natgillin/translations-raw huggingface dataset:
4. 3)
Inducers of CYP1A2:
23 CYP1A2- fremmere:
23 4.6 Pregnancy and lactation
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 DULOXETINE BOEHRINGER INGELHEIM in clinical trials in SUI and other lower urinary tract disorders were nausea, dry mouth fatigue and constipation.
Øget perspira - tion
Skin and Subcutaneous Tissue Disorders
Lysfølsomheds reaktioner Kontaktdermatit is Nældefeber
Sweating increased
Stevens - Johnson syndrom Angioneurotisk ødem
Rash Increased tendency to
almindelig
Dermatitis contact Urticaria
Generel utilpashed Varmefølelse
Malaise Feeling hot Feeling abnormal Thirst
Kuldegysninger Generel unormal følelse Tørst Immunsystemet Lever og galdeveje
disorders
almindelig
symptoms Gynaecological haemorrhage
De mest almindelige bivirkninger er svimmelhed, sensoriske forstyrrelser (inklusiv paræstesi), 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 blev optaget elektrokardiogrammer for 755 duloxetinbehandlede patienter med SUI og 779 placebo- behandlede 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.
De mest almindelige observerede bivirkninger hos patienter med diabetiske neuropatiske smerter i behandling med DULOXETINE BOEHRINGER INGELHEIM var: kvalme, hovedpine, mundtørhed 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.
27
common
Hovedpine (13, 8%) Søvnighed (10, 7%)
Headache (13.8%) Somnolence (10.7%) Eye Disorders
Anafylaktisk reaktion
Immune system disorders
Leversvigt Icterus
Anaphylactic reaction
Ikke almindelig
Frequency not
Meget Almindelig Ikke almindelig Sjælden Meget
common
Ikke kendt
disorder
almindelig
known
Her viste laboratorieprøverne en lille sænkning.
30 duloxetine-treated patients while those laboratory tests showed a slight decrease in the routine care group.
Der er sket dødsfald, hovedsageligt med samtidig overdosering af 30 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 placebo- behandlet gruppe.
Differences were observed
31 Livskvalitet:
Quality of Life:
65% duloxetinbehandlede patienter mod 40% placebo- behandlede.
At least 30% reported pain reduction was recorded in approximately 65% of duloxetine treated patients versus 40% for placebo.
Hos patienter, som havde oplevet somnolens, blev der målt klinisk respons hos 60% af de duloxetinbehandlede patienter og 30% af de placebo- behandlede patienter.
Clinical response rates in patients experiencing somnolence were 60% on duloxetine and 30% on placebo.
32 Duloxetin metaboliseres i udstrakt grad, og metabolitterne udskilles hovedsageligt med urinen.
Duloxetine is extensively metabolised and the metabolites are excreted principally in urine.
33 afkommet i 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).
EU/ X/ XX/ XXX/ XX 34 EU/ X/ XX/ XXX/ XX
EU/ X/ XX/ XXX/ XX EU/ X/ XX/ XXX/ XX
Der er ingen erfaring med brug af DULOXETINE BOEHRINGER INGELHEIM hos børn (se pkt.
Children and adolescents There is no experience in children (see section 4.4).
4. 4).
Hepatic impairment DULOXETINE BOEHRINGER INGELHEIM should not be used in patients with liver disease resulting in hepatic impairment (see sections 4.3 and 5.2).
Leverinsufficiens:
Renal insufficiency No dosage adjustment is necessary for patients with mild or moderate renal dysfunction (creatinine clearance 30 to 80 ml/ min).
4. 3 og 5. 2).
DULOXETINE BOEHRINGER INGELHEIM should not be used in patients with severe renal impairment (creatinine clearance < 30 ml/ min; see section 4.3)..
Dosisjustering er ikke nødvendig til patienter med let eller moderat nedsat nyrefunktion (kreatinin - clearance 30- 80 ml/ min).
