FrancophonIA/ELRC3.0 huggingface dataset:
English: In controlled studies in normal volunteers, sertraline did not cause sedation and did not interfere with psychomotor performance.
Slovenian: V kontroliranih študijah pri zdravih prostovoljcih sertralin ni povzročil sedacije in ni vplival na psihomotorično zmogljivost.
English: “Combined data from the 3 studies of PTSD in the general population found a lower response rate in males compared to females.
Slovenian: „Združeni podatki iz treh študij o PTSM pri splošni populacij kažejo na nižji delež odziva pri moških v primerjavi z ženskami.
English: Use in children and adolescents under 18 years of age Sertraline should not be used in the treatment of children and adolescents under the age of 18 years, except for patients with obsessive compulsive disorder aged 6-17 years old.
Slovenian: Uporaba pri otrocih in mladostnikih, mlajših od 18 let Sertralina ne smete uporabljati za zdravljenje otrok in mladostnikov, mlajših od 18 let, razen za zdravljenje bolnikov z obsesivno-kompulzivno motnjo, starih od 6 do 17 let.
English: The data submitted to support the additional indication anxiety treatment indication proposed by the MAH consisted of various studies showing that the sertraline groups consistently had a greater reduction in the Ham-D Factor for anxiety and somatisation than the placebo group.
Slovenian: Podatke, predložene v podporo dodatni indikaciji zdravljenja anksioznosti, ki jo je predlagal imetnik dovoljenja za promet z zdravilom, so sestavljale različne študije, ki kažejo, da je imela skupina, zdravljena s sertralinom, v primerjavi s tisto, ki je prejemala placebo, dosledno večje zmanjšanje faktorja Ham-D za anksioznost in somatizacijo.
English: The most common side effects in children and adolescents were headache, insomnia, diarrhoea and feeling sick.
Slovenian: Najpogostejši neželeni učinki pri otrocih in mladostnikih so bili glavobol, nespečnost, driska in slabost v želodcu.
English: Concomitant intake of pimozide is contraindicated (see section 4.5).
Slovenian: Kontraindicirana je tudi sočasna uporaba s pimozidom (glejte poglavje 4.5).
English: Signs and symptoms of hyponatraemia include headache, difficulty concentrating, memory impairment, confusion, weakness and unsteadiness which may lead to falls.
Slovenian: Med znaki in simptomi hiponatriemije so glavobol, težave s koncentracijo, poslabšanje spomina, zmedenost, šibkost in negotovost pri gibanju, ki lahko povzroči padce.
English: Do not mix sertraline oral concentrate with anything other than the liquids listed.
Slovenian: Koncentrata za peroralno raztopino sertralina ne mešajte z ničimer drugim kot z naštetimi tekočinami.
English: In total, 13 short term RCTs were carried out in support of the MDD indication, in addition to one randomised withdrawal study and several other long-term studies.
Slovenian: V podporo indikaciji HDM je bilo izvedenih skupno 13 kratkoročnih, randomiziranih kliničnih preskušanj, poleg ene randomizirane ukinitvene ter več drugih dolgoročnih študij.
English: Section 4.1 - Indications: Obsessive Compulsive Disorder (In paediatric patients)
Slovenian: Poglavje 4.1 - Indikacije: Obsesivno kompulzivna motnja (pri pediatričnih bolnikih)
English: Since the bioavailability of sertraline capsules is increased in the presence of food, it is recommended that sertraline capsules be administered with meals.
Slovenian: Biološka uporabnost sertralina v kapsulah se v prisotnosti hrane zveča, zato je priporočljivo, da bolniki kapsule sertralina vzamejo ob obrokih.
English: In some Member States, OCD is also indicated in children and adolescents (aged 6-17).
Slovenian: V nekaterih državah članicah je indiciran tudi za zdravljenje OKM pri otrocih in mladostnikih (starih od 6 do 17 let).
English: Combined data from the 3 studies of PTSD in the general population found a lower response rate in males compared to females.
Slovenian: Združeni podatki 3 študij PTSD v splošni populaciji so pri moških pokazali manjši delež odziva kot pri ženskah.
English: • Medicines to treat excessive stomach acid and ulcers (cimetidine).
