natgillin/translations-raw huggingface dataset:
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.
Volume of solvent to add (ml)
Volumen vehikla, ki ga dodamo (ml)
• Hypodermic Device Safety Information and Instructions for Use leaflet
• Informacije o varnosti in Navodila za uporabo podkožne naprave.
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 sedation (ZYPADHERA 8.2%, placebo 2.0%).
V kliničnih preskušanjih z zdravilom ZYPADHERA so o samo enem neželenem učinku poročali s statistično značilno višjo stopnjo pri skupini z zdravilom ZYPADHERA kot v skupini s placebom, sedaciji (zdravilo ZYPADHERA 8,2 %, placebo 2,0 %).
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 19/11/2008
Datum pridobitve dovoljenja za promet: 19/11/2008 Datum zadnjega podaljšanja dovoljenja za promet: 26/08/2013
Driving and using machines Do not drive or operate machinery for the remainder of the day after each injection.
Vpliv na sposobnost upravljanja vozil in strojev Ne vozite ali upravljajte s stroji preostanek dneva po vsakem injiciranju.
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.
Acute (single-dose) toxicity
Akutna toksičnost (toksičnost po enkratnem odmerku)
Common: Elevated cholesterol levels15
Pogosti: Zvišane ravni holesterola15
Shake the vial vigorously until the suspension appears smooth and is consistent in color and texture.
Močno pretresite vialo, dokler ni suspenzija enakomerna ter skladne barve in sestave.
Consider referral to a dietician or help with a diet plan if necessary.
Če je potrebno, razmislite o obisku dietetika ali prosite za pomoč glede načina prehranjevanja.
Do not drink any alcohol if you have been given ZYPADHERA as together with alcohol it may make you feel drowsy.
Jemanje zdravila ZYPADHERA skupaj z alkoholom Če ste dobili zdravilo ZYPADHERA, ne pijte nobenega alkohola, saj lahko skupaj z alkoholom povzročita občutek zaspanosti.
In the same clinical trials, cerebrovascular adverse reactions (CVAEvents e.g., stroke, transient ischemic attack), including fatalities, were reported.
V istih kliničnih preskušanjih so poročali o cerebrovaskularnih neželenih učinkih (cerebrovascular adverse events - CVAE, npr. o možganski kapi, tranzitorni ishemični ataki), vključno s smrtnimi izidi.
Olanzapine administered with lithium or valproate resulted in increased levels (≥10%) of tremor, dry mouth, increased appetite, and weight gain.
Olanzapin dan z litijem ali valproatom je povzročil zvišane ravni (≥ 10 %) tresenja, suhih ust, povečanega apetita in povečanja telesne mase.
No studies on the effects on the ability to drive and use machines have been performed.
4.7 Vpliv na sposobnost vožnje in upravljanja s stroji Študije o vplivu na sposobnost vožnje in upravljanja s stroji niso bile izvedene.
If foam forms, let vial stand to allow foam to dissipate.
Če se tvori pena, pustite vialo stati nekaj časa, da pena razpade.
300 mg/2 weeks
300 mg/2 tedna
• Very rarely, medicines of this type may cause unusual movements mainly of the face or tongue or a combination of fever, faster breathing, sweating, muscle stiffness and drowsiness or sleepiness.
• Zelo redko tovrstna zdravila lahko povzročijo nenavadne zgibke predvsem v mišicah obraza ali jezika ali kombinacijo zvišanja telesne temperature, pospešenega dihanja, znojenja,
One vial of 3 ml solvent.
Ena viala s 3 ml vehikla.
Seat the needle firmly on the device with a push and a clockwise twist, then pull the needle cap straight away from the needle.
Čvrsto pritrdite iglo na pripomoček s pritiskom ter obračanjem v smeri urnega kazalca, nato potegnite pokrovček igle naravnost stran od igle.
What ZYPADHERA is and what it is used for What you need to know before you are given ZYPADHERA How ZYPADHERA is given
Kaj je zdravilo ZYPADHERA in zakaj ga uporabljamo Kaj morate vedeti, preden boste dobili zdravilo ZYPADHERA Kako dobite zdravilo ZYPADHERA
The effectiveness of ZYPADHERA in the treatment and maintenance treatment of schizophrenia is consistent with the established effectiveness of the oral formulation of olanzapine.
