natgillin/translations-raw huggingface dataset:
Dehydration
Laringitis Sinkopa2
Hyperglycemia (reported especially in diabetic patients) SIADH Hyponatremia
8
Infections and infestations Laryngitis Vascular Disorders
izločanja antidiuretičneg a hormona Hiponatriemija
Syncope2 Blood pressure increase
Zvišan krvni tlak
Hypertensive crisis Orthostatic hypotension2 Peripheral coldness
Hipertenzivna kriza Ortostatska hipotenzija2 Hladni periferni deli
General Disorders and Administration Site Conditions Fatigue (10.9%)
Splošne težave in spremembe na mestu aplikacije Utrujenost (10, 9%)
Abdominal pain Pruritus Weakness Chills
Bolečina v trebuhu Srbež Šibkost Mrzlica
Malaise Feeling hot Feeling abnormal Thirst
Bolehnost Občutek vročine Neobičajno počutje Žeja
Gait disturbance Feeling cold
Motnja hoje Občutek mraza
Chest pain
Bolečina v prsnem košu
Hyper- sensitivity disorder
Preobčutljivost
Hepato-biliary disorders
Bolezni jeter, žolčnika in žolčevodov Motnje reprodukcije in dojk Psihiatrične motnje
Hepatitis3 Elevated liver enzymes (ALT, AST, alkaline phosphatase) Acute liver injury
Hepatitis3 Zvišani jetrni encimi (ALT, AST, alkalna fosfataza) Akutna okvara jeter Menopavzalni simptomi Ginekološka krvavitev
Hepatic failure Jaundice
Odpoved jeter Zlatenica
Reproductive System and Breast Disorders Menopausal
Nespečnost Anksioznost
Very Common Uncommon Rare Very
Dezorientacija Halucinacije Nenavadne
Frequency not known
Samomorilno obnašanje
symptoms Gynaecological haemorrhage
Motnje spanja sanje Agitacija Apatija
Rare
Razmišljanje o samomoru4
Insomnia AnxietySlee p disorder Agitation Libido decreased
Zmanjšanje Bruksizem libida Nenormalen orgazem
Hallucinations
Manija Agresija in jeza5
Suicidal behaviour Suicidal ideation 4 Mania Aggression and anger 5
O primerih tinitusa so poročali tudi po prekinitvi zdravljenja.
Cases of tinnitus have also been reported after treatment discontinuation.
4 Med zdravljenjem z duloksetinom ali kmalu po prekinitvi zdravljenja so poročali o primerih razmišljanja o samomoru in samomorilnem obnašanju (glejte poglavje 4. 4).
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.
5 O primerih agresije in jeze so poročali zlasti ob začetku zdravljenja in po prekinitvi zdravljenja.
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.
Reakcije, o katerih najpogosteje poročajo so omotica, senzorične motnje (vključno s parestezijo), motnje spanja (vključno z nespečnostjo in intenzivnimi sanjami), agitacija ali tesnobnost, slabost in/ ali bruhanje, tresenje, glavobol, razdražljivost, driska, hiperhidroza in vrtoglavica.
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.
9 Navadno so pri SSRI in SNRI ti dogodki blagi do zmerni in samoomejujoči, vendar so pri nekaterih bolnikih lahko resni in/ ali trajajo dlje.
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).
Ko zdravljenje z duloksetinom več ni potrebno, je priporočena postopna prekinitev zdravljenja z zmanjševanjem odmerka zdravila (glejte poglavji 4. 2 in 4. 4).
Electrocardiograms were obtained from 755 duloxetine-treated patients with SUI and 779 placebo- treated patients in 12-week clinical trials.
V 12- tedenskih kliničnih preskušanjih so 755 bolnicam s SUI, ki so prejemale duloksetin, in 779 bolnicam, ki so prejemale placebo, napravili elektrokardiograme.
The heart rate-corrected QT interval in duloxetine-treated patients did not differ from that seen in placebo-treated patients.
QT interval, korigiran s srčno frekvenco, se pri bolnicah, zdravljenih z duloksetinom, ni razlikoval od vrednosti pri bolnicah, ki so prejemale placebo.
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.
