FrancophonIA/ELRC3.0 huggingface dataset:
English: BLISTER FOR STEGLATRO 15 mg
Danish: BLISTER TIL STEGLATRO 15 mg
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 ertugliflozin (see sections 4.2, 4.4, and 4.8).
Danish: Der kan derfor være behov for en lavere dosis insulin eller insulinsekretionsfremkaldende stof for at nedsætte risikoen for hypoglykæmi ved anvendelse i kombination med ertugliflozin (se pkt.
English: How to take Steglatro
Danish: Sådan skal du tage Steglatro
English: Steglatro should not be initiated in patients with an eGFR below 60 ml/min/1.73 m 2 or CrCl below 60 ml/min.
Danish: Behandling med Steglatro må ikke initieres hos patienter med eGFR under 60 ml/min/1,73 m 2 eller
English: CARTON FOR STEGLATRO 15 mg
Danish: KARTON TIL STEGLATRO 15 mg
English: CARTON FOR STEGLATRO 5 mg
Danish: KARTON TIL STEGLATRO 5 mg
English: Steglatro 15 mg tablets ertugliflozin
Danish: Steglatro 15 mg tabletter ertugliflozin
English: Steglatro 5 mg tablets ertugliflozin
Danish: Steglatro 5 mg tabletter ertugliflozin
English: Steglatro 5 mg film-coated tablets Each tablet contains 5 mg ertugliflozin (as ertugliflozin L-pyroglutamic acid).
Danish: Steglatro 5 mg filmovertrukne tabletter Hver tablet indeholder 5 mg ertugliflozin (som ertugliflozin L-pyroglutaminsyre).
English: Each film-coated tablet contains 5 mg ertugliflozin (as ertugliflozin L-pyroglutamic acid).
Danish: Hver filmovertrukken tablet indeholder 5 mg ertugliflozin (som ertugliflozin L-pyroglutaminsyre).
English: Each film-coated tablet contains 15 mg ertugliflozin (as ertugliflozin L-pyroglutamic acid).
Danish: Hver filmovertrukken tablet indeholder 15 mg ertugliflozin (som ertugliflozin L-pyroglutaminsyre).
English: Steglatro 5 mg film-coated tablets Steglatro 15 mg film-coated tablets ertugliflozin
Danish: Steglatro 5 mg filmovertrukne tabletter Steglatro 15 mg filmovertrukne tabletter ertugliflozin
English: Steglatro 15 mg film-coated tablets Each tablet contains 15 mg ertugliflozin (as ertugliflozin L-pyroglutamic acid).
Danish: Steglatro 15 mg filmovertrukne tabletter Hver tablet indeholder 15 mg ertugliflozin (som ertugliflozin L-pyroglutaminsyre).
English: In patients where DKA is suspected or diagnosed, treatment with ertugliflozin should be discontinued immediately.
Danish: Behandlingen med ertugliflozin skal straks seponeres hos patienter med formodet eller diagnosticeret diabetisk ketoacidose.
English: Steglatro 5 mg film-coated tablets Steglatro 15 mg film-coated tablets
Danish: Steglatro 5 mg filmovertrukne tabletter Steglatro 15 mg filmovertrukne tabletter
English: Steglatro 15 mg film-coated tablets ertugliflozin
Danish: Steglatro 15 mg filmovertrukne tabletter ertugliflozin
English: Steglatro 5 mg film-coated tablets
Danish: Steglatro 5 mg filmovertrukne tabletter
English: Steglatro 5 mg film-coated tablets ertugliflozin
Danish: Steglatro 5 mg filmovertrukne tabletter ertugliflozin
English: CrCl is persistently below 45 ml/min due to a reduction of efficacy.
Danish: CrCl under 60 ml/min.
English: • dizziness
Danish: • svedtendens
English: Steglatro 15 mg film-coated tablets
Danish: Steglatro 15 mg filmovertrukne tabletter
English: o Each Steglatro 15 mg film-coated tablet contains 15 mg ertugliflozin (as ertugliflozin L-pyroglutamic acid).
