FrancophonIA/ELRC3.0 huggingface dataset:
English: Exviera is not recommended in patients with moderate hepatic impairment (Child-Pugh B) (see sections 4.4 and 4.8).
Danish: Det anbefales ikke at bruge Exviera til patienter med moderat nedsat leverfunktion (ChildPugh B) (se pkt.
English: Treated subjects (N=394) had a median age of 54 years (range: 19 to 71); 49.0% were prior pegIFN/RBV null responders; 21.8/% were prior pegIFN/RBV partial responders; and 29.2% were prior pegIFN/RBV relapsers; 57.6% were male; 8.1% were Black; 19.8% had a body mass index of at least 30 kg/m2; 20.6% had a history of depression or bipolar disorder; 89.6% had IL28B non-CC genotype; 87.1% had baseline HCV RNA levels of at least 800,000 IU per mL; 17.8% had portal fibrosis (F2) and 14.5% had bridging fibrosis (F3); 58.4% had HCV genotype 1a infection; 41.4% had HCV genotype 1b infection.
Danish: De behandlede patienter (N = 394) havde en median alder på 54 år (interval: 19-71); 49,0 % var tidligere ikke-respondere på pegIFN/RBV; 21,8 % var tidligere delvise respondere på pegIFN/RBV, og 29,2 % var patienter med tidligere recidiv efter pegIFN/RBV-behandling; 57,6 % var mænd; 8,1 % var sorte; 19,8 % havde et BMI på mindst 30 kg/m2; 20,6 % havde depression eller bipolar lidelse i anamnesen; 89,6 % havde genotype IL28B non-C/C; 87,1 % havde et HCV-rna-niveau på mindst
English: The recommended dose is one tablet taken once a day.
Danish: Den anbefalede dosis er én tablet én gang dagligt.
English: Qtern contains two different active substances, which work in different ways:
Danish: Qtern indeholder to forskellige aktive stoffer, der virker på hver sin måde:
English: This is a summary of the European public assessment report (EPAR) for Qtern.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Qtern.
English: The full EPAR for Qtern can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Qtern findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Other information about Qtern
Danish: Andre oplysninger om Qtern
English: What is Qtern and what is it used for?
Danish: Hvad er Qtern, og hvad anvendes det til?
English: Why is Qtern approved?
Danish: Hvorfor blev Qtern godkendt?
English: What measures are being taken to ensure the safe and effective use of Qtern?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Qtern?
English: HbA1c levels were on average around 9% at the start of the study.
Danish: HbA1c-niveauerne lå gennemsnitligt omkring 9 % ved undersøgelsens start.
English: The CHMP therefore considered that Qtern should only be used in patients already receiving at least one component to avoid over-treatment and so that the value of each component can be judged individually.
Danish: CHMP vurderede derfor, at Qtern kun bør bruges hos patienter, der allerede får mindst én komponent, så overbehandling undgås, og værdien af hver enkelt komponent kan bedømmes individuelt.
English: It is not intended to provide practical advice on how to use Qtern.
Danish: Det er ikke en praktisk vejledning i, hvordan Qtern bør anvendes.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Qtern'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 Qtern opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: Dapagliflozin has been authorised in the European Union (EU) as Forxiga since 2012;
Danish: Dapagliflozin har været godkendt i EU under navnet Forxiga siden 2012.
English: What are the risks associated with Qtern?
Danish: Hvilke risici er der forbundet med Qtern?
English: Dapagliflozin in combination with saxagliptin (the same combination as in Qtern) was evaluated in 3 main studies involving 1,169 adults with type 2 diabetes.
Danish: Dapagliflozin i kombination med saxagliptin (samme kombination som i Qtern) blev undersøgt i tre hovedundersøgelser, som omfattede 1 169 voksne patienter med type 2-diabetes.
English: HbA1c levels were around 8% at the start of the study.
Danish: HbA1c-niveauerne lå på ca. 8 % ved undersøgelsens start.
English: • saxagliptin, is a dipeptidyl-peptidase-4 (DPP-4) inhibitor.
Danish: • Saxagliptin er en dipeptidyl-peptidase-4 (DPP-4) -hæmmer.
English: For more information about treatment with Qtern, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Qtern, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: On the basis of previous studies with the individual components of Qtern used together with a sulphonylurea, the CHMP also approved the combination of Qtern with a sulphonylurea.
