FrancophonIA/ELRC3.0 huggingface dataset:
English: ** p-value <0.005
Danish: ** p-værdi < 0,005.
English: Completers using last observation carried forward (LOCF) prior to glycaemic rescue therapy 1 mean adjusted for baseline value
Danish: ved brug af sidste observation føres videre (LOCF) før blodsukkerregulerende behovsbehandling.
English: ** p-value <0.001
Danish: ** p-værdi < 0,001.
English: genital tract infections and increased urination (see description of selected side effects).
Danish: Hypoglykæmi ved en kombination med insulin og/eller sulfonylurinstof, urinvejsinfektioner, genitale infektioner og øget vandladning (se beskrivelse af udvalgte bivirkninger) var de hyppigst rapporterede bivirkninger.
English: In addition, Synjardy can be used as an alternative to taking both empagliflozin and metformin as single tablets.
Danish: Synjardy kan endvidere bruges i stedet for at tage både empagliflozin og metformin som særskilte tabletter Hvis du bruger Synjardy, skal du stoppe med at tage de særskilte tabletter, med empagliflozin og metformin, for at undgå en overdosis.
English: Patients with baseline HbA1c ≥9% In a pre-specified analysis of subjects with baseline HbA1c ≥9.0%, treatment with empagliflozin
Danish: Patienter med baseline-HbA1c ≥ 9 %
English: Hepatic injury
Danish: Hepatitis3
English: HbA1c of <7% compared to linagliptin 5 mg. Clinically meaningful reductions in HbA1c were maintained for 52 weeks.
Danish: En højere andel af patienter behandlet med empagliflozin plus linagliptin og med baseline-HbA1c ≥ 7,0 % opnåede en HbA1c-målværdi på < 7 % sammenlignet med linagliptin 5 mg. Klinisk betydende fald i HbA1c varede ved i 52 uger.
English: Uncommon • straining or pain when emptying the bladder
Danish: Ikke almindelige: • Det er svært at lade vandet, eller det gør ondt
English: A total of 4704 patients with type 2 diabetes were treated in 7 double-blind, placebo or active-controlled clinical studies of at least 24 weeks duration, of which 1109 patients received empagliflozin 10 mg and 1863 received empagliflozin 25 mg as add-on to metformin therapy.
Danish: I alt 4.704 patienter med type 2-diabetes blev behandlet i 7 dobbeltblindede, placebokontrollerede eller aktivt kontrollerede kliniske studier af mindst 24 ugers varighed.
English: 2 Mean adjusted for baseline HbA1c, baseline eGFR, geographical region and number of antihypertensive medicinal products 3 LOCF, values after taking antidiabetic rescue therapy or changing antihypertensive rescue therapy censored
Danish: 2Middelværdi korrigeret for baseline-HbA1c, baseline-eGFR, geografisk område og antal antihypertensiva.
English: Major hypoglycaemia (hypoglycaemia requiring assistance) The frequency of patients with major hypoglycaemic events was low (<1%) and similar for empagliflozin and placebo as add-on to metformin.
Danish: Hyppigheden var lav (< 1 %) og den samme for empagliflozin plus metformin som for placebo plus metformin.
English: * p-value <0.0001 ** p-value <0.01
Danish: ** p-værdi < 0,0001.
English: If you get any side effects, talk to your doctor, pharmacist or nurse.
Danish: Hvis du oplever bivirkninger, bør du tale med din læge, sygeplejerske eller apoteket.Dette gælder også mulige bivirkninger, som ikke er medtaget i denne indlægsseddel.
English: Therefore, avoid consumption of alcohol and medicines containing alcohol when taking Synjardy (see section 4, ‘Possible side effects').
Danish: Du skal undgå alkohol, herunder lægemidler der indeholder alkohol, mens du tager Synjardy.
English: • feeling or being very sick
Danish: • Kvalme eller kraftig utilpashed
English: No patient had a major hypoglycaemic event in the combination with metformin and a sulphonylurea.
Danish: I kombination med metformin og et sulfonylurinstof sås ingen tilfælde af behandlingskrævende hypoglykæmi.
