natgillin/translations-raw huggingface dataset:
Når duloxetin blev givet i doser af 60 mg to gange dagligt sammen med en enkelt dosis af desipramin, et CYP2D6- substrat, blev AUC for desipramin forøget 3 gange.
When duloxetine was administered at a dose of 60 mg twice daily with a single dose of desipramine, a CYP2D6 substrate, the AUC of desipramine increased 3-fold.
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.
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 ARICLAIM 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' 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.
Der er ikke udført specifikke in vivo- interaktionsstudier.
Specific in vivo drug interaction studies have not been performed.
Antikoagulanter og antitrombotiske midler:
Anticoagulants and antiplatelet agents:
Der bør udvises forsigtighed, når duloxetin gives sammen med orale antikoagulanter eller antitrombotiske midler på grund af en potentiel øget risiko for blødning.
Caution should be exercised when duloxetine is combined with oral anticoagulants or antiplatelet agents due to a potential increased risk of bleeding.
Endvidere er der rapporteret stigning i INR- værdier, når duloxetin blev givet sammen med warfarin.
Furthermore, increases in INR values have been reported when duloxetine was co-administered with warfarin.
Samtidig administration af ARICLAIM med aluminium - og magnesiumholdige antacida eller med famotidin har ingen signifikant virkning på absorptions - 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 ARICLAIM 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 ARICLAIM og potente CYP1A2- hæmmere sandsynligvis medføre højere koncentrationer af duloxetin.
Inhibitors of CYP1A2: because CYP1A2 is involved in duloxetine metabolism, concomitant use of ARICLAIM with potent inhibitors of CYP1A2 is likely to result in higher concentrations of duloxetine.
Fluvoxamin (100 mg én gang daglig), en potent CYP1A2- hæmmer, mindskede den tilsyneladende plasma- clearance for duloxetin med omtrent 77% og øgede AUC0- t 6 gange.
Fluvoxamine (100 mg once daily), a potent inhibitor of CYP1A2, decreased the apparent plasma clearance of duloxetine by about 77% and increased AUC0-t 6-fold.
4. 3)
Therefore ARICLAIM should not be administered in combination with potent inhibitors of CYP1A2 like fluvoxamine (see section 4.3).
CYP1A2- fremmere:
Inducers of CYP1A2:
Befolkningspharmakokinetiske 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.
4. 6 Graviditet og amning
6 4.6 Pregnancy and lactation
Graviditet Der er ingen data for brug af duloxetin hos gravide kvinder.
Pregnancy There are no data on the use of duloxetine in pregnant women.
5. 3).
Studies in animals have shown reproductive toxicity at systemic exposure levels (AUC) of duloxetine lower than the maximum clinical exposure (see section 5.3).
Som for andre serotonerge lægemidler kan seponeringssymptomer forekomme hos det nyfødte barn, hvis moderen har indtaget duloxetin i den sidste del af graviditeten.
As with other serotoninergic medicinal product, discontinuation symptoms may occur in the neonate after maternal duloxetine use near term.
Dette er baseret på et forsøg med 6 mælkeproducerende patienter, der ikke ammede deres børn.
Breast feeding Duloxetine is very weakly excreted into human milk based on a study of 6 lactating patients, who did not breast feed their children.
5. 2).
The estimated daily infant dose on a mg/ kg basis is approximately 0.14% of the maternal dose (see section 5.2).
4. 3).
As the safety of duloxetine in infants is not known, the use of ARICLAIM while breast-feeding is not recommended.
De mest almindelige rapporterede bivirkninger hos patienter i behandling med ARICLAIM 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 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 ARICLAIM in clinical trials in SUI and other lower urinary tract disorders were nausea, dry mouth fatigue and constipation.
Forsøgene omfattede 958 duloxetin- behandlede 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.
Imidlertid var størstedelen af de oftest forekommende bivirkninger milde til moderate og ophørte inden for 30 dage (f. eks. kvalme).
