natgillin/translations-raw huggingface dataset:
People with MPS I disease have either a low level or no level of an enzyme called α-L-iduronidase, which breaks down specific substances (glycosaminoglycans) in the body. 
Ljudje z boleznijo MPS I imajo ali zmanjšano stopnjo aktivnosti encima -L-iduronidaza ali pa le-ta sploh ni prisoten.
They accumulate in many tissues in the body, which causes the symptoms of MPS I. 
Posledica odsotnosti oz. zmanjšane aktivnosti encima je, da se glikozaminoglikani ne razgradijo in ne predelajo v telesu, ampak se nabirajo v mnogih tkivih v telesu, kar povzroča simptome MPS I.
NAME OF THE MEDICINAL PRODUCT Aldurazyme 100 U/ml concentrate for solution for infusion laronidase 
Aldurazyme, 100 e/ml koncentrat za raztopino za infundiranje laronidaza
Careful consideration should be given to the patient's clinical status prior to administration of Aldurazyme. 
Bolniki s predhodnimi akutnimi obolenji so še bolj izpostavljeni reakcijam ob infuziji zdravila Aldurazyme, zato je pri takih bolnikih potrebno nameniti dodatno pozornost na klinično stanje bolnika pred infundiranjem zdravila Aldurazyme.
Mean change from pre-treatment baseline Percent predicted FVC (%)1 
Aldurazyme/Aldurazyme Placebo/Aldurazyme po 208 tednih po 182 tednih povprečna sprememba glede na izhodišče pred zdravljenjem predvideni odstotek FVC (%)1
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 
PRILOGA II A. IZDELOVALEC BIOLOŠKE ZDRAVILNE UČINKOVINE IN IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJ B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM D. POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA
ADRs were all mild to moderate in severity. 
Vsi neželeni učinki so bili blagi ali zmerni.
Add the combined volumes of Aldurazyme to the sodium chloride 9 mg/ml (0.9%) solution for infusion. 
To količino zdravila Aldurazyme nato dodajte raztopini 0,9% natrijevega klorida za infundiranje.
• paleness 
• omotica
Patients with an acute underlying illness at the time of Aldurazyme infusion appear to be at greater risk for IARs. 
Pri bolnikih, ki se zdravijo z zdravilom Aldurazyme, se lahko razvijejo reakcije ob infuziji.
Sodium phosphate monobasic, monohydrate Sodium phosphate dibasic, heptahydrate Polysorbate 80 
Natrijev dihidrogenfosfat monohidrat
UNIQUE IDENTIFIER - HUMAN READABLE DATA PC: 
EDINSTVENA OZNAKA - V BERLJIVI OBLIKI
Thereafter, they progressively decreased during the following weeks. 
Nato sta se v nadaljnjih tednih postopoma zmanjševala.
The most important points are: 
Najpomembnejše točke so:
This is done once and is called the ‘activation' process. 
To je treba narediti le enkrat in ta postopek imenujemo "aktivacija".
Steps 1 to 5 below show you how to do this. 
Koraki, oštevilčeni od 1 do 5 spodaj, kažejo, kako to naredite.
This is used in exactly the same way. 
Ta se uporablja povsem enako.
If it is orange, go to Section 2. 
Če je oranžno, pojdite na 2. poglavje.
Specific recommendations regarding intake of such medicinal products are given in section 4.5. 
Specifična priporočila glede jemanja takšnih zdravil so navedena v poglavju 4.5.
Printed on the inside: 
Natisnjeno na notranji strani:
After first use: 14 days 
Po prvi uporabi: 14 dni
Section 1 - IMPORTANT INFORMATION 
1. poglavje - POMEMBNE INFORMACIJE
Take care not to injure yourself when the needle is exposed. 
Pazite, da se ne poškodujete, ko je igla izpostavljena.
You must first use all 14 doses from this pen. 
Najprej morate porabiti vseh 14 odmerkov iz tega peresnika.
Your dose will be correct and you can keep following the instructions. 
Odmerek, ki ga boste dobili, bo pravilen in še naprej lahko sledite navodilom.
Insulin glargine was continuously titrated during this period. 
