FrancophonIA/ELRC3.0 huggingface dataset:
English: This binding prevents translation of the protein apoC-III, thus removing an inhibitor of triglyceride clearance and enabling metabolism through an LPL-independent pathway.
Danish: Denne binding forhindrer translation af protein apoC-III, hvilket ophæver hæmningen af triglycerid-clearancen og muliggør metabolisme via en LPL-uafhængig vej.
English: Allow the injection to reach to room temperature
Danish: Lad injektionen opnå rumtemperatur
English: Volanesorsen was rapidly and widely distributed to tissues following subcutaneous or intravenous administration in all species evaluated.
Danish: Volanesorsen blev fordelt hurtigt og bredt til vævene efter subkutan eller intravenøs administration hos alle undersøgte arter.
English: Table 2: Summary of adverse reactions in clinical studies in patients with FCS (N=86) System Organ Class
Danish: Oversigt over bivirkninger i kliniske studier med FCS-patienter (N=86) Systemorganklasse
English: Avoid injecting at the waistline where your clothing may rub or press the injection area.
Danish: Undgå injektioner i taljeområdet, hvor dit tøj kan gnide mod eller trykke på injektionsområdet.
English: Main inclusion criteria were a diagnosis of FCS (Type 1 hyperlipoproteinemia) in combination with a history of chylomicronemia evidenced by documentation of lactescent serum or documentation of fasting TG measurement ≥ 880 mg/dl.
Danish: Hovedinklusionskriteriet var en FCS-diagnose (hyperlipoproteinæmi af type 1) i kombination med chylomikronæmi i anamnesen påvist ved dokumenteret lactescerende serum eller dokumenteret fastende TG-måling ≥ 880 mg/dl.
English: Single- and multiple-dose pharmacokinetics of volanesorsen in healthy volunteers and patients with hypertriglyceridemia have shown that the Cmax of volanesorsen is dose-proportional over a dose range of 100 to 400 mg and the AUC is slightly more than dose-proportional over the same dose range.
Danish: Farmakokinetikken af volanesorsen efter enkelt og gentagen dosering hos raske frivillige og patienter med hypertriglyceridæmi har vist, at Cmax af volanesorsen er dosisproportionel i dosisområdet 100 til 400 mg, og at AUC er lidt mere end dosisproportionelt i samme dosisområde.
English: Contusion (3, 3%)
Danish: Kontusion (3, 3 %)
English: - Any liver or kidney problems.
Danish: - Lever- eller nyreproblemer.
English: Patients should be re-downtitrated to 285 mg every 2 weeks if the higher 285 mg once weekly dose does not provide significant additional triglyceride reduction after 9 months.
Danish: Patienterne bør nedtitreres igen til 285 mg hver anden uge, hvis den højere dosis på 285 mg én gang ugentligt ikke giver en signifikant yderligere reduktion i triglycerid efter 9 måneder.
English: Ask your pharmacist or see your local public health government website (where available) for more details on how you should dispose of sharps in your location.
Danish: Kontakt apotekspersonalet, eller se de lokale sundhedsmyndigheders hjemmeside (hvis en sådan findes) vedrørende yderligere oplysninger om, hvordan du skal bortskaffe skarpe genstande i dit område.
English: The objective of the programme is to provide information on the risks of thrombocytopaenia and bleeding; advise on platelet monitoring and provide details about the dose frequency adjustment algorithm.
Danish: Formålet med programmet er at give oplysninger om risikoen for trombocytopeni og blødning, rådgive om monitorering af trombocyttallet samt give oplysninger om algoritmen for justering af dosishyppighed.
English: Mean age was 46 years (range 20-75 years; 5 patients ≥65 years old); 45% were men; 80% were White, 17% were Asian, and 3% were of other races.
Danish: Gennemsnitsalderen var 46 år (interval 20-75 år; 5 patienter ≥ 65 år); 45 % var mænd; 80 % var hvide, 17 % var asiatere og 3 % var af andre racer.
English: Waylivra is indicated as an adjunct to diet in adult patients with genetically confirmed familial chylomicronemia syndrome (FCS) and at high risk for pancreatitis, in whom response to diet and triglyceride lowering therapy has been inadequate.
