natgillin/translations-raw huggingface dataset:
Due to the slow dissolution of the olanzapine pamoate salt which provides a slow continuous release of olanzapine that is complete approximately six to eight months after the last injection, supervision by a clinician, especially during the first 2 months after discontinuation of ZYPADHERA, is needed when switching to another antipsychotic product and is considered medically appropriate. 
Sistemsko zbranih podatkov glede prehoda bolnikov z zdravilom ZYPADHERA na druga antipsihotična zdravila ni. Zaradi počasnega raztapljanja soli olanzapinijevaga pamoata, ki omogoča počasno, nenehno sproščanje olanzapina in se zaključi šest do osem mesecev po zadnjem injiciranju, je potreben nadzor zdravnika, zlasti prva 2 meseca po prekinitvi zdravila
Because of this risk, do not drive or operate machinery for the remainder of the day after each injection. 
Zaradi tveganja preostanek dneva po vsakem injiciranju ne vozite in ne upravljajte s stroji.
If the medicine is not used right away, it should be shaken vigorously to re-suspend. 
Če zdravila ne uporabimo takoj, ga moramo močno pretresti, da se ponovno suspendira.
The frequency terms listed are defined as follows: Very common (≥ 1/10), 
Našteti izrazi pogostnosti so definirani kot sledi: zelo pogosti
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
Long-term exposure (at least 48 weeks) 
S kratkoročnim zdravljenjem (srednje trajanje 47 dni)
MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 
A. IZDELOVALEC ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJE
The most commonly reported injection site related adverse reaction was pain (5%); some other injection site adverse reactions reported were (in decreasing frequency): nodule type reactions, erythema type reactions, non-specific injection site reactions, irritation, oedema type reactions, bruising, haemorrhage, and anaesthesia. 
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,
Investigations Elevated plasma prolactin levels8 
Zvišan plazemske koncentracije prolaktina8
Very common symptoms in overdose (>10% incidence) include tachycardia, agitation/aggressiveness, dysarthria, various extrapyramidal symptoms, and reduced level of consciousness ranging from sedation to coma. 
Znaki in simptomi Zelo pogosti simptomi pri prevelikem odmerjanju (incidenca > 10 %) vključujejo tahikardijo, vznemirjenost/nasilnost, dizartrijo, različne ekstrapiramidne simptome in motnje zavesti v razponu od sedacije do kome.
Your doctor or nurse will make it into a suspension that will be given as an injection using the vial of solvent for ZYPADHERA that comes as a clear, colourless to slightly yellow solution in a clear glass vial. 
Vaš zdravnik ali medicinska sestra bosta z uporabo viale vehikla za zdravilo ZYPADHERA , ki je bistra, brezbarvna do rahlo rumena raztopina v brezbarvni stekleni viali, pripravila iz praška suspenzijo, ki vam jo bodo injicirali.
After reconstitution: 150 mg/ml olanzapine. 
Po rekonstituciji: 150 mg/ml olanzapina.
EU/1/08/479/002 
EU/1/08/479/001 EU/1/08/479/002 EU/1/08/479/003
Patients should be treated initially with oral olanzapine before administering ZYPADHERA, to establish tolerability and response. 
Pred dajanjem zdravila ZYPADHERA morajo biti bolniki najprej zdravljeni s peroralnim olanzapinom, da se ugotovi prenašanje in odziv.
ZYPADHERA has not been studied in the paediatric population. 
Pediatrična populacija Zdravila ZYPADHERA pri mladostnikih niso preučevali.
common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the data available). 
(≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do
Additional signs may include elevated creatine phosphokinase, myoglobinuria 
Dodatni znaki lahko vključujejo zvišano kreatin-kinazo, mioglobinurijo (rabdomioliza) in akutno ledvično odpoved.
hypotonia, tremor, somnolence, respiratory distress, or feeding disorder. 
zaspanost, nemir, težave z dihanjem in motnje hranjenja.
Ventricular tachycardia/fibrill ation, sudden death (see section 
Prekatna tahikardija/fibrilacij a, nenadna smrt (glejte poglavje 4.4)11
There was a 3-fold increase in CVAE in patients treated with oral olanzapine compared to patients treated with placebo (1.3% vs. 0.4%, respectively). 
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
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).
Adverse reactions seen with olanzapine pamoate 
Neželeni učinki, ki so jih opazili pri olanzapinijevem pamoatu
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). 
v primerjavi z moškimi (27,3 l/h) ali pri nekadilcih (18,6 l/h) v primerjavi s kadilci (27,7 l/h).
The active substance is olanzapine. 
Učinkovina je olanzapin.
