natgillin/translations-raw huggingface dataset:
Active-controlled study versus insulin glargine as add-on to metformin  sulphonylurea The efficacy of Eperzan was evaluated in a 3-year, randomised (2:1), open-label, insulin glargine-controlled noninferiority study (n = 735).
Učinkovitost zdravila Eperzan so ocenili v 3-letni randomizirani (2:1), odprti, z insulinom glarginom kontrolirani študiji neinferiornosti (n = 735).
Glucose control
Uravnavanje glukoze
Results at 52 weeks in a placebo-controlled study comparing Eperzan 30 mg SC weekly as add-on therapy in patients inadequately controlled on pioglitazone >30 mg daily  metformin >1,500 mg daily
Rezultati (po 52 tednih) s placebom kontrolirane študije, ki je primerjala 30 mg zdravila Eperzan na teden subkutano kot dodatka zdravljenju bolnikov, neustrezno urejenih na pioglitazonu > 30 mg na dan ± metforminu > 1.500 mg na dan
If you use too much Eperzan, contact a doctor or pharmacist for advice.
Če ste uporabili večji odmerek zdravila Eperzan, kot bi smeli Če ste uporabili preveč zdravila Eperzan, se posvetujte z zdravnikom ali farmacevtom.
Thyroid C-cell tumours were observed in 2 year rodent carcinogenicity studies with other GLP-1 receptor agonists.
V 2-letnih študijah kancerogenosti drugih agonistov receptorjev GLP-1 so opažali tumorje ščitničnih celic C. V študijah teh drugih zdravil pri glodalcih je bila s hiperplazijo ščitničnih celic C in tumorji povezana zvišana koncentracija kalcitonina v serumu.
Placebo Metformin 1,500 mg daily
Placebo + metformin ≥ 1.500 mg na dan
ATTACHING NEEDLE, REMOVING AIR FROM CARTRIDGE, AND PREPARING PEN FOR INJECTION (STEPS 5-7)
ODSTRANJEVANJE POKROVČKOV IGLE IN INJICIRANJE ZDRAVILA (7.
DO NOT attach by screwing the needle on
NE NAMESTITE igle s privijanjem
Body weight has no clinically relevant effect on albiglutide AUC over the range 44 to 158 kg. A 20% increase in body weight resulted in an approximate 18.5% increase in clearance.
Telesna masa v razponu od 44 do 158 kg ni klinično pomembno vplivala na AUC albiglutida.
You inject Eperzan under your skin in your stomach area, upper leg (thigh) or in the back of your upper arm. You can inject the same area of your body each week, but don't inject in exactly the same place every time.
Zdravilo Eperzan si injicirate pod kožo na področje trebuha, zgornjega dela noge (stegna) ali zadnje strani zgornjega dela roke (nadlakta).
anhydrous (see section 2 under ‘Sodium content'), trehalose dihydrate, mannitol, polysorbate 80.
- Pomožne snovi so: natrijev dihidrogenfosfat monohidrat in brezvodni natrijev hidrogenfosfat (glejte poglavje 2 pod naslovom "Vsebnost natrija"), trehaloza-dihidrat, manitol, polisorbat 80.
On background therapy of metformin 1,500 mg daily plus glimepiride 4 mg daily, Eperzan 30 mg SC weekly (with optional uptitration to 50 mg weekly after a minimum of 4 weeks) was compared to placebo or pioglitazone 30 mg daily (with optional titration to 45 mg/day).
Na podlagi osnovnega zdravljenja s ≥ 1.500 mg metformina na dan + 4 mg glimepirida na dan so 30 mg zdravila Eperzan subkutano na teden (s fakultativnim zvišanjem na 50 mg na teden po najmanj 4 tednih) primerjali s placebom ali 30 mg pioglitazona na dan (s fakultativnim titriranjem na 45 mg na dan).
Treatment with Eperzan resulted in statistically significant reductions in HbA1c from baseline at Week 26 compared to sitagliptin.
Zdravljenje z zdravilom Eperzan je v primerjavi s sitagliptinom do 26. tedna statistično značilno znižalo HbA1c v primerjavi z izhodiščem.
