natgillin/translations-raw huggingface dataset:
In Study V9235, patients on a stable laxative regimen at screening (52.4%) were allowed to continue using that same regimen without change throughout the study duration.
U ispitivanju V9235, bolesnicima na stabilnom režimu laksativima (52,4%) na probiru bilo je dopušteno da nastave uzimati taj isti režim bez promjene tijekom cijelog trajanja ispitivanja.
Treatment difference
Terapijska razlika
What Rizmoic looks like and contents of the pack
Kako Rizmoic izgleda i sadržaj pakiranja
7 film-coated tablets 10 film-coated tablets 28 film-coated tablets 30 film-coated tablets 84 film-coated tablets 100 film-coated tablets
7 filmom obloženih tableta 10 filmom obloženih tableta 28 filmom obloženih tableta 30 filmom obloženih tableta 84 filmom obložene tablete 100 filmom obloženih tableta
Patients with cardiovascular conditions
Bolesnici s kardiovaskularnim bolestima
It is therefore considered that the presented cases are sufficient to support an update to the product information to both section 4.4 and 4.8.
Stoga se smatra da su prikazani slučajevi dovoljni da podupru potrebu za ažuriranjem informacija o lijeku u dijelu 4.4 i u dijelu 4.8.
Stop taking Rizmoic and contact your doctor if you get a combination of 3 or more of the following symptoms of opioid withdrawal on the same day:
Prestanite uzimati Rizmoic i obratite se svom liječniku ako razvijete kombinaciju od 3 ili više sljedećih simptoma ustezanja od opioida istog dana:
What you need to know before you take Rizmoic Do not take Rizmoic:
Što morate znati prije nego počnete uzimati Rizmoic Nemojte uzimati Rizmoic:
Patients responding, n (%) p value* *Statistically significant: p-values based on the Chi-square test.
Bolesnici s terapijskim odgovorom, n (%) p vrijednost* *Statistički značajno: p-vrijednosti na temelju hi-kvadrat testa.
Pharmacotherapeutic group: Drugs for constipation, peripheral opioid receptor antagonists, ATC code: A06AH05.
Farmakoterapijska skupina: lijekovi za konstipaciju, antagonisti perifernih opioidnih receptora, ATK oznaka: A06AH05.
Due to the limited therapeutic experience in patients 75 years old and older, naldemedine therapy should be initiated with caution in this age group.
Zbog ograničenog terapijskog iskustva u bolesnika u dobi od 75 godina i starijih, terapiju naldemedinom u ove dobne skupine treba započeti s oprezom.
If you are being treated with an opioid medicine for cancer.
Ako se liječite opioidnim lijekom zbog raka.
In vitro data also showed that naldemedine is not a direct inhibitor of OATP1B1, OATP1B3, OAT1 and OAT3 transporters.
In vitro podaci također su pokazali da naldemedin nije izravni inhibitor prijenosnika OATP1B1, OATP1B3, OAT1 i OAT3.
The frequency categories are defined using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon
Kategorije učestalosti definirane su prema sljedećoj konvenciji: vrlo često (≥1/10); često (≥1/100 i <1/10); manje često (≥1/1000 i <1/100); rijetko (≥1/10 000 i <1/1000);
If you take more Rizmoic than you should
Ako uzmete više lijeka Rizmoic nego što ste trebali
The apparent terminal elimination half-life of naldemedine is approximately 11 hours, and the apparent total clearance (CL/F) of naldemedine is 8.4 L/h.
Prividno terminalno poluvrijeme eliminacije naldemedina iznosi približno 11 sati, a prividni ukupni klirens (CL/F) naldemedina iznosi 8,4 l/h.
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).
Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja lijeka Rizmoic u jednoj ili više podskupina pedijatrijske populacije u liječenju konstipacije uzrokovane opioidima (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
Aluminium/aluminium blister containing 7, 10 or 14 film-coated tablets.
Aluminij/aluminij blister koji sadrži 7, 10 ili 14 filmom obloženih tableta.
• The recommended dose is one 200 microgram tablet once daily.
• Preporučena doza je jedna tableta od 200 mikrograma jedanput dnevno.
• an enlarged colon due to a condition known as Ogilvie's syndrome;
• prošireno debelo crijevo zbog stanja koje se naziva Ogilviejev sindrom
The effects of the medicine in pregnant women are not known.
Nisu poznati učinci ovog lijeka u trudnica.
These patients should be clinically monitored when taking Rizmoic.
Te je bolesnike potrebno klinički pratiti dok uzimaju Rizmoic.
Naldemedine should not be used during pregnancy unless the clinical condition of the woman requires treatment with naldemedine.
