FrancophonIA/ELRC3.0 huggingface dataset:
English: Treatment with 50 mg a day of Betmiga was shown to be effective in reducing the number of urination and incontinence episodes.
Danish: Behandling med Betmiga 50 mg dagligt viste sig at være effektiv til at mindske antallet af vandladninger og episoder med ufrivillig vandladning.
English: Betmiga is used in adults with overactive bladder syndrome.
Danish: Betmiga anvendes til behandling af voksne med overaktiv blære.
English: Betmiga 50 mg resulted in a reduction of 1.5 incontinence episodes per day compared with a reduction of 1.1 incontinence episodes per day for placebo.
Danish: Betmiga 50 mg medførte en reduktion på 1,5 episoder med ufrivillig vandladning pr. dag, sammenholdt med en reduktion på 1,1 episode pr. dag for placebo.
English: What is Betmiga?
Danish: Hvad er Betmiga?
English: For the full list of all side effects reported with Betmiga, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Betmiga fremgår af indlægssedlen.
English: What is Betmiga used for?
Danish: Hvad anvendes Betmiga til?
English: How has Betmiga been studied?
Danish: Hvordan blev Betmiga undersøgt?
English: What benefit has Betmiga shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Betmiga?
English: How is Betmiga used?
Danish: Hvordan anvendes Betmiga?
English: How does Betmiga work?
Danish: Hvordan virker Betmiga?
English: The use of more than one of these products concomitantly should be avoided.
Danish: Brug af flere end et af disse lægemidler samtidig bør undgås.
English: 8 Falls were more common in the elderly (≥65 years old).
Danish: 8Fald var hyppigst hos ældre (≥65 år)
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/ risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Danish: • når risikostyringssystemet ændres, særlig som følge af, at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i benefit/risk-forholdet, eller som følge af, at en vigtig milepæl (lægemiddelovervågning eller risikominimering) er nået.
English: Do not drive or use any tools or machines until you know how Cymbalta affects you.
Danish: Du må ikke køre bil eller arbejde med værktøj eller maskiner, før du ved, hvordan Cymbalta påvirker dig.
English: Some patients who stop taking Cymbalta suddenly have had symptoms such as:
Danish: Nogle patienter, som pludselig holdt op med at tage Cymbalta, oplevede symptomer som:
English: To help you remember to take Cymbalta, you may find it easier to take it at the same times every day.
Danish: Det kan være lettere at huske at tage Cymbalta, hvis du tager det på samme tidspunkt hver dag.
English: Other psychiatric conditions for which Cymbalta is prescribed can also be associated with an increased risk of suicide-related events.
Danish: Andre psykiske tilstande, som Cymbalta anvendes til, kan ligeledes være forbundet med en øget risiko for selvmordsrelaterede handlinger.
English: • Tell your doctor if you become pregnant, or you are trying to become pregnant, while you are taking Cymbalta.
Danish: • Fortæl din læge, hvis du bliver gravid, eller hvis du prøver at blive gravid, mens du tager Cymbalta.
English: If your doctor thinks that you no longer need Cymbalta he or she will ask you to reduce your dose over at least 2 weeks before stopping treatment altogether.
Danish: Hvis lægen mener, at du ikke længere behøver at tage Cymbalta, vil lægen bede dig reducere dosis over mindst 2 uger, før du stopper behandlingen helt.
English: • If you take Cymbalta near the end of your pregnancy, your baby might have some symptoms when it is born.
Danish: • Hvis du tager Cymbalta i slutningen af graviditeten, kan dit barn udvise visse symptomer, når det bliver født.
English: Taking a MAOI together with many prescription medicines, including Cymbalta, can cause serious or even life-threatening side effects.
Danish: Hvis du tager en MAO-hæmmer sammen med en række forskellige receptpligtige lægemidler, heriblandt Cymbalta, kan det medføre alvorlige og endda livstruende bivirkninger.
English: Cymbalta should normally not be used for children and adolescents under 18 years.
Danish: Cymbalta bør normalt ikke bruges til behandling af børn og unge under 18 år.
