natgillin/translations-raw huggingface dataset:
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Du kan finde yderligere information om Xyrem på Det europæiske Lægemiddelagenturs (EMEAs) hjemmeside: http: // www. emea. europa. eu /
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu/
Det aktive stof i Yentreve er duloxetin, der hæmmer genoptagelsen af serotonin- noradrenalin (SNRI).
The active substance in Yentreve, duloxetine, is a serotonin-noradrenaline re-uptake inhibitor (SNRI).
Det virker ved at forhindre, at neurotransmitterne 5- hydroxytryptamin (også kaldet serotonin) og noradrenalin genoptages i nervecellerne i hjernen og rygmarven.
It works by preventing the neurotransmitters 5-hydroxytryptamine (also called serotonin) and noradrenaline from being taken back up into nerve cells in the brain and spinal cord.
Det vides ikke med sikkerhed, hvordan denne mekanisme virker på stressinkontinens, men duloxetin menes at øge koncentrationen af 5- hydroxytryptamin og noradrenalin omkring de nerver, der kontrollerer urinrørets muskel, og derved forstærkes urinrørets lukning under opbevaring af urinen.
How duloxetine works in SUI is not clear but it is thought that, by increasing the levels of 5-hydroxytryptamine and noradrenaline at the level of the nerves that control the muscle of the urethra (the tube that leads from the bladder to outside), duloxetine causes a stronger closure of the urethra during urine storage.
Reproduction is authorised provided the source is acknowledged Hvordan blev Yentreve undersøgt?
Reproduction is authorised provided the source is acknowledged. dummy treatment).
Hovedmålene for lægemidlets virkning var dels hyppigheden af inkontinensepisoder (IEF dvs. det ugentlige antal inkontinensepisoder) angivet i dagskemaer, dels den opnåede scoreværdi i et spørgeskema om inkontinensrelateret livskvalitet (I- QOL).
The main measures of effectiveness were incontinence episode frequency (IEF, the number of episodes of incontinence per week) recorded in patient diaries and the patients’ scores on an incontinence-specific quality-of-life questionnaire (I-QOL).
4- 5 færre ugentlige inkontinensepisoder end før undersøgelsen.
In all four studies, the patients treated with Yentreve had fewer episodes of incontinence after 12 weeks, with about four or five fewer episodes of incontinence per week, in comparison with the number before the study.
Hyppigheden af inkontinensepisoderne faldt med 52% i Yentreve - gruppen, sammenholdt med et fald på 33% i placebogruppen.
The IEF decreased by 52% in the Yentreve group, compared with a decrease of 33% in the placebo-treated group.
Også den opnåede score i I- QOL- spørgeskemaerne var bedre i Yentreve- gruppen end i placebogruppen.
The I-QOL questionnaire scores were also improved in the Yentreve group compared with the placebo group.
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved Yentreve opvejede risiciene ved behandling af moderat til svær stressinkontinens.
The Committee for Medicinal Products for Human Use (CHMP) decided that Yentreve’ s benefits are greater than its risks for the treatment of moderate to severe SUI.
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Yentreve til Eli Lilly Nederland B. V. den 11. august 2004.
The European Commission granted a marketing authorisation valid throughout the European Union for Yentreve to Eli Lilly Nederland B. V. on 11 August 2004.
