FrancophonIA/ELRC3.0 huggingface dataset:
English: You must wait at least 14 days after you have stopped taking an MAOI before you can take DULOXETINE BOEHRINGER INGELHEIM.
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 DULOXETIN BOEHRINGER INGELHEIM.
English: To help you remember to take DULOXETINE BOEHRINGER INGELHEIM, you may find it easier to take it at the same times every day.
Danish: Det kan være lettere at huske at tage DULOXETIN BOEHRINGER INGELHEIM, hvis du tager det på samme tidspunkt hver dag.
English: Based on the half-life of duloxetine, at least 5 days should be allowed after stopping DULOXETINE BOEHRINGER INGELHEIM before starting an MAOI (see section 4.3).
Danish: På baggrund af duloxetins halveringstid skal der gå mindst 5 dage efter endt behandling med DULOXETINE BOEHRINGER INGELHEIM, før en behandling med en MAO-hæmmer påbegyndes (se afsnit 4.3).
English: Your doctor should decide whether you can take DULOXETINE BOEHRINGER INGELHEIM with other medicines.
Danish: Din læge bør afgøre om DULOXETIN BOEHRINGER INGELHEIM kan tages sammen med anden medicin.
English: In the 12 week acute phase of three clinical trials of duloxetine in patients with diabetic neuropathic pain, small but statistically significant increases in fasting blood glucose were observed in duloxetinetreated patients HbA1c was stable in both duloxetine-treated and placebo-treated patients.
Danish: I de kliniske 12-ugers akut fase duloxetin forsøg med patienter med diabetisk neuropatisk smerte blev der observeret en lille men statistisk signifikant stigning i faste blodglucose hos duloxetinbehandlede patienter.HbA1C var stabilt hos både duloxetin-behandlede og placebo-behandlede patienter.
English: For patients not experiencing somnolence, clinical response was observed in 47% of patients receiving duloxetine and 27% patients on placebo.
Danish: Hos patienter, som ikke havde oplevet somnolens, blev der observeret klinisk respons hos 47 % af de duloxetinbehandlede patienter og 27 % af de placebobehandlede patienter.
English: 4Cases of aggression and anger have been reported particularly early in treatment of after treatment discontinuation.
Danish: 4 Sager med aggression og angst er blevet rapporteret, især tidligt i behandlingen eller efter behandlingsophør.
English: Also, you need to wait at least 5 days after you stop taking DULOXETINE BOEHRINGER INGELHEIM before you take a MAOI.
Danish: Du skal ligeledes vente mindst 5 dage, efter at du er holdt op med at tage DULOXETIN BOEHRINGER INGELHEIM, før du må begynde at tage en MAO-hæmmer.
English: For selective, reversible MAOIs, like moclobemide, the risk of serotonin syndrome is lower.
Danish: Risikoen for serotoninsyndrom for selektive, reversible MAO-hæmmere som moclobemid er lavere.
English: Monoamine Oxidase Inhibitors (MAOIs): due to the risk of serotonin syndrome, DULOXETINE BOEHRINGER INGELHEIM should not be used in combination with nonselective irreversible monoamine oxidase inhibitors (MAOIs), or within at least 14 days of discontinuing treatment with an
Danish: Monoaminoxidasehæmmere (MAO-hæmmere): På grund af risikoen for serotoninsyndrom må DULOXETINE BOEHRINGER INGELHEIM ikke anvendes sammen med ikke-selektive, irreversible monoaminoxidasehæmmere (MAO-hæmmere) eller i mindst 14 dage efter afbrudt behandling med en MAO-hæmmer.
English: CNS medicinal products: the risk of using duloxetine in combination with other CNS-active medicinal products has not been systematically evaluated, except in the cases described in this section.
Danish: CNS-lægemidler: Foruden de nedenfor nævnte interaktioner er risikoen ved brug af duloxetin i kombination med andre CNS-aktive lægemidler ikke blevet systematisk undersøgt.
English: If you take more DULOXETINE BOEHRINGER INGELHEIM than you should Call your doctor or pharmacist immediately if you take more than the amount of DULOXETINE BOEHRINGER INGELHEIM prescribed by your doctor.
