FrancophonIA/ELRC3.0 huggingface dataset:
English: The elimination of serum romiplostim is in part dependent on the TPO receptor on platelets.
Danish: Elimineringen af romiplostim i serum afhænger delvist af TPO-receptoren på trombocytterne.
English: • Take the Nplate self injection kit out of the refrigerator.
Danish: • Tag selvinjektionssættet til Nplate ud af køleskabet.
English: Patients eligible for self-administration of Nplate should be trained in these procedures.
Danish: Patienter, der er egnede til selv at indgive Nplate, skal undervises i disse procedurer.
English: All subjects were negative for neutralising activity to TPO.
Danish: Alle forsøgspersoner var negative for neutraliserende aktivitet over for TPO.
English: After suitable training, your doctor may also allow you to inject Nplate yourself.
Danish: Efter passende oplæring vil Deres læge muligvis også give Dem lov til selv at injicere Nplate.
English: Both subjects tested negative for neutralising antibodies to romiplostim at 4 months after the end of dosing.
Danish: Begge forsøgspersoner blev testet negative for neutraliserende antistoffer mod romiplostim 4 måneder efter sidste dosis.
English: The composite bleeding episode was defined as clinically significant bleeding events or the use of a rescue medication to prevent a clinical significant bleeding event during weeks 2 through 25 of the treatment period.
Danish: Den kombinerede blødningshændelse blev defineret som klinisk signifikante blødningshændelser eller brug af "rescue"-lægemiddel for at forhindre en klinisk signifikant blødningshændelse i løbet af uge 2 til 25 i behandlingsperioden.
English: The safety and efficacy of romiplostim in children under the age of one year has not been established.
Danish: Romiplostims sikkerhed og virkning hos børn under 1 år er endnu ikke klarlagt.
English: In the placebo group, 0% to 7% of patients were able achieve a platelet count response during the 6 months of treatment.
Danish: I placebogruppen opnåede 0 % til 7 % af patienterne en trombocytrespons i løbet af den 6 måneder lange behandlingsperiode.
English: Any excess dissolved Nplate must be thrown away immediately after completing the injection process.
Danish: Opløst Nplate, der er tilovers, skal kasseres straks, efter at proceduren med injektion er overstået.
English: Check the expiry date on the self injection kit.
Danish: Kontrollér udløbsdatoen på selvinjektionssættet.
English: Multiple myeloma Myelofibrosis
Danish: Myelomatose Myelofibrose
English: Additionally, 2.5% (7/282) developed neutralising antibodies to romiplostim.
Danish: Derudover udviklede 2,5 % (7/282) neutraliserende antistoffer mod romiplostim.
English: Your initial dose is 1 microgram of Nplate per kilogram of your body weight once a week.
Danish: Deres startdosis er 1 mikrogram Nplate pr. kilogram legemsvægt én gang om ugen.
English: In both studies, efficacy was determined by an increase in the proportion of patients who achieved a durable platelet response.
Danish: I begge undersøgelser blev virkningen bestemt ud fra stigningen i andelen af patienter med en varig trombocyt-respons.
English: Pharmacokinetic data of romiplostim were collected from two studies in 21 paediatric subjects with ITP.
Danish: Der blev indsamlet farmakokinetiske data for romiplostim fra to undersøgelser med 21 pædiatriske patienter med ITP.
English: 9/L for at least 4 weeks without dose adjustment may, at the discretion of the supervising physician, self-administer Nplate solution for injection.
Danish: 9/l i mindst 4 uger uden dosisjustering kan, efter den inspicerende læges skøn, selv indgive Nplate injektionsvækse, opløsning.
English: Of the 271 patients who received romiplostim in ITP clinical trials, 55 (20%) were age 65 and over, and 27 (10%) were 75 and over.
Danish: Af de 271 patienter, som fik romiplostim i de kliniske forsøg vedrørende ITP, var 55 (20 %) 65 år eller derover, og 27 (10 %) var 75 år eller derover.
English: Study S1 (212) evaluated patients who were non-splenectomised and had an inadequate response or were intolerant to prior therapies.
