natgillin/translations-raw huggingface dataset:
• 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.
• 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.
Before using Suliqua, the instructions for use included in the package leaflet must be read carefully.
Pred uporabo zdravila Suliqua mora bolnik natančno prebrati navodilo za uporabo, priloženo zdravilu.
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.
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.
What to do if you experience hypoglycaemia?
Kaj storiti, če se vam pojavi hipoglikemija?
• Try again if the needle does not come off the first time.
• Če se igla ne sname prvič, poskusite znova.
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 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.
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.
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.
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).
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).
You may need to talk about:
Med vprašanji, o katerih se boste morali pogovoriti, so:
B. Pull off the pen cap.
B. Snemite pokrovček peresnika.
• Indigestion (dyspepsia)
• težave s prebavo (dispepsija)
Discard the pen after this period.
Po tem času morate peresnik zavreči.
How to use Suliqua
Kako uporabljati zdravilo Suliqua
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.
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.
Body weight has no clinically relevant effect on lixisenatide AUC.
Telesna masa nima klinično pomembnega vpliva na AUC liksisenatida.
The mean BMI at baseline was 31.7 kg/m2 with 63.4% of patients having a BMI ≥30 kg/m2.
Povprečni izhodiščni ITM je bil 31,7 kg/m2 in 63,4 % bolnikov je imelo ITM ≥ 30 kg/m2.
• 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.
• 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.
- Never re-use needles.
- Igel nikdar ne uporabljajte ponovno.
• If you find it hard to press the injection button in, do not force it as this may break your pen:
• Če gumb za injiciranje težko pritisnete noter, ne uporabite sile, ker lahko poškodujete peresnik:
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.
Pred prvo uporabo je treba peresnik vzeti iz hladilnika in ga za 1 do 2 uri pustiti na temperaturi do 25 °C.
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.
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 %.
If you have missed a dose of Suliqua or if you have not injected enough insulin, your blood sugar level may become too high (hyperglycaemia):
Če ste izpustili odmerek zdravila Suliqua ali niste injicirali dovolj insulina, se vam lahko krvni sladkor preveč zviša (hiperglikemija).
Warning signs of hypoglycaemia
Opozorilni znaki hipoglikemije
The cardiovascular safety of insulin glargine and lixisenatide has been established in the ORIGIN and ELIXA clinical trials, respectively.
Srčno-žilno varnost insulina glargin so proučili v kliničnem preskušanju ORIGIN, liksisenatida pa v kliničnem preskušanju ELIXA.
• Beta-blockers or clonidine, for high blood pressure.
• Antagoniste adrenergičnih receptorjev beta ali klonidin, za visok krvni tlak.
At Week 30, Suliqua provided statistically significant improvement in HbA1c (p-value <0.0001) compared to the individual components.
Po 30 tednih je zdravilo Suliqua v primerjavi z vsako posamezno učinkovino statistično značilno izboljšalo HbA1c (vrednost p < 0,0001).
In the event of blocked needles patients must follow the instructions described in the “Instructions for Use” accompanying the package leaflet.
Če je igla zamašena, mora bolnik slediti "Navodilom za uporabo", priloženim navodilu za uporabo zdravila.
The Outcome Reduction with Initial Glargine Intervention trial (i.e., ORIGIN) was an open-label, randomised, 12,537 patient study that compared LANTUS to standard care on the time to first occurrence of a major adverse cardiovascular event (MACE).
Preskušanje ORIGIN (Outcome Reduction with Initial Glargine Intervention) je bilo odprta, randomizirana študija, ki je zajela 12.537 bolnikov in je primerjala čas do prvega pojava pomembnega neželenega srčno-žilnega dogodka (MACE, major adverse cardiovascular event) z zdravilom LANTUS in običajnim zdravljenjem.
• If you think your pen is damaged, do not use it. Get a new one.
• Če menite, da je peresnik poškodovan, ga ne uporabite.
30-60 dose steps (1 dose step = 1 unit of insulin glargine + 0.33 micrograms of lixisenatide)
30-60 odmernih korakov (1 odmerni korak = 1 enota insulina glargina + 0,33 mikrograma liksisenatida)
• This pen provides a dose of 30 to 60 dose steps in one injection, in steps of 1 dose step.
