natgillin/translations-raw huggingface dataset:
During antipsychotic treatment, improvement in the patient’ s clinical condition may take several days to some weeks.
V času antipsihotičnega zdravljenja lahko traja nekaj dni do nekaj tednov, da pride do izboljšanja kliničnega stanja bolnika.
During treatment dosage may subsequently be adjusted on the basis of individual clinical status.
Med zdravljenjem se lahko odmerek na podlagi individualnega kliničnega stanja kasneje prilagodi.
After clinical reassessment dosage may be adjusted within the range 150 mg to 300 mg every 2 weeks or 300 to 405 mg every 4 weeks.
Po ponovni klinični oceni lahko prilagodimo odmerek v razponu 150 mg do 300 mg vsake 2 tedna ali 300 do 405 mg vsake 4 tedne.
Supplementation Supplementation with oral olanzapine was not authorised in double-blind clinical studies.
Dopolnjevanje V dvojno slepih kliničnih študijah ni bilo dovoljeno dopolnjevanje s peroralnim olanzapinom.
If oral olanzapine supplementation is clinically indicated, then the combined total dose of olanzapine from both formulations should not exceed the corresponding maximum oral olanzapine dose of 20 mg/ day.
Če je peroralni olanzapin klinično indiciran, kombiniran celokupni odmerek olanzapina iz obeh oblik ne sme preseči ustreznega najvišjega odmerka peroralnega olanzapina 20 mg/ dan.
Switching to other antipsychotic medicinal products There are no systematically collected data to specifically address switching patients from ZYPADHERA to other antipsychotic medicinal products.
Prehod na druga antipsihotična zdravila Sistemsko zbranih podatkov glede prehoda bolnikov z zdravilom ZYPADHERA na druga antipsihotična zdravila ni.
Elderly patients ZYPADHERA has not been systematically studied in elderly patients (> 65 years).
Starejši bolniki Zdravila ZYPADHERA niso sistemsko preučevali pri starejših bolnikih (> 65 let).
ZYPADHERA is not recommended for treatment in the elderly population unless a well-tolerated and effective dosage regimen using oral olanzapine has been established.
Zdravila ZYPADHERA ne priporočamo za zdravljenje starejše populacije, razen če se dobro prenaša in je ugotovljen učinkovit režim odmerjanja z uporabo peroralnega olanzapina.
A lower starting dose (150 mg/ 4 weeks) is not routinely indicated, but should be considered for those 65 and over when clinical factors warrant.
Nižji začetni odmerek (150 mg/ 4 tedne) ni rutinsko priporočen, vendar ga je treba upoštevati pri bolnikih, starih 65 let in več, kadar to upravičujejo klinični dejavniki.
ZYPADHERA is not recommended to be started in patients > 75 years (see section 4.4).
Uvajanje zdravila ZYPADHERA pri bolnikih > 75 let ni priporočeno (glejte poglavje 4. 4).
Patients with renal and/ or hepatic impairment Unless a well-tolerated and effective dosage regimen using oral olanzapine has been established in such patients, ZYPADHERA should not be used.
Bolniki z okvarjenim ledvičnim in/ ali jetrnim delovanjem Pri teh bolnikih ne smemo uporabljati zdravila ZYPADHERA, razen če se dobro prenaša in je ugotovljen učinkovit režim odmerjanja z uporabo peroralnega olanzapina.
In cases of moderate hepatic insufficiency (cirrhosis, Child- Pugh Class A or B), the starting dose should be 150 mg every 4 weeks and only increased with caution.
V primerih zmerno okvarjenega delovanja jeter (ciroza, Child- Pugh razreda A ali B) mora biti začetni odmerek 150 mg vsake 4 tedne in se lahko zvišuje le previdno.
Paediatric patients
Otroci in mladostniki Zaradi pomanjkanja podatkov glede varnosti in učinkovitosti, zdravila ZYPADHERA ne priporočamo
3 ZYPADHERA is not recommended for use in children and adolescents below 18 years due to a lack of data on safety and efficacy.
3 za uporabo pri otrocih in mladostnikih, mlajših od 18 let.
Special care must be taken to apply appropriate injection technique to avoid inadvertent intravascular or subcutaneous injection (see section 6.6).
Potrebna je posebna previdnost glede uporabe ustrezne tehnike injiciranja v izogib nenamernega intravaskularnega ali subkutanega injiciranja (glejte poglavje 6. 6).
