FrancophonIA/ELRC3.0 huggingface dataset:
English: In patients with normal renal function or mild renal impairment (baseline eGFR ≥ 60 mL/min/1.73 m2) this grouping of reactions were reported in 1.3 % and 0.8 % of patients who received dapagliflozin 10 mg and placebo, respectively.
Danish: Hos patienter med normal eller let nedsat nyrefunktion (baseline eGRF ≥ 60 ml/min/1,73m blev denne type bivirkninger set hos 1,3 % og 0,8 % af patienter, der fik dapagliflozin 10 mg hhv.
English: For the add-on to metformin study, HbA1c reductions were sustained through Week 102 (-0.78 % and 0.02 % adjusted mean change from baseline for dapagliflozin 10 mg and placebo, respectively).
Danish: I studiet med tillægsbehandling til metformin var reduktionen i HbA1c vedvarende til og med uge 102 (-0,78 % og 0,02 % justeret gennemsnitlig ændring fra baseline for henholdsvis dapagliflozin 10 mg og placebo).
English: Dapagliflozin as an add-on to metformin alone or metformin plus sitagliptin, sulphonylurea or insulin (with or without additional oral glucose-lowering medicinal products, including metformin) resulted in statistically significant body weight reduction up to 24 weeks (p < 0.0001, Tables 3, 4 and 5).
Danish: Dapagliflozin som tillægsbehandling til metformin alene eller metformin plus sitagliptin, sulfonylurinstof eller insulin (med eller uden yderligere oral glucosesænkende lægemidler, herunder metformin) resulterede i statistisk signifikant reduktion af legemsvægt op til 24 uger (p < 0,0001, tabel 3, 4 og 5).
English: Very common (may affect more than 1 in 10 people)
Danish: Meget almindelig (kan forekomme hos mere end 1 ud af 10 personer)
English: In an add-on to insulin study up to 104 weeks, episodes of major hypoglycaemia were reported in 0.5 % and 1.0 % of subjects in dapagliflozin 10 mg plus insulin at Weeks 24 and 104, respectively, and in 0.5 % of subjects treated with placebo plus insulin groups at Weeks 24 and 104.
Danish: I et studie af tillægsbehandling til insulin op til 104 uger blev der rapporteret om tilfælde af svær hypoglykæmi hos 0,5 % og 1,0 % af de forsøgspersoner, som fik dapagliflozin 10 mg og insulin, i henholdsvis uge 24 og 104, og hos 0,5 % af de forsøgspersoner, som fik placebo og insulin, i uge 24 og 104.
English: Very rare (may affect up to 1 in 10,000 people)
Danish: Meget sjælden (kan forekomme hos op til 1 ud af 10.000 personer)
English: EU/1/13/900/009 Xigduo 5 mg/1000 mg 56 tablets EU/1/13/900/010 Xigduo 5 mg/1000 mg 60 tablets EU/1/13/900/011 Xigduo 5 mg/1000 mg 60 x 1 tablet (unit dose) EU/1/13/900/012 Xigduo 5 mg/1000 mg 196 (2 x 98) tablets (multipack)
Danish: Xigduo 5 mg/1000 mg filmovertrukne tabletter EU/1/13/900/007 Xigduo 5 mg/1000 mg 14 tabletter EU/1/13/900/008 Xigduo 5 mg/1000 mg 28 tabletter EU/1/13/900/009 Xigduo 5 mg/1000 mg 56 tabletter EU/1/13/900/010 Xigduo 5 mg/1000 mg 60 tabletter EU/1/13/900/011 Xigduo 5 mg/1000 mg 60 x 1 tablet (enkeltdosis) EU/1/13/900/012 Xigduo 5 mg/1000 mg 196 (2 x 98) tabletter (multipakning)
English: In subjects ≥ 65 years of age, adverse reactions related to renal impairment or failure were reported in 7.7 % of subjects treated with dapagliflozin and 3.8 % of subjects treated with placebo (see section 4.4).
Danish: Blandt forsøgspersoner ≥ 65 år blev der rapporteret om bivirkninger relateret til nedsat nyrefunktion eller nyresvigt hos 7,7 % af de forsøgspersoner, der fik dapagliflozin, og hos 3,8 % af dem, der fik placebo (se pkt.
