natgillin/translations-raw huggingface dataset:
There are no well controlled studies in pregnant women.
Pri nosečnicah ni ustreznih in dobro nadzorovanih študij.
If you are being treated for this disorder, your doctor will want to monitor you closely (see Use in children and adolescents below).
Če se zdravite za to boleznijo, vas bo vaš zdravnik hotel pozorno spremljati (glejte Uporaba pri otrocih in mladostnikih spodaj).
The mixture may be a little cloudy, but this is normal.
Mešanica je lahko rahlo motna, toda to je normalno.
Distribution Approximately 98% of the circulating drug is bound to plasma proteins.
Porazdelitev Približno 98 % zdravila v obtoku je vezanega na plazemske beljakovine.
(For symptoms, see section 4.
(Za simptome glejte poglavje 4.
In a majority of instances the complications begin immediately or soon (<24 hours) after delivery.
Večinoma se zapleti pojavijo takoj ali kmalu (< 24 ur) po porodu.
The National Competent Authorities, coordinated by the Reference Member State, shall ensure that the following conditions are fulfilled by the Marketing Authorisation Holders:
Pristojni nacionalni organi, ki jih usklajuje referenčna država članica, morajo zagotoviti, da imetniki dovoljenja za promet z zdravilom izpolnijo naslednje pogoje:
This medicinal product contains 12 % ethanol (alcohol) and must be diluted before use.
Zdravilo vsebuje 12 % etanola (alkohola) in ga je treba pred uporabo razredčiti.
The primary efficacy variable was defined based on the average number of panic attacks during the last two weeks of treatment.
Glavni pokazatelj učinkovitosti je bil opredeljen na podlagi povprečnega števila paničnih napadov v zadnjih dveh tednih zdravljenja.
Medicines should not be disposed of via wastewater or household waste.
Zdravila ne smete vreči v odpadne vode ali gospodinjske odpadke.
However, the CHMP considered that the two positive studies allow to conclude on efficacy and adopted the following indication:
Vendar pa je CHMP ocenil, da dve pozitivni študiji dopuščata sklep o učinkovitosti, in sprejel naslednjo indikacijo:
• If you are a young adult.
- Če ste mlajša odrasla oseba.
Patients with depression should be treated for a sufficient period of time of at least 6 months to ensure they are free from symptoms.
Bolnike z depresijo je treba zdraviti dovolj dolgo, vsaj 6 mesecev, da so zanesljivo brez simptomov.
The results show that only two of the four studies demonstrated efficacy while the remaining two studies were negative.
Rezultati so pokazali, da le dve od štirih študij izkazujeta učinkovitost zdravila, medtem ko sta preostali dve študiji negativni.
In the other three short term studies, most patients were females with PTSD due to domestic abuse or sexual/physical trauma.
V preostalih treh kratkoročnih študijah je bila večina bolnikov ženskega spola s PTSM zaradi zlorabe v domačem okolju ali spolne/fizične travme.
Injury and poisoning
Poškodbe in zastrupitve poškodba
This may be water, ginger ale, lemon/lime soda, lemonade or orange juice.
To je lahko voda, ingverjevo pivo, limonina/limetina soda, limonada ali pomarančni sok.
Increasing the dose may be harmful to patients who develop such symptoms.
Povečanje odmerka je lahko škodljivo za bolnike, ki razvijejo take simptome.
Therefore the CHMP considered that long-term efficacy (maintenance of effect) has not been demonstrated.
CHMP je zato menil, da dolgoročna učinkovitost (vzdrževanje učinka) ni bila dokazana.
In addition, the MAH proposed harmonised wordings for sections 4.4, 4.5, 4.6, 4.7, 4.8 and 4.9 as well as for sections 5.1, 5.2 and 5.3.
Poleg tega je imetnik dovoljenja za promet z zdravilom predlagal usklajena besedila za poglavja 4.4, 4.5, 4.6, 4.7, 4.8 in 4.9 ter poglavja 5.1, 5.2 in 5.3.
Vetenskapsvägen 10 191 90 Sollentuna Sweden
Vetenskapsvägen 10 191 90 Sollentuna Švedska
Pooled analysis and postmarketing experience (frequency not known).
