FrancophonIA/ELRC3.0 huggingface dataset:
English: Possible hypersensitivity reactions including angioedema, erythema, generalised pruritus and rash with dyspnoea, have been reported with albiglutide.
Danish: Mulige overfølsomhedsreaktioner herunder angioødem, erythema, generaliseret kløe, udslæt og dyspnø, er blevet rapporteret med albiglutid.
English: Simvastatin AUC was decreased by 40% and simvastatin Cmax was increased by 18%.
Danish: Simvastatin-AUC blev reduceret med 40 %, og simvastatin-Cmax blev øget med 18 %.
English: Body weight has no clinically relevant effect on albiglutide AUC over the range 44 to 158 kg. A 20% increase in body weight resulted in an approximate 18.5% increase in clearance.
Danish: Legemsvægt havde ingen klinisk relevant effekt på albiglutids AUC i intervallet 44 til 158 kg. En forøgelse af legemsvægten på 20 % resulterede i en stigning i clearance på ca. 18,5 %.
English: Eperzan that has been frozen must not be used.
Danish: Vejledning i brug Eperzan, der har været udsat for frost, må ikke anvendes.
English: A decision should be made whether to discontinue breast-feeding or to discontinue therapy, taking into account the benefit of breast-feeding for the child and the benefit of therapy for the mother.
Danish: Det skal besluttes, om amning skal ophøre eller Eperzan seponeres, idet der tages højde for fordelene ved amning for barnet i forhold til de terapeutiske fordele for moderen.
English: Albiglutide delays gastric emptying, and has the potential to impact the absorption of concomitantly administered oral medicinal products.
Danish: Albiglutid forsinker ventrikeltømningen og har potentialet til at påvirke absorptionen af samtidigt administrerede orale lægemidler.
English: If a dose is missed, it should be administered as soon as possible within 3 days after the missed dose.
Danish: Hvis en dosis glemmes, bør den administreres så hurtigt som muligt inden for 3 dage efter den glemte dosis.
English: Use Eperzan only if it is a clear yellow solution and contains no particles.
Danish: Eperzan må kun anvendes, hvis det er en klar, gul injektionsvæske, som ikke indeholder partikler.
English: Active-controlled study versus sitagliptin in patients with type 2 diabetes and different degrees of renal impairment
Danish: Aktivt kontrolleret studie versus sitagliptin hos patienter med type2-diabetes og forskellige grader af nedsat nyrefunktion
English: Exposures at the 30 mg and 50 mg dose levels were consistent with a dose-proportional increase.
Danish: Eksponeringerne ved dosisniveauerne 30 mg og 50 mg var i overensstemmelse med en dosisproportional stigning.
English: • because your body does not make enough insulin to control the level of sugar in your blood or
Danish: • fordi din krop ikke danner nok insulin til at regulere sukkerniveauet i dit blod eller
English: An endpoint called MACE+ (major adverse cardiac events plus) included hospitalisation for unstable angina in addition to the MACE endpoints (acute myocardial infarction, stroke, and CV death).
Danish: Et endepunkt kaldet MACE+ (Major Adverse Cardiac Events plus) omfattede hospitalsindlæggelse på grund af ustabil angina pectoris ud over MACE-endepunkterne (akut myokardieinfarkt, apopleksi og kardiovaskulær død).
English: Wait 30 Minutes
Danish: Vent 30 minutter
English: Description of selected adverse reactions:
Danish: Beskrivelse af udvalgte bivirkninger:
English: • if you have Type 1 (insulin-dependent) diabetes or ketoacidosis (a very serious complication of diabetes which happens when your body is not able to break down glucose because there is not enough insulin), this medicine will not be right for you.
Danish: • Hvis du har type 1-diabetes (insulinkrævende diabetes) eller ketoacidose (en meget alvorlig komplikation ved diabetes, som opstår, når din krop ikke er i stand til at nedbryde glukose, fordi der ikke er nok insulin), vil dette lægemiddel ikke være velegnet til dig.
English: During clinical studies of patients with type 2 diabetes, the highest dose of Eperzan administered was 100 mg subcutaneously every four weeks for 12 weeks.
