natgillin/translations-raw huggingface dataset:
What if I leave my pen for more than 15 minutes after turning the pen to the Number 2 (Step
Kaj, če čakam več kot 15 minut po obratu peresnika na številko 2 (2. korak)?
Patients with severe renal impairment receiving Eperzan experienced a higher frequency of diarrhoea, nausea, and vomiting compared to patients with mild or moderate renal impairment.
Okvara ledvic Bolniki s hudo okvaro ledvic, ki so prejemali zdravilo Eperzan, so imeli drisko, navzeo in bruhanje pogosteje kot bolniki z blago ali zmerno okvaro ledvic.
Treatment with Eperzan resulted in a mean weight loss for Eperzan (-0.7 kg) compared to a mean weight gain for insulin lispro (+0.8 kg) and the difference between treatment groups was statistically significant (see Table 6).
Zdravljenje z zdravilom Eperzan je v povprečju povzročilo zmanjšanje telesne mase z zdravilom Eperzan (0,7 kg), medtem ko se je z insulinom lispro telesna masa v povprečju povečala (+0,8 kg); razlika med terapevtskima skupinama je bila statistično značilna (glejte preglednico 6).
The model-adjusted mean decrease in HbA1c from baseline with Eperzan was -0.80 (n = 125), -0.83 (n = 98), and -1.08 (n = 19) in patients with mild (eGFR 60 to 89 ml/min/1.73m2), moderate (eGFR 30 to 59 ml/min/1.73m2), and severe (eGFR <30 ml/min/1.73m2) renal impairment, respectively (see Table 9).
Za model korigirano povprečno znižanje HbA1c v primerjavi z izhodiščem je bilo za zdravilo Eperzan -0,80 (n = 125) pri bolnikih z blago okvaro ledvic (eGFR od 60 do 89 ml/min/1,73 m2), -0,83 (n = 98) pri bolnikih z zmerno okvaro ledvic (eGFR od 30 do 59 ml/min/1,73 m2) in -1,08 (n = 19) pri bolnikih s hudo okvaro ledvic (eGFR < 30 ml/min/1,73 m2) (glejte preglednico 9).
A single dose of simvastatin (80 mg) was administered with steady-state albiglutide (50 mg weekly).
Enkraten odmerek simvastatina (80 mg) so uporabili v stanju dinamičnega ravnovesja albiglutida (50 mg na teden).
Albiglutide did not meaningfully alter the pharmacokinetics of a single-dose of digoxin (0.5 mg) when coadministered with steady-state albiglutide (50 mg weekly).
Albiglutid ni pomembno spremenil farmakokinetike enkratnega odmerka digoksina (0,5 mg), če je bil ta uporabljen sočasno v stanju dinamičnega ravnovesja albiglutida (50 mg na teden).
A prolonged period of observation and treatment for these symptoms may be necessary, taking into account the half-life of albiglutide (5 days).
Zaradi razpolovnega časa albiglutida (5 dni) bi lahko bilo potrebno podaljšano opazovanje in zdravljenje teh simptomov.
There is no therapeutic experience with Eperzan in patients with type 1 diabetes mellitus and it should not be used in these patients.
4.4 Posebna opozorila in previdnostni ukrepi Z zdravilom Eperzan ni terapevtskih izkušenj pri bolnikih s sladkorno boleznijo tipa 1; pri teh bolnikih se ga ne sme uporabljati.
The efficacy of Eperzan was evaluated in a 3-year randomised, double-blind, placebo-controlled, multicentre study (n = 296) in patients inadequately controlled on diet and exercise.
Monoterapija Učinkovitost zdravila Eperzan so ocenili v 3-letni randomizirani, dvojno slepi, s placebom kontrolirani multicentrični študiji (n = 296) bolnikov, nezadostno urejenih z dieto in telesno dejavnostjo.
After mixing, wait 15 minutes before injection
Po mešanju počakajte 15 minut, preden injicirate.
Non-clinical data reveal no special hazards for humans based on studies of safety pharmacology or repeatdose toxicity.
