FrancophonIA/ELRC3.0 huggingface dataset:
English: These results support efficacy across the entire duration of treatment and improvement in PANSS and was observed as early as day 4 with significant separation from placebo in the 25 mg and 150 mg Xeplion groups by day 8.
Slovenian: V tej študiji so v skupinah, ki so ju zdravili s 100 mg/4 tedne in 150 mg /4 teden dokazali statistično pomembno superiornost rezultata PSP v primerjavi s placebom, pri skupini, ki so jo zdravili s 25 mg/4 tedne pa ne. Ti rezultati podpirajo učinkovitost med celotnim trajanjem zdravljenja in vrednosti lestvice PANSS, ki so jo opazili že 4. dan, pri čemer sta se v skupinah, ki sta prejemali 25 in 150 mg zdravila Xeplion, do osmega dneva pomembno razlikovala od placeba.
English: 3 mg daily
Slovenian: 3 mg na dan
English: Each pre-filled syringe contains 39 mg paliperidone palmitate equivalent to 25 mg paliperidone.
Slovenian: Ena napolnjena injekcijska brizga vsebuje 39 mg paliperidonijevega palmitata v količini, ki ustreza 25 mg paliperidona.
English: The total exposure of paliperidone following Xeplion administration was dose-proportional over a 25-150 mg dose range, and less than dose-proportional for Cmax for doses exceeding 50 mg.
Slovenian: Cmax pa je bila manj kot sorazmerna z odmerki, večjimi od 50 mg.
English: As dangerously low numbers of a certain type of white blood cell needed to fight infection in your blood has been seen very rarely with patients taking this medicine, your doctor may check your white blood cell counts.
Slovenian: Pri bolnikih, ki so prejemali to zdravilo, so zelo redko opazili nevarno majhno število določenih vrst belih krvnih celic, ki jih potrebujete za obrambo pred okužbo.
English: • bone or muscle ache, back pain, joint pain
Slovenian: • bolečina v kosteh ali mišicah, bolečina v hrbtu, bolečina v sklepih
English: Each pre-filled syringe contains 78 mg paliperidone palmitate equivalent to 50 mg paliperidone.
Slovenian: Ena napolnjena injekcijska brizga vsebuje 78 mg paliperidonijevega palmitata v količini, ki ustreza 50 mg paliperidona.
English: If more than 6 months have elapsed since the last injection of Xeplion, initiate dosing as described for the initial recommended initiation of Xeplion above.
Slovenian: Spuščeni mesečni vzdrževalni odmerki (> 6 mesecev) Če je od zadnjega injiciranja zdravila Xeplion preteklo več kot 6 mesecev, odmerjanje začnite tako, kot je zgoraj opisano za prvo uvajanje zdravila Xeplion.
English: Xeplion 50 mg injection Paliperidone IM
Slovenian: Xeplion 50 mg injekcija paliperidon i.m.
English: Cerebrovascular adverse reactions
Slovenian: Možganskožilni neželeni učinki
English: • shaking of the head
Slovenian: • tresenje glave
English: 75 mg prolonged release suspension for injection
Slovenian: 75 mg suspenzija za injiciranje s podaljšanim sproščanjem
English: 100 mg monthly
Slovenian: 100 mg na mesec
English: Manufacturer Janssen Pharmaceutica NV Turnhoutseweg 30
Slovenian: Janssen Pharmaceutica N.V.
English: 150 mg prolonged release suspension for injection
Slovenian: 150 mg suspenzija za injiciranje s podaljšanim sproščanjem
English: 100 mg prolonged release suspension for injection
Slovenian: 100 mg suspenzija za injiciranje s podaljšanim sproščanjem
English: 75 mg monthly
Slovenian: 75 mg na mesec
English: • abdominal pain, vomiting, nausea, constipation, diarrhoea, indigestion, toothache
Slovenian: • bolečina v trebuhu, bruhanje, slabost, zaprtje, driska, prebavne motnje, zobobol
English: Citric acid monohydrate Disodium hydrogen phosphate anhydrous Sodium dihydrogen phosphate monohydrate Sodium hydroxide (for pH adjustment) Water for injections
Slovenian: 6.1 Seznam pomožnih snovi polisorbat 20 polietilenglikol 4000 citronsa kislina monohidrat brezvodni natrijev hidrogenfosfat natrijev dihidrogenfosfat monohidrat natrijev hidroksid (za uravnavanje pH) voda za injekcije
English: R092670-PSY-3004 Mean baseline (SD) Mean change (SD) P-value (vs.