Danish: I kliniske studier med patienter med type 2-diabetes var den højeste dosis af Eperzan, der blev administreret, 100 mg subkutant hver 4. uge i 12 uger.
English: In the event of a suspected overdose, the appropriate supportive clinical care should be instituted, as dictated by the subject's clinical status.
Danish: Ved mistanke om overdosering skal der indledes hensigtsmæssig understøttende behandling i henhold til personens kliniske status.
English: It is unknown whether the reduced offspring body weight was caused by a direct albiglutide effect on the offspring or secondary to effects on the dam.
Danish: Det vides ikke, om afkommets reducerede kropsvægt skyldtes en direkte virkning af albiglutid på afkommet eller var sekundær til virkninger på moderdyret.
English: Severe allergic reactions
Danish: Alvorlige allergiske reaktioner
English: Across the 8 clinical trials, and including subjects in all treatment groups, a total of 19% of patients (N = 937) were 65 years of age and older, and 2% (N = 112) were 75 years of age and older, 52%
Danish: På tværs af de 8 kliniske studier og inklusive personer i alle behandlingsgrupper var i alt 19 % af patienterne (N = 937) 65 år og derover, og 2 % (N = 112) var 75 år og derover.
English: There are no data on the effects of Eperzan on human fertility.
Danish: Der foreligger ingen data om virkningen af Eperzan på human fertilitet.
English: These findings are consistent with lactational ileus syndrome which has been previously reported in mice.
Danish: Disse fund stemmer overens med laktationsrelateret ileussyndrom, som tidligere er rapporteret hos mus.
English: Sixty seven percent of patients were Caucasian, 15% African American/African heritage and 11% Asian; 26% of patients were Hispanic/Latino.
Danish: 67 % af patienterne var kaukasiere, 15 % var afroamerikanere/af afrikansk herkomst, og 11 % var asiater.
English: If you have heard and felt the injection button “click” and slowly counted to 5 before pulling the needle out of your skin, you should have received the full dose of your medicine.
Danish: Hvis du har hørt/følt injektionsknappen "klikke" og talt langsomt til 5, før du trak nålen ud af huden, bør du have fået den rigtige dosis af din medicin.
English: After I give my medicine, there is some liquid still seen in the clear cartridge.
Danish: Når jeg har taget min medicin, er der stadig noget væske tilbage i den gennemsigtige cylinderampul.
English: Hold the pen upright before attaching the needle.
Danish: Hold pennen opad før nålen sættes på.
English: DO NOT rest the back of the device (where the injection button is exposed) on a flat surface while removing needle caps.
Danish: DU MÅ IKKE hvile bunden af anordningen (hvor injektionsknappen er kommet frem) på en flad overflade, mens du fjerner nålehætterne.
English: You can use your abdomen, thigh, or upper arm.
Danish: Du kan bruge din mave, lår eller overarm.
English: Mortalities have not been observed in previous toxicology studies in nonlactating or non-pregnant mice, nor in pregnant mice.
Danish: Der er ikke observeret mortaliteter i tidligere toksikologistudier hos ikke-diegivende eller ikke-drægtige mus, og heller ikke hos drægtige mus.
English: • chest infection (pneumonia)
Danish: • lungebetændelse (pneumoni)
English: The use of Eperzan does not require specific blood glucose self-monitoring.
Danish: Behandling med Eparzan kræver ikke specifik selvmonitorering af blodglucose.
English: Rock Pen Again
Danish: Vip pennen igen
English: Severe gastrointestinal disease
Danish: Svær gastrointestinal sygdom
English: Once weekly.
Danish: Én gang ugentligt.
English: Store in a refrigerator (between 2C and 8C).
Danish: Opbevares i køleskab (mellem 2 C og 8 C).
English: Change at Week 52b
Danish: Ændring ved uge 52b
English: If you miss a dose, inject the next dose as soon as possible within 3 days after the missed dose.
Danish: Hvis du glemmer en dosis, så injicer den næste dosis så hurtigt som muligt inden for 3 dage efter den glemte dosis.
