FrancophonIA/ELRC3.0 huggingface dataset:
English: In this trial, documented symptomatic hypoglycaemia (defined as plasma glucose ≤3.9 mmol/L accompanied by symptoms) was reported by 47.2% of patients treated with liraglutide 3.0 mg/day and by 51.8% of patients treated with placebo.
Slovenian: V tem preskušanju so se simptomi hipoglikemije (določeni kot koncentracija glukoze v krvi ≤ 3,9 mmol/l ter spremljajoči simptomi) pojavili pri 47,2 % bolnikov, zdravljenih z liraglutidom 3,0 mg/dan, in pri 51,8 % bolnikov,
English: Saxenda is not recommended for use in patients with severe hepatic impairment and should be used cautiously in patients with mild or moderate hepatic impairment (see sections 4.4 and 5.2).
Slovenian: Zdravljenje z zdravilom Saxenda ni priporočljivo pri bolnikih s hudo okvaro jeter, pri bolnikih z blago ali zmerno okvaro jeter pa je zdravilo treba uporabljati previdno (glejte poglavji 4.4 in 5.2).
English: • If you forget a dose and remember it within 12 hours from when you usually use the dose, inject it as soon as you remember.
Slovenian: Če ste pozabili uporabiti zdravilo Saxenda • Če ste pozabili uporabiti odmerek in je minilo manj kot 12 ur od takrat, ko ga običajno uporabite, ga injicirajte takoj, ko se spomnite.
English: Systolic blood pressure, mmHg
Slovenian: Sistolični krvni tlak v mmHg
English: Saxenda is not recommended for use in paediatric patients.
Slovenian: Pediatrična populacija Uporaba zdravila Saxenda pri pediatričnih bolnikih ni priporočljiva.
English: A mean increase in heart rate from baseline of 2.5 beats per minute (ranging across trials from 1.6 to 3.6 beats per minute) has been observed with liraglutide in clinical phase 3 trials.
Slovenian: Frekvenca srčnega utripa se je od izhodišča v povprečju povišala za 2,5 utripa na minuto (v različnih preskušanjih se je frekvenca povišala za 1,6 do 3,6 utripa na minuto).
English: Please read these instructions carefully before using your Saxenda pre-filled pen.
Slovenian: Pred uporabo napolnjenega injekcijskega peresnika Saxenda natančno preberite ta navodila.
English: When you are not using the pen, keep the pen cap on in order to protect it from light.
Slovenian: Kadar injekcijskega peresnika ne uporabljate, naj bo vedno pokrit s pokrovčkom za zagotovitev zaščite pred svetlobo.
English: If a dose is missed within 12 hours from when it is usually taken, the patient should take the dose as soon as possible.
Slovenian: Če bolnik pozabi uporabiti zdravilo in je od takrat, ko ga običajno uporabi, minilo manj kot 12 ur, si mora odmerek injicirati čim prej.
English: People with diabetes
Slovenian: Bolniki s sladkorno boleznijo
English: In vitro, liraglutide has shown very low potential to be involved in pharmacokinetic interactions with other active substances related to cytochrome P450 (CYP) and plasma protein binding.
Slovenian: 4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij V poskusih in vitro je bila ugotovljena zelo majhna možnost medsebojnega farmakokinetičnega delovanja liraglutida in drugih učinkovin, ki bi bilo povezano s citokromom P450 (CYP) ali vezavo na beljakovine v plazmi.
English: Baseline values are means, changes from baseline at week 32 are estimated means (leastsquares) and treatment contrasts at week 32 are estimated treatment differences (95% CI).
Slovenian: Izhodiščni vrednosti telesne mase sta povprečji, spremembe v 32. tednu glede na izhodišče so ocenjena povprečja (metoda najmanjših kvadratov) in razlike v 32. tednu zaradi zdravljenja so ocenjene razlike zdravljenja (95 % IZ).
English: Atorvastatin Cmax was decreased by 38% and median tmax was delayed from 1 h to 3 h with liraglutide.
Slovenian: Pri zdravljenju z liraglutidom se je Cmax atorvastatina zmanjšala za 38 %, mediani tmax pa se je podaljšal z 1 na 3 ure.
English: Excipients: disodium phosphate dihydrate, propylene glycol, phenol, hydrochloric acid/sodium hydroxide (for pH adjustment), water for injections
Slovenian: Pomožne snovi: natrijev hidrogenfosfat dihidrat, propilenglikol, fenol, klorovodikova kislina/natrijev hidroksid (za uravnavanje pH) in voda za injekcije.