Danish: I undersøgelse S1 (212) indgik ikke-splenektomerede patienter, som havde en utilfredsstillende respons på tidligere behandlinger, eller som var intolerante mod tidligere behandlinger.
English: If you have very high blood platelet counts this may increase the risk of blood clotting.
Danish: Hvis De har et meget højt blodpladetal, kan dette øge risikoen for blodpropper.
English: It is recommended that, if treatment with romiplostim is discontinued, ITP treatment be restarted according to current treatment guidelines.
Danish: Ved seponering af behandling med romiplostim tilrådes det, at ITP-behandlingen genoptages i henhold til de aktuelle retningslinjer for behandling.
English: Therefore, examinations for cellular morphological abnormalities using peripheral blood smear and complete blood count (CBC) prior to and during treatment with romiplostim are recommended.
Danish: Undersøgelser af cellulære morfologiske abnormiteter ved brug af perifere blodudstrygninger og et fuldstændigt blodbillede (CBC, Complete blood count) tilrådes derfor før og under behandling med romiplostim.
English: Romiplostim is an Fc-peptide fusion protein (peptibody) that signals and activates intracellular transcriptional pathways via the TPO receptor (also known as cMpl) to increase platelet production.
Danish: Romiplostim er et Fc-peptid-fusionsprotein (peptibody), som signalerer og aktiverer intracellulære transkriptionsveje via TPO-receptoren (også betegnet cMpl) til at øge trombocytproduktion.
English: 9/L in the absence of rescue medication) was 93.8% (n = 61) and was similar across age groups.
Danish: 9/l og fravær af "rescue"-lægemiddel) på 93,8 % (n = 61), og forekomsten var ens på tværs af aldersgrupperne.
English: If you stop using Nplate
Danish: Hvis De holder op med at bruge Nplate
English: These instructions are for patients who are already trained by their healthcare professional, such as your doctor, nurse, or pharmacist, in self injection.
Danish: Disse instruktioner er beregnet til patienter, der af sundhedspersonale (for eksempel lægen, en sygeplejerske eller apotekspersonale) allerede har fået undervisning i selvinjektion af Nplate.
English: The HAT pack includes materials for HCPs on how to select and train patients for self-administration of romiplostim; and for patients, in order to help them with the process of preparation and self-administration of the correct dose of romiplostim.
Danish: HAT-pakken indeholder materialer til sundhedspersonalet med information om udvælgelse og undervisning af patienterne i selvadministration af romiplostim og til patienterne som en hjælp til processen med klargøring og selvadministration af den korrekte dosis romiplostim.
English: In the paediatric studies, 282 paediatric ITP subjects were treated with romiplostim in 2 controlled and 3 uncontrolled clinical trials.
Danish: I de pædiatriske undersøgelser blev 282 pædiatriske ITP-patienter behandlet med romiplostim i to kontrollerede og tre ikke-kontrollerede kliniske forsøg.
English: Treatment with romiplostim should be discontinued if the platelet count does not increase to a level sufficient to avoid clinically important bleeding after four weeks of romiplostim therapy at the highest weekly dose of 10 mcg/kg.
Danish: Behandlingen med romiplostim bør seponeres, hvis trombocyttallet ikke stiger til et niveau, der er tilstrækkeligt til at undgå klinisk betydende blødning efter 4 ugers behandling med romiplostim ved den højeste ugentlige dosis på 10 mikrog/kg.
English: If you are also taking medicines which prevent blood clots (anticoagulants or antiplatelet therapy) there is a greater risk of bleeding.
Danish: Hvis De også tager lægemidler til forebyggelse af blodpropper (behandling med koagulationshæmmende eller blodpladefunktionshæmmende midler), er der større risiko for blødning.
English: Of the 157 subjects randomised to the romiplostim group, three subjects did not receive romiplostim.
Danish: 3 ud af de 157 patienter, der var randomiseret til romiplostim-gruppen, fik ikke romiplostim.
English: Note: This may take up to 2 minutes for the powder to completely dissolve.
Danish: Bemærk: Det kan tage op til 2 minutter, før pulveret er opløst helt.
