FrancophonIA/ELRC3.0 huggingface dataset:
English: Suliqua is not recommended in patients with severe renal impairment and end-stage renal disease as there is no sufficient therapeutic experience with use of lixisenatide.
Slovenian: Zdravilo Suliqua ni priporočljivo za bolnike s hudo okvaro ledvic ali končno odpovedjo ledvic, ker pri njih z liksisenatidom ni dovolj terapevtskih izkušenj.
English: Paediatric population There is no relevant use of Suliqua in the paediatric population.
Slovenian: Pediatrična populacija Zdravilo Suliqua ni namenjeno za uporabo pri pediatričnih bolnikih.
English: At the end of the run-in period, patients with an HbA1c between 7 and 10% , FPG ≤7.77 mmol/L and insulin glargine daily dose of 20 to 50 units, were randomised to either Suliqua (n=367) or insulin glargine (n=369).
Slovenian: Na koncu obdobja uvajanja so bolnike, ki so imeli HbA1c med 7 % in 10 %, glukozo v plazmi na tešče ≤ 7,77 mmol/l in dnevni odmerek insulina glargin od 20 do 50 enot, randomizirali ali na zdravilo Suliqua (n = 367) ali na insulin glargin (n = 369).
English: Many factors may affect your blood sugar level.
Slovenian: Na koncentracijo krvnega sladkorja lahko vplivajo številni dejavniki.
English: The dose should be adjusted on an individual basis, based on glucose monitoring.
Slovenian: Odmerek je treba prilagoditi vsakemu bolniku posamezno na podlagi meritev glukoze.
English: The dose window on the pen shows the number of dose steps.
Slovenian: Odmerno okence na peresniku prikazuje število odmernih korakov.
English: What Suliqua looks like and contents of the pack Suliqua is a clear and colourless solution for injection (injection) filled in a glass cartridge inserted in a SoloStar pre-filled pen.
Slovenian: Zdravilo Suliqua je bistra in brezbarvna raztopina za injiciranje (injekcija) v steklenem vložku, vstavljenem v napolnjen injekcijski peresnik SoloStar.
English: • Do not use your pen if there is still no medicine coming out of the needle tip.
Slovenian: • Ne uporabite peresnika, če iz konice igle še vedno ne pride nič zdravila.
English: • insulin glargine: a long-acting type of insulin which helps control blood sugar (glucose)
Slovenian: • insulin glargin: dolgodelujoč insulin, ki pomaga uravnavati krvni sladkor (glukozo) skozi ves dan.
English: Animal studies with lixisenatide or insulin glargine do not indicate direct harmful effects with respect to fertility.
Slovenian: Študije z liksisenatidom ali insulinom glargin na živalih ne kažejo neposrednih škodljivih učinkov na plodnost.
English: Suliqua combines two active substances with complementary mechanisms of action to improve glycaemic control: insulin glargine, a basal insulin analog (mainly targeting fasting plasma glucose), and lixisenatide, a GLP-1 receptor agonist (mainly targeting postprandial glucose).
Slovenian: Zdravilo Suliqua vsebuje dve zdravilni učinkovini, ki s komplementarnima mehanizmoma delovanja izboljšata urejenost glikemije: insulin glargin, bazalni insulinski analog (v prvi vrsti namenjen urejanju glukoze v plazmi na tešče), in liksisenatid, agonist receptorjev GLP-1 (v prvi vrsti namenjen urejanju postprandialne glukoze).
English: Substances that may enhance the blood-glucose-lowering effect and increase susceptibility to hypoglycaemia include anti-hyperglycaemic medicinal products, angiotensin converting enzyme (ACE) inhibitors, disopyramide, fibrates, fluoxetine, monoamine oxidase (MAO) inhibitors, pentoxifylline, propoxyphene, salicylates and sulfonamide antibiotics.
Slovenian: Med zdravili, ki lahko stopnjujejo znižanje glukoze v krvi in povečajo nagnjenost k hipoglikemiji, so antihiperglikemična zdravila, zaviralci angiotenzinske konvertaze (ACE), dizopiramid, fibrati, fluoksetin, zaviralci monoaminooksidaze (MAO), pentoksifilin, propoksifen, salicilati in sulfonamidni antibiotiki.
