natgillin/translations-raw huggingface dataset:
As opposed to both insulin glulisine treatment regimens, lixisenatide reduced body weight (table 5).
V nasprotju z obema shemama zdravljenja, ki sta vključevali insulin glulizin, je liksisenatid zmanjšal telesno maso (preglednica 5).
In embryo-foetal development studies, malformations, growth retardation, ossification retardation and skeletal effects were observed in rats at all doses (5-fold exposure ratio compared to human exposure) and in rabbits at high doses (32-fold exposure ratio compared to human exposure) of lixisenatide.
V študijah embrio fetalnega razvoja so malformacije, upočasnitev rasti, zapoznelo osifikacijo in skeletne učinke so opažali pri podganah pri vseh odmerkih (5-kratno razmerje izpostavljenosti v primerjavi z izpostavljenostjo pri človeku) ter pri kuncih pri velikih odmerkih (32-kratno razmerje izpostavljenosti v primerjavi z izpostavljenostjo pri človeku) liksenatida.
If not, do not use this Treatment Initiation pack.
Če ni takšna, ne uporabite tega pakiranja za uvedbo zdravljenja.
- you have severe kidney disease or you are on dialysis as the use of this medicine will not be recommended
- če imate hudo bolezen ledvic ali ste na dializi, ker uporaba tega zdravila v tem primeru ni priporočljiva.
Also check it has not passed the expiry date.
Preverite tudi, da ni že pretekel rok uporabnosti.
In case of air bubbles see the “Questions and answers” section.
Če opazite mehurčke, glejte poglavje "Vprašanja in odgovori".
In patients newly started on insulin, body weight remained almost unchanged in the lixisenatide group while an increase was shown in the placebo group.
Bolnikom, ki so jim na novo uvedli insulin, se telesna masa v skupini z liksenatidom skoraj ni spremenila, v skupini s placebom pa se je povečala.
Lyxumia should not be used if it has been frozen.
Zdravila Lyxumia se ne sme uporabiti, če je bilo zmrznjeno.
• Low blood sugar (when Lyxumia is taken with metformin)
• nizek krvni sladkor (ce jemljete zdravilo Lyxumia z metforminom)
The pen is to be used for one patient only.
Peresnik je namenjen za uporabo pri enem samem bolniku.
The Lyxumia Treatment Initiation pack includes two different coloured pens.
Pakiranje za uvedbo zdravljenja z zdravilom Lyxumia vsebuje dva peresnika različnih barv.
What Lyxumia looks like and contents of the pack Lyxumia is a clear and colourless solution for injection (injection) filled in a glass cartridge inserted in a pre-filled pen.
Izgled zdravila Lyxumia in vsebina pakiranja Zdravilo Lyxumia je bistra in brezbarvna raztopina za injiciranje (injekcija) v steklenem vložku, vstavljenem v napolnjen injekcijski peresnik.
As lixisenatide is cleared primarily by the kidney, no pharmacokinetic study has been performed in patients with acute or chronic hepatic impairment.
Liksisenatid se izloča predvsem preko ledvic, zato farmakokinetičnih študij pri bolnikih z akutno ali kronično okvaro jeter niso izvedli.
The tmax of digoxin was delayed by 1.5 hour and the Cmax was reduced by
tmax digoksina se je podaljšal za 1,5 ure in njegova Cmax se je znižala za
CV: cardiovascular, MI: myocardial infarction, HF: hospitalization for heart failure, Revasc: coronary revascularization procedure, HR: hazard ratio, CI: confidence interval.
MI: miokardni infarkt, SP: sprejem v bolnišnico zaradi srčnega popuščanja, revask: koronarni revaskularizacijski postopek, ROg: razmerje ogroženosti, IZ: interval zaupanja.
Lixisenatide action is mediated via a specific interaction with GLP-1 receptors, leading to an increase in intracellular cyclic adenosine monophosphate (cAMP).
Liksisenatid deluje preko specifične interakcije z receptorji GLP-1 in tako poveča znotrajcelično koncentracijo cikličnega adenozinmonofosfata (cAMP).
Women of childbearing potential Lyxumia is not recommended in women of childbearing potential not using contraception.
Ženske v rodni dobi Zdravilo Lyxumia ni priporočljivo za ženske v rodni dobi, ki ne uporabljajo kontracepcije.
The incidence of hypoglycaemia was mainly increased in the lixisenatide group during the first 6 weeks of treatment and thereafter, was similar to the placebo group.
