FrancophonIA/ELRC3.0 huggingface dataset:
English: The frequency of adverse reactions reported during post-marketing use cannot be determined as they are derived from spontaneous reports.
Danish: Hyppigheden af bivirkninger rapporteret ved brug efter markedsføring kan ikke bestemmes, da de er afledt af spontane rapporter.
English: Every 4 Week (Q4W) Dosing Regimen
Danish: Hver 4. uge (Q4W) doseringsregimen
English: Hold the Praluent pen like this.
Danish:  Hold Praluent-pennen på denne måde.
English: Continue to follow your cholesterol-lowering diet while taking this medicine.
Danish: • Bliv ved med at følge din kolesterolsænkende diæt, mens du er i behandling med denne medicin.
English: General allergic reactions
Danish: Generelle allergiske reaktioner
English: Human immunoglobulin G (IgG) is excreted in human milk, in particular in colostrum; the use of Praluent is not recommended in breast-feeding women during this period.
Danish: Human immunoglobulin G (IgG) udskilles i human mælk, især i kolostrum; brug af Praluent anbefales ikke til ammende kvinder i denne periode.
English: • Do not use skin that is tender, hard, red or hot.
Danish: • Du må ikke injicere i hud, der er øm, hård, rød eller varm.
English: Two studies were conducted in patients who were not concomitantly treated with a statin, including one study in patients with documented statin intolerance.
Danish: To studier blev udført i patienter, som ikke var i samtidig behandling med et statin, inklusive et studie i patienter med dokumenteret statin-intolerans.
English: • Check that you have the correct product and the correct dose.
Danish: • Kontroller at du har det rigtige produkt og den korrekte dosis.
English: • Your injection is complete, when the window has turned completely yellow, you may hear a second click.
Danish: • Injektionen er færdig, når vinduet er helt gult, og der lyder måske endnu et klik.
English: No difference was seen in the incidence of pruritus.
Danish: Der blev ikke observeret nogen forskel i forekomsten af pruritus.
English: ALTERNATIVE study
Danish: ALTERNATIVE-studiet
English: Primary endpoint (MACEplus a)
Danish: Primary endpoint (MACEplusa)
English: • “Bad” cholesterol is normally removed from your blood by binding to specific “receptors” (docking stations) in your liver.
Danish: • “Dårligt” kolesterol fjernes normalt fra blodet ved at binde sig til særlige “receptorer” (docking stationer) i leveren.
English: Overall, 71.6% of patients were categorized at high or very high CV risk and not at their LDL-C target.
Danish: I alt blev 71,6% af patienterne kategoriseret med høj eller meget høj CV risiko og ikke på deres LDL-C mål.
English: Release the button immediately
Danish: Slip knappen med det samme
English: Excluding injection site reactions (ISRs) that occurred after these placebo injections, the frequency of ISRs was 11.8%.
Danish: Bortset fra reaktioner på injektionsstedet (ISR) som opstod efter disse placeboinjektioner, var hyppigheden af ISR 11,8%.
English: In controlled clinical studies, no safety issues were identified with more frequent dosing than the recommended every 2 week dosing schedule.
Danish: I kontrollerede kliniske studier blev der ikke identificeret sikkerhedsproblemer ved en hyppigere dosering end den anbefalede dosering hver 2. uge.
English: There are no data from the use of Praluent in pregnant women.
Danish: Der foreligger ingen data om brug af Praluent til gravide kvinder.
English: • Do not remove the pen until the entire window has turned yellow.
Danish: • Du må ikke fjerne pennen, før hele vinduet er blevet gult.
English: It is not known whether alirocumab is excreted in human milk.
Danish: Det vides ikke, om alirocumab udskilles i human mælk.
English: • Make sure you can see the window.
Danish: • Sørg for at du kan se pennens vindue.
English: In the event of an overdose, the patient should be treated symptomatically, and supportive measures instituted as required.
Danish: I tilfælde af en overdosering skal patienten behandles symptomatisk, og understøttende behandling iværksættes efter behov.
English: Two elimination phases were observed for alirocumab.
