FrancophonIA/ELRC3.0 huggingface dataset:
English: The specific indication approved.
Slovenian: Odobrena specifična indikacija.
English: A risk to the breastfed infant cannot be excluded.
Slovenian: Tveganja za dojenega otroka ni mogoče izključiti.
English: Symptoms you should be aware of
Slovenian: Simptomi na katere morate biti še posebej pozorni
English: Ratio Roflumilast/Placebo
Slovenian: Razmerje roflumilast/placebo
English: In case of overdose, it is recommended that the appropriate supportive medical care is provided.
Slovenian: V primeru prevelikega odmerjanja je priporočljivo zagotoviti ustrezno podporno zdravstveno oskrbo.
English: Children and adolescents Daxas should not be used by children and adolescents under 18 years of age.
Slovenian: Otroci in mladostniki Zdravila Daxas se ne sme uporabljati pri otrocih in mladostnikih, mlajših od 18 let.
English: Analysis model
Slovenian: Analizni model
English: Continue taking your medicine at the usual times.
Slovenian: Nadaljujte z jemanjem zdravila ob običajnem času.
English: Do not stop taking these medicines or reduce their dose unless advised by your doctor.
Slovenian: Ne prenehajte z uporabo teh zdravil ali zmanjšajte odmerka, razen če vam tako svetuje zdravnik.
English: Interim Study Reports - with each PSUR.
Slovenian: Vmesna poročila o študiji - z vsakim PSUR-om.
English: You may need to take Daxas for several weeks to achieve its beneficial effect.
Slovenian: Morda boste morali jemati zdravilo Daxas več tednov, da doseže svoj ugoden učinek.
English: The tablet should be swallowed with water and taken at the same time every day.
Slovenian: Tableto je treba pogoltniti z vodo in vzeti vsak dan ob istem času.
English: Body weight <60 kg
Slovenian: Telesna masa, manjša od 60 kg
English: - if you have moderate or severe liver problems.
Slovenian: - če imate zmerne ali hude težave z jetri.
English: The tablet can be taken with or without food.
Slovenian: Tableto se lahko jemlje s hrano ali brez nje.
English: Take the tablet at the same time every day.
Slovenian: Tableto vzemite vsak dan ob istem času.
English: • Educational material for the physician.
Slovenian: • Izobraževalno gradivo za zdravnika
English: Moderate or severe
Slovenian: Zmerno ali hudo
English: In uncommon cases allergic reactions may occur.
Slovenian: Občasno se lahko pojavijo alergijske reakcije.
English: • severe infection
Slovenian: • resno okužbo.
English: Other diseases
Slovenian: Druge bolezni
English: A combination of factors, such as in black, non-smoking females, might lead to an increase of exposure and persistent intolerability.
Slovenian: Kombinacija dejavnikov, npr. pri temnopoltih ženskah nekadilkah, bi lahko povzročila povečano izpostavljenost in trajno intoleranco.
English: Talk to your doctor if, while taking this medicine, you observe an unintentional loss of body weight (not related to a diet or exercise programme).
Slovenian: Pogovorite se z zdravnikom, če v času jemanja tega zdravila opazite nenamerno izgubo telesne mase (ki ni povezana z dieto ali programom telesne vadbe).
English: The major reasons for trial discontinuation were withdrawal of consent and reported adverse events.
Slovenian: Glavni razlogi za izključitev iz preskušanja so bili umik soglasja in sporočeni neželeni učinki.
English: Patients with no history of exacerbations were excluded.
Slovenian: Bolniki brez anamneze poslabšanj so bili izključeni.
English: Negative binomial regression
Slovenian: Negativna binomska regresija
English: Talk to your doctor if these side effects do not resolve within the first weeks of treatment.
Slovenian: Pogovorite se z zdravnikom, če ti neželeni učinki ne minejo v prvih tednih zdravljenja.
English: 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), not known (cannot be estimated from the available data).
Slovenian: 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) in neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: The improvement in lung function was apparent at the first visit after 4 weeks and was maintained up to one year (end of treatment period).
Slovenian: Izboljšanje pljučne funkcije je bilo opazno že ob prvem obisku po 4 tednih in se je obdržalo do enega leta (zaključek zdravljenja).
