FrancophonIA/ELRC3.0 huggingface dataset:
English: You should also tell your doctor if you are taking any of the following:
Danish: Du bør også fortælle din læge, hvis du tager noget af nedenstående medicin:
English: De la Industria, 30, 28108 Alcobendas, Madrid, Spain.
Danish: De la Industria 30, 28108 Alcobendas, Madrid, Spanien.
English: Depression, suicidal ideation and behaviour
Danish: Depression, selvmordsforestillinger og -adfærd
English: DO NOT stop taking your capsules without the advice of your doctor even if you feel better.
Danish: DU MÅ IKKE holde op med at tage kapslerne uden at have konsulteret din læge, heller ikke selv om du har fået det bedre.
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 (pharmacovililance 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 risk/benefit-forholdet, eller som følge af, at en vigtig milepæl (lægemiddelovervågning eller risikominimering) er nået.
English: 9 Estimated frequency based on all clinical trial data.
Danish: 9Estimeret hyppighed baseret på data fra alle kliniske studier.
English: • Tell your doctor if you become pregnant, or you are trying to become pregnant, while you are taking ARICLAIM.
Danish: • Fortæl det til din læge, hvis du bliver gravid, eller hvis du prøver at blive gravid, mens du tager ARICLAIM.
English: There may be loss of feeling in the affected area, or sensations such as touch, heat, cold or pressure may cause pain).
Danish: Der kan forekomme følelsesløshed i det angrebne område, eller påvirkninger såsom berøring, varme, kulde eller tryk kan fremkalde smerte).
English: ARICLAIM is for oral use.
Danish: ARICLAIM er til oral brug.
English: If you take ARICLAIM near the end of your pregnancy, your baby might have some symptoms when it is born.
Danish: Hvis du tager ARICLAIM i slutningen af graviditeten, kan dit barn udvise visse symptomer når det bliver født.
English: If your doctor thinks that you no longer need ARICLAIM 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 ARICLAIM, vil denne bede dig reducere dosis over mindst 2 uger, før du stopper behandlingen helt.
English: These symptoms usually begin during the first 24 hours after the baby is born.
Danish: Symptomerne opstår som regel indenfor de første 24 timer efter at barnet er født.
English: Frequency estimate: 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).
Danish: Skønnet hyppighed: Meget almindelig (≥1/10, almindelig (≥1/100 til <1/10), ikke almindelige (≥1/1.000 til <1/100), sjælden (≥1/10.000 til <1/1.000), meget sjælden (<1/10.000).
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal
Danish: Indehaveren af markedsføringstilladelsen skal fremsende PSUR'er for dette lægemiddel i overensstemmelse med kravene på listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF og offentliggjort på den europæiske webportal for lægemidler.
English: Based upon the overlap in the range of clearance, gender-based pharmacokinetic differences do not justify the recommendation for using a lower dose for female patients.
Danish: Baseret på overlappet i clearenceintervallerne, berettiger den kønsbaserede forskel i farmakokinetik ikke en anbefaling for brug af lavere dosis til kvinder.
English: Talk with your doctor about how long you should keep taking ARICLAIM.
Danish: Tal med din læge om, hvor længe du skal blive ved med at tage ARICLAIM.
English: In addition, long-term safety data in children and adolescents concerning growth, maturation and cognitive and behavioural development are lacking.
Danish: Derudover mangler der data for langtidssikkerheden hos børn og unge hvad angår vækst, modning, kognitiv udvikling og adfærdsudvikling.
English: Patients not demonstrating a pain reduction of 30% within 60 days of treatment were unlikely to reach this level during further treatment.
Danish: Det er usandsynligt, at patienter, som ikke opnåede en smertereduktion på 30 % inden for 60 dage, skulle kunne opnå dette niveau af smertereduktion ved yderligere behandling.
English: ARICLAIM should normally not be used for children and adolescents under 18 years.
Danish: ARICLAIM bør normalt ikke bruges til behandling af børn og unge under 18 år.
English: Date of latest renewal: 24 June 2009
Danish: Dato for første markedsføringstilladelse: 11. august 2004 Dato for seneste fornyelse: 24. juni 2009
English: Make sure your midwife and/or doctor knows you are on ARICLAIM.
Danish: Du skal sikre dig, at din jordemoder og/eller læge ved, at du tager ARICLAIM.
