natgillin/translations-raw huggingface dataset:
Musculoskeletal disorders Rare: arthralgia, myalgia 
Bolezni mišično-skeletnega sistema Redki: artralgija, mialgija
Urinary excretion of unchanged paroxetine is generally less than 2% of dose whilst that of metabolites is about 64% of dose. 
Na splošno se z urinom v nespremenjeni obliki izloči manj kot 2 % odmerka paroksetina, v obliki metabolitov pa se izloči približno 64 % odmerka.
Patients with a history of suicidal behaviour or thoughts, or those exhibiting a significant degree of suicidal ideation prior to commencement of treatment, are at a greater risk of suicidal thoughts or suicide attempts, and should receive careful monitoring during treatment. 
Pri bolnikih s samomorilnim vedenjem ali mislimi v anamnezi ali bolnikih, ki kažejo znatno stopnjo samomorilne miselnosti pred pričetkom zdravljenja obstaja večje tveganje za samomorilne misli ali samomorilne poskuse in jih je potrebno med zdravljenjem skrbno nadzorovati.
In rats, increased pup mortality and delayed ossification were observed. 
Pri podganah so opazili večjo smrtnost med mladiči in zakasnelo osifikacijo.
Pharmacotherapeutic group: Antidepressants - selective serotonin reuptake inhibitors, ATC code: N06A B05 
Farmakoterapevtska skupina: Antidepresivi - selektivni zaviralci prevzema serotonina, Oznaka ATC: N06A B05.
Adverse drug reactions are listed below by system organ class and frequency. 
Spodaj navedeni neželeni učinki so razvrščeni po organskih sistemih in pogostnosti.
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). 
Na splošno ti simptomi minejo sami po sebi v 2 tednih, pri posameznikih pa lahko trajajo dlje časa (2-3 mesece ali več).
Metabolite excretion is biphasic, being initially a result of first-pass metabolism and subsequently controlled by systemic elimination of paroxetine. 
Izločanje presnovkov je dvofazno, na začetku kot posledica metabolizma prvega prehoda, nato pa pod nadzorom sistemskega izločanja paroksetina.
Therefore, patients treated with higher doses, those treated for a longer duration and patients whose treatment is abruptly stopped may be at an increased risk of withdrawal symptoms upon stopping treatment with paroxetine. 
Zato je lahko pri bolnikih, zdravljenih z višjimi odmerki, zdravljenih dalj časa, ter pri bolnikih, kjer zdravljenje nenadoma prekinemo, tveganje za pojav odtegnitvenih simptomov ob ukinitvi zdravljenja s paroksetinom povečano.
On the basis of the available data the CHMP considered that the above information on the symptoms which can occur in the neonate after maternal paroxetine use in later stages of pregnancy, should be included in section 4.6 (Pregnancy and Lactation) of the SPC. 
Na podlagi razpoložljivih podatkov so v CHMP sklenili, da je treba zgoraj navedene podatke o simptomih, ki se lahko pojavijo pri novorojenčku po materini uporabi paroksetina v zadnjih mesecih nosečnosti, vključiti v poglavje 4.6 (Nosečnost in dojenje) SPC-ja.
Common: dizziness, tremor 
Pogosti: omotica, tremor
There has been a concern about withdrawal reactions associated with paroxetine since its licensing. 
V zvezi z odtegnitvenimi reakcijami, povezanimi s paroksetinom, so se od pridobitve dovoljenja pojavile zaskrbljenosti.
This results in disproportionate increases in plasma concentrations of paroxetine and hence pharmacokinetic parameters are not constant, resulting in non-linear kinetics. 
To povzroči nesorazmerno povečanje koncentracij paroksetina v plazmi, zaradi česar so farmakokinetični parametri nestalni, kar se kaže v nelinearni farmakokinetiki.
Withdrawal symptoms when treatment is discontinued are common, particularly if discontinuation is abrupt (see section 4.8 Undesirable effects). 
Odtegnitveni simptomi po prekinitvi zdravljenja so pogosti, še posebej, če se zdravljenje prekine nenadno (glejte poglavje 4.8 Neželeni učinki).
Paroxetine use has been associated with the development of akathisia. 
Uporabo paroksetina povezujejo z razvojem akatizije.
However, the non-linearity is generally small and is confined to those subjects who achieve low plasma levels at low doses. 
