natgillin/translations-raw huggingface dataset:
This includes any possible side effects not listed in this leaflet. 
Posvetujte se tudi, če opazite katerekoli neželene učinke, ki niso omenjeni v tem navodilu.
Xeristar 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. 
Zdravljenje z zdravilom Xeristar 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.
How to take Xeristar 
Kako jemati zdravilo Xeristar
Xeristar 60 mg to 120 mg once daily demonstrated statistically significant superiority compared to placebo (p<0.001) on the prevention of relapse, as measured by time to relapse. 
Zdravljenje z zdravilom Xeristar 60 mg do 120 mg enkrat na dan se je izkazalo za statistično značilno boljše v primerjavi s placebom (p < 0,001) pri preprečevanju relapsa, kar so izmerili s časom do relapsa.
Xeristar must not be used in patients with liver disease resulting in hepatic impairment (see sections 4.3 and 5.2). 
Zdravila Xeristar pri bolnikih z obolenjem jeter, ki ima za posledico okvarjeno delovanje jeter, ne smemo uporabljati (glejte poglavji 4.3 in 5.2).
Multipack: 500 (25 packs of 20) hard gastro-resistant capsules Multipack: 100 (5 packs of 20) hard gastro-resistant capsules 
Večje pakiranje: 500 (25 pakiranj po 20) trdih gastrorezistentnih kapsul
No dosage adjustment is necessary for patients with mild or moderate renal dysfunction (creatinine clearance 30 to 80 ml/min). 
Pri bolnikih z blago do zmerno okvarjenim delovanjem ledvic (očistek kreatinina 30 do 80 ml/min)
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). 
Zdravila ki zvišajo nivo serotonina: triptani, tramadol, triptofan, SSRI (kot sta paroksetin in fluoksetin), SNRI (kot je venlafaksin), triciklični antidepresivi (kot sta klomipramin, amitriptilin),
In a relapse prevention study, patients responding to 12-weeks of acute treatment with open-label Xeristar 60 mg once daily were randomised to either Xeristar 60 mg once daily or placebo for a further 6-months. 
V študiji preprečevanja relapsa so bolnike, ki so se odzvali na 12-tedensko akutno zdravljenje z znanim zdravilom, zdravilom Xeristar 60 mg enkrat na dan, naključno razporedili v skupini, kjer so nadaljnjih 6 mesecev prejemali ali zdravilo Xeristar 60 mg enkrat na dan ali placebo.
As the safety of duloxetine in infants is not known, the use of Xeristar while breast-feeding is not recommended. 
Ker varnost uporabe duloksetina pri dojenčkih ni znana,
• Tell your doctor if you are breast-feeding. 
• Obvestite svojega zdravnika, če dojite.
The efficacy of Xeristar at the recommended dose of 60 mg once a day was demonstrated in three out of three randomised, double-blind, placebo-controlled, fixed dose acute studies in adult outpatients with major depressive disorder. 
Učinkovitost zdravila Xeristar v priporočenem odmerku 60 mg enkrat na dan so pokazali v treh od treh randomiziranih dvojno slepih s placebom kontroliranih akutnih preskušanjih z določenim odmerkom pri odraslih bolnikih z veliko depresivno motnjo, zdravljenih ambulantno.
Xeristar 30 mg Xeristar 30 mg is available in packs of 7 and 28 hard gastro-resistant capsules. 
Xeristar 30 mg Zdravilo Xeristar 30 mg je na voljo v pakiranju po 7 in 28 trdnih gastrorezistentnih kapsul.
Tell your doctor if you do not start to feel better after this time. 
Posvetujte se s svojim zdravnikom, če se vaše počutje v tem času ne bo izboljšalo.
The effect of Xeristar 60 mg once a day in elderly depressed patients (≥65 years) was specifically examined in a study that showed a statistically significant difference in the reduction of the HAMD17 score for duloxetine-treated patients compared to placebo. 
Pri starejših depresivnih bolnikih (≥ 65 let) so posebej preučevali učinek zdravila Xeristar 60 mg enkrat na dan v študiji, ki je pokazala statistično pomembno razliko v zmanjšanju HAMD17 rezultata za bolnike, ki so bili zdravljeni z duloksetinom, v primerjavi s tistimi, ki so prejemali placebo.