Danish: Hvis du har taget for meget DULOXETIN BOEHRINGER INGELHEIM Kontakt omgående lægen eller apoteket, hvis du har taget mere DULOXETIN BOEHRINGER INGELHEIM, end lægen har ordineret.
English: Cases of overdoses, alone or in combination with other medicinal products, with duloxetine doses of 5400mg were reported.
Danish: Der er rapporteret tilfælde af overdosering af duloxetin, alene eller i kombination med andre lægemidler, i doser på 5400 mg. Der er sket dødsfald, hovedsageligt med samtidig overdosering af andre lægemidler.
English: However, caution should be exercised when treating the elderly (see section
Danish: Det er en generel anbefaling, at der bør udvises forsigtighed ved behandling af ældre (se pkt.
English: In the 12 week acute phase of three clinical trials of duloxetine in patients with diabetic neuropathic pain, small but statistically significant increases in fasting blood glucose were observed in duloxetinetreated patients.
Danish: I de kliniske 12-ugers akut fase duloxetin forsøg med patienter med diabetisk neuropatisk smerte blev der observeret en lille men statistisk signifikant stigning i faste blodglucose hos duloxetinbehandlede patienter.
English: When stopping treatment with DULOXETINE BOEHRINGER INGELHEIM 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 DULOXETINE BOEHRINGER INGELHEIM skal dosis gradvis reduceres over en periode på mindst en til to uger for at mindske risikoen for seponeringssymptomer (se pkt.
English: Metabolism and Nutrition Disorders Decreased
Danish: Metabolisme og ernæring Nedsat appetit
English: • depression, anxiety and urinary incontinence.
Danish: • depression, angst og stressinkontinens
English: Effects of other medicinal products on duloxetine Antacids and H2 antagonists: co-administration of duloxetine with aluminium- and magnesiumcontaining 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: Antacida og H2-antagonister: 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: Caution is advised if DULOXETINE BOEHRINGER INGELHEIM is co-administered with medicinal products that are predominantly metabolised by CYP2D6 (risperidone, tricyclic antidepressants [TCAs] such as nortriptyline, amitriptyline, and imipramine) particularly if they have a narrow therapeutic index (such as flecainide, propafenone and metoprolol).
Danish: Det anbefales at udvise forsigtighed ved administration af DULOXETINE BOEHRINGER INGELHEIM sammen med præparater, som hovedsageligt metaboliseres via CYP2D6 (risperidon, tricycliske antidepressiva [TCA'er] såsom nortriptylin, amitriptylin og imipramin), specielt hvis disse præparater har et snævert terapeutisk indeks (som f.eks. flecainid, propafenon og metoprolol).
English: Therefore DULOXETINE BOEHRINGER INGELHEIM should not be administered in combination with potent inhibitors of CYP1A2 like fluvoxamine (see section 4.3).
Danish: Behandling med DULOXETINE BOEHRINGER INGELHEIM bør derfor ikke kombineres med potente CYP1A2-hæmmere som fluvoxamin (se pkt.
English: 5Cases of suicidal ideation and suicidal behaviours have been reported during duloxetine therapy or early after treatment discontinuation (see section 4.4)
Danish: 5 Sager med selvmordsforestillinger og -adfærd er blevet rapporteret under duloxetinbehandling eller tidligt efter behandlingsophør (se pkt.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 8th October 2008
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN
English: General Disorders and Administration Site Conditions Fatigue
Danish: Almene symptomer og reaktioner på administrationsstedet Træthed
English: The main ingredient of DULOXETINE BOEHRINGER INGELHEIM, duloxetine, is used in other medicines for other conditions:
Danish: Det aktive stof (duloxetin) i DULOXETIN BOEHRINGER INGELHEIM bruges i andre lægemidler mod andre tilstande:
English: • grinding of teeth, feeling hot/cold, thirst, throat tightness, nose bleeds
Danish: • tænderskæren, dehydrering, varm/kold følelse, tørst, halssammensnøring eller næseblod
English: Important information about some of the ingredients of DULOXETINE BOEHRINGER INGELHEIM
Danish: Vigtig information om nogle af de øvrige indholdsstoffer i DULOXETIN BOEHRINGER INGELHEIM
English: DULOXETINE BOEHRINGER INGELHEIM may be associated with sedation and dizziness.