Danish: Der er observeret to eliminationsfaser for alirocumab.
English: Clinical efficacy and safety in prevention of cardiovascular events
Danish: Klinisk virkning og sikkerhed ved forebyggelse af kardiovaskulære hændelser
English: The safety profile in ODYSSEY OUTCOMES was consistent with the overall safety profile described in the phase 3 controlled trials.
Danish: Sikkerhedsprofilen for ODYSSEY OUTCOMES var i overenstemmelse med den samlede sikkherhedsprofil beskrevet i de kontrollerede fase 3 studier.
English: Steady state was reached after 2 to 3 doses with an accumulation ratio up to a maximum of about 2-fold.
Danish: Steady state blev nået efter 2-3 doser med en akkumulationsrate op til et maksimum på ca. det dobbelte.
English: The fluctuations between Cmax and Ctrough were higher for the every 4 weeks dosage regimen.
Danish: Udsving mellem Cmax og Cmin var højere for hver 4. uge dosisregimen.
English: The long-term consequences of continuing alirocumab treatment in the presence of ADA are unknown.
Danish: De langvarige konsekvenser af fortsat behandling med alirocumab ved tilstedeværelse af ADA kendes ikke.
English:  Check if the window has turned yellow, before removing the pen.
Danish:  Kontroller om vinduet er blevet gult, før du fjerner pennen.
English: No difference in the safety profile was observed between the two doses (75 mg and 150 mg) used in the phase 3 program.
Danish: Der blev ikke observeret nogen forskel på sikkerhedsprofilen mellem de to doser (75 mg og 150 mg), der blev anvendt i fase 3 programmet.
English: Although no safety issues were observed in patients over 75 years of age, data are limited in this age group.
Danish: Selvom der ikke er observeret sikkerhedsproblemer hos patienter over 75 år, er data for denne aldersgruppe begrænset.
English: There is no specific treatment for Praluent overdose.
Danish: Der er ingen specifik behandling i tilfælde af overdosering med Praluent.
English: LDL-C reduction was consistent regardless of concomitantly used statins and doses.
Danish: LDL-C-reduktion var konsistent uanset samtidig administration af statiner og dosis.
English: Every 4 week dosing study
Danish: Hver 4. uge doseringsstudie
English: Although similar efficacy was observed in patients over 75 years, data are limited in this age group.
Danish: Selvom en tilsvarende effekt blev observeret hos patienter over 75 år, er data begrænsede for denne aldersgruppe.
English: LONG TERM study
Danish: LONG TERM studiet
English: (See picture).
Danish: (se billedet herunder).
English: Adverse reactions are presented by system organ class.
Danish: Bivirkningerne er anført efter systemorganklasse.
English: Do not stop using Praluent without talking with your doctor.
Danish: Du må ikke stoppe med at bruge Praluent uden at tale med lægen.
English: • If you see any blood, press a cotton ball or gauze on the site until the bleeding stops.
Danish: • Hvis det bløder, kan du presse en vattot eller gaze på stedet, indtil blødningen stopper.
English: However, reduction of LDL-C is maintained during the dosing interval when alirocumab is administered every two weeks.
Danish: Reduktionen i LDL-C opretholdes imidlertid i doseringsintervallet, når alirocumab administreres hver 2. uge.
English: Non-clinical data reveal no special hazard for humans based on evaluations of safety pharmacology, and repeated dose toxicity.
Danish: Prækliniske data viser ingen speciel risiko for mennesker baseret på evaluering af sikkerhedsfarmakologi og toksicitet efter gentagne doser.
English: The Kaplan-Meier estimates of the cumulative incidence of the primary endpoint for the overall patient population over time are presented in Figure 1.
Danish: Kaplan-Meier estimater for den samlede forekomst af det primære endepunkt i den samlede patientpopulation over tid er vist i figur 1.
English: Monoclonal antibodies are proteins that recognise and bind to other unique proteins.
Danish: Monoklonale antistoffer er proteiner, der genkender og binder til andre unikke proteiner.