English: • redness of the skin (erythema),itching or an itchy rash (hives)
Danish: • rødme af huden (erytem), kløe eller kløende udslæt (nældefeber)
English: At Week 104, adjusted mean change from baseline in HbA1c was -0.32 % for dapagliflozin and -0.14 % for glipizide, respectively.
Danish: I uge 104 var den justerede gennemsnitlige ændring i HbA1c fra baseline henholdsvis -0,32 % for dapagliflozin og -0,14 % for glipizid.
English: • if you have an increase in the amount of red blood cells in your blood, seen in tests.
Danish: • hvis du har fået taget blodprøver, som viste et forhøjet antal røde blodlegemer i dit blod.
English: Dapagliflozin as an add-on with either metformin alone, metformin in combination with sitagliptin, sulphonylurea or insulin (with or without additional oral glucose-lowering medicinal products, including metformin) resulted in statistically significant mean reductions in HbA1c at 24 weeks compared with subjects receiving placebo (p < 0.0001; Tables 3, 4 and 5).
Danish: Dapagliflozin som tillægsbehandling enten med metformin alene, metformin i kombination med sitagliptin, sulfonylurinstof eller insulin (med eller uden yderligere oral glucosesænkende medicin, herunder metformin) resulterede i statistisk signifikant gennemsnitlig reduktion i HbA1c efter 24 uger sammenlignet med forsøgspersoner, der fik placebo (p < 0,0001; Tabel 3, 4 og 5).
English: Therefore a lower dose of insulin or an insulin secretagogue may be required to reduce the risk of hypoglycaemia when used in combination with metformin (see sections 4.2 and 4.8)
Danish: Derfor kan det være nødvendigt at give en lavere dosis af insulin eller et ß-cellestimulerende middel for at nedsætte risikoen for hypoglykæmi, når det anvendes sammen med metformin (se pkt.
English: At Week 208, adjusted mean change from baseline in HbA1c was -0.10 % for dapagliflozin and 0.20 % for glipizide, respectively.
Danish: I uge 208 var den justerede gennemsnitlige ændring i HbA1c i forhold til baseline hhv. -0,10 % for dapagliflozin og 0,20 % for glipizid.
English: In subjects ≥ 65 years of age, adverse reactions of volume depletion, most commonly reported as hypotension, were reported in 1.7 % and 0.8 % of dapagliflozin-treated subjects and placebo-treated subjects, respectively (see section 4.4).
Danish: Hos forsøgspersoner ≥ 65 år blev der rapporteret bivirkninger i form af volumendepletering, der almindeligvis viste sig som hypotension, hos 1,7 % og 0,8 % af de forsøgspersoner, der fik henholdsvis dapagliflozin og placebo (se pkt.
English: Haematocrit increased Creatinine renal clearance decreased Dyslipidaemia
Danish: Forhøjet hæmatokrit Nedsat renal kreatininclearan ce
English: Reactions related to volume depletion (including, reports of dehydration, hypovolaemia or hypotension) were reported in 1.1 % and 0.7 % of subjects who received dapagliflozin 10 mg and placebo, respectively; serious reactions occurred in < 0.2 % of subjects balanced between dapagliflozin 10 mg and placebo (see section 4.4).
Danish: Bivirkninger relateret til volumendepletering (inklusive indberetninger om dehydrering, hypovolæmi eller hypotension) blev rapporteret hos 1,1 % og 0,7 % af forsøgspersoner, som fik behandling med henholdsvis dapagliflozin 10 mg og placebo.
English: • diabetic ketoacidosis, seen rarely (may affect up to 1 in 1,000 people) These are the signs of diabetic ketoacidosis (see also section 2 Warnings and precautions): - increased levels of “ketone bodies” in your urine or blood - rapid weight loss - feeling sick or being sick - stomach pain - excessive thirst - fast and deep breathing - confusion - unusual sleepiness or tiredness - a sweet smell to your breath, a sweet or metallic taste in your mouth or a different odour to your urine or sweat.
