FrancophonIA/ELRC3.0 huggingface dataset:
English: Clinical studies did not identify significant differences in steady state pharmacokinetic parameters or TTR reduction according to gender or race (non-Caucasian vs. Caucasian).
Danish: Kliniske studier identificerede ikke signifikante forskelle i farmakokinetiske parametre eller TTR-reduktion ved steady-state i henhold til køn eller race (ikke-kaukasisk vs. kaukasisk).
English: hATTR amyloidosis is caused by problems with a protein in the body called ‘transthyretin' (TTR).
Danish: hATTR amyloidose er forårsaget af problemer med et protein i kroppen, som kaldes “transthyretin” (TTR).
English: The diluted solution for infusion should be prepared by a healthcare professional using aseptic technique as follows:
Danish: Den fortyndede opløsning til infusion skal forberedes af sundhedspersonale ved brug af aseptisk teknik, som følger:
English: There were no significant differences in steady state pharmacokinetic parameters or TTR reduction between patients < 65 years of age and ≥ 65 years of age.
Danish: Der var ingen signifikante forskelle i farmakokinetiske parametre eller reduktion i TTR ved steady-state mellem patienter < 65 år og ≥ 65 år.
English: One additional patient had pre-existing anti-drug antibodies.
Danish: En patient mere havde forudeksisterende antistoffer mod lægemidlet.
English: If the infusion is interrupted, resumption of the infusion at a slower infusion rate may be considered after symptoms have resolved.
Danish: Hvis infusionen afbrydes, kan det overvejes at genstarte den ved en lavere infusionshastighed, efter symptomerne har fortaget sig.
English: Your doctor may tell you to stop taking Onpattro.
Danish: Lægen kan beslutte, at du skal stoppe med at tage Onpattro.
English: Onpattro has not been studied in patients with prior liver transplant; however, no dose adjustments are considered necessary.
Danish: Onpattro er ikke blevet undersøgt hos patienter med tidligere levertransplantation, men dosisjustering anses ikke for nødvendig.
English: Onpattro will reduce the level of vitamin A in your blood, which is important for normal development of your unborn child.
Danish: Onpattro nedsætter mængden af vitamin A i blodet, som er vigtigt for et ufødt barns normale udvikling.
English: • Withdraw the entire contents of one or more vials into a single sterile syringe.
Danish: • Træk hele indholdet af et eller flere hætteglas op i en enkelt steril injektionssprøjte.
English: • Reasons triggering HCPs to consider whether the patient should stop home infusions and return to the clinic to receive the infusions.
Danish: • omstændigheder som bør udløse, at sundhedspersonale overvejer, om patienten bør stoppe hjemmeinfusioner og vende tilbage til klinikken for at få infusionerne.
English: Both too high and too low levels of vitamin A can harm the development of your unborn child.
Danish: Både for høje og for lave niveauer af vitamin A kan have en skadelig virkning på udviklingen af det ufødte barn.
English: Plasma protein binding of Onpattro is low, with ≤ 2.1% binding observed in vitro with human serum albumin and human α1-acid glycoprotein.
Danish: Plasmaproteinbindingen af Onpattro er lav med ≤ 2,1 % binding observeret in vitro med humant serumalbumin og human α1-syre glykoprotein.
English: The active substance in Onpattro is patisiran.
Danish: Det aktive stof i Onpattro er patisiran.
English: Approximately half (53%) of patients had prior treatment with tafamidis meglumine or diflunisal.
Danish: Cirka halvdelen (53 %) af patienterne var tidligere blevet behandlet med tafamidismeglumin eller diflunisal.
English: Talk to your doctor about stopping breast-feeding or treatment with Onpattro.
Danish: Tal med lægen om at stoppe amning eller behandling med Onpattro.
English: Onpattro contains patisiran, a double-stranded small interfering ribonucleic acid (siRNA) that specifically targets a genetically conserved sequence in the 3' untranslated region of all mutant and wild-type TTR mRNA.