Slovenian: R092670-PSY-3004 Srednja izhodiščna vrednost (SD) Srednja sprememba (SD) Vrednost p (v primerjavi s placebom)
English: • breast discomfort, enlargement of the glands in your breasts, breast enlargement
Slovenian: • neprijeten občutek v dojkah, povečanje žlez v dojkah, povečanje dojk, izcedek iz nožnice
English: R092670-PSY-3007* Mean baseline (SD) Mean change (SD) P-value (vs.
Slovenian: R092670-PSY-3007* Srednja izhodiščna vrednost (SD) Srednja sprememba (SD) Vrednost p (v primerjavi s placebom)
English: Xeplion 75 mg prolonged release suspension for injection Paliperidone
Slovenian: Xeplion 75 mg suspenzija za injiciranje s podaljšanim sproščanjem paliperidon
English: The normal monthly cycle of injections in either the deltoid or gluteal muscle of 25 mg to 150 mg based on individual patient tolerability and/or efficacy should be followed thereafter.
Slovenian: Potem sledi normalni mesečni cikel injiciranja vzdrževalnih odmerkov od 25 do 150 mg v deltoidno ali glutealno mišico.
English: For those < 90 kg, the 1-inch, 23 gauge needle (25.4 mm x 0.64 mm) is recommended.
Slovenian: Pri bolnikih < 90 kg priporočamo iglo dolgo 25,4 mm in široko 0,64 mm (1 palec, velikost 23).
English: An antiemetic effect was observed in preclinical studies with paliperidone.
Slovenian: V predkliničnih študijah paliperidona so opazili antiemetično delovanje.
English: R092670-PSY-3003 Mean baseline (SD) Mean change (SD) P-value (vs.
Slovenian: R092670-PSY-3003 Srednja izhodiščna vrednost (SD) Srednja sprememba (SD) Vrednost p (v primerjavi s placebom)
English: Warnings and precautions Talk to your doctor, pharmacist or nurse before using Xeplion.
Slovenian: Pred začetkom jemanja zdravila Xeplion se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: Reproductive system and breast disorders amenorrhoea, galactorrhoea erectile dysfunction, ejaculation disorder, menstrual disorder e, gynaecomastia, sexual dysfunction, breast pain breast discomfort, breast engorgement, breast enlargement, vaginal discharge priapism
Slovenian: erektilna disfunkcija, motnje ejakulacije, menstrualne motnje e, ginekomastija, spolna disfunkcija, bolečine v dojkah neprijeten občutek v dojkah, nabreklost dojk, povečanje dojk, izcedek iz nožnice priapizem
English: For GLUTEAL injection, use the 1½-inch, 22 gauge needle (38.1 mm x 0.72 mm) (needle with grey coloured hub).
Slovenian: Za injiciranje v GLUTEALNO mišico uporabite iglo velikosti 38,1 mm x 0,72 mm (1 ½- palca, 22 G) (igla s sivim nastavkom).
English: How to store Xeplion
Slovenian: Shranjevanje zdravila Xeplion
English: Prolonged release suspension for injection.
Slovenian: suspenzija za injiciranje s podaljšanim sproščanjem komplet za uvedbo zdravljenja
English: 6.3 Shelf life
Slovenian: DD/MM/LLLL
English: Gluteal injections should be alternated between the two gluteal muscles.
Slovenian: Injiciranje v glutealno mišico
English: Xeplion 100 mg prolonged release suspension for injection Paliperidone
Slovenian: Xeplion 100 mg suspenzija za injiciranje s podaljšanim sproščanjem paliperidon
English: • abnormal posture
Slovenian: • omotica
English: Adverse Drug Reaction Frequency
Slovenian: Neželeni učinek Pogostnost
English: body temperature increased, gait abnormal, chest pain, chest discomfort, malaise, induration hypothermia, chills, thirst, drug withdrawal syndrome, injection site abscess, injection site cellulitis, injection site cyst, injection site haematoma body temperature decreased, injection site necrosis, injection site ulcer
Slovenian: Splošne težave in spremembe na mestu aplikacije pireksija, astenija, utrujenost, reakcija na mestu injiciranja edem obraza, edem e, povišana telesna temperatura, nenormalna drža, bolečina v prsnem košu, neprijeten občutek v prsnem košu, splošno slabo počutje, induracija hipotermija, mrazenje, žeja, sindrom odtegnitve zdravila, absces na mestu injiciranja, celulitis na mestu injiciranja, cista na mestu injiciranja hematom na mestu injiciranja znižana telesna temperatura, nekroza na mestu injiciranja, razjeda na mestu injiciranja
English: Xeplion 150 mg prolonged release suspension for injection Paliperidone
Slovenian: Xeplion 150 mg suspenzija za injiciranje s podaljšanim sproščanjem paliperidon
English: For those ≥ 90 kg, the 1½ inch, 22 gauge needle (38.1 mm x 0.72 mm) is recommended.