• unusual movement (a common side effect that may affect up to 1 in 10 people) mainly of the face or tongue; 
• nenavadne zgibke (pogost neželeni učinek, ki se lahko pojavi pri največ 1 od 10
METHOD OF ADMINISTRATION Read the package leaflet before use 
POSTOPEK UPORABE ZDRAVILA Pred uporabo preberite priloženo navodilo.
Visually confirm that the needle is fully engaged into the needle protection sheath. 
S pregledom zagotovite, da je igla popolnoma nameščena v varnostni pripomoček za iglo.
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
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).
• difficulty walking 
• težave pri hoji
• Liver or kidney disease 
• obolenje jeter ali ledvic • bolezni krvi
ZYPADHERA 210 mg, 300 mg or 405 mg powder and solvent for prolonged release suspension for injection must not be confused with olanzapine 10 mg powder for solution for injection. 
Zdravila ZYPADHERA 210 mg, 300 mg ali 405 mg prašek in vehikel za suspenzijo za injiciranje s podaljšanim sproščanjem ne smete zamenjati z olanzapin 10 mg praškom za raztopino za injiciranje.
Gynaecomastia/ breast enlargement in males 
Ginekomastija/p ovečanje dojk pri moških
DO NOT INJECT INTRAVENOUSLY OR SUBCUTANEOUSLY. 
NE INJICIRAJTE INTRAVENSKO ALI SUBKUTANO.
In the event of an injection site related adverse reaction occuring, appropriate measures to manage these events should be taken (see section 
V primeru pojava neželenega učinka na mestu injiciranja, je za uravnavo teh učinkov potrebno izvesti ustrezne ukrepe
Following short term treatment (median duration 47 days), weight gain ≥ 7% of baseline body weight was very common (22.2 %), ≥ 15 % was common (4.2 %) and ≥ 25 % was uncommon (0.8 %). 
povezano zvečanje telesne mase za ≥ 7 % od osnovne telesne mase je bilo zelo pogosto (22,2 %), za ≥ 15 % pogosto (4,2 %) in za ≥ 25 % občasno (0,8 %).
ZYPADHERA is given in doses of 150 mg to 300 mg every 2 weeks or 300 mg to 405 mg every 4 weeks. 
Zdravilo ZYPADHERA se običajno da v odmerkih po 150 mg do 300 mg vsake 2 tedna ali 300 mg do 405 mg vsake 4 tedne.
• Vial of ZYPADHERA powder for prolonged release suspension for injection 
• Vialo zdravila ZYPADHERA prašek za suspenzijo za injiciranje s podaljšanim sproščanjem
ZYPADHERA is not recommended for treatment in the elderly population unless a well-tolerated and effective dose 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.
Determine which needle will be used to administer the injection to the patient. 
Izberite iglo, ki jo boste uporabili za injiciranje.
• Vial of solvent for ZYPADHERA 
• Vialo vehikla za zdravilo ZYPADHERA
Once withdrawn from vial into the syringe, the suspension should be used immediately. 
Ko zdravilo enkrat izvlečemo iz viale v injekcijsko brizgo, moramo suspenzijo takoj uporabiti.
anticholinergic effects, transient asymptomatic elevations of hepatic aminotransferases (see section 4.4), rash, asthenia, fatigue, pyrexia, arthralgia, increased alkaline phosphatase, high gamma glutamyltransferase, high uric acid, high creatine phosphokinase and oedema. 
glikozurija, povečan apetit, omotica, akatizija, parkinsonizem, levkopenija, nevtropenija (glejte poglavje 4.4), diskinezija, ortostatska hipotenzija, antiholinergični učinki, prehodna asimptomatska zvišanja jetrnih aminotransferaz (glejte poglavje 4.4), izpuščaj, astenija, utrujenost, pireksija, artralgija, zvišana alkalna fosfataza, visoka raven gama glutamiltransferaze, visoka raven sečne kisline, visoka raven kreatin-fosfokinaze in edem.
The side effects listed below have been observed when oral olanzapine has been given but may occur following administration of ZYPADHERA. 
Po peroralnem jemanju olanzapina so pri bolnikih opazili neželene učinke, ki so navedeni spodaj, lahko pa se pojavijo tudi po dajanju zdravila ZYPADHERA.
• High blood sugar and high levels of fat (triglycerides and cholesterol) have been seen in patients taking ZYPADHERA. 
• Pri bolnikih, ki so jemali zdravilo ZYPADHERA, so opazili visok nivo sladkorja v krvi in visok nivo maščob (trigliceridov in holesterola).
ZYPADHERA is a powder and solvent for prolonged release suspension for injection. 
