natgillin/translations-raw huggingface dataset:
The CHMP considered that open label studies are not appropriate to demonstrate long term efficacy for regulatory purposes, and that a single study cannot be sufficient to support a paediatric indication.
CHMP je menil, da neslepe študije niso primerne za dokazovanje dolgoročne učinkovitosti za regulativne namene in da ena sama študija ne more zadostovati za podporo uporabi v pediatriji.
Close surveillance by the physician is required.
Potreben je natančen zdravniški nadzor.
The interference of depressive symptoms and their effect on PTSD is still a concern because this was not sufficiently controlled for.
Medsebojno delovanje simptomov depresije in njihovih učinkov na PTSM še vedno predstavlja zadržek, kajti to ni bilo zadostno nadzorovano.
Evidence was found that the early postnatal mortality was due to in-utero exposure after day 15 of pregnancy.
Ugotovili so, da je bila zgodnja postnatalna umrljivost posledica izpostavljenosti in utero po 15. dnevu brejosti.
The CHMP was of the opinion that the second relapse definition used in this study, based on only the investigators judgement rather than on objective measures of OCD, cannot be considered to be an acceptable relapse definition as it is not objective and not necessarily based on disorder specific symptoms.
CHMP je menil, da opredelitve druge ponovitve, uporabljene v tej študiji, ki je temeljila le na preiskovalčevi presoji in ne na objektivnih merilih za OKM, ni mogoče šteti za sprejemljivo opredelitev ponovitve, saj ni objektivna in ni nujno povezana z določenimi simptomi motnje.
The CHMP was of the opinion that overall, modest short-term efficacy was demonstrated in these studies.
CHMP je menil, da je bila v celoti vzeto v teh študijah dokazana zmerna kratkoročna učinkovitost.
The low occurrence of relapse in this study suggest that relapse prevention after 1 year of treatment may not be necessary but the study did not provide information regarding the need for relapse prevention after acute treatment (12 weeks).
Nizek pojav ponovitve bolezni v tej študiji nakazuje, da po enoletnem zdravljenju preprečevanje ponovitve morda ni potrebno, vendar pa študija ni dala informacij o potrebi po preprečevanju ponovitev bolezni po akutnem zdravljenju (12- tedenskem).
provided the following text concerning PTSD is inserted in section 5.1:
če se v poglavje 5.1 vključi naslednje besedilo, ki se nanaša na PTSM:
This is most likely to occur during the first few weeks of treatment.
To se najverjetneje lahko pojavi v prvih nekaj tednih zdravljenja.
Medicinal products containing lactose
Zdravila, ki vsebujejo laktozo
Abnormal bleeding/Haemorrhage
Nenormalne krvavitve/hemoragija
Do not use Zoloft together with pimozide.
Ne uporabljajte zdravila Zoloft skupaj s pimozidom.
Sertraline had no effect on the beta-adrenergic blocking ability of atenolol.
Sertralin ni vplival na beta-adrenergično zaviralno zmožnost atenolola.
However, concerns remain about the lack of evidence with respect to relapse prevention.
Vendar pa ostajajo zadržki v zvezi s pomanjkanjem podatkov glede preprečevanja ponovitve.
There were no significant differences between boys and girls regarding clearance.
Očistek se pri dečkih in deklicah ni pomembno razlikoval.
When stopping treatment with Sertraline it is recommended to reduce the dose gradually over a period of several weeks or months, depending on the patient's needs.
Ko končujemo zdravljenje s sertralinom je priporočljivo zmanjševati odmerek postopoma v obdobju nekaj tednov ali mesecev, odvisno od bolnikovih potreb.
Adolescents could be dosed like adults.
Pri mladostnikih je mogoče uporabiti enako odmerjanje kot pri odraslih.
Paediatric-onset OCD shares important similarities with the adult disorder but also shows important differences.
Pojav OKM v pediatriji izkazuje velike podobnosti z motnjo pri odraslih, vendar pa kaže tudi na velike razlike.