English: Insulin glargine (100 units/ml)** ≥30 to ≤60 units
Slovenian: Insulin glargin (100 enot/ml)** ≥30 do ≤60 enot
English: • Diuretics, for high blood pressure or fluid retention.
Slovenian: • Diuretike, za visok krvni tlak ali zastajanje tekočine.
English: In the switch from basal insulin clinical study the starting dose was 20 dose steps (20 units insulin glargine and 10 mcg lixisenatide) or 30 dose steps, (30 units insulin glargine and 10 mcg lixisenatide), see section 4.2, depending on the previous insulin dose.
Slovenian: V klinični študiji prehoda z bazalnega insulina je bil začetni odmerek 20 odmernih korakov (20 enot insulina glargin in 10 mcg liksisenatida) ali 30 odmernih korakov (30 enot insulina glargin in 10 mcg liksisenatida) (glejte poglavje 4.2), odvisno od predhodnega odmerka insulina.
English: Always use another Suliqua (30- 60) pen to complete your dose and no other pen.
Slovenian: Za dokončanje odmerka vedno uporabite drug peresnik Suliqua (30-60) in nobenega drugega.
English: 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.
Slovenian: Podaljšanja tmax niso opazili, če je bil atorvastatin uporabljen zvečer in liksisenatid zjutraj, toda AUC atorvastatina se je znižala za 27 % in njegova Cmax za 66 %.
English: • Inject it into the front of your thighs, upper arms or the front of your waist (abdomen).
Slovenian: • Injicirajte ga v sprednji del stegna, v nadlaket ali sprednji del trebuha.
English: The mean BMI at baseline was 31.1 kg/m2 with 57.3% of patients having a BMI ≥30 kg/m2.
Slovenian: Povprečni izhodiščni ITM je bil 31,1 kg/m2 in 57,3 % bolnikov je imelo ITM ≥ 30 kg/m2.
English: 20 dose steps (20 units/10 mcg)*
Slovenian: 20 odmernih korakov (20 enot/10 mcg)*
English: If you do, you might not get your full dose (underdosing) or get too much (overdosing) as the needle could block.
Slovenian: Če jih uporabite ponovno, se lahko zgodi, da ne boste dobili celotnega odmerka zdravila (premajhno odmerjanje), ali boste dobili prevelik odmerek (preveliko odmerjanje), ker se igla lahko zamaši.
English: Patients in the Suliqua group reported a statistically significantly greater decrease in the average 7-point self-monitored plasma glucose (SMPG) profile from baseline to Week 30 (-3.35 mmol/L) compared to patients in the insulin glargine group (-2.66 mmol/L; difference -0.69 mmol/L) and patients in the lixisenatide group (-1.95 mmol/L; difference -1.40 mmol/L) (p<0.0001 for both comparisons).
Slovenian: Bolniki, ki so prejemali zdravilo Suliqua, so dosegli statistično značilno večje znižanje povprečne 7-točkovne vrednosti samomerjenja glukoze v plazmi od izhodišča do 30. tedna (-3,35 mmol/l) kot bolniki, ki so prejemali insulin glargin (-2,66 mmol/l, razlika -0,69 mmol/l), in bolniki, ki so prejemali liksisenatid (-1,95 mmol/l, razlika -1,40 mmol/l) (p < 0,0001 za obe primerjavi).
English: Grip and squeeze the widest part of the outer needle cap.
Slovenian: Primite in stisnite najširši del zunanjega pokrovčka igle.
English: A new needle must always be attached before each use.
Slovenian: Pred vsako uporabo je treba na peresnik vedno namestiti novo iglo.
English: If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before using this medicine.
Slovenian: Če kaj od naštetega velja za vas (ali če ste negotovi), se posvetujte zzdravnikom, farmacevtom ali medicinsko sestro, preden uporabite to zdravilo.
English: Warning signs of hyperglycaemia
Slovenian: Opozorilni znaki hiperglikemije
English: Consistent with a relatively constant concentration/time profile of insulin glargine over 24 hours with no pronounced peak when administered alone, the glucose utilisation rate/time profile was similar when given in the insulin glargine/lixisenatide combination.