Incidenca hipoglikemij se je med prejemniki liksisenatida povečala predvsem v prvih 6 tednih zdravljenja, pozneje pa je bila podobna kot med prejemniki placeba.
If such medicinal products are to be administered with food, patients should be advised to, if possible, take them with a meal when lixisenatide is not administered.
Če mora bolnik takšna zdravila jemati s hrano, mu je treba svetovati, naj jih po možnosti vzame ob tistih obrokih, pri katerih ne vzame liksisenatida.
Pack sizes of 1, 2 or 6 pre-filled pens.
Velikost pakiranj z 1, 2 ali 6 napolnjenimi peresniki.
Efficacy and safety of Lyxumia in patients older than 70 years was addressed in a specifically dedicated placebo-controlled study (176 patients randomised to lixisenatide, including 62 patients ≥75 years of age).
Učinkovitost in varnost zdravila Lyxumia pri bolnikih, starejših od 70 let, je obravnavala posebna namenska, s placebom kontrolirana študija (176 bolnikov randomiziranih na liksisenatid, vključno z 62 bolniki, starimi ≥ 75 let).
The GLP-1 receptor is the target for native GLP-1, an endogenous incretin hormone that potentiates glucose-dependent insulin secretion from the pancreatic beta cells.
Receptor GLP-1 je ciljno mesto delovanja naravnega GLP-1; to je endogeni inkretinski hormon, ki poveča od glukoze odvisno izločanje insulina iz pankreatičnih celic beta.
A clinical study was conducted in insulin-naive patients insufficiently controlled on oral antidiabetic agents.
Klinično študijo so izvedli pri bolnikih, ki še niso bili zdravljeni z insulinom in so bili nezadostno urejeni s peroralnimi antidiabetiki.
Secondary composite endpoints primary + HF primary + HF + Revasc 661 (21.8%) 659 (21.7%) Individual components of composites CV death
Primarni + SP + revask 661 (21,8 %) 659 (21,7 %) Posamezni elementi sestavljenih opazovanih dogodkov Srčno-žilna smrt
This was also confirmed in an 8-week study versus liraglutide, administered before breakfast, in combination with insulin glargine with or without metformin.
To je bilo potrjeno tudi v 8-tedenski študiji z liraglutidom zaužitim pred zajtrkom, v kombinaciji z insulinom glarginom z ali brez metformina.
No related effect on spermatogenesis was seen in healthy men.
Pri zdravih moških niso ugotovili podobnega vpliva na spermatogenezo.
Step F. Repeat all steps in Section 3 for each injection.
Korak F. Za vsako injiciranje ponovite vse korake, opisane v 3. poglavju.
Sulfonylureas or glinides were not used with basal insulin as background therapy.
Sulfonilsečnine ali glinidi niso bili uporabljeni z bazalnim insulinom kot osnovno zdravljenje.
The ELIXA study was a randomized, double-blind, placebo-controlled, multinational study that evaluated cardiovascular (CV) outcomes during treatment with lixisenatide in patients with type 2 diabetes mellitus after a recent Acute Coronary Syndrome.
Študija ELIXA je bila randomizirana, dvojno slepa, s placebom kontrolirana mednarodna študija, ki je ocenjevala srčno-žilne izide med zdravljenjem z liksisenatidom pri bolnikih s sladkorno boleznijo tipa 2 po nedavnem akutnem koronarnem sindromu.
Your doctor may want to control your blood sugar level and then, decide to reduce your dose of basal insulin or sulphonylurea.
Zdravnik vam bo morda želel uravnati koncentracijo krvnega sladkorja in se bo potem odločil za zmanjšanje vašega odmerka bazalnega insulina ali sulfonilsečnine.
Following administration of a single dose of an oral contraceptive medicinal product (ethinylestradiol 0.03 mg/levonorgestrel 0.15 mg) 1 hour before or 11 hours after 10 mcg lixisenatide, the Cmax, AUC, t1/2 and tmax of ethinylestradiol and levonorgestrel were unchanged.
Po uporabi enega samega odmerka peroralnega kontraceptiva (0,03 mg etinilestradiol/0,15 mg levonorgestrela) 1 uro pred ali 11 ur po uporabi 10 mcg liksisenatida se Cmax, AUC, t1/2 in tmax etinilestradiola in levonorgestrela niso spremenili.
