natgillin/translations-raw huggingface dataset:
The European Commission issued a decision on 2 June 2009.
Evropska komisija je odločbo izdala dne 2. junija 2009.
Ref. EMEA/403687/2009 EMEA/A-29/1094
EMEA/403708/2009 EMEA/A-29/1094
Dr. Karl Broich (Germany)
dr. Karl Broich (Nemčija)
The company wanted the authorisation to be recognised in Austria, Bulgaria, the Czech Republic, Hungary, Poland, Romania and Slovakia (the concerned Member States).
Družba je želela, da dovoljenje za promet z zdravilom priznajo tudi v Avstriji, Bolgariji, Češki republiki, Madžarski, Poljski, Romuniji in Slovaški (zadevne države članice).
London, 4 June 2009 Doc.
London, 4. junija 2009 Sklic dok.
Medicines are bioequivalent when they produce the same levels of active substance in the body.
Zdravila so biološko enakovredna, ko dosegajo enake ravni zdravilne učinkovine v telesu.
Questions and answers on the referral for Betavert N tablets containing betahistine dihydrochloride (8 or 16 mg)
Vprašanja in odgovori v zvezi z napotitvijo za zdravilo Betavert N tablete, ki vsebujejo betahistin dihidroklorid (8 ali 16 mg)
However, the member states were not able to reach an agreement and the German medicines regulatory agency referred the matter to the CHMP for arbitration on 30 October 2008.
Ker pa omenjene države članice niso dosegle soglasja, je nemški regulatorni organ dne 30. oktobra 2008 zadevo napotil na CHMP v arbitražo.
Patients with Menière's disease have vertigo (a spinning sensation), often associated with feeling sick or vomiting, tinnitus (ringing in the ear) and hearing loss.
Bolniki z Menierjevo boleznijo imajo vrtoglavico (občutek vrtenja), pogosto povezano s slabostjo ali bruhanjem, tinitusom (zvonjenjem v ušesu) in izgubo sluha.
This allows a dilation of the blood vessels in the inner ear, thus helping the pressure to drop and relieving the symptoms of the disease.
To omogoča razširitev krvnih žil v notranjem ušesu, kar povzroči padec pritiska in blaži simptome bolezni.
Why was Betavert N reviewed?
Zakaj je bilo zdravilo Betavert N pregledano?
Based on evaluation of the currently available data and the scientific discussion within the Committee, the CHMP was of the opinion that bioequivalence between Betavert N and Betaserc 8 had been demonstrated.
Na podlagi ocene trenutno razpoložljivih podatkov in znanstvene razprave v okviru Odbora je CHMP menil, da je bila biološka enakovrednost med zdravilom Betavert N in Betaserc 8 dokazana.
Menière's disease is a disease where an accumulation of fluid in the inner ear causes a build-up of pressure.
Menierova bolezen je bolezen, pri kateri nabiranje tekočine v notranjem ušesu povzroča povečanje pritiska.
This means that Betavert N is similar to a ‘reference medicine' already authorised in the European Union (EU) called Betaserc 8.
To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Betaserc 8.
The active substance in Betavert N, betahistine, is an analogue of histamine, a naturally-occurring substance in the body that is involved in many processes.
Zdravilna učinkovina v zdravilu Betavert N, betahistin, je analog histamina, naravno prisotne snovi v telesu, ki je prisotna v številnih postopkih.
Betavert N is used to treat patients with Menière's disease.
Zdravilo Betavert N se uporablja za zdravljenje bolnikov z Menierovo boleznijo.
Betavert N is a ‘generic medicine'.
Zdravilo Betavert N je „generično zdravilo“.
The grounds for the referral were concerns expressed by the Czech Republic that Betavert N had not been shown to be bioequivalent to Betaserc 8.
Razlogi za napotitev so bili zadržki Češke republike, da se zdravilo Betavert N ni izkazalo kot biološko enakovredno zdravilu Betaserc 8.
In Menière's disease, betahistine is thought to attach to some receptors to which histamine normally attaches.
Pri Menierjevi bolezni naj bi se betahistin vezal na receptorje, na katere se običajno veže histamin.
The CHMP therefore concluded that Betavert N could be considered a generic medicine of Betaserc 8, and the marketing authorisation for Betavert N should be granted in all concerned Member States.
