FrancophonIA/ELRC3.0 huggingface dataset:
English: This means that it is similar to a ‘reference medicine' containing the same active substances, but Vylaer Spiromax is given using a different inhaler.
Slovenian: To pomeni, da je podobno referenčnemu zdravilu, ki vsebuje isti zdravilni učinkovini, vendar se zdravilo Vylaer Spiromax uporablja z drugačnim inhalatorjem.
English: It can be used in patients whose disease is not adequately controlled by treatment with other asthma medicines called corticosteroids and ‘short-acting beta-2 agonists' taken by inhalation, or in patients whose disease is adequately controlled by treatment with corticosteroids and ‘long-acting beta-2 agonists' taken by inhalation.
Slovenian: Uporablja se lahko pri bolnikih, pri katerih bolezni ne moremo ustrezno nadzorovati z drugimi zdravili za zdravljenje astme, imenovanimi inhalacijski kortikosteroidi in kratkodelujoči agonisti adrenergičnih receptorjev beta-2, ali pri katerih je bolezen že ustrezno nadzorovana z inhalacijskimi kortikosteroidi in dolgodelujočimi agonisti adrenergičnih receptorjev beta-2.
English: Studies were carried out to show that Vylaer Spiromax is bioequivalent to the reference medicine (i.e. produces the same level of the active substance in the body) and that the two medicines act in the same way.
Slovenian: Izvedene so bile študije, ki so pokazale, da je zdravilo Vylaer Spiromax biološko enakovredno referenčnemu zdravilu (tj. da dosega enako raven zdravilne učinkovine v telesu) in da obe zdravili enako delujeta.
English: This is a summary of the European public assessment report (EPAR) for Vylaer Spiromax.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Vylaer Spiromax.
English: Vylaer Spiromax is also used to relieve the symptoms of severe chronic obstructive pulmonary disease (COPD) in adults who have had exacerbations (flare-ups) of the disease in the past despite regular treatment.
Slovenian: Zdravilo Vylaer Spiromax se uporablja tudi za zdravljenje simptomov hude kronične obstruktivne pljučne bolezni (KOPB) pri odraslih s ponavljajočimi se poslabšanji simptomov bolezni v preteklosti kljub rednemu zdravljenju.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that Vylaer Spiromax 160/4.5 microgram and 320/9 microgram have been shown to have comparable quality and to be equivalent to the corresponding strengths of Symbicort Turbohaler.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da ima zdravilo Vylaer Spiromax v jakostih 160/4,5 mikrograma in 320/9 mikrogramov primerljivo raven kakovosti kot zdravilo Symbicort Turbohaler ter da mu je pri ustrezajočih jakostih enakovredno.
English: The benefits and risks of Vylaer Spiromax are therefore taken to be the same as those of the reference medicine.
Slovenian: Koristi in tveganja zdravila Vylaer Spiromax so torej enaki kot pri referenčnemu zdravilu.
English: What measures are being taken to ensure the safe and effective use of Vylaer Spiromax?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Vylaer Spiromax?
English: This leads to a reduction in the release of substances that are involved in the inflammation process, such as histamine, thereby helping to keep the airways clear and allowing the patient to breathe more easily.
Slovenian: S tem se zmanjša sproščanje snovi, ki sodelujejo v vnetnih procesih, na primer histamina, kar pripomore k ohranjanju prehodnosti dihalnih poti in bolniku olajša dihanje.
English: It is available as an inhalation powder in a portable inhaler device, and each inhalation provides a fixed dose of the medicine.
Slovenian: Zdravilo je na voljo v obliki praška za inhaliranje v prenosnem pripomočku za inhaliranje, pri čemer se z vsako inhalacijo bolniku dovede fiksni odmerek zdravila.
English: The reference medicine for Vylaer Spiromax is Symbicort Turbohaler.
Slovenian: Referenčno zdravilo za zdravilo Vylaer Spiromax je Symbicort Turbohaler.
English: The two active substances in Vylaer Spiromax are well known and are present in several medicines used to treat asthma and COPD, either alone or in combination with other medicines.
Slovenian: Zdravilni učinkovini v zdravilu Vylaer Spiromax sta dobro znani in sta prisotni v več zdravilih, ki se samostojno ali v kombinaciji z drugimi zdravili uporabljajo za zdravljenje astme in KOPB.
English: It works by attaching to receptors known as beta-2 receptors found in the muscles of the airways.
Slovenian: Deluje tako, da se veže na receptorje, imenovane adrenergični receptorji beta-2, ki so v dihalnih mišicah.
