natgillin/translations-raw huggingface dataset:
Svær forstoppelse, som kan medføre hospitalsindlæggelse, er forekommet efter indtagelse af Truberzi.
Severe constipation that can lead to hospitalization has happened after taking Truberzi.
• En gennemsnitsscore for ‘Worst Abdominal Pain' (WAP) i de forudgående 24 timer på > 3,0 på en skala fra 0 til 10 i ugen inden randomisering.
• 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.
Fortæl din læge: - hvor meget alkohol, du drikker (fx antal genstande om dagen); - hvis du får bivirkninger såsom svimmelhed og søvnighed.
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.
Alle patienter skal instrueres i ikke at indtage alkohol under behandling med eluxadolin.
All patients should be instructed not to use alcohol while on treatment with eluxadoline.
• En gennemsnitsscore for globale symptomer på > 2,0 på en skala fra 0 til 4 (0 står for ingen symptomer, 1 står for lette symptomer, 2 står for moderate symptomer, 3 står for kraftige symptomer, og 4 står for meget kraftige symptomer) i ugen inden randomisering.
• 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
Forekomst af sådanne bivirkninger hos patienter med intakte galdeveje kan ikke udelukkes.
The occurrence of such events in patients with an intact biliary tract cannot be excluded.
Lægemidler, der forårsager obstipation
Medicinal products that cause constipation
Eluxadolins absolutte biotilgængelighed er ikke fastlagt, men skønnes at være lav på grund af den begrænsede absorption og first pass-effekten.
The absolute bioavailability of eluxadoline has not been determined but is estimated to be low due to limited absorption and first pass effects.
PCTFE/PVC/Al-blister med 14 filmovertrukne tabletter.
PCTFE/PVC/Al-blister containing 14 film-coated tablets.
Eluxadolin Dette lægemiddel er underlagt supplerende overvågning.
Eluxadoline This medicine is subject to additional monitoring.
Gastrisk lavage eller indgift af kul bør overvejes.
Gastric lavage or charcoal administration should be considered.
Behandlingen skal initieres og overvåges af en læge med erfaring i diagnostik og behandling af mavetarm-sygdomme.
The treatment should be initiated and supervised by a physician experienced in diagnosis and management of gastrointestinal disorders.
Undersøgelse af lægemiddelinteraktioner
Assessment of drug interactions
Respons, BSS på < 5
BSS <5 Response
Abdominal distention Gastroøsofageal refluks4
Abdominal distention Gastroesophageal reflux disease4
Du vil dog kunne få bivirkninger såsom søvnighed eller svimmelhed, mens du tager Truberzi, og det kan påvirke din evne til at køre bil eller betjene maskiner.
However, you may experience side effects such as sleepiness or dizziness while taking Truberzi which might affect your ability to drive or use machines.
Undgå hyppig anvendelse af loperamid (et lægemiddel til behandling af diaré), hvis du tager Truberzi, da det kan øge risikoen for forstoppelse.
Avoid frequent use of loperamide (a medicine used to treat diarrhoea) if you are taking Truberzi as this may increase the risk of constipation.
På baggrund af de fysisk-kemiske og biofarmaceutiske egenskaber (meget lav oral biotilgængelighed) forventes eluxadolin at have minimal tendens til at medføre misbrug eller afhængighed.
Based on the physical-chemical and biopharmaceutical properties (very low oral bioavailability), eluxadoline is expected to have minimal abuse or dependence liability.
Tabletterne skal tages oralt (gennem munden) morgen og aften sammen med mad.
The tablets should be taken orally with food in the morning and in the evening.
Det aktive stof har lineær farmakokinetik uden akkumulering efter gentagen dosering to gange dagligt.
The active substance has linear pharmacokinetics with no accumulation upon repeated twice daily dosing.
Mængden af uforandret eluxadolin, der blev genfundet i urinen, var 0,01 % og 0,05 % af dosis hos henholdsvis deltagere med ESRD og raske deltagere.
Unchanged eluxadoline recovered in urine was 0.01% and 0.05% of dose in ESRD and healthy participants, respectively.
Truberzi er et lægemiddel, der indeholder det aktive stof eluxadolin.
Truberzi is a medicine that contains the active substance eluxadoline.