Slovenian: • Zdravila za zdravljenje čezmerne želodčne kisline in razjed (cimetidin)
English: Panic disorder, Social anxiety disorder and Post Traumatic Stress Disorder: For panic disorder, social anxiety disorder and post traumatic stress disorder, treatment should be started at (1.25 ml) 25 mg/day, and increased to (2.5 ml) 50 mg/day after one week.
Slovenian: Panična motnja, socialna anksiozna motnja in posttravmatska stresna motnja (PTSM): Pri panični motnji, posttravmatski stresni motnji ter pri socialni fobiji je začetni odmerek (1,25 ml) 25 mg enkrat na dan, ki ga bo zdravnik po enem tednu povišal na (2,5 ml) 50 mg enkrat na dan.
English: At clinical doses, sertraline blocks the uptake of serotonin into human platelets.
Slovenian: V kliničnih odmerkih sertralin zavre privzem serotonina v človeške trombocite.
English: • Post traumatic stress disorder (PTSD) (in adults).
Slovenian: • Posttravmatske stresne motnje (PTSM) (pri odraslih).
English: • Obsessive compulsive disorder (OCD) (in adults and children and adolescents aged 6-17 years old).
Slovenian: • Obsesivno kompulzivne motnje (OKM) (pri odraslih in mladostnikih starih 6-17 let).
English: Aminotransferarase Increased*, Aspartate Aminotransferase Increased*, Semen Abnormal
Slovenian: zvišanje alaninaminotransferaze*, zvišanje aspartataminotransferaze*.
English: Elderly patients may be at greater risk of developing hyponatraemia with SSRIs and SNRIs.
Slovenian: Starejši bolniki imajo med uporabo SSRI in SNRI morda večje tveganje za pojav hiponatriemije.
English: Section 4.1 - Indications: Social Anxiety Disorder
Slovenian: Poglavje 4.1 - Indikacije: Socialna anksiozna motnja
English: Reproductive System and Breast Disorders** Ejaculation
Slovenian: Motnje reprodukcije in dojk**
English: “Sertraline is indicated for the treatment of obsessive compulsive disorder (OCD) in adults”,
Slovenian: „Sertralin je indiciran za zdravljenje obsesivno kompulzivne motnje (OKM) pri odraslih“,
English: Your doctor will advise you on how long to take this medication for.
Slovenian: Zdravnik vam bo svetoval kako dolgo jemati zdravilo Zoloft.
English: • If you are having electro-convulsive therapy (ECT).
Slovenian: • Ali vas zdravijo z elektrokonvulzivno terapijo (EKT)?
English: Sertraline dosing does not have to be adjusted based on the degree of renal impairment.
Slovenian: Odmerjanja sertralina ni potrebno prilagoditi stopnji ledvične okvare.
English: Vision Abnormal
Slovenian: nenormalen vid
English: Possible Side Effects).
Slovenian: Možni neželeni učinki).
English: Pfizer Hellas A.E., 243 Messoghion Ave., 154 51 Ν. Psychiko, Athens Greece
Slovenian: Pfizer Hellas A.E., 243 Messoghion Ave., 154 51 Ν. Psychiko, Athens Grčija
English: “Continued treatment in panic disorder and OCD should be evaluated regularly, as relapse prevention has not been shown for these disorders”.
Slovenian: „Nadaljevanje zdravljenja pri panični motnji in obsesivno kompulzivni motnji (OKM) je treba redno ocenjevati, saj pri teh motnjah preprečevanje ponovitev (recidivov) bolezni ni bilo dokazano.“
English: In addition, co-administration of phenytoin may cause a reduction of sertraline plasma levels.
Slovenian: Poleg tega lahko sočasno jemanje fenitoina povzroči znižanje plazemske koncentracije sertralina.
English: Signs and symptoms associated with more severe and/or acute cases have included hallucination, syncope, seizure, coma, respiratory arrest, and death.
Slovenian: Med znaki in simptomi, ki so spremljali hujše in/ali akutne primere, so halucinacije, sinkopa, konvulzije, koma, zastoj dihanja in smrt.
English: The antibiotic linezolid is a weak reversible and non-selective MAOI and should not be given to patients treated with sertraline (see section 4.3).
Slovenian: Reverzibilni neselektivni zaviralci MAO (linezolid) Antibiotik linezolid je šibek reverzibilen, neselektiven zaviralec MAO, zato ga ne smejo dobiti bolniki, ki prejemajo sertralin (glejte poglavje 4.3).
