FrancophonIA/ELRC3.0 huggingface dataset:
English: These are symptoms of Serotonin Syndrome.
Slovenian: To so simptomi serotoninskega sindroma.
English: • If you have suffered from bleeding disorders or have been taking medicines which thin the blood (eg acetylsalicyclic acid (aspirin), or warfarin) or may increase the risk of bleeding.
Slovenian: • Če ste imeli motnje strjevanja krvi ali ste jemali zdravila, ki redčijo kri (npr. acetilsalicilno kislino (aspirin) ali varfarin) ali lahko povečajo tveganje za krvavitve.
English: Pharmacokinetics of sertraline was studied in 29 paediatric patients aged 6-12 years old, and 32 adolescent patients aged 13-17 years old.
Slovenian: Farmakokinetiko sertralina so raziskali pri 29 pediatričnih bolnikih, starih od 6 do 12 let, in 32 mladostniških bolnikih, starih od 13 do 17 let.
English: If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered.
Slovenian: V primeru, da se pri zmanjševanju odmerka ali pri ukinitvi zdravljenja pojavijo neznosni simptomi, je potrebno razmisliti o ponovni uvedbi predhodno predpisanega odmerka.
English: The two short-term placebo controlled studies were conducted in patients with social anxiety disorder.
Slovenian: Dve kratkoročni s placebom kontrolirani študiji sta bili izvedeni z bolniki s socialno anksiozno motnjo.
English: Activated charcoal, which may be used with a cathartic, may be as or more effective than lavage, and should be considered in treating overdose.
Slovenian: Aktivno oglje, ki se lahko uporabi z odvajalom, utegne biti enako učinkovito ali učinkovitejše kot izpiranje želodca, zato je treba pri zdravljenju prevelikega odmerjanja razmisliti o njegovi uporabi.
English: • If you have suffered from manic depressive illness (bipolar disorder) or schizophrenia.
Slovenian: • Trpite za manično depresijo (bipolarna motnja) ali shizofrenijo.
English: In addition, long-term safety data in children and adolescents concerning growth, maturation and cognitive and behavioural development are lacking.
Slovenian: Poleg tega pri otrocih in mladostnikih manjkajo podatki o varnosti na dolgi rok v zvezi z rastjo, odraščanjem ter kognitivnim in vedenjskim razvojem.
English: Efficacy is not shown in paediatric major depressive disorder.
Slovenian: Učinkovitost ni dokazana za hudo depresivno motnjo pri pediatričnih bolnikih.
English: These symptoms could be due to either serotonergic effects or withdrawal symptoms.
Slovenian: Ti simptomi so lahko posledica serotoninergičnih učinkov ali odtegnitvene reakcije.
English: The safety and efficacy of sertraline (50-200 mg/day) was examined in the treatment of non-depressed children (6-12 years old) and adolescent (13-17 years old) outpatients with obsessive compulsive disorder (OCD).
Slovenian: Varnost in učinkovitost sertralina (50-200 mg/dan) so raziskali pri ambulantno zdravljenih nedepresivnih otrocih (6-12 let) in mladostnikih (13-17 let) z obsesivno-kompulzivno motnjo (OKM).
English: Prevention of recurrence of major depressive episodes”.
Slovenian: Preprečevanju ponovnih hudih depresivnih epizod“.
English: The texts proposed by the MAH were in general accepted by the CHMP, with some occasional minor amendments.
Slovenian: Besedila, ki jih je predlagal imetnik dovoljenja za promet z zdravilom, je CHMP v splošnem sprejel, z nekaj manjšimi dopolnitvami.
English: Noting that MDD is considered to be a chronic or chronic intermittent condition where treatment is aimed at amelioration and possibly interruption of the natural course of the episode, the CHMP considered it unnecessary to accept this separate indication.
Slovenian: Ob upoštevanju, da je HDM kronično oz. občasno kronično obolenje, pri katerem je namen zdravljenja izboljšati in po možnosti prekiniti naravni potek epizode, je CHMP zaključil, da ni treba sprejeti te ločene indikacije.
