natgillin/translations-raw huggingface dataset:
V. den 20. november 2006.
The European Commission granted a marketing authorisation valid throughout the European Union for Byetta to Eli Lilly Nederland B. V. on 20 November 2006.
Den fuldstændige EPAR for Byetta findes her.
The full EPAR for Byetta can be found here.
EU/ 1/ 06/ 362/ 001 EU/ 1/ 06/ 362/ 002 EU/ 1/ 06/ 362/ 003 EU/ 1/ 06/ 362/ 004
EU number EU/ 1/ 06/ 362/ 001 EU/ 1/ 06/ 362/ 002 EU/ 1/ 06/ 362/ 003 EU/ 1/ 06/ 362/ 004
BYETTA BYETTA BYETTA BYETTA
Invented name BYETTA BYETTA BYETTA BYETTA
5 mikrogram 5 mikrogram 10 mikrogram 10 mikrogram
Strength 5 micrograms 5 micrograms 10 micrograms 10 micrograms
Injektionsvæske, opløsning Injektionsvæske, opløsning Injektionsvæske, opløsning Injektionsvæske, opløsning
Pharmaceutical Form Solution for injection Solution for injection Solution for injection Solution for injection
subkutan brug subkutan brug subkutan brug subkutan brug
Route of administration subcutaneous use subcutaneous use subcutaneous use subcutaneous use
Præfyldt pen (glas) Præfyldt pen (glas) Præfyldt pen (glas) Præfyldt pen (glas)
Packaging Pre-filled pen (glass) Pre-filled pen (glass) Pre-filled pen (glass) Pre-filled pen (glass)
1, 2 ml 1, 2 ml 2, 4 ml 2, 4 ml
Content 1,2 ml 1,2 ml 2,4 ml 2,4 ml
1 præfyldt pen 3 præfyldte penne 1 præfyldt pen 3 præfyldte penne
Package size 1 pre-filled pen 3 pre-filled pens 1 pre-filled pen 3 pre-filled pens
BYETTA 5 mikrogram, opløsning til injektion i en fyldt pen
BYETTA 5 micrograms solution for injection, prefilled pen
Hver dosis indeholder 5 mikrogram (µg) syntetisk exenatid i 20 mikroliter (µl), (0, 25 mg syntetisk exenatid pr. ml).
Each dose contains 5 micrograms(µg) synthetic exenatide in 20 microlitres(µl), (0.25 mg exenatide per ml).
Hver dosis indeholder 44 µg metacresol
Each dose contains 44 µg metacresol.
Dette lægemiddel indeholder mindre end 1 mmol natrium pr. dosis, dvs. betragtes som værende natriumfrit.
This medicinal product contains less than 1mmol sodium per dose, i. e. essentially “ sodium-free”.
Injektionsvæske, opløsning i en fyldt pen.
Solution for injection, pre-filled pen.
BYETTA er indiceret til behandling af type 2- diabetes mellitus i kombination med metformin og/ eller sulfonylurinstof til patienter, der ikke har opnået tilstrækkelig glykæmisk kontrol ved den maksimale tolerable dosis for disse orale behandlinger.
BYETTA is indicated for treatment of type 2 diabetes mellitus in combination with metformin, and/ or sulphonylureas in patients who have not achieved adequate glycaemic control on maximally tolerated doses of these oral therapies.
BYETTA- behandling kan initieres med 5 µg exenatid pr. dosis indgivet to gange dagligt i mindst en måned for at forbedre tolerancen.
BYETTA therapy should be initiated at 5 µg exenatide per dose administered twice daily (BID) for at least one month in order to improve tolerability.
Dosis af BYETTA kan derefter øges til 10 µg to gange dagligt for yderligere at forbedre den glykæmiske kontrol.
The dose of exenatide can then be increased to 10 µg BID to further improve glycaemic control.
Doser højere end 10 µg to gange dagligt anbefales ikke.
Doses higher than 10µg BID are not recommended.
BYETTA er tilgængelig som fyldte penne med enten 5 µg eller 10 µg exenatid pr. dosis.
BYETTA is available as either a 5 µg or a 10 µg exenatide per dose pre-filled pen.
6 timer eller mere i mellem).
BYETTA can be administered at any time within the 60-minute period before the morning and evening meal (or two main meals of the day, approximately 6 hours or more apart).