Use in patients who are in an acutely agitated or severely psychotic state ZYPADHERA should not be used to treat patients with schizophrenia who are in an acutely agitated or severely psychotic state such that immediate symptom control is warranted.
Uporaba pri bolnikih, ki so v akutno agitiranem ali hudem psihotičnem stanju Za zagotovitev takojšnjega nadzora simptomov, zdravila ZYPADHERA ne smemo uporabljati za zdravljenje bolnikov s shizofrenijo, ki so v akutno agitiranem ali hudem psihotičnem stanju.
These events occurred in < 0.1% of injections and approximately 1.4% of patients.
Sindrom po injiciranju Med pre- marketinškimi kliničnimi študijami so se pri < 0, 1% injiciranj in približno 1, 4% bolnikov pojavili dogodki, ki so vključevali znake in simptome značilne za preveliko odmerjanje olanzapina.
Most of these patients have developed symptoms of sedation (ranging from mild in severity up to coma) and/ or delirium (including confusion, disorientation, agitation, anxiety and other cognitive impairment).
Pri večini teh bolnikov so se razvili simptomi sedacije (v razponu od blage do kome) in/ ali delirija (vključno z zmedenostjo, neorientacijo, agitacijo, anksioznostjo in drugimi kognitivnimi poslabšanji).
Other symptoms noted include extrapyramidal symptoms, dysarthria, ataxia, aggression, dizziness, weakness, hypertension and convulsion.
Drugi opaženi simptomi so vljučevali ekstrapiramidne simptome, disartrijo, ataksijo, agresijo, omotico, šibkost, hipertenzijo in konvulzije.
In most cases, initial signs and symptoms related to this event have appeared within 1 hour following injection, and in all cases full recovery was reported to have occurred within 24 – 72 hours after injection.
V večini primerov so se začetni znaki in simptomi, povezani s tem dogodkom, pojavili v 1 uri po injiciranju in v vseh primerih so poročali o popolnem okrevanju v 24 - 72 urah po injiciranju.
Events occurred rarely (< 1 in 1,000 injections) between 1 and 3 hours, and very rarely (< 1 in 10,000 injections) after 3 hours.
Dogodki so se redko pojavili (< 1 od 1. 000 injiciranj) med 1 in 3 urami in zelo redko (< 1 od 10. 000 injiciranj) po 3 urah.
Prior to giving the injection, the healthcare professional should determine that the patient will not travel alone to their destination.
Pred dajanjem injekcije mora zdravstveno osebje zagotoviti, da bolnik ne bo sam odšel do svojega doma.
After each injection, patients should be observed in a healthcare facility by appropriately qualified personnel for at least 3 hours for signs and symptoms consistent with olanzapine overdose.
Po vsakem injiciranju mora ustrezno usposobljeno osebje v zdravstvenih ustanovah najmanj 3 ure opazovati bolnike za znake in simptome značilne za preveliko odmerjanje olanzapina.
If an overdose is suspected, close medical supervision and monitoring should continue until examination indicates that signs and symptoms have resolved.
Če obstaja sum na preveliko odmerjanje, je potreben nadaljnji nadzor in spremljanje dokler preiskava ne potrdi, da so se znaki in simptomi izboljšali.
For the remainder of the day after injection, patients should be advised to be vigilant for signs and symptoms of overdose secondary to post injection adverse reactions, be able to obtain assistance if needed and should not drive or operate machinery (see section 4.7).
Za preostanek dneva po injiciranju, je potrebno bolnike opozoriti, naj bodo pozorni na znake in simptome prevelikega odmerjanja, ki nastopijo sekundarno po neželenih reakcijah po injiciranju, da bodo lahko po potrebi poiskali pomoč ter naj ne vozijo ali upravljajo s stroji (glejte poglavje 4. 7).
(see section 4.5)
Če so parenteralni benzodiazepini nujni za uravnavanje neželenih reakcij po injiciranju, je priporočeno skrbno ovrednotiti klinično stanje pretirane sedacije in kardiorespiratorne depresije (glejte poglavje 4. 5).
Injection Site Related Adverse Events The most commonly reported injection site related adverse event was pain.
Neželeni učinki na mestu injiciranja Najpogosteje poročani neželeni učinek na mestu injiciranja je bila bolečina.
The majority of these events was reported to be of “ mild” to “ moderate” severity.
Večino teh učinkov so poročali kot “ blagih ” do “ zmernih ” glede resnosti.
