FrancophonIA/ELRC3.0 huggingface dataset:
English: The following adverse reactions were reported in patients treated with alirocumab in pooled controlled studies and/or post-marketing use (see Table 1).
Danish: Følgende bivirkninger blev rapporteret hos patienter behandlet med alirocumab i poolede kontrollerede studier og/eller efter markedsføring (se tabel 1).
English:  Look at the label on the pen.
Danish:  Læs etiketten på pennen.
English: The dose of Praluent can be individualised based on patient characteristics such as baseline LDL-C level, goal of therapy, and response.
Danish: Dosis af Praluent kan tilpasses den enkelte patient baseret på patientkarakteristika så som baseline LDL-C niveau, mål for behandlingen og respons.
English: Statins and other lipid-modifying therapy are known to increase production of PCSK9, the protein targeted by alirocumab.
Danish: Statiner og anden lipidmodificerende behandling er kendt for at øge produktionen af PCSK9, som er det protein alirocumab er rettet imod.
English: • Praluent is a monoclonal antibody (a type of specialised protein designed to attach to a target substance in the body).
Danish: • Praluent er et monoklonalt antistof (en type af specialiseret protein designet til at binde til et specifikt stof i kroppen).
English: The discontinuation rate due to local injection site reactions was comparable between the two groups (0.2% in the alirocumab group versus 0.3% in the control group).
Danish: Seponeringshyppigheden på grund af lokale reaktioner ved injektionsstedet var sammenlignelig de to grupper imellem (0,2 % i alirocumab-gruppen versus 0,3 % i kontrolgruppen).
English: After removal from the refrigerator, Praluent must be used within 30 days or discarded.
Danish: Efter udtagning fra køleskab skal Praluent bruges inden for 30 dage eller bortskaffes.
English: • Do not heat the syringe, let it warm up on its own.
Danish: • Du må ikke opvarme sprøjten, lad den selv blive varm.
English: In genetic studies in humans, PCSK9 variants with either loss-of-function or gain-of-function mutations have been identified.
Danish: I genetiske studier i mennesker er der identificeret PCSK9-varianter med enten loss of function-mutationer eller gain of function-mutationer.
English: A concentration-dependent reduction in free PCSK9 and LDL-C is observed until target saturation is achieved.
Danish: En koncentrationsafhængig reduktion i frit PCSK9 og LDL-C kan observeres, indtil den ønskede mætning er nået.
English: <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000) and not known (cannot be estimated from the available data).
Danish: Hyppighederne er defineret som: meget almindelig (≥ 1/10), almindelig (≥ 1/100 til <1/10), ikke almindelig (≥ 1/1.000 til <1/100), sjælden (≥1/10.000 til <1/1.000), meget sjælden (<1/10.000) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Talk to your doctor, pharmacist or nurse about all your medical conditions, including allergies, before using Praluent.
Danish: Kontakt lægen, apotekspersonalet eller sundhedspersonalet vedrørende dine sygdomme, herunder allergier, før du bruger Praluent.
English: • Adults with high cholesterol levels in their blood and with cardiovascular disease to reduce cardiovascular risk.
Danish: • Voksne med højt kolesterolniveau i blodet og hjertekarsygdom for at mindske risikoen for hjertekar-hændelser.
English: • Take the syringe out of the packaging by holding the syringe body.
Danish: • Tag sprøjten ud af pakningen ved at tage fat om cylinderen.
English: ODYSSEY OUTCOMES study
Danish: ODYSSEY OUTCOMES-studiet
English: In animal studies, there were no adverse effects on surrogate markers of fertility (see section 5.3).
Danish: I dyrestudier var der ingen ændringer af surrogatmarkører for fertilitet (se pkt.
English: However, maternal toxicity was noted in pregnant rats at systemic exposures estimated to be approximately 5.3 times greater than the human exposure at the 150 mg Q2W dose (based on exposure measured in non-pregnant rats during a 5-week toxicology study).
Danish: Der blev imidlertid observeret maternal toksicitet i drægtige rotter ved systemiske eksponeringer, der blev estimeret til at være ca. 5,3 gange højere end den humane eksponering ved en dosis på 150 mg hver 2. uge (baseret på eksponering målt i ikkedrægtige rotter under et toksikologistudie af 5 ugers varighed).