English: Body temperature increased Weight decreased Weight increased
Danish: Forhøjet legemstemperatur Nedsat vægt
English: • Push the vial adapter down onto the vial until it is firmly in place and you can't push down any more.
Danish: • Skub hætteglasadapteren ned på hætteglasset, indtil den sidder godt fast, og den ikke kan skubbes længere ned.
English: Nplate is not recommended for use in children aged under 1 year.
Danish: Nplate anbefales ikke til brug til børn under 1 år.
English: • pain in your hands and feet;
Danish: • smerter i hænder og fødder,
English: Following the first 4-weeks of study romiplostim maintained platelet counts ≥ 50 x 10
Danish: Efter de første 4 uger af undersøgelsen opretholdt romiplostim trombocyttal ≥ 50 x 10
English: Alterations in red (decrease) and white (increase) blood cell parameters have been observed in non-clinical toxicology studies (rat and monkey) as well as in ITP patients.
Danish: Ændringer i parametre for røde (et fald) og hvide (en stigning) blodlegemer er observeret i ikke-kliniske toksikologistudier (rotter og aber) og hos ITP-patienter.
English: Study S4 (279) was a phase 3 study with 24 weeks of romiplostim treatment and study S5 (195) was a phase 1/2 study with 12 weeks of romiplostim treatment (up to 16 weeks for eligible responders who enter a 4-week pharmacokinetic assessment period).
Danish: Undersøgelse S4 (279) var en fase III-undersøgelse med 24 ugers behandling med romiplostim, og undersøgelse S5 (195) var en fase I/II-undersøgelse med 12 ugers behandling med romiplostim (op til 16 uger for egnede respondenter, som indgik i en 4-ugers farmakokinetisk vurderingsperiode).
English: Once your platelet count is under control, your doctor will continue to regularly check your blood.
Danish: Efter Deres blodpladetal er kommet under kontrol, fortsætter lægen med at kontrollere Deres blod regelmæssigt.
English: Dermatitis contact Dry skin
Danish: Kontaktdermatitis Tør hud
English: Possible side effects in adults with ITP
Danish: Bivirkninger hos voksne med ITP
English: Hypersensitivity** Angioedema
Danish: Overfølsomhed** Angioødem
English: Of the 66 subjects enrolled in the study, 63 subjects had ITP > 12 months of duration.
Danish: Af de 66 forsøgspersoner, som var optaget i undersøgelsen, havde 63 personer haft ITP i > 12 måneder.
English: • Visually confirm that the needle tip is covered.
Danish: • Kontrollér visuelt, at kanylespidsen er dækket.
English: Results from pivotal placebo-controlled studies
Danish: Resultater fra pivotale placebokontrollerede undersøgelser
English: If needed, you may cover the injection site with a plaster.
Danish: Om nødvendigt kan De sætte et plaster på injektionsstedet.
English: • Do a final check to ensure the correct amount of liquid for your dose is in the syringe and all air bubbles have been removed.
Danish: • Udfør en sidste kontrol for at sikre, at den korrekte mængde væske til den ordinerede dosis er i sprøjten, og alle luftbobler er fjernet.
English: • The clear plastic plunger rod MUST always be attached first before breaking the white tip off of the pre-filled water syringe.
Danish: • Den gennemsigtige stempelstang af plast SKAL altid sættes på først, inden den hvide spids brækkes af den fyldte sprøjte med sterilt vand.
English: e Stable dose defined as dose maintained within ± 1 mcg/kg during the last 8 weeks of treatment.
Danish: Stabil dosis defineres som dosis uforandret inden for ± 1 mikrog/kg i de sidste 8 uger med behandling.
English: If you stop taking Nplate your platelet count will have to be monitored, and your doctor will discuss appropriate precautions with you.
Danish: Hvis De ophører med at få Nplate, skal Deres blodpladetal overvåges, og Deres læge vil drøfte passende forsigtighedsregler med Dem.
English: A total of 3.2% (9/282) subjects had binding antibodies to TPO at any time during romiplostim treatment.
