FrancophonIA/ELRC3.0 huggingface dataset:
English: Sodium phosphate monobasic monohydrate, Sodium phosphate dibasic heptahydrate, Polysorbate 80,
Danish: Natriumdihydrogenphosphatmonohydrat, Dinatriumphosphatheptahydrat, Polysorbat 80,
English: Withdraw and discard a volume of the sodium chloride 9 mg/ml (0.9%) solution for infusion from the infusion bag equal to the total volume of Aldurazyme to be added.
Danish: • Udtag og kasser en mængde 9 mg/ml (0,9%) natriumchloridopløsning til infusion fra infusionsposen, der svarer til den samlede mængde Aldurazyme, der skal tilsættes.
English: Additionally, a few patients who had a prior history of severe MPS I- related upper airway and pulmonary involvement, experienced severe reactions including bronchospasm, respiratory arrest, and facial oedema (see section 4.4).
Danish: Desuden oplevede nogle få patienter med tidligere forekomst af svære MPS I-relaterede tilstande i de øvre luftveje og lunger alvorlige reaktioner, herunder bronkospasmer, respirationsophør og ansigtsødemer (se pkt.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Aldurazyme 100 U/ml concentrate for solution for infusion laronidase
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Aldurazyme 100 E/ml koncentrat til infusionsvæske, opløsning Laronidase
English: Each vial of 5 ml contains 500 U of laronidase.
Danish: Hvert hætteglas på 5 ml indeholder 500 U laronidase.
English: Preparation of the Aldurazyme Infusion (Use Aseptic Technique) Determine the number of vials to be diluted based on the individual patient's weight.
Danish: • Beregn det antal hætteglas, der skal fortyndes, på basis af den enkelte patients vægt.
English: One ml of the solution in the vial contains 100 U of laronidase.
Danish: 1 ml af opløsningen i hætteglasset indeholder 100 E laronidase.
English: mean 5.6median 3.0 0.009 0.9 - 8.6
Danish: middel median 3,0 0,009
English: What Aldurazyme looks like and contents of the pack Aldurazyme is supplied as a concentrate for solution for infusion.
Danish: Aldurazyme leveres som et koncentrat til opløsning til infusion.
English: median 38.5 0.066 -2.0 - 79.0
Danish: middel median 38,5 0,066
English: 25 vials of concentrate for solution for infusion.
Danish: 25 hætteglas koncentrat til infusionsvæske, opløsning.
English: Very common chills
Danish: Pyreksi meget almindelig
English: Add the combined volumes of Aldurazyme to the sodium chloride 9 mg/ml (0.9%) solution for infusion.
Danish: • Tilsæt de samlede mængder Aldurazyme til 9 mg/ml (0,9%) natriumchloridopløsningen til infusion.
English: Severe hypersensitivity (e.g. anaphylactic reaction) to the active substance or to any of the excipients listed in section 6.1 (see sections 4.4 and 4.8).
Danish: Svær overfølsomhed (f.eks. anafylaktisk reaktion) over for det aktive stof eller over for et eller flere af hjælpestofferne anført i pkt.
English: Sodium phosphate monobasic, monohydrate Sodium phosphate dibasic, heptahydrate Polysorbate 80
Danish: Natriumdihydrogenphosphatmonohydrat Dinatriumphosphatheptahydrat Polysorbat 80
English: Nausea, abdominal pain Vomiting, diarrhoea
Danish: Mave-tarm-kanalen Kvalme, abdominalsmerter
English: - If you have any further questions, ask your doctor or your pharmacist.
Danish: Er du i tvivl, så spørg lægen.
English: Erythema, facial edema, laryngeal edema, edema peripheral
Danish: Erytem, ansigtsødem, larynxødem, perifert ødem
English: • restlessness
Danish: • hvileløshed
English: Each vial of 5 ml contains 1.29 mmol sodium.
Danish: Hjælpestof, som behandleren skal være opmærksom på Hvert hætteglas med 5 ml indeholder 1,29 mm natrium.
English: Store at 2°C - 8°C.
Danish: Opbevares ved 2 °C - 8 °C Genzyme Europe B.V.
