FrancophonIA/ELRC3.0 huggingface dataset:
English: For patients switching from separate tablets of dapagliflozin and metformin Patients switching from separate tablets of dapagliflozin (10 mg total daily dose) and metformin to Xigduo should receive the same daily dose of dapagliflozin and metformin already being taken or the nearest therapeutically appropriate dose of metformin.
Danish: Patienter, der skifter fra separate dapagliflozintabletter (10 mg total daglig dosis) og metformintabletter til Xigduo bør modtage den samme daglige dosis dapagliflozin og metformin, der tages allerede, eller den nærmeste terapeutisk egnede dosis metformin.
English: Haematocrit values >55% were reported in 1.3% of the subjects treated with dapagliflozin 10 mg versus 0.4% of placebo subjects.
Danish: Hæmatokritværdier > 55 % blev rapporteret hos 1,3 % af forsøgspersonerne behandlet med 10 mg dapagliflozin versus 0,4 % for placebo.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - PART OF MULTIPACK - WITH BLUE BOX
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE ÆSKE - DEL AF MULTIPAKNING - MED BLUE BOX
English: Tell your doctor before you start taking this medicineif you have any of these signs.
Danish: Kontakt lægen, før du tager dette lægemiddel, hvis du får et af disse symptomer.
English: The risk of lactic acidosis must be considered in the event of non-specific signs such as muscle cramps with digestive disorders, abdominal pain and severe asthenia.
Danish: Risikoen for laktatacidose skal overvejes i tilfælde at ikke-specifikke tegn, såsom muskelkramper ved fordøjelsesproblemer, mavesmerter og svær asteni.
English: Polyvinyl alcohol (E1203) Macrogol 3350 (E1520(iii)) Talc (E553b)
Danish: − filmovertræk: polyvinylalkohol (E1203), macrogol 3350 (E1520(iii)), talcum (E553b),
English: The signs include rapid weight loss, feeling sick or being sick, stomach pain, fast and deep breathing, sleepiness, a sweet smell to your breath, a sweet or metallic taste in your mouth or a different odour to your urine or sweat.
Danish: Symptomerne omfatter hurtigt vægttab, kvalme eller opkastning, mavesmerter, hurtig og dyb vejrtrækning, søvnighed, en sød lugt fra din ånde, en sød eller metallisk smag i munden eller en anden lugt fra urin eller sved.
English: Results of (LOCFa) placebo-controlled studies up to 24 weeks of dapagliflozin in add-on combination with metformin or metformin plus sitagliptin
Danish: Resultater af (LOCFa) placebokontrollerede studier op til 24 uger med dapagliflozin som tillægskombination med metformin eller metformin plus sitagliptin
English: INFORMATION IN BRAILLE xigduo 5 mg/1,000 mg
Danish: INFORMATION I BRAILLESKRIFT xigduo 5 mg/1000 mg
English: (95% CI) Abbreviations: QD: once daily; BID: twice daily Metformin ≥ 1500 mg/day;
Danish: Forkortelser: QD: én gang dagligt; BID: to gange dagligt
English: In patients with normal renal function or mild renal impairment (baseline eGFR ≥ 60 mL/min/1.73m2) 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/1,73m2) blev denne type bivirkninger set hos 1,3 % og 0,8 % af patienter, der fik dapagliflozin 10 mg hhv. placebo.
English: Therefore, this medicinal product must not be used in patients with moderate to severe renal impairment (patients with CrCl < 60 ml/min or estimated glomerular filtration rate [eGFR] < 60 ml/min/1.73 m2; see section 4.3).
Danish: Derfor må dette lægemiddel ikke anvendes til patienter med moderat til svær nedsat nyrefunktion (patienter med CrCl < 60 ml/min eller estimeret glomerular filtrationshastighed [eGFR] < 60 ml/min/1,73 m2; se pkt.