Insulin glargin so med tem obdobjem stalno titrirali.
Using the wrong medicine could be harmful to your health. 
Uporaba nepravega zdravila lahko škoduje zdravju.
Section 2 - GETTING STARTED 
2. poglavje - KAKO ZAČETI
Both pens are used in the same way. 
Oba peresnika se uporabljata na enak način.
What if there are air bubbles in the container? 
Kaj, če so v vsebniku zračni mehurčki?
Do not take two doses at the same time to make up for a forgotten injection. 
Ne uporabite dveh odmerkov hkrati, da bi nadomestili pozabljeno injekcijo.
Your dose has now been given. 
Zdaj ste dobili odmerek.
A treatment initiation pack is also available for use during the first 28 days of treatment. 
Za uporabo v prvih 28 dneh zdravljenja je na voljo tudi pakiranje za uvedbo zdravljenja.
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products. 
Ker študij kompatibilnosti ni, tega zdravila ne smemo mešati z drugimi zdravili.
Check the liquid. 
Preverite tekočino.
The arrow will now be pointing towards the needle. 
Puščica bo zdaj kazala k igli.
What if no liquid comes out during activation? 
Kaj, če med aktiviranjem ne pride ven nič tekočine?
For your first injection go directly to Section 3 - Step C. 
Za prvo injiciranje pojdite naravnost na 3. poglavje - korak C.
Warfarin and other coumarin derivatives 
Varfarin in ostali kumarinski derivati
Glycerol 85% 
85 % glicerol
Small air bubbles in the container are normal - they will not harm you. 
Prisotnost majhnih zračnih mehurčkov je normalna in vam ne bodo škodovali.
These medicinal products should be taken in a standardised way in relation to lixisenatide. 
Takšna zdravila je treba jemati na standardiziran način glede na liksenatid.
Frequencies of adverse reactions are defined as: very common: ≥1/10; common: ≥1/100 to <1/10; uncommon: ≥1/1,000 to <1/100; rare: ≥1/10,000 to <1/1,000; very rare: <1/10,000). 
Pogostnosti neželenih učinkov so opredeljene kot: zelo pogosti: ≥ 1/10, pogosti: ≥ 1/100 do < 1/10, občasni: ≥ 1/1.000 do < 1/100, redki: ≥ 1/10.000 do < 1/1.000, zelo redki: < 1/10.000).
• Always read the "Instructions for Use" provided in the box. 
• Vedno preberite "Navodila za uporabo", ki so priložena v škatli.
Coronary revascularization 368 (12.1%) 356 (11.7%) procedure 
Koronarni revaskularizacijski 368 (12,1 %) 356 (11,7 %) postopek
This may make it difficult to concentrate and you may feel dizzy or sleepy. 
Posledica je lahko, da se težko zberete, in lahko ste omotični ali zaspani.
Lixisenatide has a moderate level of binding (55%) to human proteins. 
Liksisenatid se zmerno (55 %) veže na človeške beljakovine.
The majority of reactions were mild in intensity and usually did not result in discontinuation of the treatment. 
Večina reakcij je bila blagih in po navadi niso povzročile prekinitve zdravljenja.
You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine. 
O neželenih učinkih lahko poročate tudi neposredno na nacionalni center za poročanje, ki je naveden v Prilogi V. S tem, ko poročate o neželenih učinkih, lahko prispevate k zagotovitvi več informacij o varnosti zdravila.
These reactions were mostly mild and transient. 
Ti učinki so bili večinoma blagi in prehodni.
Remove the needle from the pen, attach a new one and repeat Steps 4 and 5 only. 
Odstranite iglo s peresnika, namestite novo in ponovite samo 4. in 5. korak.
In the example above, the dose number shows there are 13 injections left. 
V zgornjem primeru število odmerkov kaže, da je preostalo še 13 injiciranj.
Do this even if there is some medicine left in the pen. 
To storite tudi v primeru, da je v njem še ostalo nekaj zdravila.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 01 February 2013 
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 01 Februar 2013 Datum zadnjega podaljšanja:
It is used in adults with type 2 diabetes. 