English: If you have diabetes, do not use Saxenda as a replacement for insulin.
Slovenian: Bolniki s sladkorno boleznijo Če imate sladkorno bolezen, zdravila Saxenda ne smete uporabljati kot zamenjavo za insulin.
English: Needles are not included.
Slovenian: Injekcijske igle niso priložene.
English: • Trial 4 (SCALE Maintenance - 1923): A 56-week trial assessing body weight maintenance and weight loss in 422 randomised (305 completers) obese and overweight patients with hypertension or dyslipidaemia after a preceding weight loss of ≥5% induced by a low-calorie diet.
Slovenian: • Preskušanje 4 (SCALE Maintenance - 1923): 56-tedensko preskušanje, v katerem so ocenjevali obvladovanje in izgubo telesne mase pri 422 randomiziranih bolnikih z debelostjo in bolnikih s prekomerno telesno maso (305 jih je zaključilo), ki so imeli po predhodni izgubi ≥ 5 % telesne mase z dieto z zmanjšanim vnosom kalorij hipertenzijo ali dislipidemijo.
English: Hypersensitivity to liraglutide or to any of the excipients listed in section 6.1.
Slovenian: Preobčutljivost na liraglutid ali katero koli pomožno snov, navedeno v poglavju 6.1. 4.4 Posebna opozorila in previdnostni ukrepi
English: Lifestyle intervention in the form of an energy-restricted diet and exercise counselling was background therapy for all patients.
Slovenian: Vsem bolnikom so kot osnovno zdravljenje svetovali spremembo življenjskega sloga v obliki diete z omejenim vnosom energije in telesno vadbo.
English: • You doctor will instruct you to gradually increase your dose by 0.6 mg usually each week until you reach the recommended dose of 3.0 mg once a day.
Slovenian: • Zdravnik vam bo svetoval, kako postopno povečujete odmerek za 0,6 mg (običajno vsak teden),
English: Patients with type 2 diabetes mellitus receiving liraglutide in combination with insulin and/or sulfonylurea may have an increased risk of hypoglycaemia.
Slovenian: Bolniki s sladkorno boleznijo tipa 2, ki uporabljajo liraglutid skupaj z insulinom in/ali sulfonilsečnino,
English: Press and hold in the dose button until the dose counter returns to 0.
Slovenian: Pritisnite na potisni gumb in ga držite, dokler se števec odmerka ne vrne na 0.
English: 3.0 mg once a day
Slovenian: 3,0 mg enkrat na dan
English: A drop of solution may appear at the needle tip.
Slovenian: Na konici igle se lahko pojavi kapljica raztopine.
English: For body weight, HbA1c, FPG, blood pressure and waist circumference, baseline values are means, changes from baseline at week 160 are estimated means (least-squares) and treatment contrasts at week
Slovenian: Pri telesni masi, HbA1c, koncentraciji glukoze v plazmi na tešče, krvnem tlaku in obsegu pasu so izhodiščne vrednosti povprečne vrednosti, spremembe v 160. tednu glede na izhodišče so ocenjena povprečja (metoda najmanjših kvadratov) in razlike v 160. tednu zaradi zdravljenja so ocenjene razlike zdravljenja.
English: Do not use Saxenda if you are pregnant, think that you might be pregnant or are planning to have a baby.
Slovenian: Če ste noseči, menite, da bi lahko bili noseči ali načrtujete zanositev, zdravila Saxenda ne uporabljajte, saj ni znano, če vpliva na otroka.
English: The mean age was 64 years and the mean BMI was 32.5 kg/m².
Slovenian: Povprečna starost je bila 64 let in povprečni ITM je bil
English: Early responders were defined as patients who achieved ≥5% weight loss after 12 weeks on treatment dose of liraglutide (4 weeks of dose escalation and 12 weeks on treatment dose).
Slovenian: Izguba telesne mase po 12 tednih zdravljenja z liraglutidom (3,0 mg) Bolniki z zgodnjim odzivom so tisti, ki so po 12 tednih zdravljenja s terapevtskim odmerkom liraglutida (4 tedni povečevanja odmerka in 12 tednov na terapevtskem odmerku) dosegli ≥ 5 %
English: A majority of the reported events occurred in patients who had experienced nausea, vomiting or diarrhoea leading to volume depletion (see section 4.4).
