natgillin/translations-raw huggingface dataset:
Diabetic ketoacidosis has been reported in insulin-dependent patients after rapid discontinuation or dose reduction of insulin (see section 4.2).
Pri bolnikih, odvisnih od insulina, so po hitrem prenehanju uporabe ali zmanjšanju odmerka insulina poročali o diabetični ketoacidozi (glejte poglavje 4.2).
If no drop appears, repeat step 2 ‘Check the flow' up to 6 times.
Če se kapljica ne pojavi, ponovite korak 2 "Preverite pretok" največ
Upon initiation of liraglutide treatment in patients on warfarin or other coumarin derivatives, more frequent monitoring of International Normalised Ratio (INR) is recommended.
Pri bolnikih, ki uporabljajo varfarin ali druge kumarinske derivate, na začetku zdravljenja z liraglutidom priporočamo pogostejši nadzor mednarodnega normaliziranega razmerja
Cholelithiasis*** Cholecystitis***
holecistitis***
Patients with mild or moderate renal impairment (creatinine clearance ≥30 ml/min) may experience more gastrointestinal effects when treated with Saxenda.
Bolniki z blago ali zmerno okvaro ledvic (očistek kreatinina ≥ 30 ml/min) imajo lahko med zdravljenjem z zdravilom Saxenda več neželenih učinkov na prebavilih.
You can keep the pen for 1 month when stored at a temperature below 30°C or in a refrigerator (2°C to 8°C).
Injekcijski peresnik lahko shranjujete 1 mesec pri temperaturi do 30 °C ali v hladilniku (2 °C - 8 °C).
Consult your doctor before you continue.
Pred nadaljevanjem zdravljenja se posvetujte z zdravnikom.
Baseline, kg (SD)
Izhodiščna telesna masa v kg (SD)
The patient should be advised to discard the injection needle after each injection and store the pen without an injection needle attached.
Bolnika opozorite, naj po vsakem injiciranju zdravila injekcijsko iglo zavrže v skladu z lokalnimi predpisi in shrani injekcijski peresnik brez nameščene igle.
• you are taking medicines for diabetes called ‘sulfonylurea' (such as glimepiride or glibenclamide) or if you are taking insulin - you may get low blood sugar (hypoglycaemia)
• jemljete zdravila za sladkorno bolezen, imenovana sulfonilsečnine (npr. glimepirid ali glibenklamid) ali uporabljate insulin.
Most episodes of gastrointestinal events were mild to moderate, transient and the majority did not lead to discontinuation of therapy.
Neželeni učinki na prebavilih Večina primerov neželenih učinkov na prebavilih je bila blagih do zmernih, prehodne narave in večina ni vodila v prekinitev zdravljenja.
Saxenda pre-filled pen and needle (example)
Napolnjeni injekcijski peresnik Saxenda in igla (primer)
Saxenda contains less than 1 mmol sodium (23 mg) per dose, therefore the medicinal product is essentially ‘sodium-free'.
Zdravilo Saxenda vsebuje manj kot 1 mmol natrija (23 mg) na odmerek, kar v bistvu pomeni, da je zdravilo "brez natrija".
• If the needle is removed earlier, you may see a stream of solution coming from the needle tip.
• Če boste iglo izvlekli prej, lahko iz igle brizgne curek raztopine.
The dose selector clicks differently when turned forward, backwards or past the number of mg left.
Izbirnik odmerka klika z drugačnim zvokom, ko ga vrtite naprej, nazaj ali mimo števila preostalih mg. Ne štejte klikov injekcijskega peresnika.
• Do not use Saxenda in combination with other medicines that contain GLP-1 receptor agonists
• Zdravila Saxenda ne uporabljajte v kombinaciji z drugimi zdravili, ki vsebujejo agoniste receptorjev za GLP-1 (npr. eksenatid, liksisenatid).
• Delay in the emptying of the stomach
• zakasnelo praznjenje želodca
Dosing with liraglutide during mid-gestation caused a reduction in maternal weight and foetal growth with equivocal effects on ribs in rats and skeletal variation in the rabbit.