English: (95% CI) a Full analysis set (FAS) using last observation carried forward (LOCF) prior to glycaemic rescue therapy bSubgroup analysis for patients on additional background of metformin (FAS, LOCF) 1 Mean adjusted for baseline value
Danish: CI) a Fuldstændigt analysedatasæt (FAS) ved brug af sidste observation føres videre (LOCF) før blodsukkerregulerende behovsbehandling.
English: Race
Danish: • Kløe
English: This helps to lower blood sugar levels, which are too high in patients with type 2 diabetes.
Danish: Herved sænkes blodsukkeret som er for højt, når man har
English: For patients inadequately controlled on metformin monotherapy or metformin in combination with other glucose-lowering medicinal products including insulin In patients not adequately controlled on metformin alone or in combination with other glucose-lowering medicinal products, including insulin, the recommended starting dose of Synjardy should provide empagliflozin 5 mg twice daily (10 mg daily dose) and the dose of metformin similar to the dose already being taken.
Danish: Til patienter med utilstrækkelig glykæmisk kontrol på metformin alene eller på metformin i kombination med andre glukosesænkende lægemidler, herunder insulin.
English: No data in humans are available on excretion of empagliflozin into milk.
Danish: Det er ukendt om empagliflozin udskilles i modermælken hos mennesker.
English: 1 Bottle
Danish: 1 flaske
English: 200 mg (1 mg/ml) after reconstitution
Danish: 200 mg (1 mg/ml) efter rekonstituering
English: 200 mg Powder for oral solution Oral use
Danish: 200 mg Pulver til oral opløsning Oral anvendelse
English: Invented name Strength Pharmaceutical form Route of administration Packaging
Danish: Særnavn Styrke Lægemiddelform Indgivelsevej
English: Bottle (HDPE) 14 capsules
Danish: 14 tabletter 14 kapsler
English: 20 mg Gastro-resistant capsule, hard
Danish: 20 mg Enterotabletter
English: Pack size
Danish: 7 tabletter
English: 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea.europa.eu http://www.emea.europa.eu catechol-O-methyl transferase (COMT).
Danish: 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea.europa.eu http://www.emea.europa.eu© European Medicines Agency, 2008.
English: The marketing authorisation was renewed on 16 September 2003 and on 16 September 2008.
Danish: Denne tilladelse blev fornyet den 16. september 2003 og den 16. september 2008.
English: Other information about Comtess:
Danish: Andre oplysninger om Comtess:
English: Comtess was more effective than placebo in both studies.
Danish: Comtess var mere effektivt end placebo i begge undersøgelser.
English: Comtess should not be used in patients with:
Danish: Comtess må ikke anvendes hos patienter med:
English: The patients then lose their ability to control their movements reliably.
Danish: Patienterne mister derved evnen til styre sine bevægelser.
English: It is available as brown-orange tablets (200 mg).
Danish: Det leveres som orangebrune tabletter (200 mg).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Comtess on 16 September 1998.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse for Comtess med gyldighed i hele Den Europæiske Union den 16. september 1998.
English: The full EPAR for Comtess is available here.
Danish: Den fuldstændige EPAR for Comtess findes her.
English: It should not be used with combinations that are ‘modified release' (when the levodopa is released slowly over a few hours).
Danish: Det må ikke anvendes sammen med kombinationer med "modificeret frigivelse" (hvor levodopa frigives langsomt i løbet af nogle få timer).
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) COMTESS EPAR summary for the public
Danish: EUROPÆISK OFFENTLIG VURDERINGSRAPPORT (EPAR) COMTESS EPAR - sammendrag for offentligheden
English: The Committee recommended that Comtess be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Comtess.
English: Comtess is a medicine that contains the active substance entacapone.
Danish: Comtess er et lægemiddel, der indeholder det aktive stof entakapon.
English: Fluctuations happen when the effects of the medication wear off and symptoms re-emerge.
Danish: Fluktuationer forekommer, når behandlingens virkning aftager og symptomerne vender tilbage.
English: In the second study, the ‘on' time was increased by 35 minutes compared with placebo.