EU- nummer EU/ 1/ 04/ 280/ 001 EU/ 1/ 04/ 280/ 002 EU/ 1/ 04/ 280/ 003 EU/ 1/ 04/ 280/ 004 EU/ 1/ 04/ 280/ 005 EU/ 1/ 04/ 280/ 006 EU/ 1/ 04/ 280/ 007 EU/ 1/ 04/ 280/ 008
EU/ 1/ 04/ 280/ 001 EU/ 1/ 04/ 280/ 002 EU/ 1/ 04/ 280/ 003 EU/ 1/ 04/ 280/ 004 EU/ 1/ 04/ 280/ 005 EU/ 1/ 04/ 280/ 006 EU/ 1/ 04/ 280/ 007 EU/ 1/ 04/ 280/ 008
Særnavn Yentreve Yentreve Yentreve Yentreve Yentreve Yentreve Yentreve Yentreve
Yentreve Yentreve Yentreve Yentreve Yentreve Yentreve Yentreve Yentreve
Styrke 20 mg 40 mg 40 mg 40 mg 40 mg 40 mg 20 mg 20 mg
20 mg 40 mg 40 mg 40 mg 40 mg 40 mg 20 mg 20 mg
Lægemiddelform Enterokapsler, hårde Enterokapsler, hårde Enterokapsler, hårde Enterokapsler, hårde Enterokapsler, hårde Enterokapsler, hårde Enterokapsler, hårde Enterokapsler, hårde
Hard gastro-resistant capsules Hard gastro-resistant capsules Hard gastro-resistant capsules Hard gastro-resistant capsules Hard gastro-resistant capsules Hard gastro-resistant capsules Hard gastro-resistant capsules Hard gastro-resistant capsules
Emballage Blisterpakning (PVC/ PE/ PCTFE, alu) Blisterpakning (PVC/ PE/ PCTFE, alu) Blisterpakning (PVC/ PE/ PCTFE, alu) Blisterpakning (PVC/ PE/ PCTFE, alu) Blisterpakning (PVC/ PE/ PCTFE, alu) Blisterpakning (PVC/ PE/ PCTFE, alu) Blisterpakning (PVC/ PE/ PCTFE, alu) Blisterpakning (PVC/ PE/ PCTFE, alu)
blister (PVC/ PE/ PCTFE/ alu) blister (PVC/ PE/ PCTFE/ alu) blister (PVC/ PE/ PCTFE/ alu) blister (PVC/ PE/ PCTFE/ alu) blister (PVC/ PE/ PCTFE/ alu) blister (PVC/ PE/ PCTFE/ alu) blister (PVC/ PE/ PCTFE/ alu) blister (PVC/ PE/ PCTFE/ alu)
Paknings- størrelse 28 kapsler 28 kapsler 56 kapsler 98 kapsler 140 kapsler 2 x 98 kapsler 56 kapsler 98 kapsler
56 28 56 98 140 2 x 98 28 98
Mat orange kapselbund med påskriften "40 mg" og mat blå kapseltop med påskriften "9545".
The capsule has an Opaque orange body, imprinted with ’ 40mg’ and an opaque blue cap, imprinted with ‘ 9545’.
5. 1).
YENTREVE is indicated for women for the treatment of moderate to severe Stress Urinary Incontinence (SUI), (see section 5.1).
Ved at kombinere YENTREVE med bækkenbundstræning kan der muligvis opnås en bedre effekt end ved hver af de to behandlinger alene.
Combining YENTREVE with a pelvic floor muscle training (PFMT) program may be more effective than either treatment alone.
4. 3).
YENTREVE should not be used in women with liver disease resulting in hepatic impairment (see section 4.3).
Sikkerheden og effekten af duloxetin til patienter i disse aldersgrupper er ikke blevet undersøgt.
The safety and efficacy of duloxetine in patients in these age groups have not been studied.
YENTREVE anbefales derfor ikke til børn og unge.
Therefore, administration of YENTREVE to children and adolescents is not recommended.
4. 4 og 4. 8).
When stopping treatment with YENTREVE 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).
4. 5).
YENTREVE should not be used in combination with nonselective, irreversible Monoamine Oxidase Inhibitors - MAOIs (see section 4.5).
4. 5).
YENTREVE should not be used in combination with CYP1A2 inhibitors, like fluvoxamine, ciprofloxacin or enoxacine since the combination results in elevated plasma concentrations of duloxetine (see section 4.5).
4. 4 og 4. 8).
The initiation of treatment with YENTREVE 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).
Mani og krampeanfald YENTREVE skal anvendes med forsigtighed til patienter med en anamnese med mani eller en diagnose med bipolar forstyrrelse og/ eller krampeanfald.
Mania and Seizures YENTREVE should be used with caution in patients with a history of mania or a diagnosis of bipolar disorder, and/ or seizures.
4. 5).
Use with antidepressants The use of YENTREVE in combination with antidepressants (especially with SSRI, SNRI and reversible MAOIs) is not recommended (see below “ Depression, suicidal ideation and behaviour” and Section 4.5).
Prikbladet perikum Bivirkninger kan blive mere almindelige ved samtidig brug af YENTREVE og naturlægemidler med indhold af prikbladet perikum (Hypericum perforatum).
St John’ s wort Undesirable effects may be more common during concomitant use of YENTREVE and herbal preparations containing St John’ s wort (Hypericum perforatum).
Der bør ligeledes
Duloxetine should be used with caution in patients whose conditions could be compromised by an increased heart rate or by an increase in blood pressure.
