FrancophonIA/ELRC3.0 huggingface dataset:
English: Naldemedine should not be used during pregnancy unless the clinical condition of the woman requires treatment with naldemedine.
Slovenian: Naldemedina v nosečnosti ne smemo uporabljati, razen če klinično stanje nosečnice zahteva zdravljenje z naldemedinom.
English: NL-8448 CN Heerenveen 8448 CN Heerenveen
Slovenian: NL-8448 CN Heerenveen 8448 CN Heerenveen Nizozemska
English: See 'Other medicines and Rizmoic'.
Slovenian: Glejte 'Druga zdravila in zdravilo Rizmoic'.
English: Alteration of the analgesic dosing regimen prior to initiating Rizmoic is not required.
Slovenian: Spreminjanje sheme odmerjanja analgetika pred uvajanjem zdravila Rizmoic ni potrebno.
English: If you are being treated with an opioid medicine for cancer.
Slovenian: Če se zdravite z opioidnim zdravilom zaradi raka.
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Slovenian: 4.3 Kontraindikacije Preobčutljivost na učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1.
English: In vitro data also showed that naldemedine is not a direct inhibitor of OATP1B1, OATP1B3, OAT1 and OAT3 transporters.
Slovenian: Podatki in vitro so pokazali tudi, da naldemedin ni direkten inhibitor prenašalcev OATP1B1, OATP1B3, OAT1 in OAT3.
English: In the event of an overdose, patients should be closely monitored for potential signs and symptoms of opioid withdrawal syndrome (see section 4.4) and provided with appropriate supportive care.
Slovenian: V primeru prevelikega odmerka je treba bolnike skrbno spremljati glede možnih znakov in simptomov sindroma odtegnitve opioidov (glejte poglavje 4.4) in jim nuditi ustrezno podporno nego.
English: Subjects were required to be treated with opioids for ≥14 days prior to Screening and had to be receiving a stable dose.
Slovenian: Preiskovanci so morali biti zdravljeni z opioidi ≥ 14 dni pred presejanjem in so morali prejemati stabilen odmerek.
English: Based on these data, naldemedine can be taken with or without food (see section 4.2).
Slovenian: Na podlagi teh podatkov se naldemedin lahko jemlje s hrano ali brez nje (glejte poglavje 4.2).
English: Do not breast-feed during treatment with Rizmoic as it is not known if naldemedine passes into breast milk.
Slovenian: Med zdravljenjem z zdravilom Rizmoic ne dojite, ker ni znano, ali naldemedin prehaja v materino mleko.
English: Rizmoic must be discontinued if treatment with the opioid pain medicinal product is discontinued.
Slovenian: Zdravilo Rizmoic je treba ukiniti, če se prekine zdravljenje z opioidnim protibolečinskim zdravilom.
English: • an enlarged colon due to a condition known as Ogilvie's syndrome;
Slovenian: • zvečano debelo črevo zaradi bolezni, ki se imenuje Ogilviejev sindrom;
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) v minimalnih količinah izloča v mleko.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Rizmoic in one or more subsets of the paediatric population in the treatment of 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 Rizmoic za eno ali več podskupin pediatrične populacije za zdravljenje z opioidi povzročenega zaprtja (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: For patients receiving laxative therapy at the Screening visit, it had to be continued at a stable dose until the end of the Treatment Period.
Slovenian: Bolniki, ki so ob presejalnem pregledu prejemali zdravljenje z odvajali, so morali nadaljevati s stabilnim odmerkom do konca obdobja zdravljenja.
English: Available data in rats have shown excretion of naldemedine in milk (see section 5.3).
Slovenian: Podatki, ki so na voljo pri podganah, so pokazali izločanje naldemedina v mleko (glejte poglavje 5.3).
English: Three-day earlier vaginal opening indicative of an early onset of sexual maturity was also observed, but only at high exposures considered sufficiently in excess of the maximum human exposure at an oral dose of 200 micrograms.