Danish: I alt 3,2 % (9/282) af forsøgspersonerne havde bindende antistoffer mod TPO til enhver tid under behandling med romiplostim.
English: No statistically significant differences in the overall incidence of bleeding events were observed between Nplate and placebo treated patients.
Danish: Der blev ikke observeret nogen statistisk signifikante forskelle i den samlede forekomst af blødningshændelser mellem Nplate-behandlede og placebo-behandlede patienter.
English: Nplate is supplied as a 1 pack or multipack comprising 4 packs.
Danish: Nplate leveres som en pakning med 1 stk. eller en multipakke bestående af 4 pakninger.
English: Mannitol (E421)
Danish: Mannitol (E421) Saccharose
English: Cases of thromboembolic events (TEEs), including portal vein thrombosis, have been reported in patients with chronic liver disease receiving romiplostim.
Danish: Tilfælde af tromboemboliske hændelser (TEE'er), herunder portal venetrombose, er rapporteret hos patienter med kronisk leversygdom, som får romiplostim.
English: Thrombocytosis in paediatric subjects occurred uncommonly (≥ 1/1,000 to < 1/100), with a subject incidence of 1 (0.4%).
Danish: Trombocytose hos pædiatriske forsøgspersoner forekom ikke almindeligvis (≥ 1/1.000 til < 1/100) med en incidensrate på 1 (0,4 %).
English: Patients requiring rescue medicinal products were not considered for durable platelet response.
Danish: Patienter, som har behov for ”rescue”-lægemidler, blev ikke taget i betragtning for varig trombocytrespons.
English: Nplate is not recommended for use if you are pregnant unless indicated by your doctor.
Danish: Brug af Nplate frarådes under graviditet, medmindre Deres læge har foreskrevet det.
English: Romiplostim should be used with caution in these populations.
Danish: Romiplostim skal bruges med forsigtighed til disse patienter.
English: Always cover the needle with the pink safety cover before disposal.
Danish: Kanylen skal altid dækkes med den lyserøde sikkerhedshætte, inden den kasseres.
English: Paediatric subjects who had completed a prior romiplostim study (including study S4) were allowed to enroll in study S6 (340), an open-label extension study evaluating the safety and efficacy of long-term dosing of romiplostim in thrombocytopenic paediatric subjects with ITP.
Danish: Pædiatriske forsøgspersoner, som havde gennemført en tidligere undersøgelse med romiplostim (herunder undersøgelse S4), fik lov til at blive optaget i undersøgelse S6 (340), en åben forlængelsesundersøgelse, der evaluerede sikkerheden og virkningen af langvarig dosering af romiplostim til trombocytopeniske pædiatriske patienter med ITP.
English: Nplate is a sterile but unpreserved medicinal product and is intended for single use only.
Danish: Nplate er et sterilt, men ukonserveret lægemiddel og er kun beregnet til engangsbrug.
English: The paediatric adverse reactions are derived from each of the paediatric ITP randomised safety set (2 controlled clinical trials) and paediatric ITP safety set (2 controlled and 3 uncontrolled clinical trials) where the subject incidence was at least 5% higher in the romiplostim arm compared to placebo and at least a 5% subject incidence in romiplostim-treated subjects.
Danish: De pædiatriske bivirkninger er afledt af hvert af de randomiserede sikkerhedssæt for pædiatrisk ITP (2 kontrollerede kliniske forsøg) og sikkerhedssæt for pædiatrisk ITP (2 kontrollerede og 3 ikke-kontrollerede kliniske forsøg), hvor incidensraten var mindst 5 % højere i romiplostim-armen sammenlignet med placebo og mindst 5 % hos romiplostim-behandlede patienter.
English: No other diluents have been tested.
Danish: Der er ikke testet andre fortyndingsmidler.
English: There were no antibodies detected to TPO.
Danish: Der blev ikke fundet antistoffer mod TPO.
English: Corticosteroids, danazol, and azathioprine use may be reduced or discontinued when given in combination with romiplostim (see section 5.1).
Danish: Brug af kortikosteroider, danazol og azathioprin kan reduceres eller seponeres, når de gives i kombination med romiplostim (se pkt.
