FrancophonIA/ELRC3.0 huggingface dataset:
English: Eperzan should be discontinued at least 1 month before a planned pregnancy due to the long washout period for albiglutide.
Danish: Eperzan bør seponeres mindst 1 måned før en planlagt graviditet på grund af den lange udvaskningsperiode for albiglutid.
English: This can make it difficult to concentrate and make you dizzy or sleepy.
Danish: Dette kan bevirke, at du har svært ved at koncentrere dig og gøre dig svimmel eller søvnig.
English: A few drops of liquid may come out of the needle.
Danish: Der kan måske komme nogle få dråber væske ud af nålen.
English: 7a Choose your injection site (Figure P).
Danish: 7a Vælg dit injektionssted (Figur P).
English: It should be yellow and see-through, without any particles (Figure K).
Danish: Det skal være gult og klart uden partikler (Figur K).
English: If there is a possibility that you could become pregnant, you must use effective contraception while using this medicine.
Danish: Hvis der er mulighed for, at du kan blive gravid, skal du anvende et effektivt præventionsmiddel, når du tager dette lægemiddel.
English: Use within 8 hours of reconstitution.
Danish: Skal anvendes inden for 8 timer efter rekonstitution.
English: No dose adjustment is required based on age.
Danish: Det er ikke nødvendigt at justere dosis på grund af alder.
English: As long as the needle has not been attached, the pen can be used for up to 8 hours from the time Step 2 was started.
Danish: Så længe nålen ikke er blevet sat på, kan pennen bruges i op til 8 timer efter, at trin 2 blev påbegyndt.
English: Figure A * Injection Button is inside the pen until the pen is ready for injection.
Danish: Figur A * Injektionsknappen sidder inden i pennen, indtil pennen er klar til injektion.
English: Talk to your doctor if you are taking acarbose and Eperzan at the same time.
Danish: Tal med lægen, hvis du tager acarbose og Eperzan på samme tid.
English: Alternate method of reconstitution (healthcare professional use only):
Danish: Alternativ metode til rekonstitution (kun for læger og sundhedspersonale):
English: When Eperzan is added to existing metformin therapy, the current metformin dose can be continued unchanged.
Danish: Når Eperzan føjes til eksisterende metforminbehandling, kan den aktuelle metformindosis forblive uændret.
English: You can use Eperzan at any time of day, with or without meals.
Danish: Du kan tage Eperzan når som helst på dagen sammen med eller uden mad.
English: It is okay to have large air bubbles on top of the liquid.
Danish: Det er i orden, at der er store luftbobler på toppen af væsken.
English: Each pen injector should be used by one person only and is for single use.
Danish: Hver injektionspen bør kun anvendes af én person og er til engangsbrug.
English: No overall differences in glycaemic effectiveness or body weight were observed across demographic subgroups (age, gender, race/ethnicity, duration of diabetes).
Danish: Der blev ikke observeret nogen overordnede forskelle i glykæmisk effektivitet eller på legemsvægt på tværs af demografiske undergrupper (alder, køn, race/etnicitet, varighed af diabetes).
English: 5 Times min. sec.
Danish: 5 gange min. sek.
English: The day of weekly administration can be changed if necessary as long as the last dose was administered 4 or more days previously.
Danish: Dagen for ugentlig administration kan ændres, hvis det er nødvendigt, så længe sidste dosis blev administreret mindst 4 dage tidligere.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, (see also earlier in section 2 ‘Warnings and precautions').
Danish: Fortæl det altid til lægen eller apotekspersonalet, hvis du tager anden medicin eller har gjort det for nylig (se også tidligere under punkt 2 'Advarsler og forsigtighedsregler').
English: Eperzan may be administered at any time of day without regard to meals.
Danish: Eperzan kan administreres på et hvilket som helst tidspunkt af dagen uden hensyntagen til måltider.
English: Remaining cartons must be stored at 2C to 8C until required.
Danish: De resterende pakninger skal opbevares ved 2C til 8C indtil anvendelse.
