natgillin/translations-raw huggingface dataset:
Hence, no restriction in timing of intake of these medicinal products in relation to immediate-release exenatide injection are needed.
Zato časovne omejitve jemanja teh zdravil glede na injiciranje eksenatida v obliki s takojšnjim sproščanjem niso potrebne.
The most frequent adverse reactions were mainly gastrointestinal related (nausea, vomiting and diarrhoea).
Najpogostejši neželeni učinki so bili večinoma povezani s prebavili (navzea, bruhanje in diareja).
• Pull off inner needle shield and throw away.
• Snemite notranjo zaščito igle in jo zavrzite.
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.
V kliničnih študijah pri bolnikih z blago okvaro ledvic, ki so jemali kombinacijo s sulfonilsečnino, je bila incidenca hipoglikemije večja v primerjavi z bolniki z normalnim delovanjem ledvic.
Most episodes of hypoglycaemia were mild to moderate in intensity, and resolved with oral administration of carbohydrate.
Večina epizod hipoglikemije je bila po intenzivnosti blaga do zmerna in so jih odpravili s peroralnim dajanjem ogljikovih hidratov.
• The injection button was not pushed in all the way and a complete dose was not delivered.
• Gumba za injiciranje niste pritisnili do konca in niste prejeli celotnega odmerka.
Byetta 10 mcg: Each dose contains 88 mcg metacresol.
Byetta 10 μg: En odmerek vsebuje 88 μg metakrezola.
• Pen preparation is complete when the is in the centre of the dose window AND you have seen a stream or several drops come from the needle tip.
• Priprava injekcijskega peresnika je zaključena, ko je v sredini okenca za odmerjanje IN je iz konice igle izšel curek ali nekaj kapelj.
• The pen is now ready to reset.
• Injekcijski peresnik je sedaj pripravljen za ponovno nastavitev.
Immediate-release exenatide should be used with caution and dose escalation from 5 mcg to 10 mcg should proceed conservatively in patients > 70 years.
Eksenatid v obliki s takojšnjim sproščanjem moramo uporabljati previdno ter previdno višati odmerek od 5 μg do 10 μg pri bolnikih > 70 let.
Most episodes of nausea were mild to moderate and occurred in a dose-dependent fashion.
Večina epizod navzee so bile blage do zmerne in so se pojavljale v odvisnosti od odmerka.
keep out air bubbles, reduce needle clogs, and decrease the risk of infection.
To bo preprečilo iztekanje zdravila Byetta, nastanek zračnih mehurčkov, zmanjšalo zamaške v igli in zmanjšalo tveganje za infekcijo.
When immediate-release exenatide was used in combination with basal insulin therapy the incidence and types of other adverse events observed were similar to those seen in the controlled clinical trials with exenatide as monotherapy, with metformin and/or sulphonylurea or a thiazolidinedione, with or without metformin.
Ko se je eksenatid v obliki s takojšnjim sproščanjem uporabljalo v kombinaciji z bazalnim insulinom, sta bili pogostnost in vrste drugih neželenih učinkov podobni tistim, ki so jih opazili v nadzorovanih kliničnih preskušanjih pri monoterapiji z eksenatidom, z metforminom in/ali sulfonilsečnino ali tiazolidindionom, z ali brez metformina.
Immediate-release exenatide lowered HbA1c from 8.21 (n=228) and 8.6% (n=222) by 1.13 and 1.01% while insulin glargine lowered from 8.24 (n=227) by 1.10% and biphasic insulin aspart from 8.67 (n=224) by 0.86%.
Eksenatid v obliki s takojšnjim sproščanjem je zmanjšalo HbA1C z 8,21 (n=228) in 8,6 % (n=222) za 1,13 in 1,01 %, medtem, ko je insulin glargin zmanjšal z 8,24 (n=227) za 1,10 % in dvofazni insulin aspart z 8,67 (n=224) za 0,86 %.
How to use Byetta
Kako uporabljati zdravilo Byetta
All patients assigned to immediate-release exenatide initially received 5 mcg BID for four weeks.
Vsi bolniki, razvrščeni na zdravljenje z eksenatidom v obliki s takojšnjim sproščanjem, so sprva štiri tedne prejemali po 5 µg dvakrat na dan.
Anaphylactic reaction Metabolism and nutrition disorders Hypoglycaemia (with metformin and a sulphonylurea) Hypoglycaemia (with a sulphonylurea) Decreased appetite Dehydration, generally associated with nausea, vomiting and/or diarrhoea.
