natgillin/translations-raw huggingface dataset:
3 Perikum Uønskede virkninger kan forekomme hyppigere ved samtidig brug af DULOXETINE BOEHRINGER INGELHEIM og naturlægemidler samt kosttilskud indeholdende perikum (Hypericum perforatum).
3 St John’ s wort Undesirable effects may be more common during concomitant use of DULOXETINE BOEHRINGER INGELHEIM and herbal preparations containing St John’ s wort (Hypericum perforatum).
Mydriasis Der er rapporteret om tilfælde af mydriasis i forbindelse med duloxetin, og der skal derfor udvises forsigtighed ved udskrivning af duloxetin til patienter med forhøjet intraokulært tryk eller til patienter med risiko for akut snævervinklet glaukom.
Mydriasis Mydriasis has been reported in association with duloxetine, therefore, caution should be used when prescribing duloxetine in patients with increased intraocular pressure, or those at risk of acute narrow- angle glaucoma.
DULOXETINE BOEHRINGER INGELHEIM og placebo.
In a clinical trial adverse events seen on abrupt treatment discontinuation occurred in approximately 44% of patients treated with DULOXETINE BOEHRINGER INGELHEIM and 24% of patients taking placebo.
Risikoen for seponeringssymptomer set for SSRI og SNRI kan afhænge af flere faktorer blandt andet behandlingsvarigheden, dosis og hvor hurtigt dosis reduceres.
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.
Hyponatriæmi Hyponatriæmi er blevet rapporteret, hovedsagligt hos ældre, i sjældne tilfælde ved indgivelse af DULOXETINE BOEHRINGER INGELHEIM.
Hyponatremia Hyponatremia has been reported rarely, predominantly in the elderly, when administering DULOXETINE BOEHRINGER INGELHEIM.
4 Depression, selvmordsforestillinger og - adfærd Selvom DULOXETINE BOEHRINGER INGELHEIM ikke er godkendt til behandling af depression, findes dets aktive lægemiddelstof (duloxetin) også i et antidepressivt lægemiddel.
Depression, suicidal ideation and behaviour Although DULOXETINE BOEHRINGER INGELHEIM is not indicated for the treatment of depression, its active ingredient (duloxetine) also exists as an antidepressant medication.
Depression er forbundet med en øget risiko for selvmordstanker, at forvolde skade på sig selv og selvmord (selvmordsrelaterede handlinger).
Depression is 4 associated with an increased risk of suicidal thoughts, self harm and suicide (suicide-related events).
4. 8).
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 Cases of suicidal thoughts and suicidal behaviours have been reported during duloxetine therapy or early after treatment discontinuation (see section 4.8).
Hvis patienten under DULOXETINE BOEHRINGER INGELHEIM- behandling, udvikler agitation eller depressive symptomer bør en specialist konsulteres, eftersom depression er en alvorlig medicinsk tilstand.
If while on DULOXETINE BOEHRINGER INGELHEIM therapy, the patient develops agitation or depressive symptoms, specialised medical advice should be sought, as depression is a serious medical condition.
4. 2).
If a decision to initiate antidepressant pharmacological therapy is taken, the gradual discontinuation of DULOXETINE BOEHRINGER INGELHEIM is recommended (see Section 4.2).
Saccharose DULOXETINE BOEHRINGER INGELHEIM- enterokapsler indeholder saccharose.
Sucrose DULOXETINE BOEHRINGER INGELHEIM gastro-resistant capsules contain sucrose.
Patienter med sjældne arvelige lidelser som fructoseintolerans, glucose- galactose- malabsorption eller invertase - isomaltase- insufficiens bør ikke tage denne medicin.
Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose- isomaltase insufficiency should not take this medicine.
På grund af risikoen for serotoninsyndrom må DULOXETINE BOEHRINGER INGELHEIM ikke anvendes sammen med ikke- selektive, irreversible monoaminooxidasehæmmere (MAO- hæmmere) samt i mindst 14 dage efter afbrudt behandling med en MAO- hæmmer.