English: The lyophilised powder contained within the pen must be reconstituted prior to administration.
Danish: Det frysetørrede pulver i pennen skal rekonstitueres før administration.
English: Questions and answers about the instructions for use of the pre-filled pen
Danish: Spørgsmål og svar til vejledningen i brug af den fyldte pen
English: The dose may be increased to 50 mg once weekly based on individual glycaemic response.
Danish: Dosis kan øges til 50 mg én gang ugentligt baseret på den individuelle glykæmiske respons.
English: What if I do not attach the needle as instructed?
Danish: Hvad sker der, hvis jeg ikke sætter nålen på som instrueret?
English: The clinical experience in patients >75 years is very limited (see section 5.2).
Danish: Den kliniske erfaring med patienter > 75 år er meget begrænset (se pkt.
English: If it has been more than 8 hours since the medicine was mixed in Step 2, throw away the pen and use another pen.
Danish: Hvis der er gået mere end 8 timer efter, at medicinen blev blandet i trin 2, skal du kassere pennen og bruge en ny pen.
English: Patients should be informed of the characteristic symptom of acute pancreatitis.
Danish: Patienterne bør informeres om det karakteristiske symptom på akut pancreatitis.
English: Because this method relies on appropriate swirling and visual inspection of the solution, it is intended only for healthcare professionals.
Danish: Da denne metode afhænger af korrekt rotation og visuel inspektion af injektionsvæsken, er den kun beregnet til læger og sundhedspersonale.
English: Other Supplies Needed
Danish: Andre nødvendige ting
English: Your doctor will decide if you can use Eperzan, and will explain the symptoms of pancreatitis (see ‘Conditions you need to look out for'
Danish: Lægen vil vurdere, om du kan tage Eperzan, og vil forklare dig symptomerne på pancreatitis (se ”Forhold du skal være opmærksom på”
English: If the needle is attached before Step 5, some of the medicine may be lost during mixing.
Danish: Hvis nålen sættes på før trin 5, kan noget af lægemidlet gå tabt under sammenblandingen.
English: • if you have ever had pancreatitis (inflammation of the pancreas).
Danish: • hvis du har haft pancreatitis (betændelse i bugspytkirtlen).
English: It is very important that you continue to follow any diet and lifestyle advice from your doctor while taking Eperzan.
Danish: Det er meget vigtigt, at du fortsat følger de råd, som lægen har givet dig omkring kost og livsstil, samtidig med, at du tager Eperzan.
English: Choice of other medicinal products and dose selection should be considered accordingly, as adverse reactions may continue and efficacy may, at least partly, persist until albiglutide levels decline.
Danish: Valg af andre lægemidler og dosis bør overvejes i overensstemmelse hermed, da bivirkninger fortsat kan forekomme og effekten kan vare ved, i hvert fald delvist, indtil albiglutid-niveauet falder.
English: If this happens, don't drive or use machines.
Danish: Hvis det sker, må du ikke køre bil eller motorcykel eller betjene maskiner.
English: Eperzan must not be injected into a vein (intravenously) or into a muscle (intramuscularly).
Danish: Eperzan må ikke injiceres ind i en vene (intravenøst) eller ind i en muskel (intramuskulært).
English: 1b Check dosage and expiration date on pen (Figure E).
Danish: 1b Kontroller dosis og udløbsdatoen på pennen (Figur E).
English: These data exclude the use of antidiabetic therapies permitted after the efficacy assessment if glycaemic thresholds were exceeded.
Danish: Disse data omfatter ikke brugen af antidiabetiske behandlinger, som var tilladt efter vurdering af effekten, hvis de glykæmiske grænseværdier var overskredet.
English: • severe stomach (abdominal) pain that does not go away, this can be a symptom of pancreatitis.
Danish: • voldsomme mavesmerter, der ikke går over, kan dette være et symptom på pancreatitis.
English: Avoid shaking as this can result in foaming.
