natgillin/translations-raw huggingface dataset:
When used in combination with a sulphonylurea or a basal insulin, patients should be advised to take precautions to avoid hypoglycaemia while driving and using machines.
Pri uporabi zdravila v kombinaciji s sulfonilsečnino ali bazalnim insulinom je treba bolnike opozoriti, naj upoštevajo previdnostne ukrepe za preprečitev hipoglikemije med vožnjo in upravljanjem s stroji.
Patients receiving medicinal products of either a narrow therapeutic ratio or medicinal products that require careful clinical monitoring should be followed closely, especially at the time of initiation of lixisenatide treatment.
Bolnike, ki prejemajo zdravila, ki imajo bodisi ozko terapevtsko razmerje ali zahtevajo skrbno klinično spremljanje, je treba bolnika natančno spremljati, zlati v času uvedbe zdravljenja z liksisenatidom.
The injection is administered once daily, within the hour prior to any meal of the day.
Injekcija se uporablja enkrat na dan, v eni uri pred katerim koli dnevnim obrokom.
First activate your new pen
Najprej aktivirajte novi peresnik
In addition, hypoglycaemia (when Lyxumia was used in combination with a sulphonylurea and/or a basal insulin) and headache occurred.
Poleg tega sta se pojavljala hipoglikemija (če je bilo zdravilo Lyxumia uporabljeno v kombinaciji s sulfonilsečnino in/ali bazalnim insulinom) in glavobol.
This is because low blood sugar (hypoglycaemia) can occur.
Pojavi se vam namreč lahko nizek krvni sladkor (hipoglikemija).
Lyxumia 20 micrograms solution for injection EU/1/12/811/002 (1 pre-filled pen) EU/1/12/811/003 (2 pre-filled pens) EU/1/12/811/004 (6 pre-filled pens)
Lyxumia 20 mikrogramov raztopina za injiciranje EU/1/12/811/002 (1 napolnjen injekcijski peresnik) EU/1/12/811/003 (2 napolnjena injekcijska peresnika) EU/1/12/811/004 (6 napolnjenih injekcijskih peresnikov)
Sanofi-Aventis Deutschland GmbH Brüningstrasse 50, Industriepark Höchst 65926 Frankfurt am Main Germany
Sanofi-Aventis Deutschland GmbH Brüningstrasse 50, Industriepark Höchst 65926 Frankfurt am Main Nemčija
Patients (%) achieving HbA1c <7.0% Mean body weight (kg) Baseline
Bolniki (%), ki so dosegli HbA1c < 7,0 % Povprečna telesna masa (kg)
Once the green 10 micrograms Lyxumia pen is empty you must continue your treatment by taking your next injection when it is due, using the purple 20 microgram Lyxumia pen.
Ko je zeleni peresnik Lyxumia 10 mikrogramov prazen, morate zdravljenje nadaljevati z naslednjo injekcijo, ko je zanjo čas; za to injekcijo morate uporabiti škrlaten injekcijski peresnik Lyxumia 20 mikrogramov.
Lixisenatide has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis and therefore, the use of lixisenatide is not recommended in these patients.
Liksisenatid ni raziskan pri bolnikih s hudimi boleznimi prebavil, vključno s hudo gastroparezo, zato uporaba liksisenatida pri teh bolnikih ni priporočljiva.
Do not store with a needle attached.
Ne shranjujte s pritrjeno iglo.
If pancreatitis is suspected, lixisenatide should be discontinued ; if acute pancreatitis is confirmed, lixisenatide should not be restarted.
V primeru suma na pankreatitis je treba zdravljenje z liksisenatidom prekiniti; če je diagnoza akutnega pankreatitisa potrjena, se zdravljenja z liksisenatidom ne sme ponovno uvesti.
Treatment with Lyxumia resulted in reductions in 2-hour post-prandial glucose after a test-meal statistically superior to placebo whatever the background treatment.
Zdravljenje z zdravilom Lyxumia je postprandialno glukozo 2 uri po testnem obroku znižalo statistično značilno bolje kot placebo, ne glede na osnovno zdravljenje.
No such increase for tmax was observed when atorvastatin was administered in the evening and lixisenatide in the morning but the AUC and Cmax of atorvastatin were increased by 27% and 66%, respectively.
Takšnega podaljšanja tmax niso opazili, če je bil atorvastatin uporabljen zvečer in liksisenatid zjutraj, toda AUC atorvastatina se je zmanjšala za 27 %, njegova Cmax pa za 66 %.
