FrancophonIA/ELRC3.0 huggingface dataset:
English: Viracept should be used with caution in patients who have problems with their liver or kidneys.
Danish: Viracept bør anvendes med forsigtighed til patienter med lever- eller nyreproblemer.
English: It is used in combination with other antiviral medicines to treat adults, adolescents and children over three years of age who are infected with human immunodeficiency virus (HIV-1), the virus that causes acquired immune deficiency syndrome (AIDS).
Danish: Det anvendes i kombination med andre antiretrovirale lægemidler til behandling af voksne, unge og børn over tre år, der er smittet med human immundefekt virus (HIV-1).
English: In the first study, Viracept in combination with stavudine (another antiviral medicine) was compared with stavudine alone in 308 patients who had not taken stavudine or a protease inhibitor in the past.
Danish: I den første undersøgelse blev Viracept i kombination med stavudin (et andet antiretroviralt lægemiddel) sammenlignet med stavudin alene hos 308 patienter, som ikke tidligere havde været behandlet med stavudin eller proteasehæmmere.
English: Doctors should only prescribe Viracept to patients who have already taken medicines in the same class as Viracept (protease inhibitors) once they have looked at the antiviral medicines the patient has taken before and the likelihood that the virus will respond to the medicine.
Danish: Lægen bør inden ordinering af Viracept til patienter, der tidligere har været behandlet med lægemidler i samme klasse som Viracept (proteasehæmmere), først undersøge, hvilket antiretroviralt lægemiddel patienten tidligere har fået samt vurdere, om det er sandsynligt, at viruset vil reagere på lægemidlet.
English: Three studies have compared the effectiveness of dosing Viracept twice and three times a day, in combination with stavudine and lamivudine in 635 patients.
Danish: I tre undersøgelser af 635 patienter sammenlignede man virkningen af doseringerne af Viracept to og tre gange om dagen i kombination med stavudin og lamivudin.
English: What benefit has Viracept shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Viracept?
English: Viracept, in combination with other antiviral medicines, was more effective than the comparator medicines in both main studies.
Danish: I begge hovedundersøgelser havde Viracept i kombination med andre antiretrovirale lægemidler større virkning end de lægemidler, Viracept blev sammenlignet med.
English: How is Viracept used?
Danish: Hvordan virker Viracept?
English: See the package leaflet for the full list of these medicines.
Danish: Den fuldstændige liste over disse lægemidler fremgår af indlægssedlen.
English: • St John's wort (a herbal preparation used to treat depression);
Danish: • perikum (en drogetilberedning, der anvendes til behandling af depression)
English: See the package leaflet for full details.
Danish: De fuldstændige oplysninger herom fremgår af indlægssedlen.
English: (Invented) Name Strength Pharmaceutica l form
Danish: (Særnavn) Navn Styrke Lægemiddelfor m
English: Aristo Pharma GmbH Wallenroder Strasse 8-10 D-13435 Berlin Germany
Danish: Aristo Pharma GmbH Wallenroder Strasse 8-10 D-13435 Berlin Tyskland
English: Diotop 75 mg / 20 mg modified release hard capsules
Danish: 75 mg/20 mg hårde kapsler med modificeret udløsning
English: The events were most frequently reported during the first months on treatment.
Danish: Hændelserne blev rapporteret hyppigst i de første måneder af behandlingen.
English: The mean duration of diabetes was 13.9 years.
Danish: Gennemsnitsvarigheden af diabetes var 13,9 år.
English: These reactions have usually been mild.
Danish: Disse reaktioner har som regel været milde.
English: • You should use this medicine once a week on the same day each week if possible.
Danish: • Du skal bruge dette lægemiddel én gang ugentligt på den samme dag hver uge, hvis det er muligt.
English: The relevance for humans is considered to be low, but cannot be completely excluded.
Danish: Relevansen af dette for mennesker anses for at være lav, men kan ikke udelukkes helt.
English: • You can give yourself the injection at any time of the day - regardless of meals.
