FrancophonIA/ELRC3.0 huggingface dataset:
English: Additionally, it is known that the use of aripiprazole is associated with other ADR that may predispose to falls, such as somnolence, sedation, dizziness or hypotension.
Croatian: Osim toga, poznato je da je primjena aripiprazola povezana s drugim nuspojavama koje mogu predisponirati bolesnika za pad, kao što su somnolencija, sedacija, omaglica ili hipotenzija.
English: Additionally, from the EudraVigilance database, at least one case is retrieved with a positive rechallenge, which conveys a probable causal association of aripiprazole use with oculogyric crisis.
Croatian: Nadalje, u bazi podataka EudraVigilance pronađen je najmanje jedan slučaj ponovne pojave nuspojave nakon ponovnog uvođenja lijeka (pozitivan rechallenge), koji ukazuje na vjerojatnu uzročnu povezanost primjene aripiprazola s okulogirnom krizom.
English: Look for signs or symptoms of inadvertent intravenous administration.
Croatian: Provjerite da nema znakova ili simptoma nehotične intravenske primjene.
English: • diabetic ketoacidosis (ketones in the blood and urine) or coma
Croatian: • dijabetička ketoacidoza (ketoni u krvi i mokraći) ili koma
English: Important: the solvent vial contains an overfill.
Croatian: Važno: bočica otapala sadrži suvišak otapala.
English: It is important that you carry on receiving Abilify Maintena for as long as your doctor has told you to.
Croatian: Važno je da nastavite primati Abilify Maintena onoliko dugo koliko Vam je to rekao liječnik.
English: > 6 weeks
Croatian: > 6 tjedana
English: Based on results of a full range of standard genotoxicity tests, aripiprazole was considered nongenotoxic.
Croatian: Na temelju rezultata cijelog niza standardnih pretraga genotoksičnosti, aripiprazol se ne smatra genotoksičnim.
English: Steady state concentrations for the typical subject were attained by the fourth dose for both sites of administration.
Croatian: Koncentracije u stanju dinamičke ravnoteže kod tipičnog ispitanika postigle su se do četvrte doze kod oba mjesta primjene.
English: • have any difficulty in swallowing
Croatian: • ikakvih teškoća s gutanjem
English: A single-dose study with oral administration of aripiprazole to subjects with varying degrees of liver cirrhosis (Child-Pugh Classes A, B, and C) did not reveal a significant effect of hepatic impairment on the pharmacokinetics of aripiprazole and dehydro-aripiprazole, but the study included only 3 patients with Class C liver cirrhosis, which is insufficient to draw conclusions on their metabolic capacity.
Croatian: Ispitivanje jednostruke doze oralno primijenjenog aripiprazola ispitanicima s različitim stupnjem ciroze jetre (Child-Pugh stadij A, B i C) nije otkrilo značajni utjecaj oštećenja funkcije jetre na farmakokinetiku aripiprazola i dehidroaripiprazola, ali ispitivanje je uključilo samo 3 bolesnika s cirozom jetre stadija C, što nije dovoljno da bi se mogli izvući zaključci o njihovom metaboličkom kapacitetu.
English: Solvent for Abilify Maintena Water for injections
Croatian: Otapalo za Abilify Maintena voda za injekcije
English: Injection site pain (incidence 5.1 %), had a median onset on day 2 after the injection and a median duration of 4 days.
Croatian: Bol na mjestu injekcije (incidencija 5,1 %) počeo bi nakon medijana od 2 dana nakon injekcije, a medijan trajanja iznosio je 4 dana.
English: The side effects listed below may also occur after receiving Abilify Maintena.
Croatian: Niže navedene nuspojave također mogu nastati nakon primanja lijeka Abilify Maintena.
English: • low level of a specific type of white blood cells (neutropenia), low haemoglobin or red blood cell count, low level of blood platelets
Croatian: • niska razina određene vrste bijelih krvnih stanica (neutropenija), niski hemoglobin ili broj crvenih krvnih stanica, niska razina krvnih pločica
English: Akathisia was the most frequently observed EPS symptom (Abilify Maintena 11.4 % and placebo group 3.5 %).
Croatian: Akatizija je bila najčešće opažen EPS simptom (Abilify Maintena 11,4 % i placebo 3,5 %).