Slovenian: Večinoma se je pojavila pri bolnikih, ki so imeli zmanjšan volumen krvi (hipovolemijo) zaradi navzee, bruhanja ali driske (glejte poglavje 4.4).
English: Dose counter stopped:
Slovenian: primer števec odmerka se je ustavil: preostalo je še
English: • Changed sense of taste
Slovenian: • sprememba okušanja
English: Hypoglycaemia in patients with type 2 diabetes mellitus treated with insulin
Slovenian: Hipoglikemija pri bolnikih s sladkorno boleznijo tipa 2, zdravljenih z insulinom
English: This is because it is not known if Saxenda passes into breast milk.
Slovenian: Če dojite, zdravila Saxenda ne uporabljajte, saj ni znano, če prehaja v materino mleko.
English: In trial 4, more patients maintained the weight loss achieved prior to treatment initiation with liraglutide than with placebo (81.4% and 48.9%, respectively).
Slovenian: V preskušanju 4 je več bolnikov (81,4 %), ki so prejemali liraglutid, obdržalo pred začetkom zdravljenja izgubljeno telesno maso, v primerjavi z bolniki, ki so prejemali placebo (48,9 %).
English: This may prevent blocked needles, contamination, infection, leakage of solution and inaccurate dosing.
Slovenian: Tako lahko preprečite zamašitev igel, kontaminacijo, okužbo, puščanje raztopine in netočno odmerjanje.
English: In clinical trials in overweight or obese patients without type 2 diabetes mellitus treated with Saxenda in combination with diet and exercise, no severe hypoglycaemic events (requiring third party assistance) were reported.
Slovenian: V kliničnih preskušanjih pri bolnikih s prekomerno telesno maso ali z debelostjo, ki niso imeli sladkorne bolezni tipa 2 in so bili zdravljeni z zdravilom Saxenda v kombinaciji z dieto in telesno vadbo, o hudih primerih hipoglikemije (ki bi zahtevala pomoč tretje osebe) niso poročali.
English: • Reduced kidney function
Slovenian: • oslabljeno delovanje ledvic
English: No dose adjustment is required for patients with mild or moderate renal impairment (creatinine clearance ≥30 ml/min).
Slovenian: Pri zdravljenju bolnikov z blago ali zmerno okvaro ledvic (očistek kreatinina ≥ 30 ml/min)
English: Hypoglycaemia in patients without type 2 diabetes mellitus
Slovenian: Hipoglikemija pri bolnikih brez sladkorne bolezni tipa 2
English: Saxenda (N=1472) Placebo (N=738)
Slovenian: Placebo (N=738)
English: At week 160, while on treatment, 3% treated with Saxenda and 11% treated with placebo were diagnosed with type 2 diabetes mellitus.
Slovenian: V 160. tednu so med zdravljenjem sladkorno bolezen tipa 2 ugotovili pri 3 % bolnikov, ki so se zdravili z zdravilom Saxenda, in 11 % bolnikov, ki so prejemali placebo.
English: Among patients concomitantly treated with sulfonylurea, 60.9% of patients treated with liraglutide 3.0 mg/day and 60.0% of patients treated with placebo reported documented symptomatic hypoglycaemic events.
Slovenian: Med bolniki, ki so hkrati prejemali sulfonilsečnine, so se simptomi hipoglikemije pojavili pri 60,9 % bolnikov, zdravljenih z liraglutidom 3,0 mg/dan, in pri 60,0 % bolnikov, ki so prejemali placebo.
English: Non-lethal thyroid C-cell tumours were seen in two-year carcinogenicity studies in rats and mice.
Slovenian: V dveletni študiji kancerogenosti so pri podganah in miših opazili tumorje parafolikularnih celic ščitnice, ki niso bili smrtni.
English: Interaction studies have been performed with 1.8 mg liraglutide.
Slovenian: Študije medsebojnega delovanja so izvedli z liraglutidom v odmerku 1,8 mg. Odmerka 1,8 mg in
English: The hazard ratio and 95% CI is 0.33 [0.12; 0.90] for liraglutide versus placebo.
Slovenian: Razmerje ogroženosti in 95 % interval zaupanja za liraglutid v primerjavi s placebom je 0,33 [0,12; 0,90].
English: Cardiovascular evaluation
Slovenian: Vrednotenje srčno-žilnega sistema
English: The effect on rate of gastric emptying was equivalent between liraglutide 1.8 mg and 3.0 mg, (paracetamol AUC0-300 min).
Slovenian: 3,0 mg imata enak učinek na hitrost praznjenja želodca (paracetamol AUC0-300 min).
