natgillin/translations-raw huggingface dataset:
• 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.
• 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.
Stratified analysis by age on children and adolescents indicated no difference in effect sizes between these two groups.
Stratificirana analiza po starosti pri otrocih in mladostnikih ni pokazala nikakršne razlike pri velikosti učinka med tema dvema skupinama.
<[To be completed nationally]>
<[Dopolnjeno nacionalno]>
This is most likely to occur within the first few weeks of treatment.
Najverjetneje se pojavi v prvih nekaj tednih zdravljenja.
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).
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).
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.
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.
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.
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.
Doses above 80 mg/day have not been systematically evaluated.
Odmerkov, višjih od 80 mg/dan, niso sistematično vrednotili.
Eli Lilly Italia S.p.A., Via Gramsci 731/733, 50019 Sesto Fiorentino (Fi), ITALY
Eli Lilly Italia S.p.A., Via Gramsci 731/733, 50019 Sesto Fiorentino (Fi), ITALIJA
The significance of these findings in humans is unknown.
Pomen teh izsledkov za človeka ni znan.
In managing overdosage, consider the possibility of multiple drug involvement.
Pri zdravljenju prevelikega odmerjanja je treba pomisliti na možnost vpletenosti večih zdravil.
There is only limited data on safety and efficacy beyond 9 weeks.
Obstajajo le omejeni podatki o varnosti in učinkovitosti zdravljenja, daljšega od 9 tednov.
Pregnancy: Data on a large number of exposed pregnancies do not indicate a teratogenic effect of fluoxetine.
Nosečnost: Podatki iz velikega števila izpostavljenih nosečnosti ne kažejo na teratogeni učinek fluoksetina.
In general, efficacy of fluoxetine was modest.
Na splošno je bila učinkovitost fluoksetina zmerna.
The capsule and liquid dosage forms are bioequivalent.
Odmerni obliki kapsule in raztopine sta bioekvivalentni.
If a good therapeutic response has been obtained, treatment can be continued at a dosage adjusted on an individual basis.
Če dosežemo dober odziv na zdravljenje, lahko zdravljenje nadaljujemo s posamezniku prilagojenim odmerjanjem.
If, based on clinical need, a decision to treat is nevertheless taken, the patient should be carefully monitored for the appearance of suicidal symptoms.
Če se na podlagi klinične potrebe vseeno odločite za zdravljenje, morate bolnika natančno spremljati za pojav simptomov samomorilnosti.
Most people find that any symptoms on stopping (Invented name)® are mild and go away on their own within a few weeks.
Večina ljudi ugotovi, da so simptomi ob prenehanju jemanja (Izmišljeno ime)® blagi in izginejo sami po sebi v nekaj tednih.
Seizures: Seizures are a potential risk with antidepressant drugs.
Krči: Krči so možno tveganje pri antidepresivnih zdravilih.
Patients were included if they had symptoms of sufficient severity to impair social and occupational function and relationships with others.
Bolnice so vključili, če so bili njihovi simptomi dovolj hudi, da so okvarjali družbeno in poklicno delovanje ter medosebna razmerja.
• Children and adolescents aged 8 to 18 years with depression: Treatment should be started and be supervised by a specialist.
• otroci in mladostniki z depresijo, stari 8 do 18 let: Zdravljenje začne in nadzira zdravnik specialist.
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.
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.
Patients with depression should be treated for a period of at least 6 months.
Bolnike z depresijo zdravimo v obdobju najmanj 6 mesecev.
This will also apply if fluoxetine has been taken in the previous 5 weeks.
Enako velja, če je bolnik jemal fluoksetin v zadnjih 5 tednih.
• Tell your doctor immediately if your skin starts to turn red and then blister or peel.
• Nemudoma povejte svojemu zdravniku, če postane vaša koža rdeča, če se pojavijo mehurji ali če se koža začne lupiti.
Taking (Invented name)® with food or drink
Jemanje zdravila (Izmišljeno ime)® skupaj s hrano ali pijačo
Use with triptans carries the additional risk of coronary vasoconstriction and hypertension.
Sočasna uporaba s triptani prinaša dodatno tveganje koronarne vazokonstrikcije in hipertenzije.
Alcohol: In formal testing, fluoxetine did not raise blood alcohol levels or enhance the effects of alcohol.
Alkohol: V formalnih testiranjih fluoksetin ni povišal koncentracije alkohola v krvi ali okrepil učinkov alkohola.
Ireland, Italy, Netherlands, Portugal, Spain, UK: Prozac Luxembourg: Prozac, Fontex <[See Annex I - To be completed nationally]>
Irska, Italija, Nizozemska, Portugalska, Španija, Velika Britanija: Prozac Luksemburg: Prozac, Fontex <[Glejte Dodatek I - Dopolnjeno nacionalno]>
PHARMACEUTICAL FORM Hard capsules.