(see section 4.8)
V primeru pojava neželenega učinka na mestu injiciranja, je za uravnavo teh učinkov potrebno izvesti ustrezne ukrepe (glejte poglavje 4. 8).
Dementia-related psychosis and/ or behavioural disturbances Olanzapine is not approved for the treatment of dementia-related psychosis and/ or behavioural disturbances and is not recommended for use in this particular group of patients because of an increase
Psihoza povezana z demenco in/ ali vedenjske motnje Olanzapin ni odobren za zdravljenje bolnikov s psihozo, povezano z demenco in/ ali vedenjskimi motnjami ter ni priporočljiv za uporabo pri teh skupinah bolnikov zaradi povečane umrljivosti in tveganja za cerebrovaskularne dogodke.
In placebo-controlled clinical trials (6-12 weeks duration) of elderly patients (mean age 78 years) with dementia-related psychosis and/ or disturbed behaviours, there was a 2-fold increase in the incidence of death in oral olanzapine-treated patients compared to patients treated with placebo (3.5% vs.
V kliničnih preskušanjih, kontroliranih s placebom (ki so trajali 6- 12 tednov), pri starejših bolnikih s psihozo, povezano z demenco in/ ali vedenjskimi motnjami (povprečna starost 78 let), je bilo 2- kratno povečanje incidence smrti pri bolnikih, zdravljenih s peroralnim olanzapinom, v primerjavi z bolniki, zdravljenimi s placebom (3, 5% v primerjavi z
1.5%, respectively).
4 1, 5%).
There was a 3-fold increase in CVAE in patients treated with oral olanzapine compared to patients treated with placebo (1.3% vs.
Pri bolnikih, zdravljenih s peroralnim olanzapinom, je bila 3- krat večja pojavnost CVAE v primerjavi z bolniki, ki so prejemali placebo (1, 3% v primerjavi z 0, 4%).
In clinical trials, worsening of Parkinsonian symptomatology and hallucinations were reported very commonly and more frequently than with placebo (see section 4.8), and oral olanzapine was not more effective than placebo in the treatment of psychotic symptoms.
V kliničnih preskušanjih so o poslabšanju parkinsonske simptomatike in halucinacijah poročali zelo pogosto in pogosteje kot pri placebu (glejte poglavje 4. 8), peroralni olanzapin pa ni bil bolj učinkovit kot placebo pri zdravljenju psihotičnih simptomov.
Oral olanzapine was started at 2.5 mg/ day and titrated to a maximum of 15 mg/ day based on investigator judgement.
Začetni odmerek peroralnega olanzapina je bil 2, 5 mg na dan in nato postopoma zviševan do najvišjega odmerka 15 mg na dan na podlagi presoje preiskovalca.
Neuroleptic Malignant Syndrome (NMS) NMS is a potentially life-threatening condition associated with antipsychotic medicinal products.
Nevroleptični maligni sindrom (NMS) NMS je potencialno življenje ogrožajoče stanje, povezano z antipsihotiki.
Hyperglycaemia and diabetes Hyperglycaemia and/ or development or exacerbation of diabetes occasionally associated with ketoacidosis or coma has been reported rarely, including some fatal cases (see section 4.8).
Hiperglikemija in diabetes Redko so poročali o hiperglikemiji in/ ali razvoju ali poslabšanju sladkorne bolezni, občasno povezanih s ketoacidozo ali komo, vključujoč nekaj primerov s smrtnim izidom (glejte poglavje 4. 8).
Patients treated with any antipsychotic agents, including ZYPADHERA, should be observed for signs and symptoms of hyperglycaemia (such as polydipsia, polyuria, polyphagia, and weakness) and patients with diabetes mellitus or with risk factors for diabetes mellitus should be monitored regularly for worsening of glucose control.
Bolnike, zdravljene s katerimkoli antipsihotikom, vključno z zdravilom ZYPADHERA, moramo opazovati za znake in simptome hiperglikemije (kot so polidipsija, poliurija, polifagija in šibkost) ter redno spremljati bolnike s sladkorno boleznijo ali dejavniki tveganja za sladkorno bolezen glede poslabšanja nadzora glukoze.
Weight should be monitored regularly.
Redno moramo spremljati telesno maso.
Patients treated with any antipsychotic agents, including ZYPADHERA, should be monitored regularly for lipids in accordance with utilised antipsychotic guidelines.
