natgillin/translations-raw huggingface dataset:
Patients with known or suspected sphincter of Oddi disease or dysfunction and/or biliary tract or pancreatic disease, including a history of pancreatitis, must not receive Truberzi (see section 4.3).
Bolniki z znano ali domnevno boleznijo ali nepravilnim delovanjem Oddijevega sfinktra in/ali boleznijo žolčnih poti ali trebušne slinavke, vključno z anamnezo pankreatitisa, ne smejo prejeti zdravila Truberzi (glejte poglavje 4.3).
Efficacy of eluxadoline was assessed using an overall responder analyses as defined by the simultaneous improvement in the daily WAP score by ≥30% as compared to the baseline weekly average AND a reduction in the BSS to <5 on at least 50% of the days within a time interval.
Učinkovitost eluksadolina je bila ocenjena z analizo splošnega odziva, opredeljenega s sočasnim izboljšanjem dnevne ocene WAP za ≥ 30 % v primerjavi z izhodiščnim tedenskim povprečjem IN z zmanjšanjem ocene BSS na <5 na najmanj 50 % dni v določenem časovnem intervalu.
However, you may experience side effects such as sleepiness or dizziness while taking Truberzi which might affect your ability to drive or use machines.
Vendar se lahko med jemanjem zdravila Truberzi pojavijo neželeni učinki, kot sta zaspanost in omotica, ki lahko vplivajo na vašo sposobnost vožnje ali upravljanja s stroji.
Systemic exposure to medicinal products metabolised by CYP3A4 may be decreased when coadministered with Eluxadoline.
Sistemska izpostavljenost zdravilom, ki se presnavljajo s CYP3A4, se lahko ob sočasni uporabi z eluksadolinom zmanjša.
There is limited amount of data from the use of eluxadoline in pregnant women.
Podatki o uporabi eluksadolina pri nosečnicah so omejeni.
If you forget to take Truberzi
Če ste pozabili vzeti zdravilo Truberzi
Eluxadoline increases the exposure of the co-administered OATP1B1 substrate; rosuvastatin (see section 5.2) by up to 40% of the total exposure which is usually not considered to be clinically relevant.
Substrati OATP1B1 Eluksadolin poveča izpostavljenost sočasno uporabljenemu substratu OATP1B1, rosuvastatinu (glejte poglavje 5.2), za do 40 % celotne izpostavljenosti, kar navadno ne šteje za klinično pomembno.
These symptoms occur uncommonly (may affect up to 1 in 100 people) and may indicate pancreas or bile duct system problems (e.g. inflammation of the pancreas or spasm of the sphincter of Oddi).
Ti simptomi so občasni (pojavijo se lahko pri največ 1 od 100 ljudi) in lahko kažejo na težave s trebušno slinavko ali žolčevodom (npr. vnetje trebušne slinavke ali spazem Oddijevega sfinktra).
Avoid taking Truberzi with any other medicines that may cause constipation such as opioids (e.g. fentanyl [used to treat pain]) or anticholinergics (e.g. atropine [used to treat cardiac disorders among other indications]).
Izogibajte se jemanju zdravila Truberzi s katerimkoli drugim zdravilom, ki bi lahko povzročilo zaprtost, kot so opioidi (npr. fentanil [za lajšanje bolečine]) ali antiholinergiki (npr. atropin [ki se poleg drugih indikacij uporabljajo za zdravljenje bolezni srca]).
In clinical studies, events of sphincter of Oddi spasm manifested as elevated hepatic enzymes associated with abdominal pain in 8 patients, pancreatitis in 1 patient and abdominal pain with lipase elevation less than 3 times the upper limit of normal in 1 patient.
V kliničnih študijah se je spazem Oddijevega sfinktra izrazil kot zvišana raven jetrnih encimov s spremljajočimi bolečinami v trebuhu pri 8 bolnikih, kot pankreatitis pri 1 bolniku in kot bolečine v trebuhu z zvišano ravnjo lipaze do manj kot 3-kratne zgornje meje normalne vrednosti pri 1 bolniku.
Truberzi is contraindicated in patients without a gallbladder and other conditions that increase the risk of developing pancreatitis (see section 4.3).
Zdravilo Truberzi je kontraindicirano pri bolnikih brez žolčnika in pri drugih stanjih, ki povečujejo tveganje za pojav pankreatitisa (glejte poglavje 4.3).
Eluxadoline is also an agonist at the kappa opioid receptor (κOR).