Slovenian: Ugotovili so tudi tri dni zgodnejše vaginalno odprtje, ki kaže na zgodnji nastop spolne zrelosti, a le pri velikih izpostavljenostih, za katere so smatrali, da dovolj presegajo največjo človeško izpostavljenost pri peroralnem odmerku 200 mikrogramov.
English: In cases of severe diarrhoea or abdominal pain, the patient should be monitored and treated for dehydration using rehydration and appropriate treatment as needed (see section 4.8).
Slovenian: V primeru hude driske ali bolečin v trebuhu je treba bolnika spremljati in zdraviti dehidracijo z uporabo rehidracije in ustreznega zdravljenja po potrebi (glejte poglavje 4.8).
English: The agreed update is aligned with the wording reflected in the product informations for methylnaltrexone and naloxegol.
Slovenian: Dogovorjena posodobitev je usklajena z besedilom v informacijah o zdravilu za metilnaltrekson in naloksegol.
English: The medicine is available in aluminium blisters, containing 7,10 or 14 tablets.
Slovenian: Zdravilo je na voljo v aluminijastih pretisnih omotih, ki vsebujejo po 7 ali 14 tablet.
English: EU/1/18/1291/001 7 film-coated tablets EU/1/18/1291/002 28 film-coated tablets EU/1/18/1291/003 84 film-coated tablets EU/1/18/1291/004 10 film-coated tablets EU/1/18/1291/005 30 film-coated tablets EU/1/18/1291/006 100 film-coated tablets
Slovenian: EU/1/18/1291/001 7 filmsko obloženih tablet EU/1/18/1291/002 28 filmsko obloženih tablet EU/1/18/1291/003 84 filmsko obloženih tablet EU/1/18/1291/004 10 filmsko obloženih tablet EU/1/18/1291/005 30 filmsko obloženih tablet EU/1/18/1291/006 100 filmsko obloženih tablet
English: Naldemedine is highly bound to serum proteins, predominantly to human serum albumin and to a lesser extent to α1-acid-glycoprotein and γ-globulin, with a mean protein binding ratio in humans of 93.2%.
Slovenian: Naldemedin se v veliki meri veže na plazemske beljakovine, pretežno na človeški serumski albumin in v manjši meri na α1-kisli-glikoprotein in γ-globulin, s povprečnim razmerjem vezave beljakovin pri ljudeh 93,2 %.
English: Opioid pain medicinal products
Slovenian: Opioidna protibolečinska zdravila
English: There are no data from the use of naldemedine in pregnant women.
Slovenian: Ni podatkov o uporabi naldemedina pri nosečnicah.
English: On the basis of the scientific conclusions for naldemedine the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing naldemedine is unchanged subject to the proposed changes to the product information.
Slovenian: Na podlagi znanstvenih zaključkov za naldemedin odbor CHMP meni, da je razmerje med koristjo in tveganjem zdravil(-a), ki vsebuje(-jo) naldemedin, nespremenjeno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
English: Naldemedine has no or negligible influence on the ability to drive and use machines.
Slovenian: Naldemedin nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
English: • cancer of the bowel or peritoneum.
Slovenian: • raka črevesa ali peritoneja (potrebušnice).
English: Patients should be monitored for the development of severe, persistent or worsening abdominal pain.
Slovenian: Bolnike je treba spremljati glede razvoja hude, trdovratne ali naraščajoče bolečine v trebuhu.
English: The effect on oestrous cycle is not considered clinically relevant at the proposed therapeutic dose.
Slovenian: Menijo, da vpliv na estrusni cikel pri predlaganem terapevtskem odmerku ni klinično pomemben.
English: • a stomach ulcer;
Slovenian: • želodčno razjedo (ulkus);
English: Patients with evidence of significant structural abnormalities of the gastrointestinal tract were not enrolled in these studies.
Slovenian: Bolnikov z znaki pomembnih strukturnih nepravilnosti prebavil v te študije niso vključili.
English: Additionally, patients who were not on laxatives within 30 days prior to Screening and only received rescue laxative at or after Screening were considered non-LIR.
Slovenian: Poleg njih so bolniki, ki v 30 dneh pred presejanjem niso bili na odvajalih ali so prejeli samo rešilno odvajalo ob presejanju ali po njem, veljali za non-LIR.
