FrancophonIA/ELRC3.0 huggingface dataset:
English: A lower or less frequent dose should be considered.
Slovenian: Treba je razmisliti o nižjem odmerku ali manj pogostem odmerjanju.
English: In patients who develop these symptoms, increasing the dose may be detrimental.
Slovenian: Za bolnike, pri katerih se ti simptomi pojavijo, je večanje odmerka lahko škodljivo.
English: Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, (up to five weeks ago) including medicines obtained without prescription.
Slovenian: Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katerokoli zdravilo (do pet tednov nazaj), tudi če ste ga dobili brez recepta.
English: 203, Bureaux de la Colline 92213 Saint Cloud, FRANCE
Slovenian: 203, Bureaux de la Colline 92213 Saint Cloud, Francija
English: • You can take (Invented name)® with or without food, whichever you prefer.
Slovenian: • (Izmišljeno ime)® lahko vzamete z ali brez hrane, kakor vam je ljubše.
English: The need for treatment should be reassessed periodically.
Slovenian: Redno je treba ocenjevati potrebo po zdravljenju.
English: Dista S.A., Avenida Industria 30 28108 Alcobendas - Madrid SPAIN
Slovenian: Dista S.A., Avenida Industria 30 28108 Alcobendas - Madrid ŠPANIJA
English: Patients should be advised to avoid driving a car or operating hazardous machinery until they are reasonably certain that their performance is not affected.
Slovenian: Bolnikom svetujemo, naj ne vozijo avtomobila ali upravljajo nevarnih strojev, dokler niso utemeljeno prepričani, da njihove sposobnosti vožnje in upravljanja strojev niso prizadete.
English: Additionally in Children and Adolescents (8-18 years) - fluoxetine may slow growth or possibly delay sexual maturity.
Slovenian: Dodatno pri otrocih in mladostnikih (8-18 let) - fluoksetin lahko upočasni rast ali zakasni spolno zrelost.
English: The risk of withdrawal symptoms may be dependent on several factors including the duration and dose of therapy and the rate of dose reduction.
Slovenian: Tveganje za odtegnitvene simptome je odvisno od številnih dejavnikov, vključno s trajanjem in odmerkom terapije in stopnjo zmanjševanja odmerka.
English: • have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Slovenian: • vam je vaš zdravnik povedal, da imate intoleranco za nekatere sladkorje, se pred jemanjem tega zdravila posvetujte z vašim zdravnikom.
English: However, clinical experience in acute cardiac disease is limited, therefore caution is advisable.
Slovenian: Vendar pa so klinične izkušnje pri akutnih srčnih obolenjih omejene, zato priporočamo previdnost.
English: There is no information on whether the effect was reversible.
Slovenian: Ni informacij o tem, ali so ti učinki reverzibilni.
English: Generally these symptoms are selflimiting and usually resolve within 2 weeks, though in some individuals they may be prolonged (2-3 months or more).
Slovenian: Večinoma so ti simptomi samoomejujoči in navadno v 2 tednih izzvenijo, čeprav lahko pri nekaterih posameznikih trajajo dlje (2-3 mesece ali več).
English: They usually occur within the first few days of discontinuing treatment.
Slovenian: Navadno se pojavijo v prvih dneh po prekinitvi zdravljenja.
English: When stopping (Invented name)®, your doctor will help you to reduce your dose slowly over one or two weeks - this should help reduce the chance of withdrawal effects.
Slovenian: Ko prenehate jemati (Izmišljeno ime)®, vam bo vaš zdravnik pomagal zmanjševati vaš odmerek počasi, v obdobju enega ali dveh tednov - to bo pripomoglo k zmanjšanju možnosti za pojav odtegnitvenih učinkov.
English: If your doctor has prescribed (Invented name)® for a patient under 18 and you want to discuss this, please go back to your doctor.
Slovenian: Če je vaš zdravnik predpisal (Izmišljeno ime)® bolniku, mlajšemu od 18 let, in se želite o tem pogovoriti, se vrnite k zdravniku.
English: Patients with depression should be treated for a sufficient period of at least 6 months to ensure that they are free from symptoms.
Slovenian: Bolnike z depresijo moramo zdraviti zadosti dolgo, najmanj 6 mesecev, da zagotovimo, da so brez simptomov.