Danish: Undgå at ryste, da dette kan medføre skumdannelse.
English: • After the powder and liquid are mixed within the pen, the pen should be used within 8 hours.
Danish: • Efter at pulveret og væsken er blandet inde i pennen, skal pennen bruges inden for 8 timer.
English: If necessary you can change the day of the week on which you use Eperzan, as long as it is at least 4 days since your last dose.
Danish: Hvis det er nødvendigt, kan du ændre den dag i ugen, hvor du tager Eperzan, så længe der går mindst 4 dage efter din sidste dosis.
English: When using Eperzan with insulin, each medicinal product must be administered as a separate injection.
Danish: Når Eperzan anvendes i kombination med insulin, skal hvert lægemiddel administreres som en særskilt injektion.
English: These are rare in people taking Eperzan (may affect up to 1 in 1000 people).
Danish: Disse er sjældne hos personer der tager Eperzan (kan forekomme hos op til 1 ud af 1.000 personer).
English: At the end of this period the pen should be used or discarded.
Danish: Ved afslutningen på denne periode skal pennen anvendes eller bortskaffes.
English: min. sec.
Danish: min. sek.
English: These types of gastrointestinal events may lead to dehydration, and worsen renal function.
Danish: Disse gastrointestinale bivirkninger kan medføre dehydrering og forværre nyrefunktionen.
English: Push Down Slowly
Danish: Tryk langsomt ned
English: If pancreatitis is suspected, Eperzan should be discontinued; if pancreatitis is confirmed, Eperzan should not be restarted.
Danish: Hvis der er mistanke om pancreatitis, skal Eperzan seponeres; hvis pancreatitis bekræftes, bør behandling med Eperzan ikke genoptages.
English: Glucagon-like peptide-1 (GLP-1) analogues.
Danish: Glucagon-lignende peptid-1 receptor (GLP-1) analog.
English: • because your body is not able to use the insulin properly.
Danish: • Fordi din krop ikke er i stand til at udnytte insulinen ordentligt.
English: Eperzan is not recommended if you have these
Danish: Eperzan anbefales ikke, hvis du har disse tilstande.
English: When diet and exercise alone do not provide adequate glycaemic control in patients for whom use of metformin is considered inappropriate due to contraindications or intolerance.
Danish: Når kost og motion alene ikke giver tilstrækkelig glykæmisk kontrol hos patienter, hvor anvendelse af metformin ikke anses for at være hensigtsmæssig på grund af kontraindikationer eller intolerance.
English: Glaxo Operations UK Limited (Trading as Glaxo Wellcome Operations) Harmire Road
Danish: Glaxo Operations UK Limited (Forhandler som Glaxo Wellcome Operations) Harmire Road
English: A decrease in halflife of simvastatin and simvastatin acid from ~7 hours to 3.5 hours was observed.
Danish: Der blev observeret et fald i halveringstiden af simvastatin og simvastatinsyre fra ~7 timer til 3,5 timer.
English: Diarrhoea (13% versus 9%), nausea (12% versus 11%), vomiting (5% versus 4%), and constipation (5% versus 4%) were the most frequently reported, and the majority of events occurred within the first 6 months.
Danish: Diarré (13 % versus 9 %), kvalme (12 % versus 11 %), opkastning (5 % versus 4 %) og obstipation (5 % versus 4 %) var de hyppigst rapporterede bivirkninger, og størstedelen forekom i løbet af de første 6 måneder.
English: Stop taking Eperzan and talk to your doctor straight away
Danish: Stop med at tage Eperzan, og kontakt lægen med det samme.
English: There is no therapeutic experience with Eperzan in patients with type 1 diabetes mellitus and it should not be used in these patients.
Danish: Der er ingen terapeutisk erfaring med Eperzan hos patienter med type 1-diabetes mellitus, og det bør ikke anvendes til disse patienter.
English: Hold Upright and Twist to 3
Danish: Hold lodret og drej til tallet 3
English: Check Medicine
Danish: Undersøg medicinen
English: For Eperzan, these were single episodes of pneumonia in patients participating in studies with 32 weeks up to 3 years of observation.