Predklinični podatki na osnovi študij farmakološke varnosti in toksičnosti ponavljajočih se odmerkov ne kažejo posebnih tveganj za človeka.
Rock Pen Again
Znova zanihajte peresnik
What if I leave my pen for more than 30 minutes after turning the pen to the Number 2 (Step
Kaj, če čakam več kot 30 minut po obratu peresnika na številko 2 (2. korak)?
REMOVING BOTH NEEDLE CAPS AND INJECTING YOUR MEDICINE (STEPS 7-8) After I turn the pen to Number 3 (Step 6), there are still some small air bubbles remaining.
KORAK) Ko peresnik obrnem na številko 3 (6. korak), je v vložku še vedno nekaj majhnih mehurčkov zraka.
After mixing, wait 30 minutes before injection
Po mešanju počakajte 30 minut, preden injicirate.
• A new pen (Figure A).
• Nov peresnik (Slika A)
A statistically significant decrease in body weight was observed for Eperzan compared to an increase in body weight for insulin glargine and the difference in weight change was statistically significant (see Table 7).
Z zdravilom Eperzan so opažali statistično značilno znižanje telesne mase, z insulinom glarginom pa njeno povečanje; razlika v spremembi telesne mase je bila statistično značilna (glejte preglednico 7).
However, if you take Eperzan with sulphonylurea or insulin, you may get low blood sugar (hypoglycaemia).
Vendar če uporabljate zdravilo Eperzan skupaj s sulfonilsečnino ali insulinom, se vam lahko pojavi nizek krvni sladkor (hipoglikemija).
4 pen needles
4 igle za peresnik
Eperzan 30 mg SC weekly (with uptitration to 50 mg weekly at Week 6) was compared to liraglutide 1.8 mg daily (titrated up from 0.6 mg at Week 1 and 1.2 mg at Week 1 to Week 2) in patients inadequately controlled on monotherapy or combination oral antidiabetic therapy (metformin, thiazolidinedione, or sulphonylureas).
Zdravilo Eperzan 30 mg subkutano na teden (z zvišanjem na 50 mg na teden 6. teden) so primerjali z 1,8 mg liraglutida na dan (titriranega od 0,6 mg 1. teden in 1,2 mg 1. do 2. teden) pri bolnikih, neustrezno urejenih z monoterapijo ali kombinacijo peroralnih antidiabetikov (metformin, tiazolidindion ali sulfonilsečnine).
Patients (%) Achieving HbA1c <7% Body Weight (kg)
Bolniki (%), ki so dosegli HbA1c < 7 % Telesna masa (kg)
In patients who completed the study (52 weeks), the adjusted mean change in baseline in HbA1c was -1.0% for Eperzan (N = 121) and -0.9% for insulin lispro (N = 141).
Pri bolnikih, ki so dokončali študijo (52 tednov) je bila korigirana povprečna sprememba HbA1c v primerjavi z izhodiščem -1,0 % za zdravilo Eperzan (N = 121) in -0,9 % za insulin lispro (N = 141).
The clinical experience in patients >75 years is very limited (see section 5.2).
Kliničnih izkušenj z bolniki, starimi ≥ 75 let, je zelo malo
At 26 weeks, the between-treatment difference in HbA1c of 0.2% for Eperzan and insulin lispro met the pre-specified noninferiority margin (0.4%).
Po 26 tednih je bila razlika HbA1c med zdravljenjema za zdravilo Eperzan in insulin lispro 0,2 % in je dosegla vnaprej opredeljeno mejo neinferiornosti (0,4 %).
Solvent: A clear, colourless solution.
Vehikel: bistra, brezbarvna raztopina.
Age had no clinically relevant effect on the pharmacokinetics of albiglutide based on a population pharmacokinetic analysis of subjects aged 24-83 years (see section 4.2).
Na podlagi populacijske farmakokinetične analize preiskovancev, starih od 24 do 83 let, starost ni klinično pomembno vplivala na farmakokinetiko albiglutida (glejte poglavje 4.2).
