FrancophonIA/ELRC3.0 huggingface dataset:
English: Pharmacotherapeutic group: antipropulsives, ATC code: A07DA06 Mechanism of action
Slovenian: Farmakoterapevtska skupina: antiperistaltiki, oznaka ATC: A07DA06 Mehanizem delovanja
English: No dose adjustment is necessary.
Slovenian: Prilagajanje odmerkov ni potrebno.
English: Assessment of drug interactions
Slovenian: Ocena interakcij med zdravili
English: If you are pregnant or breast-feeding or you think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Slovenian: Če ste noseči ali dojite, menite, da bi lahko bili noseči, ali načrtujete zanositev, se posvetujte z zdravnikom, preden vzamete to zdravilo.
English: • an average of worst abdominal pain (WAP) scores in the past 24 hours of >3.0 on a 0 to 10 scale over the week prior to randomization.
Slovenian: • povprečna ocena najhujše bolečine v trebuhu (WAP) v zadnjih 24 urah >3,0 na lestvici od 0 do 10 v tednu pred randomizacijo;
English: Patients should be instructed if they miss a dose (delay of 4 hours) to take the next dose at the regular time and not to take 2 doses at the same time to make up for a missed dose.
Slovenian: Bolnikom je treba naročiti, naj ob izpuščenem odmerku (4-urna zamuda) vzamejo naslednji odmerek ob običajnem času in naj ne vzamejo 2 odmerkov hkrati, da bi nadomestili izpuščenega.
English: • Hepatic impairment (Child-Pugh Class A-C).
Slovenian: • Okvara jeter (Child-Pugh razred A-C).
English: These patients may be at risk for severe complications of bowel obstruction.
Slovenian: Ti bolniki so lahko v nevarnosti za hude zaplete zapore črevesa.
English: Warner Chilcott Deutschland GmbH Dr.-Otto-Roehm-Strasse 2-4, 64331 Weiterstadt, Germany
Slovenian: Warner Chilcott Deutschland GmbH Dr.-Otto-Roehm-Strasse 2-4, 64331 Weiterstadt,
English: Results for endpoints were based on electronic daily diary entries by patients.
Slovenian: Rezultati za opazovana dogodka so temeljili na zapisih v elektronskem dnevniku, ki so jih dnevno vnašali bolniki.
English: The efficacy results for ≥50% of responder days (primary composite endpoint) over 6 months are shown in Table 2.
Slovenian: Rezultati učinkovitosti za ≥ 50 % odzivnih dni (primarni sestavljeni opazovani dogodek) v 6 mesecih so v preglednici 2.
English: Somnolence and sedation
Slovenian: Zaspanost in sedacija
English: Please report to your doctor: - how much alcohol you drink (e.g. daily number of drinks); - if you experience any effects, such as dizziness and sleepiness.
Slovenian: - koliko alkohola popijete (na primer dnevno število pijač); - če imate kakršne koli učinke, kot sta omotica in zaspanost.
English: What you need to know before you take Truberzi 3.
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Truberzi 3.
English: The effect on other statins which are more sensitive OATP1B1 substrates (e.g. simvastatin and atorvastatin), however, may be more pronounced.
Slovenian: Učinek na druge statine, ki so občutljivejši substrati OATP1B1 (npr. simvastatin in atorvastatin), je lahko izrazitejši.
English: Do not take Truberzi with any of the above medicines.
Slovenian: Zdravila Truberzi ne jemljite sočasno z nobenim od zgoraj naštetih zdravil.
English: Do not use this medicine after the expiry date which is stated on blister and the carton after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na pretisnem omotu in škatli poleg oznake »EXP«.
English: The treatment should be initiated and supervised by a physician experienced in diagnosis and management of gastrointestinal disorders.
Slovenian: Zdravljenje mora začeti in nadzorovati zdravnik, ki ima izkušnje z diagnostiko in vodenjem bolezni prebavil.
English: However, such an increase is unlikely to be of clinical significance (see section 5.2).
Slovenian: Vendar ni verjetno, da bi bilo tako povečanje klinično pomembno (glejte poglavje 5.2).