Danish: I den anden undersøgelsen var "on"-perioden 35 minutter længere end med placebo.
English: What is Comtess?
Danish: Hvad er Comtess?
English: When patients first add Comtess to their existing medication, they may need to take a lower daily dose of levodopa, either by changing how often they take it, or by reducing the amount of levodopa taken in each dose.
Danish: Når patienterne første gang bruger Comtess som tillægsbehandling til den medicin, de får i forvejen, kan det være nødvendigt at mindske den daglige dosis af levodopa, enten ved at ændre på, hvor ofte dosen tages eller ved at mindske mængden af levodopa for hver dosis.
English: It is taken as one tablet with each dose of the other medicine, up to a maximum of 10 tablets a day.
Danish: Der tages én tablet af Comtess sammen med hver dosis af den anden medicin, dog højst 10 tabletter dagligt.
English: It can be taken with or without food.
Danish: Det kan tages sammen med et måltid eller mellem måltiderne.
English: What is the risk associated with Comtess?
Danish: Hvilken risiko er der forbundet med Comtess?
English: The most common side effects with Comtess (seen in between 1 and 10 patients in 100) are dyskinesia (uncontrollable movements), nausea (feeling sick) and harmless urine discoloration.
Danish: De almindeligste bivirkninger ved Comtess (der ses hos mellem 1 og 10 patienter af hver 100) er ufrivillige bevægelser (dyskinesi), kvalme og harmløs farvning af urinen.
English: The active substance in Comtess, entacapone, works to restore the levels of dopamine in the parts of the brain that control movement and co-ordination.
Danish: Det aktive stof i Comtess, entakapon, genopretter indholdet af dopamin i de dele af hjernen, der styrer bevægelser og koordination.
English: The main measure of effectiveness was the time spent in the ‘on' state (the time when levodopa is controlling the symptoms of Parkinson's disease) after the first levodopa dose of the morning in the first study, and over one day in the second study.
Danish: Behandlingens virkning blev hovedsagelig bedømt på, hvor længe patienterne blev i "on"-tilstand (dvs. den periode, hvor levodopa kontrollerer symptomerne på Parkinsons sygdom) efter den første dosis levodopa om morgenen i den første undersøgelse, og i løbet af dagen i den anden undersøgelse.
English: Comtess is used to treat patients with Parkinson's disease.
Danish: Comtess anvendes til behandling af Parkinsons sygdom.
English: Comtess should not be used in people who may be hypersensitive (allergic) to entacapone or any of the other ingredients.
Danish: Comtess må ikke anvendes hos patienter, der kan være overfølsomme (allergiske) over for entakapon eller andre af indholdsstofferne.
English: Why has Comtess been approved?
Danish: Hvorfor blev Comtess godkendt?
English: Comtess can only be used with conventional combinations of levodopa.
Danish: Comtess kan kun anvendes sammen med sædvanlige kombinationer af levodopa.
English: In the first study, adding Comtess increased the ‘on' time by 1 hour and 18 minutes more than adding placebo.
Danish: I den første undersøgelse gav tillægsbehandling med Comtess en "on"-periode, der var 1 time og 18 minutter længere end ved tillægsbehandling med placebo.
English: For the full list of all side effects reported with Comtess, see the Package Leaflet.
Danish: Den fuldstændige liste over de indberettede bivirkninger for Comtess fremgår af indlægssedlen.
English: Comtess is only used in combination either with levodopa and benserazide or with levodopa and carbidopa.
Danish: Comtess anvendes kun i kombination med enten levodopa og benserazid eller levodopa og carbidopa.
English: They are linked with a reduction in the effects of levodopa, when the patient experiences sudden switches between being ‘on' and able to move, and being ‘off' and having difficulties moving about.
Danish: De er forbundet med den aftagende virkning af levodopa, der for patienten medfører pludselige skift mellem "on-perioder" hvor patienten er i stand til at bevæge sig, og "off-perioder", hvor patienten har vanskeligt ved at bevæge sig.