3 years. 
6.3 Rok uporabnosti 3 leta
The use of Xeristar while breastfeeding is not recommended. 
Uporabo zdravila Xeristar v času dojenja odsvetujemo.
EU/1/04/297/007 (500 hard gastro-resistant capsules) (25 packs of 20) EU/1/04/297/008 (100 hard gastro-resistant capsules) (5 packs of 20) 
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/04/297/007 (500 trdih gastrorezistentnih kapsul) (25 pakiranj po 20) EU/1/04/297/008 (100 trdih gastrorezistentnih kapsul) (5 pakiranj po 20)
Response and remission rates were also higher with Xeristar compared to placebo. 
Ob uporabi zdravila Xeristar v primerjavi s placebom so bile višje tudi stopnje odziva in remisije.
− are taking fluvoxamine which is usually used to treat depression, ciprofloxacin or enoxacin which are used to treat some infections 
- jemljete fluvoksamin, ki se običajno uporablja za zdravljenje depresije, ciprofloksacin ali enoksacin, ki se uporablja za zdravljenje nekaterih okužb - jemljete druga zdravila, ki vsebujejo duloksetin (glejte »Druga zdravila in zdravilo Xeristar«)
Based on the half-life of duloxetine, at least 5 days should be allowed after stopping Xeristar before starting an MAOI (see section 4.3). 
Na podlagi razpolovnega časa duloksetina pa mora po prenehanju jemanja zdravila Xeristar preteči vsaj 5 dni pred začetkom jemanja MAOI
A single study has been performed in paediatric patients with juvenile primary fibromyalgia syndrome (JPFS) in which the duloxetine-treated group did not separate from placebo group for the primary efficacy measure. 
juvenile primary fibromyalgia syndrome), pri kateri se skupina, zdravljena z duloksetinom, glede primarnega opazovanega dogodka učinkovitosti ni razlikovala od skupine, ki je prejemala placebo.
EU/1/04/297/002 (28 hard gastro-resistant capsules) EU/1/04/297/003 (84 hard gastro-resistant capsules) EU/1/04/297/004 (98 hard gastro-resistant capsules) EU/1/04/297/005 (56 hard gastro-resistant capsules) 
EU/1/04/297/002 (28 trdih gastrorezistentnih kapsul) EU/1/04/297/003 (84 trdih gastrorezistentnih kapsul) EU/1/04/297/004 (98 trdih gastrorezistentnih kapsul) EU/1/04/297/005 (56 trdih gastrorezistentnih kapsul)
Talk to your doctor before you take Xeristar if you: - are taking other medicines to treat depression (see ‘Other medicines and Xeristar') - are taking St. John's Wort, a herbal treatment (Hypericum perforatum) - have kidney disease - have had seizures (fits) - have had mania - suffer from bipolar disorder - have eye problems, such as certain kinds of glaucoma (increased pressure in the eye) - have a history of bleeding disorders (tendency to develop bruises), especially if you are pregnant (see ‘Pregnancy and breast-feeding‘) - are at risk of low sodium levels (for example if you are taking diuretics, especially if you are elderly) - are currently being treated with another medicine which may cause liver damage - are taking other medicines containing duloxetine (see ‘Other medicines and Xeristar') 
- ste v preteklosti imeli motnje strjevanja krvi (nagnjenost k razvoju podplutb), sploh če ste noseči (glejte »Nosečnost in dojenje«) - imate tveganje za nizek nivo natrija (če na primer jemljete diuretike, sploh če ste starejši) - se trenutno zdravite z drugimi zdravili, ki lahko povzročijo poškodbo jeter
In a relapse prevention study, patients responding to 6 months of acute treatment with open-label Xeristar were randomised to either Xeristar or placebo for a further 6-months. 
V študiji preprečevanja relapsa so bolnike, ki so se odzvali na 6-tedensko akutno zdravljenje z znanim zdravilom Xeristar, naključno razporedili v skupini, kjer so nadaljnjih 6 mesecev prejemali ali zdravilo
Neither duloxetine (30-120 mg) nor the active control arm (fluoxetine 20-40 mg) statistically separated from placebo on change from baseline to endpoint in the Children´s Depression Rating Scale-Revised (CDRS-R) total score. 