English: It is not known if albiglutide is excreted in human milk.
Danish: Det er ukendt, om albiglutid udskilles i human mælk.
English: Acarbose is contraindicated in patients with intestinal obstruction.
Danish: Acarbose er kontraindiceret hos patienter med tarmobstruktion.
English: Adverse reactions from phase III studies during the entire treatment periods and postmarketing reports
Danish: Bivirkninger i fase III-studier over hele behandlingsperioden og postmarketing rapporter Systemorganklasse Meget almindelig
English: Each pen contains a white to yellow powder and a colourless solvent in separate compartments.
Danish: Hver pen indeholder et hvidt til gulligt pulver og et farveløst opløsningsmiddel (solvens) i to forskellige rum.
English: were male, with a mean body mass index (BMI) of 33 kg/m2.
Danish: Patienterne havde et gennemsnitligt body mass index (BMI) på 33 kg/m2.
English: What you need to know before you take Eperzan 3.
Danish: Det skal du vide, før du begynder at tage Eperzan 3.
English: The clinical relevance of the observed thyroid C-cell tumours in rodents is unknown.
Danish: Den kliniske relevans af de observerede thyreoide-C-celle-tumorer hos gnavere kendes ikke.
English: Given that albiglutide is an albumin-based protein therapeutic agent, it is likely to be present in human milk.
Danish: Da albiglutid er et albuminbaseret terapeutisk protein, er det sandsynligvis til stede i human mælk.
English: Don't stop unless your doctor advises you to.
Danish: Du må ikke stoppe med at tage Eperzan, medmindre lægen råder dig til det.
English: Don't use Eperzan:
Danish: Tag ikke Eperzan:
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Eperzan in one or more subsets of the paediatric population in the treatment of type 2 diabetes mellitus (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med Eperzan i en eller flere undergrupper af den pædiatriske population ved type 2-diabetes mellitus (se pkt.
English: Viewing Window Number Window
Danish: Inspektionsvindue Nummervindue
English: Albiglutide is produced in Saccharomyces cerevisiae cells by recombinant DNA technology.
Danish: Albiglutid dannes i Saccharomyces cerevisiae-celler ved hjælp af rekombinant DNA-teknologi.
English: If you do not hear a “click” when the [2] or when the [3] is moved into the number window, you may not have the number fully centered in the window.
Danish: Hvis du ikke hører et "klik", når [2] eller når [3] kommer til syne i nummervinduet, er det måske, fordi du ikke har centreret nummeret helt i vinduet.
English: The change from baseline in weight did not differ significantly between treatment groups (see Table 4).
Danish: Ændringen i vægt i forhold til baseline var ikke signifikant forskellig mellem behandlingsgrupperne (se tabel 4).
English: Inspect the pen to ensure that the number ‘1' is visible in the number window.
Danish: Inspicer pennen for at sikre, at nummeret ‘1' er synligt i nummervinduet.
English: Gastrointestinal events occurred with a higher frequency for Eperzan compared to all comparators (38% versus 32%).
Danish: Gastrointestinale bivirkninger forekom med en større hyppighed ved Eperzan sammenlignet med alle komparatorer (38 % versus 32 %).
English: Risk of acute pancreatitis (an inflamed pancreas) Pancreatitis has been reported as an uncommon side effect.
Danish: Risiko for akut pancreatitis (betændelse i bugspytkirtlen) Pancreatitis er blevet rapporteret som en ikke almindelig bivirkning.
English: In addition no clinically relevant effects on luteinizing hormone, follicle-stimulating hormone, or progesterone were observed when albiglutide and a combination oral contraceptive were co-administered.
Danish: Derudover blev der ikke observeret nogen klinisk relevant effekt på luteiniserende hormon, follikelstimulerende hormon eller progesteron, når albiglutid og et oralt kombinationskontraceptivum blev administreret samtidigt.
English: Complete dissolution for the 50 mg pen usually occurs within 7 minutes but may take up to 10 minutes.
Danish: For 50 mg pennen er pulveret normalt fuldstændigt opløst inden for 7 minutter, men det kan tage op til 10 minutter.
