natgillin/translations-raw huggingface dataset:
I kliniske studier var forekomsten af hypoglykæmi almindelig blandt de patienter, der modtog vildagliptin 100 mg daglig kombineret med metformin (1%) og ikke almindelig blandt de patienter, som modtog placebo + metformin (0, 4%).
In clinical trials, the incidence of hypoglycaemia was common in patients receiving vildagliptin 100 mg daily in combination with metformin (1%) and uncommon in patients receiving placebo + metformin (0.4%).
I kliniske studier ændrede vægten sig ikke fra baseline, når 100 mg vildagliptin blev givet daglig sammen med metformin (+0, 2 kg og - 1, 0 kg for henholdsvis vildagliptin og placebo).
In clinical trials, weight did not change from baseline when vildagliptin 100 mg daily was added to metformin (+0.2 kg and -1.0 kg for vildagliptin and placebo, respectively).
Tabel 1
5 Table 1
Bivirkninger rapporteret hos patienter, der modtog Galvus 100 mg daglig i kombination med metformin i dobbeltblindede studier (N=208)
Adverse reactions reported in patients who received Galvus 100 mg daily in combination with metformin in double-blind studies (N=208)
Kombination med et sulfonylurea I kontrollerede studier af kombinationen af vildagliptin 50 mg daglig + et sulfonylurea, var den samlede udtræden af studierne på grund af bivirkninger 0, 6% for gruppen, der fik vildagliptin 50 mg + et sulfonylurea, mod 0% for gruppen, der fik placebo + et sulfonylurea.
Combination with a sulphonylurea In controlled clinical trials with the combination of vildagliptin 50 mg + a sulphonylurea, the overall incidence of withdrawals due to adverse reactions was 0.6% in the vildagliptin 50 mg + sulphonylurea vs 0% in the placebo + sulphonylurea treatment group.
I kliniske studier var forekomsten af hypoglykæmi 1, 2%, når 50 mg vildagliptin én gang daglig blev kombineret med glimepirid mod 0, 6% for placebo + glimepirid.
In clinical trials, the incidence of hypoglycaemia when vildagliptin 50 mg once daily was added to glimepiride was 1.2% versus 0.6% for placebo + glimepiride.
I kliniske studier ændrede vægten sig ikke fra baseline, når vildagliptin 50 mg daglig blev givet sammen med glimepirid (- 0, 1 kg og - 0, 4 kg for henholdsvis vildagliptin og placebo).
In clinical trials, weight did not change from baseline when vildagliptin 50 mg daily was added to glimepiride (-0.1 kg and -0.4 kg for vildagliptin and placebo, respectively).
Bivirkninger rapporteret hos patienter, der modtog Galvus 50 mg daglig i kombination med et sulfonylurea i dobbeltblindede studier (N=170)
Adverse reactions reported in patients who received Galvus 50 mg in combination with a sulphonylurea in double-blind studies (N=170)
Infektioner Meget
Very rare
og parasitære sygdomme sjælden Snue
Nasopharyngitis
Kombination med et glitazon I kontrollerede studier af kombinationen af vildagliptin 100 mg daglig + et glitazon, blev der ikke rapporteret nogen udtræden af studierne på grund af bivirkninger, hverken i gruppen, der fik vildagliptin 100 mg daglig + met glitazon, eller i gruppen, der fik placebo + et glitazon.
Combination with a thiazolidinedione In controlled clinical trials with the combination of vildagliptin 100 mg daily+ a thiazolidinedione, no withdrawal due to adverse reactions was reported in either the vildagliptin 100 mg daily + thiazolidinedione or the placebo + thiazolidinedione treatment groups.
I kliniske studier var forekomsten af hypoglykæmi ikke almindelig blandet de patienter, der modtog vildagliptin + pioglitazon (0, 6%), men almindelig blandt de patienter, som modtog placebo + pioglitazon (1, 9%).
In clinical trials, the incidence of hypoglycaemia was uncommon in patients receiving vildagliptin + pioglitazone (0.6%) but common in patients receiving placebo + pioglitazone (1.9%).
I pioglitazon- tillægsstudiet var den absolutte vægtstigning 1, 4 for placebo og 2, 7 kg for Galvus 100 mg daglig.
In the pioglitazone add-on study, the absolute weight increases with placebo, Galvus 100 mg daily were 1.4 and 2.7 kg, respectively.