Tal med lægen eller apotekspersonalet, hvis du er usikker på, om noget af ovenstående gælder for dig.
Talk to your doctor or pharmacist if you are unsure if any of the above apply to you.
Efter en oral dosis på 1.000 mg til raske frivillige mænd blev M11 påvist i urin, men ikke i det systemiske kredsløb.
Following a 1,000 mg oral dose in healthy male volunteers, M11 was detected in urine but not in systemic circulation.
En betydelig andel af patienter med diagnosen IBS-D kan være påvirket af galdesyremalabsorption som en mulig årsag til IBS-D-symptomerne.
A relevant proportion of patients diagnosed with IBS-D may be affected by bile-acid malabsorption as a potential reason for IBS-D symptoms.
Det er ukendt, om eluxadolin udskilles i human mælk.
It is unknown whether eluxadoline is excreted in human milk.
Alle tilfælde forsvandt efter seponering af Truberzi, og symptomerne var typisk bedret den efterfølgende dag.
All events resolved upon discontinuation of Truberzi, with symptoms typically improved by the following day.
Eluxadolins virkning og sikkerhed hos IBS-D-patienter blev fastlagt i to randomiserede, multinationale, dobbeltblinde, placebokontrollerede multicenterstudier (studie 1 og 2).
The efficacy and safety of eluxadoline in IBS-D patients was established in two randomized, multicenter, multi-national, double-blind, placebo-controlled studies (Studies 1 & 2).
Der er utilstrækkelige data fra anvendelse af eluxadolin til gravide kvinder.
There is limited amount of data from the use of eluxadoline in pregnant women.
Generelt var der en øget hyppighed af bivirkninger i den ældre population sammenlignet med patienter < 65 år, hvilket var konsistent på tværs af alle behandlingsgrupper, herunder placebogruppen.
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.
Risikoen for obstipation ved eluxadolin hos patienter med andre IBS-undertyper er ukendt, men kan være øget.
Risk of constipation with eluxadoline in patients with other IBS sub-types is unknown, but may be increased.
Truberzi er kontraindiceret hos patienter uden galdeblære.
Truberzi is contraindicated in patients without a gallbladder.
Eluxadolin findes fortrinsvis som (S,S)-diastereomeren (> 99 %) og gennemgår kun ringe eller slet ingen chiral omdannelse in vivo.
Eluxadoline exists predominantly as the (S,S)-diastereomer (>99%) and undergoes little or no chiral conversion in vivo.
Cirka 50 % af tilfældene af obstipation opstod inden for de første 2 behandlingsuger.
Approximately 50% of constipation events occurred within the first 2 weeks of treatment.
Virkningen på andre statiner, der er mere følsomme OATP1B1-substrater (fx simvastatin og atorvastatin) kan imidlertid være mere udtalt.
The effect on other statins which are more sensitive OATP1B1 substrates (e.g. simvastatin and atorvastatin), however, may be more pronounced.
En overdosis af eluxadolin kan give symptomer, der skyldes, at lægemidlets kendte farmakodynamiske virkninger øges.
An overdose of eluxadoline may result in symptoms resulting from an exaggeration of the known pharmacodynamic effects of the medicinal product.
Der er blevet indberettet alvorlige tilfælde, der resulterede i hospitalsindlæggelse og død, især hos patienter uden galdeblære.
Serious cases resulting in hospitalization and death, primarily in patients without a gallbladder have been reported.
80 % (8/10) af tilfældene af spasmer i sphincter Oddi forekom inden for den første behandlingsuge.
80% (8/10) of sphincter of Oddi spasm events presented within the first week of treatment.
Brug ikke lægemidlet efter den udløbsdato, der står på blisteret og kartonen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
Do not use this medicine after the expiry date which is stated on blister and the carton after EXP.
Anvendelse af eluxadolin sammen med andre lægemidler, der kan forårsage obstipation (for eksempel antikolinergika, opioider osv.), skal også undgås.
The use of eluxadoline with other medicinal products that may cause constipation (for example anticholinergics, opioids etc) should also be avoided.
Eluxadolins sikkerhed og virkning i denne undergruppe af IBS-D-patienter er ikke klarlagt.
The safety and efficacy of eluxadoline in this subgroup of IBS-D patients has not been established.
