FrancophonIA/ELRC3.0 huggingface dataset:
English: - in whom glycaemic control is markedly improved, - who have experienced recurrent and/or recent events of hypoglycaemia, - in whom hypoglycaemia develops gradually, - who are elderly, - after transfer from animal insulin to human insulin, - in whom an autonomic neuropathy is present, - with a long history of diabetes, - suffering from a psychiatric illness, - receiving concurrent treatment with certain other medicinal products (see section 4.5).
Danish: - patienter, hvor den glykæmiske kontrol er forbedret betydeligt, - patienter, som har oplevet tilbagevendende og/eller nylige episoder med hypoglykæmi, - patienter, hvor hypoglykæmi udvikles gradvist, - ældre patienter, - efter skift fra animalsk insulin til human insulin, - patienter, som lider af autonom neuropati, - patienter med en lang diabetes-anamnese, - patienter, som har en psykisk lidelse, - patienter, som er i samtidig behandling med visse andre lægemidler (se pkt.
English: Substances that may reduce the blood-glucose-lowering effect include corticosteroids, danazol, diazoxide, diuretics, glucagon, isoniazid, oestrogens and progestogens, phenothiazine derivatives, somatropin, sympathomimetic medicinal products (e.g. epinephrine [adrenaline], salbutamol, terbutaline), thyroid hormones, atypical antipsychotic medicinal products (e.g. clozapine and olanzapine) and protease inhibitors.
Danish: Stoffer, som kan nedsætte den blodsukkersænkende effekt, omfatter kortikosteroider, danazol, diazoxid, diuretika, glucagon, isoniazid, østrogener og gestagener, phenthiazinderivater, somatropin, sympatomimetiske lægemidler (f.eks. adrenalin, salbutamol, terbutalin), thyreoideahormoner, atypiske antipsykotiske lægemidler (f.eks. clozapin og olanzapin) og proteasehæmmere.
English: Storing your pen
Danish: Opbevaring af pennen
English: Tel: +48 22 549 51 00 msdpolska@merck.com
Danish: Tlf.: +48 22 549 51 00 msdpolska@merck.com
English: The first co-primary efficacy outcome was the time to the first occurrence of CV death, nonfatal myocardial infarction (MI), or nonfatal stroke, and the second co-primary efficacy outcome was the
Danish: Det første sammensatte primære endepunkt var tid til første forekomst af CV-død, ikke-letalt myokardieinfarkt (MI) eller ikke-letal apopleksi, og det andet sammensatte primære endepunkt var tid til første forekomst af enhver af de første primære endepunkter, revaskulariseringsprocedure (koronar, karotid eller perifer) eller indlæggelse pga. hjertesvigt.
English: Physiological concentrations of endogenous IGF-1 may activate the mitogenic-proliferative pathway; however, the therapeutic concentrations found in insulin therapy, including in LUSDUNA therapy, are considerably lower than the pharmacological concentrations required to activate the IGF-1 pathway.
Danish: De terapeutiske koncentrationer ved insulinbehandling, inklusive behandling med LUSDUNA, er dog betydeligt lavere end den farmakologiske koncentration, som kræves for at aktivere IGF-1-mekanismen.
English: EU/1/16/1162/001 1 pre-filled pen of 3 mL EU/1/16/1162/002 5 pre-filled pens of 3 mL
Danish: EU/1/16/1162/001 1 fyldt pen a 3 ml EU/1/16/1162/002 5 fyldte penne a 3 ml
English: Tel: +40 21 529 29 00 msdromania@merck.com
Danish: Tlf.: +40 21 529 29 00 msdromania@merck.com
English: Inform your doctor as soon as possible if you experience signs of heart failure such as unusual shortness of breath or rapid increase in weight or localised swelling (oedema).
Danish: Hvis du oplever tegn på hjertesvigt såsom unormal åndenød, hurtig vægtstigning eller lokal væskeophobning (ødemer), skal du kontakte din læge så hurtigt som muligt.
English: LUSDUNA contains insulin glargine.
Danish: Lusduna indeholder insulin glargin.