English: Care should be taken if you drink alcohol while you are being treated with ARICLAIM.
Danish: Du bør udvise forsigtighed, hvis du drikker alkohol, samtidig med, at du er i behandling med ARICLAIM.
English: Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase insufficiency should not take this medicine.
Danish: Patienter med sjældne arvelige lidelser som fructoseintolerans, glucose-galactose-malabsorption eller invertase-isomaltase-insufficiens bør ikke tage denne medicin.
English: Pharmacotherapeutic group: Other antidepressants.
Danish: Farmakoterapeutisk gruppe: Andre antidepressiva.
English: ARICLAIM may cause a sensation of restlessness or an inability to sit or stand still.
Danish: ARICLAIM kan give en følelse af uro eller manglende evne til at sidde eller stå stille.
English: Your doctor should decide whether you can take ARICLAIM with other medicines.
Danish: Din læge bør afgøre om ARICLAIM kan tages sammen med anden medicin.
English: ARICLAIM may be associated with sedation and dizziness.
Danish: ARICLAIM kan være forbundet med sedation og svimmelhed.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the RMP presented in Module 1.8.2. of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Danish: Indehaveren af markedsføringstilladelsen skal udføre de påkrævede aktiviteter og foranstaltninger vedrørende lægemiddelovervågning, som er beskrevet i den godkendte RMP, der fremgår af modul 1.8.2 i markedsføringstilladelsen, og enhver efterfølgende godkendt opdatering af RMP.
English: The pharmacokinetics of duloxetine demonstrate large intersubject variability (generally 50-60%), partly due to gender, age, smoking status and CYP2D6 metaboliser status.
Danish: Duloxetins farmakokinetik viser stor variation mellem patienter (generelt 50-60 %), delvist på grund af køn, alder, ryger ikkeryger status og CYP2D6 metaboliseringsstatus.
English: You may be more likely to think like this if you: - have previously had thoughts about killing or harming yourself - are a young adult.
Danish: Du vil mere sandsynligt tænke på dette, hvis du: - tidligere har haft tanker om at begå selvmord eller om at skade dig selv.
English: Taking a MAOI together with many prescription medicines, including ARICLAIM, can cause serious or even life-threatening side effects.
Danish: Hvis du tager en MAO-hæmmer sammen med en række forskellige receptpligtige lægemidler, heriblandt ARICLAIM, kan det medføre alvorlige og endda livstruende bivirkninger.
English: Gender: Pharmacokinetic differences have been identified between males and females (apparent plasma clearance is approximately 50% lower in females).
Danish: Køn: Der er fundet farmakokinetiske forskelle mellem mænd og kvinder (den tilsyneladende plasmaclearance er tilnærmelsesvis 50 % lavere hos kvinder).
English: Very rare side effects (may affect up to 1 in 10,000 people) • inflammation of the blood vessels in the skin (cutaneous vasculitis)
Danish: Meget sjældne bivirkninger (kan ske hos op til 1 ud af 10.000 patienter) • Betændelse i hudens blodkar (kutan vaskulitis)
English: The antibiotic linezolid is a reversible non-selective MAOI and should not be given to patients treated with ARICLAIM (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 ARICLAIM (se afsnit 4.4).
English: Physicians should encourage patients to report any distressing thoughts or feelings or depressive symptoms at any time.
Danish: Læger bør opfordre patienter til at rapportere alle bekymrende tanker, følelser eller depressive symptomer, de måtte have på et hvilket som helst tidspunkt.
English: No clinically significant differences were observed for QT, PR, QRS, or QTcB measurements between duloxetine-treated and placebo-treated patients.
Danish: Der blev ikke observeret nogen klinisk signifikante forskelle på QT-, PR-, QRS- eller QTcB-målinger mellem duloxetinbehandlede og placebobehandlede patienter.
English: ARICLAIM should be used in pregnancy only if the potential benefit justifies the potential risk to the foetus.
Danish: ARICLAIM bør kun bruges under graviditeten, hvis de potentielle behandlingsfordele opvejer de potentielle risici for fosteret.
English: If you are depressed and/or have anxiety disorders you can sometimes have thoughts of harming or killing yourself.
Danish: Hvis du har en depression eller lider af en angstsygdom, kan du af og til få tanker om at skade dig selv eller begå selvmord.