Forekomsten af perifert ødem, når vildagliptin 100 mg daglig blev anvendt i tillæg til maksimal dosis af baggrunds- pioglitazon (45 mg én gang daglig), var 7, 0%, sammenlignet med 2, 5% for baggrunds - pioglitazon alene.
The incidence of peripheral oedema when vildagliptin 100 mg daily was added to a maximum dose of background pioglitazone (45 mg once daily) was 7.0%, compared to 2.5% for background pioglitazone alone.
Tabel 3
6 Table 3
Bivirkninger rapporteret hos patienter, der modtog Galvus 100 mg daglig i kombination med et glitazon i dobbeltblindede studier (N=158)
Adverse reactions reported in patients who received Galvus 100 mg daily in combination with a thiazolidinedione in double-blind studies (N=158)
6 Metabolisme og ernæring
Metabolism and nutrition disorders
Vægtøgning Hypoglykæmi
Weight increase Hypoglycaemia
I kontrollerede monoterapistudier med vildagliptin var den samlede hyppighed af udtræden på grund af bivirkninger ikke større for de patienter, der modtog behandling med vildagliptin- doser på 100 mg daglig (0, 3%) end for de patienter, der fik placebo (0, 6%) eller sammenligningsstoffer (0, 5%).
In addition, in controlled monotherapy trials with vildagliptin the overall incidence of withdrawals due to adverse reactions was no greater for patients treated with vildagliptin at doses of 100 mg daily (0.3%) than for placebo (0.6%) or comparators (0.5%).
Der blev ikke rapporteret nogen alvorlige eller svære bivirkninger.
In comparative controlled monotherapy studies, hypoglycaemia was uncommon, reported in 0.4% (7 of 1,855) of patients treated with vildagliptin 100 mg daily compared to 0.2% (2 of 1,082) of patients in the groups treated with an active comparator or placebo, with no serious or severe events reported.
I kliniske studier ændrede vægten sig ikke fra baseline, når vildagliptin 100 mg daglig blev givet som monoterapi (- 0, 3 kg og - 1, 3 kg for henholdsvis vildagliptin og placebo).
In clinical trials, weight did not change from baseline when vildagliptin 100 mg daily was administered as monotherapy (-0.3 kg and -1.3 kg for vildagliptin and placebo, respectively).
Bivirkninger rapporteret hos patienter, der modtog Galvus 100 mg daglig som monoterapi i dobbeltblindede studier (N=1. 855)
Adverse reactions reported in patients who received Galvus 100 mg daily as monotherapy in double-blind studies (N=1,855)
Infektion i de øvre luftveje Nasopharyngitis
Upper respiratory tract infection Nasopharyngitis
Ved 600 mg oplevede en forsøgsperson ødem i hænder og fødder og en stigning i kreatininfosfokinase (CPK), aspartataminotransferase (ASAT), C- reaktivt protein (CRP) og myoglobin.
At 600 mg, one subject experienced oedema of the feet and hands, and increases in creatine phosphokinase (CPK), aspartate aminotransferase (AST), C-reactive protein (CRP) and myoglobin levels.
Behandling I tilfælde af en overdosering anbefales understøttende behandling.
7 Management In the event of an overdose, supportive management is recommended.
Dipeptidylpeptidase 4 (DPP- 4) - hæmmere, ATC- kode:
Dipeptidyl peptidase 4 (DPP-4) inhibitors, ATC code:
Vildagliptin tilhører klassen af ø- celle- forstærkere og er en potent og selektiv DPP- 4- hæmmer.
Vildagliptin, a member of the islet enhancer class, is a potent and selective DPP-4 inhibitor.
Administration af vildagliptin resulterer i hurtig og fuldstændig hæmning af DPP- 4- aktiviteten, hvilket resulterer i øgede fastende og postprandiale endogene niveauer af inkretinhormonerne GLP- 1 (glukagonlignende peptid 1) og GIP (glukoseafhængigt insulinotropt polypeptid).
The administration of vildagliptin results in a rapid and complete inhibition of DPP-4 activity, resulting in increased fasting and postprandial endogenous levels of the incretin hormones GLP-1 (glucagon-like peptide 1) and GIP (glucose-dependent insulinotropic polypeptide).
Behandling med vildagliptin 50- 100 mg daglig hos patienter med type 2- diabetes forbedrede markørerne for betacellefunktionen signifikant, herunder HOMA- β (Homeostasis Model Assessment- β), forholdet mellem proinsulin og insulin og målinger af betacellereaktionsevnen fra den hyppigst anvendte måltidstolerancetest.
