FrancophonIA/ELRC3.0 huggingface dataset:
English: There are no adequate data from the use of lixisenatide in pregnant women.
Danish: Der er ikke tilstrækkelige data fra brug af lixisenatid til gravide kvinder.
English: The mean duration of diabetes was approximately 9 years.
Danish: Den gennemsnitlige varighed af diabetes var ca. 9 år.
English: Needles are not included in the pack.
Danish: Nåle er ikke inkluderet i pakningen.
English: These signs often develop before the signs of a low sugar level in the brain.
Danish: Disse tegn går ofte forud for tegnene på lavt blodsukker i hjernen.
English: • You may need to repeat this step up to 3 times before seeing medicine.
Danish: • Det kan være nødvendigt at gentage dette trin op til 3 gange, før der kommer væske ud.
English: Of the 1479 patients who started the run-in phase, 1170 were randomised.
Danish: Af de 1.479 patienter, som indgik i indkøringsfasen, blev 1.170 randomiseret.
English: Other important information about using the pre-filled pens
Danish: Andre vigtige oplysninger om brug af fyldte penne
English: Discuss with your doctor which pen is suitable for your needs.
Danish: Tal med lægen om, hvilken pen der passer til dit behov.
English: Suliqua can be used in elderly patients.
Danish: Suliqua kan anvendes til ældre patienter.
English: • What you should do in an emergency if you feel unwell or become ill.
Danish: • Hvad du skal gøre, hvis du føler dig utilpas eller bliver syg.
English: The therapeutic experience of Suliqua in patients ≥75 years of age is limited.
Danish: Den terapeutiske erfaring med Suliqua hos patienter ≥75 år er begrænset.
English: Allergic reactions (urticaria) possibly related with Suliqua have been reported in 0.3% of patients.
Danish: Allergiske reaktioner (urticaria), som muligvis er relateret til Suliqua, er blevet rapporteret hos 0,3 % af patienterne.
English: • Each pen contains more than 1 dose.
Danish: • Hver pen indeholder mere end en dosis.
English: • Somatropin, a growth hormone.
Danish: • Somatropin, et væksthormon.
English: Use only in this pen.
Danish: Må kun anvendes i denne pen.
English: • You have a certain type of nerve damage (called “diabetic autonomic neuropathy”).
Danish: • Du har en bestemt sygdom med beskadigelse af nerverne (kaldet ”diabetisk autonom neuropati”).
English: • Any other medicine to treat diabetes.
Danish: • Et hvilket som helst andet lægemiddel til behandling af diabetes.
English: If you do, you may not get the correct amount of medicine.
Danish: Hvis du gør det, får du muligvis ikke den rigtige dosis.
English: • You can clean the outside of your pen by wiping it with a damp cloth (water only).
Danish: • Du kan rengøre ydersiden af pennen ved at tørre den af med en fugtig klud (kun opvredet i vand).
English: See also section 2 “What you need to know before you use Suliqua” for information on sodium and metacresol.
Danish: Se også punkt 2 ”Det skal du vide, før du tager Suliqua” for oplysninger om natrium og metacresol.
English: Mixing or diluting can change its time/action profile and mixing can cause precipitation.
Danish: Blanding eller fortynding kan ændre dets tids/virkningsprofil, og blanding kan forårsage udfældning.
English: Patients should be instructed to always use a new needle.
Danish: Patienten skal instrueres i altid at anvende en ny nål.
English: These injections should be given even if it is not certain that you have hypoglycaemia.
Danish: Du skal også have disse injektioner, selvom det ikke er sikkert, at du har hypoglykæmi.
English: If a dose greater than 40 dose steps is needed, your doctor will prescribe a different strength.
Danish: Hvis du har brug for en dosis, der er over 40 dosistrin, vil din læge ordinere en anden styrke til dig.
English: See table and figure below for the other endpoints in the study.
Danish: Se nedenstående tabel og figur for studiets øvrige endepunkter.