In order to provide long-term safety evidence, the MAH proposed to augment the current Data Capture Aid (DCA) and to monitor all reported paediatric (less than 18 years of age) adverse events (AEs) in the pharmacovigilance safety database and look in more detail for AEs of interest in these cases.
Da bi imetnik dovoljenja za promet z zdravilom zagotovil dolgoročne podatke o varnosti, je predlagal, da bi razširil obstoječe podatke DCA (Data Capture Aid) in spremljal vse opažene neželene učinke pri pediatričnih bolnikih (mlajših od 18 let) v farmakovigilančni podatkovni bazi o varnosti ter podrobneje preučil neželene učinke v teh primerih.
In rare cases this syndrome may occur when you are taking certain medicines at the same time as sertraline.
V redkih primerih se ta sindrom lahko pojavi, ko jemljete določena zdravila sočasno s sertralinom.
The two long-term studies were not designed to assess relapse prevention and the significant results that were obtained were with respect to subjectively defined relapse, which is not acceptable.
Dve dolgoročni študiji nista bili načrtovani tako, da bi ocenili preprečevanje ponovitev, pridobljeni bistveni rezultati pa so temeljili na subjektivni opredelitvi ponovitve, kar ni sprejemljivo.
Dose changes should not occur at intervals of less than one week.”
Odmerka se ne sme spreminjati v intervalu, krajšem od enega tedna.“
The assessment of the evidence for long-term efficacy and relapse prevention indicates the studies were not performed strictly according to guidelines and the long-term (24 weeks) study does suggest efficacy of long term treatment but includes exposure therapy arms which may have interfered with the interpretation of the results.
Vrednotenje dokazov o dolgoročni učinkovitosti in o preprečevanju ponovitev kaže, da študije niso bile izvedene strogo v skladu s smernicami ter da dolgoročna, 24-tedenska študija nakazuje učinkovitost dolgoročnega zdravljenja, vendar vključuje krake z izpostavitveno terapijo, kar bi utegnilo izkriviti razlago rezultatov.
Social anxiety disorder (social phobia) is an illness linked to anxiety.
Socialna fobija (socialna anksiozna motnja) je bolezen povezana s tesnobnostjo.
In clinical trials with children and adolescents, the side effects were generally similar to adults (see above).
V kliničnih preskušanjih pri otrocih in mladostnikih so bili neželeni učinki praviloma podobni kot pri odraslih (glejte zgoraj).
The effects obtained in the short-term studies seem limited to women while no effect could be demonstrated in men and the CHMP considered this to be due to differences in baseline variables between males and females.
Učinki, pridobljeni v kratkoročnih študijah, se zdijo omejeni na ženske, medtem ko pri moških učinka ni bilo mogoče dokazati, zato je CHMP menil, da je to posledica razlik v izhodiščnih spremenljivkah med moškimi in ženskami.
According to the MAH, differences in this section are related to differences in the formulations that have been approved.
Kot navaja imetnik dovoljenja za promet z zdravilom, so razlike v tem poglavju povezane z razlikami med odobrenimi formulacijami zdravila.
If your doctor has prescribed Zoloft to a patient less than 18 years old and you want to discuss this, please contact him/her.
Če je vaš zdravnik predpisal zdravilo Zoloft za bolnika, mlajšega od 18 let, in se želite pogovoriti o tem, se vrnite k zdravniku.
The pattern and incidence of adverse reactions in the elderly was similar to that in younger patients.
Vzorec in pogostnost neželenih reakcij sta bila pri starejših bolnikih podobna kot pri mlajših.
Therefore, the overall results of the sertraline studies are supportive of short- and long-term efficacy and, as no unexpected safety issues emerged against the known safety profile of sertraline in the treatment of depression, the CHMP considered the benefit/risk balance for the indication social anxiety disorder to be positive, and approved the following indication:
Celokupni rezultati študij sertralina podpirajo kratko- in dolgoročno učinkovitost in ker se niso pojavili nepričakovani novi varnostni zadržki glede na znan varnostni profil sertralina pri zdravljenju depresije, je CHMP menil, da je razmerje med koristnostmi in tveganji za indikacijo socialne anksiozne motnje pozitivno, ter odobril naslednjo indikacijo:
• If you have or have previously had suicidal thoughts (see below-thoughts of suicide and worsening of your depression or anxiety disorder).