Danish: DULOXETINE BOEHRINGER INGELHEIM kan være forbundet med sedation og svimmelhed.
English: In clinical trials adverse events seen on abrupt treatment discontinuation occurred in approximately 45% of patients treated with DULOXETINE BOEHRINGER INGELHEIM and 23% of patients taking placebo.
Danish: I kliniske forsøg er der observeret utilsigtede hændelser ved pludselig afbrydelse af behandlingen hos ca. 45 % og 23 % af patienterne behandlet med hhv. DULOXETINE BOEHRINGER INGELHEIM og placebo.
English: However, the concomitant use of DULOXETINE BOEHRINGER INGELHEIM with selective, reversible MAOIs is not recommended (see section 4.4).
Danish: Samtidig brug af DULOXETINE BOEHRINGER INGELHEIM og selektive, reversible MAOhæmmere anbefales dog ikke (se pkt.
English: DULOXETINE BOEHRINGER INGELHEIM is for oral use.
Danish: DULOXETIN BOEHRINGER INGELHEIM er til oral brug.
English: Store in the original package.
Danish: Opbevares i den originale yderemballage.
English: Hyponatremia
Danish: Hyponatriæmi
English: Rare side effects (these can affect from 1 to 10 users in 10,000 patients treated)
Danish: Sjældne bivirkninger (det sker hos mellem 1 til 10 ud af 10.000 patienter)
English: Caution should be exercised when using DULOXETINE BOEHRINGER INGELHEIM in combination with antidepressants.
Danish: Der bør udvises forsigtighed ved samtidig brug af DULOXETINE BOEHRINGER INGELHEIM og antidepressiva.
English: Hypersensitivity disorder Anaphylactic reaction
Danish: Overfølsomhed Anafylaktisk reaktion
English: DULOXETINE BOEHRINGER INGELHEIM should not be used in combination with fluvoxamine, ciprofloxacin or enoxacine (i.e. potent CYP1A2 inhibitors) since the combination results in elevated plasma concentrations of duloxetine (see section 4.5).
Danish: DULOXETINE BOEHRINGER INGELHEIM må ikke anvendes sammen med potente CYP1A2 hæmmere, som fluvoxamin, ciprofloxacin og enoxacin, idet kombinationen resulterer i forhøjet plasmakoncentration af duloxetin (se pkt.
English: • tremor or numbness, including numbness or tingling of the skin
Danish: • rysten eller følelsesløshed, inklusive følelsesløshed eller prikken/snurren i huden
English: • abnormal periods, including heavy or prolonged periods
Danish: • unormal menstruation med kraftig eller forlænget blødning
English: 2Cases 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 3 Se pkt 4.4.
English: If a decision to initiate antidepressant pharmacological therapy is taken, the gradual discontinuation of DULOXETINE BOEHRINGER INGELHEIM is recommended (see Section 4.2).
Danish: Hvis det vurderes, at der skal iværksættes en farmakologisk antidepressiv behandling, bør DULOXETINE BOEHRINGER INGELHEIM gradvist seponeres (se pkt.
English: (See end of Section 2 for further information on sucrose) Capsule shell: gelatin, sodium lauryl sulphate, titanium dioxide (E171), indigo carmine (E132), iron oxide yellow (E172) (60 mg only) and edible green ink (30 mg) or edible white ink (60 mg).
Danish: 2 for yderligere information om saccharose) Kapsellåg og -bund: Gelatine, natriumlaurilsulfat, titandioxid (E171), indigotin (E132), gul jernoxid (E172) (kun i 60 mg) og Edible Green Ink (30 mg) eller Edible White Ink (60 mg).
English: Special populations:
Danish: Særlige patientgrupper:
English: Acute liver injury
Danish: Akut leverskade
English: Undesirable effects may be more common during concomitant use of DULOXETINE BOEHRINGER INGELHEIM and herbal preparations containing St John's wort (Hypericum perforatum).
Danish: Uønskede virkninger kan forekomme hyppigere ved samtidig brug af DULOXETINE BOEHRINGER INGELHEIM og naturlægemidler samt kosttilskud indeholdende perikon (hypericum perforatum).
English: The plasma concentration of duloxetine displays large inter-individual variability (see 5.2).
Danish: Der ses store inter-individuelle variationer i plasmakoncentrationen af duloxetin (se pkt.