Nelinearnost pa je na splošno majhna in je omejena le na tiste osebe, pri katerih se z majhnimi odmerki dosežejo majhne koncentracije v plazmi.
Based on the above data concerning withdrawal reactions and suicidal behaviour, UK considered that there was Community interest to reassess the balance of risks and benefits of paroxetine and requested the CHMP to give an opinion on whether the marketing authorisations for paroxetine containing medicinal products should be maintained, varied or withdrawn. 
Na podlagi zgoraj navedenih podatkov o odtegnitvenih reakcijah in samomorilnem vedenju, so v Veliki Britaniji ocenili, da naj se v Skupnosti ponovno oceni razmerje tveganj in koristi paroksetina in zaprosili Odbor za lastniška zdravila (CHMP - Committee for Proprietary Medicinal Products) za mnenje o ohranitvi, spremembah ali preklicu dovoljenj za promet z zdravili, vsebujočimi paroksetin.
Following evacuation, 20 to 30 g of activated charcoal may be administered every 4 to 6 h during the first 24 h after ingestion. 
Po izpraznitvi se lahko med prvimi 24 urami po zaužitju zdravila vsake 4 do 6 ur daje 20 do 30 g aktivnega oglja.
There are insufficient data concerning the risk of suicide related behaviour in treatment naïve patients, but careful monitoring might be warranted. 
Pri zdravljenju predhodno nezdravljenih bolnikov je premalo podatkov o tveganju za samomorilno vedenje, vendar pa je skrben nadzor lahko utemeljen.
Alpharma ApS Rua Virgílio Correia, 11-A 1600-219 Lisboa Portugal 
Portugalska Alpharma ApS Rua Virgílio Correia, 11-A 1600-219 Lisboa Portugal
Multipharma BV, Gemeenschapspolderweg 28 P.O.Box 216 
Nizozemska Multipharma BV, Gemeenschapspolderweg 28 P.O.Box 216
Clinical experience has shown that therapy with paroxetine is not associated with impairment of cognitive or psychomotor function. 
Klinične izkušnje so pokazale, da zdravljenje s paroksetinom ni povezano z okvaro kognitivnega in psihomotoričnega delovanja.
Instituto Luso-Fármaco, Lda. 
Portugalska Instituto Luso-Fármaco, Lda.
Generics UK Ltd. Potters Bar 
Madžarska Generics UK Ltd. Potters Bar
Phospholipidosis was not observed in primate studies of up to one-year duration at doses that were 6 times higher than the recommended range of clinical doses. 
V študijah na primatih, ki so trajale do enega leta, pa pri odmerkih, ki so bili šestkrat večji od priporočenih kliničnih odmerkov, fosfolipidoze niso opazili.
Overall the incidence of seizures is less than 0.1% in patients treated with paroxetine. 
Celotna pojavnost epileptičnih napadov je pri s paroksetinom zdravljenih bolnikih manjša od 0,1 %.
As with all antidepressant medicinal products, dosage should be reviewed and adjusted if necessary within 3 to 4 weeks of initiation of therapy and thereafter as judged clinically appropriate. 
V 3 do 4 tednih po začetku zdravljenja je, tako kot pri vseh antidepresivih, odmerjanje potrebno oceniti in ga po potrebi prilagoditi, kasneje pa mora biti odmerjanje v skladu s presojo kliničnega stanja.
In addition, the CHMP agreed that information with regards to the dose response studies should be included in section 5.1 (Pharmacodynamic Properties) of the SPC. 
Poleg tega so v CHMP soglašali, da je treba podatke o študijah odziva na odmerek vključiti v poglavje 5.1 (Farmakodinamične lastnosti) SPC-ja.
Known hypersensitivity to paroxetine or any of the excipients. 
Znana preobčutljivost za paroksetin ali katero koli pomožno snov.
Hyponatraemia has been reported rarely, predominantly in the elderly. 
O hiponatriemiji so poročali redko in predvsem pri starostnikih.
4.4 Special Warnings and Special Precautions for use 
4.4 Posebna opozorila in previdnostni ukrepi
Analysis of the available data from clinical trials and spontaneous reporting data indicate that the risk of withdrawal reactions is dependent on several factors including the duration and dose of therapy and the rate of dose reduction. 