Eluxadolin reverserer desuden det hyperalgesiske respons i en dyremodel af akutte colitis-inducerede viscerale smerter.
Eluxadoline also reverses hyperalgesic responses in an animal model of acute colitis-induced visceral pain.
Studie 1 (IBS-3001) fortsatte dobbeltblindet i yderligere 26 uger for at undersøge den langsigtede sikkerhed (i alt 52 ugers behandling) efterfulgt af 2 ugers opfølgning.
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.
Indgift af eluxadolin i forbindelse med et fedtholdigt måltid reducerede både Cmax (50 %) og AUC (60 %) signifikant uden nogen virkning på Tmax.
The administration of eluxadoline with a high fat meal significantly decreased both Cmax (50%) and AUC (60%) without any effect on Tmax.
En dosis på 75 mg to gange dagligt kan derfor overvejes til denne population, men benefit-risk-forholdet skal vurderes jævnligt og ses i sammenhæng med sværhedsgraden af patientens symptomer (se pkt.
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).
Disse patienter kan have risiko for alvorlige komplikationer af tarmobstruktion.
These patients may be at risk for severe complications of bowel obstruction.
Hos rotter blev eluxadolin udskilt i mælk på en tilnærmelsesvis dosisproportionel måde med en maksimal koncentration, der var lavere end plasmakoncentrationen.
In rat, eluxadoline was excreted into milk in an approximately dose proportional manner with maximal concentrations less than plasma concentrations.
Behandling med eluxadolin medførte desuden signifikante forbedringer hos de patienter, hvis IBS-Dsymptomer ikke blev kontrolleret i tilstrækkelig grad af loperamid inden inklusion i studiet.
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.
Efter en enkelt oral dosis på 300 mg [14C] eluxadolin til raske mænd blev 82,2 % af det samlede [14C] eluxadolin påvist i fæces inden for 336 timer, og mindre end 1 % blev påvist i urin inden for 192 timer.
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.
Der deltog i alt 1.282 patienter i studie 1 (IBS-3001) og 1.146 patienter i studie 2 (IBS-3002), som fik Truberzi 75 mg, Truberzi 100 mg eller placebo to gange dagligt.
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.
Din læge vil muligvis ordinere en lavere dosis på én 75 mg tablet to gange dagligt, hvis du: - er 65 år eller derover - ikke kan tåle dosen på 100 mg
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;
Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med Truberzi i en eller flere undergrupper af den pædiatriske population med IBS-D (se pkt.
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).
Hvad angår det daglige kombinerede respons begyndte eluxadolin at adskille sig fra placebo kort tid efter behandlingsstart, og der blev observeret en maksimal virkning efter 4-6 uger, som blev opretholdt under hele behandlingsforløbet.
For the daily composite response, eluxadoline began to separate from placebo shortly after initiating treatment with a maximal effect seen at 4-6 weeks that was maintained throughout the course of treatment.
Farmakokinetiske data fra raske frivillige, der blev puljet på tværs af fase 1-studier (med anvendelse af en enkelt oral dosis på 100 mg) og analyseret for potentielle forskelle baseret på køn, alder, etnicitet og BMI, viste ingen signifikante forskelle.
Pharmacokinetic data for healthy volunteers pooled across Phase 1 studies (using the 100 mg single oral dose) and analyzed for potential differences based on sex, age, race, and BMI demonstrated no significant differences.
Forbedringer i globale symptomer på IBS blev vurderet på baggrund af et responsendepunkt for tilstrækkelig lindring, defineret som tilstrækkelig lindring af IBS-symptomer mindst 50 % af ugerne, og et responsendepunkt for globale symptomer, defineret som en daglig klassificering af globale symptomer som ingen eller lette mindst 50 % af dagene.
Improvements in global symptoms of IBS were assessed based on an adequate relief response endpoint defined as achieving adequate relief of IBS symptoms on at least 50% of weeks and on a global symptom response endpoint defined by a daily rating of global symptoms of none or mild on at least 50% of days.
Det skal du vide, før du begynder at tage Truberzi 3.
What you need to know before you take Truberzi 3.