• Imate ali ste imeli samomorilske misli (glejte spodaj Misli na samomor in poslabšanje depresije ali anksiozne motnje).
In both sections, caution is advised and a lower or less frequent dose should be used in patients with hepatic impairment.
V obeh poglavjih je priporočena previdnost ter nižji ali manj pogosti odmerki pri bolnikih z okvaro jeter.
Depression is a clinical illness with symptoms like feeling sad, unable to sleep properly or to enjoy life as you used to.
Depresija je klinična bolezen s simptomi kot so potrtost, če slabo spite ali če se ne veselite življenja, tako kot ste se ga včasih.
Other serotonergic drugs See section 4.4.
Druga serotoninergična zdravila Glejte poglavje 4.4
Overall, the results of the two studies combined are suggestive of maintenances of effect over the long-term.
Gledano v celoti, kažejo skupni rezultati dveh študij na dolgoročno vzdrževanje učinka.
Another concern is the effect on depression and the chronicity effect, as only subgroups defined by <5 year or >5years chronicity were examined while chronic PTSD according to DSM criteria starts at >3 months.
Drugi pomislek je učinek na depresijo in učinek kroničnosti, kajti preučevani sta bili le podskupini s kroničnim pojavom bolezni < 5 let in > 5 let, medtem ko kronična PTSM, glede na merila DSM, nastopi, kadar traja več kot 3 mesece.
Put the dropper back on the bottle after use.
Po uporabi namestite kapalko nazaj na stekleničko.
The CHMP concluded that short-term efficacy has been demonstrated, but that concerns remain over the lack of evidence with respect to relapse prevention.
CHMP je zaključil, da je bila kratkoročna učinkovitost dokazana, vendar pa ostajajo zadržki glede pomanjkanja dokazov o preprečevanju ponovitve bolezni.
In patients who develop these symptoms, increasing the dose may be detrimental.
Bolnikom, pri katerih se pojavijo ti simptomi, lahko zvečanje odmerka škoduje.
Wort may last for 1-2 weeks.
Učinki šentjanževke lahko trajajo od 1 do 2 tedna.
The recommendation derived from the evidence regarding efficacy and safety is to grant the following indication for the treatment of OCD:
Na podlagi dokazov o učinkovitosti in varnosti se priporoča, da se odobri naslednja indikacija za zdravljenje OKM:
A direct effect on PTSD while controlling for the effect on depression was not demonstrated.
Neposredni učinek na PTSM pri nadzorovanem vplivu na depresijo ni bil dokazan.
Regarding the dosage, there are no reasons to believe that dose-response effects would be evident in children and adolescents, and subsequently disappear in adulthood and the CHMP considered that there is no evidence to support the minimum effective dose in children and in adolescents.
Glede odmerjanja ni razlogov za oceno, da bi bila povezava med odmerkom in odzivom pri otrocih in mladostnikih dokazljiva ter nato v odraslosti postopoma izginila, zato je CHMP menil, da ni dokazov, ki bi podpirali najmanjši učinkoviti odmerek pri otrocih in mladostnikih.
Tell your doctor before you take Zoloft, if you suffer from or have suffered in the past from any of the following conditions:
Preden vzamete zdravilo Zoloft, morate zdravniku povedati, če imate ali ste kdaj v preteklosti imeli kaj od naslednjega:
Use the dropper to measure the dose, as prescribed by the doctor.
Odmerjanje odmerka Za odmerjanje odmerka uporabite kapalko, v skladu z navodili zdravnika.
• If you develop a severe skin rash that causes blistering (erythema multiforme), (this can affect the mouth and tongue).
• Če se vam pojavi hud izpuščaj na koži, ki povzroči nastanek mehurjev (multiformni eritem); prizadene lahko tudi usta in jezik.