(fluoksetin 20-40 mg) se pri razliki med osnovnim in končnim stanjem glede na točke pregledane lestvice za merjenje depresije pri otrocih (CDRS-R, Children´s Depression Rating Scale-Revised) nista statistično razlikovali od placeba.
In an open label long-term uncontrolled study, the pain reduction in patients responding to 8-weeks of acute treatment of Xeristar 60 mg once daily was maintained for a further 6-months as measured by change on the Brief Pain Inventory (BPI) 24-hour average pain item. 
tedensko akutno zdravljenje z zdravilom Xeristar 60 mg enkrat na dan, ohranilo nadaljnjih 6 mesecev (merjeno s spremembo postavke 24-urne povprečne bolečine vprašalnika BPI (Brief Pain Inventory)).
Xeristar with food, drink and alcohol 
Zdravilo Xeristar skupaj s hrano, pijačo in z alkoholom Zdravilo Xeristar lahko vzamete s hrano ali brez nje.
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. 
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
The concomitant use of Xeristar with selective, reversible MAOIs, like moclobemide, is not recommended (see section 4.4). 
Sočasno uporabo zdravila Xeristar s selektivnimi reverzibilnimi MAOI, kakršen je npr. moklobemid, odsvetujemo (glejte poglavje 4.4).
Opaque white body, imprinted with ‘30 mg' and an opaque blue cap, imprinted with ‘9543'. 
Neprozorno belo telo z vtisnjenim napisom ‘30 mg' ter neprozoren moder pokrovček z vtisnjeno oznako ‘9543'.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIPACK- INNER CARTON FOR 60 MG HARD GASTRO-RESISTANT CAPSULES (without blue box) 
NOTRANJA ŠKATLA VEČJEGA PAKIRANJA ZA 60 MG TRDE GASTROREZISTENTNE KAPSULE (brez modrega okenca)
• 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. 
• 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,
• diabetic neuropathic pain, depression, anxiety and urinary incontinence Using more than one of these medicines at the same time should be avoided. 
• bolečina diabetične nevropatije, depresije, anksioznosti in urinske inkontinence
There have been reports of bleeding abnormalities, such as ecchymoses, purpura and gastrointestinal haemorrhage with selective serotonin reuptake inhibitors (SSRIs) and serotonin/noradrenaline reuptake inhibitors (SNRIs), including duloxetine. 
Pri selektivnih zaviralcih prevzema serotonina (selective serotonin reuptake inhibitors, SSRI) in selektivnih zaviralcih prevzema noradrenalina (selective noradrenaline reuptake inhibitors, SNRI),
The usual starting dose of Xeristar is 30 mg once a day after which most patients will receive 60 mg once a day, but your doctor will prescribe the dose that is right for you. 
Običajen začetni odmerek zdravila Xeristar je 30 mg enkrat na dan, kasneje bo večina bolnikov prejela
Dizziness, sensory disturbances (including paraesthesia or electric shock-like sensations, particularly in the head), sleep disturbances (including insomnia and intense dreams), fatigue, somnolence, agitation or anxiety, nausea and/or vomiting, tremor, headache, myalgia, irritability, diarrhoea, hyperhydrosis and vertigo are the most commonly reported reactions. 
Reakcije, o katerih najpogosteje poročajo so omotica, senzorične motnje (vključno s parestezijo ali občutki, podobnimi električnemu šoku, predvsem v glavi), motnje spanja (vključno z nespečnostjo in intenzivnimi sanjami), utrujenost, zaspanost, agitacija ali tesnobnost, slabost in/ali bruhanje, tresenje, glavobol, mialgija, razdražljivost, driska, hiperhidroza in vrtoglavica.
Discontinuation symptoms seen with duloxetine may include hypotonia, tremor, jitteriness, feeding difficulty, respiratory distress and seizures. 
Simptomi lahko vključujejo ohlapnost mišic, tresenje, živčnost, probleme s hranjenjem, probleme z dihanjem in krče.