English: (95% CI) Subjects (%) achieving: HbA1c < 7% Adjusted for baseline Body weight (kg) Baseline (mean) Change from Baselinec Difference from Placeboc (95% CI)
Danish: (95 % CI) Forsøgspersoner (%), der opnår: HbA1c < 7 % Justeret for baseline Legemsvægt (kg) Baseline (gennemsnit) Ændring fra baselinec Forskel fra placeboc (95 % CI)
English: Analysis of the results for overweight patients treated with metformin after failure of diet alone showed: - a significant reduction of the absolute risk of any diabetes-related complication in the metformin group (29.8 events/1,000 patient-years) versus diet alone (43.3 events/1,000 patient-years), p=0.0023, and versus the combined sulphonylurea and insulin monotherapy groups (40.1 events/1,000 patient-years), p=0.0034; - a significant reduction of the absolute risk of any diabetes-related mortality: metformin 7.5 events/1,000 patient-years, diet alone 12.7 events/1,000 patient-years, p=0.017; - a significant reduction of the absolute risk of overall mortality: metformin 13.5 events/1,000 patient-years versus diet alone 20.6 events/1,000 patient-years, (p=0.011), and versus the combined sulphonylurea and insulin monotherapy groups 18.9 events/1,000 patient-years (p=0.021); - a significant reduction in the absolute risk of myocardial infarction: metformin 11 events/1,000 patient-years, diet alone 18 events/1,000 patient-years, (p=0.01).
Danish: - en signifikant reduktion af den absolutte risiko for samlet mortalitet: metformin 13,5 hændelser/1000 patientår versus diæt alene 20,6 hændelser/1000 patientår, (p=0,011), og versus den kombinerede gruppe af sulfonylurinstoffer og insulin-monoterapigruppen 18,9 hændelser/1000 patientår (p=0,021); - en signifikant reduktion af den absolutte risiko for myokardieinfarkt: metformin 11 hændelser/1000 patientår, diæt alene 18 hændelser/1000 patientår, (p=0,01).
English: At Week 104 for insulin (with or without additional oral glucose-lowering medicinal products, including metformin), the HbA1c reductions were -0.71% and -0.06% adjusted mean change from baseline for dapagliflozin 10 mg and placebo, respectively.
Danish: I uge 104 var reduktionen i HbA1c ved insulin (med eller uden tillæg af oral glucosesænkende medicin, herunder metformin) -0,71 % og -0,06 % justeret gennemsnitlig ændring fra baseline for henholdsvis dapagliflozin 10 mg og placebo.
English: Adverse reactions in dapagliflozin and metformin immediate-release clinical trial and postmarketing dataa
Danish: Bivirkninger for dapagliflozin og metformin IR (immediate release) fra kliniske forsøg samt fra postmarketingdataa
English: *,b,d
Danish: *,f
English: (95% CI) Body weight (kg) Baseline (mean) Change from baselinec Difference from placeboc
Danish: (95 % CI) Legemsvægt (kg) Baseline (gennemsnitlig) Ændring fra baselinec Forskel fra placeboc
English: Your doctor may ask you to stop taking this medicine until you recover in order to prevent dehydration.
Danish: For at forebygge dehydrering vil din læge måske bede dig om at stoppe med dette lægemiddel, indtil du får det bedre.
English: HbA1c analyzed using LRM (Longitudinal repeated measures analysis) Least squares mean adjusted for baseline value p-value < 0.0001 versus placebo + oral glucose-lowering medicinal product(s)
Danish: HbA1c analyseret ved hjælp af LRM (Longitudinal repeated measures analysis) cMiddelværdi fundet ved mindste kvadraters metode justeret for baselineværdi p-værdi < 0,0001 versus placebo + oralt/orale glucosesænkende lægemiddel/lægemidler
English: Other medicines and Xigduo Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.
Danish: Fortæl det altid til lægen, apotekspersonalet eller sundhedspersonalet, hvis du bruger anden medicin eller har gjort det for nylig.
English: In a pre-specified analysis of subjects with baseline HbA1c ≥ 9.0%, treatment with dapagliflozin 10 mg resulted in statistically significant reductions in HbA1c at Week 24 as an add-on to metformin (adjusted mean change from baseline: -1.32% and -0.53% for dapagliflozin and placebo, respectively).