Analiza razpoložljivih podatkov iz kliničnih preskušanj in podatkov iz spontanih poročil kažejo, da je tveganje za odtegnitvene reakcije odvisno od več dejavnikov, vključno s trajanjem in odmerkom zdravljenja ter hitrostjo nižanja odmerka.
Discontinuation of paroxetine (particularly when abrupt) commonly leads to withdrawal symptoms. 
Prekinitev zdravljenja s paroksetinom (še posebej nenadna) pogosto vodi do odtegnitvenih simptomov.
Behavioural and EEG studies indicate that paroxetine is weakly activating at doses generally above those required to inhibit 5-HT uptake. 
Vedenjske in elektroencefalogramske (EEG) študije kažejo, da je paroksetin v odmerkih, ki so na splošno večji od tistih, ki so potrebni za zaviranje prevzema 5-HT, slabo aktivirajoč.
The CHMP also agreed that the above-mentioned information with regards to longterm efficacy should be included in section 5.1 (Pharmacodynamic Properties) of the Summary of Product Characteristics (SPC). 
V CHMP so tudi soglašali, da je treba zgoraj navedene podatke glede dolgoročne učinkovitosti vključiti v poglavje 5.1 (Farmakodinamične lastnosti) v Povzetku glavnih značilnosti zdravila (Summary of Product Characteristics, SPC).
In essence similar methods were employed in examining differences in risk of suicidal events among GP (General Practitioner) patients treated with different antidepressants. 
Uporabili so podobne metode pri iskanju razlik v tveganju za samomorilne dogodke med bolniki zdravnikov splošne medicine, zdravljenih z različnimi antidepresivi.
Paroxetine is chemically unrelated to the tricyclic, tetracyclic and other available antidepressants. 
Paroksetin kemično ni soroden tricikličnim, tetracikličnim in drugim antidepresivom, ki so na voljo.
Paroxetine is associated with an increased risk of suicidal and hostility related behaviours in the paediatric population (7-17 years old), a possibility of an increased risk of suicidal related behaviours in young adults (18-29 years), is also associated with withdrawal reactions which can be severe in intensity and prolonged in duration and with the development of akathisia. 
Paroksetin je povezan s povečanim tveganjem za samomor in sovražna vedenja v pediatrični populaciji (7-17 let starosti), možnostjo za povečano tveganje za s samomorilnostjo povezana vedenja pri mladih odraslih (18-29 let), povezan pa je tudi z odtegnitvenimi reakcijami, ki so lahko resne jakosti ter podaljšanega trajanja ter z razvojem akatizije.
Treatment with paroxetine should be initiated cautiously two weeks after terminating treatment with an irreversible MAOI or 24 hours after terminating treatment with a reversible MAO inhibitor. 
Zdravljenje s paroksetinom je potrebno uvesti previdno dva tedna po zaključku zdravljenja z ireverzibilnim zaviralcem monoaminooksidaz ali 24 ur po zaključku zdravljenja z reverzibilnim zaviralcem monoaminooksidaz.
Available data, including data from clinical trials, indicate an increased risk of akathisia associated with the use of paroxetine. 
Razpoložljivi podatki, vključno s podatki iz kliničnih preskušanj, kažejo povečano tveganje za akatizijo, povezano z uporabo paroksetina.
No studies are available in children and adolescents in the other currently approved indications for adults. 
Pri otrocih in mladostnikih za druge trenutno odobrene indikacije pri odraslih ni objavljenih študij.
Inclusion of information on the symptoms which can occur in the neonate after maternal paroxetine use in later stages of pregnancy. 
Vključitev podatkov o simptomih, ki se lahko pojavijo pri novorojenčku po materini uporabi paroksetina v zadnjih mesecih nosečnosti.
Due to first-pass metabolism, the amount of paroxetine available to the systemic circulation is less than that absorbed from the gastrointestinal tract. 
Zaradi metabolizma prvega prehoda je količina paroksetina v sistemskem obtoku manjša od tiste, ki se absorbira iz prebavil.
1382 Gr Weesp The Netherlands 
1382 Gr Weesp
Paroxetine should not be used in combination with thioridazine, because, as with other drugs which inhibit the hepatic enzyme CYP450 2D6, paroxetine can elevate plasma levels of thioridazine (see section 4.5 Interactions with other medicinal products and other forms of interaction). 
