FrancophonIA/ELRC3.0 huggingface dataset:
English: Lojuxta 40 mg: each hard capsule contains lomitapide mesylate equivalent to 40 mg lomitapide.
Danish: Lojuxta 40 mg: Hver hård kapsel indeholder lomitapidmesylat svarende til 40 mg lomitapid.
English: Lojuxta 60 mg: each hard capsule contains lomitapide mesylate equivalent to 60 mg lomitapide.
Danish: Lojuxta 60 mg: Hver hård kapsel indeholder lomitapidmesylat svarende til 60 mg lomitapid.
English: Haematuria
Danish: Flatulens
English: Lojuxta 30 mg hard capsules
Danish: Lojuxta, kapsler, hårde, 30 mg
English: Each hard capsule contains lomitapide mesylate equivalent to 40 mg lomitapide.
Danish: Hver hård kapsel indeholder lomitapidmesylat svarende til 40 mg lomitapid.
English: Lojuxta 5 mg hard capsules Lojuxta 10 mg hard capsules Lojuxta 20 mg hard capsules Lojuxta 30 mg hard capsules Lojuxta 40 mg hard capsules Lojuxta 60 mg hard capsules lomitapide
Danish: Lojuxta, kapsler, hårde, 5 mg Lojuxta, kapsler, hårde, 10 mg Lojuxta, kapsler, hårde, 20 mg Lojuxta, kapsler, hårde, 30 mg Lojuxta, kapsler, hårde, 40 mg Lojuxta, kapsler, hårde, 60 mg lomitapid
English: Eructation
Danish: Hæmaturi
English: Package sizes are:
Danish: Pakningsstørrelser:
English: Each hard capsule contains lomitapide mesylate equivalent to 10 mg lomitapide.
Danish: Hver hård kapsel indeholder lomitapidmesylat svarende til 10 mg lomitapid.
English: • The capsule shell for the 30 mg capsule contains gelatin, titanium dioxide (E171), red iron oxide
Danish: • Kapselskallen til 30 mg kapsler indeholder gelatine, titandioxid (E171), jernoxid, rød (E172)
English: Lojuxta 5 mg hard capsules Lojuxta 10 mg hard capsules Lojuxta 20 mg hard capsules Lojuxta 30 mg hard capsules Lojuxta 40 mg hard capsules Lojuxta 60 mg hard capsules
Danish: Lojuxta, kapsler, hårde, 5 mg Lojuxta, kapsler, hårde, 10 mg Lojuxta, kapsler, hårde, 20 mg Lojuxta, kapsler, hårde, 30 mg Lojuxta, kapsler, hårde, 40 mg Lojuxta, kapsler, hårde, 60 mg
English: The use of St. John's Wort should be avoided with Lojuxta.
Danish: Perikum bør ikke anvendes sammen med Lojuxta.
English: Lojuxta 10 mg hard capsules
Danish: Lojuxta, kapsler, hårde, 10 mg
English: Lojuxta 60 mg hard capsules
Danish: Lojuxta, kapsler, hårde, 60 mg
English: See package leaflet for further information.
Danish: Yderligere oplysninger herom fremgår af indlægssedlen.
English: • The capsule shell for the 60 mg capsule contains gelatin, titanium dioxide (E171) and yellow iron oxide (E172).
Danish: • .Kapselskallen til 60 mg kapsler indeholder gelatine, titandioxid (E171) og jernoxid, gul
English: Black iron oxide (E172) Propylene glycol
Danish: Jernoxid, sort (E172)
English: Lojuxta 40 mg hard capsules
Danish: Lojuxta, kapsler, hårde, 40 mg
English: • The capsule shell for the 40 mg capsule contains gelatin, titanium dioxide (E171) and yellow iron oxide (E172).
Danish: • Kapselskallen til 40 mg kapsler indeholder gelatine, titandioxid (E171) og jernoxid, gul
English: CYP3A4 inhibitors increase the exposure of lomitapide, with strong inhibitors increasing exposure approximately 27-fold.
Danish: CYP3A4-hæmmere øger eksponeringen for lomitapid.
English: Rectal tenesmus
Danish: Rektale tenesmer Aerofagi
English: Lower gastrointestinal haemorrhage Reflux oesophagitis
Danish: Nedre gastrointestinal blødning Refluksøsofagitis
English: Haematemesis
Danish: Vægttab
English: ALT or AST
Danish: Lever og galdeveje
English: • medicines to treat urinary incontinence (e.g. propiverine)
Danish: • lægemidler til behandling af ufrivillig vandladning (f.eks. propiverin)
English: • burping
Danish: • tarmluft
English: • swelling of the eye
Danish: • hævede øjne
English: Fatigue Asthenia
Danish: Træthed Asteni
English: This summary was last updated in 01-2017.