English: • an average global symptom score >2.0 on a 0-4 scale (0 corresponds to no symptoms, 1 corresponds to mild symptoms, 2 corresponds to moderate symptoms, 3 corresponds to severe symptoms and 4 corresponds to very severe symptoms) over the week prior to randomization
Slovenian: • povprečna ocena globalnih simptomov > 2,0 na lestvici 0-4 (0 ustreza odsotnosti simptomov, 1 ustreza blagim simptomom, 2 zmernim simptomom, 3 hudim simptomom in 4 zelo hudim simptomom) v tednu pred randomizacijo.
English: An overdose of eluxadoline may result in symptoms resulting from an exaggeration of the known pharmacodynamic effects of the medicinal product.
Slovenian: Prevelik odmerek eluksadolina lahko povzroči simptome, ki so posledica pretiranih znanih farmakodinamičnih učinkov zdravila.
English: What Truberzi is and what it is used for 2.
Slovenian: Kaj je zdravilo Truberzi in za kaj ga uporabljamo 2.
English: Take special care if you are 65 years of age or older, as there is a higher risk that you may have certain side effects (see section 4).
Slovenian: Če ste stari 65 let ali več, bodite še posebej previdni, saj ste v večji nevarnosti za nekatere neželene učinke (glejte poglavje 4).
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Truberzi therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Slovenian: Odločiti se je treba med prenehanjem dojenja in prenehanjem/prekinitvijo zdravljenja z zdravilom Truberzi, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja za mater.
English: The safety and efficacy of eluxadoline in children aged 0 to18 years have not yet been established.
Slovenian: Pediatrična populacija Varnost in učinkovitost eluksadolina pri otrocih, starih od 0 do 18 let, še nista dokazani.
English: It is unlikely that Truberzi will affect your ability to drive or use tools or machines.
Slovenian: Ni verjetno, da bo zdravilo Truberzi vplivalo na vašo sposobnost vožnje in upravljanja orodja ali strojev.
English: Following a 1,000 mg oral dose in healthy male volunteers, M11 was detected in urine but not in systemic circulation.
Slovenian: Po peroralnem odmerku 1000 mg pri zdravih moških prostovoljcih so odkrili M11 v urinu, ne pa tudi v sistemskem krvnem obtoku.
English: The safety and efficacy of eluxadoline in this subgroup of IBS-D patients has not been established.
Slovenian: Varnost in učinkovitost eluksadolina v tej podskupini bolnikov z IBS-D nista dokazani.
English: The tablets are packed in PCTFE/PVC/Al-blisters.
Slovenian: Tablete so pakirane v pretisnih omotih iz PCTFE/PVC/Al.
English: The absolute bioavailability of eluxadoline has not been determined but is estimated to be low due to limited absorption and first pass effects.
Slovenian: Absolutna biološka uporabnost eluksadolina ni ugotovljena, vendar je ocenjena na nizko zaradi omejene absorpcije in učinkov presnove prvega prehoda.
English: As patient's genetic disposition may be unknown, it is recommended that patients be monitored for impaired mental or physical abilities needed to perform potentially hazardous activities such as driving a car or using machines (see sections 4.7. and 4.8).
Slovenian: Ker bolnikova genska nagnjenost morda ni znana, se priporoča spremljanje bolnikov zaradi morebitnega poslabšanja duševnih ali telesnih sposobnosti, ki so potrebne za opravljanje potencialno nevarnih dejavnosti, kot sta vožnja avtomobila ali upravljanje strojev (glejte poglavji 4.7 in 4.8).
English: Other substrates potentially affected include e.g. sartans (valsartan, olmesaran).
Slovenian: Med drugimi substrati, na katere bi to lahko vplivalo, so npr. sartani (valsartan, olmesaran).
English: Overall, patients had a mean age of 45 years (range 18-80 years with 10% at least 65 years of age or older), 66% female, 86% white, 12% black, and 27% Hispanic.
Slovenian: V splošnem je bila povprečna starost bolnikov 45 let (razpon 18-80 let z 10 % bolnikov, starih najmanj 65 let) in med njimi je bilo 66 % žensk, 86 % belcev, 12 % temnopoltih ter 27 % Latinoameričanov.
English: Do not stop taking Truberzi without first talking to your doctor as your symptoms may worsen.
Slovenian: Zdravila Truberzi ne prenehajte jemati, ne da bi se posvetovali z zdravnikom, saj se lahko vaši simptomi poslabšajo.