Slovenian: Pri bolnikih  90 kg priporočamo iglo dolgo 38,1 mm in široko 0,72 mm (1½ palca, velikost 22).
English: • skin discolouration, flaky itchy scalp or skin
Slovenian: • sprememba barve kože, luščenje in srbenje lasišča ali kože
English: Gastrointestinal disorders abdominal pain, vomiting, nausea, constipation, diarrhoea, dyspepsia, toothache abdominal discomfort, gastroenteritis, dysphagia, dry mouth, flatulence pancreatitis, swollen tongue, faecal incontinence, faecaloma, cheilitis intestinal obstruction, ileus
Slovenian: Bolezni prebavil bolečina v trebuhu, bruhanje, navzea, obstipacija, driska, dispepsija, zobobol neudobje v trebuhu, gastroenteritis, disfagija, suha usta.
English: 25 mg prolonged release suspension for injection
Slovenian: 25 mg suspenzija za injiciranje s podaljšanim sproščanjem
English: 50 mg monthly
Slovenian: 50 mg na mesec
English: There was a statistically significant increase in mammary gland adenocarcinomas in female rats at 10, 30 and 60 mg/kg/month.
Slovenian: Pri odmerkih 10, 30 in 60 mg/kg/mesec je bila pojavnost adenokarcinomov mlečnih žlez pri samicah podgan statistično značilno povečana.
English: Each pre-filled syringe contains paliperidone palmitate equivalent to 150 mg paliperidone.
Slovenian: Ena napolnjena injekcijska brizga vsebuje paliperidonijev palmitat v količini, ki ustreza 150 mg paliperidona.
English: Each pre-filled syringe contains paliperidone palmitate equivalent to 75 mg paliperidone.
Slovenian: Ena napolnjena injekcijska brizga vsebuje paliperidonijev palmitat v količini, ki ustreza 75 mg paliperidona.
English: Each pre-filled syringe contains paliperidone palmitate equivalent to 100 mg paliperidone.
Slovenian: Ena napolnjena injekcijska brizga vsebuje paliperidonijev palmitat v količini, ki ustreza 100 mg paliperidona.
English: Current or past use of medicinal products with alpha 1a-adrenergic antagonist effect should be made known to the ophthalmic surgeon in advance of surgery.
Slovenian: Očesni kirurg mora biti pred operacijo seznanjen, če bolnik jemlje oziroma je jemal zdravila z antagonističnim učinkom na receptorje alfa-1a.
English: Recommended initiation of Xeplion is with a dose of 150 mg on treatment day 1 and 100 mg one week later (day 8), both administered in the deltoid muscle in order to attain therapeutic concentrations rapidly (see section 5.2).
Slovenian: Priporočeno je, da se zdravilo Xeplion uvede s prvim začetnim odmerkom 150 mg (1. dan zdravljenja) in drugim začetnim odmerkom 100 mg (8. dan zdravljenja).
English: Xeplion 25 mg prolonged release suspension for injection Paliperidone
Slovenian: Xeplion 25 mg suspenzija za injiciranje s podaljšanim sproščanjem paliperidon
English: Each pre-filled syringe contains paliperidone palmitate equivalent to 50 mg paliperidone.
Slovenian: Ena napolnjena injekcijska brizga vsebuje paliperidonijev palmitat, v količini, ki ustreza 50 mg paliperidona.
English: Each pre-filled syringe contains paliperidone palmitate equivalent to 25 mg paliperidone.
Slovenian: Ena napolnjena injekcijska brizga vsebuje paliperidonijev palmitat v količini, ki ustreza 25 mg paliperidona.