Bolnike, zdravljene s katerimkoli antipsihotikom, vključno z zdravilom ZYPADHERA, moramo redno spremljati glede lipidov, v skladu z znanimi priporočili za antipsihotike.
5 Anticholinergic activity While olanzapine demonstrated anticholinergic activity in vitro, experience during the clinical trials revealed a low incidence of related events.
Antiholinergično delovanje Medtem ko je olanzapin pokazal antiholinergično delovanje v pogojih in vitro, so izkušnje kliničnih
Discontinuation of treatment Acute symptoms such as sweating, insomnia, tremor, anxiety, nausea, or vomiting have been reported very rarely (< 0.01%) when oral olanzapine is stopped abruptly.
Prekinitev zdravljenja Zelo redko (< 0, 01%) so pri nenadni prekinitvi zdravljenja s peroralnim olanzapinom poročali o akutnih simptomih, kot so znojenje, nespečnost, tresenje, občutek tesnobe, slabost ali bruhanje.
QT interval In clinical trials with oral olanzapine, clinically meaningful QTc prolongations (Fridericia QT correction [QTcF] ≥ 500 milliseconds [msec] at any time post baseline in patients with baseline QTcF < 500 msec) were uncommon (0.1% to 1%) in patients treated with olanzapine, with no significant differences in associated cardiac events compared to placebo.
QT interval V kliničnih preskušanjih s peroralnim olanzapinom so bila klinično pomembna podaljšanja QTc (QT korekcija Fridericia [QTcF] ≥ 500 milisekund [msek] kadarkoli nad osnovno vrednostjo pri bolnikih z osnovno vrednostjo QTcF < 500 msek) pri bolnikih, zdravljenih z olanzapinom, redka (od 0, 1% do 1%), brez pomembnih razlik v spremljajočih srčnih dogodkih v primerjavi z bolniki, zdravljenimi s placebom.
6 Tardive Dyskinesia In comparator studies of one year or less duration, olanzapine was associated with a statistically significant lower incidence of treatment emergent dyskinesia.
6 Tardivne diskinezije V primerjalnih študijah, ki so trajale eno leto ali manj, so olanzapin povezovali s statistično značilno manjšo incidenco diskinezij, ki se pojavijo ob zdravljenju.
Use in elderly patients (> 75 years) No information on the use of ZYPADHERA in patients > 75 years is available.
Uporaba pri starejših bolnikih (> 75 let) Na voljo ni podatkov o uporabi zdravila ZYPADHERA pri bolnikih starejših > 75 let.
Thus no particular interaction is expected as verified through in vivo studies where no inhibition of metabolism of the following active substances was found: tricyclic antidepressant (representing
Zato ni pričakovati kakega posebnega medsebojnega delovanja, kar je bilo potrjeno s študijami in vivo, kjer niso opazili nobenega zaviranja presnove naslednjih učinkovin: tricikličnih antidepresivov (ki predstavljajo predvsem pot CYP2D6), varfarina (CYP2C9), teofilina (CYP1A2) ali diazepama
7 mostly CYP2D6 pathway), warfarin (CYP2C9), theophylline (CYP1A2) or diazepam (CYP3A4 and 2C19).
7 (CYP3A4 in 2C19).
Patients should be advised not to drive or operate machinery for the remainder of the day after each injection due to the possibility of a post-injection syndrome event leading to symptoms consistent with olanzapine overdose (see section 4.4).
Bolnike je potrebno opozoriti naj preostanek dneva po injiciranju ne vozijo ali upravljajo s stroji zaradi možnega sindroma po injiciranju, ki lahko vodi do simptomov, značilnih za preveliko odmerjanje olanzapina (glejte poglavje 4. 4).
Post-injection syndrome events have occurred with ZYPADHERA leading to symptoms consistent with olanzapine overdose (see sections 4.2 and 4.4).
Dogodki sindroma po injiciranju so se pojavljali pri zdravilu ZYPADHERA in so vodili do simptomov, značilnih za preveliko odmerjanje olanzapina (glejte poglavji 4. 2 in 4. 4).
Clinical signs and symptoms included symptoms of sedation (ranging from mild in severity up to coma) and/ or delirium (including confusion, disorientation, agitation, anxiety and other cognitive impairment).
Klinični znaki in simptomi so vključevali simptome sedacije (v razponu od blage do kome) in/ ali delirija (vključno z zmedenostjo, neorientacijo, agitacijo, anksioznostjo in drugimi kognitivnimi poslabšanji).
