FrancophonIA/ELRC3.0 huggingface dataset:
English: Then push firmly on.
Croatian: Zatim čvrsto pritisnite.
English: • throw the pen away and use a new one.
Croatian: • bacite brizgalicu i upotrijebite novu.
English: Packs of 3, 5 and 10 pre-filled pens.
Croatian: Pakiranja od 3, 5 ili 10 napunjenih brizgalica.
English: Empty pens must never be reused and must be properly discarded.
Croatian: Prazne brizgalice se ne smiju nikada ponovno upotrijebiti i moraju se propisno zbrinuti.
English: • How to correctly store your medicine while travelling.
Croatian: • tome kako ispravno čuvati lijek za vrijeme putovanja
English: • You have a certain type of nerve damage (called “diabetic autonomic neuropathy”).
Croatian: • bolujete od određene vrste oštećenja živaca (zvane „dijabetička autonomna neuropatija“),
English: ** If a different basal insulin was used:
Croatian: ** Ako se koristio drugi bazalni inzulin:
English: (such as acetylsalicylic acid).
Croatian: (poput acetilsalicilatne kiseline)
English: If the pen is damaged, has not been stored correctly, if you are not sure that it is working properly or you notice that your blood sugar control is unexpectedly getting worse:
Croatian: Ako je brizgalica oštećena, nije ispravno čuvana, ako niste sigurni da li radi ispravno ili ako primijetite da Vam se regulacija šećera u krvi neočekivano pogoršava:
English: Then press all the way in and hold.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI
English: • During the switch to this type of combination medicine and in the weeks after the switch you should measure your blood sugar levels more frequently.
Croatian: • Tijekom prijelaza na ovu kombinaciju lijekova i u tjednima nakon prijelaza trebate češće mjeriti svoju razinu šećera u krvi.
English: Test your blood glucose levels after 10-15 minutes after taking sugar.
Croatian: Provjerite razinu glukoze u krvi 10-15 minuta nakon uzimanja šećera.
English: Use only in this pen.
Croatian: Koristiti samo u ovoj brizgalici.
English: Pharmacists should also check that patients have been trained on how to use the pen.
Croatian: Ljekarnici također trebaju provjeriti jesu li bolesnici obučeni kako se koristi brizgalica.
English: Learn to inject:
Croatian: Naučite injicirati:
English: Dispose of the needle safely after each use.
Croatian: Igle uklonite na siguran način nakon svake uporabe.
English: Do not over-tighten.
Croatian: Nemojte je previše zategnuti.
English: • You are recovering from an injury, operation or other stress.
Croatian: • Oporavljate se od ozljede, operacije ili nekog drugog stresa.
English: In such cases, you may develop severe hypoglycaemia (and even pass out) before you know what is happening.
Croatian: U takvim slučajevima može se razviti teška hipoglikemija (možete se čak i onesvijestiti) prije nego što postanete svjesni što se događa.
English: • Each pen contains more than 1 dose.
Croatian: Svaka brizgalica sadrži više od jedne doze.
English: Specific recommendations regarding intake of such medicinal products are given in section 4.5.
Croatian: Posebne preporuke o uzimanju takvih lijekova opisane su u dijelu 4.5.
English: • You have had diabetes for a long time.
Croatian: • dugo imate šećernu bolest
English: Discuss with your doctor which pen is suitable for your needs.
Croatian: Razgovarajte sa svojim liječnikom koja je brizgalica prikladna za Vaše potrebe.
English: • Check your blood sugar and then inject your next dose at the usual time.
Croatian: • Provjerite razinu šećera u krvi i nakon toga injicirajte sljedeću dozu u uobičajeno vrijeme.
English: • If your medicine is available in the country you are visiting.
Croatian: • tome da li je lijek dostupan u zemlji koju posjećujete
English: DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION Date of first authorisation: 11 January 2017
Croatian: Datum prvog odobrenja: 11. siječanj 2017.
English: The incidence of formation of antilixisenatide antibodies was approximately 43%.
Croatian: Incidencija stvaranja protutijela na liksisenatid bila je približno 43%.
English: • You are under stress - such as emotional distress or excitement.
