FrancophonIA/ELRC3.0 huggingface dataset:
English: Cases of liver injury, including severe elevations of liver enzymes (>10 times upper limit of normal), hepatitis and jaundice have been reported with duloxetine (see section 4.8).
Slovenian: Ob zdravljenju z duloksetinom so poročali o primerih okvare jeter, vključno z zvišanjem vrednosti jetrnih encimov (> 10-kratna zgornja meja normalnih vrednosti), hepatitisom in zlatenico (glejte poglavje 4.8).
English: In addition, one patient who transitioned from placebo to duloxetine experienced a suicidal behaviour while taking duloxetine.
Slovenian: En bolnik, ki je prešel iz placeba na duloksetin, je občutil samomorilno vedenje med jemanjem duloksetina.
English: A meta-analysis of placebo-controlled clinical trials of antidepressant medicinal products in psychiatric disorders showed an increased risk of suicidal behaviour with antidepressants compared to placebo in patients less than 25 years old.
Slovenian: Metaanaliza s placebom nadzorovanih kliničnih preskušanj antidepresivov pri odraslih bolnikih s psihiatričnimi motnjami je pokazala, da pri bolnikih, mlajših od 25 let, pri uporabi antidepresivov obstaja večje tveganje za pojav samomorilnega vedenja kot pri uporabi placeba.
English: Duloxetine is administered as a single enantiomer.
Slovenian: Duloksetin dajemo kot enojni enantiomer.
English: Make sure your midwife and/or doctor knows you are on Duloxetine Lilly.
Slovenian: Medicinski sestri, babici in/ali zdravniku povejte, da jemljete zdravilo Duloksetin Lilly.
English: The efficacy and safety of Duloxetine Lilly 30-120 mg once daily in elderly patients with generalised anxiety disorder was similar to that seen in studies of younger adult patients.
Slovenian: Učinkovitost in varnost zdravila Duloksetin Lilly 30-120 mg enkrat na dan pri starejših bolnikih z generalizirano anksiozno motnjo sta bili podobni kot v študijah z mlajšimi odraslimi bolniki.
English: During 52 weeks of placebo-controlled double blind treatment, duloxetine-treated patients with recurrent MDD had a significantly longer symptom free period (p<0.001) compared with patients randomised to placebo.
Slovenian: Med 52-tedenskim s placebom kontroliranim dvojno slepim zdravljenjem so imeli bolniki z veliko depresivno motnjo, ki so se zdravili z duloksetinom, znatno daljše obdobje brez simptomov (p < 0,001) v primerjavi z bolniki, ki so bili randomizirani za zdravljenje s placebom.
English: Caution is advised in patients taking anticoagulants and/or medicinal products known to affect platelet function (e.g. NSAIDs or acetylsalicylic acid (ASA)), and in patients with known bleeding tendencies.
Slovenian: Pri bolnikih, ki jemljejo zdravila proti strjevanju krvi in/ali druga zdravila, za katera je znano, da vplivajo na delovanje trombocitov (npr. nesteroidne protivnetne učinkovine (NSAID) ali acetilsalicilna kislina (acetylsalicylic acid, ASA)), ter pri bolnikih z znano nagnjenostjo h krvavitvam je potrebna previdnost.
English: • vomiting blood, or black tarry stools (faeces), gastroenteritis, burping, difficulty swallowing
Slovenian: • bruhanje krvi ali črno blato, gastroenteritis, riganje, težave pri požiranju
English: After an oral dose the apparent plasma clearance of duloxetine ranges from 33 to 261 l/hr (mean 101 l/hr).
Slovenian: Po peroralnem odmerku je očitni plazemski očistek duloksetina od 33 do 261 l/h (povprečno 101 l/h).
English: Mydriasis has been reported in association with duloxetine, therefore, caution should be used when prescribing Duloxetine Lilly to patients with increased intraocular pressure, or those at risk of acute narrow-angle glaucoma.
Slovenian: V povezavi z duloksetinom so poročali o midriazi, zato je pri predpisovanju zdravila Duloksetin Lilly bolnikom s povišanim intraokularnim tlakom ali s tveganjem za akutni glavkom z zaprtim zakotjem potrebna previdnost.