English: Merck Sharp & Dohme de España, S.A. Tel: +34 91 321 06 00 msd_info@merck.com
Danish: Merck Sharp & Dohme de España, S.A. Tlf.: +34 91 321 06 00 msd_info@merck.com
English: If you use more LUSDUNA than you should - If you have injected too much LUSDUNA, your blood sugar level may become too low (hypoglycaemia).
Danish: Hvis du har taget for meget Lusduna - Hvis du har injiceret for meget Lusduna, kan dit blodsukker blive for lavt (hypoglykæmi).
English: EU/1/16/1162/003 10 (2 packs of 5) pre-filled pens of 3 mL
Danish: EU/1/16/1162/003 10 (2 pakninger a 5) fyldte penne a 3 ml
English: Carefully read the instructions for use included in the pack before using Nexvue.
Danish: Læs brugsanvisningen i pakningen omhyggeligt inden brug af Nexvue.
English: Packs of 1, 5 and multipacks containing 10 (2 packs of 5) pens.
Danish: Pakninger med 1 og 5 penne og multipakninger med 10 penne (2 pakninger a 5 penne).
English: Other medicines and LUSDUNA
Danish: Brug af anden medicin sammen med Lusduna
English: Parts of your pen
Danish: Pennens komponenter
English: Always use this medicine exactly as your doctor has told you.
Danish: Tag altid Lusduna nøjagtigt efter lægens anvisning.
English: Each mL of the solution contains 100 units of the insulin glargine (equivalent to 3.64 mg).
Danish: Hver ml opløsning indeholder 100 enheder insulin glargin (svarende til 3,64 mg).
English: Switching insulins
Danish: Forveksling af insuliner
English: Combination of LUSDUNA with pioglitazone
Danish: Kombinationsbehandling med LUSDUNA og pioglitazon
English: Merck Sharp & Dohme, Lda Tel: +351 21 4465700 clic@merck.com
Danish: Merck Sharp & Dohme, Lda Tlf.: +351 21 4465700 clic@merck.com
English: What you need to know before you use LUSDUNA
Danish: Det skal du vide, før du begynder at tage Lusduna
English: The cartridge is sealed in a disposable pen injector.
Danish: Cylinderampullen er forseglet i en injektionspen til engangsbrug.
English: SIA Merck Sharp & Dohme Latvija Tel: + 371 67364224 msd_lv@merck.com
Danish: SIA Merck Sharp & Dohme Latvija Tlf.: + 371 67364224 msd_lv@merck.com
English: Merck Sharp & Dohme OÜ Tel.: +372 6144 200 msdeesti@merck.com
Danish: Merck Sharp & Dohme OÜ Tlf.: +372 6144 200 msdeesti@merck.com
English: Recap the pen after use in order to protect from light.
Danish: Hætten skal sættes tilbage på pennen for at beskytte mod lys
English: Medicines that may cause your blood sugar level to rise (hyperglycaemia) include: - corticosteroids (such as "cortisone" used to treat inflammation), - danazol (medicine acting on ovulation), - diazoxide (used to treat low blood sugar), - diuretics (used to treat high blood pressure or excessive fluid retention), - glucagon (pancreas hormone used to treat severe hypoglycaemia), - isoniazid (used to treat tuberculosis), - oestrogens and progestogens (such as in the contraceptive pill used for birth control), - phenothiazine derivatives (used to treat psychiatric disorders), - somatropin (growth hormone), - sympathomimetic medicines (such as epinephrine [adrenaline], salbutamol, terbutaline used to treat asthma), - thyroid hormones (used to treat thyroid gland disorders), - atypical antipsychotic medicines (such as clozapine, olanzapine), - protease inhibitors (used to treat HIV).
Danish: Medicin, der kan få dit blodsukker til at stige (hyperglykæmi) omfatter: - kortikosteroider (såsom kortison, der anvendes til behandling af inflammation (en betændelseslignende tilstand)), - danazol (medicin der virker på ægløsning), - diazoxid (anvendes til behandling af lavt blodsukker), - vanddrivende lægemidler (anvendes til behandling af forhøjet blodtryk eller væskeophobning), - glucagon (bugspytkirtelhormon, der anvendes til behandling af alvorlig hypoglykæmi), - isoniazid (anvendes til behandling af tuberkulose), - østrogener og gestagener (findes i f.eks. p-piller og anvendes til forebyggelse af svangerskab), - phenthiazinderivater (anvendes til behandling af psykiske sygdomme), - somatropin (væksthormon), - sympatomimetika (såsom adrenalin, salbutamol eller terbutalin, der anvendes til behandling af
English: Dial your dose Dial your dose by turning the dial until the correct number lines up with the black line on the window.