Naldemedin se ne smije primjenjivati tijekom trudnoće osim ako kliničko stanje žene ne zahtijeva liječenje naldemedinom.
The following side effects may happen with this medicine:
Uz ovaj se lijek mogu pojaviti sljedeće nuspojave:
Other medicines and Rizmoic
Drugi lijekovi i Rizmoic
Do not use this medicine after the expiry date which is stated on the carton and blisters after EXP.
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i blisterima iza oznake „EXP“.
Pack sizes of 7, 10, 28, 30, 84 or 100 tablets.
Veličine pakiranja od 7, 10, 28, 30, 84 ili 100 tablete.
• a disease causing severe inflammation of the digestive tract such as Crohn's disease .
• bolest koja uzrokuje jaku upalu probavnog sustava, kao što je Crohnova bolest.
Therefore, treatment with naldemedine is not expected to alter the pharmacokinetics of co-administered medicines that are substrates of these enzymes and transporters.
Stoga se ne očekuje da će liječenje naldemedinom mijenjati farmakokinetiku istodobno primijenjenih lijekova koji su supstrati ovih enzima i prijenosnika.
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove: http://www.ema.europa.eu
None of the identified cases are without significant confounding factors and the difficulties in definitively determining causality are acknowledged.
U svim utvrđenim slučajevima postoje značajni zbunjujući čimbenici i potvrđene su teškoće u konačnom određivanju uzročno-posljedične povezanosti.
The efficacy and safety were also assessed in the laxative inadequate responders (LIR) and non-LIR subgroups.
Djelotvornost i sigurnost bile su procijenjene i u podskupini bolesnika s neadekvatnim odgovorom na laksative (podskupina LIR prema engl. laxative inadequate responders) i podskupini ne-LIR.
Subjects were required to be treated with opioids for ≥14 days prior to Screening and had to be receiving a stable dose.
Ispitanici su morali biti liječeni opioidima tijekom ≥14 dana prije probira i morali su dobivati stabilnu dozu.
If you are not sure, talk to your doctor or pharmacist before taking Rizmoic.
Ako niste sigurni, obratite se liječniku ili ljekarniku prije nego što uzmete Rizmoic.
Talk to your doctor or pharmacist before taking Rizmoic: - if you suffer from a disease which may affect your bowel wall such as:
Obratite se svom liječniku ili ljekarniku prije nego što uzmete Rizmoic: - ako bolujete od bolesti koja može zahvatiti stijenku crijeva kao što je:
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.
Ipak, s obzirom na vrijeme do nastupa nuspojava i mehanizam djelovanja naldemedina koji dovodi do povećanja propulzivnih kontrakcija intestinalnih mišića, smatra se uvjerljivim da je naldemedin mogao pridonijeti događajima perforacije u onih bolesnika koji su već bili pod povećanim rizikom zbog prisutnosti dodatnih čimbenika rizika, uključujući osnovnu bolest i istodobne terapije.
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
EU/1/18/1291/001 7 filmom obloženih tableta EU/1/18/1291/002 28 filmom obloženih tableta EU/1/18/1291/003 84 filmom obložene tablete EU/1/18/1291/004 10 filmom obloženih tableta EU/1/18/1291/005 30 filmom obloženih tableta EU/1/18/1291/006 100 filmom obloženih tableta
At therapeutic doses, most opioids (e.g morphine, meperidine, methadone) are excreted into breast milk in minimal amounts.
Pri terapijskim dozama većina se opioida (npr. morfij, meperidin, metadon) izlučuje u mlijeko u minimalnim količinama.
- if you have severe liver disease such as alcoholic liver disease, viral liver infection or impaired liver function.
- ako imate tešku bolest jetre poput bolesti jetre uzrokovane alkoholom, virusne infekcije jetre ili oštećene funkcije jetre
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.
U slučaju predoziranja, bolesnike je potrebno pažljivo pratiti zbog mogućih znakova i simptoma sindroma ustezanja od opioida (vidjeti dio 4.4) te im treba osigurati odgovarajuću potpornu skrb.
Gastrointestinal perforation is added a new adverse reaction with a frequency “Not known”.
Gastrointestinalna perforacija dodana je kao nova nuspojava, s učestalošću „nepoznato“.
No dose adjustment is required in patients older than 65 years of age (see section 5.2).
Nije potrebna prilagodba doze u bolesnika starijih od 65 godina (vidjeti dio 5.2).
A QTc study performed with naldemedine in healthy volunteers did not indicate any prolongation of the QT interval.