Croatian: • ako ste pod stresom - kao što je emocionalna uznemirenost ili uzbuđenost.
English: • Change the place within the area you inject each day.
Croatian: • Svakodnevno mijenjate mjesto unutar područja u koje injicirate lijek.
English: Other medicines and Suliqua
Croatian: Drugi lijekovi i Suliqua
English: What Suliqua is and what it is used for
Croatian: Što je Suliqua i za što se koristi
English: These injections should be given even if it is not certain that you have hypoglycaemia.
Croatian: Te injekcije se trebaju primijeniti i onda kad nije sigurno da imate hipoglikemiju.
English: What other people should do if you have hypoglycaemia
Croatian: Što bi druge osobe trebale napraviti ako Vi imate hipoglikemiju
English: Industriepark Hochst 65926 Frankfurt am Main GERMANY
Croatian: Industriepark Hochst 65926 Frankfurt am Main Njemačka
English: If you do not follow all of these instructions, you may get too much or too little medicine.
Croatian: Ako ne budete slijedili sve ove upute, možete primijeniti previše ili premalo lijeka.
English: Units of medicine in your pen
Croatian: Jedinice lijeka u Vašoj brizgalici
English: • To prevent infection being passed from one person to another, pens should never be used for more than one person, even when the needle is changed
Croatian: • Kako bi se spriječio prijenos zaraze s jedne na drugu osobu, istu brizgalicu nikada ne smije koristiti više od jedne osobe, čak i kada se promijeni igla.
English: Turn your pen several times with your other hand to remove the needle.
Croatian: Okrenite svoju brizgalicu s drugom rukom nekoliko puta kako biste uklonili iglu.
English: • severe pain in your stomach area (abdomen) that will not go away.
Croatian: • jaku bol u području trbuha (abdomena) koja ne prolazi.
English: Please see the information regarding medicines that should not stay too long in your stomach in the section Other medicines and Suliqua.
Croatian: Molimo pogledajte informacije koje se odnose na lijekove koji se ne smiju predugo zadržavati u Vašem želucu u dijelu Drugi lijekovi i Suliqua.
English: It is preferable that the prandial injection is performed before the same meal every day, when the most convenient meal has been chosen.
Croatian: Poželjno je da se prandijalna injekcija primijeni prije istog obroka svaki dan, kad se odabere najprikladniji obrok.
English: • You do not eat enough, or eat food containing less carbohydrates than normal - artificial sweeteners are not carbohydrates.
Croatian: • Ne jedete dovoljno ili jedete hranu koja sadrži manje ugljikohidrata nego što je uobičajeno umjetni zaslađivači nisu ugljikohidrati).
English: Change the injection site with each injection to help prevent these changes.
Croatian: Promijenite mjesto injiciranja kod svake injekcije kako biste pomogli spriječiti takve promjene na koži.
English: When needed, Suliqua can be injected before the next meal.
Croatian: Ako je potrebno, lijek Suliqua se može injicirati prije sljedećeg obroka.
English: • If no medicine comes out after the third time, the needle may be blocked.
Croatian: Ako lijek ne izlazi niti nakon trećeg puta, igla je možda začepljena.
English: Do not stop using this medicine without talking to your doctor.
Croatian: Nemojte prestati primjenjivati ovaj lijek bez savjetovanja s liječnikom.
English: Follow closely your doctor's instructions for dose, monitoring (blood and urine tests), diet and physical activity (physical work and exercise) and injection technique.
Croatian: Pažljivo slijedite upute liječnika o dozi, kontroli (pretrage krvi i mokraće), prehrani i tjelesnoj aktivnosti (fizički rad i tjelovježba) i tehnici injiciranja.
English: D. Keep the injection button held in and when you see "0" in the dose window, slowly count to 10.
Croatian: Držite dugme za injiciranje pritisnutim i kada ugledate '0' na prozorčiću za prikaz doze, polako brojite do 10.
English: The therapeutic experience of Suliqua in patients ≥75 years of age is limited.
Croatian: Terapijsko iskustvo s lijekom Suliqua u bolesnika ≥75 godina je ograničeno.