Slovenian: V skladu z relativno stalnim profilom koncentracije insulina glargin skozi čas v 24 urah, brez izrazitega vrha, če je uporabljen sam, je bil profil hitrosti porabe glukoze skozi čas podoben, če je bil insulin glargin uporabljen v kombinaciji z liksisenatidom.
English: The dose of Suliqua must be individualised based on clinical response and is titrated based on the patient's need for insulin (see section 4.2).
Slovenian: Odmerek zdravila Suliqua je treba prilagoditi vsakemu bolniku posamezno glede na klinični odziv in ga prilagajati glede na bolnikovo potrebo po insulinu (glejte poglavje 4.2).
English: • Disopyramide, for some heart problems.
Slovenian: • Dizopiramid, za zdravljenje določenih težav s srcem.
English: If your blood sugar falls too low, you may pass out (become unconscious).
Slovenian: Če se vam krvni sladkor preveč zniža, se lahko onesvestite (izgubite zavest).
English: What Suliqua is and what it is used for What you need to know before you use Suliqua How to use Suliqua
Slovenian: Kaj je zdravilo Suliqua in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Suliqua Kako uporabljati zdravilo Suliqua Možni neželeni učinki
English: This pen is peach coloured with an orange injection button.
Slovenian: Ta peresnik je breskove barve in ima oranžen gumb za injiciranje.
English: Gastrointestinal adverse reactions were mostly mild and transient in nature.
Slovenian: Neželeni učinki na prebavilih so bili večinoma blagi in prehodni.
English: Administration of Suliqua may cause formation of antibodies against insulin glargine and/or lixisenatide.
Slovenian: Uporaba zdravila Suliqua lahko povzroči nastanek protiteles proti insulinu glargin in/ali liksisenatidu.
English: • Ensure that you use the right medicine.
Slovenian: • Preverite, da uporabljate pravo zdravilo.
English: Beta-blockers, clonidine, lithium salts or alcohol may either potentiate or weaken the blood-glucose-lowering effect of insulin.
Slovenian: Antagonisti adrenergičnih receptorjev beta, klonidin, litijeve soli in alkohol lahko vpliv insulina na znižanje glukoze v krvi povečajo ali zmanjšajo.
English: 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.
Slovenian: Če bolnik prejema zdravila, ki imajo ozko terapevtsko okno ali zahtevajo natančen klinični nadzor, je treba bolnika natančno kontrolirati, zlasti med uvedbo zdravljenja z liksisenatidom.
English: The combination of medicinal products in this pen is for the daily injection of 10 to 40 dose steps of Suliqua.
Slovenian: Kombinacija zdravil v tem injekcijskem peresniku je namenjena za dnevno injiciranje od 10 do 40 odmernih korakov zdravila Suliqua.
English: • Talk with your healthcare provider about how to inject, before using your pen.
Slovenian: • Preden uporabite peresnik, se z zdravstvenim delavcem pogovorite, kako injicirati zdravilo.
English: • Your low blood sugar comes on slowly.
Slovenian: • če se vam krvni sladkor znižuje počasi,
English: No dose adjustment of lixisenatide is needed in patients with hepatic impairment (see section 5.2).
Slovenian: Bolnikom z okvaro jeter odmerka liksisenatida ni treba prilagoditi (glejte poglavje 5.2).
English: There is no clinical data on exposed pregnancies from controlled clinical studies with use of Suliqua, insulin glargine, or lixisenatide.
Slovenian: Kliničnih podatkov iz kontroliranih kliničnih študij o uporabi zdravila Suliqua, insulina glargin in liksisenatida pri nosečnicah ni.
English: STEP 3: Do a safety test Always do a safety test before each injection to:
Slovenian: KORAK: Opravite varnostni preizkus Pred vsakim injiciranjem opravite varnostni preizkus:
English: • Medicines to relieve pain and lower fever, such as pentoxifylline, propoxyphene and salicylates
Slovenian: • Zdravila za olajšanje bolečin in znižanje zvišane telesne temperature, na primer pentoksifilin,
English: Do not use this medicine after the expiry date which is stated on the carton and on the label of the pen after “EXP”.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in nalepki injekcijskega peresnika poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
English: • Too high blood sugar (hyperglycaemia).