English: Lower weight children may need lower doses.
Slovenian: Otroci z manjšo telesno maso lahko potrebujejo nižje odmerke.
English: When dosing is stopped, active drug substances will persist in the body for weeks.
Slovenian: Ko odmerjanje prekinemo, ostanejo zdravilne učinkovine zdravila v telesu še nekaj tednov.
English: Children and adolescents (see section 4.4 Special warnings and precautions for use):
Slovenian: Otroci in mladostniki (glejte poglavje 4.4 Posebna opozorila in previdnostni ukrepi):
English: Fluoxetine is extensively bound to plasma proteins (about 95%) and it is widely distributed (Volume of Distribution: 20 - 40 l/kg).
Slovenian: Fluoksetin se obsežno (približno 95 %) veže na plazemske beljakovine in se široko porazdeljuje (volumen porazdelitve: 20-40 l/kg).
English: National Competent Authorities, coordinated by the Reference Member State (RMS), shall ensure that the following conditions are fulfilled by the Marketing Authorisation Holders:
Slovenian: Pristojni nacionalni organi, ki jih je usklajevala referenčna država članica, zagotovijo, da imetniki dovoljenja za promet z zdravilom izpolnijo naslednje pogoje:
English: Therefore, regular monitoring for the occurrence of mania/hypomania is recommended.
Slovenian: Zato priporočamo redno nadzorovanje z namenom odkritja manije/hipomanije.
English: Patients (and caregivers of patients) should be alerted about the need to monitor for the emergence of such events and to seek medical advice immediately if these symptoms present.
Slovenian: Bolnike (in skrbnike bolnikov) moramo opozoriti, da spremljajo pojav takih dogodkov in da v primeru prisotnosti omenjenih simptomov takoj poiščejo zdravniško pomoč.
English: • Taking your medicine at the same time each day may help you to remember to take it regularly.
Slovenian: • Če boste zdravilo jemali vsak dan ob istem času, se boste nanj laže spomnili.
English: Fluoxetine is extensively metabolised by the polymorphic enzyme CYP2D6.
Slovenian: Fluoksetin obsežno presnavlja polimorfni encim CYP2D6.
English: Subsequently, the physician may continue decreasing the dose, but at a more gradual rate.
Slovenian: Zdravnik bo kasneje morda nadaljeval z zmanjševanjem odmerka zdravila, vendar bolj postopno.
English: • are using medicinal products that effect the coagulation of blood (see ‘Taking other medicines').
Slovenian: • jemljete zdravila, ki učinkujejo na strjevanje krvi (glejte ‘Jemanje drugih zdravil')
English: • Children and adolescents: The mean fluoxetine concentration in children is approximately 2fold higher than that observed in adolescents and the mean norfluoxetine concentration 1.5-fold higher.
Slovenian: • Otroci in mladostniki: Srednja koncentracija fluoksetina pri otrocih je približno 2-krat višja od opažene koncentracije pri mladostnikih ter srednja koncentracija norfluoksetina 1,5-krat višja.
English: Stratified analysis by age on children and adolescents indicated no difference in effect sizes between these two groups.
Slovenian: Stratificirana analiza po starosti pri otrocih in mladostnikih ni pokazala nikakršne razlike pri velikosti učinka med tema dvema skupinama.
English: <[To be completed nationally]>
Slovenian: <[Dopolnjeno nacionalno]>
English: This is most likely to occur within the first few weeks of treatment.
Slovenian: Najverjetneje se pojavi v prvih nekaj tednih zdravljenja.
English: Efficacy in the fluoxetine trials may depend on the inclusion of a selective patient population (one that has not spontaneously recovered within a period of 3-5 weeks and whose depression persisted in the face of considerable attention).
Slovenian: Učinkovitost v preskušanjih s fluoksetinom je lahko odvisna od vključevanja izbrane populacije bolnikov (populacije bolnikov, ki v obdobju 3-5 tednov niso spontano okrevali in katerih depresija je vztrajala ne glede na precejšnjo oskrbo).
English: While there are no systematic studies to answer the question of how long to continue fluoxetine treatment, OCD is a chronic condition and it is reasonable to consider continuation beyond 10 weeks in responding patients.