36 Discontinuation of treatment Abrupt discontinuation should be avoided.
Ved forekomst af utålelige symptomer efter en nedsættelse af dosis eller ved seponering kan det overvejes at vende tilbage til den tidligere ordinerede dosis.
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). If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered.
4. 5).
Concomitant use of DULOXETINE BOEHRINGER INGELHEIM with nonselective, irreversible Monoamine Oxidase Inhibitors (MAOIs) is contraindicated (see section 4.5).
4. 5).
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).
Mani og krampeanfald DULOXETINE BOEHRINGER INGELHEIM skal anvendes med forsigtighed til patienter med en anamnese med mani eller en diagnose med bipolar forstyrrelse og/ eller krampeanfald.
Mania and seizures DULOXETINE BOEHRINGER INGELHEIM should be used with caution in patients with a history of mania or a diagnosis of bipolar disorder, and/ or seizures.
Mydriasis Der er rapporteret om tilfælde af mydriasis i forbindelse med duloxetin, og der skal derfor udvises forsigtighed ved udskrivning af DULOXETINE BOEHRINGER INGELHEIM 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 BOEHRINGER INGELHEIM to patients with increased intraocular pressure, or those at risk of acute narrow-angle glaucoma.
37 Nedsat nyrefunktion Forhøjede plasmakoncentrationer af duloxetin forekommer hos patienter med svært nedsat nyre - funktion i hæmodialyse (kreatinin- clearance < 30 ml/ min.).
Renal impairment Increased plasma concentrations of duloxetine occur in patients with severe renal impairment on haemodialysis (creatinine clearance < 30 ml/ min).
4. 2.
For patients with severe renal impairment, see section 4.3. ee section 4.2 for information on patients with mild or moderate renal dysfunction.
Samtidig brug af antidepressiva Der bør udvises forsigtighed ved samtidig brug af DULOXETINE BOEHRINGER INGELHEIM og antidepressiva.
Use with antidepressants 37 Caution should be exercised when using DULOXETINE BOEHRINGER INGELHEIM in combination with antidepressants.
Perikum Uønskede virkninger kan forekomme hyppigere ved samtidig brug af DULOXETINE BOEHRINGER INGELHEIM og naturlægemidler samt kosttilskud indeholdende perikum (hypericum perforatum).
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).
Depression, selvmordsforestillinger og - adfærd Selvom DULOXETINE BOEHRINGER INGELHEIM ikke er indiceret til behandling af depression, findes det aktive stof (duloxetin) også som 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.
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).
Hyponatriæmi Hyponatriæmi er i sjældne tilfælde, hovedsagligt hos ældre, blevet rapporteret ved indgivelse af DULOXETINE BOEHRINGER INGELHEIM.
Hyponatremia Hyponatremia has been reported rarely, predominantly in the elderly, when administering DULOXETINE BOEHRINGER INGELHEIM.
DULOXETINE BOEHRINGER INGELHEIM og placebo.
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.
Risikoen for seponeringssymptomer set for SSRI og SNRI kan afhænge af flere faktorer blandt andet behandlingsvarigheden, dosis og hvor hurtigt dosis reduceres.
38 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.
Som konsekvens deraf anbefales det 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).
Consequently, caution is advised when DULOXETINE BOEHRINGER INGELHEIM is taken in combination with other centrally acting medicinal products and substances including alcohol and sedative medicinal products (e. g. benzodiazepines, morphinomimetics, antipsychotics, phenobarbital, sedative antihistamines).
På grund af risikoen for serotoninsyndrom må DULOXETINE BOEHRINGER INGELHEIM ikke anvendes sammen med ikke- selektive, irreversible monoaminooxidasehæmmere (MAO- hæmmere) eller 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.
39 Risikoen for serotoninsyndrom for selektive, reversible MAO- hæmmere som moclobemid er lavere.
For selective, reversible MAOIs, like moclobemide, the risk of serotonin syndrome is lower.