English: The use of Praluent is not recommended during pregnancy unless the clinical condition of the woman requires treatment with alirocumab.
Danish: Brug af Praluent anbefales ikke under graviditet, medmindre kvindens kliniske tilstand kræver behandling med alirocumab.
English: Specific metabolism studies were not conducted, because alirocumab is a protein.
Danish: Der er ikke udført specifikke biotransformationsstudier, eftersom alirocumab er et protein.
English: Praluent has no or negligible influence on the ability to drive and use machines.
Danish: Praluent påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: Driving and using machines This medicine is not expected to have any effect on your ability to drive or use machines.
Danish: Trafik- og arbejdssikkerhed Denne medicin forventes ikke at påvirke din evne til at køre bil eller betjene maskiner.
English: Combination therapy with a statin
Danish: Kombinationsbehandling med et statin
English: Praluent helps lower your levels of “bad” cholesterol (also called “LDL cholesterol”).
Danish: Praluent medvirker til at sænke niveauet af det “dårlige” kolesterol (også kaldet “LDL kolesterol”).
English: Alirocumab is expected to degrade to small peptides and individual amino acids.
Danish: Alirocumab forventes at nedbrydes til små peptider og aminosyrer.
English: Table 3: Efficacy of Alirocumab in ODYSSEY OUTCOMES (Overall Population)
Danish: Tabel 3: Alirocumabs virkning i ODYSSEY OUTCOMES (samlet population)
English:  Pull pen away from your skin.
Danish:  Fjern pennen fra huden.
English: Reproductive toxicology studies in rats and monkeys indicated that alirocumab, like other IgG antibodies, crosses the placental barrier.
Danish: Reproduktionstoksicitetsstudier i rotter og aber tydede på, at alirocumab, i lighed med andre IgG-antistoffer, krydser placentabarrieren.
English: Without Background Statin
Danish: Uden statin som baggrundsbehandling
English: HIGH FH study
Danish: HIGH FH-studiet
English: • redness, itching, swelling, pain/tenderness where the medicine was injected (local injection site reactions)
Danish: • rødme, kløe, hævelse, smerter/ømhed hvor medicinen blev injiceret (lokale reaktioner ved injektionsstedet).
English: Overall, 730 (7.7%) of 9451 patients switched to placebo.
Danish: Samlet set skiftede 730 (7,7 %) af de 9.451 patienter til placebo.
English: SANOFI CHIMIE 9 Quai Jules Guesde 94403 Vitry-sur-Seine France
Danish: SANOFI CHIMIE 9 Quai Jules Guesde 94403 Vitry-sur-Seine Frankrig
English: Alirocumab binds to PCSK9.
Danish: Alirocumab binder til PCSK9.
English: The lipid-lowering effect of alirocumab was observed within 15 days after the first dose reaching maximum effect at approximately 4 weeks.
Danish: Alirocumabs lipidsænkende virkning blev observeret inden for 15 dage efter den første dosis og nåede maksimal virkning ved ca. uge 4.
English: The pen will not work if the yellow safety cover is not depressed fully.
Danish: Pennen virker ikke, hvis den gule beskyttelseshætte ikke er trykket helt ned.
English: • Do not heat the pen, let it warm up on its own.
Danish: • Du må ikke opvarme pennen, lad den selv blive varm.
English: Praluent is not recommended for children and adolescents under 18 years old.
Danish: Praluent frarådes til børn og unge under 18 år.
English: Do not get rid of any air bubbles in the syringe before the injection.
Danish: Du skal ikke forsøge at fjerne eventuelle luftbobler i sprøjten inden injektionen.
English: FH I and FH II studies
Danish: FH I- og FH II-studierne
English: This did not translate into a clinically meaningful difference in LDL-C lowering.
Danish: Dette medførte ikke en klinisk relevant forskel i reduktion af LDL-C.
English: There were no adverse effects on fetal growth or development in rats or monkeys.
Danish: Der var ingen ændringer i fostervægt og -udvikling i rotter eller aber.
