FrancophonIA/ELRC3.0 huggingface dataset:
English: In comparator studies of one year or less duration, olanzapine was associated with a statistically significant lower incidence of treatment emergent dyskinesia.
Croatian: U poredbenim ispitivanjima u trajanju od godinu dana ili kraće olanzapin je bio povezan sa statistički značajno manjom incidencijom diskinezije koja se javlja uslijed liječenja.
English: Volume of solvent to add (ml)
Croatian: Volumen otapala koji se dodaje (ml)
English: A lower starting dose of olanzapine should be considered in patients who are using fluvoxamine or any other CYP1A2 inhibitors, such as ciprofloxacin.
Croatian: Stoga se mora razmotriti primjena niže početne doze olanzapina u bolesnika koji se liječe fluvoksaminom ili nekim drugim inhibitorima CYP1A2, npr. ciprofloksacinom.
English: Olanzapine had no teratogenic effects.
Croatian: Reproduktivna toksičnost Olanzapin nije pokazao teratogene učinke.
English: Ventricular tachycardia/fibrill ation, sudden death (see section
Croatian: ventrikularna tahikardija/ fibrilacija iznenadna smrt (vidjeti dio 4.4)11
English: Risk factors that may predispose this patient population to increased mortality include age > 65 years, dysphagia, sedation, malnutrition and dehydration, pulmonary conditions (e.g., pneumonia, with or without aspiration), or concomitant use of benzodiazepines.
Croatian: Čimbenici rizika za povećanu smrtnost u ovih bolesnika su dob > 65 godina, disfagija, sedacija, malnutricija i dehidracija, plućne bolesti (npr. pneumonija s aspiracijom ili bez nje) ili istodobna primjena benzodiazepina.
English: Growth parameters were decreased at high doses.
Croatian: Kod visokih doza su bili sniženi pokazatelji rasta.
English: 8 In clinical trials of up to 12 weeks, plasma prolactin concentrations exceeded the upper limit of normal range in approximately 30% of olanzapine treated patients with normal baseline prolactin value.
Croatian: 8 U kliničkim ispitivanjima u trajanju do 12 tjedana, koncentracije prolaktina u plazmi bile su veće od uobičajene gornje granice u približno 30% bolesnika liječenih olanzapinom s normalnom vrijednošću prolaktina na početku mjerenja.
English: However, as clinical experience with olanzapine in patients with concomitant illness is limited, caution is advised when prescribing for patients with prostatic hypertrophy, or paralytic ileus and related conditions.
Croatian: Ipak, zbog ograničenog kliničkog iskustva s olanzapinom u bolesnika s različitim istodobno prisutnim bolestima, savjetuje se oprez kod njegova propisivanja bolesnicima s hipertrofijom prostate ili paralitičkim ileusom i povezanim stanjima.
English: If you are given more ZYPADHERA than needed This medicine will be given to you under medical supervision, it is therefore unlikely that you will be given too much.
Croatian: Ovaj lijek će Vam biti dan pod medicinskim nadzorom i zato nije vjerojatno da ćete ga dobiti previše.
English: A lower starting dose (150 mg every 4 weeks) should be considered for such patients.
Croatian: U tih se bolesnika u obzir mora uzeti niža početna doza (150 mg svaka 4 tjedna).
English: Other medicines and ZYPADHERA Tell your doctor if you are taking, have recently taken or might take any other medicines.
Croatian: Obavijestite svog liječnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2. of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Croatian: Nositelj odobrenja obavljat će zadane aktivnosti i intervencije, detaljno objašnjene u dogovorenom Planu upravljanja rizikom (RMP), koji se nalazi u Modulu 1.8.2.
English: Neutropenia has been reported commonly when olanzapine and valproate are used concomitantly (see section 4.8).
Croatian: Neutropenija je bila često prijavljivana kod istodobne primjene olanzapina i valproata (vidjeti dio 4.8).