Anafilaktična reakcija Presnovne in prehranske motnje Hipoglikemija (z metforminom in sulfonilsečnino) Hipoglikemija (s sulfonilsečnino) Zmanjšan apetit Dehidracija, na splošno povezana z navzeo, bruhanjem in/ali diarejo Bolezni živčevja Glavobol
Do not use Byetta:
Ne uporabljajte zdravila Byetta
Byetta 5 mcg: Each dose contains 44 mcg metacresol.
Byetta 5 μg: En odmerek vsebuje 44 μg metakrezola.
• STOP taking this medicineand contact your doctor immediately if you experience severe and persistent stomach pain, with or without vomiting, because you could have an inflamed pancreas (pancreatitis).
• Če se vam pojavijo hude in dolgotrajne bolečine v trebuhu, z bruhanjem ali brez njega, PRENEHAJTE z jemanjem tega zdravila in takoj pokličite svojega zdravnika, kajti lahko imate vnetje trebušne slinavke (pankreatitis).
What Byetta looks like and contents of the pack
Izgled zdravila Byetta in vsebina pakiranja
In these studies the incidence of hypoglycaemia was similar for immediate-release exenatide and insulin treatment.
V teh študijah je bila incidenca hipoglikemije podobna za zdravljenje z eksenatidom v obliki s takojšnjim sproščanjem in insulinom.
Following a basal insulin optimization (BIO) phase, patients with HbA1c7.0% were randomized to add either immediate-release exenatide or insulin lispro to their existing regimen of insulin glargine and metformin.
Po fazi optimizacije bazalnega insulina (OBI) so bolnike s HbA1c > 7,0 % randomizirali ali na eksenatid v obliki s takojšnjim sproščanjem ali na insulin lispro, oba dodana obstoječemu zdravljenju z insulinom glarginom in metforminom.
Diabetic ketoacidosis has been reported in insulin-dependent patients after rapid discontinuation or dose reduction of insulin (see section 4.2)
Pri bolnikih, odvisnih od insulina, so po hitri ukinitvi ali zmanjšanju odmerka insulina poročali o diabetični ketoacidozi (glejte poglavje 4.2).
Type I glass cartridge with a (bromobutyl) rubber plunger, rubber disc, and aluminium seal.
Vložek iz stekla tipa I z (bromobutilnim) gumijastim batom, gumijasto opno in aluminijastim pokrovčkom.
Make sure that the 5 with the line under it is in the centre of the dose window.
Prepričajte se, da je podčrtana 5 na sredini okenca za odmerjanje.
There have been uncommon, spontaneously reported events of altered renal function, including increased serum creatinine, renal impairment, worsened chronic renal failure and acute renal failure, sometimes requiring hemodialysis.
Občasno so spontano poročali o primerih spremenjenega delovanja ledvic, vključno z zvišanjem kreatinina v serumu, okvaro ledvic, poslabšanjem kronične odpovedi ledvic in akutno odpovedjo ledvic, z občasno potrebo po hemodializi.
If you stop using Byetta
Če ste prenehali uporabljati zdravilo Byetta
Since immediate-release exenatide has been marketed, acute pancreatitis has been reported with a frequency not known and acute renal failure has been reported uncommonly (see section 4.4).
Po začetku trženja eksenatida v obliki s takojšnjim sproščanjem so poročali o akutnem pankreatitisu z neznano pogostnostjo in o akutni odpovedi ledvic z občasno pogostnostjo (glejte poglavje 4.4).
• White particles may appear on the outside tip of the cartridge during normal use.
• Med običajno uporabo se na zunanjem koncu vložka lahko pojavijo beli delci.
Note: If the needle is not secure, you may not get your full dose.
Opomba: Če igla ni dobro nameščena, se lahko zgodi, da ne dobite celotnega odmerka.
• Mark the date when you first used your pen and the date 30 days later in the spaces below:
• V poseben prostor spodaj vpišite datum vaše prve uporabe injekcijskega peresnika in datum po 30 dnevih:
• decreased in kidney function
• zmanjšano delovanje ledvic
Exenatide 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).
Uporabe eksenatida ne priporočamo bolnikom s končno stopnjo bolezni ledvic ali hudo okvaro ledvic (očistek kreatinina < 30 ml/min) (glejte poglavje 4.4).
