natgillin/translations-raw huggingface dataset:
This study includes a comparison group consisting of paediatric patients receiving psychotherapy alone.”
Ta študija vključuje primerjalno skupino, sestavljeno iz pediatričnih bolnikov, ki so zdravljeni le s psihoterapijo“.
Longer-term treatment may also be appropriate for prevention of recurrence of major depressive episodes (MDE).
Dolgotrajno zdravljenje je lahko primerno tudi za preprečevanje recidivov hudih depresivnih epizod.
Never drink the concentrate undiluted.
Nikoli ne pijte nerazredčenega zdravila.
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.
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.
Sertraline is indicated for the treatment of:
Sertralin je indiciran za zdravljenje:
Do not use Zoloft after the expiry date which is stated on the pack.
Zdravila Zoloft ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na ovojnini.
Sertraline concentrate for oral solution contains 12% ethanol (see sections 4.3 and 4.5), glycerol and butylhydroxytoluene.
Setralin koncentrat za peroralno raztopino vsebuje 12% etanola (glejte poglavje 4.3 in 4.5), glicerol in butilhidroksitoluen.
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,
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“,
Regarding the use of sertraline in Hepatic Insufficiency and in Renal Insufficiency, the CHMP agreed with the wording proposed by the MAH for harmonisation.
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.
levomepromazine and olanzapine).
levomepromazin in olanzapin)
Activation of hypomania or mania
Sprožitev manije ali hipomanije
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.
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.
The study included children and adolescents aged 617.
Študija je vključevala otroke in mladostnike, stare od 6 do 17 let.
• Allergic reaction or allergy, which may include symptoms such as an itchy skin rash, breathing problems, wheezing, swollen eyelids, face or lips.
• Alergijska reakcija ali alergija, ki lahko obsega simptome, kot so srbeči izpuščaj na koži, težave z dihanjem, piskajoče dihanje, oteklost vek, obraza in ustnic.
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.
Morda bi bilo koristno, če za težave z depresijo ali anksioznostjo poveste sorodniku ali dobremu prijatelju, in ga prosite, da prebere to navodilo.
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.
CHMP se je strinjal, da je celokupna varnost sertralina pri zdravljenju PTSM podobna varnosti pri zdravljenju hude depresivne motnje in ne predstavlja novih zadržkov.
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).
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).
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.
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.
Like all medicines, Zoloft can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo Zoloft neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
Seizures may occur with sertraline therapy: sertraline should be avoided in patients with unstable epilepsy and patients with controlled epilepsy should be carefully monitored.
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.
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:
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:
In the treatment of social anxiety disorder, sexual dysfunction (ejaculation failure) in men occurred in 14% for sertraline vs 0% in placebo.
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.
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.
Etanol: Vsebnost alkohola je potrebno upoštevati pri bolnikih z jetrno okvaro, anamnezo zlorabe alkohola, epilepsijo, poškodbo ali boleznijo možganov, nosečnicah in otrocih.
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.
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.
Suicide/suicidal thoughts/suicide attempts or clinical worsening Depression is associated with an increased risk of suicidal thoughts, self harm and suicide (suiciderelated events).
Samomor/samomorilne misli ali klinično poslabšanje Depresija je povezana z večjim tveganjem za pojav samomorilnih misli, samopoškodovanja in samomorilnosti (s samomorom povezani dogodki).
In addition, these conditions may be co-morbid with major depressive disorder.
Poleg tega pa se ta stanja lahko pojavijo sočasno s hudo depresivno motnjo.
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).
Na splošno ti simptomi minejo sami, po navadi v 2 tednih, pri nekaterih posameznikih pa so lahko dolgotrajni (2 do 3 mesece ali več).
It is devoid of stimulant, sedative or anticholinergic activity or cardiotoxicity in animals.
Pri živalih ne deluje stimulacijsko, sedativno ali antiholinergično in ni kardiotoksičen.
Psychotropic drugs such as sertraline may influence your ability to drive or use machines.
Psihotropna zdravila, kot je zdravilo Zoloft, lahko vplivajo na vašo sposobnost za upravljanje vozil in strojev.