-2.6 (-3.2, -2.0) c a Intent to treat population - last observation carried forward b Adjusted mean c P<0.05 for treatment difference
-2,6 (-3,2, -2,0) c a Populacija z-namenom-zdravljenja - prenos zadnjega opažanja b Korigirano povprečje c p < 0,05 za razliko med zdravljenji
When diet and exercise alone do not provide adequate glycaemic control in patients for whom use of metformin is considered inappropriate due to contraindications or intolerance.
Pri bolnikih, za katere uporaba metformina zaradi kontraindikacij ali intolerance ni primerna, samo z dieto in telesno dejavnostjo pa glikemija ni ustrezno urejena.
• Throw away the pen if leaking or jammed.
• Če peresnik pušča ali se zatakne, ga zavrzite.
At 52 weeks, treatment with Eperzan resulted in statistically significant reductions from baseline in HbA1c compared to placebo.
tednih je zdravljenje z zdravilom Eperzan v primerjavi s placebom statistično značilno znižalo HbA1c v primerjavi z izhodiščem.
Each pen delivers a single 30 mg or 50 mg dose of Eperzan in a volume of 0.5 ml.
En peresnik odda en 30 mg ali 50 mg odmerek zdravila Eperzan v volumnu 0,5 ml. Velikost pakiranja:
On background therapy of metformin 1,500 mg daily, Eperzan 30 mg SC weekly (with optional uptitration to 50 mg weekly after a minimum of 4 weeks) was compared to sitagliptin 100 mg daily, glimepiride 2 mg daily (with optional titration to 4 mg daily), or placebo.
Na podlagi osnovnega zdravljenja z ≥ 1.500 mg metformina na dan so 30 mg zdravila Eperzan subkutano na teden (s fakultativnim zvišanjem na 50 mg na teden po najmanj 4 tednih) primerjali s 100 mg sitagliptina na dan, 2 mg glimepirida na dan (s fakultativnim titriranjem na 4 mg na dan) ali placebom.
Add-on to insulin glargine
Dodatek insulinu glarginu
You should see the [2] in the number window (Figure G).
V številčnem okencu morate videti [2] (Slika G).
Difference from placebo + met + glimb (95% CI)
Razlika od kombinacije placebo + met + glimb (95 % IZ)
Patients may store the pens at room temperature, not exceeding 30C, for no more than a total of 4 weeks prior to use.
Bolniki lahko peresnike shranjujejo na sobni temperaturi, ki ne presega 30 °C, a ne več kot skupaj 4 tedne pred uporabo.
Gastric motility
Motiliteta želodca
3 Place pen into cup with clear cartridge pointing up (Figure I).
3 Položite peresnik v posodico tako, da je prozorni vložek obrnjen navzgor (Slika I).
Common: may affect up to 1 in 10 people:
Pogosti: pojavijo se lahko pri do 1 od 10 bolnikov:
The primary endpoint was change in HbA1c from baseline at 26 weeks.
Primarni opazovani dogodek je bila sprememba HbA1c od izhodišča po 26 tednih.
If you stop using Eperzan, your blood sugar levels may be affected.
Eperzan, to lahko vpliva na koncentracijo sladkorja v vaši krvi.
Results at 52 weeks in a placebo-controlled study comparing Eperzan 30 mg SC weekly (with optional uptitration to 50 mg weekly) to pioglitazone 30 mg daily (with optional titration to 45 mg/day) as add-on therapy in patients inadequately controlled on metformin + sulphonylurea (glimepiride 4 mg daily)
Rezultati (po 52 tednih) s placebom kontrolirane študije, ki je primerjala 30 mg zdravila Eperzan na teden subkutano (s fakultativnim zvišanjem na 50 mg na teden) s 30 mg pioglitazona na dan (s fakultativnim titriranjem na 45 mg/dan) kot dodatka zdravljenju bolnikov, neustrezno urejenih s kombinacijo metformin + sulfonilsečnina (glimepirid 4 mg na dan)
It may be necessary to reduce the dose of concomitantly administered insulin secretagogues (such as sulphonylureas) or insulin to reduce the risk of hypoglycaemia when starting Eperzan (see sections 4.4 and 4.8).