Treatment with vildagliptin 50-100 mg daily in patients with type 2 diabetes significantly improved markers of beta cell function including HOMA-β (Homeostasis Model Assessment–β), proinsulin to insulin ratio and measures of beta cell responsiveness from the frequently-sampled meal tolerance test.
Hos ikke- diabetiske personer (normal glykæmi) stimulerer vildagliptin ikke insulinsekretionen eller sænker glukoseniveauet.
In non-diabetic (normal glycaemic) individuals, vildagliptin does not stimulate insulin secretion or reduce glucose levels.
Vildagliptin forbedrer også alfacellernes følsomhed over for glukose ved at øge de endogene GLP- 1 - niveauer, og det resulterer i mere glukosepassende glukagonsekretion.
By increasing endogenous GLP-1 levels, vildagliptin also enhances the sensitivity of alpha cells to glucose, resulting in more glucose-appropriate glucagon secretion.
Den større øgning af insulin/ glukagon- ratioen under hyperglykæmi på grund af forhøjede inkretinhormonniveauer bevirker, at der sker et fald i fastende og postprandial glukoseproduktion i leveren, hvilket fører til mindsket glykæmi.
The enhanced increase in the insulin/ glucagon ratio during hyperglycaemia due to increased incretin hormone levels results in a decrease in fasting and postprandial hepatic glucose production, leading to reduced glycaemia.
Dette blev ikke observeret med vildagliptinbehandling.
The known effect of increased GLP-1 levels delaying gastric emptying is not observed with vildagliptin treatment.
I alt 5. 759 patienter med type 2- diabetes deltog i 13 dobbeltblindede, placebo - eller aktivkontrollerede kliniske forsøg af mindst 12 ugers varighed.
A total of 5,759 patients with type 2 diabetes participated in 13 double-blind placebo- or active- controlled clinical trials of at least 12-weeks’ treatment duration.
I disse forsøg blev vildagliptin givet til 3. 784 patienter med en daglig dosis på 50 mg én gang daglig (N=1. 102), 50 mg to gange daglig (N=2. 027) eller 100 mg én gang daglig (N=655).
In these studies, vildagliptin was administered to 3,784 patients at daily doses of 50 mg once daily (N=1,102), 50 mg twice daily (N=2,027) or 100 mg once daily (N=655).
Henholdsvis 2. 069 og 1. 715 mandlige og kvindelige patienter modtog vildagliptin 50 mg en gang daglig eller 100 mg daglig.
The number of male and female patients receiving vildagliptin 50 mg once daily or 100 mg daily was 2,069 and 1,715, respectively.
664 af de patienter, som modtog vildagliptin 50 mg én gang daglig eller 100 mg daglig, var ≥ 65 år, og 121 af patienterne var ≥ 75 år.
The number of patients receiving vildagliptin 50 mg once daily or 100 mg daily who were ≥ 65 years of age was 664 and 121 of the patients were ≥ 75 years of age.
I disse forsøg blev vildagliptin givet som monoterapi til medicin- naive patienter med type 2- diabetes eller som kombinationsbehandling til patienter, som var utilstrækkeligt kontrolleret med andre antidiabetiske lægemidler.
In these trials, vildagliptin was administered as monotherapy in drug-naïve patients with type 2 diabetes or in combination in patients not adequately controlled by other antidiabetic medicinal products.
Generelt forbedrede vildagliptin den glykæmiske kontrol, når det blev givet som monoterapi eller kombineret med metformin, et sulfonylurea, eller et glitazon, målt ved klinisk relevante reduktioner af HbA1c fra baseline ved studiets endpoint (se tabel 5).
Overall, vildagliptin improved glycaemic control when given as monotherapy or when used in combination with metformin, a sulphonylurea, and a thiazolidinedione, as measured by clinically relevant reductions in HbA1c from baseline at study endpoint (see Table 5).
I kliniske studier var størrelsen af HbA1c- reduktionerne med vildagliptin større hos patienter med højere baseline HbA1c.
In clinical trials, the magnitude of HbA1c reductions with vildagliptin was greater in patients with higher baseline HbA1c.
I et 52- ugers dobbeltblindet kontrolleret forsøg reducerede vildagliptin (50 mg to gange daglig) baseline- HbA1c med - 1% sammenlignet med - 1, 6% for metformin (titreret til 2 g/ dag) blev statistisk non- inferioritet ikke opnået.