Due to the large volume of distribution of sertraline, forced diuresis, dialysis, haemoperfusion and exchange transfusion are unlikely to be of benefit.
Ker je volumen porazdelitve sertralina velik, je malo verjetno, da bi prisiljena diureza, dializa, hemoperfuzija in izmenjevalna transfuzija koristile.
Major depressive episodes.
Hudih depresivnih epizod.
These may be increased when first starting antidepressants, since these medicines all take time to work, usually about two weeks but sometimes longer.
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.
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).
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).
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).
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).
ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
DODATEK I SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, POT UPORABE, IMETNIKI DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH
Manic/hypomanic symptoms have been reported to emerge in a small proportion of patients treated with marketed antidepressant and antiobsessional drugs, including sertraline.
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.
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.
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.
Neoplasms benign, malignant (including cysts and polyps) Neoplasm†
Benigne in maligne neoplazme (vključno s cistami in polipi) neoplazme†
Other drug interactions, digoxin, atenolol, cimetidine Co-administration with cimetidine caused a substantial decrease in sertraline clearance.
Medsebojno delovanje z drugimi zdravili, digoksin, atenolol,cimetidin Sočasna uporaba s cimetidinom je bistveno zmanjšala očistek sertralina.
If sertraline is administered to patients with hepatic impairment, a lower or less frequent dose should be considered.
Če se sertralin uporabi pri bolnikih z okvaro jeter, je treba razmisliti o manjšem odmerku ali redkejšem odmerjanju.
The risk of withdrawal symptoms may be dependent on several factors including the duration and dose of therapy and the rate of dose reduction.
Tveganje za odtegnitvene simptome je lahko odvisno od več dejavnikov, tudi od trajanja zdravljenja, odmerka zdravila in hitrosti zmanjševanja odmerka.
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.
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.
Sertraline has no affinity for muscarinic (cholinergic), serotonergic, dopaminergic, adrenergic, histaminergic, GABA or benzodiazepine receptors.
Sertralin nima afinitete za muskarinske (holinergične), serotoninergične, dopaminergične, adrenergične, histaminergične, GABA ali benzodiazepinske receptorje.
The following adverse reactions were reported from controlled trials (n=281 patients treated with sertraline):
V nadzorovanih preskušanjih (n = 281 bolnikov, zdravljenih s sertralinom) so bili opisani naslednji neželeni učinki):
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.
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.
Physicians must monitor paediatric patients on long term treatment for abnormalities in these body systems.
Pediatrične bolnike, ki so na dolgotrajnem zdravljenju, morajo zdravniki nadzorovati glede nepravilnosti v organskih sistemih.
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.
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).
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.
Sertralin spada v skupino zdravil, imenovanih selektivni zaviralci ponovnega privzema serotonina (SSRI); ta zdravila se uporabljajo za zdravljenje depresije in/ali anksioznosti.
Zoloft capsules should be taken with food.
Kapsule Zoloft jemljite s hrano.
Therefore the CHMP considers that insufficient evidence was provided to support the duration of treatment in OCD.
CHMP zato meni, da predloženi dokazi ne zadostujejo, da bi podprli trajanje zdravljenja pri OKM.
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.”
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.“
Sertraline
sertralin
Sertraline did not produce either the stimulation and anxiety associated with d-amphetamine or the sedation and psychomotor impairment associated with alprazolam.
Sertralin ni povzročil niti stimulacije in anksioznosti, ki spremljata D-amfetamin, niti sedacije in psihomotoričnega zavrtja, ki spremljata alprazolam.
Major Depressive Disorder
Hude depresivne motnje
After marketing sertraline, the following side effects have been reported:
Po prihodu sertralina na tržišče so bili opisani naslednji neželeni učinki:
The dose should be taken immediately after dilution.
Odmerek morate vzeti takoj po razredčenju.
Furthermore, if any of the symptoms listed above appear or worsen when a patient under 18 is taking Zoloft, you should inform your doctor.
Če se pojavi ali poslabša katerikoli od zgoraj navedenih simptomov pri bolnikih, ki so mlajši od 18 let in jemljejo zdravilo Zoloft, morate obvestiti svojega zdravnika.
