FrancophonIA/ELRC3.0 huggingface dataset:
English: Special precautions for disposal No special requirements
Slovenian: 6.6 Posebni varnostni ukrepi za odstranjevanje Ni posebnih zahtev.
English: If you have any further questions on the use of (Invented name)®, ask your doctor or pharmacist.
Slovenian: Če imate dodatna vprašanja o uporabi (Izmišljeno ime)®, se posvetujte z zdravnikom ali s farmacevtom.
English: Major depressive episodes: Clinical trials in patients with major depressive episodes have been conducted versus placebo and active controls.
Slovenian: Velike depresivne epizode: Pri bolnikih z velikimi depresivnimi epizodami so opravili klinična preskušanja v primerjavi s placebom in aktivnimi kontrolami.
English: In relation to testicular toxicity, effects were observed in juvenile rats in conjunction with other clinical signs of toxicity (at a dose exceeding the maximum tolerated dose) and at an exposure level that would not be tolerated chronically in humans.
Slovenian: V zvezi s škodljivim učinkom na moda so te učinke opazovali pri mladih podganah skupaj z drugimi znaki škodljivega delovanja (pri odmerku, ki je presegal največji dovoljeni odmerek) in pri ravni izpostavljenosti, ki pri dolgotrajnem zdravljenju pri ljudeh ne bi bila dopustna.
English: Of these adverse events, 17% in the fluoxetine group and 12% in the placebo group were severe in nature.
Slovenian: Od neželenih učinkov jih je bilo resnih 17 % v skupini s fluoksetinom in 12 % v skupini s placebom.
English: In clinical trials adverse events seen on treatment discontinuation occurred in approximately 60% of patients in both the fluoxetine and placebo groups.
Slovenian: V kliničnih preskušanjih so se neželeni učinki ob prekinitvi zdravljenja pojavili pri približno 60 % bolnikov, tako v skupini s fluoksetinom kot tudi v skupini s placebom.
English: Obsessive-compulsive disorder: In short-term trials (under 24 weeks), fluoxetine was shown to be significantly more effective than placebo.
Slovenian: Obsesivno-kompulzivna motnja: V kratkotrajnih preskušanjih (manj kot 24 tednov) so za fluoksetin pokazali, da je značilno učinkovitejši od placeba.
English: Do not chew the capsules.
Slovenian: Kapsul ne žvečite.
English: The safety of fluoxetine has not been systematically assessed for chronic treatment longer than 19 weeks.
Slovenian: Za kronično zdravljenje, daljše od 19 tednov, varnosti fluoksetina niso sistematično ocenili.
English: EFFICACY ISSUES
Slovenian: VPRAŠANJA GLEDE UČINKOVITOSTI
English: Nature and contents of container <[To be completed nationally]> The pack may include a measuring cup or syringe.
Slovenian: 6.5 Vrsta ovojnine in vsebina <[Dopolnjeno nacionalno]> Pakiranje lahko vključuje merilni lonček ali brizgalko.
English: When appropriate the dosage can be gradually increased up to a maximum of 60 mg.
Slovenian: Kadar je to primerno, lahko odmerek postopno povečujemo do največ 60 mg.
English: If you have any of the above side effects, you should tell your doctor immediately.
Slovenian: Če imate kaj od zgoraj naštetega, morate to takoj sporočiti svojemu zdravniku.
English: If no improvement is noted within 10 weeks, treatment with (Invented name)® should be reconsidered.
Slovenian: Če po 10 tednih ne opazimo izboljšanja, ponovno razmislimo o zdravljenju s (Izmišljeno ime)®.
English: • Hepatic insufficiency: In case of hepatic insufficiency (alcoholic cirrhosis), fluoxetine and norfluoxetine half-lives are increased to 7 and 12 days, respectively.
Slovenian: • Okvarjeno delovanje jeter: V primeru okvarjenega delovanja jeter (alkoholna ciroza) sta razpolovna časa fluoksetina in norfluoksetina podaljšana na 7 oziroma 12 dni.
English: Having considered the overall submitted data provided by the MAH in writing and in the oral explanation, the CHMP recommended the granting of the variation to the terms of the Marketing Authorisations for which the Summaries of Product Characteristics, labelling and package leaflets.