Ispitivanje utjecaja naldemedina na QTc interval u zdravih dobrovoljaca nije pokazalo produljenje QTc intervala.
The MAH identified nine cases of gastrointestinal perforation in their global database.
Nositelj odobrenja utvrdio je u svojoj globalnoj bazi podataka devet slučajeva gastrointestinalne perforacije.
The studies included a 2-week Screening Period, 2-week Treatment Period and 4-week Follow-up Period.
Ispitivanja su se sastojala od dvotjednog razdoblja probira, dvotjednog razdoblja liječenja i četverotjednog razdoblja praćenja.
• You can take Rizmoic with or without laxatives.
• Rizmoic možete uzimati s laksativima ili bez njih.
Interaction with strong P-gp inhibitors
Interakcija s jakim inhibitorima P-gp-a
In juvenile toxicity studies in rats, at the same dose levels, exposure in juvenile animals (PND 10) was increased compared to adult animals (2.3 to 7.4-fold).
U ispitivanjima toksičnosti u mladunčadi štakora, izloženost mladih životinja (PND 10) pri dozama iste razine bila je veća od one u odraslih životinja (2,3 do 7,4 puta).
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).
Bolesnici su smjeli primati laksativ(e) za hitno olakšanje tegoba po potrebi, bez obzira na to jesu li bili na stabilnom režimu laksativima na početku ispitivanja (osim tijekom 24 sata od početka razdoblja liječenja).
The absolute bioavailability of naldemedine has not been established.
Apsolutna bioraspoloživost naldemedina nije ustanovljena.
The use of naldemedine during pregnancy may precipitate opioid withdrawal in a fetus due to the immature fetal blood brain barrier.
Primjena naldemedina tijekom trudnoće može izazvati ustezanje od opioida u fetusa zbog nezrelosti fetalne krvno-moždane barijere.
Based on these data, naldemedine can be taken with or without food (see section 4.2).
S obzirom na ove podatke, naldemedin se može uzimati s hranom ili bez nje (vidjeti dio 4.2).
The medicine is available in aluminium blisters, containing 7,10 or 14 tablets.
Ovaj je lijek dostupan u aluminijskim blisterima koji sadrže 7, 10 ili 14 tableta.
Film coating: hypromellose , talc and yellow iron oxide (E172).
Film-ovojnica: hipromeloza, talk i žuti željezov oksid (E172).
The peak plasma concentration was reduced by 35% and time to achieve peak plasma concentration was delayed from 0.75 hours in the fasted state to 2.5 hours in the fed state, whereas no significant difference was observed in the area under the plasma concentration-time curve by food intake.
Vršna koncentracija u plazmi bila je snižena za 35%, a vrijeme do postizanja vršne koncentracije u plazmi produljeno s 0,75 sati u stanju natašte na 2,5 sati u sitom stanju, dok u površini ispod krivulje plazmatska koncentracija-vrijeme nije bila opažena nikakva značajna razlika kod uzimanja hrane.
The effect of severe hepatic impairment (Child-Pugh Class C) on the pharmacokinetics of naldemedine was not evaluated.
Učinak teškog oštećenja funkcije jetre (Child-Pugh stadij C) na farmakokinetiku naldemedina nije procijenjen.
Do not breast-feed during treatment with Rizmoic as it is not known if naldemedine passes into breast milk.
Nemojte dojiti tijekom liječenja lijekom Rizmoic jer nije poznato prelazi li naldemedin u majčino mlijeko.
There is no experience in patients treated for constipation induced by partial opioid mu-agonists (e.g. buprenorphine).
Ne postoji iskustvo u bolesnika liječenih zbog konstipacije izazvane parcijalnim opioidnim agonistima μ-receptora (npr. buprenorfinom).
There is no specific antidote for naldemedine.
Ne postoji specifičan antidot za naldemedin.
Naldemedine functions as a peripherally-acting mu-opioid receptor antagonist in tissues such as the gastrointestinal tract, thereby decreasing the constipating effects of opioids without reversing the central nervous system (CNS)-mediated opioid effects.
Naldemedin funkcionira kao antagonist mi-opioidnih receptora s perifernim djelovanjem u tkivima kao što je gastrointestinalni trakt pa tako smanjuje konstipacijske učinke opioida bez poništavanja njihovih opioidnih učinaka posredovanih središnjim živčanim sustavom (SŽS).
If any of the above apply to you, or you are not sure, talk to your doctor or pharmacist before taking Rizmoic.
Ako se nešto od gore navedenog odnosi na Vas ili niste sigurni, obratite se svom liječniku ili ljekarniku prije nego što uzmete Rizmoic.