Danish: • diabetisk ketoacidose, ses sjældent (kan forekomme hos op til 1 ud af 1.000 personer) Nedenstående symptomer er tegnene på diabetisk ketoacidose (se også punkt 2 Advarsler og forsigtighedsregler): - forhøjet niveau af ”ketonstoffer” i urinen eller blodet - hurtigt vægttab - kvalme eller opkastning
English: Caution should be exercised in patients for whom a dapagliflozin-induced drop in blood pressure could pose a risk, such as patients with known cardiovascular disease, patients on anti-hypertensive therapy with a history of hypotension or elderly patients.
Danish: Dette gælder patienter med kendt hjertekarsygdom, patienter i antihypertensiv behandling med hypotension i anamnesen samt ældre patienter.
English: See section 4.4 Reported in ≥ 2 % of subjects and ≥ 1 % more and at least 3 more subjects treated with dapagliflozin 10 mg compared to placebo.
Danish: *Rapporteret hos ≥ 2 % af forsøgspersonerne og hos ≥ 1 % flere og mindst 3 forsøgspersoner flere behandlet med dapagliflozin 10 mg end med placebo.
English: Results of a 24-week placebo-controlled study of dapagliflozin in add-on combination with metformin and a sulphonylurea
Danish: Resultater fra et 24-ugers placebokontrolleret studie med dapagliflozin som tillægsbehandling til metformin og et sulfonylurinstof Tillægskombination Sulfonylurinstof + metformin
English: • Lactic acidosis, seen very rarely (may affect up to 1 user in 10,000) Xigduo may cause a very rare, but very serious side effect called lactic acidosis (see section “Warnings and precautions”).
Danish: Xigduo kan forårsage en meget sjælden, men meget alvorlig bivirkning, der kaldes laktatacidose (se afsnittet ”Advarsler og forsigtighedsregler”).
English: Manufacturer AstraZeneca GmbH Tinsdaler Weg 183 22880 Wedel Germany
Danish: Fremstiller AstraZeneca GmbH Tinsdaler Weg 183
English: While a causal relationship between dapagliflozin and bladder cancer is unlikely (see sections 4.8 and 5.3), as a precautionary measure, this medicinal product is not recommended for use in patients concomitantly treated with pioglitazone.
Danish: 4.8 og 5.3), bør dette lægemiddel af forsigtighedsmæssige hensyn ikke anvendes til patienter, der er i samtidig behandling med pioglitazon.
English: Patients who may be at higher risk of DKA include patients with a low beta-cell function reserve (e.g. type 2 diabetes patients with low C-peptide or latent autoimmune diabetes in adults (LADA) or patients with a history of pancreatitis), patients with conditions that lead to restricted food intake or severe dehydration, patients for whom insulin doses are reduced and patients with increased insulin requirements due to acute medical illness, surgery or alcohol abuse.
Danish: eller patienter med pankreatitis i anamnesen), patienter med tilstande, der medfører lav fødeindtagelse eller alvorlig dehydrering, patienter, hvis insulindosis er reduceret, samt patienter med øget behov for insulin på grund af akut sygdom, operation eller alkoholmisbrug.
English: As an add-on therapy to metformin in an active-controlled non-inferiority study, dapagliflozin resulted in a statistically significant body weight change compared with glipizide of -4.65 kg at 52 weeks (p < 0.0001, Table 2) that was sustained at 104 and 208 weeks (-5.06 kg and -4.38 kg, respectively).
Danish: I et aktivt kontrolleret non-inferioritetsstudie resulterede dapagliflozin som tillægsbehandling til metformin i en statistisk signifikant vægtændring sammenlignet med glipizid på -4,65 kg efter 52 uger (p < 0,0001, tabel 2).
English: Polyvinyl alcohol (E1203) Macrogol 3350 (E1520(iii))
Danish: Polyvinylalkohol (E1203) Macrogol 3350 (E1520(iii)) Talcum (E553b) Titandioxid (E171) Gul jernoxid (E172) Rød jernoxid (E172)
English: For patients inadequately controlled on metformin monotherapy or metformin in combination with other glucose-lowering medicinal products including insulin The recommended dose is one tablet twice daily.
