natgillin/translations-raw huggingface dataset:
All 3 ZYPADHERA treatment groups showed statistically significantly greater improvement than placebo beginning by end of Week 1.
Vse tri skupine zdravljenja z zdravilom ZYPADHERA so pokazale začetek stastistično značilnega večjega izboljšanja kot placebo na koncu 1. tedna.
The second, a long term study in clinically stable patients (n=1065) (baseline mean Total PANSS Score 54.33 to 57.75) who were initially treated with oral olanzapine for 4 to 8 weeks and then switched to continue on oral olanzapine or to ZYPADHERA for 24 weeks.
Druga je bila dolgoročna študija klinično stabilnih bolnikov (n=1065) (povprečni osnovni celokupni PANSS rezultat 54, 33 do57, 75), ki so bili najprej 4 do 8 tednov zdravljeni s peroralnim olanzapinom in so nato zamenjali ter 24 tednov nadaljevali na peroralnem olanzapinu ali zdravilu ZYPADHERA.
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
Skupine zdravljenja z zdravilom 13 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%).
The combined 150 mg and 300 mg/ 2 week treatment group was non inferior to the 405 mg/ 4 week treatment group (exacerbation rates 10% for each group) at 24 weeks after randomisation.
24 tednov po randomizaciji kombinirani skupini zdravljenja 150 mg in 300 mg/ 2 tedna nista bili inferiorni glede na skupino zdravljenja s 405 mg/ 4 tedne (posamezni stopnji poslabšanja 10% za vsako skupino).
Paediatric population ZYPADHERA has not been studied in the paediatric population.
Pediatrična populacija Zdravila ZYPADHERA pri mladostnikih niso preučevali.
The experience in adolescents (ages 13 to 17 years) is limited to short term oral olanzapine efficacy data in schizophrenia (6 weeks) and mania associated with bipolar I disorder (3 weeks), involving less than 200 adolescents.
Izkušnje pri mladostnikih (starih 13 do 17 let) so omejene na kratkoročne podatke o učinkovitosti peroralnega olanzapina pri shizofreniji (6 tednov) in maniji povezani z bipolarno I motnjo (3 tedni), ki vključujejo manj kot 200 mladostnikov.
Oral olanzapine was used as a flexible dose starting with 2.5 and ranging up to 20 mg/ day.
Olanzapin so uporabljali kot prilagodljiv odmerek, ki so ga začeli z 2, 5 mg in zviševali do 20 mg/ dan.
The major circulating metabolite is the 10-N-glucuronide.
V krvi je poglavitni metabolit 10- N - glukuronid.
Cytochromes P450-CYP1A2 and P450-CYP2D6 contribute to the formation of the N-desmethyl and 2-hydroxymethyl metabolites; both exhibited significantly less in vivo pharmacological activity than olanzapine in animal studies.
Citokroma P450- CYP1A2 in P450- CYP2D6 prispevata k tvorbi N- demetilnih in 2 - hidroksimetilnih metabolitov, oboji so v študijah na živalih pokazali pomembno manj farmakološke aktivnosti in vivo kot olanzapin.
After a single IM injection with ZYPADHERA the slow dissolution of the olanzapine pamoate salt in muscle tissue begins immediately and provides a slow continuous release of olanzapine for more than four weeks.
Po enkratnem i. m. injiciranju zdravila ZYPADHERA se v mišičnem tkivu takoj začne počasno raztapljanje olanzapinijevega pamoata ter zagotavlja počasno, nenehno sproščanje olanzapina več kot štiri tedne.
Antipsychotic supplementation is not required at the initiation of ZYPADHERA treatment (see section 4.2).
Pri uvajanju zdravljenja z zdravilom ZYPADHERA ni potrebno dodajanje antipsihotikov (glejte poglavje 4. 2).
The combination of the release profile and the dosage regimen (IM injection every two or four weeks) result in sustained olanzapine plasma concentrations.
Kombinacija profila sproščanja in režima odmerjanja (i. m. injiciranje vsake dva ali štiri tedne) vodi v podaljšane plazemske koncentracije olanzapina.
The plasma protein binding of olanzapine is about 93% over the concentration range of 7 to about 1000 ng/ mL.
Vezava olanzapina na plazemske beljakovine je bila okoli 93% v razponu koncentracij od približno 7 do približno 1000 ng/ ml.
In plasma, olanzapine is bound to albumin and α 1-acid glycoprotein.
V plazmi se olanzapin veže predvsem na albumin in α1- kisli glikoprotein.
