FrancophonIA/ELRC3.0 huggingface dataset:
English: • depression; abnormal dreams;
Danish: • depression; abnorme drømme,
English: In all developmental studies neutralising antibodies were formed, which may have inhibited romiplostim effects.
Danish: I alle udviklingsundersøgelser blev der dannet neutraliserende antistoffer, som kan have hæmmet romiplostims virkning.
English: The serum concentrations varied among patients and did not correlate with the dose administered.
Danish: Serumkoncentrationerne varierede blandt patienterne og korrelerede ikke med den indgivne dosis.
English: A total of 66 subjects were enrolled in this study, including 54 subjects (82%) who had completed study S4.
Danish: Der blev i alt optaget 66 forsøgspersoner i denne undersøgelse, herunder 54 forsøgspersoner (82 %), der havde fuldført undersøgelse S4.
English: ITP is a disease in which your body's immune system destroys its own platelets.
Danish: ITP er en sygdom, hvor kroppens immunforsvar ødelægger sine egne blodplader.
English: It must be clear and colourless and fully dissolved.
Danish: Den skal være klar og farveløs og helt opløst.
English: • Physicians involved in the prescribing of romiplostim are provided with a dosing calculator to simplify the calculation of the correct dose and as a guide to the correct reconstitution, dilution (if required) and administration procedures.
Danish: • Læger, der er involveret i ordination af romiplostim, får udleveret en dosisberegner, som skal forenkle beregningen af den korrekte dosis og som en guide til korrekt rekonstitution, fortynding (hvis påkrævet) og administration.
English: 9/L for at least 4 weeks without dose adjustment) has been achieved.
Danish: 9/l i mindst 4 uger uden justering af dosis).
English: Home Administration Training (HAT) pack
Danish: HAT-pakke (Home Administration Training)
English: Study 2 splenectomised patients
Danish: Undersøgelse 2 Splenektomerede patienter
English: • Do not pull plunger back to more than 1 mL.
Danish: • Træk ikke stemplet tilbage til mere end 1 ml-mærket.
English: As a result for a given dose, patients with high platelet counts are associated with low serum concentrations and vice versa.
Danish: Ved en given dosis forbindes patienter med høje trombocyttal derfor med lave serumkoncentrationer og omvendt.
English: Your doctor will ensure that you receive the right amount of Nplate.
Danish: Deres læge vil sikre, at De får den rigtige dosis Nplate.
English: • if you are allergic to other medicines that are produced by DNA technology using the micro-organism Escherichia coli (E. coli).
Danish: • hvis De er allergisk over for andre lægemidler, som er fremstillet vha. DNA-teknologi under anvendelse af mikroorganismen Escherichia coli (E. coli).
English: • Note: After injecting the water into the vial it is common for the plunger to move back up.
Danish: • Bemærk: Efter injektion af vandet ind i hætteglasset er det normalt, at stemplet bevæger sig op igen.
English: A summary of the key efficacy endpoints is presented below.
Danish: En oversigt over de vigtigste effektmål er vist nedenfor.
English: Please read the instructions at the end of this leaflet on how to inject Nplate, as discussed with your doctor.
Danish: Læs instruktionerne sidst i denne indlægsseddel med information om, hvordan Nplate skal injiceres, som De har gennemgået det med Deres læge.
English: Time to reach the maximum effect on platelet count is approximately 10-14 days, and is independent of the dose.
Danish: Den maksimale virkning på trombocyttal ses efter 10-14 dage og er uafhængig af dosis.
English: Depression Abnormal dreams
Danish: Depression Abnorme drømme
English: Do not re-use Nplate!
Danish: Genbrug ikke Nplate!
English: In general, effects observed during these studies were related to the thrombopoietic activity of romiplostim and were similar regardless of study duration.
Danish: Generelt var virkningerne, som sås i disse undersøgelser, relateret til romiplostims trombopoietiske aktivitet og var stort set ens uanset undersøgelsens varighed.
