natgillin/translations-raw huggingface dataset:
In a phase 4 study 33 MPS I patients received 1 of 4 dose regimens: 100 U/kg IV every week (recommended dose), 200 U/kg IV every week, 200 U/kg IV every 2 weeks or 300 U/kg IV every 2 weeks. 
U ispitivanju faze IV su 33 bolesnika oboljela od MPS I primala lijek prema jednom od sljedeća četiri režima doziranja: 100 U/kg intravenski svaki tjedan (preporučena doza), 200 U/kg i.v. svaki tjedan,
median 38.5 0.066 -2.0 - 79.0 
srednja vrijednost medijan 38,5 0,066
Genzyme Ireland Ltd., IDA Industrial Park, Old Kilmeaden Road, Waterford, Ireland 
Genzyme Ltd., 37 Hollands Road, Haverhill, Suffolk CB9 8PU, Ujedinjeno Kraljevstvo Genzyme Ireland Ltd., IDA Industrial Park, Old Kilmeaden Road, Waterford, Irska
Very common oxygen saturation decreased Very common 
Pretrage povišen krvni tlak vrlo često smanjena zasićenost kisikom vrlo često
Patients who have developed antibodies or symptoms of IARs should be treated with caution when administering Aldurazyme (see sections 4.3 and 4.8). 
Aldurazyme se mora primjenjivati uz oprez kod bolesnika u kojih su se razvila protutijela ili simptomi reakcije povezane s infuzijom (vidjeti dijelove 4.3 i 4.8).
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (1 VIAL, 10 VIALS, 25 VIALS) 
KUTIJA (1 BOČICA, 10 BOČICA, 25 BOČICA)
METHOD AND ROUTE(S) OF ADMINISTRATION Intravenous use. 
NAČIN I PUT(EVI) PRIMJENE LIJEKA
NAME OF THE MEDICINAL PRODUCT Aldurazyme 100 U/ml concentrate for solution for infusion laronidase 
Aldurazyme 100 U/ml koncentrat za otopinu za infuziju laronidaza
Method of administration Aldurazyme is to be administered as an intravenous infusion. 
Aldurazyme se primjenjuje intravenskom infuzijom.
• paleness 
• omaglica
Patients with absent to low antibody levels showed a robust reduction in urinary GAG level, whereas patients with high antibody titers showed variable reduction in urinary GAG. 
Kod bolesnika bez protutijela ili s niskom razinom protutijela opaženo je snažno smanjenje glikozaminoglikana (GAG) u mokraći, dok je kod bolesnika s visokim titrom protutijela smanjenje
How Aldurazyme is given 
Kako primjenjivati Aldurazyme
Four patients underwent dosage increases to 200 U/kg for the last 26 weeks because of elevated urinary GAG levels at Week 22. 
GAG-a u mokraći u 22. tjednu četvorici je bolesnika doza u posljednjih 26 tjedana povećana na
Sodium phosphate monobasic, monohydrate Sodium phosphate dibasic, heptahydrate Polysorbate 80 
natrijev klorid natrijev dihidrogenfosfat hidrat natrijev hidrogenfosfat heptahidrat polisorbat 80 voda za injekcije
What Aldurazyme looks like and contents of the pack Aldurazyme is supplied as a concentrate for solution for infusion. 
Aldurazyme je dostupan u obliku koncentrata za otopinu za infuziju.
One ml of the solution in the vial contains 100 U of laronidase. 
Jedan mililitar otopine u bočici sadrži 100 U laronidaze.
Dosage 
MedDRA
To be taken into consideration by patients on a controlled sodium diet. 
O tome treba voditi računa kod bolesnika koji su na režimu prehrane s ograničenjem unosa natrija.
ADRs were all mild to moderate in severity. 
Sve su nuspojave bile blage do umjerene težine.
Musculoskeletal and connective tissue disorders 
Poremećaji mišićno koštanog sustava i vezivnog tkiva artropatija, artralgija,
It is a solution that is clear to slightly opalescent, and colourless to pale yellow. 
Ta je otopina bistra do blago opalescentna te bezbojna do blijedožuta.
• tingling 
• trnci
Any unused solution should be discarded. 
Neupotrijebljenu otopinu nužno je zbrinuti.