Kumulativna analiza in izkušnje iz obdobja trženja (pogostnost ni znana).
Only a small amount (<0.2%) of unchanged sertraline is excreted in the urine.
Le malo (< 0,2 %) nespremenjenega sertralina se izloči v urinu.
Zoloft was included in the list of products for Summary of Products Characteristics (SPC) harmonisation, drawn up by the CMD(h), in accordance with Article 30(2) of Directive 2001/83/EC, as amended.
Zdravilo Zoloft je bilo vključeno na seznam zdravil za uskladitev povzetka glavnih značilnosti zdravila (SPC), ki ga je pripravila skupina CMD(h), v skladu s členom 30(2) Direktive 2001/83/ES, kakor je bila spremenjena.
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF ZOLOFT AND ASSOCIATED NAMES (SEE ANNEX I)
SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVILA ZOLOFT IN Z NJIM POVEZANIH IMEN (GLEJTE DODATEK I)
Establish and maintain an airway and ensure adequate oxygenation and ventilation, if necessary.
Zagotoviti in vzdrževati je treba prehodne dihalne poti ter poskrbeti za oksigenacijo in ventilacijo, če je potrebno.
de Europa, 20 B Parque Empresarial La Moraleja 28108 Alcobendas (Madrid) SPAIN
de Europa, 20 B Parque Empresarial La Moraleja 28108 Alcobendas (Madrid) Španija
In summary, the CHMP adopted the following harmonised wording:
Tako je CHMP sprejel naslednje usklajeno besedilo:
Furthermore, the CHMP was of the opinion that the effect of sertraline on PTSD is at least partly due to its effect on depression (HAMD).
CHMP je nadalje menil, da je učinek sertralina na PTSM vsaj deloma posledica njegovega učinka na depresijo (HAMD).
Subsequently, the physician may continue decreasing the dose, but at a more gradual rate.
Zdravnik lahko kasneje nadaljuje z zmanjševanjem odmerka, vendar bolj postopoma.
Sertraline should be administered once daily, either in the morning or evening.
Sertralin je treba uporabljati enkrat na dan, zjutraj ali zvečer.
The CHMP concluded that the safety in children and adolescents has not sufficiently been established and that a commitment to further investigate safety in paediatric patients is required.
CHMP je zaključil, da varnost pri otrocih in mladostnikih ni bila zadostno dokazana ter da je potrebna zaveza k nadaljnjemu proučevanju varnosti pri pediatričnih bolnikih.
Tell your doctor immediately: If you experience any of the following symptoms after taking this medicine, these symptoms can be serious.
Takoj povejte zdravniku: Če se vam po zaužitju tega zdravila pojavi kateri od naslednjih simptomov, kajti ti simptomi so lahko resni.
• If you are taking or have taken disulfiram with the last 2 weeks.
• Če jemljete ali ste v zadnjih dveh tednih jemali disulfiram.
- the Summaries of Products Characteristic, labelling and package leaflet proposed by the Marketing Authorisation Holders have been assessed based on the documentation submitted and the scientific discussion within the Committee,
- povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo, ki so jih predlagali imetniki dovoljenja za promet, so bili ocenjeni na podlagi predložene dokumentacije in znanstvene razprave znotraj Odbora,
Long term safety and efficacy data are lacking for this paediatric population.
Dolgoročni podatki o varnosti in učinkovitosti za to pediatrično populacijo niso na voljo.
Taking other medicines:
Jemanje drugih zdravil
Zoloft can be used to treat:
Zoloft se lahko uporablja za zdravljenje:
Some medicines can affect the way Zoloft works, or Zoloft itself can reduce the effectiveness of other medicines taken at the same time.
Nekatera zdravila lahko vplivajo na delovanje zdravila Zoloft ali pa lahko zdravilo Zoloft zmanjša učinkovitost drugih zdravil, ki jih jemljemo sočasno.
The dropper is found in the carton.
Kapalko najdete v škatli.
Special Precautions
Posebna previdnost
Talk to your doctor if you are taking the following medicine:
Posvetujte se s svojim zdravnikom, če jemljete katero od naslednjih zdravil:
Therefore, any overdosage should be medically treated aggressively.
