FrancophonIA/ELRC3.0 huggingface dataset:
English: In clinical trials, clinically meaningful QTc prolongations (Fridericia QT correction [QTcF] ≥ 500 milliseconds [msec] at any time post baseline in patients with baseline QTcF< 500 msec) were uncommon (0.1% to 1%) in patients treated with olanzapine, with no significant differences in associated cardiac events compared to placebo.
Slovenian: V kliničnih preizkušanjih so bila klinično pomembna podaljšanja intervala QTc (interval QT, popravljen po Fridericiju /Friderici QT correction, QTcF/, ≥ 500 milisekund /ms/ kadarkoli nad osnovno vrednostjo pri bolnikih z osnovno vrednostjo QTcF < 500 ms) pri bolnikih, zdravljenih z olanzapinom, redka (od 0,1 % do 1 %) in brez pomembnih razlik v spremljajočih srčnih dogodkih v primerjavi z bolniki, zdravljenimi s placebom.
English: Blood and the lymphatic system disorders Eosinophilia
Slovenian: Bolezni krvi in limfatičnega sistema Eozinofilija
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.
Slovenian: Pri bolnikih z zvišano vrednostjo ALT in/ali AST, bolnikih z znaki in simptomi okvarjenega delovanja jeter, bolnikih s stanji, povezanimi z zmanjšano rezervo v jetrnem delovanju, in pri bolnikih, ki se zdravijo s potencialno hepatotoksičnimi zdravili, je potrebna previdnost.
English: Adverse event identified from spontaneous post-marketing reporting with frequency determined utilising the Olanzapine Integrated Database.
Slovenian: Neželeni učinki, ugotovljeni pri spontanem poročanju v obdobju trženja s pogostostjo, določeno z uporabo integrirane baze podatkov za olanzapin.
English: The concomitant use of olanzapine with anti-Parkinsonian medicinal products in patients with Parkinson's disease and dementia is not recommended (see section 4.4).
Slovenian: Pri bolnikih s Parkinsonovo boleznijo in demenco ni priporočeno sočasno jemanje olanzapina in antiparkinsonskih zdravil (gl. poglavje 4.4).
English: Zalasta has been shown to prevent recurrence of these symptoms in patients with bipolar disorder whose manic episode has responded to olanzapine treatment.
Slovenian: Zdravilo Zalasta dokazano preprečuje ponoven pojav teh simptomov pri bolnikih z bipolarno motnjo, pri katerih se je manična epizoda po zdravljenju z olanzapinom izboljšala.
English: Zalasta tablets contain lactose.
Slovenian: Zdravilo Zalasta vsebuje laktozo.
English: Thus no particular interaction is expected as verified through in vivo studies where no inhibition of metabolism of the following active substances was found: tricyclic antidepressant (representing mostly CYP2D6 pathway), warfarin (CYP2C9), theophylline (CYP1A2) or diazepam (CYP3A4 and 2C19).
Slovenian: To so potrdile tudi raziskave in vivo, v katerih niso ugotovili nobenega zaviranja presnove tricikličnih antidepresivov (ki se presnavljajo s CYP2D6), varfarina (CYP2C9), teofilina (CYP1A2) ali diazepama (CYP3A4 in 2C19).
English: See section 2 "Zalasta contains aspartame".
Slovenian: Glejte poglavje 2 "Zdravilo Zalasta vsebuje aspartam".
English: , elevated triglyceride levels
Slovenian: , zvišane ravni trigliceridov
English: In a second 12-month recurrence prevention study in manic episode patients who achieved remission with a combination of olanzapine and lithium and were then randomised to olanzapine or lithium alone, olanzapine was statistically non-inferior to lithium on the primary endpoint of bipolar recurrence (olanzapine 30.0%, lithium 38.3%; p=0.055).
Slovenian: V drugi 12-mesečni raziskavi o preprečevanju ponovitve bolezni pri bolnikih z manično epizodo, ki so z zdravljenjem s kombinacijo olanzapina in litija dosegli remisijo, nato pa so jim naključno predpisali samo olanzapin ali samo litij, je bil olanzapin ob primarni končni točki ponovitve bipolarne motnje primerljiv z litijem (olanzapin 30 %, litij 38,3 %; p=0,055).
