FrancophonIA/ELRC3.0 huggingface dataset:
English: Serotonergic agents: In rare cases, serotonin syndrome has been reported in patients using SSRIs/SNRIs concomitantly with serotonergic agents.
Slovenian: Serotonergična zdravila: pri bolnikih, ki so SSRI/ SNRI uporabljali sočasno s serotonergičnimi zdravili, so v redkih primerih poročali o serotoninskem sindromu.
English: Medicines like Xeristar (so called SSRIs/SNRIs) may cause symptoms of sexual dysfunction (see section 4).
Slovenian: Zdravila, kot je zdravilo Xeristar (t. i. SSRI/SNRI), lahko povzročijo simptome spolne disfunkcije
English: Xeristar 60 mg is available in packs of 28, 56, 84, and 98 hard gastro-resistant capsules and in multipacks containing 100 (5 packs of 20) and 500 (25 packs of 20) hard gastro-resistant capsules.
Slovenian: Xeristar 60 mg Zdravilo Xeristar 60 mg je na voljo v pakiranju po 28, 56, 84 in 98 trdnih gastrorezistentnih kapsul in v večjem pakiranju po 100 (5 pakiranj po 20) in 500 (25 pakiranj po 20) trdnih gastrorezistentnih kapsul.
English: Xeristar must not be used in patients with severe renal impairment (creatinine clearance <30 ml/min; see section 4.3).
Slovenian: Zdravila Xeristar ne smemo uporabljati pri bolnikih s hudo okvarjenim delovanjem ledvic (očistek kreatinina < 30 ml/min, glejte poglavje 4.3).
English: 28 hard gastro-resistant capsules 84 hard gastro-resistant capsules 98 hard gastro-resistant capsules 56 hard gastro-resistant capsules
Slovenian: 28 trdih gastrorezistentnih kapsul 84 trdih gastrorezistentnih kapsul 98 trdih gastrorezistentnih kapsul 56 trdih gastrorezistentnih kapsul
English: • inflammation of the blood vessels in the skin (cutaneous vasculitis)
Slovenian: vnetje krvnih žil v koži (kožni vaskulitis)
English: Your doctor will tell you if you should be taking Xeristar.
Slovenian: Vaš zdravnik vam bo povedal, če smete jemati zdravilo Xeristar.
English: EU/1/04/297/005 EU/1/04/297/006 EU/1/04/297/007 EU/1/04/297/008
Slovenian: EU/1/04/297/001 EU/1/04/297/002 EU/1/04/297/003 EU/1/04/297/004 EU/1/04/297/005 EU/1/04/297/006 EU/1/04/297/007 EU/1/04/297/008
English: Therefore Xeristar should not be administered in combination with potent inhibitors of CYP1A2 like fluvoxamine (see section 4.3).
Slovenian: Zato zdravila Xeristar ne smemo dajati skupaj z močnimi zaviralci CYP1A2, denimo s fluvoksaminom (glejte poglavje 4.3).
English: Xeristar is used in adults to treat:
Slovenian: Zdravilo Xeristar pri odraslih se uporablja za zdravljenje: • depresije
English: The usual dose of Xeristar is 60 mg once a day, but your doctor will prescribe the dose that is right for you.
Slovenian: 60 mg enkrat na dan, vendar vam bo vaš zdravnik predpisal odmerek, ki je pravi za vas.
English: The model predicted duloxetine steady state plasma concentrations in paediatric patients were mostly within theconcentration range observed in adult patients.
Slovenian: Z modelom predvidene plazmske koncentracije duloksetina v stanju ravnotežja so bile večinoma znotraj obsega koncentracij,
English: Xeristar 30 mg is available in packs of 7 and 28 capsules.
Slovenian: Zdravilo Xeristar 30 mg je na voljo v pakiranju po 7 in 28 kapsul.
English: Capsule shell
Slovenian: Ovojnica kapsule
English: b. Tabulated summary of adverse reactions
Slovenian: b. V preglednici prikazan povzetek neželenih učinkov
English: Paediatric population: 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: Pediatrična populacija: 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: 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.
Slovenian: 24-urne povprečne bolečine, kar smo zbrali iz dnevnih dnevnikov bolnikov na podlagi 11-točkovne Likertove lestvice.
English: Xeristar contains the active substance duloxetine.
Slovenian: Zdravilo Xeristar vsebuje učinkovino duloksetin.
English: Xeristar demonstrated statistical superiority over placebo as measured by improvement in the 17-item Hamilton Depression Rating Scale (HAM-D) total score (including both the emotional and somatic symptoms of depression).
Slovenian: Zdravilo Xeristar se je izkazalo za statistično boljše kot placebo, kar so izmerili z izboljšanjem skupnega števila točk po Hamiltonovi lestvici za ocenjevanje depresije s 17 postavkami (Hamilton Depression Rating Scale, HAM-D), ki vključuje čustvene in tudi somatske simptome depresije.