3 udvises forsigtighed, når duloxetin bruges sammen med lægemidler, der kan forringe dets metabolisme (se pkt.
Caution should also be exercised when duloxetine is used 3 with medicinal products that may impair its metabolism (see section 4.5).
YENTREVE og placebo.
In a clinical trial adverse events seen on abrupt treatment discontinuation occurred in approximately 44% of patients treated with YENTREVE and 24% of patients taking placebo.
Der skal udvises forsigtighed ved behandling af følgende patienter med øget risiko for hyponatriæmi:
Hyponatremia Hyponatremia has been reported rarely, predominantly in the elderly, when administering YENTREVE.
Depression, selvmordsforestillinger og - adfærd Selvom YENTREVE ikke er godkendt til behandling af depression, findes dets aktive lægemiddelstof (duloxetin) også i et antidepressivt lægemiddel.
Depression, suicidal ideation and behaviour Although YENTREVE is not indicated for the treatment of depression, its active ingredient (duloxetine) also exists as an antidepressant medication.
Læger bør opfordre patienterne til at rapportere, hvis de
A meta-analysis of placebo- controlled clinical trials of antidepressants 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).
4 på noget tidspunkt er bekymrede over deres tanker, følelser eller depressive symptomer.
Physicians should encourage patients to report any distressing thoughts or feelings or depressive symptoms at any time.
4. 2).
If a decision to initiate antidepressant pharmacological therapy is taken, the gradual discontinuation of YENTREVE is recommended (see Section 4.2).
Brug hos børn og unge under 18 år Der er ikke foretaget nogen kliniske forsøg med duloxetin på børn.
4 Use in children and adolescents under 18 years of age No clinical trials have been conducted with duloxetine in paediatric populations.
Saccharose YENTREVE- enterokapsler indeholder saccharose.
Sucrose YENTREVE hard gastro-resistant capsules contain sucrose.
På grund af risikoen for serotoninsyndrom må YENTREVE 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, YENTREVE 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 YENTREVE, 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 YENTREVE before starting an MAOI (see section 4.3).
Der er i sjældne tilfælde rapporteret om serotoninsyndrom hos patienter i behandling med SSRI- præparater sammen med serotonerge lægemidler.
Serotonin syndrome: in rare cases, serotonin syndrome has been reported in patients using SSRIs concomitantly with serotonergic medicinal products.
Det anbefales at udvise forsigtighed, hvis YENTREVE anvendes sammen med serotonerge antidepressiva som SSRI - præparater, tricykliske præparater (f. eks. clomipramin eller amitriptylin), venlafaxin eller triptaner, tramadol og tryptophan.
The use of YENTREVE in combination with serotonergic antidepressants like SSRIs, tricyclics like clomipramine or amitriptyline, venlafaxine, or triptans, tramadol and tryptophan is not recommended.
Det anbefales at udvise forsigtighed, når YENTREVE 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 YENTREVE is taken in combination with other centrally acting medicinal product or substances, including alcohol and sedative medicinal product (benzodiazepines, morphinomimetics, antipsychotics, phenobarbital, sedative antihistamines).
5 Duloxetins virkning på andre lægemidler Lægemidler, der metaboliseres via CYP1A2:
Effect of duloxetine on other medicinal products Medicinal products metabolised by CYP1A2:
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 5 affect the pharmacokinetics of its active 5-hydroxyl metabolite and no dosage adjustment is recommended.
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 YENTREVE 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).
In vitro- studier viser, at duloxetin ikke inducerer CYP3A 'nedbrydende s aktivitet.
Oral contraceptives and other steroidal agents: results of in vitro studies demonstrate that duloxetine does not induce the catalytic activity of CYP3A.
Der er ikke udført specifikke in vivo- interaktionsstudier.
Specific in vivo medicinal product interaction studies have not been performed.
Samtidig administration af YENTREVE med aluminium - og magnesiumholdige antacida eller med famotidin har ingen signifikant virkning på absorbtions - hastigheden 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 YENTREVE 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 YENTREVE og potente CYP1A2- hæmmere sandsynligvis medføre højere koncentrationer af duloxetin.
Inhibitors of CYP1A2: because CYP1A2 is involved in duloxetine metabolism, concomitant use of YENTREVE with potent inhibitors of CYP1A2 is likely to result in higher concentrations of duloxetine.
4. 3)
Therefore YENTREVE should not be administered in combination with potent inhibitors of CYP1A2 like fluvoxamine (see section 4.3).