English: Eli Lilly and Company Limited Tel: + 44-(0) 1256 315000
Slovenian: United Kingdom Eli Lilly and Company Limited Tel: + 44-(0) 1256 315000
English: Hypertension3,7 Orthostatic hypotension2
Slovenian: Hipertenzija3,7 ortostatska hipotenzija2 hladni periferni deli hipertenzivna kriza3,6
English: Pharmacokinetic data on duloxetine is limited in patients with mild or moderate renal impairment.
Slovenian: Farmakokinetičnih podatkov o duloksetinu je pri bolnikih z blago ali zmerno okvarjenim delovanjem ledvic malo.
English: Capsule shell: gelatin, sodium lauryl sulfate, titanium dioxide (E171), indigo carmine (E132), yellow iron oxide (E172) (60 mg only) and edible green ink (30 mg) or edible white ink (60 mg).
Slovenian: Ovojnica kapsule: želatina, natrijev lavrilsulfat, titanov dioksid (E171), indigotin (E132), rumeni železov oksid (E172) (samo 60 mg) in užitno zeleno črnilo (30 mg) ali užitno belo črnilo (60 mg).
English: data on elderly patients exposed to the maximum dose (120mg per day) are limited and thus, caution is recommended when treating this population.
Slovenian: Vendar pa je podatkov pri starejših bolnikih, ki so bili izpostavljeni maksimalnemu odmerku (120 mg na dan) malo, in je zato pri zdravljenju te populacije potrebna previdnost.
English: Effects of other medicinal products on duloxetine Antacids and H2 antagonists: Co-administration of duloxetine with aluminium- and magnesiumcontaining antacids or duloxetine with famotidine had no significant effect on the rate or extent of duloxetine absorption after administration of a 40 mg oral dose.
Slovenian: Antacidi in antagonisti H2: sočasno dajanje duloksetina z antacidi, vsebujočimi aluminij in magnezij, ali duloksetina s famotidinom ni imelo pomembnega učinka na hitrost ali obseg absorpcije duloksetina po dajanju 40 mg peroralnega odmerka.
English: 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.
Slovenian: 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.
English: Duloxetine normalised pain thresholds in several preclinical models of neuropathic and inflammatory pain and attenuated pain behaviour in a model of persistent pain.
Slovenian: V številnih predkliničnih modelih nevropatske in vnetne bolečine je duloksetin normaliziral prag za bolečino ter zmanjšal za bolečino značilno vedenje v modelu vztrajne bolečine.
English: The 60 mg capsules are blue and green and are printed with ‘60 mg' and the code ‘9542'.
Slovenian: 60 mg kapsule so modre in zelene z napisom ‘60 mg' in oznako ‘9542'.
English: Tel: +372 6 817 280
Slovenian: Eesti Tel: +372 6 817 280
English: Treatment of diabetic peripheral neuropathic pain.
Slovenian: Zdravljenje bolečine diabetične periferne nevropatije.
English: The antibiotic linezolid is a reversible non-selective MAOI and should not be given to patients treated with Duloxetine Lilly (see section 4.4).
Slovenian: Antibiotik linezolid je reverzibilen, neselektiven MAOI in ga bolniki, zdravljeni z zdravilom Duloksetin Lilly, ne smejo prejemati (glejte poglavje 4.4).
English: Duloxetine Lilly must not be used in patients with severe renal impairment (creatinine clearance <30 ml/min; see section 4.3).
Slovenian: Zdravila Duloksetin Lilly ne smemo uporabljati pri bolnikih s hudo okvarjenim delovanjem ledvic (očistek kreatinina < 30 ml/min; glejte poglavje 4.3).
English: This includes any possible side effects not listed in this leaflet.
Slovenian: Posvetujete se tudi, če opazite katerekoli neželene učinke, ki niso navedeni v tem navodilu.
English: Symptoms of overdose include sleepiness, coma, serotonin syndrome (a rare reaction which may cause feelings of great happiness, drowsiness, clumsiness, restlessness, feeling of being drunk, fever, sweating or rigid muscles), fits, vomiting and fast heart rate.
Slovenian: Simptomi prevelikega odmerka vključujejo zaspanost, komo, serotoninski sindrom (redka reakcija, ki lahko povzroči občutke velike sreče, zaspanost, okornost, nemir, občutek pijanosti, vročino, znojenje ali toge mišice), krče, bruhanje in pospešeno bitje srca.