English: Cymbalta is for oral use.
Danish: Cymbalta er til oral brug.
English: Age: Pharmacokinetic differences have been identified between younger and elderly females (≥65 years) (AUC increases by about 25% and half-life is about 25% longer in the elderly), although the magnitude of these changes is not sufficient to justify adjustments to the dose.
Danish: Alder: Der er fundet farmakokinetiske forskelle mellem yngre og ældre kvinder (≥ 65 år) (AUCværdien forøges med ca. 25%, og halveringstiden er ca. 25% længere hos ældre) men omfanget af disse forandringer er ikke tilstrækkelige til at retfærdiggøre dosisjusteringer.
English: Talk with your doctor about how long you should keep taking Cymbalta.
Danish: Tal med din læge om, hvor længe du skal blive ved med at tage Cymbalta.
English: Cymbalta is indicated in adults.
Danish: Cymbalta er indiceret til voksne.
English: • Make sure your midwife and/or doctor knows you are on Cymbalta.
Danish: • Du skal sikre dig, at din jordemoder og/eller læge ved, at du tager Cymbalta.
English: Cymbalta may cause a sensation of restlessness or an inability to sit or stand still.
Danish: Cymbalta kan give en følelse af uro eller manglende evne til at sidde eller stå stille.
English: Care should be taken if you drink alcohol while you are being treated with Cymbalta.
Danish: Du bør udvise forsigtighed, hvis du drikker alkohol, samtidig med, at du er i behandling med Cymbalta.
English: The antibiotic linezolid is a reversible non-selective MAOI and should not be given to patients treated with Cymbalta (see section 4.4).
Danish: Det antibiotiske lægemiddel linezolid er en reversibel ikke-selektiv MAOI og bør ikke gives til patienter, der er i behandling med Cymbalta (se afsnit 4.4).
English: Your doctor should decide whether you can take Cymbalta with other medicines.
Danish: Din læge bør afgøre, om Cymbalta kan tages sammen med anden medicin.
English: • If you take Cymbalta near the end of your pregnancy there is an increased risk of excessive vaginal bleeding shortly after birth, especially if you have a history of bleeding disorders.
Danish: • Hvis du tager Cymbalta i slutningen af graviditeten, er der en øget risiko for kraftig vaginal blødning kort efter fødslen, især hvis du tidligere har haft blødningsforstyrrelser.
English: Cymbalta starts to work in most people with depression or anxiety within two weeks of starting treatment, but it may take 2-4 weeks before you feel better.
Danish: Hos de fleste mennesker med depression eller angst begynder Cymbalta at virke inden for de første to uger, men det kan vare 2-4 uger, før du får det bedre.
English: You should inform your doctor if any of the symptoms listed above develop or worsen when patients under 18 are taking Cymbalta.
Danish: Du skal fortælle din læge, hvis et af ovenstående symptomer opstår eller forværres hos en patient under 18 år, som er i behandling med Cymbalta.
English: Medicines like Cymbalta (so called SSRIs/SNRIs) may cause symptoms of sexual dysfunction (see section 4).
Danish: Lægemidler som Cymbalta (såkaldte SSRI/SNRI'er) kan give symptomer på seksuel dysfunktion (se pkt.
English: Aggression and anger4
Danish: Aggression og vrede4
English: The dose may be adjusted up to 120 mg a day based on your response to Cymbalta.
Danish: Dosis kan justeres op til 120 mg dagligt afhængigt af dit respons på Cymbalta.
English: Cymbalta should be used in pregnancy only if the potential benefit justifies the potential risk to the foetus.
Danish: Cymbalta bør kun bruges under graviditeten, hvis de potentielle behandlingsfordele opvejer de potentielle risici for fosteret.
English: Cymbalta is used in adults to treat:
Danish: Cymbalta anvendes hos voksne til behandling af
English: The usual starting dose of Cymbalta is 30 mg once a day after which most patients will receive 60 mg once a day, but your doctor will prescribe the dose that is right for you.