Eluksadolin je tudi agonist opioidnih receptorjev kapa (κOR).
Avoid use with other drugs that may cause constipation (see section 4.5).
Izogibajte se istočasni uporabi z zdravili, ki lahko povzročijo zaprtost (glejte poglavje 4.5).
For patients who are unable to tolerate the 200 mg daily dose (one 100 mg tablet, twice daily), the dose can be lowered to 150 mg daily (one 75 mg tablet twice daily).
Pri bolnikih, ki ne morejo prenašati dnevnega odmerka 200 mg (po ena 100 mg tableta dvakrat dnevno), se lahko odmerek zmanjša na 150 mg dnevno (po ena 75 mg tableta dvakrat dnevno).
If you stop taking Truberzi
Če ste prenehali jemati zdravilo Truberzi
Eluxadoline must not be used in patients with a history of or known or suspected hepatic impairment (Child-Pugh Class A-C) (see section 4.3).
Eluksadolin se ne sme uporabljati pri bolnikih z anamnezo okvare jeter ali znano ali domnevno okvaro jeter (Child-Pugh razred A-C) (glejte poglavje 4.3).
Unchanged eluxadoline recovered in urine was 0.01% and 0.05% of dose in ESRD and healthy participants, respectively.
Nespremenjeni eluksadolin, izločen v urinu, je znašal 0,01 % pri udeležencih s končno fazo ledvične odpovedi (ESRD) in 0,05 % pri zdravih udeležencih.
• an average daily stool consistency score (BSS) of ≥5.5 and at least 5 days with a BSS score ≥5
• povprečna dnevna ocena konsistence blata (BSS) ≥5,5 in vsaj 5 dni z oceno BSS ≥5 na lestvici od 1 do 7 v tednu pred randomizacijo.
Truberzi is indicated in adults for the treatment of irritable bowel syndrome with diarrhoea (IBS-D).
Zdravilo Truberzi je indicirano pri odraslih za zdravljenje sindroma razdražljivega črevesa z drisko (IBS-D - irritable bowel syndrome with diarrhoea).
In both studies, the proportion of patients who were composite responders to Truberzi 100 mg twice daily was statistically significantly higher than placebo.
V obeh študijah je bil delež bolnikov s sestavljenim odzivom na zdravilo Truberzi v odmerku 100 mg dvakrat dnevno statistično pomembno večji kot pri placebu.
In animals, eluxadoline interacts with opioid receptors in the gut.
Pri živalih eluksadolin sodeluje z opioidnimi receptorji v črevesju.
Since bioavailability is limited, the pharmacodynamic activity of eluxadoline is based predominantly on local action within the GI tract.
Glede na omejeno biološko uporabnost temelji farmakodinamična aktivnost eluksadolina zlasti na lokalnem delovanju v prebavilih.
Patients should be instructed to stop the treatment immediately and seek medical attention if they experience symptoms suggestive of sphincter of Oddi spasm such as acute worsening of abdominal pain (e.g. acute epigastric or biliary [i.e., right upper quadrant] pain) that may radiate to the back or shoulder, with or without nausea and vomiting.
Bolnikom je treba naročiti, naj nemudoma prenehajo jemati zdravilo in poiščejo zdravniško pomoč, če se pojavijo simptomi, ki nakazujejo spazem Oddijevega sfinktra, kot je akutno poslabšanje bolečine v trebuhu (npr. akutna epigastrična ali biliarna bolečina [tj. v zgornjem desnem kvadrantu]), ki lahko seva v hrbet ali rame, z navzeo in bruhanjem ali brez njiju.
Upon administration of multiple oral doses twice daily, there was no accumulation of active substance.
Po uporabi več peroralnih odmerkov dvakrat dnevno ni prišlo do kopičenja učinkovine.
Eluxadoline should not be administered concomitantly with such medicinal products (see section 4.3).
Eluksadolin se ne sme uporabljati sočasno s takimi zdravili (glejte poglavje 4.3).
Increased ALT Increased AST 1“Somnolence” term includes: somnolence and sedation.
1 Izraz »zaspanost« vključuje: zaspanost in sedacijo.
Placebo n=382
Placeb o n=382
• A history of pancreatitis; or known or suspected structural diseases of the pancreas, including pancreatic duct obstruction.
• Anamneza pankreatitisa ali znane ali domnevne strukturne bolezni trebušne slinavke, vključno z zaporo vodov trebušne slinavke.