Zato je vsako preveliko odmerjanje treba odločno zdraviti.
For the randomised withdrawal study, patients were recruited from the short-term studies described above and from another 10 week study.
Za randomizirano ukinitveno študijo so bili bolniki izbrani iz zgoraj opisanih kratkoročnih študij in iz nadaljnje 10-tedenske študije.
The presented double-blind 12 week study in 187 children (6-17 years) supports the efficacy of sertraline but there was no justification for the dose in children and the clinical relevance of the results has not been established.
Predstavljena dvojno slepa 12-tedenska študija pri 187 otrocih (starih od 6 do 17 let) podpira učinkovitost sertralina, vendar pa ni nobene utemeljitve odmerka pri otrocih, prav tako tudi ni bila določena klinična pomembnost rezultatov.
As improvement may not occur during the first few weeks or more of treatment, patients should be closely monitored until such improvement occurs.
Ker se prvih nekaj tednov zdravljenja ali dlje zdravstveno stanje morda še ne bo izboljšalo, je treba bolnike skrbno nadzirati, vse dokler ne pride do izboljšanja.
Taking Zoloft together with the following medicines may cause serious side effects:
Jemanje zdravila Zoloft skupaj z naslednjimi zdravili lahko povzroči resne neželene učinke:
Always take the labelled medicine package with you, whether there is any medication left or not.
S seboj vedno vzemite ovojnino zdravila, ne glede na to, ali je v njej ostalo še kaj zdravila ali ne.
Your doctor may wish to stop your treatment.
Zdravnik utegne vaše zdravljenje prekiniti.
• Serotonin Syndrome.
• Serotoninski sindrom.
The MAH submitted data from a number of studies to support the proposed harmonised text for this section.
Imetnik dovoljenja za promet je predložil podatke iz številnih študij, ki podpirajo predlagano usklajeno besedilo tega poglavja.
All studies included patients with Obsessive Compulsive Disorder (OCD) according to DSM-III or III-R.
Pri vseh študijah so bili vključeni bolniki z obsesivno kompulzivno motnjo (OKM) glede na DSM-III ali III-R.
“Long-term efficacy data are lacking for this paediatric population, however, clinical trials for up to 64 weeks have been conducted and the safety profile is consistent with that of adults.
„Podatki o dolgoročni učinkovitosti so pri pediatrični populaciji pomanjkljivi, vendar so bila izvedena klinična preskušanja v trajanju do 64 tednov, varnostni profil pa je skladen z varnostjo pri odraslih.
They usually occur within the first few days of discontinuing treatment, but there have been very rare reports of such symptoms in patients who have inadvertently missed a dose.
Ponavadi se pojavijo prve dni po prenehanju zdravljenja, v zelo redkih primerih pa so o takšnih simptomih poročali pri bolnikih, ki so pomotoma izpustili odmerek.
Less frequently reported was coma.
Redkeje je bila opisana koma.
Put the dropper on the bottle and tighten well.
Namestite kapalko na stekleničko in jo dobro privijte.
Neonates should be observed if maternal use of sertraline continues into the later stages of pregnancy, particularly the third trimester.
Novorojenčke je treba opazovati, če se uporaba sertralina pri materi nadaljuje v poznejše obdobje nosečnosti, zlasti v tretje trimesečje.
In over 600 paediatric patients treated with sertraline, the overall profile of adverse reactions was generally similar to that seen in adult studies.
Pri več kot 600 pediatričnih bolnikih, zdravljenih s sertralinom, je bil celotni profil neželenih reakcij na splošno podoben kot v študijah pri odraslih.
Observed foetotoxicity was probably related to maternal toxicity.
Opažena fetotoksičnost je bila verjetno povezana s toksičnostjo za samice-matere.
There was one suicide attempt and one reported case of sertraline overdose, but no death occurred in the studies.
Opisana sta bila en poskus samomora in en primer prekomernega odmerjanja sertralina, vendar v študijah ni prišlo do smrti.
There are no specific antidotes to sertraline.
Za sertralin ni specifičnih antidotov.