Uporaba liraglutida v srednjem obdobju gestacije je bila povezana z zmanjšanjem telesne mase matere in zastojem rasti ploda, vpliv na rebra podgan ter variacije skeleta pri kuncih pa ni bil povsem pojasnjen.
Saxenda is given as an injection under the skin (subcutaneous injection).
Kam injicirati zdravilo Zdravilo Saxenda je namenjeno injiciranju pod kožo (subkutani uporabi).
Saxenda is available in pack sizes containing 1, 3 or 5 pens.
Zdravilo Saxenda je na voljo v pakiranjih z 1, s 3 ali s 5 injekcijskimi peresniki.
Figure 1 Change from baseline in body weight (%) by time in trial 1 (0-56 weeks)
Slika 1 Spremembe telesne mase (%) v času glede na izhodišče v preskušanju 1 (0-56 tedna)
The pen is designed to be used with NovoFine or NovoTwist disposable needles up to a length of 8 mm and as thin as 32G.
Injekcijski peresnik je namenjen uporabi z injekcijskimi iglami NovoFine ali NovoTwist za enkratno uporabo, dolžine do 8 mm in ne tanjšimi kot 32G.
It only shows approximately how much solution is left in your pen.
Ta namreč prikazuje le, koliko je približno še ostalo raztopine v injekcijskem peresniku.
• The best places to inject are the front of your waist (abdomen), the front of your thighs or your upper arm.
• Najprimernejša mesta za injiciranje zdravila so trebuh, sprednji predel stegen ali nadlakti.
The exposure of liraglutide decreases with an increase in baseline body weight.
Izpostavljenost liraglutidu upada z naraščajočo izhodiščno telesno maso.
What Saxenda looks like and contents of the pack
Izgled zdravila Saxenda in vsebina pakiranja
In patients treated with GLP-1 receptor agonists, there have been reports of acute renal failure.
Pri bolnikih, zdravljenih z agonisti receptorjev GLP-1, so poročali o akutni ledvični odpovedi.
Saxenda has no or negligible influence on the ability to drive and use machines.
4.7 Vpliv na sposobnost vožnje in upravljanja strojev Zdravilo Saxenda nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
Exposure associated with 3.0 mg liraglutide was found to be comparable between the children aged 7 to 11, adolescents and adult subjects, after correction for body weight.
Izpostavljenost liraglutidu, povezana z jemanjem odmerka 3,0 mg, je bila po prilagoditvi glede na telesno maso pri otrocih (starih 7-11 let), mladostnikih in odraslih, primerljiva.
With continued treatment with liraglutide, 86.2% of these early responders are predicted to achieve a weight loss of ≥5% and 51% are predicted to achieve a weight loss of ≥10%
Predvidoma naj bi po 1 letu zdravljenja 86,2 % bolnikov z zgodnjim odzivom doseglo izgubo telesne mase ≥ 5 %, 51 % pa naj bi doseglo ≥ 10 % izgubo telesne mase.
Treatment with liraglutide significantly improved glycaemic parameters across sub-populations with normoglycaemia, pre-diabetes and type 2 diabetes mellitus.
Zdravljenje z liraglutidom je pomembno izboljšalo glikemične vrednosti pri bolnikih z normoglikemijo, preddiabetesom in sladkorno boleznijo tipa 2.
The background treatment at trial start was either diet and exercise alone, metformin, a sulfonylurea, a glitazone as single agents or any combination hereof.
Na začetku preskušanja so se bolniki zdravili ali samo z dieto in telesno vadbo, ali pa so prejemali metformin, sulfonilsečnino ali glitazon kot samostojno zdravilo oz. v kateri koli kombinaciji.
The pharmacokinetics of liraglutide was evaluated in patients with varying degree of hepatic impairment in a single-dose trial (0.75 mg).
Farmakokinetiko liraglutida pri bolnikih z različno stopnjo okvare jeter so ocenili v preskušanju z enkratnim odmerkom (0,75 mg).
Liraglutide significantly reduced the rate of major adverse cardiovascular events (primary endpoint events, MACE) vs. placebo (3.41 vs. 3.90 per 100 patient years of observation in the liraglutide and placebo groups, respectively) with a risk reduction of 13%, HR 0.87, [0.78, 0.97] [95% CI]) (p=0.005) (see figure 4).