Treatment Initiation pack - Contains two pre-filled pens each with 14 doses.
Pakiranje za uvedbo zdravljenja - vsebuje dva napolnjena injekcijska peresnika; v vsakem peresniku je 14 odmerkov.
This helps prevent contamination of Lyxumia or possible needle blockage.
Tako boste preprečili kontaminacijo zdravila Lyxumia in morebitno zamašitev igle.
If still no liquid comes out, your Lyxumia pen may be damaged.
Če še vedno ne priteče nič tekočine, je peresnik Lyxumia morda pokvarjen.
These changes are not clinically relevant and therefore, no dose adjustment for atorvastatin is required when co-administered with lixisenatide.
Te spremembe niso klinično pomembne, zato med sočasno uporabo z liksisenatida odmerka atorvastatina ni treba prilagoditi.
During clinical studies, doses up to 30 mcg of lixisenatide twice a day were administered to type 2 diabetic patients in a 13-week study.
V kliničnih študijah so odmerke do 30 mcg liksisenatida dvakrat na dan uporabljali pri sladkornih bolnikih tipa 2 v 13-tedenski študiji.
Lixisenatide slows gastric emptying thereby reducing the rate at which meal-derived glucose appears in the circulation.
Liksisenatid upočasni praznjenje želodca in tako zmanjša hitrost, s katero se glukoza iz obroka pojavi v krvnem obtoku.
When you are not using the pen, keep the cap on the pen in order to protect from light.
Kadar peresnika ne uporabljate, pokrovček obdržite na peresniku za zagotovitev zaščite pred svetlobo.
• You can clean the outside of your Lyxumia pen by wiping it with a damp cloth.
• Zunanjost peresnika Lyxumia lahko očistite tako, da ga obrišete z vlažno krpico.
Starting dose: dosing is initiated at 10 mcg lixisenatide once daily for 14 days.
Začetni odmerek: zdravljenje je treba začeti z 10 mcg liksisenatida enkrat na dan 14 dni.
It is not known if Lyxumia passes into your milk.
Ni znano, ali zdravilo Lyxumia prehaja v materino mleko.
sanofi-aventis groupe 54, rue La Boétie F - 75008 Paris France
sanofi-aventis groupe 54, rue La Boétie F - 75008 Pariz Francija
Press the injection button all the way in. You may feel or hear a “click”.
Morda boste čutili ali slišali "klik".
Animal studies did not indicate direct harmful effects with respect to male and female fertility in rats.
Študije na živalih pri podganah niso pokazale neposrednih ali posrednih škodljivih učinkov na plodnost samcev in samic.
1 pre-filled pen of 3 ml (14 doses) 2 pre-filled pens of 3 ml (2x14 doses) 6 pre-filled pens of 3 ml (6x14 doses)
1 napolnjen injekcijski peresnik s 3 ml (14 odmerkov) 2 napolnjena injekcijska peresnika s 3 ml (2 x 14 odmerkov) 6 napolnjenih injekcijskih peresnikov s 3 ml (6 x 14 odmerkov)
Add-on treatment to metformin alone
Dodatek zdravljenju z metforminom samim
Sanofi-Aventis Deutschland GmbH Industriepark Höchst - 65926 Frankfurt am Main Germany
Sanofi Aventis Deutschland GmbH Industriepark Höchst - 65926 Frankfurt am Main Nemčija
After stopping the treatment, few antibody positive patients were followed up for antibody status; the percentage decreased to approximately 90% within 3 months and 30% at 6 months or beyond.
Po prenehanju zdravljenja je bilo nekaj pacientov s pozitivnimi protitelesi spremljanih glede izvida protiteles; koncetracija protiteles se je v 3 mesecih znižala za približno 90 % in v 6 mesecih za 30 % ali dlje.
Gastro-resistant formulations containing substances sensitive to stomach degradation, should be administered 1 hour before or 4 hours after lixisenatide injection.
Gastrorezistentne oblike, ki vsebujejo učinkovine, občutljive na razgradnjo v želodcu, je treba uporabiti 1 uro pred injiciranjem liksisenatida ali 4 ure po injiciranju.
Inject Lyxumia in the hour before any meal of the day.
Zdravilo Lyxumia injicirajte v uri pred katerim koli dnevnim obrokom.
Mean HbA1c (±SD) in the lixisenatide and placebo groups was 7.72 (±1.32)% and 7.64 (±1.28)% at baseline and 7.46 (±1.51)% and 7.61 (±1.48)% at 24 months, respectively.
