FrancophonIA/ELRC3.0 huggingface dataset:
English: A significantly higher proportion of patients receiving romiplostim achieved a durable platelet response compared to patients receiving placebo in both studies.
Danish: En markant større andel af de patienter, der fik romiplostim, opnåede en varig trombocytrespons end de patienter, der fik placebo i begge undersøgelser.
English: Contents of the pack and other information Instructions for preparing and giving an injection of Nplate
Danish: Pakningsstørrelser og yderligere oplysninger Instruktioner til tilberedelse og indgivelse af en injektion med Nplate
English: Set up materials for an injection Step 2.
Danish: Klargøring af materialerne til en injektion Trin 2.
English: With the other hand, hold the syringe (like a pencil) at a 45-degree angle to the skin.
Danish: Hold sprøjten (som en blyant) med en 45 graders vinkel i forhold til huden med den anden hånd.
English: Carton containing 1 or 4 vials of romiplostim.
Danish: Kartonen indeholder 1 eller 4 hætteglas romiplostim.
English: Thrombocytopenia is likely to reoccur upon discontinuation of treatment with romiplostim.
Danish: Det er sandsynligt, at trombocytopeni recidiverer efter ophør af behandling med romiplostim.
English: In another ITP clinical trial, no accumulation in serum concentrations was observed after 6 weekly doses of romiplostim (3 mcg/kg).
Danish: I et andet klinisk forsøg relateret til ITP sås der ikke akkumulering i serumkoncentrationer efter 6 ugentlige doser romiplostim (3 mikrog/kg).
English: No. (%) patients with durable platelet response with stable dose e
Danish: Antal (%) patienter med varig trombocyt-respons ved stabil dosis e
English: Although high doses were tested in the animal studies, due to differences between the laboratory species and humans with regard to the sensitivity for the pharmacodynamic effect of romiplostim and the effect of neutralising antibodies, safety margins cannot be reliably estimated.
Danish: Selvom højere doser blev testet i dyreforsøg, kan sikkerhedsmargen ikke med sikkerhed fastslås pga. forskellene mellem laboratoriearterne og mennesker mht. følsomheden mod romiplostims farmakodynamiske virkning og virkningen af de neutraliserende antistoffer.
English: RECONSTITUTION PACK INNER CARTON WITHOUT BLUE BOX
Danish: INDRE KARTON UDEN BLÅ BOKS TIL REKONSTITUTIONSPAKNING
English: While 5.8% and 3.9% of the subjects were positive for developing binding antibodies to romiplostim and TPO respectively, only 2 subjects (0.4%) were positive for neutralising antibodies to romiplostim but these antibodies did not cross react with endogenous TPO.
Danish: Mens 5,8 % og 3,9 % af forsøgspersonerne havde udviklet bindende antistoffer mod henholdsvis romiplostim og TPO, havde kun 2 forsøgspersoner (0,4 %) neutraliserende antistoffer mod romiplostim, men disse antistoffer krydsreagerede ikke med endogen TPO.
English: Elimination half-life of romiplostim in ITP patients ranged from 1 to 34 days (median, 3.5 days).
Danish: Halveringstiden for romiplostim hos patienter med ITP varierede mellem 1 og 34 dage (median 3,5 dage).
English: In Study S6 (340), intensive romiplostim concentrations were available from 4 subjects (2 at 7 mcg/kg and 2 at 9 mcg/kg).
Danish: I undersøgelse S6 (340) var der intensive romiplostimkoncentrationer tilgængelige fra 4 forsøgspersoner (2 ved 7 mikrog/kg og 2 ved 9 mikrog/kg).
English: The most common adverse reactions observed include hypersensitivity reactions (including cases of rash, urticaria and angioedema) and headache.
Danish: De mest almindelige bivirkninger, der blev observeret, omfattede blandt andet overfølsomhedsreaktioner (herunder tilfælde af udslæt, urticaria og angioødem) samt hovedpine.
English: The diagnosis of ITP in adults and elderly patients should have been confirmed by the exclusion of other clinical entities presenting with thrombocytopenia, in particular the diagnosis of MDS must be excluded.