Danish: Onpattro indeholder patisiran, en dobbelt-strenget lille interfererende ribonukleinsyre (siRNA), som er specifikt rettet mod en genetisk bevaret sekvens i den 3' utranslaterede region af alle muterede og vildtype TTR mRNA.
English: Each of the following medicinal products should be given on the day of Onpattro infusion at least 60 minutes prior to the start of infusion:
Danish: Hver af de følgende lægemidler skal gives på dagen for infusion af Onpattro mindst 60 minutter inden start af infusion:
English: Onpattro is a white to off-white, opalescent, homogeneous solution.
Danish: Onpattro er en hvid til off-white, opaliserende, homogen opløsning.
English: In Onpattro-treated patients, all IRRs were either mild (95.2%) or moderate (4.8%) in severity.
Danish: Hos patienter behandlet med Onpattro var alle IRR'er enten af mild (95,2 %) eller moderat (4,8 %) sværhedsgrad.
English: The safety and efficacy of Onpattro in children or adolescents < 18 years of age have not been established.
Danish: Sikkerhed og virkning af Onpattro hos børn og unge under 18 år er endnu ikke klarlagt.
English: Close monitoring of the foetus should be carried out in the event of an unplanned pregnancy, especially during the first trimester (see section 4.4).
Danish: Fosteret skal monitoreres tæt i tilfælde af en ikke-planlagt graviditet, navnlig i det første trimester (se pkt.
English: Onpattro is given as a drip into a vein (called an ‘intravenous infusion').
Danish: Onpattro gives som et drop i en vene (kaldet en “intravenøs infusion”).
English: • The appropriate infusion rate;
Danish: • den passende infusionshastighed,
English: • Pain, redness, burning sensation, or swelling at or near the infusion site
Danish: • Smerter, rødme, brændende fornemmelse eller hævelse på eller nær infusionsstedet
English: There were no adverse effects on the pups.
Danish: Der blev ikke set nogen bivirkninger hos ungerne.
English: Antidrug antibody titres were low and transient with no evidence of an effect on clinical efficacy, the safety profile, or the pharmacokinetic or pharmacodynamic profiles of Onpattro.
Danish: Antistoftitre mod lægemidlet var lave og forbigående uden tegn på en indvirkning på klinisk effekt, sikkerhedsprofilen eller den farmakokinetiske eller farmakodynamiske profil af Onpattro.
English: Some patients who experience IRRs may benefit from a slower infusion rate or additional or higher doses of one or more of the premedications with subsequent infusions to reduce the risk of IRRs.
Danish: Nogle patienter, som får IRR'er, kan have gavn af en langsommere infusionshastighed eller flere eller højere doser af en eller flere præmedikamenter med efterfølgende infusioner for at reducere riskoen for IRR'er.
English: Vitamin A supplementation should be discontinued during the first trimester, unless the pregnant woman has clinical signs of vitamin A deficiency.
Danish: Tilskud af vitamin A skal seponeres under første trimester medmindre den gravide kvinde har kliniske tegn på A-vitaminmangel.
English: Patients were randomised 2:1 to receive 300 micrograms per kg Onpattro or placebo via intravenous infusion once every 3 weeks for 18 months.
Danish: Patienter blev randomiseret i et forhold på 2:1 til at få Onpattro 300 mikrogram per kg eller placebo via intravenøs infusion en gang hver 3. uge i 18 måneder.
English: N-terminal pro-B type natriuretic peptide (NT-proBNP) was 727 ng/L and 711 ng/L at baseline (geometric mean) in Onpattro-treated and placebo-treated patients, respectively.
Danish: N-terminal pro-B-type natriuretisk peptid (NTproBNP) var 727 ng/l og 711 ng/l ved baseline (geometrisk gennemsnit) hos patienter behandlet med hhv. Onpattro og placebo.
English: The MAH shall ensure that in each MS where Onpattro is marketed, all health care professionals (HCPs) and patients are provided with educational materials in order to ensure the safe and sustainable administration of the product in the home setting, aiming at preventing and/or minimising the important identified risk of Infusion Related Reactions (IRRs).