English: The Committee for Medicinal Products for Human Use (CHMP) decided that Comtess's benefits are greater than its risks as an adjunct to standard preparations of levodopa/benserazide or levodopa/carbidopa for use in patients with Parkinson's disease and end-of-dose motor fluctuations, who cannot be stabilised on those combinations.
Danish: Udvalget for Humanmedicinske Lægemidler (CHMP) besluttede, at fordelene ved Comtess opvejer risiciene som tillægsbehandling til sædvanlige præparater med levodopa/benserazid eller levodopa/carbidopa til patienter med Parkinsons sygdom og motoriske end-of-dose fluktuationer, når sygdommen ikke kan stabiliseres med sådanne kombinationsbehandlinger.
English: Comtess is used together with levodopa (either a combination of levodopa and benserazide or a combination of levodopa and carbidopa) when the patient is having ‘fluctuations' towards the end of the period between two doses of their medication.
Danish: Comtess anvendes sammen med levodopa (en kombination enten af levodopa og benserazid eller af levodopa og carbidopa), når patienterne får fluktuationer hen mod slutningen af perioden mellem to doser af medicinen.
English: What benefit has Comtess shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, der er ved Comtess?
English: Comtess is used when these fluctuations cannot be treated with the standard levodopacontaining combination alone.
Danish: Comtess anvendes, når disse fluktuationer ikke kan behandles alene med levodopa-standardkombinationen Lægemidlet udleveres kun efter recept.
English: • a history of neuroleptic malignant syndrome (a dangerous nervous system disorder usually caused by antipsychotic medicines) or rhabdomyolysis (breakdown of muscle fibres).
Danish: • tidligere påvist malignt neuroleptikasyndrom (en farlig nervesygdom, sædvanligvis forårsaget af antipsykotiske lægemidler) eller rhabdomyolyse (nedbrydning af muskelfibrene) Comtess må ikke anvendes sammen med anden medicin, der tilhører gruppen af monoaminoxidasehæmmere (et antidepressionsmiddel).
English: Entacapone blocks an enzyme that is involved in the breakdown of levodopa in the body called
Danish: Entakapon blokerer et enzym kaldet catechol-O-methyltransferase (COMT), som er med til at nedbryde levodopa i kroppen.
English: How has Comtess been studied?
Danish: Hvordan blev Comtess undersøgt?
English: It only works when it is taken with levodopa, a copy of the neurotransmitter dopamine that can be taken by mouth.
Danish: Levodopa svarer til neurotransmitteren dopamin, som kan indtages gennem munden.
English: What is Comtess used for?
Danish: Hvad anvendes Comtess til?
English: How does Comtess work?
Danish: Hvordan virker Comtess?
English: How is Comtess used?
Danish: Hvordan anvendes Comtess?
English: See the Summary of Product Characteristics (also part of the EPAR) for full details.
Danish: De nærmere oplysninger fremgår af produktresuméet, der ligeledes er en del af denne EPAR.
English: Comtess has been studied in a total of 376 patients with Parkinson's disease, in two six-month studies that measured the effects of adding Comtess or placebo (a dummy medicine) to the patient's combination of levodopa and carbidopa or levodopa and benserazide.
Danish: I disse undersøgelser registreredes virkningen af at bruge enten Comtess eller placebo (virkningsløs medicin) som tillægsbehandling til patientens kombinationsbehandling med levodopa og carbidopa eller levodopa og benserazid.
English: Patients under 18 years of age.
Danish: Patienter under 18 år.
English: These beneficial effects were maintained for up to 52 weeks.
Danish: Disse gavnlige virkninger blev opretholdt i op til 52 uger.
English: The volume of distribution (Vss) is 9 L.
Danish: Fordelingsvolumen (Vss) er 9 l.
English: The absolute risk increase for such events is unlikely to exceed 1% per year based on existing data (uncommon).
Danish: Den absolutte risikoøgning for sådanne hændelser overstiger sandsynligvis ikke 1% pr. år baseret på eksisterende data (Ikke almindelig).
English: Further to the assessment of:
Danish: efter vurdering af:
English: There is no clinical experience of overdose.
Danish: Der er ingen klinisk erfaring med overdosering.