Olanzapine plasma clearance after oral olanzapine is lower in females (18.9 l/ hr) versus males (27.3 l/ hr), and in non-smokers (18.6 l/ hr) versus smokers (27.7 l/ hr).
Plazemski očistek olanzapina po peroralnem dajanju olanzapina je nižji pri ženskah (18, 9 l/ h) v primerjavi z moškimi (27, 3 l/ h) ali pri nekadilcih (18, 6 l/ h) v primerjavi s kadilci (27, 7 l/ h).
Similar pharmacokinetic differences between males and females and smokers and nonsmokers were observed in ZYPADHERA clinical trials.
Podobno so opazovali farmakokinetične razlike med moškimi in ženskimi ter kadilci in nekadilci pri kliničnih preskušanjih z zdravilom ZYPADHERA.
After repeated IM injections with 150 to 300 mg ZYPADHERA every two weeks, the 10th to 90th percentile of steady-state plasma concentrations of olanzapine were between 4.2 and 73.2 ng/ ml.
Po ponovljenih i. m. injiciranjih z 150 mg do 300 mg zdravila ZYPADHERA vsake dva tedna, sta bila 10- ti in 90- ti odstotek plazemskih koncentracij olanzapina v stanju dinamičnega ravnovesja med 4, 2 in 73, 2 ng/ ml.
The plasma concentrations of olanzapine observed across the dose range of 150mg every 4 weeks to 300mg every 2 weeks illustrate increased systemic olanzapine exposure with increased ZYPADHERA doses.
Plazemske koncentracije olanzapina, ki so jih opazovali v razponu odmerka od 150 mg vsake 4 tedne do 300 mg vsake 2 tedna kažejo na povišano sistemsko izpostavljenost olanzapinu pri zvišanih odmerkih zdravila ZYPADHERA.
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.
Med začetnimi tremi meseci zdravljenja z zdravilom ZYPADHERA so opazili kopičenje olanzapina, vendar ni bilo dodatnega kopičenja med dolgoročno uporabo (12 mesecev) pri bolnikih, katerim so injicirali do 300 mg vsake dva tedna.
No specific investigations have been conducted in the elderly with ZYPADHERA.
Zdravila
ZYPADHERA is not recommended for treatment in the elderly population (65 years and over) unless a well-tolerated and effective dosage regimen using oral olanzapine has been established.
14 ZYPADHERA ne priporočamo za zdravljenje starejše populacije (65 let in več), razen če se dobro prenaša in je ugotovljen učinkovit režim odmerjanja z uporabo peroralnega olanzapina.
In healthy elderly (65 and over) versus non-elderly subjects, the mean elimination half-life was prolonged (51.8 versus
Pri zdravih starejših osebah (65 let in več) v primerjavi z nestarejšimi je bil srednji razpolovni čas izločanja podaljšan (51, 8 v primerjavi s 33, 8 ure) in očistek zmanjšan (17, 5 v primerjavi z 18, 2 l/ h).
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).
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).
Although patients with renal impairment were not studied with ZYPADHERA, it is recommended that a well-tolerated and effective dosage regimen using oral olanzapine is established in patients with renal impairment before treatment with ZYPADHERA is initiated (see section 4.2).
Čeprav z zdravilom ZYPADHERA niso preiskovali bolnikov z okvarjenim delovanjem ledvic, pred začetkom zdravljenja z zdravilom ZYPADHERA priporočamo, da se dobro prenaša in je ugotovljen učinkovit režim odmerjanja z uporabo peroralnega olanzapina pri bolnikih z okvarjenim delovanjem ledvic (glejte poglavje 4. 2).
In smoking subjects with mild hepatic dysfunction, mean elimination half-life (39.3 hours) of orally administered olanzapine was prolonged and clearance (18.0 l/ hr) was reduced analogous to non- smoking healthy subjects (48.8 hours and 14.1 l/ hr, respectively).
Pri kadilcih z blagimi motnjami v delovanju jeter je bil srednji razpolovni čas izločanja peroralno danega olanzapina (39, 3 ure) podaljšan in očistek (18, 0 l/ h) zmanjšan tako kot pri zdravih nekadilcih (48, 8 ur oziroma 14, 1 l/ h).
Although patients with hepatic impairment were not studied with ZYPADHERA, it is recommended that a well-tolerated and effective dosage regimen using oral olanzapine is established in patients with hepatic impairment before treatment with ZYPADHERA is initiated (see section 4.2).