English: Caution is advisable if DULOXETINE BOEHRINGER INGELHEIM is used concomitantly with serotonergic antidepressants like SSRIs, tricyclics like clomipramine or amitriptyline, St John's wort (Hypericum perforatum), venlafaxine or triptans, tramadol, pethidine and tryptophan.
Danish: Det anbefales at udvise forsigtighed, hvis DULOXETINE BOEHRINGER INGELHEIM anvendes sammen med serotonerge antidepressiva som SSRI-præparater, tricykliske præparater (f.eks. clomipramin eller amitriptylin), perikon (hypericum perforatum), venlafaxin eller triptaner, tramadol, pethidin og tryptophan.
English: DULOXETINE BOEHRINGER INGELHEIM is available in two strengths: 30 and 60 mg.
Danish: DULOXETIN BOEHRINGER INGELHEIM findes i 2 styrker: 30 og 60 mg.
English: A MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLER(E) ANSVARLIG(E) FOR BATCHFRIGIVELSE
English: Constipation Diarrhoea Vomiting Dyspepsia Flatulence
Danish: Opkastning Dyspepsi Flatulens
English: Dizziness, sensory disturbances (including paraesthesia), sleep disturbances (including insomnia and intense dreams), agitation or anxiety, nausea and/or vomiting, tremor ,headache, irritability, diarrhoea, hyperhydrosis and vertigo are the most commonly reported reactions.
Danish: De mest almindelige bivirkninger er svimmelhed, sensoriske forstyrrelser (inklusive paræstesi), søvnforstyrrelser (inklusive søvnløshed og intense drømme), opstemthed eller angst, kvalme og/eller opkastning, rysten, hovedpine, irritabilitet, diaré, hyperhidrosis og vertigo.
English: Use in children and adolescents under 18 years of age DULOXETINE BOEHRINGER INGELHEIM should normally not be used for children and adolescents under 18 years.
Danish: DULOXETIN BOEHRINGER INGELHEIM bør normalt ikke bruges til behandling af børn og unge under 18 år.
English: Gastroenteritis Eructation Gastritis
Danish: Gastroenteritis Opstød
English: As the safety of duloxetine in infants is not known, the use of DULOXETINE BOEHRINGER INGELHEIM while breast-feeding is not recommended.
Danish: Eftersom sikkerheden af duloxetin hos spædbørn ikke er kendt, frarådes behandling med DULOXETINE BOEHRINGER INGELHEIM i den periode der ammes.
English: Uncommon side effects (these can affect from 1 to 10 users in 1,000 patients treated)
Danish: Ikke almindelige bivirkninger (det sker hos mellem 1 til 10 ud af 1.000 patienter)
English: 3See section 4.4
Danish: 4.2 og 4.4).
English: Mania Hallucinations anger4
Danish: Hallucinationer Aggression og vrede4
English: • passing bright red blood in your stools, vomiting blood, or black tarry stools (faeces)
Danish: • frisk rødt blod i afføringen, opkastning af blod og sort tjærefarvet afføring
English: (reported especially in diabetic patients)
Danish: Hyperglykæmi (især rapporteret hos diabetikere)
English: feeling of being drunk, fever, sweating or rigid muscles)
Danish: beruselsesfornemmelse, feber, tendens til at svede eller muskelstivhed), kramper eller stivhed
English: Excipients: sucrose 17.2 mg.
Danish: Hjælpestof: Saccharose 8,6 mg
English: These medicines increase the risk of side effects; if you get any unusual symptom taking any of these medicines together with DULOXETINE BOEHRINGER INGELHEIM, you should see your doctor.
Danish: Oplever du uventede virkninger, mens du tager en af disse typer medicin sammen med DULOXETIN BOEHRINGER INGELHEIM, skal du kontakte din læge.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Boehringer Ingelheim International GmbH, Binger Str. 173 D-55216 Ingelheim am Rhein, Germany.
Danish: NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Boehringer Ingelheim International GmbH, Binger Str. 173 D-55216 Ingelheim am Rhein, Tyskland.
English: Musculoskeletal and connective tissue disorders Musculoskeletal pain
Danish: Knogler, led, muskler og bindevæv Musculoskeletale smerter
English: DULOXETINE BOEHRINGER INGELHEIM should not be used in patients with severe renal impairment (creatinine clearance <30 ml/min; see section 4.3).