In patients who were treated for at least 104 weeks, the adjusted mean change in baseline in HbA1c was -0.97% for Eperzan (N = 182) and -1.04% for insulin glargine (N = 102).
Pri bolnikih, zdravljenih vsaj 104 tedne, je bila korigirana povprečna sprememba HbA1c v primerjavi z izhodiščem -0,97 % za zdravilo Eperzan (N = 182) in -1,04 % za insulin glargin (N = 102).
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON - 4 pen pack
PODATKI NA ZUNANJI OVOJNINI ŠKATLA - pakiranje s 4 peresniki
Compared to placebo, treatment with Eperzan resulted in statistically significant reductions from baseline in HbA1c (-0.8% for Eperzan versus -0.1% for placebo, p<0.05) and FPG (-1.3 mmol/l for Eperzan versus +0.4 mmol/l for placebo, p<0.05) at 52 weeks.
Zdravljenje z zdravilom Eperzan je v primerjavi s placebom od izhodišča do 52. tedna statistično značilno znižalo HbA1c (-0,8 % Eperzan, -0,1 % placebo, p < 0,05) in glukozo v plazmi na tešče (-1,3 mmol/l Eperzan in +0,4 mmol/l placebo, p < 0,05).
Insulin lispro Insulin glargine ( 20 units per day)
Insulin lispro Insulin glargin (≥ 20 enot na dan)
Other side effects reported with Eperzan
Drugi neželeni učinki, opisani z zdravilom Eperzan
No overall differences in glycaemic effectiveness or body weight were observed across demographic subgroups (age, gender, race/ethnicity, duration of diabetes).
Po demografskih podskupinah (starost, spol, rasa/etnična pripadnost, trajanje sladkorne bolezni) v celoti niso opažali razlik v učinkovitosti, kar zadeva glikemijo, ali v telesni masi.
The most common events leading to discontinuation of Eperzan were reactions at the injection site and GI related events, each
Najpogostejši neželeni učinki, ki so povzročili prenehanje uporabe zdravila Eperzan, so bile reakcije na mestu injiciranja in učinki na prebavilih; enih in drugih je bilo < 2 %.
The change from baseline in HbA1c at the 6 month timepoint was also statistically significant for the 30 mg (0.9%) and 50 mg (1.1%) weekly doses of Eperzan (see Table 2).
Statistično značilni sta bili tudi spremembi izhodiščnega HbA1c po 6 mesecih, tako za tedenski odmerek 30 mg (0,9 %) kot 50 mg (1,1 %) zdravila Eperzan (glejte preglednico 2).
Step 4 Rock pen and check medicine
4. korak Zanihajte peresnik in preverite zdravilo
IMPORTANT: You may hear a “click” when you first start twisting the cartridge from [2] to [3].
POMEMBNO: Ko boste začeli sukati vložek od [2] proti [3], boste morda zaslišali "klik".
How to use Eperzan
Kako uporabljati zdravilo Eperzan
The adjusted mean change in body weight from baseline at 104 weeks was -2.6 kg for Eperzan (N = 184) and +1.4 kg for insulin glargine (N = 104).
Korigirana povprečna sprememba telesne mase v primerjavi z izhodiščem je bila po 104 tednih -2,6 kg za zdravilo Eperzan (N = 184) in +1,4 kg insulin glargin (N = 104).
Dispose of the pen as instructed by your doctor, pharmacist or nurse.
Peresnik zavrzite, kot vam je naročil zdravnik, farmacevt ali medicinska sestra.
In clinical trials, acute pancreatitis has been reported in association with Eperzan (see section 4.8).
kliničnih preskušanjih so poročali o akutnem pankreatitisu v povezavi z zdravilom Eperzan (glejte poglavje
Treatment with Eperzan did not meet the pre-specified noninferiority margin (0.3%) against pioglitazone for HbA1c.
Zdravljenje z zdravilom Eperzan v primerjavi s pioglitazonom ni doseglo vnaprej opredeljene meje neinferiornosti (0,3 %) za HbA1c.