Povprečni HbA1c (± standardni odklon) je bil izhodiščno v skupini z liksisenatidom 7,72 (± 1,32) % in v skupini s placebom 7,64 (± 1,28) %, po 24 mesecih pa v prvi 7,46 (± 1,51) % in v drugi 7,61 (± 1,48) %.
Ask your doctor, pharmacist or nurse which needle gauge and length is best for you.
Svojega zdravnika, farmacevta ali medicinsko sestro vprašajte, katera številka in dolžina igle je za vas najprimernejša.
The incidence of nausea was higher in the lixisenatide group (26.1%) compared to the placebo group (6.2%) and the incidence of vomiting was higher in the lixisenatide group (10.5%) than in the placebo group (1.8%).
Incidenca navzee je bila v skupini z liksisenatidom večja (26,1 %) kot v skupini s placebom (6,2 %), prav tako je bila večja incidenca bruhanja (skupina z liksisenatidom 10,5 %, skupina s placebom 1,8 %).
Check that the activation window is orange.
Prepričajte se, da je aktivacijsko okence oranžno.
There have been few reported events of acute pancreatitis with lixisenatide although a causal relationship has not been established.
Z liksisenatidom so bili opisani maloštevilni primeri akutnega pankreatitisa, a vzročne povezanosti niso ugotovili.
• Low blood sugar (hypoglycaemia (“hypo”) especially when Lyxumia is used with insulin or a sulphonylurea
• Nizek sladkor v krvi (hipoglikemija (»hipa«)), še posebej, kadar z zdravilom Lyxumia jemljete druge insuline ali sulfonilsečnino.
Patients treated with lixisenatide should be advised of the potential risk of dehydration in relation to gastrointestinal adverse reactions and take precautions to avoid fluid depletion.
Bolnike, ki prejemajo liksisenatid, je treba seznaniti z možnim tveganjem za dehidracijo, povezano s neželenimi učinki v prebavilih; naročiti jim je treba, naj upoštevajo previdnostne ukrepe za preprečitev pomanjkanja tekočine.
Step B. Attach a new needle and remove the needle caps
Korak B. Namestite novo iglo in odstranite pokrovčka igle
There is no therapeutic experience in patients with severe renal impairment (creatinine clearance less than 30 ml/min) or end-stage renal disease and therefore, it is not recommended to use lixisenatide in these populations (see section 5.2).
Pri bolnikih s hudo okvaro ledvic (očistek kreatinina < 30 ml/min) ali s končno odpovedjo ledvic terapevtskih izkušenj ni, zato liksisenatida v teh populacijah ni priporočljivo uporabljati (glejte poglavje 5.2).
After concomitant administration of lixisenatide 20 mcg and digoxin 0.25 mg at steady state, the AUC of digoxin was not affected.
Po sočasni uporabi 20 mcg liksisenatida in 0,25 mg digoksina v stanju dinamičnega ravnovesja se AUC digoksina ni spremenila.
• Each Lyxumia pen contains 14 pre-set doses.
• En peresnik Lyxumia vsebuje 14 prednastavljenih odmerkov.
Excipients: glycerol 85%, sodium acetate trihydrate, methionine, metacresol (see leaflet for further information), hydrochloric acid and sodium hydroxide solution (for pH adjustment), water for injections.
Pomožne snovi: 85 % glicerol, natrijev acetat trihidrat, metionin, metakrezol (za dodatne informacije glejte navodilo za uporabo), klorovodikova kislina in raztopina natrijevega hidroksida (za prilagoditev pH), voda za injekcije.
Ask your doctor, pharmacist or nurse about how to inject correctly.
Svojega zdravnika, farmacevta ali medicinsko sestro vprašajte, kako pravilno injicirati zdravilo.
An increased incidence of gastrointestinal disorders was observed.
Opažali so večjo incidenco prebavnih motenj.
Lixisenatide stimulates insulin secretion when blood glucose is increased but not at normoglycaemia, which limits the risk of hypoglycaemia.
Liksisenatid spodbudi izločanje insulina, če je krvni sladkor zvišan, ne pa tudi med normoglikemijo; to zmanjša tveganje za hipoglikemijo.
When administered once daily, lixisenatide improves glycaemic control through the immediate and sustained effects of lowering both post-prandial and fasting glucose concentrations in patients with type 2 diabetes.
Liksisenatid med uporabo enkrat na dan sladkornim bolnikom tipa 2 izboljša urejenost glikemije s takojšnjim in stalnim učinkom, tako da zmanjša postprandialno koncentracijo glukoze in koncentracijo glukoze na tešče.