English: Patients should be advised not to drive or operate machinery for the remainder of the day after each injection due to the possibility of a post-injection syndrome event leading to symptoms consistent with olanzapine overdose (see section 4.4).
Croatian: Bolesnicima se mora savjetovati da ne upravljaju vozilom ili rade sa strojevima tijekom ostatka dana nakon svake primljene injekcije zbog mogućnosti razvoja postinjekcijskog sindroma, događaja koji dovodi do simptoma koji odgovaraju predoziranju olanzapinom (vidjeti dio 4.4).
English: Other very common side effects (may affect more than 1 in 10 people) include weight gain; and increases in levels of prolactin in the blood.
Croatian: Druge vrlo česte nuspojave (mogu se javiti u manje od 1 na 10 osoba) uključuju porast tjelesne težine i povišenje razina prolaktina u krvi.
English: Clinically significant weight gain was observed across all baseline Body Mass Index (BMI) categories.
Croatian: Klinički značajan porast tjelesne težine uočen je za sve početne kategorije indeksa tjelesne mase
English: 14 Observed for fasting normal levels at baseline (< 1.016 mmol/l) which increased to high (≥ 1.467 mmol/l) and changes in fasting triglycerides from borderline at baseline (≥ 1.016 mmol/l< 1.467 mmol/l) to high (≥ 1.467 mmol/l).
Croatian: 14 Porast s normalnih vrijednosti natašte na početku (< 1,016 mmol/l) na visoke (≥ 1,467 mmol/l) i promjene triglicerida natašte od graničnih na početku (≥ 1,016 mmol/l - < 1,467 mmol/l) do visokih
English: Reversible effects consistent with elevated prolactin in rats included decreased weights of ovaries and uterus and morphologic changes in vaginal epithelium and in mammary gland.
Croatian: Reverzibilni učinci koji su odgovarali povišenoj razini prolaktina u štakora uključivali su smanjenu težinu ovarija i uterusa te morfološke promjene epitela vagine i mliječnih žlijezda.
English: Consider referral to a dietician or help with a diet plan if necessary.
Croatian: Ako je potrebno, razmislite o odlasku dijetetičaru ili zatražite pomoć pri slaganju plana prehrane.
English: There have been reports of agitation, hypertonia,
Croatian: Prijavljene su agitacija, hipertonija, hipotonija, tremor,
English: If an overdose is suspected, close medical supervision and monitoring should continue until examination indicates that signs and symptoms have resolved.
Croatian: Ako se posumnja na predoziranje, mora se nastaviti pažljiv medicinski nadzor i praćenje dok se pregledom ne ustanovi da su se znakovi i simptomi povukli.
English: If any blood is drawn into the syringe, discard the syringe and the dose and begin reconstitution and administration procedure again.
Croatian: Ukoliko se pojavi krv u štrcaljki, štrcaljku i dozu lijeka treba ukloniti te ponoviti postupak rekonstitucije i primjene.
English: If this happens, you may have the symptoms listed below after your injection.
Croatian: Ako se to dogodi, nakon davanja injekcije mogu se javiti niže navedeni simptomi.
English: However, the incidence of death was higher in oral olanzapine-treated than in placebo-treated patients independent of these risk factors.
Croatian: Usprkos tome, incidencija smrtnih ishoda bila je viša u bolesnika liječenih oralnim olanzapinom u odnosu na bolesnike koji su primali placebo, neovisno o ovim čimbenicima rizika.
English: 210 mg/2 weeks or 405 mg/4 weeks
Croatian: 210 mg/2 tjedna ili 405 mg/4 tjedna
English: 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.
Croatian: Međutim, sistemske koncentracije u ovim ispitivanjima bile su općenito niže od onih u ispitivanjima oralnih pripravaka; stoga su podaci koji se odnose na oralni oblik olanzapina navedeni u daljnjem tekstu kao referentni.
English: Figure A: Tap firmly to mix 10.
Croatian: Slika A: Čvrsto lupkajte da se promiješa 10.