Danish: På grundlag af tidligere undersøgelser med de enkelte komponenter i Qtern brugt i kombination med et sulfonylurinstof godkendte CHMP også kombinationen af Qtern med et sulfonylurinstof.
English: Qtern is available as tablets (5 mg saxagliptin and 10 mg dapagliflozin) and can only be obtained with a prescription.
Danish: Qtern fås som tabletter (5 mg saxagliptin og 10 mg dapagliflozin) og udleveres kun efter recept.
English: The most common side effects with Qtern (which may affect more than 1 in 10 people) are upper respiratory tract infection (such as nose and throat infections) and, when used with a sulphonylurea, hypoglycaemia (low blood glucose levels).
Danish: De hyppigste bivirkninger ved Qtern (som optræder hos mere end 1 ud af 10 patienter) er øvre luftvejsinfektioner (f.eks. i næse og svælg) og for lavt blodsukkerniveau (hypoglykæmi) ved anvendelse med et sulfonylurinstof.
English: The company also provided studies that were used in the authorisation of Forxiga and Onglyza where saxagliptin or dapagliflozin were used together with a sulphonylurea.
Danish: Virksomheden fremlagde også undersøgelser, der blev brugt til godkendelse af Forxiga og Onglyza, hvor saxagliptin eller dapagliflozin blev anvendt sammen med et sulfonylurinstof.
English: Regarding its safety profile, Qtern was well tolerated with side effects being characteristic of SGLT2 and DDP-4 inhibitors.
Danish: For så vidt angår sikkerhedsprofilen for Qtern var dette lægemiddel veltolereret med bivirkninger, der var karakteristiske for SGLT2- og DDP-4-hæmmere.
English: It contains the active substances saxagliptin and dapagliflozin.
Danish: Det indeholder de aktive stoffer saxagliptin og dapagliflozin.
English: Although both components of Qtern contribute to lowering blood glucose levels, the effects of each may vary in different patients.
Danish: Selvom begge komponenter i Qtern bidrager til at nedsætte blodsukkerniveauet, kan virkningen af dem svinge fra patient til patient.
English: Saxagliptin also reduces the amount of glucose made by the liver, by increasing insulin levels and decreasing the levels of the hormone glucagon.
Danish: Saxagliptin reducerer også den mængde glukose, der produceres af leveren, ved at øge insulinkoncentrationerne og mindske koncentrationerne af hormonet glukagon.
English: Qtern must not be used in people who are hypersensitive (allergic) to saxagliptin, dapagliflozin, any of the other ingredients or who have ever had a serious allergic reaction to any DPP-4 or SGLT2 inhibitor.
Danish: Qtern må ikke anvendes hos patienter, som er overfølsomme (allergiske) over for saxagliptin, dapagliflozin eller andre af indholdsstofferne, eller som tidligere har haft en alvorlig allergisk reaktion over for en DPP-4- eller en SGLT2-hæmmer.
English: It works by blocking the breakdown of incretin hormones in the body.
Danish: Det virker ved at blokere kroppens nedbrydning af de såkaldte inkretinhormoner.
English: For practical information about using Qtern, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Qtern, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: Qtern is used to treat adults with type 2 diabetes to improve control of their blood glucose (sugar) levels.
Danish: Qtern anvendes til at behandle voksne patienter med type 2-sukkersyge for at forbedre kontrollen med deres blodsukkerniveau.
English: How is Qtern used?
Danish: Hvordan anvendes Qtern?
English: For the full list of all side effects reported with Qtern, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Qtern fremgår af indlægssedlen.
English: Qtern can also be used to replace saxagliptin and dapagliflozin taken as separate tablets.
Danish: Qtern kan derudover anvendes til at erstatte saxagliptin og dapagliflozin taget som separate tabletter.
English: Qtern is used in patients whose blood glucose levels are not satisfactorily controlled with:
Danish: Qtern bruges hos patienter, hvis blodsukkerniveau ikke er tilstrækkeligt kontrolleret, med:
English: Type 2 diabetes is a disease in which the pancreas does not make enough insulin to control the levels of glucose in the blood or when the body is unable to respond to insulin effectively.
Danish: Ved type 2-sukkersyge producerer bugspytkirtlen enten ikke nok insulin til at regulere blodsukkerniveaet, eller kroppen er ikke i stand til at udnytte insulinet tilstrækkeligt.
English: What benefits of Qtern have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Qtern?