Danish: Til patienter, der er utilstrækkeligt kontrolleret på monoterapi med metformin eller metformin i kombination med andre glucosesænkende lægemidler, herunder insulin
English: Fungal infection
Danish: Urinvejsinfektio
English: - hypersensitivity to the active substances or to any of the excipients listed in section 6.1; - any type of acute metabolic acidosis (such as lactic acidosis, diabetic ketoacidosis); - diabetic pre-coma; - severe renal failure (GFR < 30 mL/min) (see sections 4.4 and 5.2); - acute conditions with the potential to alter renal function such as: dehydration, severe infection, shock; - acute or chronic disease which may cause tissue hypoxia such as: cardiac or respiratory failure, recent myocardial infarction, shock; - hepatic impairment (see sections 4.2, 4.4 and 5.2); - acute alcohol intoxication, alcoholism (see section 4.5).
Danish: 4.4 og 5.2); - akutte tilstande med potentiale til at ændre nyrefunktionen såsom: dehydrering, svær infektion, shock; akut eller kronisk sygdom som kan forårsage vævshypoksi såsom: hjerte- eller respirationssvigt, nyligt overstået myokardieinfarkt, shock; nedsat leverfunktion (se pkt.
English: This medicinal product is not recommended for use in patients receiving loop diuretics (see section 4.5) or who are volume depleted, e.g. due to acute illness (such as gastrointestinal illness).
Danish: 4.5), eller som er volumendepleterede, f.eks. på grund af akut sygdom (såsom mave-tarmsygdom).
English: In a 52-week, active-controlled non-inferiority study (with 52- and 104-week extension periods), dapagliflozin 10 mg was evaluated as add-on therapy to metformin compared with a sulphonylurea
Danish: Dapagliflozin 10 mg blev evalueret i et 52-ugers aktivt kontrolleret non-inferioritets-studie (med forlængelsesperioder på 52 og 104 uger) som tillægsbehandling til metformin sammenlignet med et sulfonylurinstof (glipizid) som tillægsbehandling til metformin hos forsøgspersoner med utilstrækkelig glykæmisk kontrol (HbA1c > 6,5 % og ≤ 10 %).
English: Change from baseline Difference from placebo d
Danish: Baseline (gennemsnit) Ændring fra baseline Forskel fra placebo d
English: Use in patients at risk for volume depletion, hypotension and/or electrolyte imbalances Due to its mechanism of action, dapagliflozin increases diuresis associated with a modest decrease in blood pressure (see section 5.1), which may be more pronounced in patients with high blood glucose concentrations.
Danish: På grund af dapagliflozins virkningsmekanisme øges diuresen, hvilket er forbundet med et moderat blodtryksfald (se pkt.
English: The efficacy of dapagliflozin, a component of this medicinal product, is dependent on renal function, and efficacy is reduced in patients who have moderate renal impairment and likely absent in patients with severe renal impairment.Therefore, this medicinal product is not recommended for use in patients with moderate to severe renal impairment (patients with GFR < 60 mL/min) (see section 4.2).
Danish: Virkningen af dapagliflozin, en bestanddel af dette lægemiddel, er afhængig af nyrefunktionen, og virkningen reduceres hos patienter, som har moderat nedsat nyrefunktion, og er sandsynligvis ikke til stede hos patienter med svær nedsat nyrefunktion.
English: • discomfort when passing water (urine)
Danish: • ubehag ved vandladning
English: Lactic acidosis Vitamin B
Danish: Vitamin B12mangel h,§
English: If you take more Xigduo than you should
Danish: Hvis du har taget for meget Xigduo
English: Kidney function
Danish: Nykturi Nedsat nyrefunktion
English: Hepatic impairment
Danish: Svampeinfekti on
English: Liver function disorder
Danish: Forstyrrelser i leverfunktionen Hepatitis
English: • dry mouth
Danish: • muskelkramper
English: The Committee retained its other concerns.
Danish: Udvalget fastholdt sine øvrige betænkeligheder.
English: London, 20 November 2008 Doc.
Danish: London, den 20. november 2008 Dok.
English: It is usually fatal in adulthood.
Danish: Sygdommen er sædvanligvis dødelig i voksenalderen.
English: International non-proprietary name (INN): idebenone
Danish: Internationalt fællesnavn (INN): idebenon
English: It was to be available as tablets (150 mg).
Danish: Det skulle have været leveret som tabletter (150 mg).
