natgillin/translations-raw huggingface dataset:
Baseret på den høje variabilitet imellem forsøgspersonerne, kan akkumulering i en undergruppe af patienter med karcinoid syndrom ikke udelukkes. 
Based on the high inter-subject variability observed, accumulation in a subset of patients with carcinoid syndrome cannot be excluded.
Hos patienter med moderat nedsat leverfunktion (Child-Pugh score B), kan det være nødvendigt at reducere dosis til 250 mg én gang dagligt afhængigt af tolerabilitet. 
In patients with moderate hepatic impairment (Child Pugh score B), it may be necessary to reduce the dose to 250 mg once daily according to tolerability.
En post-hoc-analyse viste, at det gennemsnitlige antal daglige korttidsvirkende SSA-injektioner anvendt som rescue-medicin over 12-ugers DBT-perioden var 0,3 og 0,7 i henholdsvis telotristatethyl 250 mg og placebogruppen. 
A post-hoc analysis showed that the average number of daily short-acting SSA injections used for rescue therapy over the 12-week DBT period was 0.3 and 0.7 in the telotristat ethyl 250 mg and placebo groups, respectively.
Figur 1: Gennemsnitlig ændring fra baseline i antal afføringer per studieuge i løbet af den dobbeltblindede behandlingsperiode, Intent-to-Treat population 
Figure 1 - Mean change from baseline in BMs by study week during the DBT period, Intent-toTreat Population
Studiet omfattede en 12-ugers dobbeltblind behandlingsperiode, hvor patienterne indledningsvis tog placebo (n = 45), telotristatethyl 250 mg (n = 45) eller en højere dosis (telotristatethyl 500 mg; n = 45) 
The study included a 12-week double-blind treatment (DBT) period, in which patients initially received placebo (n=45), telotristat ethyl 250 mg (n=45) or a higher dose (telotristat ethyl 500 mg; n=45) tid.
Den tilsyneladende halveringstid for telotristatethyl hos normale, raske frivillige forsøgspersoner var efter en enkelt 500 mg oral dosis 14C-telotristatethyl ca. 0,6 time, og for dets aktive metabolit var den 5 timer. 
The apparent half-life of telotristat ethyl in normal healthy volunteers following a single 500 mg oral dose 14C-telotristat ethyl was approximately 0.6 hour and that of its active metabolite was 5 hours.
Hos patienter med nedsat leverfunktion anbefales kontinuerlig overvågning for bivirkninger og forværring af leverfunktionen. 
In patients with hepatic impairment, continuous monitoring for adverse events and worsening of liver function is recommended.
Variabiliteten af de væsentligste plasma LP-778902 PK-parametre var højere hos forsøgspersoner med svært til moderat nedsat nyrefunktion med CV% i intervallet fra 53,3 % for Cmax til 77,3 % for AUC sammenlignet med henholdsvis 45,4 % for Cmax og 39,7 % for AUC hos forsøgspersoner, der var raske eller havde let nedsat nyrefunktion. 
Variability of the main plasma telotristat PK parameters was higher in subjects with severe to moderate renal impairment, with CV% ranging from 53.3% for Cmax to 77.3% for AUC as compared to 45.4% for Cmax and 39.7% for AUC in healthy to mildly impaired subjects, respectively.
• kvalme eller opkastning, unormalt mørk urin, gul hud eller gule øjne, smerte øverst til højre i maven. 
• feeling or being sick, abnormally dark urine, yellow skin or eyes, pain in the upper right belly.
Da den fulde effekt af telotristat blev observeret (i de sidste 6 uger af den dobbeltblinde behandlingsperiode) var andelen af respondenter med mindst 30 % reduktion i antal afføringer 51 % (23/45) i 250 mg gruppen versus 22 % (10/45) i placebogruppen (post-hoc analyse). 
When the full effect of telotristat is observed (during the last 6 weeks of the DBT period) the proportion of responders with at least 30% BM reduction was 51% (23/45) in the 250 mg group versus 22% (10/45) in the placebo group (post-hoc analysis).
Af andelen af patienter, som var "meget tilfredse", var 0/9 (0 %) på placebo, 5/9 (56 %) på telotristatethyl 250 mg 3 gange dagligt og 7/15 (47 %) på en højere dosis telotristatethyl. 
