FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Slovenian: Zdravila 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.
English: Clinical signs and symptoms included symptoms of sedation (ranging from mild in severity up to coma) and/or delirium (including confusion, disorientation, agitation, anxiety and other cognitive impairment).
Slovenian: Klinični znaki in simptomi so vključevali simptome sedacije (v razponu od blage do kome) in/ali delirija (vključno z zmedenostjo, neorientacijo, agitacijo, anksioznostjo in drugimi kognitivnimi poslabšanji).
English: Engage the needle safety device and remove needle from syringe.
Slovenian: Namestite varnostni pripomoček za iglo in odstranite iglo z injekcijske brizge.
English: Maintenance treatment of adult patients with schizophrenia sufficiently stabilised during acute treatment with oral olanzapine.
Slovenian: Vzdrževalno zdravljenje odraslih bolnikov s shizofrenijo, ki so med akutnim zdravljenjem zadostno stabilizirani s peroralno obliko olanzapina.
English: Maintenance dose after 2 months of ZYPADHERA treatment
Slovenian: Vzdrževalni odmerek po 2 mesecih zdravljenja z zdravilom
English: After each injection, patients should be observed in a healthcare facility by appropriately qualified personnel for at least 3 hours for signs and symptoms consistent with olanzapine overdose.
Slovenian: Po vsakem injiciranju mora ustrezno usposobljeno osebje v zdravstvenih ustanovah najmanj 3 ure opazovati bolnike za znake in simptome, značilne za preveliko odmerjanje olanzapina.
English: Solvent: clear, colourless to slightly yellow solution.
Slovenian: Prašek: trden rumen Vehikel: bistra, brezbarvna do rahlo rumena raztopina.
English: - Description of post injection syndrome - Recommendation for a 3-hour on-site observation period post injection - Recommendation for informing patients that for the remainder of the day of the injection, they should not drive or operate machinery, should be vigilant for signs and symptoms of a post injection syndrome event, and should be able to obtain assistance if needed - Description of the most common symptoms reported with olanzapine overdose that represent the clinical manifestation in post injection syndrome events - Recommendation for appropriate monitoring until the event resolves if an event should occur
Slovenian: - Opis sindroma po injiciranju - Priporočilo za 3-urno opazovanje na mestu po injiciranju - Priporočilo o obvestilu bolnikom, da preostanek dneva po injiciranju ne vozijo in ne upravljajo s stroji, da morajo biti pozorni na znake in simptome sindroma po injiciranju ter da morajo imeti možnost po potrebi poiskati pomoč - Opis najpogostejših simptomov, ki so jih poročali pri prevelikem odmerjanju olanzapina in predstavljajo klinično izražene učinke pri sindromu po injiciranju
English: Pneumonia, increased body temperature, lethargy, erythema, visual hallucinations and urinary incontinence were observed commonly.
Slovenian: povišano telesno temperaturo, letargijo, eritem, vidne halucinacije ter inkontinenco urina.
English: Patients treated with any antipsychoticmedicines, including ZYPADHERA, should be monitored regularly for lipids in accordance with utilised antipsychotic guidelines, e.g. at baseline, 12 weeks after starting olanzapine treatment and every 5 years thereafter.
Slovenian: vključno z zdravilom ZYPADHERA, moramo redno spremljati glede lipidov, v skladu z znanimi priporočili za antipsihotike, npr. na začetku, 12 tednov po začetku jemanja olanzapina in nato vsakih 5 let.
English: Other medicines and ZYPADHERA Tell your doctor if you are taking, have recently taken or might take any other medicines.
Slovenian: Obvestite svojega zdravnika, če jemljete ali ste pred kratkim jemali ali pa boste morda začeli jemati katerokoli drugo zdravilo.
English: 210 mg/2 weeks or 405 mg/4 weeks 150 mg/2 weeks or 300 mg/4 weeks
Slovenian: 10 mg/dan 210 mg/2 tedna ali 405 mg/4 tedne 150 mg/2 tedna ali 300 mg/4 tedne 15 mg/dan 300 mg/2 tedna
English: Open the pre-packaged Hypodermic syringe and needle with needle protection device.
Slovenian: Odprite predhodno pakiranje podkožne injekcijske brizge in igle z varnostnim pripomočkom za iglo.
English: Undesirable alterations in lipids have been observed in olanzapine-treated patients in placebo-controlled clinical trials (see section 4.8).
Slovenian: V kliničnih preskušanjih, kontroliranih s placebom, so pri bolnikih zdravljenih z olanzapinom opažali neželene spremembe lipidov (glejte poglavje 4.8).