English: • dapagliflozin works by blocking a protein in the kidneys called sodium-glucose co-transporter 2 (SGLT2).
Danish: • Dapagliflozin virker ved at blokere proteinet natrium-glukose-kotransporter 2 (SGLT2) i nyrerne.
English: As a result of the action of both active substances, the blood glucose is reduced and this helps to control type 2 diabetes.
Danish: Tilsammen nedsætter de to aktive stoffer blodsukkeret og forbedrer dermed reguleringen af type 2sukkersyge.
English: The CHMP concluded that Qtern is effective when using it to replace saxagliptin and dapagliflozin taken as separate tablets.
Danish: Udvalget vurderede, at Qtern er effektivt, når det bruges til at erstatte saxagliptin og dapagliflozin taget som separate tabletter.
English: • metformin and one of the components of Qtern;
Danish: • metformin og én af komponenterne i Qtern
English: The first study included patients whose blood glucose levels were not satisfactorily controlled with metformin alone.
Danish: Den første undersøgelse omfattede patienter, hvis blodsukkerniveau ikke var tilstrækkeligt reguleret med metformin alene.
English: Results showed that when saxagliptin and dapagliflozin were taken together with metformin, they decreased HbA1c levels by 1.5 percentage points after 24 weeks, compared with a reduction of 0.9 percentage points with saxagliptin and metformin and 1.2 percentage points with dapagliflozin and metformin.
Danish: Resultaterne viste, at saxagliptin og dapagliflozin taget sammen med metformin reducerede HbA1c-niveauet med 1,5 procentpoint efter 24 uger sammenholdt med en reduktion på 0,9 procentpoint med saxagliptin og metformin og 1,2 procentpoint med dapagliflozin og metformin.
English: The CHMP also considered Qtern to be effective at controlling blood glucose levels when used in patients who were not satisfactorily controlled with metformin plus either saxagliptin or dapagliflozin.
Danish: CHMP vurderede også, at Qtern er effektivt til at regulere blodsukkerniveauet hos patienter, der ikke er tilstrækkeligt reguleret med metformin taget enten sammen med saxagliptin eller dapagliflozin.
English: • metformin, a sulphonylurea and one of the components of Qtern.
Danish: • metformin, et sulfonylurinstof og én af komponenterne i Qtern.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Qtern have been included in the summary of product characteristics and the package leaflet.
Danish: Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som sundhedspersonale og patienter skal følge for at sikre risikofri og effektiv anvendelse af Qtern.
English: The second study included patients whose blood glucose levels were not satisfactorily controlled with metformin and dapagliflozin.
Danish: Den anden undersøgelse omfattede patienter, hvis blodsukkerniveau ikke var tilstrækkeligt reguleret med metformin og dapagliflozin.
English: Results showed that adding saxagliptin to treatment with dapagliflozin and metformin for 24 weeks reduced HbA1c levels by 0.5 percentage points, compared with a reduction of 0.2 percentage points when placebo (a dummy treatment) was added to treatment with dapagliflozin and metformin.
Danish: Resultaterne viste, at tilføjelse af saxagliptin til behandling med dapagliflozin og metformin i 24 uger reducerede HbA1c-niveauerne med 0,5 procentpoint sammenlignet med en reduktion på 0,2 procentpoint, når placebo (en uvirksom behandling) blev tilføjet behandlingen med dapagliflozin og metformin.
English: • a sulphonylurea and one of the components of Qtern;
Danish: • et sulfonylurinstof og én af komponenterne i Qtern
English: A further study, which included patients not controlled with metformin and saxagliptin, showed that adding dapagliflozin to treatment with saxagliptin and metformin for 24 weeks reduced HbA1c levels by 0.8 percentage points, compared with a reduction of 0.1 percentage points when placebo was added to saxagliptin and metformin.
Danish: En yderligere undersøgelse, der omfattede patienter, hvis blodsukkerniveau ikke var tilstrækkeligt reguleret med metformin og saxagliptin, viste, at tilføjelse af dapagliflozin til behandling med saxagliptin og metformin i 24 uger reducerede HbA1c-niveauerne med 0,8 procentpoint sammenlignet med en reduktion på 0,1 procentpoint, når placebo blev tilføjet behandlingen med saxagliptin og metformin.
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 bedømt på ændringen i blodets indhold af glykosyleret hæmoglobin (HbA1c) efter 24 ugers behandling.