Slovenian: Po preučitvi vseh predloženih podatkov, ki jih je pisno in z ustno razlago zagotovil imetnik dovoljenja za promet z zdravilom, je CHMP priporočil odobritev spremembe pogojev dovoljenj za promet z zdravilom, katerega Povzetki glavnih značilnostih zdravila, Označevanje in Navodila za uporabo so navedeni v Dodatku III.
English: • Make sure you do not run out of medicine.
Slovenian: • Poskrbite, da vam ne zmanjka zdravila.
English: The MAHs committed to provide this protocol to the RMS as soon as it is made available to them.
Slovenian: Imetnik dovoljenja za promet z zdravilom je prevzel obveznost, da bo priskrbel ta protokol referenčni državi članici kakor hitro mu bo na voljo.
English: In addition, these conditions may be co-morbid with major depressive disorder.
Slovenian: Poleg tega se ta stanja lahko pojavljajo hkrati z veliko depresivno epizodo.
English: In these two studies the mean absolute changes in CDRS-R from baseline to endpoint were 20 for fluoxetine versus 11 for placebo, P=0.002 and 22 for fluoxetine versus 15 for placebo, P<0.001.
Slovenian: V obeh študijah so bile srednje absolutne spremembe na lestvici CDRS-R od osnovne do končne vrednosti 20 za fluoksetin proti 11 za placebo, P=0,002 in 22 za fluoksetin proti 15 za placebo, P<0,001.
English: • Make sure you do not run out of capsules.
Slovenian: • Poskrbite, da vam ne zmanjka kapsul.
English: Austria: Fluctine
Slovenian: Avstrija: Fluctine
English: • the CHMP agreed that fluoxetine is effective in children and adolescents aged 8 years and above in the indication of moderate to severe major depressive episodes, if depression is unresponsive to psychological therapy after 4-6 sessions.
Slovenian: • CHMP se je strinjal, da je fluoksetin učinkovit pri otrocih in mladostnikih, starih 8 let in več, pri indikaciji zmerne do močno izražene hude epizode depresije, če se depresija ne odziva na psihološko zdravljenje po 4 do 6 seansah.
English: Although there may be an increased potential for undesirable effects at higher doses, in some patients, with insufficient response to 20 mg, the dose may be increased gradually up to a maximum of 60 mg (see section 5.1).
Slovenian: Kljub večji možnosti pojava neželenih učinkov pri višjih odmerkih, lahko pri nekaterih bolnikih z nezadostnim odgovorom na 20 mg, odmerek postopno večamo, do največ 60 mg (glejte poglavje 5.1).
English: Isolated cases of growth retardation have also been reported from clinical use.
Slovenian: V klinični uporabi so poročali tudi o osamljenih primerih zastoja v rasti.
English: Long-term efficacy (more than 3 months) has not been demonstrated in bulimia nervosa.
Slovenian: Pri bulimiji dolgoročne učinkovitosti (dlje kot 3 mesece) niso dokazali.
English: Dose response: In the fixed dose studies of patients with major depression there is a flat dose response curve, providing no suggestion of advantage in terms of efficacy for using higher than the recommended doses.
Slovenian: Odgovor na odmerek: V študijah z določenimi odmerki zdravila pri bolnikih z veliko depresijo je krivulja odgovora na odmerek ravna, kar glede učinkovitosti ne kaže na prednost višjih odmerkov pred predpisanimi.
English: In paediatric trials, mania and hypomania were commonly reported (see section 4.8).
Slovenian: V pediatričnih preskušanjih so pogosto poročali o maniji in hipomaniji (glejte poglavje 4.8).
English: France: Prozac, Fluoxétine Lilly
Slovenian: Francija: Prozac, Fluoxétine Lilly
English: Other ingredients are: Benzoic Acid, Sucrose, Glycerin, Mint flavour (containing 0.23% alcohol) and Purified Water.
Slovenian: Pomožni snovi so: benzojska kislina, saharoza, glicerol, aroma poprove mete (vsebuje 0,23 % alkohola) in prečiščena voda.
English: MANUFACTURER'S BATCH NUMBER Lot:
Slovenian: IZDELOVALČEVA ŠTEVILKA SERIJE IZDELAVE ZDRAVILA Lot:
English: Combinations requiring precautions for use: MAOI-B (selegeline): risk of serotonin syndrome.
Slovenian: Kombinacije, ki zahtevajo previdnostne ukrepe: Zaviralec monoaminooksidaze-B (selegelin): nevarnost serotoninskega sindroma.