Slovenian: • Previsok krvni sladkor (hiperglikemija).
English: • Throw away your used pen as instructed by your pharmacist or local authority.
Slovenian: • Uporabljeni peresnik zavrzite, kot vam naroči farmacevt, ali po določilih lokalnega pristojnega organa.
English: The pen may be stored for a maximum of 28 days out of the refrigerator, but below 25°C.
Slovenian: Po prvi uporabi ali če injekcijski peresnik nosite s seboj za rezervo Peresnik je lahko shranjen zunaj hladilnika največ 28 dni, vendar na temperaturi do 25 °C.
English: Medicine that may reduce warning signs of low blood sugar Beta-blockers and some other medicines (such as clonidine, guanethidine, reserpine - for high blood pressure) may make it harder to recognise warning signs of your low blood sugar levels (hypoglycaemia).
Slovenian: Zdravila, ki lahko zmanjšajo opozorilne znake nizkega krvnega sladkorja Antagonisti adrenergičnih receptorjev beta in nekatera druga zdravila (npr. klonidin, gvanetidin, rezerpin - za visok krvni tlak) lahko otežijo prepoznavanje opozorilnih znakov prenizkega krvnega sladkorja (hipoglikemije).
English: Examples of signs that your blood sugar level is falling too much or too fast include: sweating, clammy skin, feeling anxious, fast or irregular heartbeat, high blood pressure and palpitations.
Slovenian: Med znaki pretiranega ali prehitrega znižanja krvnega sladkorja so znojenje, vlažna in lepljiva koža, občutek tesnobe, hitro ali neredno bitje srca, visok krvni tlak in razbijanje srca (palpitacije).
English: [-1.9 to -0.9]
Slovenian: [-1,9 do -0,9]
English: For lixisenatide no dose adjustment is required based on age.
Slovenian: Odmerka liksisenatida ni treba prilagoditi glede na starost.
English: Keep these Instructions For Use leaflet for future reference.
Slovenian: Ta navodila za uporabo shranite, da jih boste lahko pogledali v prihodnje.
English: Hyperglycaemia (high blood sugar levels)
Slovenian: Hiperglikemija (visok krvni sladkor)
English: Only in this case, it is okay to inject a partial dose of less than 10 dose steps.
Slovenian: Le v takšnem primeru je sprejemljivo, da injicirate delen odmerek, manjši od 10 odmernih korakov.
English: [-1.8 to -0.9]
Slovenian: [-1,8 do -0,9]
English: The combination of medicinal products in this pen is for the daily injection of 30 to 60 dose steps Suliqua.
Slovenian: Kombinacija zdravil v tem injekcijskem peresniku je namenjena za dnevno injiciranje od 30 do 60 odmernih korakov zdravila Suliqua.
English: The dose must be individualised based on clinical response and is titrated based on the patient's need for insulin.
Slovenian: Odmerek je treba prilagoditi vsakemu bolniku posamezno glede na klinični odziv in ga prilagajati glede na bolnikovo potrebo po insulinu.
English: • loss of fluids from your body (dehydration) e.g. in case of vomiting and diarrhoea.
Slovenian: • če izgubljate tekočino (dehidracija), npr. v primeru bruhanja ali driske.
English: 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.
Slovenian: A podaljšanje tmax, opaženo po uporabi paracetamola od 1 do 4 ure po liksisenatidu, je treba upoštevati, če je zaradi učinkovitosti potreben hiter začetek delovanja.
English: The maximum daily dose is 60 units insulin glargine and 20 mcg lixisenatide corresponding to 60 dose steps.
Slovenian: Največji dnevni odmerek je 60 enot insulina glargin in 20 mcg liksisenatida; to ustreza 60 odmernim korakom.
English: Always use another Suliqua (10-40) pen to complete your dose and no other pen.
Slovenian: Za dokončanje odmerka vedno uporabite drug peresnik Suliqua (10-40) in nobenega drugega.
English: The re-use of needles increases the risk of blocked needles which may cause under- or overdosing.