English: Olanzapine is an antipsychotic, antimanic and mood stabilising agent that demonstrates a broad pharmacologic profile across a number of receptor systems.
Croatian: Olanzapin je antipsihotik s antimaničnim učinkom i učinkom na stabilizaciju raspoloženja koji svoj široki spektar farmakološkog djelovanja ispoljava preko brojnih receptorskih sustava.
English: In a Positron Emission Tomography (PET) study in patients treated with ZYPADHERA (300 mg/4 weeks), mean D2 receptor occupancy was 60% or higher at the end of a 6 month period, a level consistent with that found during treatment with oral olanzapine.
Croatian: U ispitivanju u kojem je korištena pozitronska emisijska tomografija (PET) u bolesnika liječenih lijekom ZYPADHERA (300 mg/4 tjedna), prosječna zaposjednutost D2 receptora bila je 60% ili više na kraju razdoblja od 6 mjeseci, što predstavlja razinu koja odgovara onoj utvrđenoj tijekom liječenja oralnim olanzapinom.
English: In placebocontrolled clinical trials (6-12 weeks duration) of elderly patients (mean age 78 years) with dementiarelated psychosis and/or disturbed behaviours, there was a 2-fold increase in the incidence of death in oral olanzapine-treated patients compared to patients treated with placebo (3.5% vs. 1.5%, respectively).
Croatian: U placebom kontroliranim kliničkim ispitivanjima (trajanja 6-12 tjedana) sa starijim bolesnicima (prosječna dob 78 godina) s psihozom povezanom s demencijom i/ili poremećajima ponašanja, incidencija smrtnih ishoda u bolesnika liječenih oralnim oblikom olanzapina bila je dvostruko veća u usporedbi s bolesnicima koji su primali placebo (3,5% naspram 1,5%).
English: Patients treated with any antipsychoticmedicines, including ZYPADHERA, should be observed for signs and symptoms of hyperglycaemia (such as polydipsia, polyuria, polyphagia, and weakness) and patients with diabetes mellitus or with risk factors for diabetes mellitus should be monitored regularly for worsening of glucose control.
Croatian: U bolesnika koji se liječe antipsihoticima, uključujući lijek ZYPADHERA, mora se obratiti pozornost na znakove i simptome hiperglikemije (kao što su polidipsija, poliurija, polifagija i slabost), a bolesnike s dijabetesom mellitusom ili bolesnike s čimbenicima rizika za nastanak dijabetesa mellitusa mora se redovito kontrolirati zbog mogućeg pogoršanja glikemije.
English: In order to identify the first ZYPADHERA dose for all patients the scheme in Table 1 should be considered.
Croatian: Za sve se bolesnike prilikom određivanja prve doze lijeka ZYPADHERA mora razmotriti shema u
English: Postural hypotension was infrequently observed in the elderly in olanzapine clinical trials.
Croatian: Posturalna hipotenzija je rijetko opažena u starijih bolesnika u kliničkim ispitivanjima olanzapina.
English: NMS is a potentially life-threatening condition associated with antipsychotic medicinal products.
Croatian: MNS je po život opasno stanje povezano s primjenom antipsihotika.
English: The injection must not be given after the expiry date which is stated on the carton.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji.
English: 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.
Croatian: U drugom, dugotrajnom ispitivanju, klinički stabilni bolesnici (n=1065) (s početnom srednjom vrijednošću PANSS ocjene od 54,33 do 57,75) su najprije liječeni oralnim olanzapinom kroz 4 do 8 tjedana, a potom prebačeni na nastavak liječenja oralnim olanzapinom ili lijekom ZYPADHERA
English: ZYPADHERA is not recommended to be started in patients >75 years (see section 4.4).
Croatian: Ne preporučuje se započinjati liječenje lijekom ZYPADHERA u bolesnika starijih od 75 godina (vidjeti dio 4.4).