English: • drug withdrawal symptoms in new-born infant
Croatian: • simptomi ustezanja od lijeka u novorođenčeta
English: • pain at the injection site, hardening of the skin at the injection site
Croatian: • bol na mjestu injekcije, otvrdnuće kože na mjestu injekcije
English: • spasm of the muscles around the voice box
Croatian: • grč mišića oko glasnica
English: The 95 % CI (-5.26, 3.99) for the difference in the estimated proportion of patients experiencing impending relapse by end of Week 26 excluded the predefined non-inferiority margin, 11.5 %.
Croatian: Interval pouzdanosti (CI) od 95 % (−5,26, 3,99) za razliku u procijenjenom udjelu bolesnika koji su doživjeli prijeteći relaps do kraja 26. tjedna isključio je unaprijed definiranu marginu neinferiornosti,
English: Cases of serotonin syndrome have been reported in patients taking aripiprazole, and possible signs and symptoms for this condition can occur especially in cases of concomitant use with other serotonergic medicinal products, such as SSRI/SNRI, or with medicinal products that are known to increase aripiprazole concentrations (see section 4.8).
Croatian: Zabilježeni su slučajevi serotoninskog sindroma u bolesnika koji uzimaju aripiprazol, a mogući znakovi i simptomi ovog stanja mogu nastati osobito u slučajevima istodobne primjene s drugim serotonergičkim lijekovima, kao što su SSRI/SNRI, ili s lijekovima za koje se zna da povećavaju koncentracije aripiprazola (vidjeti dio 4.8).
English: • spontaneous flow of milk from the breasts (galactorrhoea)
Croatian: • spontano lučenje mlijeka iz dojki (galaktoreja)
English: H. Lundbeck A/S Ottiliavej 9, 2500 Valby Denmark
Croatian: Lundbeck A/S Ottiliavej 9, 2500 Valby Danska
English: • unable to keep still, difficulty sitting still
Croatian: • nemogućnost mirovanja, otežano mirno sjedenje
English: Volume to Inject
Croatian: Volumen koji će se ubrizgati
English: • low levels of white blood cells
Croatian: • niske razine bijelih krvnih stanica
English: Step 4: Injection procedure a) Detach the luer lock syringe containing the recommended volume of reconstituted Abilify Maintena suspension from the vial.
Croatian: Korak 4: Postupak davanja injekcije a) Odvojite štrcaljku s priključkom tipa luer lock, koja sadrži preporučeni volumen rekonstituirane suspenzije lijeka Abilify Maintena, od bočice.
English: If a patient develops signs and symptoms indicative of NMS, or presents with unexplained high fever without additional clinical manifestations of NMS, all antipsychotics, including aripiprazole, must be discontinued (see section 4.8).
Croatian: Ako bolesnik razvije znakove i simptome koji ukazuju na NMS ili dobije neobjašnivu vrućicu bez dodatnih kliničkih znakova NMS-a, primjena antipsihotika mora se prekinuti, uključujući aripiprazol (vidjeti dio 4.8).
English: In trials in stable patients with schizophrenia, Abilify Maintena was associated with a higher frequency of EPS symptoms (18.4 %) than oral aripiprazole treatment (11.7 %).
Croatian: U ispitivanjima u stabilnih bolesnika sa shizofrenijom, Abilify Maintena bio je povezan s većom učestalošću EPS simptoma (18,4 %) nego liječenje oralnim aripiprazolom (11,7 %).
English: The primary endpoint (change in PANSS total score from baseline to week 10) showed superiority of Abilify Maintena (n = 167) over placebo (n = 172).
Croatian: Primarni ishod (promjena ukupnog rezultata na ljestvici PANSS od početka do 10. tjedna) pokazao je superiornost lijeka Abilify Maintena (n = 167) u odnosu na placebo (n = 172).
English: Aripiprazole is extensively metabolised by the liver primarily by three biotransformation pathways: dehydrogenation, hydroxylation, and N-dealkylation.
Croatian: Aripiprazol se opsežno metabolizira u jetri putem tri biotransformacijska puta: dehidrogenacije, hidroksilacije i N-dealkilacije.