Slovenian: Ponovna uporaba igel poveča tveganje za zamašitev, to pa lahko povzroči premajhno ali preveliko odmerjanje.
English: Starting dose and pen
Slovenian: Začetni odmerek in peresnik
English: Factors increasing the susceptibility to hypoglycaemia require particularly close monitoring and may necessitate dose adjustment.
Slovenian: Posebej natančno je treba nadzirati dejavnike, ki povečujejo nagnjenost k hipoglikemijam, in potrebna je lahko prilagoditev odmerka.
English: • Keep your pen at room temperature, below 25°C.
Slovenian: • Peresnik shranjujte na sobni temperaturi do 25 °C.
English: • Make sure you have the correct medicine.
Slovenian: • Prepričajte se, da imate pravo zdravilo.
English: There are no clinically relevant differences in the rate of absorption when lixisenatide as monotherapy is administered subcutaneously in the abdomen, deltoid, or thigh.
Slovenian: Hitrost absorpcije se ne razlikuje klinično pomembno, če je liksisenatid kot monoterapija injiciran subkutano v trebuh, deltoidni predel ali stegno.
English: Only in this case, it is okay to inject a partial dose of less than 30 dose steps.
Slovenian: Le v takšnem primeru je sprejemljivo, da injicirate delen odmerek, manjši od 30 odmernih korakov.
English: • Suliqua is supplied in a pre-filled pen and must only be used with this device; patients, carers and healthcare professionals must never use a syringe to withdraw insulin glargine/lixisenatide from a pre-filled pen or dosing errors and serious harm can result.
Slovenian: • Zdravilo Suliqua je na voljo v napolnjenem injekcijskem peresniku in se ga sme uporabljati le s tem pripomočkom; bolniki, njihovi negovalci in zdravstveni delavci ne smejo nikoli uporabiti brizge, da bi potegnili insulin glargin/liksisenatid iz napolnjenega injekcijskega peresnika, ker to lahko povzroči napake pri odmerjanju in resno škodo bolniku.
English: Before using Suliqua, the instructions for use included in the package leaflet must be read carefully.
Slovenian: Pred uporabo zdravila Suliqua mora bolnik natančno prebrati navodilo za uporabo, priloženo zdravilu.
English: When lixisenatide 20 mcg and atorvastatin 40 mg were co-administered in the morning for 6 days, the exposure to atorvastatin was not affected, while Cmax was decreased by 31% and tmax was delayed by 3.25 hours.
Slovenian: Če sta bila liksisenatid v odmerku 20 mcg in atorvastatin v odmerku 40 mg sočasno uporabljena zjutraj 6 dni, to ni vplivalo na izpostavljenost atorvastatinu, a Cmax se je znižala za 31 % in tmax se je podaljšal za 3,25 ure.
English: What to do if you experience hypoglycaemia?
Slovenian: Kaj storiti, če se vam pojavi hipoglikemija?
English: • Try again if the needle does not come off the first time.
Slovenian: • Če se igla ne sname prvič, poskusite znova.
English: 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.
Slovenian: 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 znižala 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.
English: Patients with type 2 diabetes, treated with metformin alone or metformin and a second OAD treatment that could be a sulfonylurea or a glinide or a sodium-glucose co-transporter-2 (SGLT-2) inhibitor or a dipeptidyl peptidase-4 (DPP-4) inhibitor, and who were not adequately controlled with this treatment (HbA1c range 7.5% to 10% for patients previously treated with metformin alone and 7.0% to 9% for patients previously treated with metformin and a second oral anti-diabetic treatment) entered a run-in period for 4 weeks.
Slovenian: V 4-tedensko uvajalno obdobje so vstopili bolniki s sladkorno boleznijo tipa 2, ki so prejemali ali sam metformin ali metformin skupaj z drugim POAD (to je bila lahko sulfonilsečnina, glinid, zaviralec SGLT-2 [natrij-glukoznega koprenašalca 2] ali zaviralec DPP-4 [dipeptidilpeptidaze-4]) in ki s takšnim zdravljenjem niso bili ustrezno urejeni: to je pomenilo HbA1c od 7,5 % do 10 % pri bolnikih, ki so predhodno prejemali le metformin oziroma od 7,0 % do 9 % pri bolnikih, ki so poleg metformina prejemali še drug peroralni antidiabetik.