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 MAOI.
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).
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).
Der er i sjældne tilfælde rapporteret om serotoninsyndrom hos patienter i behandling med SSRI- præparater (f. eks. paroxetin eller fluoxetin) sammen med serotonerge læge - midler.
5 Serotonin syndrome: in rare cases, serotonin syndrome has been reported in patients using SSRIs (e. g. paroxetine, fluoxetine) concomitantly with serotonergic medicinal products.
Det anbefales at udvise forsigtighed, hvis DULOXETINE BOEHRINGER INGELHEIM anvendes sammen med serotonerge antidepressiva som SSRI- præparater, tricykliske præparater (f. eks. clomipramin eller amitriptylin), perikum (Hypericum perforatum), venlafaxin eller triptaner, tramadol, petidin og tryptophan.
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.
Det anbefales at udvise forsigtighed, når DULOXETINE BOEHRINGER INGELHEIM tages sammen med andre centralt virkende lægemidler eller stoffer, herunder alkohol og sederende lægemidler (benzodiazepiner, morfinlignende præparater, antipsykotika, phenobarbital, sederende antihistaminer).
CNS medicinal products: caution is advised when DULOXETINE BOEHRINGER INGELHEIM is taken in combination with other centrally acting medicinal products or substances, including alcohol and sedative medicinal products (benzodiazepines, morphinomimetics, antipsychotics, phenobarbital, sedative antihistamines).
Det anbefales at udvise forsigtighed ved administration af duloxetin 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).
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).
Samtidig administration af DULOXETINE BOEHRINGER INGELHEIM 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.
Effects of other medicinal products on duloxetine Antacids and H2 antagonists: co-administration of DULOXETINE BOEHRINGER INGELHEIM with aluminium- and magnesium-containing antacids or with famotidine had no significant effect on the rate or extent of duloxetine absorption after administration of a 40 mg oral dose.
Da CYP1A2 er involveret i metaboliseringen af duloxetin, vil samtidig behandling med DULOXETINE BOEHRINGER INGELHEIM og potente CYP1A2- hæmmere sandsynligvis medføre højere koncentrationer af duloxetin.
Inhibitors of CYP1A2: because CYP1A2 is involved in duloxetine metabolism, concomitant use of DULOXETINE BOEHRINGER INGELHEIM with potent inhibitors of CYP1A2 is likely to result in higher concentrations of duloxetine.
4. 3)
Therefore DULOXETINE BOEHRINGER INGELHEIM should not be administered in combination with potent inhibitors of CYP1A2 like fluvoxamine (see section 4.3).
6 CYP1A2- fremmere:
Inducers of CYP1A2:
Befolkningsfarmakokinetiske analyser har vist, at rygere har næsten 50% lavere plasmakoncentration af duloxetin sammenlignet med ikke- rygere.
Population pharmacokinetic studies analyses have shown that smokers have almost 50% lower plasma concentrations of duloxetine compared with non-smokers.
DULOXETINE BOEHRINGER INGELHEIM bør kun bruges under graviditeten, hvis de potentielle behandlingsfordele opvejer de potentielle risici for fosteret.
DULOXETINE BOEHRINGER INGELHEIM should be used in pregnancy 6 only if the potential benefit justifies the potential risk to the foetus.
4. 3).
As the safety of duloxetine in infants is not known, the use of DULOXETINE BOEHRINGER INGELHEIM while breast-feeding is not recommended.
De mest almindelige rapporterede bivirkninger hos patienter i behandling med DULOXETINE BOEHRINGER INGELHEIM i kliniske forsøg med SUI og andre lidelser i de nedre urinveje var kvalme, mundtørhed, træthed og forstoppelse.