Regarding the dosing of paediatric patients with OCD, the CHMP requested the insertion of a warning in section 4.4 and adopted the following wording:
V zvezi z odmerjanjem pri pediatričnih bolnikih z OKM je CHMP zahteval vključitev opozorila v poglavje 4.4 in sprejel naslednje besedilo:
The safety of sertraline has not fully been established in pregnant women.
Varnost sertralina pri nosečnicah še ni popolnoma dokazana.
Obsessive Compulsive Disorder:
Obsesivno kompulzivna motnja:
Over 700 elderly patients (>65 years) have participated in clinical studies.
V kliničnih študijah pri tej populaciji bolnikov je sodelovalo prek 700 starejših bolnikov (> 65 let).
• Take special care if you are elderly as you may be more at risk of having low sodium level in your blood (see above).
• Posebno pozorni bodite, če ste starejši; ker je tveganje za nizek nivo natrija v krvi povečano (glejte zgoraj).
Pharmacokinetics in specific patient groups
Farmakokinetika pri posebnih skupinah bolnikov
Dosage during long-term therapy should be kept at the lowest effective level, with subsequent adjustment depending on therapeutic response.
Med dolgotrajnim vzdrževalnim zdravljenjem je treba odmerek ohranjati na najnižji učinkoviti ravni in ga pozneje prilagajati glede na terapevtski odziv.
Therefore it is considered that insufficient evidence was provided to support the duration of treatment in panic disorders.
Zato je bilo ocenjeno, da je bilo predloženih premalo dokazov, ki bi podpirali trajanje zdravljenja pri paničnih motnjah.
Your doctor will want to gradually reduce your dose of Zoloft over several weeks, before you finally stop taking this medicine.
Zdravnik vam bo odmerek zdravila Zoloft zmanjševal postopoma nekaj tednov, preden ga boste dokončno nehali jemati.
Symptoms of serotonergic syndrome may also occur with other products of the same class (triptans).
Simptomi serotoninergičnega sindroma se lahko pojavijo tudi z drugimi zdravili iz iste skupine (triptani).
In addition, the relapse prevention study did not provide evidence with respect to the necessity to continue treatment after an acute treatment phase (of about 10-12 weeks).
Poleg tega študija o preprečevanju bolezni ni dala dokazov o nujnosti nadaljevanja zdravljenja po akutni fazi (po približno 10- do 12-tedenskem zdravljenju).
In conclusion, the lack of consistent efficacy and the unknown origin of the low response in the negative study are of concern.
Ne nazadnje predstavljata zadržek odsotnost konsistentne učinkovitosti in neznani izvor nizkega odziva v negativni študiji.
One study recruited male military veterans, in which the primarily cause of PTSD was largely combat related and exhibiting longstanding PTSD.
V eni študiji so bili zajeti moški vojaški veterani, pri katerih je bil osnovni vzrok bolezni pretežno povezan z vojno in ki so kazali dolgotrajno PTSM.
The oral concentrate formulation contains a small amount of alcohol.
Koncentrat za peroralno raztopino vsebuje majhno količino alkohola.
The first time you open the bottle of oral concentrate, you should put the pipette on the bottle as follows:
Ko prvič odprete stekleničko s koncentratom za peroralno raztopino, morate na stekleničko namestiti kapalko po spodnjem navodilu:
The effect on anxiety is considered to be part of the antidepressant effect, and the indication can therefore not be granted.
Ocenjeno je bilo, da so učinki na anksioznost del antidepresivnega učinka, zato indikacije ni mogoče odobriti.
Do not stop taking Zoloft unless your doctor tells you to.
Ne nehajte jemati zdravila Zoloft, razen če vam to naroči zdravnik.
• Depression and prevention of recurrence of depression (in adults).
• Depresije in preprečevanje ponovnega pojava depresije (pri odraslih).
In conclusion, the CHMP was of the opinion that sertraline demonstrates a modest short-term effect and that the safety seems acceptable.
CHMP je na koncu menil, da sertralin izkazuje zmerno kratkoročno učinkovitost in da je varnost sprejemljiva.
In conclusion, the recurrence study is the first recurrence-prevention study in a trial with depressive patients who had experienced at least three documented episodes of major depressive disorder within the last 4 years.