The proportions of patients who were “very satisfied” were 0/9 (0%) on placebo, 5/9 (56%) on telotristat ethyl 250 mg tid and 7/15 (47%) on a higher dose of telotristat ethyl.
Som forholdsregel anbefales det, at patienter med svært nedsat nyrefunktion monitoreres for tegn på nedsat tolerabilitet. 
As a precautionary measure, it is recommended that patients with severe renal impairment will be monitored for signs of reduced tolerability.
Dosering Den anbefalede dosis er 250 mg 3 gange dagligt (tid). 
Posology The recommended dose is 250 mg three times daily (tid).
Alle patienter havde vel-differentieret metastatisk neuroendokrin tumor med karcinoid syndrom. 
All patients had well-differentiated metastatic neuroendocrine tumour with carcinoid syndrome.
På grund af den høje variabilitet anbefales det som forholdsregel, at patienter med svært nedsat nyrefunktion monitoreres for tegn på nedsat tolerabilitet. 
Given the high variability observed, it is recommended as a precautionary measure that patients with severe renal impairment will be monitored for signs of reduced tolerability.
Patienten skal ikke tage en dobbeltdosis som erstatning for den glemte dosis. 
Patients should not take a double dose to make up for a missed dose.
Polyvinylalkohol - delvist hydrolyseret (E1203) Titandioxid (E171) 
Polyvinyl alcohol (partially hydrolysed) (E1203) Titanium dioxide (E171) Macrogol 3350 (E1521)
Både pro-druget (telotristatethyl) og dets aktive metabolit (telotristat) er inhibitorer af Ltryptophanhydroxylaser (TPH1 og TPH2, de hastighedsbestemmende trin i biosyntesen af serotonin). 
Both the prodrug (telotristat ethyl) and its active metabolite (telotristat) are inhibitors of L-tryptophan hydroxylases (TPH1 and TPH2, the rate limiting steps in serotonin biosynthesis).
I et 26 ugers gentagen dosis studie blev toksiciteten undersøgt hos rotter og NOAEL (No-Observed Adverse Effect level) for 50 mg/kg/dag bestemt. 
In a 26-week repeat-dose toxicity study in rats a No-Observed Adverse Effect Level (NOAEL) of 50 mg/kg/day was determined.
På baggrund af post marketing og kliniske data anbefales det at opdatere punkt 4.8 og inkludere kvalme som en bivirkning i punkt 4.8 under systemorganklassen Mave-tarm-kanalen med hyppigheden "meget almindelig". 
Based on post marketing and clinical data it is recommended to update section 4.8 to include nausea as an adverse drug reaction in Section 4.8 under the SOC Gastrointestinal disorders with a frequency “very common”.
Samtidig anvendelse af Xermelo kan nedsætte effekten af lægemidler, som er CYP2B6 substrater (fx valproinsyre, bupropion, sertralin) ved at nedsætte deres systemiske eksponering. 
Concomitant use of Xermelo may decrease the efficacy of medicinal products that are CYP2B6 substrates (e.g. valproic acid, bupropion, sertraline) by decreasing their systemic exposure.
Ændringer i gennemsnit over 12 uger: gennemsnit (SD) 
Number of patients Change averaged over 12 weeks: mean (SD)
Det gennemsnitlige antal daglige afføringer ved baseline var henholdsvis 2,2 og 2,5 i placebo (n = 25) og i 250 mg gruppen (n = 25). 
The mean number of daily BM at baseline was 2.2 and 2.5 respectively in the placebo (n=25) and 250 mg group (n=25).
Primært endepunkt: ændring fra baseline i afføringer/dag i gennemsnit over 12 uger 
Primary endpoint: change from baseline in BMs/day averaged over 12 weeks
Cytokromer 
Cytochromes
Samtidig anvendelse af telotristatetiprat (Xermelo, hippuratsaltet af telotristatethyl) og syrereducerende lægemidler (omeprazol og famotidin) viste, at AUC for telotristatethyl blev øget 2-3 gange, mens AUC for den aktive metabolit (telotristat) forblev uændret. 
Concomitant use of telotristat etiprate (Xermelo, the hippurate salt of telotristat ethyl) with acidreducers (omeprazole and famotidine) showed that the AUC of telotristat ethyl was increased 2-3 fold, while the AUC of the active metabolite (telotristat) was not changed.