Danish: Den sædvanlige startdosis af Cymbalta er 30 mg en gang dagligt, hvorefter de fleste patienter vil få 60 mg en gang dagligt, men din læge vil fastlægge den dosis, som passer til dig.
English: Your doctor may continue to give you Cymbalta when you are feeling better to prevent your depression or anxiety from returning
Danish: Din læge kan vælge at fortsætte din behandling med Cymbalta efter, at du har fået det bedre for at forebygge, at din depression eller angst skal vende tilbage.
English: Cymbalta increases the levels of serotonin and noradrenaline in the nervous system.
Danish: Cymbalta øger indholdet af serotonin og noradrenalin i nervesystemet.
English: Call your doctor or pharmacist immediately if you take more than the amount of Cymbalta prescribed by your doctor.
Danish: Kontakt omgående lægen eller apoteket, hvis du har taget mere Cymbalta, end lægen har ordineret.
English: Cymbalta may be associated with sedation and dizziness.
Danish: Cymbalta kan være forbundet med sedation og svimmelhed.
English: Each capsule of Cymbalta contains pellets of duloxetine hydrochloride with a covering to protect them from stomach acid.
Danish: Hver Cymbalta kapsel indeholder pellets af duloxetinhydrochlorid med en belægning, som beskytter dem mod mavesyre.
English: You should use Cymbalta only after discussing the potential benefits and any potential risks to your unborn child with your doctor.
Danish: Du må kun bruge Cymbalta efter, at du har talt med din læge om de mulige fordele for dig og de mulige risici for dit ufødte barn.
English: Major Depressive Disorder and Generalised Anxiety Disorder: Depression is associated with an increased risk of suicidal thoughts, self harm and suicide (suicide-related events).
Danish: Moderate til svære depressioner og generaliseret angst: Depression er forbundet med en øget risiko for selvmordstanker, at forvolde skade på sig selv og selvmord (selvmordsrelaterede handlinger).
English: Tolerability of Cymbalta 60 mg once daily in elderly patients was comparable to that seen in the younger adults.
Danish: Tolerancen af Cymbalta 60 mg en gang dagligt hos ældre patienter var sammenlignelig med den, der blev set hos yngre voksne.
English: The modelpredicted duloxetine steady state plasma concentrations in paediatric patients were mostly within the concentration range observed in adult patients.
Danish: De modelforventede steady state-plasmaskoncentrationer af duloxetin hos pædiatriske patienter var generelt inden for koncentrationsintervallet observeret hos voksne patienter.
English: Diabetic Peripheral Neuropathic Pain: The efficacy of Cymbalta as a treatment for diabetic neuropathic pain was established in 2 randomised, 12-week, double-blind, placebo-controlled, fixed dose studies in adults (22 to 88 years) having diabetic neuropathic pain for at least 6 months.
Danish: Perifere diabetiske neuropatiske smerter: Effekten af Cymbalta som en behandling af diabetiske neuropatiske smerter blev etableret i 2 randomiserede 12-ugers, dobbeltblinde, placebokontrollerede studier med fast dosis hos voksne (22 til 88 år), som havde haft diabetiske neuropatiske smerter i mindst 6 måneder.
English: Cymbalta may make you feel sleepy or dizzy.
Danish: Cymbalta kan gøre dig søvnig og svimmel.
English: Also, the long-term safety effects concerning growth, maturation, and cognitive and behavioural development of Cymbalta in this age group have not yet been demonstrated.
Danish: Ydermere foreligger der endnu ikke data på langtidssikkerhed hos denne aldersgruppe hvad angår vækst, modning, kognitiv- og adfærdsudvikling ved brug af Cymbalta.
English: The co-administration of duloxetine (40 mg twice daily) increases steady state AUC of tolterodine (2 mg twice daily) by 71 %, but does not affect the pharmacokinetics of its active 5-hydroxyl metabolite and no dosage adjustment is recommended.
Danish: Samtidig behandling med duloxetin (40 mg to gange dagligt) forøger steady state AUC for tolterodin (2 mg to gange dagligt) med 71%, men påvirker ikke farmakokinetikken for tolterodins aktive 5-hydroxy-metabolit, og der anbefales ingen dosisjustering.