FARMACEVTSKA OBLIKA Trde kapsule.
Some cases were possibly due to the syndrome of inappropriate antidiuretic hormone secretion.
V nekaterih primerih je bila morda posledica sindroma nepravilnega izločanja antidiuretskega hormona.
If you have not improved, your treatment should be reassessed.
Če se vaše stanje ni izboljšalo, je treba zdravljenje ponovno oceniti.
It is general clinical experience that the risk of suicide may increase in the early stages of recovery.
Izkušnje iz klinične prakse kažejo, da je tveganje za samomor v zgodnjem obdobju po okrevanju lahko večje.
Some clinicians advocate concomitant behavioural psychotherapy for patients who have done well on pharmacotherapy.
Nekateri zdravniki zagovarjajo sočasno vedenjsko psihoterapijo pri bolnikih, ki se dobro odzivajo na farmakoterapijo.
Clinical trial experience with daily doses greater than 20mg is minimal.
Izkušnje iz kliničnih preskušanj z dnevnimi odmerki, večjimi od 20 mg, so minimalne.
Forced diuresis, dialysis, haemoperfusion, and exchange transfusion are unlikely to be of benefit.
Forsirana diureza, dializa, hemoperfuzija in izmenjalna transfuzija najverjetneje niso koristne.
These long half-lives are responsible for persistence of the drug for 5-6 weeks after discontinuation.
Ti dolgi razpolovni časi so vzrok za trajanje navzočnosti zdravila še 5-6 tednov po prekinitvi.
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.
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.
Insulin and/or oral hypoglycaemic dosage may need to be adjusted.
Odmerjanje insulina in/ali peroralnega hipoglikemika bo morda treba prilagoditi.
Prozac is currently approved for the treatment of major depressive episodes, obsessive-compulsive disorder and bulimia nervosa, in adults.
Prozac je trenutno registriran za zdravljenje hudih epizod depresije, obsesivno-kompulzivnih motenj in bulimije nervoze pri odraslih.
Use in children and adolescents under 18 years of age
Uporaba pri otrocih in mladostnikih, mlajših od 18 let
Therefore, this Product Information may not necessarily represent the current text.
Dodatek III torej ne predstavlja nujno zadnje različice besedila.
Very rare cases of idiosyncratic hepatitis.
Zelo redki so primeri idiosinkratičnega hepatitisa.
Clinical evaluation of the effect of fluoxetine on sexual maturation
Klinično vrednotenje učinka fluoksetina na spolno dozorevanje
• have liver problems (your doctor may need to adjust your dosage)
• imate težave z jetri (vaš zdravnik bo morda moral prilagoditi vaš odmerek)
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.
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.
If fluoxetine has been prescribed chronically and/or at a high dose, a longer interval should be considered.
Če je bil fluoksetin predpisovan kronično in/ali v visokih odmerkih, je treba upoštevati daljši interval.
This risk persists until significant remission occurs.
Tveganje ostaja vse, dokler ne dosežemo pomembne remisije.
Your doctor should review the need for continuing treatment beyond 6 months.
Vaš zdravnik naj oceni potrebo po nadaljevanju zdravljenja po 6 mesecih.
If either is slowed, referral to a paediatrician should be considered.
Če je katerikoli upočasnjen, je treba razmisliti o nasvetu pediatra.
Patients using oral contraceptives were excluded.
Bolnice, ki so jemale peroralne kontraceptive, so izključili.
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.
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.
You should inform your doctor if any of the symptoms listed above develop or worsen when patients under 18 are taking (Invented name)®.
Svojega zdravnika obvestite, če se pojavi ali poslabša katerikoli od zgoraj navedenih simptomov pri bolnikih, mlajših od 18 let, ki jemljejo (Izmišljeno ime)®.
Activated charcoal, which may be used with sorbitol, may be as or more effective than emesis or lavage.
Aktivno oglje, ki ga lahko uporabimo skupaj s sorbitolom, je lahko vsaj toliko ali bolj učinkovito kot bruhanje ali izpiranje želodca.
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.
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.
Results from this study would demonstrate whether fluoxetine is associated with an effect on the HPG axis in juvenile rats.
Rezultati te raziskave bi pokazali, ali je fluoksetin povezan z učinkom na os HPG pri mladih podganah.
Fluoxetine should be avoided in patients with unstable seizure disorders/epilepsy and patients with controlled epilepsy should be carefully monitored.
Fluoksetina ne uporabljamo pri bolnikih z nestabilnimi obolenji s krči/epilepsijo, bolnike z nadzorovano epilepsijo pa je treba skrbno spremljati.