BYETTA må ikke indgives efter et måltid.
BYETTA should not be administered after a meal.
BYETTA anbefales til brug til patienter med type 2- diabetes, som allerede får behandling med metformin og/ eller sulfonylurinstof.
BYETTA is recommended for use in patients with type 2 diabetes mellitus who are already receiving metformin and/ or a sulphonylurea.
Når BYETTA tilføjes eksisterende metformin- behandling, kan den aktuelle dosering af metformin fortsættes, da der ikke forventes øget risiko for hypoglykæmi sammenlignet med metformin alene.
When BYETTA is added to existing metformin therapy, the current dose of metformin can be continued as no increased risk of hypoglycaemia is anticipated, compared to metformin alone.
4. 4).
When BYETTA is added to sulphonylurea therapy, a reduction in the dose of sulphonylurea should be considered to reduce the risk of hypoglycaemia (see section 4.4.).
2 BYETTA- dosis behøver ikke at blive justeret dagligt på baggrund af glykæmisk selv- monitorering.
The dose of BYETTA does not need to be adjusted on a day-by-day basis depending on self- monitored glycaemia.
Det kan dog være nødvendigt, at patienterne selv skal overvåge deres blodglukose for at justere dosis af sulfonylurinstof.
However, blood glucose self-monitoring may become necessary to adjust the dose of sulphonylureas.
5. 1).
2 Limited experience exists concerning the combination of BYETTA with thiazolidinediones (see section 5.1).
Specifikke patientgrupper Ældre patienter BYETTA bør bruges med forsigtighed, og dosisøgning fra 5 µg til 10 µg bør foregå forsigtigt hos patienter > 70 år.
Specific patient groups Elderly BYETTA should be used with caution and dose escalation from 5 µg to 10 µg should proceed conservatively in patients > 70 years.
Den kliniske erfaring med patienter > 75 år er meget begrænset.
The clinical experience in patients > 75 years is very limited.
Patienter med nedsat nyrefunktion Der er ikke behov for dosisjustering af exenatid hos patienter med let nedsat nyrefunktion (kreatinin - clearance 50- 80 ml/ min).
Patients with renal impairment No dosage adjustment of BYETTA is necessary in patients with mild renal impairment (creatinine clearance 50 – 80 ml/ min).
5. 2).
In patients with moderate renal impairment (creatinine clearance:30-50 ml/ min), dose escalation from 5 µg to 10 µg should proceed conservatively (see section 5.2).
4. 4).
BYETTA is not recommended for use in patients with end-stage renal disease or severe renal impairment (creatinine clearance < 30 ml/ min) (see section 4.4).
5. 2).
Patients with hepatic impairment No dosage adjustment of BYETTA is necessary in patients with hepatic impairment (see section 5.2).
Børn og unge Sikkerhed og virkning af exenatid er ikke dokumenteret hos patienter under 18 år (se pkt.
Children and adolescents The safety and effectiveness of exenatide have not been established in patients under 18 years of age.
5. 2).
(see section 5.2).
BYETTA må ikke anvendes til patienter med type 1- diabetes mellitus eller til behandling af diabetisk ketoacidose.
BYETTA should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.
BYETTA bør ikke bruges af patienter med type 2- diabetes, der har brug for insulin på grund af tab af betacellefunktion.
BYETTA should not be used in type 2 diabetes patients who require insulin therapy due to betacell failure.
BYETTA bør ikke injiceres intravenøst eller intramuskulært.
Intravenous or intramuscular injection of BYETTA is not recommended.
Hos dialysepatienter med terminal nyresygdom, gav enkeltdoser af BYETTA 5 µg flere og værre gastrointestinale bivirkninger.
In patients with end-stage renal disease receiving dialysis, single doses of BYETTA 5 µg increased frequency and severity of undesirable gastrointestinal effects.
BYETTA bør ikke bruges til patienter med terminal nyresygdom eller svært nedsat nyrefunktion (kreatinin- clearance < 30 ml/ min).
BYETTA is not recommended for use in patients with end-stage renal disease or severe renal impairment (creatinine clearance < 30 ml/ min).
Den kliniske erfaring med patienter, der har moderat nedsat nyrefunktion, er meget begrænset.
The clinical experience in patients with moderate renal impairment is very limited.