Danish: Dette sammendrag blev sidst ajourført 01-2017.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Jardiance on 22 May 2014.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Jardiance den 22. maj 2014.
English: On average, patients in the study were followed up for 3.1 years.
Danish: Patienterne i undersøgelsen blev i gennemsnit fulgt i 3,1 år.
English: This is a summary of the European public assessment report (EPAR) for Jardiance.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Jardiance.
English: The full EPAR and risk management plan summary for Jardiance can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR og resuméet af risikostyringsplanen for Jardiance findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Regarding safety, overall the side effects were considered manageable.
Danish: Vedrørende sikkerheden kunne bivirkningerne i det store hele håndteres.
English: Supportive evidence was provided from a further six studies.
Danish: Dette blev underbygget af yderligere seks undersøgelser.
English: Other information about Jardiance
Danish: Andre oplysninger om Jardiance
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Jardiance's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) afgjorde, at fordelene ved Jardiance overstiger risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: Jardiance contains the active substance empagliflozin.
Danish: Jardiance indeholder det aktive stof empagliflozin.
English: What measures are being taken to ensure the safe and effective use of Jardiance?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Jardiance?
English: Why is Jardiance approved?
Danish: Hvorfor blev Jardiance godkendt?
English: The recommended starting dose is 10 mg once a day, which can be increased if necessary to 25 mg daily in suitable patients.
Danish: Den anbefalede startdosis er 10 mg én gang dagligt, og dosis kan om nødvendigt øges til 25 mg dagligt, afhængigt af patienten.
English: In those receiving Jardiance, cardiovascular events occurred in 10.5% (490 out of 4,687) of patients compared with 12.1% (282 out of 2,333) of patients receiving placebo.
Danish: Der opstod kardiovaskulære hændelser hos 10,5 % (490 ud af 4 687) af de patienter, der fik Jardiance, sammenholdt med 12,1 % (282 ud af 2 333) af dem, der fik placebo.
English: Jardiance is available as tablets (10 and 25 mg) and can only be obtained with a prescription.
Danish: Jardiance fås som tabletter (10 og 25 mg) og udleveres kun efter recept.
English: It is not intended to provide practical advice on how to use Jardiance.
Danish: Det er ikke en praktisk vejledning i, hvordan Jardiance bør anvendes.
English: What is Jardiance and what is it used for?
Danish: Hvad er Jardiance, og hvad anvendes det til?
English: A beneficial effect of Jardiance on blood glucose has been shown in four main studies involving over 2,700 patients.
Danish: Jardiance havde gavnlig virkning på blodsukkeret i fire hovedundersøgelser med over 2 700 patienter.
English: When blood sugar levels decrease, HbA1C levels also decrease.
Danish: Når blodsukkeret falder, falder indholdet af HbA1C også.
English: There was also supportive evidence suggesting benefit when the medicine was combined with insulin.
Danish: Desuden var der understøttende dokumentation, der viste en gavnlig virkning af at kombinere lægemidlet med insulin.
English: The study involved patients with type 2 diabetes who already had cardiovascular disease (such as angina, heart attack and stroke).
Danish: Undersøgelsen omfattede patienter med type 2-diabetes, som allerede havde hjerte-karsygdomme (såsom angina, hjerteanfald eller slagtilfælde).
English: The main measure of effectiveness was the occurrence of one of three major cardiovascular events: stroke, heart attack or death caused by cardiovascular disease.
Danish: Virkningen blev hovedsageligt bedømt på forekomsten af én af tre alvorlige kardiovaskulære hændelser: slagtilfælde, hjerteanfald eller dødsfald forårsaget af hjerte-kar-sygdom.
English: What are the risks associated with Jardiance?
Danish: Hvilke risici er der forbundet med Jardiance?
English: It can also be used as an ‘add-on' to other diabetes medicines.
Danish: Det kan desuden anvendes som tillægsbehandling til andre lægemidler mod diabetes.
English: Jardiance can be used on its own in patients who cannot take metformin (another diabetes medicine).
Danish: Jardiance kan anvendes som enebehandling til patienter, som ikke kan tage metformin (et andet lægemiddel mod diabetes).
English: For more information about treatment with Jardiance, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Jardiance, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: The active substance in Jardiance, empagliflozin, works by blocking a protein in the kidneys called sodium-glucose co-transporter 2 (SGLT2).