CHMP je zato zaključil, da se zdravilo Betavert N lahko obravnava kot generično zdravilo zdravila Betaserc 8 ter da se lahko dovoljenje za promet z zdravilom Betavert N odobri v vseh zadevnih državah.
Hennig Arzneimittel GmbH & Co. KG submitted Betavert N for mutual recognition on the basis of the initial authorisation granted by Germany on 18 April 2007.
KG je predložila vlogo za medsebojno priznavanje zdravila Betavert N na podlagi prvotnega dovoljenja za promet z zdravilom, odobrenega v Nemčiji 18. aprila 2007.
What is Betavert N?
Kaj je zdravilo Betavert N?
The European Medicines Agency (EMEA) has completed an arbitration procedure following a disagreement among Member States of the European Union regarding the authorisation of the medicine Betavert N. The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Betavert N outweigh its risks, and the marketing authorisation granted in Germany can be recognised in other Member States of the European Union.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri Agenciji je zaključil, da koristi zdravila Betavert N odtehtajo njegova tveganja ter da se lahko dovoljenje za promet z zdravilom, odobreno v Nemčiji, prizna v drugih državah članicah Evropske unije.
Company responses provided on: 11 February 2009 Opinion date:
Datum izdaje mnenja:
The duration of exposure was between 3.5 and 5 years.
Izpostavljenost je trajala med 3,5 in 5 let.
Time from randomization (months)
Čas od randomizacije (meseci)
Observed values for patients completing each scheduled visit
Izmerjene vrednosti pri bolnikih, ki so zaključili vsak načrtovan obisk
Your doctor will assess your treatment on a regular basis.
Zdravnik bo redno ocenjeval vaše zdravljenje.
Detailed instructions for use are provided on the other side of this leaflet.
Podrobna navodila za uporabo so opisana na drugi strani tega navodila.
30 months After first use: 1 month
30 mesecev Po prvi uporabi: 1 mesec.
Be very careful to calculate correctly.
Bodite zelo pozorni, da odmerek pravilno izračunate.
The pain may be felt through to your back or right shoulder.
Bolečina lahko izžareva v hrbet ali desno ramo.
Currently available data are described in sections 4.8, 5.1 and 5.2 but no recommendation on posology can be made.
Trenutno razpoložljivi podatki so opisani v poglavjih 4.8, 5.1 in 5.2, vendar priporočil o odmerjanju ni mogoče podati.
Take the medicine pack with you.
Zdravilo vzemite s seboj.
Using the wrong medicine could be harmful to your health.
Z uporabo napačnega zdravila lahko ogrozite svoje zdravje.
SD=standard deviation.
SD = standardna deviacija.
***See section 4.4.
***Glejte poglavje 4.4.
• You can use Saxenda at any time of the day, with or without food and drink.
• Zdravilo Saxenda lahko uporabite ob kateri koli uri, s hrano in pijačo ali brez njiju.
Your doctor will tell you how to treat low blood sugar and what to do if you notice these warning signs
Zdravnik vam bo povedal, kako zdraviti nizek krvni sladkor in kaj storiti, če opazite te opozorilne znake.
Your doctor will tell you how much Saxenda to use each week.
Zdravnik vam bo povedal, koliko zdravila Saxenda uporabite vsak teden.
• Feeling weak or tired
• šibkost ali utrujenost
Time in weeks
Čas v tednih
The majority of events were mild.
Večina dogodkov je bila blagih.
Liraglutide is extensively bound to plasma protein (>98%).
Liraglutid je v veliki meri vezan na beljakovine v plazmi (> 98 %).
Liraglutide should not be used during pregnancy.
Liraglutida se ne sme uporabljati med nosečnostjo.
Pancreatitis is a serious, potentially life-threatening medical condition.
Pankreatitis je resna in potencialno življenjsko ogrožajoča bolezen.
Your treatment will start at a low dose which will be gradually increased over the first five weeks of treatment.
Zdravljenje boste začeli z nizkim odmerkom, nato pa ga boste v prvih petih tednih zdravljenja postopno povečevali.
The heart rate peaked after approximately 6 weeks.
Frekvenca srčnega utripa je dosegla najvišjo vrednost po približno 6 tednih.