Der har været sjældne, spontane bivirkningsrapporter om ændret nyrefunktion, inklusive forøget serum- kreatinin, nedsat nyrefunktion, forværring af kronisk nyresvigt og akut nyresvigt, der i nogle tilfælde krævede dialyse.
There have been rare, spontaneously reported events of altered renal function, including increased serum creatinine, renal impairment, worsened chronic renal failure and acute renal failure, sometimes requiring hemodialysis.
Nogle af disse tilfælde opstod hos patienter, der i forvejen var udsat for forhold, der kunne påvirke hydreringen, inklusive kvalme, opkastning og/ eller diaré og/ eller indtagelse af pharmakologiske stoffer, der vides at påvirke nyrefunktionen/ hydreringen.
Some of these events occurred in patients experiencing events that may affect hydration, including nausea, vomiting, and/ or diarrhoea and/ or receiving pharmacological agents known to affect renal function/ hydration status.
Sådanne samtidige pharmakologiske stoffer kunne være ACE- hæmmere, angiotensin- II- antagonister, nonsteroide antiinflammatoriske midler og diuretika.
Concomitant agents included angiotensin converting enzymes inhibitors, angiotensin-II antagonists, nonsteroidal anti-inflammatory medicinal products and diuretics.
Den ændrede nyrefunktion var reversibel med støttende behandling og seponering af de lægemidler, der kan have forårsaget funktionsændringerne, inklusive BYETTA.
Reversibility of altered renal function has been observed with supportive treatment and discontinuation of potentially causative agents, including BYETTA.
3 BYETTA er ikke blevet undersøgt hos patienter med svær mave- tarmsygdom, herunder gastroparese.
BYETTA has not been studied in patients with severe gastrointestinal disease, including gastroparesis.
BYETTA bør ikke bruges til patienter med alvorlig mave- tarmsygdom.
Therefore, the use of BYETTA is not recommended in patients with severe gastrointestinal disease.
Der har været sjældne, spontane bivirkningsrapporter om akut pankreatitis.
3 There have been rare, spontaneously reported events of acute pancreatitis.
Patienter bør informeres om de karakteristiske symptomer på akut pankreatitis: vedvarende, svære smerter i maven.
Patients should be informed of the characteristic symptom of acute pancreatitis: persistent, severe abdominal pain.
Det er observeret, at pankreatitis kan forsvinde ved støttende behandling.
Resolution of pancreatitis has been observed with supportive treatment.
Hvis der er mistanke om pankreatitis, bør BYETTA og andre potentielt mistænkte lægemidler seponeres.
If pancreatitis is suspected, BYETTA and other potentially suspect medicinal products should be discontinued.
Samtidig brug af BYETTA og insulin, D- phenylalaninderivater( meglitinider) eller alfa - glucosidasehæmmere er ikke blevet undersøgt og kan derfor ikke anbefales.
The concurrent use of BYETTA with insulin, D-phenylalanine derivatives(meglitinides), or alpha-glucosidase inhibitors has not been studied and cannot be recommended.
Erfaring med patienter med BMI ≤ 25 er begrænset.
The experience in patients with BMI ≤ 25 is limited.
Dette lægemiddel indeholder metacresol, hvilket kan fremkalde allergiske reaktioner.
This medicinal product contains metacresol, which may cause allergic reactions.
Hypoglykæmi Når BYETTA blev anvendt i kombination med sulfonylurinstof, var forekomsten af hypoglykæmi højere end for placebo i kombination med sulfonylurinstof.
Hypoglycaemia When BYETTA was used in combination with a sulphonylurea, the incidence of hypoglycaemia was increased over that of placebo in combination with a sulphonylurea.
I de kliniske forsøg, hvor patienterne fik kombinationsbehandling med sulfonylurinstof, havde de patienter, som havde let nedsat nyrefunktion en forøget forekomst af hypoglykæmi sammenlignet med patienter med normal nyrefunktion.
In the clinical studies patients on a sulphonylurea combination, with mild renal impairment had an increased incidence of hypoglycaemia compared to patients with normal renal function.
Interaktion Den langsommere ventrikeltømning, som BYETTA forårsager, kan muligvis reducere absorptions - graden og - hastigheden af orale lægemidler.
Interactions The effect of BYETTA to slow gastric emptying may reduce the extent and rate of absorption of orally administered medicinal products.