However, the majority of the most frequent adverse events were mild to moderate and resolved within 30 days of occurrence (e. g. nausea).
Bivirkninger Skønnet hyppighed:
Adverse reactions Frequency estimate:
Meget almindelig (≥ 1/ 10), almindelig (≥ 1/ 100 og < 1/ 10), ikke almindelig (≥1/ 1. 000 og < 1/ 100), sjælden (≥1/ 10. 000 og < 1/ 1. 000), meget sjælden (< 1/ 10. 000) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
Very common (≥ 1/ 10), common (≥ 1/ 100 and < 1/ 10), uncommon (≥ 1/ 1,000 and < 1/ 100), rare (≥ 1/ 10,000 and < 1/ 1,000), very rare (< 1/ 10,000), not known (cannot be estimated from the available data).
Indenfor hver frekvensgruppe er bivirkningerne opført med hensyn til faldende alvorlighed.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Meget Almindelig Ikke almindelig Sjælden Meget
Very Common Uncommon Rare Very
Ikke kendt
Frequency not known
sjælden
Rare
Undersøgelser Hjerte
Investigations Cardiac Disorders
Vægtnedgang Vægtøgning Øget blodkolesterol
Weight decrease Weight increase Blood cholesterol increased
Øget kreatinin - kinase
Creatinine phosphokinase increase
Palpitationer
Palpitations Nervous System Disorders
Supra - ventrikulær arytmi, hovedsagelig atrieflimren
Supra-ventricular arrhythmia, mainly atrial fibrillation
Hovedpine Svimmelhed Rysten Letargi Søvnighed Paræstesier
Headache Dizziness Tremor Lethargy Somnolence Paraesthesia
Dårlig søvnkvalitet Smags - forstyrrelse Koncentrations - besvær Nervøsitet Smagsforstyrrelse
Poor quality of sleep Disturbance in attention Nervousness Dysgeusia
Dyskinesi Myoclonus
Dyskinesia Myoclonus
Serotonin - syndrom Psykomotorisk uro Kramper Akathisi Ekstra - pyramidale symptomer
Serotonin syndrome Psychomotor restlessness Convulsions AkathisiaExtrapyramidal symptoms
Øre og labyrint
Eye Disorders
Synsforstyrrelser Mydriasis
Visual disturbance Mydriasis
Luftveje, thorax og mediastinum Mave- tarmkanalen
Respiratory, thoracic and mediastinal disorders Gastrointestinal Disorders
Epistaxis Halsen snører sig sammen
Epistaxis Throat tightness
Kvalme (23, 3%) Mundtørhed (11, 9%) Forstoppelse (10, 3%) Nyrer og urinveje
Nausea (23.3%) Dry mouth (11.9%) Constipation (10.3%)
Diarré Opkastning Dyspepsi
Diarrhoea Vomiting Dyspepsia
Gastroenteritis Stomatitis Gastritis Flatulens Opstød Dårlig ånde
Gastroenteritis Haematochezia Stomatitis Gastritis Flatulence Eructation Breath odour
Frisk blødning per rectum
Gastrointestinal haemorrhage
Gastrointestinal blødning
Renals and Urinary Disorders
Besværet vandladning Dysuria Natlig vand - ladning Abnorm urinlugt
Urinary hesitation Dysuria Nocturia Urine odour abnormal
Nedsat urinmængde Polyuri
Urine flow decreased Polyuria
Tilbageholdelse af urin
Urinary retention
Øget perspira - tion
Sweating increased
Udslæt Øget tendens til at få blå mærker Nattesved Koldsved
Rash Increased tendency to
Lysfølsomheds reaktioner Kontaktderma - titis Nældefeber
Photo- sensitivity reactions 8
Stevens - Johnson syndrom Angioneurotisk ødem
Stevens-Johnson Syndrome Angioneurotic oedema
Knogler, led, muskler og bindevæv
Very
Muskelspasmer Muskelstivhed Musculoskeletale smerter Trismus
Common
Muskelsitren
Uncommon
Det endokrine system
Very Common Uncommon Rare Very
Hypotyroidisme