English: = Amount to inject in mL
Danish: = Mængde, som skal injiceres, i ml
English: Treatment should remain under the supervision of a physician who is experienced in the treatment of haematological diseases.
Danish: Behandling skal ske under supervision af en læge med erfaring i behandling af hæmatologiske sygdomme.
English: The safety and efficacy of romiplostim was evaluated in two placebo-controlled, double-blind studies.
Danish: Romiplostims sikkerhed og virkning blev vurderet i to placebokontrollerede, dobbeltblindede undersøgelser.
English: Before you begin Step 4 please note the following:
Danish: Inden De går i gang med trin 4, bemærk følgende:
English: The mild form of these bone marrow changes is called “increased reticulin” and has been observed in Nplate clinical trials.
Danish: Den milde form for disse knoglemarvsforandringer kaldes “forhøjet retikulin” og er blevet observeret i kliniske forsøg med Nplate.
English: Because the dose is < 23 mcg, dilution is required to ensure accurate dosing.
Danish: Da dosen er < 23 mikrog, kræves der fortynding for at sikre en nøjagtig dosering.
English: Dilution is required to ensure accurate dosing.
Danish: Der kræves fortynding for at sikre nøjagtig dosering.
English: If you have missed a dose of Nplate, your doctor will discuss with you when you should have your next dose.
Danish: Hvis De har glemt at tage en dosis af Nplate, vil Deres læge drøfte med Dem, hvornår De skal have Deres næste dosis.
English: • Select a well lit, flat work surface, such as a table.
Danish: • Find et fladt arbejdsområde med god belysning, for eksempel et bord.
English: Stop and contact your healthcare professional.
Danish: Stop proceduren og kontakt Deres sundhedsmedarbejder.
English: Study 1 non-splenectomised patients
Danish: Undersøgelse 1 Ikke-splenektomerede patienter
English: Patients received single subcutaneous weekly injections for 24 weeks.
Danish: Patienterne fik subkutane injektioner en gang om ugen i 24 uger.
English: This study evaluated non-splenectomised patients with ITP and platelet counts < 50 x 10
Danish: I dette studie undersøgte man ikke-splenektomerede patienter med ITP og trombocyttal < 50 x 10
English: - The active substance is romiplostim.
Danish: - Aktivt stof: romiplostim.
English: After the platelet count has fallen to < 150 x 10
Danish: Når trombocyttallet er faldet til < 150 x 10
English: It is very important the product is prepared correctly and the correct dose is taken.
Danish: Det er meget vigtigt, at De tilbereder Nplate rigtigt og tager den korrekte dosis.
English: Multiple dose romiplostim toxicology studies were conducted in rats for 4 weeks and in monkeys for up to 6 months.
Danish: Toksikologiske undersøgelser med flere doser romiplostim blev foretaget hos rotter i 4 uger og hos aber i op til 6 måneder.
English: Abdomen, except for the 5 centimetre area right around the navel
Danish: Maven - bortset fra 5 centimeter rundt om navlen
English: All the 63 subjects received at least 1 dose of romiplostim.
Danish: Alle 63 forsøgspersoner fik mindst 1 dosis romiplostim.
English: If your doctor has allowed you to self-inject, you should follow up with your doctor every month to have the doctor determine if Nplate is working for you or if another treatment needs to be considered.
Danish: Hvis Deres læge har givet Dem lov til selv at injicere, bør De gå til kontrol hos Deres læge hver måned, så lægen kan fastlægge, om Nplate virker for Dem, eller om en anden behandling skal overvejes.
English: Toxicokinetic studies showed no interaction of the antibodies with the measured concentrations.
Danish: Toksikokinetiske undersøgelser viste ingen interaktion med antistoffer ved de målte koncentrationer.
English: IMMEDIATELY continue to step 7.
Danish: Fortsæt STRAKS til trin 7.
English: Before you begin Step 3 please note the following:
Danish: Inden De går i gang med trin 3, bemærk følgende:
English: Dilution (required when the calculated individual patient dose is less than 23 mcg)
Danish: Fortynding (påkrævet når den beregnede individuelle patientdosis er på mindre end 23 mikrogram)
English: Long-term use of Nplate may cause changes in your bone marrow.