ZYPADHERA je prašek in vehikel za suspenzijo za injiciranje s podaljšanim sproščanjem.
• acute confusion, seizures (epilepsy), coma, a combination of fever, faster breathing, sweating, muscle stiffness, and drowsiness or sleepiness; slower breathing, aspiration, high or low blood pressure, abnormal rhythms of the heart. 
hitrega dihanja, znojenja, okorelosti mišic in omotičnosti ali zaspanosti; upočasnjeno dihanje, aspiracijo, visok ali nizek krvni tlak, motnje srčnega ritma.
However, caution should be exercised when olanzapine is prescribed with medicines known to increase QTc interval, especially in the elderly, in patients with congenital long QT syndrome, congestive heart failure, heart hypertrophy, hypokalaemia or hypomagnesaemia. 
Vendar pa je potrebna previdnost, kadar predpisujemo olanzapin skupaj z zdravili, za katera je znano, da podaljšujejo QTc interval, posebno pri starejših, pri bolnikih s prirojenim sindromom dolgega
A decrease in the dose of olanzapine should be considered if treatment with an inhibitor of CYP1A2 is initiated. 
Upoštevati je treba znižanje odmerka olanzapina, če se uvede zdravljenje z zaviralcem
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
3 Observed for fasting normal levels at baseline (< 5.17 mmol/l) which increased to high (≥ 6.2 mmol/l). 
3Opazovano pri osnovnih normalnih ravneh na tešče (< 5,17 mmol/l), ki so se povišale na visoke (≥ 6,2 mmol/l).
While overdose is less likely with parenteral than oral medicinal products, reference information for oral olanzapine overdose is presented below: 
Medtem ko je preveliko odmerjanje manj verjetno pri parenteralnih kot peroralnih zdravilih,
After reconstitution each ml of suspension contains 150 mg olanzapine. 
Po rekonstituciji 1 ml suspenzije vsebuje 150 mg olanzapina.
(≥ 2.26 mmol/l). 
(≥ 4,39 mmol/l - < 5,17 mmol/l) na visoke (≥ 5,17 mmol/l).
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,
Marketing Authorisation Holder Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands. 
IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, Nizozemska
AS THE SHEATH IS PRESSED (Fig. 1), THE NEEDLE IS FIRMLY ENGAGED INTO THE SHEATH (Fig. 2). 
KO JE ZAŠČITA PRITISNJENA (slika 1), JE IGLA POPOLNOMA NAMEŠČENA V
Injection site related adverse events 
Neželeni učinki na mestu injiciranja
High creatine phosphokinase11 High Gamma Glutamyltransfera se 10 
Visoka raven gamaglutamiltransferaze10
After reconstitution: 1ml suspension contains 150 mg/ml olanzapine. 
Po rekonstituciji: 1 ml suspenzije vsebuje 150 mg/ml olanzapina.
What you need to know before you are given ZYPADHERA 
Kaj morate vedeti, preden boste dobili zdravilo ZYPADHERA Zdravila ZYPADHERA ne uporabljajte:
Injection site pain 
Bolečina na mestu injiciranja
- If you get any side effects, talk to your doctor or nurse. 
− Če opazite katerikoli neželeni učinek, se posvetujte s svojim zdravnikom ali z medicinsko sestro.
What ZYPADHERA looks like and contents of the pack ZYPADHERA powder for prolonged release suspension for injection comes as a yellow powder in a clear glass vial. 
ZYPADHERA prašek za suspenzijo za injiciranje s podaljšanim sproščanjem je na voljo kot rumen prašek v brezbarvni stekleni viali.
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 vsaka 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. Plazemske koncentracije olanzapina, ki so jih opazovali v razponu odmerka od 150 mg vsake 4 tedne do 300 mg vsaka 2 tedna, kažejo na povišano sistemsko izpostavljenost olanzapinu pri zvišanih odmerkih zdravila
• A recent heart attack, heart disease, sick sinus syndrome, (abnormal heart rhythms), 
• nedavni srčni napad, srčno obolenje, sindrom bolezni sinusnega vozla (motnje srčnega ritma), nestabilna angina pektoris ali nizek krvni tlak
13 Following short term treatment (median duration 22 days), weight gain ≥ 7% of baseline body weight (kg) was very common (40.6 %), ≥ 15% of baseline body weight was common (7.1 %) and ≥ 25 % was common (2.5 %). 
≥ 7 % od osnovne telesne mase (kg) je bilo zelo pogosto (40,6 %), za ≥ 15 % pogosto (7,1 %) in za ≥ 25 % občasno (2,5 %).
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.