In a 52-week double-blind controlled trial, vildagliptin (50 mg twice daily) reduced baseline HbA1c by -1% compared to -1.6% for metformin (titrated to 2 g/ day) statistical non-inferiority was not achieved.
De patienter, der blev behandlet med vildagliptin, rapporterede signifikant lavere incidens af gastrointestinale bivirkninger i forhold til de patienter, der blev behandlet med metformin.
8 Patients treated with vildagliptin reported significantly lower incidences of gastrointestinal adverse reactions versus those treated with metformin.
I et 24- ugers dobbeltblindet kontrolleret forsøg blev vildagliptin (50 mg to gange daglig) sammenlignet med rosiglitazon (8 mg én gang daglig).
In a 24-week double-blind controlled trial, vildagliptin (50 mg twice daily) was compared to rosiglitazone (8 mg once daily).
Middelreduktionerne var - 1, 20% med vildagliptin og - 1, 48% med rosiglitazon hos patienter med en gennemsnitlig baseline- HbA1c på 8, 7%.
Mean reductions were -1.20% with vildagliptin and -1.48% with rosiglitazone in patients with mean baseline HbA1c of 8.7%.
8 Patienter, der modtog rosiglitazon, oplevede en gennemsnitlig vægtstigning (+1, 6 kg), mens de, der modtog vildagliptin, ikke oplevede nogen vægtstigning (- 0, 3 kg).
Patients receiving rosiglitazone experienced a mean increase in weight (+1.6 kg) while those receiving vildagliptin experienced no weight gain (-0.3 kg).
Forekomsten af perifert ødem var lavere i vildagliptin- gruppen end i rosiglitazon- gruppen (henholdsvis 2, 1% mod 4, 1%).
4.1% respectively).
Nøgleresultater for vildagliptins virkning i placebokontrollerede monoterapiforsøg og forsøg med tillægskombinationsbehandling (primær ITT- population)
Key efficacy results of vildagliptin in placebo-controlled monotherapy trials and in add-on combination therapy trials (primary efficacy ITT population)
Placebokontrollerede
Monotherapy placebo
Gennemsnitlig Gennemsnitlig
Mean change
Placebokorrigeret
Placebo-
monoterapistudier
controlled studies
baseline
baseline
ændring fra baseline i
from baseline in
gennemsnitlig ændring
corrected mean
HbA1c
HbA1c (%)
i HbA1c (%) ved uge 24 (95% CI)
change in HbA1c (%) at week 24 (95%CI)
Studie 2301:
Study 2301:
Vildagliptin 50 mg to gange daglig (N=90)
Vildagliptin 50 mg twice daily (N=90)
Vildagliptin 50 mg to gange daglig (N=79)
Vildagliptin 50 mg twice daily (N=79)
* p < 0, 05 for sammenligning mod placebo Tillægs - / kombinationsstudier Vildagliptin 50 mg to gange daglig + metformin (N=143)
* p < 0.05 for comparison versus placebo Add-on / Combination studies Vildagliptin 50 mg twice daily + metformin (N=143)
* p < 0, 05 for sammenligning mod placebo + sammenligningsstof
* p < 0.05 for comparison versus placebo + comparator
Absorption Efter oral administration fastende absorberes vildagliptin hurtigt med maksimal plasmakoncentration ved 1, 7 timer.
Absorption Following oral administration in the fasting state, vildagliptin is rapidly absorbed, with peak plasma concentrations observed at 1.7 hours.
Administration af vildagliptin sammen med mad resulterede i et fald i Cmax (19%).
Administration of vildagliptin with food resulted in a decreased Cmax (19%).
Fordeling Vildagliptins plasmaproteinbinding er lav (9, 3%), og vildagliptin fordeles ligeligt mellem plasma og erytrocytter.
Distribution The plasma protein binding of vildagliptin is low (9.3%) and vildagliptin distributes equally between plasma and red blood cells.
Biotransformation Metabolisering er den vigtigste eliminationsvej for vildagliptin hos mennesker, idet den udgør 69% af dosis.
Biotransformation Metabolism is the major elimination pathway for vildagliptin in humans, accounting for 69% of the dose.
In vitro data i humane nyre- mikrosomer indikerer, at nyren kan være et af de hovedorganer, der medvirker til hydrolysen af vildagliptin til dets inaktive hovedmetabolit, LAY151.