English: NAME OF THE MEDICINAL PRODUCT Aldurazyme 100 U/ml concentrate for solution for infusion
Danish: LÆGEMIDLETS NAVN Aldurazyme 100 E/ml koncentrat til infusionsvæske, opløsning.
English: NAME OF THE MEDICINAL PRODUCT Aldurazyme 100 U/ml concentrate for solution for infusion laronidase
Danish: Aldurazyme 100 E/ml koncentrat til infusionsvæske, opløsning Laronidase
English: 10 vials of concentrate for solution for infusion.
Danish: 10 hætteglas koncentrat til ionfusionsvæske, opløsning.
English: - The other ingredients are sodium chloride, sodium phosphate monobasic monohydrate, sodium phosphate dibasic heptahydrate, polysorbate 80, water for injections.
Danish: - Øvrige indholdsstoffer: Natriumchlorid, natriumdihydrogenphosphatmonohydrat,
English: • swelling of the neck
Danish: • hævelse i hals
English: • hives
Danish: • hoste
English: Elderly
Danish: MedDRA
English: Nederland
Danish: United Kingdom
English: Arthropathy, arthralgia, back pain, pain in extremity
Danish: Artropati, artralgi, rygsmerter, ekstremitetssmerter
English: This is used in exactly the same way.
Danish: Denne bruges på nøjagtig samme måde.
English: Thereafter, they progressively decreased during the following weeks.
Danish: Derefter faldt de progressivt i de efterfølgende uger.
English: This is done once and is called the ‘activation' process.
Danish: Dette gøres kun en gang, det kaldes 'aktiverings'-processen.
English: The most important points are:
Danish: De vigtigste punkter er:
English: The use of insulin is recommended instead.
Danish: Brug af insulin anbefales i stedet.
English: Steps 1 to 5 below show you how to do this.
Danish: Trin 1 til 5 viser, hvordan dette gøres.
English: Using the wrong medicine could be harmful to your health.
Danish: Brug af forkert medicin kan være skadeligt for dit helbred.
English: If it is orange, go to Section 2.
Danish: Hvis det er orange, går du til Afsnit 2.
English: Both pens are used in the same way.
Danish: Begge penne bruges på samme måde.
English: Your dose has now been given.
Danish: Nu er din dosis indgivet.
English: About your needle (supplied separately)
Danish: Om din nål (leveres separat)
English: Your doctor will tell you what to do if you get a low blood sugar.
Danish: Din læge vil fortælle dig, hvad du skal gøre, hvis du får lavt blodsukker.
English: Lixisenatide has a moderate level of binding (55%) to human proteins.
Danish: Lixisenatid har et moderat bindingsniveau (55 %) til humane proteiner.
English: You must first use all 14 doses from this pen.
Danish: Du skal først bruge alle 14 doser fra denne pen.
English: Small air bubbles in the container are normal - they will not harm you.
Danish: Det er normalt med små luftbobler i beholderen - de skader dig ikke.
English: Store below 30°C.
Danish: Opbevares under 30 °C.
English: Your dose will be correct and you can keep following the instructions.
Danish: Din dosis vil blive korrigeret, og du kan fortsætte med at følge instruktionen.
English: For your first injection go directly to Section 3 - Step C.
Danish: For din første injektion, gå direkte til Afsnit 3 - Trin C.
English: Do not try to repair the pen.
Danish: Forsøg ikke på at reparere pennen.
English: What if there are air bubbles in the container?
Danish: Hvad nu hvis der er luftbobler i beholderen?
English: Do not take two doses at the same time to make up for a forgotten injection.
Danish: Tag ikke to doser på en gang for at kompensere for en glemt injektion.
English: Repeat Section 3 for your daily injections until your pen is empty.
Danish: Gentag Afsnit 3 for dine daglige injektioner indtil din pen er tom.
English: The pen can be used for 14 days when stored at a temperature below 30°C.
Danish: Pennen kan bruges i 14 dage, hvis den opbevares ved en temperatur under 30 °C.
English: Insulin glargine was continuously titrated during this period.
Danish: Insulin glargin blev vedvarende titreret i denne periode.