BYETTA skal anvendes med forsigtighed til patienter, som er i behandling med orale lægemidler, der enten kræver hurtig absorption i mave- tarm- kanal eller lægemidler med et smalt terapeutisk indeks.
BYETTA should be used with caution in patients receiving oral medicinal products that require rapid gastrointestinal absorption and medicinal products with a narrow therapeutic ratio.
4. 5.
Specific recommendations regarding intake of such medicinal products in relation to BYETTA is given in section 4.5.
Den langsommere ventrikeltømning, som BYETTA forårsager, kan muligvis reducere absorptions - graden og - hastigheden af orale lægemidler.
The effect of BYETTA to slow gastric emptying may reduce the extent and rate of absorption of orally administered medicinal products.
Disse lægemidler bør tages på faste tidspunkter i forhold til, hvornår BYETTA injiceres.
These medicinal products should be taken in a standardised way in relation to BYETTA injection.
Hvis sådanne lægemidler skal indgives sammen med føde, skal patienterne rådes til at tage dem i forbindelse med et måltid, hvor BYETTA ikke indgives, hvis det er muligt.
If such medicinal products are to be administered with food, patients should be advised to, if possible, take them with a meal when BYETTA is not administered.
I forbindelse med orale lægemidler, hvis effekt er særligt afhængig af tærskelkoncentrationer, såsom antibiotika, skal patienterne rådes til at tage disse lægemidler mindst 1 time før BYETTA- injektionen.
For oral medicinal products that are particularly dependent on threshold concentrations for efficacy, such as antibiotics, patients should be advised to take those medicinal products at least 1 hour before BYETTA injection.
Det forventes ikke, at BYETTA har nogen klinisk relevant effekt på farmakokinetikken for metformin og sulfonylurinstoffer.
BYETTA is not expected to have any clinically relevant effects on the pharmacokinetics of metformin or sulphonylureas.
Der er derfor ikke behov for restriktioner på indtagelsestidspunktet for disse lægemidler i forhold til, hvornår BYETTA injiceres.
Hence no restriction in timing of intake of these medicinal products in relation to BYETTA injection are needed.
4 Gastroresistante formuleringer, der indeholdende substanser, som er følsomme over for nedbrydning i ventriklen, såsom syrepumpehæmmere, skal indtages mindst 1 time før eller mere end 4 timer efter en injektion med BYETTA.
Gastroresistant formulations containing substances sensitive for degradation in the stomach, such as proton pump inhibitors, should be taken at least 1 hour before or more than 4 hours after BYETTA injection.
Paracetamol Paracetamol blev brugt som en model for lægemiddelstoffer med henblik på at evaluere effekten af exenatid på mavetømningen.
Paracetamol Paracetamol was used as a model medicinal product to evaluate the effect of exenatide on gastric emptying.
Tmax var forøget fra henholdsvis 0, 6 time i kontrol - perioden til 0, 9 time, 4, 2 time, 3, 3 time og 1, 6 time.
When 1000mg paracetamol was given with 10 µg BYETTA (0 h) and 1h, 2h and 4h after BYETTA injection, paracetamol AUCs were decreased by 21%, 23%, 24% and 14% respectively; Cmax was decreased by 37%, 56%, 54% and 41%, respectively; tmax was increased from 0.6h in the control period to 0.9h, 4.2h, 3.3h, and 1.6h, respectively.
Paracetamol AUC Cmax og Tmax blev ikke ændret betydeligt, når paracetamol blev givet 1 time før injektionen med BYETTA.
Paracetamol AUC, Cmax and tmax were not significantly changed when paracetamol was given 1 hour before BYETTA injection.
På baggrund af disse forsøgsresultater er der ingen grund til dosisjustering af paracetamol.
No adjustment to paracetamol dosing is required based on these study results.
4 t, sammenlignet med lovastatin indgivet alene.
4 HMG CoA reductase inhibitors Lovastatin AUC and Cmax were decreased approximately 40% and 28%, respectively, and Tmax was delayed about 4 h when BYETTA (10 µg BID) was administered concomitantly with a single dose of lovastatin (40 mg) compared with lovastatin administered alone.
5. 1).
In the 30-week placebo-controlled clinical trials, concomitant use of BYETTA and HMG CoA reductase inhibitors was not associated with consistent changes in lipid profiles (see section 5.1).