English: You should see your doctor straight away if you get symptoms such as breathing problems, swelling of face and throat and a fast heartbeat.
Slovenian: Nemudoma obiščite zdravnika, če se vam pojavijo simptomi, kot so težave z dihanjem,
English: What Saxenda is used for
Slovenian: Za kaj uporabljamo zdravilo Saxenda
English: Stay on this programme while you are using Saxenda.
Slovenian: Med uporabo zdravila Saxenda se držite predpisanega programa.
English: • Feeling generally unwell
Slovenian: • splošno slabo počutje
English: Gastrointestinal disorders were the most frequently reported adverse events in two dose escalation studies completed so far.
Slovenian: V dveh že zaključenih preskušanjih z višanjem odmerka so bili najpogosteje poročani neželeni učinki bolezni prebavil.
English: It is similar to a natural occurring hormone called glucagon-like peptide-1 (GLP-1) that is released from the intestine after a meal.
Slovenian: Podobno je naravnemu hormonu, ki ga imenujemo glukagonu podoben peptid 1 (GLP-1 - glucagon-like peptide
English: The use of Saxenda is not recommended if you have severe heart failure.
Slovenian: Uporaba zdravila Saxenda ni priporočljiva za bolnike s hudim popuščanjem srca.
English: A Approx. how much solution is left
Slovenian: A približna količina preostale raztopine
English: In the 160-week part of trial 1, the primary efficacy endpoint was the proportion of patients with onset of type 2 diabetes mellitus evaluated as time to onset.
Slovenian: V 160-tedenskem delu preskušanja 1 so vrednotili čas do nastopa sladkorne bolezni tipa 2 pri
English: This may prevent blocked needles, contamination, infection and inaccurate dosing.
Slovenian: S tem lahko preprečite zamašitev igel, kontaminacijo, okužbo in nenatančno odmerjanje.
English: If pancreatitis is suspected, liraglutide should be discontinued; if acute pancreatitis is confirmed, liraglutide should not be restarted.
Slovenian: Če se akutni pankreatitis potrdi, se zdravljenja z liraglutidom ne sme več uvesti.
English: - if you are allergic to liraglutide or any of the other ingredients of this medicine (listed in section 6).
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Saxenda Ne uporabljajte zdravila Saxenda: - če ste alergični na liraglutid ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: Injection site reactions have been reported in patients treated with Saxenda.
Slovenian: Pri bolnikih, zdravljenih z zdravilom Saxenda, so poročali o reakcijah na mestu injiciranja.
English: 1 ml solution for injection contains 6 mg liraglutide.
Slovenian: 1 ml raztopine za injiciranje vsebuje 6 mg liraglutida.
English: 2 Check the flow • Before your first injection with each new pen, check the flow.
Slovenian: • Pred injiciranjem zdravila z novim injekcijskim peresnikom vedno preverite pretok.
English: Hyperglycaemia in insulin treated patients with diabetes mellitus
Slovenian: Hiperglikemija pri bolnikih s sladkorno boleznijo, ki se zdravijo z insulinom
English: Baseline values are means, changes from baseline at week 56 are estimated means (leastsquares) and treatment contrasts at week 56 are estimated treatment differences.
Slovenian: Izhodiščni vrednosti telesne mase sta povprečji, spremembe v 56. tednu glede na izhodišče so ocenjena povprečja (metoda najmanjših kvadratov) in razlike v 56. tednu zaradi zdravljenja so ocenjene razlike zdravljenja.
English: Table 4 Trial 1: Changes from baseline in body weight, glycaemia and cardiometabolic parameters at week 160
Slovenian: Preglednica 4 (preskušanje 1): Spremembe telesne mase, glikemije in srčno-presnovnih parametrov po 160 tednih glede na izhodišče
English: Mean change at week 32, % (95% CI) Mean change at week 32, kg (95% CI)
Slovenian: Povprečna sprememba po 32 tednih v kg (95 % IZ)
English: Paracetamol (Acetaminophen)
Slovenian: Paracetamol
English: Keep the cap on the pen in order to protect from light.
Slovenian: Injekcijski peresnik naj bo pokrit s pokrovčkom za zagotovitev zaščite pred svetlobo.
English: Symptoms of hypoglycaemic events were reported by 1.6 % of patients treated with Saxenda and 1.1% of patients treated with placebo; however, these events were not confirmed by blood glucose measurements.