Uporablja se pri odraslih s sladkorno boleznijo tipa 2.
The warning signs of low blood sugar may include cold sweat, cool pale skin, headache, feeling drowsy, weak, dizzy, confused or irritable, feeling hungry, fast heart beat and feeling jittery. 
Med opozorilnimi znaki nizkega krvnega sladkorja so lahko hladno znojenje, hladna bleda koža, glavobol, zaspanost, šibkost, omotičnost, zmedenost ali razdražljivost, občutek lakote, hitro bitje srca in občutek tresenja.
This effect on HbA1c was sustained in long term studies for up to 76 weeks. 
Ta učinek na HbA1c se je v dolgoročnih študijah ohranil do 76 tednov.
It should be clear and colourless and with no particles. 
Biti mora bistra in brezbarvna, brez delcev.
No treatment-related effect was demonstrated. 
Z zdravljenjem povezanega učinka niso dokazali.
The percentage of patients who were antibody positive was similar at the end of the entire 76-week treatment period. 
Odstotek bolnikov s pozitivnimi protitelesi je bil podoben tudi ob koncu celotnega 76-tedenskega obdobja zdravljenja.
Read all of this leaflet carefully before you start using this medicine because it contains important information for you. 
Pred začetkom jemanja uporabe zdravila natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
Do not use Lyxumia - if you are allergic to lixisenatide or any of the other ingredients of this medicine (listed in section 6). 
Ne uporabljajte zdravila Lyxumia - če ste alergični na liksisenatid ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
If this happens do not drive or use any tools or machines. 
Če se vam to zgodi, ne vozite in ne uporabljajte orodij oziroma ne uporabljajte strojev.
HR [95% CI] 
ROg [95% IZ]
Overall, 37% of the patients were ≥75 years old (N=131) and 31% had moderate renal impairment (N=107). 
V celoti je bilo 37 % bolnikov starih ≥ 75 let (N = 131) in 31 % je imelo zmerno okvaro ledvic (N = 107).
This could possibly pass on infection. 
Tako se namreč lahko prenese kakšna okužba.
Similar HbA1c decreases were observed regardless of which meal was the main meal (breakfast, lunch or dinner). 
Podobno znižanje HbA1c so opažali ne glede na to, kateri obrok (zajtrk, kosilo ali večerja) je bil glavni dnevni obrok.
Lixisenatide has no or negligible influence on the ability to drive or use machines. 
Liksisenatid nima ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
Section 3 - DAILY USE OF PEN Only follow this section when the activation window is white. 
3. poglavje - VSAKODNEVNA UPORABA PERESNIKA Postopke v tem poglavju opravite le, če je aktivacijsko okence belo.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. 
Če ste noseči ali dojite, če menite, da bi lahko bili noseči, ali če načrtujete zanositev, se posvetujte s svojim zdravnikom ali s farmacevtom, preden vzamete to zdravilo.
Populations not studied Lixisenatide has not been studied in combination with dipeptidyl peptidase 4 (DPP-4) inhibitors. 
Neraziskane populacije Liksenatid ni raziskan v kombinaciji z zaviralci dipeptidil-peptidaze 4 (DPP-4).
It is not known if Lyxumia may harm your unborn child. 
Ni znano, ali lahko zdravilo Lyxumia škoduje vašemu nerojenemu otroku.
Repeat Section 3 for your daily injections until your pen is empty. 
Ponavljajte 3. poglavje za vsakodnevno injiciranje zdravila, dokler peresnik ni prazen.
The needle may be blocked or not properly screwed on. 
Morda je igla zamašena ali ni pravilno privita.
They were mostly mild and transient and occurred during the first 3 weeks after starting treatment. 
Neželena učinka sta bila večinoma blaga in prehodna ter sta se pojavila v prvih 3 tednih po začetku zdravljenja.
• Beta cell function 
• Delovanje celic beta
Figure 1: Forest plot: analyses of each individual cardiovascular event -- ITT population 
Slika 1: Drevesni diagram (forest plot): analize vsakega posameznega srčno-žilnega dogodka -populacija ZNZ
• 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 nenehno bolečino v trebuhu, ki se lahko širi v hrbet, pa tudi siljenje na bruhanje in bruhanje, ker so to lahko znaki vnetja trebušne slinavke (pankreatitisa).