Ne nazadnje je študija ponovitev prva študija o preprečevanju ponovitve bolezni v preskušanju z depresivnimi bolniki, ki so imeli v zadnjih štirih letih vsaj tri dokumentirane epizode hude depresivne motnje.
The mean half-life of sertraline is approximately 26 hours (range 22-36 hours).
Povprečni razpolovni čas sertralina je približno 26 ur (oz. v območju od 22-36 ur).
Preclinical data does not indicate any special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and carcinogenesis.
Predklinični podatki ne kažejo nobene posebne nevarnosti za človeka, kar temelji na običajnih študijah o farmakološki varnosti, ponovljivi toksičnosti odmerka, genotoksičnosti in karcinogenezi.
Postnatal pup survival and body weight were decreased only during the first days after birth.
Postnatalno preživetje mladičev in njihova telesna masa sta bila manjša le prve dni po skotitvi.
Your doctor will stop your treatment in these cases.
Zdravnik bo v takšnem primeru prekinil vaše zdravljenje.
Very common (≥1/10): Headache (22%), insomnia (21%), diarrhoea (11%) and nausea (15%).
Zelo pogosti (≥ 1/10): glavobol (22 %), nespečnost (21 %), driska (11 %) in navzea (15 %).
Therefore, is it still not clear if the efficacy results can be extrapolated to patients with a more recent onset, with acute PTSD (< 3months) and on patients with chronic PTSD (> 3months).
Zato še vedno ni jasno, ali lahko rezultate o učinkovitosti ekstrapoliramo na bolnike z nedavnim pojavom bolezni, z akutno PTSM (ki traja manj kot 3 mesece) in na bolnike s kronično PTSM (ki traja več kot 3 mesece).
If, based on clinical need, a decision to treat is nevertheless taken; the patient should be carefully monitored for appearance of suicidal symptoms.
Če se na podlagi klinične potrebe vseeno odločimo za zdravljenje, je treba bolnika natančno spremljati za pojav simptomov samomorilnosti.
Gynaecomastia, Menstrual Irregularities
ginekomastija, nepravilnosti menstruacije
Cardiac and other vital sign monitoring is recommended, along with general symptomatic and supportive measures.
Priporočljivo je nadziranje kardialnega stanja in vitalnih znakov ter splošni simptomatski in podporni ukrepi.
• If you have low sodium level in your blood, since this can occur as a result of treatment with Zoloft.
• Če imate nizek nivo natrija v krvi, ker se to lahko pojavi kot rezultat zdravljenja z Zoloftom.
To date, no adverse effects on the health of infants nursed by mothers using sertraline have been reported, but a risk cannot be excluded.
Doslej ni opisanih neželenih učinkov na zdravje dojenčkov, ki so jih matere dojile med uporabo sertralina, vendar tveganja ni mogoče izključiti.
The CHMP considered that the lack of any evidence suggesting a difference between children and adults is not equivalent to establishing that the disorder is identical in the 2 groups.
CHMP je menil, da pomanjkanje dokazov, ki bi nakazovali razliko med otroci in odraslimi, ni enakovredna dokazu, da je motnja pri teh dveh skupinah enaka.
At times, a slight haze may appear in the solution after mixing; this is normal.
Včasih se po mešanju pojavi rahla motnost; to je normalno.
No data is available for children under 6 years of age (see also section 4.4)
Za otroke do 6. leta starosti ni podatkov (glejte tudi poglavje 4.4).
You should also tell your doctor if you are taking certain medicines for hypertension, since these medicines may also alter the sodium level in your blood.
Zdravniku morate povedati tudi če jemljete zdravila za zdravljenje visokega krvnega tlaka (hipertenzije), ker ta zdravila prav tako spreminjajo nivo natrija v krvi.
Changes in dose should not be made more frequently than once per week given the 24-hour elimination half life of sertraline.
Odmerka se ne sme spreminjati pogosteje kot enkrat na teden, ker je razpolovni čas izločanja sertralina 24 ur.
• If you experience depressive symptoms with suicidal ideas.
• Če se vam pojavijo simptomi depresije z mislimi na samomor
The positive results that were obtained in two studies with respect to mean improvements on social anxiety scales and with respect to responders appear sufficiently robust to support short-term efficacy.