English: Some side effects could be serious.
Slovenian: Nekateri neželeni učinki so lahko resni.
English: EU/1/10/636/001 10 film-coated tablets EU/1/10/636/002 30 film-coated tablets EU/1/10/636/003 90 film-coated tablets EU/1/10/636/004 14 film-coated tablets EU/1/10/636/005 28 film-coated tablets EU/1/10/636/006 84 film-coated tablets EU/1/10/636/007 98 film-coated tablets
Slovenian: EU/1/10/636/001 10 filmsko obloženih tablet EU/1/10/636/002 30 filmsko obloženih tablet EU/1/10/636/003 90 filmsko obloženih tablet EU/1/10/636/004 14 filmsko obloženih tablet EU/1/10/636/005 28 filmsko obloženih tablet EU/1/10/636/006 84 filmsko obloženih tablet EU/1/10/636/007 98 filmsko obloženih tablet
English: At this low dose you will not get the full effect from the medicinetherefore it is important that you move on to the full dose (called a ‘maintenance dose') after 28 days.
Slovenian: S tem majhnim odmerkom ne boste dosegli polnega učinka zdravila, zato je pomembno, da po 28 dneh preidete na polni odmerek (imenujemo ga tudi "vzdrževalni odmerek").
English: If on one day you have forgotten to take a tablet of Daxas, just carry on the next day with the next tablet as usual.
Slovenian: Če ste na določen dan pozabili vzeti tableto zdravila Daxas, potem naslednji dan samo nadaljujte z naslednjo tableto kot običajno.
English: Each pack contains 28 tablets.
Slovenian: Eno pakiranje vsebuje 28 tablet.
English: Placebo (N=966) Rate (n)
Slovenian: Placebo (N=966) Delež (n)
English: Long-acting beta-agonists (LABAs) were allowed in the studies and were used in approximately 50% of the study population.
Slovenian: V študijah je bila dovoljena uporaba dolgo-delujočih beta agonistov (LABA), uporabljalo jih je približno 50 % preučevane populacije.
English: Daxas 500 micrograms has been studied in clinical trials for up to one year, and is intended for maintenance treatment.
Slovenian: Zdravilo Daxas 500 mikrogramov je bilo preučevano v kliničnih študijah, ki so trajale do enega leta, in je namenjeno vzdrževalnemu zdravljenju.
English: • infection with tuberculosis, herpes, hepatitis, HIV
Slovenian: • okužba s tuberkulozo, herpes, hepatitis, HIV
English: If you forget to take a tablet at the usual time, take the tablet as soon as you remember on the same day.
Slovenian: Če ste pozabili vzeti tableto ob običajnem času, jo isti dan vzemite takoj, ko se spomnite.
English: Tell your doctor or pharmacist straight away.
Slovenian: Nemudoma obvestite zdravnika ali farmacevta.
English: The Marketing Authorisation Holder shall agree the content and format of the updated educational material with the national competent authority.
Slovenian: Imetnik dovoljenja za promet z zdravilom se dogovori glede vsebine in oblike posodobljenega izobraževalnega gradiva s pristojnim organom države članice.
English: The potential risk of malignant tumours and the lack of experience in patients with past history of cancer.
Slovenian: Potencialno tveganje za maligne tumorje in pomanjkanje izkušenj pri bolnikih z anamnezo raka v preteklosti.
English: That patients should tell their doctor if they are taking any other medicines.
Slovenian: Bolniki morajo zdravniku povedati, če jemljejo katera koli druga zdravila.
English: The affinity to the PDE4C splicing variants is 5 to 10-fold lower.
Slovenian: Afiniteta za različice PDE4C je 5 do 10-krat nižja.
English: In case of an allergic reaction, stop taking Daxas and contact your doctor immediately, or go immediately to the emergency department in the nearest hospital.
Slovenian: V primeru pojava alergijske reakcije prenehajte jemati zdravilo Daxas in se nemudoma posvetujte z zdravnikom ali poiščite nujno zdravniško pomoč na urgentnem oddelku najbližje bolnišnice.
English: 28 tablets - 28-day starter pack.
Slovenian: 28 tablet - 28-dnevni začetni paket
English: Women of childbearing age should be advised to use an effective method of contraception during treatment.