INSTRUCTIONS FOR USE
NAVODILO ZA UPORABO
You and your doctor should decide whether you will use Eperzan or breast-feed.
Skupaj z zdravnikom se morate odločiti, ali boste uporabljali zdravilo
Eperzan has no or negligible influence on the ability to drive or use machines.
4.7 Vpliv na sposobnost vožnje in upravljanja s stroji Zdravilo Eperzan nima ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
Eperzan 30 mg SC weekly was compared to placebo in patients inadequately controlled on pioglitazone 30 mg daily (with or without metformin 1,500 mg daily).
Zdravilo Eperzan 30 mg subkutano na teden so primerjali s placebom pri bolnikih, neustrezno urejenih z ≥ 30 mg pioglitazona na dan (z ≥ 1.500 mg metformina na dan ali brez njega).
Following SC administration of a single 30 mg dose to subjects with type 2 diabetes, maximum concentrations were reached 3 to 5 days post dose with mean peak albiglutide concentration (Cmax) of 1.74 mcg/ml and mean area under the time-concentration curve (AUC) of 465 mcg.h/ml.
Absorpcija Po subkutani uporabi posamičnega odmerka 30 mg pri preiskovancih s sladkorno boleznijo tipa 2 je bila največja koncentracija dosežena od 3 do 5 dni po odmerku; povprečna najvišja koncentracija albiglutida (Cmax) je bila 1,74 µg/ml in povprečna površina pod krivuljo koncentracije po času (AUC) 465 µg.h/ml.
IMPORTANT: There are two needle caps, an outer and inner needle cap. 7b While holding the pen in the air, remove outer needle cap (Figure Q) and inner needle cap (Figure R).
7b Medtem ko držite peresnik v zraku, snemite zunanji pokrovček igle (Slika Q) in notranji pokrovček igle (Slika R).
No dose adjustment is necessary for patients with mild and moderate renal impairment (eGFR 60 to 89 and 30 to 59 ml/min/1.73m2, respectively) (see sections 4.4, 4.8, 5.1, 5.2).
Bolnikom z blago in zmerno okvaro ledvic (blaga: eGFR od 60 do 89 ml/min/1,73 m2; zmerna: eGFR od 30 do 59 ml/min/1,73 m2) odmerka ni treba prilagoditi (glejte poglavja 4.4, 4.8, 5.1 in 5.2).
Use Eperzan for as long as your doctor recommends.
Če ste prenehali uporabljati zdravilo Eperzan Zdravilo Eperzan uporabljajte toliko časa, kot vam svetuje zdravnik.
Eperzan 30 mg/50 mg Weekly
Eperzan 30 mg/50 mg na teden
No carcinogenicity studies have been performed with albiglutide due to immunogenicity in rodents.
Zaradi imunogenosti pri glodalcih z albiglutidom niso izvedli študij kancerogenosti.
The white injection button will also pop out from the bottom of the pen.
Iz spodnjega dela peresnika bo pogledal beli gumb za injiciranje.
Pen Body
Telo peresnika
Sitagliptin was dosed according to creatinine clearance estimated by Cockcroft-Gault formula (100 mg daily in mild, 50 mg daily in moderate, and 25 mg daily in severe renal impairment) The primary endpoint was change in HbA1c from baseline at 26 weeks.
Sitagliptin so odmerjali glede na očistek kreatinina, ocenjen po Cockcroft-Gaultovi formuli (100 mg na dan pri blagi, 50 mg na dan pri zmerni in 25 mg na dan pri hudi okvari ledvic).
You should not take acarbose if you suffer from bowel obstruction.
Če imate zaporo črevesa, ne smete jemati akarboze.
What Eperzan contains - The active substance is albiglutide.
Zdravilo Eperzan vsebuje kot zdravilno učinkovino albiglutid.
Compared to placebo, treatment with Eperzan 30 mg and 50 mg SC weekly resulted in statistically significant reductions in HbA1c from baseline at Week 52.