Urinary GAG levels decreased by 77% and 66% in the Placebo/Aldurazyme and Aldurazyme/Aldurazyme groups, respectively; at the end of the study one-third of the patients (15 of 45) had reached normal urinary GAG levels. 
Vrijednost GAG-a u mokraći smanjila se za 77% u placebo/Aldurazyme skupini, odnosno za 66% u
The following information is intended for healthcare professionals only: 
Sljedeće informacije namijenjene su samo zdravstvenim djelatnicima: Jedna bočica lijeka Aldurazyme namijenjena je isključivo za jednokratnu uporabu.
• swelling of the neck 
• proljev • oticanje vrata
• redness of the skin 
• ubrzano disanje • crvenilo kože
ADRs to Aldurazyme reported during a Phase 2 study in a total of 20 patients, under 5 years of age and mainly of the severe phenotype, treated up to 12 months are listed below. 
20 bolesnika mlađih od 5 godina i uglavnom teškog fenotipa koji su liječeni najviše 12 mjeseci.
6MWT (meters) 
Šestominutni test hodanja (metri)
Severe IARs have been reported in patients with pre-existent severe underlying upper airway involvement and therefore specifically these patients should continue to be closely monitored and only be infused with Aldurazyme in an appropriate clinical setting where resuscitation equipment to manage medical emergencies would be readily available. 
Prijavljene su teške reakcije povezane s infuzijom kod bolesnika s postojećim teškim podležećim poremećajem gornjih dišnih puteva pa te bolesnike treba i dalje pomno nadzirati, a infuziju lijeka
STATEMENT OF ACTIVE SUBSTANCE(S) 1 ml contains 100 U of laronidase. 
1 ml sadrži 100 U laronidaze.
What Aldurazyme contains - The active substance is laronidase. 
- Djelatna tvar je laronidaza.
A clear to slightly opalescent, and colourless to pale yellow solution. 
Bistra do blago opalescentna te bezbojna do blijedožuta otopina.
MARKETING AUTHORISATION NUMBER(S) EU/1/03/253/001 1 Vial 
EU/1/03/253/001 1 bočica EU/1/03/253/002 10 bočica EU/1/03/253/003 25 bočica
MANUFACTURER RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer of the biological active substance BioMarin Pharmaceutical Inc, Galli Drive Facility, 46 Galli Drive, Novato, CA 94949, USA Name and address of the manufacturer responsible for batch release Genzyme Ltd., 37 Hollands Road, Haverhill, Suffolk CB9 8PU, United Kingdom Genzyme Ireland Ltd, IDA Industrial Park, Old Kilmeaden Road, Waterford, Ireland The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch. 
Genzyme Ltd., 37 Hollands Road, Haverhill, Suffolk CB9 8PU, Ujedinjeno Kraljevstvo Genzyme Ireland Ltd, IDA Industrial Park, Old Kilmeaden Road, Waterford, Irska
NAME OF THE MEDICINAL PRODUCT Aldurazyme 100 U/ml concentrate for solution for infusion 
Aldurazyme 100 U/ml koncentrat za otopinu za infuziju
Arthropathy, arthralgia, back pain, pain in extremity 
bol u leđima, bol u ekstremitetima mišićno-koštana bol
Тел. 
CHO).
Respiratory distress, dyspnoea, cough 
Poremećaji živčanog sustava glavobolja parestezija, omaglica
A few patients who had a prior history of severe MPS I related upper airway and pulmonary involvement, experienced severe reactions including bronchospasm (airway constriction), respiratory arrest, and swelling of the face. 
javile su se teške reakcije, uključujući bronhospazam (stezanje dišnih puteva), zastoj disanja i oticanje lica.
Intravenous use 
Način primjene
Elderly 
Aldurazyme.
Vistor hf. 
Primjena u venu.
Withdraw and discard a volume of the sodium chloride 9 mg/ml (0.9%) solution for infusion from the infusion bag equal to the total volume of Aldurazyme to be added. 
Iz infuzijske vrećice izvucite i bacite volumen 0,9% otopine natrijeva klorida za infuziju
Hypotension, pallor, peripheral coldness 
Krvožilni poremećaji crvenilo praćeno osjećajem užarenosti hipotenzija, bljedoća, periferna hladnoća
General disorders and administration site conditions pyrexia 
Opći poremećaji i reakcije na mjestu primjene pireksija vrlo često zimica vrlo često
This is done once and is called the ‘activation' process. 