4. 4).
However, the concomitant use of DULOXETINE BOEHRINGER INGELHEIM with selective, reversible MAOIs is not recommended (see section 4.4).
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, pethidin 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.
Duloxetins virkning på andre lægemidler Lægemidler, der metaboliseres via CYP1A2:
39 Effect of duloxetine on other medicinal products Medicinal products metabolised by CYP1A2:
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).
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).
Som for andre serotonerge lægemidler kan seponeringssymptomer forekomme hos det nyfødte barn, hvis moderen har indtaget duloxetin i den
As with other serotoninergic medicinal products, discontinuation symptoms may occur in the neonate after maternal duloxetine use near term.
Der er ikke foretaget undersøgelser af virkningen på evnen til at føre motorkøretøj eller betjene maskiner.
4.7 Effects on ability to drive and use machines 40 No studies on the effects on the ability to drive and use machines have been performed.
Kvalme, hovedpine, mundtørhed 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.
Nervesystemet Hovedpine (13, 8%) Somnolens (10, 7%)
Headache (13.8%) Somnolence (10.7%) Eye Disorders
Mave- tarmkanalen
Frequency not
Kvalme (21, 7%) Mundtørhed (13, 2%) Nyrer og urinveje
Gastrointestinal Disorders Nausea (21.7%) Dry mouth (13.2%)
Nedsat appetit
common
Hedeture
known
Lever og galdeveje
Immune system disorders Hepato-biliary disorders
43
Insomnia
Meget
Aggression
Almindelig
Suicidal
Ikke almindelig
Abnormal dreams Anxiety
Meget Almindelig Ikke almindelig Sjælden Meget
Sleep disorder Apathy Disorientation
almindelig
and anger 5 Mania
Psykiske forstyrrelser 1
behaviour4 Suicidal ideation4
Søvnløshed Abnorme drømme Angst Uro Nedsat libido Abnorm orgasme
1
Søvnforstyrrelser Apati Desorientering Tænderskæren
AgitationLibid Bruxism o decreased Orgasm abnormal
Aggression og angst5 Mani
Hallucinations
Der er også rapporteret tilfælde af tinnitus efter behandlingsophør 2 Sager med ortostatisk hypotension og synkope er blevet rapporteret - særligt i behandlingsopstarten 3 Se pkt 4. 4.
Cases of tinnitus have also been reported after treatment discontinuation.
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.
43 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. HbA1C var stabilt hos både duloxetin- behandlede og placebo- behandlede patienter.
HbA1c was stable in both duloxetine-treated and placebo-treated patients.
Aktivt kul kan være nyttigt til 44 begrænsning af absorptionen.
Activated charcoal may be useful in limiting absorption.
Effekten af duloxetin som en behandling af diabetiske neuropatiske smerter blev etableret i 2 randomiserede 12- ugers, dobbeltblinde, placebokontrollerede forsøg med fast dosis hos voksne (22 til 88 år), som havde haft diabetiske neuropatiske smerter i mindst 6 måneder.
The efficacy of duloxetine as a treatment for diabetic neuropathic pain was established in 2 randomised, 12-week, double-blind, placebo-controlled, fixed dose studies in adults (22 to 88 years) 44 having diabetic neuropathic pain for at least 6 months.
45 Duloxetin metaboliseres i udstrakt grad, og metabolitterne udskilles hovedsageligt med urinen.
Duloxetine is extensively metabolised and the metabolites are excreted principally in urine.
Patienter med terminal nyresygdom i dialysebehandling havde et dobbelt så højt duloxetin- Cmaks. og dobbelt så høje AUC- værdier som raske patienter.
45 Renal impairment: end stage renal disease (ESRD) patients receiving dialysis had 2-fold higher duloxetine Cmax and AUC values compared with healthy subjects.