English: Based on your lifestyle, your blood sugar tests and your previous insulin use, your doctor will tell you:
Danish: Alt efter din levevis, resultatet af dine blodsukkermålinger og din eventuelle tidligere anvendelse af insulin vil din læge fortælle dig:
English: • You have not injected your Suliqua or not injected enough.
Danish: • Du ikke har injiceret Suliqua eller ikke har injiceret nok.
English: Do not stop using this medicine without talking to your doctor.
Danish: Du må ikke stoppe med at tage denne medicin uden først at tale med lægen.
English: • Try again if the needle does not come off the first time.
Danish: Prøv igen, hvis nålen ikke drejes fri den første gang.
English: 2 hour PPG (mmol/L)**
Danish: 2 timer PPG (mmol/l)**
English: • Never use your pen if it is damaged or if you are not sure that it is working properly.
Danish: • Anvend aldrig din pen, hvis den er beskadiget, eller hvis du ikke er sikker på, at den virker, som den skal.
English: • if you are allergic to insulin glargine or lixisenatide or to any of the other ingredients of this medicine (listed in section 6).
Danish: • hvis du er allergisk over for insulin glargin eller lixisenatid eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i punkt 6).
English: You will require an injection of glucose or glucagon (a medicine which increases blood sugar).
Danish: Du skal have en injektion med glucose eller glucagon (et lægemiddel, der øger blodsukkeret).
English: This may damage your pen.
Danish: Det kan beskadige pennen.
English: Patients should be informed of the characteristic symptoms of acute pancreatitis: persistent, severe abdominal pain.
Danish: Patienten skal informeres om de karakteristiske symptomer på akut pancreatitis: Vedvarende svære abdominalsmerter.
English: The median duration of study follow-up was 25.8 and 25.7 months in the lixisenatide group and the placebo group, respectively.
Danish: Den mediane opfølgningsperiode var 25,8 og 25,7 måneder i henholdsvis lixisenatid-gruppen og placebogruppen.
English: • You do not eat enough, or eat food containing less carbohydrates than normal - artificial sweeteners are not carbohydrates.
Danish: • Du ikke spiser nok eller spiser mad, der indeholder færre kulhydrater end normalt - kunstige sødestoffer er ikke kulhydrater.
English: Follow closely your doctor's instructions for dose, monitoring (blood and urine tests), diet and physical activity (physical work and exercise) and injection technique.
Danish: Du skal nøje overholde lægens anvisninger vedrørende dosering, kontrol (af blod og urin), kost og fysisk aktivitet (fysisk arbejde og motion) samt injektionsteknik.
English: The educational materials are aimed at increasing awareness about the two available strengths of the product and at minimising the risk of medication errors including mix-ups between the different strengths of the product.
Danish: Uddannelsesmaterialet har til formål at øge opmærksomheden på de to styrker, som lægemidlet findes i, og at minimere risikoen for medicineringsfejl, inklusive forveksling af lægemidlets to forskellige styrker.
English: • How to arrange the supply of your medicine, needles and other items.
Danish: • Hvordan du planlægger forsyningen af medicin, nåle osv.
English: Industriepark Hochst 65926 Frankfurt am Main GERMANY
Danish: Industriepark Hochst 65926 Frankfurt am Main TYSKLAND
English: • When to check your blood sugar level and if you need to carry out urine tests.
Danish: • Hvornår du skal kontrollere dit blodsukker, og om det er nødvendigt at undersøge urinen.
English: The incidence of formation of antilixisenatide antibodies was approximately 43%.
Danish: Hyppigheden af antistofdannelse mod lixisenatid var ca. 43 %.
English: • Do not press at an angle.
Danish: Tryk ikke i en vinkel.
English: A. Check the name and expiry date on the label of your pen.
Danish: A. Kontroller navnet og udløbsdatoen på pennens etiket.
English: The time course of action of insulins, including Suliqua, may vary between individuals and within the same individual.
Danish: Virkningsvarigheden af insuliner, inklusive Suliqua, kan variere både inter-individuelt og intraindividuelt.