What (Invented name)® is and what it is used for Before you take (Invented name)® How to take (Invented name)® Possible side effects
Kaj je (Izmišljeno ime)® in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli (Izmišljeno ime)® Kako jemati (Izmišljeno ime)® Možni neželeni učinki
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.
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.
• are having ECT (electro-convulsive therapy) treatment;
• se zdravite z EKT (elektrokonvulzivna terapija);
There is no evidence of carcinogenicity or mutagenicity from in vitro or animal studies.
Iz študij in vitro ter študij na živalih ni podatkov o kancerogenezi ali mutagenezi.
The clinical relevance of this finding has not been established.
Klinične pomembnosti tega izsledka niso ugotavljali.
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.
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.
In relation to sexual maturation, in animal studies there were indications of dose-related delay in both male and female sexual development.
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.
• If you are allergic (hypersensitive) to fluoxetine or any of the other ingredients of (Invented name)®.
• Če ste alergični na (preobčutljivi za) fluoksetin ali katerokoli sestavino (Izmišljeno ime)®.
It is important that the prescribers discusses carefully the risks and benefits of treatment with the child/young person and/or their parents.
Pomembno je, da se zdravnik, ki zdravljenje predpiše, z otrokom/mlado osebo in/ali njegovimi starši natančno pogovori o tveganjih in prednostih zdravljenja.
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.
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.
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.
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.
(Invented name)® should not be used in the treatment of children under the age of 8 years.
(Izmišljeno ime)® ne uporabljajte za zdravljenje otrok, mlajših od 8 let.
Effects on ability to drive and use machines
4.7 Vpliv na sposobnost vožnje in upravljanja s stroji
If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered.
Če se med zmanjševanjem odmerka ali po prekinitvi zdravljenja pojavijo nevzdržni simptomi, moramo razmisliti o ponovni uvedbi predhodno predpisanega odmerka.
Another study in juvenile mice (treated on postnatal days 4 to 21) has demonstrated that inhibition of the serotonin transporter had long lasting effects on the behaviour of the mice.
Druga študija pri mladih miših (zdravljenih od 4. do 21. dan postnatalno) je pokazala, da ima zaviranje serotoninskega prenašalca dolgotrajne učinke na vedenje miši.
In two studies (HCJE and TADS), the starting dose 10 mg/d was increased to 20mg/d after one week with an optional further increase to 40 mg/d in one study.
V dveh raziskavah (HCJE in TADS) so začetni odmerek 10 mg/dan po enem tednu povečali na 20 mg/dan, z možnostjo nadaljnjega povečanja na 40 mg/dan v eni raziskavi.
Fluoxetine has a non-linear pharmacokinetic profile with first pass liver effect.
Fluoksetin ima nelinearni farmakokinetični profil z učinkom prvega prehoda skozi jetra.
Children and adolescents aged 8 years and above (Moderate to severe major depressive episode):
Otroci in mladostniki, stari 8 let in več (zmerna do huda velika depresivna epizoda):
The reversibility of this effect has not been established.
Reverzibilnosti tega učinka niso ugotavljali.
The balance of benefits and risks for fluoxetine in the treatment of depression in children and adolescents in this condition is judged to be favourable.
Razmerje med koristmi in tveganji za fluoksetin pri zdravljenju depresije pri otrocih in mladostnikih v teh okoliščinah je ocenjeno kot ugodno.
Like all medicines, (Invented name)® can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi (Izmišljeno ime)® neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
However, the CHMP considered that the impact of the marked toxicity observed in the juvenile study, as well as the relevance of these data for children and adolescents were difficult to assess.
Kljub temu pa je bil Odbor za zdravila za uporabo v humani medicini (CHMP) mnenja, da je vpliv znatne toksičnosti, ki so jo ugotovili v raziskavi pri mladih živalih, kot tudi pomembnost teh podatkov za otroke in mladostnike, težko oceniti.
Do not drive or use machinery without advice from your physician or pharmacist.
Ne vozite in ne upravljajte s stroji, če se o tem niste posvetovali z vašim zdravnikom ali s farmacevtom.
The time to occur and the duration of these symptoms may be related to the long half-life of fluoxetine (4-6 days) and its active metabolite, norfluoxetine (4-16 days).
Čas do pojava in trajanje teh simptomov sta lahko povezana z dolgim razpolovnim časom fluoksetina (4-6 dni) in njegovega aktivnega presnovka, norfluoksetina (4-16 dni).
These symptoms may indicate either serotonergic effects or a withdrawal syndrome.
Ti simptomi lahko kažejo na serotoninergične učinke ali odtegnitveni sindrom.
For paediatric patients who respond to treatment, the need for continued treatment after 6 months should be reviewed.
Pri pediatričnih bolnikih, ki se na zdravljenje odzovejo, po 6 mesecih ponovno ocenimo potrebo po nadaljnjem zdravljenju.