Pozitivni rezultati, pridobljeni v dveh študijah, ki se nanašajo na povprečna izboljšanja na lestvici socialne anksioznosti in na odzivne bolnike, so se zdeli dovolj zanesljivi, da podpirajo kratkoročno učinkovitost.
• If you are allergic (hypersensitive) to sertraline or any of the other ingredients of Zoloft.
• Če ste alergični na (preobčutljivi za) sertralin ali katerokoli sestavino zdravila Zoloft
These may be signs of a condition known as Stevens Johnson Syndrome, or Toxic Epidermal Necrolysis (TEN).
To so lahko znaki bolezni, imenovane Stevens-Johnsonov sindrom ali toksična epidermalna nekroliza (TEN).
Mix the measured dose with 120 ml (one glass) of liquid.
Zmešajte odmerjeni odmerek s 120 ml (enim kozarcem) tekočine.
The primary efficacy variables in the different studies were the Liebowitz Social anxiety Symptom Scale (LSAS) and the Duke Brief Social Anxiety disorder Scale (BSPS).
Glavna pokazatelja učinkovitosti v različnih študijah sta bili lestvici Liebowitz Social anxiety Symptom Scale (LSAS) in Duke Brief Social Anxiety disorder Scale (BSPS).
“The Marketing Authorisation Holder has committed:
„Imetnik dovoljenja za promet z zdravilom se je zavezal:
The CHMP considered that because anxiety is an inherent part of the depression disorder, a decrease in Hamilton anxiety can not be seen as separate due to possible interactions with improvement of depression.
CHMP je menil, da glede na to, da je anksioznost neločljivo povezana z depresivnimi motnjami, zmanjšanja anksioznosti po Hamiltonu ni mogoče obravnavati ločeno zaradi možnih interakcij z izboljšanjem depresije.
Sertraline has not demonstrated potential for abuse.
Uporaba sertralina ni pokazala potenciala za zlorabo.
Sertraline is extensively metabolised, and excretion of unchanged drug in urine is a minor route of elimination.
Sertralin se izdatno presnovi in izločanje nespremenjenega zdravila v urinu je manj pomembna pot odstranjevanja.
The pharmacokinetic profile in adolescents or elderly is not significantly different from that in adults between 18 and 65 years.
Farmakokinetični profil se pri mladostnikih oz. starejših ljudeh ne razlikuje pomembno od tistega pri odraslih med 18. in 65. letom starosti.
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,
da bo zagotovil ustrezne neklinične javno dostopne podatke o toksičnosti pri nedoraslih živalih, da bi tako utemeljil, zakaj dodatni podatki na tem področju niso potrebni,
The safety profile of sertraline is acceptable and the CHMP concluded that the overall recommendation is to grant an indication for the treatment of panic disorder with the following wording:
Varnostni profil sertralina je sprejemljiv, CHMP pa je zaključil, da je splošno priporočilo odobritev indikacije za zdravljenje paničnih motenj z naslednjim besedilom:
Generally, such symptoms are mild to moderate.
Običajno so ti simptomi blagi do zmerni.
Postnatal developmental delays found in pups from treated dams were probably due to effects on the dams and therefore not relevant for human risk.
Postnatalni razvojni zaostanki pri mladičih samic, ki so dobivale učinkovino, so verjetno posledica učinkov na samice in torej niso pomembni za tveganje pri človeku.
No data is available for children under 6 years of age”.
Na voljo ni nobenih podatkov o zdravljenju otrok, mlajših od 6 let“.
Regarding the demonstration of the efficacy of sertraline, the CHMP considered the results of the study in war veterans (known to be a treatment resistant population) to be explained, but the reason for the negative effect in the second study unexplained, although likely to be linked to the unexpectedly high performance of the placebo group.
V zvezi z dokazovanjem učinkovitosti sertralina je CHMP menil, da so rezultati študije z vojnimi veterani (za katere je znano, da so na zdravljenje odporna populacija) razložljivi, vendar pa so razlogi za negativni rezultat v drugi študiji nepojasnjeni, čeprav so verjetno povezani z nepričakovano visokim odzivom skupine s placebom.