(primarni opazovani dogodki, MACE) v primerjavi s placebom (3,41 napram 3,90 na 100 bolnik-let opazovanja v skupini z liraglutidom oz. placebom), z zmanjšanjem tveganja za 13 %, razmerje ogroženosti 0,87 [0,78, 0,97] [95 % IZ]) (p = 0,005) (glejte sliko 4).
Diastolic blood pressure, mmHg
Diastolični krvni tlak v mmHg
Week 1
Odmerek teden 1
• Unscrew the needle and dispose of it carefully.
• Iglo odvijte in jo pazljivo zavrzite.
Figure 4 Kaplan Meier plot of time to first MACE - FAS population
Slika 4: Kaplan Meier-jeva krivulja časa do prvega pojava pomembnih srčno-žilnih neželenih dogodkov - analiza podatkov celotne populacije (FAS (Full Analysis Set) population)
• Severe and persistent pain in the abdomen (stomach area) which might reach through to your back, as well as nausea and vomiting, as it could be a sign of an inflamed pancreas
• hudo in trdovratno bolečino v trebuhu (v predelu želodca), ki lahko izžareva v hrbet, spremlja pa jo lahko tudi siljenje na bruhanje in bruhanje.
Saxenda is a weight loss medicine that contains the active substance liraglutide.
Zdravilo Saxenda je zdravilo za zmanjšanje telesne mase, ki vsebuje učinkovino liraglutid.
For patients who have achieved a weight loss of <5% after 12 weeks on treatment dose of liraglutide, the proportion of patients not reaching a weight loss of ≥10% after 1 year is 93.4%.
Od bolnikov, ki so po 12 tednih na terapevtskem odmerku liraglutida dosegli < 5 % izgubo telesne mase, jih 93,4 % ni doseglo ≥ 10 % izgube telesne mase po 1 letu zdravljenja.
There is little experience with this medicine in patients with liver problems.
Izkušenj z uporabo tega zdravila pri bolnikih z jetrnimi težavami je malo.
If there is less than 12 hours to the next dose, the patient should not take the missed dose and resume the once-daily regimen with the next scheduled dose.
Če je do naslednjega odmerka manj kot 12 ur, bolnik ne sme uporabiti izpuščenega odmerka, ampak mora nadaljevati z odmerjanjem enkrat na dan z naslednjim odmerkom.
Pack sizes of 1, 3 or 5 pre-filled pens.
V pakiranju je 1, 3 ali 5 napolnjenih injekcijskih peresnikov.
In the 56-week part of trial 1, 67.5% achieved ≥5% weight loss after 12 weeks.
V 56-tedenskem delu preskušanja 1 je 67,5 % bolnikov po 12 tednih zdravljenja doseglo ≥ 5 % izgubo telesne mase.
In the 56-week part of trial 1, fewer patients treated with liraglutide had developed type 2 diabetes mellitus compared to patients treated with placebo (0.2% vs. 1.1%).
V 56-tedenskem delu preskušanja 1 se je sladkorna bolezen tipa 2 razvila manj pogosto pri bolnikih, ki so prejemali liraglutid, kot pri bolnikih, ki so prejemali placebo (0,2 % v primerjavi z 1,1 %).
Saxenda should not be used in combination with another GLP-1 receptor agonist.
Bolniki s sladkorno boleznijo tipa 2 Zdravila Saxenda se ne sme uporabljati v kombinaciji z drugim agonistom receptorjev GLP-1.
• Trial 2 (SCALE Diabetes - 1922): A 56-week trial assessing body weight loss in 846 randomised (628 completers) obese and overweight patients with insufficiently controlled type 2 diabetes mellitus (HbA1c range 7-10%).
• Preskušanje 2 (SCALE Diabetes - 1922): 56-tedensko preskušanje, v katerem so ocenjevali izgubo telesne mase pri 846 randomiziranih bolnikih z debelostjo in bolnikih s prekomerno telesno maso (628 jih je preskušanje zaključilo), ki so imeli nezadostno urejeno sladkorno bolezen tipa 2 (HbA1c 7-10 %).
If a patient wishes to become pregnant or pregnancy occurs, treatment with liraglutide should be discontinued.