English: • Your blood sugar is often too low.
Danish: • Dit blodsukker ofte er for lavt.
English: • Your low blood sugar is always around “normal” or your diabetes control has greatly improved recently.
Danish: • Dit blodsukker altid næsten er normalt, eller hvis din diabeteskontrol for nyligt er forbedret betydeligt.
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 lav fødeindtagelse og reduceret kropsvægt.
English: Suliqua has no or negligible influence on the ability to drive or use machines.
Danish: Suliqua påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: Shelf-life after first use of the pen: 28 days
Danish: Opbevaringstid efter første anvendelse af pennen: 28 dage
English: Some medicines can change your blood sugar level.
Danish: Nogle lægemidler kan ændre dit blodsukkerniveau.
English: Populations not studied
Danish: Ikke-undersøgte populationer
English: This may cause too low blood sugar which is sometimes followed by too high blood sugar.
Danish: Det kan medføre for lavt blodsukker, som i nogle tilfælde efterfølges af for højt blodsukker.
English: Other side effects Tell your doctor, pharmacist or nurse if you notice any of the following side effects: Common: may affect up to 1 in 10 people
Danish: Andre bivirkninger Fortæl det til lægen, apotekspersonalet eller sundhedspersonalet, hvis du får en eller flere af følgende bivirkninger: Almindelig: kan forekomme hos op til 1 ud af 10 personer
English: DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION Date of first authorisation: 11 January 2017
Danish: Dato for første markedsføringstilladelse: 11. januar 2017
English: In case of hypoglycaemia, the rescue mechanism of glucagon secretion is preserved.
Danish: I tilfælde af hypoglykæmi bevares glucagonsekretionens redningsmekanisme.
English: Test your blood glucose levels after 10-15 minutes after taking sugar.
Danish: Kontroller dit blodsukker 10-15 minutter efter, du har indtaget sukker.
English: ** If a different basal insulin was used:
Danish: ** Ved anvendelse af en anden basalinsulin:
English: Do not over-tighten.
Danish: Du må ikke overspænde.
English: • Check your blood sugar and then inject your next dose at the usual time.
Danish: • Kontroller dit blodsukker, og tag derefter den næste dosis på det sædvanlige tidspunkt.
English: After first use: use within 28 days First use on: / / /
Danish: Efter første anvendelse: anvendes inden for 28 dage Åbningsdato: / / /
English: This helps stop blocked needles, contamination, and infection.
Danish: Det hjælper med at forebygge blokering af nålen, forurening og infektion.
English: Take about 15 to 20 grams sugar straight away - such as glucose, sugar cubes or a sugary drink.
Danish: Tag omgående ca. 15-20 gram sukker, f.eks. glucose, sukkerknalder eller en sukkersødet drik.
English: If you have any questions about Suliqua, the pen or about diabetes, ask your doctor, pharmacist or nurse or call the local sanofi-aventis number given at the end of the Package Leaflet (see other side).
Danish: Hvis du har spørgsmål til Suliqua, pennen eller til diabetes, kan du spørge din læge, apotekspersonalet eller sundhedspersonalet eller ringe til det lokale sanofi-aventis telefonnummer, som er anført sidst i denne indlægsseddel (se den anden side).
English: In parallel, glucagon secretion is suppressed.
Danish: Samtidig undertrykkes glucagonsekretionen.
English: If you do not follow all of these instructions, you may get too much or too little medicine.
Danish: Hvis du ikke følger denne brugervejledning fuldstændigt, kan du enten få for meget eller for lidt medicin.
English: • Only use your pen for up to 28 days after its first use.
Danish: • Du må kun bruge pennen i 28 dage efter første anvendelse.
English: Some (1.7%) patients taking insulin containing therapy, including Suliqua have experienced erythema, local edema, and pruritus at the site of injection.
Danish: Nogle (1,7 %) af de patienter, der får insulinbehandling, herunder Suliqua, har oplevet erytem, lokale ødemer og pruritus ved injektionsstedet.
