FrancophonIA/ELRC3.0 huggingface dataset:
English: Olanzapine does not inhibit the main CYP450 isoenzymes in vitro (e.g. 1A2, 2D6, 2C9, 2C19, 3A4).
Slovenian: Olanzapin ne zavira glavnih izoencimov CYP450 v pogojih in vitro (npr. 1A2, 2D6, 2C9,
English: Post-marketing reports of post-injection syndrome since the marketing authorization of ZYPADHERA are generally consistent with the experience seen in clinical studies.
Slovenian: Po pridobitvi dovoljenja za promet z zdravilom ZYPADHERA so poročila v obdobju trženja o sindromu po injiciranju v splošnem skladna z izkušnjami iz kliničnih študij.
English: New-born infants exposed to antipsychotics (including olanzapine) during the third trimester of pregnancy are at risk of adverse reactions including extrapyramidal and/or withdrawal symptoms that may vary in severity and duration following delivery.
Slovenian: Pri novorojenčkih, ki so bili med tretjim trimesečjem nosečnosti izpostavljeni antipsihotikom (vključno z olanzapinom), obstaja tveganje za pojav neželenih učinkov, vključno z ekstrapiramidnimi in/ali odtegnitvenimi simptomi, katerih jakost in čas trajanja po porodu sta lahko različna.
English: Powder None
Slovenian: Prašek Brez
English: 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).
Slovenian: 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).
English: Once the suspension has been removed from the vial, it should be injected immediately.
Slovenian: Ko je suspenzija enkrat izvlečena iz viale, mora biti takoj injicirana.
English: Hyperglycaemia and diabetes
Slovenian: Hiperglikemija in sladkorna bolezen
English: Rare side effects (may affect up to 1 in 1000 people) with ZYPADHERA include injection site infection.
Slovenian: Redki neželeni učinki (lahko se pojavijo pri največ 1 od 1.000 bolnikov) za zdravilo ZYPADHERA vključujejo okužbo na mestu injiciranja.
English: In placebocontrolled clinical trials (6-12 weeks duration) of elderly patients (mean age 78 years) with dementiarelated 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. 1.5%, respectively).
Slovenian: 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 %).
English: (See Figure A)
Slovenian: (Glejte Sliko A)
English: Post-injection syndrome reactions have occurred with ZYPADHERA leading to symptoms consistent with olanzapine overdose (see sections 4.2 and 4.4).
Slovenian: Učinki 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).
English: Remove by grasping the Luer hub of the needle protection device with thumb and forefinger, keeping the free fingers clear of the end of the device containing the needle point (Fig. 3).
Slovenian: S palcem in kazalcem odstranite s prijemom Luerjevega spoja varnostni pripomoček za iglo, pri tem pa ostale prste držite stran od konca pripomočka s konico igle (slika 3).
English: Olanzapine-treated patients had a lower incidence of Parkinsonism, akathisia and dystonia compared with titrated doses of haloperidol.
Slovenian: olanzapinom zdravljeni bolniki so imeli manjšo incidenco parkinsonizma, akatizije in distonije v primerjavi s titriranimi odmerki haloperidola.
English: Haematologic toxicity: Effects on haematology parameters were found in each species, including doserelated reductions in circulating leukocytes in mice and non-specific reductions of circulating leukocytes in rats; however, no evidence of bone marrow cytotoxicity was found.
Slovenian: Pri vsaki vrsti so odkrili učinke na hematološke parametre, vključno z odmerkom povezanimi znižanji koncentracij levkocitov v obtoku pri miših in nespecifičnim znižanjem koncentracije levkocitov v obtoku pri podganah; vendar pa niso našli dokazov citotoksičnosti za kostni mozeg.
English: The predominant pharmacologic activity is from the parent, olanzapine.
Slovenian: Prevladujoča farmakološka aktivnost izvira iz samega olanzapina.
English: Тел: + 359 2 491 41 40
Slovenian: - България Тел: + 359 2 491 41 40
English: ZYPADHERA belongs to a group of medicines called antipsychotics and is used to treat schizophrenia - a disease with symptoms such as hearing, seeing or sensing things which are not there, mistaken beliefs, unusual suspiciousness, and becoming withdrawn.