Table 1 gives the adverse reactions observed from spontaneous reporting and in placebo-controlled clinical trials (comprising a total of 7976 patients, 4370 on duloxetine and 3606 on placebo) in SUI and other lower urinary tract disorders.
Dataanalysen af fire 12- ugers placebokontrollerede kliniske forsøg med patienter med SUI viste, at de rapporterede bivirkninger typisk indtrådte i den første uge af behandlingen.
The most commonly reported adverse events in patients treated with DULOXETINE BOEHRINGER INGELHEIM in clinical trials in SUI and other lower urinary tract disorders were nausea, dry mouth fatigue and constipation.
Forsøgene omfattede 958 duloxetinbehandlede patienter og 955 placebo - behandlede patienter.
The data analysis of four 12-week, placebo-controlled clinical trials in patients with SUI, including 958 duloxetine-treated and 955 placebo-treated patients, showed that the onset of the reported adverse events typically occurred in the first week of therapy.
Meget
7
sjælden
Very
Ikke almindelig
Very Common Uncommon Rare Very
Nervesystemet
Palpitations Nervous System Disorders
Palpitationer
Tachycardia
Serotonin - syndrom Psykomotorisk uro Kramper Akatisi Ekstra - pyramidale symptomer
Serotonin syndrome Psychomotor restlessness Convulsions AkathisiaExtrapyramidal symptoms
Udslæt Øget tendens til at få blå mærker Nattesved Koldsved
Rash Increased tendency to bruise
Lysfølsomheds reaktioner Kontaktderma - titis Nældefeber
Photo- sensitivity reactions Dermatitis
Meget Almindelig Ikke almindelig Sjælden Meget
Frequency not known
Ikke kendt
common
almindelig
contact Urticaria
Muskelspasmer Muskelstivhed Musculoskeletale smerter Trismus
Muscle spasm Muscle tightness Musculo- skeletal pain Trismus
Det endokrine system Metabolisme og ernæring
Endocrine disorders
Hypotyroidisme
Hypo- thyroidism Metabolism and Nutrition Disorders
Nedsat appetit Infektioner og parasitære sygdomme Vaskulære sygdomme
Appetite decreased
Almene symptomer og reaktioner på administrationsstedet Træthed (10, 9%)
General Disorders and Administration Site Conditions Fatigue (10.9%)
Mavesmerter Pruritus Svaghed
Abdominal pain Pruritus Weakness Chills
Generel utilpashed Generel unormal
Malaise Feeling hot Feeling abnormal Thirst
Kuldegysninger følelse Varmefølelse Tørst Immunsystemet Lever og galdeveje
disorders
Det reproduktive system og mammae
Hepato-biliary disorders
Hepatitis3 Forhøjede lever - enzymer (ALAT, ASAT, alkalisk fosfatase) Akut leverskade Menopausale symptomer Gynækologisk blødning
Hepatitis3 Elevated liver enzymes (ALT, AST, alkaline phosphatase) Acute liver injury
almindelig
Gynaecological haemorrhage
Psykiske forstyrrelser 1
Psychiatric Disorders 1
Søvnløshed Angst Søvnforstyr - relser Uro Nedsat libido
Insomnia Anxiety Sleep disorder Agitation Libido decreased
Der blev optaget elektrokardiogrammer for 755 duloxetinbehandlede patienter med SUI og 779 placebobehandlede patienter i kliniske 12- ugers forsøg.
Electrocardiograms were obtained from 755 duloxetine-treated patients with SUI and 779 placebo- treated patients in 12-week clinical trials.
Tabel 2 viser observerede bivirkninger fra spontane rapporter samt fra placebokontrollerede kliniske forsøg (omfattende en total på 5253 patienter – heraf fik 3289 patienter duloxetin og 1964 patienter fik placebo).
Diabetic Peripheral Neuropathic Pain Table 2 gives the adverse reactions observed from spontaneous reporting and in placebo-controlled clinical trials (comprising a total of 5253 patients, 3289 on duloxetine and 1964 on placebo).
