FrancophonIA/ELRC3.0 huggingface dataset:
English: • have eye problems, such as certain kinds of glaucoma (increased pressure in the eye);
Danish: • har øjenproblemer, såsom visse typer af grøn stær (glaukom - forøget tryk i øjet)
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) • inflammation i hudens blodkar (kutan vasculitis)
English: Some patients who stop taking Duloxetine Zentiva suddenly have had symptoms such as:
Danish: Nogle patienter, som pludselig holdt op med at tage Duloxetine Zentiva, oplevede symptomer som:
English: 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: Der er fundet farmakokinetiske forskelle mellem yngre og ældre kvinder (≥ 65 år) (AUC- værdien 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: The corresponding figures for at least 50% pain reduction were 50% and 26% respectively.
Danish: 50 % smertereduktion var henholdsvis 50 % og 26 %.
English: To help you remember to take Duloxetine Zentiva, you may find it easier to take it at the same times every day.
Danish: Det kan være lettere at huske at tage Duloxetine Zentiva, hvis du tager det på samme tidspunkt hver dag.
English: Duloxetine Zentiva with food, drink and alcohol Duloxetine Zentiva may be taken with or without food.
Danish: Brug af Duloxetine Zentiva sammen med mad, drikke og alkohol Duloxetine Zentiva kan tages med og uden mad.
English: If your doctor thinks that you no longer need Duloxetine Zentiva 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 Duloxetine Zentiva, vil lægen bede dig reducere dosis over mindst 2 uger, før du stopper behandlingen helt.
English: • suffer from bipolar disorder;
Danish: • lider af en bipolar sygdom
English: Pharmacokinetic differences have been identified between males and females (apparent plasma clearance is approximately 50% lower in females).
Danish: Der er fundet farmakokinetiske forskelle mellem mænd og kvinder (den tilsyneladende plasmaclearance er omkring 50 % lavere hos kvinder).
English: • problems getting an erection, changes in ejaculation;
Danish: • problemer med at få erektion, ændret ejakulation
English: • are currently being treated with another medicine which may cause liver damage;
Danish: • er i samtidig behandling med medicin, som kan skade leveren
English: • If you take Duloxetine Zentiva near the end of your pregnancy, your baby might have some symptoms when it is born.
Danish: • Hvis du tager Duloxetine Zentiva i slutningen af graviditeten, kan dit barn udvise visse symptomer, når det bliver født.
English: CNS medicinal products
Danish: CNS-lægemidler
English: The risk of withdrawal symptoms seen with SSRI's and SNRI's may be dependent on several factors including the duration and dose of therapy and the rate of dose reduction.
Danish: Risikoen for seponeringssymptomer set for SSRI'er og SNRI'er kan afhænge af flere faktorer blandt andet behandlingsvarigheden, dosis og hvor hurtigt dosis reduceres.
English: Taking a MAOI together with many prescription medicines, including Duloxetine Zentiva, can cause serious or even life-threatening side effects.
Danish: Hvis du tager en MAO-hæmmer sammen med en række forskellige receptpligtige lægemidler, heriblandt Duloxetine Zentiva, kan det medføre alvorlige og endda livstruende bivirkninger.
English: • are at risk of low sodium levels (for example if you are taking diuretics, especially if you are elderly);
Danish: • har risiko for at få lavt natrium i blodet (for eksempel hvis du tager vanddrivende medicin, især hvis du er ældre)
English: Patients (and caregivers of patients) should be alerted about the need to monitor for any clinical worsening, suicidal behaviour or thoughts and unusual changes in behaviour and to seek medical advice immediately if these symptoms present.
Danish: Det skal gøres klart for patienter (og pårørende), at det er nødvendigt at være opmærksom på enhver forværring af tilstanden, selvmordsrelateret adfærd eller selvmordstanker samt usædvanlige ændringer i opførsel og straks at søge lægehjælp, hvis disse symptomer viser sig.
English: You should inform your doctor if any of the symptoms listed above develop or worsen when patients under 18 are taking Duloxetine Zentiva.
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 Duloxetine Zentiva.
English: Duloxetine may be associated with sedation and dizziness.
Danish: Duloxetin kan være forbundet med sedation og svimmelhed.