Slovenian: Čeprav ni sistematičnih študij, ki bi odgovorile na vprašanje, kako dolgo nadaljevati zdravljenje s fluoksetinom, je obsesivno-kompulzivna motnja kronično stanje in je razumno razmisliti o nadaljevanju zdravljenja tudi preko 10 tednov pri bolnikih, ki se na zdravljenje odzovejo.
English: In order to warrant a restriction of treatment to patients who are similar to those that were included in the study, the indication was restricted to patients non-responsive to several sessions of psychological therapy and to be treated in combination with psychological therapy.
Slovenian: Z namenom, da bi upravičili omejevanje zdravljenja na bolnike, ki so podobni tistim, ki so bili vključeni v raziskavo, je bila indikacija omejena na bolnike, ki se niso odzivali na več seans psihološkega zdravljenja, in ki so bili zdravljeni v kombinaciji s psihološkim zdravljenjem.
English: Doses above 80 mg/day have not been systematically evaluated.
Slovenian: Odmerkov, višjih od 80 mg/dan, niso sistematično vrednotili.
English: Eli Lilly Italia S.p.A., Via Gramsci 731/733, 50019 Sesto Fiorentino (Fi), ITALY
Slovenian: Eli Lilly Italia S.p.A., Via Gramsci 731/733, 50019 Sesto Fiorentino (Fi), ITALIJA
English: The significance of these findings in humans is unknown.
Slovenian: Pomen teh izsledkov za človeka ni znan.
English: In managing overdosage, consider the possibility of multiple drug involvement.
Slovenian: Pri zdravljenju prevelikega odmerjanja je treba pomisliti na možnost vpletenosti večih zdravil.
English: There is only limited data on safety and efficacy beyond 9 weeks.
Slovenian: Obstajajo le omejeni podatki o varnosti in učinkovitosti zdravljenja, daljšega od 9 tednov.
English: Pregnancy: Data on a large number of exposed pregnancies do not indicate a teratogenic effect of fluoxetine.
Slovenian: Nosečnost: Podatki iz velikega števila izpostavljenih nosečnosti ne kažejo na teratogeni učinek fluoksetina.
English: In general, efficacy of fluoxetine was modest.
Slovenian: Na splošno je bila učinkovitost fluoksetina zmerna.
English: The capsule and liquid dosage forms are bioequivalent.
Slovenian: Odmerni obliki kapsule in raztopine sta bioekvivalentni.
English: If a good therapeutic response has been obtained, treatment can be continued at a dosage adjusted on an individual basis.
Slovenian: Če dosežemo dober odziv na zdravljenje, lahko zdravljenje nadaljujemo s posamezniku prilagojenim odmerjanjem.
English: If, based on clinical need, a decision to treat is nevertheless taken, the patient should be carefully monitored for the appearance of suicidal symptoms.
Slovenian: Če se na podlagi klinične potrebe vseeno odločite za zdravljenje, morate bolnika natančno spremljati za pojav simptomov samomorilnosti.
English: Most people find that any symptoms on stopping (Invented name)® are mild and go away on their own within a few weeks.
Slovenian: Večina ljudi ugotovi, da so simptomi ob prenehanju jemanja (Izmišljeno ime)® blagi in izginejo sami po sebi v nekaj tednih.
English: Seizures: Seizures are a potential risk with antidepressant drugs.
Slovenian: Krči: Krči so možno tveganje pri antidepresivnih zdravilih.
English: Patients were included if they had symptoms of sufficient severity to impair social and occupational function and relationships with others.
Slovenian: Bolnice so vključili, če so bili njihovi simptomi dovolj hudi, da so okvarjali družbeno in poklicno delovanje ter medosebna razmerja.
English: • Children and adolescents aged 8 to 18 years with depression: Treatment should be started and be supervised by a specialist.
Slovenian: • otroci in mladostniki z depresijo, stari 8 do 18 let: Zdravljenje začne in nadzira zdravnik specialist.
English: Results from this study will characterize the development of testicular lesions, and the reversibility of these findings at multiple time points; and potentially identify specific cellular targets and/or neurohormonal mechanisms involved in the development of these lesions.