Danish: MAH skal sikre sig, at alle relevante sundhedspersoner og patienter i hver medlemsstat, hvor Onpattro markedsføres, har fået undervisningsmateriale for at sikre, at administration af produktet i hjemmet sker på en sikker og holdbar måde, for at forebygge og/eller minimere den vigtige, identificerede risiko for infusionsrelaterede reaktioner (IRR).
English: Changes were also seen at 9 months, the first post-baseline assessment in the study, where treatment with Onpattro led to a 16.0-point treatment difference, with a mean change from baseline of -2.0 points, compared to an increase of 14.0 points with placebo.
Danish: Der blev også set ændringer efter 9 måneder, den første vurdering efter baseline i studiet, hvor behandling med Onpattro gav en behandlingsforskel på 16,0-point med en middelændring fra baseline på -2,0 point sammenlignet med en stigning på 14,0 point med placebo.
English: All patients received premedication with a corticosteroid, paracetamol, and H1 and H2 blockers.
Danish: Alle patienter fik præmedikation med et kortikosteroid, paracetamol, og H1- og H2-blokkere.
English: The key secondary endpoint was the change from baseline to 18 months in Norfolk Quality of LifeDiabetic Neuropathy (QoL-DN) total score.
Danish: Det vigtigste sekundære endepunkt var ændring fra baseline efter 18 måneder i Norfolk Quality of Life-Diabetic Neuropathy (QoL-DN) total score.
English: • The patient should be observed during the infusion and, if clinically indicated, following the infusion.
Danish: • Patienten skal iagttages under infusion og, hvis det er klinisk indiceret, efter infusion.
English: 4.7 Effects on ability to drive and use machines On the basis of the pharmacodynamic and pharmacokinetic profiles, Onpattro is considered to have no or negligible influence on the ability to drive or use machines.
Danish: 4.7 Virkning på evnen til at føre motorkøretøj og betjene maskiner På baggrund af den farmkodynamiske og den farmakokinetiske profil anses Onpattro ikke at påvirke eller kun i ubetydelig grad at påvirke evnen til at føre motorkøretøj eller betjene maskiner.
English: The most frequently occurring adverse reactions reported in Onpattro-treated patients were peripheral oedema (29.7%) and infusion-related reactions (18.9%).
Danish: De hyppigst rapporterede bivirkninger rapporteret hos patienter behandlet med Onpattro var perifert ødem (29,7 %) og infusionsrelaterede reaktioner (18,9 %).
English: • Cough, feeling short of breath, or other breathing problems
Danish: • Hoste, åndenød eller andre vejrtrækningsproblemer
English: This medicine contains 3.99 milligrams (mg) of sodium (main component of cooking/table salt) per millilitre (mL).
Danish: Lægemidlet indeholder 3,99 milligram (mg) natrium (hovedkomponenten i bordsalt) per milliliter (ml).
English: Thereafter, vitamin A supplementation of 2500 IU per day should be resumed in the second and third trimesters if serum vitamin A levels have not returned to normal, because of the increased risk of vitamin A deficiency in the third trimester.
Danish: Derefter skal tilskud af vitamin A på 2.500 IE per dag genoptages i andet og tredje trimester, hvis serumniveauer af vitamin A endnu ikke er vendt tilbage til det normale, på grund af den forhøjede risiko for A-vitaminmangel i tredje trimester.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Danish: Inden for hver hyppighedsgruppering vises bivirkninger efter aftagende sværhedsgrad.
English: • Calculate the required volume of Onpattro based on the recommended weight-based dosage.
Danish: • Beregn det påkrævede volumen af Onpattro ud fra den anbefalede vægtbaserede dosis.
English: The primary efficacy endpoint was the change from baseline to 18 months in modified Neuropathy Impairment Score +7 (mNIS+7).
Danish: Det primære effektendepunkt var ændring fra baseline til 18 måneder i modificeret Neuropathy Impairment Score +7 (mNIS+7).
English: Among Onpattro-treated patients who experienced an IRR, 78.6% experienced the first IRR within the first 2 infusions.