Slovenian: Ženskam v rodni dobi je treba pojasniti, da morajo med zdravljenjem uporabljati učinkovito kontracepcijo.
English: In order to relieve a sudden attack of breathlessness it is very important that your doctor provides you with another medicine to be available to you at all times that can cope with such an attack.
Slovenian: Za lajšanje nenadnih napadov težkega dihanja je zelo pomembno, da vam zdravnik predpiše drugo zdravilo, ki učinkovito pomaga pri takšnih napadih in ga morate imeti vedno na razpolago.
English: You may take this medicine with or without food.
Slovenian: To zdravilo lahko jemljete s hrano ali brez nje.
English: PVC/PVDC aluminium blisters in packs of 28 tablets.
Slovenian: PVC/PVDC aluminijevi pretisni omoti v pakiranjih po 28 tablet.
English: The need to inform patients about the risks of Daxas and the precautions for safe use including:
Slovenian: Obveznost informiranja bolnikov o tveganjih zdravila Daxas in previdnostnih ukrepih za varno uporabo vključujoč:
English: 2-Sided p-value
Slovenian: 2-stranska p-vrednost
English: If possible take your medicine and this leaflet with you.
Slovenian: Če je mogoče vzemite zdravilo in to navodilo s seboj.
English: There is no evidence for a specific accumulation or retention of roflumilast or its metabolites in organs and fatty tissue.
Slovenian: Ni dokazov za specifično akumulacijo ali zadrževanje roflumilasta ali njegovih presnovkov v organih in maščobnem tkivu.
English: Before starting treatment with Daxas, inform your doctor if you are suffering from any symptoms of this kind and of any additional medicines you may take since some of those could increase the probability of these side effects.
Slovenian: Pred začetkom zdravljenja z zdravilom Daxas obvestite zdravnika, če imate kakršne koli simptome te vrste ali, če morebiti jemljete še dodatna zdravila, ker lahko katero od teh poveča verjetnost teh neželenih učinkov.
English: Roflumilast improved lung function after 4 weeks (sustained over 52 weeks).
Slovenian: Roflumilast je izboljšal pljučno funkcijo po 4 tednih (izboljšanje se je ohranilo vseh 52 tednov).
English: ANX 2.1 - The MAH commits to conduct a long-term comparative observational safety study.
Slovenian: DODATEK 2.1 - Imetnik dovoljenja za promet z zdravilom se obvezuje, da bo izvedel primerjalno opazovalno študijo dolgoročne varnosti.
English: In a human spermatogenesis study, roflumilast 500 micrograms had no effects on semen parameters or reproductive hormones during the 3-month treatment period and the following 3-month off-treatment period.
Slovenian: V študiji vplivov na spermatogenezo pri človeku roflumilast v odmerku 500 mikrogramov ni vplival na parametre sperme ali reproduktivne hormone v 3-mesečnem obdobju zdravljenja in v 3-mesečnem obdobju po zaključku zdravljenja.
English: Rescue medicinal products (salbutamol or albuterol) were allowed on an as-needed basis.
Slovenian: Zdravila za prvo pomoč (salbutamol ali albuterol) so se smela uporabljati po potrebi.
English: Thus Daxas eases breathing problems.
Slovenian: Tako zdravilo Daxas olajša težave z dihanjem.
English: Do not take Daxas - if you are allergic to roflumilast or any of the other ingredients of this medicine (listed in section
Slovenian: Ne jemljite zdravila Daxas - če ste alergični na roflumilast ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: Pharmacotherapeutic group: Drugs for obstructive airway diseases, other systemic drugs for obstructive airway diseases, ATC code: R03DX07
Slovenian: Farmakoterapevtska skupina: Zdravila za obstruktivne pljučne bolezni, druga sistemska zdravila za obstruktivne pljučne bolezni, oznaka ATC: R03DX07
English: Inhaled corticosteroids were used in 809 (61%) of the roflumilast treated patients, whereas the use of LABAs and theophylline was prohibited.
Slovenian: Inhalacijske kortikosteroide je uporabljalo 809 (61 %) bolnikov, ki so se zdravili z roflumilastom, medtem ko je bila uporaba LABA in teofilina prepovedana.