English: Rare cases reported as NMS have also been received in association with oral olanzapine.
Slovenian: Poročali so tudi o redkih primerih NMS v povezavi s peroralnim olanzapinom.
English: Additional tapping may be required if clumps remain.
Slovenian: Če so grude še vedno prisotne, bo morda potrebno dodatno stresanje.
English: • an allergy (hypersensitivity) to olanzapine or any of the other ingredients of this medicine (listed in section 6).
Slovenian: • če ste alergični na (preobčutljivi za) olanzapin ali katerokoli sestavino tega zdravila
English: (See Figure B)
Slovenian: (Glejte Sliko B)
English: Potential for olanzapine to affect other medicinal products Olanzapine may antagonise the effects of direct and indirect dopamine agonists.
Slovenian: Olanzapin lahko nasprotuje učinkom direktnih in indirektnih dopaminskih agonistov.
English: Other common side effects (may affect up to 1 in 10 people) with ZYPADHERA include sleepiness and injection site pain.
Slovenian: Drugi pogosti neželeni učinki (lahko se pojavijo pri največ do 1 od 10 bolnikov) za zdravilo ZYPADHERA zaspanost in bolečino na mestu injiciranja.
English: Use in patients who are in an acutely agitated or severely psychotic state ZYPADHERA should not be used to treat patients with schizophrenia who are in an acutely agitated or severely psychotic state such that immediate symptom control is warranted.
Slovenian: Za zagotovitev takojšnjega nadzora simptomov, zdravila ZYPADHERA ne smemo uporabljati za zdravljenje bolnikov s shizofrenijo, ki so v akutno agitiranem ali hudem psihotičnem stanju.
English: An allergic reaction may be recognised as a rash, itching, a swollen face, swollen lips or shortness of breath.
Slovenian: Alergijsko reakcijo lahko prepoznate kot izpuščaj, srbenje,
English: • aggression
Slovenian: • nasilnost
English: Rare side effects (may affect up to 1 in 1000 people) include lowering of normal body temperature; abnormal rhythms of the heart; sudden unexplained death; inflammation of the pancreas causing severe stomach pain, fever and sickness; liver disease appearing as yellowing of the skin and white parts of the eyes; muscle disease presenting as unexplained aches and pains; and prolonged and/or painful erection.
Slovenian: Redki neželeni učinki (lahko se pojavijo pri največ 1 od 1.000 bolnikov) vključujejo znižanje normalne telesne temperature, motnje srčnega ritma, nenadno nerazložljivo smrt, vnetje trebušne slinavke, ki povzroča hude bolečine v predelu želodca, zvišano telesno temperaturo in slabost, obolenje jeter, ki se kaže kot obarvanje kože in beločnic na rumeno, mišične bolezni, ki se kažejo kot nerazložljive bolečinske težave in bolečine, podaljšano in/ali bolečo erekcijo.
English: 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.
Slovenian: 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
English: Because of this risk, do not drive or operate machinery for the remainder of the day after each injection.
Slovenian: Zaradi tveganja preostanek dneva po vsakem injiciranju ne vozite in ne upravljajte s stroji.
English: If the medicine is not used right away, it should be shaken vigorously to re-suspend.
Slovenian: Če zdravila ne uporabimo takoj, ga moramo močno pretresti, da se ponovno suspendira.
English: The frequency terms listed are defined as follows: Very common (≥ 1/10),
Slovenian: Našteti izrazi pogostnosti so definirani kot sledi: zelo pogosti
English: 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).
Slovenian: Med zdravljenjem z olanzapinom v kombinaciji z litijem ali divalproeksom se je pri 17,4 % bolnikov med akutnim zdravljenjem
English: Long-term exposure (at least 48 weeks)
Slovenian: S kratkoročnim zdravljenjem (srednje trajanje 47 dni)
English: Suspension concentration is 150 mg/ml olanzapine.
Slovenian: Koncentracija suspenzije je 150 mg/ml olanzapina.
English: MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IZDELOVALEC ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJE
English: 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.
Slovenian: 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,
English: Investigations Elevated plasma prolactin levels8
Slovenian: Zvišan plazemske koncentracije prolaktina8
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: After reconstitution: 150 mg/ml olanzapine.
Slovenian: Po rekonstituciji: 150 mg/ml olanzapina.
English: EU/1/08/479/002
Slovenian: EU/1/08/479/001 EU/1/08/479/002 EU/1/08/479/003
English: Patients should be treated initially with oral olanzapine before administering ZYPADHERA, to establish tolerability and response.