English: A responder was defined as a patient with ≥3 frequency of SBMs per week and an increase from baseline ≥1 SBM per week during the 2-week Treatment Period
Slovenian: Bolnik, ki se je odzval na zdravljenje, je bil opredeljen kot bolnik s pogostnostjo ≥ 3 SBM na teden in zvečanjem od izhodišča ≥ 1 SBM na teden med 2-tedenskim obdobjem zdravljenja.
English: A population pharmacokinetic analysis from clinical studies with naldemedine did not identify a clinically meaningful effect of age, gender, body weight or race on the pharmacokinetics of naldemedine.
Slovenian: Populacijska farmakokinetična analiza podatkov iz kliničnih študij z naldemedinom ni pokazala klinično pomembnega vpliva starosti, spola, telesne mase ali rase na farmakokinetiko naldemedina.
English: If you stop taking your opioid medicine
Slovenian: Če ste prenehali jemati opioidno zdravilo
English: Patients should be advised to discontinue naldemedine and to contact their physician if opioid withdrawal occurs.
Slovenian: Bolnikom je treba svetovati, naj prekinejo jemanje naldemedina in se obrnejo na svojega zdravnika, če pride do sindroma odtegnitve opioidov.
English: The use of naldemedine during pregnancy may precipitate opioid withdrawal in a fetus due to the immature fetal blood brain barrier.
Slovenian: Uporaba naldemedina v nosečnosti lahko povzroči odtegnitev opioidov pri plodu zaradi nezrele fetalne krvno-možganske pregrade.
English: The effect of severe hepatic impairment (Child-Pugh Class C) on the pharmacokinetics of naldemedine was not evaluated.
Slovenian: Učinka hude okvare jeter (razred C po Child-Pughu) na farmakokinetiko naldemedina niso ovrednotili.
English: Shionogi B.V. Tel/Tel./Teл./Tlf/Tél/Puh/Sími/Τηλ:
Slovenian: Tel/Tel./Teл./Tlf/Tél/Puh/Sími/Τηλ: contact@shionogi.eu
English: Proportion of SBM responders in patients with cancer and OIC during the 2-week treatment period (Studies V9222 and V9236)
Slovenian: Delež bolnikov z rakom in OIC, ki so se odzvali na zdravljenje z ozirom na SBM med 2-tedenskim obdobjem zdravljenja (študiji V9222 in V9236)
English: Nevertheless, given the times to onset and the mechanism of action of Naldemedine which leads to an increase in the propulsive contractions of the intestinal muscle it is considered that Naldemedine could plausibly have contributed to perforation events in these patients who were already at increased risk due to the presence of additional risk factors including underlying disease and concomitant treatments.
Slovenian: Kljub temu, glede na časovno obdobje od pričetka zdravljenja z namedelinom do pojava gastrointestinalne perforacije in mehanizem delovanja naldemedina, ki povzroči zvečanje propulzivnih kontrakcij črevesne mišice, obstaja možnost, da bi naldemedin lahko pomembno prispeval k perforaciji pri teh bolnikih, pri katerih je bilo tveganje zaradi prisotnosti dodatnih dejavnikov tveganja, vključno z osnovno boleznijo in sočasnim zdravljenjem, že izhodiščno zvečano.
English: Naldemedine is a derivative of naltrexone to which a side chain has been added that increases the molecular weight and the polar surface area, thereby reducing its ability to cross the blood-brain barrier (BBB); the CNS penetration of naldemedine is expected to be negligible at the recommended dose.
Slovenian: Naldemedin je izpeljanka naltreksona, ki so mu dodali stransko verigo, ki zveča molekulsko maso in površino polarnega predela, s čimer se zmanjša njegova sposobnost prečkanja krvno-možganske pregrade (blood-brain barrier - BBB); pričakujemo, da bo penetracija naldemedina v CŽ pri priporočenem odmerku zanemarljiva.
English: Due to the limited therapeutic experience, patients with severe renal impairment should be clinically monitored when initiating therapy with naldemedine.