To se radi samo jednom, a naziva se postupkom ‘aktivacije'.
This is used in exactly the same way. 
Ona se upotrebljava na posve isti način.
Thereafter, they progressively decreased during the following weeks. 
Nakon toga se njihova učestalost narednih tjedana progresivno smanjivala.
Using the wrong medicine could be harmful to your health. 
Uporaba pogrešnog lijeka može naškoditi Vašem zdravlju.
If it is orange, go to Section 2. 
Ako je narančaste boje, idite na dio 2.
Your dose has now been given. 
Sada ste primili svoju dozu.
Steps 1 to 5 below show you how to do this. 
Koraci 1 do 5 navedeni u nastavku prikazuju kako se to radi.
For your first injection go directly to Section 3 - Step C. 
Za prvu injekciju idite odmah na dio 3 - korak C.
The most important points are: 
Najvažnije su sljedeće:
Small air bubbles in the container are normal - they will not harm you. 
Mali mjehurići zraka u spremniku normalna su pojava - oni Vam neće naškoditi.
After first use: 14 days 
Nakon prve primjene: 14 dana
Printed on the inside: 
Otisnuto na unutarnjoj strani:
Both pens are used in the same way. 
Obje brizgalice upotrebljavaju se na isti način.
Section 1 - IMPORTANT INFORMATION 
Dio 1 - VAŽNE INFORMACIJE
Your dose will be correct and you can keep following the instructions. 
Doza koju ćete primijeniti je točna pa možete nastaviti slijediti upute.
Do not take two doses at the same time to make up for a forgotten injection. 
Nemojte primijeniti dvije doze u isto vrijeme kako biste nadoknadili zaboravljenu injekciju.
Do this even if there is some medicine left in the pen. 
Učinite to čak i ako je u brizgalici ostala mala količina lijeka.
What if there are air bubbles in the container? 
Što ako u spremniku ima mjehurića zraka?
Specific recommendations regarding intake of such medicinal products are given in section 4.5. 
Posebne preporuke o uzimanju takvih lijekova navedene su u dijelu 4.5.
Check the liquid. 
Pregledajte tekućinu.
There is no need to measure each dose. 
Nema potrebe za odmjeravanjem svake pojedine doze.
• a basal insulin, a type of insulin which works all day. 
• bazalni inzulin, vrsta inzulina koja djeluje cijeli dan.
A treatment initiation pack is also available for use during the first 28 days of treatment. 
Dostupno je i pakiranje za početak liječenja namijenjeno za uporabu tijekom prvih 28 dana liječenja.
The arrow will now be pointing towards the needle. 
Strelica je sada usmjerena prema igli.
Stop taking Lyxumia and contact a doctor immediately if you notice any of the following serious side effects: 
Prestanite uzimati lijek Lyxumia i odmah kontaktirajte liječnika ako primjetite neku od sljedećih ozbiljnih nuspojava:
• If you cannot follow all the instructions completely on your own, or are not able to handle the pen 
• Ako ne možete potpuno sami slijediti sve upute ili ne možete rukovati brizgalicom (primjerice,
Do not try to repair the pen. 
Nemojte pokušavati popraviti brizgalicu.
Insulin glulisine TID 
Insulin glulizin TID
In the example above, the dose number shows there are 13 injections left. 
U gornjem primjeru broj doze pokazuje da je preostalo još 13 injekcija.
The majority of reactions were mild in intensity and usually did not result in discontinuation of the treatment. 
Većina reakcija bila je blagog intenziteta i obično nije rezultirala prekidom liječenja.
Similar HbA1c decreases were observed regardless of which meal was the main meal (breakfast, lunch or dinner). 
Zabilježeno je slično smanjenje vrijednosti HbA1c neovisno o tome koji je obrok bio glavni obrok (doručak, ručak ili večera).
• Before injecting a dose - before injecting you must first remove excess liquid from your new pen. 
• Prije injiciranja doze - prije injiciranja morate prvo izbaciti višak tekućine iz nove brizgalice.
You must first use all 14 doses from this pen. 
Morate primijeniti svih 14 doza iz te brizgalice.
(-2.593 to -1.396)* 
(-2,593 do -1,396)*
Attach a new needle and repeat Steps D and E only. 
Pričvrstite novu iglu i ponovite samo korake D i E.
The pen can be used for 14 days when stored at a temperature below 30°C. 