6.1 List of excipients metacresol mannitol glacial acetic acid sodium acetate trihydrate water for injections
6.1 Seznam pomožnih snovi metakrezol manitol koncentrirana ocetna kislina; ledocet natrijev acetat trihidrat voda za injekcije
STEP B Attach the Needle
KORAK B Pritrdite iglo
For placebo-treated or insulin-treated patients, < 1% withdrew due to nausea or vomiting.
< 1 % bolnikov, ki so dobivali placebo ali insulin, so zdravljenje prekinili zaradi navzee ali bruhanja.
• For your next dose, be sure to firmly push and hold the injection button in and slowly count to 5 before removing needle from skin.
• Pri naslednjem odmerjanju zagotovite, da boste gumb za injiciranje čvrsto pritisnili in držali ter počasi šteli do 5, preden boste iz kože izvlekli iglo.
Byetta is used with other diabetic medicines called metformin, sulphonylureas, thiazolidinediones and basal or long acting insulins.
Zdravilo Byetta uporabljamo skupaj z drugimi zdravili za sladkorno bolezen, ki se imenujejo metformin, sulfonilsečnine, tiazolidindioni in bazalni ali dolgo delujoči insulini.
If a patient wishes to become pregnant, or pregnancy occurs, treatment with exenatide should be discontinued.
Ženske v rodni dobi Če bolnica želi zanositi ali zanosi, moramo zdravljenje z eksenatidom prekiniti.
Your doctor may tell you to use Byetta 5 micrograms twice a day to start with.
Vaš zdravnik vam lahko za začetek predpiše zdravilo Byetta 5 mikrogramov (µg) dvakrat na dan.
Each pen has 60 doses to provide 30 days of twice-aday injections.
En injekcijski peresnik vsebuje 60 odmerkov za zagotavljanje injekcije dvakrat na dan za 30 dni.
- If you have severe problems with slowstomach emptying or food digestion, asthe use of this medicine is not recommended.
- Če imate hude težave s počasnim praznjenjem želodca ali prebavo hrane, se jemanja zdravila Byetta ne priporoča.
Immediate-release exenatide should not be administered after a meal.
Eksenatid v obliki s takojšnjim sproščanjem ne smemo dajati po obroku.
The patient should be instructed to discard the needle after each injection.
Bolnika naučite, da iglo po vsakem injiciranju zavrže.
Note: If you see several drops of Byetta leaking from the needle after the injection, the injection button was not pushed in all the way.
Opomba: Če po injiciranju nekaj kapelj zdravila Byetta izteka iz igle, gumba za injiciranje niste pritisnili do konca.
Byetta should not be used if particles appear or if the solution is cloudy and/or coloured.
Zdravila Byetta ne smete uporabljati, če se v raztopini pojavijo delci ali je raztopina motna in/ali obarvana.
Exenatide increases, on a glucose-dependent basis, the secretion of insulin from pancreatic beta cells.
V odvisnosti od glukoze eksenatid poveča izločanje insulina iz beta celic trebušne slinavke.
Make sure needle is on straight and screwed on all the way.
Prepričajte se, da je igla privita naravnost in do konca.
There were no clinically significant differences in the incidence of hypoglycaemic episodes in the immediate-release exenatide compared to the placebo group (25% and 29% respectively).
Razlike v pogostnosti epizod hipoglikemije pri dajanju eksenatida v obliki s takojšnjim sproščanjem in placeba niso bile klinično pomembne (25 % oziroma 29 %).
Where should I inject Byetta?
Kam naj injiciram zdravilo Byetta?
Immediate-release exenatide reduced HbA1c and body weight in patients treated for 30 weeks in three placebo-controlled studies, whether the immediate-release exenatide was added to metformin, a sulphonylurea or a combination of both.
Eksenatid v obliki s takojšnjim sproščanjem je zmanjšalo HbA1c in telesno maso pri bolnikih, ki so jih v treh s placebom nadzorovanih študijah zdravili 30 tednov, neodvisno od tega ali je bilo eksenatid v obliki s takojšnjim sproščanjem dodano metforminu, sulfonilsečnini ali kombinaciji obeh.
Weight loss of 2.3 kg (2.6%) was achieved with immediate-release exenatide in the 26-week study and a loss of 2.5 kg (2.7%) in a 52-week study whereas treatment with insulin was associated with weight gain.