Danish: Diagnosen ITP hos voksne og ældre patienter skal være verificeret ved udelukkelse af andre kliniske tilstande med trombocytopeni, især skal diagnosen MDS udelukkes.
English: In an ongoing paediatric clinical trial, of the subjects with an evaluable on-study bone marrow biopsy, 5 out of 27 subjects (18.5%) developed increased reticulin in cohort 1 and 2 out of 4 subjects (50.0%) developed increased reticulin in cohort 2.
Danish: I et igangværende klinisk forsøg med pædiatriske forsøgspersoner med en evaluerbar knoglemarvsbiopsi under forsøget udviklede 5 ud af 27 forsøgspersoner (18,5 %) øget retikulin i kohorte 1, og 2 ud af 4 forsøgspersoner (50,0 %) udviklede øget retikulin i kohorte 2.
English: In addition to a splenectomy, patients had a median of 6 (range, 3 to 10) treatments for ITP prior to study entry.
Danish: Ud over en splenektomi havde patienterne som median fået 6 (fra 3 til 10) behandlinger for ITP inden optagelse i undersøgelsen.
English: If formation of neutralising antibodies is suspected, contact the local representative of the Marketing Authorisation Holder (see section 6 of the Package Leaflet) for antibody testing.
Danish: Ved mistanke om dannelse af neutraliserende antistoffer skal den lokale repræsentant for indehaveren af markedsføringstilladelsen kontaktes (se indlægssedlens pkt.
English: Medicinal products used in the treatment of ITP in combination with romiplostim in clinical trials included corticosteroids, danazol, and/or azathioprine, intravenous immunoglobulin (IVIG), and anti-D immunoglobulin.
Danish: Lægemidler, der er brugt til behandling af ITP i kombination med romiplostim i kliniske forsøg, inkluderede kortikosteroider, danazol og/eller azathioprin, intravenøst immunglobulin (IVIG) og anti-D immunglobulin.
English: Rescue therapies allowed in the study were IVIG, platelet transfusions, anti-D immunoglobulin, and corticosteroids.
Danish: Tilladte ”rescue”-behandlinger i denne undersøgelse var IVIG, trombocyttransfusion, anti-D immunglobulin og kortikosteroider.
English: Underdose may result in lower than expected platelet counts and potential for bleeding.
Danish: Underdosering kan medføre trombocyttal, der er lavere end forventet, og risiko for blødning.
English: Self-administration of romiplostim is not allowed for paediatric patients.
Danish: Selvadministration af romiplostim er ikke tilladt for pædiatriske patienter.
English: A positive benefit/risk for romiplostim is only established for the treatment of thrombocytopenia associated with chronic ITP and romiplostim must not be used in other clinical conditions associated with thrombocytopenia.
Danish: Der er kun fastlagt et positivt benefit/risk forhold for romiplostim ved behandling af trombocytopeni associeret med kronisk ITP, og romiplostim må ikke anvendes til andre kliniske tilstande, der er forbundet med trombocytopeni.
English: • In adults, future dose adjustments are based on changes in platelet counts only.
Danish: • Fremtidige dosisjusteringer hos voksne er udelukkende baseret på ændringer i trombocyttal.
English: The Nplate self injection kit must be kept in the original package until use in order to protect the Nplate vial from light.
Danish: Selvinjektionssættet til Nplate skal opbevares i den originale emballage indtil anvendelse for at beskytte hætteglasset med Nplate mod lys.
English: Therefore if your doctor suspects that you have been given less Nplate than you should, it is recommended that you are monitored for any signs or symptoms of side effects and that you are given appropriate treatment immediately.
Danish: Hvis Deres læge derfor har mistanke om, at De har fået mindre Nplate, end De skulle, tilrådes det, at De overvåges for eventuelle tegn og symptomer på bivirkninger, og at De øjeblikkeligt får passende behandling.
English: In these cases, if clinically appropriate, higher cut-off levels of platelet count for dose reduction (200 x 10
Danish: I disse tilfælde kan højere grænseværdier for trombocyttal i forbindelse med dosisreduktion (200 x 10
English: Localised infection Nasopharyngitis
Danish: Lokaliseret infektion Nasofaryngit
English: After a single subcutaneous dose of 1 to 10 mcg/kg romiplostim in ITP patients, the peak platelet count was 1.3 to 14.9 times greater than the baseline platelet count over a 2 to 3 week period and the response was variable among patients.