• Ta peresnik omogoča odmerek od 30 do 60 odmernih korakov naenkrat (v eni injekciji), v korakih po 1 odmerni korak.
Insulin glargine daily dose LS insulin dose at week 30 (mean)
Dnevni odmerek insulina glargin Odmerek insulina po metodi NK po 30 tednih (povprečje)
• The prescription must state the dose range and strength of the Suliqua pre filled pen and the number of dose steps to be administered.
• Na receptu morajo biti navedeni razpon odmerkov in jakost napolnjenega injekcijskega peresnika Suliqua ter število odmernih korakov, ki jih je treba injicirati.
Suliqua is to be dosed in accordance with the individual patient's need for insulin.
Odmerek zdravila Suliqua je treba določiti individualno glede na bolnikovo potrebo po insulinu.
Before injecting Suliqua
Pred injiciranjem zdravila Suliqua
• Test your blood sugar level and, if it is high, as agreed with your doctor or nurse, test your urine for ketones as soon as you notice any of the above signs
• Čim opazite katerega od naštetih znakov, izmerite sladkor v krvi; če je visok (kot ste se dogovorili z zdravnikom ali medicinsko sestro), naredite še preizkus za ketone v urinu.
A number of substances affect glucose metabolism and may require dose adjustment of Suliqua.
Na presnovo glukoze vplivajo številne snovi in potrebna je lahko prilagoditev odmerka zdravila Suliqua.
Animal data do not indicate reproductive toxicity with insulin glargine.
Podatki na živalih ne kažejo, da bi imel insulin glargin reproduktivne toksične učinke.
If you use another anti diabetic medicine, discuss with your doctor whether, you should stop using that medicine when starting Suliqua.
Če uporabljate kakšno drugo zdravilo proti sladkorni bolezni, se z zdravnikom posvetujte, ali ga morate opustiti, preden začnete uporabljati zdravilo Suliqua.
If a dose lower than 30 dose steps is needed, use the Suliqua 100units/ml + 50 micrograms pre-filled pen (Suliqua (10-40) pen.
Če potrebujete odmerek, manjši od 30 odmernih korakov, uporabite napolnjeni injekcijski peresnik Suliqua 100 enot/ml + 50 mikrogramov (peresnik Suliqua 10-40).
Number (%) of patients achieving HbA1c< 7.0% with no body weight gain at week 30
Število (%) bolnikov, ki so po 30 tednih dosegli HbA1c < 7,0 % brez povečanja telesne mase
• This pen provides a dose of 10 to 40 dose steps in one injection, in steps of 1 dose step.
• Ta peresnik omogoča odmerek od 10 do 40 odmernih korakov naenkrat (v eni injekciji), v korakih po 1 odmerni korak.
If you do, it could lead to very high blood sugar (hyperglycaemia) and a build-up of acid in the blood (ketoacidosis).
Če zdravilo prenehate uporabljati, se vam lahko krvni sladkor zelo zviša (hiperglikemija) in v krvi se lahko nakopiči kislina (ketoacidoza).
Figure: Mean HbA1c(%) at start of screening, randomization point and Each Time Point (Completers) and at Week 30 - mITT population
Slika: Povprečni HbA1c (%) na začetku presejanja, ob randomizaciji, na vsaki časovni točki (bolniki, ki so dokončali študijo) in po 30 tednih - populacija mZNZ
• Use this pen only to inject single daily doses from 10 to 40 dose steps.
• Ta peresnik uporabljajte le za injiciranje enkratnega dnevnega odmerka od 10 do 40 odmernih korakov.
After subcutaneous administration of insulin glargine/lixisenatide combinations to patients with type 1 diabetes, insulin glargine showed no pronounced peak.
Po subkutani uporabi kombinacije insulin glargin/liksisenatid pri bolnikih s sladkorno boleznijo tipa 1 se pri insulinu glargin ni pokazal izrazit vrh.
Effect of gastric emptying on oral medicinal products The delay of gastric emptying with lixisenatide may reduce the rate of absorption of orally administered medicinal products.
Vpliv praznjenja želodca na peroralno uporabljena zdravila Upočasnitev praznjenja želodca zaradi liksisenatida lahko zmanjša hitrost absorpcije peroralno uporabljenih zdravil.