Slovenian: Zdravilo ZYPADHERA spada v skupino zdravil, imenovanih antipsihotiki in se uporablja za zdravljenje shizofrenije bolezni s simptomi kot so: prisluhi, prividi ali občutki, ki niso povezani z realnostjo, zmotna prepričanja, nenavadna sumničavost in postopno izogibanje socialnim stikom.
English: Seizures where in most cases a history of seizures or risk factors for seizures were reported11
Slovenian: Epileptični napadi, pri katerih so jih v večini primerov imeli že kdaj prej ali so poročali o dejavnikih tveganja za epileptične napade11 Distonija
English: 210 mg/2 weeks or 405 mg/4 weeks
Slovenian: 210 mg/2 tedna ali 405 mg/4 tedne
English: • One 19-gauge, 38 mm Hypodermic safety needle
Slovenian: • Eno 19-gauge, 38 mm podkožno varnostno iglo
English: Figure A: Tap firmly to mix 10.
Slovenian: Slika A: Dobro stresite, da zmešate 10.
English: STEP 2: Determining solvent volume for reconstitution This table provides the amount of solvent required to reconstitute ZYPADHERA powder for prolonged release suspension for injection.
Slovenian: KORAK 2: Določitev volumna vehikla za rekonstitucijo Ta tabela podaja količino vehikla potrebnega za rekonstitucijo ZYPADHERA praška za suspenzijo za injiciranje s podaljšanim sproščanjem.
English: No specific investigations have been conducted in the elderly with ZYPADHERA.
Slovenian: Specifičnih preiskav z zdravilom ZYPADHERA pri starejših osebah niso opravili.
English: The major circulating metabolite is the 10-N-glucuronide.
Slovenian: V krvi je poglavitni metabolit 10-N-glukuronid.
English: If an overdose is suspected, close medical supervision and monitoring should continue until examination indicates that signs and symptoms have resolved.
Slovenian: Če obstaja sum na preveliko odmerjanje, je potreben nadaljnji nadzor in spremljanje, dokler preiskava ne potrdi, da so znaki in simptomi izzveneli.
English: Age > 75 years and vascular/mixed type dementia were identified as risk factors for CVAE in association with olanzapine treatment.
Slovenian: Starost > 75 let in vaskularna/mešana demenca sta bili določeni kot dejavnika, ki prispevata k tveganju za
English: Figure C: Vigorously shake vial
Slovenian: Slika C: Močno pretresite vialo
English: STEP 1: Preparing materials Pack includes:
Slovenian: KORAK 1: Priprava materiala
English: • Stroke or “mini” stroke (temporary symptoms of stroke)
Slovenian: • možganska kap ali »majhna« možganska kap (prehodni znaki kapi)
English: If you miss an injection of ZYPADHERA
Slovenian: Če ste izpustili injekcijo zdravila ZYPADHERA
English: Distribution Oral olanzapine is rapidly distributed.
Slovenian: Peroralni olanzapin se porazdeli hitro.
English: Olanzapine demonstrated a greater in vitro affinity for serotonin 5-HT2 than dopamine D2 receptors and greater 5HT2 than D2 activity in vivo, models.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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).
Slovenian: 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).
English: Patients were randomized to receive injections of ZYPADHERA 405 mg every 4 weeks, 300 mg every 2 weeks, 210 mg every 2 weeks, or placebo every 2 weeks.
Slovenian: Bolniki so randomizirano prejemali injekcije zdravila ZYPADHERA 405 mg vsake 4 tedne, 300 mg vsake 2 tedna, 210 mg vsake 2 tedna ali placebo vsake 2 tedna.
English: ZYPADHERA is not recommended to be started in patients >75 years (see section 4.4).
Slovenian: pri bolnikih > 75 let ni priporočeno (glejte poglavje 4.4).
English: Reconstitute ZYPADHERA powder for prolonged release suspension for injection only with the solvent provided in the pack using standard aseptic techniques for reconstitution of parenteral products.
Slovenian: ZYPADHERA prašek za suspenzijo za injiciranje s podaljšanim sproščanjem rekonstituirajte samo z vehiklom, priloženim v pakiranju, z uporabo standardnih aseptičnih metod za rekonstitucijo parenteralnih zdravil.