English: Urticaria, eczema nummular
Danish: Urticaria, nummulat eksem
English: The usual starting dose for Praluent is 75 mg administered subcutaneously once every 2 weeks.
Danish: Den sædvanlige startdosis for Praluent er 75 mg administreret subkutant én gang hver 2. uge.
English: Tell your doctor if you have kidney or liver disease before using this medicine, because Praluent has been studied in few patients with severe kidney disease and not in patients with severe liver disease.
Danish: Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før du bruger dette lægemiddel, hvis du har nyre- eller leversygdom, fordi Praluent er undersøgt i få patienter med alvorlig nyresygdom og ikke i patienter med alvorlig leversygdom.
English: Alirocumab is a fully human IgG1 monoclonal antibody that binds with high affinity and specificity to proprotein convertase subtilisin kexin type 9 (PCSK9).
Danish: Alirocumab er et fuldt humant IgG1 monoklonalt antistof, som bindes med høj affinitet og specificitet til proprotein convertase subtilisin kexin type 9 (PCSK9).
English: ITT analysis - intent-to-treat population, includes all lipid data throughout the duration of the study irrespective of adherence to the study treatment.
Danish: ITT-analyse - intention-to-treat population, inkluderer alle lipiddata i studiets forløb uanset overholdelse af studiebehandlingen b ”
English: PCSK9 binds to the low-density lipoprotein receptors (LDLR) on the surface of hepatocytes to promote LDLR degradation within the liver.
Danish: PCSK9 binder til lavdensitetslipoprotein-receptorerne (LDLR) på hepatocytternes overflade for at fremme LDLR-nedbrydning i leveren.
English: Reduction in LDL-C was seen across age, gender, body mass index (BMI), race, baseline LDL-C levels, patients with heFH and non-heFH, patients with mixed dyslipidaemia, and diabetic patients.
Danish: Reduktion i LDL-C blev observeret på tværs af alder, køn, body mass index (BMI), race, LDL-C-koncentration ved baseline, patienter med og uden heFH, patienter med kombineret dyslipidæmi og patienter med diabetes.
English: If you develop a serious allergic reaction, stop using Praluent , talk to your doctor right away.
Danish: Hvis du får en alvorlig allergisk reaktion, skal du stoppe med at bruge Praluent, og straks tale med din læge.
English: The primary efficacy endpoint in all of the phase 3 studies was the mean percent reduction from baseline in LDL-C at week 24 as compared to placebo or ezetimibe.
Danish: Det primære effektmål i alle fase 3 studierne var den gennemsnitlige procentvise reduktion i LDL-C fra baseline ved uge 24 sammenlignet med placebo eller ezetimibe.
English: • Adults with high cholesterol levels in their blood (hypercholesterolaemia, heterozygous familial and non-familial, or mixed dyslipidaemia).
Danish: • Voksne med højt kolesterolniveau i blodet (hyperkolesterolæmi, heterozygot familiær og non familiær, eller kombineret dyslipidæmi).
English: A multicentre, double-blind, placebo-controlled trial included 18,924 adult patients (9462 alirocumab; 9462 placebo) followed for up to 5 years.
Danish: Et dobbeltblindt, placebokontrolleret multicenterstudie omfattede 18.924 voksne patienter (9.462 alirocumab; 9.462 placebo), som blev fulgt i op til 5 år.
English: • Do not use any area near a visible vein.
Danish: • Du må ikke injicere i områder nær en synlig blodåre.
English: At low concentrations, the elimination is predominately through saturable binding to target (PCSK9), while at higher concentrations the elimination of alirocumab is largely through a non-saturable proteolytic pathway.
Danish: Ved lave koncentrationer sker eliminationen hovedsageligt gennem mættet binding til målet (PCSK9), mens eliminationen af alirocumab ved højere koncentrationer primært sker gennem umættet proteolytisk pathway.
English: If you stop using Praluent
Danish: Hvis du holder op med at bruge Praluent
English: Do not use the pen if it has been dropped or damaged.