Zdravljenje z zdravilom Eperzan 30 mg in 50 mg subkutano tedensko je v primerjavi s placebom do 52. tedna statistično značilno znižalo HbA1c v primerjavi z izhodiščem.
Proportion Achieving HbA1c <7%
HbA1c < 7 %
In reproductive toxicology studies with albiglutide in mice, there were no effects on mating or fertility at doses up to 50 mg/kg/day (at low multiple of clinical exposure).
V študijah reproduktivne toksičnosti albiglutida pri miših v odmerkih do 50 mg/kg/dan (to je nizek večkratnik klinične izpostavljenosti) niso ugotovili vpliva na parjenje ali plodnost.
The primary endpoint was change in HbA1c from baseline at 2 years compared to placebo.
Primarni opazovani dogodek je bila sprememba HbA1c od izhodišča po 2 letih v primerjavi s placebom.
METHOD AND ROUTE(S) OF ADMINISTRATION Read package leaflet.
POSTOPEK IN POT(I) UPORABE ZDRAVILA Preberite navodilo za uporabo.
The pen injector contains powder and water which you need to mix before you can use it. After section 6 of this leaflet there are Instructions For Use giving you step-by-step instructions on how to mix your medicine and how to inject it.
Poglavju 6 tega navodila sledijo Navodila za uporabo, v katerih je korak za korakom pojasnjeno, kako zmešate zdravilo in kako ga injicirate.
The median daily dose of insulin glargine used prior to hyperglycaemic rescue was 10 units (range 2 to 40 units) at study start and 30 units (range 3 to 230 units) at Week 52.
Mediani dnevni odmerek insulina glargina, uporabljenega pred reševanjem hiperglikemije, je bil 10 enot (razpon: od 2 do 40
Carton of 4 single-dose pens and 4 pen needles.
Škatla s 4 peresniki z enkratnim odmerkom in 4 iglami za peresnik.
If you are breast-feeding you must check with your doctor before you use Eperzan.
Če dojite, se morate pred uporabo zdravila Eperzan posvetovati z zdravnikom.
The medicine can be stored at room temperature (less than 30C) for no more than a total of 4 weeks before use.
To zdravilo lahko shranjujete na sobni temperaturi (manj kot 30 °C), vendar ne več kot skupaj 4 tedne pred uporabo.
Eperzan is intended for patient self-administration as a subcutaneous injection in the abdomen, thigh or upper arm region.
Zdravilo Eperzan je namenjeno za bolnikovo samoinjiciranje, v obliki subkutane injekcije v trebuh, stegno ali nadlaket.
- on its own if your blood sugar is not properly controlled by diet and exercise alone, and you can't take metformin (another diabetes medicine)
Zdravilo Eperzan se uporablja kot pomoč za uravnavanje krvnega sladkorja, in sicer: - kot samostojno zdravljenje, če krvnega sladkorja nimate ustrezno urejenega samo z dieto in telesno dejavnostjo ter ne morete jemati metformina (drugo zdravilo za zdravljenje sladkorne bolezni) ali
Twist clear cartridge several times in the direction of the arrow until you feel/hear the pen “click” into place.
Večkrat zasučite prozorni vložek v smeri puščice, dokler ne začutite ali zaslišite, da peresnik "klikne".
The adjusted mean change in body weight from baseline at 52 weeks was -1.0 kg for Eperzan (N = 122) and +1.7 kg for insulin lispro (N = 141).
Korigirana povprečna sprememba telesne mase v primerjavi z izhodiščem je bila po 52 tednih -1,0 kg za zdravilo Eperzan (N = 122) in +1,7 kg insulin lispro (N = 141).
Eperzan should not be used while you're pregnant.
Med nosečnostjo zdravila Eperzan ne smete uporabljati.
Decreased body weight in offspring was observed in mice treated with albiglutide during gestation and lactation (see section 5.3).
Pri mladičih miši, ki so med gestacijo in laktacijo prejemale albiglutid, so opažali manjšo telesno maso (glejte poglavje 5.3).