English: The respective reduction in exacerbations seen in patients without concomitant LABAs was on average 15% (p=0.0387).
Slovenian: Zmanjšanje pogostnosti poslabšanj pri bolnikih brez sočasnega zdravljenja z LABA je znašalo v povprečju 15 % (p = 0,0387).
English: When the activity of this protein is reduced, there is less inflammation in the lungs.
Slovenian: Posledica zmanjšane aktivnosti tega proteina je zmanjšanje vnetja v pljučih.
English: What Daxas is and what it is used for
Slovenian: Kaj je zdravilo Daxas in za kaj ga uporabljamo
English: The design of the studies was parallel-group, double-blind and placebo-controlled.
Slovenian: Študije so bile zasnovane kot vzporedne, dvojno-slepe, s placebom kontrolnimi skupinami.
English: Linearity/Non-linearity
Slovenian: Linearnost/Nelinearnost
English: AstraZeneca (AstraZeneca logo)
Slovenian: AstraZeneca (logotip AstraZeneca)
English: The primary endpoint was reduction in rate of moderate or severe COPD exacerbations per patient per year.
Slovenian: Primarni opazovani dogodek je bil zmanjšanje deleža zmernih ali hudih poslabšanj KOPB na bolnika na leto.
English: That patients or their caregivers should tell their doctor if the patient develops symptoms indicative of:
Slovenian: Da morajo bolniki ali njihovi skrbniki obvestiti zdravnika, če se pri bolniku pojavijo simptomi, ki so značilni za:
English: Persistent intolerability
Slovenian: Trajna intoleranca
English: That they should tell their doctor if they have a history of any of the following conditions
Slovenian: Da opozorijo zdravnika, če imajo v anamnezi katero koli od naslednjih stanj
English: The European Medicines Agency has waived the obligation to submit the results of studies with roflumilast in all subsets of the paediatric population in chronic obstructive pulmonary disease (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z roflumilastom za vse podskupine pediatrične populacije s kronično obstruktivno pljučno boleznijo (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: 10 film-coated tablets 14 film-coated tablets 28 film-coated tablets 30 film-coated tablets 84 film-coated tablets 90 film-coated tablets 98 film-coated tablets
Slovenian: 10 filmsko obloženih tablet 14 filmsko obloženih tablet 28 filmsko obloženih tablet 30 filmsko obloženih tablet 84 filmsko obloženih tablet 90 filmsko obloženih tablet 98 filmsko obloženih tablet
English: The risk of weight decrease in underweight patients and the need to monitor the body weight at each visit and to stop the treatment in the event of an unexplained and clinically concerning weight decrease.
Slovenian: Tveganje za zmanjšanje telesne mase pri podhranjenih bolnikih, potreba po spremljanju telesne mase ob vsakem obisku in potreba po prekinitvi zdravljenja v primeru nepojasnjenega ali klinično zaskrbljujočega zmanjšanja telesne mase.
English: The fact that Daxas is not indicated for the treatment of COPD patients outside of the approved indication, nor for use in patients with asthma or alpha-1 antitrypsin deficiency.
Slovenian: Dejstvo, da zdravilo Daxas ni indicirano za zdravljenje bolnikov s KOPB izven odobrene indikacije, niti ni primerno za uporabo pri bolnikih z astmo ali pomanjkanjem alfa-1-antitripsina.
English: In one of three rat studies on fertility and embryofetal development, post-implantation losses were observed.
Slovenian: V eni od treh študij na podganah o plodnosti in embriofetalnem razvoju so zabeležili izgube po implantaciji.
English: Other medicines and Daxas
Slovenian: Druga zdravila in zdravilo Daxas
English: The lack of clinical data to support the combination with theophylline and that such combination is not recommended.
Slovenian: Pomanjkanje kliničnih podatkov, ki bi podpirali kombinacijo s teofilinom, zato takšna kombinacija ni priporočljiva.
English: Patients and caregivers should be instructed to notify the prescriber of any suicidal ideation (see also section 4.4).
Slovenian: Bolnikom in skrbnikom je treba naročiti, da zdravnika obvestijo o kakršnih koli samomorilnih mislih (glejte tudi poglavje 4.4).