Danish: Du må ikke bruge pennen, hvis den er blevet tabt eller beskadiget.
English: A reduction of all-cause mortality was also observed, with only nominal statistical significance by hierarchical testing (HR 0.85, 95% CI: 0.73, 0.98).
Danish: Der blev ligeledes observeret en reduktion i samlet mortalitet af kun nominel statistisk signifikans i hierakiske tests (HR 0,85, 95 % KI: 0,73; 0,98).
English: • Check the liquid is clear, colourless to pale yellow and free from particles; if not, do not use.
Danish: • Kontroller at væsken er klar, farveløs til svag gul og uden partikler; hvis den ikke er det, må du ikke bruge den.
English: STEP A: Getting ready for an injection
Danish: TRIN A: Klargøring af en injektion
English: Alirocumab also results in reductions in lipoprotein (a) [Lp(a)], which is a form of LDL that is bound to apolipoprotein (a).
Danish: Alirocumab resulterer også i reduktion af lipoprotein (a) [Lp(a)], som er en type LDL, der bindes til apolipoprotein (a).
English: Always check the label of your syringe to make sure you have the right medicine and the right strength.
Danish: Du skal altid læse etiketten på sprøjten for at sikre dig, at du tager den rigtige medicin og den rigtige styrke.
English: Do not give yourself a second dose without speaking to your doctor, pharmacist or nurse.
Danish: Du må ikke give dig selv en ekstra dosis, uden at tale med lægen, apotekspersonalet eller sundhedspersonalet.
English: Figure 1 Primary Composite Endpoint Cumulative Incidence Over 4 Years in ODYSSEY OUTCOMES
Danish: Figur 1 Primært sammensat endepunkt for samlet forekomst over 4 år i ODYSSEY OUTCOMES
English: • Always use the pen as described in the “Instructions for Use”.
Danish: • Brug altid pennen som beskrevet i “Brugsanvisningen”.
English: In clinical studies, there was limited representation of patients with severe renal impairment (defined as eGFR < 30 mL/min/1.73 m2) (see section 5.2).
Danish: I kliniske studier var der begrænset repræsentation af patienter med svært nedsat nyrefunktion (defineret som eGFR < 30 ml/min/1,73 m2) (se pkt.
English: • Check the liquid is clear, colourless to pale yellow and free from particles - if not, do not use (see picture A).
Danish: • Kontroller at væsken er klar, farveløs til svag gul og uden partikler - hvis den ikke er det, må du ikke bruge den (se billede A).
English: Most common adverse reactions leading to treatment discontinuation in patients treated with Praluent were local injection site reactions.
Danish: De mest almindelige bivirkninger der medførte seponering af behandlingen hos patienter, der blev behandlet med Praluent, var lokale reaktioner ved injektionsstedet.
English: The pharmacodynamic effect of alirocumab in lowering LDL-C is indirect, and mediated through the binding to PCSK9.
Danish: Alirocumabs farmakodynamiske effekt, der sænker LDL-C, er indirekte og medieret gennem binding til PCSK9.
English: • By blocking PCSK9, Praluent increases the number of receptors available to help remove the “bad”
Danish: • Ved at hæmme PCSK9 øger Praluent antallet af de receptorer, der kan medvirke til at fjerne det
English: Monthly exposure with 300 mg every 4 weeks treatment was similar to that of 150 mg every 2 weeks.
Danish: Månedlig eksponering med behandling med 300 mg hver 4. uge var sammenlignelig med 150 mg hver 2. uge.
English: Injection site reactions**
Danish: Reaktioner ved injektionsstedet**
English: 1 ml solution in a siliconised Type 1 clear glass syringe, equipped with a stainless steel staked needle, a styrene-butadiene rubber soft needle shield, and an ethylene tetrafluoroethylene -coated bromobutyl rubber plunger stopper.
Danish: 1 ml opløsning i en silikoniseret Type 1 klar glassprøjte med en rustfri stålkanyle, en blød styren-butadiengummi kanylehætte og en ethylentetrafluoroethylen-film-coated bromobutyl gummi stempelstopper.
English: Follow these instructions every time you use a Praluent pen.