4. 3).
As the safety of duloxetine in infants is not known, the use of YENTREVE while breast-feeding is not recommended.
Tabel 1 viser observerede bivirkninger fra spontane rapporter samt fra placebo- kontrollerede kliniske forsøg med SUI og andre lidelser i de nedre urinveje (omfattende en total på 7976 patienter - heraf fik 4370 patienter duloxetin og 3606 patienter fik placebo).
6 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 placebo- kontrollerede 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 YENTREVE in clinical trials in SUI and other lower urinary tract disorders were nausea, dry mouth fatigue and constipation.
Bivirkninger Skønnet hyppighed:
Adverse reactions Frequency are defined as:
Indenfor hver frekvensgruppe er bivirkningerne opført i faldende orden med hensyn til alvorlighed.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Ukendt
Rare
sjælden
Frequency not known
Undersøgelser Hjerte
Cardiac Disorders
Vægttab Vægtstigning Øget blodkolesterol
Weight decrease Weight increase Blood cholesterol increased
Kreatininkinase øget
Creatine phosphokinase increased
Hovedpine Svimmelhed Rysten Letargi Søvnighed Paræstesier
Headache Dizziness Tremor Lethargy Somnolence Paraesthesia Eye Disorders
Dårlig søvnkvalitet Koncentrations - besvær Nervøsitet Dysgeusi
Poor quality sleep Disturbance in attention Nervousness Dysgeusia
Serotoninsyn - drom Psykomotorisk uro Kramper Akatisi Ekstrapyrami - dale symptomer
Serotonin syndrome Psychomotor restlessness Convulsions Akathisia Extrapyramidal symptoms
Ører og labyrint
Blurred vision Ear and Labyrinth Disorders
7
Vertigo
Meget
Tinnitus1 Ear pain
Almindelig
Yawning
Ikke almindelig
Epistaxis Throat tightness
Meget Almindelig Ikke almindelig Sjælden Meget
Nausea Diarrhoea (23.3%) Vomiting Dry mouth Dyspepsia
Ukendt
Gastroenteritis Stomatitis Gastritis
almindelig
Haematochezia
Vertigo
Gastrointestina l haemorrhage
Tinnitus 1 Ørepine
7
sjælden
Very common
hyppighed
Common
Luftveje, thorax og mediastinum Mave- tarmkanalen
Uncommon
Gaben
Rare
Epistaxis Sammensnøret hals
Very Rare
Diarré Opkastning Dyspepsi
Frequency not known
Gastroenteritis Stomatitis Gastritis Flatulens Opstød Dårlig ånde
(11.9%) Constipation (10.3%) Renals and Urinary Disorders
Gastrointestinal blødning
Flatulence Eructation Breath odour
Urinretention Besværet vandladning Dysuri Natlig vandladning
Urinary hesitation Dysuria Nocturia Urine odour abnormal
Abnorm urinlugt
Urinary retention
Hududslæt Øget tendens til at få blå mærker Nattesved Koldsved
Rash Increased tendency to bruise Night sweats Cold sweat
Lysfølsomheds - reaktioner Kontaktderma - titis Nældefeber
Photo- sensitivity reactions Dermatitis contact Urticaria
Stevens - Johnson syndrom Angioneurotisk ødem
Stevens- Johnson Syndrome Angioneurotic oedema
Knogler, led, muskler og bindevæv Det endokrine system Metabolisme og ernæring
Muscoskeletal and connective tissue disorders Endocrine disorders Metabolism and Nutrition Disorders
Muskelkramper Muskelstivhed Musculoskeletale smerter Trismus Hypotyroidisme
Muscle spasm Muscle tightness Musculo- skeletal pain Trismus Hypo- thyroidism
Nedsat appetit Infektioner og parasitære sygdomme Vaskulære sygdomme
Appetite decreased Infections and infestations
Hypertensive kriser Ortostatisk hypotension2 Perifer kulde - fornemmelse
Hypertensive crisis Orthostatic hypotension2Pe ripheral coldness
Almene symptomer og reaktioner på administrationsstedet Træthed
General Disorders and Administration Site Conditions Fatigue (10.9%)
Mavesmerter
Gait disturbance Feeling cold
Generel
Chest pain
8
Immune system disorders
Gangforstyr -
Hyper- sensitivity
Brystsmerter
Anaphylactic reaction
Meget
8 Very common
Kløe Svaghed Kuldegysninger
disorder Hepato-biliary disorders
Hepatitis3 Forhøjede lever - enzymer (ALAT, ASAT, basisk fosfatase) Akut leverskade
Hepatitis3 Elevated liver enzymes (ALT, AST, alkaline phosphatase) Acute liver injury
Leversvigt Ikterus
Hepatic failure Jaundice
Det reproduktive system og mammae Menopausale symptomer Gynækologisk blødning Psykiske forstyrrelser 1
Reproductive System and Breast Disorders Menopausal symptoms Gynaecological haemorrhage Psychiatric Disorders 11