Slovenian: Pred dajanjem zdravila ZYPADHERA morajo biti bolniki najprej zdravljeni s peroralnim olanzapinom, da se ugotovi prenašanje in odziv.
English: ZYPADHERA has not been studied in the paediatric population.
Slovenian: Pediatrična populacija Zdravila ZYPADHERA pri mladostnikih niso preučevali.
English: 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).
Slovenian: (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do
English: Additional signs may include elevated creatine phosphokinase, myoglobinuria
Slovenian: Dodatni znaki lahko vključujejo zvišano kreatin-kinazo, mioglobinurijo (rabdomioliza) in akutno ledvično odpoved.
English: hypotonia, tremor, somnolence, respiratory distress, or feeding disorder.
Slovenian: zaspanost, nemir, težave z dihanjem in motnje hranjenja.
English: Ventricular tachycardia/fibrill ation, sudden death (see section
Slovenian: Prekatna tahikardija/fibrilacij a, nenadna smrt (glejte poglavje 4.4)11
English: 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).
Slovenian: 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
English: 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.
Slovenian: 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).
English: Adverse reactions seen with olanzapine pamoate
Slovenian: Neželeni učinki, ki so jih opazili pri olanzapinijevem pamoatu
English: 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).
Slovenian: v primerjavi z moškimi (27,3 l/h) ali pri nekadilcih (18,6 l/h) v primerjavi s kadilci (27,7 l/h).
English: The active substance is olanzapine.
Slovenian: Učinkovina je olanzapin.
English: • unusual movement (a common side effect that may affect up to 1 in 10 people) mainly of the face or tongue;
Slovenian: • nenavadne zgibke (pogost neželeni učinek, ki se lahko pojavi pri največ 1 od 10
English: METHOD OF ADMINISTRATION Read the package leaflet before use
Slovenian: POSTOPEK UPORABE ZDRAVILA Pred uporabo preberite priloženo navodilo.
English: Visually confirm that the needle is fully engaged into the needle protection sheath.
Slovenian: S pregledom zagotovite, da je igla popolnoma nameščena v varnostni pripomoček za iglo.
English: 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.
Slovenian: V primerih zmerno okvarjenega delovanja jeter (ciroza, Child-Pugh razreda A ali B) mora biti začetni odmerek
English: 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).
Slovenian: 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).
English: • difficulty walking
Slovenian: • težave pri hoji
English: • Liver or kidney disease
Slovenian: • obolenje jeter ali ledvic • bolezni krvi
English: 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.
Slovenian: 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.
English: Gynaecomastia/ breast enlargement in males
Slovenian: Ginekomastija/p ovečanje dojk pri moških
English: DO NOT INJECT INTRAVENOUSLY OR SUBCUTANEOUSLY.
Slovenian: NE INJICIRAJTE INTRAVENSKO ALI SUBKUTANO.
English: In the event of an injection site related adverse reaction occuring, appropriate measures to manage these events should be taken (see section
Slovenian: V primeru pojava neželenega učinka na mestu injiciranja, je za uravnavo teh učinkov potrebno izvesti ustrezne ukrepe
English: 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 %).
Slovenian: 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 %).
English: ZYPADHERA is given in doses of 150 mg to 300 mg every 2 weeks or 300 mg to 405 mg every 4 weeks.
Slovenian: 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.
English: • Vial of ZYPADHERA powder for prolonged release suspension for injection
Slovenian: • Vialo zdravila ZYPADHERA prašek za suspenzijo za injiciranje s podaljšanim sproščanjem
English: ZYPADHERA is not recommended for treatment in the elderly population unless a well-tolerated and effective dose regimen using oral olanzapine has been established.
Slovenian: Zdravila ZYPADHERA ne priporočamo za zdravljenje starejše populacije, razen če se dobro prenaša in je ugotovljen učinkovit režim odmerjanja z uporabo peroralnega olanzapina.
English: Determine which needle will be used to administer the injection to the patient.
Slovenian: Izberite iglo, ki jo boste uporabili za injiciranje.
English: • Vial of solvent for ZYPADHERA
Slovenian: • Vialo vehikla za zdravilo ZYPADHERA
English: Once withdrawn from vial into the syringe, the suspension should be used immediately.
Slovenian: Ko zdravilo enkrat izvlečemo iz viale v injekcijsko brizgo, moramo suspenzijo takoj uporabiti.
English: 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.
Slovenian: 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.
English: The side effects listed below have been observed when oral olanzapine has been given but may occur following administration of ZYPADHERA.
Slovenian: Po peroralnem jemanju olanzapina so pri bolnikih opazili neželene učinke, ki so navedeni spodaj, lahko pa se pojavijo tudi po dajanju zdravila ZYPADHERA.