Danish: Følg disse anvisninger hver gang du bruger en Praluent-pen.
English: 4.5 Interaction with other medicinal products and other forms of interaction
Danish: 4.5 Interaktion med andre lægemidler og andre former for interaktion Alirocumabs effekt på andre lægemidler
English: • Check that you have the correct product and the correct dose (green plunger for 75 mg/ml).
Danish: • Kontroller at du har det rigtige produkt og den korrekte dosis (grønt stempel på 75 mg/ml).
English: Blue cap
Danish: Blå hætte
English: Mean Percent Change from Baseline in Ezetimibe-Controlled Studies On Background Statin
Danish: Gennemsnitlig procentvis ændring fra baseline i ezetimibe-kontrollerede studier Med statin som baggrundsbehandling
English: The offspring of monkeys that received high doses of alirocumab weekly throughout pregnancy had a weaker secondary immune response to antigen challenge than did the offspring of control animals.
Danish: Afkom af aber, som fik høje doser alirocumab hver uge under hele drægtighedsperioden, havde et svagere sekundært immunrespons ved eksponering for antigen sammenlignet med afkommet af kontroldyr.
English: If you forget to use Praluent
Danish: Hvis du har glemt at bruge Praluent
English:  Prepare the injection site.
Danish:  Klargøring af injektionsstedet.
English: Mean changes for all other lipids/ lipoproteins were similar to the FH I and FH II studies, however statistical significance was not reached for TG, HDL-C and Apo A-1.
Danish: Gennemsnitlige ændringer for alle andre lipider/ lipoproteiner svarede til FH Iog FH II-studierne, men statistisk signifikans blev ikke nået for TG, HDL-C og Apo A-1.
English: Table 1 - Adverse Reactions reported in patients treated with alirocumab in controlled studies and post-marketing use
Danish: Tabel 1 - Bivirkninger rapporteret hos patienter, der blev behandlet med alirocumab i kontrollerede studier og efter markedsføring
English: COMBO II study
Danish: COMBO II-studiet
English: Compared to alirocumab monotherapy, the exposure to alirocumab is about 40%, 15%, and 35% lower when used concomitantly with statins, ezetimibe, and fenofibrate, respectively.
Danish: Sammenlignet med alirocumab som monoterapi er eksponering af alirocumab ca. 40 %, 15 % og 35 % lavere, når det anvendes samtidig med henholdvis statiner, ezetimibe og fenofibrat.
English: • Do not put the syringe back in the refrigerator.
Danish: • Du må ikke lægge sprøjten tilbage i køleskabet.
English: It is given: - together with a statin (a commonly used medicine that treats high cholesterol) or other cholesterol lowering medicines, if the maximum dose of a statin does not lower levels of cholesterol sufficiently or, - alone or together with other cholesterol lowering medicines when statins are not tolerated or cannot be used.
Danish: Det gives: - sammen med et statin (almindelig anvendt medicin, til behandling af forhøjet kolesterol) eller anden kolesterolsænkende medicin, hvis den maksimale dosis af et statin ikke sænker niveauet af kolesterol tilstrækkeligt, eller, - alene eller sammen med anden kolesterolsænkende medicin, når statiner ikke tolereres eller ikke kan anvendes.
English: Do not freeze the pen.
Danish: Du må ikke nedfryse pennen.
English: Anti-drug antibody responses, including NAb, were low titer and did not appear to have a clinically meaningful impact on the efficacy or safety of alirocumab, except for a higher rate of injection site reactions in patients with treatment emergent ADA compared to patients who were ADA negative (7.5% vs 3.6%).
Danish: ADA-respons, inklusive Nab, var lav titer og syntes ikke at have en klinisk betydningsfuld indvirkning på alirocumabs sikkerhed eller virkning, med undtagelse af en højere hyppighed af reaktioner ved injektionsstedet hos patienter med behandlingsrelateret ADA i forhold til patienter, som var ADA-negative (7,5 % versus 3,6 %).
English: Local injection site reactions, including erythema/redness, itching, swelling, and pain/tenderness, were reported in 6.1% of patients treated with alirocumab versus 4.1% in the control group (receiving placebo injections).