English: • bleeding beneath the surface of the skin or bruising under the skin (purpura);
Danish: • blødning under hudens overflade eller blå mærker under huden (purpura),
English: Rescue therapies defined as any therapy administered to raise platelet counts.
Danish: ”Rescue”-behandlinger defineres som enhver behandling, som gives for at forhøje trombocyttallene.
English: Patients had been diagnosed with ITP for approximately 8 years at the time of study entry.
Danish: Patienterne havde haft diagnosen ITP i cirka 8 år på tidspunktet for optagelse i undersøgelsen.
English: • Do not use components that have evidence of tampering or damage.
Danish: • Brug ikke dele, der ser ud til at være berørt eller beskadiget.
English: If you forget to use Nplate
Danish: Hvis De har glemt at bruge Nplate
English: • weight decreased; weight increased; intolerance of alcohol; loss of appetite (anorexia or decreased appetite); dehydration;
Danish: • nedsat eller øget vægt; intolerance mod alkohol; appetitløshed eller nedsat appetit; dehydrering,
English: Bone marrow changes (increased reticulin and possible bone marrow fibrosis)
Danish: Knoglemarvsforandringer (forhøjet retikulin og mulig knoglemarvsfibrose)
English: Possible side effects in children with ITP
Danish: Bivirkninger hos børn med ITP
English: Of the 22 subjects, 2 subjects had pre-existing binding non-neutralising romiplostim antibodies at baseline.
Danish: Af de 22 forsøgspersoner havde 2 forsøgspersoner eksisterende bindende ikke-neutraliserende antistoffer mod romiplostim ved baseline.
English: Study S2 (105) evaluated patients who were splenectomised and continued to have thrombocytopenia.
Danish: I undersøgelse S2 (105) indgik splenektomerede patienter, som stadig havde trombocytopeni.
English: Individual patient dose (mcg)
Danish: Individuel patientdosis (mikrog)
English: Choose and prepare an injection site Step 8.
Danish: Valg og klargøring af et injektionssted Trin 8.
English: • pain in the mouth and throat (oropharyngeal pain);
Danish: • smerter i mund og hals (oropharyngeal smerte),
English: • In paediatric patients, future dose adjustments are based on changes in platelet counts and changes in body weight.
Danish: • Fremtidige dosisjusteringer hos pædiatriske patienter er baseret på ændringer i trombocytal og ændringer i legemsvægt.
English: Deliverable product and volume
Danish: Injicérbart produkt og volumen
English: Patients had been diagnosed with ITP for approximately 2 years at the time of study entry.
Danish: Patienterne havde haft diagnosen ITP i cirka 2 år på tidspunktet for optagelse i undersøgelsen.
English: The initial dose of romiplostim is 1 mcg/kg based on actual body weight.
Danish: Initialdosis for romiplostim er 1 mikrog/kg baseret på aktuel legemsvægt.
English: Twenty-one non-splenectomised and 18 splenectomised patients received on-study ITP medical treatments (primarily corticosteroids) at the start of study.
Danish: Enogtyve ikke-splenektomerede patienter og 18 splenektomerede patienter fik en anden samtidig tilladt medicinsk behandling (primært kortikosteroider) for ITP ved undersøgelsesstart.
English: • Make sure all other materials are discarded into proper containers.
Danish: • Sørg for, at alle øvrige materialer kasseres i dertil indrettede beholdere.
English: After subcutaneous administration of 3 to 15 mcg/kg romiplostim, maximum romiplostim serum levels in ITP patients were obtained after 7-50 hours (median 14 hours).
Danish: Efter subkutan indgivelse af 3 til 15 mikrog/kg romiplostim blev maksimale romiplostim-serumniveauer hos ITP-patienter nået efter 7-50 timer (median 14 timer).
English: Increased bone marrow reticulin is believed to be a result of TPO receptor stimulation, leading to an increased number of megakaryocytes in the bone marrow, which may subsequently release cytokines.