Slovenian: Rezultati te raziskave bodo podrobno opisali razvoj poškodb na modih in reverzibilnost teh izsledkov v številnih časovnih točkah; in potencialno odkrili specifične celične tarče in/ali nevrohormonske mehanizme, ki so vpleteni pri razvoju teh poškodb.
English: Patients with depression should be treated for a period of at least 6 months.
Slovenian: Bolnike z depresijo zdravimo v obdobju najmanj 6 mesecev.
English: This will also apply if fluoxetine has been taken in the previous 5 weeks.
Slovenian: Enako velja, če je bolnik jemal fluoksetin v zadnjih 5 tednih.
English: • Tell your doctor immediately if your skin starts to turn red and then blister or peel.
Slovenian: • Nemudoma povejte svojemu zdravniku, če postane vaša koža rdeča, če se pojavijo mehurji ali če se koža začne lupiti.
English: Taking (Invented name)® with food or drink
Slovenian: Jemanje zdravila (Izmišljeno ime)® skupaj s hrano ali pijačo
English: Use with triptans carries the additional risk of coronary vasoconstriction and hypertension.
Slovenian: Sočasna uporaba s triptani prinaša dodatno tveganje koronarne vazokonstrikcije in hipertenzije.
English: Alcohol: In formal testing, fluoxetine did not raise blood alcohol levels or enhance the effects of alcohol.
Slovenian: Alkohol: V formalnih testiranjih fluoksetin ni povišal koncentracije alkohola v krvi ali okrepil učinkov alkohola.
English: Ireland, Italy, Netherlands, Portugal, Spain, UK: Prozac Luxembourg: Prozac, Fontex <[See Annex I - To be completed nationally]>
Slovenian: Irska, Italija, Nizozemska, Portugalska, Španija, Velika Britanija: Prozac Luksemburg: Prozac, Fontex <[Glejte Dodatek I - Dopolnjeno nacionalno]>
English: PHARMACEUTICAL FORM Hard capsules.
Slovenian: FARMACEVTSKA OBLIKA Trde kapsule.
English: Some cases were possibly due to the syndrome of inappropriate antidiuretic hormone secretion.
Slovenian: V nekaterih primerih je bila morda posledica sindroma nepravilnega izločanja antidiuretskega hormona.
English: If you have not improved, your treatment should be reassessed.
Slovenian: Če se vaše stanje ni izboljšalo, je treba zdravljenje ponovno oceniti.
English: It is general clinical experience that the risk of suicide may increase in the early stages of recovery.
Slovenian: Izkušnje iz klinične prakse kažejo, da je tveganje za samomor v zgodnjem obdobju po okrevanju lahko večje.
English: Some clinicians advocate concomitant behavioural psychotherapy for patients who have done well on pharmacotherapy.
Slovenian: Nekateri zdravniki zagovarjajo sočasno vedenjsko psihoterapijo pri bolnikih, ki se dobro odzivajo na farmakoterapijo.
English: Clinical trial experience with daily doses greater than 20mg is minimal.
Slovenian: Izkušnje iz kliničnih preskušanj z dnevnimi odmerki, večjimi od 20 mg, so minimalne.
English: Forced diuresis, dialysis, haemoperfusion, and exchange transfusion are unlikely to be of benefit.
Slovenian: Forsirana diureza, dializa, hemoperfuzija in izmenjalna transfuzija najverjetneje niso koristne.
English: These long half-lives are responsible for persistence of the drug for 5-6 weeks after discontinuation.
Slovenian: Ti dolgi razpolovni časi so vzrok za trajanje navzočnosti zdravila še 5-6 tednov po prekinitvi.
English: In relation to emotional behaviour, the difficulties in conducing a clinical study include problems related to defining and measuring the outcome variable (emotional behaviour), and problems related to identifying an adequate control group.
Slovenian: V zvezi s čustvenim obnašanjem težave pri izvajanju kliničnih raziskav vključujejo probleme, ki se nanašajo na določanje in merjenje rezultatske spremenljivke (čustveno obnašanje) in probleme, ki so povezani z identificiranjem ustrezne kontrolne skupine.
English: Insulin and/or oral hypoglycaemic dosage may need to be adjusted.