Brizgalica se može upotrebljavati 14 dana ako se čuva na temperaturi ispod 30°C.
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). 
Učestalost nuspojava definirana je kao: vrlo često: ≥ 1/10, često: ≥ 1/100 i < 1/10, manje često: ≥ 1/1000 i < 1/100, rijetko: ≥ 1/10 000 i < 1/1000, vrlo rijetko: < 1/10 000).
You should seek immediate medical attention if you experience symptoms like swelling of the face, tongue or throat which causes difficulty with breathing. 
Odmah zatražite liječničku pomoć ako primijetite simptome poput oticanja lica, jezika ili grla koji uzrokuju teškoće pri disanju.
It is an injectable medicine used to help your body to control your blood sugar level when it is too high. 
To je lijek u obliku injekcije koji se koristi kako bi pomogao Vašem tijelu kontrolirati razinu šećera u krvi kada je ona previsoka.
Before first use Store in a refrigerator. 
Prije prve uporabe Čuvati u hladnjaku.
Coronary revascularization 368 (12.1%) 356 (11.7%) procedure 
Postupak koronarne 368 (12,1%) 356 (11,7%) revaskularizacije
10 microgram ___ / ___ / ___ ___ / ___ / ___ 20 microgram ___ / ___ / ___ ___ / ___ / ___ 
20 mikrograma ___ / ___ / ___
• Flu (influenza) 
• gripa (influenca)
The pen is activated and ready for injections. 
Brizgalica je aktivirana i spremna za injiciranje.
Section 2 - GETTING STARTED 
Dio 2 - POČETNA PRIPREMA
Your doctor will tell you what to do if you get a low blood sugar. 
Liječnik će Vam reći što morate napraviti ako Vam se spusti razina šećera u krvi.
If you use more Lyxumia than you should, talk to your doctor immediately. 
Ako primijenite više lijeka Lyxumia nego što ste trebali, odmah se obratite svom liječniku.
Lixisenatide has a moderate level of binding (55%) to human proteins. 
Liksisenetid ima umjerenu razinu vezivanja (55%) za ljudske proteine.
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. 
Upozoravajući znakovi niske razine šećera u krvi mogu uključivati hladan znoj, hladnu blijedu kožu, glavobolju, omamljenost, slabost, omaglicu, smetenost ili razdražljivost, glad, ubrzane otkucaje srca i osjećaj treme.
The safety and efficacy of lixisenatide in children and adolescents less than 18 years of age have not yet been established. 
Sigurnost primjene i djelotvornost liksisenatida u djece i adolescenata u dobi do 18 godina nisu još ustanovljeni.
It is used in adults with type 2 diabetes. 
Koristi se u odraslih osoba sa šećernom bolešću tipa 2.
What Lyxumia is and what it is used for 
Što je Lyxumia i za što se koristi
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 važne informacije o uporabi napunjenih brizgalica Dodatne informacije o uporabi brizgalica navode se u "Uputama za uporabu".
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 01 February 2013 
Datum prvog odobrenja: 01 veljače 2013.
In the table, write the date when you activated your pen and the date to throw it away 14 days later. 
U tablicu upišite datum kada ste aktivirali brizgalicu i datum kada je morate baciti 14 dana kasnije.
It is not known if Lyxumia may harm your unborn child. 
Nije poznato može li Lyxumia naškoditi nerođenom djetetu.
Tell your doctor, pharmacist or nurse if you are using, have recently used or might use any other medicines. 
Obavijestite svog liječnika, ljekarnika ili medicinsku sestru ako uzimate, nedavno ste uzimali ili biste mogli uzeti bilo koje druge lijekove.
Follow all steps in Section 
Slijedite sve korake navedene u dijelu 2.
Check the number of doses in the pen. 
Provjerite broj doza u brizgalici.
Non-clinical data reveal no special hazards for humans based on conventional studies of safety pharmacology and toxicology. 
Neklinički podaci ne upućuju na posebnu opasnost za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije i toksikologije.
• Always use the pen as described in the “Instructions for Use”. 
• Uvijek rukujte brizgalicom kako je opisano u "Uputama za uporabu".
Remove the needle from the pen, attach a new one and repeat Steps 4 and 5 only. 
Uklonite iglu s brizgalice, pričvrstite novu iglu i ponovite samo korake 4 i 5.