Other adverse reactions observed in patients treated with ZYPADHERA were similar to those seen with oral olanzapine.
Druge neželene reakcije, ki so jih opazovali pri bolnikih, zdravljenih z zdravilom ZYPADHERA so bile podobne tistim, ki so jih opazili pri peroralnem olanzapinu.
In clinical trials with ZYPADHERA, the only adverse reaction reported at a statistically significantly higher rate in the ZYPADHERA group than in the placebo group was
V kliničnih preskušanjih z zdravilom ZYPADHERA so o samo eni neželeni reakciji poročali s statistično značilno višjo stopnjo pri skupini z zdravilom ZYPADHERA kot v skupini s placebom, sedaciji (zdravilo ZYPADHERA 8, 2%, placebo 2, 0%).
8 sedation (ZYPADHERA 8.2%, placebo 2.0%).
8 bolnikov.
In clinical trials with ZYPADHERA the incidence of injection site related adverse events was approximately 8%.
V kliničnih preskušanjih z zdravilom ZYPADHERA je bila incidenca neželenih učinkov, povezanih z mestom injiciranja približno 8%.
The most commonly reported injection site related adverse event was pain (5%); some other injection site adverse events reported were (in decreasing frequency): nodule type reactions, erythema type reactions, non-specific injection site reactions, irritation, oedema type reactions, bruising, haemorrhage, and anesthesia.
Najpogostejši neželeni učinek povezan z mestom injiciranja je bila bolečina (5%); nekatera druga poročila o neželenih učinkih na mestu injiciranja so (po padajoči pogostnosti): reakcije živčnih vozličkov, eritemske reakcije, nespecifične reakcije na mestu injiciranja, draženje, edemske reakcije, modrice, krvavitve in anestezija.
These events occurred in about 0.1 to 1.1% of patients.
Te reakcije so se pojavljale pri približno 0, 1 do 1, 1% bolnikov.
The undesirable effects listed below have been observed following administration of oral olanzapine but may occur following administration of ZYPADHERA.
Neželene učinke naštete spodaj so opazovali po dajanju peroralnega olanzapina, vendar se lahko pojavijo tudi po dajanju zdravila ZYPADHERA.
Musculoskeletal and connective tissue disorders Rhabdomyolysis Renal and urinary disorders Urinary hesitation Reproductive system and breast disorders Priapism General disorders and administration site conditions Asthenia Fatigue Oedema Investigations Elevated plasma prolactin levels8 1
Bolezni mišično- skeletnega sistema in vezivnega tkiva Rabdomioliza Bolezni sečil Težave z začetkom mokrenja Motnje reprodukcije in dojk Priapizem Splošne težave in spremembe na mestu aplikacije Astenija Utrujenost Oteklina Preiskave Zvišane plazemske koncentracije prolaktina8
10 4 Observed for fasting normal levels at baseline (< 5.56 mmol/ l) which increased to high (≥ 7 mmol/ l).
10 4 Opazovano pri osnovnih normalnih ravneh na tešče (< 5, 56 mmol/ l), ki so se povišale na visoke (≥ 7 mmol/ l).
Long-term exposure (at least 48 weeks) The proportion of patients who had adverse, clinically significant changes in weight gain, glucose, total/ LDL/ HDL cholesterol or triglycerides increased over time.
Dolgoročna izpostavljenost (najmanj 48 tednov) Delež bolnikov, ki so imeli neželene, klinično značilne spremembe telesne mase, glukoze, celokupnega/ LDL/ HDL holesterola ali trigliceridov se je s časom povečal.
During treatment with olanzapine in combination with lithium or divalproex, an increase of ≥ 7% from baseline body weight occurred in 17.4% of patients during acute treatment (up to 6 weeks).
Med zdravljenjem z olanzapinom v kombinaciji z litijem ali divalproeksom se je pri 17, 4% bolnikov med akutnim zdravljenjem (do 6 tednov) pojavilo povečanje telesne mase za ≥ 7% od osnovne.
The
Videti je, da se klinično značilno zvečanje telesne mase
11 magnitude of weight gain and the proportion of adolescent patients who had clinically significant weight gain were greater with long-term exposure (at least 24 weeks) than with short-term exposure.
Obseg povečanja telesne mase ter razmerje mladostnikov, ki so imeli klinično značilno zvečanje telesne mase, sta bila višja pri dolgoročni izpostavljenosti (najmanj 24 tednov) kot pri kratkoročni izpostavljenosti.