De mest almindelige observerede bivirkninger hos patienter med diabetiske neuropatiske smerter i behandling med DULOXETINE BOEHRINGER INGELHEIM var: kvalme, hovedpine, svimmelhed og søvnighed.
The most commonly observed adverse reactions in patients with diabetic neuropathic pain treated with DULOXETINE BOEHRINGER INGELHEIM were: nausea; headache, dry mouth and somnolence.
almindelig
Very Rare
sjælden
Frequency not
10
common
Meget
known
Ikke almindelig
Weight decrease
Sjælden Meget
Weight increase Creatinine phosphokinase increase
Ikke kendt
Blood cholesterol increased
almindelig
Cardiac Disorders
sjælden
Palpitations
Vægtnedgang
Tachycardia
Vægtøgning Øget kreatinin - kinase
Supra- ventricular arrhythmia, mainly atrial fibrillation
Takykardi
Disorders
Hovedpine (13, 8%) Søvnighed (10, 7%) Øjne
Headache (13.8%) Somnolence (10.7%) Eye Disorders
Serotonin - syndrom Kramper Akatisi Psykomotorisk uro Ekstra - pyramidale symptomer
Serotonin syndrome Convulsions Akathisia Psychomotor restlessness Extra- pyramidal symptoms
Hud og subkutane væv
Polyuria Urine flow decreased
Udslæt Øget perspira - tion Nattesved
Skin and Subcutaneous Tissue Disorders
Brystsmerter
Chest pain
Overfølsomhed
Hyper- sensitivity
Lever og galdeveje
Very
Hepatitis3 Forhøjede lever - enzymer (ALAT, ASAT, alkalisk fosfatase) Akut leverskade
Common
Leversvigt Icterus
Uncommon
12
Rare
Meget
Very Rare
Almindelig
Frequency not
Ikke almindelig
disorder
Meget Almindelig Ikke almindelig Sjælden Meget
Hepato-biliary disorders
Ikke kendt
Hepatitis3 Elevated liver enzymes (ALT, AST, alkaline phosphatase)
almindelig
Hepatic failure Jaundice
sjælden
Acute liver injury
Aggression og angst5 Mani
behaviour4 Suicidal ideation4
Selvmords - forestilling4 Selvmords - adfærd4 Hallucinationer
AgitationLibid Bruxism o decreased Orgasm abnormal
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.
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.
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.
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 duloxetine- treated patients.
I denne periode var der stigninger i HbA1C både i duloxetin - og standardbehandling- grupperne, men den gennemsnitlige stigning var 0, 3% større i gruppen behandlet med duloxetin.
In the extension phase of these studies, which lasted up to 52 weeks, there was an increase in HbA1c in both the duloxetine and routine care groups, but the mean increase was 0.3% greater in the duloxetine- treated group.
Der var også en lille stigning i faste blodglucose og i total kolesterol hos de duloxetinbehandlede patienter i modsætning til gruppen, der modtog standard - behandling.
There was also a small increase in fasting blood glucose and in total cholesterol in
Her viste laboratorieprøverne en lille sænkning.
13 duloxetine-treated patients while those laboratory tests showed a slight decrease in the routine care group.
Der blev optaget elektrokardiogrammer for 528 duloxetinbehandlede patienter og 205 placebo - behandlede patienter med diabetisk neuropatisk smerte i kliniske 13- ugers forsøg.
Electrocardiograms were obtained from 528 duloxetine-treated and 205 placebo-treated patients with diabetic neuropathic pain in clinical trials lasting up to 13-weeks.
De hjertefrekvens - korrigerede QT- intervaller hos duloxetinbehandlede patienter adskilte sig ikke fra dem, der blev observeret i placebogruppen.
The heart rate-corrected QT interval in duloxetine-treated patients did not differ from that seen in placebo-treated patients.