Sleep disorder Bruxism Disorientation Apathy behaviour5,7 Mania 
Psihiatrične motnje nespečnost agitacija zmanjšanje libida anksioznost nenormalen orgazem nenavadne sanje razmišljanje o samomoru4 motnje spanja bruksizem dezorientacija apatija samomorilno obnašanje5,7
Gastrointestinal haemorrhage7 Gastroenteritis Eructation Gastritis Dysphagia 
Gastrointestinalna krvavitev7 gastroenteritis kolcanje gastritis disfagija stomatitis hematohezija slab zadah mikroskopski kolitis9
Xeristar 30 mg hard gastro-resistant capsules Xeristar 60 mg hard gastro-resistant capsules 
Xeristar 30 mg trde gastrorezistentne kapsule Xeristar 60 mg trde gastrorezistentne kapsule
Concomitant use of Xeristar with nonselective, irreversible monoamine oxidase inhibitors (MAOIs) is contraindicated (see section 4.5). 
Zdravila Xeristar ne smemo uporabljati sočasno z neselektivnimi ireverzibilnimi zaviralci monoaminooksidaze - MAOI (glejte poglavje 4.5).
How to store Xeristar 
Shranjevanje zdravila Xeristar
Opaque green body, imprinted with ‘60 mg' and an opaque blue cap, imprinted with ‘9542'. 
Neprozorno belo telo z vtisnjenim napisom ‘60 mg' ter neprozoren moder pokrovček z vtisnjeno oznako ‘9542'.
Xeristar contains sucrose 
Zdravilo Xeristar vsebuje saharozo
Duloxetine did not show efficacy in reducing pain as measured by primary outcome measure of Brief Pain Inventory (BPI) average pain score endpoint: least squares (LS) mean change from baseline in BPI average pain score at 13 weeks was -0.97 in the placebo group, compared with -1.62 in the duloxetine 30/60 mg group (p = 0.052). 
Duloksetin ni pokazal učinkovitosti pri zmanjševanju bolečine, izmerjene z merilom primarnega izida, tj. z opazovanim dogodkom povprečne ocene bolečine po vprašalniku BPI: povprečna sprememba po metodi najmanjših kvadratov (LS) od izhodišča povprečne ocene bolečine po vprašalniku BPI po
The incidence of relapse during the 6months double-blind follow-up period was 14% for Xeristar and 42% for placebo. 
Incidenca relapsa v 6-mesečnem obdobju dvojno slepega sledenja je bila 17 %
Sodium lauryl sulfate Titanium dioxide (E171) Indigo carmine (E132) Yellow iron oxide (E172) Edible white ink 
Xeristar 60 mg želatina natrijev lavrilsulfat titanov dioksid (E171) indigotin (E132) rumeni železov oksid (E172) užitno belo črnilo
Also, you need to wait at least 5 days after you stop taking Xeristar before you take a MAOI. 
Tudi po prenehanju jemanja zdravila Xeristar morate počakati vsaj 5 dni,
Although no studies have investigated the association of PPHN to SNRI treatment, this potential risk cannot be ruled out with duloxetine taking into account the related mechanism of action (inhibition of the re-uptake of serotonin). 
tveganja ob jemanju duloksetina ni mogoče izključiti, saj je potrebno upoštevati, da gre za podoben način delovanja (zaviranje prevzema serotonina).
EU/1/04/297/001 (28 hard gastro-resistant capsules) EU/1/04/297/006 (7 hard gastro-resistant capsules) 
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/04/297/001 (28 trdih gastrorezistentnih kapsul) EU/1/04/297/006 (7 trdih gastrorezistentnih kapsul)
Gynaecological haemorrhage Menstrual disorder Sexual dysfunction Testicular pain 
Motnje reprodukcije in dojk erektilna disfunkcija motnje ejakulacije zapoznela ginekološka krvavitev motnje menstruacije spolna menopavzalni simptomi galaktoreja hiperprolaktinemija ejakulacija disfunkcija bolečina v testisih poporodna krvavitev6
Xeristar 60 mg hard gastro-resistant capsules Duloxetine 
Xeristar 60 mg trde gastrorezistentne kapsule duloksetin
Xeristar 30 mg hard gastro-resistant capsules Duloxetine 
Xeristar 30 mg trde gastrorezistentne kapsule duloksetin
− have liver disease 
Bolezni sečil
What you need to know before you take Xeristar DO NOT take Xeristar if you: 
Kaj morate vedeti, preden boste vzeli zdravilo Xeristar
- If you get any of the side effects talk to your doctor or pharmacist. 