Danish: Waylivra er indiceret i tillæg til diæt hos voksne patienter med genetisk bekræftet familiært chylomikronæmisyndrom (FCS) og høj risiko for pancreatitis, som har haft utilstrækkeligt respons på diæt og triglyceridsænkende behandling.
English: For any patient dose paused or discontinued due to severe thrombocytopenia, the benefits and risks of returning to treatment once platelet count ≥100 x 109/L should be carefully considered.
Danish: Hos patienter, der får behandlingen pauseret eller seponeret på grund af svær trombocytopeni, bør fordelene og risiciene ved at genoptage behandlingen, når trombocyttallet ≥ 100 x 109/l, overvejes nøje.
English: What you need to know before you use Waylivra Do not use Waylivra if:
Danish: Det skal du vide, før du begynder at bruge Waylivra Brug ikke Waylivra:
English: Patients were prohibited from receiving plasma apheresis within 4 weeks prior to screening or during the study; 11% of patients had previously received gene therapy for lipoprotein lipase deficiency (i.e., alipogene tiparvovec), on average 8 years prior to starting this study.
Danish: Det var ikke tilladt for patienterne at modtage plasmaferese i de sidste fire uger inden screeningen eller i løbet af studiet; 11 % af patienterne havde fået tidligere genterapi for lipoproteinlipasemangel (dvs. alipogentiparvovec), gennemsnitligt 8 år inden studiestarten.
English: For discontinued patients, a haematologist should be consulted prior to resuming treatment.
Danish: Hos patienter, der får behandlingen seponeret, bør der konsulteres en hæmatolog, inden behandlingen genoptages.
English: Anti-volanesorsen antibody formation affecting pharmacokinetics The formation of binding antibodies to volanesorsen appeared to increase total Ctrough by 2- to 19-fold.
Danish: Dannelse af antistoffer mod volanesorsen med indvirkning på farmakokinetikken Dannelsen af bindende antistoffer mod volanesorsen syntes at medføre en 2- til 19-foldig stigning i total
English: If platelet count remains below 140 x 109/L upon a second measurement, Waylivra should not be initiated (see section
Danish: Hvis trombocyttallet forbliver under 140 x 109/l ved en anden måling, bør Waylivra ikke påbegyndes (se pkt.
English: In vitro studies indicate that volanesorsen is not an inhibitor of CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1, or CYP3A4 or inducer of CYP1A2, CYP2B6, or CYP3A4.
Danish: In vitro-studier viser, at volanesorsen ikke hæmmer CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1 eller CYP3A4 og ikke inducerer CYP1A2, CYP2B6 eller CYP3A4.
English: Talk to your healthcare provider if you are unsure of where to inject.
Danish: Kontakt lægen, hvis du er i tvivl om, hvor injektionen skal gives.
English: Clinical studies included 4 patients with FCS aged 65 treated with volanesorsen in randomised control studies (phase II study CS2, 1 patient; APPROACH 3 patients), and 6 patients aged 65 and over in the open-label extension study (CS7).
Danish: De kliniske studier omfattede 4 FCS-patienter på 65 år, der blev behandlet med volanesorsen i randomiserede kontrolstudier (fase II-studie CS2, 1 patient; APPROACH 3 patienter), og 6 patienter på 65 år og derover i forlængelsesstudiet med åben behandling (CS7).
English: Pause treatment for ≥4 weeks and resume treatment after platelet levels ≥ 100 x 109/L
Danish: Pausér behandlingen i ≥ 4 uger, og genoptag den når trombocyttal ≥ 100 x 109/l
English: The European Medicines Agency has deferred the obligation to submit the results of studies with volanesorsen in one or more subsets of the paediatric population in the treatment of familial chylomicronemia syndrome (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med volanesorsen i en eller flere undergrupper af den pædiatriske population ved behandling af familiært chylomikronæmisyndrom (se pkt.
English: The estimated steady-state volume of distribution (Vss) in patients with FCS is 330 L. Volanesorsen is highly bound to human plasma proteins (>98%) and the binding is concentration independent.