Danish: DULOXETINE BOEHRINGER INGELHEIM bør ikke bruges til patienter med svært nedsat nyrefunktion (kreatinin-clearance < 30 ml/min; se pkt.
English: INFORMATION IN BRAILLE DULOXETINE BOEHRINGER INGELHEIM 30 mg
Danish: INFORMATION I BRAILLE-SKRIFT DULOXETINE BOEHRINGER INGELHEIM 30 mg
English: Edible White Ink: titanium dioxide (E171), propylene glycol, shellac, povidone.
Danish: Edible White Ink: Titandioxid (E171), propylenglycol, shellac og povidon.
English: The initiation of treatment with DULOXETINE BOEHRINGER INGELHEIM is contraindicated in patients with uncontrolled hypertension that could expose patients to a potential risk of hypertensive crisis (see sections 4.4 and 4.8).
Danish: For patienter med ukontrolleret hypertension, er der kontraindikation for opstart af behandling med DULOXETINE BOEHRINGER INGELHEIM, da det kan udsætte patienterne for en potentiel risiko for hypertensive kriser (se pkt.
English: Duloxetine is very weakly excreted into human milk based on a study of 6 lactating patients, who did not breast feed their children .
Danish: Dette er baseret på et forsøg med 6 mælkeproducerende patienter, der ikke ammede deres børn.
English: INFORMATION IN BRAILLE DULOXETINE BOEHRINGER INGELHEIM 60 mg
Danish: INFORMATION I BRAILLE-SKRIFT DULOXETINE BOEHRINGER INGELHEIM 60 mg
English: MARKETING AUTHORISATION HOLDER Boehringer Ingelheim International GmbH, Binger Str. 173 D-55216 Ingelheim am Rhein, Germany.
Danish: INDEHAVER AF MARKEDSFØRINGSTILLADELSEN Boehringer Ingelheim International GmbH, Binger Str. 173 D-55216 Ingelheim am Rhein, Tyskland.
English: • diarrhoea, constipation, being sick (vomiting), heartburn, breaking wind, stomach pain
Danish: • diarré forstoppelse, opkastning, halsbrand eller luft i maven, mavesmerter
English: DULOXETINE BOEHRINGER INGELHEIM may make you feel sleepy of dizzy.
Danish: DULOXETIN BOEHRINGER INGELHEIM kan gøre dig søvnig og svimmel.
English: - are taking other medicines to treat depression(see ‘Taking other medicines') - are taking St. John's Wort, a herbal treatment (Hypericum perforatum) - have kidney disease - have had seizures (fits) - have had mania - suffer from bipolar disorder - have eye problems, such as certain kinds of glaucoma (increased pressure in the eye) - have a history of bleeding disorders (tendency to develop bruises) - are at risk of low sodium levels - are currently being treated with another medicine which may cause liver damage - are taking other medicines containing duloxetine - have intolerance to some sugars (see end of Section 2) - are considering stopping DULOXETINE BOEHRINGER INGELHEIM (see section 3)
Danish: - tidligere har haft krampeanfald - tidligere har haft mani - lider af bipolar sygdom - har øjenproblemer, såsom visse typer af grøn stær (glaukom - forøget tryk i øjet) - tidligere har lidt af blødningsforstyrrelser (tendens til blå mærker) - har risiko for at få lavt indhold af natrium i blodet.
English: Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder: Boehringer Ingelheim International GmbH, Binger Str. 173 D-55216 Ingelheim am Rhein, Germany.
Danish: Indehaver af markedsføringstilladelsen og fremstiller Indehaver af markedsføringstilladelsen: Boehringer Ingelheim International GmbH, Binger Str. 173 D55216 Ingelheim am Rhein, Tyskland.
English: Edible green ink: black iron oxide-synthetic (E172), yellow iron oxide- synthetic (E172), propylene glycol, shellac.
Danish: Edible Green Ink: Syntetisk sort jernoxid (E172), syntetisk gul jernoxid (E172), propylenglycol og shellac.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 60 mg of duloxetine (as hydrochloride).
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver kapsel indeholder 60 mg duloxetin (som hydrochlorid).