Čeprav z zdravilom ZYPADHERA niso preiskovali bolnikov z okvarjenim delovanjem jeter, pred začetkom zdravljenja z zdravilom ZYPADHERA priporočamo, da se dobro prenaša in je ugotovljen učinkovit režim odmerjanja z uporabo peroralnega olanzapina pri bolnikih z okvarjenim delovanjem jeter (glejte poglavje 4. 2).
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.
Poglavitne ugotovitve, ki so jih ugotovili v študijah toksičnosti po večkratnem odmerjanju (podgana, pes), v 2 - letni štuudiji 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.
However, systemic concentrations in these studies were generally less than that seen at effect levels in the oral studies; thus the information on oral olanzapine is provided below for reference.
Vendar so bile sistemske koncentracije v the študijah na splošno nižje kot tiste, ki so jih opazili na nivojih učinkovanja pri peroralnih študijah; zato kot referenco spodaj navajamo podatke za peroralni olanzapin.
Acute (single-dose) toxicity Signs of oral toxicity in rodents were characteristic of potent antipsychotic compounds: hypoactivity, coma, tremors, clonic convulsions, salivation, and depressed weight gain.
Znaki toksičnosti po peroralnem dajanju pri glodavcih so bili značilni za močne antipsihotike: hipoaktivnost, koma, tresenje, klonični krči, slinjenje in zmanjšano pridobivanje telesne mase.
Repeated-dose toxicity In studies up to 3 months duration in mice and up to 1 year in rats and dogs, the predominant effects were CNS depression, anticholinergic effects, and peripheral haematological disorders.
V študijah, ki so pri miših trajale do 3 mesece, pri podganah in psih pa do 1 leta, so bili prevladujoči učinki depresija osrednjega živčevja, antiholinergični učinki in periferne hematološke motnje.
Effects on haematology parameters were found in each species, including dose-related reductions in circulating leukocytes in mice and non-specific reductions of circulating leukocytes in rats; however, no evidence of bone marrow cytotoxicity was found.
15 Pri vsaki vrsti so odkrili učinke na hematološke parametre, vključno z 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.
Reversible neutropenia, thrombocytopenia, or anaemia developed in a few dogs treated with 8 or 10 mg/ kg/ day (total olanzapine exposure [AUC] is 12- to 15-fold greater than that of a man given a 12 mg dose).
Pri nekaj psih, ki so prejemali 8 ali 10 mg/ kg/ dan (celotno izpostavljanje olanzapinu [AUC] je 12 - do 15 - krat večje kot pri človeku, ki dobi 12- miligramski odmerek), se je razvila reverzibilna nevtropenija, trombocitopenija ali anemija.
15 Olanzapine had no teratogenic effects.
Olanzapin ni imel teratogenih učinkov.
Oestrous cycles were affected at doses of 1.1 mg/ kg (3 times the maximum human dose) and reproduction parameters were influenced in rats given 3 mg/ kg (9 times the maximum human dose).
Odmerki 1, 1 mg/ kg (3- kratni maksimalni odmerek za človeka) so vplivali na estrus cikluse, odmerki 3 mg/ kg (9- kratni maksimalni odmerek za človeka) pa so pri podganah vplivali na parametre reprodukcije.
Mutagenicity Olanzapine was not mutagenic or clastogenic in a full range of standard tests, which included bacterial mutation tests and in vitro and oral in vivo mammalian tests.
Olanzapin ni bil mutagen ali klastogen v širokem razponu standardnih testov, ki je vključeval teste mutiranja bakterij ter in vitro in in vivo teste na sesalcih.
Carcinogenicity Based on the results of oral studies in mice and rats, it was concluded that olanzapine is not carcinogenic.
Na podlagi izsledkov študij peroralnega olanzapina na miših in podganah je bilo zaključeno, da olanzapin ni kancerogen.
Solvent Croscarmellose sodium Mannitol Polysorbate 80 Water for injections Hydrochloric acid (for pH adjustment) Sodium hydroxide (for pH adjustment)
Premreženi natrijev karmelozat Manitol Polisorbat 80 Voda za injekcije Klorovodikova kislina (za prilagoditev pH) Natrijev hidroksid (za prilagoditev pH)
After reconstitution in the vial:
Po rekonstituciji viale:
Chemical and physical stability of the suspension in the vials has been demonstrated for 24 hours at 20-25 °C.
Suspenzija je kemijsko in fizikalno stabilna v viali 24 ur pri 20- 25 °C.
From a microbiological point of view, the product should be used immediately.
Iz mikrobiološkega vidika moramo zdravilo takoj uporabiti.
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 20-25°C.
16 pogoji pred uporabo odgovornost uporabnika in naj običajno ne presegajo 24 ur pri 20- 25 °C.