Danish: Det estimerede distributionsvolumen ved steady state (Vss) hos FCS-patienter er 330 l. Volanesorsen har en høj plasmaproteinbindingsgrad hos mennesker (> 98 %), og bindingen er koncentrationsafhængig.
English: Patients and/or caregivers should be trained in the administration of this medicinal product in accordance with the patient information leaflet.
Danish: Patienten og/eller plejepersonen skal undervises i administration af dette lægemiddel i henhold til indlægssedlen.
English: • Upright and stable during use,
Danish: • Kan stå ret og stabilt,
English: - Other medicines that may change how your blood clots, including non-steroidal antiinflammatory medicines like ibuprofen, medicines used to prevent heart attacks and strokes such as clopidogrel, ticagrelor and prasugrel, antibiotics such as penicillin, medicines such as ranitidine (used to reduce stomach acid), and quinine (used to treat malaria).
Danish: - Andre lægemidler, der kan påvirke blodstørkningen, herunder non-steroide antiinflammatoriske lægemidler såsom ibuprofen, lægemidler til forebyggelse af hjerteanfald og slagtilfælde såsom clopidogrel, ticagrelor og prasugrel, antibiotika såsom penicillin, lægemidler såsom ranitidin (anvendes mod for meget mavesyre) og kinin (anvendes til behandling af malaria).
English: In APPROACH, the Phase 3 clinical study in patients with FCS, Waylivra reduced fasting triglycerides, total cholesterol, non-HDL cholesterol, apoC-III, apoB-48, and chylomicron triglyceride levels and increased LDL-C, HDL-C, and apoB (see Table 3).
Danish: I det kliniske fase 3-studie APPROACH med FCS-patienter reducerede Waylivra fastende triglycerider, totalkolesterol, ikke-HDL-kolesterol, apoC-III, apoB-48 og chylomikrontriglycerider og øgede LDL-C, HDL-C og apoB (se tabel 3).
English: Wash hands and gather supplies
Danish: Vask hænder, og find det nødvendigt udstyr frem
English: LS Mean Absolute Change (95% CI) mg/dL or mmol/L
Danish: LS-middelværdi af absolut ændring (95 % CI) mg/dl eller mmol/l
English: Discontinue treatment Glucocorticoids recommended
Danish: Seponer behandling Glykokortikoider anbefales.
English: It is important that you maintain this triglyceride-lowering diet whilst using Waylivra.
Danish: Det er vigtigt at du fortsætter denne triglyceridsænkende diæt under behandlingen med Waylivra.
English: Available pharmacodynamic/toxicological data in animals have shown excretion of very low amounts of volanesorsen in milk (see section 5.3).
Danish: Tilgængelige farmakodynamiske/toksikologiske data fra dyr har vist, at volanesorsen udskilles i meget små mængder i mælken (se pkt.
English: Your doctor may do a urine and/or blood test every 3 months to check for signs of damage to your kidneys.
Danish: Din læge vil muligvis foretage en urin og/eller blodprøve hver tredje måned for at se, om der er skader på dine nyrer.
English: A total of 67 patients have been treated and 50 (74%) patients remain on treatment, made up of 38 (76%) patients in the treatment-naïve group, 9 (18%) in the APPROACH-volanesorsen group and 3 (6%) in the CS16-volanesorsen group.
Danish: I alt 67 patienter er blevet behandlet, og 50 (74 %) patienter er fortsat i behandling, heraf 38 (76 %) patienter i den behandlingsnaive gruppe, 9 (18 %) i APPROACH-volanesorsengruppen og 3 (6 %) i CS16-volanesorsengruppen.
English: Before you are given this medicine other causes of high levels of triglycerides, such as diabetes or problems with your thyroid, will be ruled out by your doctor.
Danish: Før du får dette lægemiddel, vil din læge udelukke andre årsager til høje triglyceridniveauer, såsom diabetes eller problemer med din skjoldbruskkirtel.
English: Inject the liquid by holding the syringe with your thumb on the plunger, and slowly push the plunger down as far as it will go, until the syringe is completely empty (Figure K and L).