English: Other medicines and Truberzi
Slovenian: Druga zdravila in zdravilo Truberzi
English: The European Medicines Agency has deferred the obligation to submit the results of clinical studies with Truberzi in one or more subsets of the paediatric population in IBS-D (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom Truberzi za eno ali več podskupin pediatrične populacije z IBS-D (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: As a precautionary measure, it is preferable to avoid the use of Truberzi during pregnancy.
Slovenian: Iz previdnostnih razlogov se je med nosečnostjo uporabi zdravila Truberzi bolje izogibati.
English: The following adverse reactions considered related to eluxadoline treatment from clinical trials and spontaneous reporting are presented according to the MedDRA System Organ Classification and frequency convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data).
Slovenian: Naslednji neželeni učinki, ki veljajo za povezane z zdravljenjem z eluksadolinom v kliničnih preskušanjih in spontanih poročilih, so skladno s sistemom MedDRA razvrščeni po organskih sistemih in pogostnosti: zelo pogosti (≥1/10), pogosti (≥1/100 do <1/10), občasni (≥1/1.000 do <1/100), redki (≥1/10.000 do <1/1.000), zelo redki (<1/10.000) in neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: (see section 4.5).
Slovenian: (glejte poglavje 4.5).
English: If patients develop severe constipation, they should be instructed to stop Truberzi and seek medical attention.
Slovenian: Če se pri bolnikih pojavi hudo zaprtje, jim je treba naročiti, naj prenehajo jemati zdravilo Truberzi in poiščejo zdravniško pomoč.
English: Taken together these results suggest that when using the medicinal product as directed at therapeutic doses patients will not experience significant central nervous system effects or adverse events consistent with a drug of abuse.
Slovenian: Skupaj ti rezultati kažejo, da pri uporabi zdravila v predpisanih terapevtskih odmerkih bolniki ne bodo doživeli pomembnih učinkov na osrednje živčevje ali neželenih učinkov, značilnih za zdravila, ki se zlorabljajo.
English: It is unknown whether eluxadoline is excreted in human milk.
Slovenian: Ni znano, ali se eluksadolin izloča v materino mleko.
English: Bile acid malabsorption
Slovenian: Malabsorpcija žolčne kisline
English: PCTFE/PVC/Al-blister containing 14 film-coated tablets.
Slovenian: Pretisni omot iz PCTFE/PVC/Al vsebuje 14 filmsko obloženih tablet.
English: Serious cases resulting in hospitalization and death, primarily in patients without a gallbladder have been reported.
Slovenian: Poročali so o resnih primerih, ki so imeli za posledico hospitalizacijo ter smrt, do katerih je prišlo v prvi vrsti pri bolnikih brez žolčnika.
English: Eluxadoline exists predominantly as the (S,S)-diastereomer (>99%) and undergoes little or no chiral conversion in vivo.
Slovenian: Eluksadolin obstaja pretežno kot (S,S)-diastereomer (> 99 %); in vivo je podvržen kiralni pretvorbi samo v majhni meri ali sploh ne.
English: Your doctor may prescribe you a lower dose of one 75 mg tablet twice a day if you: - are 65 years of age or older; - are unable to tolerate the 100 mg dose;
Slovenian: Zdravnik vam bo morda predpisal manjši odmerek, po eno 75 mg tableto dvakrat dnevno, če: - ste stari 65 let ali več; - ne prenašate 100 mg odmerka.
English: • Hypersensitivity to eluxadoline or to any of the excipients listed in section 6.1.
Slovenian: • Preobčutljivost na eluksadolin ali katero koli pomožno snov, navedeno v poglavju 6.1.
English: Serious allergic reactions have happened in some people after taking 1 or 2 doses of Truberzi.
Slovenian: Pri nekaterih osebah je po jemanju enega ali dveh odmerkov zdravila Truberzi prišlo do resnih alergijskih reakcij.
English: Also, eluxadoline significantly improves patients quality of life as demonstrated by change from baseline score in the IBS-QOL questionnaire at weeks 12 and 26.
Slovenian: Eluksadolin tudi bistveno izboljša bolnikovo kakovost življenja, kar dokazuje sprememba od izhodiščnega rezultata pri vprašalniku IBS-QOL v 12. in 26. tednu.
English: Therefore, the 75 mg dose twice daily can be considered for this population, but its benefit risk ratio should be periodically assessed in the context of their symptoms severity (see section 4.2).