English: Compared with healthy subjects, the apparent plasma clearance of duloxetine was 79% lower, the apparent terminal half-life was 2.3 times longer, and the AUC was 3.7 times higher in patients with moderate liver disease.
Danish: Sammenlignet med raske patienter var den tilsyneladende plasmaclearance for duloxetin 79 % lavere, den tilsyneladende terminale halveringstid var 2,3 gange længere, og AUC var 3,7 gange højere hos patienter med moderat leversygdom.
English: Call your doctor or pharmacist immediately if you take more than the amount of ARICLAIM prescribed by your doctor.
Danish: Kontakt omgående lægen eller apoteket, hvis du har taget mere ARICLAIM, end lægen har ordineret.
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Danish: Hvis din læge har fortalt dig, at du ikke kan tåle visse sukkertyper, skal du kontakte din læge, inden du tager denne medicin.
English: You should inform your doctor if any of the symptoms listed above develop or worsen when patients under 18 are taking ARICLAIM.
Danish: Du skal fortælle det til din læge, hvis et af ovenstående symptomer opstår eller forværres hos en patient under 18 år, som er i behandling med ARICLAIM.
English: ARICLAIM is available in 2 strengths: 30 mg and 60 mg.
Danish: ARICLAIM findes i 2 styrker: 30 mg og 60 mg.
English: ARICLAIM may make you feel sleepy or dizzy.
Danish: ARICLAIM kan gøre dig søvnig og svimmel.
English: ARICLAIM increases the levels of serotonin and noradrenaline in the nervous system.
Danish: ARICLAIM øger indholdet af serotonin og noradrenalin i nervesystemet.
English: Dosages above 60 mg once daily, up to a maximum dose of 120 mg per day administered in evenly divided doses, have been evaluated from a safety perspective in clinical trials.
Danish: Doseringer over 60 mg én gang daglig op til maksimaldosis på 120 mg daglig i ligeligt fordelte doser er evalueret ud fra et sikkerhedsmæssigt perspektiv i kliniske studier.
English: ARICLAIM contains the active substance duloxetine.
Danish: ARICLAIM indeholder det aktive stof duloxetin.
English: The efficacy of duloxetine 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: Effekten af duloxetin 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: 2 Cases of orthostatic hypotension and syncope have been reported especially at the initiation of treatment.
Danish: 2 Sager med ortostatisk hypotension og synkope er blevet rapporteret - særligt i behandlingsopstarten.
English: If concomitant treatment with duloxetine and other serotonergic agents that may affect the serotonergic and/or dopaminergic neurotransmitter systems in clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases.
Danish: Hvis samtidig behandling med duloxetin og andre serotonerge lægemidler, som kan påvirke det serotonerge og/eller dopaminerge neurotransmittersystem, er klinisk påkrævet, anbefales det nøje at følge patienten, særligt i starten af behandlingen og ved øgning af dosis.
English: You should use ARICLAIM only after discussing the potential benefits and any potential risks to your unborn child with your doctor.
Danish: Du må kun bruge ARICLAIM efter, at du har talt med din læge om de mulige fordele for dig og de mulige risici for dit ufødte barn.
English: If you forget to take ARICLAIM
Danish: Hvis du har glemt at tage ARICLAIM
English: The amount of duloxetine in breast milk is approximately 7 µg/day while on 40 mg twice daily dosing.
Danish: Mængden af duloxetin i modermælk er ca. 7 µg/dag under en dosering på 40 mg to gange daglig.
English: However, as with any medicine, caution should be exercised when treating the elderly (see section 5.2).
Danish: Der bør dog som for al anden medicin udvises forsigtighed ved behandling af ældre (se pkt.
English: ARICLAIM should be used with caution in patients with a history of mania or a diagnosis of bipolar disorder, and/or seizures.
Danish: ARICLAIM skal anvendes med forsigtighed til patienter med en anamnese med mani eller en diagnose med bipolar forstyrrelse og/eller krampeanfald.
English: INFORMATION IN BRAILLE ARICLAIM 60 mg
Danish: INFORMATION I BRAILLESKRIFT ARICLAIM 60 mg
English: Do not start or stop taking any medicines, including those bought without a prescription and herbal remedies, before checking with your doctor.