Slovenian: Simptomi hipoglikemije so se pojavili pri 1,6 % bolnikov, zdravljenih z zdravilom Saxenda, in 1,1 % bolnikov, ki so prejemali placebo.
English: Saxenda (N=207) Placebo (N=206) Saxenda vs. placebo
Slovenian: Preglednica 7 (preskušanje 4): Spremembe telesne mase po 56 tednih glede na izhodišče Saxenda (N=207) Placebo (N=206) Saxenda vs. placebo
English: • Press and hold down the dose button until the dose counter shows 0.
Slovenian: • Pritisnite na potisni gumb in ga držite, dokler se na števcu odmerka ne pokaže 0.
English: Last observation carried forward.
Slovenian: Prenos zadnjih opaženih vrednosti naprej.
English: (pancreatitis).
Slovenian: • bruhanje.
English: and >10% weight loss with liraglutide than with placebo (tables 3-5).
Slovenian: Večji delež bolnikov, vključenih v preskušanje, je doseglo ≥ 5 % in > 10 % izgubo telesne mase z liraglutidom kot s placebom (preglednice 3-5).
English: • Problems affecting the stomach and intestines, such as indigestion (dyspepsia), inflammation in the lining of the stomach (gastritis), stomach discomfort, upper stomach pain, heartburn, feeling bloated, wind (flatulence), belching and dry mouth
Slovenian: • težave z želodcem in črevesjem, kot so: prebavne motnje (dispepsija), vnetje želodčne sluznice
English: Daily doses higher than 3.0 mg are not recommended.
Slovenian: Ni priporočljivo uporabljati dnevnih odmerkov, ki so večji od 3,0 mg. Preglednica 1 Načrt povečevanja odmerka
English: Warfarin and other coumarin derivatives
Slovenian: Varfarin in drugi kumarinski derivati Študija medsebojnega delovanja ni bila izvedena.
English: Full Analysis Set.
Slovenian: Celotni nabor za analizo.
English: Contents of the pack and other information
Slovenian: Shranjevanje zdravila Saxenda Vsebina pakiranja in dodatne informacije
English: Liraglutide exposure was reduced in patients with renal impairment compared to individuals with normal renal function in a single-dose trial (0.75 mg).
Slovenian: Izpostavljenost liraglutidu v preskušanju z enkratnim odmerkom (0,75 mg) je bila pri bolnikih z okvaro ledvic manjša kot pri osebah z normalnim delovanjem ledvic.
English: Liraglutide did not change the overall exposure of atorvastatin following single dose administration of atorvastatin 40 mg.
Slovenian: Liraglutid po enkratnem odmerku 40 mg atorvastatina ni spremenil celokupne izpostavljenosti atorvastatinu.
English: Sodium hydroxide (for pH adjustment) Water for injections
Slovenian: klorovodikova kislina in natrijev hidroksid (za uravnavanje pH) ter voda za injekcije.
English: Each pen contains 3 ml solution and is able to deliver doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg and 3.0 mg.
Slovenian: En injekcijski peresnik vsebuje 3 ml raztopine, z njim lahko injicirate 0,6 mg, 1,2 mg, 1,8 mg, 2,4 mg in 3,0 mg.
English: Table 6 Trial 3: Changes from baseline in body weight and Apnoea-Hypopnoea Index at week
Slovenian: Preglednica 6 (preskušanje 3): Spremembe telesne mase in indeksa apneje-hipopneje po 32 tednih glede na izhodišče
English: Waist circumference, cm
Slovenian: Obseg pasu v cm
English: Thyroid disease
Slovenian: Srčne bolezni tahikardija
English: Talk to your doctor, pharmacist or nurse before using Saxenda.
Slovenian: Opozorila in previdnostni ukrepi Pred začetkom uporabe zdravila Saxenda se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: Liraglutide lowered ethinylestradiol and levonorgestrel Cmax by 12% and 13%, respectively, following administration of a single dose of an oral contraceptive product.
Slovenian: Liraglutid je po enkratnem odmerku peroralnega kontraceptiva zmanjšal Cmax etinilestradiola za 12 % in levonorgestrela za 13 %.
English: In a clinical trial in overweight or obese patients with type 2 diabetes mellitus treated with Saxenda in combination with diet and exercise, severe hypoglycaemia (requiring third party assistance) was reported by 0.7% of patients treated with Saxenda and only in patients concomitantly treated with sulfonylurea.