English: These medicines might increase the risk of bleeding.
Danish: Denne medicin, øger muligvis risikoen for at du får blødninger.
English: • coughing, wheezing and shortness of breath which may be accompanied by a high temperature;
Danish: • hoste, hvæsende vejrtrækning og åndenød, som kan være ledsaget af en høj temperatur
English: • are allergic to duloxetine or any of the other ingredients of this medicine (listed in section 6);
Danish: • er allergisk over for duloxetin eller et af de øvrige indholdsstoffer i Duloxetine Zentiva (angivet i afsnit 6).
English: A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING
Danish: BILAG II A. FREMSTILLER(E) ANSVARLIG(E) FOR BATCHFRIGIVELSE B. BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING OG ANVENDELSE C. ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN D. BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET
English: • falls (mostly in elderly people), fatigue;
Danish: • fald (oftest hos ældre), træthed
English: Your doctor should decide whether you can take Duloxetine Zentiva with other medicines.
Danish: Din læge bør afgøre, om Duloxetine Zentiva kan tages sammen med anden medicin.
English: Both cytochromes P450-2D6 and 1A2 catalyse the formation of the two major metabolites glucuronide conjugate of 4-hydroxy duloxetine and sulphate conjugate of 5-hydroxy 6-methoxy duloxetine.
Danish: Både cytochrom P450-2D6 og -1A2 katalyserer dannelsen af de to hovedmetabolitter: glukuronidkonjugat af 4-hydroxy-duloxetin og sulfatkonjugat af 5-hydroxy-6-methoxy-duloxetin.
English: There may be loss of feeling in the affected area, or sensations such as touch, heat, cold or pressure may cause pain).
Danish: eller påvirkninger såsom berøring, varme, kulde eller tryk kan fremkalde smerte).
English: • If you take Duloxetine Zentiva 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 Duloxetine Zentiva i slutningen af graviditeten, er der en øget risiko for kraftig vaginal blødning kort efter fødslen, især hvis du tidligere har haft blødningsforstyrrelser.
English: Duloxetine should be used in pregnancy only if the potential benefit justifies the potential risk to the foetus.
Danish: Duloxetine bør kun bruges under graviditeten, hvis de potentielle behandlingsfordele opvejer de potentielle risici for fosteret.
English: − This medicine has been prescribed for you only.
Danish: • Lægen har ordineret dette lægemiddel til dig personligt.
English: • have had mania;
Danish: • tidligere har haft mani
English: • Make sure your midwife and/or doctor knows you are on Duloxetine Zentiva.
Danish: • Du skal sikre dig, at din jordemoder og/eller læge ved, at du tager Duloxetine Zentiva.
English: Talk with your doctor about how long you should keep taking Duloxetine Zentiva.
Danish: Tal med din læge om, hvor længe du skal blive ved med at tage Duloxetine Zentiva.
English: The usual starting dose of Duloxetine Zentiva 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 Duloxetine Zentiva er 30 mg en gang daglig, hvorefter de fleste patienter vil få 60 mg en gang daglig, men din læge vil fastlægge den dosis, som passer til dig.
English: Treatment of major depressive disorder.
Danish: Behandling af major depression.
English: Only a small proportion of patients included in pivotal clinical trials had severe depression (baseline HAM-D > 25).
Danish: Kun en lille del af de inkluderede patienter i de vigtigste kliniske studier led af moderate til svære depressioner (basislinie HAM-D>25).
English: The dose may be adjusted up to 120 mg a day based on your response to Duloxetine Zentiva.
Danish: Dosis kan justeres op til 120 mg daglig afhængigt af dit respons på Duloxetine Zentiva.
English: Duloxetine Zentiva should normally not be used for children and adolescents under 18 years.
Danish: Duloxetine Zentiva bør normalt ikke bruges til behandling af børn og unge under 18 år.
English: Stevens-Johnson Syndrome6
Danish: Stevens-Johnsons syndrom 6
English: • Oral anticoagulants or antiplatelet agents: Medicines which thin the blood or prevent the blood from clotting.
Danish: • Orale antikoagulantia eller medicin, der påvirker blodpladerne: Medicin, der fortynder blodet og modvirker dannelse af blodpropper.