Danish: • Du kan give dig selv injektionen når som helst i løbet af dagen - uafhængigt af et måltid.
English: If you forgot to inject a dose and:
Danish: Hvis du har glemt at injicere en dosis, og:
English: Ozempic is to be administered once weekly at any time of the day, with or without meals.
Danish: Ozempic skal administreres én gang ugentligt når som helst i løbet af dagen, med eller uden mad.
English: Talk to your doctor for further information.
Danish: Tal med din læge for at få yderligere information.
English: This was assessed not to be clinically relevant.
Danish: Det blev vurderet ikke at være klinisk relevant.
English: Only use the medicine in this pen as prescribed.
Danish: Brug kun medicinen i denne pen som foreskrevet.
English: How much solution is left
Danish: Hvor meget opløsning er der tilbage
English: For use by one person only.
Danish: Må kun anvendes af én person.
English: once weekly
Danish: én gang ugentligt
English: Using the wrong medicine could cause severe harm to your health.
Danish: Brug af forkert medicin kan skade dit helbred alvorligt.
English: Other secondary endpoints All cause death
Danish: Andre sekundære endepunkter Alle dødsårsager
English: Talk to your doctor if you have any questions or concerns.
Danish: Tal med din læge, hvis du har spørgsmål eller bekymringer.
English: These patients should be monitored closely and treated according to clinical guidelines.
Danish: Disse patienter skal overvåges nøje og behandles i henhold til kliniske retningslinjer.
English: METHOD OF ADMINISTRATION once weekly
Danish: ADMINISTRATIONSMETODE én gang ugentligt
English: Primary endpoint - MACE Components of MACE
Danish: Primært endepunkt - MACE Komponenter i MACE
English: Atorvastatin Cmax was decreased by 38%.
Danish: Atorvastatin Cmax blev reduceret med 38%.
English: Patients with event (%)
Danish: Patienter med en hændelse (%)
English: The day of weekly administration can be changed if necessary as long as the time between two doses is at least 3 days (>72 hours).
Danish: Dagen for den ugentlige administration kan om nødvendigt ændres, så længe tidsrummet mellem to doser er mindst 3 dage (>72 timer).
English: Appetite, energy intake and food choice
Danish: Appetit, energiindtag og valg af mad
English: The warning signs of low blood sugar may come on suddenly.
Danish: Advarselssignalerne for lavt blodsukker kan komme pludseligt.
English: • change in the way food or drink tastes
Danish: • ændringer i den måde, mad og drikke smager
English: Then inject your next dose as usual on your scheduled day.
Danish: Injicér derefter den næste dosis som sædvanligt på din planlagte dag.
English: Metabolism/Biotransformation
Danish: Metabolisme/biotransformation
English: See figure 4 for results on primary and secondary cardiovascular endpoints.
Danish: Se figur 4 vedrørende resultater for primære og sekundære kardiovaskulære endepunkter.
English: Gender, race and ethnicity
Danish: Køn, race og etnisk oprindelse
English: The reactions are listed below by system organ class and absolute frequency.
Danish: Bivirkningerne er anført nedenfor efter systemorganklasse og absolut hyppighed.
English: Therefore, it is recommended to use contraception while using this medicine.
Danish: Det anbefales derfor at anvende prævention, mens du bruger dette lægemiddel.
English: In total 98% of the patients completed the trial and the vital status was known at the end of the trial for 99.6% of the patients.
Danish: I alt gennemførte 98% af patienterne studiet, og ved studiets afslutning var den vitale status kendt for 99,6% af patienterne.
English: Your doctor may reduce your dose of these medicines before you start using this medicine.
Danish: Din læge kan sætte din dosis af disse lægemidler ned, før du begynder at bruge dette lægemiddel.
English: This medicine is not recommended in children and adolescents under 18 years as the safety and efficacy in this age group have not yet been established.
Danish: Dette lægemiddel anbefales ikke til børn og unge under 18 år, da sikkerhed og virkning endnu ikke er fastlagt hos denne aldersgruppe.