V podaljšani fazi teh študij, ki je trajala do 52 tednov, se je vrednost HbA1c zvišala tako v skupini z duloksetinom kot v skupini bolnikov, ki so prejemali rutinsko oskrbo, vendar je bilo srednje zvišanje v skupini, zdravljeni z duloksetinom, večje za 0, 3%.
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).
Preglednica 2 prikazuje neželene učinke, ki so jih opažali v spontanih poročanjih in v s placebom kontroliranih kliničnih preskušanjih (skupno 5. 253 bolnikov, 3. 289 jih je jemalo duloksetin, 1. 964 jih je dobilo placebo).
The most commonly observed adverse reactions in patients with diabetic neuropathic pain treated with ARICLAIM were: nausea; headache, dry mouth and somnolence.
Neželeni učinki, katere so pri bolnikih z bolečino diabetične nevropatije, zdravljenih z zdravilom ARICLAIM, najpogosteje opažali, so bili: slabost, glavobol, suha usta in zaspanost.
10 Table 2:
Preglednica 2:
Frequency not
Pogostnost ni znana
Investigations
Zmanjšanje telesne mase
Weight increase Creatinine phosphokinase increase
Povečanje telesne mase Zvišanje kreatinnin - fosfokinaze
Cardiac Disorders
Bolezni živčevja
Supra- ventricular arrhythmia, mainly atrial fibrillation
Supra - ventrikularna aritmija, zlasti atrijska fibrilacija
Headache (13.8%) Somnolence (10.7%) Eye Disorders
Glavobol (13, 8%) Zaspanost (10, 7%) Očesne bolezni
Dizziness Tremor Lethargy Paraesthesia
Omotica Tremor Letargija Parestezija
Dyskinesia Poor quality sleep Nervousness Myoclonus Disturbance in attention Dysgeusia
Diskinezija Slaba kvaliteta spanja Živčnost Mioklonus Motnje pozornosti Disgevzija
Serotonin syndrome Convulsions Akathisia Psychomotor restlessness Extra- pyramidal symptoms
Serotoninski sindrom Konvulzije Akatizija Psihomotoričn i nemir Ekstrapiramid ni simptomi
Visual disturbance Mydriasis
Motnje vida Midriaza
Glaucoma
Glavkom
Vertigo Ear pain
Vrtoglavica Ušesna bolečina
Respiratory, thoracic and mediastinal disorders
Bolezni dihal, prsnega koša in mediastinalnega prostora Bolezni prebavil
Nausea (21.7%) Dry mouth (13.2%)
Navzea (21, 7%) Suha usta (13, 2%) Bolezni sečil
Diarrhoea Constipation Vomiting Dyspepsia Flatulence
Driska Zaprtje Bruhanje Dispepsija Napenjanje
Gastroenteritis Stomatitis Gastritis Eructation
Gastroenteritis Hematohezija Stomatitis Slab zadah Gastritis Kolcanje
Urinary Retention Urinary hesitation Dysuria Nocturia
Zastajanje urina Odlašanje uriniranja Disurija Nokturija Poliurija Slabši curek urina
Polyuria Urine flow decreased
Bolezni kože in podkožja
Skin and Subcutaneous Tissue Disorders
Izpuščaj Povečano znojenje Nočno znojenje
Photo- sensitivity reactions Increased tendency to bruise Dermatitis contact Urticaria Cold sweat
Fotosenzitivno stne reakcije Povečano nagnjenje k modricam Kontaktni dermatitis Urtikarija Hladen znoj
Stevens- Johnson Syndrome Angio-neurotic oedema
Stevens - Johnsonov sindrom Angionevrotič ni edem
Muscoskeletal and connective tissue disorders
Bolezni mišično- skeletnega sistema in vezivnega tkiva
Musculo- skeletal pain Muscle tightness Muscle spasm
Mišično - skeletna bolečina Napetost mišic Mišični krč
Trismus
Trizem
Endocrine disorders Hypo- thyroidism Metabolism and Nutrition Disorders
Bolezni endokrinega sistema Hipotiroidize m Presnovne in prehranske motnje
Decreased Appetite
Zmanjšanje apetita
Hyperglycemia (reported especially in diabetic patients)
Hiperglikemija Dehidracija (poročana Sindrom zlasti pri neustreznega diabetičnih izločanja bolnikih) antidiuretičneg a hormona Hiponatriemija