English: • You can inject into your: o thigh o belly (except for the 5 cm area around your navel) o outer side of your upper arm (See picture).
Danish: • Du kan foretage injektionen i: o dit lår o din mave (undtagen 5 cm rundt om navlen) o ydersiden af din overarm (se billedet herunder).
English: • Do not put the pen back in the refrigerator.
Danish: • Du må ikke lægge pennen tilbage i køleskabet.
English: Do not re-use a pen.
Danish: Du må ikke genbruge en pen.
English: After removal from the refrigerator, the medicinal product must be used within 30 days or discarded.
Danish: Efter udtagning fra køleskab skal lægemidlet anvendes inden for 30 dage eller bortskaffes.
English: Elderly No dose adjustment is needed for elderly patients.
Danish: Ældre Dosisjustering er ikke nødvendig til ældre patienter.
English: If signs or symptoms of serious allergic reactions occur, treatment with Praluent must be discontinued and appropriate symptomatic treatment initiated (see section 4.3).
Danish: Hvis der opstår tegn eller symptomer på alvorlige allergiske reaktioner, skal behandling med Praluent seponeres og passende symptomatisk behandling iværksættes (se pkt.
English: • Do not remove the syringe until it is completely empty.
Danish: • Du må ikke fjerne sprøjten, før den er helt tom.
English:  Let the pen warm up at room temperature for 30 to 40 minutes.
Danish:  Lad pennen varme op ved stuetemperatur i 30-40 minutter.
English: However, the LDLR has been shown to have a low affinity for Lp(a), therefore the exact mechanism by which alirocumab lowers Lp(a) is not fully understood.
Danish: LDLR er imidlertid vist at have lav affinitet for Lp(a), og derfor er den præcise mekanisme hvormed alirocumab sænker Lp(a) ikke helt klarlagt.
English: Following intravenous administration, the volume of distribution was about 0.04 to 0.05 L/kg indicating that alirocumab is distributed primarily in the circulatory system.
Danish: Efter intravenøs administration var fordelingsvolumen ca. 0,04 til 0,05 l/kg, hvilket tyder på, at alirocumab hovedsageligt fordeles i kredsløbet.
English: The absolute bioavailability of alirocumab after subcutaneous administration was about 85% as determined by population pharmacokinetic analysis.
Danish: Alirocumabs absolutte biotilgængelighed efter subkutan administration var ca. 85 % bestemt ved populationsfarmakokinetiske analyser.
English: There was no other evidence of alirocumab-related immune dysfunction in the offspring.
Danish: Der sås ingen andre tegn på alirocumab-relateret immun dysfunktion hos afkommet.
English: The distribution of body weight and age, two covariates impacting alirocumab exposure, were different among renal function categories and most likely explain the observed pharmacokinetic differences.
Danish: Fordelingen af kropsvægt og alder, som er to kovarianter, der påvirker alirocumab-eksponering, var forskellige i nyrefunktionskategorierne og er sandsynligvis forklaringen på de observerede farmakokinetiske forskelle.
English: It is recommended to rotate the injection site with each injection.
Danish: Det anbefales at skifte injektionssted for hver injektion.
English: Praluent is indicated in adults with established atherosclerotic cardiovascular disease to reduce cardiovascular risk by lowering LDL-C levels, as an adjunct to correction of other risk factors:
Danish: Praluent er indiceret til voksne med konstateret atherosklerotisk kardiovaskulær sygdom til at reducere den kardiovaskulære risiko ved at sænke LDL-C-niveauerne som adjuvans til korrektion af andre risikofaktorer:
English: CHOICE I study
Danish: CHOICE I studie
English: Following single-dose subcutaneous administration of 100 mg to 300 mg alirocumab, there was no meaningful difference in exposure between Japanese and Caucasian healthy subjects.
Danish: Efter subkutan administration af en enkelt dosis 100 mg til 300 mg alirocumab, blev der ikke observeret nogen signifikant forskel i eksponering mellem japanske og kaukasiske raske forsøgspersoner.
English: Major CHD Event d
Danish: Major CHD Eventd
English: This is because there is no experience of using the medicine in these age groups.