Slovenian: Zaradi omejenih terapevtskih izkušenj je treba bolnike s hudo okvaro ledvic ob uvajanju zdravljenja z naldemedinom klinično spremljati.
English: Contents of the pack and other information What Rizmoic contains
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Rizmoic
English: NL-8465 RX Oudehaske
Slovenian: NL-8465 RX Oudehaske 8465 RX Oudehaske
English: Rizmoic is indicated for the treatment of opioid-induced constipation (OIC) in adult patients who have previously been treated with a laxative.
Slovenian: Zdravilo Rizmoic je indicirano za zdravljenje zaprtja, povzročenega z opioidi (opioid-induced constipation - OIC) pri odraslih bolnikih, ki so se predhodno zdravili z odvajalom.
English: Patients were allowed to receive rescue laxative(s) as needed regardless of being on a stable laxative regimen at baseline (apart from within 24 hours of the start of the Treatment Period).
Slovenian: Bolniki so smeli prejemati reševalno/-a odvajalo/-a po potrebi ne glede na to, ali so v izhodišču prejemali stabilno shemo z odvajali (razen prvih 24 ur po začetku obdobja zdravljenja).
English: There is a theoretical possibility that naldemedine provokes opioid withdrawal in a breast-fed neonate whose mother is taking an opioid receptor agonist.
Slovenian: Obstaja teoretična možnost, da bi naldemedin lahko povzročil odtegnitev opioidov pri dojenem novorojencu, katerega mati jemlje agonist opioidnega receptorja.
English: Talk to your doctor or pharmacist immediately whilst taking Rizmoic: - if you develop severe, lasting or worsening stomach pain as this could be a symptom of developing a hole in your bowel wall and can be life-threatening.
Slovenian: Med jemanjem zdravila Rizmoic se nemudoma posvetujte z zdravnikom ali farmacevtom: - če se razvije huda, dolgotrajna ali naraščajoča bolečina v trebuhu, ker bi to lahko bil simptom nastajanja luknje v črevesni steni, ki je lahko življenje ogrožujoča.
English: Clinical outcomes for studies V9231 and V9232
Slovenian: Klinični izidi v študijah V9231 in V9232
English: Concomitant use with strong CYP3A inhibitors should be avoided.
Slovenian: Sočasni uporabi z močnimi inhibitorji CYP3A se je treba izogibati.
English: It is a medicine used in adults to treat constipation caused by pain medicines, called opioids (e.g morphine, oxycodone, fentanyl, tramadol, codeine, hydromorphone, methadone).
Slovenian: To je zdravilo, ki se uporablja pri odraslih za zdravljenje zaprtja, ki ga povzročajo zdravila proti bolečinam, ki se imenujejo opioidi (npr. morfin, oksikodon, fentanil, tramadol, kodein, hidromorfon, metadon).
English: From baseline to the last 2 weeks of treatment**
Slovenian: od izhodišča do zadnjih 2 tednov zdravljenja**
English: Following oral administration of [14C]-labelled naldemedine, the primary metabolite in plasma was nor-naldemedine, with a relative exposure compared to naldemedine of approximately 9 to 13%.
Slovenian: Po peroralnem dajanju s [14C] označenega naldemedina je bil primarni presnovek v plazmi nor-naldemedin, z relativno izpostavljenostjo približno 9 do 13 % izpostavljenosti naldemedinu.
English: Talk to your doctor or pharmacist before taking Rizmoic: - if you suffer from a disease which may affect your bowel wall such as:
Slovenian: Pred začetkom jemanja zdravila Rizmoic se posvetujte z zdravnikom ali farmacevtom: - če imate kako bolezen, ki bi lahko prizadela črevesno steno, na primer:
English: Naldemedine is an antagonist of opioid binding at the mu-, delta-, and kappa-opioid receptors.
Slovenian: Naldemedin je antagonist vezave opioidov na mu-, delta- in kappa-opioidne receptorje.
English: Rizmoic can be used in patients using an opioid medicine for cancer pain or long term non-cancer pain after they have previously been treated with a laxative.