Danish: o Hver Steglatro 15 mg filmovertrukken tablet indeholder 15 mg ertugliflozin (som ertugliflozin L-pyroglutaminsyre).
English: Breast-feeding
Danish: Glimepirid
English: Other transporter-related interactions cannot be excluded.
Danish: Andre transportrelaterede interaktioner kan ikke udelukkes.
English: 95% CI
Danish: 95% KI
English: Your bladder will need some time to adapt.
Danish: Din blære har brug for nogen tid til at tilpasse sig.
English: However, caution should be exercised.
Danish: Der bør dog udvises forsigtighed.
English: Elderly patients (≥ 65 years)
Danish: Ældre (≥65 år)
English: Post-marketing experience
Danish: Post-marketing erfaringer
English: Component of a multipack, not to be sold separately.
Danish: Del af en multipakning, må ikke sælges separat.
English: The tablet may be taken with or without food.
Danish: Tabletterne kan tages med eller uden mad.
English: Week 12 (median)
Danish: Uge 12 (median)
English: Incontinence episodes per week
Danish: Inkontinensepisoder pr uge
English: Differences from placebo1
Danish: Forskel fra placebo1
English: This enables you to wait longer before you go to the toilet and it increases the amount of urine that your bladder can hold.
Danish: Dette gør, at du kan vente længere, før du behøver at gå på toilettet, og det øger den urinmængde, som din blære kan holde på.
English: Finish the course of treatment prescribed by your doctor.
Danish: Gennemfør behandlingsforløbet som din læge har foreskrevet.
English: A risk to the nursing child cannot be excluded.
Danish: En risiko for det ammede barn kan ikke udelukkes.
English: Take Emselex tablets once a day with water, at about the same time each day.
Danish: Tag Emselex-tabletter en gang daglig sammen med vand og på omtrent samme tid hver dag.
English: The steady-state volume of distribution (Vss) is estimated to be 163 litres.
Danish: Steady-state fordelingsvolumen (Vss) er estimeret til 163 l.
English: The tablets should be taken once daily with liquid.
Danish: Tabletterne bør tages en gang daglig sammen med væske.
English: The use of agents such as physostigmine can assist in reversing such symptoms.
Danish: Brug af stoffer som physostigmin kan medvirke til at revertere sådanne symptomer.
English: Multipack comprising 10 packs, each containing 14 tablets.
Danish: Multipakning bestående af 10 pakker, hver indeholdende 14 tabletter.
English: Therefore, it is important to keep taking Emselex correctly, as described above.
Danish: Det er derfor vigtigt at tage Emselex, som beskrevet ovenfor.
English: Because these spontaneously reported events are from the worldwide post-marketing experience, the frequency of events cannot be estimated from the available data.
Danish: Da disse spontant rapporterede tilfælde er baseret på erfaringer fra brug efter markedsføring på verdensplan er det ikke muligt at fastsætte frekvensen ud fra de tilgængelige data.
English: 7 tablets 14 tablets 28 tablets 49 tablets 56 tablets 98 tablets
Danish: 7 tabletter 14 tabletter 28 tabletter 49 tabletter 56 tabletter 98 tabletter
English: Patients experiencing these side effects should not drive or use machines.
Danish: Patienter, der oplever disse bivirkninger, bør ikke føre motorkøretøj eller betjene maskiner.
English: Emselex is for oral use.
Danish: Emselex er til oral anvendelse.
English: Date of latest renewal: 24 September 2009
Danish: Dato for første tilladelse: 22 Oktober 2004 Dato for seneste fornyelse: 24 September 2009
English: There was considerable overlap between the ranges of exposures seen in these two populations (see section 4.2).
Danish: Der var et betydeligt overlap mellem omfanget af eksponering set i de to populationer (se pkt.
English: This is particularly important if you are taking any of the following as your doctor may need to adjust your dose of Emselex and/or the other medicine:
Danish: Dette er specielt vigtigt, hvis du tager et af følgende lægemidler, da din læge muligvis skal justere din Emselexdosis og/eller det andet lægemiddel:
English: When seeking medical advice, make sure that you take this leaflet and your remaining tablets with you to show them to the doctor.