Če želi bolnica zanositi ali če zanosi, je treba zdravljenje z liraglutidom prekiniti.
Table 2 lists adverse reactions reported.
Preglednica 2 Poročani neželeni učinki
• Trial 3 (SCALE Sleep Apnoea - 3970): A 32-week trial assessing sleep apnoea severity and body weight loss in 359 randomised (276 completers) obese patients with moderate or severe obstructive sleep apnoea.
• Preskušanje 3 (SCALE Sleep Apnoea - 3970): 32-tedensko preskušanje, v katerem so ocenjevali resnost apneje med spanjem in izgubo telesne mase pri 359 randomiziranih bolnikih z debelostjo (276 jih je preskušanje zaključilo), ki so imeli zmerno ali hudo obstruktivno apnejo med spanjem.
• Do not try to repair your pen or pull it apart.
• Injekcijskega peresnika ne poskušajte popraviti ali razstaviti.
Always dispose of the needle after each injection to ensure convenient injections and prevent blocked needles.
Po vsakem injiciranju iglo zavrzite, da zagotovite ustrezno injiciranje in preprečite mašenje igel.
From clinical trials and post-marketing use of liraglutide overdoses have been reported up to 72 mg (24 times the recommended dose for weight management).
4.9 Preveliko odmerjanje V kliničnih preskušanjih in po prihodu liraglutida na trg so poročali o prevelikih odmerjanjih liraglutida, vse do 72 mg (24-kratnega priporočenega odmerka za obvladovanje telesne mase).
It should be injected in the abdomen, thigh or upper arm.
Injicirati ga je treba v predel trebuha, stegna ali nadlakti.
Saxenda is used for weight loss in addition to diet and exercise in adults aged 18 and above who have
Zdravilo Saxenda se kot dodatek k dieti in telesni vadbi uporablja za zmanjšanje telesne mase pri odraslih, starih 18 let ali več, ki imajo:
The pen is designed to be used with NovoFine or NovoTwist disposable needles
Injekcijski peresnik je namenjen uporabi z iglami NovoFine ali NovoTwist za enkratno uporabo.
Liraglutide exposure was lowered by 33%, 14%, 27% and 26%, respectively, in patients with mild (creatinine clearance, CrCl 50-80 ml/min), moderate (CrCl 30-50 ml/min) and severe (CrCl <30 ml/min) renal impairment and in end-stage renal disease requiring dialysis.
Pri bolnikih z blago okvaro ledvic (očistek kreatinina 50-80 ml/min) je bila izpostavljenost liraglutidu manjša za 33 %, z zmerno okvaro ledvic (očistek kreatinina 30-50 ml/min) za 14 %, s hudo okvaro ledvic (očistek kreatinina < 30 ml/min) za 27 % ter s končno odpovedjo ledvic, pri kateri je potrebna dializa, za 26 %.
There is little experience with this medicine in patients with kidney problems.
Izkušenj z uporabo tega zdravila pri bolnikih z ledvičnimi težavami je malo.
** p<0.0001.
** p < 0,0001; IZ = interval zaupanja.
Lisinopril median tmax was delayed from 6 h to 8 h with liraglutide.
Mediani tmax lizinoprila se je pri hkratnem zdravljenju z liraglutidom podaljšal s 6 na 8 ur.
Therefore, no dose adjustment of atorvastatin is required when given with liraglutide.
Zato prilagoditev odmerka atorvastatina, ko se ga uporablja skupaj z liraglutidom, ni potrebna.
As liraglutide for weight management was not investigated in subjects with mild or moderate hepatic impairment, it should be used with caution in these patients (see sections 4.2 and 5.2).
Uporabe liraglutida za obvladovanje telesne mase pri bolnikih z blago ali zmerno okvaro jeter niso preučevali, zato ga je treba pri teh bolnikih uporabljati previdno (glejte poglavji 4.2 in 5.2).