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Slovenian: DODATEK I SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, POTI UPORABE ZDRAVILA IN IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH
English: If you feel like this, contact your doctor.
Slovenian: Če imate take občutke, se obrnite na svojega zdravnika.
English: Rua Dr. António Loureiro Borges 1, Piso 1 - Arquiparque - Miraflores
Slovenian: Rua Dr. António Loureiro Borges 1, Piso 1Arquiparque - Miraflores 1499-016 Algés
English: • Do not take (Invented name)® after the expiry date which is stated on the pack.
Slovenian: • Zdravila (Izmišljeno ime)® ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli.
English: After 19 weeks of treatment, paediatric subjects treated with fluoxetine in a clinical trial gained an average of 1.1 cm less in height (p=0.004) and 1.1 kg less in weight (p=0.008) than subjects treated with placebo.
Slovenian: Po 19 tednih zdravljenja so pediatrični bolniki, ki so se zdravili s fluoksetinom, v kliničnem preskušanju pridobili v povprečju 1,1 cm manj telesne višine (p=0,004) in 1,1 kg manj telesne mase (p=0,008) v primerjavi z osebami, ki so dobivale placebo.
English: Efficacy of fluoxetine in children and adolescents in the treatment of moderate to severe major depressive episodes has been demonstrated in three short-term (8-12 weeks duration) placebocontrolled studies.
Slovenian: Učinkovitost fluoksetina pri otrocih in mladostnikih pri zdravljenju zmernih do močno izraženih hudih epizod depresije so pokazali v treh kratkotrajnih (trajale so 8 do 12 tednov) raziskavah v primerjavi s placebom.
English: In addition, only limited evidence is available concerning long-term effect on safety in children and adolescents, including effects on growth, sexual maturation and cognitive, emotional and behavioural developments (see section 5.3).
Slovenian: Poleg tega manjkajo podatki o varnosti na dolgi rok pri otrocih in mladostnikih v zvezi z rastjo, spolnim odraščanjem, kognitivnim, čustvenim in vedenjskim razvojem (glejte poglavje 5.3).
English: Fatality attributed to overdose of fluoxetine alone has been extremely rare.
Slovenian: Smrtni izid kot posledica prevelikega odmerjanja fluoksetina samega je izjemno redek.
English: Use in children and adolescents aged 8 to 18 years of age:
Slovenian: Uporaba pri otrocih in mladostnikih, starih 8 do 18 let
English: However, after repeated administration, an increase in steady-state plateau of plasma concentrations may be observed.
Slovenian: Vendar pa lahko po večkratnem dajanju opažamo povišanje platoja plazemskih koncentracij stanja dinamičnega ravnovesja.
English: Fluoxetine has practically no affinity to other receptors such as α1-, α2-, and β-adrenergic, serotonergic; dopaminergic; histaminergic1; muscarinic; and GABA receptors.
Slovenian: Fluoksetin nima praktično nobene afinitete za druge receptorje, kot so α1-, α2- in β- adrenergičnih, serotoninergičnih, dopaminergičnih, histaminergičnih1, muskarinskih in GABA receptorjev.
English: Fluoxetine is a selective inhibitor of serotonin reuptake, and this probably accounts for the mechanism of action.
Slovenian: Fluoksetin je selektivni zaviralec prevzema serotonina, kar verjetno razloži njegov način delovanja.
English: • flecainide or encainide (for heart problems), carbamazepine (for epilepsy), tricyclic antidepressants (for example imipramine, desipramine and amitriptyline); because (Invented name)® may possibly change the blood levels of these medicines, your doctor may need to lower their dose when administered with (Invented name)®.
Slovenian: • flekainid ali enkainid (za težave s srcem), karbamazepin (za epilepsijo), triciklični antidepresivi (na primer, imipramin, dezipramin in amitriptilin); ker (Izmišljeno ime)® lahko spremeni raven teh zdravil v krvi, bo ob jemanju s (Izmišljeno ime)®, vaš zdravnik morda moral zmanjšati njihov odmerek.
English: Member State Marketing Authorisation Holder Invented name Strength
Slovenian: Država članica Imetnik dovoljenja za promet z zdravilom Izmišljeno ime Jakost
English: Bulimia nervosa - Adults and the elderly: A dose of 60 mg/day is recommended.