Frequency not known
8
common
Meget
bruise Night sweats Cold sweat
Almindelig
Dermatitis contact Urticaria
Ikke almindelig
Rare
Meget Almindelig Ikke almindelig Sjælden Meget
Muscoskeletal and connective tissue disorders
Ikke kendt
Muscle spasm Muscle tightness Musculo- skeletal pain Trismus
almindelig Metabolisme og ernæring
Muscle twitching
sjælden
Endocrine disorders
Nedsat appetit Infektioner og parasitære sygdomme Vaskulære sygdomme
Hypo- thyroidism Metabolism and Nutrition Disorders
Dehydrering Laryngitis
Dehydration
Hyperglykæmi (især rapporteret hos diabetikere) SIADH Hyponatriæmi
Hyperglycemia (reported especially in diabetic patients) SIADH Hyponatremia
Hedeture
Flushing
Synkope1 Blodtryksfor - øgelse
Syncope2 Blood pressure increase
Hypertensive kriser Ortostatisk hypotension2 Perifer kulde - fornemmelse
Hypertensive crisis Orthostatic hypotension2 Peripheral coldness
Hypertension
Hypertension
Almene symptomer og reaktioner på administrationsstedet Træthed (10, 9%) Immunsystemet
General Disorders and Administration Site Conditions Fatigue (10.9%)
Mavesmerter Pruritus Svaghed Kuldegysninger
Abdominal pain Pruritus Weakness Chills
Generel utilpashed Generel unormal følelse Varmefølelse Tørst
Malaise Feeling hot Feeling abnormal Thirst
Gangforstyr - relse Føler sig kold
Gait disturbance Feeling cold
Brystsmerter
Immune system
Lever og galdeveje
Hyper- sensitivity disorder
Overfølsomhed
Anaphylactic reaction
Anafylaktisk reaktion
Hepato-biliary disorders
Hepatitis3 Forhøjede lever - enzymer (ALAT, ASAT, alkalisk fosfatase) Akut leverskade
Hepatitis3 Elevated liver enzymes (ALT, AST, alkaline phosphatase) Acute liver injury
Leversvigt Icterus
Hepatic failure Jaundice
Det reproduktive system og mammae Menopausale symptomer Gynækologisk blødning Psykiske forstyrrelser 1
Reproductive System and Breast Disorders Menopausal
Søvnløshed Angst Søvnforstyr - relser Uro Nedsat libido
Insomnia AnxietySlee p disorder Agitation Libido decreased
Desorientering Abnorme drømme Apati Tænderskæren Abnorm orgasme
Disorientation Abnormal dreams Apathy Bruxism Orgasm abnormal
Selvmordsfore - stilling Selvmords - tanker4 Mani Aggression og angst5
Suicidal behaviour Suicidal ideation 4 Mania Aggression and anger 5
Der er også rapporteret tilfælde af tinnitus efter behandlingsophør.
Cases of tinnitus have also been reported after treatment discontinuation.
5 Sager med aggression og angst er blevet rapporteret, især tidligt i behandlingen eller efter behandlingsophør.
2 Cases of orthostatic hypotension and syncope have been reported especially at the initiation of treatment 3 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.
9 Seponering af duloxetin (særlig ved pludseligt ophør) fører normal til seponeringssymptomer.
Discontinuation of duloxetine (particularly when abrupt) commonly leads to withdrawal symptoms.
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.
Generelt for SSRI - og SNRI- præparater er disse symptomer lette til moderate og selvbegrænsende, selvom de hos nogle patienter kan være svære og/ eller vedvare i længere tid.
Generally, for SSRIs and SNRIs, these events are mild to moderate and self-limiting, however, in some patients they may be severe and/ or prolonged.
4. 2 og 4. 4).