English: Following multiple intramuscular doses, the plasma concentrations of aripiprazole gradually rise to a maximum plasma concentration at a median tmax of 7 days for the gluteal muscle and 4 days for the deltoid muscle.
Croatian: Nakon višestrukih intramuskularnih doza, koncentracije aripiprazola u plazmi postupno su rasle i dosegle maksimalnu vrijednost u plazmi nakon medijana tmax od 7 dana kod primjene u glutealni mišić i 4 dana kod primjene u deltoidni mišić.
English: Vertically shake the syringe vigorously for 20 seconds until medicine is uniformly milky-white and use immediately.
Croatian: Držeći štrcaljku okomito, žustro je tresite tijekom 20 sekundi sve dok lijek ne postane jednolično mliječno bijele boje i odmah ga primijenite.
English: Aripiprazole exhibited antagonist properties in animal models of dopaminergic hyperactivity and agonist properties of dopaminergic hypoactivity.
Croatian: Aripiprazol je pokazao antagonistička svojstva na životinjskim modelima dopaminergičke hiperaktivnosti i agonistička svojstva dopaminergičke hipoaktivnosti.
English: Mean baseline (SD) Mean change (SD) P-value
Croatian: Srednja početna vrijednost (SD) Srednja vrijednost promjene (SD) P-vrijednost
English: • kidney stones, sugar (glucose) in urine
Croatian: • bubrežni kamenci, šećer (glukoza) u mokraći
English: The toxicological profile for aripiprazole administered to experimental animals by intramuscular injection is generally similar to that seen following oral administration at comparable plasma levels.
Croatian: Toksikološki profil aripiprazola primijenjenog pokusnim životinjama intramuskularnom injekcijom općenito je sličan onome opaženom nakon oralne primjene pri usporedivim razinama u plazmi.
English: Patients fulfilling the oral stabilisation requirement in the Oral Stabilisation Phase were assigned to receive, in a single-blind fashion, Abilify Maintena and began an Abilify Maintena Stabilisation Phase for a minimum of 12 weeks and a maximum of 36 weeks.
Croatian: Za bolesnike koji su zadovoljili uvjet oralne stabilizacije u fazi oralne stabilizacije određeno je, na jednostruko slijepi način, da primaju Abilify Maintena te su počeli fazu stabilizacije na lijeku Abilify Maintena u trajanju od najmanje 12 tjedana, a najviše 36 tjedana.
English: If you see more than one doctor, be sure to tell them that you are receiving Abilify Maintena.
Croatian: Ako se liječite kod više od jednog liječnika, obavezno im recite da primate Abilify
English: Oculogyric crisis: From post-marketing sources, there were 20 reports of oculogyric crisis during the interval (11 serious) and 244 reports cumulatively (92 serious).
Croatian: Okulogirna kriza: Izvori iz razdoblja nakon stavljanja lijeka u promet navode 20 prijava okulogirne krize tijekom promatranog razdoblja (11 ozbiljnih) i 244 prijave kumulativno (92 ozbiljne).
English: Oral aripiprazole 10-30 mg/day (n = 266)
Croatian: Oralni aripiprazol 10-30 mg/dan (n = 266)
English: • mental disorder characterized by defective or lost contact with reality
Croatian: • duševni poremećaj obilježen nepotpunim dodirom ili gubitkom dodira sa stvarnošću
English: Following any confirmed or suspected overdose with aripiprazole, close medical supervision and monitoring should continue until the patient recovers.
Croatian: Nakon potvrde ili sumnje na predoziranje aripiprazolom, potrebno je nastaviti s pažljivim medicinskim nadzorom i praćenjem sve dok se bolesnik ne oporavi.
English: Akathisia was the most frequently observed symptom (8.2 %) and typically started around day 10 after first injection, and lasted a median of 56 days.
Croatian: Akatizija je bila najčešće opaženi simptom (8,2 %), a obično bi počela oko 10. dana nakon prve injekcije i imala medijan trajanja od 56 dana.
English: No dosage adjustment is required for patients with mild or moderate hepatic impairment.
Croatian: Nije potrebna prilagodba doze u bolesnika s blagim ili umjerenim oštećenjem funkcije jetre.
English: g) Slowly withdraw the recommended volume from the vial into the luer lock syringe to allow for injection.