Danish: Lokale reaktioner ved injektionsstedet, inklusive erytem/rødme, kløe, hævelse og smerter/ømhed, blev rapporteret hos 6,1 % af de patienter, der blev behandlet med alirocumab versus 4,1 % i kontrolgruppen (som fik placeboinjektioner).
English: Alirocumab is a recombinant IgG1 antibody, therefore it is expected to cross the placental barrier (see section 5.3).
Danish: Alirocumab er et rekombinant IgG1 antistof og det forventes derfor at passere placentabarrieren (se pkt.
English: • Do not inject Praluent with other injectable medicines at the same spot.
Danish: • Injicer ikke Praluent sammen med anden medicin på samme sted.
English: Body weight No dose adjustment is needed in patients based on weight.
Danish: Kropsvægt Dosisjustering er ikke nødvendig baseret på patientens vægt.
English: Most injection site reactions were transient and of mild intensity.
Danish: Størstedelen af reaktionerne ved injektionsstedet var forbigående og milde.
English: Two studies (LONG TERM and HIGH FH), involving a total of 2416 patients, were performed with a 150 mg every 2 weeks (Q2W) dose only.
Danish: To studier (LONG TERM og HIGH FH) med i alt 2416 patienter blev udført med kun én dosis på 150 mg hver 2. uge.
English: Alirocumab is a human IgG1 monoclonal antibody produced in Chinese Hamster Ovary cells by recombinant DNA technology.
Danish: Alirocumab er et humant IgG1 monoklonalt antistof fremstillet ved rekombinant DNA-teknologi i ovarieceller fra kinesiske hamstre.
English: The results are presented in Table 3.
Danish: Resultaterne er vist i tabel 3.
English: In in vitro assays, alirocumab did not induce Fc-mediated effector function activity (antibody-dependent cell-mediated toxicity and complement-dependent cytotoxicity) either in the presence or absence of PCSK9 and no soluble immune complexes capable of binding complement proteins were observed for alirocumab when bound to PCSK9.
Danish: I in vitro analyser inducerede alirocumab ikke Fc-medieret aktivitet for effektorfunktion (antistofafhængig cellemedieret toksicitet og komplement-afhængig cytotoksicitet), hverken ved tilstedeværelse eller fravær af PCSK9, og der er ikke blevet observeret opløselige immunkomplekser, som er i stand til at binde komplementproteiner, når alirocumab bindes til PCSK9.
English: Therefore, alirocumab treatment can produce reductions in these remnant lipoproteins as evidenced by its reductions in apolipoprotein B (Apo B), non-high-density lipoprotein cholesterol (non-HDL-C) and triglycerides (TG).
Danish: Derfor kan behandling med alirocumab reducere disse lipoprotein-rester som vist ved dets reduktion af apolipoprotein B (Apo B), non-højdensiteteslipoprotein kolesterol (non-HDL-C) og triglycerider (TG).
English: Read the package leaflet and the detailed instructions for use leaflet before use.
Danish: Læs indlægssedlen og den detaljerede brugsanvisning inden brug.
English: In published genetic studies as well as clinical and observational trials with lipid lowering therapies an increased risk of new onset of diabetes has been associated with lower levels of LDL-C.
Danish: I publicerede genetikstudier samt kliniske studier og observationsstudier med lipidsænkende behandling er lave LDL-C-niveauer blevet associeret med en øget risiko for nyopstået diabetes.
English: Praluent blocks a protein called PCSK9.
Danish: Praluent hæmmer et protein, der hedder PCSK9
English: The LONG TERM study included 17.7% heFH patients, 34.6% with type 2 diabetes mellitus, and 68.6% with a history of coronary heart disease.
Danish: LONG TERM studiet omfattede 17,7 % heFH-patienter, 34,6 % med type 2-diabetes mellitus og 68,6 % med koronar hjertesygdom i anamnesen.
English: The index ACS event was a myocardial infarction in 83.2% of patients (34.6% STEMI, 48.6% NSTEMI) and an episode of unstable angina in 16.8% of patients.
Danish: Registreret AKS-hændelse var myokardieinfarkt hos 83,2 % af patienterne (34,6 % STEMI, 48,6 % NSTEMI) og et tilfælde med ustabil angina hos 16,8 % af patienterne.