Slovenian: Zato pri tej skupini bolnikov pride v poštev odmerek 75 mg dvakrat dnevno, vendar je treba redno ocenjevati razmerje med koristjo in tveganjem v kontekstu resnosti njihovih simptomov (glejte poglavje 4.2).
English: All events resolved upon discontinuation of Truberzi, with symptoms typically improved by the following day.
Slovenian: Po prenehanju zdravljenja z zdravilom Truberzi so vsi ti učinki izginili; simptomi so se navadno izboljšali že naslednji dan.
English: Available pharmacodynamic/toxicological data in animals have shown excretion of eluxadoline in milk (for details see section 5.3).
Slovenian: Razpoložljivi farmakodinamični/toksikološki podatki pri živalih kažejo na izločanje eluksadolina v mleko (za podrobnosti glejte poglavje 5.3).
English: A relevant proportion of patients diagnosed with IBS-D may be affected by bile-acid malabsorption as a potential reason for IBS-D symptoms.
Slovenian: Pri pomembnem deležu bolnikov z diagnozo IBS-D je lahko malabsorpcija žolčne kisline možen razlog za simptome IBS-D.
English: All pancreatic events, whether or not associated with sphincter of Oddi spasm, were retrospectively evaluated as mild, indicating an absence of organ failure and local or systemic complications.
Slovenian: Vse učinke, povezane s trebušno slinavko, ne glede na povezavo s spazmom Oddijevega sfinktra, so naknadno ocenili kot blage, kar kaže na odsotnost odpovedi organov in lokalnih ali sistemskih zapletov.
English: However, caution should be exercised in patients receiving high doses of OATP1B1 substrates (see section 4.5).
Slovenian: Vendar pa je potrebna previdnost pri bolnikih, ki prejemajo velike odmerke substratov OATP1B1 (glejte poglavje 4.5).
English: Study1 (IBS-3001) continued double-blinded for an additional 26 weeks for long-term safety (total of 52 weeks of treatment), followed by a 2-week follow-up.
Slovenian: Študija 1 (IBS-3001) se je še dodatnih 26 tednov nadaljevala kot dvojno slepa z namenom preučevanja dolgoročne varnosti (skupaj 52 tednov zdravljenja), temu pa je sledilo 2-tedensko spremljanje.
English: Following a single oral dose of 300 mg [14C] eluxadoline in healthy male subjects, 82.2% of the total [14C] eluxadoline was recovered in faeces in 336 hours and less than 1% was recovered in urine in 192 hours.
Slovenian: Po enkratnem peroralnem odmerku 300 mg [14C]-eluksadolina pri zdravih moških se je 82,2 % celotnega odmerka [14C]-eluksadolina izločilo v blatu v 336 urah in manj kot 1 % v urinu v 192 urah.
English: Contents of the pack and other information What Truberzi contains
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Truberzi
English: • Patients without a gallbladder (e.g. due to cholecystectomy or agenesis).
Slovenian: • Bolniki brez žolčnika (na primer zaradi holecistektomije ali agenezije).
English: During the 4 week single-blind withdrawal period in Study 2 (IBS-3002), no evidence of rebound diarrhoea or abdominal pain was demonstrated.
Slovenian: Med 4-tedenskim enojno slepim odtegnitvenim obdobjem v študiji 2 (IBS-3002) ni bilo znakov povratnega učinka na drisko ali bolečine v trebuhu.
English: A total of 1,282 patients in Study 1 (IBS-3001) and 1,146 patients in Study 2 (IBS-3002) were enrolled and received treatment with Truberzi 75 mg, Truberzi 100 mg or placebo twice daily.
Slovenian: Skupno število 1282 bolnikov v študiji 1 (IBS-3001) in 1146 bolnikov v študiji 2 (IBS-3002) je dvakrat dnevno prejemalo zdravilo Truberzi 75 mg, Truberzi 100 mg ali placebo.
English: Talk to your doctor or pharmacist if you are unsure if any of the above apply to you.
Slovenian: Posvetujte se z zdravnikom ali farmacevtom, če niste prepričani, ali kar koli od naštetega velja za vas.
English: In rat, eluxadoline was excreted into milk in an approximately dose proportional manner with maximal concentrations less than plasma concentrations.
