FrancophonIA/ELRC3.0 huggingface dataset:
English: In essence similar methods were employed in examining differences in risk of suicidal events among GP (General Practitioner) patients treated with different antidepressants.
Slovenian: Uporabili so podobne metode pri iskanju razlik v tveganju za samomorilne dogodke med bolniki zdravnikov splošne medicine, zdravljenih z različnimi antidepresivi.
English: Paroxetine is chemically unrelated to the tricyclic, tetracyclic and other available antidepressants.
Slovenian: Paroksetin kemično ni soroden tricikličnim, tetracikličnim in drugim antidepresivom, ki so na voljo.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Available data, including data from clinical trials, indicate an increased risk of akathisia associated with the use of paroxetine.
Slovenian: Razpoložljivi podatki, vključno s podatki iz kliničnih preskušanj, kažejo povečano tveganje za akatizijo, povezano z uporabo paroksetina.
English: No studies are available in children and adolescents in the other currently approved indications for adults.
Slovenian: Pri otrocih in mladostnikih za druge trenutno odobrene indikacije pri odraslih ni objavljenih študij.
English: Inclusion of information on the symptoms which can occur in the neonate after maternal paroxetine use in later stages of pregnancy.
Slovenian: Vključitev podatkov o simptomih, ki se lahko pojavijo pri novorojenčku po materini uporabi paroksetina v zadnjih mesecih nosečnosti.
English: Due to first-pass metabolism, the amount of paroxetine available to the systemic circulation is less than that absorbed from the gastrointestinal tract.
Slovenian: Zaradi metabolizma prvega prehoda je količina paroksetina v sistemskem obtoku manjša od tiste, ki se absorbira iz prebavil.
English: Luxembourg Merck s.a., 288 Brusselsesteenweg, B-3090 Overijse Belgium
Slovenian: Luksemburg Merck s.a., 288 Brusselsesteenweg, B-3090 Overijse Belgium
English: 1382 Gr Weesp The Netherlands
Slovenian: 1382 Gr Weesp
English: 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).
Slovenian: 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).
English: In the treatment of depressive disorders, paroxetine exhibits comparable efficacy to standard antidepressants.
Slovenian: Pri zdravljenju depresivnih motenj je učinkovitost paroksetina primerljiva z učinkovitostjo standardnih antidepresivov.
English: 2970 Hørsholm
Slovenian: 2970 Hørsholm Denmark
English: Reproduction toxicity studies in rats have shown that paroxetine affects male and female fertility.
Slovenian: Študije o vplivu na sposobnost razmnoževanja pri podganah so pokazale, da je paroksetin prizadel plodnost samcev in samic.
English: Generally these symptoms are mild to moderate, however, in some patients they may be severe in intensity.
Slovenian: Na splošno so ti simptomi blagi do zmerni, vendar pa so pri nekaterih bolnikih lahko tudi hujše intenzitete.
English: 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.
Slovenian: 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.
English: Caution should also be exercised in those patients at risk of hyponatraemia e.g. from concomitant medications and cirrhosis.
Slovenian: Previdnost je potrebna tudi pri bolnikih pri katerih obstaja tveganje za hiponatriemijo npr. zaradi sočasnega zdravljenja ali ciroze.
English: The recommended dose is 40 mg daily.
Slovenian: Priporočeni odmerek je 40 mg dnevno.
English: Rua José Galhardo no. 3, loja 3C/v 1750-131 Lisboa Portugal
Slovenian: Rua José Galhardo n o. 3, loja 3C/v 1750-131 Lisboa Portugal
English: Belgium Merck n.v./s.a.
Slovenian: Merck n.v./s.a.
English: Small amounts of paroxetine are excreted into breast milk.
Slovenian: Paroksetin se v majhnih količinah izloča v materino mleko.
English: Endocrine disorders Very rare: syndrome of inappropriate anti-diuretic hormone secretion (SIADH).
Slovenian: Bolezni endokrinega sistema Zelo redki: sindrom neustreznega izločanja antidiuretičnega hormona (SIADH)
English: Long-term use should be regularly evaluated (see section 5.1 Pharmacodynamic Properties).
Slovenian: Dolgotrajno zdravljenje je potrebno redno vrednotiti (glejte poglavje 5.1 Farmakodinamične lastnosti).
English: GlaxoSmithkline Produtos Farmacêuticos, Lda.