However, in a clinical study in healthy subjects, administration of eluxadoline 100 mg twice daily for one week, with a single oral dose of 4 mg of midazolam resulted in no change to the midazolam Cmax and a slight decrease in AUC (~10%).
Vendar pa v klinični študiji, izvedeni pri zdravih osebah, uporaba 100 mg eluksadolina en teden dvakrat dnevno, z enim peroralnim odmerkom 4 mg midazolama, ni povzročila spremembe Cmax midazolama,
Eluxadoline also reverses hyperalgesic responses in an animal model of acute colitis-induced visceral pain.
Eluksadolin tudi odpravi hiperalgezične odzive pri živalskem modelu akutne visceralne bolečine, ki je posledica kolitisa.
Risk of constipation with eluxadoline in patients with other IBS sub-types is unknown, but may be increased.
Tveganje za pojav zaprtosti med zdravljenjem z eluksadolinom pri bolnikih z drugimi podtipi sindroma razdražljivega črevesa ni znano, vendar je lahko zvečano.
Single supratherapeutic oral doses of eluxadoline up to 1,000 mg and single intranasal doses up to 200 mg were associated with a higher incidence of adverse events than a 100 mg single dose, especially gastrointestinal and central nervous system events.
Posamezni supraterapevtski peroralni odmerki eluksadolina do 1000 mg in posamezni intranazalni odmerki do 200 mg so bili v primerjavi s posameznim odmerkom 100 mg povezani z večjo incidenco neželenih učinkov, zlasti na prebavila in osrednje živčevje.
Eluxadoline has a minor influence on the ability to drive and use machines.
Eluksadolin ima blag vpliv na sposobnost vožnje in upravljanja strojev.
The frequency of serious adverse events, gastrointestinal events, and events leading to discontinuation tended to be lower for the 75 mg dose compared to the 100 mg dose.
Pogostnost resnih neželenih učinkov, učinkov na prebavila in učinkov, ki so povzročili prenehanje zdravljenja, je bila večinoma manjša pri odmerku 75 mg v primerjavi s 100 mg.
What Truberzi looks like and contents of the pack
Izgled zdravila Truberzi in vsebina pakiranja
Stop taking Truberzi right away and get emergency medical care if you have signs or symptoms of an allergic reaction, including: - swelling of your face, lips, mouth, tongue, and/or throat - shortness of breath or other breathing problems - chest pain or tightness - itching - rash - hives
Takoj prenehajte jemati zdravilo Truberzi in poiščite zdravniško pomoč, če imate znake ali simptome alergijske reakcije, kar vključuje: - oteklino obraza, ustnic, ust, jezika in/ali žrela; - težko dihanje ali druge težave z dihanjem;
Patients receiving eluxadoline also reported significant reductions in bowel movement frequency and abdominal bloating compared to placebo as demonstrated by changes from baseline in daily bowel movements and bloating score at Weeks 12 and 26.
Bolniki, ki so prejemali eluksadolin, so poročali tudi o pomembnem zmanjšanju pogostosti odvajanja blata in napihnjenosti trebuha v primerjavi s placebom, kot je razvidno iz sprememb v primerjavi z izhodiščem v dnevnem odvajanju blata in oceni napihnjenosti v 12. in 26. tednu.
Truberzi is available in packs containing 28 or 56 film-coated tablets and in a multipack of 168 film-coated tablets comprising 3 cartons, each containing 56 film-coated tablets.
Zdravilo Truberzi je na voljo v pakiranjih, ki vsebujejo po 28 ali 56 filmsko obloženih tablet, in v velikih pakiranjih s 168 filmsko obloženimi tabletami, ki vsebujejo 3 škatle po 56 filmsko obloženih tablet.
In patients with IBS-D, no signal for central nervous system-mediated adverse events was identified.
Pri bolnikih z IBS-D niso ugotovili nobenih znakov neželenih učinkov, ki bi nastali zaradi vpliva na osrednje živčevje.
Patients should be informed of and monitored for signs and symptoms suggestive of pancreatitis e.g. abdominal pain, that may radiate to the back or shoulder, nausea and vomiting.
Bolnike je treba o tem poučiti in pri njih spremljati pojav znakov in simptomov, ki kažejo na pankreatitis, npr. bolečine v trebuhu, ki se lahko širijo v hrbet ali ramena, navzea in bruhanje.
Given eluxadoline's action at opioid receptors, administration of a narcotic mu opioid antagonist, such as naloxone, should be considered.