Pen ready for injections (white window) 
Brizgalica spremna za injiciranje (bijeli prozorčić)
If you have injected yourself before activating the pen, do not correct this by giving yourself a second injection. 
Ako ste si injicirali lijek prije aktivacije brizgalice, nemojte to pokušati ispraviti dajući si drugu injekciju.
It is important to avoid dehydration by drinking plenty of fluids, especially when starting treatment with Lyxumia 
Važno je spriječiti dehidraciju pijenjem veće količine tekućine, osobito na početku liječenja lijekom Lyxumia
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). 
Ako imate bilo kakvih pitanja o lijeku Lyxumia ili o šećernoj bolesti, obratite se svom liječniku, ljekarniku ili medicinskoj sestri, ili nazovite lokalnog predstavnika tvrtke sanofi-aventis, čiji je broj naveden u "Uputi o lijeku: Informaciji za korisnika" (priložena zasebno u kutiji).
Step 5 The pen is now activated 
Korak 5 Brizgalica je sada aktivirana
An increased incidence of gastrointestinal disorders was observed. 
Primijećena je povišena incidencija gastrointestinalnih poremećaja.
Severe gastrointestinal disease 
Teška gastrointestinalana bolest
If a patient wishes to become pregnant, or pregnancy occurs, treatment with Lyxumia should be discontinued. 
Ako bolesnica želi zatrudnjeti ili zatrudni, treba prekinuti liječenje lijekom Lyxumia.
Check the label on your pen to make sure you have the correct medicine. 
Provjerite naljepnicu na brizgalici kako biste bili sigurni da imate pravi lijek.
Other medicines and Lyxumia 
Drugi lijekovi i Lyxumia
Section 3 - DAILY USE OF PEN Only follow this section when the activation window is white. 
Dio 3 - SVAKODNEVNA UPORABA BRIZGALICE Slijedite upute iz ovoga dijela samo ako je prozorčić za aktivaciju bijele boje.
The tmax of ramipril and ramiprilat were delayed by approximately 2.5 hours. 
Postizanje tmax ramiprila i ramiprilata odgodilo se za približno 2,5 sata.
During use of the pen 
Za vrijeme uporabe brizgalice
• If another person is giving the injection, they should take care not to injure anyone accidentally with the needle. 
• Ako Vam injekciju daje netko drugi, mora pripaziti da nekoga slučajno ne ozlijedi iglom.
They were mostly mild and transient and occurred during the first 3 weeks after starting treatment. 
Navedene nuspojave uglavnom su bile blage i prolazne, a javljale su se tijekom prva 3 tjedna nakon početka liječenja.
• Protect your Lyxumia pens from dust and dirt. 
• Zaštitite Lyxumia brizgalice od prašine i prljavštine.
• Allow your pen to warm at room temperature before using. 
• Dopustite da se prije uporabe brizgalica ugrije na sobnu temperaturu.
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. 
Nema iskustva s primjenom lijeka Lyxumia u djece i adolescenata mlađih od 18 godina i stoga se primjena lijeka Lyxumia ne preporučuje u ovoj dobnoj skupini.
(-0.170 to 0.064) 
(-0,170 do 0,064)
Once you have thrown away the green pen continue to Section 4 to begin using the purple pen. 
Nakon što bacite zelenu brizgalicu, idite na dio 4 da biste počeli upotrebljavati ljubičastu brizgalicu.
Throw away a pen 14 days after activation. 
Brizgalicu bacite 14 dana nakon aktivacije.
• Keep your Lyxumia pens in a safe place out of the reach and sight of children. 
• Čuvajte Lyxumia brizgalice na sigurnom mjestu izvan dohvata i pogleda djece.
What if it is hard to press the injection button all the way in? 
Što ako je teško pritisnuti dugme za injiciranje do kraja?
This effect on HbA1c was sustained in long term studies for up to 76 weeks. 
Takav se učinak na HbA1c u dugotrajnim ispitivanjima održao do 76. tjedna.
If you use more Lyxumia than you should 
Ako primijenite više lijeka Lyxumia nego što ste trebali
An attached needle might lead to contamination and possible intake of air which might impact the dose accuracy. 
Pričvršćena igla mogla bi dovesti do onečišćenja i ulaska zraka, što bi moglo utjecati na preciznost doze.