• Only use this pen to inject single daily doses from 30 to 60 dose steps.
• Ta peresnik uporabljajte le za injiciranje enkratnega dnevnega odmerka od 30 do 60 odmernih korakov.
Your blood sugar level may fall (hypoglycaemia) if you take:
Krvni sladkor se vam lahko zniža (hipoglikemija), če jemljete:
When to inject Suliqua
Kdaj injicirati zdravilo Suliqua
Places to inject
Mesta za injiciranje
• For Suliqua, one dose step always contains one unit of insulin, regardless of the Suliqua pre-filled pen being used (10-40 pen or 30-60 pen).
Pri zdravilu Suliqua en odmerni korak vedno vsebuje eno enoto insulina, ne glede na to, kateri napolnjeni injekcijski peresnik zdravila Suliqua je uporabljen (peresnik 10-40 ali peresnik 30-60).
In patients with mild to moderate renal impairment using Suliqua, frequent glucose monitoring and dose adjustment may be necessary.
Bolniki z blago ali zmerno okvaro ledvic, ki uporabljajo zdravilo Suliqua, lahko potrebujejo pogoste meritve glukoze in prilagoditve odmerka.
Paediatric population No studies have been performed with Suliqua in children and adolescents below 18 years of age.
Pediatrična populacija Pri otrocih in mladostnikih, mlajših od 18 let, niso izvedli študij zdravila Suliqua.
If pancreatitis is suspected, Suliqua should be discontinued; if acute pancreatitis is confirmed, lixisenatide should not be restarted.
Če je akutni pankreatitis potrjen, se liksisenatida ne sme znova začeti uporabljati.
SoloStar Clear colourless solution.
SoloStar Bistra, brezbarvna raztopina.
Suliqua is to be injected subcutaneously in the abdomen, deltoid, or thigh.
Zdravilo Suliqua je treba injicirati subkutano v trebuh, deltoidni predel ali stegno.
sanofi-aventis groupe 54, rue La Boétie 75008 Paris France
sanofi-aventis groupe 54, rue La Boétie 75008 Pariz Francija
10-40 dose steps (1 dose step = 1 unit of insulin glargine + 0.5 micrograms of lixisenatide)
10-40 odmernih korakov (1 odmerni korak = 1 enota insulina glargina + 0,5 mikrograma liksisenatida)
No dedicated cardiovascular outcome trial has been conducted with Suliqua.
Namenskih preskušanj za ugotavljanje srčno-žilnih izidov z zdravilom Suliqua niso izvedli.
Hypoglycaemia (low blood sugar levels)
Hipoglikemija (nizek krvni sladkor)
Clinical study in patients with Type 2 diabetes insufficiently controlled on OAD treatment A total of 1170 patients with type 2 diabetes were randomised in an open label, 30-week, activecontrolled study to evaluate the efficacy and safety of Suliqua compared to the individual components, insulin glargine (100 units/ml) and lixisenatide (20 mcg).
Skupno 1170 bolnikov s sladkorno boleznijo tipa 2 so randomizirali v odprti, 30-tedenski, z zdravilno učinkovino kontrolirani študiji za oceno učinkovitosti in varnosti zdravila Suliqua v primerjavi s posameznima učinkovinama, insulinom glargin (100 enot/ml) in liksisenatidom (20 mcg).
Therapy with basal insulin or oral glucose lowering medicinal product other than metformin should be discontinued prior to initiation of Suliqua.
Pred uvedbo zdravila Suliqua je treba ukiniti zdravljenje z bazalnim insulinom ali peroralnimi zdravili za zniževanje glukoze, razen metformina.
A further delay in tmax and a reduced Cmax of paracetamol have been predicted with the 20 mcg maintenance dose.
V primeru vzdrževalnega odmerka 20 mikrogramov je mogoče pričakovati dodatno podaljšanje tmax in zmanjšanje Cmax paracetamola.
A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) ANDMANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
A. IZDELOVALEC (IZDELOVALCI) BIOLOŠKE ZDRAVILNE UČINKOVINE (UČINKOVIN) IN IZDELOVALEC (IZDELOVALCI), ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJ
• Provide patients with the patient guide prior to prescribing or dispensing Suliqua.