Slovenian: Portugalska GlaxoSmithkline Produtos Farmacêuticos, Lda.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Rare: convulsions.
Slovenian: Redki: konvulzije
English: No correlation has been found between paroxetine plasma concentrations and clinical effect (adverse experiences and efficacy).
Slovenian: Odvisnosti med koncentracijami paroksetina v plazmi in kliničnim učinkom (neželeni učinki in učinkovitost) niso zasledili.
English: ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARIES OF PRODUCT CHARACTERISTICS PRESENTED BY THE EMEA
Slovenian: 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)
English: 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).
Slovenian: 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).
English: Expansion of withdrawal symptoms seen on discontinuation of paroxetine treatment and inclusion of information on adverse events from paediatric clinical trials.
Slovenian: Razširitev odtegnitvenih simptomov, opaženih ob ukinitvi zdravljenja s paroksetinom ter vključitev podatkov o neželenih učinkih iz pediatričnih kliničnih preskušanj.
English: MARKETING AUTHORISATION NUMBER(S) [To be completed nationally]
Slovenian: ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET [potrebno dopolniti lokalno]
English: As with other antidepressants, including other SSRIs, paroxetine inhibits the hepatic cytochrome P450 enzyme CYP2D6.
Slovenian: Tako kot drugi antidepresivi, vključno z drugimi selektivnimi zaviralci prevzema serotonina, tudi paroksetin zavira jetrni citokrom P450 encim CYP2D6.
English: The taper phase regimen used in clinical trials involved decreasing the daily dose by 10 mg at weekly intervals.
Slovenian: V kliničnih raziskavah je bil v fazi ukinjanja zdravila uporabljen režim zniževanja dnevnega odmerka po 10 mg v tedenskih intervalih.
English: two weeks after discontinuation of an irreversible MAOI, or at least 24hrs after discontinuation of a reversible MAOI (e.g. moclobemide).
Slovenian: dva tedna po ukinitvi ireverzibilnega zaviralca monoaminooksidaz, ali vsaj 24 ur po ukinitvi reverzibilnega zaviralca monoaminooksidaz (npr. moklobemid).
English: The overall safety profile of paroxetine containing medicinal products was reviewed by the CHMP.
Slovenian: V CHMP so pregledali celotni varnostni profil zdravil, vsebujočih paroksetin.
English: 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.
Slovenian: 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.
English: Approximately 95% of the paroxetine present is protein bound at therapeutic concentrations.
Slovenian: V terapevtskih koncentracijah je približno 95 % paroksetina v plazmi vezanega na proteine.
English: Box 51409 CY-3505 Limassol Cyprus
Slovenian: Medochemie Ltd P.O. Box 51409 CY-3505 Limassol Cyprus
English: Epilepsy As with other antidepressants, paroxetine should be used with caution in patients with epilepsy.
Slovenian: Epilepsija Tako kot druge antidepresive je potrebno tudi paroksetin pri bolnikih z epilepsijo uporabljati previdno.
English: - The Committee considered that efficacy has not been demonstrated in children and adolescents with major depressive disorder.
Slovenian: - je Odbor upošteval, da učinkovitost pri otrocih in mladostnikih z veliko depresivno motnjo ni bila dokazana.
English: Generally these events are mild to moderate and are self-limiting, however, in some patients they may be severe and/or prolonged.
Slovenian: 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.
English: 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).
Slovenian: 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).
English: 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.
Slovenian: 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.
English: Transient increases or decreases of blood pressure have been reported following treatment with paroxetine, usually in patients with pre-existing hypertension or anxiety.
Slovenian: Po zdravljenju s paroksetinom so o prehodnem povišanju ali znižanju krvnega tlaka običajno poročali pri bolnikih, ki so že predhodno bili hipertenzivni ali anksiozni.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Denmark NM Pharma A/S Lautrupvang 8
Slovenian: NM Pharma A/S Lautrupvang 8
English: Genotoxicity: Genotoxicity was not observed in a battery of in vitro and in vivo tests.
Slovenian: Genotoksičnost: V nizu raziskav in vitro in in vivo testov genotoksičnosti niso opazili.
English: The recommended dose is 20 mg daily.
Slovenian: Priporočeni odmerek je 20 mg dnevno.