English: This makes sure that the solution flows.
Danish: Dette sikrer opløsningens gennemløb.
English: This is especially important if you take more than one type of injectable medicine.
Danish: Dette er især vigtigt, hvis du tager flere typer injicerbar medicin.
English: Maximum concentration was reached 1 to 3 days post dose.
Danish: Maksimumkoncentrationen blev nået 1 til 3 dage efter dosering.
English: Weekly doses higher than 1 mg are not recommended.
Danish: Ugentlige doser større end 1 mg anbefales ikke.
English: There were 158 events of new or worsening nephropathy.
Danish: Der var 158 tilfælde af ny eller forværret nefropati.
English: This is especially important if you have kidney problems.
Danish: Det er særligt vigtigt, hvis du har nyreproblemer.
English: • Before you use the pen for the first time, your doctor or nurse will show you how to use it.
Danish: • Inden du anvender pennen for første gang, vil din læge eller sygeplejerske vise dig, hvordan den bruges.
English: It is important that you drink plenty of fluids to prevent dehydration.
Danish: Det er vigtigt, at du drikker rigeligt med væske for at undgå dehydrering.
English: Frequent blood testing to determine the ability of your blood to clot may be required.
Danish: Hyppige blodprøver til at bestemme blodets evne til at størkne kan være nødvendige.
English: • severe allergic reactions (anaphylactic reactions).
Danish: • alvorlige allergiske reaktioner (anafylaktiske reaktioner).
English: If you wish to become pregnant, you should stop using this medicine at least two months in advance.
Danish: Hvis du gerne vil være gravid, bør du stoppe med dette lægemiddel mindst to måneder før.
English: • fast pulse
Danish: • hurtig puls
English: Steady state exposure was achieved following 4-5 weeks of once weekly administration.
Danish: Steady state-eksponering blev opnået efter 4-5 uger med administration én gang ugentligt.
English: Cardiac electrophysiology (QTc)
Danish: Kardiel elektrofysiologi (QTc)
English: See step 2 ‘Check the flow'.
Danish: Se trin 2 ‘Kontrollér gennemløbet'.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 08 February 2018
Danish: Dato for første markedsføringstilladelse: 08 februar 2018
English: Clear and colourless or almost colourless, isotonic solution; pH=7.4.
Danish: Klar og farveløs eller næsten farveløs, isotonisk opløsning; pH=7,4.
English: In 8 phase 3a trials 4,792 patients were exposed to semaglutide.
Danish: I 8 fase 3a-studier blev 4.792 patienter eksponeret for semaglutid.
English: Do not change your dose unless your doctor has told you to.
Danish: Du må ikke ændre din dosis, medmindre din læge har bedt dig om det.
English: • diarrhoea - this usually goes away over time
Danish: • diarré - dette forsvinder som regel med tiden
English: The events led to treatment discontinuation in 3.9% and 5% of patients.
Danish: Hændelserne førte til seponering af behandlingen hos henholdsvis 3,9% og 5% af patienterne.
English: Do not use this medicine after the expiry date which is stated on the pen label and carton after 'EXP'.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pennen og æsken efter 'EXP'.
English: Postnatal growth and development were evaluated in cynomolgus monkeys.
Danish: Postnatal vækst og udvikling blev vurderet hos cynomolgus-aber.
English: To help you remember to inject this medicine once a week only, it is recommended to note the chosen weekday (e.g. Wednesday) on the carton and to write the date on the carton every time you have injected it.
Danish: For at du bedre kan huske kun at injicere dette lægemiddel én gang ugentligt, anbefales det, at du noterer den valgte ugedag (f.eks. onsdag) på æsken og skriver datoen på æsken, hver gang du har injiceret det.
English: No other treatment-related tumours were observed.
Danish: Der blev ikke observeret andre behandlingsrelaterede tumorer.
English: This medicine should not be used during pregnancy, as it is not known if it may affect your unborn child.