Change the needle as described in step 5 ‘After your injection' and repeat all steps starting with step 1 ‘Prepare your pen with a new needle'.
Zamenjajte iglo, kot je opisano v koraku 5 "Po injiciranju", in ponovite vse korake, začenši s korakom 1 "Pripravite injekcijski peresnik z novo injekcijsko iglo".
Heart rate should be monitored at regular intervals consistent with usual clinical practice.
Frekvenco srčnega utripa je treba spremljati v rednih intervalih, skladno z običajno klinično prakso.
It is important to avoid dehydration by drinking plenty of fluids.
Pomembno je preprečiti dehidracijo, tako da pijete veliko tekočine.
The majority of events were mild or moderate.
Večina dogodkov je bila blagih ali zmernih.
This leaflet was last revised in Other sources of information
Navodilo je bilo nazadnje posodobljeno Drugi viri informacij
Summary of the safety profile:
Povzetek varnostnega profila
Both treatment periods were followed by a 12-week off drug/placebo observational follow-up period.
Obema zdravljenjema je sledilo 12-tedensko opazovalno obdobje brez uporabe zdravila/placeba.
Cumulative Frequency (%)
Kumulativna pogostost (%)
It is not recommended if you are 75 years or older.
Uporaba zdravila ni priporočljiva, če ste stari 75 let ali več.
• Do not inject Saxenda which has been frozen.
• Ne injicirajte zdravila Saxenda, ki je bilo zamrznjeno.
Usually, you will be told to follow the table below.
Običajno vam bo naročil, da uporabite spodnjo preglednico.
Liraglutide does not increase energy expenditure compared to placebo.
Liraglutid v primerjavi s placebom ne poveča porabe energije.
This is normal, but you must still check the flow if you use a new pen for the first time.
To je normalno, vendar pa morate kljub temu še preveriti pretok, če boste uporabili nov injekcijski peresnik.
• Turn the dose selector until the dose counter shows the flow check symbol (
• Vrtite izbirnik odmerka, dokler se na števcu odmerka ne pokaže simbol preverjanja pretoka (
• Allergic reactions including skin rash
• alergijske reakcije, vključno s kožnim izpuščajem
Before first use:
Pred prvo uporabo
The safety and efficacy of Saxenda in children and adolescents below 18 years of age have not yet been established.
Varnost in učinkovitost zdravila Saxenda pri otrocih in mladostnikih, mlajših od 18 let, še nista bili dokazani.
These tumours were not seen in monkeys treated for 20 months.
Teh tumorjev niso opazili pri opicah, ki so jim zdravilo dajali 20 mesecev.
HR: 0.87 95% CI 0.78; 0.97 p<0.001 for non-inferiority p=0.005 for superiority
95 % IZ 0,78; 0,97 p<0,001 za neinferiornost p=0,005 za superiornost
Your doctor will start you on a diet and exercise programme.
Zdravnik vam bo predpisal dieto in program telesne vadbe.
Interaction studies did not show any clinically relevant delay of absorption and therefore no dose adjustment is required.
Študije medsebojnega delovanja niso pokazale klinično pomembne upočasnitve absorpcije, zato prilagoditev odmerka ni potrebna.
Liraglutide binds to and activates the GLP-1 receptor (GLP-1R).
Liraglutid se veže na receptor za GLP-1 (GLP-1R) in ga aktivira.
The long-term clinical impact of this mean increase in heart rate has not been established.
Dolgoročnih kliničnih učinkov tega zvišanja niso ugotovili.
The urine and faeces radioactivity was mainly excreted during the first 6-8 days and corresponded to three minor metabolites, respectively.
Radioaktivnost v urinu in blatu se je v glavnem pojavila v prvih 6-8 dneh in je šla na račun treh manj pomembnih presnovkov.
For further instructions on administration, see section 6.6.
Za dodatna navodila glede uporabe zdravila glejte poglavje 6.6.
Stop taking Saxenda and contact a doctor immediately if you experience severe pain in your upper abdomen, usually worst on the right side under the ribs.
Prenehajte z uporabo zdravila Saxenda in se nemudoma posvetujte z zdravnikom, če občutite hudo bolečino v zgornjem delu trebuha, ki je običajno hujša na desni strani pod rebri.