English: Reconstitution and administration by the patient Full instructions for reconstitution and administration to be used by the patient are provided in the Instructions for Use section of the Package Leaflet.
Danish: Rekonstitution og administration udført af patienten Der findes en udførlig instruktion i rekonstitution og administration til patienten i afsnittet 'Vejledning i brug' i indlægssedlen.
English: IMPORTANT: You may hear a “click” when you first start twisting the cartridge from [2] to [3].
Danish: VIGTIGT: Du hører måske et ”klik”, når du starte med at dreje cylinderampullen fra [2] til [3].
English: You and your doctor should decide whether you will use Eperzan or breast-feed.
Danish: Du og lægen skal i fællesskab afgøre, om du skal tage Eperzan eller amme.
English: None of these antibodies were shown to neutralise the activity of albiglutide in an in vitro assay and antibody formation was generally transient and was not associated with reduced efficacy (HbA1c and FPG).
Danish: Ingen af disse antistoffer kunne påvises at neutralisere aktiviteten af albiglutid i et in vitro assay, og dannelsen af antistoffer var generelt forbigående og ikke forbundet med reduceret effekt (HbA1c og faste plasma-glucose (FPG)).
English: Dehydration, sometimes leading to renal impairment and acute renal failure, has been reported in patients treated with albiglutide and has occurred in patients without gastrointestinal side effects.
Danish: Dehydrering der kan føre til nedsat nyrefunktion og akut nyresvigt, er blevet indberettet hos patienter behandlet med albiglutid og er forekommet hos patienter uden gastrointestionale bivirkninger.
English: Adverse reactions reported from a pooled analysis of seven placebo- and active-controlled phase III studies over the entire treatment period are presented in Table 1.
Danish: Bivirkningerne, der blev rapporteret fra en samlet analyse af 7 placebokontrollerede eller aktivt kontrollerede fase III-studier over hele behandlingsperioden, er vist i tabel 1.
English: Eperzan has no or negligible influence on your ability to drive or use machines.
Danish: Eperzan har ingen eller kun en ubetydelig indflydelse på din evne til at køre bil og betjene maskiner.
English: Sodium dihydrogen phosphate monohydrate
Danish: Natriumdihydrogenphosphatmonohydrat
English: Use of GLP-1 receptor agonists may be associated with gastrointestinal adverse reactions.
Danish: Anvendelse af GLP-1-receptoragonister kan være forbundet med gastrointestinale bivirkninger.
English: A meta-analysis of 9 clinical studies (8 major effectiveness studies and 1 phase II dose finding study) of up to 3 years duration was conducted to assess the cardiovascular safety of Eperzan (N=2,524) compared to all comparators (N=2,583) within these trials.
Danish: En metaanalyse af 9 kliniske studier (8 major effekt-studier og 1 fase II-dosisbestemmelses-studie) af op til 3 års varighed blev udført for at bestemme den kardiovaskulære sikkerhed ved Eperzan (N = 2.524) sammenlignet med alle komparatorerne (N = 2.583) i disse studier.
English: Eperzan contains the active ingredient albiglutide which belongs to a group of medicines called GLP-1 receptor agonists that are used to lower blood sugar (glucose) in adults with Type 2 diabetes.
Danish: Eperzan indeholder det aktive indholdsstof albiglutid, som tilhører gruppen af lægemidler kaldet GLP-1receptor-agonister, der anvendes til at sænke niveauet af sukker (glucose) i blodet hos voksne med type 2diabetes.
English: Albiglutide also produced dose-dependent increases in serum calcitonin levels in a 21-day study in mice, suggesting that thyroid tumours in rodents are a theoretical possibility for albiglutide as well.
Danish: Albiglutid bevirkede også dosisafhængige stigninger i serumcalcitonin-niveauer i et 21-dages studie med mus, hvilket kan antyde, at thyreoide tumorer hos gnavere også er en teoretisk mulighed for albiglutid.
English: There is no information about the safety of Eperzan in pregnant women.
Danish: Der findes ingen oplysninger om sikkerheden af Eperzan til gravide kvinder.