Danish: Blandt patienter behandlet med Onpattro, som havde en IRR, havde 78,6 % deres første IRR i forbindelse med de første 2 infusioner.
English: If you miss your dose of Onpattro
Danish: Hvis du har glemt at få din dosis af Onpattro
English: Placebo N=77
Danish: Placebo N=77 Onpattro Placebo
English: During the first 60 days of pregnancy, both too high or too low vitamin A levels may be associated with an increased risk of foetal malformation.
Danish: I graviditetens første 60 dage kan både for høje og for lave niveauer af vitamin A være forbundet med en forøget risiko for føtale misdannelser.
English: The mean ± SD terminal elimination half-life (t1/2β) of patisiran was 3.2 ± 1.8 days.
Danish: Patisirans gennemsnitlige ± SD terminale halveringstid (t1/2β) var 3,2 ± 1,8 dage.
English: There was no accumulation of AUCτ at steady-state compared to the first dose.
Danish: Der var ingen akkumulering af AUCτ ved steady-state sammenlignet med den første dosis.
English: • Filter Onpattro through a sterile 0.45 micron polyethersulfone (PES) syringe filter into a sterile container.
Danish: • Filtrér Onpattro gennem et sterilt 0,45-mikron polyethersulfon (PES) filter til injektionssprøjten ind i en steril beholder.
English: For clinical management of IRRs, see section 4.4.
Danish: For klinisk behandling af IRR'er, se pkt.
English: Patients receiving Onpattro should take oral supplementation of approximately 2500 IU vitamin A per day to reduce the potential risk of ocular toxicity due to vitamin A deficiency.
Danish: Patienter, som får Onpattro, skal tage oralt tilskud med cirka 2.500 IE vitamin A dagligt for at reducere den potentielle risiko for okulær toksicitet på grund A-vitaminmangel.
English: PEG2000-C-DMG excretion in humans was not measured.
Danish: Udskillelse af PEG2000-C-DMG hos mennesker blev ikke målt.
English: • In people with this illness, abnormally shaped TTR proteins clump together to make deposits called ‘amyloid'.
Danish: • Hos patienter med denne sygdom klumper unormalt formede TTR proteiner sig sammen og producerer aflejringer, som kaldes “amyloid”.
English: Marketing Authorisation Holder Alnylam Netherlands B.V.
Danish: Indehaver af markedsføringstilladelsen Alnylam Netherlands B.V.
English: Therapy should be initiated under the supervision of a physician knowledgeable in the management of amyloidosis.
Danish: Behandling skal initieres under opsyn af en læge med erfaring i behandling af amyloidose.
English: If an IRR occurs, slowing or interrupting the infusion and institution of medical management (e.g., corticosteroids or other symptomatic treatment) should be considered, as clinically indicated.
Danish: Hvis en IRR skulle forekomme, bør det overvejes at reducere infusionshastigheden eller afbryde infusionen og starte medicinsk behandling (f.eks. kortikosteroider eller anden symptomatisk behandling), som det er klinisk indiceret.
English: DLin-MC3-DMA is primarily metabolised to 4-dimethylaminobutyric acid (DMBA) by hydrolysis.
Danish: DLin-MC3-DMA metaboliseres primært til 4-dimethylamino-smørsyre (DMBA) via hydrolyse.
English: Therefore, women of child-bearing age should not be pregnant when starting treatment with Onpattro and should practice effective contraception (see section “Pregnancy, breast-feeding and contraception” below).
Danish: Kvinder i den fødedygtige alder må derfor ikke være gravide, når de starter behandlingen med Onpattro og skal bruge sikker prævention (se nedenstående punkt ”Graviditet, amning og prævention”).
English: The Norfolk QoL-DN questionnaire (patient-reported) includes domains relating to small fibre, large fibre, and autonomic nerve function, symptoms, and activities of daily living, with the total score ranging from -4 to 136, where an increasing score indicates worsening quality of life.