In vitro data in human kidney microsomes suggest that the kidney may be one of the major organs contributing to the hydrolysis of vildagliptin to its major inactive metabolite, LAY151.
Vildagliptin metaboliseres ikke af CYP 450- enzymer i målbart omfang.
Vildagliptin is not metabolised by CYP 450 enzymes to any quantifiable extent.
Derfor forventes vildagliptin ikke at blive påvirket af samtidig administration af præparater, som er CYP 450- hæmmere og/ eller - induktorer.
Accordingly, the metabolic clearance of vildagliptin is not anticipated to be affected by co-medications that are CYP 9 450 inhibitors and/ or inducers.
In vitro- studier har vist, at vildagliptin ikke hæmmer/ inducerer CYP 450- enzymer.
In vitro studies demonstrated that vildagliptin does not inhibit/ induce CYP 450 enzymes.
Derfor vil vildagliptin sandsynligvis ikke påvirke den metaboliske clearance af samtidigt administrerede præparater, som metaboliseres af CYP 1A2, CYP 2C8, CYP 2C9, CYP 2C19, CYP 2D6, CYP 2E1 eller CYP 3A4/ 5.
Therefore, vildagliptin is not likely to affect metabolic clearance of co-medications metabolised by CYP 1A2, CYP 2C8, CYP 2C9, CYP 2C19, CYP 2D6, CYP 2E1 or CYP 3A4/ 5.
85% af dosis udskilt i ruinen, og 15% af dosis genfindes i fæces.
Elimination Following oral administration of [14C] vildagliptin, approximately 85% of the dose was excreted into the urine and 15% of the dose is recovered in the faeces.
Efter intravenøs administration til raske forsøgspersoner er den totale plasma - og 9 renale clearance af vildagliptin henholdsvis 41 og 13 l/ t.
After intravenous administration to healthy subjects, the total plasma and renal clearances of vildagliptin are 41 and 13 l/ h, respectively.
3 timer.
The elimination half- life after oral administration is approximately 3 hours.
Karakteristika hos patienten Køn Der blev ikke observeret nogen klinisk relevante forskelle i vildagliptins farmakokinetik hos mandlige og kvindelige forsøgspersoner inden for et bredt interval af alder og BMI.
Characteristics in patients Gender No clinically relevant differences in the pharmacokinetics of vildagliptin were observed between male and female healthy subjects within a wide range of age and body mass index (BMI).
Vildagliptins DPP- 4 - hæmning er ikke afhængig af køn.
DPP-4 inhibition by vildagliptin is not affected by gender.
Alder Hos raske ældre forsøgspersoner (≥ 70 år) steg den samlede eksponering for vildagliptin (100 mg en gang daglig) med 32%, og den maksimale plasmakoncentration steg med 18% sammenlignet med unge raske forsøgspersoner (18- 40 år).
Age In healthy elderly subjects (≥ 70 years), the overall exposure of vildagliptin (100 mg once daily) was increased by 32%, with an 18% increase in peak plasma concentration as compared to young healthy subjects (18-40 years).
Nedsat leverfunktion Virkningen af nedsat leverfunktion på vildagliptins farmakokinetik blev studeret hos patienter med let, moderat og stærkt nedsat leverfunktion baseret på Child- Pugh- scorerne (der går fra 6 for let til 12 for svær) sammenlignet med raske forsøgspersoner.
Hepatic impairment The effect of impaired hepatic function on the pharmacokinetics of vildagliptin was studied in patients with mild, moderate and severe hepatic impairment based on the Child-Pugh scores (ranging from 6 for mild to 12 for severe) in comparison with healthy subjects.
Eksponeringen for vildagliptin efter en enkelt dosis hos patienter med let og moderat nedsat leverfunktion var reduceret (med henholdsvis 20% og 8%), mens eksponeringen for vildagliptin hos patienter med stærkt nedsat leverfunktion var øget med 22%.
The exposure to vildagliptin after a single dose in patients with mild and moderate hepatic impairment was decreased (20% and 8%, respectively), while the exposure to vildagliptin for patients with severe impairment was increased by 22%.
Den maksimale ændring (stigning eller fald) i eksponeringen for vildagliptin er ~30%, hvilket ikke betragtes som klinisk relevant.
The maximum change (increase or decrease) in the exposure to vildagliptin is ~30%, which is not considered to be clinically relevant.