Det er nødvendigt at være opmærksom på eventuelle øgninger i LDL- C eller i totalkolesterolet, selvom det ikke er nødvendigt med en på forhånd fastlagt dosisjustering.
Although no predetermined dose adjustment is required, one should be aware of possible changes in LDL-C or total cholesterol.
Digoxin, lisinopril og warfarin Der blev observeret en forsinkelse i Tmax på omkring 2 timer, når digoxin, lisinopril eller warfarin blev indtaget 30 min. efter exenatid.
Digoxin, lisinopril and warfarin A delay in tmax of about 2h was observed when digoxin, lisinopril or warfarin was administered 30 min after exenatide.
Siden introduktion på markedet er der imidlertid blevet rapporteret forøget INR ved samtidig brug af warfarin og BYETTA.
However, since market introduction, increased INR has been reported during concomitant use of warfarin and BYETTA.
4. 8).
INR should be closely monitored during initiation and dose increase of BYETTA therapy in patients on warfarin and/ or cumarol derivatives (see section 4.8).
Ethinylestradiol og levonorgestrel Administration af oral kontraception (kombination af 30 µg ethinylestradiol og 150 µg levonorgestrel) én time før BYETTA (10 µg to gange dagligt) ændrede ikke AUC, Cmax eller Cmin af hverken ethinylestradiol eller levonorgestrel.
Ethinyl estradiol and levonorgestrel Administration of a combination oral contraceptive (30 µg ethinyl estradiol plus 150 µg levonorgestrel) one hour before BYETTA (10 µg BID) did not alter the AUC, Cmax or Cmin of either ethinyl estradiol or levonorgestrel.
Administration af oral kontraception 30 min. efter BYETTA påvirkede ikke AUC, men resulterede i en reduktion af Cmax for ethinylestradiol med 45%, og Cmax for levonorgestrel med 27- 41%, og en forsinkelse i tmax med 2- 4 timer pga. forsinket ventrikeltømning.
Administration of the oral contraceptive 30 minutes after BYETTA did not affect AUC but resulted in a reduction of the Cmax of ethinyl estradiol by 45%, and Cmax of levonorgestrel by 27-41%, and a delay in tmax by 2-4 h due to delayed gastric emptying.
Der er ikke tilstrækkelige data for brug af BYETTA til gravide kvinder.
There are no adequate data from the use of BYETTA in pregnant women.
I stedet anbefales insulinbehandling.
BYETTA should not be used during pregnancy and the use of insulin is recommended.
Behandlingen med BYETTA bør ophøre, hvis en patient ønsker at blive gravid eller bliver gravid.
If a patient wishes to become pregnant, or pregnancy occurs, treatment with BYETTA should be discontinued.
Det er uvist, om exenatid bliver udskilt i modermælk.
It is unknown whether exenatide is excreted in human milk.
BYETTA bør ikke anvendes til kvinder, der ammer.
BYETTA should not be used if breast feeding.
Der er ikke udført forsøg angående virkningen på evnen til at føre motorkøretøjer eller til at betjene maskiner.
No studies on the effects on the ability to drive and use machines have been performed.
Hvis BYETTA anvendes i kombination med sulfonylurinstof, skal patienterne rådes til at udvise forsigtighed for at undgå hypoglykæmi under bilkørsel eller ved betjening af maskiner.
When BYETTA is used in combination with a sulphonylurea, patients should be advised to take precautions to avoid hypoglycaemia while driving and using machines.
Tabel 1 indeholder en liste med rapporterede bivirkninger fra fase 3- forsøg.
Table 1 lists adverse reactions reported from Phase 3 studies.
Tabellen viser forekomsten af bivirkninger med en hyppighed på > 5% der samtidig er mere hyppige blandt BYETTA- behandlede patienter end insulin - eller placebo- behandlede patienter.
The table presents adverse reactions that occurred with an incidence ≥ 5% and more frequently among BYETTA-treated patients than insulin- or placebo-treated patients.
Tabellen indeholder også de bivirkninger, der optrådte med en incidens på > 1% og med en statistisk signifikant højere incidens eller > 2X højere incidens blandt BYETTA- behandlede patienter end insulin - eller placebo - behandlede patienter.