It is therefore advised that when duloxetine treatment is no longer required, gradual discontinuation by dose tapering should be carried out (see sections 4.2 and 4.4).
Der blev optaget elektrokardiogrammer for 755 duloxetin- behandlede 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 hjertefrekvenskorrigerede QT- intervaller hos duloxetin- behandlede 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.
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 duloxetin- behandlede 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 var stabilt hos både duloxetin- behandlede og placebo- behandlede patienter.
HbA1c was stable in both duloxetine-treated and placebo-treated patients.
I denne periode var der stigninger i HbA1C både i duloxetin - og standardbehandling- grupperne, 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.
Her viste laboratorieprøverne en lille sænkning.
There was also a small increase in fasting blood glucose and in total cholesterol in duloxetine-treated patients while those laboratory tests showed a slight decrease in the routine care group.
Tabel 2 viser observerede bivirkninger fra spontane rapporter samt fra placebo- kontrollerede 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 ARICLAIM var: kvalme, hovedpine, svimmelhed og søvnighed.
The most commonly observed adverse reactions in patients with diabetic neuropathic pain treated with ARICLAIM were: nausea; headache, dry mouth and somnolence.
Tabel 2:
10 Table 2:
Meget Almindelig Ikke almindelig Sjælden Meget
Rare
almindelig
Frequency not
sjælden
common
Undersøgelser Hjerte
Investigations
Vægtøgning Øget kreatinin - kinase
Weight increase Creatinine phosphokinase increase
Palpitationer
Cardiac Disorders
Takykardi
Palpitations
Almindelig
Tachycardia
Meget Almindelig Ikke almindelig Sjælden Meget
Supra- ventricular arrhythmia, mainly atrial fibrillation
almindelig
Nervous System
sjælden
Disorders
Nervesystemet Hovedpine (13, 8%) Søvnighed (10, 7%) Øjne
Headache (13.8%) Somnolence (10.7%) Eye Disorders
Svimmelhed Rysten Letargi Paræstesier
Dizziness Tremor Lethargy Paraesthesia
Dyskinesi Dårlig søvnkvalitet Nervøsitet Myoclonus Koncentrations - besvær Smags - forstyrrelse
Dyskinesia Poor quality sleep Nervousness Myoclonus Disturbance in attention Dysgeusia
Serotonin - syndrom Kramper Akathisi Psykomotorisk uro Ekstra - pyramidale symptomer
Serotonin syndrome Convulsions Akathisia Psychomotor restlessness Extra- pyramidal symptoms
Tinnitus1
Tinnitus 1
Luftveje, thorax og mediastinum Mave- tarmkanalen
Respiratory, thoracic and mediastinal disorders
Kvalme (21, 7%) Mundtørhed (13, 2%) Nyrer og urinveje
Nausea (21.7%) Dry mouth (13.2%)
Diaré Forstoppelse Opkastning Dyspepsi Flatulens
Diarrhoea Constipation Vomiting Dyspepsia Flatulence
Gastroenteritis Stomatitis Gastritis Opstød
Gastroenteritis Stomatitis Gastritis Eructation
Frisk blødning per rectum Dårlig ånde
Haematochezia Breath odour
Tilbageholdelse af urin Besværet vandladning Dysuria Natlig vandladning Polyuri Nedsat urinmængde
Urinary Retention Urinary hesitation Dysuria Nocturia
Hud og subkutane væv
11
Udslæt Øget perspira - tion Nattesved
Very
Lysfølsomheds reaktioner Øget tendens til at få blå mærker Kontaktdermatitis Nældefeber Koldsved
Common
Stevens - Johnson syndrom Angioneurotisk ødem
Uncommon
Knogler, led, muskler og bindevæv
Rare
Musculoskele - tale smerter Muskelstivhed Muskelspasmer
Very Rare
Muskelsitren
Frequency not
Trismus
common
Det endokrine system Hypotyroidisme
Polyuria Urine flow decreased
Meget
Skin and Subcutaneous Tissue Disorders
Almindelig
Rash Sweating increased Night sweats
Ikke almindelig