Severe adverse reactions have been reported in patients who have recently been discontinued from an MAOI and started on sertraline, or have recently had sertraline therapy discontinued prior to initiation of an MAOI.
Opisani so bili hudi neželeni učinki pri bolnikih, ki so pred kratkim nehali dobivati zaviralec MAO in so začeli zdravljenje s sertralinom, ali so pred kratkim nehali dobivati sertralin in jim je bil uveden zaviralec MAO.
In addition, a trend toward greater improvement in the sertraline group than the placebo group was also observed on the CGI Severity scale (p=0.089).
Poleg tega so v skupini s sertralinom v primerjavi s skupino s placebom opazili tudi trend k večjemu izboljšanju na lestvici CGI-S (CGI Severity; p = 0,089).
While the mechanism of this interaction is unknown, due to the narrow therapeutic index of pimozide, concomitant administration of sertraline and pimozide is contraindicated (see section 4.3).
Mehanizem tega medsebojnega delovanja ni znan, a zaradi ozkega terapevtskega indeksa pimozida je sočasna uporaba sertralina in pimozida kontraindicirana (glejte poglavje 4.3).
For CY-BOCs the mean baseline and change from baseline scores for the placebo group was 22.25 ± 6.15 and -3.4 ± 0.82, respectively, while for the sertraline group, the mean baseline and change from baseline scores were 23.36 ± 4.56 and -6.8 ± 0.87, respectively.
V skupini s placebom je bil izhodiščni seštevek CY-BOC 22,25 ± 6,15 in sprememba od izhodišča -3,4 ± 0,82, v skupini s sertralinom pa je bil izhodiščni seštevek CY-BOC 23,36 ± 4,56 in sprememba od izhodišča -6,8 ± 0,87.
[See Annex I - To be completed nationally] Sertraline
[Glejte dodatek I - izpolni država posebej] sertralin
OCD and Panic disorders are illnesses linked to anxiety with symptoms like being constantly troubled by persistent ideas (obsessions) that make you carry out repetitive rituals (compulsions).
Obsesivno kompulzivna motnja (OKM) in panična motnja sta bolezni, ki sta povezani s tesnobnostjo, s simptomi kot so trdovratne misli in prepričanja (obsesije), ki vas silijo v ponavljajoče se rituale (kompulzije).
Two previous additional open label extension studies (that were not submitted within the context of this dossier) showed serious AEs, some of which were possibly related to study drug, including severe aggressive reactions, nervousness and paranoid reactions, two severe grand mal seizures,
Dve prejšnji, dodatni neslepi razširjeni študiji, (ki nista bili predloženi v okviru te dokumentacije), sta izkazali resne neželene učinke, pri čemer so bili nekateri verjetno povezani s proučevanim zdravilom in so vključevali hude agresivne reakcije, živčnost in paranoidne reakcije, dva težka generalizirana epileptična napada ter poslabšanje samomorilnega in nasilnega razmišljanja.
Clinical pharmacology studies have shown that sertraline has no effect on psychomotor performance.
Klinične farmakološke študije so pokazale, da sertralin ne vpliva na psihomotorično zmogljivost.
Panic disorder, with or without agoraphobia.
Panične motnje z agorafobijo ali brez nje.
Sertraline concentrate for oral solution must be diluted before use (see section 6.6).
Koncentrat za peroralno raztopino sertralina je treba pred uporabo razredčiti (glejte poglavje 6.6).
Moreover, with respect to safety, no data was submitted on endocrine parameters, effects on cognition and other maturation parameters.
Nadalje niso bili glede varnosti predloženi nobeni podatki o učinkih na endokrine dejavnike, učinkih na kognitivno dojemanje ter na druge dejavnike razvoja.
• If you experience agitation, confusion, diarrhoea, high temperature and blood pressure, excessive sweating and rapid heartbeat.
• Če se vam pojavijo vznemirjenost, zmedenost, driska, visoka telesna temperatura in visok krvni tlak, čezmerno potenje in hitro bitje srca.