Samtidig anvendelse af Xermelo kan nedsætte effekten af lægemidler, der er CYP3A4 substrater (fx midazolam, everolimus, sunitinib, simvastatin, ethinyløstradiol, amlodipin, cyclosporin ...) ved at nedsætte deres systemiske eksponering (se pkt. 
Concomitant use of Xermelo may decrease the efficacy of medicinal products that are CYP3A4 substrates (e.g. midazolam, everolimus, sunitinib, simvastatin, ethinyloestradiol, amlodipine, cyclosporine…) by decreasing their systemic exposure (see section 5.2).
Et studie, der undersøgte effekten af korttidsvirkende octreotid (3 doser af 300 mikrogram indgivet med 8 timers interval) på enkelt-dosis farmakokinetik for Xermelo hos raske forsøgspersoner, viste en henholdsvis 83 % og 81 % nedsættelse af Cmax og AUC for telotristatethyl og telotristat (se pkt. 
A study examining the effect of short-acting octreotide (3 doses of 200◦micrograms given 8◦hours apart) on the single dose pharmacokinetics of Xermelo in normal healthy volunteers showed an 83% and 81% decrease in Cmax and AUC of telotristat ethyl and telotristat, respectively (see section 4.5).
I et specifikt klinisk lægemiddel interaktionsstudie, blev Cmax og AUC for fexofenadin (et P-gp og MRP2-substrat) øget med 16 % når en enkelt 180 mg fexofenadin dosis blev co-administreret oralt sammen med en 500 mg telotristatethyl dosis administreret 3 gange dagligt (dobbelt af anbefalet dosis) i 5 dage. 
In a specific clinical DDI study, the Cmax and AUC of fexofenadine (a P-gp and MRP-2 substrate) increased by 16% when a single 180 mg dose of fexofenadine was co-administered orally with a dose of telotristat ethyl 500 mg administered tid (twice the recommended dose) for 5 days.
I den 12-ugers dobbeltblinde behandlingsperiode af studiet blev gennemsnitlige ugentlige reduktioner i afføringsfrekvensen for patienter på telotristat observeret så tidligt som efter 3 uger, med de største reduktioner i de sidste 6 uger af den dobbeltblinde behandlingsperiode sammenlignet med placebo (se figur 1). 
In the 12-week DBT period of the study, average weekly reductions in BM frequency on telotristat were observed as early as 3 weeks, with the greatest reductions occurring during the last 6 weeks of the DBT period, compared with placebo (refer to Figure 1).
CYP2B6 substrater 
CYP2B6 substrates
• lægemidler, der sænker kolesteroltallet, såsom simvastatin. 
• medicines used to lower cholesterol levels, such as simvastatin.
Hvis du har glemt at tage Xermelo 
If you forget to take Xermelo
Endelig anbefales det at tilføje depression og nedtrykt sindstilstand til produktresuméets punkt 4.8 og indlægssedlens punkt 4 under Psykiske forstyrrelser med hyppigheden "almindelig". 
Finally, it is recommended to add depression and depressed mood to section 4.8 of the SmPC and section 4 of PL under Psychiatric disorders with frequency “common”.
Depression, nedtrykt sindstilstand 
Depression, depressed mood
Inden for hver enkelt frekvensgruppe er bivirkningerne opstillet efter, hvor alvorlige, de er. 
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness
Antal patienter Baseline gennemsnita (SD) 
Number of patients Baseline mean (SD)
Hvis du holder op med at tage Xermelo 
If you stop taking Xermelo
Pakningsstørrelser og yderligere oplysninger Xermelo indeholder: 
Contents of the pack and other information What Xermelo contains
Hos rotter blev der observeret et fald i serotonin (5-HT) i hjernen ved doser ≥ 1.000 mg/kg/dag af telotristat etiprat peroralt. 
In rats decrease in brain serotonin (5-HT) was observed at doses≥1,000 mg/kg/day of telotristat etiprate per os.
Hvide til råhvide filmovertrukne ovale tabletter (cirka 17 mm lange og 7,5 mm brede) præget med ”TE” på den ene side og ”250” på den anden side. 
White to off-white film-coated oval tablets (approximately 17 mm long by 7.5 mm wide) with ‘T-E' debossed on one side and ‘250' debossed on the other side.
Telotristatethyl inhiberer CYP3A4 in vitro, hvilket tyder på en potentiel interaktion med CYP3A4 substrat. 