Paroksetin se ne sme uporabljati v kombinaciji s tioridazinom, saj lahko, podobno kot druga zdravila, ki zavirajo jetrni encim CYP450 2D6, tudi paroksetin poveča plazemske vrednosti tioridazina (glejte poglavje 4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij).
In the treatment of depressive disorders, paroxetine exhibits comparable efficacy to standard antidepressants. 
Pri zdravljenju depresivnih motenj je učinkovitost paroksetina primerljiva z učinkovitostjo standardnih antidepresivov.
Reproduction toxicity studies in rats have shown that paroxetine affects male and female fertility. 
Študije o vplivu na sposobnost razmnoževanja pri podganah so pokazale, da je paroksetin prizadel plodnost samcev in samic.
Generally these symptoms are mild to moderate, however, in some patients they may be severe in intensity. 
Na splošno so ti simptomi blagi do zmerni, vendar pa so pri nekaterih bolnikih lahko tudi hujše intenzitete.
On the basis of the available data the CHMP concluded that if after some weeks on the recommended dose insufficient response is seen some patients may benefit from having their dose gradually increased (in 10 mg steps) up to a maximum of 50mg/day for MDD, SAD, GAD and PTSD and up to a maximum of 60mg/day for OCD and panic disorder. 
Na podlagi razpoložljivih podatkov so v CHMP zaključili, da če po nekaj tednih prejemanja priporočenega odmerka opažamo nezadosten odziv, je lahko pri določenih bolnikih koristno postopno višanje odmerka (v korakih po 10 mg) do največ 50 mg/dan za MDD, SAD, GAD in PTSD ter do največ 60 mg/dan za OCD in panično motnjo.
Caution should also be exercised in those patients at risk of hyponatraemia e.g. from concomitant medications and cirrhosis. 
Previdnost je potrebna tudi pri bolnikih pri katerih obstaja tveganje za hiponatriemijo npr. zaradi sočasnega zdravljenja ali ciroze.
The recommended dose is 40 mg daily. 
Priporočeni odmerek je 40 mg dnevno.
Small amounts of paroxetine are excreted into breast milk. 
Paroksetin se v majhnih količinah izloča v materino mleko.
Endocrine disorders Very rare: syndrome of inappropriate anti-diuretic hormone secretion (SIADH). 
Bolezni endokrinega sistema Zelo redki: sindrom neustreznega izločanja antidiuretičnega hormona (SIADH)
Long-term use should be regularly evaluated (see section 5.1 Pharmacodynamic Properties). 
Dolgotrajno zdravljenje je potrebno redno vrednotiti (glejte poglavje 5.1 Farmakodinamične lastnosti).
GlaxoSmithkline Produtos Farmacêuticos, Lda. 
Portugalska GlaxoSmithkline Produtos Farmacêuticos, Lda.
In accordance with this selective action, in vitro studies have indicated that, in contrast to tricyclic antidepressants, paroxetine has little affinity for alpha1, alpha2 and beta-adrenoceptors, dopamine (D2), 5-HT1 like, 5-HT2 and histamine (H1) receptors. 
S selektivnim delovanjem so skladne tudi ugotovitve in vitro študij, ki kažejo, da ima paroksetin, za razliko od tricikličnih antidepresivov, le majhno afiniteto za alfa1, alfa2 in beta adrenoreceptorje, dopaminske (D2), 5-HT1 podobne receptorje, 5-HT2 in histaminske (H1) receptorje.
The use of paroxetine has been associated with the development of akathisia, which is characterized by an inner sense of restlessness and psychomotor agitation such as an inability to sit or stand still usually associated with subjective distress. 
Uporaba paroksetina je bila povezana s pojavom akatizije, za katero so značilni notranji občutek nervoznosti in psihomotorična agitacija kot sta nezmožnost mirnega sedenja ali stoje, običajno v povezavi s subjektivnim distresom.
Rare: convulsions. 
Redki: konvulzije
No correlation has been found between paroxetine plasma concentrations and clinical effect (adverse experiences and efficacy). 
Odvisnosti med koncentracijami paroksetina v plazmi in kliničnim učinkom (neželeni učinki in učinkovitost) niso zasledili.
ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARIES OF PRODUCT CHARACTERISTICS PRESENTED BY THE EMEA 
DODATEK II ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA DOPOLNILO POVZETKOV GLAVNIH ZNAČILNOSTI ZDRAVILA, PREDSTAVLJENO S STRANI EVROPSKE AGENCIJE ZA VREDNOTENJE ZDRAVIL (European Agency for Evaluation of Medicinal Products-EMEA)
Dosage of paroxetine should be increased gradually until an optimal response is reached (see section 4.3 Contraindications and section 4.5 Interactions with other medicinal products and other forms of interaction). 
Odmerjanje paroksetina je potrebno povečevati postopoma dokler ni dosežen optimalen odziv (glejte poglavje 4.3 Kontraindikacije in poglavje 4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij).
Expansion of withdrawal symptoms seen on discontinuation of paroxetine treatment and inclusion of information on adverse events from paediatric clinical trials. 
Razširitev odtegnitvenih simptomov, opaženih ob ukinitvi zdravljenja s paroksetinom ter vključitev podatkov o neželenih učinkih iz pediatričnih kliničnih preskušanj.
MARKETING AUTHORISATION NUMBER(S) [To be completed nationally] 
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET [potrebno dopolniti lokalno]
As with other antidepressants, including other SSRIs, paroxetine inhibits the hepatic cytochrome P450 enzyme CYP2D6. 
Tako kot drugi antidepresivi, vključno z drugimi selektivnimi zaviralci prevzema serotonina, tudi paroksetin zavira jetrni citokrom P450 encim CYP2D6.
The taper phase regimen used in clinical trials involved decreasing the daily dose by 10 mg at weekly intervals. 
V kliničnih raziskavah je bil v fazi ukinjanja zdravila uporabljen režim zniževanja dnevnega odmerka po 10 mg v tedenskih intervalih.
two weeks after discontinuation of an irreversible MAOI, or at least 24hrs after discontinuation of a reversible MAOI (e.g. moclobemide). 
dva tedna po ukinitvi ireverzibilnega zaviralca monoaminooksidaz, ali vsaj 24 ur po ukinitvi reverzibilnega zaviralca monoaminooksidaz (npr. moklobemid).
The overall safety profile of paroxetine containing medicinal products was reviewed by the CHMP. 
V CHMP so pregledali celotni varnostni profil zdravil, vsebujočih paroksetin.
As with other selective 5-HT uptake inhibitors, paroxetine causes symptoms of excessive 5-HT receptor stimulation when administered to animals previously given monoamine oxidase (MAO) inhibitors or tryptophan. 
Tako kot drugi selektivni zaviralci prevzema serotonina, povzroča paroksetin simptome pretirane stimulacije 5-HT receptorjev, če se ga daje živalim, katerim so bili predhodno dani zaviralci monoaminooksidaz ali triptofan.
Approximately 95% of the paroxetine present is protein bound at therapeutic concentrations. 
V terapevtskih koncentracijah je približno 95 % paroksetina v plazmi vezanega na proteine.
Box 51409 CY-3505 Limassol Cyprus 
Medochemie Ltd P.O. Box 51409 CY-3505 Limassol Cyprus
Epilepsy As with other antidepressants, paroxetine should be used with caution in patients with epilepsy. 
Epilepsija Tako kot druge antidepresive je potrebno tudi paroksetin pri bolnikih z epilepsijo uporabljati previdno.
- The Committee considered that efficacy has not been demonstrated in children and adolescents with major depressive disorder. 
- je Odbor upošteval, da učinkovitost pri otrocih in mladostnikih z veliko depresivno motnjo ni bila dokazana.
Generally these events are mild to moderate and are self-limiting, however, in some patients they may be severe and/or prolonged. 
Na splošno so ti neželeni učinki blagi do zmerni in minejo sami po sebi, vendar pa so pri nekaterih bolnikih lahko tudi hudi in/ali trajajo dlje časa.
In addition, in these trials efficacy has not been adequately demonstrated (see section 4.4 Special Warnings and Special Precautions for use and section 4.8 Undesirable Effects). 
Razen tega pa v teh raziskavah učinkovitost ni bila zadostno dokazana (glejte poglavje 4.4 Posebna opozorila in previdnostni ukrepi ter poglavje 4.8 Neželeni učinki).
These include certain tricyclic antidepressants (e.g. clomipramine, nortriptyline, and desipramine), phenothiazine neuroleptics (e.g. perphenazine and thioridazine, see section 4.3 Contraindications), risperidone, certain Type 1c antiarrhythmics (e.g. propafenone and flecainide) and metoprolol. 