Danish: Indgiv væsken ved at holde sprøjten med tommelfingeren på stemplet og trykke langsomt på stemplet, indtil det ikke kan komme længere, og sprøjten er helt tømt (figur K og L).
English: Instructions for use are provided at the end of this leaflet.
Danish: Du finder brugsvejledningen sidst i denne indlægsseddel.
English: Treatment should also be discontinued for any clinical symptoms or signs of renal impairment pending the previous confirmatory assessments.
Danish: Behandlingen bør ligeledes seponeres i tilfælde af alle kliniske symptomer eller tegn på nedsat nyrefunktion, mens der afventes resultat på tidligere bekræftende undersøgelser.
English: During this 6 week period, this medicine can be stored at either room temperature or put back in the refrigerator.
Danish: I løbet af denne 6-ugers periode kan lægemidlet enten opbevares ved rumtemperaur eller sættes tilbage i køleskabet.
English: Out of the 50 patients still on treatment, 8 have had a dose pause, 8 have had a dose adjustment and 29 have had both a dose pause and a dose adjustment.
Danish: Ud af de 50 patienter, der stadig er i behandling, har 8 patienter haft en doseringspause, 8 har fået en dosisjustering og 29 har både haft en doseringspause og fået en dosisjustering.
English: Volanesorsen is an antisense oligonucleotide designed to inhibit the formation of apoC-III, a protein that is recognised to regulate both triglyceride metabolism and hepatic clearance of chylomicrons and other triglyceride-rich lipoproteins.
Danish: Volanesorsen er et antisense-oligonukleotid, der er designet til at hæmme dannelsen af apoC-III, som er et protein, der regulerer både triglyceridmetabolismen og den hepatiske clearance af chylomikroner og andre triglycerid-rige lipoproteiner.
English: The recommended starting dose is 285 mg in 1.5 ml injected subcutaneously once weekly for 3 months.
Danish: Den anbefalede startdosis er 285 mg i 1,5 ml injiceret subkutant én gang ugentligt i tre måneder.
English: APPROACH study in patients with FCS
Danish: APPROACH-studiet med FCS-patienter
English: Table 5: Additional Results for Changes in Triglycerides in the APPROACH study (Primary endpoint at Month 3)
Danish: Yderligere resultater vedrørende triglyceridændringer i APPROACH-studiet (primært endepunkt ved måned 3)
English: • The Patient/carer guide shall contain the following key messages: o Relevant information on thrombocytopaenia and severe bleeding o Importance of monitoring platelet levels o Possible need for dose adjustments or treatment pauses based on platelet test results o Need to be aware of and alert to the signs of thrombocytopaenia and the importance of seeking immediate assistance from a health professional o Information about the FCS disease registry and the PASS study and encouragement to participate in those studies.
Danish: • Vejledningen til patienten/omsorgsgiveren skal indeholde følgende nøgleinformation: o Relevante oplysninger om trombocytopeni og svær blødning o Vigtigheden af at monitorere trombocyttallet o Det mulige behov for dosisjustering eller pauser i behandlingen baseret på testresultaterne for trombocyttallet o Behovet for at være opmærksom på tegn på trombocytopeni og vigtigheden af øjeblikkelig at søge lægehjælp hos sundhedspersonalet o Oplysninger om registret for FCS-sygdom og PASS-studiet og opfordring til at deltage i disse studier.
English: Waylivra led to a statistically significant reduction in triglyceride levels as compared to placebo at the primary efficacy endpoint, defined as percent change from baseline to Month 3 in fasting triglycerides, in addition to a lower incidence of pancreatitis over the 52-week treatment period in a post-hoc analysis (Table 4).
Danish: Waylivra medførte en statistisk signifikant reduktion i triglyceridniveauet i forhold til placebo, hvad angik det primære effektendemål, som var defineret som den procentvise ændring i fastende triglycerider fra baseline til måned 3, og en lavere forekomst af pancreatitis i behandlingsperioden på 52 uger i en post hoc-analyse (tabel 4).
English: Due to the poor oral bioavailability of this medicinal product, it is considered unlikely that these low milk concentrations would result in systemic exposure from nursing.
Danish: På grund af den ringe orale biotilgængelighed af dette lægemiddel anses det for usandsynligt, at disse lave mælkekoncentrationer skulle resultere i systemisk eksponering ved amning.
English: Waylivra with alcohol
Danish: Brug af Waylivra sammen med alkohol
English: Do not take out of the packaging or remove the needle cap until you are ready to inject.
Danish: Du må ikke tage sprøjten ud af pakningen eller tage kanylehætten af, før du er klar til at indgive injektionen.
English: No starting dose adjustment is necessary in patients with mild to moderate renal impairment.
Danish: Det er ikke nødvendigt at justere startdosen hos patienter med mild til moderat nyreinsufficiens.
English: When you first receive Waylivra the pre-filled syringes should be stored in their packaging in the refrigerator (2 °C-8 °C).
Danish: Når du får udleveret de fyldte injektionssprøjter med Waylivra, skal du opbevare dem i pakningen i køleskabet (2 °C - 8 °C).
English: The CS7 study is an ongoing multicentre, open-label extension Phase 3 study designed to evaluate the safety and efficacy of dosing and extended dosing with volanesorsen in patients with FCS.
Danish: CS7-studiet er et igangværende fase 3-forlængelsesstudie med åben behandling på flere centre, der er designet til at evaluere sikkerheden og virkningen af dosering og forlænget dosering af volanesorsen hos FCS-patienter.
English: This can lead to inflammation of your pancreas, causing severe pain.
Danish: Dette kan føre til betændelse i bugspytkirtlen med kraftige smerter til følge.
English: At a drug concentration 4.1 times the peak drug plasma concentrations (Cmax) of the maximum recommended dose (285 mg subcutaneous injection), volanesorsen did not prolong the heart-rate corrected QT (QTc) interval.
Danish: Ved en lægemiddelkoncentration, der var 4,1 gange højere end den maksimale plasmakoncentration af lægemidlet (Cmax) ved den maksimale anbefalede dosis (subkutan injektion på 285 mg), forlængede volanesorsen ikke det hjertefrekvenskorrigerede QT-interval (QTc-intervallet).
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Danish: Det skal besluttes, om amning skal ophøre eller behandling med volanesorsen seponeres, idet der tages højde for fordelene ved amning for barnet i forhold til de terapeutiske fordele for moderen.
English: Mean body mass index was 25 kg/m2.
Danish: Gennemsnits-BMI var 25 kg/m2.
English: Immediately after the injection, dispose of the used syringe as instructed by your healthcare professional, usually into a sharps disposal container (Figure N) by following these steps.
Danish: Bortskaf sprøjten umiddelbart efter injektionen i henhold til lægens eller sundhedspersonalets anvisninger, typisk i en kanylebeholder (figur N), ved at følge disse trin.
English: Monitoring Frequency
Danish: Monitoreringshyppighed
English: This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say it is essentially ‘sodium-free'.
Danish: Dette lægemiddel indeholder mindre end 1 mmol (23 mg) natrium pr. dosis, dvs. det er i det væsentlige natrium-frit.
English: The mean fasting triglyceride percent change was significantly different between volanesorsen and placebo arms at 3, 6, and 12 months; the volanesorsen arm included patients who did not complete dosing but who returned for assessments over the 52-week study.
Danish: Den gennemsnitlige procentvise ændring i fastende triglycerider var signifikant forskellig i volanesorsenog placeboarmen efter 3, 6 og 12 måneder; volanesorsenarmen omfattede patienter, som ikke fuldførte doseringen, men som vendte tilbage til vurderinger i løbet af studiet af 52 ugers varighed.
English: Always keep your sharps container away from children and pets.
Danish: Opbevar altid kanylebeholderen utilgængeligt for børn og kæledyr.
English: If you stop using Waylivra
Danish: Hvis du holder op med at bruge Waylivra
English: The solution should be clear and colourless to slightly yellow.
Danish: Opløsningen skal være klar og farveløs til let gullig.
English: Arms - Back of upper area as shown (Figure F).