English: However, during the re-examination of the opinion, the intended use of the medicine was restricted to children only.
Danish: Under revurderingen af udtalelsen var den planlagte anvendelse af lægemidlet dog begrænset til børn.
English: The company that applied for authorisation is Santhera Pharmaceuticals (Deutschland) GmbH.
Danish: Virksomheden, der ansøgte om tilladelse, er Santhera Pharmaceuticals (Deutschland) GmbH.
English: There are no consequences on the use of idebenone in its existing indications, for which the balance of benefits and risks remains unchanged.
Danish: Det får ingen konsekvenser at anvende idebenon til de eksisterende indikationer, for hvilke benefit/risk-forholdet forbliver uændret.
English: What is Sovrima?
Danish: Hvad er Sovrima?
English: Frataxin plays a role in building the energy-producing parts of cells.
Danish: Frataxin spiller en rolle i opbygningen af de energiproducerende dele af cellerne.
English: What is happening with idebenone for cognitive disorders and Alzheimer's disease?
Danish: Hvad sker der med idebenon til kognitive forstyrrelser og Alzheimers sygdom?
English: Questions and answers on recommendation for the refusal of the marketing authorisation for Sovrima
Danish: Spørgsmål og svar vedrørende anbefalingen af afslag på ansøgningen om markedsføringstilladelse for Sovrima
English: The effectiveness of Sovrima was studied in one main study involving 48 patients.
Danish: Virkningen af Sovrima blev undersøgt i en hovedundersøgelse, som omfattede 48 patienter.
English: The effects of Sovrima were first tested in experimental models before being studied in humans.
Danish: Virkningerne af Sovrima blev først testet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
English: Patients with Friedreich's ataxia do not have enough of a protein called frataxin.
Danish: Patienter med Friedreichs ataksi producerer ikke tilstrækkeligt af et protein kaldet frataxin.
English: In the initial application, it was intended for use in children and young adults, as well as in adults whose disease had been diagnosed within the past five years and in adults with cardiomyopathy (harm to the heart muscle).
Danish: I den indledende ansøgning var det beregnet til behandling af børn og unge samt voksne, hvis sygdom var blevet diagnosticeret inden for de seneste fem år, og til voksne med kardiomyopati (skade på hjertemuskulaturen).
English: The study compared the effectiveness of three different doses of Sovrima (5, 15 and 40 mg per kilogram body weight) with that of placebo (a dummy treatment) over six months.
Danish: I undersøgelsen blev virkningen af tre forskellige doser af Sovrima (5, 15 og 40 mg pr. kg legemsvægt) sammenlignet med placebo (en virkningsløs behandling) i seks måneder.
English: The active substance in Sovrima, idebenone, has been available in some countries in Europe since the 1990s for cognitive disorders (problems with thinking, learning and memory) and for Alzheimer's disease.
Danish: Det aktive stof i Sovrima, idebenon, har været på markedet i flere europæiske lande siden 1990'erne til behandling af kognitive forstyrrelser (vanskeligheder med at tænke, lære og huske) samt Alzheimers sygdom.
English: After having considered the grounds for this request, the CHMP re-examined the initial opinion, and confirmed the refusal of the marketing authorisation on 20 November 2008.
Danish: Efter at have drøftet begrundelserne for denne anmodning revurderede CHMP den oprindelige udtalelse og bekræftede anbefalingen af afslag på ansøgningen om markedsføringstilladelse den 20. november 2008.
English: Friedreich's ataxia is an inherited disease.
Danish: Friedreichs ataksi er en arvelig sygdom.
English: This was expected to protect cells from damage and to reduce the symptoms of Friedreich's ataxia.
Danish: Dette forventedes at beskytte cellerne mod skader og mindske symptomerne på Friedreichs ataksi.
English: On 24 July 2008, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Sovrima 150 mg tablets, intended for the treatment of Friedreich's ataxia.
Danish: Den 24. juli 2008 vedtog Udvalget for Humanmedicinske Lægemidler (CHMP) en negativ udtalelse, der anbefalede afslag på ansøgning om markedsføringstilladelse for lægemidlet Sovrima 150 mg tabletter, beregnet til behandling af Friedreichs ataksi.