210 mg powder:
210 mg prašek:
Type I glass vial.
Viala iz stekla tipa I.
Bromobutyl stopper with rust colour seal.
Brombutilna zaporka z obročkom rjaste barve.
3 ml solvent:
3 ml vehikel:
Butyl stopper with purple seal.
Butilna zaporka s škrlatnim pečatom.
One carton contains one vial of powder and one vial of solvent.
Ena škatla vsebuje eno vialo s praškom in eno vialo vehikla.
16 6.6 Special precautions for disposal and other handling
6. 6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom
FOR INTRAMUSCULAR GLUTEAL INJECTION ONLY.
SAMO ZA GLOBOKO INTRAMUSKULARNO GLUTEALNO INJEKCIJO.
DO NOT ADMINSTER INTRAVENOUSLY OR SUBCUTANEOUSLY.
NE DAJAJTE INTRAVENSKO ALI SUBKUTANO.
RECONSTITUTION STEP 1:
REKONSTITUCIJA KORAK 1:
Assembling and preparing materials
Zbiranje in priprava materiala
Other materials needed:
Dodatno potreben material:
One 3 ml syringe Three 19-gauge, 35 mm needles for injection (For obese patients, 19-gauge, 50 mm needles are recommended)
Ena 3 ml injekcijska brizga Tri 19- gauge, 35 mm igle za injiciranje (Za debele bolnike priporočamo 19- gauge, 50 mm igle)
Reconstitute ZYPADHERA powder for suspension for injection only with the solvent for parenteral use provided in the pack using standard aseptic techniques for reconstitution of parenteral products.
ZYPADHERA prašek za suspenzijo za injiciranje rekonstituirajte samo z vehiklom za parenteralno uporabo, priloženim v pakiranju, z uporabo standardnih aseptičnih metod za rekonstitucijo parenteralnih zdravil.
ZYPADHERA powder for suspension for injection must not be combined in the syringe with any substance other than the solvent for parenteral use.
ZYPADHERA prašek za suspenzijo za injiciranje ne smete mešati v injekcijski brizgi z nobenim drugim zdravilom, razen z vehiklom za parenteralno uporabo.
Determining solvent volume for reconstitution This table provides the amount of solvent required to reconstitute ZYPADHERA powder for suspension for injection.
Določitev volumna vehikla za rekonstitucijo Ta tabela podaja količino vehikla potrebnega za rekonstitucijo ZYPADHERA praška za suspenzijo za injiciranje.
ZYPADHERA
Jakost viale
Volume of solvent to add
Volumen vehikla, ki ga
vial strength (mg) 210 300 405
ZYPADHERA (mg)
(ml) 1.3 1.8 2.3
(ml)
It is important to note that there is more solvent in the vial to reconstitute than is needed.
Pomembno je opozoriti, da je v viali več vehikla, kot ga je potrebno za rekonstitucijo.
STEP 3:
KORAK 3:
Reconstituting ZYPADHERA 1.
Rekonstitucija zdravila ZYPADHERA 1.
Inject the required solvent volume into the ZYPADHERA powder vial.
Injicirajte potreben volumen vehikla v vialo s praškom ZYPADHERA.
Remove the needle, holding the vial upright to prevent any loss of solvent.
Odstranite iglo in medtem držite vialo naravnost, da preprečite kakršnokoli izgubo vehikla.
Tap the vial firmly and repeatedly on a hard surface, protected to cushion impact, until no powder is visible.
Vialo dobro stresite ob trdo podlago, zaščiteno za omilitev stika, in ponavljajte, dokler ni vidnega nič praška.
Figure A:
17 Slika A:
Tap firmly to mix
Dobro stresite, da zmešate
Unsuspended powder appears as light yellow, dry clumps clinging to the bottom of the vial.
Nesuspendiran prašek se pojavi kot rumena, suha gruda, pritrjena na dno viale.
Check for unsuspended powder
Preverite, da ni nesuspendiranega praška
Vigorously shake vial
Močno pretresite vialo
If the product is not used right away, it should be shaken vigorously to re-suspend.
Če zdravila ne uporabite takoj, ga morate močno pretresti, da se ponovno suspendira.
ADMINISTRATION STEP 1:
DAJANJE KORAK 1:
Injecting ZYPADHERA This table confirms the final ZYPADHERA suspension volume to inject.
Injiciranje zdravila ZYPADHERA Ta tabela določa končne volumne suspenzije zdravila ZYPADHERA za injiciranje.
Suspension concentration is 150 mg/ ml.
Koncentracija suspenzije je 150 mg/ ml.