Der blev ikke observeret nogen klinisk signifikante forskelle på QT -, PR -, QRS - eller QTcB- målinger mellem duloxetinbehandlede og placebobehandlede patienter.
No clinically significant differences were observed for QT, PR, QRS, or QTcB measurements between duloxetine- treated and placebo-treated patients.
Der er sket dødsfald, hovedsageligt med samtidig overdosering af 13 andre lægemidler.
Cases of overdoses, alone or in combination with other medicinal products, with duloxetine doses of 4800mg were reported.
I alle fire forsøg havde den duloxetinbehandlede gruppe en gennemsnitlig reduktion i Incontinece Episode Frequence (IEF) på 50% eller mere sammenlignet med 33% i den placebobehandlet gruppe.
Incontinence Episode Frequency: in all four studies the duloxetine-treated group had a 50% or greater median decrease in IEF compared with 33% in the placebo-treated group.
Virkningen af DULOXETINE BOEHRINGER INGELHEIM er ikke blevet undersøgt længere end 3 måneder i placebokontrollerede studier.
The efficacy of DULOXETINE BOEHRINGER INGELHEIM has not been evaluated for longer than 3 months in placebo-controlled studies.
Den kliniske fordel ved DULOXETINE BOEHRINGER INGELHEIM sammenlignet med placebo er ikke blevet undersøgt hos kvinder med let SUI, defineret i randomiserede forsøg som kvinder med IEF < 14 om ugen.
The clinical benefit of DULOXETINE BOEHRINGER INGELHEIM compared with placebo has not been demonstrated in women with mild SUI, defined in randomised trials as those with IEF < 14 per week.
For disse kvinder kan DULOXETINE BOEHRINGER INGELHEIM nok ikke yde nogen fordele udover det som konservativ livsstilsomlægninger kan bidrage med.
In these women, DULOXETINE BOEHRINGER INGELHEIM may provide no benefit beyond that afforded by more conservative behavioural interventions.
14 Livskvalitet:
Quality of Life:
Resultater fra livskvalitets - / Incontinence Quality of Life (I- QOL) undersøgelser viste sig signifikant forbedret i gruppen med duloxetinbehandlede patienter sammenlignet med placebo - gruppen (9, 2 mod 5, 9 i score forbedring, p < 0, 001).
Incontinence Quality of Life (I-QOL) questionnaire scores were significantly improved in the duloxetine-treated patient group compared with the placebo-treated group (9.2 versus 5.9 score improvement, p < .001).
Der er begrænset data som tyder på, at fordelene ved DULOXETINE BOEHRINGER INGELHEIM ikke mindskes hos kvinder med stressinkontinens, som tidligere er blevet opereret for inkontinens.
DULOXETINE BOEHRINGER INGELHEIM and Prior Continence Surgery: there are limited data that suggest that the benefits of DULOXETINE BOEHRINGER INGELHEIM are not diminished in women with stress urinary incontinence who have previously undergone continence surgery.
I løbet af et blindt, randomiseret, kontrolleret 12- ugers forsøg viste DULOXETINE BOEHRINGER INGELHEIM større reduktioner i IEF i forhold til enten placebo- behandlingen eller med bækkenbundsøvelser alene.
DULOXETINE BOEHRINGER INGELHEIM and Pelvic Floor Muscle Training (PFMT): during a 12- week blinded, randomised, controlled study, DULOXETINE BOEHRINGER INGELHEIM demonstrated greater reductions in IEF compared with either placebo treatment or with PFMT alone.
Kombinationsbehandling (duloxetin + bækkenbundsøvelser) viste større forbedring både med hensyn til brug af bind og tilstandsspecifikke livskvalitetsmålinger end DULOXETINE BOEHRINGER INGELHEIM alene eller bækkenbundsøvelser alene.