Danish: Langvarig brug af Nplate kan medføre forandringer af knoglemarven.
English: Nplate works by stimulating the bone marrow (part of the bone which makes blood cells) to produce more platelets.
Danish: Nplate virker ved at stimulere knoglemarven (den del af knoglen, som producerer blodceller) til at producere flere blodplader.
English: It is important that you do not try to give yourself the injection unless you have received training from your doctor, nurse or pharmacist.
Danish: Det er vigtigt, at De ikke forsøger at injicere Dem selv, medmindre De har fået undervisning i det af Deres læge, sundhedspersonalet eller apotekspersonalet.
English: The peptibody molecule is comprised of a human immunoglobulin IgG1 Fc domain, with each single-chain subunit covalently linked at the C-terminus to a peptide chain containing 2 TPO receptor-binding domains.
Danish: Peptibody-molekylet består af et humant immunglobulin IgG1 Fc-domæne med hver enkeltkædet underenhed bundet kovalent ved C-terminalen til en peptidkæde med to TPO-receptorbindende domæner.
English: In paediatric studies, the incidence of binding antibodies to romiplostim at any time was 7.8% (22/282).
Danish: I pædiatriske undersøgelser var forekomsten af bindende antistoffer mod romiplostim til enhver tid 7,8 % (22/282).
English: Of these, 65 subjects (98.5%) received at least 1 dose of romiplostim.
Danish: Af disse fik 65 forsøgspersoner (98,5 %) mindst 1 dosis romiplostim.
English: • Slowly push back on the plunger to leave only the amount prescribed by your healthcare professional.
Danish: • Træk langsomt stemplet tilbage, så der kun er den mængde tilbage, som De har fået ordineret af deres sundhedsmedarbejder.
English: The incidence of pre-existing antibodies to romiplostim and TPO was 8.0% and 5.4%, respectively.
Danish: Forekomsten af præeksisterende antistoffer mod romiplostim og TPO var henholdsvis 8,0 % og 5,4 %.
English: Concurrent anaemia and leucocytosis (within a 4-week window) may occur in patients regardless of splenectomy status, but have been seen more often in patients who have had a prior splenectomy.
Danish: Der kan opstå samtidig anæmi og leukocytose (inden for en periode på 4 uger) hos patienter, uanset splenektomi-status, men er set hyppigere hos patienter, der tidligere har fået foretaget splenektomi.
English: In some paediatric patients, accurate dosing relies on an additional dilution step after reconstitution which may increase the risk for medication errors (see section 4.2).
Danish: Hos visse pædiatriske patienter afhænger nøjagtig dosering af et yderligere fortyndingstrin efter rekonstituering, hvilket muligvis øger risikoen for medicineringsfejl (se pkt.
English: • Keep filled syringe in your hand and do not touch syringe tip.
Danish: • Hold den fyldte sprøjte i hånden og rør ikke ved sprøjtespidsen.
English: Reinitiate treatment with Nplate in accordance with dosing and administration recommendations.
Danish: Genstart behandling med Nplate i overensstemmelse med anbefalingerne for dosering og administration.
English: Always use Nplate exactly as your doctor has told you.
Danish: Brug altid Nplate nøjagtigt efter lægens anvisning.
English: Slowly push the plunger up to force the air bubbles out of the syringe.
Danish: Skub langsomt stemplet op for at tvinge luftboblerne ud af sprøjten.
English: A maximum once weekly dose of 10 mcg/kg should not be exceeded.
Danish: En maksimal ugentlig dosis på 10 mikrog/kg må ikke overskrides.
English: It is unknown whether romiplostim/metabolites are excreted in human milk.
Danish: Det er ukendt, om romiplostim/metabolitterne udskilles i human mælk.
English: • Do not touch the top of vial adapter.
Danish: • Rør ikke ved toppen af adapteren.