English: DRESS appears initially as flu-like symptoms with a rash on the face and then with an extended rash, high temperature, enlarged lymph nodes, increased levels of liver enzymes seen on blood tests and an increase in a type of white blood cells (eosinophilia).
Croatian: najprije nastupa u obliku simptoma nalik gripi praćenih osipom na licu, a zatim se javljaju proširen osip, visoka tjelesna temperatura, povećani limfni čvorovi, povišene vrijednosti jetrenih enzima vidljive u nalazima krvnih pretraga te povišene vrijednosti jedne vrste bijelih krvnih stanica (eozinofilija).
English: • A recent heart attack, heart disease, sick sinus syndrome, (abnormal heart rhythms),
Croatian: • imali ste nedavno srčani udar, imate bolest srca, sindrom bolesnog sinusa,
English: 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).
Croatian: U ispitivanjima u koja su bili uključeni bolesnici između 13 i 17 godina starosti uočene su različite nuspojave, uključujući porast tjelesne težine, promjene metaboličkih parametara i porast vrijednosti prolaktina (vidjeti dijelove 4.8 i
English: In the study, the risk of olanzapine was comparable to the risk of atypical antipsychotics included in a pooled analysis.
Croatian: U ispitivanju je rizik pri liječenju olanzapinom bio je usporediv s rizikom pri liječenju atipičnim antipsihoticima uključenim u objedinjenu analizu.
English: Inject the solvent volume into the powder vial.
Croatian: Ubrizgajte volumen otapala u bočicu s praškom.
English: • One Hypodermic syringe and safety needle (Hypodermic Device)
Croatian: • Jednu hipodermalnu štrcaljku i zaštićenu iglu (hipodermalna naprava)
English: In the offspring of rats given olanzapine, delays in foetal development and transient decreases in offspring activity levels were seen.
Croatian: U potomstvu štakora tretiranih olanzapinom primijećeno je zaostajanje u fetalnom razvoju i prolazno sniženje stupnja aktivnosti.
English: The suspended product will be yellow and opaque.
Croatian: Suspendirani lijek bit će žut i neproziran. (vidjeti Sliku C)
English: Reconstitute ZYPADHERA powder for prolonged release suspension for injection only with the solvent provided in the pack using standard aseptic techniques for reconstitution of parenteral products.
Croatian: Rekonstituirajte ZYPADHERA prašak za suspenziju za injekciju s produljenim oslobađanjem samo s otapalom koje se nalazi u pakiranju, koristeći standardne aseptičke tehnike za pripremu parenteralnih pripravaka.
English: Oral olanzapine was started at 2.5 mg/day and titrated to a maximum of 15 mg/day based on investigator judgement.
Croatian: Liječenje oralnim olanzapinom započeto je dozom od 2,5 mg/dan i postupno je povećavano do najviše 15 mg/dan u skladu s procjenom ispitivača.
English: 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).
Croatian: U zdravih starijih osoba (65 godina i stariji) u odnosu na mlađe osobe srednja vrijednost poluvremena eliminacije bila je produljena (51,8 naspram 33,8 sati) i klirens je bio snižen (17,5 naspram 18,2 l/h).
English: Oral olanzapine was used as a flexible dose starting with 2.5 and ranging up to 20 mg/day.
Croatian: Doza oralnog olanzapina bila je promjenjiva s početnom dozom od 2,5 mg koja se onda povisivala do 20 mg/dan.
English: In the same clinical trials, cerebrovascular adverse reactions (CVAEvents e.g., stroke, transient ischemic attack), including fatalities, were reported.
Croatian: U istim kliničkim ispitivanjima prijavljene su cerebrovaskularne nuspojave (cerebrovaskularni događaji, npr. moždani udar, prolazni ishemijski napadaji), od kojih su neke imale smrtni ishod.
English: One vial of 3 ml solvent.
Croatian: Jedna bočica s 3 ml otapala.
English: The frequency terms listed are defined as follows: Very common (≥ 1/10), common (≥ 1/100 to < 1/10).