Infections and infestations Laryngitis Vascular Disorders
Infekcijske in parazitske bolezni Laringitis Žilne bolezni Sinkopa2
Syncope2 Orthostatic hypotension2 Blood pressure increase Peripheral coldness
Ortostatska hipotenzija2
Hypertensive crisis Hypertension
Hipertenzivna kriza Hipertenzija
General Disorders and Administration Site Conditions
Zvišan krvni tlak Hladni periferni deli Splošne težave in spremembe na mestu aplikacije
Fatigue Abdominal pain
Utrujenost Bolečina v trebuhu
Feeling hot Malaise Gait disturbance Feeling abnormal Feeling cold Thirst Chills
Občutek vročine Bolehnost Motnja hoje Neobičajno počutje Občutek mraza Žeja Mrzlica
Uncommon
sistema
Very Rare
Preobčutljivost
Frequency not
Anafilaktična reakcija
Hepato-biliary disorders
Bolezni jeter, žolčnika in žolčevodov Motnje reprodukcije in dojk
Hepatitis3 Elevated liver enzymes (ALT, AST, alkaline phosphatase)
Hepatitis3 Zvišani jetrni encimi (ALT, AST, alkalna fosfataza) Akutna okvara jeter
Reproductive System and Breast Disorders
Erektilna disfunkcija Psihiatrične motnje
Sexual dysfunction Ejaculation disorder Ejaculation delayed Gynaecological haemorrhage
Seksualna disfunkcija Motnje ejakulacije Zapoznela ejakulacija Ginekološka krvavitev
Psychiatric Disorders
Nespečnost Nenavadne
Insomnia
Motnje spanja Agresija in jeza5 Apatija
Aggression
Samomorilno obnašanje4
Suicidal
sanje
Abnormal dreams Anxiety
Dezorientacija Manija
behaviour4 Suicidal ideation4
Razmišljanje o samomoru4
AgitationLibid Bruxism o decreased Orgasm abnormal
Anksioznost Agitacija Zmanjšanje libida Nenormalen orgazem
Cases of tinnitus have also been reported after treatment discontinuation.
O primerih tinitusa so poročali tudi po prekinitvi zdravljenja.
2 Cases of orthostatic hypotension and syncope have been reported especially at the initiation of treatment.
3 Glejte poglavje 4. 4.
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.
5 O primerih agresije in jeze so poročali zlasti ob začetku zdravljenja in po prekinitvi zdravljenja.
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.
Navadno so pri SSRI in SNRI ti dogodki blagi do zmerni in samoomejujoči, vendar so pri nekaterih bolnikih lahko resni in/ ali trajajo dlje.
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).
12 postopna prekinitev zdravljenja z zmanjševanjem odmerka zdravila (glejte poglavji 4. 2 in 4. 4).
There was also a small increase in fasting blood glucose and in total cholesterol in
V podaljšani fazi teh študij, ki je trajala do 52 tednov, se je vrednost HbA1c zvišala tako v skupini z duloksetinom kot v skupini bolnikov, ki so prejemali rutinsko oskrbo, vendar je bilo srednje zvišanje v skupini, zdravljeni z duloksetinom, večje za 0, 3%.
13 duloxetine-treated patients while those laboratory tests showed a slight decrease in the routine care group.
Pri bolnikih, zdravljenih z duloksetinom, so se tudi vrednosti glukoze v krvi na tešče in vrednosti celokupnega holesterola malo zvišale, medtem, ko so bile vrednosti teh laboratorijskih testov v skupini bolnikov z rutinsko oskrbo rahlo nižje.
Electrocardiograms were obtained from 528 duloxetine-treated and 205 placebo-treated patients with diabetic neuropathic pain in clinical trials lasting up to 13-weeks.
V do 13- tedenskih kliničnih preskušanjih so 528 bolnikom z bolečino diabetične nevropatije, zdravljenim z duloksetinom, in 205 bolnikom, ki so prejemali placebo, napravili elektrokardiograme.
Cases of overdoses, alone or in combination with other medicinal products, with duloxetine doses of 4800mg were reported.