Danish: Når du søger lægehjælp, skal du sikre dig, at du medbringer denne indlægsseddel og pakningen med de resterende tabletter for at vise dem til lægen.
English: • Do not use this medicine after the expiry date which is stated on the carton and blister.
Danish: • Brug ikke lægemidlet efter den udløbsdato, der står på pakningen og blisterkortet.
English: • Do not use if the pack is damaged or shows signs of tampering.
Danish: • Brug ikke lægemidlet, hvis pakningen er beskadiget eller viser tegn på at have været åbnet.
English: Your doctor will tell you how long your treatment with Emselex will last.
Danish: Din læge vil fortælle dig hvor længe behandlingen med Emselex skal vare.
English: However the data available do not indicate that darifenacin changes either midazolam clearance or bioavailability.
Danish: Tilgængelige data tyder dog ikke på, at darifenacin ændrer hverken midazolam clearance eller biotilgængelighed.
English: Other causes of frequent urination (heart failure or renal disease) should be assessed before treatment with Emselex.
Danish: Andre årsager til hyppig vandladning (hjertesvigt eller renal sygdom) bør undersøges før behandling med Emselex.
English: The side effects caused by Emselex are usually mild and temporary.
Danish: Bivirkninger forårsaget af Emselex er normalt milde og forbigående.
English: Emselex is not recommended during pregnancy.
Danish: Emselex anbefales ikke under graviditet.
English: It is not known whether this selectivity for the M3 receptor translates into any clinical advantage when treating symptoms of overactive bladder syndrome.
Danish: Det vides ikke, om denne selektivitet for M3 receptorer, kan overføres til nogen klinisk fordel, når symptomer på overaktiv blæresyndrom behandles.
English: Emselex with food and drink
Danish: Brug af Emselex sammen med mad og drikke
English: If urinary tract infection is present, an appropriate antibacterial therapy should be started.
Danish: Hvis urinvejsinfektion forekommer, skal passende antibakteriel behandling startes.
English: The adverse reactions are ranked under heading of frequency using the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data).
Danish: Frekvensen af bivirkninger er defineret som følgende: Meget almindelig (≥1/10), almindelig (≥1/100 til <1/10), ikke almindelig (≥1/1.000 til <1/100), sjælden (≥1/10.000 til <1/1.000), meget sjælden (<1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Women of child bearing potential should be made aware of the lack of fertility data, and Emselex should only be given after consideration of individual risks and benefits.
Danish: Kvinder i den fødedygtige alder bør informeres om manglen på fertilitetsdata, og Emselex bør kun gives, efter individuelle risici og fordele er vurderet.
English: There are limited amount of data from the use of darifenacin in pregnant women.
Danish: Der er begrænset dokumentation for brugen af darifenacin hos gravide kvinder.
English: Emselex reduces the activity of an overactive bladder.
Danish: Emselex nedsætter aktiviteten af en overaktiv blære.
English: The increase in digoxin exposure could be caused by competition between darifenacin and digoxin for P-glycoprotein.
Danish: Den øgede digoxin eksponering kan skyldes konkurrence mellem darifenacin og digoxin om P-glycoprotein.
English: Toxic megacolon.
Danish: • Toksisk megacolon.
English: Emselex is contraindicated in patients with:
Danish: Emselex er kontraindiceret hos patienter med
English: Emselex is not recommended for use in children below 18 years of age due to a lack of data on safety and efficacy.
Danish: Emselex bør ikke anvendes til børn under 18 år pga. manglende dokumentation for sikkerhed og virkning.
English: You should not drive or use machines if you are affected by these symptoms.
Danish: Du bør ikke køre bil eller betjene maskiner, hvis du oplever disse bivirkninger.
English: Darifenacin was not teratogenic in rats and rabbits at doses up to 50 and 30 mg/kg/day, respectively.
Danish: Darifenacin var ikke teratogent i rotter og kaniner i doser op til henholdsvis 50 og 30 mg/kg/dag.
English: Not known (frequency cannot be estimated from the available data) Depressed mood/mood alterations, hallucination.