English: The first warning signs of hypoglycaemia may change, be weaker or missing altogether if:
Croatian: Prvi znakovi koji upozoravaju na hipoglikemiju mogu se promijeniti, biti manje izraženi ili potpuno izostati ako:
English: Suliqua can be used in elderly patients.
Croatian: Suliqua se može primjenjivati u starijih bolesnika.
English: It is important to avoid dehydration by drinking plenty of fluids, especially during the first weeks of treatment with Suliqua.
Croatian: Vrlo je bitno izbjeći dehidraciju uzimanjem dovoljno tekućine, a posebice prilikom prvih tjedana liječenja lijekom Suliqua.
English: • Your medicine has become less effective - for example because it was not stored properly.
Croatian: • Vaš lijek je postao manje djelotvoran - primjerice zbog nepravilnog čuvanja.
English: B. Push the needle into your skin as shown by your healthcare provider.
Croatian: Ubodite iglu u kožu kako Vam je pokazao Vaš zdravstveni radnik.
English: STEP 5: Inject the dose
Croatian: KORAK 5: Injicirajte dozu
English: Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder: sanofi-aventis groupe
Croatian: Nositelj odobrenja za stavljanje lijeka u promet i proizvođač Nositelj odobrenja za stavljanje lijeka u promet: sanofi-aventis groupe
English: The educational materials are aimed at increasing awareness about the two available strengths of the product and at minimising the risk of medication errors including mix-ups between the different strengths of the product.
Croatian: Edukacijski materijali usmjereni su na povećanje svjesnosti o dvije dostupne različite jačine lijeka i na minimizaciju rizika od medikacijskih pogrešaka uključujući i zamjenu između dviju različitih jačina lijeka.
English: The Patient Guide shall contain the following key messages:
Croatian: Vodič za bolesnike mora sadržavati sljedeće ključne poruke:
English: • Your pen does not work properly.
Croatian: • Vaša brizgalica ne radi ispravno.
English: Severe hypoglycaemia**
Croatian: Teška hipoglikemija**
English: Patients should be instructed to always use a new needle.
Croatian: Bolesnike treba savjetovati da uvijek koriste novu iglu.
English: • Danazol, for endometriosis.
Croatian: • danazol, za liječenje endometrioze
English: The Healthcare Professional Guide shall contain the following key messages:
Croatian: Vodič za zdravstvene radnike mora sadržavati sljedeće ključne poruke:
English: Number of subjects (mITT)
Croatian: Broj ispitanika (mITT)
English: Suliqua has no or negligible influence on the ability to drive or use machines.
Croatian: Suliqua ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima ili rada sa strojevima.
English: Severe gastrointestinal disease
Croatian: Teška gastrointestinalna bolest
English: • Ask for help if you have problems handling the pen, for example if you have problems with your sight.
Croatian: • Zatražite pomoć ako imate poteškoća s rukovanjem brizgalicom, npr. ako imate problema s vidom.
English: The medicine may not work very well.
Croatian: Može se dogoditi da zbog toga lijek ne djeluje dobro.
English: If such medicinal products are to be administered with food, patients should be advised to, if possible, take them with a meal when lixisenatide is not administered.
Croatian: Ako se takvi lijekovi trebaju primijeniti uz hranu, bolesnike treba savjetovati da ih, ako je moguće, uzmu uz obrok uz koji ne primjenjuju liksisenatid.
English: Allergic reactions (urticaria) possibly related with Suliqua have been reported in 0.3% of patients.
Croatian: Alergijske reakcije (urtikarija) za koje postoji mogućnost da su povezane s lijekom Suliqua prijavljene su u 0,3% bolesnika.
English: Your thumb could block the dose selector from turning.
Croatian: Vaš palac bi mogao spriječiti okretanje izbornika doze.
English: 4.6 Fertility, pregnancy and lactation
Croatian: 4.6 Plodnost, trudnoća i dojenje/laktacija
English: Ask your doctor or pharmacist if you are not sure.
Croatian: Pitajte Vašeg liječnika ili ljekarnika ako niste sigurni.
English: • Your pen contains a total of 300 dose steps.