It must not be administered intravenously or intramuscularly.
Ne sme se ga aplicirati intravensko ali intramuskularno.
Do not increase your dose further.
Odmerka več ne zvišujte.
Flow check symbol selected
simbol preverjanja pretoka izbran
• Use Saxenda at about the same time each day - choose a time of the day that works best for you.
• Zdravilo Saxenda uporabljajte vsak dan ob približno istem času - izberite si uro, ki je za vas najprimernejša.
The following effects may happen:
Pojavita se lahko:
The reactions usually occurred during the first weeks of treatment and diminished within a few days or weeks on continued treatment.
Reakcije so se navadno pojavile v prvih tednih zdravljenja in so med nadaljevanjem zdravljenja po nekaj dneh ali tednih izzvenele.
These findings in rodents are caused by a non-genotoxic, specific GLP-1 receptor-mediated mechanism to which rodents are particularly sensitive.
Pri glodavcih so ti učinki posledica negenotoksičnega, specifično prek receptorjev GLP-1 posredovanega mehanizma, za katerega so glodavci zelo občutljivi.
****From controlled phase 2, 3a and 3b clinical trials.
****Iz kontroliranih kliničnih preskušanj 2, 3a in 3b faze Opis izbranih neželenih učinkov
Once you reach the recommended dose of 3.0 mg in week 5 of treatment, keep using this dose until your treatment period ends.
Ko v 5. tednu zdravljenja dosežete priporočeni odmerek 3,0 mg, še naprej uporabljajte ta odmerek do zaključka zdravljenja.
• Do not inject into a vein or muscle.
• Zdravila ne injicirajte v veno ali mišico.
If you do that, you may not get the intended effect of this medicine.
Če to storite, je možno, da zdravilo ne bo imelo želenega učinka.
If you select the wrong dose, you can turn the dose selector forward or backwards to the correct dose.
Če izberete napačen odmerek, lahko z vrtenjem izbirnika odmerka naprej ali nazaj izberete pravilen odmerek.
Use in these patients is not recommended (see section 4.2).
Uporaba pri teh bolnikih ni priporočljiva (glejte poglavje 4.2).
GLP-1 receptors are also expressed in specific locations in the heart, vasculature, immune system and kidneys.
Receptorji za GLP-1 so izraženi tudi na določenih mestih v srcu, ožilju, imunskem sistemu in ledvicah.
• Check the name and coloured label of your pen, to make sure that it contains Saxenda.
• Preverite ime in barvno nalepko na injekcijskem peresniku in se tako prepričajte, da vsebuje zdravilo Saxenda.
Important information about some of the ingredients of Saxenda
Pomembne informacije o nekaterih sestavinah zdravila Saxenda
3 Select your dose
3 Izberite odmerek
A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
A. PROIZVAJALEC BIOLOŠKE UČINKOVINE IN PROIZVAJALEC, ODGOVOREN ZA SPROŠČANJE SERIJ
If you adjust your insulin dose your doctor may recommend you to monitor your blood sugar more frequently.
Če boste prilagodili odmerek insulina, vam bo zdravnik morda priporočil pogostejše spremljanje sladkorja v krvi;
If so, the full dose will not be delivered.
V tem primeru ne boste prejeli celotnega odmerka.
If necessary, clean it with a mild detergent on a moistened cloth.
Po potrebi ga očistite s krpo, navlaženo z blagim detergentom.
• Trial 1 (SCALE Obesity & Pre-Diabetes - 1839): A total of 3,731 patients with obesity (BMI
• Preskušanje 1 (SCALE Obesity & Pre-Diabetes - 1839): Skupno 3.731 bolnikov z debelostjo
This may help you eat less food and reduce your body weight.
Tako vam lahko pomaga zmanjšati količino zaužite hrane in zmanjšati telesno maso.
If you do not check the flow before your first injection with each new pen, you may not get the prescribed dose and the intended effect of Saxenda.
Če pred prvim injiciranjem z novim injekcijskim peresnikom ne preverite pretoka, morda ne boste prejeli predpisanega odmerka in želenega učinka zdravila Saxenda.
The Liraglutide Effect and Action in Diabetes Evaluation of Cardiovascular Outcomes Results (LEADER) trial included 9,340 patients with insufficiently controlled type 2 diabetes.
Preskušanje LEADER (Liraglutide Effect and Action in Diabetes Evaluation of Cardiovascular Outcome Results) je vključevalo 9.340 bolnikov z neustrezno nadzorovano sladkorno boleznijo tipa 2.
• Do not use a double dose or increase the dose on the following day to make up for the missed dose.
• Ne uporabite dvojnega odmerka oziroma ne povečajte odmerka naslednji dan, da bi nadoknadili zamujeni odmerek.
• When you first start using Saxenda, the starting dose is 0.6 mg once a day, for at least one week.
• Ko boste prvič začeli uporabljati zdravilo Saxenda, bo začetni odmerek 0,6 mg enkrat na dan vsaj en teden.
Other medicines and Saxenda
Druga zdravila in zdravilo Saxenda
Saxenda works by acting on receptors in the brain that control your appetite, causing you to feel fuller and less hungry.
Zdravilo Saxenda deluje na receptorje v možganih, ki nadzorujejo apetit, in povzroči, da se počutite bolj siti in manj lačni.
The mean apparent volume of distribution after subcutaneous administration is 20-25 L (for a person weighing approximately 100 kg).
Povprečni navidezni volumen porazdelitve po subkutani aplikaciji je 20-25 l (za osebo, katere telesna masa je približno 100 kg).
**Insomnia was mainly seen during the first 3 months of treatment.
**Nespečnost se je v glavnem pojavljala v prvih treh mesecih zdravljenja.
Saxenda is administered once daily at any time, independent of meals.
Zdravilo Saxenda je treba aplicirati enkrat na dan, ob kateri koli uri, ne glede na obroke.
Two minor plasma metabolites were detected (≤9% and ≤5% of total plasma radioactivity exposure).
Odkrili so tudi dva manj pomembna presnovka v plazmi (≤ 9 % in ≤ 5 % celotne plazemske izpostavljenosti radioaktivnosti).
Saxenda should not be used if it has been frozen.
Zdravila Saxenda ne smete uporabiti, če je bilo zamrznjeno.
There is no clinical experience in patients with congestive heart failure New York Heart Association (NYHA) class IV, and liraglutide is therefore not recommended for use in these patients.
Kliničnih izkušenj pri zdravljenju bolnikov s srčnim popuščanjem razreda IV po razvrstitvi New York Heart Association (NYHA) ni in zato uporaba liraglutida pri teh bolnikih ni priporočljiva.
All 3,731 patients were randomised to 56 weeks of treatment and the 2,254 patients with pre-diabetes at screening were randomised to 160 weeks of treatment.
Vseh 3.731 bolnikov so randomizirali na 56-tedensko zdravljenje, 2.254 bolnikov z ugotovljenim preddiabetesom pri presejanju pa so randomizirali na 160-tedensko zdravljenje.
Do not use this medicine if the solution is not clear and colourless or almost colourless.
Ne uporabljajte tega zdravila, če raztopina ni bistra in brezbarvna ali skoraj brezbarvna.
In the 160-weeks part of trial 1, the weight loss occurred mainly in the first year and was sustained throughout 160 weeks.
V 160-tedenskem delu preskušanja 1 je do zmanjšanja telesne mase prišlo predvsem v prvem letu zdravljenja, zmanjšanje pa se je ohranilo vseh 160 tednov.
However, dizziness can be experienced mainly during the first 3 months of treatment with Saxenda.
Toda pojavi se lahko omotica, predvsem v prvih 3 mesecih zdravljenja z zdravilom Saxenda.
Change in Body Weight (%) Saxenda Placebo
Sprememba telesne mase (%) Saxenda Placebo
If you need any further information, talk to your doctor.
Če potrebujete dodatne informacije, se posvetujte z zdravnikom.
The risk of hypoglycaemia may be lowered by a reduction in the dose of insulin and/or sulfonylurea.
Tveganje za hipoglikemijo je mogoče zmanjšati z zmanjšanjem odmerka insulina in/ali sulfonilsečnine.
Get help from a person with good eyesight who is trained to use the Saxenda pre-filled pen.
Pomaga naj vam oseba, ki dobro vidi in je usposobljena za uporabo napolnjenega injekcijskega peresnika Saxenda.
Cholelithiasis and cholecystitis may lead to hospitalisation and cholecystectomy.
Holelitiaza in holecistitis lahko vodita v hospitalizacijo in holecistektomijo.
Missing post-baseline values were imputed using the last observation carried forward.
Manjkajoče po-izhodiščne vrednosti so bile pripisane s prenosom zadnje opaženih vrednosti naprej.
If you stop using Saxenda
Če ste prenehali uporabljati zdravilo Saxenda
The European Medicines Agency has deferred the obligation to submit the results of studies with Saxenda in one or more subsets of the paediatric population in the treatment of obesity and in the treatment of Prader-Willi Syndrome (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov preskušanj z zdravilom Saxenda za eno ali več podskupin pediatrične populacije za zdravljenje debelosti in sindroma Prader-Willi (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
There are limited data from the use of liraglutide in pregnant women.
Podatki o uporabi liraglutida pri nosečnicah so omejeni.
In particular, tell your doctor, pharmacist or nurse if:
Še posebej pomembno je, da obvestite zdravnika, farmacevta ali medicinsko sestro, če:
Specific data on weight loss, responders, time course and cumulative distribution of weight change (%) for trials 1-4 are presented in tables 3-7 and figures 1, 2 and 3.
Specifični podatki o izgubi telesne mase, odzivnosti bolnikov, poteku in celokupni porazdelitvi sprememb telesne mase (%) za preskušanja 1-4 so prikazani v preglednicah 3-7 in slikah 1, 2 in 3.
It is not known whether liraglutide is excreted in human milk.
Ni znano, ali se liraglutid izloča v materino mleko.
Liraglutide should therefore be used with caution in patients with thyroid disease.
Liraglutid je zato treba pri bolnikih z boleznijo ščitnice uporabljati previdno.
See section 4 for the warning signs of low blood sugar.
Za opozorilne znake nizkega krvnega sladkorja glejte poglavje 4.
Saxenda is supplied as a clear and colourless or almost colourless solution for injection in a pre-filled pen.
Zdravilo Saxenda je na voljo kot bistra in brezbarvna ali skoraj brezbarvna raztopina za injiciranje v napolnjenem injekcijskem peresniku.
The 3.0 mg daily dose of liraglutide provided adequate systemic exposures over the body weight range of 60-234 kg evaluated for exposure response in the clinical trials.
Dnevni odmerek 3 mg liraglutida je zagotavljal zadostno sistemsko izpostavljenost za telesno maso 60-234 kg, izmerjeno kot odziv na izpostavljenost v kliničnih preskušanjih.
• Insert the needle into your skin as your doctor or nurse has shown you.
• Iglo zabodite v kožo, kot sta vam pokazala zdravnik ali medicinska sestra.
There was no clinically relevant effect on the overall exposure of either ethinylestradiol or levonorgestrel.
Klinično pomembnega vpliva na celokupno izpostavljenost etinilestradiolu ali levonorgestrelu ni bilo.
Apart from a slight decrease in the number of live implants, animal studies did not indicate harmful effects with respect to fertility (see section 5.3).
Razen rahlega zmanjšanja števila živih ugnezdenj, študije na živalih niso pokazale škodljivih učinkov na plodnost (glejte poglavje 5.3).
None of the reports included severe hypoglycaemia.
Noben dogodek pa ni vključeval hude hipoglikemije.
Overall, gastrointestinal reactions were the most frequently reported adverse reactions during treatment (67.9%) (see section ‘Description of selected adverse reactions').
Na splošno so bili učinki na prebavilih najpogosteje opisani neželeni učinki (67,9 %) med zdravljenjem (glejte podpoglavje "Opis izbranih neželenih učinkov").
During 24 hours following administration of a single [3H]-liraglutide dose to healthy subjects, the major component in plasma was intact liraglutide.
V 24 urah po aplikaciji enkratnega odmerka [3H]-liraglutida zdravim osebam je bila glavna komponenta v plazmi nespremenjen liraglutid.
Adverse reactions are listed by system organ class and frequency.
Neželeni učinki so navedeni glede na organski sistem in pogostnost.
Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila: http://www.ema.europa.eu/.