English: 1 pack containing:
Danish: 1 pakning, der indeholder:
English: • Do not open items until directed in instructions.
Danish: • Åbn ikke artiklerne, før der står i instruktionerne, at De skal.
English: Caution should be used during preparation of Nplate in calculating the dose and reconstitution with the correct volume of sterile water for injection.
Danish: Der skal udvises forsigtighed under tilberedelse af Nplate i forbindelse med beregning af dosis og fortynding med den korrekte mængde sterilt vand til injektionsvæsker.
English: Romiplostim had no observed effect on the fertility of rats.
Danish: Der sås ingen virkning af romiplostim på fertiliteten hos rotter.
English: • Physicians who express an interest in initiating self-administration for specific patients are provided with a HAT pack for those patients.
Danish: • Læger, der er interesseret i at iværksætte selvadministration for bestemte patienter, vil få udleveret HAT-pakker til de pågældende patienter.
English: The primary endpoint was the incidence of durable response, defined as achieving at least 6 weekly platelet counts of ≥ 50 x 10
Danish: Det primære endepunkt var forekomsten af varigt respons defineret som opnåelse af mindst 6 ugentlige trombocyttal på ≥ 50 x 10
English: If reconstituted product is not used immediately, the syringe should not be removed from the vial adapter to maintain microbiological integrity.
Danish: Hvis det rekonstituerede præparat ikke anvendes med det samme, bør sprøjten ikke tages op af hætteglasadapteren for at bevare mikrobiologisk integritet.
English: 9/L during weeks 18 through 25 of treatment.
Danish: 9/l i løbet af uge 18 til 25 af behandlingen.
English: However, no subject showed any bone marrow abnormalities that were inconsistent with an underlying diagnosis of ITP at baseline or on-treatment.
Danish: Dog udviste ingen af forsøgspersonerne nogen knoglemarvsabnormaliteter, der var uforenelige med en underliggende diagnose af ITP ved baseline eller i behandling.
English: No overall differences in safety or efficacy have been observed between older and younger patients in the placebo-controlled studies.
Danish: Der blev ikke observeret nogen generel forskel på sikkerhed eller virkning for ældre og yngre patienter i de placebokontrollerede undersøgelser.
English: This non-linear decrease in volume of distribution is in line with the (megakaryocyte and platelet) target-mediated binding of romiplostim, which may be saturated at the higher doses applied.
Danish: Denne non-lineære reduktion i fordelingsvolumen svarer til den (megakaryocyt og trombocyt) target-medierede binding af romiplostim, som kan være mættet ved de højere anvendte doser.
English: If the use of romiplostim is deemed necessary, platelet count should be closely monitored to minimise the risk of thromboembolic complications.
Danish: Hvis det anses for nødvendigt at bruge romiplostim, skal trombocyttallet monitoreres nøje for at mindske risikoen for tromboemboliske komplikationer.
English: Your doctor will decide if abnormal blood tests mean that you should have bone marrow tests or if you should stop taking Nplate.
Danish: Deres læge vil afgøre, om unormale blodprøver er ensbetydende med, at De skal have foretaget knoglemarvsprøver, eller om De skal stoppe med at tage Nplate.
English: Administer subcutaneous injection following local protocols and good aseptic technique.
Danish: Injicer subkutant i henhold til lokale retningslinjer og god aseptisk teknik.
English: Nplate is administered once a week as an injection under the skin (subcutaneous).
Danish: Nplate indgives én gang om ugen som en injektion under huden (subkutant).
English: Nplate is not recommended for use in children below age 18.
Danish: Nplate anbefales ikke til brug til børn under 18 år.
English: Dextrose (5%) in water or sterile water for injection should not be used for the dilution.
Danish: Dextrose (5 %) i vand eller sterilt vand til injektion bør ikke anvendes til fortynding.
English: What Nplate contains
Danish: Nplate indeholder
English: The volume of romiplostim to administer is calculated based on body weight, dose required, and concentration of product.
Danish: Indgivelsesvolumen af romiplostim beregnes baseret på legemsvægt, påkrævet dosis og koncentration af produktet.