English: The main measure of effectiveness was the change in the level of a substance in the blood called deoxyguanosine, which is a marker of cell damage caused by highly reactive forms of oxygen.
Danish: Det primære effektmål var ændringen i blodets indhold af et stof, der kaldes deoxyguanosin, som er en markør for celleskade forårsaget af højt reaktive iltformer.
English: Sovrima is a medicine that contains the active substance idebenone.
Danish: Sovrima er et lægemiddel, der indeholder det aktive stof idebenon.
English: It is expected to work by enhancing the production of energy within cells and possibly by neutralising the highly reactive forms of oxygen.
Danish: Det forventes at virke ved at øge produktionen af energi i cellerne og muligvis ved at neutralisere de højt reaktive iltformer.
English: The active substance in Sovrima, idebenone, is an antioxidant agent.
Danish: Det aktive stof i Sovrima, idebenon, er en antioxidant.
English: When frataxin is missing, the production of energy is severely impaired and highly reactive and toxic forms of oxygen are produced.
Danish: Når der mangler frataxin, hæmmes produktionen af energi kraftigt, og der dannes højt reaktive og giftige iltformer.
English: It has a range of symptoms that gradually get worse, including difficulty walking, an inability to co-ordinate movements, muscle weakness, speech problems, damage to the heart muscle, and diabetes.
Danish: En række af sygdommens symptomer, som gradvist forværres, er bl.a. gangbesvær, manglende evne til at koordinere bevægelserne, muskelsvaghed, taleproblemer, skade på hjertemuskulaturen samt sukkersyge.
English: Sovrima did not show a significant improvement compared with placebo, with respect to the main measure of effectiveness, as well as to other evaluated parameters.
Danish: Der blev ikke observeret en væsentlig forbedring ved behandling med Sovrima i forhold til placebo, hvad angik det primære effektmål samt andre evaluerede parametre.
English: The study looked also at the effectiveness of Sovrima in controlling movements, as measured on standard scales for ataxia symptoms, at its impact on daily activities as measured using a questionnaire, and at its effect on heart function.
Danish: I undersøgelsen så man også på Sovrimas virkning med hensyn til styring af bevægelser, målt på en standardskala for symptomer på ataksi, dets indvirkning på de daglige aktiviteter, målt ved hjælp af et spørgeskema, og dets effekt på hjertefunktionen.
English: In November 2008, following the re-examination, the CHMP removed its concern over the intermediate dose of Sovrima.
Danish: I november 2008 fjernede CHMP efter revurderingen sine betænkeligheder med hensyn til den mellemste dosis af Sovrima.
English: What was Sovrima expected to be used for?
Danish: Hvad forventedes Sovrima anvendt til?
English: These highly reactive forms of oxygen damage cells in the brain, the spinal cord and nerves, as well as in the heart and pancreas, causing the symptoms of the disease.
Danish: Disse højt reaktive iltformer skader hjerne-, rygmarvs- og nerveceller samt celler i hjertet og bugspytkirtlen, hvilket forårsager sygdommens symptomer.
English: Therefore, at that point in time, the CHMP was of the opinion that the benefits of Sovrima in the treatment of Friedreich's ataxia did not outweigh its risks.
Danish: Derfor var CHMP på daværende tidspunkt af den opfattelse, at fordelene ved Sovrima til behandling af Friedreichs ataksi ikke opvejede risiciene herved.
English: The CHMP also had concerns that there was no clear explanation for the fact that the intermediate dose of Sovrima seemed to be more effective than the higher dose.
Danish: CHMP havde også betænkelighed ved, at der ikke var nogen klar begrundelse for, at middeldosis af Sovrima tilsyneladende var mere effektiv end den høje dosis.
English: The CHMP noted that it would be useful to have more information on the effects of Sovrima on preventing heart disease getting worse in children.
Danish: CHMP bemærkede, at det ville være nyttigt med flere oplysninger om virkningerne af Sovrima med hensyn til forebyggelse af forværring af hjertesygdom hos børn.
English: In July 2008, the CHMP was concerned that the effectiveness of Sovrima had not been demonstrated in the single study performed.
Danish: I juli 2008 fandt CHMP grund til betænkelighed ved, at effekten af Sovrima ikke var blevet påvist i den ene undersøgelse, der var gennemført.