Danish: Ikke kendt (kan ikke vurderes ud fra tilgængelige data) Nedtrykthed/humørsvingninger, hallucinationer.
English: Only a small percentage of the excreted dose was unchanged darifenacin (3%).
Danish: Kun en lille procentdel af den udskilte mængde var uomdannet darifenacin (3%).
English: The elimination half-life of darifenacin following chronic dosing is approximately 13-19 hours.
Danish: Eliminations halveringstiden af darifenacin efter kontinuerlig dosering er ca. 13-19 timer.
English: The M3 receptor is the major subtype that controls urinary bladder muscle contraction.
Danish: M3 receptoren er den vigtigste undergruppe der kontrollerer urinblærens muskelkontraktion.
English: Darifenacin is a selective muscarinic M3 receptor antagonist (M3 SRA) in vitro.
Danish: Darifenacin er en selektiv muskarin M3 receptorantagonist (M3 SRA) in vitro.
English: However, the adjustment of Emselex doses is not necessary.
Danish: Justering af Emselexdosis er dog ikke nødvendig.
English: There are no human fertility data for darifenacin.
Danish: Der findes ikke humane fertilitetsdata for darifenacin.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Danish: Inden for hver frekvensgruppe er bivirkningerne præsenteret i faldende rækkefølge af alvorlighed.
English: If you have any of these symptoms whilst taking Emselex, consult your doctor for advice on changing the dose or considering an alternative treatment.
Danish: Hvis du oplever nogen af disse bivirkninger, mens du tager Emselex, skal du kontakte din læge for råd om ændring af doseringen eller overvejelse af alternativ behandling.
English: Some side effects could be serious Serious allergic reactions including swelling, mainly of the face and throat.
Danish: Nogle bivirkninger kan være alvorlige Alvorlige allergiske reaktioner inklusiv hævelse, hovedsageligt i ansigtet og halsen.
English: Following administration of an oral dose of 14C-darifenacin solution to healthy volunteers, approximately 60% of the radioactivity was recovered in the urine and 40% in the faeces.
Danish: Efter oral administration af 14C-darifenacin til frivillige raske forsøgspersoner, blev cirka 60% af radioaktiviteten genfundet i urinen og 40% i fæces.
English: Darifenacin is a lipophilic base and is 98% bound to plasma proteins (primarily to alpha-1-acidglycoprotein).
Danish: Darifenacin er en lipofil base, 98% er bundet til plasmaproteiner (primært alfa-1-syre-glycoprotein).
English: Darifenacin is excreted in the milk of rats.
Danish: Darifenacin udskilles i mælk hos rotter.
English: Therefore, inhibitors of these enzymes may increase darifenacin exposure.
Danish: Hæmmere af disse enzymer kan derfor øge darifenacins eksponering.
English: It is not known whether darifenacin is excreted in human milk.
Danish: Det er ukendt, om darifenacin udskilles i human mælk.
English: N-dealkylation of the pyrrolidine nitrogen.
Danish: N-dealkylering af nitrogen i pyrrolidin.
English: The observed differences from placebo for males in terms of percentage and absolute reductions in incontinence episodes was lower than for females.
Danish: Den observerede forskel fra placebo i form af procentisk og absolut reduktion i inkontinensepisoder var lavere for mænd end for kvinder.
English: Potent P-glycoprotein inhibitors such as ciclosporin and verapamil should also be avoided.
Danish: Potente P-glycoprotein hæmmere som ciclosporin og verapamil bør også undgås.
English: They can be taken with or without food, and must be swallowed whole and not chewed, divided or crushed.
Danish: De kan tages med eller uden mad og skal synkes hele.
English: Do not stop treatment early because you do not see an immediate effect.
Danish: Du må ikke stoppe behandlingen, selvom du ikke mærker nogen umiddelbar virkning.
English: Urinary retention.
Danish: • Urinretention.
English: Pharmacotherapeutic group: Urologicals, drugs for urinary frequency and incontinence; ATC code: G04BD10.
Danish: Farmakoterapeutisk klassifikation: Urologika, lægemidler til urinfrekvens og -inkontinens, ATC-kode: G04BD10.