Danish: Patienter med HbA1c ≥ 9 % ved baseline I en planlagt analyse af forsøgspersoner med HbA1c ≥ 9,0 % ved baseline resulterede behandling med dapagliflozin 10 mg i statistisk signifikant reduktion af HbA1c ved uge 24 som tillægsbehandling til metformin (justeret gennemsnitlig ændring fra baseline: -1,32 % og -0,53 % for henholdsvis dapagliflozin og placebo).
English: (95% CI) LOCF: Last observation carried forward bRandomised and treated subjects with baseline and at least 1 post-baseline efficacy measurement Least squares mean adjusted for baseline value dNon-inferior to glipizide + metformin p-value < 0.0001
Danish: aLOCF: Last observation carried forward bRandomiserede og behandlede forsøgspersoner med baselineværdi og mindst 1 effektmåling efter baseline cLeast squares mean justeret for baselineværdi dNon-inferioritet over for glipizid + metformin *p-værdi < 0,0001
English: 2Sitagliptin 100 mg/day aLOCF: Last observation (prior to rescue for rescued subjects) carried forward Placebo-controlled 16-week study cAll randomised subjects who took at least one dose of double-blind study medicinal product during the short-term double-blind period dLeast squares mean adjusted for baseline value p-value < 0.0001 versus placebo + oral glucose-lowering medicinal product **p-value < 0.05 versus placebo + oral glucose-lowering medicinal product ***The percent change in body weight was analysed as a key secondary endpoint (p < 0.0001); absolute body weight change (in kg) was analysed with a nominal p-value (p < 0.0001).
Danish: 1Metformin ≥ 1500 mg/dag; 2Sitagliptin 100 mg/dag aLOCF: Last observation carried forward (før akut behandling af forsøgspersoner) bPlacebokontrolleret 16-ugers studie cAlle randomiserede forsøgspersoner, som tog mindst én dosis dobbeltblind forsøgsmedicin i den dobbeltblinde periode for korttidsstudierne d Least squares mean justeret for baselineværdi * p-værdi < 0,0001 versus placebo + oralt glucosesænkende lægemiddel ** p-værdi < 0,05 versus placebo + oralt glucosesænkende lægemiddel ***Den procentvise ændring i legemsvægt blev analyseret som et sekundært nøgleendepunkt (p < 0,0001); absolut ændring i legemsvægt (i kg) blev analyseret med en nominel p-værdi (p < 0,0001).
English: Signs of ‘lactic acidosis' are: - feeling or being very sick - vomiting, stomach ache - muscular cramps - severe tiredness - difficulty breathing.
Danish: Tegnene på "laktatacidose" er: - voldsom kvalme eller opkastning - opkastning eller mavepine - muskelkramper - udtalt træthed - vejrtrækningsbesvær.
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: HbA1c (%) Baseline (mean) Change from baselinec Difference from placeboc
Danish: HbA1c (%) Baseline (gennemsnitlig) Ændring fra baselinec Forskel fra placeboc
English: Titanium dioxide (E171) Iron oxide yellow (E172)
Danish: titandioxid (E171), jernoxider (E172).
English: LOCF: Last observation (prior to or on the date of the first insulin up-titration, if needed) carried forward All randomised subjects who took at least one dose of double-blind study medicinal product during the short-term double-blind period cLeast squares mean adjusted for baseline value and presence of oral glucose-lowering medicinal product p-value < 0.0001 versus placebo + insulin ± oral glucose-lowering medicinal product **p-value < 0.05 versus placebo + insulin ± oral glucose-lowering medicinal product
Danish: aLOCF: Last observation carried forward (før eller på datoen for den første optitrering af insulin, hvis nødvendigt) bAlle randomiserede forsøgspersoner, som tog mindst én dosis af lægemidlet i den dobbeltblinde periode i korttidsstudierne cLeast squares mean justeret for baselineværdi og tilstedeværelse af oralt glucosesænkende lægemiddel *p-værdi < 0,0001 versus placebo + insulin ± oralt glucosesænkende lægemiddel **p-værdi < 0,05 versus placebo + insulin ± oralt glucosesænkende lægemiddel
English: ≥ 15 mg/kg/day (associated with pup exposures that are ≥ 29 times the human values at the maximum recommended human dose).