English: Cymbalta should be used with caution in patients with a history of mania or a diagnosis of bipolar disorder, and/or seizures.
Danish: Cymbalta skal anvendes med forsigtighed til patienter med en anamnese med mani eller en diagnose med bipolar forstyrrelse og/eller krampeanfald.
English: You must wait at least 14 days after you have stopped taking an MAOI before you can take Cymbalta.
Danish: Du skal vente mindst 14 dage efter, at du er holdt op med at tage en MAO-hæmmer, før du må begynde at tage Cymbalta.
English: • Cymbalta may cause effects that you may not be aware of, such as increases in liver enzymes or blood levels of potassium, creatine phosphokinase, sugar, or cholesterol
Danish: • Cymbalta kan medføre bivirkninger, som du måske ikke er opmærksom på, f.eks. forhøjede leverenzymer eller forhøjede værdier af kalium, kreatinkinase, sukker eller kolesterol i blodet
English: The incidence of relapse during the 6months double-blind follow-up period was 14% for Cymbalta and 42% for placebo.
Danish: Incidensen af tilbagefald under den 6-måneders dobbeltblinde followup periode var 14 % for Cymbalta og 42 % for placebo.
English: Despite this, your doctor may prescribe Cymbalta for patients under 18 because he/she decides that this is in their best interests.
Danish: På trods af dette kan din læge ordinere Cymbalta til patienter under 18 år, hvis lægen skønner, at det er til patientens bedste.
English: Cymbalta contains the active substance duloxetine.
Danish: Cymbalta indeholder det aktive stof duloxetin.
English: The most commonly reported adverse reactions in patients treated with Cymbalta were nausea, headache, dry mouth, somnolence, and dizziness.
Danish: De hyppigst rapporterede bivirkninger hos patienter i behandling med Cymbalta var kvalme, hovedpine, mundtørhed, søvnighed og svimmelhed.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Cymbalta in all subsets of the paediatric population in the treatment of major depressive disorder, diabetic neuropathic pain and generalised anxiety disorder.
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med Cymbalta i alle undergrupper af den pædiatriske population med moderat til svær depression, diabetisk neuropatisk smerte og generaliseret angst (se pkt.
English: Based on the half-life of duloxetine, at least 5 days should be allowed after stopping Cymbalta before starting an MAOI (see section 4.3).
Danish: På baggrund af duloxetins halveringstid skal der gå mindst 5 dage efter endt behandling med Cymbalta, før en behandling med en MAO-hæmmer påbegyndes (se afsnit 4.3).
English: Cymbalta is available in 2 strengths: 30 mg and 60 mg.
Danish: Cymbalta findes i to styrker: 30 mg og 60 mg:
English: In a relapse prevention study, patients responding to 6 months of acute treatment with open-label Cymbalta were randomised to either Cymbalta or placebo for a further 6-months.
Danish: I et studie med forebyggelse af tilbagefald blev de patienter, som responderede på 6 måneders akut behandling med open-label Cymbalta, randomiseret til enten Cymbalta eller placebo i yderligere 6 måneder.
English: Monoamine oxidase inhibitors (MAOIs): You should not take Cymbalta if you are taking, or have recently taken (within the last 14 days) another antidepressant medicine called a monoamine oxidase inhibitor (MAOI).
Danish: Monoaminoxidasehæmmere (MAO-hæmmere): Du må ikke tage Cymbalta, hvis du tager, eller inden for de sidste 14 dage har taget et antidepressivt lægemiddel kaldet en MAO-hæmmer.
English: Major Depressive Disorder: Cymbalta was studied in a clinical programme involving 3,158 patients (1,285 patient-years of exposure) meeting DSM-IV criteria for major depression.
Danish: Moderate til svære depressioner: I et klinisk forsøgsprogram med 3.158 patienter (svarende til 1.285 patientår) blev Cymbalta undersøgt mod DSM-IV kriterierne for moderate til svære depressioner.