English: Dizziness Akathisia Parkinsonism Dyskinesia
Slovenian: Omotica Akatizija Parkinsonizem Diskinezije
English: An increase to a dose greater than the recommended starting dose is advised only after appropriate clinical reassessment and should generally occur at intervals of not less than 24 hours.
Slovenian: Večje povečanje od priporočenega začetnega odmerka priporočamo le po ponovni klinični oceni.
English: Tolerance developed to the CNS depression.
Slovenian: Po depresiji osrednjega živčevja se je razvila toleranca.
English: You should swallow the tablets whole with water.
Slovenian: Tablete Zalasta pogoltnite cele z vodo.
English: Photon Emission Computed Tomography (SPECT) imaging study in schizophrenic patients revealed that olanzapine-responsive patients had lower striatal D2 occupancy than some other antipsychotic- and risperidone-responsive patients, while being comparable to clozapine-responsive patients.
Slovenian: Slikovna raziskava SPECT (Single Photon Emission Computed Tomography) je pri bolnikih s shizofrenijo razkrila, da je bila zasedenost striatnih receptorjev D2 pri bolnikih, ki so se odzivali na olanzapin, manjša kot pri bolnikih, ki so se odzivali na nekatere druge antipsihotike in na risperidon, medtem ko je bila primerljiva z bolniki, ki so se odzivali na klozapin.
English: Abdominal distension 9 Pancreatitis
Slovenian: 9 Pankreatitis
English: There was a 3-fold increase in CVAE in patients treated with olanzapine compared to patients treated with placebo (1.3% vs. 0.4%, respectively).
Slovenian: Pri bolnikih, zdravljenih z olanzapinom, je bilo teh dogodkov 3-krat več kot pri bolnikih, ki so jemali placebo (1,3 % v primerjavi z 0,4 %).
English: The most frequently (seen in ≥ 1% of patients) reported adverse reactions associated with the use of olanzapine in clinical trials were somnolence, weight gain, eosinophilia, elevated prolactin, cholesterol, glucose and triglyceride levels (see section 4.4), glucosuria, increased appetite, dizziness, akathisia, parkinsonism, leukopenia, neutropenia (see section 4.4), dyskinesia, orthostatic hypotension, 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: Najpogostejši neželeni učinki, ki so jih ugotavljali med kliničnim preizkušanjem, so bili zaspanost, povečanje telesne mase, eozinofilija, zvišane vrednosti prolaktina, holesterola, glukoze in trigliceridov (gl. poglavje 4.4), glikozurija, povečan apetit, omotica, akatizija, parkinsonizem, levkopenija, nevtropenija (gl. poglavje 4.4), diskinezija, ortostatska hipotenzija, antiholinergični učinki, prehodna asimptomatska zvišanja ravni jetrnih aminotransferaz (gl. 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: In a co-therapy study of patients treated with lithium or valproate for a minimum of 2 weeks, the addition of olanzapine 10 mg (co-therapy with lithium or valproate) resulted in a greater reduction in symptoms of mania than lithium or valproate monotherapy after 6 weeks.
Slovenian: V raziskavi, v kateri so vsaj dva tedna spremljali sočasno zdravljenje bolnikov z litijem ali valproatom, je dodatek 10 mg olanzapina bolj zmanjšal jakost simptomov manije po 6 tednih kot pri monoterapiji z litijem ali valproatom.
English: In clinical trials in patients with drug-induced (dopamine agonist) psychosis associated with Parkinson's disease, worsening of Parkinsonian symptomatology and hallucinations were reported very commonly and more frequently than with placebo.
Slovenian: V kliničnih preizkušanjih na bolnikih s psihozami, ki so jih povzročila zdravila (dopaminski agonisti), povezana s Parkinsonovo boleznijo, so pogosto ter pogosteje kot pri placebu poročali o poslabšanju simptomatike Parkinsonove bolezni in halucinacijah.