In vitro, telotristat ethyl inhibited CYP3A4, suggesting a potential interaction with CYP3A4 substrates.
Loperamid (CES2-inhibitor) havde en moderat effekt på metabolismen af telotristatethyl in vitro, og reducerede dannelsen af telotristatethyl med < 30 % (se pkt. 
In vitro loperamide (CES2 inhibitor) had a moderate effect on the metabolism of telotristat ethyl, reducing the formation of telotristat by <30% (see section 4.5).
Bør ikke anvendes til patienter med arvelig galactoseintolerans, en særlig form for hereditær lactasemangel (Lapp Lactase deficiency) eller glucose/galactosemalabsorption. 
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
• medicin mod diarré - Xermelo og disse lægemidler nedsætter tarmbevægelserne (antal afføringer), og sammen kan de forårsage alvorlig forstoppelse. 
Xermelo and these medicines reduce the number of your bowel movements and taken together, they can cause severe constipation.
Kvinder i den fertile alder Kvinder i den fertile alder skal anvende sikker antikonception under behandling med telotristat. 
Women of childbearing potential should be advised to use adequate contraception during treatment with telotristat.
Xermelo påvirker i mindre grad evnen til at føre motorkøretøj og betjene maskiner. 
Telotristat has minor influence on the ability to drive and use machines.
I et in vivo klinisk interaktionsstudie med midazolam (et følsomt CYP3A4 substrat), var den systemiske eksponering for samtidig administreret midazolam, efter administration af multiple telotristatethyl doser, signifikant reduceret (se pkt. 
In an in vivo clinical drug-drug interaction (DDI) study with midazolam (a sensitive CYP3A4 substrate), following administration of multiple doses of telotristat ethyl, the systemic exposure to concomitant midazolam was significantly decreased (see section 4.5).
Ændringen fra baseline i daglige antal afføringer i gennemsnit over 12 uger var henholdsvis +0,1 og -0,5 i placebo- og 250 mg-grupperne. 
The change from baseline in daily BM averaged over 12 weeks was +0.1 and -0.5 in the placebo and 250 mg groups respectively.
I fase 1 studier viste dosering med telotristatethyl hos raske forsøgspersoner (dosisinterval: 100 mg én gang dagligt til 500 mg 3 gange dagligt) statistisk signifikante reduktioner fra baseline for serotonin i fuldblod og 5-hydroxyindoleddikesyre (u5-HIAA) i urin over 24 timer sammenlignet med placebo. 
In Phase 1 studies, dosing with telotristat ethyl in healthy subjects (dose range: 100 mg once daily to 500 mg tid) produced statistically significant reductions from baseline in whole blood serotonin and 24-hour urinary 5-hydroxyindoleacetic acid (u5-HIAA) compared with placebo.
Det skal du vide, før du begynder at tage Xermelo Tag ikke Xermelo: 
What you need to know before you take Xermelo Do not take Xermelo:
Baseret på in vitro-data forventes der ikke interaktion med andre P450 cytokromer. 
Other CYPs Based on in vitro findings, no clinically-relevant interaction is expected with other cytochromes P450.
For klinisk håndtering af forhøjede leverenzymer, se pkt. 
For clinical management of elevated hepatic enzymes, see section 4.4.
Loperamid forårsagede en mindre end 30 % (<30 %) nedgang i dannelsen af telotristat (aktiv metabolit) in vitro (se pkt. 
Loperamide caused a <30% decrease in the formation of telotristat (active metabolite) in vitro (see section 5.2).
Træthed kan forekomme efter indtagelse af telotristat (se pkt. 
Fatigue may occur following administration of telotristat (see section 4.8).
Når 3 mg midazolam blev co-administreret oralt efter 5-dages behandling med telotristatethyl 500 mg 3 gange dagligt (dobbelt af anbefalet dosis), var den gennemsnitlige Cmax og AUC0-inf for midazolam nedsat med henholdsvis 25 % og 48 %, sammenlignet med midazolam administreret alene. 
When 3 mg midazolam was coadministered orally after 5-day treatment with telotristat ethyl 500 mg tid (twice the recommended dose), the mean Cmax, and AUC0-inf for midazolam were decreased by 25%, and 48%, respectively, compared with administration of midazolam alone.