English: Consequently, caution is advised when Cymbalta is taken in combination with other centrally acting medicinal products or substances, including alcohol and sedative medicinal products (e.g. benzodiazepines, morphinomimetics, antipsychotics, phenobarbital, sedative antihistamines).
Danish: Som konsekvens heraf anbefales det at udvise forsigtighed, når Cymbalta tages sammen med andre centralt virkende lægemidler eller stoffer, herunder alkohol og sederende lægemidler (f.eks. benzodiazepiner, morphinlignende præparater, antipsykotika, phenobarbital, sederende antihistaminer).
English: Also, you need to wait at least 5 days after you stop taking Cymbalta before you take a MAOI.
Danish: Du skal ligeledes vente mindst 5 dage, efter at du er holdt op med at tage Cymbalta, før du må begynde at tage en MAO-hæmmer.
English: Capsule content: hypromellose, hypromellose acetate succinate, sucrose, sugar spheres, talc, titanium dioxide (E171), triethyl citrate (See end of section 2 for further information on sucrose).
Danish: Kapselindhold: Hypromellose, hypromelloseacetatsuccinat, saccharose, saccharosekugler, talcum, titandioxid (E171), triethylcitrat (se sidst i afsnit 2 for yderligere information om saccharose).
English: − have liver disease
Danish: - har en leversygdom.
English: However, as with any medicine, caution should be exercised when treating the elderly, especially with Cymbalta 120 mg per day for major depressive disorder or generalised anxiety disorder, for which data are limited (see sections 4.4 and 5.2).
Danish: Der bør dog som for al anden medicin udvises forsigtighed ved behandling af ældre, især ved behandling med Cymbalta 120 mg dagligt for moderate til svære depressioner eller generaliseret angst, da der er begrænsede data tilgængelige (se pkt.
English: Response and remission rates were also higher with Cymbalta compared to placebo.
Danish: Graden af respons og bedring var også højere med Cymbalta sammenlignet med placebo.
English: Mydriasis has been reported in association with duloxetine, therefore, caution should be used when prescribing Cymbalta to patients with increased intraocular pressure, or those at risk of acute narrowangle glaucoma.
Danish: Der er rapporteret om tilfælde af mydriasis i forbindelse med duloxetin, og der skal derfor udvises forsigtighed ved udskrivning af Cymbalta til patienter med forhøjet intraokulært tryk eller til patienter med risiko for akut snævervinklet glaukom.
English: Cymbalta demonstrated statistical superiority over placebo as measured by improvement in the 17item Hamilton Depression Rating Scale (HAM-D) total score (including both the emotional and somatic symptoms of depression).
Danish: Cymbalta viste sig signifikant bedre end placebo målt som forbedring i total score på Hamilton 17punkts skalaen (HAM-D) (inklusiv både følelses og somatiske symptomer ved depression).
English: Cymbalta showed comparable efficacy results to venlafaxine in terms of improvements on the HAM-A total score.
Danish: Cymbalta viste sammenlignelige resultater med venlafaxin udtrykt i HAM-A totalscore.
English: Inhibitors of CYP1A2: Because CYP1A2 is involved in duloxetine metabolism, concomitant use of duloxetine with potent inhibitors of CYP1A2 is likely to result in higher concentrations of duloxetine.
Danish: CYP1A2-hæmmere: Da CYP1A2 er involveret i metaboliseringen af duloxetin, vil samtidig behandling med Cymbalta og potente CYP1A2-hæmmere sandsynligvis medføre højere koncentrationer af duloxetin.
English: Therefore Cymbalta should not be administered in combination with potent inhibitors of CYP1A2 like fluvoxamine (see section 4.3).
Danish: Cymbalta bør derfor ikke gives i kombination med potente CYP1A2-hæmmere som fluvoxamin (se pkt.
English: Generalised Anxiety Disorder: Cymbalta demonstrated statistically significant superiority over placebo in five out of five studies including four randomised, double-blind, placebo-controlled acute studies and a relapse prevention study in adult patients with generalised anxiety disorder.