Selvom der ikke er påvist direkte interaktioner med andre lægemidler, skal kronisk anvendelse af loperamid sammen med eluxadolin undgås, da det kan øge risikoen for obstipation.
Although no direct drug-drug interactions have been demonstrated, chronic use of loperamide with eluxadoline should be avoided as this may increase the risk of constipation.
Der foreligger ingen data vedrørende eluxadolins indvirkning på human fertilitet.
No human data on the effect of eluxadoline on fertility are available.
Det skal du vide, før du begynder at tage Truberzi Tag ikke Truberzi:
What you need to know before you take Truberzi Do not take Truberzi:
Da patientens genetiske disposition kan være ukendt, anbefales det, at patienterne kontrolleres for svækkelse af deres mentale eller fysiske evne til at udføre potentielt farlige aktiviteter, for eksempel bilkørsel eller betjening af maskiner (se pkt.
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).
Cmax og AUC for metabolitten 1-hydroxy-midazolam blev øget med henholdsvis ca. 14 % og 7 %, hvilket tyder på, at eluxadolin kan være en let CYP3A4-induktor og kan nedsætte eksponeringen for samdigt indgivne CYP3A4-substrater.
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.
Det skal besluttes, om amning eller behandling med Truberzi skal ophøre, idet der tages højde for fordelene ved amning for barnet i forhold til de terapeutiske fordele for moderen.
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.
Hvis patienterne udvikler svær obstipation, skal de informeres om at afbryde behandlingen med Truberzi og søge læge.
If patients develop severe constipation, they should be instructed to stop Truberzi and seek medical attention.
• Patienter uden galdeblære (fx på grund af kolecystektomi eller agenesi).
• Patients without a gallbladder (e.g. due to cholecystectomy or agenesis).
Truberzi er kontraindiceret hos patienter uden galdeblære og ved andre tilstande, der øger risikoen for udvikling af pancreatitis (se pkt.
Truberzi is contraindicated in patients without a gallbladder and other conditions that increase the risk of developing pancreatitis (see section 4.3).
I lyset af eluxadolins virkning på opioidreceptorer bør indgift af en my-opioid-antagonist, såsom naloxon, overvejes.
Given eluxadoline's action at opioid receptors, administration of a narcotic mu opioid antagonist, such as naloxone, should be considered.
In vitro studier viser, at eluxadolin hverken inducerer CYP1A2, CYP2B6, CYP2C9, CYP2C19 eller CYP3A4 og heller ikke hæmmer CYP1A2, CYP2A6, CYP2B6, CYP2C9, CYP2C19, CYP2C8 og CYP2D6 ved klinisk relevante koncentrationer.
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.
Patienterne havde en gennemsnitsalder på 45 år (1880 år, heraf 10 % ≥ 65 år), 66 % var kvinder, 86 % var hvide, 12 % var sorte, og 27 % var af latinamerikansk oprindelse.
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.
Ud af de 5 rapporterede tilfælde var 3 forbundet med et overforbrug af alkohol, 1 var forbundet med galdeslam, og i et tilfælde seponerede patienten eluxadolin 2 uger inden symptomernes indtræden.
Of the 5 cases reported, 3 were associated with excessive alcohol intake, 1 was associated with biliary sludge, and in one case the patient discontinued eluxadoline 2 weeks prior to the onset of symptoms.
Hvis naloxon administreres, skal patienten monitoreres nøje for at vurdere, om symptomerne på overdosering vender tilbage, hvilket kan tyde på, at en yderligere injektion af naloxon er nødvendig.
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.
Pakningsstørrelser og yderligere oplysninger Truberzi indeholder:
Contents of the pack and other information What Truberzi contains
I en farmakokinetisk populationsanalyse var eluxadolins estimerede tilsyneladende fordelingsvolumen 27.100 l. Hos raske forsøgspersoner var eluxadolin moderat (81 %) bundet til plasmaproteiner.
In a population pharmacokinetic analysis, the estimated apparent volume of distribution of eluxadoline was 27,100 L. In healthy subjects, eluxadoline was moderately (81%) bound to plasma proteins.
Eluxadolin påvirker i mindre grad evnen til at føre motorkøretøj og betjene maskiner.
Eluxadoline has a minor influence on the ability to drive and use machines.