Efter administration af en enkelt 500 mg dosis af telotristatethyl (dobbelt af anbefalet dosis) til raske fastende forsøgsdeltagere var den gennemsnitlige Cmax og AUC0-inf henholdsvis 4,4 ng/ml og 6,23 ng∙t/ml for telotristatethyl. 
Following administration of a single 500 mg dose of telotristat ethyl (twice the recommended dosage) under fasted conditions in healthy subjects, the mean Cmax and AUC0-inf were 4.4 ng/mL and 6.23 ng•hr/mL, respectively for telotristat ethyl.
Hos hunde blev der observeret et fald i 5-HT og 5-HIAA-niveauerne i hjernen ved doser af telotristat etiprat peroralt på henholdsvis 200 mg/kg/dag og 30 mg/kg/dag. 
In dogs decreases in brain 5-HT and 5-HIAA levels were observed at dose of 200 mg/kg/day and 30 mg/kg/day of telotristat etiprate per os, respectively.
Samlet forlod 18 patienter (13,2 %) studiet præmaturt i den dobbeltblindede forsøgsperiode, 7 patienter fra placebogruppen, 3 fra gruppen som fik telotristatethyl 250 mg og 8 fra gruppen, som fik den højere dosis. 
Overall, 18 patients (13.2%) prematurely discontinued from the study during the DBT Period, 7 patients in the placebo group, 3 in the telotristat ethyl 250 mg group and 8 in the higher dose group.
Derfor er det ikke nødvendigt at ændre dosis hos patienter med let, moderat eller svært nedsat nyrefunktion, der ikke er dialysekrævende. 
Therefore, dose adjustment does not appear necessary in patients with mild, moderate or severe renal impairment; who are not requiring dialysis.
Du kan opleve forstoppelse, vandig diarré, bleg hud (anæmi), kvalme, opkastning, vægttab, rygsmerter eller mavesmerter, især efter at have spist, eller problemer med at lade vandet (vandladning). 
• Impacted stools (bowel obstruction, faecaloma), you may experience, constipation, watery diarrhoea, pale skin (anaemia), nausea, vomiting, weight loss, back pain or stomach pains particularly after eating or a reduction in passing water (urination).
(≥1/10); almindelig (≥1/100 til <1/10); ikke almindelig (≥1/1.000 til <1/100); sjælden (≥1/10.000 til 
Adverse reactions are listed by MedDRA body system organ class and by frequency using the following 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).
Samtidig anvendelse af korttidsvirkende octreotid og Xermelo nedsatte den systemiske eksponering for telotristatethyl og telotristat, den aktive metabolit (se pkt. 
Concomitant administration of short-acting octreotide with Xermelo significantly decreased the systemic exposure of telotristat ethyl and telotristat, the active metabolite (see section 5.2).
Hos patienter behandlet med 500 mg 3 gange dagligt (dobbelt af anbefalet dosis), blev der fundet en median akkumulationsratio på 1,095 baseret på AUC0-4h (minimum, 0,274; maksimum, 11,46; n=16; uge 24), her var variabiliteten imellem forsøgspersonerne højere (% CV = 141,8 %). 
In patients treated at 500 mg tid (twice the recommended dose), a median accumulation ratio based on AUC0-4h of 1.095 (minimum, 0.274; maximum, 11.46; n=16; week 24) was observed, with a high inter-subject variability (%CV = 141.8%).
Der kræves ingen dosisjustering for patienter med let, moderat eller svært nedsat nyrefunktion, der ikke kræver dialyse (se pkt. 
No change in dosage is required in patients with mild, moderate or severe renal impairment; who are not requiring dialysis (see section 5.2).
Der var 40 % patienter (10/25) med varig forbedring (som vist i Tabel 2) i gruppen med telotristatethyl 250 mg, mod 0 % i placebogruppen (0/26) (p = 0,001). 
There were 40% patients (10/25) with durable response (as defined in Table2) in the telotristat ethyl 250 mg group, versus 0% in the placebo group (0/26) (p=0.001).
Xermelo indeholder det aktive stof telotristatethyl. 
This medicine contains the active substance telotristat ethyl.
Der er observeret forhøjede leverenzymer i kliniske studier (se pkt. 
Elevations in hepatic enzymes were observed in clinical studies (see section 4.8).
Xermelo indeholder lactose 
Xermelo contains lactose
Den hyppigst rapporterede bivirkning hos patienter, der fik telotristatethyl 250 mg 3 gange dagligt, var mavesmerter (25,7 %; 18/70) mod placebo (19,7 %; 14/71). 