Glede na delovanje eluksadolina na opioidne receptorje je treba razmisliti o uporabi opioidnega antagonista receptorjev mi z narkotičnim učinkom, kot je nalokson.
The most common adverse reactions (incidence of >5%) reported were constipation (7% and 8% of patients receiving 75 mg and 100 mg respectively), nausea (8% and 7% of patients receiving 75 mg and 100 mg respectively) and abdominal pain (6% and 7% of patients receiving 75 mg and 100 mg respectively).
Najpogostejši opaženi neželeni učinki (incidenca >5 %) so bili zaprtost (pri 7 % bolnikov, ki so prejemali 75 mg, in pri 8 % bolnikov, ki so prejemali 100 mg), navzea (pri 8 % bolnikov, ki so prejemali 75 mg, in pri 7 % bolnikov, ki so prejemali 100 mg) in bolečine v trebuhu (pri 6 % bolnikov, ki so prejemali 75 mg, in pri 7 % bolnikov, ki so prejemali 100 mg).
Stop taking Truberzi and call your doctor right away if you develop severe constipation while taking Truberzi.
Takoj prenehajte jemati zdravilo Truberzi in se posvetujte s svojim zdravnikom, če imate med jemanjem zdravila Truberzi hudo zaprtje.
These medicines can include: - rosuvastatin (statin used to treat high cholesterol and to prevent cardiovascular disease); - valsartan and olmesartan (used to treat high blood pressure);
- rosuvastatin (statin, ki se uporablja za zdravljenje visoke ravni holesterola ter za preprečevanje bolezni srca in ožilja); - valsartan in olmesartan (uporabljata se za zdravljenje visokega krvnega tlaka);
Truberzi is a medicine that contains the active substance eluxadoline.
Truberzi je zdravilo, ki vsebuje zdravilno učinkovino eluksadolin.
• A history of chronic or severe constipation or sequelae from constipation, or known or suspected mechanical gastrointestinal obstruction.
• Anamneza kronične ali hude zaprtosti ali posledic zaprtosti ali znana ali domnevna mehanska zapora prebavil.
The main symptoms of IBS-D include: - stomach ache; - stomach discomfort; - diarrhoea; - urgent bowel movements.
Glavni simptomi IBS-D vključujejo: - bolečine v trebuhu; - neprijeten občutek v trebuhu;
Eluxadoline's systemic exposure following oral administration is low and is consistent with its local action in the GI tract.
Sistemska izpostavljenost eluksadolinu po peroralni uporabi je majhna in skladna z njegovim lokalnim delovanjem v prebavilih.
Stop taking Truberzi and seek medical attention immediately if you develop any of the following while taking this medicine: - new or worsening pain in the belly, with or without nausea and vomiting;
Prenehajte jemati zdravilo Truberzi in takoj poiščite zdravniško pomoč, če se pri vas med jemanjem tega zdravila pojavi kar koli od naslednjega: - nova ali poslabšana bolečina v trebuhu, s siljenjem na bruhanje in bruhanjem ali brez njiju;
Eluxadoline has very low oral bioavailability and exerts no detectable central nervous system (CNS)-mediated effects when administered orally to animals at effective doses.
Eluksadolin ima zelo majhno peroralno biološko uporabnost in nima zaznavnih učinkov na osrednje živčevje, če se peroralno daje živalim v učinkovitih odmerkih.
Overall, there was an increased frequency of adverse events reported for patients aged 65 years or greater in the clinical studies.
V splošnem so v kliničnih študijah poročali o zvečani pogostnosti neželenih učinkov pri bolnikih, starih 65 let ali več.
Hepatic impairment or coadministration with cysclosporine results in significant increases in plasma concentrations of eluxadoline.
Okvara jeter ali sočasna uporaba s ciklosporinom povzroči pomembno zvišanje plazemskih koncentracij eluksadolina.
An abuse liability study with 100 mg and 200 mg intranasal doses of eluxadoline resulted in higher systemic concentrations of eluxadoline that produced changes in pupil diameter but were associated with drug disliking.
V študiji tveganja za zlorabo z intranazalnimi odmerki eluksadolina 100 mg in 200 mg so bile sistemske koncentracije eluksadolina višje in so povzročile spremembe premera zenice, vendar so bile povezane z neugodjem pri uporabi zdravila.
Additional cases of pancreatitis not associated with sphincter of Oddi spasm were reported in clinical studies.
V kliničnih študijah so poročali o dodatnih primerih pankreatitisa, ki niso bili povezani s spazmom Oddijevega sfinktra.