• If you feel restless and feel like you cannot sit or stand still, you may have something called akathisia; increasing your dose of (Invented name)® may make you feel worse.
• Če ste nemirni in imate občutek, da ne morete sedeti ali stati pri miru, imate lahko stanje, ki ga imenujemo akatizija; večanje odmerka (Izmišljeno ime)® lahko povzroči, da se boste počutili slabše.
Treatment should be initiated and monitored under specialist supervision.
Zdravljenje naj začne in nadzira zdravnik specialist.
Two of these trials were sponsored by the MAH (HCJE and X065) and were reviewed during the MR variation procedure.
Dve izmed teh raziskav je sponzoriral imetnik dovoljenja za promet z zdravilom (HCJE in X065) in sta bili pregledani med postopkom, ki se je nanašal na spremembo po postopku medsebojnega priznavanja.
In relation to suicidality, the CHMP concluded that the current warning of the product information already informs doctors and parents to monitor patients carefully for the appearance of suicidal behaviour, self-harm or hostility, particularly at the beginning of treatment.
V zvezi s samomorilnostjo je CHMP zaključil, da sedanje opozorilo v podatkih o zdravilu že obvešča zdravnike in bolnike, da je treba bolnike skrbno spremljati zaradi morebitnega pojava samomorilnega vedenja, samopoškodovanja ali sovražnosti, zlasti na začetku zdravljenja.
• have diabetes your doctor may need to adjust your dose of insulin or other antidiabetic treatment);
• imate sladkorno bolezen (vaš zdravnik bo morda moral prilagoditi vaš odmerek insulina ali drugega zdravila za sladkorno bolezen),
Additionally, only limited information concerning the long-term safety of (Invented name)® on growth, puberty, mental, emotional and behavioural development in this age group is available.
Poleg tega so za (Izmišljeno ime)® dostopne zgolj omejene informacije o varnostnih učinkih na dolgi rok v zvezi z rastjo, puberteto, duševnim, čustvenim in vedenjskim razvojem v tej starostni skupini.
Patients with a history of suicide-related events, those exhibiting a significant degree of suicidal ideation prior to commencement of treatment are known to be at greater risk of suicidal thoughts or suicide attempts, and should receive careful monitoring during treatment.
Bolniki s predhodnimi dogodki, povezanimi s samomorom, in bolniki, ki pred začetkom zdravljenja kažejo pomembno stopnjo samomorilnega mišljenja, imajo večje tveganje za samomorilne misli ali poskuse samomora in jih moramo med zdravljenjem skrbno spremljati.
If treatment with fluoxetine is considered necessary, discontinuation of breastfeeding should be considered; however, if breastfeeding is continued, the lowest effective dose of fluoxetine should be prescribed.
Če je zdravljenje s fluoksetinom nujno potrebno, je treba razmisliti o prekinitvi dojenja; če pa se z dojenjem nadaljuje, moramo predpisati najnižji učinkoviti odmerek fluoksetina.
• You should avoid alcohol while you are taking this medicine.
• Med jemanjem tega zdravila se izogibajte pitju alkohola.
• warfarin or other medicines used to thin the blood; (Invented name)® may alter the effect of these medicines on the blood.
• varfarin ali druga zdravila za redčenje krvi; (Izmišljeno ime)® lahko spremeni učinek teh zdravil na kri.
In both studies, patients met criteria for moderate to severe MDD (DSM-III or DSM-IV) at three different evaluations by practising child psychiatrists.
V obeh študijah so bolniki izpolnjevali kriterije za zmerno do hudo veliko depresivno motnjo (po kriterijih DSM-III ali DSM-IV) na podlagi treh različnih ocen otroških psihiatrov v praksi.
Belgium: Prozac, Fontex, Fluoxetine ‘Lilly'
Belgija: Prozac, Fontex, Fluoxetine ‘Lilly'
(Invented name)® oral liquid contains sugar which may be harmful to the teeth.
Prozac peroralna raztopina vsebuje sladkor, ki je lahko škodljiv za zobe.
In paediatric clinical trials, fluoxetine treatment was associated with a decrease in alkaline phosphatase levels.
V pediatričnih kliničnih preskušanjih so zdravljenje s fluoksetinom povezovali z zmanjšanjem vrednosti alkalne fosfataze.
Whole body - chills, sensitivity to sunlight, weight loss.
Po vsem telesu - mrazenje, preobčutljivost za sončno svetlobo, izguba telesne mase.
Although fluoxetine has been shown not to affect psychomotor performance in healthy volunteers, any psychoactive drug may impair judgment or skills.
Čeprav fluoksetin dokazano ne vpliva na psihomotorične sposobnosti zdravih prostovoljcev, lahko katerokoli psihoaktivno zdravilo poslabša presojo ali sposobnosti.