English: Treatment initiation pack
Slovenian: Učinki pri skupini zdravil
English: 50 mg prolonged release suspension for injection
Slovenian: 50 mg suspenzija za injiciranje s podaljšanim sproščanjem
English: should discontinue Xeplion and have their WBC followed until recovery.
Slovenian: 9/l) je potrebno zdravljenje z zdravilom Xeplion ukiniti in spremljati število levkocitov do normalizacije.
English: • dizziness
Slovenian: • padci
English: Events of leucopenia, neutropenia, and agranulocytosis have been reported with Xeplion.
Slovenian: Pri uporabi zdravila Xeplion, so poročali o primerih levkopenije, nevtropenije in agranulocitoze.
English: Xeplion 50 mg prolonged release suspension for injection Paliperidone
Slovenian: Xeplion 50 mg suspenzija za injiciranje s podaljšanim sproščanjem paliperidon
English: • irritability, depression, anxiety
Slovenian: zmanjšan apetitrazdražljivost, depresija, tesnoba
English: 1 pre-filled syringe
Slovenian: 1 napolnjena injekcijska brizga 2 igli
English: Torsade de pointes and ventricular fibrillation have been reported in a patient in the setting of overdose with oral paliperidone.
Slovenian: Pri enem bolniku, ki je vzel prevelik odmerek peroralnega paliperidona, so poročali o tahikardiji torsade de pointes in ventrikularni fibrilaciji.
English: in your blood
Slovenian: ki uravnava sladkor v krvi) v krvi
English: Pharmacotherapeutic group: Psycholeptics, other antipsychotics.
Slovenian: Zdravilo Xeplion vsebuje učinkovino paliperidon, ki pripada skupini antipsihotičnih zdravil.
English: Long acting paliperidone palmitate injection versus oral prolonged release paliperidone
Slovenian: Dolgodelujoči injicirani paliperidonijev palmitat v primerjavi s peroralnim paliperidonom s podaljšanim sproščanjem
English: 150 mg monthly
Slovenian: 150 mg na mesec
English: • lack of emotion
Slovenian: • čustvena otopelost
English: R092670-SCH-201
Slovenian: R092670-SCH-201 Srednja izhodiščna vrednost (SD) Srednja sprememba (SD) Vrednost p (v primerjavi s placebom)
English: (day 8) time point.
Slovenian: čas (dnevi od randomizacije)
English: Annex I List of the names, pharmaceutical form, strengths of the medicinal products, route of administration, marketing authorisation holders in the member states
Slovenian: Priloga I Seznam imen, farmacevtskih oblik, jakosti zdravila, poti uporabe zdravila, imetnikov dovoljenja za promet z zdravilom v državah članicah
English: Strengths Phramaceutical form
Slovenian: LEFLUNOMID ACTAVIS 100 MG 100 mg
English: ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε.
Slovenian: Ελλάδα ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε.
English: The maintenance of the effect has not been evaluated.
Slovenian: Vzdrževanja tega učinka niso ocenjevali.
English: These changes do not have any clinical significance.
Slovenian: Te spremembe nimajo kakega kliničnega pomena.
English: Current available data are described in sections 4.8, 5.1 and 5.2.
Slovenian: Trenutni razpoložljivi podatki so opisani v poglavjih 4.8, 5.1 in 5.2.
English: 4.8 Undesirable effects a. Summary of the safety profile
Slovenian: 4.8 Neželeni učinki a. Povzetek varnostnega profila:
English: These medicines might increase the risk of bleeding.
Slovenian: Ta zdravila lahko povečajo tveganje za krvavitev.
English: Children and adolescents under 18 years of age
Slovenian: Otroci in mladostniki, mlajši od 18 let
English: The most commonly reported reactions are listed in section 4.8.
Slovenian: Najpogosteje poročane reakcije so navedene v poglavju 4.8.
English: Talk to your doctor if you have high blood pressure or heart disease.
Slovenian: Pogovorite se z zdravnikom, če imate visok krvni tlak ali srčno bolezen.
English: Component of a multipack, can't be sold separately.
Slovenian: Sestavni del večjega pakiranja, ne sme se prodajati ločeno.
English: 8 Falls were more common in the elderly (≥65 years old).
Slovenian: 8Padci so bili bolj pogosti pri starejših (≥ 65 let).
English: Concerning risk factors for suicidality in depression, see above.
Slovenian: Za dejavnike tveganja za samomorilnost pri depresiji, glejte zgoraj.
English: ATC code: N06AX21.
