FrancophonIA/ELRC3.0 huggingface dataset:
English: • Sandoz staff will be trained on the correct use of Erelzi in order to support HCPs in case of questions
Danish: • Sandoz-personale vil blive trænet i korrekt brug af Erelzi for at kunne yde support til sundhedspersoner i tilfælde af spørgsmål.
English: Do not use Erelzi
Danish: Brug ikke Erelzi
English: Treatment with etanercept should continue until remission is achieved, for up to 24 weeks.
Danish: Behandlingen med etanercept bør fortsættes indtil remission er nået, i op til 24 uger.
English: • Your doctor will also give you a Patient Alert Card, which contains important safety information that you need to be aware of before and during treatment with Erelzi.
Danish: • Din læge vil give dig et 'Patientkort', som indeholder vigtig sikkerhedsinformation, som du skal være opmærksom på, før og under behandlingen med Erelzi.
English: common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data).
Danish: De følgende kategorier benyttes: meget almindelig (≥1/10); almindelig (≥1/100 til <1/10); ikke almindelig (≥1/1.000 til <1/100); sjælden (≥1/10.000 til <1/1.000); meget sjælden (<1/10.000); ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: This indicates the injection is almost complete.
Danish: Det markerer, at indsprøjtningen næsten er afsluttet.
English: The following list of adverse reactions is based on experience from clinical trials in adults and on post-marketing experience.
Danish: Følgende liste over bivirkninger er baseret på erfaringer fra kliniske forsøg på voksne og på postmarketing erfaring.
English: Simulation of dosing suggests that while older children (1017 years of age) will have serum levels close to those seen in adults, younger children will have appreciably lower levels.
Danish: Dosissimulering antyder, at mens ældre børn (10-17 år gamle) vil have serumniveauer tæt på dem, der ses hos voksne, vil yngre børn have væsentligt lavere niveauer.
English: • Keep holding the pen firmly against your skin.
Danish: • Bliv ved med at holde pennen fast ind mod din hud.
English: It is important not to try to inject yourself until you have been trained by your doctor, nurse or pharmacist.
Danish: Det er vigtigt, at du ikke forsøger at klare indsprøjtningen selv, før du er blevet undervist i at gøre det af din læge, sygeplejersken eller apotekspersonalet.
English: If you received Erelzi during pregnancy, your baby may have a higher risk of getting an infection.
Danish: Hvis du har taget Erelzi under graviditeten, kan dit spædbarn have en øget risiko for at få en infektion.
English: If you have used more Erelzi 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 Erelzi, 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: • Very rare (may affect up to 1 in 10,000 people): Failure of the bone marrow to produce crucial blood cells.
Danish: • Meget sjælden (kan forekomme hos op til 1 ud af 10.000 personer): Knoglemarvens manglende evne til at danne vigtige blodceller.
English: • Brief introduction to the aim of the Patient Alert Card
Danish: • Kort introduktion til formålet med patientinformationskortet
English: If this occurs, you should stop using Erelzi.
Danish: Hvis dette sker, skal du ophøre med at bruge Erelzi.
English: • Vaccinations: If possible, children should be up to date with all vaccinations before using Erelzi.
Danish: • Vaccinationer: Hvis det er muligt, skal børn være ajour med alle vaccinationer, før du får Erelzi.
English: Mean (SE) annualized change from baseline in total sharp score
Danish: MIDDEL (SE) ÆNDRING FRA BASELINE I TOTAL SHARP SCORE PÅ ÅRSBASIS
English: By touching them, the needle guard may be activated too early.
Danish: Rører du ved dem, kan de måske blive aktiveret for tidligt.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Danish: • når risikostyringssystemet ændres, særlig som følge af at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i benefit/risk-forholdet, eller som følge af at en vigtig milepæl (lægemiddelovervågning eller risikominimering) er nået.
English: Talk to your doctor before taking Erelzi.
Danish: Kontakt lægen, før du tager Erelzi.
English: • Request to ask the doctor to record test, date and results of last TB screening on the alert card
Danish: • Anmodning om at bede lægen om at registrere testen, datoen og resultaterne af den seneste TB-screening på informationskortet
English: Caregivers and healthcare professionals only:
Danish: Kun for omsorgspersoner og sygeplejersker:
English: DO NOT USE
Danish: MÅ IKKE BRUGES
English: • Check the green indicator fills the window and has stopped moving.
Danish: • Kontroller, at den grønne indikator fylder vinduet og er stoppet med at bevæge sig.