Učinkovitost zdravila ZYPADHERA pri zdravljenju in vzdrževanju zdravljenja shizofrenije je v skladu z ugotovljeno učinkovitostjo peroralne oblike olanzapina.
ZYPADHERA vial strength (mg)
Jakost viale ZYPADHERA (mg)
• A blocked intestine (Paralytic ileus)
• zapora črevesa (paralitični ileus)
In healthy elderly (65 and over) versus non-elderly subjects, the mean elimination half-life was prolonged (51.8 versus 33.8 hours) and the clearance was reduced (17.5 versus 18.2 l/hr).
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).
• blood clots in the veins (an uncommon side effect that may affect up to 1in 100 people) especially in the legs (symptoms include swelling, pain, and redness in the leg), which may travel through blood vessels to the lungs causing chest pain and difficulty in breathing.
• krvne strdke v venah (občasen neželeni učinek, ki se lahko pojavi pri največ 1 od 100 bolnikov), posebej v nogah (simptomi vključujejo otekanje, bolečino in rdečino na nogah), ki lahko po žilah potujejo v pljuča ter povzročijo bolečino v pljučih in težave z dihanjem.
Visually check the vial for clumps.
Dobro preglejte vialo glede grud.
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.
injiciranju zdravila ZYPADHERA se v mišičnem tkivu takoj začne počasno raztapljanje olanzapinijevega pamoata ter zagotavlja počasno, nenehno sproščanje olanzapina več kot štiri tedne.
Olanzapine does not inhibit the main CYP450 isoenzymes in vitro (e.g. 1A2, 2D6, 2C9, 2C19, 3A4).
Olanzapin ne zavira glavnih izoencimov CYP450 v pogojih in vitro (npr. 1A2, 2D6, 2C9,
Post-marketing reports of post-injection syndrome since the marketing authorization of ZYPADHERA are generally consistent with the experience seen in clinical studies.
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.
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.
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.
Powder None
Prašek Brez
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).
Once the suspension has been removed from the vial, it should be injected immediately.
Ko je suspenzija enkrat izvlečena iz viale, mora biti takoj injicirana.
Hyperglycaemia and diabetes
Hiperglikemija in sladkorna bolezen
Rare side effects (may affect up to 1 in 1000 people) with ZYPADHERA include injection site infection.
Redki neželeni učinki (lahko se pojavijo pri največ 1 od 1.000 bolnikov) za zdravilo ZYPADHERA vključujejo okužbo na mestu injiciranja.
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).
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 %).
(See Figure A)
(Glejte Sliko A)
Post-injection syndrome reactions have occurred with ZYPADHERA leading to symptoms consistent with olanzapine overdose (see sections 4.2 and 4.4).
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).
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).
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).
Olanzapine-treated patients had a lower incidence of Parkinsonism, akathisia and dystonia compared with titrated doses of haloperidol.
olanzapinom zdravljeni bolniki so imeli manjšo incidenco parkinsonizma, akatizije in distonije v primerjavi s titriranimi odmerki haloperidola.
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.
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.
The predominant pharmacologic activity is from the parent, olanzapine.
Prevladujoča farmakološka aktivnost izvira iz samega olanzapina.
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- България Тел: + 359 2 491 41 40
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.
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.
Seizures where in most cases a history of seizures or risk factors for seizures were reported11
Epileptični napadi, pri katerih so jih v večini primerov imeli že kdaj prej ali so poročali o dejavnikih tveganja za epileptične napade11 Distonija
210 mg/2 weeks or 405 mg/4 weeks
210 mg/2 tedna ali 405 mg/4 tedne
• One 19-gauge, 38 mm Hypodermic safety needle
• Eno 19-gauge, 38 mm podkožno varnostno iglo
Figure A: Tap firmly to mix 10.
Slika A: Dobro stresite, da zmešate 10.
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.
KORAK 2: Določitev volumna vehikla za rekonstitucijo Ta tabela podaja količino vehikla potrebnega za rekonstitucijo ZYPADHERA praška za suspenzijo za injiciranje s podaljšanim sproščanjem.
No specific investigations have been conducted in the elderly with ZYPADHERA.
Specifičnih preiskav z zdravilom ZYPADHERA pri starejših osebah niso opravili.
The major circulating metabolite is the 10-N-glucuronide.
V krvi je poglavitni metabolit 10-N-glukuronid.
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 znaki in simptomi izzveneli.
Age > 75 years and vascular/mixed type dementia were identified as risk factors for CVAE in association with olanzapine treatment.