Danish: Det skyldes, at man ikke har nogen erfaring med brug af Praluent til denne aldersgruppe.
English: * including mainly oropharyngeal pain, rhinorrhea, sneezing ** including erythema/redness, itching, swelling, pain/tenderness
Danish: * inklusiv hovedsagelig orofaryngeale smerter, rhinoré, nysen ** inklusiv erytem/rødme, kløe, hævelse, smerter/ømhed
English: Do not
Danish: Det må du ikke
English: Do not use this medicine if it looks discoloured or cloudy, or if it contains visible flakes or particles.
Danish: Brug ikke lægemidlet, hvis det er misfarvet, grumset eller indeholder synlige flager eller partikler.
English: Praluent should not be injected into areas of active skin disease or injury such as sunburns, skin rashes, inflammation, or skin infections.
Danish: Praluent bør ikke injiceres i områder med aktiv hudsygdom eller skader som f.eks. solskoldning, hududslæt, inflammation eller hudinfektioner.
English: In all clinical studies background lipid lowering therapies could not be adjusted by trial design.
Danish: I alle kliniske studier kunne lipidsænkende baggrundsbehandling ikke justeres i forhold til studiedesign.
English: • Do not use if the window appears solid yellow (see picture B).
Danish: • Du må ikke bruge pennen, hvis vinduet er helt gult (se billede B).
English: Effects of other medicinal products on alirocumab
Danish: Andre lægemidlers effekt på alirocumab
English: • Check the use by date and do not use if this date has passed.
Danish: • Kontroller udløbsdatoen og brug den ikke, hvis datoen er overskredet.
English: Hazard Ratio: 0.85 95% CI (0.78, 0.93)
Danish: Hazard ratio: 0,85 95 % KI (0,78; 0,93)
English: • Check the use by date: do not use if this date has passed.
Danish: • Kontroller udløbsdatoen: du må ikke bruge den, hvis datoen er udløbet.
English: Patients with severe hepatic impairment (Child-Pugh C) have not been studied (see section 5.2).
Danish: Patienter med svært nedsat leverfunktion (Child-Pugh C) er ikke blevet undersøgt (se pkt.
English:  Let the syringe warm up at room temperature for 30 to 40 minutes.
Danish:  Lad sprøjten varme op ved stuetemperatur i 30-40 minutter.
English: Praluent must not be co-administered with other injectable medicinal products at the same injection site.
Danish: Praluent må ikke administreres sammen med andre injektionspræparater på samme injektionssted.
English: Based on a population pharmacokinetic analysis, age was associated with a small difference in alirocumab exposure at steady state, with no impact on efficacy or safety.
Danish: Baseret på en populationsfarmakokinetisk undersøgelse er alder associeret med en lille forskel i eksponeringen for alirocumab ved steady state, uden at dette påvirker virkning eller sikkerhed.
English: Frequencies for all adverse reactions identified from clinical trials have been calculated based on their incidence in pooled phase 3 clinical trials.
Danish: Hyppigheden af alle bivirkninger, der blev identificeret i kliniske studier, er beregnet baseret på deres forekomst i de poolede kliniske fase 3 studier.
English: • Inject all of the solution by slowly and steadily pushing down the plunger.
Danish: • Injicer al væsken ved langsomt og roligt at trykke stemplet i bund.
English: • Pull the needle out of the skin at the same angle as it was inserted.
Danish: • Træk kanylen ud af huden i den samme vinkel, som da du førte den ind.
English: Always check the label of your pen to make sure you have the right medicine and the right strength.
Danish: Du skal altid læse etiketten på pennen for at sikre dig, at du tager den rigtige medicin og den rigtige styrke.
English: Lipid levels can be assessed 4 to 8 weeks after treatment initiation or titration, and dose adjusted accordingly (up-titration or down-titration).
Danish: Lipidniveauer kan vurderes 4 til 8 uger efter behandlingsstart eller titrering, og dosis justeres herefter (optitrering eller nedtitrering).