Danish: For Eperzan var der enkeltstående episoder af pneumoni hos patienter, der deltog i studier med observation i 32 uger og op til 3 år.
English: Based on the results of population pharmacokinetic analyses, there is no clinically relevant effect of gender on clearance.
Danish: På baggrund af resultaterne af de farmakokinetiske populationsanalyser er der ingen klinisk relevant effekt af køn på clearancen.
English: Step 8 Deliver injection 8a Insert needle straight into the injection site.
Danish: Trin 8 Afgiv injektionen 8a Stik nålen lige ind på injektionsstedet.
English: The percentage of patients who developed antibodies to albiglutide on treatment was 4% (137/3,267).
Danish: Procentdelen af patienter, som under behandling dannede antistoffer imod albiglutid, var 4 % (137/3.267).
English: Non-clinical data reveal no special hazards for humans based on studies of safety pharmacology or repeatdose toxicity.
Danish: Prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra studier af sikkerhedsfarmakologi eller toksicitet efter gentagne doser.
English: A needle is provided with each pen.
Danish: Der følger en nål med til hver pen.
English: Patient frequencies are defined as: very common ≥1/10; common ≥1/100 to <1/10; uncommon ≥1/1,000 to <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 hos patienterne er defineret som: meget almindelig ≥ 1/10, almindelig ≥ 1/100 til < 1/10, ikke almindelig ≥ 1/1.000 til < 1/100 og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: If you are planning to have a baby, your doctor may decide to stop your treatment with Eperzan at least one month before you try to get pregnant.
Danish: Hvis du planlægger at få et barn, kan lægen beslutte at stoppe din behandling med Eperzan mindst én måned før, du prøver at blive gravid.
English: Based on the results of population pharmacokinetic analyses that included Caucasian, African American/African, Asian and Hispanic/Non-Hispanic patients, race and ethnicity had no clinically meaningful effect on the pharmacokinetics of Eperzan clearance.
Danish: På baggrund af resultaterne af de farmakokinetiske populationsanalyser, der omfattede kaukasiske, afroamerikanske/afrikanske, asiatiske og latinamerikanske/ikke-latinamerikanske patienter, havde race og etnicitet ingen klinisk betydningsfuld effekt på farmakokinetikken af Eperzans clearance.
English: † The numbers on the clear cartridge represent stages of preparation for your medicine.
Danish: † Numrene på den gennemsigtige cylinderampul repræsenterer trinnene for klargøring af din medicin.
English: Step 7 Prepare for injection
Danish: Trin 7 Klargør injektionen
English: The recommended dose is 30 mg once a week, injected on the same day each week.
Danish: Den anbefalede dosis er 30 mg én gang om ugen injiceret samme dag hver uge.
English: The warning signs of low blood sugar may include cold sweat, cool pale skin, headache, feeling drowsy, weakness, dizziness, feeling confused or irritable, feeling hungry, fast heart beat and feeling jittery.
Danish: Advarselstegnene på for lavt blodsukker kan omfatte koldsved, kølig og bleg hud, hovedpine, døsighed, svaghed, svimmelhed, følelse af forvirring eller irritabilitet, sult, hurtig puls og skælven.
English: This can result in particles floating in the clear cartridge, not getting your full dose, or a blocked needle.
Danish: Dette kan resultere i, at der flyder partikler rundt i den gennemsigtige cylinderampul, du ikke får din fulde dosis eller en tilstoppet nål.
English: These events were predominately mild and did not lead to discontinuation.
Danish: Disse reaktioner var generelt lette og medførte ikke seponering.
English: You may give both injections in the same body area (for example, your stomach area), but you should not give the injections very close together.
Danish: Du kan give begge injektioner i samme kropsområde (for eksempel i maveområdet), men du skal ikke give injektionerne lige ved siden af hinanden.