• raised and itchy rashes,
• izbočene in srbeče izpuščaje,
DO NOT turn the cartridge to [3] (Step 6b) before attaching the needle (Step 5).
NE OBRNITE vložka na [3] (6b.
You must wait 30 minutes for the medicine to dissolve before continuing.
Preden nadaljujete, morate počakati 30 minut, da se zdravilo raztopi.
How to take Eperzan
Kako jemati zdravilo Eperzan
You must wait 15 minutes for the medicine to dissolve before continuing.
Preden nadaljujete, morate počakati 15 minut, da se zdravilo raztopi.
6a With needle pointing up, gently tap the clear cartridge 2-3 times to bring large air bubbles to the top (Figure N).
6. korak Odstranite zrak iz vložka 6a Medtem, ko je igla obrnjena navzgor, 2-krat ali 3-krat rahlo potrkajte po prozornem vložku, da se bodo veliki zračni mehurčki dvignili na vrh (Slika N).
Dehydration, sometimes leading to renal impairment and acute renal failure, has been reported in patients treated with albiglutide and has occurred in patients without gastrointestinal side effects.
Pri bolnikih, ki so se zdravili z albiglutidom, so poročali o dehidraciji, ki se je pojavila pri bolnikih brez gastrointestinalnih neželenih učinkov, in včasih vodi v ovaro ledvic ali akutno ledvično okvaro.
For shelf life of the reconstituted product, see section 6.3.
Za rok uporabnosti pripravljenega zdravila glejte poglavje 6.3.
Sodium content This medicine contains less than 1 mmol sodium (23 mg) per 0.5 ml dose, so is essentially ‘sodium free'.
Zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na 0,5-ml odmerek; to pomeni, da je praktično "brez natrija".
The efficacy of Eperzan was evaluated in a 52 week, randomised, open-label, multicentre noninferiority study (n = 563).
Učinkovitost zdravila Eperzan so ocenili v 52-tedenski randomizirani, odprti multicentrični študiji neinferiornosti (n = 563).
Change at Week 26b Difference from lispro insulinb (95% CI)
Sprememba po 26 tednihb Razlika od insulina lisprob (95 % IZ)
Glimepiride 2 to 4 mg daily + Metformin 1,500 mgd aily
Glimepirid 2 do 4 mg na dan + metformin ≥ 1.500 mg na dan
There are no or limited amount of data from the use of Eperzan in pregnant women.
O uporabi zdravila Eperzan pri nosečnicah je podatkov malo ali jih ni.
Results of an active-controlled trial of Eperzan 30 mg SC weekly (with uptitration to 50 mg weekly) versus liraglutide 1.8 mg daily at 32 weeksa
Rezultati z aktivno učinkovino kontroliranega preskušanja zdravila Eperzan 30 mg subkutano na teden (z zvišanjem na 50 mg na teden) v primerjavi z 1,8 mg liraglutida na dan po 32 tedniha Eperzan 30 mg/50 mg na teden
The incidence of pancreatitis (adjudicated as likely to be related to therapy) in the clinical studies was 0.3% for Eperzan compared to 0% for placebo and 0.1% for comparators (i.e. liraglutide, pioglitazone, glimepiride, sitagliptin, and insulin glargine) with or without additional background antidiabetic therapy (e.g. metformin).
Incidenca pankreatitisa (po presoji ocenjenega kot verjetno povezanega z zdravljenjem) je bila v kliničnih študijah 0,3 % za zdravilo Eperzan, 0 % za placebo in 0,1 % za primerjalna zdravila (tj. liraglutid,
Pens are supplied in packs of 4 pens and 4 needles and multipacks comprising 3 packs, each containing 4 pens and 4 needles.
Peresniki so na voljo v pakiranjih s 4 peresniki in 4 iglami ter v skupnih pakiranjih (3 pakiranja s 4 peresniki in 4 iglami za peresnike).