English: By blocking the action of SGLT2, dapagliflozin 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 dapagliflozin, at nyrerne udskiller mere glukose gennem urinen, så glukoseindholdet i blodet falder.
English: How does Qtern work?
Danish: Hvordan virker Qtern?
English: Invented name Strength Pharmaceutical Form Route of Administration
Danish: Styrke Lægemiddelform Administration Emballage Indhold (Koncentration)
English: However, there was a consensus that several other factors may contribute to an increased systemic exposure and therefore the risk cannot be excluded.
Danish: Der var imidlertid konsensus om, at adskillige andre faktorer kan medvirke til en øget systemisk eksponering, og derfor kan risikoen ikke udelukkes.
English: • The implementation of the 7-day prescription validity rule, in order not to impact on existing national legislation where 7 days validity exists;
Danish: • Gennemførelsen af reglen om 7 dages receptgyldighed for ikke at påvirke eksisterende national lovgivning, hvor der findes en receptgyldighed på 7 dage
English: Pregnancy is an absolute contraindication for all oral retinoids in the EU.
Danish: Graviditet er en absolut kontraindikation for alle orale retinoider i EU.
English: • The Pharmacovigilance Risk Assessment Committee (PRAC) considered the procedure under Article 31 of Directive 2001/83/EC for retinoid-containing medicinal products.
Danish: • Udvalget for risikovurdering inden for lægemiddelovervågning (PRAC) gennemførte proceduren vedrørende lægemidler indeholdende retinoider i henhold til artikel 31 i direktiv 2001/83/EF.
English: After reviewing all the available data to address the concerns discussed, the PRAC adopted a recommendation on 8 February 2018 which was then considered by the CHMP, in accordance with Article 107k of Directive 2001/83/EC.
Danish: Efter at have gennemgået de tilgængelige data vedtog PRAC den 8. februar 2018 en anbefaling, der efterfølgende blev vurderet af CHMP, jf. artikel 107k i direktiv 2001/83/EF.
English: The PRAC acknowledged that the implementation of the following elements of the PPP need to be considered and agreed at national level to account for the different healthcare systems in the EU:
Danish: PRAC anerkendte, at implementeringen af følgende elementer i graviditetsforebyggelsesprogrammet skal drøftes og aftales på nationalt plan for at tage højde for de forskellige sundhedsvæsener i EU:
English: Nevertheless, the PRAC considers that the data from patients presented in case series, spontaneous case reports and individual patients' experiences are considered to be very important.
Danish: Ikke desto mindre vurderer PRAC, at de data fra patienter, der er fremlagt i sygehistorier, spontane indberetninger og individuelle patienters erfaringer, er væsentlige.
English: The indications for the topical retinoids are non-life-threatening and there is no absolute clinical need for the treatment during pregnancy and pregnancy should be excluded before prescribing.
Danish: Indikationerne for de topikale retinoider er ikke-livstruende, og der er intet absolut klinisk behov for behandling under graviditet, og graviditet bør udelukkes før ordinering.
English: The human data on congenital malformations after oral retinoid exposure show a significant risk of retinoid embryopathy (of up to 30% of fetuses exposed); furthermore it is known that approximately one-third of pregnant patients exposed to oral retinoids during pregnancy will have spontaneous abortions.
Danish: Data for medfødte misdannelser hos mennesker efter eksponering for orale retinoider viser en signifikant risiko for retinoid-relateret embryopati (på op til 30 % af de eksponerede fostre); det er ydermere kendt, at ca. en tredjedel af de gravide patienter, der bliver eksponeret for orale retinoider, vil opleve spontan abort.
English: The PRAC noted that despite the introduction of pregnancy prevention measures, including pregnancy prevention programmes (PPPs), cases of pregnancy during treatment with oral retinoid continue to be reported in the EU.
Danish: PRAC bemærkede, at der på trods af iværksættelse af foranstaltninger til forebyggelse af graviditet, herunder graviditetsforebyggelsesprogrammer, fortsat indberettes tilfælde af graviditet under behandling med orale retinoider i EU.
English: The CHMP clarified that the communication plan should be modified to say ‘healthcare professionals who may be involved in the management of patients treated with retinoids'.
Danish: CHMP præciserede, at ordlyden i kommunikationsplanen bør ændres, så den siger "sundhedspersoner, der kan blive involveret i retinoid-behandling af patienter".
English: The PRAC noted the systemic exposure is negligible following topical application of retinoids and that this does not appear to be affected to a clinically significant degree by the severity or extent of skin disease.