Danish: Det aktive stof i Jardiance, empagliflozin, virker ved at blokere et protein i nyrerne kaldet natriumglukose-kotransporter 2 (SGLT2).
English: Jardiance was also shown to reduce cardiovascular events in patients with type 2 diabetes who already had cardiovascular disease.
Danish: Jardiance viste sig desuden at reducere kardiovaskulære hændelser hos patienter med type 2-diabetes, som allerede havde hjerte-kar-sygdomme.
English: However, the blood glucose lowering effects of the medicine are lower in patients with kidney impairment, and the CHMP recommended that the medicine not be used in some patients, depending on their kidney function.
Danish: Lægemidlets evne til at sænke blodsukkeret er dog mindre hos patienter med nedsat nyrefunktion, og CHMP frarådede derfor brug af lægemidlet hos visse patienter, afhængigt af nyrefunktionen.
English: Jardiance is a diabetes medicine used with diet and exercise to treat adults whose type 2 diabetes is not satisfactorily controlled.
Danish: Jardiance er et lægemiddel mod diabetes (sukkersyge), der anvendes sammen med diæt og motion til behandling af voksne, hvis type 2-diabetes ikke er tilstrækkeligt reguleret.
English: For the full list of all side effects and restrictions with Jardiance, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger og begrænsninger ved Jardiance fremgår af indlægssedlen.
English: The most common side effect with Jardiance (which may affect more than 1 in 10 people) is hypoglycaemia (low blood sugar) when the medicine is taken with a sulphonylurea or insulin.
Danish: Den hyppigste bivirkning ved Jardiance (som optræder hos mere end 1 ud af 10 personer), er for lavt blodsukker (hypoglykæmi), når lægemidlet tages sammen med et sulfonylurinstof eller insulin.
English: Jardiance was compared with placebo (a dummy treatment) when used alone or added to treatment with other diabetes medicines (metformin, pioglitazone, or metformin plus either pioglitazone or another type of diabetes medicine called a sulphonylurea).
Danish: Jardiance blev sammenlignet med placebo (en virkningsløs behandling), hvor det dels blev anvendt som enebehandling, dels som tillægsbehandling til andre diabeteslægemidler (metformin, pioglitazon, eller metformin sammen med enten pioglitazon eller et sulfonylurinstof, der er en anden type lægemiddel mod diabetes).
English: For practical information about using Jardiance, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Jardiance, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: If Jardiance is used in combination with insulin or sulphonylureas (medicines that make the body produce insulin), the doses of these may need to be reduced to decrease the risk of hypoglycaemia (low blood sugar levels).
Danish: Hvis Jardiance tages sammen med insulin eller sulfonylurinstoffer (lægemidler, der øger insulinproduktionen), kan det være nødvendigt at nedsætte dosis af disse lægemidler for at undgå for lavt blodsukker (hypoglykæmi).
English: Type 2 diabetes is a disease in which the body does not make enough insulin to control the level of glucose (sugar) in the blood or when the body is unable to use insulin effectively.
Danish: Ved type 2-diabetes producerer kroppen enten ikke nok insulin til at regulere blodsukkeret (blodets indhold af glukose), eller også er kroppen ikke i stand til at udnytte insulinet effektivt.
English: What benefits of Jardiance have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Jardiance?
English: The main measure of effectiveness was the change in the level of a substance in the blood called glycosylated haemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled, after 24 weeks of treatment.
Danish: Virkningen blev hovedsagelig bedømt på ændringen i blodets indhold af glykosyleret hæmoglobin (HbA1c) efter 24 ugers behandling.
English: This leads to high levels of glucose in the blood.
Danish: Dette fører til for højt blodsukker.
English: How is Jardiance used?
Danish: Hvordan anvendes Jardiance?
English: As blood is filtered by the kidneys, SGLT2 stops glucose in the bloodstream from being passed out into the urine.
Danish: Når blodet filtreres i nyrerne, forhindrer SGLT2 glukosen i blodbanen i at blive udskilt i urinen.
English: How does Jardiance work?
Danish: Hvordan virker Jardiance?
English: By blocking the action of SGLT2, empagliflozin causes more glucose to be removed via the kidney, through the urine, thereby reducing the levels of glucose in the blood.
Danish: Ved at blokere virkningen af SGLT2 bevirker empagliflozin, at nyrerne udskiller mere glukose gennem urinen, så blodsukkerniveauet falder.
English: All the studies showed a modest but clinically meaningful decrease in HbA1c with Jardiance compared with placebo: in the study investigating use of Jardiance without other medicines, the reduction in HbA1c was 0.74% more than placebo with the 10 mg dose and 0.85% more than placebo with the 25 mg dose.