Danish: Indstil din dosis ved at dreje på dosisvælgeren, indtil det korrekte tal står ud for den sorte markør i dosisvinduet.
English: What LUSDUNA looks like and contents of the pack LUSDUNA 100 units/mL solution for injection in a pre-filled pen is a clear and colourless solution.
Danish: Udseende og pakningsstørrelser Lusduna 100 enheder/ml, injektionsvæske, opløsning, i fyldt pen, er en klar farveløs opløsning.
English: In clinical studies, antibodies that cross-react with human insulin and insulin glargine were observed with the same frequency in both NPH-insulin and insulin glargine treatment groups.
Danish: Antistoffer med krydsreaktion over for humant insulin og insulin glargin blev observeret i kliniske studier med samme forekomst i både gruppen, der fik NPH-insulin, og gruppen, der fik insulin glargin.
English: Insert the needle Simply insert the needle fully into the skin.
Danish: Indfør nålen Stik nålen ind under huden.
English: Do not use Nexvue if it is damaged or not working properly; it has to be discarded and a new pen has to be used.
Danish: Anvend ikke Nexvue, hvis den er skadet eller ikke virker ordentligt.
English: - your insulin pen does not work properly, - you are doing less exercise than usual, you are under stress (emotional distress, excitement), or you have an injury, operation, infection or fever, - you are taking or have taken certain other medicines (see section 2, "Other medicines and
Danish: ophidselse), eller hvis du har en skade, er blevet opereret, har en infektion eller feber, - du tager eller har taget visse andre lægemidler (se punkt 2, "Brug af anden medicin sammen
English: LUSDUNA contains insulin glargine, an insulin analogue, and has a prolonged duration of action.
Danish: LUSDUNA indeholder insulin glargin, en insulin-analog.
English: EU/1/16/1162/003 5 pre-filled pens of 3 mL
Danish: EU/1/16/1162/003 5 fyldte penne a 3 ml
English: In healthy subjects and diabetic patients, insulin serum concentrations indicated a slower and much more prolonged absorption and showed a lack of a peak after subcutaneous injection of insulin glargine in comparison to human NPH insulin.
Danish: Efter subkutan injektion af insulin glargin til raske forsøgspersoner og diabetespatienter indikerer serumkoncentrationen af insulin en langsommere og forlænget absorption uden koncentrationstoppe sammenlignet med NPH-insulin.
English: Rarely, insulin may cause sodium retention and oedema particularly if previously poor metabolic control is improved by intensified insulin therapy.
Danish: Dette ses især, hvis en tidligere dårlig metabolisk kontrol forbedres ved en intensiveret insulinbehandling.
English: Push needle on Push the needle onto the pen.
Danish: Tryk nålen på Tryk nålen fast på pennen.
English: Insulin glargine
Danish: Insulincylinderampul
English: • Your pen is usable for up to 28 days after removal from the refrigerator.
Danish: • Når pennen er taget ud af køleskabet, kan den bruges i op til 28 dage.
English: The prolonged duration of action of insulin glargine is dependent on its injection into subcutaneous tissue.
Danish: Injektion af insulin glargin i subkutant væv er en forudsætning for den lange virkningsvarighed.
English: Pharmacotherapeutic group: Drugs used in diabetes, insulins and analogues for injection, long-acting.
Danish: Insuliner og analoger til injektion, langtidsvirkende.
English: For information on the treatment of hypoglycaemia, see section “Hyperglycaemia and Hypoglycaemia” at the end of this leaflet.
Danish: For information om behandling af hypoglykæmi, se punktet “Hyperglykæmi og hypoglykæmi” sidst i denne indlægsseddel.
English: See section “Hyperglycaemia and Hypoglycaemia” at the end of this leaflet.