English: Gastric lavage may be indicated if performed soon after ingestion or in symptomatic patients.
Slovenian: Izpiranje želodca je lahko indicirano, če ga opravimo kmalu po zaužitju ali pri simptomatskih bolnikih.
English: In patients responding to duloxetine, and with a history of repeated episodes of major depression, further long-term treatment at a dose of 60 to 120 mg/day could be considered.
Slovenian: Pri bolnikih, ki se odzovejo na zdravljenje z duloksetinom in imajo v anamnezi ponavljajoče epizode velikih depresij, lahko razmislimo o nadaljnjem dolgotrajnem zdravljenju z odmerkom od 60 do 120 mg na dan. Generalizirana anksiozna motnja
English: • inflammation of the liver that may cause abdominal pain and yellowing of the skin or whites of the eyes
Slovenian: • vnetje jeter, ki lahko povzroči bolečine v trebuhu in rumeno obarvanje kože ali beločnice
English: Hyponatraemia has been reported when administering Duloxetine Lilly, including cases with serum sodium lower than 110 mmol/l.
Slovenian: Ob dajanju zdravila Duloksetin Lilly so poročali o hiponatriemiji, vključno s primeri, ko je bila serumska koncentracija natrija pod 110 mmol/l.
English: Weight decrease Weight increase Blood creatine phosphokinase increased
Slovenian: Preiskave zmanjšanje telesne mase povečanje telesne mase zvišanje krvne kreatininfosfokinaze zvišanje krvnega kalija zvišanje krvnega holesterola
English: Tolerability of Duloxetine Lilly 60 mg once daily in elderly patients was comparable to that seen in the younger adults.
Slovenian: Prenašanje zdravila Duloksetin Lilly 60 mg enkrat na dan pri starejših bolnikih je bilo primerljivo s tistim, ki je bilo opaženo pri mlajših odraslih.
English: • suicidal thoughts, difficulty sleeping, grinding or clenching the teeth, feeling disorientated, lack of motivation
Slovenian: • samomorilne misli, težave s spanjem, škrtanje ali drgetanje z zobmi, občutek zmedenosti,
English: Hyponatraemia
Slovenian: Hiponatriemija
English: Marketing Authorisation Holder and Manufacturer
Slovenian: Imetnik dovoljenja za promet z zdravilom in izdelovalec:
English: The incidence of relapse during the 6-months double-blind follow-up period was 14% for Duloxetine Lilly and 42% for placebo.
Slovenian: Incidenca relapsa v 6-mesečnem obdobju dvojno slepega sledenja je bila 14 % pri prejemnikih zdravila Duloksetin Lilly oziroma 42 % pri prejemnikih placeba.
English: Duloxetine Lilly should normally not be used for children and adolescents under 18 years.
Slovenian: Zdravilo Duloksetin Lilly pri otrocih in mladostnikih, mlajših od 18 let, običajno ne uporabljamo.
English: The 30 mg capsules are blue and white and are printed with ‘30 mg' and the code ‘9543'.
Slovenian: 30 mg kapsule so modre in bele z napisom ‘30 mg' in oznako ‘9543'.
English: In clinical trials adverse events seen on abrupt treatment discontinuation occurred in approximately 45% of patients treated with Duloxetine Lilly and 23% of patients taking placebo.
Slovenian: V kliničnih preskušanjih so se neželeni učinki ob nenadni prekinitvi zdravljenja pojavili pri približno 45 % bolnikov, ki so jemali zdravilo Duloksetin Lilly in pri 23 % bolnikov, ki so dobivali placebo.
English: 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).
Slovenian: Ko zdravljenje z duloksetinom več ni potrebno, je priporočena postopna prekinitev zdravljenja z zmanjševanjem odmerka zdravila (glejte poglavji 4.2 in 4.4).
English: DO NOT stop taking your capsules without the advice of your doctor even if you feel better.
Slovenian: Če ste prenehali jemati zdravilo Duloksetin Lilly NE prenehajte jemati svojih kapsul, če vam ni tako svetoval zdravnik, tudi če se bolje počutite.
English: For patients not experiencing somnolence, clinical response was observed in 47% of patients receiving duloxetine and 27% of patients on placebo.
Slovenian: 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.
English: 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.