• Preden bolnikom predpišete ali izdate zdravilo Suliqua, jim izročite Vodnik za bolnike.
Your blood sugar level may rise (hyperglycaemia) if you take:
Krvni sladkor se vam lahko zviša (hiperglikemija), če jemljete:
The re-use of insulin pen needles increases the risk of blocked needles, which may cause under- or overdosing.
Ponovna uporaba igel za insulinski peresnik poveča tveganje za zamašitev, to pa lahko povzroči premajhno ali preveliko odmerjanje.
sanofi-aventis groupe 54, rue La Boétie F-75008 Paris France
sanofi-aventis groupe 54, rue La Boétie F-75008 Pariz Francija
Each Suliqua pen contains 3 ml of solution
En peresnik Suliqua vsebuje 3 ml raztopine.
No increase in mean heart rate was seen in all Phase 3 studies with Suliqua.
V nobeni študiji 3. faze zdravila Suliqua niso opazili povečanja povprečne srčne frekvence.
• The active substances are insulin glargine and lixisenatide.
• Zdravilni učinkovini sta insulin glargin in liksisenatid.
AUC was comparable while there was a small decrease in Cmax of lixisenatide of 22-34% compared with separate simultaneous administration of insulin glargine and lixisenatide, which is not likely to be clinically significant.
V primerjavi z ločenim injiciranjem insulina glargin in liksisenatida so ugotovili majhno zmanjšanje Cmax (za 22 do 34 %) liksisenatida, kar pa verjetno ni klinično pomembno.
Nasopharyngitis Upper respiratory tract infection
Infekcijske in parazitske bolezni nazofaringitis okužba zgornjih dihal
If you notice signs of your blood sugar being too low (hypoglycaemia), take action to increase your blood sugar level straight away (see the box at the end of this leaflet).
Če opazite znake prenizkega krvnega sladkorja (hipoglikemije), ukrepajte tako, da boste krvni sladkor takoj zvišali (glejte okvir na koncu tega navodila za uporabo).
• Switch from basal insulin
• Prehod z bazalnega insulina
At Week 30, Suliqua provided statistically significant improvement in HbA1c (p-value <0.0001) compared to insulin glargine.
Po 30 tednih je zdravilo Suliqua v primerjavi z insulinom glargin statistično značilno izboljšalo HbA1c (vrednost p < 0,0001).
• If you find it hard to press the injection button in, do not force it as this may break your pen.
• Če gumb za injiciranje težko pritisnete, ne uporabite sile, ker lahko poškodujete peresnik.
Mild episodes of hypoglycaemia can usually be treated with oral carbohydrates.
Blage hipoglikemije je po navadi mogoče odpraviti z uživanjem ogljikovih hidratov.
While using this medicine be aware of the following and talk to doctor, pharmacist or nurse before using Suliqua:
Med uporabo tega zdravila se zavedajte naslednjega in se pred uporabo zdravila Suliqua posvetujte z zdravnikom, farmacevtom ali medicinsko sestro:
• Too low blood sugar (hypoglycaemia).
• Prenizek krvni sladkor (hipoglikemija).
Units of medicine in your pen
Enote zdravila v peresniku
You must always check the label before each injection to avoid mix-ups between Suliqua and other insulins.
Pred vsakim injiciranjem morate vedno preveriti nalepko zdravila, da pomotoma ne zamenjate zdravila Suliqua s kakšnim drugim insulinom.
• Do not use your pen after the expiry date.
• Peresnika ne uporabljajte po preteku roka uporabnosti.
Solution for injection SoloStar
raztopina za injiciranje SoloStar
• Add-on to metformin [insulin naïve]
• Dodatek metforminu [bolniki, še nezdravljeni z insulinom]
Add-on to metformin [insulin naïve]
Dodatek metforminu [bolniki, še nezdravljeni z insulinom]
Suliqua should not be used during breast-feeding.
Zdravila Suliqua se ne sme uporabljati med obdobjem dojenja.
Insulin glargine has not been studied in patients with renal impairment.
Insulin glargin pri bolnikih z okvaro ledvic ni raziskan.
• One dose step contains one unit of insulin glargine plus a fixed amount of lixisenatide.
• En odmerni korak vsebuje eno enoto insulina glargina in fiksno količino liksisenatida.
Hepatic dysfunction is not expected to affect the pharmacokinetics of lixisenatide.
Ni pričakovati, da bi moteno delovanje jeter vplivalo na farmakokinetiko liksisenatida.
• Always perform a safety test. See STEP 3.
potem opravite varnostni preizkus (glejte 3.
The combination of insulin glargine and lixisenatide has no impact on the pharmacodynamics of of insulin glargine.
Kombinacija insulina glargin in liksisenatida ne vpliva na farmakodinamiko insulina glargina.
• Your blood sugar is often too low.
• Če imate pogosto prenizek krvni sladkor.
It is preferable that the prandial injection is performed before the same meal every day, when the most convenient meal has been chosen.
Potem, ko je izbran obrok, pred katerim je injiciranje zdravila za bolnika najbolj ustrezno, je treba prandialno injekcijo po možnosti uporabljati vsak dan pred istim obrokom.
• For doses >40 dose steps/day titration must be continued with Suliqua (30-60) pen.
• Za odmerke > 40 odmernih korakov na dan je treba prilagajanje nadaljevati s peresnikom Suliqua
Store the pen away from direct heat or direct light.
Peresnik shranjujte tako, da ni izpostavljen neposredni vročini ali neposredni svetlobi.
- Never use a syringe to remove medicine from your pen.
- Nikdar ne uporabite brizge za jemanje zdravila iz peresnika.
Pull off the pen cap.
Snemite pokrovček peresnika.
After screening, eligible patients (n=1018) entered a 6 week run-in phase where patients remained on or switched to insulin glargine, in case they took another basal insulin, and had their insulin dose titrated/stabilised while continuing metformin (if previously taken).
Med tem obdobjem so ostali na insulinu glargin oziroma so nanj prešli, če so prej uporabljali kakšen drug bazalni insulin, odmerek insulina pa so jim prilagajali/stabilizirali med nadaljnjo uporabo metformina (če so ga jemali že prej).
In parallel, glucagon secretion is suppressed.
Vzporedno s tem zavre izločanje glukagona.
• A reminder on the need to report all medication errors with Suliqua will be part of the healthcare professional guide.
• Del vodnika za zdravstvene delavce bo opozorilo, da je treba poročati o vseh napakah pri uporabi zdravila Suliqua.
The delay of gastric emptying with lixisenatide may reduce the rate of absorption of orally administered medicinal products.
Upočasnitev praznjenja želodca zaradi liksisenatida lahko zmanjša hitrost absorpcije peroralno uporabljenih zdravil.
Suliqua (30-60) pen contains insulin glargine and lixisenatide.
Injekcijski peresnik Suliqua (30-60) vsebuje insulin glargin in liksisenatid.
The insulin glargine/lixisenatide ratio has no relevant impact on the PK of insulin glargine and lixisenatide in Suliqua.
Razmerje insulin glargin/liksisenatid nima pomembnega vpliva na farmakokinetiko insulina glargin in liksisenatida v zdravilu Suliqua.
• You lose carbohydrates from being sick (vomiting) or diarrhoea.
• Izgubljate ogljikove hidrate zaradi bruhanja ali driske.
• You change the area where you inject Suliqua.
• če zamenjate predel, kamor injicirate zdravilo Suliqua, npr. s stegna na nadlaket.
Figure - Mean HbA1c (%) at start of screening, at randomization, Each Time Point (Completers) and at Week 30 - mITT population
Slika - Povprečni HbA1c (%) na začetku presejanja, ob randomizaciji, na vsaki časovni točki (bolniki, ki so dokončali študijo) in po 30 tednih (LOCF*) - populacija mZNZ
Gender has no clinically relevant effect on the pharmacokinetics of lixisenatide
Spol nima klinično pomembnega vpliva na farmakokinetiko liksisenatida.
• Do not use a syringe to remove medicine from your pen.
• Ne uporabite brizge za jemanje zdravila iz peresnika.
Always do a safety test before each injection to:
Pred vsakim injiciranjem opravite varnostni preizkus:
• Do not use the pen if your single daily dose is less than 30 dose steps, shown as white numbers on a black background.
• Ne uporabite tega peresnika, če je vaš enkratni dnevni odmerek manj kot 30 odmernih korakov (prikazano z belimi številkami na črnem ozadju).