Danish: Start eller afbryd ikke behandlingen med medicin, det gælder også for medicin, som ikke er på recept samt naturlægemidler, før du har talt med din læge.
English: Generally, for SSRIs and SNRIs, these events are mild to moderate and self-limiting, however, in some patients they may be severe and/or prolonged.
Danish: Generelt for SSRI- og SNRI-præparater er disse symptomer lette til moderate og selvbegrænsende, selvom de hos nogle patienter kan være svære og/eller vedvare i længere tid.
English: Anticoagulants and antiplatelet agents: Caution should be exercised when duloxetine is combined with oral anticoagulants or antiplatelet agents due to a potential increased risk of bleeding attributable to a pharmacodynamic interaction.
Danish: Antikoagulanter og antitrombotiske midler: Der bør udvises forsigtighed, når duloxetin gives sammen med orale antikoagulanter eller antitrombotiske midler på grund af en potentiel øget risiko for blødning, der kan tilskrives en farmakodynamisk interaktion.
English: Despite this, your doctor may prescribe ARICLAIM for patients under 18 because he/she decides that this is in their best interests.
Danish: På trods af dette kan din læge ordinere ARICLAIM til patienter under 18 år, hvis lægen skønner, at det er til patientens bedste.
English: Infections and infestations Immune system disorders
Danish: Infektioner og parasitære sygdomme Immunsystemet
English: Ejaculation delayed
Danish: Urinretention Forsinket
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 daglig) forøger steady state AUC for tolterodin (2 mg to gange daglig) med 71 %, men påvirker ikke farmakokinetikken for tolterodins aktive 5-hydroxy-metabolit, og der anbefales ingen dosisjustering.
English: You must wait at least 14 days after you have stopped taking an MAOI before you can take ARICLAIM.
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 ARICLAIM.
English: 6 Estimated frequency of post-marketing surveillance reported adverse reactions; not observed in placebo-controlled clinical trials.
Danish: 6 Estimeret hyppighed af bivirkninger rapporteret efter markedsføring; ikke set i placebo-kontrollerede kliniske studier.
English: If while on ARICLAIM therapy, the patient develops agitation or depressive symptoms, specialised medical advice should be sought, as depression is a serious medical condition.
Danish: Hvis patienten, under ARICLAIM-behandling, udvikler agitation eller depressive symptomer, bør en specialist konsulteres, eftersom depression er en alvorlig medicinsk tilstand.
English: However, the majority of common adverse reactions were mild to moderate, they usually started early in therapy, and most tended to subside even as therapy was continued.
Danish: Størstedelen af de almindelige bivirkninger var dog milde til moderate, de indtrådte typisk i starten af behandlingen, og de fleste aftog ved fortsat behandling.
English: Although ARICLAIM is not indicated for the treatment of depression, its active ingredient (duloxetine) also exists as an antidepressant medicinal product.
Danish: Selvom ARICLAIM ikke er indiceret til behandling af depression, findes det aktive stof (duloxetin) også som et antidepressivt lægemiddel.
English: • Ariclaim 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: • Ariclaim 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: Caution should also be exercised when duloxetine is used with medicinal products that may impair its metabolism (see section 4.5).
Danish: Der bør ligeledes udvises forsigtighed, når duloxetin bruges sammen med medicin, der kan forringe dets metabolisme (se pkt.
English: Medicines that cause sleepiness: These include medicines prescribed by your doctor including benzodiazepines, strong painkillers, antipsychotics, phenobarbital and antihistamines.
Danish: Medicin der virker sløvende: Dette omfatter medicin ordineret af din læge inklusive benzodiazepiner, stærk smertestillende medicin, antipsykotika, phenobarbital og antihistaminer.
English: Also, you need to wait at least 5 days after you stop taking ARICLAIM before you take a MAOI.
Danish: Du skal ligeledes vente mindst 5 dage, efter at du er holdt op med at tage ARICLAIM, før du må begynde at tage en MAO-hæmmer.
English: Breast-feeding mothers: The disposition of duloxetine was studied in 6 lactating women who were at least 12-weeks postpartum.
Danish: Ammende mødre: Duloxetins fordelingen i kroppen blev undersøgt hos 6 ammende kvinder, som havde født mindst 12 uger forinden.
English: ARICLAIM is used in adults to treat a condition called diabetic neuropathic pain (often described as burning, stabbing, stinging, shooting or aching or like an electric shock.