English: For the regular treatment of asthma, the recommended dose is 1 to 4 inhalations twice a day, depending on the strength being used and the severity of the asthma.
Slovenian: Priporočeni odmerek za redno zdravljenje astme je od 1 do 4 vpihi dvakrat na dan, kar je odvisno od uporabljene jakosti zdravila in izraženosti astme.
English: For more information about treatment with Vylaer Spiromax, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Vylaer Spiromax preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: What is Vylaer Spiromax and what is it used for?
Slovenian: Kaj je zdravilo Vylaer Spiromax in za kaj se uporablja?
English: A risk management plan has been developed to ensure that Vylaer Spiromax is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Vylaer Spiromax je bil pripravljen načrt obvladovanja tveganj.
English: For practical information about using Vylaer Spiromax, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Vylaer Spiromax naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: For asthma reliever therapy, patients should take a separate ‘reliever inhaler' to relieve their symptoms.
Slovenian: Pri olajševalnem zdravljenju astme morajo bolniki za lajšanje simptomov uporabiti ločen „inhalator z olajševalcem“.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Vylaer Spiromax, including the appropriate precautions to be followed by healthcare professionals and patients.
Slovenian: V skladu s tem načrtom so bile v povzetek glavnih značilnosti tega zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
English: The Committee recommended that Vylaer Spiromax be given marketing authorisation.
Slovenian: Priporočil je, da se za zdravilo Vylaer Spiromax izda dovoljenje za promet.
English: What are the benefits and risks of Vylaer Spiromax?
Slovenian: Kakšne so koristi in tveganja, povezani z zdravilom Vylaer Spiromax?
English: When inhaled it mainly attaches to the receptors in the airways and causes the muscles to relax, which keeps the airways open and helps with the patient's breathing.
Slovenian: Ob vdihu se v glavnem veže na receptorje v dihalnih poteh in sprošča mišice, s čimer ohranja dihalne poti odprte in bolniku olajša dihanje.
English: Vylaer Spiromax is a medicine that contains the active substances budesonide and formoterol.
Slovenian: Vylaer Spiromax je zdravilo, ki vsebuje zdravilni učinkovini budezonid in formoterol.
English: Other information about Vylaer Spiromax
Slovenian: Druge informacije o zdravilu Vylaer Spiromax
English: Vylaer Spiromax is a ‘hybrid medicine'.
Slovenian: Zdravilo Vylaer Spiromax je „hibridno zdravilo“.
English: Why is Vylaer Spiromax approved?
Slovenian: Zakaj je bilo zdravilo Vylaer Spiromax odobreno?
English: How does Vylaer Spiromax work?
Slovenian: Kako zdravilo Vylaer Spiromax deluje?
English: How is Vylaer Spiromax used?
Slovenian: Kako se zdravilo Vylaer Spiromax uporablja?
English: It is not intended to provide practical advice on how to use Vylaer Spiromax.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: Date of first authorisation: 8 December 2014 Date of latest renewal: 23 September 2019
Slovenian: Datum prve odobritve: 8. december 2014 Datum zadnjega podaljšanja: 23. september 2019
English: 2132NP Hoofddorp The Netherlands
Slovenian: 2132NP Hoofddorp Nizozemska
English: Patients over 65 years of age have been represented in the phase III studies.
Slovenian: Bolniki, starejši od 65 let, so bili zastopani v študijah III. faze.
English: Not known (frequency cannot be estimated from the available data):
Slovenian: Neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov):
English: Northumberland, NE61 3YA United Kingdom
Slovenian: Northumberland, NE61 3YA Velika Britanija
English: • if your opioid medicine is to be stopped for more than 24 hours
Slovenian: • če morate svoje opioidno zdravilo nehati jemati za več kot 24 ur.
English: • Stir and drink immediately
Slovenian: • Zmešajte in takoj popijte.
English: • excessive sweating
Slovenian: • prekomerno znojenje
English: Of the 844 patients who were randomized, 61.1% completed the study (defined as completing the 2-week follow-up visit after the 52-week treatment period).
Slovenian: Od 844 randomiziranih bolnikov jih je študijo dokončalo 61,1 % (dokončanje je bilo opredeljeno kot opravljen 2-tedenski spremljevalni pregled po 52-tedenskem obdobju zdravljenja).
English: Constipation related to opioids can result in symptoms such as:
Slovenian: Zaprtje, povezano z opioidi, lahko povzroči simptome, kakršni so:
English: Opioid withdrawal symptoms may affect up to 1 in 100 people.