Danish: Se punktet ”Hyperglykæmi og hypoglykæmi” sidst i denne indlægsseddel.
English: Do a safety check each time you inject.
Danish: Udfør altid en sikkerhedstest før hver injektion.
English: - you lose carbohydrates due to vomiting or diarrhoea, - you drink alcohol, particularly if you are not eating much, - you are doing more exercise than usual or a different type of physical activity, - you are recovering from an injury or operation or other stress, - you are recovering from an illness or from fever, - you are taking or have stopped taking certain other medicines (see section 2, "Other medicines and LUSDUNA").
Danish: Hvis du for eksempel: - har taget for meget insulin, - springer måltider over eller udsætter dem, - ikke spiser nok eller spiser mad, der indeholder færre kulhydrater end normalt (sukker og sukkerlignende stoffer kaldes kulhydrater; kunstige sødemidler er imidlertid IKKE kulhydrater), - mister kulhydrater på grund af opkastning og diarré, - drikker alkohol, især hvis du ikke spiser ret meget, - får mere motion end normalt eller udøver en anden form for fysisk aktivitet, - er ved at komme dig efter en skade, en operation eller anden form for belastning, - er ved at komme dig efter en sygdom eller feber, - tager eller er holdt op med at tage visse andre lægemidler (se punkt 2, ”Brug af anden medicin sammen med Lusduna”).
English: Remove the pen cap.
Danish: Tag penhætten af.
English: Do not share it with anyone else.
Danish: Lån ikke pennen ud til andre.
English: Prepare for your injection
Danish: Klargøring til injektionen
English: - disopyramide (used to treat certain heart conditions), - fluoxetine (used to treat depression), - fibrates (used to lower high levels of blood lipids), - monoamine oxidase (MAO) inhibitors (used to treat depression), - pentoxifylline, propoxyphene, salicylates (such as acetylsalicylic acid, used to relieve pain and lower fever), - somatostatin analogues (such as octreotide, used to treat an uncommon condition in which you make too much growth hormone), - sulphonamide antibiotics.
Danish: Medicin, der kan få dit blodsukker til at falde (hypoglykæmi) omfatter: - alle øvrige lægemidler til behandling af diabetes, - angiotensinkonverterende enzym (ACE)-hæmmere (anvendes til behandling af visse hjertesygdomme eller forhøjet blodtryk), - disopyramid (anvendes til behandling af visse hjertesygdomme), - fluoxetin (anvendes til behandling af depression), - fibrater (anvendes til at sænke høje niveauer af lipider i blodet), - monoaminoxidase (MAO)-hæmmere (anvendes til behandling af depression), - pentoxifyllin, propoxyphen, salicylater (såsom acetylsalicylsyre, der anvendes smertestillende og febernedsættende), - somatostatinanaloger (f.eks. octreotid, der anvendes til behandling af en sjælden lidelse, hvor kroppen producerer for meget væksthormon),
English: You should keep it at room temperature (below 30°C).
Danish: • Du må ikke lægge pennen tilbage i køleskabet eller nedfryse den. Opbevar den ved stuetemperatur (under 30 °C).
English: LUSDUNA 100 units/mLsolution for injection in a pre-filled pen (Nexvue)
Danish: Lusduna 100 enheder/ml injektionsvæske, opløsning, i fyldt pen (Nexvue)
English: MedDRA system organ
Danish: systemorganklasse
English: Examples include: - you have not injected your insulin or not injected enough, or if it has become less effective, for
Danish: Hvis du for eksempel: - ikke har injiceret din insulin eller ikke har injiceret nok, eller hvis det har mistet noget af sin virkning f.eks. på grund af forkert opbevaring, - din insulinpen ikke fungerer tilfredsstillende, - dyrker mindre motion end sædvanlig eller er stresset (følelsesmæssigt ude af balance,
English: Check the dose window...
Danish: Kontroller dosisvinduet...
English: 1 pre-filled pen of 3 mL 5 pre-filled pens of 3 mL
Danish: 5 fyldte penne a 3 ml
English: Check to make sure insulin comes out of the pen.
Danish: Kontroller, at der kommer en dråbe insulin til syne på nålens spids.