English: Care should be taken if you drink alcohol while you are being treated with Duloxetine Zentiva.
Danish: Du bør udvise forsigtighed, hvis du drikker alkohol, samtidig med, at du er i behandling med Duloxetine Zentiva.
English: • difficulty or inability to pass urine, difficulty to start urinating, needing to pass urine during the night, needing to pass more urine than normal, having a decreased urine flow;
Danish: • besværet eller manglende evne til at lade vandet, besvær med at påbegynde vandladning, behov for vandladning i løbet af natten, behov for hyppigere vandladning end normalt, nedsat urinmængde
English: • throat inflammation that causes a hoarse voice;
Danish: • halsbetændelse, som forårsager hæs stemme
English: Duloxetine Zentiva may cause a sensation of restlessness or an inability to sit or stand still.
Danish: Duloxetine Zentiva kan give en følelse af uro eller manglende evne til at sidde eller stå stille.
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: • 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 halsen (angioødem)
English: Opaque PVC/PCTFE/Alu blisters, paper folding box.
Danish: Uigennemsigtig PVC/PCTFF/Alu-blister, foldet papæske.
English: Medicines like Duloxetine Zentiva (so called SSRIs/SNRIs) may cause symptoms of sexual dysfunction (see section 4).
Danish: Lægemidler som Duloxetine Zentiva (såkaldte SSRI/SNRI'er) kan give symptomer på seksuel dysfunktion (se afsnit 4).
English: In animal studies, duloxetine had no effect on male fertility, and effects in females were only evident at doses that caused maternal toxicity.
Danish: I dyrestudier, påvirker duloxetin ikke hanners fertilitet, og påvirkning af hunners fertilitet er kun set ved doser, som forårsagede maternel toksicitet.
English: 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: Der bør udvises forsigtighed, når duloxetin gives sammen med orale antikoagulantia eller antitrombotiske midler på grund af en potentiel øget risiko for blødning, der kan tilskrives en farmakodynamisk interaktion.
English: Your doctor may continue to give you Duloxetine Zentiva when you are feeling better to prevent your depression or anxiety from returning.
Danish: Din læge kan vælge at fortsætte din behandling med Duloxetine Zentiva efter, at du har fået det bedre for at forebygge, at din depression eller angst skal vende tilbage.
English: • serious allergic reaction which causes difficulty in breathing or dizziness with swollen tongue or lips, allergic reactions;
Danish: • alvorlige allergiske reaktioner, som forårsager åndedrætsbesvær eller svimmelhed og hævelse af tunge eller læber, allergiske reaktioner
English: Suicidal behaviour5,7 Mania
Danish: Selvmords-relateret adfærd5,7
English: SPECIAL STORAGE CONDITIONS Store in the original package in order to protect from moisture.
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Opbevares i original emballage for at beskytte mod fugt.
English: Duloxetine Zentiva 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 Duloxetine Zentiva at virke indenfor de første to uger, men det kan vare 2-4 uger, før du får det bedre.
English: • menopausal symptoms, abnormal production of breast milk in men or women.
Danish: • symptomer på overgangsalder, unormal mælkeproduktion hos mænd og kvinder
English: • night sweats, hives, cold sweats, sensitivity to sunlight, increased tendency to bruise;
Danish: • natlig sveden, nældefeber, koldsved, øget følsomhed over for sollys, øget tendens til blå mærker
English: Do not take Duloxetine Zentiva if you:
Danish: Tag ikke Duloxetine Zentiva hvis du:
English: During the 52-week placebocontrolled double blind treatment phase 14.4% of the duloxetine-treated patients and 33.1% of the placebo-treated patients experience a return of their depressive symptoms (p < 0.001).
Danish: I løbet af den 52 uger lange placebo-kontrollerede dobbeltblinde behandlingsperiode oplevede 14,4 % af de duloxetin-behandlede patienter og 33,1 % af de placebo- behandlede patienter en tilbagevenden af deres depressive symptomer (p<0,001).
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 5hydroxyl 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: Excipient(s) with known effect: each capsule contains 84.51 - 93.14 mg of sucrose.
Danish: Hjælpestof, som behandleren skal være opmærksom på: Hver kapsel indeholder 84,51 - 93,14 mg saccharose.