Croatian: g) Polako izvucite preporučeni volumen iz bočice u štrcaljku s priključkom tipa luer lock kako biste mogli dati injekciju.
English: The second trial was a 52-week, randomised, withdrawal, double-blind, trial conducted in US adult patients with a current diagnosis of schizophrenia.
Croatian: Drugo ispitivanje bilo je 52-tjedno, randomizirano, dvostruko slijepo ispitivanje ustezanja lijeka provedeno u odraslih bolesnika s aktualnom dijagnozom shizofrenije u Sjedinjenim Državama.
English: In clinical trials and post-marketing experience, accidental or intentional acute overdose of aripiprazole alone was identified in adult patients with reported estimated doses up to 1,260 mg (41 times highest recommended daily aripiprazole dose) with no fatalities.
Croatian: U kliničkim ispitivanjima i iskustvu nakon stavljanja lijeka u promet utvrđeno je slučajno ili namjerno akutno predoziranje samo aripiprazolom u odraslih bolesnika dozama, koje su prema zabilježenoj procjeni iznosile do 1260 mg (41 puta više od preporučene dnevne doze aripiprazola), bez smrtnih ishoda.
English: After plunger rod is at complete stop, middle stopper will be at the indicator line.
Croatian: Kad je klip zakrenut do kraja, srednji čep se nalazi u razini linijske oznake.
English: All ADRs are listed by system organ class and frequency; very common (≥ 1/10), 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)
Croatian: često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000), vrlo rijetko (<10 000) i nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Aripiprazole Long-Acting Injectable 50 mg/25 mg (n = 131)
Croatian: Dugodjelujući aripiprazol u injekcijama od 50 mg/25 mg (n = 131)
English: • muscle weakness, tenderness or pain and particularly, if at the same time, you feel unwell, have a high temperature or have dark urine.
Croatian: • slabost, osjetljivost ili bol mišića, osobito ako se istodobno loše osjećate, imate povišenu tjelesnu temperaturu ili tamnu boju mokraće.
English: In the same trials with oral aripiprazole, cerebrovascular adverse reactions (e.g. stroke, transient ischaemic attack), including fatalities, were reported in patients (mean age: 84 years; range: 78-88 years).
Croatian: U istim kliničkim ispitivanjima oralnog aripiprazola, u bolesnika su zabilježene cerebrovaskularne nuspojave (npr. moždani udar, tranzitorna ishemijska ataka), uključujući smrtne slučajeve, (srednja vrijednost dobi: 84 godina; raspon: 78-88 godina).
English: Based on results from trials with oral administration of aripiprazole, aripiprazole is widely distributed throughout the body with an apparent volume of distribution of 4.9 l/kg, indicating extensive extravascular distribution.
Croatian: Na temelju rezultata ispitivanja oralne primjene aripiprazola, aripiprazol se naširoko distribuira po cijelom tijelu uz prividni volumen distribucije od 4,9 l/kg, koji ukazuje na opsežnu ekstravaskularnu distribuciju.
English: What Abilify Maintena looks like and contents of the pack
Croatian: Kako Abilify Maintena izgleda i sadržaj pakiranja
English: The efficacy of Abilify Maintena in acutely relapsed adult patients with schizophrenia was established in a short-term (12-week), randomised, double-blind, placebo-controlled trial (n = 339).
Croatian: Djelotvornost lijeka Abilify Maintena u odraslih bolesnika s akutnim relapsom shizofrenije ustanovljena je u kratkotrajnom (12 tjedana), randomiziranom, dvostruko slijepom, placebom kontroliranom ispitivanju (n = 339).
English: The occurrence of suicidal behaviour is inherent in psychotic illnesses, and in some cases has been reported early after initiation or switch of antipsychotic treatment, including treatment with aripiprazole (see section 4.8).
Croatian: Pojava suicidalnog ponašanja svojstvena je psihotičkim bolestima, a u nekim je slučajevima to zabilježeno ubrzo nakon početka ili promjene antipsihotičke terapije, uključujući liječenje aripiprazolom (vidjeti dio 4.8).
English: • loss of appetite (anorexia), difficulty in swallowing
Croatian: • gubitak apetita (anoreksija), otežano gutanje
English: The potentially medically serious signs and symptoms reported included somnolence, transient loss of consciousness and extrapyramidal symptoms.