Za zmanjšanje tveganja za hipoglikemijo po uvedbi zdravila Eperzan bi lahko bilo potrebno znižanje odmerka sočasno uporabljenih insulinskih sekretagogov (kot so sulfonilsečnine) ali insulina (glejte poglavji 4.4 in 4.8).
Multipack containing 12 single-dose pens and 12 pen needles (3 packs of 4 pens and 4 needles).
Skupno pakiranje vsebuje 12 peresnikov z enkratnim odmerkom in 12 igel za peresnike (3 pakiranja s 4 peresniki in 4 iglami).
Results at 26 weeks in a study comparing Eperzan 30 mg SC weekly (with optional uptitration to 50 mg weekly) to prandial insulin lispro as add-on therapy in patients inadequately controlled on insulin glargine alone
Rezultati (po 26 tednih) študije, ki je primerjala 30 mg zdravila Eperzan na teden subkutano (s fakultativnim zvišanjem na 50 mg na teden) s prandialnim insulinom lispro kot dodatkom zdravljenju bolnikov, neustrezno urejenih z insulinom glarginom samim
1.55 (1.05, 2.06) c a Intent to treat population - last observation carried forward b Adjusted mean c P<0.05 for treatment difference
1,55 (1,05, 2,06) c a Populacija z-namenom-zdravljenja - prenos zadnjega opažanja b Korigirano povprečje c p < 0,05 za razliko med zdravljenji
Change at Week 52b Difference from placebob (95% CI)
Sprememba po 52 tednihb Razlika od placebab (95 % IZ)
Eperzan 30 mg/50 mg Weekly + Metformin 1,500 mg daily + Glimepiride 4 mg daily
Eperzan 30 mg/50 mg na teden + metformin ≥ 1.500 mg na dan + glimepirid 4 mg na dan
Difference from glimepiride + metforminb , (95% CI) a Intent to treat population - last observation carried forward b Adjusted mean c P<0.05 for treatment difference
Razlika od kombinacije glimepirid + metforminb, (95 % IZ) a Populacija z-namenom-zdravljenja - prenos zadnjega opažanja b Korigirano povprečje c p < 0,05 za razliko med zdravljenji Dodatek pioglitazonu
Discard pen after use.
Peresnik po uporabi zavrzite.
Immune system disorders
Bolezni imunskega sistema preobčutljivo stna reakcija
Infections and infestations
Infekcijske in parazitske bolezni pljučnica
A single carton of 4 pens and 4 needles may be stored at room temperature, not exceeding 30C, for no more than a total of 4 weeks prior to use.
Posamezno škatlo s 4 peresniki in 4 iglami se lahko shranjuje pri sobni temperaturi, ki ne presega 30 °C, vendar ne več kot skupaj 4 tedne pred uporabo.
In pre- and postnatal development studies in mice administered albiglutide during pregnancy or while nursing, reduced pre-weaning body weight of F1 offspring was observed at 1 mg/kg/day (at exposures below clinical exposure).
so ob odmerkih ≥ 1 mg/kg/dan (izpostavljenosti, manjše od klinične izpostavljenosti) pri mladičih F1 opažali zmanjšano telesno maso pred odstavitvijo.
There were no albiglutide related findings in thyroids of monkeys given up to 50 mg/kg/week for up to 52 weeks (75 times clinical exposure based on AUC).
V ščitnicah opic, ki so dobivale odmerek 50 mg/kg/teden (75-kratnik klinične izpostavljenosti na podlagi AUC) do 52 tednov, niso ugotovili z albiglutidom povezanih sprememb.
This dose was associated with an increased frequency of nausea, vomiting, and headache.