Pen Date of activation
Peresnik Datum aktivacije
This medicine contains metacresol which may cause allergic reactions.
To zdravilo vsebuje metakrezol, ki lahko povzroči alergijske reakcije.
The most common adverse reactions which led to treatment discontinuation in the lixisenatide group were nausea (3.1%) and vomiting (1.2%).
Najpogostejša neželena učinka, zaradi katerih so zdravljenje prekinili med prejemniki liksisenatida, sta bila navzea (3,1 %) in bruhanje (1,2 %).
As a peptide, lixisenatide is eliminated through glomerular filtration, followed by tubular reabsorption and subsequent metabolic degradation, resulting in smaller peptides and amino acids, which are reintroduced in the protein metabolism.
Liksisenatid je peptid in se tako izloča z glomerularno filtracijo, ki ji sledi tubularna reabsorpcija in nadaljnja presnovna razgradnja; nastanejo manjši peptidi in aminokisline, ki se vrnejo v presnovo beljakovin.
• Post-prandial glucose
• Postprandialna glukoza
Inject Lyxumia into the skin (subcutaneously) of your stomach area (abdomen), upper leg (thigh) or upper arm.
Zdravilo Lyxumia injicirajte v kožo (podkožno) na trebuhu, zgornjem delu noge (stegnu) ali zgornjem delu roke.
Grasp a fold of skin and insert the needle (see the “Injection sites” section about where to inject).
Primite kožno gubo in zabodite iglo (glejte poglavje "Mesta injiciranja" za informacije o tem, kam injicirati zdravilo).
Very common side effects: may affect more than 1 in 10 people
Zelo pogosti neželeni učinki: pojavijo se lahko pri več kot 1 od 10 oseb
If you stop using Lyxumia, your blood sugar levels can increase.
Če prenehate uporabljati zdravilo Lyxumia, se vam lahko koncentracija krvnega sladkorja zviša.
Following administration of a single dose of paracetamol 1,000 mg, paracetamol AUC and t1/2 were unchanged whatever the timing of its administration (before or after the lixisenatide injection).
Po uporabi enega samega odmerka 1000 mg paracetamola se AUC in t1/2 paracetamola nista spremenila, ne glede na čas uporabe (pred injiciranjem liksisenatida ali po njem).
Lixisenatide provided significant improvements in HbA1c (-0.64% change compared to placebo; 95% CI: -0.810% to -0.464%; p<0.0001), from a mean baseline HbA1c of 8.0%.
Liksisenatid je v primerjavi s placebom značilno izboljšal HbA1c (-0,64 % v primerjavi s placebom, 95 % IZ: -0,810 % do -0,464 %, p < 0,0001) s povprečnega izhodiščnega HbA1c 8,0 %.
Irrespective of the dose and whether lixisenatide was administered as single or multiple doses, the median tmax is 1 to 3.5 hours in patients with type 2 diabetes.
Ne glede na odmerek in ne glede na to, ali je bil liksisenatid uporabljen v enkratnem odmerku ali v večkratnih odmerkih, je bil mediani tmax pri sladkornih bolnikih tipa 2 od 1 do 3,5 ure.
How much to inject
Koliko zdravila injicirati
Efficacy of Lyxumia was also assessed in two randomised, open-label, active-controlled study (versus exenatide or versus insulin glulisine) and in a meal time study (in total 1,067 patients randomised to lixisenatide).
Učinkovitost zdravila Lyxumia so ocenili tudi v dveh randomiziranih, odprtih, z zdravilno učinkovino kontroliranih študijah (v primerjavi z eksenatidom ali v primerjavi z insulinom glulisinom) in v študiji ob obroku (skupno 1.067 bolnikov randomiziranih na liksisenatid).
Do not stop using Lyxumia without talking with your doctor.
Če ste prenehali uporabljati zdravilo Lyxumia Ne prenehajte uporabljati zdravila Lyxumia, ne da bi se posvetovali s svojim zdravnikom.
• Cold (upper respiratory tract infection)
• prehlad (okužba zgornjih dihal)
People aged ≥70 years The efficacy and safety of lixisenatide in people aged ≥70 years with type 2 diabetes was evaluated in a double-blind, placebo-controlled study of 24 weeks duration.
Učinkovitost in varnost liksisenatida pri osebah, starih ≥ 70 let in s sladkorno boleznijo tipa 2, so ocenili v dvojno slepi, s placebom kontrolirani 24-tedenski študiji.