English: Also check it has not passed the expiry date.
Danish: Kontroller også, at den ikke har overskredet udløbsdatoen.
English: You do not need to replace the needle between activation and your first injection.
Danish: Du behøver ikke at udskifte nålen mellem aktiveringen og din første injektion.
English: Section 2 - GETTING STARTED
Danish: Afsnit 2 - KOM GODT I GANG
English: It is used in adults with type 2 diabetes.
Danish: Det bruges til voksne med type 2-diabetes.
English: • a basal insulin, a type of insulin which works all day.
Danish: • basalinsulin, en insulintype, der virker hele dagen.
English: The arrow will now be pointing towards the needle.
Danish: Pilen vil nu pege mod nålen.
English: Activation window
Danish: Aktiveringsvindue
English: No treatment-related effect was demonstrated.
Danish: Der blev ikke påvist behandlingsrelateret effekt.
English: A treatment initiation pack is also available for use during the first 28 days of treatment.
Danish: Der fås også en behandlingsopstartspakning til brug ved de første 28 dages behandling.
English: Section 3 - DAILY USE OF PEN Only follow this section when the activation window is white.
Danish: Afsnit 3 - DAGLIG BRUG AF PENNEN Følg kun dette afsnit, hvis aktiveringsvinduet er hvidt.
English: Do this even if there is some medicine left in the pen.
Danish: Gør dette selv hvis der er medicin tilbage i pennen.
English: HR [95% CI]
Danish: HR [95 % KI]
English: After first use: 14 days
Danish: Efter anbrud: 14 dage
English: Take care not to injure yourself when the needle is exposed.
Danish: Pas på ikke at skade dig selv, når nålen er ubeskyttet.
English: There is no need to measure each dose.
Danish: Der er ikke brug for at afmåle dosis.
English: Figure 1: Forest plot: analyses of each individual cardiovascular event -- ITT population
Danish: Figur 1: Forest plot: Analyse af hver individuel kardiovaskulær hændelse - ITT population
English: This may make it difficult to concentrate and you may feel dizzy or sleepy.
Danish: Det kan gøre det vanskeligt at koncentrere dig, og du kan føle dig svimmel eller søvnig.
English: The antibody status (positive or negative) is not predictive of the reduction of HbA1c for an individual patient.
Danish: Antistofstatus (positiv eller negativ) er ikke prædikativ for reduktionen af HbA1c for den enkelte patient.
English: Check the number of doses in the pen.
Danish: Kontroller antallet af doser i pennen.
English: These medicinal products should be taken in a standardised way in relation to lixisenatide.
Danish: Disse lægemidler bør tages på en standardiseret måde i forhold til lixisenatid.
English: Do not activate this pen again.
Danish: Aktiver ikke denne pen igen.
English: It is not known if Lyxumia may harm your unborn child.
Danish: Det vides ikke, om Lyxumia kan skade dit ufødte barn.
English: The pen is to be used for one patient only.
Danish: Pennen må kun bruges til én patient.
English: The pictures below show how the activation window on the injection button of your pen changes after activation.
Danish: Billederne nedenfor viser, hvordan aktiveringsvinduet på din pens injektionsknap ændres efter aktiveringen.
English: Stop taking Lyxumia and contact a doctor immediately if you notice any of the following serious side effects:
Danish: Stop med at tage Lyxumia og kontakt straks din læge, hvis du får nogle af følgende alvorlige bivirkninger:
English: This is to make sure that it is working correctly and that the dose for your first injection is correct.
Danish: Dette er for at sikre, at den fungerer korrekt, og at dosis til din første injektion er korrekt.
English: What if no liquid comes out during activation?
Danish: Hvad nu hvis der ikke kommer noget væske ud under aktiveringen?
English: In the example above, the dose number shows there are 13 injections left.
Danish: I ovenstående eksempel viser dosisantallet, at der er 13 injektioner tilbage.
English: The level of HbA1c reduction was comparable between groups (table 5).
Danish: Niveauet for reduktion i HbA1c var sammenligneligt grupperne imellem (tabel 5).
English: Press the injection button all the way in. You may feel or hear a “click”.