Combined therapy (duloxetine + PFMT) showed greater improvement in both pad use and condition- specific quality of life measures than DULOXETINE BOEHRINGER INGELHEIM alone or PFMT alone.
Hos patienter, som havde oplevet somnolens, blev der målt klinisk respons hos 60% af de duloxetinbehandlede patienter og 30% af de placebobehandlede patienter.
Clinical response rates in patients experiencing somnolence were 60% on duloxetine and 30% on placebo.
15 Duloxetin metaboliseres i udstrakt grad, og metabolitterne udskilles hovedsageligt med urinen.
Duloxetine is extensively metabolised and the metabolites are excreted principally in urine.
Duloxetin fremkaldte adfærdsmæssige bivirkninger hos afkommet i 16 et pre - / postnatal toxicitetstudie med rotter, hvor hunrotter blev udsat for systemiske påvirkninger under den maksimale kliniske eksponering (AUC).
In pre/ postnatal toxicity study in the rat, duloxetine induced adverse behavioural effects in the offspring at systemic exposures levels below maximum clinical exposure (AUC).
Hypromellose Hypromelloseacetatsuccinat Saccharose Saccharosekugler Talcum Titandioxid (E171) Triethylcitrat.
Hypromellose Acetate Succinate Sucrose Sugar spheres Talc Titanium dioxide (E171) Triethyl citrate.
DULOXETINE BOEHRINGER INGELHEIM 20 mg hårde enterokapsler
DULOXETINE BOEHRINGER INGELHEIM 20 mg hard gastro-resistant capsules.
19 Leverinsufficiens:
19 The therapeutic benefit should regularly (at least every three months) be reassessed.
20 Perikum Uønskede virkninger kan forekomme hyppigere ved samtidig brug af DULOXETINE BOEHRINGER INGELHEIM og naturlægemidler samt kosttilskud indeholdende perikum (Hypericum perforatum).
20 St John’ s wort Undesirable effects may be more common during concomitant use of DULOXETINE BOEHRINGER INGELHEIM and herbal preparations containing St John’ s wort (Hypericum perforatum).
DULOXETINE BOEHRINGER INGELHEIM og placebo.
In a clinical trial, adverse events seen on abrupt treatment discontinuation occurred in approximately 44% of patients treated with DULOXETINE BOEHRINGER INGELHEIM and 24% of patients taking placebo.
21 Depression, selvmordsforestillinger og - adfærd Selvom DULOXETINE BOEHRINGER INGELHEIM ikke er godkendt til behandling af depression, findes dets aktive lægemiddelstof (duloxetin) også i et antidepressivt lægemiddel.
21 Depression, suicidal ideation and behaviour Although DULOXETINE BOEHRINGER INGELHEIM is not indicated for the treatment of depression, its active ingredient (duloxetine) also exists as an antidepressant medication.
Hvis patienten under DULOXETINE BOEHRINGER INGELHEIM- behandling udvikler agitation eller depressive symptomer bør en specialist konsulteres, eftersom depression er en alvorlig medicinsk tilstand.
If while on DULOXETINE BOEHRINGER INGELHEIM therapy, the patient develops agitation or depressive symptoms, specialised medical advice should be sought, as depression is a serious medical condition.
22 4. 5 Interaktion med andre lægemidler og andre former for interaktion
22 4.5 Interaction with other medicinal products and other forms of interaction
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.
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.
In vitro studier viser, at duloxetin ikke inducerer CYP3A' s nedbrydende aktivitet.
Oral contraceptives and other steroidal agents: results of in vitro studies demonstrate that duloxetine does not induce the catalytic activity of CYP3A.
Behandling med DULOXETINE BOEHRINGER INGELHEIM bør derfor ikke kombineres med potente CYP1A2- hæmmere som fluvoxamin (se pkt.
Therefore DULOXETINE BOEHRINGER INGELHEIM should not be administered in combination with potent inhibitors of CYP1A2 like fluvoxamine (see section 4.3).