Serious adverse reactions of pancreatitis (0.2% and 0.3% of patients receiving 75 mg and 100 mg respectively) and sphincter of Oddi spasm (0.2% of patients receiving 75 mg and 0.8% of patients receiving 100 mg) may also occur.
Lahko se pojavita tudi resna neželena učinka pankreatitis (pri 0,2 % bolnikov, ki so prejemali 75 mg, in pri 0,3 % bolnikov, ki so prejemali 100 mg) in spazem Oddijevega sfinktra (pri 0,2 % bolnikov, ki so prejemali 75 mg, in pri 0,8 % bolnikov, ki so prejemali 100 mg).
Due to events of somnolence and sedation observed in clinical studies, caution should be exercised (see sections 4.4 and 4.5).
V kliničnih študijah so opazili pojav zaspanosti in sedacije, zato je potrebna previdnost (glejte poglavji 4.4 in 4.5).
Co-administration of eluxadoline with rosuvastatin (an OATP1B1 substrate) resulted in an up to 1.4-fold increase in exposure of rosuvastatin and the major active metabolite, n-desmethyl rosuvastatin compared to administration of rosuvastatin alone.
Pri sočasni uporabi eluksadolina z rosuvastatinom (substrat OATP1B1) je prišlo do 1,4-kratnega povečanja izpostavljenosti rosuvastatinu in glavnemu aktivnemu presnovku, N-desmetil rosuvastatinu, v primerjavi z uporabo samega rosuvastatina.
The proportion of patients who were global symptom responders was statistically significantly higher than placebo for Truberzi 100 mg twice daily over 6 month interval in Study 2 and numerically higher than placebo in Study 1.
Delež bolnikov z odzivom globalnih simptomov je bil statistično pomembno večji od placeba za zdravilo Truberzi v odmerku 100 mg dvakrat dnevno v 6-mesečnem obdobju v študiji 2 in številčno večji od placeba v študiji 1.
These medicines can include: - ciclosporin (immunosuppressant used to reduce inflammation); - gemfibrozil (used to lower lipid levels); - atazanavir, lopinavir, ritonavir, saquinavir, tipranavir (antiretrovirals used to treat HIV); - rifampicin (antibiotic used to treat infections).
Med temi zdravili so lahko: - ciklosporin (imunosupresiv, ki se uporablja za zmanjšanje vnetja); - gemfibrozil (uporablja se za zniževanje ravni lipidov); - atazanavir, lopinavir, ritonavir, sakvinavir, tipranavir (protiretrovirusna zdravila za zdravljenje okužbe z virusom HIV); - rifampicin (antibiotik za zdravljenje okužb).
Most of the reported cases of serious pancreatitis occurred within a week of starting treatment with eluxadoline and some patients developed symptoms even after one to two doses but cases of pancreatitis after longer duration of treatment have also been reported.
Večina poročanih primerov resnega pankreatitisa se je pojavila v enem tednu od začetka zdravljenja z eluksadolinom, pri nekaterih bolnikih pa so se razvili simptomi celo po enem ali dveh odmerkih.
3 “Sphincter of Oddi spasm” term includes: manifestation as pancreatitis (terms include alcoholic pancreatitis, pancreatitis, and pancreatitis acute) and hepatic enzyme elevations with abdominal pain (terms include abdominal pain, abdominal pain upper, dyspepsia, and sphincter of Oddi dysfunction).
3 Izraz »spazem Oddijevega sfinktra« vključuje: pojav pankreatitisa (izrazi vključujejo alkoholni pankreatitis, pankreatitis in akutni pankreatitis) in zvišane ravni jetrnih encimov z bolečinami v trebuhu (izrazi vključujejo bolečine v trebuhu, bolečine v zgornjem delu trebuha, dispepsijo in nepravilno delovanje Oddijevega sfinktra).
MRP2 inhibitors
Zaviralci MRP2
Film-coating: polyvinyl alcohol (E1203); titanium dioxide (E171); macrogol 3350 (E1521); talc (E553b); iron oxide yellow (E172) and iron oxide red (E172).
• filmska obloga: polivinilalkohol (E1203), titanov dioksid (E171), makrogol 3350 (E1521), smukec (E553b), rumeni železov oksid (E172) in rdeči železov oksid (E172).
How to take Truberzi
Kako jemati zdravilo Truberzi
Loss of efficacy can occur, especially when medicinal products with low dose and narrow therapeutic index (e.g. alfentanil, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus, tacrolimus), are co-administered with Eluxadoline.