English: STEP 1: Injecting ZYPADHERA
Slovenian: KORAK 1: Injiciranje zdravila ZYPADHERA
English: Oral olanzapine was started at 2.5 mg/day and titrated to a maximum of 15 mg/day based on investigator judgement.
Slovenian: 2,5 mg na dan in nato postopoma zviševan do najvišjega odmerka 15 mg na dan na podlagi presoje preiskovalca.
English: Unsuspended powder appears as yellow, dry clumps clinging to the vial.
Slovenian: Nesuspendiran prašek se pojavi kot rumena, suha gruda, na steni viale.
English: Supplementation with oral olanzapine was not authorised in double-blind clinical studies.
Slovenian: V dvojno slepih kliničnih študijah ni bilo dovoljeno dopolnjevanje s peroralnim olanzapinom.
English: Intramuscular use.
Slovenian: Za intramuskularno uporabo.
English: Caution should be exercised in patients who receive medicinal products that can induce hypotension or sedation.
Slovenian: Pri bolnikih, ki prejemajo zdravila, ki lahko vplivajo na hipotenzijo ali sedacijo, je potrebna previdnost.
English: Tell the doctor if you or someone else in your family has a history of blood clots, as medicines like these have been associated with formation of blood clots.
Slovenian: Če ste vi ali kdo iz vaše družine v preteklosti imeli krvne strdke, morate o tem obvestiti svojega zdravnika, saj lahko zdravila, kot je to,
English: Elevated cholesterol levels2,3
Slovenian: Zvišane ravni holesterola2,3
English: In comparator studies of one year or less duration, olanzapine was associated with a statistically significant lower incidence of treatment emergent dyskinesia.
Slovenian: 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.
English: 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).
Slovenian: 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 statistično značilno večja znižanja celokupnega PANSS rezultata v primerjavi s placebom (-8,6; -8,2 oziroma -5,2).
English: ZYPADHERA treatment groups of 150 mg and 300 mg given every 2 weeks (doses pooled for analysis) and 405 mg given every 4 weeks were non inferior to the combined doses of 10, 15 and 20 mg of oral olanzapine (doses pooled for analysis) as measured by rates of exacerbation of symptoms of schizophrenia (respective exacerbation rates, 10%, 10% 7%).
Slovenian: Skupine zdravljenja z zdravilom ZYPADHERA 150 mg in 300 mg, ki so ga prejeli vsake 2 tedna (združena odmerka za analizo) in 405 mg, ki so ga prejeli vsake 4 tedne niso bile inferiorne glede na kombinirane odmerke 10, 15 in 20 mg peroralnega olanzapina (združeni odmerki za analizo) kot so izmerili s stopnjami poslabšanja simptomov shizofrenije (posamezne stopnje poslabšanja 10 %, 10 %, 7 %).
English: In renally impaired patients (creatinine clearance < 10 ml/min) versus healthy subjects, there was no significant difference in mean elimination half-life (37.7 versus 32.4 hours) or clearance (21.2 versus 25.0 l/hr).
Slovenian: Okvarjeno delovanje ledvic Pri bolnikih z okvarjenim delovanjem ledvic (očistek kreatinina < 10 ml/min) v primerjavi z zdravimi osebami ni bilo značilne razlike v srednjem razpolovnem času izločanja (37,7 v primerjavi z 32,4 ure) ali očistku (21,2 v primerjavi s 25,0 l/h).
English: (See Figure C)
Slovenian: (Glejte Sliko C)
English: FOR INTRAMUSCULAR USE ONLY.
Slovenian: SAMO ZA INTRAMUSKULARNO UPORABO.
English: Antipsychotic supplementation is not required at the initiation of ZYPADHERA treatment (see section 4.2).
Slovenian: Pri uvajanju zdravljenja z zdravilom ZYPADHERA ni potrebno dodajanje antipsihotikov (glejte poglavje 4.2).
English: • excessive sleepiness, dizziness, confusion, disorientation, difficulty talking, difficulty walking, muscle stiffness or shaking, weakness, irritability, aggression, anxiety, increase in blood pressure, or convulsions and can lead to unconsciousness.