Patients should be advised to report severe, persistent or worsening symptoms to their physician.
Bolesnicima treba savjetovati da svom liječniku prijave jake simptome ili simptome koji su perzistirajući ili se pogoršavaju.
Taking into account the PRAC Assessment Report on the PSUR(s) for naldemedine, the scientific conclusions of CHMP are as follows:
Uzimajući u obzir PRAC-ovo izvješće o ocjeni periodičkog(ih) izvješća o neškodljivosti lijeka (PSUR) za naldemedin, znanstveni zaključci CHMP-a su sljedeći:
Rizmoic has no influence on your ability to drive or to use machines.
Rizmoic ne utječe na sposobnost upravljanja vozilima ili rada pomoću strojeva.
There is limited experience in patients treated with opioid pain medicinal product(s) at daily doses of more than the equivalent of 400 mg of morphine.
Iskustvo je ograničeno u bolesnika liječenih opioidnim analgetikom (analgeticima) u dnevnim dozama višim od onih koje odgovaraju 400 mg morfija.
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.
Opaženo je i tri dana ranije otvaranje vagine, što ukazuje na rani nastup spolne zrelosti, ali samo pri izloženosti visokim dozama koje se smatraju dovoljno većima od maksimalne izloženosti u ljudi kod primjene peroralne doze od 200 mikrograma.
Using these medicines with Rizmoic may affect the way naldemedine works or increase its side effects.
Primjena ovih lijekova s lijekom Rizmoic može utjecati na način na koji naldemedin djeluje i pojačati njegove nuspojave.
If obstruction or perforation are suspected, naldemedine must be discontinued (see section 4.3).
U slučaju sumnje na opstrukciju ili perforaciju, primjenu naldemedina mora se prekinuti (vidjeti dio 4.3).
Annex IV Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)
Prilog IV. Znanstveni zaključci i razlozi za izmjenu uvjeta odobrenja za stavljanje lijeka u promet
Patients having disruptions to the blood-brain barrier (e.g., primary brain malignancies, central nervous system (CNS) metastases or other inflammatory conditions, active multiple sclerosis and advanced Alzheimer's disease) may be at increased risk of opioid withdrawal or reduced analgesia.
Bolesnici s narušenom krvno-moždanom barijerom (npr. primarne zloćudne bolesti mozga, metastaze u središnjem živčanom sustavu (SŽS) ili druga upalna stanja, aktivna multipla skleroza ili uznapredovala Alzheimerova bolest) mogu imati povećan rizik od ustezanja od opioida i smanjene analgezije.
No human data on the effect of naldemedine on fertility are available.
Nema dostupnih podataka o učinku naldemedina na plodnost u ljudi.
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Unutar svake skupine po učestalosti nuspojave su prikazane slijedom prema sve manjoj ozbiljnosti.
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.
Nadalje, bolesnici koji nisu primali laksative unutar 30 dana prije probira ili su primili samo laksativ za hitno olakšanje tegoba na probiru ili poslije njega smatrali su se ne-LIR-bolesnicima.
There is a theoretical possibility that naldemedine provokes opioid withdrawal in a breast-fed neonate whose mother is taking an opioid receptor agonist.
Postoji teoretska mogućnost da naldemedin izazove ustezanje od opioida u dojenog novorođenčeta čija majka uzima agonist opioidnih receptora.
Naldemedine did not cause significant induction of CYP1A2, CYP2B6 or CYP3A4 isozymes.
Naldemedin nije uzrokovao značajnu indukciju izoenzima CYP1A2, CYP2B6 ili CYP3A4.
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).
U slučajevima jakog proljeva ili bola u abdomenu, bolesnika treba pratiti i po potrebi dehidraciju bolesnika liječiti rehidracijom i odgovarajućom terapijom (vidjeti dio 4.8).
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.
Na temelju znanstvenih zaključaka za naldemedin, CHMP smatra da je omjer koristi i rizika lijeka(ova) koji sadrži(e) naldemedin nepromijenjen, uz predložene izmjene informacija o lijeku.
Due to the limited therapeutic experience, patients with severe renal impairment should be clinically monitored when initiating therapy with naldemedine.
Zbog ograničenog terapijskog iskustva, bolesnike s teškim oštećenjem funkcije bubrega potrebno je klinički pratiti kad započinju terapiju naldemedinom.
• There is no need to alter the dose of your opioid medicine before starting Rizmoic.
• Nije potrebno mijenjati dozu opioidnog analgetika prije početka uzimanja lijeka Rizmoic.
Naldemedine is an antagonist of opioid binding at the mu-, delta-, and kappa-opioid receptors.