Pride lahko do izgube učinkovitosti, zlasti ob sočasni uporabi zdravil z majhnim odmerkom ali ozkim terapevtskim indeksom (npr. alfentanil, dihidroergotamin, ergotamin, fentanil, pimozid, kinidin, sirolimus, takrolimus) z eluksadolinom.
Although exposure of eluxadoline was significantly increased in ESRD participants not yet on dialysis compared with matched, healthy participants with normal renal function, such an increase is unlikely to be of clinical significance because the geometric mean Cmax and AUC0-t in the participants with ESRD was in the same range as observed in several larger studies in healthy volunteers.
Čeprav je bila izpostavljenost eluksadolinu bistveno večja pri udeležencih s končno fazo ledvične odpovedi (ESRD), ki se še niso zdravili z dializo, v primerjavi z ujemajočimi se, zdravimi udeleženci z normalnim delovanjem ledvic, ni verjetno, da bi bilo tako povečanje klinično pomembno, saj je bilo geometrično povprečje Cmax in AUC0-t pri udeležencih s končno fazo ledvične odpovedi
Additionally, the proportion of patients who were composite responders to eluxadoline at each 4-week interval for months 1 through 6 was higher than placebo for both doses in both Phase 3 studies demonstrating that efficacy is maintained with continuous eluxadoline treatment.
Poleg tega je bil delež bolnikov, ki so dosegli sestavljeni odziv na eluksadolin v vsakem 4-tedenskem intervalu od 1. do 6. meseca, večji od placeba pri obeh odmerkih v obeh študijah faze 3, kar dokazuje,
These patients are at increased risk for acute pancreatitis (see section 4.4).
Ti bolniki imajo zvečano tveganje za akutni pankreatitis (glejte poglavje 4.4).
Eluxadoline is not an inducer/inhibitor of major CYP enzymes, however, eluxadoline has some potential for the metabolism based inactivation of CYP3A4.
Eluksadolin ne inducira/zavira glavnih encimov CYP, vendar ima potencial za deaktivacijo CYP3A4 na podlagi presnove.
Considering the short half-life of naloxone, repeated administration may be necessary.
Glede na kratek razpolovni čas naloksona bo morda potrebno večkratno dajanje.
The usual recommended dose is one 100 mg tablet twice a day.
Običajni priporočeni odmerek je ena 100 mg tableta dvakrat dnevno.
Study 2 (IBS-3002) included a 4-week single-blinded, placebo-withdrawal period upon completion of the 26-week treatment period.
Študija 2 (IBS-3002) je po končanem 26-tedenskem obdobju zdravljenja vključevala še 4-tedensko enojno slepo odtegnitveno obdobje s placebom.
In the event of naloxone administration, subjects should be monitored closely for the return of overdose symptoms, which may indicate need for repeated naloxone injection.
Pri dajanju naloksona je treba bolnika natančno opazovati, saj je vrnitev simptomov prevelikega odmerka lahko znak, da je potrebna še ena injekcija naloksona.
Table 2: Efficacy Results in Randomized Clinical Studies Study 1 (IBS 3001)
Preglednica 2: Rezultati učinkovitosti v randomiziranih kliničnih študijah
Co-administration of OATP1B1 inhibitors (cyclosporine, gemfibrozil, antiretrovirals [atazanavir, lopinavir, ritonavir, saquinavir, tipranavir], rifampin) with eluxadoline may increase exposure to eluxadoline (see section 5.2).
atazanavir, lopinavir, ritonavir, sakvinavir, tipranavir], rifampicin) z eluksadolinom lahko zveča izpostavljenost eluksadolinu (glejte poglavje 5.2).
OATP1B1 substrates
Substrati OATP1B1
It is a substrate and an inhibitor of the hepatic uptake transporter OATP1B1; and a substrate for the hepatic efflux transporter MRP2.
Je substrat in zaviralec jetrnega privzemnega prenašalca OATP1B1 ter substrat jetrnega izločevalnega prenašalca MRP2.
Most of the reported cases of serious sphincter of Oddi spasm occurred within a week of starting treatment with eluxadoline and some developed symptoms after one to two doses.
Večina zabeleženih primerov hudih spazmov Oddijevega sfinktra se je pojavila v prvem tednu po začetku zdravljenja z eluksadolinom, pri čemer so se pri nekaterih bolnikih simptomi pojavili že po enem ali dveh odmerkih.