12 Adverse event identified from spontaneous post-marketing reporting with frequency estimated at the upper limit of the 95% confidence interval utilising the Olanzapine Integrated Database. 
ocenjeno na zgornjo mejo 95 % intervala zaupanja, določeno z uporabo integrirane baze podatkov za olanzapin.
The metabolism of olanzapine may be induced by smoking. 
Kajenje lahko inducira presnavljanje olanzapina.
NAME OF THE MEDICINAL PRODUCT 
Imetnik dovoljenja za promet z zdravilom
Thromboembolis m (including pulmonary embolism and deep vein thrombosis) (see section 4.4) 
(vključno s pljučno embolijo in globoko vensko trombozo) (glejte poglavje
ZYPADHERA should only be administered by deep intramuscular gluteal injection by a healthcare professional trained in the appropriate injection technique and in locations where post-injection observation and access to appropriate medical care in the case of overdose can be assured. 
Uporablja se ga lahko le tam, kjer je možno opazovanje bolnika po injiciranju in kjer je možno zagotoviti ustrezne medicinske ukrepe v primeru prevelikega odmerjanja.
Olanzapine pamoate monohydrate equivalent to 405 mg olanzapine. 
Olanzapinijev pamoat monohidrat, ki ustreza 405 mg olanzapina.
However, the incidence of death was higher in oral olanzapine-treated than in placebo-treated patients independent of these risk factors. 
neodvisno od omenjenih dejavnikov tveganja, večja pri bolnikih zdravljenih s peroralnim olanzapinom, kot pri bolnikih zdravljenih s placebom.
What ZYPADHERA contains 
Kaj vsebuje zdravilo ZYPADHERA
Other common side effects (may affect up to 1 in 10 people) include changes in the levels of some blood cells, circulating fats and in early treatment, temporary increases in liver enzymes; increases in the level of sugars in the blood and urine; increases in levels of uric acid and creatine phosphokinase in the blood; feeling more hungry; dizziness; restlessness; tremor; unusual movements (dyskinesias); constipation; dry mouth; rash; loss of strength; extreme tiredness; water retention leading to swelling of the hands, ankles or feet; fever; joint pain; and sexual dysfunctions such as decreased libido in males and females or erectile dysfunction in males. 
Drugi pogosti neželeni učinki (lahko se pojavijo pri največ 1 od 10 bolnikov) vključujejo spremembe v ravneh nekaterih krvnih celic in maščob v krvnem obtoku in v začetnih obdobjih zdravljenja, začasno zvišanje jetrnih encimov, zvišanja v ravni sladkorjev v krvi in urinu, zvišanja v ravni sečne kisline in kreatin-fosfokinaze v krvi, večji občutek lakote, omotico, nemirnost, tresenje, nenavadne gibe (diskinezijo), zaprtje, suha usta, izpuščaj,
20 mg/day 
20 mg/dan 300 mg/2 tedna
If this has happened to you, tell your nurse or doctor. 
povejte svoji medicinski sestri ali zdravniku.
For obese patients, the 50 mm needle is recommended for injection: If the 50 mm needle is to be used for injection, attach the 38 mm safety needle to the syringe to withdraw the required suspension volume. 
Če boste za injiciranje uporabili 50 mm iglo, pritrdite na injekcijsko brizgo 38 mm varnostno iglo, da izvlečete potrebni volumen suspenzije.
Olanzapine pamoate monohydrate equivalent to 300 mg olanzapine. 
Olanzapinijev pamoat monohidrat, ki ustreza 300 mg olanzapina.
• Diabetes 
• sladkorna bolezen
One vial of powder for prolonged release suspension for injection. 
Ena viala s praškom za suspenzijo za injiciranje s podaljšanim sproščanjem.
Dystonia (including oculogyration)11 Tardive dyskinesia11 
(vključno z okulogiracijo)11
Other uncommon side effects (may affect up to 1 in 100 people) include hypersensitivity (e.g. swelling in the mouth and throat, itching; rash); diabetes or the worsening of diabetes, occasionally associated with ketoacidosis (ketones in the blood and urine) or coma; seizures, usually associated with a history of seizures (epilepsy); muscle stiffness or spasms (including eye movements); restless legs syndrome; problems with speech; stuttering; slow heart rate; sensitivity to sunlight; bleeding from the nose: abdominal distension; memory loss or forgetfulness; urinary incontinence; lack of ability to urinate; hair loss; absence or decrease in menstrual periods; and changes in breasts in males and females such as an abnormal production of breast milk or abnormal growth. 