• Medicines called monoamine oxidase inhibitors (MAOIs), like moclobemid (to treat depression) and selegiline (to treat Parkinson's disease) and the antibiotic linezolid.
• Skupina zdravil, imenovanih zaviralci monoaminooksidaze (MAOI), kot moklobemid (za zdravljenje depresije), selegilin (za zdravljenje Parkinsonove bolezni) in antibiotik linezolid.
In studies of patients with mild to moderate renal impairment (creatinine clearance 30-60 ml/min) or moderate to severe renal impairment (creatinine clearance 10-29 ml/min), multiple-dose pharmacokinetic parameters (AUC0-24 or Cmax) were not significantly different compared with controls.
V študijah bolnikov z blago do zmerno okvaro ledvic (očistek kreatinina 30-60 ml/min [0,5-1 ml/sek]) ali zmerno do hudo okvaro ledvic (očistek kreatinina 10-29 ml/min [0,167-0,483 ml/sek]) se farmakokinetični parametri (AUC0-24 oz. Cmax) pri uporabi več odmerkov niso pomembno razlikovali od tistih pri kontrolnih osebah.
Generally neglible to undetectable levels were found in infant serum, with one exception of an infant with serum levels about 50% of the maternal level (but without a noticeable health effect in this infant).
Koncentracija v dojenčkovem serumu je bila na splošno zanemarljiva do nezaznavna; izjema je bil dojenček, ki je imel koncentracijo v serumu okrog 50 % materine koncentracije, vendar pri tem dojenčku ni bilo opaznih učinkov na njegovo zdravstveno stanje.
Children and adolescents with obsessive compulsive disorder Age 13-17 years: Initially 50 mg once daily.
Otroci in mladostniki z obsesivno-kompulzivno motnjo Starost 13 - 17 let: začetni odmerek - 50 mg enkrat na dan.
Clinical relevant interactions may occur with other CYP 2D6 substrates with a narrow therapeutic index like class 1C antiarrhythmics such as propafenone and flecainide, TCAs and typical antipsychotics, especially at higher sertraline dose levels.
Klinično pomembna medsebojna delovanja se lahko pojavijo z drugimi substrati CYP 2D6 z ozkim terapevtskim indeksom, npr. antiaritmiki iz skupine 1C, kakršna sta propafenon in flekainid, tricikličnimi antidepresivi in tipičnimi antipsihotiki, zlasti med uporabo večjih odmerkov sertralina.
The results of the short-term studies show that 3 of the 5 placebo controlled studies demonstrated statistically significant results and that these results are supported by responders analysis that indicate a higher proportion of responders in the active arms compared to placebo.
Rezultati kratkoročnih študij kažejo, da tri od petih s placebom kontroliranih študij dokazujejo statistično pomembne rezultate ter da te rezultate podpira analiza bolnikov, ki so se odzvali na zdravljenje, kar nakazuje višji delež odzivnih bolnikov med tistimi, ki so prejemali učinkovino, kot pri tistih, ki so dobivali placebo.
The CHMP implemented the following text in section 4.2 of the SPC, to indicate that the need for continued treatment should be regularly evaluated:
CHMP je v poglavje 4.2 povzetka glavnih značilnosti zdravila vključil naslednje besedilo, ki nakazuje, da je treba potrebo po nadaljevanju zdravljenja redno ocenjevati.
Accordingly, prothrombin time should be carefully monitored when sertraline therapy is initiated or stopped.
Glede na to je treba protrombinski čas po začetku ali koncu zdravljenja s sertralinom skrbno nadzorovati.
When stopping treatment with sertraline the dose should be gradually reduced over a period of at least one to two weeks in order to reduce the risk of withdrawal reactions (see sections 4.4 and 4.8).
Pri ukinitvi zdravljenja s sertralinom je potrebno postopno zmanjševati odmerek najmanj v obdobju enega do dveh tednov, da tako zmanjšamo tveganje za pojav odtegnitvenih reakcij (glejte poglavji 4.4 in 4.8).
• Products containing the amino acid tryptophan.
• Izdelke, ki vsebujejo aminokislino triptofan.