English: Follow the steps as described in this leaflet and use as many self injection kits as necessary to complete your prescribed dose of Nplate.
Danish: Følg trinene som beskrevet i denne indlægsseddel og brug så mange selvinjektionssæt som er nødvendige for at få Deres ordinerede dosis af Nplate.
English: Caution should be used when administering romiplostim to patients with known risk factors for thromboembolism including but not limited to inherited (e.g.
Danish: Der skal udvises forsigtighed ved administration af romiplostim til patienter med kendte risikofaktorer for tromboembolisme, herunder, men ikke begrænset til arvelige (f.eks.
English: A bone marrow aspirate and biopsy should normally have been done over the course of the disease and treatment, particularly in patients over 60 years of age, for those with systemic symptoms or abnormal signs such as increased peripheral blast cells.
Danish: Der skal normalt være udført knoglemarvsaspirat og -biopsi i sygdoms- og behandlingsforløbet, især hos patienter over 60 år samt hos patienter med systemiske symptomer eller abnorme tegn såsom øget antal perifere blastceller.
English: • Note: It may take up to 2 minutes for the powder to completely dissolve.
Danish: • Bemærk: Det kan tage op til 2 minutter, inden pulveret er helt opløst.
English: Your doctor, nurse or pharmacist will show you how to inject yourself with Nplate.
Danish: Deres læge, sundhedspersonalet eller apotekspersonalet vil vise Dem, hvordan De injicerer Dem selv med Nplate.
English: Romiplostim pharmacokinetics appear not affected by age, weight and gender to a clinically significant extent.
Danish: Romiplostims farmakokinetik synes ikke at være signifikant påvirket af alder, vægt og køn.
English: A total of 2.2% (4/184) adult patients developed binding, non-neutralising antibody against TPO.
Danish: I alt 2,2 % (4/184) af voksne patienter udviklede bindende, ikke-neutraliserende antistof mod TPO.
English: Nplate has moderate influence on the ability to drive and use machines.
Danish: Nplate påvirker i moderat grad evnen til at føre motorkøretøj og betjene maskiner.
English: Your doctor may decide to take a bone marrow biopsy if they decide it is necessary to ensure that you have ITP, and not another condition such as Myelodysplastic Syndrome (MDS).
Danish: Deres læge kan beslutte at tage en knoglemarvsbiopsi, hvis lægen mener, det er nødvendigt for at sikre, at De har ITP og ikke andre lidelser som f.eks. myelodysplastisk syndrom (MDS).
English: If available, comparison to a prior bone marrow biopsy should be made.
Danish: Om muligt skal denne sammenlignes med en tidligere knoglemarvsbiopsi.
English: • changes in some blood tests (increase in transaminase; blood lactate dehydrogenase increased);
Danish: • ændringer i nogle blodprøver (forhøjet transaminase, forhøjet laktatdehydrogenase i blodet),
English: Loss of response to romiplostim
Danish: Tab af respons på romiplostim
English: Romiplostim is produced by recombinant DNA technology in Escherichia coli (E. coli).
Danish: Romiplostim fremstilles ved hjælp af rekombinant DNA-teknologi i Escherichia coli (E. coli).
English: See section 4.8 for information on the increases of reticulin observed in romiplostim clinical trials.
Danish: 4.8 indeholder information om stigninger i retikulin, der er observeret i kliniske undersøgelser med romiplostim.
English: The safety and efficacy of romiplostim 250/500 mcg powder and solvent for solution for injection, also used for self-administration in eligible adult patients, have not been established in patients aged under 18 years.
Danish: Sikkerheden og effekten af romiplostim 250/500 mikrog pulver og solvens til injektionsvæske, opløsning, også brugt til selvadministration af egnede voksne patienter, er ikke fastlagt hos patienter under 18 år.
English: Your doctor will take regular blood samples to measure how your platelets are responding and may adjust your dose as necessary.