Croatian: Učestalost je definirana kako slijedi: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10).
English: Olanzapine is not indicated for use in the treatment of children and adolescents.
Croatian: Primjena olanzapina nije indicirana u liječenju djece i adolescenata.
English: Haematologic toxicity: Effects on haematology parameters were found in each species, including doserelated reductions in circulating leukocytes in mice and non-specific reductions of circulating leukocytes in rats; however, no evidence of bone marrow cytotoxicity was found.
Croatian: Učinci na hematološke parametre nađeni su kod svih vrsta, a uključivali su o dozi ovisno smanjenje broja leukocita u cirkulaciji miševa i nespecifično smanjenje broja leukocita u cirkulaciji štakora; međutim, nisu uočeni znakovi citotoksičnosti u koštanoj srži.
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.
Croatian: Vaš liječnik ili medicinska sestra će od praška pripremiti suspenziju za injekciju koristeći bočicu otapala za lijek ZYPADHERA koje je bistra, bezbojna do svijetložuta otopina u bočici od prozirnog stakla.
English: 6 In clinical trials, the incidence of Parkinsonism and dystonia in olanzapine-treated patients was numerically higher, but not statistically significantly different from placebo.
Croatian: 6 Incidencija parkinsonizma i distonije u bolesnika liječenih olanzapinom u kliničkim ispitivanjima bila je brojčano viša, ali ne i statistički značajno različita od placeba.
English: Animal behavioural studies with olanzapine indicated 5HT, dopamine, and cholinergic antagonism, consistent with the receptor-binding profile.
Croatian: U ispitivanjima ponašanja na životinjama nakon davanja olanzapina uočen je antagonizam 5HT, dopaminskih i kolinergičkih receptora koji odgovara profilu vezanja na receptore.
English: GENERAL CLASSIFICATION FOR SUPPLY Medicinal product subject to restricted medical prescription.
Croatian: 14. NAČIN IZDAVANJA LIJEKA Lijek se izdaje na ograničeni recept.
English: The proportion of patients who had adverse, clinically significant changes in weight gain, glucose, total/LDL/HDL cholesterol or triglycerides increased over time.
Croatian: Udio bolesnika s klinički značajnim nuspojavama poput porasta tjelesne težine, razine glukoze, ukupnog/LDL/HDL kolesterola ili triglicerida povećava se s vremenom.
English: 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).
Croatian: U nekolicine pasa se razvila reverzibilna neutropenija, trombocitopenija ili anemija pri dozama od 8 odnosno 10 mg/kg/dan (ukupna izloženost olanzapinu [AUC] bila je 12 do 15 puta veća nego što je u čovjeka koji je primio dozu od 12 mg).
English: STEP 2: Determining solvent volume for reconstitution This table provides the amount of solvent required to reconstitute ZYPADHERA powder for prolonged release suspension for injection.
Croatian: KORAK 2: Određivanje volumena otapala za rekonstituciju Sljedeća tablica prikazuje potrebnu količinu otapala za pripremu ZYPADHERA praška za suspenziju za injekciju s produljenim oslobađanjem.
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.
Croatian: Nakon ponovljenih intramuskularnih injekcija sa 150 do 300 mg lijeka ZYPADHERA svaka dva tjedna, deseti do devedeseti percentil koncentracije olanzapina u plazmi u stanju dinamičke ravnoteže iznosili su između 4,2 i 73,2 ng/ml.
English: Special care must be taken to apply appropriate injection technique to avoid inadvertent intravascular or subcutaneous injection (see section 6.6).
Croatian: 4.4 Posebna upozorenja i mjere opreza pri uporabi Mora se obratiti posebna pozornost da se prilikom primjene koristi odgovarajuća tehnika davanja injekcija kako bi se izbjeglo slučajno intravaskularno ili supkutano injiciranje (vidjeti dio 6.6).
English: The use of olanzapine in the treatment of dopamine agonist associated psychosis in patients with Parkinson's disease is not recommended.