Danish: Tryk injektionsknappen helt ind. Du kan mærke eller høre et ”klik”.
English: Too much Lyxumia can make you feel sick or be sick.
Danish: For meget Lyxumia kan gøre, at føler dig dårligt tilpas eller bliver syg.
English: The apparent volume of distribution after subcutaneous administration of lixisenatide (Vz/F) is approximately 100 L.
Danish: Det tilsyneladende distributionsvolumen efter subkutan administration af lixisenatid (Vz/F) er cirka 100 L.
English: It is important to avoid dehydration by drinking plenty of fluids, especially when starting treatment with Lyxumia
Danish: Det er vigtigt at undgå dehydrering, så drik masser af væske, særligt ved opstart af behandling med Lyxumia
English: This effect on HbA1c was sustained in long term studies for up to 76 weeks.
Danish: Denne effekt på HbA1c blev opretholdt i langtidsstudier i op til 76 uger.
English: Within each system organ class, adverse reactions are presented in order of decreasing frequency.
Danish: Inden for hver systemorganklasse er bivirkningerne præsenteret i rækkefølge efter faldende frekvens.
English: The safety and efficacy of lixisenatide in children and adolescents less than 18 years of age have not yet been established.
Danish: Lixisenatids sikkerhed og virkning hos børn og unge under 18 år er endnu ikke klarlagt.
English: It is an injectable medicine used to help your body to control your blood sugar level when it is too high.
Danish: Det er en medicin til injektion, der bruges til at hjælpe din krop med at kontrollere dit blodsukkerniveau, når det er for højt.
English: The needle may be blocked or not properly screwed on.
Danish: Nålen kan være blokeret eller ukorrekt skruet på.
English: Check the label on your pen to make sure you have the correct medicine.
Danish: Kontroller etiketten på pennen for at sikre dig, at du har den rigtige medicin.
English: Printed on the inside:
Danish: Printet på indersiden
English: • Before injecting a dose - before injecting you must first remove excess liquid from your new pen.
Danish: • Før injicering af en dosis - før injektionen skal du først fjerne overskydende væske fra din nye pen.
English: This could possibly pass on infection.
Danish: Derved kan der overføres infektion.
English: Lyxumia must be injected under the skin and can be injected in any of the areas shown above in blue.
Danish: Lyxumia skal injiceres under huden, og det kan injiceres i ethvert af de områder, der er vist ovenfor i blåt.
English: It should be clear and colourless with no particles.
Danish: Den skal være klar og farveløs uden partikler.
English: If you have injected yourself before activating the pen, do not correct this by giving yourself a second injection.
Danish: Hvis du har injiceret dig selv, før du aktiverede pennen, skal du ikke korrigere det ved at give dig selv en injektion til.
English: - you suffer from heart problems which can cause shortness of breath or ankle swelling, since there is limited experience in this population.
Danish: - du lider af hjerteproblemer, hvilket kan forårsage stakåndethed eller hævelse af anklerne, idet der er begrænset erfaring hos denne befolkning.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking 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 eller apotekspersonaletet til råds, før du tager dette lægemiddel.
English: The AUC and Cmax of the active metabolite (ramiprilat) were not affected.
Danish: AUC og Cmax for den aktive metabolit (ramiprilat) påvirkedes ikke.
English: Frail patients, including patients at risk for malnutrition, patients with recent cardiovascular events and patients with moderate to severe cognitive impairment were excluded.
Danish: Skrøbelige patienter, inklusiv patienter i risiko for fejlernæring, patienter med nylige kardiovaskulære hændelser og patienter med moderat til svær kognitiv svækkelse blev udelukket.
English: Similar HbA1c decreases were observed regardless of which meal was the main meal (breakfast, lunch or dinner).
Danish: Sammenlignelige HbA1creduktioner blev observeret uanset hvilket måltid, der var hovedmåltidet (morgenmad, frokost eller aftensmad).
English: If a patient wishes to become pregnant, or pregnancy occurs, treatment with Lyxumia should be discontinued.
Danish: Hvis en patient ønsker at blive gravid, eller hvis der forekommer graviditet, bør behandling med Lyxumia seponeres.