Slovenian: Bulimija nervoza - Odrasli in starejši: Priporočeni odmerek je 60 mg/dan.
English: Moderate to severe major depressive episode, if depression is unresponsive to psychological therapy after 4-6 sessions.
Slovenian: Zmerna do huda velika depresivna epizoda, kadar je depresija neodzivna na psihološko terapijo po 4-6 srečanjih.
English: Bulimia nervosa: In short term trials (under 16 weeks), in out-patients fulfilling DSM-III-R-criteria for bulimia nervosa, fluoxetine 60 mg/day was shown to be significantly more effective than placebo for the reduction of bingeing and purging activities.
Slovenian: Bulimija nervoza: V kratkotrajnih preskušanjih (do 16 tednov) pri ambulantno vodenih bolnikih, ki izpolnjujejo merila DSM-III-R za bulimijo nervozo, so za fluoksetin v odmerku 60 mg/dan pokazali, da je značilno učinkovitejši od placeba pri zmanjševanju prenajedanja in bruhanja.
English: • If you take too much, go to your nearest hospital emergency department (or casualty) or tell your doctor straight away.
Slovenian: • Če zaužijete preveč, pojdite na urgentni oddelek najbližje bolnišnice ali takoj sporočite svojemu zdravniku.
English: Sweden: Fontex <[See Annex I - To be completed nationally]>
Slovenian: Švedska: Fontex <[Glejte Dodatek I - Dopolnjeno nacionalno]>
English: In study X065, the starting dose was 20 mg/d, which, in case of intolerance, could be decreased to every second day of administration.
Slovenian: V raziskavi X065 je začetni odmerek znašal 20 mg/dan, v primeru neprenašanja pa so ga vsak drugi dan dajanja lahko zmanjševali (20 mg vsak drugi dan).
English: MAOinhibitors type B (selegeline) can be used with (Invented name)® provided that your doctor monitors you closely.
Slovenian: Zaviralce MAO tipa B lahko uporabljate skupaj z zdravilom (Izmišljeno ime)®, v primeru, da vas vaš zdravnik natančno nadzira.
English: • Measure the right amount of medicine using the measuring cup, syringe or a measuring spoon, then drink it.
Slovenian: • Z merilnim lončkom, brizgalko ali merilno žlico odmerite ustrezno količino zdravila in nato popijte.
English: Fluoxetine is primarily metabolised by the liver to the active metabolite norfluoxetine (desmethylfluoxetine), by desmethylation.
Slovenian: Fluoksetin se večinoma presnavlja v jetrih v aktivni presnovek norfluoksetin (desmetilfluoksetin) z desmetilacijo.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Oral use.
Slovenian: POSTOPEK IN POT(I) UPORABE ZDRAVILA Za peroralno uporabo.
English: Depression is associated with an increased risk of suicidal thoughts, self harm and suicide (suicide related events).
Slovenian: Depresija je povezana z večjim tveganjem za samomorilne misli, samopoškodbe in samomor (s samomorom povezanimi dogodki).
English: If (Invented name)® treatment is started or stopped when you are taking warfarin, your doctor will need to perform certain tests.
Slovenian: Če med jemanjem varfarina začnete ali prekinete zdravljenje s (Izmišljeno ime)®, bo moral vaš zdravnik narediti določene teste.
English: When fluoxetine is used in combination with lithium your doctor will carry out more frequent check-ups.
Slovenian: Če jemljete fluoksetin v kombinaciji z litijem, vas bo vaš zdravnik naročal na pogostejše preglede.
English: Withdrawal symptoms seen on discontinuation of fluoxetine treatments: Discontinuation of fluoxetine commonly leads to withdrawal symptoms.
Slovenian: Odtegnitveni simptomi ob prekinitvi zdravljenja s fluoksetinom: Prekinitev zdravljenja s fluoksetinom navadno povzroči odtegnitvene simptome.
English: • have a history of bleeding disorders or you develop bruises or unusual bleeding.
Slovenian: • ste imeli kdaj motnje v strjevanju krvi ali se pri vas pojavljajo modrice ali nenavadne krvavitve.
English: • Do not store your (Invented name)® above 25°C.
Slovenian: • (Izmišljeno ime)® shranjujte pri temperaturi do 25 oC!
English: Rats administered 30 mg/kg also had decreased femur lengths compared with controls and skeletal muscle degeneration, necrosis and regeneration.