Ta odmerek je bil povezan z večjo pogostnostjo navzee,
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER LABEL - Multipack containing 12 single-dose pens and 12 pen needles (3 packs of 4 pens and 4 needles ) -with blue box
ZUNANJA NALEPKA - Skupno pakiranje vsebuje 12 peresnikov z enkratnim odmerkom in 12 igel za peresnike (3 pakiranja s 4 peresniki in 4 iglami) - z modro škatlo
Albiglutide slowed gastric emptying compared with placebo for both solids and liquids when 100 mg was administered as a single dose in healthy subjects.
Enkraten odmerek 100 mg albiglutida je pri zdravih prostovoljcih v primerjavi s placebom upočasnil želodčno praznjenje trdnih in tekočih snovi.
Risk of acute pancreatitis (an inflamed pancreas) Pancreatitis has been reported as an uncommon side effect.
Kot občasen neželen učinek je bil opisan pankreatitis.
Questions and answers about the instructions for use of the pre-filled pen
Vsebina pakiranja in dodatne informacije Navodila za uporabo napolnjenega injekcijskega peresnika (na hrbtni strani) Vprašanja in odgovori o navodilih za uporabo napolnjenega injekcijskega peresnika
Results at 52 weeks in an active-controlled study comparing Eperzan 30 mg SC weekly (with optional uptitration to 50 mg weekly) to insulin glargine (titrated weekly per prescribing information) as addon therapy in patients inadequately controlled on metformin  sulfonylurea
Rezultati (po 52 tednih) z aktivno učinkovino kontrolirane študije, ki je primerjala 30 mg zdravila Eperzan na teden subkutano (s fakultativnim zvišanjem na 50 mg na teden) z insulinom glarginom (titriranim tedensko v skladu z informacijami za predpisovanje) kot dodatkom zdravljenju bolnikov, neustrezno urejenih z metforminom ± sulfonilsečnino
UNIQUE IDENTIFIER - HUMAN READABLE DATA
EDINSTVENA OZNAKA - V BERLJIVI OBLIKI PODATKI NA ZUNANJI OVOJNINI
Placebo + Metformin 1,500 mg daily + Glimepiride 4 mg daily
Placebo + metformin ≥ 1.500 mg na dan + glimepirid 4 mg na dan
Step 9 Dispose pen
5. korak Namestite iglo
Placebo Sitagliptin Glimepiride Albiglutide x axis; Weeks (Rescue free), y axis; Probability of event
Os x: tedni (brez rešilnega ukrepanja), os y: verjetnost dogodka
Across the 8 clinical trials, and including subjects in all treatment groups, a total of 19% of patients (N = 937) were 65 years of age and older, and 2% (N = 112) were 75 years of age and older, 52%
(N = 937) starih 65 let ali več in 2 % (N = 112) starih 75 let ali več; 52 % je bilo moških in povprečni indeks telesne mase (ITM) je bil 33 kg/m2.
Pioglitazone + Metformin 1,500 mg daily + Glimepiride 4 mg daily
Pioglitazon + metformin ≥ 1.500 mg na dan + glimepirid 4 mg na dan
Reduced F1 body weight reversed post-weaning with the exception of F1 females from dams treated perinatally (end of gestation to 10 days postpartum) at 5 mg/kg/day with no other effects on development.
Zmanjšana telesna masa je pri F1 izginila po odstavitvi; izjema so bile samice F1 samic-mater, ki so perinatalno (od konca gestacije do 10 dni po skotitvi) prejemale
Eperzan 30 mg/50 mg Weekly + Metformin 1,500 mg daily
Eperzan 30 mg/50 mg na teden + metformin ≥ 1.500 mg na dan
Waiting may result in a blocked or clogged needle.
To lahko povzroči zamašitev igle.
Over 2,300 patients have received Eperzan in 8 placebo- or active-controlled phase III studies.
V 8 študijah III. faze, kontroliranih s placebom ali aktivno učinkovino, je zdravilo Eperzan prejemalo več kot
Step 1 Check Pen
1. korak Preverite peresnik
Similar exposure is achieved with SC administration of albiglutide in the abdomen, thigh, or upper arm.
Izpostavljenost je po subkutanem injiciranju albiglutida v trebuh, stegno ali nadlaket podobna.