Danish: Dette lægemiddel må ikke bruges under graviditet, da det er ukendt, om det kan påvirke dit ufødte barn.
English: If so, the full dose will not be delivered.
Danish: Hvis det sker, bliver den fulde dosis ikke indgivet.
English: The injection site can be changed without dose adjustment.
Danish: Injektionsstedet kan ændres uden dosisjustering.
English: If you become pregnant when using this medicine, talk to your doctor right away, as your treatment will need to be changed.
Danish: Hvis du bliver gravid, mens du bruger dette lægemiddel, skal du omgående tale med din læge, da din behandling skal ændres.
English: EXP Discard pen 6 weeks after first use.
Danish: EXP Pennen skal bortskaffes 6 uger efter første anvendelse.
English: Avoid driving or using machines if you get any signs of low blood sugar.
Danish: Undgå at køre bil eller betjene maskiner, hvis du oplever tegn på lavt blodsukker.
English: The treatment difference appeared early and persisted throughout the trial.
Danish: Behandlingsforskellen viste sig tidligt og vedblev igennem studiet.
English: If your pen is already in use, go to step 3 ‘Select your dose'.
Danish: Hvis din pen allerede er i brug, så gå til trin 3 ‘Valg af dosis'.
English: • on its own - if your blood sugar is not controlled well enough by diet and exercise alone, and you cannot use metformin (another diabetes medicine) or
Danish: • alene - hvis dit blodsukker ikke er tilstrækkeligt kontrolleret med kost og motion alene, og du ikke kan bruge metformin (et andet lægemiddel mod diabetes), eller
English: • Always keep your pen and needles out of the sight and reach of others, especially children.
Danish: • Opbevar altid pennen og nålene ude af syne og utilgængeligt for andre, især børn.
English: The safety and efficacy of semaglutide in children and adolescents below 18 years have not yet been established.
Danish: Sikkerheden og virkningen af semaglutid hos børn og unge under 18 år er endnu ikke klarlagt.
English: Needles and other waste material should be disposed of in accordance with local requirements.
Danish: Nåle og andet affald skal bortskaffes i henhold til lokale retningslinjer.
English: If a dose is missed, it should be administered as soon as possible and within 5 days after the missed dose.
Danish: Hvis en dosis glemmes, skal den administreres hurtigst muligt og inden for 5 dage efter den glemte dosis.
English: Ozempic is given as an injection under the skin (subcutaneous injection).
Danish: Ozempic gives som en injektion under huden (subkutan injektion).
English: • with other medicines for diabetes - when they are not enough to control your blood sugar levels.
Danish: • med andre lægemidler mod diabetes - når disse ikke i tilstrækkelig grad kan kontrollere dit blodsukkerniveau.
English: Frequencies are defined as: very common: (≥1/10); common: (≥1/100 to <1/10); uncommon: (≥1/1,000 to <1/100); rare: (≥1/10,000 to <1/1,000) and very rare: (<1/10,000).
Danish: Hyppighederne er defineret som følger: meget almindelig: (≥1/10), almindelig: (≥1/100 til <1/10), ikke almindelig: (≥1/1.000 til <1/100), sjælden: (≥1/10.000 til <1/1.000) og meget sjælden: (<1/10.000).
English: If you do not check the flow before your first injection with each new pen, you may not get the prescribed dose and the intended effect of Ozempic.
Danish: Hvis du ikke kontrollerer gennemløbet før den første injektion med hver ny pen, får du muligvis ikke den ordinerede dosis, og opnår ikke den tilsigtede virkning af Ozempic.
English: The pen is for use by one person only.
Danish: Pennen er kun beregnet til én person.
English: Cmax was not affected for any of the compounds.
Danish: Cmax blev ikke påvirket for nogen af stofferne.
English: Gender, race (White, Black or African-American, Asian) and ethnicity (Hispanic or Latino, nonHispanic or -Latino) had no effect on the pharmacokinetics of semaglutide.