English: The design is largely adequate but because this trial is performed in patients with recurrent depressive episodes, the adequate wording of the SPC should mention the description of patient populations and previous episodes in section 5.1.
Slovenian: Zasnova je pretežno ustrezna, ker pa so bila preskušanja izvedena z bolniki s ponovitvijo depresivnih epizod, mora biti v ustreznem besedilu povzetka glavnih značilnosti zdravila v poglavju 5.1 omenjen opis populacij bolnikov in predhodne epizode.
English: Use the dropper provided to remove the required amount of sertraline oral concentrate and dilute with approximately 120 ml (one glass) of water, ginger ale, lemon/lime soda, lemonade or orange juice.
Slovenian: Za odvzem potrebne količine koncentrata za peroralno raztopino sertralina uporabite priloženo kapalko; raztopino razredčite s približno 120 ml (enim kozarcem) vode, ingverjevega piva, gazirane limonade, limonade ali pomarančnega soka.
English: Patients (and caregivers of patients) should be alerted about the need to monitor for any clinical worsening, suicidal behaviour or thoughts and unusual changes in behaviour and to seek medical advice immediately if these symptoms present.
Slovenian: Bolnike (in skrbnike bolnikov) je treba opozoriti, da morajo biti pozorni na kakršnokoli klinično poslabšanje, pojav samomorilnega vedenja, misli na samomor in pojav neobičajnih vedenjskih sprememb, ter da se morajo v primeru, da takšni simptomi ne minejo, nemudoma posvetovati z zdravnikom.
English: There were no significant differences in plasma protein binding observed between the two groups.
Slovenian: Vezava na beljakovine v plazmi se med skupinama ni pomembno razlikovala.
English: Very Common
Slovenian: Zelo redki
English: The results of these studies indicate a positive benefit/risk balance for MDD.
Slovenian: Rezultati teh študij za indikacijo HDM kažejo pozitivno razmerje med koristmi in tveganji.
English: The CHMP agreed to the general aspects of the proposed study but requested the inclusion of a control group, consisting for instance of patients not treated with SSRIs or treated by psychotherapy alone.
Slovenian: CHMP se je strinjal s splošnimi vidiki predlagane študije, vendar je zahteval vključitev kontrolne skupine, ki jo sestavljajo na primer bolniki, ki niso zdravljeni s selektivnimi zaviralci ponovnega privzema serotonina ali pa so zdravljeni le s psihoterapijo.
English: Patients randomized to sertraline showed significantly greater improvement than those randomised to placebo on the Children's Yale-Brown Obsessive Compulsive Scale CY-BOCS (p =0.005) the NIMH Global Obsessive Compulsive Scale (p=0.019), and the CGI Improvement (p =0.002) scales.
Slovenian: Pri bolnikih, razvrščenih na sertralin, so v primerjavi z razvrščenimi na placebo ugotovili značilno večja izboljšanja na lestvicah CY-BOCS (Children's Yale-Brown Obsessive Compulsive Scale; p = 0,005), NIMH-GOCS (NIMH Global Obsessive Compulsive Scale; p = 0,019) in CGI-I (CGI Improvement; p = 0,002).
English: The evidence in support of the MDD indication was considered acceptable, and the CHMP focused on the assessment of the evidence supporting the additional indication: “including depression accompanied by symptoms of anxiety, in patients with or without a history of mania”.
Slovenian: Dokazi v podporo indikaciji HDM so bili ocenjeni kot sprejemljivi, zato se je CHPM osredotočil na ocenjevanje dokazov, ki podpirajo dodatno indikacijo: „vključno z depresijo, ki jo spremljajo simptomi anksioznosti, pri bolnikih z anamnezo manije ali brez nje“.
English: On the evidence available, sertraline has a wide margin of safety in overdose.
Slovenian: Po podatkih, ki so na voljo, ima sertralin pri prevelikem odmerjanju široko varnostno mejo.
English: This study includes a comparison group consisting of paediatric patients receiving psychotherapy alone.”
Slovenian: Ta študija vključuje primerjalno skupino, sestavljeno iz pediatričnih bolnikov, ki so zdravljeni le s psihoterapijo“.