On background therapy of metformin 1,500 mg daily (with or without sulphonylurea), Eperzan 30 mg SC weekly (with optional uptitration to 50 mg weekly) was compared to insulin glargine (started at 10 units and titrated weekly per prescribing information).
Na podlagi osnovnega zdravljenja s ≥ 1.500 mg metformina na dan (s sulfonilsečnino ali brez nje) so zdravilo Eperzan 30 mg subkutano na teden (s fakultativnim zvišanjem na 50 mg na teden) primerjali z insulinom glarginom (uvedenim z odmerkom 10 enot in titriranim tedensko v skladu z informacijami za predpisovanje).
Eperzan is supplied as a pen for self injection.
Zdravilo Eperzan je na voljo kot peresnik za samoinjiciranje.
PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for solution for injection Multipack:12 pens (3 cartons of 4 pens/4 needles) Do not sell separately
FARMACEVTSKA OBLIKA IN VSEBINA Prašek in vehikel za raztopino za injiciranje Skupno pakiranje: 12 peresnikov (3 škatle s 4 peresniki/4 iglami)
Placebo + Pioglitazone 30 mg daily (+/- Metformin 1,500 mg daily)
Placebo + pioglitazon ≥ 30 mg na dan (+/- metformin ≥ 1.500 mg na dan)
Eperzan 30 mg powder and solvent for solution for injection albiglutide
Eperzan 30 mg prašek in vehikel za raztopino za injiciranje albiglutid
Eperzan 50 mg powder and solvent for solution for injection albiglutide
Eperzan 50 mg prašek in vehikel za raztopino za injiciranje albiglutid
Albiglutide slowed gastric emptying compared with placebo for both solids and liquids when 100 mg was administered as a single dose in healthy subjects (see section 5.1).
Enkraten odmerek 100 mg albiglutida je pri zdravih prostovoljcih v primerjavi s placebom upočasnil želodčno praznjenje trdnih in tekočih snovi (glejte poglavje 5.1).
Results at 104 weeks in a placebo-controlled study comparing Eperzan 30 mg SC weekly (with optional uptitration to 50 mg weekly) to sitagliptin 100 mg daily and glimepiride 2 to 4 mg daily as add-on therapy in patients inadequately controlled on metformin >1,500 mg daily
Rezultati (po 104 tednih) s placebom kontrolirane študije, ki je primerjala 30 mg zdravila Eperzan na teden subkutano (s fakultativnim zvišanjem na 50 mg na teden) s 100 mg sitagliptina na dan in 2 do 4 mg glimepirida na dan kot dodatka zdravljenju bolnikov, neustrezno urejenih na metforminu > 1.500 mg na dan
The primary endpoint was change in HbA1c from baseline at 52 weeks compared to placebo.
Primarni opazovani dogodek je bila sprememba HbA1c od izhodišča po 52 tednih v primerjavi s placebom.
On background therapy of insulin glargine (started at 10 units and titrated to  20 units per day), Eperzan 30 mg SC once weekly (with uptitration to 50 mg if inadequately controlled after Week 8) was compared to prandial insulin lispro (administered daily at mealtimes, started according to standard of care and titrated to effect).
Na podlagi osnovnega zdravljenja z insulinom glarginom (uvedenim z odmerkom 10 enot in titriranim do ≥ 20 enot na dan) so zdravilo Eperzan 30 mg subkutano enkrat na teden (z zvišanjem na 50 mg, če bolezen po 8. tednu ni bila ustrezno urejena) primerjali s prandialnim insulinom lispro (uporabljanim vsak dan ob obrokih, uvedenim v skladu s standardno oskrbo in titriranim do učinka).
In addition no clinically relevant effects on luteinizing hormone, follicle-stimulating hormone, or progesterone were observed when albiglutide and a combination oral contraceptive were co-administered.
Poleg tega med sočasno uporabo albiglutida in kombiniranih peroralnih kontraceptivov niso ugotovili klinično pomembnih vplivov na luteinizirajoči hormon, folikle stimulirajoči hormon ali progesteron.