(-2.257 to -1.062) 
(-2,257 do -1,062)
The body weight reduction is independent from the occurrence of nausea and vomiting. 
Smanjenje tjelesne težine neovisno je o pojavi mučnine i povraćanja.
What if I forget to activate the Lyxumia pen or inject myself before activation? 
Što ako zaboravim aktivirati Lyxumia brizgalicu ili ako si injiciram lijek prije aktivacije?
The level of HbA1c reduction was comparable between groups (table 5). 
Vrijednosti smanjenja HbA1c bile su usporedive između skupina (tablica 5).
If no liquid comes out see the “Questions and answers” section. 
Ako iz brizgalice ne izađe tekućina, pročitajte dio "Pitanja i odgovori".
Keep the outer needle cap - you will need it to remove the needle later. 
Sačuvajte vanjski zatvarač igle - kasnije ćete ga trebati za uklanjanje igle.
No treatment-related effect was demonstrated. 
Nisu opaženi učinci povezani s liječenjem.
Lixisenatide is a selective GLP-1 receptor agonist. 
Liksisenatid je selektivni agonist GLP-1 receptora.
HR [95% CI] 
OH [95% IP]
(0.095 to 0.328) 
(0,095 do 0,328)
It should be clear and colourless and with no particles. 
Mora biti bistra i bezbojna i ne smije sadržavati čestice.
• Do not repeat the activation process or you will not obtain 14 doses from your Lyxumia pen. 
• Nemojte ponavljati postupak aktivacije jer u protivnom nećete moći primijeniti 14 doza iz Lyxumia brizgalice.
Paracetamol was used as a model medicinal product to evaluate the effect of lixisenatide on gastric emptying. 
Paracetamol je korišten kao model lijeka za ocjenu učinka liksisenatida na pražnjenje želuca.
Clinical studies with Lyxumia indicate improved beta-cell function as measured by the homeostasis model assessment for beta-cell function (HOMA-β). 
Klinička ispitivanja lijeka Lyxumia upućuju na poboljšanje funkcije beta stanica mjerene procjenom modela homeostaze za funkciju beta-stanica (HOMA-β).
This medicinal product contains metacresol, which may cause allergic reactions. 
Ovaj lijek sadrži metakrezol, koji može uzrokovati alergijske reakcije.
This could possibly pass on infection. 
Na taj bi se način mogla prenijeti infekcija.
This may make it difficult to concentrate and you may feel dizzy or sleepy. 
To može izazvati teškoće u koncentraciji te prouzročiti osjećaj omaglice ili pospanosti.
Lyxumia should not be used if it has been frozen. 
Lyxumia se ne smije upotrijebiti ako je bila zamrznuta.
Body weight reduction was sustained in long term studies up to 76 weeks. 
Smanjenje tjelesne težine u dugotrajnim se ispitivanjima održalo do 76. tjedna.
The apparent volume of distribution after subcutaneous administration of lixisenatide (Vz/F) is approximately 100 L. 
Prividan volumen distribucije nakon supkutane primjene liksisenatida (Vz/F) iznosi približno 100 l.
Populations not studied Lixisenatide has not been studied in combination with dipeptidyl peptidase 4 (DPP-4) inhibitors. 
Populacije u kojima lijek nije ispitivan Liksisenatid nije ispitivan u kombinaciji s inhibitorima dipeptil-peptidaze 4 (DPP-4).
• Only use needles that are compatible for use with Lyxumia pen (see “Instructions for Use”). 
• Koristite samo igle koje su odgovarajuće za primjenu s Lyxumia brizgalicom (vidjeti "Upute za uporabu").
- you are taking other medicines, as there are other medicines such as antibiotics or stomach resistant tablets or capsules that should not stay too long in your stomach (see section Other medicines and Lyxumia) 
- uzimate druge lijekove, jer postoje neki lijekovi, poput antibiotika ili želučanootpornih tableta ili kapsula, koji se ne smiju predugo zadržavati u želucu (vidjeti dio Drugi lijekovi i Lyxumia)
The use of insulin is recommended instead. 
Umjesto toga se preporučuje primjena inzulina.
• Always check the label to ensure you have the correct Lyxumia pen. 
• Uvijek provjerite naljepnicu kako biste bili sigurni da imate pravu Lyxumia brizgalicu.
Each dose contains 540 micrograms of metacresol. 
Jedna doza sadrži 540 mikrograma metakrezola.