Difference from glimepiride + metforminb, (95% CI)
Razlika od kombinacije glimepirid + metforminb, (95 % IZ)
-0.6 (-1.1, -0.1)c a Intent to treat population - Last Observation Carried Forward (ITT-LOCF) b Adjusted mean c P<0.05 for treatment difference
-0,6 (-1,1, -0,1)c a Populacija z-namenom-zdravljenja - prenos zadnjega opažanja (ITT-LOCF - intent to treat popuation - last observation carried forward)
Results at 52 weeks in a placebo-controlled study with two doses of Eperzan (30 vs. 50 mg SC weekly) as monotherapy
Rezultati s placebom kontrolirane študije dveh odmerkov zdravila Eperzan (30 mg v primerjavi s 50 mg subkutano na teden) kot monoterapije po 52 tednih
Difference from placebo + metforminb, (95% CI)
Razlika od kombinacije placebo + metforminb, (95 % IZ)
PARTICULARS TO APPEAR ON INTERMEDIATE PACKAGING CARTON - Multipack containing 12 single-dose pens and 12 pen needles (3 packs of 4 pens and 4 needles) - without blue box
ŠKATLA - Skupno pakiranje vsebuje 12 peresnikov z enkratnim odmerkom in 12 igel za peresnike (3 pakiranja s 4 peresniki in 4 iglami) - brez modre škatle
Eperzan 30 mg Weekly + Pioglitazone 30 mg daily (+/- Metformin 1,500 mg daily)
Eperzan 30 mg na teden + pioglitazon ≥ 30 mg na dan (+/- metformin ≥ 1.500 mg na dan)
Waiting the full 15 minutes ensures that the medicine powder and water are mixed the right way, even though it may look like it is mixed sooner.
S tem, da počakate polnih 15 minut, boste zagotovili, da sta prašek z zdravilom in voda pravilno premešana,
• indigestion
• bruhanje,
MIXING YOUR MEDICINE AND WAITING 30 MINUTES (STEPS 2-3) What if I do not wait 30 minutes after turning the pen to the Number 2?
KORAK) Kaj, če po obratu peresnika na številko 2 ne počakam 30 minut?
Proportion Achieving HbA1c <7% Body Weight (kg)
Delež bolnikov, ki so dosegli HbA1c < 7 % Telesna masa (kg)
Waiting the full 30 minutes ensures that the medicine powder and water are mixed the right way, even though it may look like it is mixed sooner.
S tem, da počakate polnih 30 minut, boste zagotovili, da sta prašek z zdravilom in voda pravilno premešana,
The primary endpoint was change in HbA1c from baseline at 32 weeks.
Primarni opazovani dogodek je bila sprememba HbA1c od izhodišča po 32 tednih.
The efficacy of Eperzan was evaluated in a 3-year, randomised, double-blind, multicentre study (n = 299).
Učinkovitost zdravila Eperzan so ocenili v 3-letni randomizirani, dvojno slepi multicentrični študiji (n =
-1.5 (-2.1, -1.0) c a Intent to treat population - last observation carried forward b Adjusted mean c P<0.05 for treatment difference
-1,5 (-2,1, -1,0) c a Populacija z-namenom-zdravljenja - prenos zadnjega opažanja b Korigirano povprečje c p < 0,05 za razliko med zdravljenji
Check with your doctor, nurse or pharmacist before you use Eperzan if you think any of these apply to you.
Če menite, da kaj od tega velja za vas, se posvetujte z zdravnikom, medicinsko sestro ali farmacevtom, preden uporabite zdravilo Eperzan.
Difference from placebo + pioglitazoneb (95% CI) a Intent to treat population - last observation carried forward b Adjusted mean c P<0.05 for treatment difference
Razlika od kombinacije placebo + pioglitazonb (95 % IZ) a Populacija z-namenom-zdravljenja - prenos zadnjega opažanja b Korigirano povprečje c p < 0,05 za razliko med zdravljenji Dodatek kombinaciji metformin + sulfonilsečnina
Each 50 mg pen delivers 50 mg albiglutide in a volume of 0.5 ml.