Pull the needle out of your skin.
Potegnite iglo iz kože.
If you miss a dose of Lyxumia, you can inject it in the hour before your next meal.
Če ste izpustili odmerek zdravila Lyxumia, si ga lahko injicirate v uri pred naslednjim obrokom.
• Cardiovascular evaluation
• Kardiovaskularni parametri
Median treatment duration was 22.4 months in the lixisenatide group and 23.3 months in the placebo group, and the median duration of study follow-up was 25.8 and 25.7 months, respectively.
Mediano trajanje zdravljenja je bilo 22,4 meseca v skupini z liksisenatidom in 23,3 meseca v skupini s placebom, mediano trajanje spremljanja pa je bilo v prvi 25,8 meseca in v drugi 25,7 meseca.
Overall, 6068 patients were randomized 1:1 to either placebo or lixisenatide 20 mcg (following a starting dose of 10 mcg during the first 2 weeks).
V celoti so 6068 bolnikov v razmerju 1:1 randomizirali ali na placebo ali na 20 mikrogramov liksisenatida (po začetnem odmerku 10 mikrogramov v prvih 2 tednih).
Some medicines such as antibiotics or stomach resistant tablets or capsules that should not stay too long in your stomach may need to be taken at least one hour before or four hours after your Lyxumia injection.
Nekatera zdravila, npr. antibiotike ali gastrorezistentne tablete ali kapsule, ki v želodcu ne smejo ostati predolgo, je treba vzeti najmanj eno uro pred injekcijo zdravila Lyxumia ali štiri ure po injekciji.
After activation of the pen:
Po aktivaciji peresnika:
• These pens are only for one person.
• Ta peresnika sta namenjena le za uporabo pri eni sami osebi.
At the end of the main 24-week treatment period, 32.2% of the patients having a positive antibody status had an antibody concentration above the lower limit of quantification, and at the end of the entire 76-week treatment period, 44.7% of the patients had an antibody concentration above the lower limit of quantification.
Na koncu glavnega 24-tedenskega obdobja zdravljenja je imelo 32,2 % bolnikov s pozitivnim izvidom protiteles koncentracijo protiteles nad spodnjo mejo kvantifikacije, na koncu celotnega 76-tedenskega obdobja zdravljenja pa je imelo koncentracijo protiteles nad spodnjo mejo kvantifikacije 44,7 % teh bolnikov.
• Protect your Lyxumia pens from dust and dirt.
• Peresnike Lyxumia zaščitite pred prahom in umazanijo.
There are no adequate data from the use of Lyxumia in pregnant women.
O uporabi zdravila Lyxumia pri nosečnicah ni zadostnih podatkov.
Table 5: Active-controlled study in combination with basal insulin with or without metformin (26-week results) - (mITT) and safety population
Preglednica 5: Z zdravilno učinkovino kontrolirana študija v kombinaciji z bazalnim insulinom (z metforminom ali brez njega) (26-tedenski rezultati) - (mZNZ) in varnostna populacija
This study consisted of a 12-week run-in period with introduction and titration of insulin glargine and of a 24-week treatment period during which patients receive either lixisenatide or placebo in combination with insulin glargine and metformin with or without thiazolidinediones.
Študija je obsegala 12-tedensko uvajalno obdobje z uvedbo in titriranjem insulina glargina ter 24-tedensko obdobje zdravljenja; med obdobjem zdravljenja so bolniki prejemali ali liksisenatid ali placebo v kombinaciji z insulinom glarginom in metforminom, s tiazolidindioni ali brez njih.
The green 10 micrograms Lyxumia pen is empty when the black plunger has reached ‘0' on the dose scale and the injection button cannot be pulled out fully.
Zeleni peresnik Lyxumia 10 mikrogramov je prazen, ko črni bat doseže oznako "0" na merilu odmerka in se gumba za injiciranje ne da več povsem izvleči.
Neonatal growth was reduced in male rats exposed to high doses of lixisenatide during late gestation and lactation, with a slightly increased pup mortality observed.
Neonatalna rast je bila manjša pri samcih podgan, ki so bili v obdobju pozne brejosti in med dojenjem izpostavljeni visokim odmerkom liksisenatida; opaženo je bilo rahlo povečanje umrljivosti mladičev.