If no liquid comes out see the “Questions and answers” section. 
Če ne priteče nič tekočine, glejte poglavje "Vprašanja in odgovori".
Other important information about using the pre-filled pens There is more information on how to use the pens in the “Instructions for Use”. 
Druge pomembne informacije o uporabi napolnjenih injekcijskih peresnikov Več informacij o uporabi peresnika boste našli v "Navodilih za uporabo".
Check the number of doses in the pen. 
Preverite število odmerkov v peresniku.
Body weight reduction was sustained in long term studies up to 76 weeks. 
Znižanje telesne mase se je v dolgoročnih študijah ohranilo do 76 tednov.
It is important to avoid dehydration by drinking plenty of fluids, especially when starting treatment with Lyxumia 
Pomembno je preprečiti dehidracijo (izsušitev) s pitjem veliko tekočine, zlasti na začetku zdravljenja z zdravilom Lyxumia.
The pictures below show how the activation window on the injection button of your pen changes after activation. 
Spodnji sliki kažeta, kako se aktivacijsko okence na gumbu za injiciranje po aktivaciji spremeni.
• Before injecting a dose - before injecting you must first remove excess liquid from your new pen. 
• Pred injiciranjem odmerka - pred injiciranjem morate iz novega peresnika najprej odstraniti odvečno tekočino.
Lixisenatide should not be used for treatment of diabetic ketoacidosis. 
Liksisenatid se ne sme uporabljati za zdravljenje diabetične ketoacidoze.
The pen is activated and ready for injections. 
Peresnik je aktiviran in pripravljen za injiciranje.
Point the needle into a suitable container (like a paper cup or tissue) to capture the liquid so that it can be thrown away. 
Usmerite iglo v primeren vsebnik (npr. papirnat kozarec ali papirnat robček), da boste tekočino prestregli in jo boste lahko zavrgli.
Throw away a pen 14 days after activation. 
Peresnik zavrzite 14 dni po aktivaciji.
The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP. 
Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih sprejetih posodobitvah RMP
Patients should be informed of the characteristic symptoms of acute pancreatitis: persistent, severe abdominal pain. 
Bolnike je treba seznaniti z značilnimi simptomi akutnega pankreatitisa: trdovratnimi, hudimi bolečinami v trebuhu.
Your doctor will tell you what to do if you get a low blood sugar. 
Zdravnik vam bo povedal, kaj morate storiti, če se vam pojavi nizek sladkor v krvi (hipa).
Do not try to repair the pen. 
Peresnika ne poskušajte popraviti.
There is no need to measure each dose. 
Posameznega odmerka vam ni treba meriti.
- you suffer from heart problems which can cause shortness of breath or ankle swelling, since there is limited experience in this population. 
- če imate težave s srcem, ki lahko povzročajo kratko sapo in otekanje gležnjev, saj obstaja le malo izkušenj v tej populaciji.
The patient should be instructed to discard the needle after each use in accordance with local requirements and to store the pen without the needle attached. 
Bolniku je treba naročiti, da mora iglo po vsaki uporabi zavreči v skladu z lokalnimi zahtevami in peresnik shraniti brez nameščene igle.
The majority of injection site reactions were mild, regardless of antibody status. 
Večina reakcij na mestu injiciranja je bila blagih, ne glede na izvid protiteles.
• Only use needles that are compatible for use with Lyxumia pen (see “Instructions for Use”). 
• Uporabljajte le igle, ki so združljive z injekcijskim peresnikom Lyxumia (glejte "Navodila za uporabo").
Frequency of occurrence 
Pogostnost pojavljanja
Most of these reported allergic reactions were mild in severity. 
Večina opisanih alergijskih reakcij je bila blagih.
In case of overdose, appropriate supportive treatment should be initiated according to the patient's clinical signs and symptoms and the lixisenatide dose should be reduced to the prescribed dose. 
V primeru prevelikega odmerjanja je treba uvesti ustrezno podporno zdravljenje, na podlagi bolnikovih znakov in simptomov, odmerek liksisenatida pa je treba zmanjšati na predpisani odmerek.