The warning signs of low blood sugar may come on suddenly and can include: cold sweat, cool pale skin, headache, fast heartbeat, feeling sick,
• nizek krvni sladkor (hipoglikemija); opozorilni znaki nizkega krvnega sladkorja se lahko pojavijo nenadoma in lahko vključujejo: hladno znojenje, hladno in bledo kožo, glavobol, hitro bitje srca, občutek slabosti, hudo lakoto, spremembe vida, zaspanost, šibkost, živčnost, tesnobo, zmedenost, težave z zbranostjo in tresenje (tremor).
Week 4
4 tedni
Never try to put the inner needle cap back on the needle.
Nikoli ne poskušajte na iglo znova namestiti notranjega pokrovčka igle, ker se lahko zbodete.
• The pen scale shows you approximately how much solution is left in your pen.
• Merilo preostanka prikazuje, koliko je približno še ostalo raztopine v injekcijskem peresniku.
If it shows 3.0, at least 3.0 mg are left in your pen.
Če števec odmerka kaže 3,0, je v injekcijskem peresniku na voljo še vsaj 3,0 mg.
Liraglutide stimulates insulin secretion and lowers glucagon secretion in a glucose-dependent manner which results in a lowering of fasting and post-prandial glucose.
Liraglutid v odvisnosti od koncentracije glukoze spodbuja izločanje insulina in zmanjšuje izločanje glukagona, kar vodi v zmanjšanje koncentracije glukoze na tešče in po obrokih.
No dosage adjustment is required based on age.
Prilagoditev odmerka glede na starost ni potrebna.
After first use: Store below 30°C or store in a refrigerator (2°C-8°C).
Po prvi uporabi: shranjujte pri temperaturi do 30 °C ali v hladilniku (2 °C - 8 °C).
Also, in these patients documented symptomatic hypoglycaemia was reported by 43.6% of patients treated with Saxenda and in 27.3% of patients treated with placebo.
V tej populaciji so se simptomi hipoglikemije pojavili pri 43,6 % bolnikov, zdravljenih z zdravilom Saxenda, in pri 27,3 % bolnikov, ki so prejemali placebo.
Signs may include reduction in urine volume, metallic taste in mouth and easily bruising.
• akutna odpoved ledvic; znaki lahko vključujejo zmanjšano količino urina, kovinski okus v ustih in nagnjenost k podplutbam
Talk to your doctor if you have palpitations (you feel aware of your heartbeat) or if you have feelings of a racing heartbeat while at rest during Saxenda treatment.
Če imate ob uporabi zdravila Saxenda palpitacije (se zavedate svojega srčnega utripa) ali če imate v mirovanju občutek hitrega srčnega utripa, se posvetujte z zdravnikom.
An increase in heart rate was observed with liraglutide in clinical trials (see section 5.1).
V kliničnih preskušanjih so ob uporabi liraglutida poročali o zvišanju frekvence srčnega utripa (glejte poglavje 5.1).
In all the long-term clinical trials with Saxenda, there were 6 MACE for patients treated with liraglutide and 10 MACE for placebo-treated patients.
V dolgoročnih kliničnih preskušanjih zdravila Saxenda so se pomembni srčno-žilni neželeni dogodki pojavili 6 bolnikom, ki so se zdravili z liraglutidom, in 10 bolnikom, ki so prejemali placebo.
Major adverse cardiovascular events (MACE) were adjudicated by an external independent group of experts and defined as non-fatal myocardial infarction, non-fatal stroke and cardiovascular death.
O pomembnih srčno-žilnih neželenih dogodkih je odločala zunanja neodvisna skupina strokovnjakov in jih opredelila kot miokardni infarkt, ki ni povzročil smrti, možganska kap, ki ni povzročila smrti, in smrt zaradi srčno-žilnih zapletov.
Saxenda Placebo Last observation carried forward (LOCF)
Saxenda Placebo Prenos zadnje opažene vrednosti naprej
In clinical trials for weight management, a higher rate of cholelithiasis and cholecystitis was observed in patients treated with liraglutide than in patients on placebo.
V kliničnih preskušanjih obvladovanja telesne mase so pri bolnikih, zdravljenih z liraglutidom, opazili večjo pojavnost holelitiaze in holecistitisa kot pri bolnikih, ki so prejemali placebo.
In clinical trials in type 2 diabetes, thyroid adverse events, such as goitre, have been reported in particular in patients with pre-existing thyroid disease.
V kliničnih preskušanjih pri sladkorni bolezni tipa 2 so bili opisani neželeni učinki, ki so povezani s ščitnico, kot je golša, in to zlasti pri bolnikih z obstoječo boleznijo ščitnice.
In a clinical trial in overweight or obese patients with type 2 diabetes mellitus treated with insulin and liraglutide 3.0 mg/day in combination with diet and exercise and up to 2 OADs, severe hypoglycaemia (requiring third party assistance) was reported by 1.5% of patients treated with liraglutide 3.0 mg/day.
V kliničnem preskušanju pri bolnikih s prekomerno telesno maso ali z debelostjo, ki so imeli sladkorno bolezen tipa 2 in so bili zdravljeni z insulinom in liraglutidom 3,0 mg/dan, v kombinaciji z dieto in telesno vadbo in do dvema peroralnima antidiabetikoma, je o hudi hipoglikemiji (ki je zahtevala pomoč tretje osebe) poročalo 1,5 % bolnikov, zdravljenih z liraglutidom 3,0 mg/dan.
Across the trial populations, greater proportions of the patients achieved ≥5%
Delež bolnikov, ki so izgubili ≥ 5 %
At week 0 patients were randomised to receive either Saxenda or placebo.
V tednu 0 so bolnike randomizirali v skupino, ki je prejemala zdravilo Saxenda, ali v skupino, ki je prejemala placebo.
More patients with pre-diabetes at baseline had reversed their prediabetes compared to patients treated with placebo (69.2% vs. 32.7%).
Prav tako se je večjemu deležu bolnikov s preddiabetesom na začetku preskušanja spreobrnil potek preddiabetesa, v primerjavi s tistimi, ki so prejemali placebo (69,2 % v primerjavi z 32,7 %).
• Injection site reactions (such as bruising, pain, irritation, itching and rash)
• žolčni kamni • reakcije na mestu injiciranja (npr. podplutbe, bolečina, draženje, srbenje in izpuščaj)
≥30 kg/m²) or with overweight (BMI ≥27 kg/m²) with dyslipidaemia and/or hypertension were stratified according to pre-diabetes status at screening and BMI at baseline (≥30 kg/m² or
(ITM ≥ 30 kg/m²) ali s prekomerno telesno maso (ITM ≥ 27 kg/m²) z dislipidemijo in/ali hipertenzijo so stratificirali glede na ugotovljeni preddiabetični status pri presejanju in ITM v izhodišču (≥ 30 kg/m² ali < 30 kg/m²).
Inflamed gall bladder and gallstones
Vnetje žolčnika in žolčni kamni
In trial 2, 50.4% achieved ≥5% weight loss after 12 weeks.
V preskušanju 2 je 50,4 % bolnikov po 12 tednih zdravljenja doseglo ≥ 5 % izgubo telesne mase.
Therapeutic experience in patients ≥75 years of age is limited and use in these patients is not recommended (see sections 4.4 and 5.2).
starih 75 let ali več, je malo, zato uporaba zdravila pri teh bolnikih ni priporočljiva (glejte poglavji 4.4
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.
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,
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).
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).
• 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.
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.
Systolic blood pressure, mmHg
Sistolični krvni tlak v mmHg
Saxenda is not recommended for use in paediatric patients.
Pediatrična populacija Uporaba zdravila Saxenda pri pediatričnih bolnikih ni priporočljiva.
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.
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).
Please read these instructions carefully before using your Saxenda pre-filled pen.
Pred uporabo napolnjenega injekcijskega peresnika Saxenda natančno preberite ta navodila.
When you are not using the pen, keep the pen cap on in order to protect it from light.
Kadar injekcijskega peresnika ne uporabljate, naj bo vedno pokrit s pokrovčkom za zagotovitev zaščite pred svetlobo.
If a dose is missed within 12 hours from when it is usually taken, the patient should take the dose as soon as possible.
Če bolnik pozabi uporabiti zdravilo in je od takrat, ko ga običajno uporabi, minilo manj kot 12 ur, si mora odmerek injicirati čim prej.
People with diabetes
Bolniki s sladkorno boleznijo
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.
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.
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).
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).