Danish: Efter en enkelt subkutan dosis på 1 til 10 mikrog/kg romiplostim hos ITP-patienter var det maksimale trombocyttal 1,3 til 14,9 gange højere end trombocyttallet ved baseline over en periode på 2 til 3 uger, og responsen varierede fra patient til patient.
English: Protein urine present
Danish: Protein i urinen
English: Your doctor may decide that it is best for you to inject Nplate.
Danish: Deres læge vil muligvis beslutte, at det er bedst, hvis De selv injicerer Nplate.
English: • influenza; localised infection; inflammation of the passages in the nose and throat (nasopharyngitis);
Danish: • influenza; lokaliseret infektion; betændelse i næse og hals (nasofaryngit),
English: In 6 additional patients reticulin was observed upon bone marrow biopsy (see section 4.4).
Danish: Hos yderligere seks patienter blev der fundet retikulin ved knoglemarvsbiopsi (se pkt.
English: 9/L for 4 or more times during study weeks 2-25 but without durable platelet response.
Danish: 9/l 4 gange eller mere i uge 2-25 af undersøgelsen, men uden en varig trombocytrespons.
English: Your dose may be adjusted further in order to maintain long-term control of your platelet count.
Danish: Deres dosis kan justeres yderligere for at holde blodpladetallet under kontrol på lang sigt.
English: Patients should be closely monitored for a decrease in platelet count and medically managed to avoid bleeding upon discontinuation of treatment with romiplostim.
Danish: Patienterne skal overvåges tæt for faldende trombocyttal og skal behandles medicinsk for at undgå blødning efter ophør af behandling med romiplostim.
English: Of these 9 subjects, 2 subjects had pre-existing binding non-neutralising antibodies to TPO.
Danish: Af disse 9 forsøgspersoner havde 2 forsøgspersoner eksisterende bindende ikke-neutraliserende antistoffer mod TPO.
English: • muscles pain or weakness (myalgia);
Danish: • muskelsmerter eller -svaghed (myalgi),
English: • Note: If there is any colour or particles in the liquid, contact your healthcare professional.
Danish: • Bemærk: Kontakt Deres sundhedsmedarbejder, hvis der er farve eller partikler i væsken.
English: Reconstitute lyophilised product and then dilute the product as described in section 6.6.
Danish: Rekonstituer det frysetørrede produkt og fortynd derefter produktet som beskrevet i pkt.
English: Therefore if your doctor suspects that you have been given more Nplate than you should, it is recommended that you are monitored for any signs or symptoms of side effects and that you are given appropriate treatment immediately.
Danish: Hvis Deres læge derfor har mistanke om, at De har fået mere Nplate, end De skulle, tilrådes det, at De overvåges for eventuelle tegn og symptomer på bivirkninger, og at De øjeblikkeligt gives passende behandling.
English: Injection site reactions were also related to romiplostim administration.
Danish: Reaktioner på injektionsstedet var også forbundet med indgift af romiplostim.
English: Factor V Leiden) or acquired risk factors (e.g. ATIII deficiency, antiphospholipid syndrome), advanced age, patients with prolonged periods of immobilisation, malignancies, contraceptives and hormone replacement therapy, surgery/trauma, obesity and smoking.
Danish: Faktor V Leiden) eller erhvervede (f.eks. ATIII-mangel, antifosfolipid-syndrom) risikofaktorer, fremskreden alder, patienter med længere tids immobilisering, maligne sygdomme, antikonceptionsmidler og hormonsubstitutionsbehandling (HRT), kirurgi/traume, fedme og rygning.
English: Studies in animals have shown that romiplostim crossed the placenta and increased foetal platelet counts.
Danish: Dyrestudier har påvist, at romiplostim krydser placenta og forhøjer trombocyttallene hos fostre.
English: In the longer duration chronic monkey study, there was no effect on the erythroid and leukocytic lineages when romiplostim was administered for 6 months where the administration of romiplostim was decreased from thrice weekly to once weekly.