Slovenian: Zdravilo Rizmoic lahko uporabljamo pri bolnikih, ki uporabljajo opioidno zdravilo proti bolečinam zaradi raka ali dolgotrajnim bolečinam drugega izvora, potem ko so se predhodno zdravili z odvajalom
English: None of the identified cases are without significant confounding factors and the difficulties in definitively determining causality are acknowledged.
Slovenian: V vseh ugotovljenih primerih so prisotni drugi pomembni možni vzročni dejavniki, kar otežuje definitivno določitev vzročnosti.
English: Film coating: hypromellose , talc and yellow iron oxide (E172).
Slovenian: Filmska obloga: hipromeloza, smukec in rumeni železov oksid (E172).
English: Use in patients with severe hepatic impairment is not recommended (see sections 4.4 and 5.2).
Slovenian: Uporaba pri bolnikih s hudo okvaro jeter ni priporočljiva (glejte poglavji 4.4 in 5.2).
English: Not all pack sizes may be marketed in your country.
Slovenian: V vaši državi na trgu morda ni vseh navedenih pakiranj.
English: If you are not sure, talk to your doctor or pharmacist before taking Rizmoic.
Slovenian: Če ste negotovi, se posvetujte z zdravnikom ali farmacevtom, preden vzamete zdravilo Rizmoic.
English: In clinical studies, patients with OIC who were administered 0.4 mg/day (twice the recommended dose) over 4 weeks had an increased incidence of GI-related adverse drug reactions including diarrhoea and abdominal pain frequently within 1-2 days after initial dosing.
Slovenian: V kliničnih študijah so imeli bolniki z OIC, ki so 4 tedne prejemali 0,4 mg/dan (dvakraten priporočeni odmerek), zvečano pogostnost neželenih učinkov na zdravilo, povezanih s prebavili, vključno z drisko in bolečino v trebuhu, pogosto v 1-2 dneh po začetku odmerjanja.
English: Following oral administration of radiolabelled naldemedine, 57.3% and 34.8% of the dose was excreted in urine and faeces for the [oxadiazole-14C]-naldemedine and 20.4% and 64.3% of the dose was excreted as the [carbonyl-14C]naldemedine in urine and faeces, respectively.
Slovenian: 57,3 % oziroma 34,8 % odmerka izločilo v urinu oziroma blatu v obliki [oksadiazol-14C]-naldemedina, 20,4 % oziroma 64,3 % odmerka pa se je izločilo v urinu oziroma blatu v obliki [karbonil-14C]
English: All study participants took previous laxatives at some time for the treatment of OIC prior to entering the trials V9231 or V9232.
Slovenian: Vsi preiskovanci v študiji so v določenem trenutku v preteklosti jemali odvajala za zdravljenje OIC pred vstopom v preskušanje V9231 oziroma V9232.
English: Two of the nine cases have been classified as cases of interest by the MAH, one of which they consider ‘possibly related' and other ‘probably related'.
Slovenian: Dva od teh devetih primerov je imetnik dovoljenja za promet z zdravilom opredelil kot pomembna, za enega od njiju je vzročno povezavo ocenil kot možno', za drugega pa kot verjetno.
English: Aluminium/aluminium blister containing 7, 10 or 14 film-coated tablets.
Slovenian: Pretisni omot iz aluminija/aluminija, ki vsebuje 7,10 ali 14 filmsko obloženih tablet.
English: Interaction with strong and moderate CYP3A inducers Rifampicin, a strong CYP3A inducer, significantly decreased exposure to naldemedine by 83% .
Slovenian: Interakcije z močnimi in zmernimi induktorji CYP3A Rifampicin, močan induktor CYP3A, je značilno zmanjšal izpostavljenost naldemedinu za 83 %.
English: From baseline to the last 2 weeks of treatment***
Slovenian: od izhodišča do zadnjih 2 tednov zdravljenja***
English: Very common (may affect more than 1 in 10 people):
Slovenian: Zelo pogosti (lahko se pojavijo pri več kot 1 od 10 bolnikov):
English: Pack sizes of 7, 10, 28, 30, 84 or 100 film-coated tablets.