Danish: Norfolk QoL-DN spørgeskemaet (patientrapporteret) inkluderer domæner relateret til funktionen af små og store nervefibre samt autonom nervefunktion, symptomer og almindelige dagligdags aktiviteter med en total score mellem -4 og 136, hvor en stigende score angiver forværring af livskvalitet.
English: • Onpattro must be diluted prior to intravenous infusion.
Danish: • Onpattro skal fortyndes inden intravenøs infusion.
English: In general, all findings observed at the end of dosing in the rat and monkey toxicity studies had either a full recovery or were observed with reduced severity at the end of the 60-90 day recovery period, indicating at least partial reversibility.
Danish: Generelt blev der hos alle fund, som blev observeret ved afslutning af dosering i toksicitetsundersøgelser hos rotter og aber, enten observeret fuld restitution eller nedsat sværhedsgrad ved udgangen af restitutionsperioden på 60-90 dage.
English: Through a natural process called RNA interference (RNAi), patisiran causes the catalytic degradation of TTR mRNA in the liver, resulting in a reduction of serum TTR protein.
Danish: Gennem en naturlig proces kaldet RNA-interferens (RNAi), forårsager patisiran katalytisk nedbrydning af TTR mRNA i leveren, hvilket resulterer i en reduktion af TTR protein i serum.
English: • Onpattro is a white to off-white, opalescent, homogeneous concentrate for solution for infusion.
Danish: • Onpattro er et hvidt til off-white, opaliserende, homogent koncentrat til infusionsvæske,
English: Patisiran is formulated as lipid nanoparticles to deliver the siRNA to hepatocytes, the primary source of TTR protein in the circulation.
Danish: Patisiran er formuleret som lipidnanopartikler med henblik på at levere siRNA til hepatocytter, hovedkilden til TTR protein i kredsløbet.
English: The efficacy of Onpattro was studied in a randomised, double-blind, placebo-controlled study in 225 hATTR amyloidosis patients with a TTR mutation and symptomatic polyneuropathy.
Danish: Effekten af Onpattro blev undersøgt i et randomiseret, dobbeltblindet, placebokontrolleret studie hos 225 patienter med hATTR amyloidose med en TTR-mutation og symptomatisk polyneuropati.
English: In rabbits, Onpattro generated spontaneous abortions, reduced embryo-foetal survival, and reduced foetal body weights at maternally toxic doses ≥ 1 mg/kg (HED 3.2 times the RHD).
Danish: Hos kaniner forårsagede Onpattro spontane aborter, reduceret embryo-føtal overlevelse, og reduceret fostervægt ved maternelt toksiske doser ≥ 1 mg/kg, (HED 3,2 gange RHD).
English: • Gently invert the bag to mix the solution.
Danish: • Vend forsigtigt posen for at blande opløsningen.
English: In rats and monkeys, PEG2000-C-DMG is eliminated unchanged in the bile.
Danish: Hos rotter og aber elimineres PEG2000-C-DMG uændret i galden.
English: Treatment with Onpattro lowers the amount of vitamin A in your blood.
Danish: Behandling med Onpattro reducerer mængden af vitamin A i blodet.
English: If you have an infusion-related reaction, your doctor or nurse may slow down or stop your infusion, and you may need to take other medicines to control the symptoms.
Danish: Hvis du har en infusionsrelateret reaktion, vil din læge eller sygeplejerske muligvis stoppe eller reducere hastigheden af din infusion, og du skal muligvis tage andre lægemidler for at behandle symptomerne.
English: Baseline, Mean (SD)
Danish: Baseline, gennemsnit (SD)
English: • Patients to inform immediately the HCP if they experience any of the signs and symptoms of IRRs.
Danish: • at patienterne straks skal informere sundhedspersonalet, hvis de oplever tegn og symptomer på
English: Across clinical studies, the most common symptoms (reported in ≥ 2% of patients) of IRRs were flushing, back pain, nausea, abdominal pain, dyspnoea, and headache.
Danish: På tværs af kliniske studier var de mest almindelige symptomer (rapporteret hos ≥ 2 % af patienterne) på IRR'er rødmen, rygsmerter, kvalme, mavesmerter, dyspnø og hovedpine.