The most frequently reported adverse event in patients receiving telotristat ethyl 250 mg tid was abdominal pain (25.7%; 18/70) versus placebo (19.7%; 14/71).
Effekten og sikkerheden af telotristat til behandling af karcinoid syndrom hos patienter med metastatiske neuroendokrine tumorer, der modtog SSA-behandling, blev fastslået i et 12-ugers dobbeltblind, placebokontrolleret, randomiseret, multicenter fase-3 studie hos voksne patienter. 
The efficacy and safety of telotristat for the treatment of carcinoid syndrome in patients with metastatic neuroendocrine tumours who were receiving SSA therapy was established in a 12-week double-blind, placebo-controlled, randomised, multicentre phase 3 trial in adult patients, which included a 36-week extension during which all patients were treated with open-label telotristat (TELESTAR Study).
Xermelo 250 mg filmovertrukne tabletter telotristatethyl 
Xermelo 250 mg film-coated tablets telotristat ethyl
Xermelo skal indtages sammen med mad (se pkt. 
Xermelo should be taken with food (see sections 5.1 and 5.2).
Hos forsøgspersoner med svært til moderat nedsat nyrefunktion blev der observeret en stigning (1,3 gange) i maksimal eksponering Cmax af telotristatethyl og en stigning (<1,52 gange) i plasmaeksponering (AUC) og Cmax af den aktive metabolit telotristat sammenlignet med forsøgspersoner, der var raske eller havde let nedsat nyrefunktion. 
In the subjects with severe to moderate renal impairment, an increase (1.3- fold) in peak exposure Cmax of telotristat ethyl and an increase (<1.52- fold) in plasma exposure (AUC) and Cmax of its active metabolite telotristat was observed compared to healthy to mildly impaired subjects.
Xermelo 250 mg filmovertrukne tabletter 
Xermelo 250 mg film-coated tablets
• medicin til behandling af epilepsi, såsom valproat. 
• medicines used to treat epilepsy, such as valproic acid.
Det anbefales også, at indehaveren af markedsføringstilladelsen tilføjer bivirkningen "intestinal obstruktion" i produktresuméets punkt 4.8 og indlægssedlens punkt 4 med hyppigheden "ikke almindelig". 
It is also recommended that the MAH should add the ADR “intestinal obstruction” to the section 4.8 of the SmPC and section 4 of PL with the frequency “uncommon”.
I den samlede sikkerhedspopulation (239 patienter) blev alvorlig forstoppelse observeret hos 3 patienter behandlet med en højere dosis (500 mg). 
Serious constipation was observed in 3 patients treated with a higher dose (500 mg) in the overall safety population (239 patients).
Fortæl det straks til lægen, hvis du bemærker en af følgende bivirkninger: 
Tell your doctor immediately if you notice any of the following side effects:
NOAEL for parental/maternel/prænatal og postnatal toksicitet er 500 mg/kg/dag hos rotter, svarende til 3 til 4 gange den estimerede humane eksponering (AUC0-24) for den aktive metabolit LP-778902 ved MRHD. 
The NOAEL for parental / maternal / prenatal and postnatal toxicity is 500 mg/kg/day in rats corresponding to 3 to 4 times the estimated human exposure (AUC0-24) of the active metabolite LP-778902 at the MRHD.
• Træthed eller svaghed 
• Feeling tired or weak (fatigue)
Hos kaniner er NOAEL for maternel og prænatal toksicitet 125 mg/kg/dag, svarende til 1,5 til 4 gange den estimerede humane eksponering (AUC0-24) for den aktive metabolit LP-778902 ved MRHD. 
In rabbits the NOAEL for maternal and prenatal toxicity is 125 mg/kg/d corresponding to 1.5 to 4 times the estimated human exposure (AUC0-24) of the active metabolite LP-778902 at the MRHD.
Fortæl lægen eller apotekspersonalet, hvis du oplever nogen af bivirkningerne anført herover. 
Tell your doctor, pharmacist or nurse if you notice any of the side effects listed above.
PVC/PCTFE/PVC/Aluminium blister. 
PVC/PCTFE/PVC/Al blister The blisters are packaged in a carton.
Fortæl det straks til lægen, hvis du oplever en af følgende bivirkninger: 
Tell your doctor immediately if you experience any of the following side effects: