FrancophonIA/ELRC3.0 huggingface dataset:
English: Prior to launch of Waylivra in each Member State, the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Danish: Inden lancering af Waylivra i de enkelte medlemslande skal indehaveren af markedsføringstilladelsen (MAH) være enig med den relevante nationale myndighed om indholdet og formatet af uddannelsesprogrammet, herunder kommunikationsmedier, distributionsmetoder og eventuelle andre aspekter af programmet.
English: There may be special local laws regarding how you should throw away used needles and syringes.
Danish: Der kan være særlige lokale lovkrav vedrørende bortskaffelse af brugte kanyler og sprøjter.
English: You should refer to the date you have written on the carton to be sure.
Danish: Se den dato, du har noteret på kartonen, for at være sikker.
English: The safety and efficacy in patients with severe renal impairment has not been established and these patients should be closely observed.
Danish: Sikkerheden og virkningen hos patienter med svær nyreinsufficiens er endnu ikke klarlagt, og sådanne patienter bør overvåges nøje.
English: Very common (N, %)
Danish: Meget almindelig (N, %)
English: You may also apply ice to the injection site to reduce pain, redness, or discomfort (Figure P).
Danish: Du kan også lægge is på injektionsstedet for at lindre smerter, rødme eller ubehag (figur P).
English: • Made of heavy-duty plastic,
Danish: • Er fremstillet af hård plast,
English: May be kept at room temperature for up to 6 weeks.
Danish: Kan opbevares ved rumtemperatur i op til 6 uger.
English: Haemodialysis is unlikely to be beneficial given that volanesorsen is rapidly distributed into cells.
Danish: Hæmodialyse har sandsynligvis ingen gavnlig virkning, eftersom volanesorsen fordeles hurtigt til cellerne.
English: • Physician educational material
Danish: • Undervisningsmateriale til lægen
English: Lipid Parameter (g/L for apoC-III, apoB, apoB-48; mmol/L for cholesterol, triglycerides)
Danish: Lipidparameter (g/l for apoC-III, apoB, apoB-48; mmol/l for kolesterol, triglycerider)
English: Injecting 6.
Danish: Injektion 6.
English: Do not attempt to remove the air bubble.
Danish: Forsøg ikke at fjerne luftboblen.
English: The absolute bioavailability of volanesorsen following a single subcutaneous administration is approximately 80% (most likely higher because an AUC of 0 to 24 hours was used and volanesorsen has a half-life of >2 weeks).
Danish: Den absolutte biotilgængelighed af volanesorsen efter en enkelt subkutan administration er cirka 80 % (højst sandsynligt højere, idet der blev anvendt AUC fra time 0 til 24, og volanesorsen har en halveringstid >2 uger).
English: Check the expiry date on the carton.
Danish: Kontrollér udløbsdatoen på kartonen.
English: The needle should be inserted at a 45 degree angle to the skin surface (Figure J).
Danish: Kanylen skal indføres i en vinkel på 45 grader i forhold til hudoverfladen (figur J).
English: Talk to your doctor, pharmacist or nurse before using Waylivra if you have or have had any of the following medical problems: - Very high triglyceride levels which are not due to FCS.
Danish: Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før du bruger Waylivra, hvis du har eller har haft et af nedenstående helbredsproblemer: - Meget højt triglyceridniveau, som ikke skyldes FCS.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, genotoxicity, carcinogenicity or toxicity to reproduction and development.
Danish: Prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, genotoksicitet, karcinogenicitet eller udviklings- og reproduktionstoksicitet.
English: The parent drug and 5- to 7-mer chain-shortened metabolites accounted for approximately 26% and 55% of oligonucleotides recovered in urine, respectively.
Danish: Moderstoffet og kædeafkortede 5- til 7-mer-metabolitter udgjorde henholdsvis cirka 26 % og 55 % af de oligonukleotider, der blev genfundet i urinen.
English: Elimination involves both metabolism in tissues and excretion in urine.
Danish: Eliminationen sker både via metabolisme i vævene og udskillelse i urinen.
English: It is not known if Waylivra passes into breast milk.
Danish: Det vides ikke, om Waylivra går over i modermælken.
English: In the case of a positive assessment, a broader assessment of renal function, including serum creatinine and a 24-hour collection to quantify the proteinuria and assess creatinine clearance, should be performed.
Danish: I tilfælde af et positivt resultat, bør der foretages en bredere undersøgelse af nyrefunktionen, herunder serumkreatinin og en 24-timers indsamling for at kvantificere proteinuri og vurdere kreatininclearance.
English: No starting dose adjustment is necessary for elderly patients.
Danish: Det er ikke nødvendigt at justere startdosen hos ældre patienter.
English: It should be removed from refrigerated storage (2 ° to 8 °C) at least 30 minutes before use.
Danish: Den skal tages ud af køleskabet (2 ° til 8 °C) mindst 30 minutter inden brug.
English: You or your caregiver will be trained on how to use Waylivra according to the instructions in this leaflet.
Danish: Du eller din omsorgsperson vil blive undervist i at indgive Waylivra i henhold til vejledningen i denne indlægsseddel.
English: Storage Storage information
Danish: Opbevaring Opbevaringsoplysninger
English: All patients enrolled either had participated in the APPROACH Study, in the CS16 Study, or were new FCS patients and had completed qualification assessments prior to receiving volanesorsen 285 mg once per week or a reduced frequency for safety or tolerability reasons determined in their index study.
Danish: Alle de patienter, der blev inkluderet, havde enten deltaget i APPROACH-studiet eller i CS16-studiet eller var nye FCS-patienter, der havde fuldført kvalifikationsvurderingerne, inden de kunne få 285 mg volanesorsen én gang om ugen eller ved en reduceret hyppighed som følge af fastlagte sikkerheds- eller tolerabilitshensyn i deres indeksstudie.
English: Waylivra should be injected under your skin in the way the doctor, nurse or pharmacist has shown you, and you should make sure you inject all of the liquid in the syringe.
Danish: Waylivra skal sprøjtes ind under huden på den måde, som lægen, sundhedspersonalet eller apotekspersonalet har vist dig, og du skal sørge for at indsprøjte al væsken i sprøjten.
English: Each ml contains 200 mg volanesorsen sodium, equivalent to 190 mg volanesorsen.
Danish: Hver ml indeholder 200 mg volanesorsennatrium, svarende til 190 mg volanesorsen.
English: Store in a refrigerator (2 ° - 8 °C).
Danish: Opbevares i køleskab (2 °C - 8 °C).
English: o That patients should be made aware of the possibility of thrombocytopaenia and to seek medical attention immediately in case of signs of bleeding.
Danish: o Patienterne skal gøres opmærksomme på muligheden for trombocytopeni og om straks at søge lægehjælp ved tegn på blødning.
English: Date of first removal from fridge:
Danish: Dato for første udtagning af køleskab:
English: Following subcutaneous injection, peak plasma concentrations of volanesorsen are typically reached in 2 to 4 hours.
Danish: Efter subkutan injektion nås den maksimale plasmakoncentration af volanesorsen typisk i løbet af 2 til 4 timer.
English: Volanesorsen had no effect on fertility in mice.
Danish: Volanesorsen påvirkede ikke fertiliteten hos mus.
English: Immunogenicity and inflammation
Danish: Immunogenicitet og inflammation
English: Clean your chosen injection site with an alcohol pad (Figure G).
Danish: Rengør det valgte injektionssted med en alkoholserviet (figur G).
English: It is important to tell your doctor if you are already being treated with any of the following: - Medicines to prevent blood clots, e.g., acetylsalicylic acid, dipyridamol or warfarin.
Danish: Det er vigtigt, at du fortæller det til lægen, hvis du allerede er i behandling med nogen af nedenstående lægemidler: - Lægemidler til forebyggelse af blodpropper, f.eks. acetylsalicylsyre, dipyridamol eller warfarin.
English: Both volanesorsen and shorter oligonucleotide metabolites (predominantly 7-mer metabolites (generated either from 3′-deletions or 5′-deletions))
Danish: Både volanesorsen og de kortere oligonukleotidmetabolitter (primært 7-mer-metabolitter (genereret fra enten 3′-deletioner eller 5′
English: If signs and symptoms of hepatotoxicity develop, use of the hepatotoxic medicinal product should be discontinued.
Danish: Hvis der opstår tegn og symptomer på hepatotoksicitet, bør behandlingen med det hepatotoksiske lægemiddel seponeres.
English: You should continue the very low-fat diet that your doctor has prescribed during treatment with Waylivra.
Danish: Du skal fortsætte med at følge den meget fedtfattige diæt, som lægen har anvist, under behandlingen med Waylivra.
English: The effect of taking Waylivra with alcohol is not known.
Danish: Virkningen af Waylivra i kombination med alkohol er ikke kendt.
English: FCS is a genetic disease which gives rise to abnormally high levels of fats called triglycerides in the blood.
Danish: FCS er en genetisk sygdom, der medfører unormalt høje niveauer af nogle fedtstoffer i blodet, der kaldes triglycerider.
English: - Severe tiredness (fatigue), weakness or lack of energy, fluid retention, chest pain unrelated to the heart o
Danish: - Udpræget træthed (fatigue), svaghed eller manglende energi, væskeophobning, brystsmerter uden relation til hjertet
English: There were no significant differences in treatment effect across the stratification factors of presence or absence of concurrent omega-3 fatty acids or fibrates.
Danish: Der var ingen signifikante forskelle i behandlingsvirkningen på tværs af stratifikationsfaktorerne, som bestod af tilstedeværelse af eller mangel på samtidige omega-3-fedtsyrer eller fibrater.
English: You will only be given Waylivra if genetic testing has confirmed you have FCS and your risk for pancreatitis is considered very high..
Danish: Du vil kun få Waylivra, hvis det er blevet bekræftet gennem genetisk testning, at du har FCS, og din risiko for betændelse i bugspytkirtlen betragtes som at være meget høj.
English: It is unknown whether triglyceride lowering by volanesorsen and the potentially ensuing decrease in inflammation leads to normalisation of CYP enzyme expression.
Danish: Det vides ikke, om volanesorsen-forårsagede fald i triglycerider og den deraf følgende potentielle inflammationshæmning fører til normalisering af ekspressionen af CYP-enzymer.
English: If formation of anti-drug antibodies with a clinically significant effect is suspected, contact the Marketing Authorisation Holder to discuss antibody testing.
Danish: Hvis der er mistanke om dannelse af antistoffer mod lægemidler med en klinisk signifikant virkning, skal indehaveren af markedsføringstilladelsen kontaktes for at drøfte antistoftest.
English: If the platelet count is below 140 x 109/L another measurement should be taken approximately a week later to reassess.
Danish: Hvis trombocyttallet er under 140 x 109/l, bør der tages en anden måling ca. en uge senere for at revurdere.
English: No clinical data on the effect of this medicinal product on human fertility are available.
Danish: Der foreligger ingen kliniske data om dette lægemiddels indvirkning på fertiliteten hos mennesker.
English: In individual monkeys, severe thrombocytopenia was noted in the 9 month study of drug treated groups at clinically relevant exposures and has also been observed in clinical studies.
Danish: Svær trombocytopeni blev noteret hos enkelte aber i et 9-måneders studie med lægemiddelbehandlede grupper ved klinisk relevante eksponeringer og er også observeret i kliniske studier.
English: Waylivra is not likely to affect your ability to drive or use machines.
Danish: Waylivra påvirker sandsynligvis ikke evnen til at føre motorkøretøj eller betjene maskiner.
English: Patients should be instructed to give the injection on the same day of the week, according to medically determined frequency of administration.
Danish: Patienterne bør instrueres i at tage injektionen på den samme ugedag i henhold til den af lægen anviste administrationshyppighed.
English: Diagnosis of FCS required documentation of at least one of the following: a) Confirmed homozygote, compound heterozygote, or double heterozygote for known loss-offunction mutations in Type 1-causing genes (such as LPL, APOC2, GPIHBP1, or LMF1)
Danish: FCS-diagnosen krævede dokumentation for mindst en af følgende tilstande: a) Bekræftet homozygot, sammensat heterozygot eller dobbelt heterozygot for kendte funktionstabsmutationer i type 1-forårsagende gener (såsom LPL, APOC2, GPIHBP1 eller LMF1)
English: In the case of overdose, patients should be carefully observed and supportive care administered, as appropriate.
Danish: I tilfælde af overdosering bør patienten holdes under tæt observation og have understøttende behandling efter behov.
English: - A low number of platelets, a type of cell in your blood that clump together to help it clot (thrombocytopenia); your doctor will do a blood test before you start using this medicine to check the number of platelets in your blood.
Danish: - Lavt antal blodplader, som er en type celler i blodet, der klumper sammen og hjælper blodet med at størkne (trombocytopeni); lægen vil tage en blodprøve, inden du begynder at bruge dette lægemiddel, for at kontrollere antallet af blodplader i dit blod.
English: The first injection administered by the patient or caregiver should be performed under the guidance of an appropriately qualified health care professional.
Danish: Den første injektion, som patienten eller dennes plejeperson selv indgiver, skal gives under vejledning af en behørigt kvalificeret sundhedsperson.
English: LS Mean Percent Change (95% CI)
Danish: LS-middelværdi af procentvis ændring (95 % CI)
English: - you have a condition called thrombocytopenia, which means that you have a very low number of platelets in your blood (less than 140 x 109/L).
Danish: - hvis du har trombocytopeni, som er en tilstand, hvor du har et meget lavt antal blodplader i blodet (under 140 x 109/l).
English: Treatment should be discontinued if there is a single increase in ALT or AST > 8 x ULN, or an increase > 5 x ULN, which persists for ≥ 2 weeks, or lesser increases in ALT or AST that are associated with total bilirubin > 2 x ULN or INR > 1.5.
Danish: Behandlingen bør seponeres, hvis der er en enkelt stigning i ALAT eller ASAT > 8 x ULN eller en stigning > 5 x ULN, som varer ved i ≥ 2 uger, eller mindre stigninger i ALAT eller ASAT, som er forbundet med en total bilirubin > 2 x ULN eller en INRværdi > 1,5.
English: No evidence of altered safety profile or clinical response was associated with presence of anti-drug antibodies.
Danish: Der er ikke set tegn på en ændret sikkerhedsprofil eller klinisk respons i forbindelse med tilstedeværelsen af antistoffer mod lægemidler.
English: After a 6-week diet run-in period, the mean fasting triglyceride level at baseline was 2,209 mg/dL (25.0 mmol/L).
Danish: Efter en 6ugers indkøringsperiode med diæt var det gennemsnitlige fastende triglyceridniveau ved baseline 2.209 mg/dl (25,0 mmol/l).
English: Co. Louth Ireland
Danish: Co. Louth Ireand
English: • Capable of being closed with a tight-fitting, Puncture resistant lid, without sharps being able to come out,
Danish: • Kan lukkes tæt til og har et punkturfast låg, så skarpe genstande ikke kan komme ud,
English: Insert the needle into the injection site with a quick, firm motion without touching the plunger head.
Danish: Før kanylen ind i injektionsstedet i en hurtig og bestemt bevægelse uden at røre ved stempelhovedet.
English: Chronic or unexplained thrombocytopenia.
Danish: Kronisk eller uforklarlig trombocytopeni.
English: If the expiry date on the syringe label has passed during the 6 week period at room temperature, the syringe should not be used and should be discarded.
Danish: Hvis udløbsdatoen på sprøjteetiketten overskrides i løbet af den 6-ugers periode ved rumtemperatur, må sprøjten ikke anvendes, og den skal bortskaffes.
English: Volanesorsen is not a substrate for CYP metabolism, and is metabolised in tissues by endonucleases to form shorter oligonucleotides that are then substrates for additional metabolism by exonucleases.
Danish: Volanesorsen er ikke et substrat for CYP-metabolisme, og det metaboliseres i væv via endonukleaser til kortere oligonukleotider, som så er substrater for yderligere metabolisme via exonukleaser.
English: The medicinal product is not metabolised via the cytochrome P450 enzyme system in the liver, therefore dose adjustment is unlikely to be required in patients with hepatic impairment.
Danish: Dette lægemiddel metaboliseres ikke via cytochrom P450-enzymsystemet i leveren, og derfor er det sandsynligvis ikke nødvendigt at justere dosen hos patienter med nedsat leverfunktion.
English: Based on the population pharmacokinetic analysis, age, body weight, sex, or race has no clinically relevant effect on volanesorsen exposure.
Danish: Baseret på en populationsfarmakokinetisk analyse har alder, legemsvægt, køn eller race ingen klinisk relevant indvirkning på eksponeringen for volanesorsen.
English: Patients must be reminded to read the patient leaflet and the patient/carer guide.
Danish: Patienterne skal mindes om at læse indlægssedlen og vejledningen til patienten/omsorgsgiveren.
English: What you need to know before you use Waylivra 3.
Danish: Det skal du vide, før du begynder at bruge Waylivra 3.
English: Percent Change from Baseline in Fasting Triglycerides: Subset of Patients with Non-Missing Endpoints, Full Analysis Set
Danish: Procentvis ændring i fastende triglycerider i forhold til baseline: Undergruppe af patienter uden manglende endepunkter, fuldt analysesæt
English: Choose an injection site If self-injecting:
Danish: Vælg et injektionssted Hvis du skal give dig selv en injektion:
English: Table 6: Summary of Fasting Triglycerides (Mean (SD, SEM), mg/dL) Over Time in Study CS7
Danish: Oversigt over fastende triglycerider (middel (SD, SEM), mg/dl) over tid i studie CS7
English: Percent of patientsc with ≥ 40% reduction in fasting triglycerides** a The Month 3 endpoint was defined as the average of Week 12 (Day 78) and Week 13 (Day 85) fasting assessments.
Danish: Procentdel af patienterc med ≥ 40 % reduktion i fastende triglycerider** a Endepunktet ved måned 3 var defineret som gennemsnittet af fastende vurderinger ved uge 12 (dag 78) og uge 13 (dag 85).
English: Effects of Waylivra on lipid parameters
Danish: Waylivras indvirkning på lipidparametre
English: Waylivra may be given after you have already received other medicines used to lower the levels of triglycerides in blood without them having much effect.
Danish: Du vil muligvis få Waylivra, efter du allerede har fået andre lægemidler til sænkning af indholdet af triglycerider i dit blod, som dog ikke har haft nogen særlig virkning.
English: Your doctor may also do a blood test every 3 months to check for signs of damage to your liver.
Danish: Din læge vil muligvis også foretage en blodprøve hver tredje måned for at se, om der er skader på din lever.
English: Stomach - Stomach area as shown, except for 2 inches around the belly button.
Danish: Mave - Maveområde med undtagelse af 5 cm omkring navlen, som vist.
English: Common (N, %)
Danish: Almindelig (N, %)
English: Urine tests
Danish: Urinprøver
English: *p-value < 0.0001 (primary efficacy endpoint) Difference= LS Mean of [volanesorsen % Change - Placebo % Change] (ANCOVA model)
Danish: *p-værdi < 0,0001 (primært effektendepunkt) Forskel = LS-middelværdi af [volanesorsen %-vis ændring - placebo %-vis ændring] (ANCOVA-model)
English: Monitoring of inflammation should be assessed through quarterly assessment of erythrocyte sedimentation rate (ESR).
Danish: Monitorering af inflammation bør vurderes ved vurdering af erytrocytsænkningshastigheden (ESR) hvert kvartal.