Z eksenatidom v obliki s takojšnjim sproščanjem so v 26 tedenski študiji dosegli zmanjšanje mase za 2,3 kg (2,6 %) in v 52-tedenski študiji za 2,5 kg (2,7 %), medtem ko je bilo zdravljenje z insulinom povezano s povečanjem mase.
There was no significant difference in body weight between treatment groups in change from baseline to endpoint (-1.4 versus -0.8 kg).
Med izhodiščno in končno vrednostjo telesne mase ni bilo značilne razlike med skupinama zdravljenja (-1,4 proti -0,8 kg).
In patients where existing therapy also included a sulphonylurea the incidence of patients with at least one minor hypoglycaemic episode was 48% and 54% respectively and one patient reported major hypoglycaemia.
Pri bolnikih, pri katerih je obstoječe zdravljenje vključevalo tudi sulfonilsečnino, je bila pogostnost blage hipoglikemije 48 % oziroma 54 %, en bolnik pa je poročal o hudi hipoglikemiji.
Similar exposure is achieved with subcutaneous administration of exenatide in the abdomen, thigh, or arm.
Podobno izpostavljenost dosežemo s subkutanim dajanjem eksenatida v trebuh, stegno ali roko.
Of the immediate-release exenatide patients, 12% were treated with a thiazolidinedione and immediate-release exenatide and 82% were treated with a thiazolidinedione, metformin and immediate-release exenatide.
12 % bolnikov na eksenatidu v obliki s takojšnjim sproščanjem je bilo zdravljenih s tiazolidindionom in eksenatidom v obliki s takojšnjim sproščanjem, 82 % pa s tiazolidindionom, metforminom in eksenatidom v obliki s takojšnjim sproščanjem.
When immediate-release exenatide is used in combination with basal insulin, the dose of basal insulin should be evaluated.
Ko se eksenatid v obliki s takojšnjim sproščanjem uporablja v kombinaciji z bazalnim insulinom, je potrebno ovrednotiti odmerek bazalnega insulina.
You will not need to test your sugar levels on a day-by-day basis to set the dose of Byetta.
Za nastavitev ustreznega odmerka zdravila Byetta vam ne bo potrebno dnevno preverjati ravni sladkorja.
Exenatide slows gastric emptying thereby reducing the rate at which meal-derived glucose appears in the circulation.
Eksenatid upočasni praznjenje želodca, s čimer zmanjša hitrost, s katero se glukoza iz obroka pojavi v krvnem obtoku.
Byetta with food
Zdravilo Byetta skupaj s hrano
• Remove the needle after each injection.
• Iglo odstranite po vsakem injiciranju.
See Commonly Asked Questions, numbers 5 and 9, in Section 4 of this user manual.
Glejte Pogosta vprašanja, številki 5 in 9, v Poglavju 4 tega Priročnika za uporabo.
A reduction in body weight was seen in patients treated with immediate-release exenatide irrespective of the occurrence of nausea although the reduction was larger in the group with nausea (mean reduction 2.4 kg versus 1.7 kg) in the long-term controlled studies of up to 52 weeks.
Pri bolnikih zdravljenih z eksenatidom v obliki s takojšnjim sproščanjem so zmanjšanje telesne mase opazili neodvisno od pojava navzee, čeprav je bilo v do 52 tednov trajajočih dolgoročnih nadzorovanih študijah zmanjšanje večje v skupini z navzeo (povprečno zmanjšanje 2,4 kg proti 1,7 kg).
In patients with moderate renal impairment (creatinine clearance 30-50 ml/min), dose escalation from 5 mcg to 10 mcg should proceed conservatively (see section 5.2).
Pri bolnikih z zmerno okvaro ledvic (očistek kreatinina 30-50 ml/min) previdno višamo odmerek od 5 μg do 10 μg (glejte poglavje 5.2).
USER MANUAL CONTENTS
VSEBINA PRIROČNIKA ZA UPORABNIKA
• Byettais injected twice a day,the pen contains enough medicine for 30 days.
• Zdravilo Byetta se injicira dvakrat na dan, tako da injekcijski peresnik vsebuje količino zdravila za 30 dni.
WHAT YOU NEED TO KNOW ABOUT YOUR BYETTA PEN
KAJ MORATE VEDETI O VAŠEM INJEKCIJSKEM PERESNIKU BYETTA
Byetta is available in pack sizes of 1 and 3 pre-filled pens.
Zdravilo je na voljo v velikostih pakiranja po 1 in 3 napolnjeni injekcijski peresniki.