English: Longer-term treatment may also be appropriate for prevention of recurrence of major depressive episodes (MDE).
Slovenian: Dolgotrajno zdravljenje je lahko primerno tudi za preprečevanje recidivov hudih depresivnih epizod.
English: Never drink the concentrate undiluted.
Slovenian: Nikoli ne pijte nerazredčenega zdravila.
English: Patients under 18 have an increased risk of undesirable effects, such as suicide attempt, suicidal thoughts and hostility (mainly aggressiveness, oppositional behaviour and anger) when they are treated with this class of medicines.
Slovenian: Vedeti morate, da je pri bolnikih, mlajših od 18 let, večje tveganje za neželene učinke, npr. poskus samomora, samomorilne misli in sovražnost (večinoma nasilno vedenje, nasprotujoče vedenje in jezo), ko jemljejo zdravila iz te skupine.
English: Sertraline is indicated for the treatment of:
Slovenian: Sertralin je indiciran za zdravljenje:
English: Do not use Zoloft after the expiry date which is stated on the pack.
Slovenian: Zdravila Zoloft ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na ovojnini.
English: Sertraline concentrate for oral solution contains 12% ethanol (see sections 4.3 and 4.5), glycerol and butylhydroxytoluene.
Slovenian: Setralin koncentrat za peroralno raztopino vsebuje 12% etanola (glejte poglavje 4.3 in 4.5), glicerol in butilhidroksitoluen.
English: This study includes a comparison group consisting of paediatric patients receiving psychotherapy alone” and also “to provide the relevant non-clinical data on juvenile animal toxicity available in the public domain, in order to justify why no further data needs to be generated in this field” were obtained from the Marketing Authorisation Holder,
Slovenian: Ta študija vključuje primerjalno skupino, sestavljeno iz pediatričnih bolnikov, ki so zdravljeni le s psihoterapijo“ in še „zagotovil ustrezne neklinične javno dostopne podatke o toksičnosti pri nedoraslih živalih, da bi tako utemeljil, zakaj dodatni podatki na tem področju niso potrebni“,
English: Regarding the use of sertraline in Hepatic Insufficiency and in Renal Insufficiency, the CHMP agreed with the wording proposed by the MAH for harmonisation.
Slovenian: V zvezi z uporabo sertralina pri bolnikih z jetrno insuficienco in ledvično insuficienco se CHMP strinja s predlaganim besedilom, ki ga je za uskladitev predlagal imetnik dovoljenja za promet z zdravilom.
English: levomepromazine and olanzapine).
Slovenian: levomepromazin in olanzapin)
English: Activation of hypomania or mania
Slovenian: Sprožitev manije ali hipomanije
English: This has been confirmed by in-vivo interaction studies with CYP3A4 substrates (endogenous cortisol, carbamazepine, terfenadine, alprazolam), CYP2C19 substrate diazepam, and CYP2C9 substrates tolbutamide, glibenclamide and phenytoin.
Slovenian: To so potrdile študije medsebojnega delovanja in vivo s substrati CYP3A4 (endogeni kortizol, karbamazepin, terfenadin, alprazolam), substratom CYP2C19 diazepamom in substrati CYP2C9 tolbutamidom, glibenklamidom in fenitoinom.
English: The study included children and adolescents aged 617.
Slovenian: Študija je vključevala otroke in mladostnike, stare od 6 do 17 let.
English: • Allergic reaction or allergy, which may include symptoms such as an itchy skin rash, breathing problems, wheezing, swollen eyelids, face or lips.
Slovenian: • Alergijska reakcija ali alergija, ki lahko obsega simptome, kot so srbeči izpuščaj na koži, težave z dihanjem, piskajoče dihanje, oteklost vek, obraza in ustnic.
English: You may find it helpful to tell a relative or close friend that you are depressed or have an anxiety disorder, and ask them to read this leaflet.
Slovenian: Morda bi bilo koristno, če za težave z depresijo ali anksioznostjo poveste sorodniku ali dobremu prijatelju, in ga prosite, da prebere to navodilo.