English: Musculoskeletal and connective tissue disorders Arthralgia
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva Artralgija
English: In cases of moderate hepatic insufficiency (cirrhosis, Child-Pugh Class A or B), the starting dose should be 5 mg and only increased with caution.
Slovenian: Bolnike z zmerno okvarjenim jetrnim delovanjem (ciroza, stopnja jetrne okvare Child-Pugh razreda A ali B) začnite zdraviti z odmerkom po 5 mg in ga previdno povečujte
English: Common: Elevated cholesterol levels
Slovenian: Pogosti: Zvišane ravni holesterola
English: In clinical trials, the incidence of Parkinsonism and dystonia in olanzapine-treated patients was numerically higher, but not statistically significantly different from placebo.
Slovenian: V kliničnih preizkušanjih je bila incidenca parkinsonizma in distonije pri bolnikih, zdravljenih z olanzapinom, pogostejša, a se ni statistično značilno razlikovala od skupine, ki je jemala placebo.
English: As it exhibits in vitro dopamine antagonism, olanzapine may antagonize the effects of direct and indirect dopamine agonists.
Slovenian: V pogojih in vitro deluje olanzapin kot antagonist dopamina, zato lahko zavira posredne in neposredne učinke dopaminskih agonistov.
English: In a single oral dose (10 mg) Positron Emission Tomography (PET) study in healthy volunteers, olanzapine produced a higher 5 HT2A than dopamine D2 receptor occupancy.
Slovenian: Pri pozitronski emisijski tomografiji (PET) s posameznim peroralnim odmerkom (10 mg) pri zdravih prostovoljcih je olanzapin povzročil večjo zasedenost receptorjev 5-HT2A kot dopaminskih receptorjev D2.
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.
Slovenian: Reverzibilni učinki zaradi povečane koncentracije prolaktina so pri podganah povzročili zmanjšanje mase jajčnikov in maternice ter morfološke spremembe v epiteliju nožnice in mlečni žlezi.
English: The daily dose of Zalasta is between 5 mg and 20 mg.
Slovenian: Dnevni odmerek zdravila Zalasta je od 5 mg do 20 mg.
English: Leukopenia
Slovenian: Levkopenija
English: Clinically significant weight gain (≥ 7%) appears to occur more frequently in the adolescent population compared to adults with comparable exposures.
Slovenian: Iz podatkov je razvidno, da je klinično pomembno povečanje telesne mase (≥ 7 %) pogostejše pri mladostnikih kot pri odraslih.
English: Symptomatic treatment and monitoring of vital organ function should be instituted according to clinical presentation, including treatment of hypotension and circulatory collapse and support of respiratory function.
Slovenian: Glede na klinično sliko je treba uvesti simptomatsko zdravljenje hipotenzije in cirkulatorne odpovedi ter podpreti dihanje in spremljati delovanje vitalnih organov.
English: What Zalasta is and what it is used for What you need to know before you take Zalasta How to take Zalasta
Slovenian: Kaj je zdravilo Zalasta in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Zalasta Kako jemati zdravilo Zalasta Možni neželeni učinki
English: Based on the results of studies in mice and rats, it was concluded that olanzapine is not carcinogenic.
Slovenian: Raziskave, v katerih so mišim in podganam peroralno dajali olanzapin, niso potrdile kancerogenosti olanzapina.
English: Olanzapine demonstrated a greater in vitro affinity for serotonin 5 HT2 than dopamine D2 receptors and greater 5 HT2 than D2 activity in vivo, models.
Slovenian: V pogojih in vitro je olanzapin pokazal večjo afiniteto za serotoninske 5-HT2 kot za dopaminske receptorje D2, v modelih in vivo pa večjo aktivnost 5-HT2 kot D2.
English: In patients whose manic episode has responded to olanzapine treatment, olanzapine is indicated for the prevention of recurrence in patients with bipolar disorder (see section 5.1).