English: In the phase 3 studies, 31% of patients had type 2 diabetes mellitus, and 64% of patients had a history of coronary heart disease.
Danish: I fase 3 studierne havde 31 % af patienterne type 2-diabetes mellitus, og 64 % af patienterne havde koronar hjertesygdom i anamnesen.
English: • Do not rub the skin after the injection.
Danish: • Du må ikke gnide på huden efter injektionen.
English: There are no data on adverse effects on fertility in humans.
Danish: Der foreligger ingen data om ændringer af fertiliteten hos mennesker.
English: Limited data are available in patients with severe renal impairment; in these patients the exposure to alirocumab was approximately 2-fold higher compared with subjects with normal renal function.
Danish: Der foreligger begrænsede data for patienter med svært nedsat nyrefunktion; hos disse patienter var eksponeringen for alirocumab cirka 2 gange så høj sammenligned med forsøgspersoner med normal nyrefunktion.
English: Praluent is injected as a subcutaneous injection into the thigh, abdomen or upper arm.
Danish: Praluent administreres som subkutan injektion i låret, abdomen eller overarmen.
English: • You can stand or sit to give yourself an injection.
Danish: • Du kan enten stå op eller sidde ned, når du foretager injektionen.
English: The safety and efficacy of Praluent in children and adolescents less than 18 years of age have not been established.
Danish: Praluents sikkerhed og virkning hos børn og unge under 18 år er ikke klarlagt.
English: Most patients (88.8%) were receiving high intensity statin therapy with or without other LMT at randomization.
Danish: Størstedelen af patienterne (88,8 %) fik højintensiv statinbehandling med eller uden anden LMT ved randomisering.
English: When co-administered with a statin, the median apparent half-life of alirocumab was 12 days.
Danish: Ved samtidig administration af et statin var alirocumabs mediane tilsyneladende halveringstid 12 dage.
English: Monotherapy or as add-on to non-statin lipid-modifying therapy
Danish: Monoterapi eller tillæg til non-statin lipidmodificerende behandling
English: Of these 2615 patients, 805 (30.8%) were down-titrated to 75 mg Q2W.
Danish: Af disse 2.615 patienter blev 805 (30,8 %) nedtitreret til 75 mg Q2W.
English: • PCSK9 lowers the number of these receptors in the liver - this causes your “bad” cholesterol to be higher than it should.
Danish: • PCSK9 sænker antallet af disse receptorer i leveren - det resulterer i, at dit “dårlige” kolesterol bliver for højt.
English: For study results with respect to effects on LDL-C, cardiovascular events and populations studied see section
Danish: 5.1 vedrørende studieresultater for virkningerne på LDL-C, kardiovaskulære hændelser og undersøgte populationer.
English: Three of the ten studies were conducted exclusively in patients with heterozygous familial hypercholesterolaemia (heFH).
Danish: Tre af de ti studier blev udelukkende udført i patienter med heterozygot familiær hyperkolesterolæmi (heFH).
English: Since the effects of alirocumab on the breast-fed infant are unknown, a decision should be made whether to discontinue nursing or to discontinue Praluent during this period.
Danish: Da effekterne af alirocumab på det diende barn er ukendt, skal det besluttes, om amning skal ophøre eller behandling med Praluent skal seponeres i denne periode.
English: General allergic reactions were reported more frequently in the alirocumab group (8.1% of patients) than in the control group (7.0% of patients), mainly due to a difference in the incidence of pruritus.
Danish: Generelle allergiske reaktioner blev rapporteret mere hyppigt i alirocumab-gruppen (8,1 % af patienterne) end i kontrolgruppen (7,0 % af patienterne), hovedsageligt på grund af en forskel i hyppigheden af pruritus.
English: The patient may either self-inject Praluent, or a caregiver may administer Praluent, after guidance has been provided by a healthcare professional on proper subcutaneous injection technique.
Danish: Patienten kan enten selv injicere Praluent eller en omsorgsperson kan administrere Praluent efter at have fået vejledning af en læge eller sygeplejerske om korrekt subkutan injektionsteknik.