English: A total of 401 patients were enrolled, from which 203 were treated with etanercept.
Danish: Ialt 401 patienter blev inkluderet, af hvilke 203 blev behandlet med etanercept.
English: • The recommended site is the front of your thighs.
Danish: • Det anbefalede sted er forsiden af dine lår.
English: Administration of Erelzi should be discontinued if a patient develops a serious infection.
Danish: Indgivelse af Erelzi skal ophøre, hvis en patient udvikler en alvorlig infektion.
English: Other etanercept products with appropriate dosage forms for children are available.
Danish: Der er andre etanercept-præparater tilgængelige, med passende doseringsformer til børn.
English: You or the child should not use Erelzi with medicines that contain the active substance anakinra or abatacept.
Danish: Du eller barnet bør ikke bruge Erelzi sammen med medicin, som indeholder de aktive stoffer anakinra eller abatacept.
English: Before starting treatment with Erelzi, all patients must be evaluated for both active and inactive (‘latent') tuberculosis.
Danish: Før behandling med Erelzi påbegyndes, skal alle patienter undersøges for både aktiv og inaktiv (latent) tuberkulose.
English: The central volume of distribution of etanercept is 7.6 l, while the volume of distribution at steady-state is 10.4 l. Elimination
Danish: Den centrale distributionsvolumen for etanercept er 7,6 l, mens distributionsvolumen ved steady-state er 10,4 l.
English: This card provides important safety information for patients, including information relating to infections and to worsening of congestive heart failure related to Erelzi.
Danish: Dette kort giver vigtige sikkerhedsoplysninger til patienter, herunder oplysninger vedrørende infektioner og forværring af hjerteinsufficiens, der er relateret til Erelzi.
English: The results of this controlled trial were expressed in percentage improvement in rheumatoid arthritis using American College of Rheumatology (ACR) response criteria.
Danish: Resultaterne af dette kontrollerede forsøg blev angivet i procentvis forbedring af reumatoid artrit ved anvendelse af American College of Rheumatology's (ACR) kriterier for respons.
English: • Use the pen within 5 minutes of removing the cap.
Danish: • Du skal bruge pennen inden for 5 minutter, efter du har fjernet hætten.
English: An educational program is developed in order to assist in training and educating HCPs for proper use of Erelzi:
Danish: Der udarbejdes et uddannelsesprogram for at hjælpe med træning og uddannelse af sundehdspersoner i korrekt brug af Erelzi:
English: Frequency Not Known (Cannot be Estimated from Available Data)
Danish: Ikke kendt (kan ikke estimeres ud fra forhåndenværen de data)
English: It is recommended that paediatric patients, if possible, be brought up to date with all immunisations in agreement with current immunisation guidelines prior to initiating Erelzi therapy (see Vaccinations, above).
Danish: Det anbefales, at pædiatriske patienter om muligt bringes à jour med al immunisering i overensstemmelse med gældende retningslinjer for immunisering, før behandling med Erelzi påbegyndes (se Vaccinationer ovenfor).
English: It is important that you tell the baby's doctors and other healthcare professionals about the use of Erelzi 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 Erelzi under graviditeten, inden dit spædbarn vaccineres (for mere information, se afsnit 2 ”Vaccinationer”).
English: In post-marketing 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: Erelzi is a medicine that is made from two human proteins.
Danish: Erelzi er et lægemiddel fremstillet af to proteiner, som findes naturligt hos mennesker.
English: After discontinuation of etanercept, symptoms of arthritis generally returned within a month.
Danish: Efter ophør med etanercept vendte symptomerne på arthritis almindeligvis tilbage inden for en måned.
English: In order to minimize the risk for the most critical side effects “infection” and “worsening of congestive heart failure” of Erelzi, a Patient Alert Card has been developed.
Danish: For at minimere risikoen for de mest kritiske bivirkninger af Erelzi, “infektion” og “forværring af hjerteinsufficiens”, er der blevet udformet et patientinformationskort.
English: A-6336 Langkampfen AUSTRIA
Danish: A-6336 Langkampfen Østrig
English: • There may be a small amount of blood at the injection site.
Danish: • Der kan være en lille smule blod på indsprøjtningsstedet.
English: Do not use the pen if the expiry date has passed.
Danish: Brug ikke pennen, hvis udløbsdatoen er overskredet.
English: If you feel that the effect of Erelzi is too strong or too weak, talk to your doctor or pharmacist.
Danish: Hvis du føler, at virkningen af Erelzi er for stærk eller for svag, skal du kontakte din læge eller apotek.