Slovenian: Pri podganah se je eluksadolin izločal z mlekom približno sorazmerno z odmerkom, pri čemer so bile najvišje koncentracije nižje od koncentracij v plazmi.
English: What you need to know before you take Truberzi Do not take Truberzi:
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Truberzi Ne jemljite zdravila Truberzi:
English: Given eluxadoline's local action in the GI tract, low Foral and lack of metabolism, prospective clinical studies regarding differences in age, body mass index (BMI), ethnicity, and gender were deemed unnecessary.
Slovenian: Glede na lokalno delovanje eluksadolina v prebavilih, nizko vrednost Foral in pomanjkljivo presnovo so se prospektivne klinične študije glede razlik v starosti, indeksu telesne mase (ITM), narodnosti in spolu zdele nepotrebne.
English: Treatment with eluxadoline also resulted in significant improvements in patients whose IBS-D symptoms were not adequately controlled with use of loperamide prior to enrolment.
Slovenian: Pri zdravljenju z eluksadolinom so dosegli pomembno izboljšanje tudi bolniki, pri katerih pred vključitvijo v študijo simptomi IBS-D niso bili ustrezno nadzorovani z uporabo loperamida.
English: Cmax and AUC for the metabolite 1hydroxy-midazolam increased by ~14% and 7% respectively, suggesting that eluxadoline may be a mild inducer of CYP3A4 and may decrease the exposure of concomitantly administered CYP3A4 substrates.
Slovenian: Cmax in AUC za presnovek 1-hidroksi midazolam sta se povečala za približno 14 % in 7 %, kar kaže na to, da je eluksadolin lahko blag induktor CYP3A4 in da lahko zmanjša izpostavljenost sočasno uporabljenim substratom CYP3A4
English: The administration of eluxadoline with a high fat meal significantly decreased both Cmax (50%) and AUC (60%) without any effect on Tmax.
Slovenian: Pri dajanju eluksadolina z zelo mastnim obrokom sta se pomembno zmanjšali vrednosti Cmax (50 %) in AUC (60 %), medtem ko vpliva na Tmax ni bilo.
English: Eluxadoline should not be used in children and adolescents as it has not been studied in this population (see section 4.2).
Slovenian: Eluksadolin se ne sme uporabljati pri otrocih in mladostnikih, saj pri tej populaciji ni raziskan (glejte poglavje 4.2).
English: Truberzi is contraindicated in patients without a gallbladder.
Slovenian: Zdravilo Truberzi je kontraindicirano pri bolnikih brez žolčnika.
English: Supporting the lack of systemic pharmacodynamic effects are results from an oral abuse liability study in recreational opioid users that showed oral doses up to 1,000 mg did not produce significant pupillary constriction or significant drug liking.
Slovenian: Pomanjkanje sistemskih farmakodinamičnih učinkov podpirajo tudi rezultati študije tveganja za peroralno zlorabo pri uporabnikih, ki rekreativno uporabljajo opioide, ki so pokazali, da peroralni odmerki do 1000 mg niso povzročili pomembne zožitve zenice ali ugajanja zdravila.
English: What Truberzi is and what it is used for
Slovenian: Kaj je zdravilo Truberzi in za kaj ga uporabljamo
English: All pancreatic events resolved with lipase normalization upon discontinuation of eluxadoline, with 80% (4/5) resolving within 1 week of treatment discontinuation (see section 4.4).
Slovenian: Vsi učinki, povezani s trebušno slinavko, so minili ob normalizaciji ravni lipaze ob prenehanju zdravljenja z eluksadolinom, pri čemer jih je 80 % (4/5) minilo v 1 tednu po prekinitvi zdravljenja (glejte poglavje 4.4).
English: Avoid taking Truberzi with any other medicines that may cause constipation (see Section 2: Other medicines and Truberzi).
Slovenian: Izogibajte se sočasni uporabi zdravila Truberzi z zdravili, ki lahko povzročijo zaprtost (glejte poglavje 2: Druga zdravila in zdravilo Truberzi).
English: (see sections 4.2 and 4.4).
Slovenian: (glejte poglavja 4.2, 4.3 in 4.4).
English: Composite Response
Slovenian: Sestavljeni odziv
English: There was an overall increased frequency of adverse events in the older population compared to patients <65 years which was comparable across all treatment groups, including placebo.