Nedsat nyrefunktion Hos patienter med let, moderat eller svært nedsat nyrefunktion var den systemiske eksponering for vildagliptin øget (Cmax 8- 66%, AUC 32- 134%), og den totale body- clearance var reduceret sammenlignet med forsøgspersoner med normal nyrefunktion.
Renal impairment In subjects with mild, moderate, or severe renal impairment, systemic exposure to vildagliptin was increased (Cmax 8-66%; AUC 32-134%) and total body clearance was reduced compared to subjects with normal renal function.
Etnisk gruppe Begrænsede data tyder på, at etnicitet ikke har nogen større indflydelse på vildagliptins farmakokinetik.
Ethnic group Limited data suggest that race does not have any major influence on vildagliptin pharmacokinetics.
Der blev observeret intrakardielle impulsledningsforsinkelser hos hunde med en NOEL (No Observed Effect Level) på 15 mg/ kg (7 gange human eksponering baseret på Cmax).
Intra-cardiac impulse conduction delays were observed in dogs with a no-effect dose of 15 mg/ kg (7- fold human exposure based on Cmax).
NOEL hos rotter var 25 mg/ kg (5 gange den humane eksponering baseret på AUC) og hos mus 750 mg/ kg (142 gange den humane eksponering).
The no- effect dose in rats was 25 mg/ kg (5-fold human exposure based on AUC) and in mice 750 mg/ kg (142- fold human exposure).
Den embryo - føtale toksicitet blev evalueret hos rotter og kaniner.
Embryo-foetal toxicity was evaluated in rats and rabbits.
10 på 75 mg/ kg (10 gange human eksponering).
An increased incidence of wavy ribs was observed in rats in association with reduced maternal body weight parameters, with a no-effect dose of 75 mg/ kg (10-fold human exposure).
Hos kaniner blev der kun bemærket øget føtal vægt og skeletvariationer, som kunne tyde på forsinket udvikling i forbindelse med svær maternel toksicitet med en nuleffektdosis på 50 mg/ kg (9 gange human eksponering).
In rabbits, decreased foetal weight and skeletal variations indicative of developmental delays were noted only in the presence of severe maternal toxicity, with a no-effect dose of 50 mg/ kg (9-fold human exposure).
Der blev kun observeret fund i forbindelse med maternel toksicitet ved ≥ 150 mg/ kg, og de omfattede et forbigående fald i legemsvægten og nedsat motorisk aktivitet i F1- generationen.
Findings were only observed in association with maternal toxicity at ≥ 150 mg/ kg and included a transient decrease in body weight and reduced motor activity in the F1 generation.
200 gange human eksponering ved den maksimale anbefalede dosis).
A two-year carcinogenicity study was conducted in rats at oral doses up to 900 mg/ kg (approximately 200 times human exposure at the maximum recommended dose).
Der blev udført endnu et toårigt karcinogenicitetsstudie på mus med orale doser på op til 1. 000 mg/ kg.
Another two-year carcinogenicity study was conducted in mice at oral doses up to 1,000 mg/ kg.
Der blev observeret en stigning i incidensen af mammært adenokarcinom og hæmangiosarkom med en nuleffektdosis på henholdsvis 500 mg/ kg (59 gange den humane eksponering) og 100 mg/ kg (16 gange den humane eksponering).
An increased incidence of mammary adenocarcinomas and haemangiosarcomas was observed with a no-effect dose of 500 mg/ kg (59-fold human exposure) and 100 mg/ kg (16-fold human exposure), respectively.
I et 13- ugers toksikologistudie på cynomolgusaber er der registreret hudlæsioner ved doser ≥ 5 mg/ kg/ dag.
In a 13-week toxicology study in cynomolgus monkeys, skin lesions have been recorded at doses ≥ 5 mg/ kg/ day.
Ved 5 mg/ kg/ dag (omtrent svarende til human AUC- eksponering ved en dosis på 100 mg), blev der kun observeret vabler.
At 5 mg/ kg/ day (approximately equivalent to human AUC exposure at the 100 mg dose), only blisters were observed.
Der blev observeret flagende og afskallende hud, sårskorper og halesår med korrelerende histopatologiske forandringer ved doser ≥ 20 mg/ kg/ dag (omtrent 3 gange den humane AUC- eksponering ved dosis på 100 mg).
Flaking skin, peeling skin, scabs and tail sores with correlating histopathological changes were noted at doses ≥ 20 mg/ kg/ day (approximately 3 times human AUC exposure at the 100 mg dose).