- Če opazite katerikoli neželeni učinek, se posvetujte s svojim zdravnikom ali s farmacevtom.
Call your doctor or pharmacist immediately if you take more than the amount of Xeristar prescribed by your doctor. 
Če vzamete večjo količino zdravila Xeristar, kot vam je predpisal vaš zdravnik, nemudoma pokličite svojega zdravnika ali farmacevta.
Xeristar is a hard gastro-resistant capsule. 
FARMACEVTSKA OBLIKA trde gastrorezistentne kapsule
− are taking other medicines containing duloxetine (see ‘Other medicines and Xeristar') Talk to your doctor if you have high blood pressure or heart disease. 
- jemljete druga zdravila, ki vsebujejo duloksetin (glejte »Druga zdravila in zdravilo Xeristar«)
Check with your doctor if you are already taking other medicines containing duloxetine. 
Če že jemljete druga zdravila, ki vsebujejo duloksetin, se o tem pogovorite s svojim zdravnikom.
Xeristar is for oral use. 
Zdravilo Xeristar jemljemo peroralno.
Xeristar contains sucrose. 
Zdravilo Xeristar vsebuje saharozo.
Suicide-related behaviours (suicide attempts and suicidal thoughts), and hostility (predominantly aggression, oppositional behaviour and anger), were more frequently observed in clinical trials among children and adolescents treated with antidepressants compared to those treated with placebo. 
ki so prejemali placebo, so pogosteje opažali s samomorom povezana vedenja (poskusi samomora in samomorilne misli) in sovražnost (zlasti nasilnost, nasprotovalno vedenje in jezo).
• night sweats, hives, cold sweats, sensitivity to sunlight, increased tendency to bruise 
• vnetje jeter, ki lahko povzroči bolečine v trebuhu in rumeno obarvanje kože ali beločnice • nočno potenje, koprivnica, hladen znoj, občutljivost na sončno svetlobo, povečano nagnjenje k modricam
Sodium lauryl sulfate Titanium dioxide (E171) Indigo carmine (E132) Edible green ink 
Xeristar 30 mg želatina natrijev lavrilsulfat titanov dioksid (E171) indigotin (E132)
• large pupils (the dark centre of the eye), problems with eyesight 
• večje zenice (temni osrednji del očesa), motnja vida • omotica ali vrtoglavica (vertiga), ušesna bolečina
Contains sucrose See leaflet for further information 
Shranjevanje zdravila Xeristar Vsebina pakiranja in dodatne informacije
Monoamine oxidase inhibitors (MAOIs): You should not take Xeristar if you are taking, or have recently taken (within the last 14 days) another antidepressant medicine called a monoamine oxidase inhibitor (MAOI). 
NE jemljite zdravila Xeristar, če: - ste alergični (preobčutljivi) na duloksetin ali katerokoli drugo sestavino tega zdravila (navedeno v poglavju 6) - imate obolenje jeter - imate hudo obolenje ledvic - jemljete ali ste v zadnjih 14 dneh jemali drugo antidepresivno zdravilo, imenovano zaviralec monoaminooksidaze (MAOI) (glejte »Druga zdravila in zdravilo Xeristar«)
− are taking or have taken within the last 14 days, another medicine known as a monoamine oxidase inhibitor (MAOI) (see ‘Other medicines and Xeristar') 
14 dneh vzeli drugo antidepresivno zdravilo, imenovano zaviralec monoaminooksidaze (MAOI).
• feeling of dizziness or “spinning” (vertigo), ear pain 
• občutek slabosti (navzea), suha usta
Xeristar 30 mg hard gastro-resistant capsules. 
30 mg trde gastrorezistentne kapsule
Metabolism and nutrition disorders Decreased 
Presnovne in prehranske motnje zmanjšanje apetita hiperglikemija
Xeristar 60 mg hard gastro-resistant capsules. 