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 or 4 hours after lixisenatide injection.
V primeru peroralno uporabljenih zdravil, katerih učinkovitost je še posebej odvisna od pražnih koncentracij (kot so npr. antibiotiki), je treba bolnikom svetovati, naj takšna zdravila vzamejo vsaj 1 uro pred injiciranjem liksisenatida ali 4 ure po injiciranju.
Hydrochloric acid (for pH adjustment) Sodium hydroxide solution (for pH adjustment) Water for injections
Klorovodikova kislina (za prilagoditev pH) Raztopina natrijevega hidroksida (za prilagoditev pH) Voda za injekcije
Patients receiving Lyxumia with a sulphonylurea or with a basal insulin may have an increased risk of hypoglycaemia.
Bolniki, ki dobivajo zdravilo Lyxumia s sulfonilsečnino ali z bazalnim insulinom, imajo lahko večje tveganje za hipoglikemijo.
If not, do not use this pen.
Če ni, peresnika ne uporabite.
Lyxumia should not be given in combination with basal insulin and a sulphonylurea due to increased risk of hypoglycaemia (see section 4.4).
Zdravilo Lyxumia se ne sme uporabljati v kombinaciji z bazalnim insulinom in sulfonilsečnino, zaradi povečanega tveganja za hipoglikemijo (glejte poglavje 4.4).
The table also includes adverse reactions with a frequency ≥1% in the Lyxumia group if the frequency was greater than 2 times the frequency for all comparators group.
Preglednica prikazuje tudi neželene učinke, ki so se med prejemniki zdravila Lyxumia pojavili s pogostnostjo ≥ 1 %, če je bila pogostnost večja kot 2kratna pogostnost v vseh primerjalnih skupinah.
Line up the needle with the pen.
Uravnajte iglo s peresnikom.
Table 1: Adverse reactions reported in placebo- and active-controlled phase III studies during the entire treatment period (including the period beyond the main 24-week treatment period in studies with ≥76 weeks of total treatment).
Preglednica 1: Neželeni učinki, zabeleženi v študijah III. faze, kontroliranih s placebom ali zdravilno učinkovino, med celotnim obdobjem zdravljenja (vključno z obdobjem, ki zajema več kot 24-tedensko obdobje zdravljenja v študijah, v katerih je celotno zdravljenje trajalo ≥ 76 tednov).
There are no clinically relevant differences in the rate of absorption when lixisenatide is administered subcutaneously in the abdomen, thigh, or arm.
Hitrost absorpcije se ne razlikuje klinično pomembno, če je liksisenatid injiciran subkutano v trebuh, stegno ali roko.
- The other ingredients are glycerol 85 %, sodium acetate trihydrate, methionine, metacresol, hydrochloric acid (for pH adjustment), sodium hydroxide solution (for pH adjustment) and water for injections.
- Pomožne snovi so 85 % glicerol, natrijev acetat trihidrat, metionin, metakrezol, klorovodikova kislina (za uravnavanje pH), raztopina natrijevega hidroksida (za prilagoditev pH) in voda za injekcije.
Do not use this Lyxumia Treatment Initiation pack.
Ne uporabite tega pakiranja zdravila Lyxumia za uvedbo zdravljenja.
Lyxumia 10 micrograms solution for injection EU/1/12/811/001 (1 pre-filled pen)
Lyxumia 10 mikrogramov raztopina za injiciranje EU/1/12/811/001 (1 napolnjen injekcijski peresnik)
Sulphonylurea as background therapy with or without metformin
Sulfonilsečnina kot osnovno zdravljenje, z metforminom ali brez njega
The plunger will move along the dose scale after each injection.
Bat se bo po vsakem injiciranju pomaknil vzdolž merila odmerka.
The window remains white after activation.
Okence po aktivaciji ostane belo.
Marketing Authorisation Holder sanofi-aventis groupe 54, rue La Boétie F - 75008 Paris
Imetnik dovoljenja za promet sanofi-aventis groupe 54, rue La Boétie F - 75008 Pariz Francija
Check that the activation window is now white.
Preverite, da je aktivacijsko okence zdaj belo.
If a dose is missed, it should be injected within the hour prior to the next meal.
Če bolnik izpusti odmerek, ga mora injicirati v teku ene ure pred naslednjim obrokom.