Danish: Køn, race (hvide, sorte eller afro-amerikanere, asiatisk) og etnisk oprindelse (spansk eller latinamerikaner, ikke-spansk eller ikke-latinamerikaner) havde ingen effekt på farmakokinetikken af semaglutid.
English: The postprandial triglyceride and VLDL cholesterol response to a high fat meal was reduced by >40%.
Danish: Det postprandiale triglycerid- og VLDL-cholesterolrespons på et måltid med højt fedtindhold blev reduceret med >40%.
English: - In this case, you have not received any medicine - even though the dose counter has moved from the original dose that you have set.
Danish: - I så fald har du ikke fået noget medicin - selvom dosistælleren har bevæget sig fra den oprindelige dosis, du valgte.
English: This is normal, but you must still check the flow, if you use a new pen for the first time.
Danish: Dette er normalt, men du skal stadig kontrollere gennemløbet, når du bruger en ny pen første gang.
English: Approximately 3% of the dose was excreted as intact semaglutide via urine.
Danish: Ca. 3% af dosis blev udskilt som intakt semaglutid via urinen.
English: After one year of treatment, a weight loss of ≥5% and ≥10% was achieved for more subjects with
Danish: Efter ét års behandling var der opnået et vægttab på ≥5% og ≥10% hos flere forsøgspersoner med
English: Rapid improvement in glucose control has been associated with a temporary worsening of diabetic retinopathy, but other mechanisms cannot be excluded.
Danish: Hurtig forbedret kontrol af glucose i blodet har været forbundet med en forbigående forværring af diabetisk retinopati, men andre mekanismer kan ikke udelukkes.
English: If a patient wishes to become pregnant, or pregnancy occurs, semaglutide should be discontinued.
Danish: Hvis en patient ønsker at blive gravid, eller der konstateres graviditet, skal semaglutid seponeres.
English: Preclinical data reveal no special hazards for humans based on conventional studies of safety pharmacology, repeat-dose toxicity or genotoxicity.
Danish: Prækliniske data viser ingen specielle risici for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, toksicitet efter gentagne doser eller genotoksicitet.
English: • Before your first injection with each new pen, check the flow.
Danish: • Inden din første injektion med en ny pen, skal du kontrollere gennemløbet.
English: Therefore, semaglutide should not be used during pregnancy.
Danish: Semaglutid må derfor ikke anvendes under graviditet.
English: Use semaglutide once a week Write the weekday you choose to inject I injected my weekly dose on the below dates subcutaneous use
Danish: Brug semaglutid én gang ugentligt Notér den ugedag, du vælger at injicere Jeg injicerede min ugentlige dosis på datoerne nedenfor subkutan anvendelse
English: Number of subjects at risk
Danish: Antal forsøgspersoner med risiko
English: Your doctor may ask you to test your blood sugar levels.
Danish: Lægen vil måske bede dig om at måle dit blodsukkerniveau.
English: In each case, patients can then resume their regular once weekly dosing schedule.
Danish: I hvert enkelt tilfælde kan patienterne derefter fortsætte med deres faste plan med én ugentlig dosis.
English: No dose adjustment is required based on age.
Danish: Dosisjustering, baseret på alder, er ikke nødvendig.
English: If you have diabetic eye disease and are using insulin, this medicine may lead to a worsening of your vision, and this may require treatment.
Danish: Hvis du har diabetisk øjensygdom og bruger insulin, kan dette lægemiddel være forbundet med en forværring af dit syn, og dette kan kræve behandling.
English: You should seek immediate medical help and inform your doctor straight away if you get symptoms such as breathing problems, swelling of face and throat and a fast heartbeat.
Danish: Du skal straks søge lægehjælp og informere din læge hurtigst muligt, hvis du får symptomer såsom åndedrætsbesvær, hævelse af ansigt og hals samt hurtig hjerterytme (puls).
English: Age had no effect on the pharmacokinetics of semaglutide based on data from phase 3a studies including patients of 20-86 years of age.
Danish: Alder havde ingen effekt på farmakokinetikken af semaglutid baseret på data fra fase 3a-studier med patienter i alderen 20-86 år.