A trend for a decrease in triglycerides has been observed with weight loss.
Z zmanjšanjem mase so opazili trend za zmanjšanje trigliceridov.
Your Byetta pen is suitable for use with Becton, Dickinson and Company pen injection needles.
Vaš injekcijski peresnik Byetta je primeren za uporabo z injekcijskimi iglami za peresnik proizvajalca Becton, Dickinson and Company.
• Use a Byettapen for only 30 days after setting up a new pen for first use.
• Injekcijski peresnik Byetta uporabljajte samo 30 dni po pripravi novega injekcijskega peresnika za prvo uporabo.
However, since market introduction, increased INR (International Normalized Ratio) has been reported spontaneously during concomitant use of warfarin and exenatide.
Vendar so od uvedbe na trg med sočasno uporabo varfarina in eksenatida v obliki s takojšnjim sproščanjem spontano poročali o povišanem INR (International Normalised Ratio).
• Check pen label to make sure it is your 10 microgram pen.
• Preverite oznako na injekcijskem peresniku, da zagotovite uporabo vašega 10 µg injekcijskega peresnika.
5 mcg: Each pre-filled pen contains 60 doses (approximately 1.2 ml of solution).
5 µg: En napolnjen injekcijski peresnik vsebuje 60 odmerkov (približno 1,2 ml raztopine).
Non-clinical data reveal no special hazards for humans based on conventional studies of safety pharmacology, repeat-dose toxicity, or genotoxicity.
Predklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih odmerkih ali genotoksičnosti ne kažejo posebnih tveganj za človeka.
• You have firmly pushed the injection button in all the way until it stops and
• ste čvrsto pritisnili gumb za injiciranje vse do konca in
• Check pen label to make sure it is your 5 microgram pen.
• Preverite oznako na injekcijskem peresniku, da zagotovite uporabo vašega 5 µg injekcijskega peresnika.
In patients with end-stage renal disease receiving dialysis, single doses of immediate-release exenatide 5 mcg increased frequency and severity of gastrointestinal adverse reactions.
Pri bolnikih s končno stopnjo bolezni ledvic na dializi so enkratni odmerki eksenatida v obliki s takojšnjim sproščanjem 5 μg povečali pogostnost in resnost neželenih učinkov na prebavila.
Pack size of 1 and 3 pens.
Velikost pakiranja je 1 in 3 injekcijski peresniki.
• Store in a refrigerator (2 ºC to 8 ºC).
• Shranjujte v hladilniku (2  C do 8 C).
• The dose knob was not turned all the way.
• Gumba za odmerjanje niste obrnili do konca.
In clinical trials, background therapies included metformin, a sulphonylurea, a thiazolidinedione, or a combination of oral glucose-lowering medicinal products.
Osnovna zdravljenja so v kliničnih študijah obsegala metformin, sulfonilsečnino, tiazolidindion ali kombinacijo peroralnih zdravil za zniževanje glukoze.
One to deliver doses of 5micrograms and one 10micrograms.
Eden za dajanje odmerkov 5 mikrogramov (µg) in drugi 10 mikrogramov (µg).
No pharmacokinetic study has been performed in patients with hepatic insufficiency.
Pri bolnikih z okvaro jeter niso opravili nobenih farmakokinetičnih študij.
In a 24-week study, where either insulin lispro protamine suspension or insulin glargine was added to existing therapy of immediate-release exenatide and metformin, metformin and sulphonylurea or metformin and pioglitazone, HbA1c was lowered by 1.2% (n=170) and by 1.4% (n=167) respectively from a baseline of 8.2%.
V 24-tedenski študiji, kjer so že obstoječem zdravljenju z eksenatidom v obliki s takojšnjim sproščanjem in metforminom, metforminom in sulfonilsečnino ali metforminom in pioglitazonom dodali suspenzijo insulina lispro- protamin ali insulina glargin, se je vrednost HbA1c znižala za 1,2 % (n=170) oziroma 1,4 % (n=167) od začetne vrednosti 8,2 %.
Weight increase of 0.2 kg was observed for patients on insulin lispro protamine suspension and 0.6 kg for insulin glargine treated patients from a baseline of 102 kg and 103 kg respectively.
Pri bolnikih, ki so uporabljali suspenzijo insulina lispro-protamin, so opazili povečanje telesne mase za 0,2 kg, pri bolnikih, ki so uporabljali insulin glargin, pa za 0,6 kg od začetne vrednosti 102 kg oziroma 103 kg.