Slovenian: Pri bolnikih z manično epizodo bipolarne motnje, ki so pokazali odziv na zdravljenje z olanzapinom, je olanzapin indiciran za preprečevanje ponovnega pojava bolezni (gl. poglavje 5.1).
English: See section 2 "Zalasta contains lactose".
Slovenian: Glejte poglavje 2 "Zdravilo Zalasta vsebuje laktozo".
English: NMS is a potentially life-threatening condition associated with antipsychotic medicinal products.
Slovenian: Nevroleptični maligni sindrom (NMS) je stanje, ki je povezano z jemanjem antipsihotikov in lahko ogroža življenje.
English: Elevated cholesterol levels
Slovenian: Zvišane ravni holesterola
English: In a 12-month recurrence prevention study in manic episode patients who achieved remission on olanzapine and were then randomised to olanzapine or placebo, olanzapine demonstrated statistically significant superiority over placebo on the primary endpoint of bipolar recurrence.
Slovenian: V 12-mesečni raziskavi o ponovitvi bolezni pri bolnikih z manično epizodo, ki so z zdravljenjem z olanzapinom dosegli remisijo, nato pa so jim naključno predpisali jemanje olanzapin ali placebo, je bil olanzapin ob primarni končni točki ponovitve bipolarne motnje statistično značilno boljši od placeba.
English: In an 18-month co-therapy study in manic or mixed episode patients stabilised with olanzapine plus a mood stabiliser (lithium or valproate), long-term olanzapine co-therapy with lithium or valproate was not statistically significantly superior to lithium or valproate alone in delaying bipolar recurrence, defined according to syndromic (diagnostic) criteria.
Slovenian: V 18-mesečni raziskavi o sočasnem zdravljenju bolnikov z manično ali mešano epizodo, stabiliziranih z olanzapinom in s stabilizatorjem razpoloženja (litijem ali valproatom), dolgotrajno sočasno zdravljenje z olanzapinom in litijem ali valproatom pri odlogu ponovnega pojava bipolarne motnje, določene po sindromnih (diagnostičnih) merili, ni bilo statistično značilno bolj ugodno od zdravljenja samo z litijem ali samo z valproatom.
English: In non-smoking versus smoking subjects (males and females) the mean elimination half-life was prolonged (38.6 versus 30.4 hr) and the clearance was reduced (18.6 versus 27.7 l/hr).
Slovenian: V primerjavi med kadilci in nekadilci (moškimi in ženskami) je bil srednji razpolovni čas izločanj pri nekadilcih podaljšan (38,6 v primerjavi s 30,4 ure), očistek pa zmanjšan (18,6 v primerjavi s 27,7 l/h).
English: Investigations Elevated plasma prolactin levels
Slovenian: Preiskave Zvišane plazemske koncentracije prolaktina
English: - The other ingredients are mannitol, microcrystalline cellulose, crospovidone, low-substituted hydroxypropylcellulose, aspartame, calcium silicate, magnesium stearate.
Slovenian: - Druge sestavine zdravila (pomožne snovi) so manitol, mikrokristalna celuloza, krospovidon, hidroksipropilceluloza, aspartam, kalcijev silikat in magnezijev stearat.
English: Adverse event identified from clinical trials in the Olanzapine Integrated Database.
Slovenian: Neželeni učinki, ugotovljeni v kliničnih študijah v integrirani bazi podatkov za olanzapin.
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).
Slovenian: Občasno so poročali o hiperglikemiji in/ali razvoju ali poslabšanju sladkorne bolezni, vključno z nekaj primeri, povezanimi s ketoacidozo, komo ali s smrtnim izidom(gl. poglavje 4.8).
English: The frequency terms listed are defined as follows: Very common (≥ 1/10), common (≥ 1/100 to < 1/10).
Slovenian: Neželeni učinki so navedeni po padajoči resnosti, njihova pogostost pa je definirana z naslednjimi opisi: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10),
English: • carbamazepine (an anti-epileptic and mood stabiliser), fluvoxamine (an antidepressant), or ciprofloxacin (an antibiotic), - it may be necessary to change your Zalasta dose.