Slovenian: Pri starejši populaciji so opazili splošno zvečanje pogostnosti neželenih učinkov v primerjavi z bolniki, mlajšimi od 65 let, kar je bilo primerljivo v vseh zdravljenih skupinah, vključno s prejemniki placeba.
English: When the threshold for abdominal pain response was increased to ≥40% or ≥50% improvement from baseline in daily worst abdominal pain, the proportion of abdominal pain responders was 6%-7% higher for eluxadoline 100 mg twice daily compared to placebo which was statistically significant (P ≤ 0.009) for the pooled (Study 1 and Study 2) data.
Slovenian: Ko so zvišali prag za odziv bolečin v trebuhu na ≥ 40- ali ≥ 50-odstotno izboljšanje dnevnih najhujših bolečin v trebuhu glede na izhodišče, je bil delež odzivnih bolnikov za 6-7 % večji pri eluksadolinu v odmerku 100 mg dvakrat dnevno v primerjavi s placebom, kar je statistično pomembno (P ≤ 0,009) v kontekstu združenih (študija 1 in študija 2) podatkov.
English: Of 1,795 IBS-D patients who were enrolled in clinical studies of eluxadoline and assigned to 75 mg or 100 mg twice daily, 139 (7.7%) were at least 65 years of age, while 15 (0.8%) were at least 75 years old.
Slovenian: Od 1795 bolnikov z IBS-D, ki so bili vključeni v klinične študije eluksadolina in razvrščeni v skupini z odmerkom 75 mg ali 100 mg dvakrat dnevno, jih je bilo 139 (7,7 %) starih najmanj 65 let in 15 (0,8 %) najmanj 75 let.
English: In rats, there was no effect on mating, fertility and fecundity indices (see section 5.3).
Slovenian: Pri podganah ni bilo učinkov na parjenje, plodnost in kazalce plodnosti (glejte poglavje 5.3).
English: Some medicines may increase the level of Truberzi in the blood.
Slovenian: Nekatera zdravila lahko zvišajo koncentracijo zdravila Truberzi v krvi.
English: Hypersensitivity6
Slovenian: Preobčutljivost6
English: Based on the physical-chemical and biopharmaceutical properties (very low oral bioavailability), eluxadoline is expected to have minimal abuse or dependence liability.
Slovenian: Odvisnost od zdravila in potencial za zlorabo Na podlagi fizikalno-kemijskih in biofarmacevtskih lastnosti (zelo majhna peroralna biološka uporabnost) se pri eluksadolinu pričakuje minimalno tveganje za zlorabo ali odvisnost.
English: Abdominal distention Gastroesophageal reflux disease4
Slovenian: bruhanje flatulenca abdominalna distenzija gastroezofagealna refluksna bolezen4
English: Eluxadoline is a locally acting, mixed mu opioid receptor (μOR) agonist and delta opioid receptor
Slovenian: Eluksadolin je lokalno delujoč, mešan agonist opioidnih receptorjev mi (μOR) in antagonist opioidnih receptorjev delta (δOR).
English: In vitro studies indicate that eluxadoline is neither an inducer of CYP1A2, CYP2B6, CYP2C9, CYP2C19, and CYP3A4, nor an inhibitor of CYP1A2, CYP2A6, CYP2B6, CYP2C9, CYP2C19, CYP2C8 and CYP2D6 at clinically relevant concentrations.
Slovenian: CYP1A2, CYP2B6, CYP2C9, CYP2C19 in CYP3A4 niti zaviralec CYP1A2, CYP2A6, CYP2B6, CYP2C9, CYP2C19, CYP2C8 in CYP2D6.
English: 4 “Gastrooesophageal reflux disease” term includes gastrooesophageal reflux disease, dyspepsia and gastritis.
Slovenian: 4 Izraz »gastroezofagealna refluksna bolezen« vključuje gastroezofagealno refluksno bolezen,
English: However, given the potential for increased sensitivity to experience undesirable effects, it may be considered to initiate eluxadoline treatment in a dosage of 150 mg daily (one 75 mg tablet twice daily).
Slovenian: Vendar se, glede na možnost povečane občutljivosti za pojav neželenih učinkov, lahko razmisli o začetku zdravljenja z eluksadolinom v odmerku 150 mg dnevno (ena 75 mg tableta dvakrat dnevno).