English: - Keep this leaflet.
Danish: Hold pennen lige.
English: For information on the treatment of hyperglycaemia, see section “Hyperglycaemia and Hypoglycaemia” at the end of this leaflet.
Danish: For information om behandling af hyperglykæmi, se punktet “Hyperglykæmi og hypoglykæmi”
English: Clean the cartridge head with an alcohol swab.
Danish: Påsætning af en ny nål Rengør cylinderampulhovedet med en spritserviet.
English: LUSDUNA 100 units/mL solution for injection in a pre-filled pen Insulin glargine
Danish: LUSDUNA 100 enheder/ml injektionsvæske, opløsning, i fyldt pen insulin glargin
English: Give the injection
Danish: Injektion af dosis
English: In-use pens
Danish: Indre nålehætte
English: Plasma “trough” levels of insulin glargine and its main M1 and M2 metabolites were measured in children treated with insulin glargine, revealing plasma concentration patterns similar to adults, and providing no evidence for accumulation of insulin glargine or its metabolites with chronic dosing.
Danish: Plasma-dal-koncentrationen af insulin glargin og dets vigtigste M1- og M2metabolitter blev målt hos børn som fik insulin glargin.
English: In patients with proliferative retinopathy, particularly if not treated with photocoagulation, severe hypoglycaemic episodes may result in transient amaurosis.
Danish: Alvorlige hypoglykæmiske episoder kan medføre forbigående amaurose hos patienter med proliferativ retinopati, især hvis denne ikke er behandlet med fotokoagulation.
English: A 24-week parallel group study was conducted in 125 children with type 1 diabetes mellitus aged 2 to 6 years, comparing insulin glargine given once daily in the morning to NPH insulin given once or twice daily as basal insulin.
Danish: Studiet sammenlignede insulin glargin administreret en gang dagligt om morgenen med NPH-insulin administreret en eller to gange dagligt som basalinsulin.
English: Press outer needle cap on firmly and use it to unscrew the needle.
Danish: Sæt den ydre nålehætte på med et fast tryk og brug den til at skrue nålen af.
English: Before using Nexvue, the instructions for use included in the pack must be read carefully (see section 6.6).
Danish: Brugsanvisningen i Nexvue-pakningen skal læses omhyggeligt før Nexvue anvendes (se pkt.
English: Excipients
Danish: Dosisvindue
English: Change the injection site with each injection to help prevent these skin changes.
Danish: Disse hudforandringer kan helt eller delvis undgås, hvis du skifter injektionssted ved hver injektion.
English: For more information, see section “Hyperglycaemia and Hypoglycaemia” at the end of this leaflet.
Danish: Yderligere oplysninger findes i punktet “Hyperglykæmi og hypoglykæmi” sidst i denne indlægsseddel.
English: Throw away the inner cap; you will not need it again.
Danish: Du får ikke brug for den igen.
English: Remove inner needle cap and throw away
Danish: Fjern den indre nålehætte og kasser den
English: Put used needles in a closeable, puncture-resistant sharps container.
Danish: Læg brugte nåle i en kanylebeholder med låg.
English: Insulin antibodies formation
Danish: Insulinantistoffer
English: Check your insulin
Danish: Kontroller insulinet
English: Getting ready
Danish: Forberedelse
English: LUSDUNA 100 units/mL solution for injection in a pre-filled pen
Danish: LUSDUNA 100 enheder/ml injektionsvæske, opløsning, i fyldt pen
English: Before using Nexvue, the instructions for use included in the pack must be read carefully.
Danish: Brugsanvisningen i Nexvue-pakningen skal læses omhyggeligt før Nexvue anvendes.
English: 5342 CC Oss
Danish: Organon Molenstraat 110 5342 CC Oss Holland
English: Do not put LUSDUNA next to the freezer compartment or a freezer pack.
Danish: Må ikke nedfryses eller komme i direkte berøring med frostboks eller fryseelementer.
English: Screw needle Screw the needle onto the pen to attach it.
Danish: Skru nålen på Skru nålen på pennen, så den sidder fast.
