or contains particles.
Danish: Brug ikke dette lægemiddel hvis du bemærker, at opløsningen ikke er klar eller indeholder partikler.
English: In this situation, the benefit/risk balance of LIFMIOR therapy should be very carefully considered.
Danish: I denne situation bør risk-benefit-forholdet ved behandlingen med LIFMIOR overvejes meget nøje.
English: The use of LIFMIOR is not expected to affect the ability to drive or use machines.
Danish: Anvendelse af LIFMIOR forventes ikke at påvirke evnen til at køre bil eller betjene maskiner.
English: Clearance is approximately 0.066 l/hr in patients with rheumatoid arthritis, somewhat lower than the value of 0.11 l/hr observed in healthy volunteers.
Danish: Clearance er ca. 0,066 l/t hos patienter med reumatoid artrit, hvilket er noget lavere end værdien på 0,11 l/t, som blev observeret hos sunde frivillige.
English: Some vaccines, such as oral polio vaccine, should not be given while using LIFMIOR.
Danish: Nogle vacciner, som for eksempel oral poliovaccine, må ikke gives, mens man får LIFMIOR.
English: • The needle will remain in the long part of the package.
Danish: • Kanylen bliver siddende i den lange del af pakningen.
English: There have been rare reports of lupus, lupus-related conditions, and vasculitis.
Danish: Der har været sjældne rapporter om lupus, lupus-relaterede sygdomme og vaskulitis.
English: • Inspect the expiry dates on both the vial label and the syringe label.
Danish: • Kontroller udløbsdatoen på både glassets og sprøjtens mærkat.
English: The effect of LIFMIOR on radiographic progression was maintained in patients who continued on treatment during the second year.
Danish: LIFMIORs effekt på den røntgenologiske progression blev fastholdt hos de patienter, som fortsatte med behandling i løbet af det andet år.
English: If you notice any of the following, the child may need urgent medical attention.
Danish: Hvis du bemærker noget af følgende, kan barnet have brug for omgående lægehjælp.