English: • Your blood sugar levels are almost normal or are unstable.
Danish: • Dit blodsukker er næsten normalt eller ustabilt.
English: • You are doing more exercise than usual or a different type of physical activity.
Danish: • Du dyrker mere motion, end du plejer, eller laver en anden form for fysisk aktivitet.
English: • Contact your doctor straight away if you have severe hyperglycaemia or ketoacidosis.
Danish: • Kontakt straks læge, hvis du får alvorlig hyperglykæmi eller ketoacidose.
English: - lixisenatide and/or insulin in combination with a sulfonylurea may result in an increased risk of hypoglycaemia.
Danish: - lixisenatid og/eller insulin i kombination med et sulfonylurinstof kan resultere i en øget risiko for hypoglykæmi.
English: Before you use insulin glargine/lixisenatide, be clear on how many dose steps you require.
Danish: Før du anvender insulin glargin/lixisenatid, skal du vide, hvor mange dosistrin du har brug for.
English: Use in elderly patients (65 years and over) If you are 65 years or older, talk to your doctor as you may need a lower dose.
Danish: Brug til ældre (65 år og derover) Hvis du er 65 år eller ældre, så tal med din læge, da du muligvis skal have en lavere dosis.
English: Paediatric population There is no relevant use of Suliqua in the paediatric population.
Danish: Pædiatrisk population Det er ikke relevant at anvende Suliqua hos den pædiatriske population.
English: • Danazol, for endometriosis.
Danish: • Danazol, til behandling af endometriose.
English: The tmax of ramipril and ramiprilat were delayed by approximately 2.5 hours.
Danish: Tmax for ramipril og ramiprilat forsinkedes cirka 2,5 time.
English: No interaction studies with Suliqua have been performed.
Danish: Der er ikke udført interaktionsstudier med Suliqua.
English: It should be considered whether it is advisable to drive or use machines in these circumstances.
Danish: I sådanne tilfælde bør det overvejes, om bilkørsel eller betjening af maskiner er tilrådelig.
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, skal patienterne rådes til om muligt ikke at tage dem til det måltid, hvor lixisenatid gives.
English: • in a vein.
Danish: • i en blodåre.
English: The mean diabetes duration was approximately 12 years and the mean duration of previous basal insulin treatment was approximately 3 years.
Danish: Den gennemsnitlige varighed af diabetes var ca.12 år, og den gennemsnitlige varighed af tidligere behandling med basalinsulin var ca. 3 år.
English: This may mean your Suliqua dose has to change.
Danish: Det kan betyde, at din Suliqua-dosis skal ændres.
English: • You have recently changed from animal insulin to a manufactured insulin, like there is in
Danish: • Du for nyligt har skiftet fra insulin udvundet fra dyr (animalsk insulin) til fremstillet insulin som i Suliqua.
English: • You are under stress - such as emotional distress or excitement.
Danish: • Du er stresset - f.eks. hvis du er følelsesmæssigt ude af balance eller ophidset.
English: • You find it hard to recognise when your blood sugar is too low.
Danish: • Du har svært ved at mærke, når dit blodsukker er for lavt.
English: Suliqua should not be used during pregnancy.
Danish: Suliqua bør ikke anvendes under graviditet.
English: If pancreatitis is suspected, Suliqua should be discontinued; if acute pancreatitis is confirmed, lixisenatide should not be restarted.
Danish: Hvis der er mistanke om pancreatitis, skal Suliqua seponeres, og hvis akut pancreatitis bekræftes, må lixisenatidbehandling ikke genoptages.
English: No related effect on spermatogenesis was seen in healthy men.
Danish: Der blev ikke set påvirkning af spermatogenesen hos raske mænd.
English: In patients treated with Suliqua, the incidence of related nausea, diarrhoea and vomiting was 8.4%, 2.2% and 2.2%, respectively.
Danish: Hos patienter, der blev behandlet med Suliqua, var hyppigheden af behandlingsrelateret kvalme, diarré og opkastning henholdsvis 8,4 %, 2,2 % og 2,2 %.