Danish: Yderligere udviklingstoksicitet var begrænset til dosisrelaterede reduktioner i ungernes legemsvægt og blev kun observeret ved doser ≥ 15 mg/kg/dag (forbundet med eksponeringer af ungerne, der var ≥ 29 gange de humane værdier ved den maksimale anbefalede humane dosis).
English: Pharmacodynamic interactions
Danish: Dapagliflozin Farmakodynamiske interaktioner
English: NAME OF THE MEDICINAL PRODUCT Xigduo 5 mg/850 mg film-coated tablets
Danish: LÆGEMIDLETS NAVN Xigduo 5 mg/850 mg filmovertrukne tabletter
English: HbA1c (%) Baseline (mean) Change from baselinec Difference from glipizide + metforminc (95% CI)
Danish: Legemsvægt (kg) Baseline (gennemsnitligt) Ændring fra baselinec Forskel fra glipizid + metforminc (95 % CI)
English: Baseline (mean) Change from baselined
Danish: Baseline (gennemsnit) Ændring fra baselined
English: − tablet core: hydroxypropyl cellulose (E463), microcrystalline cellulose (E460(i)), magnesium stearate (E470b), sodium starch glycolate.
Danish: − tabletkerne: hydroxypropylcellulose (E463), mikrokrystallinsk cellulose (E460(i)),
English: Constipation** Dry mouth**
Danish: Forstoppelse** Mundtørhed**
English: HbA1c (%) Baseline (mean) Change from baselined
Danish: HbA1c (%) Baseline (gennemsnit) Ændring fra baselined
English: This medicinal product must not be used in patients with moderate to severe renal impairment (patients with creatinine clearance [CrCl] < 60 ml/min or estimated glomerular filtration rate [eGFR] < 60 ml/min/1.73 m2, see sections 4.3, 4.4, 4.8, 5.1 and 5.2).
Danish: Dette lægemiddel må ikke anvendes til patienter med moderat til svært nedsat nyrefunktion (patienter med kreatininclearance [CrCl] < 60 ml/min eller estimeret glomerulær filtrationshastighed [eGFR] < 60 ml/min/1,73 m2 (se pkt.
English: NAME OF THE MEDICINAL PRODUCT Xigduo 5 mg/1,000 mg film-coated tablets
Danish: LÆGEMIDLETS NAVN Xigduo 5 mg/1000 mg filmovertrukne tabletter
English: Reported in ≥ 2% of subjects and ≥ 1 % more and at least 3 more subjects treated with dapagliflozin 10 mg compared to placebo.
Danish: 4.4 *Rapporteret hos ≥ 2 % af forsøgspersonerne og hos ≥ 1 % flere og mindst 3 forsøgspersoner flere behandlet med dapagliflozin 10 mg end med placebo.
English: Creatinine renal clearance decreasedb Dyslipidaemiaj
Danish: Nedsat renal kreatininclearan ceb
English: - hypersensitivity to the active substances or to any of the excipients listed in section 6.1; - diabetic ketoacidosis, diabetic pre-coma; - moderate and severe renal impairment (creatinine clearance < 60 ml/min; eGFR < 60 ml/min/1.73 m2) (see sections 4.2, 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: 4.2, 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: Diabetic ketoacidosisk Lactic acidosis Vitamin B12 deficiencyh,
Danish: Vitamin B12mangelh,§
English: − film-coating: polyvinyl alcohol (E1203), macrogol 3350 (E1520(iii)), talc (E553b), titanium dioxide (E171), iron oxides (E172).
Danish: Polyvinylalkohol (E1203) Macrogol 3350 (E1520(iii)) Talcum (E553b) Titandioxid (E171) Gul jernoxid (E172) Rød jernoxid (E172)
English: Fungal infection**
Danish: Rygsmerter*
English: Signs include feeling or being very sick, vomiting, stomach ache, muscular cramps, severe tiredness, or difficulty breathing.
Danish: Symptomerne omfatter kvalme eller opkastning, mavesmerter, muskelkramper, udtalt træthed eller vejrtrækningsbesvær.