60 mg trde gastrorezistentne kapsule
Eli Lilly Italia S.p.A. Tel: + 39- 055 42571 
Quintiles Commercial Italia srl Tel: + 39-02-957941
Constipation Diarrhoea Abdominal pain Vomiting Dyspepsia Flatulence 
Bolezni živčevja glavobol zaspanost omotica letargija tremor parestezija
Caution is advised if Xeristar 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). 
(risperidon, triciklični antidepresivi [tricyclic antidepressants, TCAs], kot so nortriptilin, amitriptilin in imipramin) in zlasti če imajo ozek terapevtski indeks (kot na primer s flekainidom, propafenonom in metoprololom), svetujemo previdnost.
A randomised, double-blind, placebo-controlled study was performed in 272 patients aged 7-17 years with generalised anxiety disorder. 
Pri 272 bolnikih z generalizirano anksiozno motnjo, starih od 7 do 17 let, so opravili randomizirano,
Overall, Xeristar's efficacy has been demonstrated at daily doses between 60 and 120 mg in a total of five out of seven randomised, double-blind, placebo-controlled, fixed dose acute studies in adult outpatients with major depressive disorder. 
120 mg v skupaj petih od sedmih randomiziranih dvojno slepih s placebom kontroliranih akutnih preskušanjih z določenim odmerkom pri odraslih bolnikih z veliko depresivno motnjo, zdravljenih ambulantno.
28 hard gastro-resistant capsules 7 hard gastro-resistant capsules 
FARMACEVTSKA OBLIKA IN VSEBINA 28 trdih gastrorezistentnih kapsul 7 trdih gastrorezistentnih kapsul
Contents of the pack and other information What Xeristar contains 
Ob sočasni uporabi zdravila Xeristar in pripravkov rastlinskega izvora, ki vsebujejo šentjanževko
Pollakiuria 
Dojenje
Each capsule contains 30 mg of duloxetine (as hydrochloride). 
Ena kapsula vsebuje 30 mg duloksetina v obliki duloksetinijevega klorida.
Package leaflet: information for the user Xeristar 30 mg hard gastro-resistant capsules Xeristar 60 mg hard gastro-resistant capsules 
Navodilo za uporabo Xeristar 30 mg trde gastrorezistentne kapsule Xeristar 60 mg trde gastrorezistentne kapsule duloksetin (v obliki duloksetinijevega klorida)
Uncommon side effects (may affect up to 1 in 100 people) 
Pogosti neželeni učinki (se lahko pojavijo pri največ 1 od 10 bolnikov)
The incidence of relapse during the 6-months double-blind follow-up period was 17% and 29% for duloxetine and placebo, respectively. 
oziroma 29 % ob uporabi duloksetina oziroma placeba.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum pridobitve dovoljenja za promet: 17. december 2004
Content (concentration) Package size 
Vsebina (koncentracija) Velikost pakiranja ampula (steklo) 3 ml
EU Number Invented name Strength Pharmaceutical form Route of administration Packaging 
Farmacevtska oblika Pot uporabe Ovojnina
3 vials l t o r 
3 viale k s
Vial (glass) 
3 ampule viala (steklo)
This overview was last updated in 09-2019. 
Povzetek je bil nazadnje posodobljen 09-2019.
The safety profile was similar for all the diseases and was considered acceptable. 
Varnostni profil je bil podoben za vse bolezni in je bil ocenjen kot sprejemljiv.
Soliris is given weekly initially and then every two or three weeks. 
Zdravilo Soliris se na začetku daje tedensko, nato pa vsaka dva ali tri tedne.
Further information on Soliris can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Soliris. 
Nadaljnje informacije za zdravilo Soliris so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/Soliris.
Further information on the orphan designations can be found on the European Medicines Agency's website (PNH: 17 October 2003; aHUS: 24 July 2009; myasthenia gravis: 29 July 2014; NMOSD: 24 April 2019). 
Nadaljnje informacije glede določitve zdravila sirote lahko najdete na spletni strani Evropske agencije za zdravila (PNH: 17. oktober 2003; aHUS: 24. julij 2009; miastenija gravis: 29. julij 2014; NMOSD: 24. april 2019).