English: The CHMP agreed that overall, the safety of sertraline in the treatment of PTSD is similar to that of major depressive disorder) MDD and does not present any new issues.
Slovenian: CHMP se je strinjal, da je celokupna varnost sertralina pri zdravljenju PTSM podobna varnosti pri zdravljenju hude depresivne motnje in ne predstavlja novih zadržkov.
English: Sertraline is approved for the treatment of depression and in addition, the product is approved in some Member States for the treatment of social anxiety disorder, panic disorder (with or without agoraphobia disorder), post-traumatic stress disorder (PTSD), and obsessive-compulsive disorder (OCD).
Slovenian: Sertralin je odobren za zdravljenje depresije, poleg tega pa je zdravilo v nekaterih državah članicah odobreno za zdravljenje socialno anksiozne motnje, panične motnje (z agorafobično motnjo ali brez nje), posttravmatske stresne motnje (PTSM) in obsesivno kompulzivne motnje (OKM).
English: Regarding safety, the incidence of all adverse events is within the range reported for the application of sertraline in major depression and the post-marketing experience does not indicate any adverse events which deserve special attention or concern in the application for this indication.
Slovenian: Glede varnosti je pojavnost vseh neželenih učinkov znotraj razpona, opaženega pri uporabi sertralina za zdravljenje hude depresije, postmarketinške izkušnje pa prav tako ne kažejo na neželene učinke, katerim bi bilo pri uporabi za to indikacijo treba posvečati posebno pozornost ali skrb.
English: Like all medicines, Zoloft can cause side effects, although not everybody gets them.
Slovenian: Kot vsa zdravila ima lahko tudi zdravilo Zoloft neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
English: Seizures may occur with sertraline therapy: sertraline should be avoided in patients with unstable epilepsy and patients with controlled epilepsy should be carefully monitored.
Slovenian: Med zdravljenjem s sertralinom se lahko pojavijo konvulzivni napadi: uporabi sertralina se morate izogniti pri bolnikih z nestabilno epilepsijo, bolnike z urejeno epilepsijo pa morate natančno spremljati.
English: The CHMP was of the opinion that based on the previous discussion within the committee and given the revised study synopsis submitted by the MAH, the OCD indication in paediatric patients is now also considered acceptable and therefore adopted the following indication:
Slovenian: CHMP je glede na prejšnje razprave v odboru in popravljen oris študije, ki ga je predložil imetnik dovoljenja za promet z zdravilom, menil, da je sedaj tudi indikacijo za OKM pri pediatričnih bolnikih mogoče šteti za sprejemljivo, je zato sprejel naslednjo indikacijo:
English: In the treatment of social anxiety disorder, sexual dysfunction (ejaculation failure) in men occurred in 14% for sertraline vs 0% in placebo.
Slovenian: Pri zdravljenju socialne anksiozne motnje se je spolna disfunkcija (nezmožnost ejakulacije) pojavila pri 14 % moških, ki so dobivali sertralin, in pri 0 % tistih, ki so dobivali placebo.
English: Ethanol: The alcohol content has to be taken into consideration in patients with liver impairment, alcohol abuse, epilepsy, brain trauma or disease, pregnant women and children.
Slovenian: Etanol: Vsebnost alkohola je potrebno upoštevati pri bolnikih z jetrno okvaro, anamnezo zlorabe alkohola, epilepsijo, poškodbo ali boleznijo možganov, nosečnicah in otrocih.
English: The provided results also indicate that relapse rates in the sertraline/sertraline arm are significantly lower compared to the rates in sertraline/placebo and placebo/placebo arms.
Slovenian: Predloženi rezultati prav tako kažejo, da je stopnja ponovitev bolezni v kraku sertralin/sertralin bistveno nižja od stopnje pri krakih sertralin/placebo in placebo/placebo.
English: Suicide/suicidal thoughts/suicide attempts or clinical worsening Depression is associated with an increased risk of suicidal thoughts, self harm and suicide (suiciderelated events).