Starost > 75 let in vaskularna/mešana demenca sta bili določeni kot dejavnika, ki prispevata k tveganju za
Figure C: Vigorously shake vial
Slika C: Močno pretresite vialo
STEP 1: Preparing materials Pack includes:
KORAK 1: Priprava materiala
• Stroke or “mini” stroke (temporary symptoms of stroke)
• možganska kap ali »majhna« možganska kap (prehodni znaki kapi)
If you miss an injection of ZYPADHERA
Če ste izpustili injekcijo zdravila ZYPADHERA
Distribution Oral olanzapine is rapidly distributed.
Peroralni olanzapin se porazdeli hitro.
Olanzapine demonstrated a greater in vitro affinity for serotonin 5-HT2 than dopamine D2 receptors and greater 5HT2 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.
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).
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.
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.
ZYPADHERA is not recommended to be started in patients >75 years (see section 4.4).
pri bolnikih > 75 let ni priporočeno (glejte poglavje 4.4).
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.
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.
STEP 1: Injecting ZYPADHERA
KORAK 1: Injiciranje zdravila ZYPADHERA
Oral olanzapine was started at 2.5 mg/day and titrated to a maximum of 15 mg/day based on investigator judgement.
2,5 mg na dan in nato postopoma zviševan do najvišjega odmerka 15 mg na dan na podlagi presoje preiskovalca.
Unsuspended powder appears as yellow, dry clumps clinging to the vial.
Nesuspendiran prašek se pojavi kot rumena, suha gruda, na steni viale.
Supplementation with oral olanzapine was not authorised in double-blind clinical studies.
V dvojno slepih kliničnih študijah ni bilo dovoljeno dopolnjevanje s peroralnim olanzapinom.
Intramuscular use.
Za intramuskularno uporabo.
Caution should be exercised in patients who receive medicinal products that can induce hypotension or sedation.
Pri bolnikih, ki prejemajo zdravila, ki lahko vplivajo na hipotenzijo ali sedacijo, je potrebna previdnost.
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.
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,
Elevated cholesterol levels2,3
Zvišane ravni holesterola2,3
In comparator studies of one year or less duration, olanzapine was associated with a statistically significant lower incidence of treatment emergent dyskinesia.
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.
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 statistično značilno večja znižanja celokupnega PANSS rezultata v primerjavi s placebom (-8,6; -8,2 oziroma -5,2).
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%).
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 %).
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).
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).
(See Figure C)
(Glejte Sliko C)
FOR INTRAMUSCULAR USE ONLY.
SAMO ZA INTRAMUSKULARNO UPORABO.
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).
• 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.
• pretirano zaspanost, omotico, zmedenost, dezorientacijo, težave pri govoru, težave pri hoji, okorelost ali tresenje mišic, šibkost, razdražljivost, agresijo, anksioznost,
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.
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.
FOR DEEP INTRAMUSCULAR GLUTEAL INJECTION ONLY.
SAMO ZA GLOBOKO, INTRAMUSKULARNO, GLUTEALNO INJICIRANJE.
Clinical monitoring is recommended and an increase of olanzapine dose may be considered if necessary (see section 4.5).
Priporoča se klinično spremljanje in če je potrebno, se lahko presodi o povišanju odmerka olanzapina (glejte poglavje 4.5).
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.).
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).
This table confirms the final ZYPADHERA suspension volume to inject.
Ta tabela določa končne volumne suspenzije zdravila ZYPADHERA za injiciranje.
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.
(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.
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.
Perform a one-handed technique by GENTLY pressing the sheath against a flat surface.
Metodo ene-roke izvedite z NEŽNIM pritiskanjem zaščite proti ravni površini.
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).
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).
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).
Table 1 Recommended dose scheme between oral olanzapine and ZYPADHERA Target oral olanzapine dose Recommended starting dose of ZYPADHERA
Tabela 1 Priporočena shema odmerjanja med peroralnim olanzapinom in zdravilom ZYPADHERA Ciljni odmerek peroralnega olanzapina
The solvent excipients are carmellose sodium, mannitol, polysorbate 80, water for injections, hydrochloric acid, sodium hydroxide.
Pomožne snovi vehikla so natrijev karmelozat, manitol, polisorbat 80, voda za injekcije, klorovodikova kislina, natrijev hidroksid.
Carmellose sodium Mannitol
Natrijev karmelozat