English: Lipohypertrophy Lipoatrophy Musculoskeletal and connective tissue disorders
Danish: Knogler, led, muskler og bindevæv
English: Pradaxa received a marketing authorisation valid throughout the EU on 18 March 2008.
Danish: Pradaxa fik en markedsføringstilladelse med gyldighed i hele EU den 18. marts 2008.
English: There was one death in each group (less than 1%).
Danish: Der sås ét dødsfald i hver gruppe (under 1 %).
English: In the study, around 18,000 adults were treated for one to three years.
Danish: I dette studie blev ca. 18.000 voksne behandlet i 1-3 år.
English: Further information on Pradaxa can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Yderligere information om Pradaxa findes på agenturets websted under:ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: This means that it is converted into dabigatran in the body.
Danish: Det betyder, at det omdannes til dabigatran i kroppen.
English: Other information about Pradaxa
Danish: Andre oplysninger om Pradaxa
English: As for all medicines, data on the use of Pradaxa are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brugen af Pradaxa løbende overvåget.
English: What measures are being taken to ensure the safe and effective use of Pradaxa?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Pradaxa?
English: Pradaxa (dabigatran etexilate)
Danish: Pradaxa (dabigatranetexilat)
English: Pradaxa, which is taken by mouth, is more convenient for patients.
Danish: Pradaxa, der tages gennem munden, er mere bekvem for patienterne.
English: Why is Pradaxa authorised in the EU?
Danish: Hvorfor er Pradaxa godkendt i EU?
English: Therefore the European Medicines Agency decided that Pradaxa's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede derfor, at fordelene ved Pradaxa opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: An overview of Pradaxa and why it is authorised in the EU
Danish: En oversigt over Pradaxa, og hvorfor det er godkendt i EU
English: What is Pradaxa and what is it used for?
Danish: Hvad er Pradaxa, og hvad anvendes det til?
English: Three patients in the Pradaxa group died (less than 1%), but two of these deaths were unrelated to blood clots.
Danish: Tre patienter i Pradaxagruppen døde (under 1 %), men to af disse dødsfald var ikke relateret til blodpropper.
English: Pradaxa is available as capsules (75, 110 and 150 mg) and can only be obtained with a prescription.
Danish: Pradaxa fås som kapsler (75, 110 og 150 mg) og fås kun på recept.
English: Pradaxa is an anticoagulant medicine used for:
Danish: Pradaxa er et blodfortyndende lægemiddel, der anvendes til:
English: In both studies, there was some evidence that a 220 mg dose of Pradaxa may be more effective than a 150 mg dose.
Danish: I begge studier sås en vis evidens for, at en dosis på 220 mg Pradaxa kan være mere effektivt end en dosis på 150 mg.
English: All patients at increased risk of bleeding should be monitored closely and the doctor may reduce the dose of Pradaxa.
Danish: Alle patienter med øget risiko for blødning bør overvåges tæt, og lægen kan reducere dosen af Pradaxa.
English: However, the number of bleeding events was lower for Pradaxa than for warfarin.
Danish: Antallet af blødningshændelser var imidlertid lavere for Pradaxa end for warfarin.
English: The second study involved a total of 3,494 patients who had had a hip replacement.
Danish: Det andet studie omfattede i alt 3.494 patienter, der havde fået udskiftet en hofte.
English: What are the risks associated with Pradaxa?
Danish: Hvilke risici er der forbundet med Pradaxa?
English: The most common side effect with Pradaxa (which may affect more than 1 in 10 people) is bleeding.
Danish: Den hyppigste bivirkning ved Pradaxa (som kan forekomme hos mere end 1 ud af 10 patienter) er blødning.
English: Pradaxa must also not be used in patients with serious liver problems or in patients being treated with certain medicines.
Danish: Pradaxa må heller ikke anvendes hos patienter med alvorlige leverproblemer eller hos patienter i behandling med visse lægemidler.
English: The dose and duration of treatment depend on the condition Pradaxa is being used to treat, the patient's age and kidney function, and other medicines the patient is taking.
Danish: Dosen og behandlingsvarigheden afhænger af, hvilken tilstand Pradaxa gives for, patientens alder og nyrefunktion, samt hvilke andre lægemidler patienten tager.