Danish: I undersøgelsen med Jardiance som enebehandling faldt HbA1c 0,74 % mere end ved placebo sammen med 10 mg-dosen, og 0,85 % mere end ved placebo sammen med 25 mg-dosen.
English: Another main study showed that adding Jardiance to usual treatment reduced adverse cardiovascular (heart and blood vessels) effects.
Danish: En anden hovedundersøgelse viste, at Jardiance som tillægsbehandling gav færre hjerte-karbivirkninger.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Jardiance have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Jardiance.
English: Modest but clinically meaningful reductions in HbA1c were also seen when Jardiance was added to other medicines.
Danish: Alle undersøgelser viste et let, men klinisk betydningsfuldt fald i HbA1c med Jardiance i forhold til placebo.
English: Because Jardiance relies on the working of the kidneys for its effect, treatment with this medicine is not recommended in patients with moderately or severely impaired kidney function.
Danish: Brug af Jardiance frarådes derfor hos patienter med moderat eller stærkt nedsat nyrefunktion.
English: Some of these were continuations of the main studies, and suggested that the benefits of the medicine continued with longer therapy.
Danish: Nogle af disse var fortsættelser af hovedundersøgelserne.
English: In addition, beneficial reductions in weight and blood pressure were seen in patients treated with Jardiance.
Danish: Desuden medførte behandling med Jardiance vægttab og lavere blodtryk til gavn for patienterne.
English: concluded that Jardiance was shown to be effective in lowering blood glucose levels in patients with type 2 diabetes, when given alone or in combination with other diabetes medicines with different mechanisms of action.
Danish: Det gælder både, når det gives alene, og når det gives i kombination med andre diabeteslægemidler, der har andre virkningsmekanismer.
English: Animal studies are insufficient.
Danish: Data fra dyrestudier er utilstrækkelige.
English: * Based on patient weight of 50 kg
Danish: *Baseret på en patient på 50 kg
English: In other patients, one or the other effect may be dominant.
Danish: Hos nogen patienter kan den ene eller den anden virkning dominere.
English: Swallow the tablet whole with a glass of water.
Danish: - Synk tabletten hel sammen med et glas vand.
English: In some cases you may have to stop using one of the medicines.
Danish: I nogle tilfælde kan det være nødvendigt at stoppe med at tage den ene medicin.
English: Elderly (age 65 years or over)
Danish: Ældre (65 år eller derover)
English: Many feel normal.
Danish: Mange føler sig helt raske.
English: The half-life of valsartan is 6 hours.
Danish: Halveringstiden for valsartan er 6 timer.
English: • inability to achieve or maintain erection
Danish: • manglende evne til at få eller vedligeholde erektion
English: if you have liver problems.
Danish: - hvis du har leverproblemer.
English: Talk to your doctor before drinking alcohol.
Danish: Tal med din læge, før du drikker alkohol.
English: Patients should be re-hydrated before the administration.
Danish: Patienterne skal rehydreres før administrationen.
English: Keep your appointments with the doctor even if you are feeling well.
Danish: Overhold dine aftaler med lægen, også selvom du føler dig rask.
English: Depending on how you respond to the treatment, your doctor may suggest a higher or lower dose.
Danish: Afhængigt af hvordan du reagerer på behandlingen, kan lægen foreslå en højere eller lavere dosis.
English: • CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Danish: • BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL EN SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET
English: No interaction
Danish: Ingen interaktioner
English: Do not take a double dose (two tablets at once) to make up for a forgotten tablet.
Danish: Du må ikke tage en dobbeltdosis (to tabletter samtidig) som erstatning for den glemte tablet.
English: Some side effects can be serious and need immediate medical attention:
Danish: Nogle bivirkninger kan være alvorlige og kræver omgående lægebehandling
English: All of these substances help to control high blood pressure.
Danish: Alle disse stoffer hjælper med at kontrollere et højt blodtryk.
English: The clinical significance of this effect is uncertain and not sufficient to preclude their use.
Danish: Den kliniske betydning heraf er usikker og ikke tilstrækkelig til at udelukke brugen.
English: All these changes were reversible after a 4-week recovery period and were considered to be exaggerated pharmacological effects.
Danish: Alle disse ændringer var reversible efter en 4 ugers restitutionsperiode og blev anset for at være overdrevne farmakologiske effekter.
English: You should see your doctor immediately if you experience any of the following symptoms: Common
Danish: Du skal omgående kontakte din læge, hvis du får et hvilket som helst af følgende symptomer: Almindelig
English: Do not stop taking your medecine unless your doctor tells you to.