Keep away from the freezer compartment. 
Shranjujte proč od zamrzovalnega razdelka hladilnika.
If you have any questions about Lyxumia or about diabetes, ask your doctor, pharmacist or nurse or call the local sanofi-aventis number in the Lyxumia “Package leaflet: Information for the user” (provided separately in the box). 
Če imate kakšna vprašanja o zdravilu Lyxumia ali o sladkorni bolezni, vprašajte svojega zdravnika, farmacevta ali medicinsko sestro, ali pokličite lokalno številko družbe sanofi-aventis, ki jo najdete v "Navodilu za uporabo" zdravila Lyxumia (to navodilo je posebej priloženo v škatli).
Pull the injection button out firmly until it stops. 
Gumb za injiciranje odločno izvlecite, dokler se ne ustavi.
In both species, there was a slight maternal toxicity consisting of low food consumption and reduced body weight. 
Pri obeh živalskih vrstah so bili prisotni rahli maternalni toksični učinki, ki so obsegali majhno uživanje hrane in zmanjšanje telesne mase.
The body weight reduction is independent from the occurrence of nausea and vomiting. 
Znižanje telesne mase je neodvisno od pojava navzee in bruhanja.
The antibody status (positive or negative) is not predictive of the reduction of HbA1c for an individual patient. 
Izvid protiteles (pozitiven ali negativen) pri posameznem bolniku nima napovedne vrednosti glede znižanja HbA1c.
There was no cross-reactivity versus either native glucagon or endogenous GLP-1. 
Navzkrižne reaktivnosti ni bilo ne proti naravnemu glukagonu ne proti endogenemu GLP-1.
You must dispose of the needle after each use, in an appropriate sharp's container, following local recommendations. 
Iglo morate po vsaki uporabi zavreči; zavrzite jo v ustrezen vsebnik za ostre odpadke upoštevaje lokalna priporočila.
The use of Lyxumia does not require specific blood glucose monitoring. 
Uporaba zdravila Lyxumia ne zahteva posebnega spremljanja ravni glukoze v krvi.
This effect on post-prandial glucose was confirmed in a 4-week study versus liraglutide 1.8 mg once a day in combination with metformin. 
Ta učinek na postprandialno glukozo so potrdili v 4-tedenski primerjalni študiji z 1,8 mg liraglutida enkrat na dan v kombinaciji z metforminom.
There is no experience with Lyxumia in children and adolescents less than 18 years and therefore, the use of Lyxumia is not recommended in this age group. 
Izkušenj z zdravilom Lyxumia pri otrocih in mladostnikih, mlajših od 18 let, ni, zato zdravila Lyxumia v tej starostni skupini ni priporočljivo uporabljati.
Keep it straight as you screw it on. 
Ko jo privijate, jo držite naravnost.
Before first use Store in a refrigerator. 
Pred prvo uporabo Shranjujte v hladilniku.
In in vitro studies, lixisenatide did not affect the activity of cytochrome P450 isozymes or human transporters tested. 
V študijah in vitro liksisenatid ni vplival na aktivnost izoencimov citokroma P450 ali testiranih človeških prenašalcev.
Each dose contains 540 micrograms of metacresol. 
En odmerek vsebuje 540 mikrogramov metakrezola.
An attached needle might lead to contamination and possible intake of air which might impact the dose accuracy. 
Če igla ostane nameščena, lahko pride do onesnaženja in do vstopanja zraka, ki lahko vpliva na točnost odmerka.
C-cell hyperplasia and adenoma were seen at all doses in rats and a no observed adverse effect level (NOAEL) could be not defined. 
Hiperplazijo celic C in adenome so pri podganah opažali pri vseh odmerkih: ravni brez opaženega neželenega učinka (NOAEL - no observed adverse effect level) ni bilo mogoče opredeliti.
Clinical studies with Lyxumia indicate improved beta-cell function as measured by the homeostasis model assessment for beta-cell function (HOMA-β). 
Klinične študije z zdravilom Lyxumia kažejo izboljšanje delovanja celic beta, merjeno z oceno delovanja celic beta na podlagi modela homeostaze (HOMA-ß).