Danish: I den længerevarende kroniske undersøgelse med aber var der ingen virkning på erytroide og leukocytiske afstamninger, da romiplostim blev indgivet i 6 måneder, hvor indgivelsen af romiplostim blev reduceret fra tre gange ugentligt til én gang ugentligt.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Nplate in one or more subsets of the paediatric population in the treatment of immune thrombocytopenia (idiopathic thrombocytopenic purpura) (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med Nplate i en eller flere undergrupper af den pædiatriske population ved behandling af immun trombocytopeni (idiopatisk trombocytopenisk purpura) (se pkt.
English: It is not known whether romiplostim is present in human milk.
Danish: Det vides ikke, hvorvidt romiplostim udskilles i mælken hos mennesker.
English: Once the seal is broken, pull cover off to separate the grey rubber cap from the clear plastic tip on the syringe.
Danish: Når forseglingen er brudt, skal beskyttelsen trækkes af for at fjerne den grå gummihætte fra den gennemsigtige plastspids på sprøjten.
English: Reconstitution:
Danish: Rekonsitution:
English: Patients (≥ 18 years) were randomised in a 2:1 ratio to receive a starting dose of romiplostim 1 mcg/kg or placebo.
Danish: Patienterne (≥ 18 år) blev randomiseret i forholdet 2:1 til at modtage en initialdosis af romiplostim på 1 mikrog/kg eller placebo.
English: What you need to know before you use Nplate
Danish: Det skal De vide, før De begynder at bruge Nplate
English: Within each MedDRA system organ class and frequency grouping, undesirable effects are presented in order of decreasing incidence.
Danish: Inden for hver enkelt systemorganklasse i henhold til MedDRA og frekvensgruppe er bivirkningerne opstillet efter, hvor alvorlige de er.
English: Additional medical management may include cessation of anticoagulant and/or antiplatelet therapy, reversal of anticoagulation, or platelet support.
Danish: Yderligere medicinsk behandling kan omfatte seponering af koagulationshæmmende og/eller trombocytfunktionshæmmende behandling, ophævelse af den antikoagulerende virkning eller støtte af trombocytfunktion.
English: Upper abdominal pain***
Danish: Øvre abdominalsmerter***
English: If you have MDS and receive Nplate you may have an increase in your blast cell counts and your MDS condition may worsen to become an acute myeloid leukaemia, which is a type of cancer of the blood.
Danish: Hvis De har MDS og får Nplate, kan antallet af blastceller stige, og Deres MDS kan forværres og blive til akut myeloid leukæmi, som er en type kræft i blodet.
English: • Very slowly and gently push down on plunger rod to inject all water in the syringe into the vial.
Danish: • Skub meget langsomt og forsigtigt ned på stempelstangen for at injicere alt vand i sprøjten ind i hætteglasset.
English: • Inject the prescribed dose subcutaneously as directed by your doctor, nurse or pharmacist.
Danish: • Injicer den ordinerede dosis under huden efter lægens, sygeplejerskens eller apotekspersonalets anvisninger.
English: 184 confirmed adult patients were included in this study; for these patients, the incidence of binding antibody post treatment was 3.8% (7/184) to romiplostim, of which 0.5% (1/184) was positive for neutralising antibodies to romiplostim.
Danish: Der blev inkluderet 184 bekræftede voksne patienter i denne undersøgelse, og for disse patienter var forekomsten af bindende antistof efter behandling 3,8 % (7/184) mod romiplostim, hvoraf 0,5 % (1/184) var positive for neutraliserende antistoffer mod romiplostim.
English: The pharmacokinetics of romiplostim involved target-mediated disposition, which is presumably mediated by TPO receptors on platelets and other cells of the thrombopoietic lineage such as megakaryocytes.
Danish: Romiplostims farmakokinetik involverede target-medieret aflejring, hvilket antageligt medieres af TPO-receptorer på trombocytter og andre celler af trombopoietisk afstamning, såsom megakaryocytter.
English: The incidence of binding antibody post treatment was 16% (3/19) to romiplostim, of which 5.3% (1/19) were positive for neutralising antibodies to romiplostim.