Po pripravi peresnik odda 50 mg albiglutida na 0,5-ml odmerek.
Eperzan Insulin glargine ( 20 units per day)
Insulin glargin (≥ 20 enot na dan)
Pens may be stored at room temperature, not exceeding 30C, for no more than a total of 4 weeks prior to use.
Peresniki so lahko shranjeni na sobni temperaturi, ki ne presega 30 °C, vendar ne več kot skupaj 4 tedne pred uporabo.
Each 30 mg pen delivers 30 mg albiglutide in a volume of 0.5 ml.
Po pripravi peresnik odda 30 mg albiglutida na 0,5-ml odmerek.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 30 mg
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT
Remove Outer Needle Cap
1. korak Odstranite zunanji pokrovček igle
Talk to your doctor, nurse or pharmacist before using Eperzan:
Pred začetkom uporabe zdravila Eperzan se posvetujte z zdravnikom, medicinsko sestro ali farmacevtom:
Results at 26 weeks in a study of Eperzan 30 mg SC weekly (with uptitration to 50 mg weekly if needed) versus sitagliptin (dosed according to renal function) in patients with different degrees of renal impairment
50 mg na teden, če je bilo potrebno) v primerjavi s sitagliptinom (odmerjanim glede na delovanje ledvic) pri bolnikih z različnimi stopnjami okvare ledvic
Increased mortality and morbidity were seen at all doses (1 mg/kg/day) in lactating females in mouse preand postnatal development studies.
V študijah pre- in postnatalnega razvoja so pri doječih samicah opažali večjo umrljivost in obolevnost pri vseh odmerkih (≥ 1 mg/kg/dan).
MIXING YOUR MEDICINE AND WAITING 15 MINUTES (STEPS 2-3) What if I do not wait 15 minutes after turning the pen to the Number 2?
KORAK) Kaj, če po obratu peresnika na številko 2 ne počakam 15 minut?
The primary endpoint was change in HbA1c from baseline at 52 weeks.
Primarni opazovani dogodek je bila sprememba HbA1c od izhodišča po 52 tednih.
Possible hypersensitivity reactions including angioedema, erythema, generalised pruritus and rash with dyspnoea, have been reported with albiglutide.
V kombinaciji z albiglutidom so poročali o možnih preobčutljivostnih reakcijah vključno z angioedemom
Change at Week 32b Difference from liraglutideb (95% CI)
Sprememba po 32 tednihb Razlika od liraglutidab (95 % IZ)
Gastrointestinal events with Eperzan occurred more frequently in patients with moderate to severe renal impairment (eGFR 15 to 59 ml/min/1.73 m2) than in those with mild renal impairment or normal renal function.
(eGFR od 15 do 59 ml/min/1,73 m2) kot pri bolnikih z blago okvaro ali z normalnim delovanjem ledvic.
Remove Inner Needle Cap
2. korak Odstranite notranji pokrovček igle
Change at Week 26b Difference from sitagliptinb (95% CI)
Sprememba po 26 tednihb Razlika od sitagliptinab (95 % IZ)
The between-treatment difference in HbA1c of 0.1% (-0.04, 0.27) from baseline at 52 weeks for Eperzan and insulin glargine met the prespecified noninferiority margin (0.3%).
Po 52 tednih je bila razlika HbA1c v primerjavi z izhodiščem med zdravilom Eperzan in insulinom glargin 0,1 % (-0,04, 0,27) in je dosegla vnaprej opredeljeno mejo neinferiornosti (0,3 %).
Add-on combination therapy
Dodatek v kombiniranem zdravljenju
You will mix them together by twisting the pen.
Premešate ju s sukanjem peresnika.
Powder for solution for injection:
Prašek in vehikel za raztopino za injiciranje
8b Press the injection button down slowly and steadily until you hear a “click” (Figure S).
8b Počasi in enakomerno pritiskajte gumb za injiciranje dol,
Difference from sitagliptin + metforminb, (95% CI)
Razlika od kombinacije sitagliptin + metforminb, (95 % IZ)
No clinically relevant effects on the pharmacokinetics of R-and S- enantiomers of warfarin were observed when a single dose of racemic warfarin (25 mg) was administered with steady-state albiglutide (50 mg weekly).