English: Eating food has no effect on Emselex.
Danish: Indtagelse af mad har ingen indflydelse på virkningen af Emselex.
English: Children and adolescents Emselex is not recommended for use in children and adolescents (<18 years).
Danish: Børn og unge Emselex frarådes til brug hos børn og unge (<18 år) .
English: Anticholinergic effects, in general, are dose-dependent.
Danish: I almindelighed er de antikolinerge bivirkninger dosisafhængige.
English: • Periodic Safety Update Reports
Danish: • Periodiske, opdaterede sikkerhedsindberetninger (PSUR´er)
English: Therapeutic drug monitoring for digoxin should be performed when initiating and ending darifenacin treatment as well as changing the darifenacin dose.
Danish: Monitoring af digoxin bør foretages, når behandling med darifenacin initieres og afsluttes samt ved ændring af darifenacin doseringen.
English: It is used in adults for the treatment of the symptoms of overactive bladder conditions - such as a sudden urge to rush to the toilet, needing to go to the toilet frequently and/or not getting to the toilet in time and wetting yourself (urge incontinence).
Danish: Det anvendes til voksne til behandling af tilstande med symptomer på overaktiv blære - såsom pludselig trang til hurtigt at skulle på toilettet, behov for hyppige toiletbesøg og/eller ikke at nå på toilettet i tide og derfor bliver våd (urgeinkontinens).
English: Enzyme inducers
Danish: Enzym induktorer
English: If you have the impression that the effect of Emselex is too strong or too weak, talk to your doctor or pharmacist.
Danish: Hvis du mener, at virkningerne af Emselex er for kraftige eller for svage, bør du tale med din læge eller apotek herom.
English: Therapeutic and supra-therapeutic doses of darifenacin resulted in no increase in QT/QTc interval prolongation from baseline compared to placebo at maximum darifenacin exposure.
Danish: Terapeutiske og supra-terapeutiske doser af darifenacin resulterede ikke i nogen øget forlængelse af QT/QTc interval fra basisniveau ved maksimal darifenacin eksponering, sammenlignet med placebo.
English: • if you have severe constipation (less than or equal to 2 bowel movements per week).
Danish: • hvis du lider af svær forstoppelse (2 eller færre gange afføring om ugen).
English: The active substance is darifenacin.
Danish: Aktivt stof: darifenacin.
English: However, no studies involving the interaction with antiparkinson agents and tricyclic antidepressants have been performed.
Danish: Der er dog ikke udført interaktionsstudier med anti-parkinson midler og tricykliske antidepressiva.
English: If you have taken more tablets than you have been told to take, or if someone else accidentally takes your tablets, go to your doctor or hospital for advice immediately.
Danish: Hvis du har taget flere tabletter end lægen har foreskrevet, eller hvis en anden ved et uheld indtager dine tabletter, skal du straks henvende dig til din læge eller på skadestuen for at få råd.
English: Cystometric studies performed with darifenacin in patients with involuntary bladder contractions showed increased bladder capacity, increased volume threshold for unstable contractions and diminished frequency of unstable detrusor contractions.
Danish: Cytometriske studier udført med darifenacin hos patienter med ufrivillige blærekontraktioner viste øget blærekapacitet, øget volumentærskel for ustabile kontraktioner og mindsket frekvens af ustabile detrusorkontraktioner.
English: Do not take Emselex:
Danish: Tag ikke Emselex:
English: The dose may be titrated to 15 mg daily to obtain an improved clinical response provided the dose is well tolerated.
Danish: Doseringen kan titreres til 15 mg daglig for at opnå et forbedret klinisk respons, forudsat at dosering er veltolereret.
English: Estimated darifenacin clearance is 40 litres/hour.
Danish: Darifenacinclearence er beregnet til 40 l/time.
English: Overdose with Emselex may lead to severe symptoms requiring emergency treatment in hospital.
Danish: Overdosis af Emselex kan give svære symptomer, der kræver akut behandling på sygehus.