If you forget to use Lyxumia
Če ste pozabili uporabiti zdravilo Lyxumia
Consistent with the potentially immunogenic properties of medicinal products containing proteins or peptides, patients may develop anti-lixisenatide antibodies following treatment with Lyxumia and, at the end of the main 24-week treatment period in placebo-controlled studies, 69.8% of lixisenatide patients had a positive antibody status.
V skladu z možno imunogenostjo zdravil, ki vsebujejo beljakovine ali peptide, se lahko bolnikom po zdravljenju z zdravilom Lyxumia pojavijo antiliksisenatidna protitelesa; na koncu glavnega 24tedenskega obdobja zdravljenja je v študijah kontroliranih s placebom imelo pozitiven izvid protiteles 69,8 % bolnikov.
New pen (orange window)
Nov peresnik (oranžno okence)
Add-on combination therapy with oral antidiabetics
Dodatek kombiniranemu zdravljenju s peroralnimi antidiabetiki
In the completed Phase III studies, it was observed that approximately 90% of the patients were able to remain on the once daily maintenance dose of 20 mcg Lyxumia at the end of the main 24-week treatment period.
V dokončanih študijah III. faze so ugotovili, da je lahko na koncu glavnega 24-tedenskega obdobja zdravljenja približno 90 % bolnikov ostalo na vzdrževalnem odmerku 20 mcg zdravila Lyxumia enkrat na dan.
What Lyxumia is and what it is used for
Kaj je zdravilo Lyxumia in za kaj ga uporabljamo
The reduction in Cmax is of limited clinical relevance and no dose adjustment for oral contraceptives is required.
Znižanje Cmax nima večjega kliničnega pomena in odmerka kontraceptivov ni treba prilagoditi.
No C-cell carcinoma was observed in mice and C-cell carcinoma occurred in rats with an exposure ratio relative to exposure at human therapeutic dose of about 900-fold.
Pri miših niso opazili karcinoma celic C. Pri podganah se je karcinom celic C pojavil pri približno 900-kratnem razmerju izpostavljenosti v primerjavi s terapevtskim odmerkom pri človeku.
In subjects with mild (creatinine clearance calculated by the Cockcroft-Gault formula 60-90 ml/min), moderate (creatinine clearance 30-60 ml/min) and severe renal impairment (creatinine clearance 15-30 ml/min), AUC was increased by 46%, 51% and 87%, respectively.
Med preiskovanci z blago (očistek kreatinina, izračunan po Cockcroft-Gaultovi formuli 60-90 ml/min), zmerno (očistek kreatinina 30-60 ml/min) in hudo okvaro ledvic (očistek kreatinina 15-30 ml/min) je bila AUC zvišana za 46 %, 51% in 87 %.
Before activation of the pen:
Pred aktivacijo peresnika:
• Store your unused Lyxumia pens in the refrigerator, 2°C to 8°C.
• Neuporabljene peresnike Lyxumia shranjujte v hladilniku pri temperaturi od 2 do 8°C.
The results of the primary and secondary composite efficacy endpoints and the results of all the individual components of the composite endpoints are shown in Figure 1.
Slika 1 prikazuje rezultate primarnega in sekundarnih sestavljenih opazovanih dogodkov učinkovitosti in rezultate vseh posameznih sestavin sestavljenih opazovanih dogodkov.
Do not use this Lyxumia pack.
Ne uporabite tega pakiranja zdravila Lyxumia.
After 12-week of optimal insulin glargine titration with or without metformin, inadequately controlled patients were randomised to add single dose of lixisenatide or a single dose (QD) of insulin glulisine (both before the largest meal) or insulin glulisine administered three times a day (TID) for 26 weeks.
Po 12 tednih optimalnega titriranja insulina glargina (z metforminom ali brez njega) so neustrezno nadzorovane bolnike za 26 tednov randomizirali ali na dodatek enega samega odmerka liksisenatida ali enega samega odmerka (enkrat na dan) insulina glulizina (obe zdravili so bolniki uporabili pred največjim obrokom) ali na insulin glulizin, uporabljen trikrat na dan.
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially “sodium-free”.
To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na odmerek, kar v bistvu pomeni 'brez natrija'.
Too much Lyxumia can make you feel sick or be sick.
Prevelik odmerek zdravila Lyxumia lahko povzroči slabost ali občutek slabosti.
Metformin as background therapy
Metformin kot osnovno zdravljenje
Important information about some of the ingredients of Lyxumia This medicine contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially “sodium-free”.