Slovenian: Pri dajanju duloksetina v odmerku 60 mg dvakrat na dan z enkratnim odmerkom dezipramina, substrata CYP2D6, je AUC
English: Both cytochromes P450-2D6 and 1A2 catalyse the formation of the two major metabolites glucuronide conjugate of 4-hydroxy duloxetine and sulfate conjugate of 5-hydroxy 6-methoxy duloxetine.
Slovenian: in 1A2, katalizirata tvorbo dveh poglavitnih presnovkov glukuronidnega konjugata 4-hidroksi duloksetina in sulfatnega konjugata 5-hidroksi 6-metoksi duloksetina.
English: Duloxetine is a combined serotonin (5-HT) and noradrenaline (NA) reuptake inhibitor.
Slovenian: Mehanizem delovanja Duloksetin je kombinirani zaviralec prevzema serotonina (5-HT) in noradrenalina (NA).
English: Multinucleated cells were seen in the liver in the absence of other histopathological changes in the rat carcinogenicity study.
Slovenian: V študiji kancerogenosti pri podganah so opažali večjedrne celice v jetrih, brez drugih histopatoloških sprememb.
English: Based on the half-life of duloxetine, at least 5 days should be allowed after stopping Duloxetine Lilly before starting an MAOI (see section
Slovenian: Na podlagi razpolovnega časa duloksetina pa mora po prenehanju jemanja zdravila Dulloxetin Lilly preteči vsaj 5 dni pred začetkom jemanja MAOI (glejte poglavje 4.3).
English: Duloxetine Lilly is indicated in adults.
Slovenian: Zdravilo Duloksetin Lilly je indicirano za zdravljenje odraslih.
English: 20 hard gastro-resistant capsules.
Slovenian: 20 trdih gastrorezistentnih kapsul.
English: Treatment of generalised anxiety disorder.
Slovenian: Zdravljenje generalizirane anksiozne motnje.
English: This is most likely to occur within the first few weeks of treatment.
Slovenian: Ti simptomi se najpogosteje pojavijo v prvih nekaj tednih zdravljenja.
English: • sudden involuntary jerks or twitches of the muscles, sensation of restlessness or an inability to sit or stand still, feeling nervous, difficulty concentrating, changes in sense of taste, difficulty controlling movement e.g. lack of coordination or involuntary movements of the muscles,
Slovenian: • nenadni nehoteni gibi mišic ali mišično trzanje, občutek nemira ali nezmožnosti sedenja ali stanja pri miru, živčnost, težave s koncentracijo, spremenjeno okušanje stvari, težave z nadziranjem gibov, npr. slaba koordinacija ali nehoteni gibi mišic, sindrom nemirnih nog, slaba kvaliteta spanja
English: In prenatal/postnatal toxicity studies in the rat, duloxetine induced adverse behavioural effects in the offspring at exposures below maximum clinical exposure (AUC).
Slovenian: V študijah pre- in postnatalne toksičnosti pri podganah je duloksetin povzročil neželene vedenjske učinke pri mladičih ob ravneh sistemskih izpostavljenosti, nižjih od največje klinične izpostavljenosti (AUC).
English: The efficacy of Duloxetine Lilly 30-120 mg (flexible dosing) once a day in elderly patients (>65 years) with generalised anxiety disorder was evaluated in a study that demonstrated statistically significant improvement in the HAM-A total score for duloxetine treated patients compared to placebo treated patients.
Slovenian: Učinkovitost zdravila Duloksetin Lilly 30-120 mg (prilagodljivo odmerjanje) enkrat na dan pri starejših bolnikih (> 65 let) z generalizirano anksiozno motnjo je bila ocenjena v študiji, ki je pokazala statistično pomembno izboljšanje skupnega števila točk po lestvici HAM-A za bolnike, zdravljene z duloksetinom, v primerjavi z bolniki, ki so prejemali placebo.