The table also includes adverse reactions that occurred with an incidence ≥ 1% and with a statistically significantly higher and/ or ≥ 2X incidence among BYETTA-treated patients than insulin- or placebo-treated patients.
Bivirkningerne er angivet nedenfor med foretrukken MedDRA- terminologi efter systemorganklasse og absolut frekvens.
The reactions are listed below as MedDRA preferred term by system organ class and absolute frequency.
Hyppigheden defineres som: meget almindelige (≥1/ 10) og almindelige (≥1/ 100, < 1/ 10).
Patient frequencies are defined as: very common (≥ 1/ 10) and common (≥ 1/ 100, < 1/ 10).
Tabel 1:
5 Table 1:
Rapporterede bivirkninger i kontrollerede fase 3- langtidsforsøg1
Adverse reactions reported in long term phase 3 controlled studies1
Systemorganklasse/ bivirkning
Body system/ adverse reaction terms
Hyppighed af forekomst
Frequency of occurrence
Stofskiftesygdomme sygdomme
Reactions
Hypoglykæmi (med metformin og sulfonylurinstof) 2
Metabolism and nutrition disorders Hypoglycaemia (with metformin and a sulphonylurea) 2
Hypoglykæmi (med sulfonylurinstof) Nedsat appetit Sygdomme i nervesystemet
Hypoglycaemia (with a sulphonylurea) Decreased appetite Nervous system disorders
Hovedpine2 Svimmelhed Gastrointestinale sygdomme
Headache 2 Dizziness Gastrointestinal disorders
Kvalme Opkastning Diaré Dyspepsi Mavesmerter Gastroøsofageal reflukssygdom Oppustethed Sygdomme i hud - og subkutane væv
Nausea Vomiting Diarrhoea Dyspepsia Abdominal pain Gastroesophageal reflux disease Abdominal distension Skin and subcutaneous tissue disorders
Hyperhidrose2 Almene lidelser og reaktioner på indgivelsesstedet
Hyperhidrosis 2 General disorders and administrative site conditions
Nervøsitet Asthenia2
1
1 Data fra komparatorkontrollerede fase 3- forsøg versus placebo, insulin glargine eller 30% opløseligt insulin aspart / 70% insulin aspart protamine crystaller (biphasic insulin aspart) i hvilke patienterne også fik metformin, et thiazolidindion- præparat eller sulphonylurinstof i tillæg til BYETTA eller komparator.
Data from Phase 3 comparator-controlled studies versus placebo, insulin glargine or 30% soluble insulin aspart/ 70% insulin aspart protamine crystals (biphasic insulin aspart) in which patients also received metformin, thiazolidinediones or sulphonylurea in addition to BYETTA or comparator.
2 I insulin- komparatorkontrollerede forsøg, i hvilke metformin og sulphonylurinstof blev givet som kombinationslægemidler, var incidensen for disse bivirkninger sammenlignelig for insulin - og BYETTA- behandlede patienter.
2 In insulin-comparator controlled studies in which metformin and a sulphonylurea were concomitant medicinal products, the incidence for these adverse reactions was similar for insulin- and BYETTA- treated patients.
Hypoglykæmi I forsøg med patienter, som fik behandling med BYETTA og sulfonylurinstof (med eller uden metformin), blev incidensen af hypoglykæmi forøget i forhold til placebo (23, 5% og 25, 2% i forhold
Hypoglycaemia In studies in patients treated with BYETTA and a sulphonylurea (with or without metformin), the incidence of hypoglycaemia was increased compared to placebo (23.5% and 25.2% versus 12.6% and 3.3%) and appeared to be dependent on the doses of both BYETTA and the sulphonylurea.
De fleste episoder af hypoglykæmi var milde til moderate i intensitet, og alle blev afhjulpet med oral administration af kulhydrater (tabel 2).
Most episodes of hypoglycaemia were mild to moderate in intensity, and all resolved with oral administration of carbohydrate.
Kvalme Den hyppigst rapporterede bivirkning var kvalme.
Nausea The most frequently reported adverse reaction was nausea.
Af de patienter, der blev behandlet med 5 µg eller 10 µg BYETTA, rapporterede sædvanligvis 40- 50% mindst en episode med kvalme.
In patients treated with 5 µg or 10 µg BYETTA, generally 40-50% reported at least one episode of nausea.