Slovenian: Odmerjanje insulina in/ali peroralnega hipoglikemika bo morda treba prilagoditi.
English: Prozac is currently approved for the treatment of major depressive episodes, obsessive-compulsive disorder and bulimia nervosa, in adults.
Slovenian: Prozac je trenutno registriran za zdravljenje hudih epizod depresije, obsesivno-kompulzivnih motenj in bulimije nervoze pri odraslih.
English: Use in children and adolescents under 18 years of age
Slovenian: Uporaba pri otrocih in mladostnikih, mlajših od 18 let
English: Therefore, this Product Information may not necessarily represent the current text.
Slovenian: Dodatek III torej ne predstavlja nujno zadnje različice besedila.
English: Very rare cases of idiosyncratic hepatitis.
Slovenian: Zelo redki so primeri idiosinkratičnega hepatitisa.
English: Clinical evaluation of the effect of fluoxetine on sexual maturation
Slovenian: Klinično vrednotenje učinka fluoksetina na spolno dozorevanje
English: • have liver problems (your doctor may need to adjust your dosage)
Slovenian: • imate težave z jetri (vaš zdravnik bo morda moral prilagoditi vaš odmerek)
English: The current procedure is a referral following a Mutual Recognition Procedure variation application, which concerned an extension of the indication for Prozac to include the treatment of major depressive episodes in children aged 8 to 17 years.
Slovenian: Sedanji postopek je napotitev po vložitvi spremembe po postopku medsebojnega priznavanja, pri čemer se je ta sprememba nanašala na razširitev indikacije za zdravilo Prozac, da bi bilo vključeno tudi zdravljenje hudih epizod depresije pri otrocih, starih od 8 do 17 let.
English: If fluoxetine has been prescribed chronically and/or at a high dose, a longer interval should be considered.
Slovenian: Če je bil fluoksetin predpisovan kronično in/ali v visokih odmerkih, je treba upoštevati daljši interval.
English: This risk persists until significant remission occurs.
Slovenian: Tveganje ostaja vse, dokler ne dosežemo pomembne remisije.
English: Your doctor should review the need for continuing treatment beyond 6 months.
Slovenian: Vaš zdravnik naj oceni potrebo po nadaljevanju zdravljenja po 6 mesecih.
English: If either is slowed, referral to a paediatrician should be considered.
Slovenian: Če je katerikoli upočasnjen, je treba razmisliti o nasvetu pediatra.
English: Patients using oral contraceptives were excluded.
Slovenian: Bolnice, ki so jemale peroralne kontraceptive, so izključili.
English: Note: This Product Information is the one that was Annexed to the Commission Decision on this Article 6(12) referral for fluoxetine containing medicinal products.
Slovenian: Opomba: Te informacije o zdravilu so bile priložene k odločbi Komisije v zvezi z napotitvenim postopkom, ki je bil sprožen v skladu s členom 6(12), za zdravila, ki vsebujejo fluoksetin.
English: You should inform your doctor if any of the symptoms listed above develop or worsen when patients under 18 are taking (Invented name)®.
Slovenian: Svojega zdravnika obvestite, če se pojavi ali poslabša katerikoli od zgoraj navedenih simptomov pri bolnikih, mlajših od 18 let, ki jemljejo (Izmišljeno ime)®.
English: Activated charcoal, which may be used with sorbitol, may be as or more effective than emesis or lavage.
Slovenian: Aktivno oglje, ki ga lahko uporabimo skupaj s sorbitolom, je lahko vsaj toliko ali bolj učinkovito kot bruhanje ali izpiranje želodca.
English: If you have a liver problem or are using other medication that might have an influence on fluoxetine, your doctor may decide to prescribe a lower dose or instruct you to use (Invented name)® every other day.
Slovenian: Če imate težave z jetri ali uporabljate druga zdravila, ki lahko vplivajo na fluoksetin, vam bo vaš zdravnik lahko predpisal nižji odmerek ali vam svetoval, da uporabljate (Izmišljeno ime)® vsak drugi dan.
English: Results from this study would demonstrate whether fluoxetine is associated with an effect on the HPG axis in juvenile rats.
Slovenian: Rezultati te raziskave bi pokazali, ali je fluoksetin povezan z učinkom na os HPG pri mladih podganah.