English: During use of the pen
Danish: Under brug af pennen
English: The majority of injection site reactions were mild, regardless of antibody status.
Danish: Hovedparten af reaktionerne på injektionsstedet var milde, uanset antistofstatus.
English: This is shown by the placement of the black plunger in the dose scale.
Danish: Dette vises ved placeringen af det sorte stempel på dosisskalaen.
English: There is no experience with Lyxumia in children and adolescents less than 18 years and therefore, the use of Lyxumia is not recommended in this age group.
Danish: Der foreligger ingen erfaring med Lyxumia til børn og teenagere under 18 år, og derfor anbefales brugen af Lyxumia ikke til denne aldersgruppe.
English: Body weight reduction was sustained in long term studies up to 76 weeks.
Danish: Reduktionen i legemsvægt blev fastholdt i langtidsstudier på op til 76 uger.
English: If this happens do not drive or use any tools or machines.
Danish: Hvis dette sker for dig, må du ikke køre bil eller bruge værktøjer eller maskiner.
English: Lixisenatide should not be used for treatment of diabetic ketoacidosis.
Danish: Lixisenatid bør ikke anvendes til behandling af diabetisk ketoacidose.
English: A clinical study was conducted in insulin-naive patients insufficiently controlled on oral antidiabetic agents.
Danish: Et klinisk studium blev udført i insulin-naive patienter som var utilstrækkeligt kontrolleret med orale antidiabetika.
English: In both species, there was a slight maternal toxicity consisting of low food consumption and reduced body weight.
Danish: Hos begge arter var der en beskeden maternel toksicitet resulterende i nedsat fødeindtagelse og reduceret kropsvægt.
English: • Post-prandial glucose
Danish: • Postprandial glucose
English: If such medicinal products are to be administered with food, patients should be advised to, if possible, take them with a meal when lixisenatide is not administered.
Danish: Hvis sådanne lægemidler skal tages med mad, bør patienterne rådes til, om muligt, at tage dem til et måltid, hvor lixisenatid ikke gives.
English: The pen is activated and ready for injections.
Danish: Pennen er aktiveret og klar til injektion.
English: They were mostly mild and transient and occurred during the first 3 weeks after starting treatment.
Danish: Bivirkningerne var som oftest milde og forbigående og forekom i de første 3 uger efter påbegyndt behandling.
English: The patient should be instructed to discard the needle after each use in accordance with local requirements and to store the pen without the needle attached.
Danish: Patienten bør instrueres om at kassere nålen efter hver brug i overensstemmelse med lokale krav samt at opbevare pennen uden nålen påsat.
English: Populations not studied Lixisenatide has not been studied in combination with dipeptidyl peptidase 4 (DPP-4) inhibitors.
Danish: Ikke-undersøgte populationer Lixisenatid er ikke undersøgt i kombination med dipeptidyl-peptidase-4 (DPP-4)-hæmmere.
English: • Always check the label to ensure you have the correct Lyxumia pen.
Danish: • Kontroller altid etiketten for at sikre dig, at du har den rigtige Lyxumia-pen.
English: There are no adequate data from the use of Lyxumia in pregnant women.
Danish: Der er ikke tilstrækkelige data fra brug af Lyxumia til gravide kvinder.
English: If you have any questions about Lyxumia or about diabetes, ask your doctor, pharmacist or nurse or call the local sanofi-aventis number in the Lyxumia “Package leaflet: Information for the user” (provided separately in the box).
Danish: Hvis du har nogen spørgsmål om Lyxumia eller om diabetes, så spørg din læge, apotekspersonalet eller sundhedspersonalet, eller ring til det lokale sanofi-aventis-nummer, som du finder i Lyxumia ”Indlægsseddel: Information til brugeren” (medfølger separat i æsken).
English: The window remains white after activation.
Danish: Vinduet forbliver hvidt efter aktiveringen.
English: (-2.593 to -1.396)*
Danish: (-2,593 til -1,396)*
English: Point the needle into a suitable container (like a paper cup or tissue) to capture the liquid so that it can be thrown away.