Slovenian: Povejte svojemu zdravniku, če jemljete: - zdravila za Parkinsonovo bolezen, - karbamazepin (antiepileptik in stabilizator razpoloženja), fluvoksamin (zdravilo za zdravljenje depresije) ali ciprofloksacin (antibiotik) - morda bo treba spremeniti vaš odmerek zdravila
English: Zalasta 10 mg tablets Each tablet contains 161.8 mg lactose.
Slovenian: Zalasta 10 mg tablete Ena tableta vsebuje 161,8 mg laktoze.
English: However, the incidence of death was higher in olanzapinetreated than in placebo-treated patients independent of these risk factors.
Slovenian: Vendar je bila smrtnost, neodvisno od omenjenih dejavnikov tveganja, večja pri bolnikih, zdravljenih z olanzapinom, kot pri bolnikih, zdravljenih s placebom.
English: The following symptoms may occur in newborn babies, of mothers that have used Zalasta in the last trimester (last three months of their pregnancy): shaking, muscle stiffness and/or weakness, sleepiness, agitation, breathing problems, and difficulty in feeding.
Slovenian: Pri novorojenčkih mater, ki so v zadnjih treh mesecih nosečnosti uporabljale zdravilo Zalasta, se lahko pojavijo naslednji simptomi: tresenje, okornost ali šibkost mišic, zaspanost, nemir, težave z dihanjem in motnje hranjenja.
English: Do not drink any alcohol if you have been given Zalasta as together with alcohol it may make you feel drowsy.
Slovenian: Če vam je zdravnik predpisal zdravilo Zalasta, ne pijte nobenega alkohola, saj lahko kombinacija tega zdravila in alkohola povzroči občutek zaspanosti.
English: In patients with a manic or mixed episode of bipolar disorder, olanzapine demonstrated superior efficacy to placebo and valproate semisodium (divalproex) in reduction of manic symptoms over 3 weeks.
Slovenian: Pri bolnikih z manično ali mešano epizodo bipolarne motnje je olanzapin v treh tednih veliko bolj učinkovito zmanjšal jakost maničnih simptomov kot placebo in seminatrijev valproat (divalproeks).
English: Vascular disorders Orthostatic hypotension
Slovenian: Žilne bolezni Ortostatska hipotenzija
English: Cytochromes P450-CYP1A2 and P450-CYP2D6 contribute to the formation of the N-desmethyl and 2-hydroxymethyl metabolites, both exhibited significantly less in vivo pharmacological activity than olanzapine in animal studies.
Slovenian: Citokroma P450 CYP1A2 in P450 CYP2D6 prispevata k tvorbi N-demetilnih in 2-hidroksimetilnih presnovkov.
English: Each tablet contains 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg or 20 mg olanzapine.
Slovenian: Ena tableta vsebuje 2,5 mg, 5 mg, 7,5 mg, 10 mg, 15 mg ali 20 mg olanzapina.
English: Undesirable alterations in lipids have been observed in olanzapine-treated patients in placebocontrolled clinical trials (see section 4.8).
Slovenian: V kliničnih preizkušanjih, nadzorovanih s placebom, so pri bolnikih, ki so jemali olanzapin, opazili neželene spremembe v vsebnosti lipidov (gl. poglavje 4.8).
English: In female versus male subjects the mean elimination half life was somewhat prolonged (36.7 versus 32.3 hr) and the clearance was reduced (18.9 versus 27.3 l/hr).
Slovenian: Pri ženskah v primerjavi z moškimi je bil srednji razpolovni čas izločanja nekoliko podaljšan (36,7 v primerjavi z 32,3 ure), očistek pa zmanjšan (18,9 v primerjavi s 27,3 l/h).
English: 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).
Slovenian: Klinične manifestacije so zvišana telesna temperatura, mišična okorelost, motnje zavesti in znaki avtonomne nestabilnosti (nepravilen srčni utrip ali neurejen krvni tlak, tahikardija, čezmerno znojenje in motnje srčnega ritma).