English: [Common (>1/100, <1/10) Uncommon (>1/1000, <1/100) Rare (>1/10,000, <1/1,000) Very rare
Danish: [Almindelig (>1/100, <1/10) Usædvanlig (>1/1.000, <1/100) Sjælden (>1/10.000, <1/1.000) Meget sjælden (<1/10.000)]
English: Dosage adjustment in the elderly is not necessary.
Danish: Dosisjustering til ældre er ikke nødvendig.
English: However, exposure is limited to clinical trials.
Danish: Eksponeringen er dog begrænset til kliniske undersøgelser.
English: Plasma clearance is 7.7 L/h.
Danish: Plasma-clearance er 7,7 l/t.
English: Patients should not exceed this dose.
Danish: Patienter må ikke overskride denne dosis.
English: Elderly: As with other drugs used in the elderly, it is prudent to initiate treatment with the lower recommended dose.
Danish: Ældre: Som med andre lægemidler anvendt hos ældre, er det tilrådeligt at initiere behandling med den lavest anbefalede dosis.
English: MI events in TARGET (12-month study)
Danish: MI-hændelser i TARGET (12 måneders studie)
English: Patients should not exceed this dose and the treatment duration should not exceed 5 days.
Danish: Patienter må ikke overskride denne dosis og behandlingsvarigheden må ikke overskride 5 dage.
English: Median tmax is about 2 hours post dose.
Danish: Median tmax er ca. 2 timer efter dosering.
English: In addition various conjugates (glucuronides and sulfates) of these metabolites are formed.
Danish: Derudover dannes forskellige konjugater (glucuronider og sulfater) af disse metabolitter.
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES AND NORWAY AND ICELAND
Danish: BILAG I LISTE OVER NAVNENE, LÆGEMIDDELFORMERNE, STYRKERNE PÅ LÆGEMIDLERNE, INGIVELSESVEJE OG INDEHAVERE AF MARKEDSFØRINGSTILLADELSE I MEDLEMSLANDENDE OG NORGE OG ISLAND
English: The CHMP confirmed changes to the Product Information already introduced through a type II variation adopted in May 2005 and requested further changes.
Danish: CHMP bekræftede ændringen af produktinformationen i henhold til den allerede indsendte ansøgning om en type-II-ændring, som blev godkendt i maj 2005, og anmodede om yderligere ændringer.
English: Hypertensive Patients:
Danish: Hypertensive patienter:
English: CYP2C9 polymorphism:
Danish: CYP2C9-polymorfisme:
English: Clear PVC/aluminium blisters in packs containing 2, 4, 5, 6, 10, 20, 30, 50, 100, or 600 film-coated tablets.
Danish: Klare PVC/aluminiumblistere i pakninger indeholdende 2, 4, 5, 10, 20, 30, 50, 100 eller 600 filmovertrukne tabletter.
English: Paediatric use: {Invented Name} has not been studied in children and thus is contraindicated in children under 18 years of age.
Danish: Pædiatrisk brug: {SÆRNAVN} er ikke undersøgt hos børn og er derfor kontraindikeret til børn under 18 år.
English: In elderly subjects (over 65 years old), a 15% increase in AUC was observed as compared to younger subjects.
Danish: Der er hos ældre patienter (over 65 år) set 15% stigning i AUC sammenlignet med hos yngre patienter.
English: Lumiracoxib is rapidly absorbed following oral administration.
Danish: Lumiracoxib absorberes hurtigt efter oral administration.
English: The maximum treatment duration in clinical studies was 12 months.
Danish: Den maksimale behandlingsvarighed i kliniske studier var 12 måneder.
English: Camberley Surrey GU16 7SR United Kingdom
Danish: Camberley Surrey GU16 7SR Storbritannien
English: Symptomatic relief in the treatment of osteoarthritis.
Danish: Symptomatisk lindring i behandlingen af osteoarthrose.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 12th September 2003
Danish: DATO FOR FØRSTE TILLADELSE/FORNYELSE AF TILLADELSEN
English: However, the APTC event rate was numerically higher for lumiracoxib than for naproxen but lower than for ibuprofen.