English: Fluoxetine should be avoided in patients with unstable seizure disorders/epilepsy and patients with controlled epilepsy should be carefully monitored.
Slovenian: Fluoksetina ne uporabljamo pri bolnikih z nestabilnimi obolenji s krči/epilepsijo, bolnike z nadzorovano epilepsijo pa je treba skrbno spremljati.
English: What (Invented name)® is and what it is used for Before you take (Invented name)® How to take (Invented name)® Possible side effects
Slovenian: Kaj je (Izmišljeno ime)® in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli (Izmišljeno ime)® Kako jemati (Izmišljeno ime)® Možni neželeni učinki
English: However, the product information was strengthened with appropriate warnings to inform doctors and parents about the need to monitor patients for the appearance of these events.
Slovenian: So pa bili podatki o zdravilu okrepljeni z ustreznimi opozorili, ki zdravnike in starše seznanjajo, da je potrebno bolnike spremljati zaradi morebitnega pojava teh dogodkov.
English: • are having ECT (electro-convulsive therapy) treatment;
Slovenian: • se zdravite z EKT (elektrokonvulzivna terapija);
English: There is no evidence of carcinogenicity or mutagenicity from in vitro or animal studies.
Slovenian: Iz študij in vitro ter študij na živalih ni podatkov o kancerogenezi ali mutagenezi.
English: The clinical relevance of this finding has not been established.
Slovenian: Klinične pomembnosti tega izsledka niso ugotavljali.
English: Pregnancy and lactation
Slovenian: Nosečnost in dojenje
English: The relevance of these data for a depressed child cannot be established, however the MAH has committed to perform additional studies to further explore the mechanism of these effects.
Slovenian: Pomembnosti teh podatkov za otroka z depresijo ni mogoče dokazati, vendarle pa je imetnik dovoljenja za promet z zdravilom prevzel obveznost, da bo izvedel dodatne raziskave, da bi dodatno raziskal mehanizem teh učinkov.
English: In relation to sexual maturation, in animal studies there were indications of dose-related delay in both male and female sexual development.
Slovenian: V zvezi s spolnim dozorevanjem so se pri raziskavah na živalih pojavili znaki od odmerka odvisne zakasnitve spolnega razvoja tako pri živalih moškega kot ženskega spola.
English: • If you are allergic (hypersensitive) to fluoxetine or any of the other ingredients of (Invented name)®.
Slovenian: • Če ste alergični na (preobčutljivi za) fluoksetin ali katerokoli sestavino (Izmišljeno ime)®.
English: It is important that the prescribers discusses carefully the risks and benefits of treatment with the child/young person and/or their parents.
Slovenian: Pomembno je, da se zdravnik, ki zdravljenje predpiše, z otrokom/mlado osebo in/ali njegovimi starši natančno pogovori o tveganjih in prednostih zdravljenja.
English: In addition, the evaluation of the study HCLS designed to examine the growth of fluoxetine-treated children/adolescents as compared to untreated patients with the same diagnosis provided some reassurance regarding the effect of fluoxetine on growth, as fluoxetine did not have a clinically significant impact on this parameter.
Slovenian: Poleg tega je vrednotenje raziskave HCLS, ki je bila načrtovana za preverjanje rasti otrok in mladostnikov, ki so se zdravili s fluoksetinom v primerjavi z nezdravljenimi bolniki z enako diagnozo, dalo nekatera zagotovila glede vpliva fluoksetina na rast, saj fluoksetin ni imel klinično značilnega vpliva na ta dejavnik.
English: Since it can take 3 to 4 weeks before your illness improves following treatment with fluoxetine, your doctor will monitor you closely at the start of the treatment.
Slovenian: Glede na to, da so potrebni 3 do 4 tedni po začetku zdravljenja s fluoksetinom, predno se vaša bolezen izboljša, vas bo na začetku zdravljenja vaš zdravnik skrbno nadzoroval.
English: (Invented name)® should not be used in the treatment of children under the age of 8 years.
Slovenian: (Izmišljeno ime)® ne uporabljajte za zdravljenje otrok, mlajših od 8 let.
English: Effects on ability to drive and use machines
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja s stroji