English: In healthy elderly (65 and over) versus non-elderly subjects, the mean elimination half-life was prolonged (51.8 versus 33.8 hr) and the clearance was reduced (17.5 versus 18.2 l/hr).
Slovenian: Pri zdravih starejših osebah (65 let in več) je bil v primerjavi z mlajšimi osebami srednji razpolovni čas izločanja podaljšan (51,8 v primerjavi s 33,8 ure), očistek pa zmanjšan (17,5 v primerjavi z 18,2 l/h).
English: If this happens after you have been given Zalasta tell your doctor.
Slovenian: Če se vam to zgodi potem, ko ste vzeli zdravilo Zalasta, povejte svojemu zdravniku.
English: Olanzapine-treated patients had a lower incidence of Parkinsonism, akathisia and dystonia compared with titrated doses of haloperidol.
Slovenian: Pri bolnikih, zdravljenih z olanzapinom, je bila incidenca parkinsonizma, akatizije in distonije manjša v primerjavi z bolniki, ki so jim odmerke haloperidola povečevali postopno.
English: Neutropenia has been reported commonly when olanzapine and valproate are used concomitantly (see section 4.8).
Slovenian: Ob sočasnem jemanju olanzapina in valproata so pogosto poročali o nevtropeniji (gl. poglavje 4.8).
English: Very common side effects (may affect more than 1 in 10 people) include weight gain; sleepiness and increases in levels of prolactin in the blood.
Slovenian: Zelo pogosti neželeni učinki (pojavijo se lahko pri več kot 1 od 10 bolnikov) vključujejo zvečanje telesne mase, zaspanost in povečane plazemske koncentracije prolaktina.
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: Pri kratkotrajnem zdravljenju (srednje trajanje 47 dni) je bilo povečanje telesne mase za ≥ 7 % od izhodiščne telesne mase zelo pogosto (22,2 %), povečanje za ≥ 15 % je bilo pogosto (4,2 %) ter povečanje za ≥ 25 % občasno (0,8 %).
English: 14 orodispersible tablets 28 orodispersible tablets 35 orodispersible tablets 56 orodispersible tablets 70 orodispersible tablets
Slovenian: 14 orodisperzibilnih tablet 28 orodisperzibilnih tablet 35 orodisperzibilnih tablet 56 orodisperzibilnih tablet 70 orodisperzibilnih tablet
English: Each orodispersible tablet contains 5 mg, 7.5 mg, 10 mg, 15 mg or 20 mg olanzapine.
Slovenian: Ena orodisperzibilna tableta vsebuje 5 mg, 7,5 mg, 10 mg, 15 mg ali 20 mg olanzapina.
English: What Zalasta contains - The active substance is olanzapine.
Slovenian: Kaj vsebuje zdravilo Zalasta - Učinkovina je olanzapin.
English: Zalasta orodispersible tablets are available in boxes of 14, 28, 35, 56 or 70 tablets in blisters (Alu/OPA/Alu/PVC).
Slovenian: Zalasta orodisperzibilne tablete so na voljo v škatlah s 14, z 28, s 35, 56 ali 70 tabletami v pretisnih omotih (Al/OPA/Al/PVC).
English: 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.
Slovenian: V kliničnih preskušanjih, ki so trajala do 12 tednov, so pri 30 % bolnikov z normalno začetno vrednostjo prolaktina, ki so se zdravili z olanzapinom, ugotovili zvišanje plazemske koncentracije prolaktina nad zgornjo mejo normalne vrednosti.
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 prizadenejo do 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, jetrno obolenje, 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: Hepatitis (including hepatocellular, cholestatic or mixed liver injury)
Slovenian: Hepatitis (vključno s hepatocelularno,
English: QTc interval
Slovenian: Interval QTc
English: Increased alkaline phosphatase High creatine phosphokinase High Gamma Glutamyltransferase High uric acid
Slovenian: Visoka raven kreatinfosfokinaze Visoka raven gamaglutamiltransferaze
English: Reproductive toxicity
Slovenian: Hematološka toksičnost