Søvnløshed Angst Søvnforstyr - relser Uro Nedsat libido
Insomnia AnxietySleep disorder Agitation Libido decreased
Desorientering Abnorme drømme Apati Tænderskæren Abnorm orgasme
Disorientation Hallucinations Abnormal dreams Apathy BruxismOrgas m abnormal
Selvmords - forestilling Selvmords - adfærd 4 Mani Aggression og angst 5
Suicidal behaviour Suicidal ideation4 Mania Aggression and anger5
5 Sager med aggression og angst er blevet rapporteret, især i tidligt i behandlingen eller efter behandlingsophør.
2 Cases of orthostatic hypotension and syncope have been reported especially at the initiation of treatment 23 See section 4.4 4 Cases of suicidal ideation and suicidal behaviours have been reported during duloxetine therapy or early after treatment discontinuation (see section 4.4) 5 Cases of aggression and anger have been reported particularly early in treatment of after treatment discontinuation.
De mest almindelige bivirkninger er svimmelhed, sensoriske forstyrrelser (inklusiv paraesthesia), søvnforstyrrelser (inklusiv 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.
Der er rapporteret tilfælde af overdosering af duloxetin, alene eller i kombination med andre lægemidler, i doser på 4800 mg.
9 Cases of overdoses, alone or in combination with other medicinal products, with duloxetine doses of 4800mg were reported.
Søvnighed, coma, serotoninsyndrom, kramper, opkastning og takykardi.
Signs and symptoms of overdose (duloxetine alone or with mixed medicinal products) included somnolence, coma, serotonin syndrome, seizures, vomiting and tachycardia.
I dyreforsøg fører forhøjet niveau af 5- HT og NA i den sakrale ende af rygsøjlen til øget uretral tonus via en forstærket nervus pudendus- stimulering af urinrørets tværstribede lukkemuskel kun i opbevaringsfasen af vandladningscyklussen.
In animal studies, increased levels of 5-HT and NE in the sacral spinal cord, lead to increased urethral tone via enhanced pudendal nerve stimulation to the urethral striated sphincter muscle only during the storage phase of the micturition cycle.
10 Virkningen af YENTREVE er ikke blevet undersøgt længere end 3 måneder i placebokontrollerede studier.
The efficacy of YENTREVE has not been evaluated for longer than 3 months in placebo-controlled studies.
Den kliniske fordel ved YENTREVE 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 YENTREVE compared with placebo has not been demonstrated in women with mild SUI, defined in randomised trials as those with IEF < 14 per week.
Der er begrænset data som tyder på, at fordelene ved YENTREVE ikke mindskes hos kvinder med stressinkontinens, som tidligere er blevet opereret for inkontinens.
10 YENTREVE and Prior Continence Surgery: there are limited data that suggest that the benefits of YENTREVE 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 YENTREVE større reduktioner i IEF i forhold til enten placebo- behandlingen eller med bækkenbundsøvelser alene.
YENTREVE and Pelvic Floor Muscle Training (PFMT): during a 12-week blinded, randomised, controlled study, YENTREVE demonstrated greater reductions in IEF compared with either placebo treatment or with PFMT alone.
Duloxetin har en cirka 96% binding til humane plasmaproteiner.
Duloxetine is approximately 96% bound to human plasma proteins.
25% længere hos ældre), selv om størrelsesordenen på disse forandringer ikke er tilstrækkelig til at retfærdiggøre dosisjusteringer.
Age: pharmacokinetic differences have been identified between younger and elderly females (≥ 65 years) (AUC increases by about 25% and half-life is about 25% longer in the elderly), although the magnitude of these changes is not sufficient to justify adjustments to the dose.
Moderat leversygdom (Child- Pugh- gruppe B) påvirkede duloxetins farmakokinetik.
Hepatic insufficiency: moderate liver disease (Child Pugh Class B) affected the pharmacokinetics of duloxetine.