Poročali so o primerih prevelikega odmerjanja duloksetina samega ali v kombinaciji z drugimi zdravili, s 4800 mg odmerki duloksetina.
No specific antidote for duloxetine is known but if serotonin syndrome ensues, specific treatment (such as with cyproheptadine and/ or temperature control) may be considered..
Specifičnega antidota za duloksetin ne poznamo, vendar v primeru pojava serotoninskega sindroma pretehtamo možnost uvedbe specifičnega zdravljenja (s ciproheptadinom in/ ali nadzorom temperature).
Other antidepressants.
Drugi antidepresivi.
Duloxetine is a combined serotonin (5-HT) and norepinephrine (NE) reuptake inhibitor.
Duloksetin je kombinirani zaviralec prevzema serotonina (5- HT) in noradrenalina (NA).
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.
V študijah na živalih povišane koncentracije 5- HT in NA v sakralni hrbtenjači povzročijo zvišan tonus sečnice prek ojačane stimulacije pudendalnega živca prečnoprogaste sfinktrske mišice sečnice, ki se pojavlja samo med shranjevalno fazo mikcijskega cikla.
Stress Urinary Incontinence:
13 Stresna urinska inkontinenca:
The efficacy of duloxetine 40 mg given twice daily in the treatment of SUI was established in four double-blind, placebo-controlled studies, that randomised 1913 women (22 to 83 years) with SUI; of these, 958 patients were randomised to duloxetine and 955 to placebo.
Učinkovitost 40 mg duloksetina, danega dvakrat dnevno, pri zdravljenju SUI je bila ugotovljena v štirih dvojno slepih, s placebom kontroliranih študijah, v katerih so naključno razporedili 1913 žensk (22 do 83 let) s SUI; od teh jih je bilo 958 naključno razporejenih v skupino zdravljenja z duloksetinom in 955 v skupino, ki je prejemala placebo.
The primary efficacy measures were Incontinence Episode Frequency (IEF) from diaries and an incontinence specific quality of life questionnaire score (I-QOL).
Primarni merili učinkovitosti sta bili pogostnost inkontinenčnih epizod (Incontinence Episode Frequency, IEF) iz dnevnikov zdravljenja ter število točk po vprašalniku o kakovosti življenja, specifičnem za inkontinenco (I- QOL).
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.
Pogostnost inkontinenčnih epizod: v vseh štirih študijah je imela skupina, zdravljena z duloksetinom, 50% ali večje mediano znižanje IEF v primerjavi s 33% v skupini, ki je prejemala placebo.
Differences were observed at each visit after 4 weeks (duloxetine 54%, and placebo 22%), 8 weeks (52% and 29%), and 12 weeks (52% and 33%) of medication.
Razlike so opazovali ob vsakem obisku, po 4 tednih (duloksetin 54% in placebo 22%), 8 tednih (52% in 29%) in po 12 tednih (52% in 33%) zdravljenja.
14 In an additional study limited to patients with severe SUI, all responses with duloxetine were achieved within 2 weeks.
V dodatni študiji, omejeni na bolnice s hudo SUI, so bili vsi odzivi na duloksetin doseženi v 2 tednih.
The clinical benefit of ARICLAIM compared with placebo has not been demonstrated in women with mild SUI, defined in randomised trials as those with IEF < 14 per week.
Klinične koristi zdravila ARICLAIM v primerjavi s placebom pri bolnicah z blago SUI, definirano tako v randomiziranih preskušanjih kot tistih z IEF < 14 na teden, niso dokazali.
In these women, ARICLAIM may provide no benefit beyond that afforded by more conservative behavioural interventions.
Pri teh ženskah zdravilo ARICLAIM morda ne daje koristi, v primerjavi s tistimi, kot jih dosegamo z bolj konzervativnimi vedenjskimi posredovanji.
Quality of Life:
Kakovost življenja:
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).
Rezultati števila točk po vprašalniku o kakovosti življenja glede inkontinence (Incontinence Quality of Life, I- QOL) so bili v skupini bolnic, zdravljenih z duloksetinom, v primerjavi s tistimi, ki so prejemale placebo, značilno izboljšani (izboljšanje števila točk 9, 2 v primerjavi s 5, 9, p < 0, 001).