English: The efficacy of Xeristar 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 Xeristar 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: Xeristar 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 Xeristar se je izkazalo za statistično značilno boljšo 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 following are reasons why Xeristar may not be suitable for you.
Slovenian: Opozorila in previdnostni ukrepi Spodaj so našteti razlogi, zaradi katerih morda zdravilo Xeristar za vas ni ustrezno.
English: The study included a 10 week placebo-controlled acute phase, followed by an 18 week extension treatment period.
Slovenian: kontrolirano s placebom, ki ji je sledilo 18-tedensko obdobje podaljšanega zdravljenja.
English: Mydriasis has been reported in association with duloxetine, therefore, caution should be used when prescribing Xeristar to patients with increased intraocular pressure, or those at risk of acute narrowangle glaucoma.
Slovenian: V povezavi z duloksetinom so poročali o midriazi, zato je pri predpisovanju zdravila Xeristar bolnikom s povišanim intraokularnim tlakom ali s tveganjem za akutni glavkom z zaprtim zakotjem potrebna previdnost.
English: The efficacy and safety of Xeristar 30-120 mg once daily in elderly patients with generalised anxiety disorder was similar to that seen in studies of younger adult patients.
Slovenian: Xeristar 30-120 mg enkrat na dan pri starejših bolnikih z generalizirano anksiozno motnjo sta bili podobni kot v študijah z mlajšimi odraslimi bolniki.
English: This includes any possible side effects not listed in this leaflet.
Slovenian: Posvetujte se tudi, če opazite katerekoli neželene učinke, ki niso omenjeni v tem navodilu.
English: 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.
Slovenian: 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.
English: How to take Xeristar
Slovenian: Kako jemati zdravilo Xeristar
English: 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.
Slovenian: 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.
English: Xeristar must not be used in patients with liver disease resulting in hepatic impairment (see sections 4.3 and 5.2).
Slovenian: Zdravila Xeristar pri bolnikih z obolenjem jeter, ki ima za posledico okvarjeno delovanje jeter, ne smemo uporabljati (glejte poglavji 4.3 in 5.2).
English: Multipack: 500 (25 packs of 20) hard gastro-resistant capsules Multipack: 100 (5 packs of 20) hard gastro-resistant capsules
Slovenian: Večje pakiranje: 500 (25 pakiranj po 20) trdih gastrorezistentnih kapsul
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)
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: 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.
Slovenian: 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.
English: As the safety of duloxetine in infants is not known, the use of Xeristar while breast-feeding is not recommended.
Slovenian: Ker varnost uporabe duloksetina pri dojenčkih ni znana,
English: • Tell your doctor if you are breast-feeding.
Slovenian: • Obvestite svojega zdravnika, če dojite.
English: 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.
Slovenian: 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.
English: Xeristar 30 mg Xeristar 30 mg is available in packs of 7 and 28 hard gastro-resistant capsules.
Slovenian: Xeristar 30 mg Zdravilo Xeristar 30 mg je na voljo v pakiranju po 7 in 28 trdnih gastrorezistentnih kapsul.
English: Tell your doctor if you do not start to feel better after this time.
Slovenian: Posvetujte se s svojim zdravnikom, če se vaše počutje v tem času ne bo izboljšalo.
English: 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.
Slovenian: 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.
English: 3 years.
Slovenian: 6.3 Rok uporabnosti 3 leta
English: The use of Xeristar while breastfeeding is not recommended.
Slovenian: Uporabo zdravila Xeristar v času dojenja odsvetujemo.
English: 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)
Slovenian: 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)
English: Response and remission rates were also higher with Xeristar compared to placebo.
Slovenian: Ob uporabi zdravila Xeristar v primerjavi s placebom so bile višje tudi stopnje odziva in remisije.
English: − are taking fluvoxamine which is usually used to treat depression, ciprofloxacin or enoxacin which are used to treat some infections
Slovenian: - 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«)
English: 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).
Slovenian: Na podlagi razpolovnega časa duloksetina pa mora po prenehanju jemanja zdravila Xeristar preteči vsaj 5 dni pred začetkom jemanja MAOI
English: 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.
Slovenian: juvenile primary fibromyalgia syndrome), pri kateri se skupina, zdravljena z duloksetinom, glede primarnega opazovanega dogodka učinkovitosti ni razlikovala od skupine, ki je prejemala placebo.
English: 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)
Slovenian: 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)
English: 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')
Slovenian: - 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
English: 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.
Slovenian: 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
English: 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.
Slovenian: (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.
English: 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.
Slovenian: 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)).
English: Xeristar with food, drink and alcohol
Slovenian: Zdravilo Xeristar skupaj s hrano, pijačo in z alkoholom Zdravilo Xeristar lahko vzamete s hrano ali brez nje.
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
English: The concomitant use of Xeristar with selective, reversible MAOIs, like moclobemide, is not recommended (see section 4.4).