English: • if you have myasthenia gravis (a disease marked by abnormal tiredness and weakness of selected muscles).
Danish: • hvis du har myastenia gravis (en sygdom, som markerer sig ved abnorm træthed og svaghed i bestemte muskler).
English: The tablets are available in blister packs containing 7, 14, 28, 49, 56 or 98 tablets or in multipacks containing 140 (10x14) tablets.
Danish: Tabletterne er tilgængelige i blisterpakninger, som indeholder 7, 14, 28, 49, 56 eller 98 tabletter eller som multipakninger indeholdende 140 (10x14) tabletter.
English: Safety and efficacy have not yet been established in patients with a neurogenic cause for detrusor over activity.
Danish: Sikkerhed og effekt er endnu ikke undersøgt hos patienter med neurologisk betinget overaktiveret detrusor.
English: Therapy should be aimed at reversing the anticholinergic symptoms under careful medical supervision.
Danish: Behandlingen skal rettes mod at modvirke de antikolinerge symptomer under nøje medicinsk overvågning.
English: After 2 weeks of starting therapy, patients should be reassessed for efficacy and safety.
Danish: Patienterne bør revurderes 2 uger efter behandlingsstart med henblik på effekt og sikkerhed.
English: Preclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and carcinogenic potential.
Danish: De prækliniske data viser ingen særlig risiko for mennesker vurderet ud fra konventionelle undersøgelser af sikkerhedsfarmakologi, toksicitet efter gentagne doser, genotoksicitet og karcinogenicitet.
English: Uncontrolled narrow-angle glaucoma.
Danish: • Ukontrolleret snævervinklet glaukom.
English: Due to genetic differences, about 7% of the Caucasians lack the CYP2D6 enzyme and are said to be poor metabolisers.
Danish: Grundet genetiske forskelle, mangler omkring 7% af kaukasiere CYP2D6 enzymet og siges at have beskeden metabolisme.
English: The effect of treatment with 15 mg and 75 mg of darifenacin on QT/QTc interval was evaluated in a study in 179 healthy adults (44% male: 56% females) aged 18 to 65 for 6 days (to steady state).
Danish: Effekten af behandling med 15 mg og 75 mg darifenacin på QT/QTc intervallet blev evalueret i et studie på 6 dage med 179 raske voksne (44% mænd: 56% kvinder) i alderen 18 til 65 år (til steady state).
English: Insomnia, thinking abnormal
Danish: Søvnløshed, unormale tanker
English: Most of the adverse reactions were of mild or moderate intensity and did not result in discontinuation in the majority of the patients.
Danish: De fleste af bivirkningerne var milde til moderate og førte hos hovedparten af patienterne ikke til seponering af behandlingen.
English: Patients with moderate hepatic impairment (Child Pugh B) should only be treated if the benefit outweighs the risk, and the dose should be restricted to 7.5 mg daily (see section 5.2).
Danish: Patienter med moderat leverfunktionsnedsættelse (Child Pugh B) bør kun behandles, hvis fordelene opvejer risiciene, og dosis bør begrænses til 7,5 mg daglig (se pkt.
English: • There are some medicines such as ciclosporin (a medicine used in transplantation to prevent organ rejection or for other conditions, e.g. rheumatoid arthritis or atopic dermatitis), verapamil (a medicine used to lower blood pressure, to correct heart rhythm or to treat angina pectoris), antifungal medicines (e.g. ketoconazole and itraconazole) and some antiviral medicines (e.g. ritonavir) that must not be taken with Emselex.
Danish: • Der er visse typer medicin såsom ciclosporin (medicin, der bruges i forbindelse med transplantation for at forhindre organafstødning eller til andre sygdomme fx reumatoid arthritis eller atopisk dermatitis), verapamil (medicin, der bruges til at sænke blodtrykket, til at korrigere hjerterytmen eller til at behandle angina pectoris), medicin mod svampeinfektioner (f.eks. ketoconazol og itraconazol) og visse antivirale lægemidler (f.eks. ritonavir), som ikke må tages sammen med Emselex.
English: Investigations Uncommon
Danish: Undersøgelser Ikke almindelig