Using a global improvement scale (PGI), significantly more women using duloxetine considered their symptoms of stress incontinence to be improved with treatment compared with women using placebo (64.6% versus 50.1%, p < .001).
Glede na lestvico splošnega izboljšanja (PGI) je značilno več žensk, ki so jemale duloksetin, ocenilo svoje simptome stresne inkontinence za izboljšane z zdravljenjem, v primerjavi z ženskami, ki so prejemale placebo (64, 6% v primerjavi s 50, 1%, p < 0, 001).
ARICLAIM and Prior Continence Surgery: there are limited data that suggest that the benefits of ARICLAIM are not diminished in women with stress urinary incontinence who have previously undergone continence surgery.
Zdravilo ARICLAIM in predhodno kirurško zdravljenje inkontinence: omejeni podatki kažejo, da koristi zdravila ARICLAIM pri bolnicah s stresno urinsko inkontinenco, ki so bile predhodno operirane zaradi inkontinence, niso zmanjšane.
ARICLAIM and Pelvic Floor Muscle Training (PFMT): during a 12-week blinded, randomised, controlled study, ARICLAIM demonstrated greater reductions in IEF compared with either placebo treatment or with PFMT alone.
Zdravilo ARICLAIM in trening mišic medeničnega dna (Pelvic Floor Muscle Training, PFMT): v 12 - tedenski slepi, randomizirani, kontrolirani študiji je zdravilo ARICLAIM pokazalo večja znižanja IEF v primerjavi ali s placebom ali s samim PFMT.
Combined therapy (duloxetine + PFMT) showed greater improvement in both pad use and condition-specific quality of life measures than ARICLAIM alone or PFMT alone.
Kombinirano zdravljenje (duloksetin + PFMT) je pokazalo večje izboljšanje tako pri porabi predlog kot pri merilih kakovosti življenja, specifičnih za stanje, kot samo zdravilo ARICLAIM ali samo PFMT.
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) having diabetic neuropathic pain for at least 6 months.
Učinkovitost duloksetina kot zdravila za bolečino pri diabetični nevropatiji so ugotavljali v 2 randomiziranih 12- tedenskih dvojno slepih s placebom kontroliranih študijah z določenim odmerkom pri odraslih (starih od 22 do 88 let), ki so imeli bolečino diabetične nevropatije vsaj 6 mesecev.
The primary outcome measure was the weekly mean of 24-hour average pain, which was collected in a daily diary by patients on an 11-point Likert scale.
Primarna mera izida je bilo tedensko povprečje 24- urne povprečne bolečine, kar smo zbrali iz dnevnih dnevnikov bolnikov na podlagi 11- točkovne Likertove lestvice.
At least 30% reported pain reduction was recorded in approximately 65% of duloxetine treated patients versus 40% for placebo.
Pri približno 65% bolnikov, zdravljenih z duloksetinom, smo zabeležili vsaj 30% poročano zmanjšanje bolečine v primerjavi s 40% pri bolnikih, ki so prejemali placebo.
The corresponding figures for at least 50% pain reduction were 50% and 26% respectively.
Ustrezne številke za vsaj 50% zmanjšanje bolečine so 50% oziroma 26%.
Clinical response rates (50% or greater improvement in pain) were analysed according to whether or not the patient experienced somnolence during treatment.
Stopnje kliničnega odziva (50% ali večje zmanjšanje bolečine) smo razčlenili na podlagi tega, ali je bolnik med zdravljenjem izkusil zaspanost.
For patients not experiencing somnolence, clinical response was observed in 47% of patients receiving duloxetine and 27% patients on placebo.
V skupini bolnikov, ki niso poročali o zaspanosti, so klinični odziv opažali pri 47% bolnikov, ki so prejemali duloksetin, in pri 27% bolnikov, ki so prejemali placebo.
Clinical response rates in patients experiencing somnolence were 60% on duloxetine and 30% on placebo.
V skupini bolnikov, ki so poročali o zaspanosti, so klinični odziv opažali pri 60% bolnikov, zdravljenih z duloksetinom, in pri 30%
Patients not demonstrating a pain reduction of 30% within 60 days of treatment were unlikely to reach this level during further treatment.