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 + metformin1
English: Baseline (mean) Change from baselinec Difference from placeboc
Danish: Baseline (gennemsnitlig) Ændring fra baselinec Forskel fra placeboc
English: EU/1/13/900/006 Xigduo 5 mg/850 mg 196 (2 x 98) tablets (multipack)
Danish: EU/1/13/900/006 Xigduo 5 mg/850 mg 196 (2 x 98) tabletter (multipakning)
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains dapagliflozin propanediol monohydrate equivalent to 5 mg dapagliflozin and 850 mg of metformin hydrochloride.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver tablet indeholder dapagliflozinpropandiolmonohydrat svarende til 5 mg dapagliflozin og 850 mg metforminhydrochlorid.
English: EU/1/13/900/012 Xigduo 5 mg/1000 mg 196 (2 x 98) tablets (multipack)
Danish: EU/1/13/900/012 Xigduo 5 mg/1000 mg 196 (2 x 98) tabletter (multipakning)
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains dapagliflozin propanediol monohydrate equivalent to 5 mg dapagliflozin and 1,000 mg of metformin hydrochloride.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver tablet indeholder dapagliflozinpropandiolmonohydrat svarende til 5 mg dapagliflozin og 1000 mg metforminhydrochlorid.
English: Baseline (mean) Change from Baselinec Difference from Placeboc
Danish: Baseline (gennemsnit) Ændring fra baselinec Forskel fra placeboc
English: • Lactic acidosis.
Danish: ”sulfonylurinstof”.
English: • Prior to initiation of treatment and at least yearly thereafter (see sections 4.2, 4.8, 5.1 and 5.2)
Danish: 4.3, 4.4, 4.8, 5.1 og 5.2).
English: NAME OF THE MEDICINAL PRODUCT Xigduo 5 mg/850 mg tablets dapagliflozin/metformin HCl
Danish: LÆGEMIDLETS NAVN Xigduo 5 mg/850 mg tabletter dapagliflozin/metformin HCl
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AstraZeneca AB
Danish: NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN AstraZeneca AB
English: NAME OF THE MEDICINAL PRODUCT Xigduo 5 mg/1,000 mg tablets dapagliflozin/metformin HCl
Danish: LÆGEMIDLETS NAVN Xigduo 5 mg/1000 mg tabletter dapagliflozin/metformin HCl
English: How to store Xigduo
Danish: Brug af anden medicin sammen med Xigduo
English: EU/1/13/900/011 Xigduo 5 mg/1000 mg 60 x 1 tablet (unit dose)
Danish: EU/1/13/900/011 Xigduo 5 mg/1000 mg 60 x 1 tablet (enkeltdosis)
English: Blood urea increased**
Danish: Øget urinstof i blodet** Vægttab**
English: EU/1/13/900/005 Xigduo 5 mg/850 mg 60 x 1 tablet (unit dose)
Danish: EU/1/13/900/005 Xigduo 5 mg/850 mg 60 x 1 tablet (enkeltdosis)
English: EU/1/13/900/010 Xigduo 5 mg/1000 mg 60 tablets
Danish: EU/1/13/900/010 Xigduo 5 mg/1000 mg 60 tabletter
English: Nocturia** Renal impairment**,b
Danish: Urinvejsinfektio n*, b, d
English: NAME OF THE MEDICINAL PRODUCT Xigduo 5 mg/850 mg film-coated tablets dapagliflozin/metformin hydrochloride
Danish: LÆGEMIDLETS NAVN Xigduo 5 mg/850 mg filmovertrukne tabletter dapagliflozin/metforminhydrochlorid
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains dapagliflozin propanediol monohydrate equivalent to 5 mg dapagliflozin and 1,000 mg of metformin hydrochloride.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder dapagliflozinpropandiolmonohydrat svarende til 5 mg dapagliflozin og 1000 mg metforminhydrochlorid.