English: Two large clinical trials evaluating the use of etanercept in the treatment of CHF were terminated early due to lack of efficacy.
Danish: To store kliniske forsøg, der evaluerede brugen af etanercept i behandlingen af CHF, blev afsluttet før tiden på grund af manglende effektivitet.
English: • Press the pen firmly against the skin to start the injection.
Danish: • Pres pennen fast ind mod huden for at begynde indsprøjtningen.
English: Do not use this medicine if the seal of the blister is broken, as it may not be safe for you to use.
Danish: Du må ikke bruge lægemidlet, hvis forseglingen på blisterpakningen er brudt, da det så måske ikke er sikkert for dig at bruge.
English: The specific activity of etanercept is 1.7 x 106 units/mg.
Danish: Etanercepts specifikke aktivitet er 1,7 x 106 enheder/mg.
English: Some vaccines, such as oral polio vaccine, should not be given while using Erelzi.
Danish: Nogle vacciner, som for eksempel oral poliovaccine, må ikke gives, mens man får Erelzi.
English: Patients who develop a new infection while undergoing treatment with Erelzi should be monitored closely.
Danish: Patienter, som udvikler en ny infektion, mens de gennemgår behandling med Erelzi, bør overvåges nøje.
English: The combination etanercept and anakinra has not demonstrated increased clinical benefit, and is therefore not recommended.
Danish: Kombinationen af etanercept og anakinra har ikke vist øgede kliniske fordele og anbefales derfor ikke.
English: In this situation, the benefit/risk balance of Erelzi therapy should be very carefully considered.
Danish: I denne situation bør risk-benefit-forholdet ved behandlingen med Erelzi overvejes meget nøje.
English: Etanercept treatment may increase mortality in patients with established sepsis.
Danish: Etanerceptbehandling kan forøge dødeligheden hos patienter med etableret sepsis.
English: It is recommended that you record the date that Erelzi is removed from the refrigerator and the date after which Erelzi should be discarded (no more than 4 weeks following the removal from the refrigerator).
Danish: Det anbefales, at du noterer den dato, hvor Erelzi tages ud af køleskabet, og den dato, hvor Erelzi skal kasseres (højst 4 uger efter, at det er taget ud af køleskabet).
English: • if you, or the child you are caring for, are allergic to etanercept or any of the other ingredients of Erelzi (listed in section 6).
Danish: • hvis du eller dit barn, er allergiske over for etanercept eller et af de øvrige indholdsstoffer i Erelzi (angivet i afsnit 6).
English: Although not conclusive, data from one of these trials suggest a possible tendency toward worsening CHF in those patients assigned to etanercept treatment.
Danish: Selvom de ikke er endelige, antyder data fra ét af disse forsøg en mulig tendens til forværret CHF hos de patienter, der var anvist til etanerceptbehandling.
English: • Request to keep the Patient Alert Card during and after treatment
Danish: • Anmodning om at opbevare patientinformationskortet under og efter behandling
English: Because immunoglobulins, in common with many medicinal products, can be excreted in human milk, a decision must be made whether to discontinue breast-feeding or to discontinue Erelzi therapy, taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Danish: Da immunglobuliner lige som mange andre lægemidler kan udskilles i human mælk, skal der tages en beslutning om, hvorvidt amning skal ophøre, eller brugen af Erelzi skal ophøre under amning, idet fordelen ved amning for barnet og fordelen ved behandlingen af kvinden tages i betragtning.
English: The use of Erelzi is not expected to affect the ability to drive or use machines.
Danish: Anvendelse af Erelzi forventes ikke at påvirke evnen til at køre bil eller betjene maskiner.
English: Contact your pharmacist if the pen fails any of these checks.
Danish: Kontakt dit apotek, hvis pennen ikke opfylder en eller flere af disse sikkerhedstjek.
English: Such symptoms may point to the existence of potentially life-threatening blood disorders, which may require discontinuation of Erelzi.
Danish: Sådanne symptomer kan pege på tilstedeværelsen af en livstruende blodsygdom, som kan kræve, at behandling med Erelzi ophører.
English: For the safety and health of you and others, needles and used syringes must never be re-used.
Danish: For din egen og andres sikkerhed må kanyler og brugte sprøjter aldrig genbruges.
English: The safety and efficacy profiles of the two etanercept treatment regimens were comparable at week 8 in their effect on signs and symptoms of RA; data at week 16 did not show comparability (non-inferiority) between the two regimens.