English: 28 hard gastro-resistant capsules 56 hard gastro-resistant capsules 84 hard gastro-resistant capsules 98 hard gastro-resistant capsules
Slovenian: 28 trdih gastrorezistentnih kapsul 56 trdih gastrorezistentnih kapsul 84 trdih gastrorezistentnih kapsul 98 trdih gastrorezistentnih kapsul
English: Multipack: 100 (5 packs of 20) hard gastro-resistant capsules Multipack: 500 (25 packs of 20) hard gastro-resistant capsules
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA Večje pakiranje: 100 (5 pakiranj po 20) trdih gastrorezistentnih kapsul Večje pakiranje: 500 (25 pakiranj po 20) trdih gastrorezistentnih kapsul
English: • increased sweating, (itchy) rash
Slovenian: • povečano znojenje, (srbeč) izpuščaj
English: Duloxetine binds to both albumin and alpha-l acid glycoprotein.
Slovenian: Veže se tako na albumin kot tudi na alfa-1 kisli glikoprotein.
English: Two patients who transitioned from placebo to duloxetine after the acute phase experienced suicidal behaviours while taking duloxetine during the extension phase.
Slovenian: Pri dveh bolnikih, ki sta po akutni fazi prešla s placeba na zdravljenje z duloksetinom, se je pojavilo samomorilno vedenje med jemanjem duloksetina v podaljšani fazi.
English: No dosage adjustment is necessary for patients with mild or moderate renal dysfunction (creatinine clearance 30 to 80 ml/min).
Slovenian: Pri bolnikih z blago do zmerno okvarjenim delovanjem ledvic (očistek kreatinina 30 do 80 ml/min) odmerka ni treba prilagajati.
English: If you forget to take Duloxetine Lilly
Slovenian: Če ste pozabili vzeti zdravilo Duloksetin Lilly
English: Based upon in vitro studies, the circulating metabolites of duloxetine are considered pharmacologically inactive.
Slovenian: Na podlagi preskušanj in vitro veljajo presnovki duloksetina v krvnem obtoku za farmakološko neaktivne.
English: • dizziness, feeling sluggish, tremor, numbness, including numbness, pricking or tingling of the skin
Slovenian: • omotica, občutek nezbranosti, tresenje, otrplost, vključno z otrplostjo, zbadanjem ali mravljinčasto kožo
English: • dizziness, tingling feelings like pins and needles or electric shock-like feelings (particularly in the head), sleep disturbances (vivid dreams, nightmares, inability to sleep), fatigue, sleepiness, feeling restless or agitated, feeling anxious, feeling sick (nausea) or being sick (vomiting), shaking (tremor), headaches, muscle pain, feeling irritable, diarrhoea, excessive sweating or vertigo.
Slovenian: • omotica, utrujenost, ščemenje (občutek zbadanja z iglami), ali občutki, podobni električnemu šoku (predvsem v glavi), motnje spanja (žive sanje, nočne more, nezmožnost spanja), utrujenost, zaspanost, občutek nemira ali razburjenosti, občutek strahu, slabost ali bruhanje, tresenje, glavoboli, bolečina v mišicah, občutek razdraženosti, driska, prekomerno znojenje ali vrtoglavica
English: Medicines that increase the level of serotonin: Triptans, tramadol, tryptophan, SSRIs (such as paroxetine and fluoxetine), SNRIs (such as venlafaxine), tricyclic antidepressants (such as clomipramine, amitriptyline), pethidine, St John's Wort and MAOIs (such as moclobemide and linezolid).
Slovenian: Zdravila, ki zvišajo nivo serotonina: triptani, tramadol, triptofan, SSRI (kot sta paroksetin in fluoksetin), SNRI (kot je venlafaksin), triciklični antidepresivi (kot sta klomipramin, amitriptilin),
English: The usually recommended dose of Duloxetine Lilly is 60 mg once a day, but your doctor will prescribe the dose that is right for you.
Slovenian: Običajen priporočeni odmerek zdravila Duloksetin Lilly je 60 mg enkrat na dan, za vas ustrezen odmerek pa vam bo predpisal zdravnik.
English: Despite this, your doctor may prescribe Duloxetine Lilly for patients under 18 because he/she decides that this is in their best interests.
Slovenian: Duloksetin Lilly tudi bolnikom, mlajšim od 18 let, če se odloči, da je to v njihovo najboljšo korist.
English: Your doctor will tell you if you should be taking Duloxetine Lilly.
Slovenian: Zdravnik vam bo povedal, če smete jemati zdravilo Duloksetin Lilly.