English: Generally these symptoms are mild to moderate; however, in some patients they may be severe in intensity.
Slovenian: Na splošno so ti simptomi blagi do zmerni, pri nekaterih bolnikih pa so lahko tudi zelo izraziti.
English: It also contains glycerol which at high doses can cause headache, abdominal pain and diarrhea.
Slovenian: Vsebuje tudi glicerol, ki lahko v velikih odmerkih povzroči glavobol, bolečine v trebuhu in drisko.
English: Cases of serum sodium levels lower than 110 mmol/l have been reported.
Slovenian: Opisani so primeri koncentracije natrija v serumu pod 110 mmol/l.
English: • Panic disorder (in adults).
Slovenian: • Panične motnje (pri odraslih).
English: Other serotonergic drugs e.g. tryptophan, fenfluramine and 5-HT agonists Co-administration of sertraline with other drugs which enhance the effects of serotonergic neurotransmission such as tryptophan or fenfluramine or 5-HT agonists, or the herbal medicine, St John's Wort (hypericum perforatum), should be undertaken with caution and avoided whenever possible due to the potential for a pharmacodynamic interaction.
Slovenian: Druga serotoninergična zdravila kot npr. triptofan, fenfluramin in agonisti 5-HT Pri sočasni uporabi sertralina z drugimi zdravili, ki stopnjujejo učinke serotoninergičnega živčnega prenosa kot je npr. triptofan, fenfluramin, agonisti 5-HT ali zdravil rastlinskega izvora, ki vsebujejo šentjanževko (Hypericum perforatum), je potrebna previdnost; če je le mogoče, se je uporabi zaradi možnih farmakodinamičnih interakcij treba izogniti.
English: After one week, the dose should be increased to 50 mg once daily.
Slovenian: Po enem tednu je treba odmerek zvečati na 50 mg enkrat na dan.
English: Withdrawal reactions when treatment is stopped are common, particularly if the treatment is stopped suddenly (see section 4 Possible side effects).
Slovenian: Odtegnitvena reakcija ob koncu zdravljenja je mogoča, še posebej če je zdravljenje prekinjeno naenkrat (glej točko 4.
English: Comments were also made to the remaining sections of the SPC, and for all sections, the labelling and the package leaflet were revised accordingly.
Slovenian: Prav tako so bile podane pripombe za druga poglavja povzetka glavnih značilnosti zdravila ter ustrezno popravljena tudi vsa poglavja označevanja in navodila za uporabo.
English: A meta-analysis of placebo-controlled clinical trials of antidepressant drugs in adult patients with psychiatric disorders showed an increased risk of suicidal behaviour with antidepressants compared to placebo in patients less than 25 years old.
Slovenian: Metaanaliza s placebom nadzorovanih kliničnih preskušanj antidepresivov pri odraslih bolnikih s psihiatričnimi motnjami je pokazala, da pri bolnikih, mlajših od 25 let, pri uporabi antidepresivov obstaja večje tveganje za pojav samomorilnega vedenja kot pri uporabi placeba.
English: Nevertheless, it is possible that your doctor decides to prescribe Zoloft to a patient under 18 if it is in the patient's interest.
Slovenian: Kljub temu lahko vaš zdravnik, če se odloči, da je to najbolje za bolnika, predpiše zdravilo Zoloft za bolnike, mlajše od 18 let.
English: Nonetheless, as some case reports have emerged of high phenytoin exposure in patients using sertraline, it is recommended that plasma phenytoin concentrations be monitored following initiation of sertraline therapy, with appropriate adjustments to the phenytoin dose.
Slovenian: Zaradi poročil o veliki izpostavljenosti fenitoinu pri bolnikih, ki so dobivali sertralin, pa je po začetku zdravljenja s sertralinom kljub temu priporočljivo nadzirati koncentracijo fenitoina v plazmi in odmerek fenitoina ustrezno prilagoditi.
English: In man, following an oral once-daily dosage of 50 to 200 mg for 14 days, peak plasma concentrations of sertraline occur at 4.5 to 8.4 hours after the daily administration of the drug.
Slovenian: Pri človeku se po peroralnem odmerjanju sertralina od 50 mg do 200 mg enkrat na dan v obdobju 14 dni največja koncentracija (Cmax) sertralina pojavi okrog 4,5 do 8,4 ure po uporabi.