Add-on combination therapy with a basal insulin
Dodatek kombiniranemu zdravljenju z bazalnim insulinom
You should seek immediate medical attention if you experience symptoms like swelling of the face, tongue or throat which causes difficulty with breathing.
Če se vam pojavijo simptomi, kot so otekanje obraza, jezika ali žrela, ki povzročajo težave z dihanjem, morate nemudoma poiskati zdravniško pomoč.
Administration of the oral contraceptive 1 hour or 4 hours after lixisenatide did not affect AUC and t1/2 of ethinylestradiol and levonorgestrel, whereas Cmax of ethinylestradiol was decreased by 52% and 39% respectively and Cmax of levonorgestrel was decreased by 46% and 20%, respectively and median tmax was delayed by 1 to 3 hours.
Uporaba peroralnega kontraceptiva 1 uro ali 4 ure po liksisenatidu ni vplivala na AUC in t1/2 etinilestradiola in levonorgestrela, toda Cmax etinilestradiola se je zmanjšala za 52 % (1 ura) oziroma 39 % (4 ure), Cmax levonorgestrela pa za 46 % (1 ura) in 20 % (4 ure); mediani tmax se je podaljšal za 1 do 3 ure.
- you are also taking a sulphonylurea or a basal insulin.
- če sočasno jemljete tudi kakšno sulfonilsečnino ali uporabljate bazalni insulin.
There is no therapeutic experience in patients with severe renal impairment (creatinine clearance less than 30 ml/min) or end-stage renal disease.
Terapevtskih izkušenj pri bolnikih s hudo okvaro ledvic (očistek kreatinina <30 ml/min) ali s končno odpovedjo ledvic ni.
Keep the cap on the pen in order to protect from light.
Pokrovček obdržite na peresniku za zagotovitev zaščite pred svetlobo.
Lixisenatide 20 mcg Placebo (N= 170)
Liksisenatid 20 mcg Placebo (N = 170)
In the subset of patients (5.2%) with the highest antibody concentrations, the mean improvement in HbA1c at Week 24 and at Week 76 was in a clinically relevant range; however there was variability in the glycaemic response and 1.9% had no decrease in HbA1c.
V podskupini bolnikov (5,2 %) z najvišjo koncentracijo protiteles je bilo povprečno izboljšanje HbA1c 24. in 76. tednu v klinično pomembnem območju, obstajala pa je variabilnost, kar zadeva glikemičen odziv in pri 1,9 % bolnikov ni bilo znižanja pri HbA1c.
Purple 20 micrograms pen activation The purple 20 micrograms Lyxumia pen must also be activated before use.
Tudi škrlatni peresnik Lyxumia 20 mikrogramov je treba pred uporabo aktivirati.
It is an injectable medicine used to help your body to control your blood sugar level when it is too high.
Uporablja se za uravnavanje koncentracije krvnega sladkorja, kadar je ta previsoka.
The addition of lixisenatide led to a significantly greater HbA1c decrease of 0.71% in the lixisenatide group compared to 0.40% in the placebo group.
Dodatek liksisenatida je v skupini z liksisenatidom povzročil značilno večje znižanje HbA1c (za 0,71 %) kot v skupini s placebom (0,40 %).
After concomitant administration of warfarin 25 mg with repeated dosing of lixisenatide 20 mcg, there were no effects on AUC or INR (International Normalised Ratio) while Cmax was reduced by 19% and tmax was delayed by 7 hours.
Po sočasni uporabi 25 mg varfarina med ponavljajočim se odmerjanjem 20 mcg liksisenatida se AUC in INR (internacionalno normalizirano razmerje) nista spremenila, Cmax se je znižala za 19 %, tmax pa se je podaljšal za 7 ur.
Step D. Press and hold the injection button to inject the dose
Korak D. Pritisnite in držite gumb za injiciranje, da boste injicirali odmerek
Skin and subcutaneous tissue disorders
Bolezni kože in podkožja urtikarija
Keep the injection button pressed in and slowly count to 5 in order to expel the last drops.
Držite gumb za injiciranje pritisnjen in počasi preštejte do 5,da boste iztisnili zadnje kapljice.
Do not use this medicine after the expiry date which is stated on the pen label and on the carton after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki peresnika in na škatli poleg oznake EXP. Datum izteka roka uporabnosti se nanaša na zadnji dan navedenega meseca.
When Lyxumia is added to existing therapy of a sulphonylurea or a basal insulin, a reduction in the dose of the sulphonylurea or the basal insulin may be considered to reduce the risk of hypoglycaemia.