Slovenian: Velikosti pakiranja po 7, 10, 28,30, 84 ali 100 filmsko obloženih tablet.
English: There is no specific antidote for naldemedine.
Slovenian: Za naldemedin ni specifičnega antidota.
English: Change in the frequency of BMs per week from baseline to each visit (LS Mean) ITT population in study V9235
Slovenian: Sprememba pogostnosti BM na teden od izhodišča do vsakega pregleda (povprečje najmanjših kvadratov (LS)) v populaciji ITT v študiji V9235
English: The absolute bioavailability of naldemedine has not been established.
Slovenian: Absolutne biološke uporabnosti naldemedina niso ugotovili.
English: The pharmacokinetics of naldemedine in the paediatric population has not been studied (see section 4.2).
Slovenian: Farmakokinetike naldemedina v pediatrični populaciji niso raziskovali (glejte poglavje 4.2).
English: This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free'.
Slovenian: To zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na tableto, kar v bistvu pomeni ‘brez natrija'.
English: Two of the nine cases were excluded by the MAH because they were not considered valid, and in the remaining five cases the MAH excluded a causal relationship in addition to the reporter.
Slovenian: Dva od teh devetih primerov je imetnik dovoljenja za promet z zdravilom opredelil kot neutemeljena, pri preostalih petih primerih pa sta takoimetnik dovoljenja za promet z zdravilom kot tudi poročevalec izključila vzročno povezavo.
English: Caution should be exercised with regards to opioid withdrawal.
Slovenian: Pri odtegovanju opioidov je potrebna previdnost.
English: Possible opioid withdrawal, defined as at least three adverse reactions potentially related to opioid withdrawal that occurred on the same day and that were not exclusively related to the gastrointestinal system, occurred in 0.8% (9/1,163) of patients with chronic non-cancer pain and OIC taking naldemedine compared to 0.2% (2/1,165) of patients taking placebo regardless of maintenance opioid treatment, and 0.6% (1/155) of patients with cancer and OIC taking naldemedine 200 micrograms compared to 0% (0/152) of patients taking placebo.
Slovenian: Možna odtegnitev opioidov, opredeljena kot vsaj trije neželeni učinki, potencialno povezani z odtegnitvijo opioidov, ki so se pojavili istega dne in niso bili izključno povezani s prebavili, se je pojavila pri 0,8 % (9/1.163) bolnikov s kronično nerakasto bolečino in OIC, ki so jemali naldemedin, v primerjavi z 0,2 % (2/1.165) bolnikov, ki so jemali placebo, ne glede na vzdrževalno opioidno zdravljenje, in pri 0,6 % (1/155) bolnikov z rakom in OIC, ki so jemali po 200 mikrogramov naldemedina, v primerjavi z 0 % (0/152) bolnikov, ki so jemali placebo.
English: Itraconazole, a strong CYP3A inhibitor, increased exposure to naldemedine 2.9 fold that may result in an increased risk of adverse reactions.
Slovenian: Itrakonazol, močan inhibitor CYP3A, je 2,9-krat zvečal izpostavljenost naldemedinu, kar lahko zveča tveganje neželenih učinkov.
English: Using these medicines with Rizmoic may affect the way naldemedine works or increase its side effects.
Slovenian: Uporaba teh zdravil skupaj z zdravilom Rizmoic lahko vpliva na način delovanja naldemedina ali zveča tveganje za pojav njegovih neželenih učinkov.
English: The patients who participated in Studies V9231, V9232 and V9235 were taking a wide range of opioids.
Slovenian: Bolniki, ki so sodelovali v študijah V9231, V9232 in V9235, so jemali veliko vrst opioidov.
English: D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Slovenian: POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA
English: For Study V9235, the efficacy of naldemedine vs. placebo was assessed as secondary endpoints by the frequency of BMs as presented in Table 4.
Slovenian: V študiji V9235 so učinkovitost naldemedina glede na placebo ocenili s pogostnostjo BM kot sekundarnimi opazovanimi dogodki, kot kaže preglednica 4.
English: Interactions with CYP3A inhibitors
Slovenian: Interakcije z inhibitorji CYP3A