Stevens- Johnson Syndrome Angio-neurotic oedema
Ikke kendt
Musculo- skeletal pain Muscle tightness Muscle spasm
sjælden
Trismus
Nedsat appetit Infektioner og parasitære sygdomme Vaskulære sygdomme
Endocrine disorders Hypo- thyroidism Metabolism and Nutrition Disorders
Hyperglykæmi (især rapporteret hos diabetikere) Laryngitis
Hyperglycemia (reported especially in diabetic patients)
Dehydrering SIADH Hyponatriæmi
Dehydration SIADH Hypo-natremia
Synkope2 Ortostatisk hypotension2 Blodtryksfor - øgelse Perifer kulde - fornemmelse
Syncope2 Orthostatic hypotension2 Blood pressure increase Peripheral coldness
Hypertensive kriser Hypertension
Hypertensive crisis Hypertension
Almene symptomer og reaktioner på administrationsstedet Immunsystemet
General Disorders and Administration Site Conditions
Varmefølelse Generel utilpashed Gangforstyrrelser Generel unormal følelse Føler sig kold Tørst Kuldegysninger
Feeling hot Malaise Gait disturbance Feeling abnormal Feeling cold Thirst Chills
Brystsmerter
Immune system disorders
Lever og galdeveje
Hyper- sensitivity
Overfølsomhed
Frequency not
Hepatitis3 Forhøjede lever - enzymer (ALAT, ASAT, alkalisk fosfatase) Akut leverskade
Hepatitis3 Elevated liver enzymes (ALT, AST, alkaline phosphatase)
Leversvigt Icterus
Acute liver injury
Seksuel dysfunktion Problemer med udløsning Forsinket udløsning Gynækologisk blødning
Sexual dysfunction Ejaculation disorder Ejaculation delayed Gynaecological haemorrhage
Psykiske forstyrrelser 1
Psychiatric Disorders
Søvnløshed Abnorme drømme Angst Uro Nedsat libido Abnorm orgasme
Abnormal dreams Anxiety
Søvnforstyrrelser Aggression og Apati angst5 Desorientering Mani Tænderskæren
Sleep disorder Apathy Disorientation
Selvmords - forestilling4 Selvmords - adfærd4 Hallucinationer
behaviour4 Suicidal ideation4
Der er også rapporteret tilfælde af tinnitus efter behandlingsophør.
AgitationLibid Bruxism o decreased Orgasm abnormal
12 2 Sager med orthostatisk hypotension og synkope er blevet rapporteret - særligt i behandlingsopstarten 3 Se pkt 4. 4.
Cases of tinnitus have also been reported after treatment discontinuation.
4 Sager med selvmordsforestillinger og - adfærd er blevet rapporteret under duloxetinbehandling eller tidligt efter behandlingsophør (se pkt.
2 Cases of orthostatic hypotension and syncope have been reported especially at the initiation of treatment.
4. 4) 5 Sager med aggression og angst er blevet rapporteret, især tidligt i behandlingen eller efter behandlingsophør.
3 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 (inklusive paraesthesi), 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 duloxetin- behandlede 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.
Extension- fasen af disse forsøg varede op til 52 uger.
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.
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.
There was also a small increase in fasting blood glucose and in total cholesterol in
Der var også en lille stigning i faste- blodglucose og i total kolesterol hos de duloxetin- behandlede patienter i modsætning til gruppen, der modtog standard - behandling.
13 duloxetine-treated patients while those laboratory tests showed a slight decrease in the routine care group.
Der blev optaget elektrokardiogrammer for 528 duloxetin- behandlede 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 duloxetin- behandlede 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 duloxetin- behandlede og placebo- behandlede patienter.
No clinically significant differences were observed for QT, PR, QRS, or QTcB measurements between duloxetine- treated and placebo-treated patients.