English: Clinical study in patients with Type 2 diabetes insufficiently controlled on basal insulin A total of 736 patients with type 2 diabetes participated in a randomised, 30-week, active-controlled, open-label, 2-treatment arm, parallel-group, multicenter study to evaluate the efficacy and safety of Suliqua compared to insulin glargine (100 units/ml).
Slovenian: Klinična študija pri bolnikih s sladkorno boleznijo tipa 2, nezadostno urejenih z bazalnim insulinom Skupno 736 bolnikov s sladkorno boleznijo tipa 2 je sodelovalo v randomizirani, 30-tedenski, z zdravilno učinkovino kontrolirani, odprti multicentrični študiji vzporednih skupin z 2 terapevtskima skupinama, ki je ocenjevala učinkovitost in varnost zdravila Suliqua v primerjavi z insulinom glargin (100 enot/ml).
English: You may need to talk about:
Slovenian: Med vprašanji, o katerih se boste morali pogovoriti, so:
English: B. Pull off the pen cap.
Slovenian: B. Snemite pokrovček peresnika.
English: • Indigestion (dyspepsia)
Slovenian: • težave s prebavo (dispepsija)
English: Discard the pen after this period.
Slovenian: Po tem času morate peresnik zavreči.
English: How to use Suliqua
Slovenian: Kako uporabljati zdravilo Suliqua
English: Patients must be instructed to always check the pen label before each injection to avoid accidental mix-ups between the two different strengths of Suliqua and mix-ups with other injectable diabetes medicinal products.
Slovenian: Bolnikom je treba naročiti, naj pred vsakim injiciranjem preverijo nalepko peresnika, da bodo preprečili neneamerne zamenjave med obema različnima jakostma zdravila Suliqua in zamenjave z drugimi injiciranimi zdravili za sladkorno bolezen.
English: Body weight has no clinically relevant effect on lixisenatide AUC.
Slovenian: Telesna masa nima klinično pomembnega vpliva na AUC liksisenatida.
English: The mean BMI at baseline was 31.7 kg/m2 with 63.4% of patients having a BMI ≥30 kg/m2.
Slovenian: Povprečni izhodiščni ITM je bil 31,7 kg/m2 in 63,4 % bolnikov je imelo ITM ≥ 30 kg/m2.
English: • Suliqua is supplied in a pre-filled pen and must only be used with this device; healthcare professionals must never use a syringe to withdraw insulin glargine/lixisenatide from a pre filled pen or dosing errors and serious harm can result.
Slovenian: • Zdravilo Suliqua je na voljo v napolnjenem injekcijskem peresniku in se ga sme uporabljati le s tem pripomočkom; zdravstveni delavci ne smejo nikoli uporabiti brizge, da bi potegnili insulin glargin/liksisenatid iz napolnjenega injekcijskega peresnika, ker to lahko povzroči napake pri odmerjanju in resno škodo bolniku.
English: - Never re-use needles.
Slovenian: - Igel nikdar ne uporabljajte ponovno.
English: • If you find it hard to press the injection button in, do not force it as this may break your pen:
Slovenian: • Če gumb za injiciranje težko pritisnete noter, ne uporabite sile, ker lahko poškodujete peresnik:
English: 6.6 Special precautions for disposal and other handling Before first use, the pen must be taken out of the refrigerator and stored below 25°C for 1 to 2 hours.
Slovenian: Pred prvo uporabo je treba peresnik vzeti iz hladilnika in ga za 1 do 2 uri pustiti na temperaturi do 25 °C.
English: 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 of lixisenatide was increased by 46%, 51% and 87%, respectively.
Slovenian: AUC liksisenatida se je pri preiskovancih z blago okvaro ledvic (očistek kreatinina po CockcroftGaultovi formuli 60-90 ml/min) povečala za 46 %, pri tistih z zmerno okvaro (očistek kreatinina 30-60 ml/min) za 51 % in pri tistih s hudo okvaro (očistek kreatinina 15-30 ml/min) za 87 %.
English: [8.1 to 22.4]
Slovenian: [8,1 do 22,4]