Danish: Sikkerheds- og effektprofilerne af de to etanercept behandlingsformer var sammenlignelige ved uge 8 med hensyn til effekten på tegn og symptomer ved reumatoid artrit; data fra uge 16 viste ikke sammenlignelighed (non-inferiority) mellem de to behandlingsformer.
English: Taking into account the PRAC Assessment Report on the PSUR(s) for etanercept (biosimilars), the scientific conclusions of CHMP are as follows:
Danish: Under hensyntagen til PRAC's vurderingsrapport om PSUR'en/PSUR'erne for etanercept (biosimilært lægemiddel) er CHMP nået frem til følgende videnskabelige konklusioner:
English: During the withdrawal period, symptoms of psoriasis gradually returned, with a median time to disease relapse of 3 months.
Danish: I den behandlingsfrie periode vendte symptomerne på psoriasis gradvist tilbage med en mediantid til sygdoms relapse på 3 måneder.
English: There have been post-marketing reports of worsening of CHF, with and without identifiable precipitating factors, in patients taking etanercept.
Danish: Der har været postmarketingrapporter om forværring af CHF, med og uden identificerbare fremskyndende faktorer hos patienter der tager etanercept.
English: If an alternate dose is required, other etanercept products offering such an option should be used.
Danish: Hvis der er behov for en anden dosis, bør der anvendes andre etanercept-præparater, der giver sådanne muligheder.
English: INSTRUCTIONS ON USE ‘QR code to be included' + www.erelzi.eu 16.
Danish: INSTRUKTIONER VEDRØRENDE ANVENDELSEN ‘QR-kode skal indsættes' + www.erelzi.eu 16.
English: • Request to ask the doctor to list other medications that may increase the risk of infection on the alert card
Danish: • Anmodning om at bede lægen angive andre lægemidler, der kan øge risikoen for infektion, på informationskortet
English: The same information is also available on www.erelzi.eu and through the code below.
Danish: Den samme information kan også ses på www.erelzi.eu og via den nedenstående kode.
English: • A needle-free AI device for demonstration will be available for patient practice use.
Danish: • Et autoinjektor-device uden kanyle til demonstration vil være tilgængelig til træningsbrug for patienterne.
English: In placebo-controlled trials, no increase in the incidence of serious infections (fatal, life-threatening, or requiring hospitalisation or intravenous antibiotics) was observed.
Danish: I placebo-kontrollerede forsøg blev der ikke observeret nogen stigning i forekomsten af alvorlige infektioner (dødelige, livstruende, eller som kræver hospitalsindlæggelse eller intravenøs antibiotikabehandling).
English: The known side effects of Erelzi include the following in groups of decreasing frequency:
Danish: Nedenstående bivirkninger for Erelzi er inddelt i grupper efter faldende frekvens.
English: Several seconds later a 2nd click will indicate that the injection is almost finished.
Danish: Flere sekunder senere lyder det andet klik, der markerer, at indsprøjtningen næsten er afsluttet.
English: The educational material is intended to prevent or reduce potential medication errors related to improper use of Erelzi prefilled-pen (autoinjector (AI):
Danish: Uddannelsesmaterialet er beregnet til at forebygge eller reducere potentielle medicineringsfejl, der er relateret til forkert brug af Erelzi fyldt pen (autoinjektor):
English: • Request to show the Patient Alert Card to any treating doctor
Danish: • Anmodning om at vise patientinformationskortet til enhver behandlende læge
English: Do not use if the safety seal has been broken.
Danish: Må ikke bruges, hvis sikkerhedsforseglingen er brudt.
English: Erelzi contains sodium
Danish: Erelzi indeholder natrium
English: This device will be provided to HCPs to support (self-) injection training and is intended to be used and trained in the HCP office or during a home care program
Danish: Dette device vil blive stillet til rådighed for sundhedspersoner for at understøtte (selv-)injektionstræning, og er beregnet til anvendelse og træning på lægeklinikken eller under et hjemmeplejeprogram
English: The injection site is the place on the body where you are going to use the pre-filled syringe.
Danish: Indsprøjtningsstedet er det sted på kroppen, hvor du vil bruge den fyldte injektionssprøjte.
English: Patients also had plaque psoriasis with a qualifying target lesion ≥ 2 cm in diameter.
Danish: Patienterne havde også plaque psoriasis med et læsionsmål på ≥ 2 cm i diameter.
English: The long-term safety of etanercept in combination with other disease-modifying antirheumatic drugs (DMARD) has not been established.