English: Belgium Eurogenerics N.V. Heizel Esplanade Heysel B 22 B-1020 Brussel
Slovenian: Heizel Esplanade Heysel B 22 B-1020 Brussel Belgium
English: Dosing should commence at the adult starting dose.
Slovenian: Odmerjanje je potrebno pričeti z začetnim odmerkom za odrasle.
English: • Posology and Method of Administration
Slovenian: • Odmerjanje in način uporabe
English: 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.
Slovenian: Po odgovorih, ki so jih CHMP posredovali MAHs, študije pri otrocih in mladostnikih za druge, pri odraslih trenutno odobrene indikacije, niso bile opravljene.
English: Inclusion of information concerning the lack of efficacy and increased risk of suicidal and hostility related behaviours in children and adolescents (7-17).
Slovenian: Vključitev podatkov o pomanjkanju učinkovitosti ter povečanem tveganju za s samomorilnostjo in sovražnostjo povezana vedenja pri otrocih in mladostnikih (7-17).
English: Cardiac Conditions The usual precautions should be observed in patients with cardiac conditions.
Slovenian: Srčne bolezni Pri bolnikih s srčnimi boleznimi je potrebno upoštevati običajne previdnostne ukrepe.
English: Medibial - Produtos Médicos e Farmacêuticos, S.A, Av. Da Siderurgia Nacional, 4745-457 S. Mamede do Coronado
Slovenian: Av. Da Siderurgia Nacional, 4745-457 S. Mamede do
English: MAJOR DEPRESSIVE EPISODE
Slovenian: Velika depresivna epizoda
English: One of the three studies achieved a significant difference in the proportion of relapsers between paroxetine (38%) compared to placebo (59%).
Slovenian: V eni od treh študij so dosegli značilno razliko v deležu bolnikov z relapsom med paroksetinom (38 %) v primerjavi s placebom (59 %).
English: Insulin and/or oral hypoglycaemic dosage may need to be adjusted.
Slovenian: Odmerjanje insulina in/ali peroralnih antidiabetikov bo morda potrebno prilagoditi.
English: Regarding safety, data from clinical trials show that paroxetine is associated with an increased risk of suicidal and hostility related behaviours in the paediatric population (7-17 years old).
Slovenian: Glede varnosti, podatki iz kliničnih preskušanj kažejo, da je paroksetin povezan s povečanim tveganjem za s samomorilnostjo in sovražnostjo povezana vedenja v pediatrični populaciji (7-17 let starih).
English: Clinical trials show similar low rates in placebo and paroxetine treated depressed patients.
Slovenian: Klinična preskušanja kažejo podobno nizke stopnje pri depresivnih bolnikih, ki prejemajo placebo ali paroksetin.
English: Available data from clinical trials, spontaneous reports and published literature show that withdrawal reactions in association with paroxetine are common when treatment is discontinued.
Slovenian: Razpoložljivi podatki iz kliničnih preskušanj, spontanih poročil in objavljene literature kažejo, da so odtegnitvene reakcije, povezane s paroksetinom, ob ukinitvi zdravljenja pogoste.
English: Patients should start on 20 mg/day and the dose may be increased gradually in 10 mg increments to the recommended dose.
Slovenian: Bolniki morajo zdravljenje pričeti z odmerkom 20 mg/dan, odmerek pa se lahko postopno povečuje za 10 mg do priporočenega odmerka.
English: Paroxetine is extensively distributed into tissues and pharmacokinetic calculations indicate that only 1% of the paroxetine in the body resides in the plasma.
Slovenian: Farmakokinetični izračuni kažejo, da se le 1 % paroksetina v telesu nahaja v plazmi.
English: 5.2 Pharmacokinetics
Slovenian: 5.2 Farmakokinetične lastnosti
English: In accordance to the results, the association between suicidality risk and paroxetine appears significant only among patients with previous depression but not among patients with previous depression and anxiety or anxiety alone.
Slovenian: Iz rezultatov sledi, da je tveganje za samomorilnost pomembno povezano z uporabo paroksetina le pri bolnikih s predhodno depresijo, ne pa tudi pri bolnikih s predhodno depresijo in tesnobo (anksiozo) ali samo tesnobo.
English: In view of these conclusions the CHMP considered that guidance with regards to the discontinuation of paroxetine (down titration), as well as a warning and a description of the withdrawal symptoms seen on discontinuation of paroxetine should be included in the respective sections of the SPC and suitable pharmaceutical forms/strengths need to be available in order to facilitate titration.