Mednje sodijo nekateri triciklični antidepresivi (npr. klomipramin, nortriptilin in dezipramin), fenotiazinski nevroleptiki (npr. perfenazin in tioridazon, glejte poglavje 4.3 Kontraindikacije), risperidon, nekateri antiaritmiki skupine 1C (npr. propafenon in flekainid) in metoprolol.
Transient increases or decreases of blood pressure have been reported following treatment with paroxetine, usually in patients with pre-existing hypertension or anxiety. 
Po zdravljenju s paroksetinom so o prehodnem povišanju ali znižanju krvnega tlaka običajno poročali pri bolnikih, ki so že predhodno bili hipertenzivni ali anksiozni.
ADVERSE EVENTS FROM PAEDIATRIC CLINICAL TRIALS In short-term (up to 10-12 weeks) clinical trials in children and adolescents, the following adverse events were observed in paroxetine treated patients at a frequency of at least 2% of patients and occurred at a rate at least twice that of placebo were: increased suicidal related behaviours (including suicide attempts and suicidal thoughts), self-harm behaviours and increased hostility. 
NEŽELENI UČINKI OPAŽENI MED KLINIČNIMI RAZISKAVAMI PRI OTROCIH V kratkotrajnih (do 10-12 tedenskih) kliničnih raziskavah pri otrocih in mladostnikih so bili, pri s paroksetinom zdravljenih bolnikih, opaženi naslednji neželeni učinki, ki so se pojavili vsaj pri 2 % bolnikov in vsaj dvakrat pogosteje kot pri placebu: pogostejše samomorilno vedenje (vključno s samomorilnimi poskusi in mislimi), samouničevalno obnašanje in okrepljena sovražnost.
Therefore, although data from the GPRD studies apparently do not confirm the findings from clinical trials with respect to increased risk in patients with anxiety disorders or in young adults, the fact that these risks were found in clinical trials justifies a warning in the SPC in relation to the risk of suicide/suicidal ideation in children and adolescents irrespective of the indication and a warning for young adults. 
Čeprav podatki iz GPRDraziskav ne potrjujejo ugotovitev kliničnih preizkušanj glede povečanega tveganja pri mladih odraslih ali pri bolnikih z anksioznimi motnjami, so ta tveganja bili ugotovljena pri kliničnih raziskavah, kar upravičuje navedbo opozorila v Povzetku glavnih značilnosti zdravila (SPC) glede tveganja za samomor oz. samomorilno razmišljanje pri otrocih in mladostnikih, ki ni odvisno od indikacije, ter opozorila za mlade odrasle.
Genotoxicity: Genotoxicity was not observed in a battery of in vitro and in vivo tests. 
Genotoksičnost: V nizu raziskav in vitro in in vivo testov genotoksičnosti niso opazili.
The recommended dose is 20 mg daily. 
Priporočeni odmerek je 20 mg dnevno.
Dosing should commence at the adult starting dose. 
Odmerjanje je potrebno pričeti z začetnim odmerkom za odrasle.
• Posology and Method of Administration 
• Odmerjanje in način uporabe
According to the answers provided by the MAHs to CHMP, no studies were performed in children and adolescents in the other currently approved indications for adults. 
Po odgovorih, ki so jih CHMP posredovali MAHs, študije pri otrocih in mladostnikih za druge, pri odraslih trenutno odobrene indikacije, niso bile opravljene.
Inclusion of information concerning the lack of efficacy and increased risk of suicidal and hostility related behaviours in children and adolescents (7-17). 
Vključitev podatkov o pomanjkanju učinkovitosti ter povečanem tveganju za s samomorilnostjo in sovražnostjo povezana vedenja pri otrocih in mladostnikih (7-17).
Cardiac Conditions The usual precautions should be observed in patients with cardiac conditions. 
Srčne bolezni Pri bolnikih s srčnimi boleznimi je potrebno upoštevati običajne previdnostne ukrepe.
Medibial - Produtos Médicos e Farmacêuticos, S.A, Av. Da Siderurgia Nacional, 4745-457 S. Mamede do Coronado 
Av. Da Siderurgia Nacional, 4745-457 S. Mamede do
MAJOR DEPRESSIVE EPISODE 
Velika depresivna epizoda