Danish: APTC-hændelsesraten var dog numerisk højere for lumiracoxib end for naproxen, men lavere end for ibuprofen.
English: The cardiovascular safety of lumiracoxib beyond 1 year of use has not been established.
Danish: Den kardiovaskulære sikkerhed af lumiracoxib ud over 1 års brug er ikke klarlagt.
English: Between November 2004 and June 2005, the MAH made an oral explanation to the CHMP on cardiovascular and skin safety aspects for lumiracoxib on 18 January 2005.
Danish: Mellem november 2004 og juni 2005 afgav indehaveren af markedsføringstilladelsen en mundtlig redegørelse til CHMP vedrørende de kardiovaskulære og hudrelaterede sikkerhedsaspekter for lumiracoxib den 18. januar 2005.
English: Two isoforms, COX-1 and COX-2 have been identified.
Danish: Der er identificeret to isoformer, COX-1 og COX-2.
English: Women who use lumiracoxib should not breastfeed.
Danish: Kvinder som anvender lumiracoxib bør ikke amme.
English: Patients with active peptic ulceration or gastrointestinal bleeding.
Danish: Patienter med aktivt peptisk ulcus eller gastrointestinal blødning.
English: No difference was observed in the plasma protein binding between the two groups.
Danish: Der sås ingen forskel i plasma-proteinbindingen mellem de 2 grupper.
English: Patients with severe hepatic disease (Child-Pugh >9).
Danish: Patienter med svær leversygdom (Child-Pugh >9).
English: Lumiracoxib crosses the placenta in rats and rabbits.
Danish: Lumiracoxib passerer placenta hos rotter og kaniner.
English: {Invented Name} film-coated tablets are administered orally and may be taken with or without food.
Danish: {Særnavn} filmovertrukne tabletter administreres oralt og kan tages med eller uden mad.
English: Patients should be adequately hydrated and consideration should be given to monitoring of renal function after initiation of concomitant therapy, and periodically thereafter.
Danish: Patienter bør hydreres tilfredsstillende og det bør overvejes at monitorere nyrefunktionen efter initiering af kombinationsbehandling samt regelmæssigt herefter.
English: Therefore anticoagulant activity should be monitored in patients taking warfarin or similar agents, particularly in the first few days after initiating or changing the dose of lumiracoxib.
Danish: Antikoagulant aktivitet bør derfor monitoreres hos patienter i behandling med warfarin eller tilsvarende midler, særligt i de første dage efter påbegyndelse af eller ændring i dosis af lumiracoxib.
English: No special precautions for storage.
Danish: Ingen særlige forholdsregler.
English: There is no additional benefit by increasing the dose to 400 mg daily.
Danish: Der er ingen yderligere fordele ved at øge dosis til 400 mg daglig.
English: The concentration of 4'-hydroxy metabolite in plasma and synovial fluid is low, thus it is unlikely to contribute to efficacy.
Danish: Koncentrationen af 4'-hydroxymetabolitten i plasma og synovialvæsken er lav, og bidrager dermed med al sandsynlighed ikke til effekten.
English: Gender: There is no difference in exposure of lumiracoxib in men and women.
Danish: Køn: Der er ingen forskel i optagelse af lumiracoxib hos mænd og kvinder.
English: {Invented Name} 100 mg and 200 mg film-coated tablets contain lactose (23.3 mg and 46.6 mg, respectively).
Danish: {Særnavn} 100 mg og 200 mg filmovertrukne tabletter indeholder lactose (23,3 mg og 46,6 mg respektivt).
English: Randomization was stratified by low-dose ASA use (24% of patients in the overall study population) and age.
Danish: Randomiseringen var stratificeret i forhold til brugen af lavdosis acetylsalicylsyre (24% af patienterne i hele studiepopulationen) og alder.
English: Pharmacotherapeutic group: Anti-inflammatory and antirheumatic products, non-steroids, coxibs, ATC code: M01 AH 06
Danish: Farmakoterapeutisk klassifikation: Antiinflammatoriske og antirheumatiske lægemidler, non-steroid, coxiber, ATC-kode: M01 AH 06