Alle tilfælde af pancreatitis blev retrospektivt vurderet til at være lette, uanset om de var forbundet med spasmer i sphincter Oddi eller ej, hvilket tyder på, at der ikke var tale om organsvigt eller lokale eller systemiske komplikationer.
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.
CYP2E1 blev hæmmet let (50 % hæmmende koncentration [IC50] cirka 20 µM [11 µg/ml]), om end dette ikke forventes at resultere i klinisk relevante interaktioner.
inhibitory concentration [IC50] of approximately 20 µM [11 µg/mL]), although this is not expected to result in any clinically meaningful interactions.
Selvom eksponeringen for eluxadolin var signifikant forhøjet hos deltagere med ESRD, der endnu ikke var i dialyse, sammenlignet med tilsvarende, raske deltagere med normal nyrefunktion, er det ikke sandsynligt, at en sådan forhøjelse vil være af klinisk betydning, fordi den geometriske middelværdi af Cmax og AUC0-t hos deltagerne med ESRD lå i samme interval som den, der blev observeret i flere større studier med raske frivillige.
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.
Tabletterne skal tages sammen med mad morgen og aften (se pkt.
The tablets should be taken with food in the morning and in the evening (see section 5.2).
Truberzi virker på tarmens overflade ved at genoprette en normal tarmfunktion og lindre følelsen af smerter og ubehag hos patienter med IBS-D.
Truberzi acts on the surface of your gut to restore the normal function of your bowels and block the sensation of pain and discomfort in IBS-D patients.
Af 1.795 IBS-D-patienter, der deltog i kliniske studier med eluxadolin og blev allokeret til 75 mg eller 100 mg to gange dagligt, var 139 (7,7 %) ≥ 65 år, mens 15 (0,8 %) var ≥ 75 år.
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.
Kombineret respons
Composite Response
Hos dyr interagerer eluxadolin med opioidreceptorer i tarmene.
In animals, eluxadoline interacts with opioid receptors in the gut.
Hvis denne dosis tåles godt, men ikke giver en tilstrækkelig virkning, kan dosis efterfølgende øges til 200 mg dagligt (én 100 mg tablet to gange dagligt).
If this dosage is well tolerated, but not sufficiently effective, dosage may subsequently be increased to 200 mg daily (one 100 mg tablet twice daily).
Eluxadolins virkning blev undersøgt med anvendelse af en samlet respondentanalyse, defineret som en forbedring i daglig WAP-score på ≥ 30 % sammenlignet med det ugentlige gennemsnit ved baseline SAMTIDIG med en reduktion i BSS til < 5 mindst 50 % af dagene inden for et tidsinterval.
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.
Forekomsten af alvorlig obstipation var under 1 % hos patienter, der fik 75 mg og 100 mg eluxadolin, og der var ingen alvorlige komplikationer af obstipation forbundet med eluxadolin i de pivotale studier.
Rates of severe constipation were less than 1% in patients receiving 75 mg and 100 mg eluxadoline and there were no serious complications of constipation related to eluxadoline use in pivotal studies.
In vitro studier i humane levermikrosomer viste, at eluxadolin ikke er en direkte CYP3A4-hæmmer ved klinisk relevante koncentrationer [IC50=450 µM], men i humane tarmmikrosomer var eluxadolin en metabolisme-afhængig CYP3A4-hæmmer med en kinact på 0,1 min-1 og K-I på 450 µM (256 µg/ml).
In vitro studies in human liver microsomes showed that eluxadoline is not a direct inhibitor of CYP3A4 at clinically relevant concentrations [IC50 =450 µM] but in human intestinal microsomes, eluxadoline was a metabolism dependent inhibitor of CYP3A4 with kinact of 0.1 min-1 and K-I of 450 µM (256 µg/mL).
• Kronisk eller alvorlig obstipation eller sequelae efter obstipation i anamnesen eller kendt eller mistanke om mekanisk gastrointestinal obstruktion.
• A history of chronic or severe constipation or sequelae from constipation, or known or suspected mechanical gastrointestinal obstruction.
Der skal dog udvises forsigtighed hos patienter, som får høje doser af OATP1B1-substrater (se pkt.
However, caution should be exercised in patients receiving high doses of OATP1B1 substrates (see section 4.5).