Danish: Arme - Bagerste, øvre område, som vist (figur F).
English: If not noticed within 48 hours, then the missed dose should be skipped and the next planned injection given.
Danish: Hvis du ikke opdager det inden for 48 timer, skal den glemte dosis springes over og den næste planlagte injektion foretages.
English: In vitro studies show that volanesorsen is not a substrate or inhibitor of P-glycoprotein (P-gp), breast cancer resistance protein (BCRP), organic anion transporting polypeptides (OATP1B1, OATP1B3), bile salt export pump (BSEP), organic cation transporters (OCT1, OCT2), or organic anion transporters (OAT1, OAT3).
Danish: In vitro-studier viser, at volanesorsen hverken er et substrat for eller en hæmmer af P-glycoprotein (P-gp), brystcancerresistent protein (BCRP), organiske aniontransporterende polypeptider (OATP1B1, OATP1B3), galdesalteksportpumpen (BSEP), organiske kationtransportører (OCT1, OCT2) eller organiske aniontransportører (OAT1, OAT3).
English: Platelet Count (x109/L)
Danish: Trombocyttal ( x 109/l)
English: Injection with cold liquid may cause injection site reactions such as pain, redness, or swelling.
Danish: Indgivelse af kold væske kan forårsage reaktioner på injektionsstedet, såsom smerter, rødme eller hævelse.
English: This medicinal product has not been studied in patients with hepatic impairment.
Danish: Dette lægemiddel er ikke blevet undersøgt hos patienter med nedsat leverfunktion.
English: Sites for injection include the abdomen, upper thigh region, or outer area of the upper arm.
Danish: Injektionsstederne omfatter abdomen, øvre lårregion, ydersiden af overarmen.
English: Use each pre-filled syringe only once and then place in a sharps disposal container for disposal according to community guidelines.
Danish: Den fyldte injektionssprøjte må kun anvendes én gang, hvorefter den lægges i en kanylebeholder med henblik på bortskaffelse i henhold til lokale retningslinjer.
English: Package leaflet: Information for the user Waylivra 285 mg solution for injection in pre-filled syringe volanesorsen ▼This medicine is subject to additional monitoring.
Danish: Indlægsseddel: Information til brugeren Waylivra 285 mg injektionsvæske, opløsning i fyldt injektionssprøjte volanesorsen ▼Dette lægemiddel er underlagt supplerende overvågning.
English: Clinically relevant pharmacokinetic interactions are not expected between volanesorsen and substrates, inducers or inhibitors of cytochrome P450 (CYP) enzymes, and drug transporters.
Danish: Der forventes ingen klinisk relevante farmakokinetiske interaktioner mellem volanesorsen og cytochrom P450 (CYP)-enzymsubstrater, -induktorer eller -hæmmere eller lægemiddeltransportører.
English: A mode of action for the observed thrombocytopenia is currently not known.
Danish: Virkningsmekanismen bag den observerede trombocytopeni er endnu ikke klarlagt.
English: Table 3: Mean Baseline and Percent Change in Lipid Parameters from Baseline to Month 3
Danish: Gennemsnitlige lipidparametre ved baseline og procentvis ændring i lipidparametrene fra baseline til måned 3
English: Platelet monitoring and dose adjustments
Danish: Trombocytmonitorering og dosisjusteringer
English: Since the administered dose will be 285 mg every two weeks, or 142.5 mg weekly, little increase in Cmax or AUC is expected upon multiple dosing in the clinical setting.
Danish: Eftersom den administrerede dosis vil være 285 mg hver anden uge eller 142,5 mg hver uge, forventes der en lille stigning i Cmax eller AUC ved gentagen dosering i klinisk praksis.
English: Prior to initiating Waylivra, secondary causes of hypertriglyceridemia (e.g. uncontrolled diabetes, hypothyroidism) should be excluded or appropriately addressed.
Danish: Sekundære årsager til hypertriglyceridæmi (f.eks. dårligt kontrolleret diabetes, hypothyroidisme) skal udelukkes eller håndteres på passende vis, inden Waylivra iværksættes.