English: DO NOT use the pen if the injection button does not pop out.
Danish: DU MÅ IKKE bruge pennen, hvis injektionsknappen ikke kommer frem.
English: The needle must be attached to allow air to escape while turning the cartridge from [2] to [3] in the number window.
Danish: Nålen skal være sat på for at tillade luft at slippe ud, mens cylinderampullen drejes fra [2] til [3] i nummervinduet.
English: This will mix the medicine powder and liquid.
Danish: Herved vil lægemiddelpulveret og væsken blive blandet.
English: • A clock or timer (Figure C).
Danish: • Et ur eller stopur (Figur C).
English: A total of 2,365 patients with type 2 diabetes were treated with Eperzan and 2,530 received other study medications in 8 active and placebo-controlled phase III clinical trials.
Danish: I alt 2.365 patienter med type 2-diabetes blev behandlet med Eperzan, og 2.530 fik andre forsøgslægemidler i 8 aktivt kontrollerede og placebokontrollerede kliniske fase III-studier.
English: These differences were not considered clinically relevant (see section 4.2).
Danish: Disse forskelle blev ikke anset for at være klinisk relevante (se pkt.
English: Most patients with severe hypoglycaemic events in clinical studies were receiving concurrent sulphonylurea or insulin and none required hospitalisation or led to withdrawal of treatment.
Danish: De fleste patienter i de kliniske studier, som havde bivirkninger med svær hypoglykæmi, fik samtidigt sulfonylurinstof eller insulin, og ingen af tilfældene krævede hospitalsindlæggelse eller førte til seponering af behandlingen.
English: Instructions for use of the pre-filled pen (overleaf)
Danish: Vejledning i brug af den fyldte pen (på næste side)
English: If it is more than 3 days after the missed dose, patients should wait and administer their next regularly scheduled weekly dose.
Danish: Hvis der er gået flere end 3 dage efter den glemte dosis, bør patienterne vente, indtil den næste regelmæssige ugentlige dosis skal tages.
English: The safety and efficacy of Eperzan in children and adolescents under 18 years have not been established (see section 5.2).
Danish: Eperzans sikkerhed og virkning hos børn og unge under 18 år er ikke klarlagt (se pkt.
English: Albiglutide is a recombinant fusion protein consisting of two copies of a 30-amino acid sequence of modified human glucagon-like peptide 1 genetically fused in series to human albumin.
Danish: Albiglutid er et rekombinant fusionsprotein, der består af to kopier af en 30-aminosyresekvens af modificeret humant glucagonlignende peptid 1, som er genetisk fusioneret i rækker med humant albumin.
English: Among patients randomised to other comparators, the incidence of symptomatic hypoglycaemia was 7% to 33% when used with a sulphonylurea or insulin and 2% to 4% in combinations without these medicinal products.
Danish: Hos patienter, der blev randomiseret til andre komparatorer, var incidensen af symptomatisk hypoglykæmi 7 % til 33 % ved samtidig anvendelse af et sulfonylurinstof eller insulin og 2 % til 4 % ved kombinationer uden disse lægemidler.
English: • rash, redness or itching of the skin where you have injected Eperzan
Danish: • udslæt, rødme eller kløe i huden, der hvor du har injiceret Eperzan.
English: However, when used in combination with a sulphonylurea or a basal insulin, blood glucose self-monitoring may become necessary to adjust the dose of the sulphonylurea or the basal insulin.
Danish: Når Eparzan anvendes i kombination med sulfonylurinstoffer eller basal insulin, kan selvmonitorering af blodglucose dog blive nødvendig for at justere dosis af sulfonylurinstof eller basal insulin.
English: This leaflet was last revised in <{MM/YYYY}>
Danish: Denne indlægsseddel blev senest ændret {MM/ÅÅÅÅ}.
English: Age had no clinically relevant effect on the pharmacokinetics of albiglutide based on a population pharmacokinetic analysis of subjects aged 24-83 years (see section 4.2).
Danish: Alder havde ingen klinisk relevant effekt på albiglutids farmakokinetik baseret på en farmakokinetisk populationsanalyse af data fra personer i alderen 24-83 år (se pkt.