Danish: Øget knoglemarvsretikulin menes at være et resultat af stimulering af TPO-receptorerne, hvilket resulterer i et øget antal megakaryocytter i knoglemarven, som efterfølgende kan afgive cytokiner.
English: In embryo-foetal development studies in mice and rats, reductions in maternal body weight were found only in mice.
Danish: I undersøgelser af embryo-føtal udvikling hos rotter og mus sås udelukkende nedsat maternel legemsvægt hos mus.
English: Romiplostim is not recommended during pregnancy and in women of childbearing potential not using contraception.
Danish: Romiplostim bør ikke anvendes under graviditeten og til kvinder i den fertile alder, som ikke anvender sikker kontraception.
English: Among the 154 subjects who received romiplostim, the total median exposure to romiplostim was 52.0 weeks and ranged from 2 to 53 weeks.
Danish: Blandt de 154 patienter, der fik romiplostim, var den samlede mediane eksponering for romiplostim 52,0 uger, interval 2 til 53 uger.
English: Patients who have a stable platelet count ≥ 50 x 10
Danish: Patienter, der har et stabilt trombocyttal på ≥ 50 x 10
English: Due to the interindividual variable platelet response, in some patients platelet count may abruptly fall below 50 x 10
Danish: På grund af den interindividuelle variation i trombocytrespons kan trombocyttallet hos nogle patienter pludseligt falde til under 50 x 10
English: • Pull back on the pink safety cover (toward the syringe and away from the needle).
Danish: • Træk den lyserøde sikkerhedshætte tilbage (mod sprøjten og væk fra kanylen).
English: Pharmacokinetics of romiplostim in patients with renal and hepatic impairment has not been investigated.
Danish: Romiplostims farmakokinetik for patienter med nyre- og leverinsufficiens er ikke blevet undersøgt.
English: Romiplostim is known to cross the placental barrier in rats and may be transmitted from the mother to the developing foetus and stimulate foetal platelet production.
Danish: Romiplostim vides at krydse placentabarrieren hos rotter og kan muligvis overføres fra moderen til det voksende foster og stimulere føtal trombocytproduktion.
English: Platelet count (x 10
Danish: Trombocyttal (x 10
English: You may have excess Nplate left over after administering your prescribed dose.
Danish: De kan have ekstra Nplate tilovers efter indgivelse af den ordinerede dosis.
English: The most frequently used weekly dose was 3-10 mcg/kg and the maximum allowed dose on study was 10 mcg/kg.
Danish: Den hyppigst anvendte ugentlige dosis var 3-10 mikrog/kg, og den maksimalt tilladte dosis i undersøgelsen var 10 mikrog/kg.
English: Your doctor will adjust your dose of Nplate to ensure that your platelet count does not become too high.
Danish: Deres læge vil justere Deres Nplate-dosis for at sørge for, at Deres blodpladetal ikke bliver for højt.
English: Uncommon: may affect up to 1 in 100 people • higher than normal platelet counts (thrombocytosis).
Danish: Ikke almindelig: kan påvirke op til 1 ud af 100 personer • blodpladetal højere end normalt (trombocytose).
English: Romiplostim has no amino acid sequence homology to endogenous TPO.
Danish: Romiplostim har ingen homologi i aminosyresekvensen med endogent TPO.
English: Gastroenteritis Pharyngitis*** Conjunctivitis*** Ear infection*** Sinusitis***
Danish: Gastroenteritis Faryngit*** Konjunktivitis*** Øreinfektion*** Sinusitis***
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Fortæl altid til lægen eller på apoteket, hvis De bruger anden medicin, har brugt det for nylig eller planlægger at bruge anden medicin.
English: Common: may affect up to 1 in 10 people (may show up in blood or urine tests)
Danish: Almindelige: kan påvirke op til 1 ud af 10 personer (kan vise sig i blod- eller urinprøver)
English: The median average weekly dose for splenectomised patients was 3 mcg/kg and for non-splenectomised patients was 2 mcg/kg.
Danish: Median for den gennemsnitlige ugentlige dosis for splenektomerede patienter var 3 mikrog/kg, og den var 2 mikrog/kg for ikke-splenektomerede patienter.