English: The AUC of simvastatin acid was increased by 36% and Cmax was increased by approximately 100%.
Danish: AUC for simvastatinsyre blev øget med 36 %, og Cmax blev øget med ca. 100 %.
English: Eperzan is used to help control your blood sugar, either:
Danish: Eperzan anvendes til at hjælpe med at regulere dit blodsukker enten
English: This will help mix the medicine.
Danish: Det vil hjælpe med at blande medicinen.
English: Use of GLP-1 receptor agonists has been associated with a risk of developing acute pancreatitis.
Danish: Brug af GLP-1-receptoragonister har været forbundet med en risiko for at udvikle akut pancreatitis.
English: Paediatric population: No pharmacokinetic data are available in paediatric patients.
Danish: Pædiatrisk population Der er ingen tilgængelige farmakokinetiske data fra pædiatriske patienter.
English: Patients treated with albiglutide should be advised of the potential risk of dehydration, and take precautions to avoid fluid depletion.
Danish: Patienter behandlet med albiglutid bør informeres om den potentielle risiko for dehydrering og tage forholdsregler for at undgå væsketab.
English: Steady-state exposures are achieved following 3-5 weeks of once-weekly administration.
Danish: Steady state-eksponering nås efter 3-5 uger ved administration én gang ugentligt.
English: There is no specific antidote for overdose with Eperzan.
Danish: Der findes ingen specifik antidot i tilfælde af overdosering med Eperzan.
English: • if you are allergic to albiglutide or any of the other ingredients of this medicine (listed in section 6).
Danish: • hvis du er allergisk over for albiglutid eller et af de øvrige indholdsstoffer i Eperzan (angivet i punkt 6).
English: UNIQUE IDENTIFIER - 2D BARCODE
Danish: ENTYDIG IDENTIFIKATOR - 2D STREGKODE
English: Eperzan has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis, and therefore it is not recommended in these patients.
Danish: Eperzan er ikke blevet undersøgt hos patienter med svær gastrointestinal sygdom, herunder svær gastroparese, og derfor anbefales det ikke til disse patienter.
English: Powder: lyophilised white to yellow powder.
Danish: Pulver: Frysetørret, hvidt til gult pulver.
English: Each pen is used to deliver one dose.
Danish: Hver pen bruges til én dosis.
English: Eperzan helps your body to increase the production of insulin when your blood sugar is high.
Danish: Eperzan hjælper din krop med at danne mere insulin, når dit blodsukker er højt.
English: The majority of the observed reduction in fasting plasma glucose occurs after a single dose, consistent with the pharmacokinetic profile of albiglutide.
Danish: Størstedelen af den observerede reduktion i plasmaniveauet af fasteglucose sker efter en enkelt dosis, i overensstemmelse med albiglutids farmakokinetiske profil.
English: The mean estimate of apparent volume of distribution of albiglutide following SC administration is 11 litres.
Danish: Det gennemsnitlige estimat af det tilsyneladende fordelingsvolumen af albiglutid efter subkutan administration er 11 liter.
English: Wait 15 Minutes
Danish: Vent 15 minutter
English: It is acceptable to inject Eperzan and insulin in the same body region but the injections should not be adjacent to each other.
Danish: Det er acceptabelt at injicere Eperzan og insulin i samme kropsdel, men injektionerne bør ikke ligge lige ved siden af hinanden.
English: Speak to your doctor about how to recognise the symptoms of ketoacidosis and seek urgent medical treatment if they occur.
Danish: Tal med lægen om, hvordan du genkender symptomerne på ketoacidose og søg omgående læge, hvis de forekommer.
English: If you are pregnant or breast-feeding, if you think you may be pregnant, or are planning to have a baby, ask your doctor, nurse or pharmacist for advice before using this medicine.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge, sygeplejerske eller apotekspersonalet til råds, før du tager dette lægemiddel.
English: In addition, albiglutide did not significantly alter the pharmacodynamic effects of warfarin as measured by the international normalized ratio.