English: No carcinogenicity studies have been performed with albiglutide due to immunogenicity in rodents.
Danish: Der er ikke udført karcinogenicitetsstudier med albiglutid på grund af immunogenicitet hos gnavere.
English: • DO NOT allow the pen to freeze.
Danish: • Pennen MÅ IKKE nedfryses.
English: For full instructions on the reconstitution and administration of Eperzan see section 6.6 and the instructions for use included in the package leaflet.
Danish: Der findes en udførlig instruktion i rekonstitution og administration af Eperzan i pkt 6.6 og i 'Vejledning i brug' i indlægssedlen.
English: As albiglutide is a recombinant protein, no genotoxicity studies have been conducted.
Danish: Da albiglutid er et rekombinant protein, er der ikke udført genotoksicitetsstudier.
English: It may affect up to 1 in 100 people.
Danish: Det kan forekomme hos op til 1 ud af 100 personer.
English: 1c Check that the pen has a [1] in the number window (Figure F).
Danish: 1c Kontroller, at der står [1] i nummervinduet (Figur F).
English: Eperzan should not be used while you're pregnant.
Danish: Du må ikke tage Eperzan, mens du er gravid.
English: Albiglutide is an agonist of the GLP-1 receptor and augments glucose-dependent insulin secretion.
Danish: Albiglutid er en GLP-1-receptoragonist og øger den glucoseafhængige insulinsekretion.
English: Hold Upright & Twist to 2
Danish: Hold lodret & drej til tallet 2
English: There are no or limited amount of data from the use of Eperzan in pregnant women.
Danish: Der er ingen eller begrænsede data fra anvendelse af Eperzan til gravide kvinder.
English: In the Phase III studies in type 2 diabetes patients, small increases in heart rate (1 to 2 bpm) were observed with albiglutide.
Danish: I fase III-studierne med type-2 diabetespatienter blev der observeret små stigninger i hjertefrekvensen (1 til 2 bpm) for albiglutid.
English: The cup, timer and container are not provided in the pack.
Danish: Bæger, stopur og beholder leveres ikke sammen med lægemidlet.
English: Step 2 Mix Medicine
Danish: Trin 2 Bland medicinen
English: After reconstitution, continue to follow the steps in the instructions for use to attach the needle, prime the pen injector and administer the injection.
Danish: Efter rekonstitution følges de næste trin i vejledningen for at påsætte nålen, fylde medicin i nålen og administrere injektionen.
English: The hazard ratio for Eperzan versus comparators for MACE+ was 1.0 (95% CI 0.68, 1.49).
Danish: Risikoforholdet for Eperzan versus komparatorer for MACE+ var 1,0 (95 % CI 0,68-1,49).
English: You should not take acarbose if you suffer from bowel obstruction.
Danish: Du må ikke tage acarbose, hvis du lider af tilstopning af tarmen.
English: Figure 1: Kaplan-Meier curve showing durability of glycaemic control (measured by time to rescue) for Eperzan, relative to two active controls (sitagliptin and glimepiride) and placebo
Danish: Figur 1: Kaplan-Meier-kurve, der viser varigheden af glykæmisk kontrol (målt ved tiden til nødmedicinering) med Eperzan i forhold til to aktive kontroller (sitagliptin og glimepirid) og placebo.
English: Read all of this leaflet carefully before you start taking this medicine, as well as all the instructions including the Pen Storage and Important Warnings.
Danish: Læs hele denne indlægsseddel grundigt før du begynder at bruge dette lægemiddel samt alle instruktionerne herunder Opbevaring af pen og Vigtige advarsler.
English: Treatment with Eperzan alone or in combination with one or two oral antidiabetic medicinal products resulted in a reduction in fasting plasma glucose from baseline as compared to placebo of 1.3 to 2.4 mmol/l.
Danish: Behandling med Eperzan alene eller i kombination med et eller to orale antidiabetika resulterede i en reduktion af plasmaniveauet af fasteglucose i forhold til baseline på 1,3 til 2,4 mmol/l sammenlignet med placebo.