English: • muscle pain, muscle tightness, muscle spasm
Danish: • muskelsmerter, muskelstivhed eller muskelkramper
English: • throat inflammation
Danish: • krampeanfald
English: Vertigo Ear pain Respiratory, thoracic and mediastinal disorders Yawning
Danish: Luftveje, thorax og mediastinum Gaben
English: • tasting things differently than usual, disturbance in attention, stiffness, spasms and involuntary movements of the muscles, muscle twitching, abnormal manner of walking
Danish: • ændret smagsoplevelse, koncentrationsbesvær, spasmer og ufrivillige bevægelser af musklerne,
English: If your doctor has prescribed DULOXETINE BOEHRINGER INGELHEIM for a patient under 18 and you want to discuss this, please go back to your doctor.
Danish: Du bedes henvende dig til din læge, hvis din læge har udskrevet DULOXETIN BOEHRINGER INGELHEIM til en patient under 18 år, og du gerne vil diskutere dette.
English: Very common side effects (these can affect more than 10 in 100 patients treated)
Danish: Almindelige bivirkninger (det sker hos mellem 1 til 10 ud af 100 patienter)
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 60 mg hard gastro-resistant capsules
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTERKORT ELLER BLISTERSTRIPS 60 MG HÅRDE ENTEROKAPSLER
English: Hypromellose.
Danish: Triethylcitrat.
English: DULOXETINE BOEHRINGER INGELHEIM 30 mg is available in packs of 7, 28 and 98 capsules.
Danish: DULOXETINE BOEHRINGER INGELHEIM 30 mg findes i pakninger med 7, 28 og 98 kapsler.
English: Angio-neurotic oedema StevensJohnson Syndrome
Danish: StevensJohnsons syndrom
English: Severe renal impairment (creatinine clearance <30 ml/min) (see section 4.4).
Danish: Svært nedsat nyrefunktion (kreatinin-clearance < 30 ml/min.).
English: DULOXETINE BOEHRINGER INGELHEIM 60 mg is available in packs of 28 and 98 capsules.
Danish: DULOXETINE BOEHRINGER INGELHEIM 60 mg findes i pakninger med 28 og 98 kapsler.
English: What DULOXETINE BOEHRINGER INGELHEIM looks like and contents of the pack DULOXETINE BOEHRINGER INGELHEIM is a hard gastro-resistant capsule Each capsule of DULOXETINE BOEHRINGER INGELHEIM contains pellets of duloxetine hydrochloride with a covering to protect them from stomach acid.
Danish: Hver DULOXETIN BOEHRINGER INGELHEIM-kapsel indeholder pellets af det aktive stof med en belægning, som beskytter dem mod mavesyre.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Boehringer Ingelheim
Danish: INDEHAVER AF MARKEDSFØRINGSTILLADELSEN Boehringer Ingelheim UDLØBSDATO EXP {MM/ÅÅÅÅ}
English: Concomitant use of DULOXETINE BOEHRINGER INGELHEIM with nonselective, irreversible Monoamine Oxidase Inhibitors (MAOIs) is contraindicated (see section 4.5).
Danish: DULOXETINE BOEHRINGER INGELHEIM må ikke anvendes sammen med ikke-selektive, irreversible monoaminoxidase-hæmmere - MAO-hæmmere (se pkt.
English: Mania and seizures
Danish: • svimmelhed og ørepine
English: The 30 mg capsules has an opaque white body, imprinted with ‘30 mg' and an opaque blue cap, imprinted with ‘9543'.
Danish: 30 mg kapslerne har mat hvid bund med påskriften "30 mg" og mat blå top med påskriften "9543".
English: Renal impairment: end stage renal disease (ESRD) patients receiving dialysis had 2-fold higher duloxetine Cmax and AUC values compared with healthy subjects.
Danish: Nedsat nyrefunktion: Patienter med terminal nyresygdom i dialysebehandling havde et dobbelt så højt duloxetin-Cmaks.
English: The 60 mg capsules has an opaque green body, imprinted with ‘60 mg' and an opaque blue cap, imprinted with ‘9542'.
Danish: 60 mg kapslerne har mat grøn bund med påskriften "60 mg" og mat blå top med påskriften "9542".
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/471/003-005
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/08/471/003-005