Final volume to inject
Končni volumen za
vial strength (mg) 210 210 300 405
ZYPADHERA (mg) 210 210 300 405
(ml) 1.0 1.4 2.0 2.7
injiciranje (ml) 1, 0 1, 4 2, 0 2, 7
Use a second needle and slowly withdraw the desired amount.
Uporabite drugo iglo in počasi izvlecite željeno količino.
Remove air bubbles to ensure a full dose.
Za zagotovitev celotnega odmerka odstranite zračne mehurčke.
Change to the third 19-gauge (35 mm or 50 mm) needle prior to injection.
Pred injiciranjem zamenjajte na novo 19- gauge (35 mm ali 50 mm) iglo.
Once ZYPADHERA has been removed from the vial into the syringe, it should be injected immediately.
Ko je zdravilo ZYPADHERA enkrat izvlečeno iz viale v injekcijsko brizgo, mora biti takoj injicirano.
DO NOT INJECT INTRAVENOUSLY.
NE INJICIRAJTE INTRAVENSKO.
Aspirate for several seconds to ensure no blood appears after insertion of the needle into the muscle.
Po vbodu igle v mišico, nekaj sekund aspirirajte za zagotovitev, da se ne pojavi kri.
If any blood is drawn into the syringe, the syringe and the dose should be discarded and fresh drug prepared.
Če v injekcijsko brizgo potegnete kakršnokoli količino krvi, injekcijsko brizgo in odmerek zavrzite ter pripravite novo zdravilo.
The injection should be performed with steady, continuous pressure.
Injiciranje mora biti izvedeno s trdnim, neprekinjenim pritiskanjem.
Discard the syringe, needles and any unused solvent in accordance with appropriate clinical procedures.
Zavrzite injekcijsko brizgo, igle in kakršenkoli neuporabljen vehikel v skladu z ustreznimi kliničnimi postopki.
Eli Lilly Nederland BV, Grootslag 1 – 5, NL-3991 RA, Houten, The Netherlands.
Eli Lilly Nederland BV, Grootslag 1 – 5, NL- 3991 RA, Houten, Nizozemska
EMEA/ H/ C/ 890/ 001 ZYPADHERA 210 mg - 1 vial + 1 vial
EMEA/ H/ C/ 890/ 001 ZYPADHERA 210 mg - 1 viala + 1 viala
DD/ MM/ YYYY
DD/ MM/ LLLL
ZYPADHERA 300 mg powder and solvent for prolonged release suspension for injection.
ZYPADHERA 300 mg prašek in vehikel za suspenzijo za injiciranje s podaljšanim sproščanjem
Each vial contains olanzapine pamoate monohydrate equivalent to 300 mg olanzapine.
Ena viala vsebuje olanzapinijev pamoat monohidrat, ki ustreza 300 mg olanzapina.
Do not confuse ZYPADHERA 300 mg powder and solvent for prolonged release suspension for injection with olanzapine 10 mg powder for solution for injection.
Ne zamenjajte zdravila ZYPADHERA 300 mg prašek in vehikel za suspenzijo za injiciranje s podaljšanim sproščanjem z olanzapin 10 mg praškom za raztopino za injiciranje.
20 Table 1
20 Tabela 1
21 Paediatric patients ZYPADHERA is not recommended for use in children and adolescents below 18 years due to a lack of data on safety and efficacy.
21 za uporabo pri otrocih in mladostnikih, mlajših od 18 let.
22 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 in mortality and the risk of cerebrovascular accident.
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
1.5%, respectively).
22%).
23 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
24 Tardive Dyskinesia In comparator studies of one year or less duration, olanzapine was associated with a statistically significant lower incidence of treatment emergent dyskinesia.
24 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.
Thus no particular interaction is expected as verified through in vivo studies where no inhibition of
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
25 metabolism of the following active substances was found: tricyclic antidepressant (representing mostly CYP2D6 pathway), warfarin (CYP2C9), theophylline (CYP1A2) or diazepam (CYP3A4 and 2C19).
25 (CYP3A4 in 2C19).
26 sedation (ZYPADHERA 8.2%, placebo 2.0%).
26 bolnikov.
28 4 Observed for fasting normal levels at baseline (< 5.56 mmol/ l) which increased to high (≥ 7 mmol/ l).
28 4 Opazovano pri osnovnih normalnih ravneh na tešče (< 5, 56 mmol/ l), ki so se povišale na visoke (≥ 7 mmol/ l).
29 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.
30 and circulatory collapse and support of respiratory function.
30 Za olanzapin ni specifičnega antidota.