Za bolnike, ki v 60 dneh zdravljenja niso izkusili 30% zmanjšanja bolečine, ni bilo verjetno, da bodo to raven dosegli med nadaljnjim zdravljenjem.
Although data from a one-year open label study offer some evidence for longer-term efficacy, no conclusive efficacy data for treatments longer than 12 weeks duration are available from placebo- controlled studies.
Čeprav podatki iz enoletne študije z znanim zdravilom posredujejo nekaj dokazov za bolj dolgoročno učinkovitost, dokončnih podatkov o učinkovitosti zdravljenja, ki traja dlje kot 12 tednov, iz s placebom kontroliranih študij nimamo.
15 5.2 Pharmacokinetic properties
5. 2 Farmakokinetične lastnosti
The pharmacokinetics of duloxetine demonstrate large intersubject variability (generally 50-60%), partly due to gender, age, smoking status and CYP2D6 metaboliser status.
Farmakokinetika duloksetina kaže veliko variabilnost med osebki (na splošno 50- 60%), deloma zaradi spola, starosti, kajenja in stanja presnavljanja s CYP2D6.
Duloxetine is well absorbed after oral administration with a Cmax occurring 6 hours post dose.
Duloksetin se po peroralnem dajanju dobro absorbira s pojavom Cmax 6 ur po odmerjanju.
The absolute oral bioavailability of duloxetine ranged from 32% to 80% (mean of 50%; N=8 subjects).
Absolutna peroralna biološka uporabnost duloksetina zavzema vrednosti od 32 do 80% (povprečje 50%; N=8 oseb).
Food delays the time to reach the peak concentration from 6 to 10 hours and it marginally decreases the extent of absorption (approximately 11%).
Hrana podaljša čas, potreben za doseganje najvišje koncentracije, s 6 na 10 ur in mejno zmanjša obseg absorpcije (približno 11%).
Duloxetine is approximately 96% bound to human plasma proteins.
Duloksetin se veže na človeške plazemske beljakovine v približno 96%.
Duloxetine binds to both albumin and alpha-1 acid glycoprotein.
Veže se tako na albumin kot tudi na alfa- 1 kisli glikoprotein.
Both CYP2D6 and CYP1A2 catalyse the formation of the two major metabolites glucuronide conjugate of 4-hydroxy duloxetine and sulphate conjugate of 5-hydroxy,6-methoxy duloxetine.
Tako CYP2D6 kot tudi CYP1A2 katalizirata tvorbo dveh poglavitnih presnovkov glukuronidnega konjugata 4- hidroksi duloksetina in sulfatnega konjugata 5- hidroksi, 6- metoksi duloksetina.
The elimination half-life of duloxetine after an oral dose ranges from 8 to 17 hours (mean of 12 hours).
Razpolovni čas izločanja duloksetina po peroralnem odmerku je od 8 do 17 ur (povprečno 12 ur).
After an intravenous dose the plasma clearance of duloxetine ranges from 22 l/ hr to 46 l/ hr (mean of 36 l/ hr) After an oral dose the apparent plasma clearance of duloxetine ranges from 33 to 261 l/ hr (mean 101 l/ hr).
Po peroralnem odmerku je očitni plazemski očistek duloksetina od 33 do 261 l/ h (povprečno 101 l/ h).
Gender: pharmacokinetic differences have been identified between males and females (apparent plasma clearance is approximatively 50% lower in females).
Spol: med moškimi in ženskami so ugotovili farmakokinetične razlike (očitni plazemski očistek je pri ženskah približno 50% nižji).
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.
Starost: ugotavljali so farmakokinetične razlike med mlajšimi in starejšimi ženskami (≥ 65 let) (pri starejših se AUC poviša za približno 25%, razpolovni čas pa je daljši za približno 25%), vendar obseg teh sprememb ni tolikšen, da bi upravičil prilagajanje odmerka.
As a general recommendation, caution should be exercised when treating the elderly (see sections 4.2 and 4.4).
V splošnem priporočamo previdnost pri zdravljenju starejših (glejte poglavji 4. 2 in 4. 4).