Slovenian: Simptomi odtegnitve opioidov se lahko pojavijo pri največ 1 od 100 bolnikov.
English: Food effects: A high-fat meal increased the extent and rate of naloxegol absorption.
Slovenian: Vplivi hrane: Zelo masten obrok je povečal obseg in hitrost absorpcije naloksegola.
English: Tablets are engraved with “nGL” on one side and the strength of the tablet on the other.
Slovenian: Tablete imajo vtisnjeno oznako »nGL« na eni strani in jakost tablete na drugi strani.
English: What Moventig is and what it is used for
Slovenian: Kaj je zdravilo Moventig in za kaj ga uporabljamo
English: Tell your doctor what opioid pain medicines you are taking and the dose of them.
Slovenian: Zdravniku povejte, katera opioidna zdravila proti bolečinam jemljete in v kakšnem odmerku.
English: Do not take Moventig if you are taking any of the following medicines (see section “Do not take Moventig”):
Slovenian: Ne jemljite zdravila Moventig, če jemljete katero od naslednjih zdravil (glejte poglavje »Ne jemljite zdravila Moventig«):
English: Do not use this medicine after the expiry date which is stated on the carton after “EXP”.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli za oznako »EXP«.
English: The observed neoplastic changes are well known hormonal and centrally mediated effects in the rat which are not relevant for humans.
Slovenian: Opažene neoplastične spremembe so dobro znani hormonski in centralno posredovani učinki pri podganah, ki za človeka niso pomembni.
English: According to the ICH E14 Guideline, this is considered a definitively negative thorough QT/QTc study.
Slovenian: Po smernici ICH E14 ta študija velja za jasno negativno temeljito študijo QT/QTc.
English: • if you have had a heart attack within the last 6 months, have heart failure with daily shortness of breath or other severe problems with your heart which cause daily symptoms
Slovenian: • če ste imeli srčni infarkt v zadnjih 6 mesecih, imate srčno popuščanje z vsakodnevnim težkim dihanjem ali imate druge težave s srcem, ki vam povzročajo vsakodnevne simptome,
English: Moventig is not recommended for use in children and adolescents below 18 years of age because it has not been studied in these age-groups.
Slovenian: Zdravila Moventig pri otrocih in mladostnikih, mlajših od 18 let, ni priporočljivo uporabljati, ker v teh starostnih skupinah ni raziskano.
English: Most such reports were observed shortly after initial administration with the medicinal product and were mild or moderate in intensity.
Slovenian: Večino takšnih primerov so opažali kmalu po začetni uporabi zdravila in so bili blagi ali zmerni.
English: (≥ 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) and not known (cannot be estimated from the available data).
Slovenian: (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000) in neznana pogostnost
English: • if you experience symptoms of opioid withdrawal syndrome (see section 4 below).
Slovenian: • če se vam pojavijo simptomi sindroma odtegnitve opioidov (glejte poglavje 4 spodaj).
English: At therapeutic doses, most opioids (e.g. morphine, meperidine, methadone) are excreted into breast milk in minimal amounts.
Slovenian: V terapevtskih odmerkih se večina opioidov (npr. morfin, meperidin, metadon) izloča v materino mleko v minimalni količini.
English: What Moventig is and what it is used for What you need to know before you take Moventig How to take Moventig
Slovenian: Kaj je zdravilo Moventig in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Moventig Kako jemati zdravilo Moventig
English: Your doctor may tell you to take a lower dose of 12.5 mg
Slovenian: Zdravnik vam bo morda naročil, da jemljite manjši odmerek 12,5 mg:
English: • Crush the tablet to a powder
Slovenian: • Zdrobite tableto v prašek.
English: This could be a symptom of damage to the wall of the gut and can be life-threatening.
Slovenian: To je lahko simptom poškodbe stene črevesa, ki je lahko smrtno nevarna.
English: The mean apparent volume of distribution during the terminal phase (Vz/F) in healthy volunteers ranged from 968 to 2,140 L across dosing groups and studies.
Slovenian: Povprečni navidezni volumen porazdelitve med terminalno fazo (Vz/F) je bil pri zdravih prostovoljcih od 968 do 2.140 l v skupinah z različnim odmerjanjem in v različnih študijah.
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 or any other opioid antagonist.
Slovenian: Preobčutljivost Preobčutljivost na učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1, ali na kateri koli drug opioidni antagonist.
English: Long-term safety and tolerability
Slovenian: Dolgoročna varnost in prenašanje
English: A QTc study performed with naloxegol in healthy volunteers did not indicate any prolongation of the QT interval.