EXP Discard pen 14 days after first use 
EXP Peresnik zavrzite 14 dni po prvi uporabi
• Always check the label to ensure you have the correct Lyxumia pen. 
• Vedno preverite nalepko in se tako prepričajte, da imate pravi peresnik Lyxumia.
A total of 350 patients were randomized (randomization ratio 
Skupaj je bilo randomiziranih 350 bolnikov (randomizacijsko razmerje 1:1).
No dose adjustment is required based on age. 
Starejši Odmerka ni treba prilagoditi glede na starost.
The level of HbA1c reduction was comparable between groups (table 5). 
Znižanje HbA1c je bilo med skupinami podobno (preglednica 5).
- you have type 1 diabetes or diabetic ketoacidosis (a complication of diabetes that occurs when the body is unable to break down glucose because there is not enough insulin) since this medicine will not be right for you 
- če imate sladkorno bolezen tipa 1 ali "diabetično ketoacidozo" (zaplet sladkorne bolezni, ki se pojavi, če telo ne more razgrajevati glukoze, ker nima dovolj insulina), ker to zdravilo ne bo primerno za vas.
• Only inject one dose per day. 
• Injicirajte le en odmerek na dan.
Step 5 The pen is now activated. 
5. korak Peresnik je zdaj aktiviran.
In case of hypoglycaemia, the rescue mechanism of glucagon secretion is preserved. 
V primeru hipoglikemije je rešilni mehanizem izločanja glukagona ohranjen.
Within each system organ class, adverse reactions are presented in order of decreasing frequency. 
Pri vsakem organskem sistemu so neželeni učinki navedeni po padajoči pogostnosti.
Frail patients, including patients at risk for malnutrition, patients with recent cardiovascular events and patients with moderate to severe cognitive impairment were excluded. 
Študija ni zajela krhkih bolnikov, vključno z bolniki s tveganjem za podhranjenost, bolniki z nedavnimi srčno-žilnimi dogodki in bolniki z zmerno do hudo kognitivno okvaro.
Keep the outer needle cap - you will need it to remove the needle later. 
Shranite zunanji pokrovček igle - pozneje ga boste potrebovali za odstranitev igle.
Check the label on your pen to make sure you have the correct medicine. 
Preverite nalepko na peresniku in se prepričajte, da imate pravo zdravilo.
In mice, these effects occurred at exposure ratio above 9.3-fold when compared to human exposure at the therapeutic dose. 
Pri miših so se ti učinki pojavili pri več kot 9,3-kratnem razmerju izpostavljenosti v primerjavi s terapevtskim odmerkom pri človeku.
• You must activate your Lyxumia pen before you use it for the first time. 
• Peresnik Lyxumia morate aktivirati, preden ga prvič uporabite.
Other side effects include 
Ostali neželeni učinki vključujejo:
Once you have thrown away the green pen continue to Section 4 to begin using the purple pen. 
Ko ste zavrgli zeleni peresnik, nadaljujte s 4. poglavjem, da boste začeli uporabljati škrlatni peresnik.
• If another person is giving the injection, they should take care not to injure anyone accidentally with the needle. 
• Če vam injekcijo daje nekdo drug, mora paziti, da z iglo po nesreči koga ne poškoduje.
What if it is hard to press the injection button all the way in? 
Kaj, če je injekcijski gumb težko pritisniti do konca noter?
Caution should be exercised in patients with a history of pancreatitis. 
Previdnost je potrebna pri bolnikih z anamnezo pankreatitisa.
The European Medicines Agency has deferred the obligation to submit the results of studies with Lyxumia in one or more subsets of the paediatric population in type 2 diabetes mellitus (see section 4.2 for information on paediatric use). 
Evropska agencija za zdravila je začasno odložila obvezo za predložitev rezultatov študij z zdravilom Lyxumia za eno ali več skupin pediatrične populacije pri sladkorni bolezni tipa 2 (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
Lixisenatide is a selective GLP-1 receptor agonist. 
Liksisenatid je selektiven agonist receptorjev GLP-1.