Slovenian: Sočasno uporabo zdravila Xeristar s selektivnimi reverzibilnimi MAOI, kakršen je npr. moklobemid, odsvetujemo (glejte poglavje 4.4).
English: Opaque white body, imprinted with ‘30 mg' and an opaque blue cap, imprinted with ‘9543'.
Slovenian: Neprozorno belo telo z vtisnjenim napisom ‘30 mg' ter neprozoren moder pokrovček z vtisnjeno oznako ‘9543'.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIPACK- INNER CARTON FOR 60 MG HARD GASTRO-RESISTANT CAPSULES (without blue box)
Slovenian: NOTRANJA ŠKATLA VEČJEGA PAKIRANJA ZA 60 MG TRDE GASTROREZISTENTNE KAPSULE (brez modrega okenca)
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,
English: • diabetic neuropathic pain, depression, anxiety and urinary incontinence Using more than one of these medicines at the same time should be avoided.
Slovenian: • bolečina diabetične nevropatije, depresije, anksioznosti in urinske inkontinence
English: 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.
Slovenian: Pri selektivnih zaviralcih prevzema serotonina (selective serotonin reuptake inhibitors, SSRI) in selektivnih zaviralcih prevzema noradrenalina (selective noradrenaline reuptake inhibitors, SNRI),
English: 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.
Slovenian: Običajen začetni odmerek zdravila Xeristar je 30 mg enkrat na dan, kasneje bo večina bolnikov prejela
English: 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.
Slovenian: 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.
English: Discontinuation symptoms seen with duloxetine may include hypotonia, tremor, jitteriness, feeding difficulty, respiratory distress and seizures.
Slovenian: Simptomi lahko vključujejo ohlapnost mišic, tresenje, živčnost, probleme s hranjenjem, probleme z dihanjem in krče.
English: Sleep disorder Bruxism Disorientation Apathy behaviour5,7 Mania
Slovenian: Psihiatrične motnje nespečnost agitacija zmanjšanje libida anksioznost nenormalen orgazem nenavadne sanje razmišljanje o samomoru4 motnje spanja bruksizem dezorientacija apatija samomorilno obnašanje5,7
English: Gastrointestinal haemorrhage7 Gastroenteritis Eructation Gastritis Dysphagia
Slovenian: Gastrointestinalna krvavitev7 gastroenteritis kolcanje gastritis disfagija stomatitis hematohezija slab zadah mikroskopski kolitis9
English: Τηλ: +357 22 715000
Slovenian: Phadisco Ltd Τηλ: +357 22 715000
English: Xeristar 30 mg hard gastro-resistant capsules Xeristar 60 mg hard gastro-resistant capsules
Slovenian: Xeristar 30 mg trde gastrorezistentne kapsule Xeristar 60 mg trde gastrorezistentne kapsule
English: Concomitant use of Xeristar with nonselective, irreversible monoamine oxidase inhibitors (MAOIs) is contraindicated (see section 4.5).
Slovenian: Zdravila Xeristar ne smemo uporabljati sočasno z neselektivnimi ireverzibilnimi zaviralci monoaminooksidaze - MAOI (glejte poglavje 4.5).
English: How to store Xeristar
Slovenian: Shranjevanje zdravila Xeristar
English: Opaque green body, imprinted with ‘60 mg' and an opaque blue cap, imprinted with ‘9542'.
Slovenian: Neprozorno belo telo z vtisnjenim napisom ‘60 mg' ter neprozoren moder pokrovček z vtisnjeno oznako ‘9542'.
English: Xeristar contains sucrose
Slovenian: Zdravilo Xeristar vsebuje saharozo
English: 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).
Slovenian: 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
English: The incidence of relapse during the 6months double-blind follow-up period was 14% for Xeristar and 42% for placebo.
Slovenian: Incidenca relapsa v 6-mesečnem obdobju dvojno slepega sledenja je bila 17 %
English: Sodium lauryl sulfate Titanium dioxide (E171) Indigo carmine (E132) Yellow iron oxide (E172) Edible white ink
Slovenian: Xeristar 60 mg želatina natrijev lavrilsulfat titanov dioksid (E171) indigotin (E132) rumeni železov oksid (E172) užitno belo črnilo
English: Also, you need to wait at least 5 days after you stop taking Xeristar before you take a MAOI.
Slovenian: Tudi po prenehanju jemanja zdravila Xeristar morate počakati vsaj 5 dni,
English: Mydriasis
Slovenian: Xeristar.
English: 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).
Slovenian: tveganja ob jemanju duloksetina ni mogoče izključiti, saj je potrebno upoštevati, da gre za podoben način delovanja (zaviranje prevzema serotonina).
English: EU/1/04/297/001 (28 hard gastro-resistant capsules) EU/1/04/297/006 (7 hard gastro-resistant capsules)
Slovenian: ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/04/297/001 (28 trdih gastrorezistentnih kapsul) EU/1/04/297/006 (7 trdih gastrorezistentnih kapsul)