Slovenian: Študija intervala QTc, ki so jo izvedli z naloksegolom pri zdravih prostovoljcih, ni pokazala podaljšanja intervala QT.
English: All these effects were observed only at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.
Slovenian: Vse te učinke so opazili samo pri izpostavljenosti, ki je močno presegala največjo izpostavljenost pri človeku, kar kaže na majhen pomen za klinično uporabo.
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.
Slovenian: Imetnik dovoljenja za promet bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih sprejetih posodobitvah RMP.
English: Pharmacotherapeutic group: Drugs for constipation, peripheral opioid receptor antagonists ATC code: A06AH03
Slovenian: Farmakoterapevtska skupina: zdravila proti zaprtju, periferno delujoči antagonisti opioidnih receptorjev; oznaka ATC: A06AH03
English: In clinical pharmacology studies, the half-life of naloxegol at therapeutic dose ranged from 6-11 hours.
Slovenian: V kliničnih farmakoloških študijah je bil razpolovni čas naloksegola v terapevtskih odmerkih od 6 do 11 ur.
English: If you have trouble swallowing the tablet you can crush it and mix with water as follows:
Slovenian: Če težko pogoltnete tableto Če težko pogoltnete tableto, jo lahko zdrobite in zmešate z vodo na naslednji način:
English: In a mass balance study in humans, a total of 6 metabolites were identified in plasma, urine and faeces.
Slovenian: V študiji masnega ravnovesja pri človeku so v plazmi, urinu in blatu ugotovili skupaj 6 presnovkov.
English: • Do not take a double dose to make up for a missed dose.
Slovenian: • Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek.
English: • hard stools (stools which are hard “like a rock”)
Slovenian: • trdo blato (blato, ki je trdo »kot kamen«),
English: The primary objective was to assess long-term safety and tolerability for naloxegol 25 mg and to compare with usual care treatment using descriptive statistics.
Slovenian: Primarni cilj je bila ocena dolgoročne varnosti in prenašanja 25 mg naloksegola in primerjava z običajnim zdravljenjem z uporabo opisnih statistik.
English: The overall benefit-risk profile for each patient should be taken into account.
Slovenian: Upoštevati je treba celotno razmerje med koristjo in tveganjem pri vsakem bolniku.
English: Moventig has no or negligible influence on the ability to drive and use machines.
Slovenian: Zdravilo Moventig nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
English: Frequency categories are defined according to the following conventions: very common (≥ 1/10), common
Slovenian: Kategorije pogostnosti so opredeljene po naslednjem dogovoru: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni
English: As there are additional data from the use of this medicine in pregnant women, the use of Moventig during pregnancy is not recommended.
Slovenian: Ker so na voljo dodatni podatki o uporabi tega zdravila pri nosečnicah, zdravila Moventig ni priporočljivo uporabljati med nosečnostjo.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Moventig in one or more subsets of the paediatric population in opioid induced constipation (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom Moventig za eno ali več podskupin pediatrične populacije pri zaprtju, povzročenem z opioidi (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: Moventig with drink
Slovenian: Zdravilo Moventig skupaj s pijačo
English: • if you have kidney problems - your doctor may tell you to take a different dose (see section below “How to take Moventig”)
Slovenian: • če imate težave z ledvicami - vaš zdravnik vam bo morda naročil, da jemljete drugačen odmerek (glejte poglavje spodaj »Kako jemati zdravilo Moventig«),
English: 12 hours until your next dose, skip the missed dose.
Slovenian: Če pa je do naslednjega odmerka manj kot 12 ur, pozabljeni odmerek izpustite.
English: Other medicines and Moventig
Slovenian: Druga zdravila in zdravilo Moventig
English: What you need to know before you take Moventig Do not take Moventig:
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Moventig Ne jemljite zdravila Moventig:
English: • clarithromycin or telithromycin - antibiotics
Slovenian: • klaritromicin ali telitromicin - antibiotika,
English: Following oral administration, naloxegol is absorbed rapidly, with peak concentrations (Cmax) achieved at less than 2 hours.
Slovenian: Po peroralni uporabi se naloksegol hitro absorbira in največjo koncentracijo (Cmax) doseže v manj kot 2 urah.
English: Overall 393 and 317 patients had at least 6 and 12 months exposure to naloxegol 25 mg, respectively, in this study, which met the specified exposure requirements.