46 met i et pre - / postnatal toxicitetstudie med rotter, hvor hunrotter blev udsat for systemiske påvirkninger under den maksimale kliniske eksponering (AUC).
In prenatal/ postnatal toxicity studies in the rat, duloxetine induced adverse behavioural effects in the offspring at exposures below maximum clinical exposure (AUC).
Syntetisk sort jernoxid (E172), syntetisk gul jernoxid (E172), propylenglycol og Shellac.
46 Black Iron Oxide-Synthetic (E172) Yellow Iron Oxide- Synthetic (E172) Propylene glycol Shellac.
MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) 47 EU/ X/ XX/ XXX/ XX EU/ X/ XX/ XXX/ XX EU/ X/ XX/ XXX/ XX
47 9.
4. 3 og 5. 2).
Hepatic impairment DULOXETINE BOEHRINGER INGELHEIM should not be used in patients with liver disease resulting in hepatic impairment (see sections 4.3 and 5.2).
50 Nedsat nyrefunktion Forhøjede plasmakoncentrationer af duloxetin forekommer hos patienter med svært nedsat nyrefunktion i hæmodialyse (kreatinin- clearance < 30 ml/ min.).
50 Renal impairment Increased plasma concentrations of duloxetine occur in patients with severe renal impairment on haemodialysis (creatinine clearance < 30 ml/ min).
Samtidig brug af antidepressiva Der bør udvises forsigtighed ved samtidig brug af DULOXETINE BOEHRINGER INGELHEIM og antidepressiva.
Use with antidepressants Caution should be exercised when using DULOXETINE BOEHRINGER INGELHEIM in combination with antidepressants.
Hvis patienten, under DULOXETINE BOEHRINGER INGELHEIM- behandling, udvikler agitation eller depressive symptomer, bør en specialist konsulteres, eftersom depression er en alvorlig medicinsk lidelse.
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).
Der skal udvises forsigtighed ved behandling af følgende patienter med øget risiko for hyponatriæmi:
Caution is required in patients at increased risk for hyponatremia; such as elderly, cirrhotic, or dehydrated patients or patients treated with diuretics.
Ældre, cirrose eller dehydrerede patienter samt
Hyponatremia may be due to a syndrome of inappropriate anti-diuretic hormone secretion (SIADH).
Hyponatriæmi kan skyldes et syndrom med uhensigtsmæssig sekretion af anti- diuretisk hormon (SIADH).
51 Discontinuation of treatment Withdrawal symptoms when treatment is discontinued are common, particularly if discontinuation is abrupt (see section 4.8).
Saccharose DULOXETINE BOEHRINGER INGELHEIM enterokapsler indeholder saccharose.
Sucrose DULOXETINE BOEHRINGER INGELHEIM gastro-resistant capsules contain sucrose.
52 Risikoen for serotoninsyndrom for selektive, reversible MAO- hæmmere som moclobemid er lavere.
For selective, reversible MAOIs, like moclobemide, the risk of serotonin syndrome is lower.
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.
52 Serotonin syndrome: in rare cases, serotonin syndrome has been reported in patients using SSRIs (e. g. paroxetine, fluoxetine) concomitantly with serotonergic medicinal products.
53 Den potentielle risiko for mennesker er ukendt.
The potential risk for humans is unknown.
Dette er baseret på et forsøg med 6 mælkeproducerende patienter, der ikke ammede deres børn.
Breast feeding 53 Duloxetine is very weakly excreted into human milk based on a study of 6 lactating patients, who did not breast feed their children.