English: A placebo-controlled trial in normal volunteers suggests that chronic administration of sertraline 200 mg/day does not produce clinically important inhibition of phenytoin metabolism.
Slovenian: V preskušanju, nadzorovanem s placebom, pri zdravih prostovoljcih kaže, da kronična uporaba 200 mg sertralina/dan klinično pomembno ne zavre presnove fenitoina.
English: Also patients taking diuretics or who are otherwise volume-depleted may be at greater risk (see Use in elderly).
Slovenian: Prav tako je lahko tveganje večje pri bolnikih, ki jemljejo diuretike ali so hipovolemični iz kakšnega drugega razloga (glejte Uporaba pri starejših).
English: • Blood thinning medicine (warfarin).
Slovenian: • Zdravila za redčenje krvi (varfarin).
English: Do not take Zoloft:
Slovenian: Ne jemljite zdravila Zoloft:
English: The use of sertraline has been associated with the development of akathisia, characterised by a subjectively unpleasant or distressing restlessness and need to move often accompanied by an inability to sit or stand still.
Slovenian: Uporabo sertralina je spremljal pojav akatizije, za katero sta značilna subjektivno neprijeten ali nadležen nemir ter potreba po gibanju, pogosto hkrati z bolnikovo nezmožnostjo, da bi stal ali sedel pri miru.
English: Prevention of relapse and recurrence was not initially requested by the MAH but proposed during the assessment by the CHMP.
Slovenian: Indikacije „preprečevanje ponovitve bolezni“ imetnik dovoljenja za promet z zdravilom ni zahteval, vendar jo je predlagal CHMP med ocenjevanjem.
English: Sertraline Oral Concentrate and disulfiram
Slovenian: Sertralin koncentrat za peroralno raztopino in disulfiram
English: provided the lack of long-term efficacy results is reflected in the SPC section 4.2, indicating the need for regular assessment of treatment continuation with the following wording:
Slovenian: če bo v poglavju 4.2 povzetka glavnih značilnosti zdravila izraženo pomanjkanje rezultatov o dolgoročni učinkovitosti, kar po navajalo na potrebo po rednem ocenjevanju nadaljevanja zdravljenja z naslednjim besedilom:
English: Sertraline concentrate for oral solution should not be used in combination with disulfiram or within 2 weeks of discontinuing treatement with disulfiram.
Slovenian: Sertralin koncentrat za peroralno raztopino se ne sme uporabljati sočasno z disulfiramom oziroma dva tedna po prenehanju zdravljenja z disulfiramom.
English: If adverse experience occurred in depression, OCD, panic disorder, PTSD and social anxiety disorder, body term reclassified by depression studies body term.
Slovenian: Če se je neželeni učinek pojavil pri depresiji, OKM, panični motnji, PTSM in socialni anksiozni motnji, je telesni izraz prerazvrščen po telesnem izrazu v študijah depresije.
English: It is therefore advised that sertraline should be gradually tapered when discontinuing treatment over a period of several weeks or months, according to the patient's needs (see section 4.2).
Slovenian: Zato je priporočljivo, da pri prenehanju zdravljenja odmerek sertralina zmanjšujete postopoma v obdobju nekaj tednov ali mesecev, odvisno od bolnikovih potreb (glejte poglavje 4.2).
English: Section 4.1 - Indications: Post-traumatic Stress Disorder (PTSD)
Slovenian: Poglavje 4.1 - Indikacije: Posttravmatska stresna motnja (PTSM)
English: Pregnancy and breast-feeding: Ask your doctor or pharmacist for advice before taking any medicine.
Slovenian: Nosečnost in dojenje Preden vzamete katerokoli zdravilo, se posvetujte z zdravnikom ali s farmacevtom.
English: Each ml of oral liquid contains 150.7 mg of alcohol.
Slovenian: En mililiter peroralne tekočine vsebuje 150,7 mg alkohola; ta lahko škoduje osebam, ki trpijo zaradi alkoholizma.
English: “Sertraline is indicated for the treatment of obsessive compulsive disorder (OCD) in adults and paediatric patients aged 6-17 years.”
Slovenian: „Sertralin je indiciran za zdravljenje obsesivno kompulzivne motnje (OKM) pri odraslih in pediatričnih bolnikih, starih od 6 do 17 let“.