Slovenian: Podgane, ki so dobivale odmerke 30 mg/kg, so imele manjše dolžine stegnenic v primerjavi s kontrolami, ter degeneracijo, nekrozo in regeneracijo skeletnih mišic.
English: Abnormal liver function has been reported rarely, with very rare cases of hepatitis.
Slovenian: Redko so poročali o nenormalnem delovanju jeter, z zelo redkimi primeri hepatitisa.
English: As with all antidepressants, fluoxetine should be discontinued in any patient entering a manic phase.
Slovenian: Kot pri vseh antidepresivih je treba zdravljenje s fluoksetinom prekiniti pri vseh bolnikih, ki vstopajo v manično fazo.
English: In one of the short-term studies, responders (in total 40 patients) were included in a 32-week placebocontrolled relapse prevention study.
Slovenian: V eni izmed kratkotrajnih raziskav so bili tisti, pri katerih je zdravilo delovalo (skupno 40 bolnikov), vključeni v 32 tednov trajajočo s placebom primerjano raziskavo preprečevanja ponovitev.
English: Suicide/suicidal thoughts: Depression is associated with an increased risk of suicidal thoughts, self harm and suicide (suicide-related events).
Slovenian: Samomor/samomorilne misli: Depresija je povezana z večjim tveganjem za samomorilne misli, samopoškodbe in samomor (s samomorom povezanimi dogodki).
English: DATE OF REVISION OF THE TEXT <[To be completed nationally]>
Slovenian: DATUM ZADNJE REVIZIJE BESEDILA <[Dopolnjeno nacionalno]>
English: On rare occasions development of a serotonin syndrome or neuroleptic malignant syndrome-like events have been reported in association with treatment of fluoxetine, particularly when given in combination with other serotonergic (among others L-tryptophan) and/or neuroleptic drugs.
Slovenian: Redko so v povezavi z zdravljenjem s fluoksetinom poročali o razvoju serotoninskega sindroma ali nevroleptičnemu malignemu sindromu podobnih dogodkov, zlasti ob dajanju v kombinaciji z drugimi serotoninergičnimi (med drugim L-triptofanom) in/ali nevroleptičnimi zdravili.
English: How to store (Invented name)® Further information
Slovenian: 5 Shranjevanje zdravila (Izmišljeno ime)® Dodatne informacije
English: Other ingredients inside the capsule are: starch flowable and dimeticone.
Slovenian: Pomožni snovi v kapsuli sta: koruzni škrob in dimetikon.
English: Rash and allergic reactions: Rash, anaphylactoid events and progressive systemic events, sometimes serious (involving skin, kidney, liver or lung) have been reported.
Slovenian: Izpuščaj in alergijske reakcije: Poročali so o izpuščaju, anafilaktoidnih reakcijah in progresivnih sistemskih reakcijah, včasih resnih (vključujejo kožo, ledvice, jetra ali pljuča).
English: Steady state plasma concentrations are dependent on body weight and are higher in lower weight children (see 4.2 Posology and method of administration).
Slovenian: Plazemske koncentracije v stanju dinamičnega ravnovesja so odvisne od telesne mase in so višje pri otrocih z manjšo telesno maso (glejte poglavje 4.2 Odmerjanje in način uporabe).
English: ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARIES OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLETS PRESENTED BY THE EMEA
Slovenian: DODATEK II ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA DOPOLNILO POVZETKOV GLAVNIH ZNAČILNOSTI ZDRAVILA, OZNAČEVANJA IN NAVODIL ZA UPORABO, KI JIH JE PREDSTAVILA EVROPSKA AGENCIJA ZA ZDRAVILA (EMEA)
English: Mania: Antidepressants should be used with caution in patients with a history of mania/hypomania.
Slovenian: Manija: Antidepresive je treba pri bolnikih z manijo/hipomanijo v anamnezi uporabljati previdno.
English: Lactation: Fluoxetine and its metabolite norfluoxetine, are known to be excreted in human breast milk.
Slovenian: Dojenje: Znano je, da se fluoksetin in njegov presnovek norfluoksetin izločata v materino mleko.
English: CYP2D6 isoenzyme: Because fluoxetine's metabolism (like tricyclic antidepressants and other selective serotonin antidepressants) involves the hepatic cytochrome CYP2D6 isoenzyme system, concomitant therapy with drugs also metabolised by this enzyme system may lead to drug interactions.