English: You should use Duloxetine Zentiva only after discussing the potential benefits and any potential risks to your unborn child with your doctor.
Danish: Du må kun tage Duloxetine Zentiva efter, at du har talt med din læge om de mulige fordele for dig og de mulige risici for dit ufødte barn.
English: When duloxetine was administered at a dose of 60 mg twice daily with a single dose of desipramine, a CYP2D6 substrate, the AUC of desipramine increased 3-fold.
Danish: Når duloxetin blev givet i doser af 60 mg to gange daglig sammen med en enkelt dosis af desipramin, et CYP2D6-substrat, blev AUC for desipramin forøget 3 gange.
English: • headache, feeling sleepy;
Danish: • hovedpine, søvnighed
English: Over the entire 36-week course of the study, 6 out of 333 patients initially randomized to duloxetine and 3 out of 225 patients initially randomized to fluoxetine experienced suicidal behaviour (exposure adjusted incidence 0.039 events per patient year for duloxetine, and 0.026 for fluoxetine).
Danish: I løbet af studiets 36 ugers varighed udviste 6 ud af 333 patienter, som initialt var randomiseret til duloxetin, og 3 ud af 225 patienter initialt randomiseret til fluoxetin selvmordsrelateret adfærd (eksponeringsjusteret forekomst var 0,039 hændelser pr. patientår for duloxetin og 0,026 for fluoxetin).
English: Major Depressive Disorder and Generalised Anxiety Disorder Depression is associated with an increased risk of suicidal thoughts, self-harm and suicide (suiciderelated 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: Medicinal products metabolised by CYP2D6
Danish: Lægemidler, der metaboliseres via CYP2D6
English: Capsule content: sucrose, maize starch, hypromellose, talc, hypromellose acetate succinate, triethyl citrate.
Danish: Kapselindhold: Saccharose, majsstivelse, hypromellose, talcum, hypromelloseacetatsuccinat, triethylcitrat.
English: Tachycardia Supra-ventricular arrhythmia, mainly atrial fibrillation
Danish: Supra- ventrikulær arytmi, hovedsagelig atrieflimren
English: 8 Falls were more common in the elderly (≥ 65 years old) 9 Estimated frequency based on all clinical trial data.
Danish: 8 Fald var hyppigst hos ældre (≥65 år) 9 Estimeret hyppighed baseret på alle kliniske studiedata 10 Estimeret hyppighed baseret på placebokontrollerede kliniske studier
English: As with other medicinal products with similar pharmacological action (antidepressants), isolated cases of suicidal ideation and suicidal behaviours have been reported during duloxetine therapy or early after treatment discontinuation.
Danish: Som for andre lægemidler med lignende farmakologisk virkning (antidepressiva) er der blevet rapporteret isolerede tilfælde af selvmordsforestillinger og -adfærd under duloxetin-behandling eller kort efter behandlingsophør.
English: • generalised anxiety disorder (chronic feeling of anxiety or nervousness);
Danish: • angst (kronisk fornemmelse af angst og nervøsitet)
English: In patients with co-morbid major depressive disorder, the starting and maintenance dose is 60 mg once daily (please see also dosing recommendation above).
Danish: Til patienter med samtidig svær depression er begyndelses- og vedligeholdelsesdosis 60 mg en gang daglig (se også ovenstående dosisanbefaling).
English: The study included a 13weekdouble-blind period where patients were randomised to duloxetine 30 mg/60 mg, or placebo daily.
Danish: Studiet inkluderede en 13 ugers dobbeltblindet periode hvor patienter blev randomiseret til duloxetin 30 mg/60 mg eller placebo dagligt.
English: The antibiotic linezolid is a reversible non-selective MAOI and should not be given to patients treated with duloxetine (see section 4.4).
Danish: Det antibiotiske lægemiddel linezolid er en reversibel ikke-selektiv MAOhæmmer og bør ikke gives til patienter, der er i behandling med duloxetin (se pkt.
English: • Duloxetine Zentiva 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: • Duloxetine Zentiva kan medføre bivirkninger, som du måske ikke er opmærksom på, f.eks. forhøjede leverenzymer eller forhøjede værdier af kalium, kreatinfosfokinase, sukker eller kolesterol i blodet
English: Duloxetine Zentiva is for oral use.