English: NAME OF THE MEDICINAL PRODUCT Xigduo 5 mg/1,000 mg film-coated tablets dapagliflozin/metformin hydrochloride
Danish: LÆGEMIDLETS NAVN Xigduo 5 mg/1000 mg filmovertrukne tabletter dapagliflozin/metforminhydrochlorid
English: MARKETING AUTHORISATION HOLDER AstraZeneca AB
Danish: INDEHAVER AF MARKEDSFØRINGSTILLADELSEN AstraZeneca AB
English: EU/1/13/900/009 Xigduo 5 mg/1000 mg 56 tablets
Danish: EU/1/13/900/009 Xigduo 5 mg/1000 mg 56 tabletter
English: EU/1/13/900/007 Xigduo 5 mg/1000 mg 14 tablets
Danish: EU/1/13/900/007 Xigduo 5 mg/1000 mg 14 tabletter
English: Package leaflet: Information for the patient Xigduo 5 mg/850 mg film-coated tablets Xigduo 5 mg/1,000 mg film-coated tablets dapagliflozin/metformin hydrochloride
Danish: Xigduo 5 mg/850 mg filmovertrukne tabletter Xigduo 5 mg/1000 mg filmovertrukne tabletter dapagliflozin/metforminhydrochlorid
English: EU/1/13/900/008 Xigduo 5 mg/1000 mg 28 tablets
Danish: EU/1/13/900/008 Xigduo 5 mg/1000 mg 28 tabletter
English: EU/1/13/900/004 Xigduo 5 mg/850 mg 60 tablets
Danish: EU/1/13/900/004 Xigduo 5 mg/850 mg 60 tabletter
English: EU/1/13/900/003 Xigduo 5 mg/850 mg 56 tablets
Danish: EU/1/13/900/003 Xigduo 5 mg/850 mg 56 tabletter
English: EU/1/13/900/002 Xigduo 5 mg/850 mg 28 tablets
Danish: EU/1/13/900/002 Xigduo 5 mg/850 mg 28 tabletter
English: EU/1/13/900/001 Xigduo 5 mg/850 mg 14 tablets
Danish: EU/1/13/900/001 Xigduo 5 mg/850 mg 14 tabletter
English: NAME OF THE MARKETING AUTHORISATION HOLDER AstraZeneca AB
Danish: NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN AstraZeneca AB
English: Add-on combination
Danish: Metformin Absorption
English: LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANT/ MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES
Danish: FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORM(ER), STYRKE(R), INDGIVELSESVEJ(E), ANSØGER(E) / INDEHAVER(E) AF MARKEDSFØRINGSTILLADELSE(R) I MEDLEMSSTATERNE
English: Invented name/ Name
Danish: Særnavn/ Navn
English: Content (concentratio n)
Danish: Indgivelsesvej Indhold (Koncentration)
English: Strength Pharmaceutic al form
Danish: Lægemiddelform
English: The European Commission granted a marketing authorisation valid throughout the European Union for Azilect on 21 February 2005.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Azilect den 21. februar 2005.
English: The studies lasted 26 and 18 weeks, respectively.
Danish: Undersøgelserne varede henholdsvis 26 og 18 uger.
English: Azilect rasagiline
Danish: Azilect rasagilin
English: It is available as tablets (1 mg).
Danish: Det fås som tabletter (1 mg).
English: The full EPAR for Azilect can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Azilect findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for Azilect.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Azilect.
English: Other information about Azilect
Danish: Andre oplysninger om Azilect
English: The standard dose of Azilect is one tablet once a day.
Danish: Den anbefalede dosis Azilect er én tablet én gang dagligt.
English: Azilect was more effective than placebo in all of the studies.
Danish: Azilect var mere effektivt end placebo i alle undersøgelserne.
English: Azilect is a medicine that contains the active substance rasagiline.
Danish: Azilect er et lægemiddel, der indeholder det aktive stof rasagilin.
English: Azilect is used to treat Parkinson's disease.
Danish: Azilect anvendes til behandling af Parkinsons sygdom.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Azilect.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om, hvordan Azilect skal anvendes.
English: Azilect can only be obtained with a prescription.
Danish: Azilect udleveres kun efter recept.
English: Azilect has been studied in three main studies involving a total of 1,563 patients with Parkinson's disease.
Danish: Azilect blev undersøgt i tre hovedundersøgelser, som omfattede i alt 1 563 patienter med Parkinsons sygdom.