When you later open the bottle, push down hard on the dropper while turning the dropper to the left (counter clockwise).
Ko pozneje odpirate stekleničko, kapalko močno pritisnite navzdol in jo hkrati zasučite v levo (v nasprotno smer urnega kazalca).
Animal studies showed evidence for effects on reproduction probably due to maternal toxicity caused by the pharmacodynamic action of the compound and/or direct pharmacodynamic action of the compound on the foetus (see 5.3).
Študije na živalih so pokazale učinke na reprodukcijo, verjetno zaradi toksičnih učinkov pri samicah-materah, ki jih je povzročilo farmakodinamično delovanje učinkovine in/ali neposredno farmakodinamično delovanje učinkovine na plod (glejte poglavje 5.3).
There are no clinical studies establishing the risks or benefits of the combined use of ECT and sertraline.
Kliničnih študij o tveganjih ali koristih kombinirane uporabe elektrokonvulzivnega zdravljenja in sertralina ni.
Efficacy and safety were not investigated with respect to long-term safety, long-term effects on endocrine parameters, on sexual, cognitive and emotional development and other maturation parameters.
Učinkovitost in varnost nista bili raziskani v zvezi z dolgoročno varnostjo, dolgoročnimi učinki na endokrine dejavnike, na spolni, kognitivni in čustveni razvoj ter na druge razvojne dejavnike.
Care and prudent medical judgment should be exercised when switching, particularly from long-acting agents such as fluoxetine.
Skrbna in preudarna zdravniška presoja je potrebna pri prehodu, zlasti z dolgodelujočih zdravil, kakršno je npr. fluoksetin.
In many cases, hyponatraemia appears to be the result of a syndrome of inappropriate antidiuretic hormone secretion (SIADH).
V številnih primerih je hiponatriemija posledica sindroma neustreznega izločanja antidiuretičnega hormona (SIADH).
Social anxiety disorder.
Socialne anksiozne motnje.
In addition, the improvements in anxiety presented by the MAH are far from impressive and not significant.
Poleg tega izboljšanje anksioznosti, ki ga je predstavil imetnik dovoljenja za promet z zdravilom, še zdaleč ni navdušujoče in ni bistveno.
If you have liver or kidney problems, please tell your doctor and follow the doctor's instructions.
Če imate težave z jetri ali ledvicami, to povejte svojemu zdravniku ter upoštevajte njegova navodila.
However, as psychotropic drugs may impair the mental or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery, the patient should be cautioned accordingly.
Vendar lahko psihotropna zdravila poslabšajo duševne in telesne sposobnosti, potrebne za potencialno nevarna opravila, npr. vožnja avtomobila in upravljanje s stroji, in bolnika je treba na to opozoriti.
The primary efficacy variable was the CAPS-2 (Clinician-Administered PTSD scale) total severity score.
Glavni pokazatelj učinkovitosti je bila celokupna lestvica resnosti CAPS-2 (ClinicianAdministered PTSD scale).
• Epilepsy or a history of seizures.
• Epilepsija ali napadi krčev v preteklosti.
In steady state for the 200 mg dose, the sertraline plasma levels in the 6-12 year old group were approximately 35% higher compared to the 13-17 year old group, and 21% higher compared to adult reference group.
V stanju dinamičnega ravnovesja z odmerkom 200 mg je bila koncentracija sertralina v plazmi v starostni skupini od 6 do 12 let približno 35 % večja kot v starostni skupini od 13 do 17 let ter 21 % večja kot v referenčni skupini odraslih.
The chronic administration of sertraline in animals was associated with down-regulation of brain norepinephrine receptors as observed with other clinically effective antidepressants and antiobsessional drugs.
Kronična uporaba sertralina pri živalih je bila povezana z zmanjšanjem števila noradrenalinskih receptorjev v možganih, podobno kot pri drugih klinično učinkovitih antidepresivih in antiobsesivnih zdravilih.