English: • High blood sugar and high levels of fat (triglycerides and cholesterol) have been seen in patients taking ZYPADHERA.
Slovenian: • Pri bolnikih, ki so jemali zdravilo ZYPADHERA, so opazili visok nivo sladkorja v krvi in visok nivo maščob (trigliceridov in holesterola).
English: ZYPADHERA is a powder and solvent for prolonged release suspension for injection.
Slovenian: ZYPADHERA je prašek in vehikel za suspenzijo za injiciranje s podaljšanim sproščanjem.
English: • 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.
Slovenian: hitrega dihanja, znojenja, okorelosti mišic in omotičnosti ali zaspanosti; upočasnjeno dihanje, aspiracijo, visok ali nizek krvni tlak, motnje srčnega ritma.
English: 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.
Slovenian: 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
English: A decrease in the dose of olanzapine should be considered if treatment with an inhibitor of CYP1A2 is initiated.
Slovenian: Upoštevati je treba znižanje odmerka olanzapina, če se uvede zdravljenje z zaviralcem
English: The first, an 8-week, placebo controlled trial conducted in adult patients (n=404) who were experiencing acute psychotic symptoms.
Slovenian: Prvo, 8-tedensko, s placebom nadzorovano preskušanje so opravili pri odraslih bolnikih
English: 3 Observed for fasting normal levels at baseline (< 5.17 mmol/l) which increased to high (≥ 6.2 mmol/l).
Slovenian: 3Opazovano pri osnovnih normalnih ravneh na tešče (< 5,17 mmol/l), ki so se povišale na visoke (≥ 6,2 mmol/l).
English: While overdose is less likely with parenteral than oral medicinal products, reference information for oral olanzapine overdose is presented below:
Slovenian: Medtem ko je preveliko odmerjanje manj verjetno pri parenteralnih kot peroralnih zdravilih,
English: After reconstitution each ml of suspension contains 150 mg olanzapine.
Slovenian: Po rekonstituciji 1 ml suspenzije vsebuje 150 mg olanzapina.
English: (≥ 2.26 mmol/l).
Slovenian: (≥ 4,39 mmol/l - < 5,17 mmol/l) na visoke (≥ 5,17 mmol/l).
English: Based on the results of oral studies in mice and rats, it was concluded that olanzapine is not carcinogenic.
Slovenian: Na podlagi izsledkov študij peroralnega olanzapina na miših in podganah je bilo zaključeno,
English: Marketing Authorisation Holder Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands.
Slovenian: IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, Nizozemska
English: AS THE SHEATH IS PRESSED (Fig. 1), THE NEEDLE IS FIRMLY ENGAGED INTO THE SHEATH (Fig. 2).
Slovenian: KO JE ZAŠČITA PRITISNJENA (slika 1), JE IGLA POPOLNOMA NAMEŠČENA V
English: Injection site related adverse events
Slovenian: Neželeni učinki na mestu injiciranja
English: High creatine phosphokinase11 High Gamma Glutamyltransfera se 10
Slovenian: Visoka raven gamaglutamiltransferaze10
English: After reconstitution: 1ml suspension contains 150 mg/ml olanzapine.
Slovenian: Po rekonstituciji: 1 ml suspenzije vsebuje 150 mg/ml olanzapina.
English: What you need to know before you are given ZYPADHERA
Slovenian: Kaj morate vedeti, preden boste dobili zdravilo ZYPADHERA Zdravila ZYPADHERA ne uporabljajte:
English: Injection site pain
Slovenian: Bolečina na mestu injiciranja
English: - If you get any side effects, talk to your doctor or nurse.
Slovenian: − Če opazite katerikoli neželeni učinek, se posvetujte s svojim zdravnikom ali z medicinsko sestro.
English: 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.
Slovenian: ZYPADHERA prašek za suspenzijo za injiciranje s podaljšanim sproščanjem je na voljo kot rumen prašek v brezbarvni stekleni viali.
English: 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.
Slovenian: 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
English: • A recent heart attack, heart disease, sick sinus syndrome, (abnormal heart rhythms),
Slovenian: • nedavni srčni napad, srčno obolenje, sindrom bolezni sinusnega vozla (motnje srčnega ritma), nestabilna angina pektoris ali nizek krvni tlak
English: 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 %).
Slovenian: ≥ 7 % od osnovne telesne mase (kg) je bilo zelo pogosto (40,6 %), za ≥ 15 % pogosto (7,1 %) in za ≥ 25 % občasno (2,5 %).