Slovenian: • pretirano zaspanost, omotico, zmedenost, dezorientacijo, težave pri govoru, težave pri hoji, okorelost ali tresenje mišic, šibkost, razdražljivost, agresijo, anksioznost,
English: One carton contains one vial of powder and one vial of solvent, one Hypodermic 3ml syringe with preattached 19-gauge, 38 mm safety needle, one 19-gauge, 38 mm Hypodermic safety needle and two 19gauge, 50 mm Hypodermic safety needles.
Slovenian: Ena škatla vsebuje eno vialo s praškom in eno vialo vehikla, eno podkožno 3 ml injekcijsko brizgo s predhodno-pritrjeno 19-gauge, 38 mm varnostno iglo, eno 19-gauge, 38 mm podkožno varnostno iglo in dve 19-gauge, 50 mm podkožni varnostni igli.
English: FOR DEEP INTRAMUSCULAR GLUTEAL INJECTION ONLY.
Slovenian: SAMO ZA GLOBOKO, INTRAMUSKULARNO, GLUTEALNO INJICIRANJE.
English: Clinical monitoring is recommended and an increase of olanzapine dose may be considered if necessary (see section 4.5).
Slovenian: Priporoča se klinično spremljanje in če je potrebno, se lahko presodi o povišanju odmerka olanzapina (glejte poglavje 4.5).
English: If an overdose is suspected, close medical supervision and monitoring should continue until examination indicates that signs and symptoms have resolved (see section 4.4.).
Slovenian: Če obstaja sum na preveliko odmerjanje, je potreben nadaljnji nadzor in spremljanje, dokler preiskava ne potrdi, da so znaki in simptomi izzveneli (glejte poglavje 4.4).
English: This table confirms the final ZYPADHERA suspension volume to inject.
Slovenian: Ta tabela določa končne volumne suspenzije zdravila ZYPADHERA za injiciranje.
English: The main findings found in repeat-dose toxicity studies (rat, dog), in a 2-year rat carcinogenicity study, and in toxicity to reproduction studies (rat, rabbit) were limited to injection site reactions for which no NOAEL could be determined.
Slovenian: (podgana, pes), v 2-letni študiji kancerogensti pri podganah ter v študijah vpliva na sposobnost razmnoževanja (podgana, zajec), so bile omejene na reakcije na mestu injiciranja, za katere ni bilo možno ugotoviti nobenega NOAEL.
English: The proportion of patients who had adverse, clinically significant changes in weight gain, glucose, total/LDL/HDL cholesterol or triglycerides increased over time.
Slovenian: 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.
English: Perform a one-handed technique by GENTLY pressing the sheath against a flat surface.
Slovenian: Metodo ene-roke izvedite z NEŽNIM pritiskanjem zaščite proti ravni površini.
English: 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).
Slovenian: 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).
English: In clinical trials in elderly patients with dementia, olanzapine treatment was associated with a higher incidence of death and cerebrovascular adverse reactions compared to placebo (see also section 4.4).
Slovenian: Dodatne informacije glede posebnih skupin bolnikov V kliničnih preskušanjih pri starejših bolnikih z demenco je bilo zdravljenje z olanzapinom povezano z višjo incidenco smrti in cerebrovaskularnih neželenih reakcij v primerjavi s placebom (glejte poglavje 4.4).
English: Table 1 Recommended dose scheme between oral olanzapine and ZYPADHERA Target oral olanzapine dose Recommended starting dose of ZYPADHERA
Slovenian: Tabela 1 Priporočena shema odmerjanja med peroralnim olanzapinom in zdravilom ZYPADHERA Ciljni odmerek peroralnega olanzapina
English: The solvent excipients are carmellose sodium, mannitol, polysorbate 80, water for injections, hydrochloric acid, sodium hydroxide.
Slovenian: Pomožne snovi vehikla so natrijev karmelozat, manitol, polisorbat 80, voda za injekcije, klorovodikova kislina, natrijev hidroksid.
English: Carmellose sodium Mannitol
Slovenian: Natrijev karmelozat
English: 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).
Slovenian: 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
English: Hepatobiliary disorders Transient, asymptomatic elevations of hepatic aminotransferases (ALT, AST), especially in early treatment (see section 4.4)
Slovenian: Prehodna asimptomatska zvišanja jetrnih aminotransferaz (ALT, AST), posebno na začetku zdravljenja (glejte poglavje 4.4)
English: Development or exacerbation of diabetes occasionally associated with ketoacidosis or coma, including some fatal cases (see section 4.4)11
Slovenian: občasno povezane s ketoacidozo ali komo, vključno z nekaj smrtnimi primeri (glejte poglavje 4.4)11
English: Post-injection syndrome
Slovenian: Sindrom po injiciranju
English: One Hypodermic syringe and safety needle.