• Pull the dose knob out until appears.
• Izvlecite gumb za odmerjanje, da se pojavi
Section 1.
Poglavje 1.
Caution should be exercised in patients with a history of pancreatitis.
Pri bolnikih, ki so v preteklosti že imeli pankreatitis je potrebna previdnost.
It is unknown whether exenatide is excreted in human milk.
Dojenje Ni znano, ali se eksenatid izloča v materino mleko.
ready to pull dose knob out ready to turn to dose position ready to inject 10 micrograms (mcg)
Pripravljen za obračanje za nastavitev odmerka Pripravljen za injiciranje 10 mikrogramov (µg)
When this medicine is used with a medicine that contains a sulphonylurea or an insulin, episodes of low blood sugar (hypoglycaemia, generally mild to moderate) can occur very commonly.
Pri uporabi tega zdravila skupaj z zdravilom, ki vsebuje sulfonilsečnino ali insulin, zelo pogosto lahko pride do epizod nizkega sladkorja v krvi (hipoglikemije, na splošno blage do zmerne).
In insulin-comparator studies immediate-release exenatide (5 mcg BID for 4 weeks, followed by 10 mcg BID) in combination with metformin and sulphonylurea significantly (statistically and clinically) improved glycaemic control, as measured by decrease in HbA1c.
V z insulinom primerjalnih študijah je eksenatid v obliki s takojšnjim sproščanjem (5 μg dvakrat na dan 4 tedne, nato 10 μg dvakrat na dan) v kombinaciji z metforminom in sulfonilsečnino značilno (statistično in klinično) izboljšalo glikemični nadzor merjen z zmanjšanjem HbA1c.
See the accompanying Pen User Manual for instructions for using the Byetta Pen.
Glejte priloženi Priročnik za uporabo injekcijskega peresnika za navodila za uporabo injekcijskega peresnika Byetta.
System organ class /adverse reaction terms
Organski sistem/Neželeni učinki
See Commonly Asked Questions, number 5, in Section 4 of this user manual.
Glejte Pogosta vprašanja, številka 5, v Poglavju 4 tega Priročnika za uporabo.
Ask your doctor if the time at which you take any tablets should be changed because this medicine slows stomach emptying and can affect medicines that need to pass through the stomach quickly, e.g.
Vprašajte svojega zdravnika, ali morate spremeniti čas jemanja katerih koli tablet, saj to zdravilo upočasni praznjenje želodca in lahko vpliva na zdravila, ki morajo hitro preiti skozi želodec, npr.: - na želodčni sok odporne tablete ali kapsule (na primer zaviralci protonske črpalke), ki se ne smejo predolgo zadrževati v želodcu, bo morda treba vzeti eno uro pred ali štiri ure po zdravilu
- Each millilitre (ml) of the solution for injection contains 0.25 milligrams (mg) of exenatide.
- En mililiter (ml) raztopine za injiciranje vsebuje 0,25 miligramov (mg) eksenatida.
Hepatic impairment No dosage adjustment is necessary in patients with hepatic impairment (see section 5.2).
Okvara jeter Pri bolnikih z okvaro jeter odmerka ni potrebno prilagajati (glejte poglavje 5.2).
Store in a refrigerator (2 ºC - 8 ºC).
Shranjujte v hladilniku (2 ºC - 8 ºC).
Proportion of patients (%) achieving HbA1c ≤ 7% (patients completing studies) Baseline weight (kg) Change of weight from baseline (kg)
Začetni HbA1c (%) Sprememba v HbA1c (%) glede na začetnega Odstotek bolnikov, ki so dosegli HbA1c ≤ 7 % Odstotek bolnikov, ki so dosegli HbA1c ≤ 7 % (bolniki, ki so dokončali študije)
NEW PEN SETUP - DO THIS ONE TIME ONLY
PRIPRAVA NOVEGA INJEKCIJSKEGA PERESNIKA - PRIPRAVITE SAMO ENKRAT
As blood glucose concentrations decrease, insulin secretion subsides.
Ko se koncentracija glukoze v krvi zniža, izločanje insulina upade.
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 immediate-release exenatide-treated patients.
V z insulinom primerjalnih nadzorovanih študijah, v katerih so bolniki sočasno dobivali metformin in sulfonilsečnino, je bila incidenca teh neželenih učinkov podobna za bolnike zdravljene z insulinom in zdravilom BYETTA.