Regarding pimozide, the CHMP agreed to the MAH proposal: “Concomitant intake of pimozide is contraindicated (see section 4.5)” and regarding hepatic impairment, the CHMP considered that patients with significant hepatic impairment are not strictly contraindicated with sertraline and that appropriate warnings about the recommended use of sertraline in patients with hepatic impairment are provided in section 4.2 and section 4.4 of the proposed harmonised SPC.
V zvezi s pimozidom se je CHMP strinjal s predlogom imetnika dovoljenja za promet z zdravilom: „Sočasna uporaba pimozida je kontraindicirana (glejte poglavje 4.5)“, v zvezi z okvaro jeter pa je CHMP menil, da pri bolnikih z znatno okvaro jeter sertralin ni strogo kontraindiciran in da so primerna opozorila o priporočeni rabi sertralina pri bolnikih z okvaro jeter zapisana v predlaganem usklajenem povzetku glavnih značilnosti zdravila v poglavjih 4.2 in 4.4.
Patients were gradual uptitrated to a 200 mg daily dose within 32 days, either with 25 mg starting dose and increment steps, or with 50 mg starting dose or increments.
Bolnikom so odmerek v 32 dneh postopoma zvečali do 200 mg na dan, bodisi z začetnim odmerkom 25 mg in povečevanjem bodisi z začetnim odmerkom 50 mg in povečevanjem.
These are symptoms of Serotonin Syndrome.
To so simptomi serotoninskega sindroma.
• 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.
• 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.
Pharmacokinetics of sertraline was studied in 29 paediatric patients aged 6-12 years old, and 32 adolescent patients aged 13-17 years old.
Farmakokinetiko sertralina so raziskali pri 29 pediatričnih bolnikih, starih od 6 do 12 let, in 32 mladostniških bolnikih, starih od 13 do 17 let.
If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered.
V primeru, da se pri zmanjševanju odmerka ali pri ukinitvi zdravljenja pojavijo neznosni simptomi, je potrebno razmisliti o ponovni uvedbi predhodno predpisanega odmerka.
The two short-term placebo controlled studies were conducted in patients with social anxiety disorder.
Dve kratkoročni s placebom kontrolirani študiji sta bili izvedeni z bolniki s socialno anksiozno motnjo.
Activated charcoal, which may be used with a cathartic, may be as or more effective than lavage, and should be considered in treating overdose.
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.
• If you have suffered from manic depressive illness (bipolar disorder) or schizophrenia.
• Trpite za manično depresijo (bipolarna motnja) ali shizofrenijo.
In addition, long-term safety data in children and adolescents concerning growth, maturation and cognitive and behavioural development are lacking.
Poleg tega pri otrocih in mladostnikih manjkajo podatki o varnosti na dolgi rok v zvezi z rastjo, odraščanjem ter kognitivnim in vedenjskim razvojem.
Efficacy is not shown in paediatric major depressive disorder.
Učinkovitost ni dokazana za hudo depresivno motnjo pri pediatričnih bolnikih.
These symptoms could be due to either serotonergic effects or withdrawal symptoms.
Ti simptomi so lahko posledica serotoninergičnih učinkov ali odtegnitvene reakcije.
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).
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).
Prevention of recurrence of major depressive episodes”.
Preprečevanju ponovnih hudih depresivnih epizod“.
The texts proposed by the MAH were in general accepted by the CHMP, with some occasional minor amendments.
Besedila, ki jih je predlagal imetnik dovoljenja za promet z zdravilom, je CHMP v splošnem sprejel, z nekaj manjšimi dopolnitvami.
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.
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.
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.
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.
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.
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.
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.
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.
There were no significant differences in plasma protein binding observed between the two groups.
Vezava na beljakovine v plazmi se med skupinama ni pomembno razlikovala.
Very Common
Zelo redki
The results of these studies indicate a positive benefit/risk balance for MDD.
Rezultati teh študij za indikacijo HDM kažejo pozitivno razmerje med koristmi in tveganji.
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.
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.
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.
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).
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”.
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“.
On the evidence available, sertraline has a wide margin of safety in overdose.
Po podatkih, ki so na voljo, ima sertralin pri prevelikem odmerjanju široko varnostno mejo.