English: Sertraline concentrate for oral solution is contraindicated with the use of disulfiram due to the alcohol content of the oral concentrate (see sections 4.4 and 4.5).
Slovenian: Koncentrat za peroralno raztopino sertralina je kontraindiciran med uporabo disulfirama, ker raztopina vsebuje alkohol (glejte poglavji 4.4 in 4.5).
English: Withdrawal symptoms seen on discontinuation of sertraline Abrupt discontinuation should be avoided.
Slovenian: Odtegnitveni simptomi, ki se pojavijo po prenehanju zdravljenja s sertralinom Nenadnemu prenehanju zdravljenja s sertralinom se je potrebno izogniti.
English: ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR THE AMENDMENT OF THE SUMMARIES OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET PRESENTED BY THE EMEA
Slovenian: DODATEK II ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA DOPOLNILO POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA, OZNAČEVANJA IN NAVODILA ZA UPORABO, KI JIH JE PREDSTAVILA EVROPSKA AGENCIJA ZA ZDRAVILA
English: When co-administering sertraline with lithium, patients should be appropriately monitored.
Slovenian: Med sočasno uporabo sertralina z zdravili, kakršno je litij, je bolnike treba ustrezno nadzorovati.
English: Thoughts of suicide and worsening of your depression or anxiety disorder: If you are depressed and/or have anxiety disorders you can sometimes have thoughts of harming or killing yourself.
Slovenian: Misli na samomor in poslabšanje depresije ali anksiozne motnje Pri bolnikih z depresijo in/ali anksiozno motnjo se občasno lahko pojavijo misli na samopoškodovanje ali samomor.
English: However, a substantial amount of data did not reveal evidence of induction of congenital malformations by sertraline.
Slovenian: Obsežni podatki niso razkrili dokazov, da bi sertralin izzval prirojene malformacije.
English: Withdrawal symptoms seen on discontinuation of sertraline treatment Withdrawal symptoms when treatment is discontinued are common, particularly if discontinuation is abrupt (see section 4.8).
Slovenian: Odtegnitveni simptomi po prenehanju zdravljenja s sertralinom Po prenehanju zdravljenja so odtegnitveni simptomi pogosti, zlasti če je prenehanje nenadno (glejte poglavje 4.8).
English: Very common side effects (occurs in more than 1 out of 10 patients): Insomnia, dizziness, sleepiness, headache, diarrhoea, feeling sick, dry mouth, ejaculation failure, fatigue.
Slovenian: Zelo pogosti neželeni učinki (pojavijo se pri več kot 1 od 10 bolnikov): Nespečnost, omotica, zaspanost, glavobol, driska, siljenje na bruhanje, suhost ust, nezmožnost ejakulacije, utrujenost.
English: If you accidentally take too much Zoloft contact your doctor at once or go to the nearest hospital casualty department.
Slovenian: Če ste vzeli večji odmerek zdravila Zoloft, kot bi smeli Če pomotoma vzamete preveč zdravila Zoloft, se takoj obrnite na svojega zdravnika, ali pojdite do najbližje nujne medicinske pomoči.
English: The undesirable effects profile commonly observed in double-blind, placebo-controlled studies in patients with OCD, panic disorder, PTSD and social anxiety disorder was similar to that observed in clinical trials in patients with depression.
Slovenian: Profil neželenih učinkov, pogosto opažen v dvojno slepih, s placebom nadzorovanih študijah pri bolnikih z OKM, panično motnjo, PTSM in socialno anksiozno motnjo, je bil podoben kot v kliničnih preskušanjih pri bolnikih z depresijo.
English: After a one week single blind placebo lead-in, patients were randomly assigned to twelve weeks of flexible dose treatment with either sertraline or placebo.
Slovenian: Po enotedenskem enojno slepem obdobju uvajanja so bolnike slučajno razvrstili na dvanajst tednov zdravljenja s prilagodljivim odmerkom sertralina ali placebom.
English: “Sertraline is indicated for the treatment of post traumatic stress disorder (PTSD)”,
Slovenian: „Sertralin je indiciran za zdravljenje posttravmatske stresne motnje (PTSM)“,
English: • Herbal medicine containing St. John's Wort (Hypericum perforatum).
Slovenian: • Zdravila rastlinskega izvora, ki vsebujejo šentjanževko (Hypericum perforatum).