Danish: Forekomsten af bindende antistof efter behandling var 16 % (3/19) mod romiplostim, hvoraf 5,3 % (1/19) var positive for neutraliserende antistoffer mod romiplostim.
English: The MAH shall agree the details of the following educational tools with the National Competent Authorities and must implement such programme nationally.
Danish: • Yderligere risikominimeringsforanstaltninger Indehaveren af markedsføringstilladelsen skal aftale indholdet i følgende uddannelsesværktøj med de relevante nationale myndigheder og implementere programmet nationalt.
English: Results of studies compared to standard of care (SOC) in non-splenectomised patients
Danish: Resultater af studier med sammenligning med standardbehandling hos ikke-splenektomerede patienter
English: The most serious adverse reactions that may occur during Nplate treatment include: reoccurrence of thrombocytopenia and bleeding after cessation of treatment, increased bone marrow reticulin, thrombotic/thromboembolic complications, medication errors and progression of existing MDS to AML.
Danish: De mest alvorlige bivirkninger, der kan opstå under behandling med Nplate, er: recidiv af trombocytopeni og blødning efter behandlingsophør, forhøjet knoglemarvsretikulin, trombotiske/tromboemboliske komplikationer, medicineringsfejl og progression af eksisterende MDS til AML.
English: c Number of weeks with platelet response is defined as number of weeks with platelet counts ≥ 50 x 109/L during study weeks 2-25.
Danish: c Antal uger med trombocytrespons defineres som antallet af uger med trombocyttal ≥ 50 x 109/l i uge 2-25 af undersøgelsen.
English: Very low platelet counts can cause bruising and serious bleeding.
Danish: Et meget lavt antal blodplader kan give blå mærker og forårsage alvorlig blødning.
English: Plunger rod for pre-filled sterile water syringe x1 Pre-filled sterile water syringe x1
Danish: Stempelstang til fyldt sprøjte med sterilt vand x1 Fyldt sprøjte med sterilt vand x1
English: Instructions for preparing and giving an injection of Nplate
Danish: Instruktioner til tilberedelse og indgivelse af en injektion med Nplate
English: • Do visually inspect the dissolved liquid for particles and/or discolouration.
Danish: • Kontrollér den opløste væske visuelt for partikler og/eller misfarvning.
English: Nplate should be used with caution in these populations.
Danish: Nplate skal anvendes med forsigtighed til disse patientgrupper.
English: The vial should not be shaken or vigorously agitated.
Danish: Hætteglasset må ikke rystes eller bevæges for meget.
English: • raised white blood cell count (leucocytosis);
Danish: • forhøjet antal hvide blodlegemer (leukocytose),
English: If you stop using Nplate, your low blood platelet count (thrombocytopenia) is likely to reoccur.
Danish: Hvis De ophører med at tage Nplate, vil Deres lave blodpladetal (trombocytopeni) sandsynligvis vende tilbage.
English: Gently tap the syringe with your fingers to separate the bubbles from the liquid.
Danish: Bank forsigtigt på sprøjten med fingrene for at adskille boblerne fra væsken.
English: *Actual body weight at initiation of treatment should always be used when calculating dose of romiplostim.
Danish: *Anvend altid den aktuelle legemsvægt ved behandlingsstart til beregning af romiplostim-dosis.
English: • Do not pull the plunger out of the back of the syringe.
Danish: • Træk ikke stemplet ud af bagsiden af sprøjten.
English: • Do not force the water into the vial.
Danish: • Vandet må ikke tvinges ind i hætteglasset.
English: Future dose adjustments are based on changes in platelet counts only and made in 1 mcg/kg increments (see table below).
Danish: Justeringer af dosis baseres derefter udelukkende på ændringer i trombocyttal og foretages i trin på 1 mikrog/kg (se tabel nedenfor).
English: The most frequently used weekly dose was between 3-5 mcg/kg (25th-75th percentile respectively; median 3 mcg/kg).
Danish: Den hyppigst anvendte ugentlige dosis var 3-5 mikrog/kg (henholdsvis 25.-75. percentil; median 3 mikrog/kg).