Slovenian: Oznaka ATC: N06AX21.
English: Monitoring of cardiac and vital signs is recommended, along with appropriate symptomatic and supportive measures.
Slovenian: Priporočamo spremljanje znakov delovanja srca in vitalnih znakov, skupaj z ustreznimi simptomatskimi in podpornimi ukrepi.
English: Subsequently, the physician may continue decreasing the dose, but at a more gradual rate.
Slovenian: Kasneje lahko zdravnik nadaljuje z zmanjševanjem odmerka, vendar bolj postopno.
English: You should also tell your doctor if you are taking any of the following:
Slovenian: Zdravniku povejte tudi, če jemljete karkoli od naslednjega:
English: Therapeutic response is usually seen after 2-4 weeks of treatment.
Slovenian: Terapevtski odziv običajno opazimo po 2-4 tednih zdravljenja.
English: Date of first authorisation: 08 December 2014 Date of latest renewal:
Slovenian: Datum pridobitve dovoljenja za promet: 8 december 2014 Datum podaljšanja dovoljenja za promet:
English: Response to treatment should be evaluated after 2 months.
Slovenian: Odziv na zdravljenje je treba ovrednotiti po 2 mesecih.
English: Talk to your doctor if you do not feel better after 2 months.
Slovenian: Posvetujte se z zdravnikom, če se vaše počutje ne izboljša po dveh mesecih.
English: For further information see section 5.1.
Slovenian: Za nadaljnje informacije glejte poglavje 5.1.
English: If you miss a dose, take it as soon as you remember.
Slovenian: Če pozabite vzeti odmerek, ga zaužijte, kakor hitro se spomnite.
English: Using more than one of these medicines at the same time should be avoided.
Slovenian: Sočasni uporabi več kot enega od teh zdravil se moramo izogibati.
English: If it is not treated, your condition may not go away and may become more serious and difficult to treat.
Slovenian: Če vašega stanja ne zdravite, se morda ne bo izboljšalo in bo postalo resnejše in težje ozdravljivo.
English: This risk persists until significant remission occurs.
Slovenian: Takšno tveganje ostaja vse dokler ne pride do znatnega izboljšanja zdravstvenega stanja.
English: The therapeutic benefit should be reassessed regularly (at least every three months) (see section 5.1).
Slovenian: Terapevtsko korist je treba redno ponovno ocenjevati (vsaj enkrat na vsake tri mesece) (glejte poglavje 5.1).
English: The underlying mechanism and the clinical relevance are unknown.
Slovenian: Vzročni mehanizem in klinični pomen nista znana.
English: The corresponding figures for at least 50% pain reduction were 50% and 26% respectively.
Slovenian: Ustrezne številke za vsaj 50 % zmanjšanje bolečine so 50 % oziroma 26 %.
English: De la Industria, 30, 28108 Alcobendas, Madrid, Spain.
Slovenian: de la Industria, 30, 28108 Alcobendas, Madrid, Španija.
English: However, if it is time for your next dose, skip the missed dose and take only a single dose as usual.
Slovenian: Če pa je že čas za vaš naslednji odmerek, pozabljeni odmerek izpustite in vzemite samo enkratni odmerek kot običajno.
English: Patients not demonstrating a pain reduction of 30% within 60 days of treatment were unlikely to reach this level during further treatment.
Slovenian: Za bolnike, ki v 60 dneh zdravljenja niso izkusili 30 % zmanjšanja bolečine, ni bilo verjetno, da bodo to raven dosegli med nadaljnjim zdravljenjem.
English: Treating your disorder properly is important to help you get better.
Slovenian: Ustrezno zdravljenje vaše bolezni je pomembno za izboljšanje vašega počutja.
English: 3 See section 4.4.
Slovenian: 3Glejte poglavje 4.4.
English: Frequency estimate: Very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000).
Slovenian: Ocene pogostnosti: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000).
English: Activated charcoal may be useful in limiting absorption.
Slovenian: Za omejevanje absorpcije utegne biti učinkovito aktivno oglje.
English: As improvement may not occur during the first few weeks or more of treatment, patients should be closely monitored until such improvement occurs.
Slovenian: Ker se prvih nekaj tednov ali dlje zdravstveno stanje morda še ne bo izboljšalo, je treba bolnike skrbno nadzirati vse dokler ne pride do izboljšanja.