Danish: Deres læge vil tage regelmæssige blodprøver for at måle, hvordan Deres blodplader reagerer, og om nødvendigt justere Deres dosis.
English: The potential interactions of romiplostim with co-administered medicinal products due to binding to plasma proteins remain unknown.
Danish: De potentielle interaktioner mellem romiplostim og samtidig anvendte lægemidler som følge af bindingen til plasmaproteiner kendes endnu ikke.
English: Guidelines for calculating individual patient dose and volume of romiplostim to administer
Danish: Retningslinjer for beregning af individuel patientdosis og ingivelsesvolumen af romiplostim
English: Adjust the amount to your prescribed dose
Danish: Juster mængden til den ordinerede dosis
English: B. Maintain pressure on plunger.
Danish: B. Oprethold trykket på stemplet.
English: This will break the seal of the white plastic cover.
Danish: Dette bryder forseglingen på den hvide plastbeskyttelse.
English: • a rare disorder characterised by periods of burning pain, redness and warmth in the feet and hands (erythromelalgia).
Danish: • en sjælden lidelse, der er kendetegnet ved perioder med brændende smerte, rødmen og varme i fødder og hænder (erytromelalgi).
English: The incidence of thrombotic/thromboembolic events observed in clinical trials was 6.0% with romiplostim and 3.6% with placebo.
Danish: Antallet af trombotiske/tromboemboliske hændelser, som blev set i kliniske undersøgelser, var 6,0 % for romiplostim og 3,6 % for placebo.
English: There was also a stimulatory effect on leukocyte production, as peripheral blood counts for neutrophils, lymphocytes, monocytes, and eosinophils were mildly increased.
Danish: Der var også en stimulatorisk effekt på leukocytproduktionen, da de perifere blodtal for neutrofiler, lymfocytter, monocytter og eosinofiler steg en anelse.
English: Your doctor will decide if you should stop using Nplate.
Danish: Deres læge beslutter, om De skal holde op med at tage Nplate.
English: This section contains information on how to give yourself an injection of Nplate.
Danish: Dette afsnit fortæller, hvordan De giver Dem selv en injektion med Nplate.
English: 9/L at study entry.
Danish: 9/l ved optagelse i undersøgelsen.
English: 77 subjects received SOC treatment according to standard institutional practice or therapeutic guidelines.
Danish: 77 patienter fik standardbehandling i henhold til institutionens standardpraksis eller terapeutiske retningslinjer.
English: Patients should be clinically evaluated periodically and continuation of treatment should be decided on an individual basis by the treating physician, and in non-splenectomised patients this should include evaluation relative to splenectomy.
Danish: Patienterne bør jævnligt undersøges klinisk, og den behandlende læge skal fastlægge individuelt for den enkelte patient, om behandlingen skal fortsætte; hos ikke-splenektomerede patienter bør dette inkludere en evaluering for så vidt angår splenektomi.
English: A. Push air into vial.
Danish: A. Skub luft ind i hætteglasset.
English: Myelofibrosis has been observed in the bone marrow of rats at all tested dose levels.
Danish: Der er blevet set myelofibrose i knoglemarven hos rotter ved alle testede dosisniveauer.
English: • Make sure the top of the plunger head lines up with the syringe marking that matches your prescribed dose.
Danish: • Sørg for, at toppen af stempelhovedet er på linje med det sprøjtemærke, der svarer til Deres ordinerede dosis.
English: The safety and efficacy of romiplostim was evaluated in two placebo-controlled, double-blind studies in adults with ITP who had completed at least one treatment prior to study entry and are representative of the entire spectrum of such ITP patients.
Danish: Romiplostims sikkerhed og virkning blev evalueret i to placebokontrollerede, dobbeltblindede undersøgelser hos voksne med ITP, som havde gennemført mindst én behandling inden optagelse i undersøgelsen, og som var repræsentative for alle sådanne patienter med ITP.
English: Talk to your doctor, pharmacist or nurse before using Nplate.
Danish: Kontakt lægen, apoteket eller sundhedspersonalet, før De bruger Nplate.