Danish: Generaliseret angst: Cymbalta viste statistisk signifikant fordel i forhold til placebo i fem ud af fem studier inklusive fire randomiserede, dobbeltblinde, placebokontrollerede akutstudier og et studie af forebyggelse af tilbagefald hos voksne patienter med generaliseret angst.
English: When stopping treatment with Cymbalta the dose should be gradually reduced over a period of at least one to two weeks in order to reduce the risk of withdrawal reactions (see sections 4.4 and 4.8).
Danish: Ved ophør af behandling med Cymbalta skal dosis gradvis reduceres over en periode på mindst en til to uger for at mindske risikoen for seponeringssymptomer (se pkt.
English: The concomitant use of Cymbalta with selective, reversible MAOIs, like moclobemide, is not recommended (see section 4.4).
Danish: Samtidig brug af Cymbalta og selektive, reversible MAO-hæmmere, som f.eks. moclobemid, anbefales ikke (se pkt.
English: As the safety of duloxetine in infants is not known, the use of Cymbalta while breast-feeding is not recommended.
Danish: Eftersom sikkerheden af duloxetin hos spædbørn ikke er kendt, frarådes behandling med Cymbalta i ammeperioden.
English: Cymbalta 60 mg is available in packs of 28, 56, 84 and 98 hard gastro-resistant capsules and in multipacks containing 100 (5 packs of 20) and 500 (25 packs of 20) hard gastro-resistant capsules.
Danish: Cymbalta 60 mg findes i pakninger med 28, 56, 84 og 98 hårde enterokapsler og i multipakninger med 100 (5 pakninger a 20) og 500 (25 pakninger a 20) hårde enterokapsler.
English: Cymbalta demonstrated statistically significant superiority over placebo as measured by improvement in the Hamilton Anxiety Scale (HAM-A) total score and by the Sheehan Disability Scale (SDS) global functional impairment score.
Danish: Cymbalta viste statistisk signifikant fordel i forhold til placebo målt som bedring på Hamilton Anxiety Scale (HAM-A) totalscore og på Sheehan Disability Scale (SDS) som score for total funktionel hæmning.
English: Use in children and adolescents under 18 years of age Cymbalta should not be used in the treatment of children and adolescents under the age of 18 years.
Danish: Cymbalta bør ikke bruges til behandling af børn og unge under 18 år.
English: Cymbalta 60 mg to 120 mg once daily demonstrated statistically significant superiority compared to placebo (p<0.001) on the prevention of relapse, as measured by time to relapse.
Danish: Cymbalta 60 mg til 120 mg en gang dagligt viste statistisk signifikant fordel sammenlignet med placebo (p<0.0001) ved forebyggelse af tilbagefald målt som tid til tilbagefald.
English: The efficacy of Cymbalta 30-120 mg (flexible dosing) once a day in elderly patients (>65 years) with generalised anxiety disorder was evaluated in a study that demonstrated statistically significant improvement in the HAM-A total score for duloxetine treated patients compared to placebo treated patients.
Danish: Effekten af Cymbalta 30-120 mg (fleksibel dosering) en gang dagligt hos ældre patienter (> 65 år) med generaliseret angst blev evalueret i et studie, som viste statistisk signifikant forbedring i HAM-Atotalscoren hos duloxetinbehandlede patienter sammenlignet med placebobehandlede patienter.
English: These medicines increase the risk of side effects; if you get any unusual symptom taking any of these medicines together with Cymbalta, you should see your doctor.
Danish: Hvis du får usædvanlige symptomer, når du tager et af disse lægemidler sammen med Cymbalta, skal du kontakte din læge.
English: Response and remission rates were also statistically significantly higher with Cymbalta compared with placebo.
Danish: Data for virkning og bedring viste sig også statistisk signifikant bedre for Cymbalta sammenlignet med placebo.
English: Cymbalta with food, drink and alcohol
Danish: Brug af Cymbalta sammen med mad, drikke og alkohol Cymbalta kan tages med og uden mad.