Če je zdravilo Lyxumia dodano obstoječemu zdravljenju s sulfonilsečnino ali bazalnemu insulinu, pride v poštev zmanjšanje odmerka sulfonilsečnine ali bazalnega insulina, da bi zmanjšali tveganje za hipoglikemijo.
Body weight change from baseline in a range from -0.38 kg to -1.80 kg was also observed in lixisenatide patients receiving stable basal insulin dose, alone or in combination with metformin or a sulphonylurea.
Znižanje telesne mase od 0,38 kg do 1,80 kg v primerjavi z izhodiščem so zabeležili tudi pri prejemnikih zdravila Lyxumia, ki so uporabljali bazalni insulin sam ali v kombinaciji z metforminom ali sulfonilsečnino.
How to activate your new Lyxumia pen
Kako aktivirate nov peresnik Lyxumia
The pen can be used for 14 days when stored at a temperature below 30°C.
Peresnik, ki je shranjen na temperaturi do 30 °C, lahko uporabljate 14 dni.
Following subcutaneous administration to patients with type 2 diabetes, the rate of lixisenatide absorption is rapid and not influenced by the dose administered.
Absorpcija liksisenatida po subkutanem injiciranju pri sladkornih bolnikih tipa 2 je hitra in uporabljeni odmerek nanjo ne vpliva.
Based on these results, no dose adjustment for paracetamol is required but the delayed tmax observed when paracetamol is administered 1-4 hours after lixisenatide should be taken into account when a rapid onset of action is required for efficacy.
Vendar pa je treba podaljšanje tmax, opaženo po uporabi paracetamola od 1 do 4 ure po liksisenatidu, upoštevati v primeru, ko je zaradi učinkovitosti potreben hiter začetek delovanja.
• Do not store your Lyxumia pen with the needle attached.
• Peresnika Lyxumia ne shranjujte z nameščeno iglo.
1 pre-filled pen of 3 ml (14 doses)
1 napolnjen injekcijski peresnik s 3 ml (14 odmerkov)
If you have any further questions on the use of this medicine, ask your doctor, nurse or pharmacist.
Če imate dodatna vprašanja o uporabi tega zdravila, se posvetujte s svojim zdravnikom, medicinsko sestro ali s farmacevtom.
Reduction of the dose of the sulphonylurea or the basal insulin may be considered to reduce the risk of hypoglycaemia (see section 4.2).
Za zmanjšanje tveganja za hipoglikemijo pride v poštev zmanjšanje odmerka sulfonilsečnine ali bazalnega insulina (glejte poglavje 4.2).
There is no therapeutic experience with lixisenatide in patients with type 1 diabetes mellitus and it should not be used in these patients.
Pri bolnikih s sladkorno boleznijo tipa 1 terapevtskih izkušenj z liksisenatidom ni, zato se ga pri teh bolnikih ne sme uporabljati.
How to use Lyxumia
Kako uporabljati zdravilo Lyxumia
The rate of symptomatic hypoglycaemic events was lower with lixisenatide (36%) compared to insulin glulisine QD and TID (47% and 52%, respectively).
Delež simptomatskih hipoglikemij je bil z liksisenatidom manjši (36 %) kot z insulinom glulizinom enkrat na dan (47 %) in trikrat na dan (52 %).
Excipient(s) with known effects
Pomožne snovi z znanim učinkom
Table 2: Placebo-controlled studies in combination with metformin (24-week results).
Preglednica 2: S placebom kontrolirane študije v kombinaciji z metforminom (24-tedenski rezultati).
Put the outer needle cap on a flat surface.
Položite zunanji pokrovček igle na ravno površino.
Basal insulin as background therapy Alone or in combination with a sulphonylurea *
Bazalni insulin kot osnovno zdravljenje Sam ali v kombinaciji s sulfonilsečnino*
Patients with hepatic impairment No dose adjustment is needed in patients with hepatic impairment (see section 5.2).
Bolniki z okvaro jeter Bolnikom z okvaro jeter odmerka ni treba prilagoditi (glejte poglavje 5.2).
How to store Lyxumia 6.
Shranjevanje zdravila Lyxumia 6.
Anaphylactic reactions were reported in 0.2% of the lixisenatide treated patients vs. none in the placebo group.
Anafilaktične reakcije so bile opisane pri 0,2 % prejemnikov liksisenatida in pri nobenem prejemniku placeba.
What Lyxumia contains - The active substance is lixisenatide.
Kaj vsebuje zdravilo Lyxumia - Zdravilna učinkovina je liksisenatid.