Croatian: Ne preporučuje se primjena olanzapina u liječenju psihoze povezane s agonistima dopamina u bolesnika s Parkinsonovom bolešću.
English: Rare side effects (may affect up to 1 in 1000 people) with ZYPADHERA include injection site infection.
Croatian: Rijetke nuspojave (mogu se javiti u manje od 1 na 1000 osoba) s lijekom ZYPADHERA uključuju infekciju na mjestu primjene injekcije.
English: Caution should be exercised in patients who consume alcohol or receive medicinal products that can cause central nervous system depression.
Croatian: Mora se s oprezom postupati u bolesnika koji konzumiraju alkohol ili uzimaju lijekove koji mogu uzrokovati depresiju SŽS-a.
English: In clinical trials in elderly patients with dementia, olanzapine treatment was associated with a higher incidence of death and cerebrovascular adverse reactions compared to placebo (see also section 4.4).
Croatian: U kliničkim ispitivanjima sa starijim bolesnicima s demencijom primjena olanzapina bila je povezana s većom incidencijom smrtnih ishoda i cerebrovaskularnih nuspojava u usporedbi s placebom (vidjeti i dio 4.4).
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 210 mg
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 210 mg
English: Caution should be used if olanzapine is being administered concomitantly with medicinal products known to increase QTc interval (see section 4.4).
Croatian: Olanzapin se mora s oprezom istodobno primjenjivati s lijekovima za koje se zna da produljuju QTc-interval (vidjeti dio 4.4).
English: After each injection you will be observed in your healthcare facility for at least 3 hours for the symptoms listed above.
Croatian: Nakon svake injekcije ostat ćete u zdravstvenoj ustanovi kroz najmanje 3 sata radi praćenja eventualne pojave ranije navedenih simptoma.
English: Hyperglycaemia and/or development or exacerbation of diabetes occasionally associated with ketoacidosis or coma has been reported uncommonly, including some fatal cases (see section 4.8).
Croatian: Hiperglikemija i/ili pojava odnosno egzacerbacija dijabetesa, ponekad povezanog s ketoacidozom ili komom, uključujući i neke smrtne slučajeve, manje je često prijavljivana nuspojava (vidjeti dio 4.8).
English: • Parkinson's disease
Croatian: • bolujete od Parkinsonove bolesti
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.
Croatian: U bolesnika koji se liječe antipsihoticima, uključujući lijek ZYPADHERA, moraju se redovito pratiti vrijednosti lipida u skladu s postojećim smjernicama za primjenu antipsihotika, npr. na početku, 12 tjedana nakon početka terapije olanzapinom i nakon toga svakih 5 godina.
English: No studies on the effects on the ability to drive and use machines have been performed.
Croatian: 4.7 Utjecaj na sposobnost upravljanja vozilima i rada sa strojevima Nisu provedena ispitivanja o utjecaju na sposobnost upravljanja vozilima i rada sa strojevima.
English: Caution should be exercised and follow-up organised in patients with elevated ALT and/or AST, in patients with signs and symptoms of hepatic impairment, in patients with pre-existing conditions associated with limited hepatic functional reserve, and in patients who are being treated with potentially hepatotoxic medicines.
Croatian: Mora se s oprezom postupati i organizirati praćenje bolesnika s povišenim ALT-om i/ili AST-om, bolesnika sa znakovima i simptomima oštećenja funkcije jetre, bolesnika s od ranije postojećim stanjima povezanima s ograničenom rezervom jetrene funkcije i bolesnika liječenih potencijalno hepatotoksičnim lijekovima.
English: STEP 1: Injecting ZYPADHERA
Croatian: Primjena KORAK 1: Injiciranje lijeka ZYPADHERA
English: The half-life of olanzapine after ZYPADHERA is 30 days compared to 30 hours following oral administration.
Croatian: Poluvijek olanzapina nakon primjene lijeka ZYPADHERA iznosi 30 dana, a nakon primjene oralnog oblika 30 sati.