English: Approximately half of patients (56%) met pre-defined criteria for cardiac involvement (defined as baseline LV wall thickness ≥ 13 mm with no history of hypertension or aortic valve disease).
Danish: Omtrent halvdelen af patienterne (56%) opfyldte prædefinerede kriterier for involvering af hjertet (defineret som tykkelse af venstre ventrikelvæg ≥ 13 mm ved baseline uden hypertension eller aortaklapsygdom i anamnesen).
English: Ninetythree percent (93%) of Onpattro-treated and 62% of placebo-treated patients completed 18 months of the assigned treatment.
Danish: Treoghalvfems (93 %) af patienter behandlet med Onpattro og 62 % af patienter behandlet med placebo fuldførte 18 måneder af den tildelte behandling.
English: The duration of infusion may be extended in the event of an IRR.
Danish: Infusionsvarigheden kan forlænges i tilfælde af en IRR.
English: Your doctor will ask you to take a daily vitamin A supplement during treatment with Onpattro.
Danish: Lægen vil bede dig tage et dagligt tilskud af vitamin A, mens du behandles med Onpattro.
English: As a precautionary measure, vitamin A and thyroid stimulating hormone (TSH) levels should be obtained early in pregnancy (see section 5.3).
Danish: Som sikkerhedsforanstaltning skal niveauer af thyroideastimulerende hormon (TSH) måles tidligt i graviditeten (se pkt.
English: Serum TTR is a carrier of retinol binding protein, which facilitates transport of vitamin A in the blood.
Danish: Serum TTR er en bærer af retinol-bindende protein, som fremmer transport af vitamin A i blodet.
English: Treatment with Onpattro reduces serum levels of vitamin A. Both too high or too low vitamin A levels may be associated with an increased risk of foetal malformation.
Danish: Behandling med Onpattro reducerer serumniveauer af vitamin A. Både for høje og for lave niveauer af vitamin A kan være forbundet med en forøget risiko for føtale misdannelser.
English: Do not use this medicine after the expiry date which is stated on the carton after ‘EXP'.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Onpattro works by lowering the amount of TTR protein that the liver makes.
Danish: Onpattro virker ved at reducere mængden af TTR protein, som leveren fremstiller.
English: This endpoint is a composite measure of motor, sensory, and autonomic polyneuropathy including assessments of motor strength and reflexes, quantitative sensory testing, nerve conduction studies, and postural blood pressure, with the score ranging from 0 to 304 points, where an increasing score indicates worsening impairment.
Danish: Endepunktet er et sammensat mål af motorisk, sensorisk og autonom polyneuropati, herunder vurderinger af motorisk styrke og reflekser, kvantitativ sensorisk testning, nerveledningsundersøgelser og ortostatisk hypotension med en score mellem 0 og 304 point, hvor en stigende score angiver tiltagende svækkelse
English: Onpattro is indicated for the treatment of hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis) in adult patients with stage 1 or stage 2 polyneuropathy.
Danish: Onpattro er indiceret til behandling af hereditær transthyretin-medieret amyloidose (hATTR amyloidose) hos voksne patienter med polyneuropati, stadie 1 og 2.
English: In spleen, lymphoid atrophy/necrosis and histiocytosis in the white pulp was observed in rats and hypocellularity of the red pulp was observed in monkeys.
Danish: I milten sås lymfeatrofi/nekrose og histiocytose i den hvide pulpa hos rotter og hypocellularitet blev observeret i den røde pulpa hos aber.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 27 August 2018
Danish: Dato for første markedsføringstilladelse: 27 august 2018 10.
English: At 18 months, the adjusted geometric mean ratio to baseline was 0.89 with Onpattro and 1.97 with placebo (ratio, 0.45; p < 0.001), representing a 55% difference in favour of Onpattro.
Danish: Ved 18 måneder var den justerede geometriske gennemsnitsratio i forhold til baseline på 0,89 med Onpattro og 1,97 med placebo (ratio, 0,45; p < 0,001), hvilket repræsenterer en forskel på 55 % til fordel for Onpattro.