Pomembne informacije o nekaterih sestavinah zdravila Lyxumia Zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na odmerek; kar v bistvu pomeni "brez natrija".
If you use more Lyxumia than you should, talk to your doctor immediately.
Če ste uporabili večji odmerek zdravila Lyxumia, kot bi smeli Če ste uporabili večji odmerek zdravila Lyxumia, kot bi smeli, se nemudoma posvetujte s svojim zdravnikom.
Throw away a used Lyxumia pen after 14 days.
Uporabljeni peresnik Lyxumia po 14 dneh zavrzite.
Inject only one dose each day.
Vsak dan injicirajte en sam odmerek.
Lyxumia should not be used during pregnancy.
Zdravila Lyxumia se ne sme uporabljati med nosečnostjo.
Use of GLP-1 receptor agonists may be associated with gastrointestinal adverse reactions.
Uporaba agonistov receptorjev GLP-1 je lahko povezana s neželenimi učinki v prebavilih.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 3 ml (14 doses)
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 3 ml (14 odmerkov)
The clinical efficacy and safety of Lyxumia were evaluated in nine randomised double-blind, placebo-controlled clinical studies including 4,508 patients with type 2 diabetes (2,869 patients randomised to lixisenatide, 47.5% men and 52.5% women, and 517 were ≥65 years of age).
Klinično učinkovitost in varnost zdravila Lyxumia so ocenili v devetih randomiziranih, dvojno slepih, s placebom kontroliranih kliničnih študijah, ki so zajele 4.508 bolnikov s sladkorno boleznijo tipa 2 (2.869 bolnikov randomiziranih na liksisenatid, 47,5 % moških in 52,5 % žensk, 517 jih je bilo starih ≥ 65 let).
After multiple dose administration in patients with type 2 diabetes, mean terminal half-life was approximately 3 hours and the mean apparent clearance (CL/F) about 35 L/h.
Po uporabi več odmerkov pri sladkornih bolnikih tipa 2 je bil povprečni končni razpolovni čas približno 3 ure in povprečni navidezni očistek (CL/F) približno 35 L/uro.
• This pen is only for one person.
• Ta peresnik je namenjen le za uporabo pri eni sami osebi.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (28 DAYS TREATMENT INITIATION PACK)
PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA (PAKIRANJE ZA 28-DNEVNO UVEDBO ZDRAVLJENJA)
Pull the needle out of your skin and remove the needle from the pen.
Potegnite iglo iz kože in odstranite iglo s peresnika.
Patients received stable dose(s) of oral antidiabetic drug(s) (OAD) and/or basal insulin as background therapy.
Bolniki so prejemali stabilen odmerek enega ali več peroralnih antidiabetikov (POAD) in/ali bazalni insulin kot osnovno zdravljenje.
What you need to know before you use Lyxumia
Kaj morate vedeti, preden boste uporabili zdravilo Lyxumia
Keep the injection button pressed in and slowly count to 5 to get the full dose.
Držite gumb za injiciranje pritisnjen in počasi preštejte do 5, da boste dobili celotni odmerek.
• Cystitis
• cistitis
Lyxumia is indicated for the treatment of adults with type 2 diabetes mellitus to achieve glycaemic control in combination with oral glucose-lowering medicinal products and/or basal insulin when these, together, with diet and exercise, do not provide adequate glycaemic control (see sections 4.4 and 5.1 for available data on the different combinations).
Zdravilo Lyxumia je indicirano za zdravljenje odraslih s sladkorno boleznijo tipa 2 za doseganje urejenosti glikemije v kombinaciji z peroralnimi antidiabetiki in/ali bazalnim insulinom takrat, ko uporaba teh zdravil skupaj z dieto in telesno dejavnostjo ne zagotavlja ustrezne urejenosti glikemije (glejte poglavji 4.4 in 5.1 za podatke o različnih kombinacijah, ki so na voljo)
The table presents adverse reactions that occurred with an incidence >5% if the frequency was higher among Lyxumia treated patients than patients treated with all comparators.
Preglednica prikazuje neželene učinke, ki so se pojavili z incidenco > 5 %, če je bila pogostnost med prejemniki zdravila Lyxumia večja kot med prejemniki vseh primerjalnih zdravil.
Pull off the outer and inner needle caps.
Snemite zunanji in notranji pokrovček igle.
It is unknown if Lyxumia is excreted in human milk.
Ni znano, ali se zdravilo Lyxumia pri človeku izloča v materinem mleku.