English: Each film-coated tablet contains 188.72 mg lactose (as monohydrate).
Slovenian: Ena filmsko obložena tableta vsebuje 188,72 mg laktoze (v obliki monohidrata).
English: Roflumilast is extensively metabolised via Phase I (cytochrome P450) and Phase II (conjugation) reactions.
Slovenian: Roflumilast se izdatno presnavlja preko reakcij Faze I (citokrom P450) in Faze II (konjugacija).
English: After discontinuation of roflumilast, the majority of patients had regained body weight after 3 months.
Slovenian: Po prenehanju zdravljenja z roflumilastom je večina bolnikov pridobila svojo prejšnjo telesno maso v 3 mesecih.
English: In this case, roflumilast treatment should be reassessed (see section 4.4).
Slovenian: V takšnem primeru je treba zdravljenje z roflumilastom ponovno ovrednotiti (glejte poglavje 4.4).
English: Daxas 500 micrograms may need to be taken for several weeks to achieve its full effect (see sections 5.1 and 5.2).
Slovenian: Zdravilo Daxas 500 mikrogramov bo morda potrebno jemati nekaj tednov, preden bo doseglo svoj polni učinek (glejte poglavji 5.1 in 5.2).
English: 250 micrograms once a day is a sub-therapeutic dose, and should be used only as a starting dose for the first 28 days (see sections 4.2 and 5.2).
Slovenian: 250 mikrogramov enkrat na dan je subterapevtski odmerek in se ga mora uporabljati le kot začetni odmerek v prvih 28 dneh zdravljenja (glejte poglavji 4.2 in 5.2).
English: Both studies included moderate to severe patients with a non-reversible airway obstruction and a FEV1 of 40% to 70% of predicted.
Slovenian: Obe študiji sta vključevali bolnike z zmerno do hudo obliko nereverzibilne obstrukcije dihalnih poti in FEV1 od 40 % do 70 % pričakovane vrednosti.
English: Body weight of underweight patients should be checked at each visit.
Slovenian: Telesno maso podhranjenih bolnikov je treba meriti ob vsakem obisku.
English: Each pack contains 10, 14, 28, 30, 84 , 90 or 98 film-coated tablets.
Slovenian: Eno pakiranje vsebuje 10, 14, 28, 30, 84, 90 ali 98 filmsko obloženih tablet.
English: Therefore, there is a low probability of relevant interactions with substances metabolised by these P450 enzymes.
Slovenian: Zato je verjetnost za pomembno medsebojno delovanje s snovmi, ki jih presnavljajo ti encimi P450, majhna.
English: Food intake does not affect the total PDE4 inhibitory activity, but delays time to maximum concentration (tmax) of roflumilast by one hour and reduces Cmax by approximately 40%.
Slovenian: Vnos hrane ne vpliva na skupno inhibitorno delovanje na PDE4, podaljša pa čas do pojava maksimalne koncentracije (tmax) roflumilasta za eno uro in zmanjša Cmax za približno 40 %.
English: Most relevant findings in safety pharmacology and toxicology studies occurred at higher doses and exposure than that intended for clinical use.
Slovenian: Najpomembnejše ugotovitve v farmakoloških in toksikoloških študijah o varnosti so zabeležili pri višjih odmerkih in stopnjah izpostavljenosti, kot so namenjene za klinično uporabo.
English: Exacerbation Category
Slovenian: Kategorija poslabšanja
English: Roflumilast is associated with an increased risk of psychiatric disorders such as insomnia, anxiety, nervousness and depression.
Slovenian: Roflumilast je povezan s povečanim tveganjem za psihiatrične motnje, npr. nespečnostjo, tesnobo, napetostjo in depresijo.
English: The patient card should include an area where patients can record their weight and the date they weighed themselves and they should be asked to bring the patient card with them at each visit.
Slovenian: Opozorilna kartica za bolnika mora vsebovati prostor, kamor bolniki lahko zabeležijo svojo telesno maso in datum tehtanja, bolnikom pa je treba naročiti, da opozorilno kartico za bolnike ob vsakem obisku prinesejo s seboj.