English: LDL-C values <25 mg/dL (<0.65 mmol/L)
Danish: LDL-C-værdier <25 mg/dl (<0,65 mmol/l)
English: • Use a 45° angle if you can only pinch 2 cm of skin.
Danish: • Hold sprøjten i en vinkel på 45°, hvis du kun kan klemme sammen om 2 cm hud.
English: Hypersensitivity, hypersensitivity vasculitis
Danish: Overfølsomhed, allergisk vaskulitis
English: Patients had experienced an acute coronary syndrome (ACS) event 4 to 52 weeks prior to randomization and were treated with a lipid-modifying-therapy (LMT) regimen that was statin-intensive (defined as atorvastatin 40 or 80 mg, or rosuvastatin 20 or 40 mg) or at maximally tolerated dose of those statins, with or without other LMT.
Danish: Patienterne havde haft en hændelse med akut koronart syndrom (AKS) 4 til 52 uger forud for randomisering og modtog et lipidmodificerende behandlings (LMT)-regime i form af intensiv statinbehandling (defineret som atorvastatin 40 eller 80 mg, eller rosuvastatin 20 eller 40 mg) eller maksimal tolereret dosis af disse statiner, med eller uden anden LMT.
English: • PCSK9 is a protein secreted by liver cells.
Danish: • PCSK9 er et protein, der udskilles af leverceller.
English: Table 2: Mean Percent Change from Baseline in LDL-C and Other Lipids/ Lipoproteins in PlaceboControlled and Ezetimibe-Controlled Studies - 75 mg and/or 150 mg Q2W Dosing Regimen
Danish: Tabel 2: Gennemsnitlig procentvis ændring fra baseline i LDL-C og andre lipider/ lipoproteiner i placebo-kontrollerede og ezetimibe-kontrollerede studier - 75 mg og/eller 150 mg Q2W doseringsregimen
English: • Check that you have the correct product and the correct dose (grey plunger for 150 mg/ml).
Danish: • Kontroller at du har det rigtige produkt og den korrekte dosis (gråt stempel på 150 mg/ml).
English: STEP B: How to inject
Danish: TRIN B: Sådan foretager du injektionen
English: Since alirocumab is a biological medicinal product, no pharmacokinetic effects of alirocumab on other medicinal products and no effect on cytochrome P450 enzymes are anticipated.
Danish: Da alirocumab er et biologisk lægemiddel forventes alirocumab ikke at have effekt på andre lægemidlers farmakokinetik, og der forventes ingen effekt på cytochrom P450 enzymer.
English: Following discontinuation of alirocumab, no rebound in LDL-C was observed, and LDL-C levels gradually returned to baseline levels.
Danish: Efter seponering af alirocumab blev der ikke observeret rebound i LDL-C, og LDL-C-koncentrationen vendte gradvist tilbage til baseline niveauet.
English: Do not touch the yellow safety cover.
Danish: Du må ikke røre ved den gule beskyttelseshætte.
English: o thigh o belly (except for the 5 cm area around your navel)
Danish: o dit lår o din mave (undtagen 5 cm rundt om navlen)
English: Prior to initiating Praluent secondary causes of hyperlipidaemia or mixed dyslipidaemia (e.g., nephrotic syndrome, hypothyroidism) should be excluded.
Danish: Inden behandling med Praluent initieres, bør sekundære årsager til hyperlipidæmi eller kombineret dyslipidæmi (f.eks. nefrotisk syndrom, hypotyroidisme) udelukkes.
English: A multicenter, double-blind, ezetimibe-controlled, 24 week study included 248 patients with documented statin intolerance due to skeletal muscle-related symptoms.
Danish: Et dobbeltblindet, ezetimibe-kontrolleret multicenterstudie af 24 ugers varighed omfattede 248 patients med dokumenteret statin-intolerans på grund af symptomer relateret til skeletmuskulaturen.
English: • Do not touch the yellow safety cover.
Danish: • Du må ikke røre den gule beskyttelseshætte.
English: • the Praluent pen
Danish: • Praluent-pennen