Drugi občasni neželeni učinki (lahko se pojavijo pri največ 1 od 100 bolnikov) vključujejo preobčutljivost (npr. otekanje v ustih in grlu, srbenje, izpuščaj), sladkorno bolezen ali poslabšanje sladkorne bolezni, občasno povezano s ketoacidozo (ketoni v krvi in urinu) ali komo, krče, običajno povezane s krči (epileptičnimi napadi) v preteklosti, mišično okorelost ali krče (vključno z obračanjem zrkel), sindrom nemirnih nog, težave pri govoru, jecljanje,
Attach the selected 50 mm or 38 mm safety needle to the syringe prior to injection. 
Pred injiciranjem pritrdite na injekcijsko brizgo izbrano 50 mm ali 38 mm varnostno iglo.
ZYPADHERA 405 mg: Each vial contains olanzapine pamoate monohydrate equivalent to 405 mg olanzapine. 
Zdravilo ZYPADHERA 405 mg: Ena viala vsebuje olanzapinijev pamoat monohidrat, ki ustreza 405 mg olanzapina.
• Weight gain has been seen in patients taking ZYPADHERA. 
• Pri bolnikih, ki so jemali zdravilo ZYPADHERA, so opazili porast telesne mase.
In clinical trials with ZYPADHERA the incidence of injection site related adverse reactions was approximately 8%. 
povezanih z mestom injiciranja, približno 8 %.
ZYPADHERA 300 mg: Each vial contains olanzapine pamoate monohydrate equivalent to 300 mg olanzapine. 
Zdravilo ZYPADHERA 300 mg: Ena viala vsebuje olanzapinijev pamoat monohidrat, ki ustreza 300 mg olanzapina.
ZYPADHERA 210 mg: Each vial contains olanzapine pamoate monohydrate equivalent to 210 mg olanzapine. 
Zdravilo ZYPADHERA 210 mg: Ena viala vsebuje olanzapinijev pamoat monohidrat, ki ustreza 210 mg olanzapina.
Olanzapine pamoate monohydrate equivalent to 210 mg olanzapine. 
Olanzapinijev pamoat monohidrat, ki ustreza 210 mg olanzapina.
ZYPADHERA 210 mg powder: Type I glass vial. 
ZYPADHERA 210 mg prašek: Viala iz stekla tipa I. Brombutilna zaporka z obročkom rjaste barve.
Acute symptoms such as sweating, insomnia, tremor, anxiety, nausea, or vomiting have been reported rarely (≥0.01% and <0.1%) when oral olanzapine is stopped abruptly. 
Redko (≥ 0,01 % in < 0,1 %) so pri nenadni prekinitvi zdravljenja s peroralnim olanzapinom poročali o akutnih simptomih, kot so znojenje, nespečnost, tresenje, občutek tesnobe, slabost ali bruhanje.
Increased alkaline phosphatase10 
Visoka raven kreatinfosfokinaze11
Solvent for ZYPADHERA 
Vehikel za zdravilo ZYPADHERA
How to store ZYPADHERA 
Kako uporabljati zdravilo ZYPADHERA
3 ml solvent: Type I glass vial. 
3 ml vehikel: Viala iz stekla tipa I. Butilna zaporka s škrlatnim pečatom.
RECONSTITUTION AND ADMINISTRATION INSTRUCTIONS 
OZNAČEVANJE IN NAVODILO ZA UPORABO
Supplementation 
Dopolnjevanje
The mean increase in olanzapine AUC was 52 % and 108 % respectively. 
52 % oziroma 108 %.
Studies in patients aged 13-17 years showed various adverse reactions, including weight gain, changes in metabolic parameters and increases in prolactin levels (see sections 4.8 and 5.1). 
spremembami v kazalcih presnove in zvišanjih ravni prolaktina (glejte poglavji 4.8 in 5.1).
A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer responsible for batch release Lilly S.A., Avda. 
Ime in naslov izdelovalca, odgovornega za sproščanje serije
Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status, and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis, and cardiac dysrhythmia). 
Klinične manifestacije NMS so zvišana telesna temperatura, okorelost mišic, motnje zavesti in znaki avtonomne nestabilnosti
Photosensitivity reaction 
Fotosenzitivnost ne reakcije Alopecija
These reactions occurred in <0.1% of injections and approximately 2% of patients. 
Med pre-marketinškimi kliničnimi študijami so se pri < 0,1 % injiciranj in približno 2 % bolnikov pojavili učinki, ki so vključevali znake in simptome, značilne za preveliko odmerjanje olanzapina.
ZYPADHERA 405 mg powder: Type I glass vial. 
ZYPADHERA 405 mg prašek: Viala iz stekla tipa I. Brombutilna zaporka z obročkom jekleno modre barve.
Restless Legs Syndrome 
Nevroleptični maligni sindrom