Undersøgelser Hjerte
common
Vægtnedgang
known
Vægtøgning Øget kreatinin - kinase
Investigations
Øget blodkolesterol
Weight decrease
Palpitationer
Weight increase Creatinine
Supra - ventrikulær arytmi, hovedsagelig atrieflimren
Blood cholesterol increased
Meget Almindelig Ikke almindelig Sjælden Meget
phosphokinase increase
Ikke kendt
Palpitations
almindelig
Tachycardia
Tinnitus 1
Tinnitus 1
mediastinum
Respiratory, thoracic and mediastinal disorders
Lysfølsomheds reaktioner Øget tendens til at få blå mærker Kontaktdermatitis Nældefeber Koldsved
Photo- sensitivity reactions Increased tendency to bruise
Sjælden Meget
common
Ikke kendt
known
almindelig
Muscle twitching
Overfølsomhed
Immune system disorders Hepato-biliary disorders
Anafylaktisk reaktion
Hyper- sensitivity disorder
Lever og galdeveje Det reproduktive system og mammae
Anaphylactic reaction
Erektil dysfunktion
Acute liver injury
Meget Almindelig Ikke almindelig Sjælden Meget
Reproductive System and Breast Disorders
Ikke kendt
Insomnia
almindelig
Aggression
sjælden
Suicidal
Psykiske lidelser 1
Abnormal dreams Anxiety
Søvnløshed Abnorme drømme Angst Uro Nedsat libido Abnorm orgasme
Sleep disorder Apathy Disorientation
Søvnforstyrrelser Apati Desorientering Tænderskæren
and anger 5 Mania
HbA1C var stabilt hos både duloxetinbehandlede og placebobehandlede 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 HbA1c was stable in both duloxetine-treated and placebo-treated patients.
Der er sket dødsfald, hovedsageligt med samtidig overdosering af andre lægemidler.
57 Cases of overdoses, alone or in combination with other medicinal products, with duloxetine doses of 4800mg were reported.
Aktivt kul kan være nyttigt til 57 begrænsning af absorptionen.
Activated charcoal may be useful in limiting absorption.
Duloxetin indgives som en enkelt enantiomer.
58 Duloxetine is administered as a single enantiomer.
58 Duloxetin metaboliseres i udstrakt grad, og metabolitterne udskilles hovedsageligt med urinen.
Duloxetine is extensively metabolised and the metabolites are excreted principally in urine.
Hunmus, som modtog duloxetin i 2 år, havde forøget incidens af hepatocellulære adenomer og karcinomer ved den høje dosis (144 mg/ kg/ dag), men disse blev betragtet som værende sekundære til den mikrosomale enzyminduktion i leveren.
Female mice receiving duloxetine for 2 years had an increased incidence of hepatocellular adenomas and carcinomas at the high dose only (144 mg/ kg/ day), but these were considered to be secondary to 59 hepatic microsomal enzyme induction.
59 met i et pre - / postnatal toxicitetstudie med rotter, hvor hunrotter blev udsat for systemiske påvirkninger under den maksimale kliniske eksponering (AUC).
In prenatal/ postnatal toxicity studies in the rat, duloxetine induced adverse behavioural effects in the offspring at exposures below maximum clinical exposure (AUC).
Gelatine, natriumlaurilsulfat, titandioxid (E171), indigotin (E132), gul jernoxid (E172) og Edible White Ink.
Gelatin Sodium Lauryl Sulfate Titanium Dioxide (E171) Indigo Carmine (E132) Yellow Iron Oxide (E172) Edible White Ink
DULOXETINE BOEHRINGER INGELHEIM 60 mg findes i pakninger med 28 og 98 kapsler.
60 DULOXETINE BOEHRINGER INGELHEIM 60 mg is available in packs of 28 and 98 capsules.
60 EU/ X/ XX/ XXX/ XX EU/ X/ XX/ XXX/ XX
EU/ X/ XX/ XXX/ XX EU/ X/ XX/ XXX/ XX
61 BILAG II
61 ANNEX II
FREMSTILLER( E) ANSVARLIG( E) FOR BATCHFRIGIVELSE
62 A MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
A.
Lilly S. A.
Avenida de la Industria No 30 28108 Alcobendas Madrid Spanien
Avda. de la Industria Nº 30, 28108 Alcobendas Madrid Spain