Danish: Ret nålen mod en passende beholder (som f.eks. et papkrus eller en serviet) for at opfange væsken, så den kan kasseres.
English: In the table, write the date when you activated your pen and the date to throw it away 14 days later.
Danish: I tabellen skriver du den dato, hvor du aktiverede din pen, og den dato, hvor du skal kassere den 14 dage senere.
English: The change in HbA1c from baseline was similar regardless of the antibody status (positive or negative).
Danish: Ændringen af HbA1c fra baseline var den samme, uanset antistofstatus (positiv eller negativ).
English: There was no cross-reactivity versus either native glucagon or endogenous GLP-1.
Danish: Der var ingen krydsreaktivitet hverken i forhold til naturligt forekommende glucagon eller endogent GLP-1.
English: What if it is hard to press the injection button all the way in?
Danish: Hvad nu hvis det er svært at trykke injektionsknappen helt ind?
English: The most frequently reported adverse reactions during clinical studies were nausea, vomiting and diarrhoea.
Danish: De hyppigst rapporterede bivirkninger under de kliniske studier var kvalme, opkastning og diarré.
English: The use of Lyxumia does not require specific blood glucose monitoring.
Danish: Brug af Lyxumia kræver ikke specifik blodsukkermonitorering.
English: Overall, 37% of the patients were ≥75 years old (N=131) and 31% had moderate renal impairment (N=107).
Danish: Samlet var 37 % af patienterne ≥75 år (N=131) og 31 % havde moderat nedsat nyrefunktion (N=107).
English: Once you have thrown away the green pen continue to Section 4 to begin using the purple pen.
Danish: Når du har bortskaffet den grønne pen, fortsæt til Afsnit 4 for at begynde at bruge den lilla pen.
English: In case of hypoglycaemia, the rescue mechanism of glucagon secretion is preserved.
Danish: I tilfælde af hypoglykæmi bevares glukagonsekretionens redningsmekanisme.
English: First activate your new pen
Danish: Aktiver først din nye pen
English: The warning signs of low blood sugar may include cold sweat, cool pale skin, headache, feeling drowsy, weak, dizzy, confused or irritable, feeling hungry, fast heart beat and feeling jittery.
Danish: Advarselssignalerne for lavt blodsukker kan omfatte koldsved, kølig, bleg hud, hovedpine, følelse af døsighed, svaghed, svimmelhed, konfusion eller irritabilitet, sultfølelse, hurtig puls og følelse af anspændthed.
English: Step F. Repeat all steps in Section 3 for each injection.
Danish: Trin F Gentag alle trin i Afsnit 3 for hver injektion.
English: • Store your unused Lyxumia pens in the refrigerator, 2°C to 8°C.
Danish: • Opbevar dine ubrugte Lyxumia-penne i køleskab ved 2 °C-8 °C.
English: Grasp a fold of skin and insert the needle (see the “Injection sites” section about where to inject).
Danish: Tag fat i en hudfold og før nålen ind (se afsnittet ”Injektionssteder” om hvor du skal injicere).
English: In parallel, glucagon secretion is suppressed.
Danish: Samtidig undertrykkes glukagonsekretionen.
English: Lixisenatide is a peptide and is not metabolised by cytochrome P450.
Danish: Lixisenatid er et peptid og metaboliseres ikke af cytochrom P450.
English: If you stop using Lyxumia, your blood sugar levels can increase.
Danish: Hvis du holder op med at tage Lyxumia, kan dine blodsukkerniveauer blive forhøjet.
English: In in vitro studies, lixisenatide did not affect the activity of cytochrome P450 isozymes or human transporters tested.
Danish: Ved in vitro studier påvirkede lixisenatid ikke aktiviteten af cytochrom P450 isozymer eller testede humane transportører.
English: • If another person is giving the injection, they should take care not to injure anyone accidentally with the needle.
Danish: • Hvis en anden person giver dig injektionen, skal vedkommende passe på ikke at komme til at skade andre med nålen.
English: Lixisenatide has no or negligible influence on the ability to drive or use machines.
Danish: Lixisenatid påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj eller betjene maskiner.