Danish: Duloxetine Zentiva er til oral brug.
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 human mælk er ca. 7 µg/dag under en dosering på 40 mg to gange daglig.
English: Despite this, your doctor may prescribe Duloxetine Zentiva for patients under 18 because he/she decides that this is in their best interests.
Danish: På trods af dette kan din læge ordinere Duloxetine Zentiva til patienter under 18 år, hvis lægen skønner, at det er til patientens bedste.
English: Anaphylactic reaction Hyper-sensitivity
Danish: Anafylaktisk reaktion Over-følsomhed
English: Each capsule of Duloxetine Zentiva contains pellets of duloxetine hydrochloride with a covering to protect them from stomach acid.
Danish: Hver Duloxetine Zentiva kapsel indeholder pellets af duloxetinhydrochlorid med en belægning, som beskytter dem mod mavesyre.
English: You should ask your doctor or pharmacist for advice.
Danish: Spørg din læge eller apotekspersonalet til råds.
English: If you take more Duloxetine Zentiva than you should Call your doctor or pharmacist immediately if you take more than the amount of Duloxetine Zentiva prescribed by your doctor.
Danish: Hvis du har taget for meget Duloxetine Zentiva Kontakt omgående lægen eller apotekspersonalet, hvis du har taget mere Duloxetine Zentiva, end lægen har ordineret.
English: Due to the risk of serotonin syndrome, duloxetine should not be used in combination with non-selective irreversible monoamine oxidase inhibitors (MAOIs), or within at least 14 days of discontinuing treatment with an MAOI.
Danish: På grund af risikoen for serotoninsyndrom må duloxetin ikke anvendes sammen med ikke-selektive, irreversible monoaminoxidasehæmmere (MAO-hæmmere) eller i mindst 14 dage efter afbrudt behandling med en MAO-hæmmer.
English: • painful urination, frequent urination;
Danish: • smertefuld vandladning, hyppig vandladning
English: Hypo-thyroidism
Danish: Hypo-tyreoidisme
English: You must wait at least 14 days after you have stopped taking an MAOI before you can take Duloxetine Zentiva.
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 Duloxetine Zentiva.
English: Duloxetine Zentiva may make you feel sleepy or dizzy.
Danish: Duloxetine Zentiva kan gøre dig søvnig og svimmel.
English: Also, the long-term safety effects concerning growth, maturation, and cognitive and behavioural development of duloxetine 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 Duloxetine Zentiva.
English: • increased blood pressure, flushing;
Danish: • forhøjet blodtryk, rødmen
English: Co-administration of duloxetine with aluminium- and magnesium-containing antacids or duloxetine with famotidine had no significant effect on the rate or extent of duloxetine absorption after administration of a 40 mg oral dose.
Danish: Samtidig administration af duloxetin med aluminium- og magnesiumholdige antacida eller med famotidin har ingen signifikant virkning på absorptionshastigheden eller absorptionsfraktionen af duloxetin efter en oral dosis på 40 mg.
English: Duloxetine Zentiva increases the levels of serotonin and noradrenaline in the nervous system.
Danish: Duloxetine Zentiva øger indholdet af serotonin og noradrenalin i nervesystemet.
English: Duloxetine is a moderate inhibitor of CYP2D6.
Danish: Duloxetin er en moderat CYP2D6-hæmmer.
English: Interstitial lung disease10
Danish: Interstitiel lungesygdom10
English: 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: Da CYP1A2 er involveret i metaboliseringen af duloxetin, vil samtidig behandling med duloxetin og potente CYP1A2-hæmmere sandsynligvis medføre højere koncentrationer af duloxetin.
English: A total of 509 paediatric patients aged 7 to 17 years with major depressive disorder and 241 paediatric patients aged 7 to 17 years with generalised anxiety disorder were treated with duloxetine in clinical trials.
Danish: I alt blev 509 pædiatriske patienter i alderen 7 til 17 år med svær depression og 241 pædiatriske patienter i alderen 7 til 17 år med generaliseret angst behandlet med duloxetin i kliniske studier.
English: Do not use this medicine after the expiry date which is stated on the carton/blister after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.