Danish: ARICLAIM er et lægemiddel til behandling af diabetiske neuropatiske smerter hos voksne (smerterne beskrives ofte som brændende, stikkende, sviende, jagende, skærende eller som et elektrisk stød.
English: • Stevens-Johnson syndrome (serious illness with blistering of the skin, mouth, eyes and genitals), serious allergic reaction which causes swelling of the face or throat (angioedema)
Danish: • Stevens-Johnsons syndrom (en alvorlig lidelse med blærer i huden, munden, øjnene og på kønsorganerne), alvorlige allergiske reaktioner, som kan forårsage hævelse i ansigtet eller
English: These usually begin at birth or within a few days of your baby being born.
Danish: Som regel opstår de ved fødslen eller indenfor få dage efter fødslen.
English: The European Medicines Agency has waived the obligation to submit the results of studies with ARICLAIM in all subsets of the paediatric population in the treatment of diabetic neuropathic pain.
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med ARICLAIM i alle undergrupper af den pædiatriske population med diabetisk neuropatisk smerte (se pkt.
English: Also, the long-term safety effects concerning growth, maturation, and cognitive and behavioural development of ARICLAIM 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 ARICLAIM.
English: Discontinuation of duloxetine (particularly when abrupt) commonly leads to withdrawal symptoms.
Danish: Seponering af duloxetin (særlig ved pludseligt ophør) fører normalt til seponeringssymptomer.
English: If a decision to initiate antidepressant pharmacological therapy is taken, the gradual discontinuation of ARICLAIM is recommended (see section 4.2).
Danish: Hvis det vurderes, at der skal iværksættes en farmakologisk antidepressiv behandling, bør ARICLAIM gradvist seponeres (se pkt.
English: A meta-analysis of placebo-controlled clinical trials of antidepressant medicinal products in psychiatric disorders showed an increased risk of suicidal behaviour with antidepressants compared to placebo in patients less than 25 years old.
Danish: En metaanalyse af placebokontrollerede kliniske studier af antidepressive lægemidler til behandling af psykiske lidelser, viste en lille forøget risiko for selvmordsadfærd med antidepressiva sammenlignet med placebo hos patienter under 25 år.
English: The safety and efficacy of duloxetine for the treatment of diabetic peripheral neuropathic pain has not been studied.
Danish: Duloxetins sikkerhed og virkning ved behandling af perifere, diabetiske, neuropatiske smerter er ikke klarlagt.
English: Hypromellose acetate succinate Sucrose
Danish: Hypromellose Hypromelloseacetatsuccinat Saccharose
English: Each capsule of ARICLAIM contains pellets of duloxetine hydrochloride with a covering to protect them from stomach acid.
Danish: Hver ARICLAIM-kapsel indeholder pellets af det aktive stof med en belægning, som beskytter dem mod mavesyre.
English: The concomitant use of ARICLAIM with selective, reversible MAOIs, like moclobemide, is not recommended (see section 4.4).
Danish: Samtidig brug af ARICLAIM og selektive, reversible MAO-hæmmere, som f.eks. moclobemid, anbefales ikke (se pkt.
English: Table 1 gives the adverse reactions observed from spontaneous reporting and in placebo-controlled clinical trials.
Danish: Tabel 1 viser observerede bivirkninger fra spontane rapporter samt fra placebokontrollerede kliniske studier.
English: What you need to know before you take ARICLAIM
Danish: Det skal du vide, før du begynder at tage ARICLAIM
English: Therefore ARICLAIM should not be administered in combination with potent inhibitors of CYP1A2 like fluvoxamine (see section 4.3).
Danish: ARICLAIM bør derfor ikke gives i kombination med potente CYP1A2-hæmmere som fluvoxamin (se pkt.
English: The following are reasons why ARICLAIM may not be suitable for you.
Danish: I følgende situationer kan du muligvis ikke bruge ARICLAIM.
English: Cases of liver injury, including severe elevations of liver enzymes (>10 times upper limit of normal), hepatitis and jaundice have been reported with duloxetine (see section 4.8).
Danish: Tilfælde af leverskade herunder alvorlig forhøjede leverenzymer (>10 gange den normale øvre grænse), hepatitis og gulsot er sjældent rapporteret for duloxetin (se pkt.