English: Semaglutide is not a substitute for insulin.
Danish: Semaglutid er ikke en erstatning for insulin.
English: If necessary, clean it with a mild detergent on a moistened cloth.
Danish: Hvis det er nødvendigt, kan den rengøres med et mildt rengøringsmiddel på en fugtig klud.
English: If you are pregnant or breast-feeding, think you might be pregnant, or are planning to have a baby, ask your doctor 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 til råds, før du bruger dette lægemiddel.
English: The enzyme neutral endopeptidase (NEP) is expected to be involved in the metabolism of semaglutide.
Danish: Enzymet neutral endopeptidase (NEP) antages at være involveret i metabolismen af semaglutid.
English: GLP--1 is a physiological hormone that has multiple actions in glucose and appetite regulation, and in the cardiovascular system.
Danish: GLP-1 er et fysiologisk hormon, der har flere funktioner i reguleringen af glucose og appetit, og i det kardiovaskulære system.
English: For diastolic blood pressure, there were no significant differences between semaglutide and comparators.
Danish: Hvad angår det diastoliske blodtryk, var der ingen signifikante forskelle mellem semaglutid og komparatorerne.
English: If more than 5 days have passed, the missed dose should be skipped, and the next dose should be administered on the regularly scheduled day.
Danish: Hvis der er gået mere end 5 dage, skal den glemte dosis springes over, og den næste dosis skal administreres på den planlagte dag.
English: Change the needle as described in step 5 ‘After your injection' and repeat all steps starting with step 1 ‘Prepare your pen with a new needle'.
Danish: Udskift nålen som beskrevet i trin 5 ‘Efter injektionen', og gentag alle trin med start fra trin 1 ‘Klargør pennen med en ny nål'.
English: Whether these effects are related to the decreased maternal food consumption as a direct GLP-1 effect is unknown.
Danish: Det er ukendt, om disse effekter er relateret til moderens nedsatte fødeindtag som en direkte effekt af GLP-1.
English: • complications of diabetic eye disease (retinopathy) - you should inform your doctor if you experience eye problems, such as changes in vision, during treatment with this medicine.
Danish: • komplikationer af diabetisk øjensygdom (retinopati) - du skal informere din læge, hvis du oplever problemer med øjnene, såsom synsændringer, under behandling med dette lægemiddel.
English: • low blood sugar (hypoglycaemia) when this medicine is used with another antidiabetic medicine
Danish: • lavt blodsukker (hypoglykæmi) når dette lægemiddel bruges sammen med et andet lægemiddel mod diabetes
English: There were 61% males, the mean age was 65 years and mean BMI was 33 kg/m2.
Danish: Der var 61% mænd, gennemsnitsalderen var 65 år, og det gennemsnitlige BMI var 33 kg/m2.
English: Ozempic can be administered with needles up to a length of 8 mm.
Danish: Ozempic kan administreres med nåle med en længde på op til 8 mm.
English: Five trials (SUSTAIN 1-5) had the glycaemic efficacy assessment as the primary objective, while one trial (SUSTAIN 6) had cardiovascular outcome as the primary objective.
Danish: Fem studier (SUSTAIN 1-5) havde vurdering af den glykæmiske virkning som primært mål, mens ét studie (SUSTAIN 6) havde kardiovaskulært udfald som primært mål.
English: However, upon initiation of semaglutide treatment in patients on warfarin or other coumarin derivatives, frequent monitoring of INR is recommended.
Danish: Ved initiering af behandling med semaglutid hos patienter i behandling med warfarin eller andre coumarinderivater anbefales dog hyppig overvågning af INR.
English: *human glucagon-like peptide-1 (GLP-1) analogue produced in Saccharomyces cerevisiae cells by recombinant DNA technology.
Danish: *Human GLP-1-analog (glukagon-lignende peptid-1) fremstillet i Saccharomyces cerevisiae-celler ved rekombinant dna-teknologi.