Naldemedin je antagonist opioida koji se vežu na mi-, delta- i kapa-opioidne receptore.
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.
Populacijskom farmakokinetičkom analizom u kliničkim ispitivanjima naldemedina nije utvrđen klinički značajan utjecaj dobi, spola, tjelesne težine ili etničke pripadnosti na farmakokinetiku naldemedina.
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.
Naldemedin je derivat naltreksona kojemu je dodan postranični lanac koji povećava molekulsku težinu i polarnu površinu molekule i tako smanjuje njezinu sposobnost prolaska kroz krvno-moždanu barijeru; očekuje se zanemarivo prodiranje naldemedina u SŽS pri preporučenoj dozi.
In in vitro studies at clinically relevant concentrations, naldemedine did not inhibit the major CYP enzymes (including CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1, CYP3A, or CYP4A11 isozymes) and is not an inhibitor of OCT1, OCT2, BCRP, P-gp, MATE1, MATE2-K or BSEP transporters.
U ispitivanjima in vitro, naldemedin u klinički značajnim koncentracijama nije inhibirao glavne enzime CYP-a (uključujući izoenzime CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1, CYP3A ili CYP4A11) i nije inhibirao prijenosnike OCT1, OCT2, BCRP, P-gp, MATE1, MATE2-K ili BSEP.
Gastrointestinal perforation
Gastrointestinalna perforacija
The overall benefit risk for each patient should be taken into account.
Za svakog pojedinog bolesnika potrebno je uzeti u obzir ukupan omjer koristi i rizika.
The patients who participated in Studies V9231, V9232 and V9235 were taking a wide range of opioids.
Bolesnici koji su sudjelovali u ispitivanjima V9231, V9232 i V9235 uzimali su razne vrste opioida.
Your opioid pain medicine may cause the following symptoms: - reduction in how often you pass stools - hard stools - stomach ache - pain in the rectum when pushing hard stools out - a feeling that the bowel is still not empty after passing stools.
Opioidni analgetik može Vam izazvati sljedeće simptome: - smanjenje broja stolica - tvrdu stolicu - bol u trbuhu - bol u završnom dijelu debelog crijeva tijekom istiskivanja tvrde stolice - osjećaj da nakon pražnjenja crijeva u crijevu i dalje ima stolice.
In the run-in and treatment periods for all three studies, bisacodyl was used as rescue laxative if patients had not had a BM for 72 hours and were allowed one-time use of an enema if after 24 hours of taking bisacodyl, they still had not had a BM.
U uvodnom razdoblju i razdoblju liječenja u sva tri ispitivanja, kao laksativ za hitno olakšanje tegoba primjenjivao se bisakodil ako bolesnici nisu imali stolicu 72 sata i smjeli su jedanput dobiti klistir ako 24 sata nakon uzimanja bisakodila i dalje nisu imali stolicu.
• Gastrointestinal perforation (a hole developing in the bowel wall)
• gastrointestinalna perforacija (stvaranje otvora u stijenci crijeva)
Interaction with strong and moderate CYP3A inducers Rifampicin, a strong CYP3A inducer, significantly decreased exposure to naldemedine by 83% .
Interakcija s jakim i umjerenim induktorima CYP3A Rifampicin, jaki induktor CYP3A, značajno je smanjio izloženost naldemedinu i to za 83%.
Opioid withdrawal syndrome is a cluster of three or more of the following signs or symptoms: dysphoric mood, nausea or vomiting, muscle aches, lacrimation or rhinorrhea, pupillary dilation or piloerection or sweating, diarrhoea, yawning, fever or insomnia.
Sindrom ustezanja od opioida obuhvaća skupinu od tri ili više sljedećih znakova ili simptoma: disforično raspoloženje, mučnina ili povraćanje, bolovi u mišićima, suzenje ili rinoreja, dilatacija zjenica ili piloerekcija ili znojenje, proljev, zijevanje, vrućica ili nesanica.
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%.
Nakon peroralne primjene nalmedina označenog pomoću [14C], primarni metabolit u plazmi bio je nor-naldemedin, uz relativnu izloženost u usporedbi s naldemedinom od približno 9 do 13%.
Store in the original package in order to protect the tablets from light and moisture.
Čuvati u originalnom pakiranju radi zaštite tableta od svjetlosti i vlage.
Itraconazole, a strong CYP3A inhibitor, increased exposure to naldemedine 2.9 fold that may result in an increased risk of adverse reactions.
Itrakonazol, jaki inhibitor CYP3A, povećava izloženost naldemedinu 2,9 puta, što može dovesti do povećanog rizika od nuspojava.