Danish: Sikkerheden på lang sigt ved etanercept-behandling i kombination med andre sygdomsmodificerende antireumatiske lægemidler (DMARDs) er ikke fastslået.
English: Rare ≥ 1/10,000 to
Danish: Sjælden ≥ 1/10.000 til
English: Be careful not to touch the needle guard wings before use.
Danish: Vær omhyggelig med ikke at røre ved aktiveringsklipsene før brug.
English: • Do not use the pen if it has been dropped with the cap removed.
Danish: • Pennen må ikke anvendes, hvis den har været tabt med hætten fjernet.
English: Name and address of the manufacturer(s) of the biological active substance(s)
Danish: Navn og adresse på fremstilleren (fremstillerne) af det biologisk aktive stof(fer)
English: A dose response was seen; results with 10 mg were intermediate between placebo and 25 mg. Etanercept was significantly better than placebo in all components of the ACR criteria, as well as other measures of rheumatoid arthritis disease activity not included in the ACR response criteria, such as morning stiffness.
Danish: Man så en dosisrespons: resultater med 10 mg lå mellem placebo og 25 mg. Etanercept var betydeligt bedre end placebo i alle dele af ACR-kriterierne såvel som andre mål for sygdomsaktiviteten af reumatoid artrit, der ikke er medtaget i ACR-responskriterierne, som f.eks. morgenstivhed.
English: Etanercept was significantly better than placebo in all measures of disease activity (p < 0.001), and responses were similar with and without concomitant methotrexate therapy.
Danish: Etanercept var signifikant bedre end placebo på alle mål for sygdomsaktivitet (p< 0,001), og responset var det samme med og uden samtidig methotrexat-behandling.
English: Erelzi can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.
Danish: Erelzi kan gives som monoterapi i tilfælde af intolerance over for methotrexat, eller hvis fortsat behandling med methotrexat er uhensigtsmæssig.
English: Do not mix the Erelzi solution with any other medicine.
Danish: Bland ikke Erelzi-opløsningen med andre lægemidler.
English: After a single subcutaneous dose of 25 mg etanercept, the average maximum serum concentration observed in healthy volunteers was 1.65 ± 0.66 µg/ml, and the area under the curve was 235 ± 96.6 µg•hr/ml.
Danish: Efter en enkelt subkutan dosis med 25 mg etanercept, var den gennemsnitlige maksimale serumkoncentration, som blev observeret hos sunde frivillige, 1,65 ± 0,66 µg/ml, og arealet under kurven var 235 ± 96,6 µg•t/ml.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 50 mg / 1.0 ml
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ENHEDER 50 mg / 1,0 ml
English: Patients were observed off treatment for the occurrence of rebound (PASI ≥ 150% of baseline) and for the time to relapse (defined as a loss of at least half of the improvement achieved between baseline and week 24).
Danish: Patienterne blev observeret uden behandling for at se forekomsten af rebound (PASI ≥ 150 % i forhold til baseline) og se tiden til relapse (defineret som tab af mindst halvdelen af forbedringen opnået mellem baseline og uge 24).
English: Children and adults taking Erelzi may have an increased risk of developing lymphoma or another cancer.
Danish: Børn og voksne, som får Erelzi, kan have øget risiko for at udvikle kræft i lymfesystemet eller andre former for kræft.
English: If you have any questions, please talk to a doctor, nurse or pharmacist who is familiar with Erelzi.
Danish: Hvis du har spørgsmål, bedes du kontakte lægen, sygeplejersken eller apotekspersonalet, som har erfaring med Erelzi.
English: However, the occurrence was rare, and the follow-up period of placebo patients was shorter than for patients receiving TNF-antagonist therapy.
Danish: Forekomsten var dog sjælden, og opfølgningstiden for placebopatienter var kortere end for patienter, der fik TNF-antagonistbehandling.
English: Erelzi is not recommended for the treatment of Wegener's granulomatosis.
Danish: Erelzi anbefales ikke til behandling af Wegeners granulomatose.
English: Stevens-Johnson syndrome, cutaneous vasculitis (including hypersensitivity vasculitis), erythema multiforme, lichenoid reactions
Danish: Stevens-Johnson syndrom, kutan vaskulitis (inklusive overfølsomhed, vaskulitis), erythema multiforme, lichenoide reaktioner
English: Solid and haematopoietic malignancies (excluding skin cancers)
Danish: Solide og hæmatopoietiske maligniteter (eksklusive hudkræft)