Slovenian: V celoti je bilo v tej študiji 25 mg naloksegola vsaj 6 mesecev izpostavljenih 393 bolnikov in 12 mesecev 317 bolnikov, ki so izpolnili opredeljene zahteve o izpostavljenosti.
English: • methadone
Slovenian: • metadon,
English: In some patients, however, a constellation of symptoms has been reported, which resembles the syndrome of central opioid withdrawal.
Slovenian: Vendar je bil pri nekaterih bolnikih opisan skupek simptomov, ki spominja na sindrom centralne odtegnitve opioidov.
English: They were often reported as having a component of cramping discomfort.
Slovenian: Pogosto je bilo poročano, da jih spremlja občutek nelagodja s krči.
English: Kyowa Kirin Holdings B.V. Bloemlaan 2
Slovenian: Kyowa Kirin Holdings B.V.
English: Contents of the pack and other information What Moventig contains
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Moventig
English: Parent naloxegol excreted in the urine accounted for less than 6% of the total administered dose.
Slovenian: V urinu izločeni matični naloksegol je predstavljal manj kot 6 % celotnega uporabljenega odmerka.
English: There is a small effect of age on the pharmacokinetics of naloxegol (approximately 0.7% increase in AUC for every year increase in age).
Slovenian: Starost v majhni meri vpliva na farmakokinetiko naloksegola (približno 0,7 % zvišanje AUC za vsako dodatno leto starosti).
English: Opioid withdrawal syndrome typically develops within minutes to several days following administration of an opioid antagonist.
Slovenian: Sindrom odtegnitve opioidov se značilno pojavi v nekaj minutah do nekaj dneh po dajanju antagonista opioidov.
English: A “symptom responder” was defined as meeting both the 12-week responder criteria and demonstrating improvement in pre-specified OIC symptoms and no deterioration in symptoms.
Slovenian: Opazovani dogodek odziva simptomov »Odziv simptomov« je bil opredeljen kot izpolnitev 12-tedenskih meril odziva in hkrati dokazano izboljšanje vnaprej opredeljenih simptomov OIC, brez poslabšanja simptomov.
English: The primary objective was to compare safety and tolerability among the three treatment groups for an additional 12 weeks (beyond that observed in Kodiac 4) using descriptive statistics.
Slovenian: Primarni cilj je bila primerjava varnosti in prenašanja v treh terapevtskih skupinah med obdobjem dodatnih 12 tednov (poleg obdobja v Kodiac 4) z uporabo opisnih statistik.
English: Safety and efficacy have not been established in patients with severe hepatic impairment (see section 5.2).
Slovenian: Varnost in učinkovitost pri bolnikih s hudo okvaro jeter nista ugotovljeni (glejte poglavje 5.2).
English: The first of three multiplicity protected secondary endpoints was the 12-week responder rate in the LIR subgroup.
Slovenian: Prvi od treh za večkratnost zavarovanih sekundarnih opazovanih dogodkov je bil 12-tedenski delež odzivnih bolnikov v podskupini LIR.
English: The safety and efficacy of naloxegol in children <18 years of age has not yet been established.
Slovenian: Pediatrična populacija Varnost in učinkovitost naloksegola pri otrocih, mlajših od 18 let, še nista ugotovljeni.
English: However, in 2 out of 8 patients (in both the moderate and severe renal impairment groups but not in the end stage renal failure group) up to 10-fold increases in the exposure of naloxegol were observed.
Slovenian: Toda pri 2 od 8 bolnikov (v skupini z zmerno in v skupini s hudo okvaro ledvic, ne pa v skupini s končno odpovedjo ledvic) so opazili do 10-krat večjo izpostavljenost naloksegolu.
English: • incomplete emptying of the rectum (after having a bowel movement, the feeling as if a stool is still in the rectum which needs to come out)
Slovenian: • nepopolna izpraznitev danke (po iztrebljanju blata ostaja občutek, kot da je blato še vedno v danki in mora ven).
English: • Pour the powder into half a glass of water (120 ml)
Slovenian: • Vsujte prašek v pol kozarca vode (120 ml).
English: Naloxegol was found to have no effect on fertility of male and female rats at oral doses up to 1,000 mg/kg per day (greater than 1,000 times the human therapeutic exposure (AUC) at the recommended human dose of 25 mg/day).
Slovenian: Ugotovljeno je, da naloksegol ne vpliva na plodnost podganjih samcev in samic pri peroralnih odmerkih do 1.000 mg/kg na dan (več kot 1.000-kratna terapevtska izpostavljenost pri človeku (AUC) ob priporočenem odmerku za človeka