Uporaba enkratnega odmerka racemnega varfarina (25 mg) v stanju dinamičnega ravnovesja albiglutida (50 mg na teden) ni klinično pomembno vplivala na farmakokinetiko R- in S-enantiomera varfarina.
Albiglutide also slows gastric emptying.
Placebo Sitagliptin Glimepiride Albiglutide
In clinical trials of at least 2 years duration, 8% of subjects in the Eperzan group discontinued active treatment because of an adverse event compared with 6% in the all comparators group.
8 % preiskovancev v skupini z zdravilom Eperzan in 6 % v skupini z vsemi primerjalnimi zdravili.
Pull off Needle Caps and Discard
Snemite pokrovčka igle in ju zavrzite
Difference from pioglitazone + met + glimb (95% CI)
Razlika od kombinacije pioglitazon + met + glimb
• feeling sick (nausea)
• občutek slabosti v želodcu (siljenje na bruhanje),
Eperzan 50 mg powder and solvent for solution for injection
Eperzan 50 mg prašek in vehikel za raztopino za injiciranje.
Difference from placebob (95% CI) a Intent to treat population - last observation carried forward b Adjusted mean c P<0.05 for treatment difference
Razlika od placebab (95 % IZ) a Populacija z-namenom-zdravljenja - prenos zadnjega opažanja b Korigirano povprečje c p < 0,05 za razliko med zdravljenji Kombinirano zdravljenje Dodatek metforminu
Effects on embryo-foetal development (embryo-foetal lethality and skeletal variations) were observed at 50 mg/kg/day (at low multiple of clinical exposure).
Pri 50 mg/kg/dan (to je nizek večkratnik klinične izpostavljenosti) so opažali vplive na embrio-fetalni razvoj (embrio-fetalna umrljivost in spremembe okostja).
Reconstitution time
Čas priprave.
Eperzan 30 mg powder and solvent for solution for injection
Eperzan 30 mg prašek in vehikel za raztopino za injiciranje.
STATEMENT OF ACTIVE SUBSTANCE(S) Each dose contains 30 mg per 0.5 ml following reconstitution.
En odmerek po pripravi vsebuje 30 mg na 0,5 ml.
Always use this medicine exactly as your doctor, nurse or pharmacist has told you.
Pri uporabi tega zdravila natančno upoštevajte navodila zdravnika, medicinske sestre ali farmacevta.
Difference from insulin glargineb (95% CI)
Sprememba po 52 tednihb Razlika od insulina glarginab (95 % IZ)
Stop taking Eperzan.
Zanihajte peresnik
Once weekly Eperzan pen 30 mg
Peresnik zdravila Eperzan 30 mg enkrat na teden
STATEMENT OF ACTIVE SUBSTANCE(S) Each dose contains 50 mg per 0.5 ml following reconstitution.
En odmerek po pripravi vsebuje 50 mg na 0,5 ml.
MARKETING AUTHORISATION NUMBER(S) EU/1/13/908/002
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET Z ZDRAVILOM EU/1/13/908/002
Step 5 Attach needle 5a Peel tab from outer needle cap (Figure L).
5a Odlepite prelepko z zunanjega pokrovčka igle (Slika L).
or
Redki
Eperzan 30 mg powder and solvent for solution for injection Each pen delivers 30 mg albiglutide per 0.5 ml dose following reconstitution.
Vsak peresnik s 30 mg odda 30 mg albiglutida v prostornini 0,5 ml. - Topilo je voda za injekcije.
MARKETING AUTHORISATION NUMBER(S) EU/1/13/908/004
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET Z ZDRAVILOM EU/1/13/908/004
Talk to your doctor if you are taking acarbose and Eperzan at the same time.
Če sočasno jemljete akarbozo in zdravilo Eperzan, se posvetujte z zdravnikom.
Discontinuation of treatment
NAČIN IZDAJANJA ZDRAVILA