English: No adverse effects were seen in rats given a single dose of 1,000 mcg/kg or in monkeys after repeated administration of romiplostim at 500 mcg/kg (100 or 50 times the maximum clinical dose of 10 mcg/kg, respectively).
Danish: Der sås ingen bivirkninger hos rotter, som fik en enkelt dosis på 1.000 mikrog/kg, eller hos aber efter gentagen indgivelse af 500 mikrog/kg romiplostim (henholdsvis 100 eller 50 gange den maksimale kliniske dosis på 10 mikrog/kg).
English: If the expiry date has passed, do not use.
Danish: Brug ikke hvis udløbsdatoen er overskredet.
English: Nplate should be administered once weekly as a subcutaneous injection.
Danish: Nplate skal indgives én gang ugentligt som en subkutan injektion.
English: Nplate's active ingredient is romiplostim, which is a protein used to treat low platelet counts in patients with immune (idiopathic) thrombocytopenic purpura (called ITP).
Danish: Nplates aktive stof er romiplostim, som er et protein, som anvendes til at behandle lave blodpladetal hos patienter med immun (idiopatisk) trombocytopenisk purpura (kaldet ITP).
English: * see section 4.4 ** Hypersensitivity reactions including cases of rash, urticaria, and angioedema *** Additional adverse reactions observed in paediatric studies
Danish: 4.4 ** Overfølsomhedsreaktioner, herunder tilfælde af udslæt, urticaria og angioødem *** Yderligere bivirkninger, der blev observeret i pædiatriske undersøgelser
English: After injecting, activate the pink safety cover by pushing the cover forward using the same hand until you hear and/or feel it click/lock.
Danish: Efter injicering skal den lyserøde sikkerhedsbeskyttelse aktiveres ved at presse beskyttelsen frem med samme hånd, indtil De hører og/eller føler et klik.
English: Remove and discard vial adapter packaging.
Danish: Fjern og bortskaf hætteglasadapterens emballage.
English: Platelets are the cells in your blood that help seal cuts and form blood clots.
Danish: Blodplader er de celler i blodet, som hjælper med at lukke sår og fremme størkning af blodet.
English: Myocardial infarction Heart rate increased
Danish: Myokardieinfarkt Øget hjertefrekvens
English: The median (Q1, Q3) average weekly dose was 4.82 mcg/kg (1.88 mcg/kg, 8.79 mcg/kg).
Danish: Den gennemsnitlige (Q1, Q3) ugentlige dosis var 4,82 mikrog/kg (1,88 mikrog/kg, 8,79 mikrog/kg).
English: Dose calculation
Danish: Beregning af dosis
English: Note: Remove all air bubbles from syringe to ensure precise solution amount is in syringe.
Danish: Bemærk: Fjern alle luftbobler i sprøjten for at sikre det præcise volumen i sprøjten.
English: The injection device and Nplate vial must NEVER be reused.
Danish: Injektionsanordningen og hætteglasset med Nplate må ALDRIG genbruges.
English: Patients had a median of 3 (range, 1 to 7) treatments for ITP prior to study entry.
Danish: Patienterne havde som medianværdi fået tre (fra 1 til 7) behandlinger for ITP inden optagelse i undersøgelsen.
English: Similar to adults with ITP, romiplostim pharmacokinetics are highly variable in paediatric subjects with ITP and are not reliable and predictive.
Danish: Romiplostims farmakokinetik hos både voksne og pædiatriske forsøgspersoner er yderst variabel og er ikke pålidelig og forudsigelig.
English: All clinically significant (≥ grade 3) bleeding events occurred at platelet counts < 30 x 10
Danish: Alle klinisk signifikante (≥ grad 3) blødningshændelser forekom ved trombocyttal < 30 x 10
English: In study S5 (195), romiplostim concentrations were available from 17 subjects at doses ranging from 1 to 10 mcg/kg.
Danish: I undersøgelse S5 (195) var der romiplostimkoncentrationer tilgængelige fra 17 forsøgspersoner i dosisintervallet 1 til 10 mikrog/kg.
English: • Draw air into syringe to 1 mL marking.
Danish: • Træk luft ind i sprøjten til 1 ml-mærket.