English: Pentamidine may cause hypoglycaemia, which may sometimes be followed by hyperglycaemia.
Danish: Pentamidin kan forårsage hypoglykæmi, som til tider efterfølges af hyperglykæmi.
English: • You are recovering from an illness or from fever.
Danish: • Du er ved at komme dig efter en sygdom eller feber.
English: Packs of 3, 5 and 10 pre-filled pens.
Danish: Pakning med 3, 5 og 10 fyldte penne.
English: Suliqua should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.
Danish: Suliqua bør ikke anvendes til patienter med type 1-diabetes eller til behandling af diabetisk ketoacidose.
English: Ask your doctor whether you can drive if:
Danish: Du skal spørge din læge, om du må køre bil og motorcykel, hvis:
English: It can even hide or stop the first signs that your blood sugar is too low.
Danish: Det kan endog skjule eller helt undertrykke de første advarselstegn, som fortæller, at dit blodsukker er for lavt.
English: No increase in mean heart rate was seen in all Phase 3 studies with Suliqua.
Danish: Der er ikke observeret nogen stigning i gennemsnitlig hjertefrekvens i nogen af fase 3-studierne med Suliqua.
English: The slowing effect of gastric emptying was maintained at the end of the study.
Danish: Den nedsættende effekt på ventrikeltømningshastigheden blev opretholdt indtil afslutningen af studiet.
English: In the presence of anti-lixisenatide antibodies, lixisenatide exposure and variability in exposure are markedly increased regardless of the dose level.
Danish: Ved tilstedeværelse af antistoffer mod lixisenatid er eksponering og variabilitet i eksponering for lixisenatid markant øget uanset dosisniveau.
English: • The Pharmacist should clarify with the prescriber any incomplete prescription.
Danish: • Apotekspersonalet skal afklare eventuelle mangelfulde recepter med den ordinerende læge.
English: • Always check the label of the pen before use to make sure you have the correct pen.
Danish: • Kontroller altid pennens etiket for at sikre, at du anvender den rigtige pen.
English: If blood glucose levels are still too low (<4 mmol/L) or hypoglycaemia comes back take another 15 to 20 gram of sugar.
Danish: Hvis dit blodsukker stadig er for lavt (under 4 mmol/l), eller hypoglykæmien vender tilbage, skal du tage yderligere 15-20 gram sukker.
English: • How to correctly store your medicine while travelling.
Danish: • Korrekt opbevaring af medicinen under rejsen.
English: Paracetamol was used as a model medicinal product to evaluate the effect of lixisenatide on gastric emptying.
Danish: Paracetamol blev anvendt som model-lægemiddel til evaluering af effekten af lixisenatid på ventrikeltømning.
English: Units of medicine in your pen
Danish: Medicinenheder i pennen
English: The lixisenatide dose is increased or decreased along with insulin glargine dose and also depends on which pen is used.
Danish: Dosis af lixisenatid øges eller reduceres sammen med dosis af insulin glargin og afhænger også af, hvilken pen der anvendes.
English: For single patient use only.
Danish: Må kun anvendes til samme patient.
English: Gastrointestinal adverse reactions (nausea, vomiting and diarrhoea) were frequently reported adverse reactions during the treatment period.
Danish: Gastrointestinale bivirkninger (kvalme, opkastning og diarré) var hyppigt rapporterede bivirkninger i løbet af behandlingsperioden.
English: Your blood sugar level may either rise or fall if you drink alcohol.
Danish: Dit blodsukker kan enten stige eller falde, hvis du drikker alkohol.
English: • If your medicine is available in the country you are visiting.
Danish: • Din medicin kan købes i det land, du skal besøge.
English: Suliqua is used to treat adults with type 2 diabetes, to help control blood sugar levels when they are too high.
Danish: Suliqua anvendes til behandling af voksne med type 2-diabetes og hjælper med at kontrollere blodsukkerniveauet, når det er for højt.