If signs and symptoms of overdose consistent with post injection syndrome are observed, appropriate supportive measures should be taken (see section 4.4).
Če so opaženi znaki in simptomi značilni za sindrom po injiciranju, je potrebno izvesti ustrezne podporne ukrepe (glejte poglavje 4. 4).
While overdose is less likely with parenteral than oral medication, reference information for oral olanzapine overdose is presented below:
Medtem ko je preveliko odmerjanje manj verjetno pri parenteralnem kor peroralnem zdravljenju, so spodaj podani referenčni podatki za preveliko odmerjanje peroralnega olanzapina:
Management of overdose There is no specific antidote for olanzapine.
Ravnanje v primeru prevelikega odmerjanja
12 and circulatory collapse and support of respiratory function.
12 Za olanzapin ni specifičnega antidota.
In preclinical studies, olanzapine exhibited a range of receptor affinities (Ki; < 100 nM) for serotonin 5-HT2A/ 2C, 5-HT3, 5-HT6; dopamine D1, D2, D3, D4, D5; cholinergic muscarinic receptors m1-m5; α -1 adrenergic; and histamine H1 receptors.
V predkliničnih študijah je olanzapin pokazal razpon afinitet do receptorjev (Ki; < 100 nM) za serotonin 5- HT2A/ 2C, 5- HT3, 5- HT6; dopamin D1, D2, D3, D4, D5; holinergičnih muskarinskih receptorjev m1- m5; adrenergičnih α1; in histaminskih H1 receptorjev.
Olanzapine demonstrated a greater in-vitro affinity for serotonin 5-HT2 than dopamine D2 receptors and greater 5-HT2 than D2 activity in vivo, models.
V pogojih in vitro je olanzapin pokazal večjo afiniteto za serotoninske 5- HT2 kot za dopaminske D2 receptorje in večjo 5- HT2 kot D2 aktivnost v modelih in vivo.
In a Positron Emission Tomography (PET) study in patients treated with ZYPADHERA (300 mg/ 4 weeks), mean D2 receptor occupancy was 60% or higher at the end of a 6 month period, a level consistent with that found during treatment with oral olanzapine.
V študiji pozitronske emisijske tomografije (PET) bolnikov, zdravljenih z zdravilom ZYPADHERA (300 mg/ 4 tedne), je bila povprečna zasedenost D2 receptorjev na koncu 6 mesečne periode zdravljenja 60% višja, kar je v skladu z nivojem, ugotovljenim med zdravljenjem s peroralnim olanzapinom.
The first, an 8-week, placebo controlled trial conducted in adult patients (n=404) who were experiencing acute psychotic symptoms.
Prvo, 8- tedensko, s placebom nadzorovano preskušanje so opravili pri odraslih bolnikih (n=404), ki so imeli akutne psihotične simptome.
Total Positive and Negative Symptom Scores (PANSS) showed significant improvement from baseline (baseline mean Total PANSS Score 101) to endpoint (mean changes -22.57, -26.32, -22.49 respectively) with each dose of ZYPADHERA (405 mg every 4 weeks, 300 mg every 2 weeks, and 210 mg every 2 weeks) as compared to placebo (mean change -8.51).
Celokupni pozitivni in negativni rezultati (PANSS) so pokazali značilno izboljšanje od osnove (povprečni osnovni celokupni PANSS rezultat 101) do končne točke (povprečna sprememba - 22, 57; - 26, 32 oziroma - 22, 49) z vsakim odmerkom zdravila ZYPADHERA (405 mg vsake 4 tedne, 300 mg vsake 2 tedna in 210 mg vsake 2 tedna) v primerjavi s placebom (povprečna sprememba - 8, 51).
Visitwise mean change from baseline to endpoint in PANSS Total score indicated that by Day 3, patients in the 300 mg/ 2 weeks and 405 mg/ 4 weeks treatment groups had statistically significantly greater reductions in PANSS Total score compared to placebo (-8.6, -8.2, and -5.2, respectively).
Glede na pregled, je povprečna sprememba z osnove do končne točke po celokupnem PANSS rezultatu pokazala, da imajo do 3. dneva bolniki v skupini zdravljenja z 300 mg/ 2 tedna in 405 mg/ 4 tedne ststistično značilno večja znižanja celokupnega PANSS rezultata v primerjavi s placebom (- 8, 6; - 8, 2 oziroma - 5, 2).