Croatian: Zabilježeni medicinski potencijalno ozbiljni znakovi i simptomi uključivali su somnolenciju, prolazni gubitak svijesti i ekstrapiramidalne simptome.
English: Aripiprazole is the predominant medicinal product moiety in systemic circulation.
Croatian: Aripiprazol je glavni oblik lijeka u sistemskoj cirkulaciji.
English: Concomitant administration of Abilify Maintena and other inducers of CYP3A4 (such as rifampicin, rifabutin, phenytoin, phenobarbital, primidone, efavirenz, nevirapine and St. John's Wort) may be expected to have similar effects.
Croatian: Istodobna primjena lijeka Abilify Maintena i drugih induktora CYP3A4 (kao što su rifampicin, rifabutin, fenitoin, fenobarbital, primidon, efavirenz, nevirapin i gospina trava) može očekivano imati slične učinke.
English: After administration of multiple dose of 400 mg or 300 mg of Abilify Maintena, the mean aripiprazole terminal elimination half-life is respectively 46.5 and 29.9 days presumably due to absorption ratelimited kinetics.
Croatian: Nakon primjene višestruke doze od 400 mg ili 300 mg lijeka Abilify Maintena, srednja vrijednost terminalnog poluvijeka eliminacije aripiprazola je 46,5 dana odnosno 29,9-dana, pretpostavlja se zbog kinetike ograničene brzinom apsorpcije.
English: On the basis of the scientific conclusions for aripiprazole the CHMP is of the opinion that the benefitrisk balance of the medicinal product(s) containing aripiprazole is unchanged subject to the proposed changes to the product information.
Croatian: Na temelju znanstvenih zaključaka za aripiprazol, CHMP smatra da je omjer koristi i rizika lijeka(ova) koji sadrži(e) aripiprazol nepromijenjen, uz predložene izmjene informacija o lijeku.
English: The aripiprazole Long-Acting Injectable 50 mg/25 mg dose was included as a low dose aripiprazole to test assay sensitivity for the non-inferiority design.
Croatian: Dugodjelujući aripiprazol u injekcijama u dozi od 50 mg/25 mg bio je uključen kao niska doza aripiprazola, kako bi se ispitala osjetljivost testa za dizajn neinferiornosti.
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).
Croatian: Kliničke manifestacije NMS-a su hiperpireksija, ukočenost mišića, promijenjeno mentalno stanje i znakovi nestabilnosti autonomnog živčanog sustava (nepravilan puls ili krvni tlak, tahikardija, diaforeza i srčana disritmija).
English: - Syringe and needle instructions.
Croatian: - Upute za štrcaljku i iglu
English: strong impulse to gamble excessively despite serious personal or family consequences altered or increased sexual interest and behaviour of significant concern to you or to others, for example, an increased sexual drive uncontrollable excessive shopping binge eating (eating large amounts of food in a short time period) or compulsive eating
Croatian: snažan nagon za pretjeranim kockanjem usprkos ozbiljnim posljedicama za osobu ili obitelj promijenjen ili povećan seksualni interes i ponašanje koje znatno zabrinjava Vas ili druge, na primjer, povećani seksualni poriv pretjerano kupovanje ili trošenje koje se ne može kontrolirati prejedanje (jedenje ogromnih količina hrane u kratkom razdoblju) ili kompulzivno jedenje (jedenje veće količine hrane nego što je normalno i više nego je potrebno za utaženje gladi) sklonost da se odluta
English: Oesophageal dysmotility and aspiration have been associated with the use of aripiprazole.
Croatian: Poremećaj motiliteta jednjaka i aspiracija povezani su s primjenom aripiprazola.
English: New-born infants exposed to antipsychotics (including aripiprazole) during the third trimester of pregnancy are at risk of adverse reactions including extrapyramidal and/or withdrawal symptoms that may vary in severity and duration following delivery.
Croatian: Novorođenčad izložena antipsihoticima (uključujući aripiprazol) tijekom trećeg tromjesečja trudnoće pod rizikom je od nuspojava uključujući ekstrapiramidalne simptome i/ili simptome ustezanja koji mogu biti različite težine i trajanja nakon porođaja.