English: Excipient(s) with known effect:
Slovenian: Druge sestavine zdravila z znanim učinkom:
English: Duloxetine Lilly 60 mg once daily demonstrated a statistically significant superiority compared to placebo (p=0.004) on the primary outcome measure, the prevention of depressive relapse, as measured by time to relapse.
Slovenian: Zdravljenje z zdravilom Duloksetin Lilly 60 mg enkrat na dan se je izkazalo za statistično značilno boljše v primerjavi s placebom (p = 0,004) pri merilu primarnega izida, preprečevanju relapsa depresije, kot so izmerili s časom do relapsa.
English: Edible white ink: titanium dioxide (E171), propylene glycol, shellac, povidone.
Slovenian: Užitno belo črnilo: titanov dioksid (E171), propilenglikol, šelak, povidon.
English: • chest pain, feeling cold, thirst, shivering, feeling hot, abnormal gait
Slovenian: • bolečina v prsnem košu, občutek mraza, žeja, drgetanje, občutek vročine, nenormalen način hoje
English: Duloxetine Lilly 30 mg is available in packs of 7, 28 and 98 hard gastro-resistant capsules.
Slovenian: Zdravilo Duloksetin Lilly 30 mg je na voljo v pakiranjih po 7, 28 in 98 trdih gastrorezistentnih kapsul.
English: At least 30% reported pain reduction was recorded in approximately 65% of duloxetine treated patients versus 40% for placebo.
Slovenian: Pri približno 65 % bolnikov, zdravljenih z duloksetinom, smo zabeležili vsaj 30 % poročano zmanjšanje bolečine v primerjavi s 40 % pri bolnikih, ki so prejemali placebo.
English: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands.
Slovenian: IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, Nizozemska.
English: Duloxetine Lilly demonstrated statistically significant superiority over placebo as measured by improvement in the Hamilton Anxiety Scale (HAM-A) total score and by the Sheehan Disability Scale (SDS) global functional impairment score.
Slovenian: Zdravilo Duloksetin Lilly se je izkazalo za statistično značilno boljše kot placebo, kar so izmerili z izboljšanjem skupnega števila točk po Hamiltonovi lestvici za ocenjevanje anksioznosti (Hamilton Anxiety Scale, HAM-A) in s skupnim rezultatom poslabšanja sposobnosti po Sheehanovi lestvici za ocenjevanje nesposobnosti (Sheehan Disability Scale, SDS).
English: The majority of cases of hyponatraemia were reported in the elderly, especially when coupled with a recent history of, or condition pre-disposing to, altered fluid balance.
Slovenian: O hiponatriemiji so v večini primerov poročali pri starejših, predvsem pri tistih, ki so imeli težave z ravnovesjem telesnih tekočin ali pa je bilo pri njih prisotno bolezensko stanje, ki lahko vodi do tega.
English: Pharmacokinetics of duloxetine in paediatric patients aged 7 to 17 years with major depressive disorder following oral administration of 20 to 120 mg once daily dosing regimen was characterized using population modelling analyses based on data from 3 studies.
Slovenian: Farmakokinetika duloksetina po peroralnem jemanju 20 do 120 mg enkrat dnevno je bila pri pediatričnih bolnikih z veliko depresivno motnjo, starih od 7 do 17 let, določena z uporabo analize populacijskega modeliranja na osnovi podatkov iz treh študij.
English: In a relapse prevention study, patients responding to 12-weeks of acute treatment with open-label Duloxetine Lilly 60 mg once daily were randomised to either Duloxetine Lilly 60 mg once daily or placebo for a further 6-months.
Slovenian: V študiji preprečevanja relapsa so bolnike, ki so se odzvali na 12-tedensko akutno zdravljenje z znanim zdravilom Duloksetin Lilly 60 mg enkrat na dan, naključno razporedili v skupini, kjer so nadaljnjih 6 mesecev prejemali ali zdravilo Duloksetin Lilly 60 mg enkrat na dan ali placebo.
English: Duloxetine should not be used in children and adolescents under the age of 18 years for the treatment of major depressive disorder because of safety and efficacy concerns (see sections 4.4, 4.8 and 5.1).
Slovenian: mlajših od 18 let, zaradi pomislekov glede varnosti in učinkovitosti (glejte poglavja 4.4, 4.8 in 5.1).
English: Effect of duloxetine on other medicinal products
Slovenian: Učinki drugih zdravil na duloksetin