English: In the event of an unexplained and clinically concerning weight decrease, the intake of roflumilast should be stopped and body weight should be further followed-up.
Slovenian: V primeru nepojasnjenega in klinično zaskrbljujočega zmanjšanja telesne mase je treba prekiniti jemanje roflumilasta in še naprej spremljati telesno maso.
English: All patients should be informed about the risks of Daxas and the precautions for safe use and should be given a patient card before starting Daxas.
Slovenian: Vse bolnike je treba obvestiti o tveganjih zdravila Daxas in previdnostnih ukrepih za varno uporabo in jim je treba dati kartico za bolnike pred začetkom jemanja zdravila.
English: The Marketing Authorisation Holder (MAH) should ensure that all Healthcare Professionals who are expected to prescribe Daxas are provided with an updated Educational pack.
Slovenian: Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da bodo imeli vsi zdravniki, ki bodo predpisovali zdravilo Daxas, na razpolago posodobljeno izobraževalno gradivo.
English: Pregnancy There are limited amount of data from the use of roflumilast in pregnant women.
Slovenian: Nosečnost Podatkov o uporabi roflumilasta pri nosečnicah je malo.
English: Take all your medicines and this leaflet with you and provide full information of your current medications.
Slovenian: S seboj vzemite vsa zdravila, ki jih jemljete in to navodilo za uporabo ter zdravstvenemu osebju posredujte podrobne podatke o trenutnem zdravljenju.
English: The observed adverse reactions for roflumilast in Study RO-2455404-RD were in line with those already included in section 4.8.
Slovenian: Neželeni učinki roflumilasta, ki so jih opazili v študiji RO-2455-404-RD, so bili v skladu s tistimi, ki so že navedeni v poglavju 4.8.
English: The rate of exacerbations (as defined in the protocols) were not significantly reduced by roflumilast in the individual studies (relative risk reduction: 13.5% in Study M2-111 and 6.6% in Study M2-112; p= not significant).
Slovenian: Roflumilast ni pomembno zmanjšal pogostnosti poslabšanj (kot so opredeljena v protokolih) v posameznih študijah (zmanjšanje relativnega tveganja: 13,5 % v študiji M2-111 in 6,6 % v študiji M2-112; p = ni pomemben).
English: PVC/PVDC aluminium blisters in packs of 10, 14, 28, 30, 84, 90 or 98 film-coated tablets.
Slovenian: PVC/PVDC aluminijevi pretisni omoti v pakiranjih po 10, 14, 28, 30, 84, 90 ali 98 filmsko obloženih tablet.
English: Roflumilast targets the PDE4A, 4B and 4D splicing variants with similar potency in the nanomolar range.
Slovenian: Roflumilast deluje na različice encima PDE4A, 4B in 4D v nanomolarnem območju z enako jakostjo.
English: There is no evidence for an immunotoxic, skin sensitising or phototoxic potential.
Slovenian: Ni dokazov o potencialni imunotoksičnosti, senzibilizaciji kože ali fototoksičnosti.
English: Allergic reactions may affect the skin and in rare cases cause swelling of the eyelids, face, lips and tongue, possibly leading to difficulties in breathing and/or a drop in blood pressure and accelerated heartbeat.
Slovenian: Alergijske reakcije lahko prizadenejo kožo in v redkih primerih povzročijo otekanje očesnih vek, obraza, ustnic in jezika, kar lahko povzroči težave z dihanjem in/ali znižanje krvnega tlaka ter hitro bitje srca.
English: Short-acting anticholinergics (SAMAs) were allowed for those patients not taking LABAs.
Slovenian: Kratko-delujoče antiholinergike (SAMA) so lahko uporabljali bolniki, ki niso jemali LABA.
English: Each tablet contains 49.7 mg lactose (as monohydrate).
Slovenian: Ena tableta vsebuje 49,7 mg laktoze (v obliki monohidrata).
English: Rare instances of suicidal ideation and behaviour, including suicide, have been observed in patients with or without history of depression, usually within the first weeks of treatment (see section 4.8).
Slovenian: Redke primere samomorilnih misli in vedenja, vključno z samomorom so opazili pri bolnikih z ali brez zgodovine depresije; običajno v prvih tednih zdravljenja (glejte poglavje 4.8).