English: Aripiprazole also exhibited moderate binding affinity for the serotonin reuptake site and no appreciable affinity for cholinergic muscarinic receptors.
Croatian: Aripiprazol je također pokazao umjereni afinitet vezanja za mjesto ponovne pohrane serotonina te nemjerljiv afinitet prema kolinergičkim muskarinskim receptorima.
English: • triptans (such as sumatriptan and zolmitripitan) used for treating migraine.
Croatian: • triptani (kao što su sumatriptan i zolmitriptan) koji se primjenjuju za liječenje migrene.
English: Step 3: Preparation prior to injection a) Remove the cover, but not the adapter from the package.
Croatian: Korak 3: Priprema prije injekcije a) Skinite pokrov, ali nemojte izvaditi nastavak iz pakiranja.
English: Twist + Pull Off b) Select one of the following hypodermic safety needles depending on the injection site and patient's weight.
Croatian: Zakrenite i odvojite b) Odaberite jednu od sljedećih hipodermalnih sigurnosnih igala ovisno o mjestu primjene injekcije i tjelesnoj težini bolesnika.
English: Following a single oral dose of [14C]-labelled aripiprazole, approximately 27 % of the administered radioactivity was recovered in the urine and approximately 60 % in the faeces.
Croatian: Nakon jedne oralne doze aripiprazola označenog izotopom [14C], približno 27 % primijenjene radioaktivnosti otkrilo se u mokraći, a približno 60 % u stolici.
English: f) Slowly inject into the gluteal or deltoid muscle.
Croatian: f) Polako ubrizgajte u glutealni ili deltoidni mišić.
English: > 4 weeks and < 6 weeks
Croatian: > 4 tjedna i < 6 tjedana
English: While overdose is less likely with parenteral than oral medicinal products, reference information for oral aripiprazole overdose is presented below.
Croatian: Iako je vjerojatnost predoziranja parenteralnim lijekovima manja nego oralnim lijekovima, u daljnjem su tekstu navedene referentne informacije za predoziranje oralnim aripiprazolom.
English: • an acutely agitated state or a severely psychotic state
Croatian: • stanja akutne uznemirenosti ili jakog psihotičnog stanja
English: The rate of death in oral aripiprazole-treated patients was 3.5 % compared to 1.7 % in placebo.
Croatian: Stopa smrti u bolesnika liječenih oralnim aripiprazolom bila je 3,5 % u usporedbi s 1,7 % u skupini koja je primala placebo.
English: Since patients treated with antipsychotics often present with acquired risk factors for VTE, all possible risk factors for VTE should be identified before and during treatment with aripiprazole and preventive measures undertaken (see section 4.8).
Croatian: Budući da bolesnici liječeni antipsihoticima često imaju stečene faktore rizika za VTE, potrebno je prepoznati sve moguće faktore rizika za VTE prije i tijekom liječenja aripiprazolom te poduzeti preventivne mjere (vidjeti dio 4.8).
English: • if you have symptoms such as swelling, pain, and redness in the leg, because this may mean you have a blood clot, which may travel through blood vessels to the lungs causing chest pain and difficulty in breathing.
Croatian: • ako imate simptome kao što su oticanje, bol i crvenilo noge, zato što to može ukazivati na krvni ugrušak, koji može putovati krvnim žilama do pluća i tamo uzrokovati bol u prsištu i otežano disanje.
English: Keep the syringe in the outer carton in order to protect from light.
Croatian: Napunjenu štrcaljku čuvati u vanjskom pakiranju radi zaštite od svjetlosti.
English: d) Withdraw air to equalise the pressure in the vial by pulling back slightly on the plunger.
Croatian: d) Izvucite zrak kako biste izjednačili tlak u bočici tako što ćete malo izvući klip.
English: causing heartburn and possibly damaging the esophagus
Croatian: uzrokujući žgaravicu i moguće oštećenje jednjaka
English: When seen, it is usually in those with significant risk factors such as history of diabetes, thyroid disorder or pituitary adenoma.
Croatian: Kada je prisutno, obično se vidi u onih sa značajnim rizičnim čimbenicima kao što su šećerna bolesti, poremećaji štitne žlijezde ili pituitarni adenom u anamnezi.