Slovenian: Izoencim CYP2D6: Ker presnova fluoksetina (kot tudi tricikličnih antidepresivov in drugih antidepresivov iz skupine selektivnih zaviralcev prevzema serotonina) vključuje jetrni izoencimski sistem citokroma CYP2D6, lahko sočasno zdravljenje z zdravili, ki se prav tako presnavljajo s tem encimskim sistemom, povzroči medsebojna delovanja zdravil.
English: Steady-state concentrations after prolonged dosing are similar to concentrations seen at 4 to 5 weeks.
Slovenian: Plazemske koncentracije v stanju dinamičnega ravnovesja po daljšem času odmerjanja so podobne koncentracijam po 4 do 5 tednih.
English: A study in juvenile mice has indicated that inhibition of the serotonin transporter prevents the accrual of bone formation.
Slovenian: Študija pri mladih miših je pokazala, da zaviranje serotoninskega prenašalca prepreči prirastek v procesu tvorbe kosti.
English: In a 19-week clinical trial decreased height and weight gain was observed in children and adolescents treated with fluoxetine (see section 4.8).
Slovenian: V 19 tedenskem kliničnem preskušanju so pri otrocih in mladostnikih, ki so jih zdravili s fluoksetinom, opažali manjši porast telesne višine in telesne mase (glejte poglavje 4.8).
English: You may not feel better immediately when you first start taking your medicine for depression.
Slovenian: Morda se po začetku jemanja vašega zdravila za depresijo ne boste takoj bolje počutili.
English: HOW TO TAKE (Invented name)®
Slovenian: KAKO JEMATI (IZMIŠLJENO IME)®
English: Health (NIMH) in United States as well as to discuss with the study investigators the improvement of the trial design by extending the duration of the follow-up and increasing of the upper age range of patients in this study during.
Slovenian: let, v okviru protokola, ki je bil razvit pod okriljem Nacionalnega inštituta za mentalno zdravje v Združenih državah, in da bo z raziskovalci, ki bodo sodelovali pri raziskavi, razpravljal o izboljšanju načrtovanja raziskave s podaljšanjem obdobja spremljanja in povečanjem območja zgornje meje starosti bolnikov med to raziskavo.
English: • lithium, tryptophan; there is an increased risk of serotonin syndrome when these drugs are coadministered with (Invented name)®.
Slovenian: • litij, triptofan; obstaja večje tveganje za razvoj serotoninskega sindroma, če ti zdravili dajemo skupaj s (Izmišljeno ime)®.
English: Non-selective MAO-inhibitors and MAO-inhibitors type A (moclobemide) should not be used with (Invented name)® as serious or even fatal reactions (serotonin syndrome) can occur (see section “Do not take (Invented name)®”).
Slovenian: Ne- selektivnih zaviralcev MAO in zaviralcev MAO tipa A (moklobemid) ne smete uporabljati s (Izmišljeno ime)®, ker se lahko pojavijo resne reakcije (serotoninski sindrom), lahko celo s smrtnim izidom (glejte poglavje “Ne jemljite zdravila (Izmišljeno ime)®”).
English: The same precautions should therefore be observed when treating patients with other psychiatric disorders.
Slovenian: Zato pri zdravljenju bolnikov z drugimi psihiatričnimi motnjami upoštevamo enake previdnostne ukrepe.
English: • Major depressive episodes
Slovenian: • velikih depresivnih epizod
English: If you have any of the following symptoms and they bother you, or last for some time, tell your doctor or a pharmacist.
Slovenian: Če imate kaj od naslednjega in vas moti ali traja dalj časa, povejte svojemu zdravniku ali farmacevtu.
English: Do not take any MAOIs for at least five weeks after you stop taking (Invented name)®.
Slovenian: Vsaj pet tednov po prenehanju jemanja (Izmišljeno ime)® ne jemljite nobenih MAOI.
English: • Renal insufficiency: After single-dose administration of fluoxetine in patients with mild, moderate or complete (anuria) renal insufficiency, kinetic parameters have not been altered when compared to healthy volunteers.
Slovenian: • Okvarjeno delovanje ledvic: Po dajanju enkratnega odmerka fluoksetina bolnikom z blago, zmerno ali popolnoma (anurija) okvarjenim delovanjem ledvic kinetične spremenljivke v primerjavi z zdravimi prostovoljci niso bile drugačne.