Slovenian: Glede na te zaključke so v CHMP menili, da je treba v dotična poglavja SPC-ja in vključiti smernice v zvezi z ukinjanjem zdravljenja s paroksetinom (nižanje odmerka), pa tudi opozorilo in opis odtegnitvenih simptomov, opaženih ob ukinitvi paroksetina, za lažje nižanje odmerkov pa je treba zagotoviti razpoložljivost ustreznih farmacevtskih oblik/jakosti.
English: The long-term efficacy of paroxetine in treating social anxiety disorder and generalised anxiety disorder and Post-traumatic Stress Disorder has not been sufficiently demonstrated.
Slovenian: Dolgoročna učinkovitost paroksetina pri zdravljenju socialne anksiozne motnje in posttravmatske stresne motnje ni bila zadostno dokazana.
English: The most common withdrawal symptoms in children and adolescents were headaches, dizziness, nausea, nervousness and abdominal pain.
Slovenian: Najpogostejši odtegnitveni simptomi pri otrocih in mladostnikih so bili glavoboli, omotica, slabost, živčnost in bolečine v trebuhu.
English: Significant and relevant results were obtained in some of the short-term studies.
Slovenian: V nekaterih kratkotrajnih študijah so dobili značilne in pomembne rezultate.
English: For children and adolescents, although no completed suicides were observed, an increased risk for suicidal and self-harm behaviours was observed in patients taking SSRIs compared to those taking TCAs and in patients taking paroxetine compared to those taking other SSRIs.
Slovenian: Pri otrocih in mladostnikih je bilo, čeprav ni bilo izvedenih samomorov, zaznano povečano tveganje za samomorilno in samopoškodovalno vedenje pri bolnikih, ki so prejemali antidepresive tipa SSRI, v primerjavi z bolniki, ki so prejemali triciklične antidepresive, ter pri bolnikih, ki so prejemali paroksetin, v primerjavi s tistimi, ki so prejemali druge antidepresive tipa SSRI.
English: Increased plasma concentrations of paroxetine occur in elderly subjects, but the range of concentrations overlaps with that observed in younger subjects.
Slovenian: Pri starejših osebah se pojavijo zvišane plazemske koncentracije paroksetina, vendar se obseg koncentracij sklada s tistim, ki so ga opazili pri mlajših osebah.
English: Strengthening of warnings concerning withdrawal symptoms seen on discontinuation of paroxetine and the need for down titration.
Slovenian: Bolj poudariti opozorila glede odtegnitvenih simptomov, opaženih ob ukinitvi zdravljenja s paroksetinom, ter o potrebi po postopnem nižanju odmerka.
English: Animal studies indicate that paroxetine is well tolerated by the cardiovascular system.
Slovenian: Študije na živalih kažejo, da paroksetin ne obremenjuje kardiovaskularnega sistema.
English: Uncommon: abnormal bleeding, predominantly of the skin and mucous membranes (mostly ecchymosis).
Slovenian: Občasni: neobičajne krvavitve, predvsem na koži in sluznicah (večinoma ekhimoze) Zelo redki: trombocitopenija
English: Rare: elevation of hepatic enzymes.
Slovenian: Redki: zvišane vrednosti jetrnih encimov
English: Serotonin Syndrome/Neuroleptic Malignant Syndrome On rare occasions development of a serotonin syndrome or neuroleptic malignant syndrome-like events may occur in association with treatment of paroxetine, particularly when given in combination with other serotonergic and/or neuroleptic drugs.
Slovenian: Serotoninski sindrom/maligni nevroleptični sindrom V povezavi z zdravljenjem s paroksetinom se lahko v redkih primerih, še posebej v primeru sočasnega zdravljenja z drugimi serotoninergičnimi in/ali nevroleptičnimi zdravili, pojavijo serotoninski sindrom ali malignemu nevroleptičnemu sindromu podobni dogodki.
English: Concomitant use of paroxetine and oral anticoagulants can lead to an increased anticoagulant activity and haemorrhagic risk.
Slovenian: Sočasna uporaba paroksetina in peroralnih antitrombotikov lahko vodi do povečane antitrombotske aktivnosti in tveganja za krvavitve.
English: Common: somnolence, insomnia.
Slovenian: Pogosti: somnolenca, nespečnost