English: In addition, long-term safety data in children and adolescents concerning growth, maturation and cognitive and behavioural development are lacking (see section 4.8).
Slovenian: Poleg tega so pomanjkljivi tudi podatki o dolgoročni varnosti pri otrocih in mladostnikih glede rasti, dozorevanja in kognitivnega ter vedenjskega razvoja (glejte poglavje 4.8).
English: • painful urination, frequent urination
Slovenian: • boleče uriniranje, pogosto uriniranje
English: You should swallow your capsule whole with a drink of water.
Slovenian: Kapsulo pogoltnite celo z nekaj vode.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/ risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Slovenian: • ob vsakršni spremembi sistema za obvladovanje tveganj, zlasti kadar je tovrstna sprememba posledica prejema novih informacij, ki lahko privedejo do znatne spremembe razmerja med koristmi in tveganji, ali kadar je ta sprememba posledica tega, da je bil dosežen pomemben mejnik (farmakovigilančni ali povezan z zmanjševanjem tveganja).
English: It is general clinical experience that the risk of suicide may increase in the early stages of recovery.
Slovenian: Splošne klinične izkušnje kažejo, da se lahko tveganje za samomor v zgodnji fazi izboljšanja lahko poveča.
English: These symptoms usually begin during the first 24 hours after the baby is born.
Slovenian: Ti simptomi se običajno pojavijo v prvih 24 urah po rojstvu.
English: Children and adolescents under 18 years of age with depression treated with this medicine had some weight loss when they first start taking this medicine.
Slovenian: Pri otrocih in mladostnikih, mlajših od 18 let, ki so se za depresijo zdravili s tem zdravilom, so ugotovili nekaj izgube telesne mase pri začetku jemanja tega zdravila.
English: 7 Not statistically significantly different from placebo.
Slovenian: 7Ni statistično različno od placeba.
English: The effect in some patients was apparent in the first week of treatment.
Slovenian: Učinek je bil pri nekaterih bolnikih opazen v prvem tednu zdravljenja.
English: Therefore, in patients with known hypertension and/or other cardiac disease, blood pressure monitoring is recommended, especially during the first month of treatment.
Slovenian: Zato pri bolnikih z znano hipertenzijo in/ali drugim srčnim obolenjem priporočamo spremljanje krvnega tlaka, zlasti v prvem mesecu zdravljenja.
English: Generally these symptoms are self-limiting and usually resolve within 2 weeks, though in some individuals they may be prolonged (2-3 months or more).
Slovenian: Navadno so ti simptomi samoomejujoči in večinoma minejo v 2 tednih, čeprav lahko pri nekaterih posameznikih trajajo dlje (2-3 mesece ali več).
English: Food delays the time to reach the peak concentration from 6 to 10 hours and it marginally decreases the extent of absorption (approximately 11 %).
Slovenian: Hrana podaljša čas, potreben za doseganje najvišje koncentracije, s 6 na 10 ur in mejno zmanjša obseg absorpcije (približno 11 %).
English: • falls (mostly in elderly people), fatigue
Slovenian: • padci (predvsem pri starejših), utrujenost
English: In patients with inadequate initial response, additional response after this time is unlikely.
Slovenian: Pri bolnikih, ki imajo nezadosten uvodni odziv, dodatni odziv po preteku tega obdobja ni verjeten.
English: The difference in mean improvement between the two active treatment arms was not significant.
Slovenian: Razlika v povprečnem izboljšanju med dvema aktivnima vejama zdravljenja ni bila značilna.
English: Do not drive or use any tools or machines until you know how Duloxetine Lilly affects you.
Slovenian: Ne vozite in ne upravljajte z orodji ali stroji, dokler ne veste, kako zdravilo Duloksetin Lilly vpliva na vas.
English: If, based on clinical need, a decision to treat is nevertheless taken, the patient should be carefully monitored for the appearance of suicidal symptoms (see section 5.1).
Slovenian: Če se na podlagi klinične potrebe za zdravljenje vseeno odločimo, moramo bolnika skrbno spremljati za primer pojava samomorilnih simptomov (glejte poglavje 5.1).
English: Patients meeting diagnostic criteria for major depressive disorder were excluded from these trials.
Slovenian: Bolnike, ki so izpolnjevali diagnostična merila za veliko depresivno epizodo, smo iz teh preskušanj izključili.
English: A free airway should be established.
Slovenian: Vzpostaviti je treba prehodno dihalno pot.