English: Call your doctor or pharmacist to get a new supply.
Danish: Kontakt lægen eller apotekspersonalet for nye forsyninger.
English: Contents of the pack and other information What Waylivra contains
Danish: Pakningsstørrelser og yderligere oplysninger Waylivra indeholder:
English: If the solution is cloudy or contains visible particulate matter, the contents must not be injected and the medicinal product should be returned to the pharmacy.
Danish: Hvis opløsningen er uklar eller indeholder synlige partikler, må indholdet ikke injiceres, og lægemidlet skal returneres til apoteket.
English: The medicine should be clear to slightly yellow in color.
Danish: Medicinen skal være klar til let gullig i farven.
English: There were no adverse events related to drug-drug interactions reported during the clinical program, however this is based on limited data.
Danish: Der blev ikke indberettet nogen bivirkninger, der var relateret til lægemiddelinteraktioner, i det kliniske program; dette er imidlertid baseret på begrænsede data.
English: You can reduce the likelihood of having injection site reaction if you wait for Waylivra to reach room temperature before injecting, and by applying ice to the injection site after injecting.
Danish: Du kan nedsætte risikoen for reaktioner på injektionsstedet, hvis du lader Waylivra opnå rumtemperatur inden indgivelsen, og hvis du bruger is på injektionsstedet efter indgivelsen.
English: Thighs - Front, middle area as shown (Figure E).
Danish: Lår - Forreste, midterste område, som vist (figur E).
English: A population pharmacokinetic analysis suggests that mild and moderate renal impairment has no clinically relevant effect on the systemic exposure of volanesorsen.
Danish: En populationsfarmakokinetisk analyse tyder på, at mild og moderat nyreinsufficiens ikke har nogen klinisk relevant indvirkning på den systemiske eksponering vor volanesorsen.
English: In the Phase 3 clinical studies (CS16 and APPROACH), 16% and 30% of volanesorsen-treated patients tested positive for anti-drug antibodies during 6-month and 12-month treatment, respectively.
Danish: I de kliniske fase 3-studier (CS16 og APPROACH) blev hhv. 16 % og 30 % af de volanesorsenbehandlede patienter testet positive for antistoffer mod lægemidlet i løbet af behandlingen på hhv. 6 måneder og 12 måneder.
English: Volanesorsen has no or negligible influence on the ability to drive and use machines.
Danish: Volanesorsen påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: Waylivra contains the active substance volanesorsen, which helps to treat a condition called familial chylomicronemia syndrome (FCS).
Danish: Waylivra indeholder det aktive stof volanesorsen, som hjælper med at behandle en sygdom, der kaldes familiært chylomikronæmisyndrom (FCS).
English: Onset of the reduction was rapid with separation from placebo seen as early as 4 weeks and maximum response seen at 12 weeks, with clinically and statistically significant triglyceride reduction maintained over 52 weeks (Figure 1).
Danish: Reduktionen indtrådte hurtigt med separation fra placebo allerede efter 4 uger og maksimalt respons efter 12 uger, og der blev opretholdt klinisk og statistisk signifikant triglyceridreduktion over 52 uger (figur 1).
English: Waylivra monitoring and treatment recommendations
Danish: Anbefalinger vedrørende behandling med Waylivra og monitorering
English: Treatment should also be discontinued for any clinical symptoms or signs of hepatic impairment or hepatitis.
Danish: Behandlingen bør også seponeres i tilfælde af alle kliniske symptomer eller tegn på nedsat leverfunktion eller hepatitis.
English: However, treatment should be discontinued in patients with a reduction in serum triglycerides <25% or who fail to achieve serum triglycerides below 22.6 mmol/L after 3 months on volanesorsen 285 mg weekly.
Danish: Behandlingen bør dog seponeres hos patienter med en reduktion i serumtriglycerid < 25 % eller patienter, som ikke opnår serumtriglycerid på under 22,6 mmol/l efter tre måneders behandling med volanesorsen 285 mg ugentligt.