Danish: PRAC bemærkede, at den systemiske eksponering er ubetydelig efter topikal anvendelse af retinoider, og at dette ikke synes at være påvirket i klinisk signifikant grad af hudsygdommens sværhedsgrad eller omfang.
English: The review confirms the already known teratogenic risks associated with the use of oral retinoids in pregnant women.
Danish: Gennemgangen bekræfter de i forvejen kendte teratogene risici ved brug af orale retinoider hos gravide kvinder.
English: Furthermore, the PRAC was requested to review any additional risk minimisation measures to ensure that these are optimal in terms of provision of information and delivery of effective risk management that is subject to appropriate monitoring.
Danish: Desuden blev PRAC anmodet om at gennemgå eventuelle yderligere risikominimerende foranstaltninger for at sikre, at disse er optimale i forhold til tilvejebringelse af oplysninger og en effektiv risikohåndtering, inklusive et hensigtsmæssigt tilsyn hermed.
English: Although the underlying risk of psychiatric disorders within the patient populations can be significant, it is advisable that patients taking oral retinoids are warned about the potential risk of psychiatric reactions and the signs and symptoms to look out for.
Danish: Selvom den underliggende risiko for psykiatriske forstyrrelser i patientpopulationerne kan være betydelig, er det tilrådeligt, at patienter i behandling med retinoider advares om den mulige risiko for psykiatriske reaktioner, og at de gøres opmærksomme på de tegn og symptomer, der er forbundet hermed.
English: • With regards to neuropsychiatric disorders, the PRAC noted the limitations of the available data and considered that a clear causal relationship could not be established with the oral retinoids.
Danish: • I forhold til neuropsykiatriske forstyrrelser bemærkede PRAC begrænsningerne i de tilgængelige data og vurderede, at en klar årsagssammenhæng med de orale retinoider ikke kan fastslås.
English: Therefore, the PRAC agrees that all oral retinoids should contain a warning about the potential risk of neuropsychiatric disorders in line with some key principles.
Danish: PRAC er derfor enig i, at alle orale retinoider bør forsynes med en advarsel om risikoen for neuropsykiatriske forstyrrelser i overensstemmelse med en række vigtige principper.
English: The PRAC has also recommended that educational materials be distributed via electronic channels such as QR codes, and websites to make better use of the existing technology bearing in mind the young patient population using these products.
Danish: PRAC anbefalede også, at uddannelsesmaterialet formidles elektronisk ved hjælp af QR-koder og websites for at bruge den eksisterende teknologi til at nå den unge patientpopulation, der anvender disse lægemidler.
English: Studies that examine the effects of human pregnancy on systemic absorption of topical retinoids are also lacking.
Danish: Der mangler også undersøgelser, der ser nærmere på indvirkningen af graviditet på systemisk absorption af topikale retinoider.
English: • The option of a pictogram/symbol to accompany the box warning wording and to be included in the visual reminder on the outer package to warn patients about the harm to unborn baby and the need for effective contraception when using the medicinal product.
Danish: • mulighed for et piktogram/symbol ved siden af den indrammede advarselstekst og i den visuelle påmindelse på yderemballagen, der advarer patienterne om skader på det ufødte barn og minder dem om behovet for at anvende sikker prævention, når de bruger lægemidlet.
English: The animal reproductive toxicity data for the oral retinoids demonstrate a typical pattern of retinoid embryopathy.
Danish: Data vedrørende reproduktionstoksicitet efter brug af orale retinoider hos dyr viser et typisk retinoid-relateret embryopatisk mønster.
English: The data suggest that the risk of adverse pregnancy outcomes is more strongly associated with the oral retinoids than the topical retinoids.
Danish: Dataene tyder på, at risikoen for negative graviditetsudfald i højere grad er forbundet med orale retinoider end med topikale retinoider.
English: However, taking into account the target patient population, the PRAC recognised the possible underlying risk of psychiatric disorders, and therefore recommended some changes to the product information such as warnings and precautions and so that the current level of available evidence is appropriately reflected.
Danish: Når der tages højde for målpopulationen, anerkendte PRAC imidlertid den mulige underliggende risiko for psykiatriske forstyrrelser og anbefalede derfor en række ændringer i produktinformationen som f.eks. advarsler og forsigtighedsregler, således at den aktuelle evidens afspejles på en hensigtsmæssig måde.