Danish: Du må ikke stoppe med at tage din medicin, medmindre din læge har fortalt dig, at du skal stoppe.
English: This metabolite is pharmacologically inactive.
Danish: Denne metabolit er farmakologisk inaktiv.
English: If it is almost time for your next dose you should simply take the next tablet at the usual time.
Danish: Hvis det næsten er tid til din næste dosis, skal du tage den næste tablet på det sædvanlige tidspunkt.
English: if you suffer from aldosteronism.
Danish: - hvis du lider af aldosteronisme.
English: Always take this medicine, even if you are feeling well People who have high blood pressure often do not notice any signs of the problem.
Danish: Tag altid denne medicin, også selvom du føler dig rask Personer med forhøjet blodtryk bemærker ofte ingen tegn på dette problem.
English: Treatment can be continued once blood pressure has been stabilised.
Danish: Behandlingen kan fortsættes, når blodtrykket igen er stabiliseret.
English: The clinical translation of these pharmacokinetic variations may be more pronounced in the elderly.
Danish: Det kliniske udtryk af disse farmakokinetiske variationer kan være mere udtalt hos ældre.
English: The combination of these substances has an additive antihypertensive effect.
Danish: Kombinationen af disse stoffer har en additiv antihypertensiv virkning.
English: The tablets should be swallowed whole with some water, at the same time of the day and preferably in the morning.
Danish: Tabletterne bør sluges hele med lidt vand på samme tidspunkt af dagen og helst om morgenen.
English: • sudden, temporary loss of consciousness
Danish: • pludseligt midlertidigt tab af bevidsthed
English: This will help you get the best results and lower the risk of side effects.
Danish: Dette vil hjælpe dig med at opnå den bedste virkning og mindske risikoen for bivirkninger.
English: Not all pack sizes or strengths may be marketed.
Danish: Ikke alle pakningsstørrelser eller styrker er nødvendigvis markedsført.
English: West Sussex, RH12 5AB United Kingdom
Danish: West Sussex, RH12 5AB Storbritannien
English: Effect of the interaction with other medicinal products
Danish: Virkning af interaktion med andre lægemidler
English: Thus, only information on interactions with other medicinal products that are known for the individual active substances is provided in this section.
Danish: Der gives derfor under dette punkt kun information om interaktioner med andre lægemidler, som er kendt fra de individueller aktive substanser.
English: • lack of energy
Danish: • manglende energi
English: Absolute bioavailability of hydrochlorothiazide is 70% after oral administration.
Danish: Hydrochlorthiazids absolutte biotilgængelighed er 70 % efter oral administration.
English: The antihypertensive effect persists over 24 hours after administration.
Danish: Den antihypertensive effekt vedvarer i 24 timer efter administration.
English: Steady-state plasma levels are reached after continuous administration for 7-8 days.
Danish: Steady-state-plasmaniveauerne opnås efter vedvarende administration i 7-8 dage.
English: Therefore, monitoring of renal function at the beginning of the treatment is recommended, as well as adequate hydration of the patient.
Danish: Monitorering af nyrefunktionen i begyndelsen af behandlingen anbefales derfor, ligesom passende hydrering af patienten.
English: PVC/PVDC blisters.
Danish: PVC/PVDC-blister.
English: Systemic lupus erythematosus
Danish: Systemisk lupus erythematosus
English: More than 95% of the absorbed dose is being excreted as unchanged compound in the urine.
Danish: Mere end 95 % af den absorberede dosis udkilles uændret i urinen.
English: See section 4.2 for information on paediatric use.
Danish: 4.2 for information om pædiatrisk anvendelse).
English: Absolute bioavailability has been calculated as between 64% and 80%.
Danish: Den absolutte biotilgængelighed er beregnet til at være mellem 64 % og 80 %.
English: Alcohol may make your blood pressure fall too much and/or increase the possibility of dizziness or fainting.
Danish: Alkohol kan få dit blodtryk til at falde for meget og/eller øge risikoen for, at du bliver svimmel eller besvimer.
English: Hydrochlorothiazide is excreted in human milk in small amounts.
Danish: Hydrochlorthiazid udskilles i human mælk i små mængder.
English: Similar outcomes have been reported with valsartan.
Danish: Tilsvarende forløb er blevet rapporteret med valsartan.
English: Your doctor may need to change the dose or take other precautions.
Danish: Det kan være nødvendigt, at din læge ændrer din dosis eller tager andre forholdssregler.
English: This can lead to permanent vision impairment, if not treated.
Danish: Det kan medføre permanent synstab, hvis det ikke bliver behandlet.