English: • Medicines to treat diabetes (tolbutamide).
Slovenian: • Zdravila za zdravljenje sladkorne bolezni (tolbutamid)
English: Section 4.1 - Indications: Obsessive Compulsive Disorder (OCD) (In adults)
Slovenian: Poglavje 4.1 - Indikacije: Obsesivno kompulzivna motnja (OKM) (pri odraslih)
English: • Medicines to treat migraines (e.g. sumatriptan).
Slovenian: • Zdravila za zdravljenje migrene (npr. sumatriptan).
English: Also reported were signs and symptoms associated with serotonin syndrome: In some cases associated with concomitant use of serotonergic drugs that included agitation, confusion, diaphoresis, diarrhoea, fever, hypertension, rigidity and tachycardia.
Slovenian: Opisani so bili tudi znaki in simptomi, povezani s serotoninskim sindromom, v nekaterih primerih med sočasno uporabo serotoninergičnih zdravil; vključevali so agitiranost, zmedenost, znojenje, drisko, zvišano telesno temperaturo, hipertenzijo, rigidnost in tahikardijo.
English: Use in elderly Elderly should be dosed carefully, as elderly may be more at risk for hyponatraemia (see section 4.4).
Slovenian: Pri starejših bolnikih je treba zdravilo odmerjati previdno, kajti tveganje za hiponatriemijo je lahko pri njih večje (glejte poglavje 4.4).
English: In most of the cases, the recommended dose in prevention of recurrence of MDE is the same as the one used during current episode.
Slovenian: Priporočeni odmerek za preprečevanje recidivov hudih depresivnih epizod je večinoma enak tistemu, ki ga bolnik dobiva med trenutno epizodo.
English: • Liver disease; your doctor may decide that you should have a lower dose of Zoloft.
Slovenian: • Obolenje jeter; zdravnik se lahko odloči za zmanjšanje odmerka.
English: Therefore sertraline should be used with caution in patients with a history of mania/hypomania.
Slovenian: Zato morate sertralin pri bolnikih z anamnezo manije ali hipomanije uporabljati previdno.
English: Hypercholesterolaem ia, Hypoglycaemia
Slovenian: hiperholesterolemija, hipoglikemija hiponatriemija
English: The maximum recommended dose is (10 ml) 200 mg/day.
Slovenian: Maksimalni priporočeni odmerek je (10 ml) 200 mg/dan.
English: Anorexia, Increased Appetite*
Slovenian: Presnovne in prehranske motnje anoreksija, povečan apetit*
English: • Sedatives (diazepam).
Slovenian: • Pomirjevala (imenujemo jih tudi sedativi; diazepam)
English: Children (6-12 years old) were initially started on a 25 mg dose.
Slovenian: Otroci (6-12 let) so začeli z 25 mg odmerki.
English: Use in nursing mothers is not recommended unless, in the judgment of the physician, the benefit outweighs the risk.
Slovenian: Uporaba pri doječih materah ni priporočljiva, razen če koristi po zdravnikovi presoji odtehtajo tveganja.
English: In a placebo-controlled trial in normal volunteers, the co-administration of sertraline with lithium did not significantly alter lithium pharmacokinetics, but did result in an increase in tremor relative to placebo, indicating a possible pharmacodynamic interaction.
Slovenian: V preskušanju, nadzorovanem s placebom, pri zdravih prostovoljcih sočasna uporaba sertralina in litija ni pomembno spremenila farmakokinetike litija, je pa v primerjavi s placebom zvečala tremor, kar nakazuje možno farmakodinamično medsebojno delovanje.
English: Take special care with Zoloft:
Slovenian: Bodite posebno pozorni pri uporabi zdravila Zoloft:
English: “Sertraline is indicated for the treatment of social anxiety disorder”.
Slovenian: „Sertralin je indiciran za zdravljenje socialne anksiozne motnje“.
English: “Sertraline is indicated for the treatment of panic disorder, with or without agoraphobia”.
Slovenian: „Sertralin je indiciran za zdravljenje panične motnje z agarafobijo ali brez nje“.
English: With the condition that the following text is inserted in section 5.1 of the SPC:
Slovenian: Pod pogojem, da se v poglavje 5.1 povzetka glavnih značilnosti zdravila vključi naslednje besedilo: