FrancophonIA/ELRC3.0 huggingface dataset:
English: The CHMP therefore recommended the strengthening of the contraindication in hypertensive patients and alerts prescribers that blood pressure needs to be monitored, especially
Danish: CHMP anbefalede derfor en stramning af kontraindikationen for hypertensive patienter, og gør de ordinerende læger kraftigt opmærksomme på, at blodtrykket skal overvåges, især i de første 2 uger efter indledningen af behandlingen.
English: There was little direct comparative safety data for individual non-steroidal anti-inflammatory drugs (NSAIDs) other than diclofenac and naproxen.
Danish: Der forelå kun få direkte komparative sikkerhedsoplysninger om enkeltstående nonsteroide antiinflammatoriske lægemidler ud over diclofenac og naproxen.
English: Based on the review of the available data, the CHMP considered that the benefits of etoricoxib outweigh the risks in the treatment of ankylosing spondylitis.
Danish: På grundlag af gennemgangen af de foreliggende data var CHMP af den opfattelse, at fordelene ved etoricoxib opvejer risiciene ved behandling af spondylitis ankylopoietica.
English: Etoricoxib is a selective inhibitor of COX-2 (cyclooxygenase 2) indicated in the symptomatic relief of osteoarthritis (OA, 30-60mg once daily (od)), rheumatoid arthritis (RA, 90mg od) and the pain and signs of inflammation associated with acute gouty arthritis (120mg od).
Danish: Etoricoxib er en selektiv COX-2-hæmmer (cyclooxygenase 2), som er indiceret til symptomatisk behandling af osteoarthritis (OA, 30-60 mg en gang dagligt), rheumatoid arthritis (RA, 90 mg en gang dagligt) og smerter og tegn på inflammation i tilknytning til akut arthritis urica (120 mg en gang dagligt).
English: At the end of the mutual recognition procedure, there was a discrepancy between different European Union (EU) Member States regarding the safety of etoricoxib at the 90mg dose in the new proposed indication.
Danish: Ved afslutningen af den gensidige anerkendelsesprocedure var der uoverensstemmelse mellem de forskellige EU-medlemsstater om sikkerheden ved etoricoxib i en dosis på 90 mg til den nye indikation.
English: The referral procedure was initiated on 20 September 2007 with the adoption of a CHMP list of questions that were to be addressed by the marketing authorisation holders (MAHs).
Danish: Proceduren for indbragte sager indledtes den 20. september 2007, hvor CHMP vedtog en liste med spørgsmål, som skulle afklares af indehaverne af markedsføringstilladelsen.
English: This referral procedure relates to a request for arbitration concerning a type II variation for a new indication to include treatment of ankylosing spondylitis (AS), at a recommended daily dose of 90mg.
Danish: Denne procedure for indbragte sager tager udgangspunkt i en anmodning om voldgift vedrørende en type II-ændring med henblik på medtagelse af en ny indikation, der skal omfatte behandling af spondylitis ankylopoietica (AS) med en anbefalet daglig dosis på 90 mg.
English: Data from clinical studies showed clinically meaningful treatment effect for the 90mg etoricoxib once daily dose for AS indication; however, some data are available to indicate that lower doses might also show effect.
Danish: Dataene fra de kliniske undersøgelser viste en klinisk meningsfuld behandlingseffekt af en dosis på 90 mg etoricoxib en gang dagligt til AS-indikationen, men der foreligger visse data, som viser, at lavere doser også kan have effekt.
English: The data further confirmed a similar CV thrombotic risk like diclofenac and some degree of upper gastrointestinal (GI) safety advantage over naproxen and diclofenac (though no particular lower GI safety advantage).
Danish: Endvidere bekræftede dataene, at der var en risiko for kardiovaskulær trombose, som svarede til risikoen ved diclofenac, og en vis grad af øvre gastrointestinal (GI) sikkerhed i forhold til naproxen og diclofenac (der fandtes dog ikke nogen særlig nedre GI sikkerhedsfordel).
English: The main unresolved areas of concern identified by France were concerns regarding long term safety of a daily dose of 90mg etoricoxib in the view of possible increased cardiovascular (CV) risk related to the use of the 90mg dose in the ankylosing spondylitis (AS) indication.
Danish: De vigtigste udestående problemer, som Frankrig påpegede, var betænkeligheder ved den langsigtede sikkerhed ved en daglig dosis på 90 mg etoricoxib i lyset af den mulige øgede kardiovaskulære risiko, som er forbundet med anvendelse af en 90 mg dosis til indikationen spondylitis ankylopoietica (AS).
English: On 26 June 2008, the CHMP, having considered the data provided by the MAHs, recommended the granting of the variation to the marketing authorisations.
Danish: Efter at have gennemgået de data, indehaverne af markedsføringstilladelsen havde fremlagt, anbefalede CHMP den 26. juni 2008 at godkende ændringen af markedsføringstilladelserne.
English: Empagliflozin has been authorised in the European Union (EU) as Jardiance since 2014.
Danish: Empagliflozin har været godkendt i Den Europæiske Union (EU) under navnet Jardiance siden 2014.
English: The full EPAR for Glyxambi can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Glyxambi findes på agenturets websted under:ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: It contains two active substances, empagliflozin and linagliptin.
Danish: Det indeholder to aktive stoffer, empagliflozin og linagliptin.
English: This is a summary of the European public assessment report (EPAR) for Glyxambi.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Glyxambi.
English: Patients were then given either empagliflozin or placebo (a dummy treatment) in addition to their existing treatment.
Danish: Patienterne fik derefter enten empagliflozin eller en virkningsløs behandling (placebo) foruden deres eksisterende behandling.
English: Glyxambi is used in the following groups:
Danish: Glyxambi anvendes hos følgende grupper:
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Glyxambi'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) konkluderede, at fordelene ved Glyxambi opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: The most common side effects with Glyxambi (which may affect more than 7 in 100 people) are urinary infections.
Danish: De hyppigste bivirkninger ved Glyxambi (som optræder hos mere end syv ud af 100 patienter) er urinvejsinfektioner.
English: • patients who are already taking empagliflozin and linagliptin as separate tablets.
Danish: • patienter, der i forvejen får empagliflozin og linagliptin som separate tabletter
English: Empagliflozin in combination with linagliptin (the same combination as in Glyxambi) was evaluated in 3 main studies involving 1,221 adults with type 2 diabetes.
Danish: Empagliflozin kombineret med linagliptin (samme kombination som i Glyxambi) er blevet vurderet i tre hovedundersøgelser med 1 221 voksne med type 2-diabetes.
English: • Linagliptin is a dipeptidyl-peptidase-4 (DPP-4) inhibitor.
Danish: • Linagliptin er en hæmmer af dipeptidyl-peptidase-4 (DPP-4).
English: What measures are being taken to ensure the safe and effective use of Glyxambi?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Glyxambi?
English: The main measure of effectiveness was the change after 24 weeks of treatment 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.
Danish: Virkningen blev hovedsagelig målt på ændringen efter 24 ugers behandling i blodets indhold af et stof kaldet glykosyleret hæmoglobin (HbA1c), som fortæller, hvor godt blodsukkeret er reguleret.
English: • patients whose blood glucose levels are not controlled well enough by a combination of one of Glyxambi's active substances (empagliflozin or linagliptin) with other diabetes medicines (metformin and/or a sulphonylurea);
Danish: • patienter, hvis blodsukker ikke er tilstrækkeligt velreguleret med en kombination af et af de aktive stoffer i Glyxambi (empagliflozin eller linagliptin) med andre lægemidler mod diabetes (metformin og/eller et sulfonylurinstof)
English: The most serious side effects are ketoacidosis (high blood levels of acids called ‘ketoacids'), pancreatitis (inflammation of the pancreas), hypersensitivity (allergic reactions) and hypoglycaemia (low blood sugar levels).
Danish: De alvorligste bivirkninger er ketoacidose (for høj blodkoncentration af ketosyrer), bugspytkirtelbetændelse (pankreatitis), allergiske reaktioner (hypersensitivitet) og for lavt blodsukker (hypoglykæmi).
English: A further study compared a fixed dose combination of empagliflozin and linagliptin (given in addition to metformin) with treatment with metformin plus either empagliflozin or linagliptin in patients who were not sufficiently controlled with metformin alone.
Danish: I endnu en undersøgelse blev en fast kombination af empagliflozin og linagliptin (givet som tillæg til metformin) sammenlignet med behandling med metformin plus enten empagliflozin eller linagliptin hos patienter, der ikke var tilstrækkelig velreguleret med metformin alene.
English: It is not intended to provide practical advice on how to use Glyxambi.
Danish: Det er ikke en praktisk vejledning i, hvordan Glyxambi bør anvendes.
English: Linagliptin has been authorised in the EU as Trajenta since
Danish: Linagliptin har været godkendt i EU under navnet Trajenta siden 2011.
English: Patients switching from empagliflozin and linagliptin to Glyxambi should receive the strength of Glyxambi that corresponds to the doses of empagliflozin and linagliptin in the separate tablets they were taking.
Danish: Patienter, der skifter fra empagliflozin og linagliptin til Glyxambi, skal have en styrke af Glyxambi, der svarer til doserne af empagliflozin og linagliptin i de separate tabletter, som de var i behandling med.
English: For more information about treatment with Glyxambi, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Glyxambi, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Regarding its safety profile, Glyxambi was well tolerated with side effects being characteristic of SGLT2 and DDP-4 inhibitors.
Danish: Hvad sikkerhedsprofilen angår, tåltes Glyxambi godt og havde bivirkninger, der er karakteristiske for SGLT2- og DDP-4-hæmmere.
English: Other information about Glyxambi
Danish: Andre oplysninger om Glyxambi
English: If Glyxambi is used in combination with insulin or a sulphonylurea, their doses may need to be reduced to decrease the risk of hypoglycaemia (low blood sugar levels).
Danish: Hvis Glyxambi bruges sammen med insulin eller et sulfonylurinstof, kan det være nødvendigt at nedsætte dosis af disse lægemidler for at mindske risikoen for at få for lavt blodsukker (hypoglykæmi).
English: After 24 weeks treatment the fixed dose combination reduced HbA1c levels to under 6.9% whereas they were around 7.3% with empagliflozin and linagliptin used alone.
Danish: Efter 24 ugers behandling medførte den faste kombination et fald i HbA1c til under 6,9 %, mens det lå på ca. 7,3 % med empagliflozin og linagliptin alene.
English: The CHMP considered that Glyxambi is effective at controlling blood glucose levels, with both components contributing to the effect.
Danish: CHMP fandt, at Glyxambi er effektivt til at regulere blodsukkeret, og at begge bestanddele bidrager til denne virkning.
English: These hormones are released after a meal and stimulate the pancreas to produce insulin.
Danish: Inkretiner er hormoner, der frigives efter et måltid og stimulerer bugspytkirtlen til at danne insulin.
English: Glyxambi must not be used in people who are hypersensitive (allergic) to empagliflozin, linagliptin, any of the other ingredients or who have ever had a serious allergic reaction to any DPP-4 or SGLT2 inhibitor.
Danish: Glyxambi må ikke anvendes hos patienter, som er overfølsomme (allergiske) over for empagliflozin, linagliptin eller andre af indholdsstofferne, eller som nogensinde har haft en alvorlig allergisk reaktion over for en DPP-4- eller SGLT2-hæmmer.
English: The HbA1c levels were around 8% before treatment.
Danish: HbA1c-koncentrationen før behandlingen var ca. 8 %.
English: Why is Glyxambi approved?
Danish: Hvorfor blev Glyxambi godkendt?
English: What is Glyxambi and what is it used for?
Danish: Hvad er Glyxambi, og hvad anvendes det til?
English: Linagliptin also reduces the amount of glucose made by the liver, by increasing insulin levels and decreasing the levels of the hormone glucagon.
Danish: Linagliptin nedsætter desuden leverens produktion af sukker ved at øge insulinindholdet og sænke indholdet af hormonet glukagon.
English: Adding linagliptin to treatment with empagliflozin and metformin for 24 weeks reduced HbA1c levels from 7.8% to 7.2%, compared with a reduction from 7.9% to 7.7% when placebo was added.
Danish: Når linagliptin blev givet som tillæg til behandlingen med empagliflozin og metformin i 24 uger faldt HbA1c-koncentrationen fra 7,8 % til 7,2 %, sammenlignet med et fald fra 7,9 % til 7,7 %, når placebo blev givet som tillæg.
English: What are the risks associated with Glyxambi?
Danish: Hvilke risici er der forbundet med Glyxambi?
English: Glyxambi is available as tablets containing 10 or 25 mg of empagliflozin with 5 mg of linagliptin, and can only be obtained with a prescription.
Danish: Glyxambi fås som tabletter, som indeholder 10 eller 25 mg empagliflozin med 5 mg linagliptin.
English: The second study included patients whose blood glucose levels were not satisfactorily controlled with metformin and empagliflozin.
Danish: Den anden undersøgelse omfattede patienter, hvis blodsukker ikke var tilfredsstillende reguleret med metformin og empagliflozin.
English: The result is a high level of glucose in the blood.
Danish: Dette medfører et højt blodsukker.
English: The two active substances in Glyxambi work in different ways to lower glucose levels:
Danish: De to aktive stoffer i Glyxambi sænker blodsukkeret på hver sin måde:
English: The first study included patients whose blood glucose levels were not satisfactorily controlled with metformin and linagliptin.
Danish: Den første undersøgelse omfattede patienter, hvis blodsukker ikke var tilfredsstillende reguleret med metformin og linagliptin.
English: For the full list of all side effects reported with Glyxambi, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Glyxambi fremgår af indlægssedlen.
English: For practical information about using Glyxambi, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Glyxambi, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: • Empagliflozin works by blocking a protein in the kidneys called sodium-glucose co-transporter 2 (SGLT2).
Danish: • Empagliflozin virker ved at blokere proteinet natrium-glukose-kotransporter 2 (SGLT2) i nyrerne.
English: HbA1c levels were just below 8% at the start of the study.
Danish: Ved begyndelsen af undersøgelsen var HbA1c-koncentrationen lige under 8 %.
English: Results showed that when empagliflozin was added to linagliptin and metformin, HbA1c levels decreased by 0.7-0.8 percentage points after 24 weeks, compared with no reduction when placebo was added.
Danish: Resultaterne viste, at når empagliflozin blev givet som tillæg til linagliptin og metformin, faldt HbA1c-koncentrationen med 0,7-0,8 procentpoint efter 24 uger.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Glyxambi 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 Glyxambi.
English: How is Glyxambi used?
Danish: Hvordan anvendes Glyxambi?
English: How does Glyxambi work?
Danish: Hvordan virker Glyxambi?
English: What benefits of Glyxambi have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Glyxambi?
English: Normally, as blood is filtered by the kidneys, SGLT2 stops glucose in the blood from being passed out into the urine.
Danish: Normalt forhindrer SGLT2, at der udskilles sukker fra blodet til urinen, når blodet filtreres af nyrerne.
English: The doctor may need to reduce the dose of Glyxambi or discontinue its use in patients with reduced kidney function.
Danish: Hos patienter med nedsat nyrefunktion vil lægen muligvis være nødt til at nedsætte dosis af Glyxambi eller afbryde behandlingen.
English: By prolonging the action of incretin hormones in the blood, linagliptin stimulates the pancreas to produce more insulin when blood glucose levels are high.
Danish: Det får bugspytkirtlen til at danne mere insulin, når blodsukkeret er højt.
English: Glyxambi is a diabetes medicine used in adults with type 2 diabetes to improve control of their blood glucose (sugar) levels.
Danish: Det anvendes til at forbedre reguleringen af blodsukkeret hos voksne med type 2-diabetes.
English: Ethinylestradiol is a synthetic estrogen while dienogest is a nortestosterone derivative which uniquely contains a cyanomethyl group at position 17α.
Danish: Ethinylestradiol er et syntetisk østrogen, mens dienogest er et nortestosteron-derivat, der unikt indeholder en cyanomethylgruppe i position 17α.
English: In view of the above and the necessity to take an action at EU level, UK considered that it was in the interest of the Union to refer the matter to the CHMP and requested on the 18 February 2016, that it give its opinion under Article 31 of Directive 2001/83/EC as to whether marketing authorisations of these products in the abovementioned indication should be maintained, varied, suspended, or revoked in relation to the below indication:
Danish: På baggrund af dette og af nødvendigheden af at gribe ind på EU-plan fandt Det Forenede Kongerige det i Unionens interesse at indbringe sagen for CHMP, og anmodede den 18. februar 2016 udvalget om i henhold til artikel 31 i direktiv 2001/83/EF at udtale sig om, hvorvidt markedsføringstilladelserne for disse produkter til ovennævnte indikation bør opretholdes, ændres, suspenderes eller inddrages i forbindelse med nedenstående indikation:
English: It is not known if the risk of VTE with DNG/EE is better or worse than that of the combined oral contraceptives containing levonorgestrel (5-7 per 10,000 women), etonorgestrel (6-12 per 10,000 women) or drospirenone (9-12 per 10,000 women as compared to 2 out of 10,000 women who do not use a combined hormonal contraceptive).
Danish: Det vides ikke, om risikoen for VTE med DNG/EE er mindre eller større end med de kombinerede orale kontraceptiva indeholdende levonorgestrel (5-7 pr. 10 000 kvinder), etonogestrel (6-12 pr. 10 000 kvinder) eller drospirenon (9-12 pr. 10 000 kvinder), sammenholdt med 2 ud af 10 000, som ikke bruger et kombineret hormonalt kontraceptivum.
English: Dienogest does not have significant androgen, mineralocorticoid or glucocorticoid effects in vivo.
Danish: Dienogest har ikke nævneværdig androgen-, mineralokortikoid- eller glukokortikoidvirkning in vivo.
English: The contraceptive effect of this combination is based on the interaction of various effects, the most important of which are seen as the inhibition of ovulation and the changes in the cervical secretion.
Danish: Den kontraceptive virkning af denne kombination bygger på samspillet mellem en række virkninger, hvoraf den vigtigste anses for at være ovulationshæmning og ændringer i cervixsekretet.
English: • The CHMP agreed that patients treated for acne should be assessed 3-6 months after starting treatment and periodically thereafter.
Danish: • CHMP fandt, at patienter, der behandles for acne, bør vurderes 3-6 måneder efter påbegyndelse af behandlingen og derefter periodisk.
English: Combined oral contraceptives (COCs) are thought to improve acne by several mechanisms.
Danish: Kombinerede orale kontraceptiva menes at give bedring i acne gennem flere mekanismer.
English: Dienogest shows antiandrogenic properties, 10-30 fold lower affinity to progesterone receptor in vitro as compared to other synthetic progestogens.
Danish: Dienogest udviser antiandrogene egenskaber og har 10-30 gange lavere in vitro-affinitet til progesteronreceptoren end andre syntetiske progestogener.
English: Oral contraceptives may also affect bone metabolism in adolescents, although this effect is likely reversible after discontinuation of treatment.
Danish: Orale kontraceptiva kan desuden påvirke knoglemetabolismen hos unge, skønt denne virkning må forventes at være reversibel efter seponering af behandlingen.
English: This is in line with the current treatment guidelines which state that combined oral contraceptives (COCs) are not indicated in mild acne, but are considered as treatment alternatives in females with moderate to severe acne.
Danish: Dette er i overensstemmelse med de gældende behandlingsretningslinjer, der fastslår, at kombinerede orale kontraceptiva ikke er indiceret ved let acne, men anses for behandlingsalternativer hos kvinder med moderat til svær acne.
English: The phase III clinical studies showed that predominantly moderate acne vulgaris dominated in the studies.
Danish: De kliniske fase III-undersøgelser omhandlede overvejende moderat acne vulgaris.
English: Therefore, the benefit-risk relationship of DNG/EE is considered favourable for a second-line treatment of women with moderate acne.
Danish: Benefit/risk-forholdet for DNG/EE anses derfor for at være gunstigt som andetvalgsbehandling af kvinder med moderat acne.
English: “Treatment of acne with moderate severity in women without contraindications for oral contraceptives and in whom topical treatment was ineffective”.
Danish: "Behandling af moderat svær acne hos kvinder, der ikke har kontraindikationer for orale kontraceptiva, og hos hvem topikal behandling har været ineffektiv".
English: When considering existing data in support of the efficacy of dienogest/ethinylestradiol, the CHMP concluded that overall there is sufficient evidence in support of the use of this combination in the acne indication.
Danish: Ved gennemgang af de foreliggende data til støtte for virkningen af dienogest/ethinylestradiol konkluderede CHMP, at der overordnet er tilstrækkelig evidens til at underbygge anvendelsen af denne kombination ved acneindikationen.
English: • The CHMP noted that the risk of VTE with dienogest containing combined hormonal contraceptive is not yet fully characterised.
Danish: • CHMP bemærkede, at risikoen for VTE med kombinerede hormonale kontraceptiva indeholdende dienogest endnu ikke er færdigkarakteriseret.
English: The risk of venous thromboembolic events (VTE) and arterial thromboembolic events (ATE) is of particular importance as to date there is insufficient data to clearly determine the relative risk for thromboembolic events compared to other combined hormonal contraceptives containing other progestogens.
Danish: Risikoen for venøse tromboemboliske hændelser og arterielle tromboemboliske hændelser er særlig vigtig, da der hidtil ikke har været tilstrækkelige data til klart at fastlægge den relative risiko for tromboemboliske hændelser i forhold til andre kombinerede hormonale kontraceptiva, der indeholder andre progestogener.
English: • The CHMP considered the procedure under Article 31 of Directive 2001/83/EC for medicines containing dienogest (DNG) 2 mg and ethinylestradiol (EE) 0.03 mg for moderately severe acne in women in whom topical treatment was ineffective.
Danish: • CHMP gennemgik proceduren i henhold til artikel 31 i direktiv 2001/83/EF for lægemidler indeholdende dienogest (DNG), 2 mg, og ethinylestradiol (EE), 0,03 mg, til moderat svær acne hos kvinder, hos hvem topikal behandling har været ineffektiv,