Slovenian: V kliničnem preskušanju pri bolnikih s prekomerno telesno maso ali z debelostjo, ki so imeli sladkorno bolezen tipa 2 in so bili zdravljeni z zdravilom Saxenda v kombinaciji z dieto in telesno vadbo, je o hudi hipoglikemiji (ki je zahtevala pomoč tretje osebe) poročalo 0,7 % bolnikov.
English: Insomnia**
Slovenian: Psihiatrične motnje nespečnost**
English: Name and address of the manufacturers of the biological active substance
Slovenian: Ime in naslov proizvajalca biološke učinkovine Novo Nordisk A/S
English: Some patients may feel dizziness when taking Saxenda mainly during the first 3 months of treatment (see section ‘Possible side effects').
Slovenian: mesecih zdravljenja (glejte poglavje "Možni neželeni učinki").
English: Always make sure that a drop appears at the needle tip before you use a new pen for the first time.
Slovenian: Preden prvič uporabite injekcijski peresnik, se vedno prepričajte, da se na konici igle pojavi kapljica.
English: For body weight, HbA1c, FPG, blood pressure and waist circumference, baseline values are means, changes from baseline at week 56 are estimated means (least-squares) and treatment contrasts at week 56
Slovenian: Pri telesni masi, HbA1c, koncentraciji glukoze v plazmi na tešče in pri obsegu pasu so izhodiščne vrednosti povprečja, spremembe v 56. tednu glede na izhodišče so ocenjena povprečja (metoda najmanjših kvadratov) in razlike v 56. tednu zaradi zdravljenja so ocenjene razlike zdravljenja.
English: Acute renal failure Renal impairment
Slovenian: Bolezni sečil akutna odpoved ledvic, okvara ledvic
English: Blood glucose self-monitoring is necessary to adjust the dose of insulin or insulin-secretagogues (see section
Slovenian: Za prilagajanje odmerka insulina ali sekretagogov insulina je potreben bolnikov samonadzor glukoze v krvi (glejte poglavje 4.4).
English: • Before you use the pen for the first time, your doctor or nurse will show you how to use the pen.
Slovenian: Kako in kdaj uporabljati zdravilo Saxenda • Preden prvič uporabite injekcijski peresnik, vam bo zdravnik ali medicinska sestra pokazal/-a,
English: The 56-week part of trial 1 assessed body weight loss in all the 3,731 randomised patients (2,590 completers).
Slovenian: 3.731 randomiziranih bolnikih (preskušanje je bilo zaključeno pri 2.590 bolnikih).
English: Among patients not concomitantly treated with sulfonylurea, 15.7% of patients treated with Saxenda and 7.6% of patients treated with placebo reported documented symptomatic hypoglycaemic events (defined as plasma glucose ≤3.9 mmol/L accompanied by symptoms).
Slovenian: Med bolniki, ki niso hkrati prejemali sulfonilsečnine, so se simptomi hipoglikemije (določeni kot koncentracija glukoze v krvi ≤ 3,9 mmol/l ter spremljajoči simptomi) pojavili pri 15,7 % bolnikov, zdravljenih z zdravilom Saxenda, in pri 7,6 % bolnikov, ki so prejemali placebo.
English: Cases of inflammation of the pancreas (pancreatitis) have been reported uncommonly in patients using Saxenda.
Slovenian: Pri bolnikih, zdravljenih z zdravilom Saxenda, so poročali o občasnih primerih vnetja trebušne slinavke (pankreatitisa).
English: Saxenda 6 mg/ml injection liraglutide
Slovenian: Saxenda 6 mg/ml injekcija liraglutid za subkutano uporabo
English: Hypoglycaemia in patients with type 2 diabetes mellitus
Slovenian: Hipoglikemija pri bolnikih s sladkorno boleznijo tipa 2
English: No dose adjustment is recommended for patients with mild or moderate hepatic impairment.
Slovenian: Pri zdravljenju bolnikov z blago ali zmerno okvaro jeter prilagoditev odmerka ni potrebna.
English: Ethnic origin had no clinically relevant effect on the pharmacokinetics of liraglutide based on the results of population pharmacokinetic analysis which included overweight and obese patients of White, Black, Asian and Hispanic/non-Hispanic groups.
Slovenian: Glede na rezultate populacijske farmakokinetične analize, ki je zajela bolnike s prekomerno telesno težo in bolnike z debelostjo bele in črne rase ter bolnike iz azijskih in latinskoameriških skupin/nelatinskoameriških skupin, etnično poreklo ne vpliva klinično pomembno na farmakokinetiko liraglutida.