Slovenian: Samomor/samomorilne misli ali klinično poslabšanje Depresija je povezana z večjim tveganjem za pojav samomorilnih misli, samopoškodovanja in samomorilnosti (s samomorom povezani dogodki).
English: In addition, these conditions may be co-morbid with major depressive disorder.
Slovenian: Poleg tega pa se ta stanja lahko pojavijo sočasno s hudo depresivno motnjo.
English: Generally these symptoms are self-limiting and usually resolve within 2 weeks, though in some individuals they may be prolonged (2-3 months or more).
Slovenian: Na splošno ti simptomi minejo sami, po navadi v 2 tednih, pri nekaterih posameznikih pa so lahko dolgotrajni (2 do 3 mesece ali več).
English: It is devoid of stimulant, sedative or anticholinergic activity or cardiotoxicity in animals.
Slovenian: Pri živalih ne deluje stimulacijsko, sedativno ali antiholinergično in ni kardiotoksičen.
English: Psychotropic drugs such as sertraline may influence your ability to drive or use machines.
Slovenian: Psihotropna zdravila, kot je zdravilo Zoloft, lahko vplivajo na vašo sposobnost za upravljanje vozil in strojev.
English: Due to the large volume of distribution of sertraline, forced diuresis, dialysis, haemoperfusion and exchange transfusion are unlikely to be of benefit.
Slovenian: Ker je volumen porazdelitve sertralina velik, je malo verjetno, da bi prisiljena diureza, dializa, hemoperfuzija in izmenjevalna transfuzija koristile.
English: Major depressive episodes.
Slovenian: Hudih depresivnih epizod.
English: These may be increased when first starting antidepressants, since these medicines all take time to work, usually about two weeks but sometimes longer.
Slovenian: Po prvi uvedbi zdravljenja z antidepresivi lahko te misli postanejo še hujše, saj ta zdravila začnejo delovati šele čez nekaj časa, običajno čez dva tedna, nekatera pa tudi kasneje.
English: For OCD, short term, 1-12 week studies only *** Cases of suicidal ideation and suicidal behaviours have been reported during sertraline therapy or early after treatment discontinuation (see section 4.4).
Slovenian: Za OKM, kratkotrajno, samo študije 1-12 tednov *** Med zdravljenjem s sertralinom ali zgodaj po prenehanju zdravljenja so bili opisani primeri samomorilnega razmišljanja in samomorilnega vedenja (glejte poglavje 4.4).
English: the CHMP has recommended the amendment of the Marketing Authorisations for which the Summary of Product Characteristics, labelling and package leaflet are set out in Annex III for Zoloft and associated names (see Annex I).
Slovenian: je CHMP priporočil dopolnitev dovoljenj za promet z zdravilom, za katera so povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo navedeni v Dodatku III za zdravilo Zoloft in z njim povezana imena (glejte Dodatek I).
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, POT UPORABE, IMETNIKI DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH
English: Manic/hypomanic symptoms have been reported to emerge in a small proportion of patients treated with marketed antidepressant and antiobsessional drugs, including sertraline.
Slovenian: O sprožitvi manije/hipomanije so poročali tudi pri majhnem deležu bolnikov, zdravljenih z drugimi antidepresivnimi in antiobsesivnimi zdravili, ki so na trgu, vključno s sertralinom.
English: The results indicated that with respect to the primary efficacy endpoint, three of the studies demonstrated statistically significant improvement in panic disorders compared to placebo, while the fourth study did not.
Slovenian: Z vidika glavnega pokazatelja učinkovitosti so rezultati treh študij pokazali statistično bistveno izboljšanje pri paničnih motnjah v primerjavi s placebom, medtem ko četrta študija tega ni pokazala.
English: Neoplasms benign, malignant (including cysts and polyps) Neoplasm†
Slovenian: Benigne in maligne neoplazme (vključno s cistami in polipi) neoplazme†
English: Other drug interactions, digoxin, atenolol, cimetidine Co-administration with cimetidine caused a substantial decrease in sertraline clearance.
Slovenian: Medsebojno delovanje z drugimi zdravili, digoksin, atenolol,cimetidin Sočasna uporaba s cimetidinom je bistveno zmanjšala očistek sertralina.