English: Number of subjects (mITT)
Danish: Antal forsøgspersoner (mITT)
English: • This will make sure you get your full dose.
Danish: Dette sikrer, at du får hele din dosis.
English: If a patient wishes to become pregnant, or pregnancy occurs, treatment with Suliqua should be discontinued.
Danish: Hvis en patient ønsker at blive gravid, eller hvis graviditet indtræder, bør Suliqua seponeres.
English: C. Place your thumb on the injection button.
Danish: C. Placer tommelfingeren på injektionsknappen.
English: Oral anti-diabetic treatment (insulin naïve patients)
Danish: Oral antidiabetisk behandling (insulinnaive patienter)
English: When the signs of hypoglycaemia may be less clear:
Danish: De første tegn på hypoglykæmi kan være mindre tydelige:
English: This medicinal product contains less than 1 mmol (23 mg) sodium per dose, i.e. it is essentially 'sodium-free'.
Danish: Dette lægemiddel indeholder mindre end 1 mmol (23 mg) natrium pr. dosis, dvs. det i det væsentlige er ‘natriumfrit'.
English: • If you turn past your dose, you can turn back down.
Danish: Hvis du drejer forbi din dosis, kan du dreje tilbage igen.
English: A. Make sure a needle is attached and the dose is set to ‘0'.
Danish: A. Sørg for, at en nål er påsat, og at dosis er indstillet til ‘0'.
English: Store pen away from direct heat or direct light.
Danish: Opbevar pennen væk fra direkte varme eller direkte lys.
English: • Suliqua is injected under the skin (subcutaneous use or “SC”).
Danish: • Suliqua injiceres under huden (subkutan anvendelse - s.c.).
English: Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder: sanofi-aventis groupe
Danish: Indehaver af markedsføringstilladelsen og fremstiller sanofi-aventis groupe
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PEN LABEL
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER ETIKET TIL PEN
English: INFORMATION IN BRAILLE Suliqua 10 - 40
Danish: INFORMATION I BRAILLESKRIFT Suliqua 10 - 40
English: It is given, with metformin, when other medicines are not enough on their own to control your blood sugar levels.
Danish: Det tages sammen med metformin, når andre lægemidler ikke er tilstrækkelige til at kontrollere blodsukkerniveauet.
English: *Insulin glargine is produced by recombinant DNA technology in Escherichia coli.
Danish: *Insulin glargin fremstilles ved rekombinant DNA-teknologi i Escherichia coli.
English: The first warning signs of hypoglycaemia may change, be weaker or missing altogether if:
Danish: De første advarselstegn på hypoglykæmi kan være anderledes, være mindre udtalte eller helt mangle, hvis:
English: 6.6 Special precautions for disposal and other handling Before first use, the pen must be taken out of the refrigerator and stored below 25°C for 1 to 2 hours.
Danish: 6.6 Regler for bortskaffelse og anden håndtering Før første anvendelse skal pennen opbevares ved stuetemperatur under 25 °C i 1-2 timer.
English: After 30 weeks of treatment with Suliqua in two phase 3 trials, the incidence of formation of antiinsulin glargine antibodies was 21.0% and 26.2%.
Danish: Efter 30 ugers behandling med Suliqua i to fase 3-studier var hyppigheden af antistofdannelse mod insulin glargin 21,0 % og 26,2 %.
English: Ask your doctor or nurse if you are not sure which foods you should eat.
Danish: Spørg din læge eller sundhedspersonalet, hvis du er i tvivl om, hvilken slags mad du skal spise.
English: • You have just started Suliqua treatment- if low blood sugar occurs, it may be more likely to happen in the morning.
Danish: • Du lige er begyndt på Suliqua-behandlingen- hvis du får lavt blodsukker, er det mest sandsynligt, at det optræder om morgenen.
English: ** Severe symptomatic hypoglycaemia was an event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions.
Danish: ** Svær hypoglykæmi var en hændelse, der krævede hjælp af en anden person til aktivt at indgive kulhydrat, glucagon eller udføre andre nødhjælpshandlinger.