Danish: Derudover ændrede albiglutid ikke de farmakodynamiske effekter af warfarin signifikant bedømt ud fra den internationalt normaliserede ratio.
English: Your doctor may increase your dose to 50 mg once weekly if your blood sugar is not controlled by the 30 mg dose.
Danish: Lægen kan sætte din dosis op til 50 mg én gang ugentligt, hvis dit blodsukker ikke er godt nok reguleret med dosen på 30 mg.
English: Choose Injection Site
Danish: Vælg injektionssted
English: Stop taking Eperzan.
Danish: Stop med at tage Eperzan.
English: This dose was associated with an increased frequency of nausea, vomiting, and headache.
Danish: Denne dosis var forbundet med en øget hyppighed af kvalme, opkastning og hovedpine.
English: 9a Pull the needle out of your skin (Figure U).
Danish: 9a Træk nålen ud af huden (Figur U).
English: Gastric motility
Danish: Gastrisk motilitet
English: The incidence rates observed for first MACE+ were 1.2 and 1.1 events per 100 person-years for Eperzan versus all comparators, respectively.
Danish: De observerede incidensrater for første MACE+ var 1,2 og 1,1 hændelser pr. 100 personår for henholdsvis Eperzan og alle komparatorer.
English: Although most patients with injection site reactions were antibody negative (~85%), injection site reactions were reported more frequently for antibody positive (41%, N = 116) than antibody negative patients (14%, N = 1,927).
Danish: Selvom de fleste patienter med reaktioner på injektionsstedet var antistof-negative (~85 %), blev der hyppigere rapporteret reaktioner på injektionsstedet hos antistof-positive (41 %, N = 116) end hos antistofnegative patienter (14 %, N = 1.927).
English: No effects were seen at 5 mg/kg/day (at exposures similar to clinical exposure).
Danish: Der blev ikke set nogen virkninger ved 5 mg/kg/dag (ved eksponeringer svarende til klinisk eksponering).
English: DO NOT use pen if there are still particles in the liquid.
Danish: DU MÅ IKKE bruge penne, hvis der er partikler i væsken.
English: • if you have a serious problem with emptying your stomach (gastroparesis) or if you have severe bowel disease (severe gastrointestinal disease).
Danish: • hvis du har et alvorligt problem med at få tømt maven (gastroparese), eller hvis du har en alvorlig mave-tarmsygdom.
English: After discontinuation, the effect of Eperzan may continue as plasma levels of albiglutide decline slowly over about 3 to 4 weeks.
Danish: Virkningen af Eperzan kan fortsætte efter seponering, da plasma-albiglutid falder langsomt over omkring 3-4 uger.
English: • A new pen (Figure A).
Danish: • En ny pen (Figur A).
English: After reconstitution, the pen should be used within 8 hours.
Danish: Efter rekonstitution bør pennen anvendes inden for 8 timer.
English: Use Eperzan for as long as your doctor recommends.
Danish: Tag Eperzan i den periode, som lægen anbefaler.
English: Eperzan should not be used during pregnancy, and is not recommended in women of childbearing potential not using effective contraception.
Danish: Eperzan bør ikke anvendes under graviditeten og anbefales ikke til kvinder i den fertile alder, som ikke anvender sikker kontraception.
English: • When initiating treatment with albiglutide, you may experience fluid loss from vomiting, nausea, diarrhoea or dehydration.
Danish: • når behandling med albiglutid påbegyndes, kan du opleve væsketaab i forbindelse med opkastning, kvalme, diarre eller dehydrering.
English: The pen has the medicine powder in one compartment and the water in another compartment.
Danish: Pennen har lægemiddelpulver i et rum og vand i et andet rum.
English: Once weekly
Danish: Én gang ugentligt
English: Acute pancreatitis
Danish: Akut pancreatitis
English: Otherwise, the pattern of adverse events was generally similar for antibody positive and negative patients.
Danish: Herudover var bivirkningsmønsteret generelt det samme hos antistof-positive og antistof-negative patienter.