English: If sertraline is administered to patients with hepatic impairment, a lower or less frequent dose should be considered.
Slovenian: Če se sertralin uporabi pri bolnikih z okvaro jeter, je treba razmisliti o manjšem odmerku ali redkejšem odmerjanju.
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 lahko odvisno od več dejavnikov, tudi od trajanja zdravljenja, odmerka zdravila in hitrosti zmanjševanja odmerka.
English: In a placebo-controlled, double-blind randomized study of the comparative abuse liability of sertraline, alprazolam and d-amphetamine in humans, sertraline did not produce positive subjective effects indicative of abuse potential.
Slovenian: V dvojno slepi, randomizirani, s placebom nadzorovani študiji, ki je primerjala možnost za zlorabo sertralina, alprazolama in D-amfetamina pri ljudeh, sertralin ni imel pozitivnih subjektivnih učinkov, ki nakazujejo možnost zlorabe.
English: Sertraline has no affinity for muscarinic (cholinergic), serotonergic, dopaminergic, adrenergic, histaminergic, GABA or benzodiazepine receptors.
Slovenian: Sertralin nima afinitete za muskarinske (holinergične), serotoninergične, dopaminergične, adrenergične, histaminergične, GABA ali benzodiazepinske receptorje.
English: The following adverse reactions were reported from controlled trials (n=281 patients treated with sertraline):
Slovenian: V nadzorovanih preskušanjih (n = 281 bolnikov, zdravljenih s sertralinom) so bili opisani naslednji neželeni učinki):
English: Patients with a history of suicide-related events, or 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.
Slovenian: Znano je, da pri bolnikih s samomorom povezanimi dogodki v anamnezi, ali bolnikih, ki kažejo znatno stopnjo samomorilne miselnosti pred uvedbo zdravljenja, obstaja večje tveganje za pojav samomorilnih misli ali poskusov samomora in jih je treba med zdravljenjem skrbno spremljati.
English: Physicians must monitor paediatric patients on long term treatment for abnormalities in these body systems.
Slovenian: Pediatrične bolnike, ki so na dolgotrajnem zdravljenju, morajo zdravniki nadzorovati glede nepravilnosti v organskih sistemih.
English: The CHMP was of the opinion that the results of these three trials do not support the addition of “including depression accompanied by symptoms of anxiety, in patients with or without a history of mania” to the Major Depressive Episodes (MDD) indication.
Slovenian: CHMP je menil, da rezultati teh treh preskušanj ne podpirajo dodatka „vključno z depresijo, ki jo spremljajo znaki anksioznosti, pri bolnikih z anamnezo manije ali brez nje“ k indikaciji hude depresivne epizode (HDM).
English: Sertraline is one of a group of medicines called Selective Serotonin Re-uptake Inhibitors (SSRIs); these medicines are used to treat depression and or anxiety disorders.
Slovenian: Sertralin spada v skupino zdravil, imenovanih selektivni zaviralci ponovnega privzema serotonina (SSRI); ta zdravila se uporabljajo za zdravljenje depresije in/ali anksioznosti.
English: Zoloft capsules should be taken with food.
Slovenian: Kapsule Zoloft jemljite s hrano.
English: Therefore the CHMP considers that insufficient evidence was provided to support the duration of treatment in OCD.
Slovenian: CHMP zato meni, da predloženi dokazi ne zadostujejo, da bi podprli trajanje zdravljenja pri OKM.
English: The number of male and female patients in the pooled general population trials was 184 and 430, respectively and hence the results in females are more robust and males were associated with other baseline variables (more substance abuse, longer duration, source of trauma etc) which are correlated with decreased effect.”
Slovenian: V preskušanjih na združeni splošni populaciji je sodelovalo 184 moških in 430 žensk, zaradi česar so rezultati pri ženskah zanesljivejši, pri moških pa so povezani z drugačnimi osnovnimi spremenljivkami (več zlorab učinkovine, daljše trajanje, izvor travme itd.), kar sovpada z zmanjšanim učinkom.“
English: Sertraline
Slovenian: sertralin