Slovenian: Ena podkožna injekcijska brizga in varnostna igla.
English: Adverse reactions seen with olanzapine The undesirable effects listed below have been observed following administration of olanzapine.
Slovenian: Neželeni učinki, ki so jih opazili pri olanzapinu Neželene učinke naštete spodaj so opazovali po dajanju olanzapina.
English: Amnesia 9
Slovenian: Amnezija9
English: The injection must not be given after the expiry date which is stated on the carton.
Slovenian: Injekcije se ne sme dajati po datumu izteka roka uporabnosti, ki je naveden na škatli zdravila ZYPADHERA.
English: - If you have any further questions, ask your doctor or nurse.
Slovenian: − Če imate dodatna vprašanja, se posvetujte z zdravnikom ali medicinsko sestro.
English: During the initial three months of treatment with ZYPADHERA, accumulation of olanzapine was observed but there was no additional accumulation during long-term use (12 months) in patients who were injected with up to 300 mg every two weeks.
Slovenian: V začetnih treh mesecih zdravljenja z zdravilom ZYPADHERA so opazili kopičenje olanzapina, vendar ni bilo dodatnega kopičenja med dolgoročno uporabo (12
English: ZYPADHERA is intended for adult patients who are sufficiently stabilised during treatment with oral olanzapine.
Slovenian: Zdravilo ZYPADHERA je namenjeno odraslim bolnikom, ki so bili med zdravljenjem s peroralno obliko olanzapina ustrezno stabilizirani.
English: • An uncommon but serious reaction might occur after you receive each injection.
Slovenian: • Vsakič, ko prejmete injekcijo, se lahko pojavi redek, vendar resen neželen učinek
English: Other symptoms noted include extrapyramidal symptoms, dysarthria, ataxia, aggression, dizziness, weakness, hypertension and convulsion.
Slovenian: Drugi opaženi simptomi so vključevali ekstrapiramidne simptome, disartrijo, ataksijo, agresijo, omotico, šibkost, hipertenzijo in konvulzije.
English: Press the needle into the sheath using a one-handed technique.
Slovenian: Pritisnite iglo v zaščito z uporabo metode ene-roke.
English: If the 38 mm needle is to be used for the injection, attach the 50 mm safety needle to withdraw the required suspension volume.
Slovenian: Če boste za injiciranje uporabili 38 mm iglo, pritrdite na injekcijsko brizgo 50 mm varnostno iglo, da izvlečete potrebni volumen suspenzije.
English: • One Hypodermic syringe and safety needle (Hypodermic Device)
Slovenian: • Eno podkožno injekcijsko brizgo in varnostno iglo (podkožna naprava)
English: One carton contains one vial of powder for prolonged release suspension for injection, one vial of 3 ml solvent, one syringe with safety needle, 19 gauge, 38mm, attached and three separate safety needles; one 19 gauge, 38mm needle and two 19 gauge 50mm needles.
Slovenian: Ena škatla vsebuje eno vialo s praškom za suspenzijo za injiciranje s podaljšanim sproščanjem, eno vialo s 3 ml vehikla, eno injekcijsko brizgo s pritrjeno varnostno iglo, 19 G, 38 mm, intremi ločenimi varnostnimi iglami: eno 19 G, 38 mm iglo in dvema 19 G, 50 mm iglama.
English: 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.
Slovenian: 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.
English: Signs of oral toxicity in rodents were characteristic of potent antipsychotic compounds: hypoactivity, coma, tremors, clonic convulsions, salivation, and depressed weight gain.
Slovenian: Znaki toksičnosti po peroralnem dajanju pri glodavcih so bili značilni za močne antipsihotike: hipoaktivnost, koma, tresenje, klonični krči, slinjenje in zmanjšano pridobivanje telesne mase.
English: After clinical reassessment dose may be adjusted within the range 150 mg to 300 mg every 2 weeks or 300 to 405 mg every 4 weeks.
Slovenian: 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.