Croatian: Vaša brizgalica sadrži ukupno 300 odmjernih koraka.
English: If you have any questions about Suliqua, the pen or about diabetes, ask your doctor, pharmacist or nurse or call the local sanofi-aventis number given at the end of the Package Leaflet (see other side).
Croatian: Ukoliko imate bilo kakvih pitanja u vezi lijeka Suliqua, o brizgalici ili šećernoj bolesti, obratite se svom liječniku, ljekarniku ili medicinskoj sestri ili nazovite broj lokalnog sanofi-aventis predstavnika naveden na kraju upute o lijeku (pogledajte drugu stranu).
English: Studies with lixisenatide in animals have shown reproductive toxicity (see section 5.3).
Croatian: Ispitivanja liksisenatida na životinjama pokazala su reproduktivnu toksičnost (vidjeti dio 5.3).
English: You will require an injection of glucose or glucagon (a medicine which increases blood sugar).
Croatian: Trebat će Vam injekcija glukoze ili glukagona (lijeka koji povisuje razinu šećera u krvi).
English: • Contact your doctor straight away if you have severe hyperglycaemia or ketoacidosis.
Croatian: • Odmah se obratite svom liječniku ako imate tešku hiperglikemiju ili ketoacidozu.
English: 75008 Paris
Croatian: F - 75008 Paris
English: This can spread around the injection site.
Croatian: Ove reakcije se mogu proširiti i oko mjesta injiciranja.
English: Lixisenatide has a low level (55%) of binding to human proteins.
Croatian: Liksisenetid se u maloj mjeri veže (55%) za ljudske proteine.
English: It can even hide or stop the first signs that your blood sugar is too low.
Croatian: Mogu čak i prikriti ili sasvim spriječiti prve znakove koji ukazuju na prenisku razinu šećera u krvi.
English: • You are recovering from an illness or from fever.
Croatian: • Oporavljate se od bolesti ili vrućice.
English: • talk to your doctor, pharmacist or nurse if you think you have a problem with your pen.
Croatian: • obratite se svom liječniku, ljekarniku ili medicinskoj sestri ako mislite da postoji problem s Vašom brizgalicom.
English: So, before taking a medicine ask your doctor if it will affect your blood sugar and what action, if any, you need to take.
Croatian: Stoga, prije nego što uzmete neki lijek, pitajte svog liječnika hoće li on utjecati na razinu šećera u krvi i što trebate učiniti ako bude potrebno.
English: For single patient use only.
Croatian: Samo za jednog bolesnika.
English: When the signs of hypoglycaemia may be less clear:
Croatian: Kada znakovi hipoglikemije mogu biti manje izraženi:
English: Tell your doctor if you are taking warfarin or other anticoagulants (medicines used to prevent clotting of the blood) as you might need to have more frequent blood tests (called ‘International Normalised Ratio' or INR test) to check your blood clotting.
Croatian: Obavijestite svog liječnika ako uzimate varfarin ili druge antikoagulanse (lijekove koji se koriste za sprječavanje zgrušavanja krvi) jer ćete možda morati češće napraviti pretrage krvi (koje se zovu 'međunarodni normalizirani omjer' ili INR) kako bi provjerili zgrušavanje krvi.
English: [-2.246 to -1.682]
Croatian: [-2,246 do -1,682]
English: What Suliqua contains
Croatian: Što Suliqua sadrži
English: The slowing effect of gastric emptying was maintained at the end of the study.
Croatian: Učinak usporavanja pražnjenja želuca je bio održan na kraju ispitivanja.
English: Before you use insulin glargine/lixisenatide, be clear on how many dose steps you require.
Croatian: Prije primjene inzulina glargina/liksisenatida, budite sigurni u to koliko Vam je odmjernih koraka potrebno.
English: • Read all of these instructions before using your pen.
Croatian: • Pročitajte cjelovite upute prije nego što upotrijebite brizgalicu.
English: Based on your lifestyle, your blood sugar tests and your previous insulin use, your doctor will tell you:
Croatian: Na temelju Vašeg načina života, rezultata pretraga razine šećera u krvi te ranije uporabe inzulina, Vaš liječnik će:
English: Adjustments in dose of the medicinal product, meal patterns, or physical activity may be needed.
Croatian: Mogu biti potrebne prilagodbe doze lijeka, rasporeda obroka ili tjelesne aktivnosti.
English: • Do not select a dose or press the injection button without a needle attached.
Croatian: Nemojte odabrati dozu ili pritisnuti dugme za injiciranje bez pričvršćene igle.
English: • The Pharmacist should clarify with the prescriber any incomplete prescription.
Croatian: • Ljekarnik mora razjasniti s propisivačem svaki nepotpuni recept
English: • You miss meals or delay them.
Croatian: • Preskočili ste ili odgodili obrok.
English: • you have a severe stomach or gut problem such as a disease of the muscles of the stomach called “gastroparesis” which results in delayed stomach emptying.
Croatian: • imate teški problem sa želucem ili crijevima, poput bolesti mišića želuca koja se zove “gastropareza”, a ima za posljedicu odgođeno pražnjenje želuca.
English: This may damage your pen.
Croatian: To može oštetiti Vašu brizgalicu.
English: If you use more Suliqua than you should
Croatian: Ako primijenite više lijeka Suliqua nego što ste trebali
English: The mean diabetes duration was approximately 12 years and the mean duration of previous basal insulin treatment was approximately 3 years.
Croatian: Srednje trajanje šećerne bolesti bilo je približno 12 godina i srednje trajanje prethodnog liječenja bazalnim inzulinom bilo je približno 3 godine.
English: Some medicines can change your blood sugar level.
Croatian: Neki lijekovi mogu promijeniti razinu Vašeg šećera u krvi.
English: It must only be used if the solution is clear, colourless, with no solid particles visible, and if it is of water-like consistency.
Croatian: Smije se upotrijebiti samo ako je otopina bistra, bezbojna, ako nema vidljivih krutih čestica i ako je vodenaste konzistencije.
English: See also section 2 “What you need to know before you use Suliqua” for information on sodium and metacresol.
Croatian: Također vidjeti dio 2 'Što morate znati prije nego počnete primjenjivati lijek Suliqua' za informacije o natriju i metakrezolu.
English: After first use: use within 28 days First use on: / / /
Croatian: Nakon prve primjene: upotrijebiti unutar 28 dana Datum otvaranja: / / /
English: Warfarin or other anticoagulants
Croatian: Varfarin i drugi antikoagulansi
English: • Always carry a spare pen and spare needles in case they get lost or stop working.
Croatian: • Uvijek imajte sa sobom rezervnu brizgalicu i rezervne igle u slučaju da one u uporabi izgubite ili da ne rade ispravno.
English: (-3.89 to -2.77)
Croatian: (-3,89 do -2,77)
English: Suliqua is used to treat adults with type 2 diabetes, to help control blood sugar levels when they are too high.
Croatian: Suliqua se koristi za liječenje odraslih osoba sa šećernom bolešću tipa 2 kako bi pomogao u kontroli razine šećera u krvi kada je ona previsoka.
English: This may mean your Suliqua dose has to change.
Croatian: To može značiti da se doza lijeka Suliqua treba promijeniti.
English: The primary composite efficacy endpoint was the time to the first occurrence of any of the following events: Cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, or hospitalisation for unstable angina.
Croatian: Primarni kompozitni ishod djelotvornosti bilo je vrijeme do prve pojave bilo kojeg od sljedećih događaja: kardiovaskularna smrt, nefatalni infarkt miokarda, nefatalni moždani udar ili hospitalizacija zbog nestabilne angine.
English: Take about 15 to 20 grams sugar straight away - such as glucose, sugar cubes or a sugary drink.
Croatian: Odmah uzmite oko 15 do 20 g šećera, primjerice glukozu, kocke šećera ili napitak koji sadrži šećer.
English: If you find it difficult to recognise your warning signs, you should avoid situations (such as driving a car) in which you or others would be put at risk by hypoglycaemia.
Croatian: Ako teško prepoznajete upozoravajuće znakove, izbjegavajte situacije(primjerice vožnju automobila) u kojima zbog hipoglikemije možete sebe ili druge izložiti riziku.
English: • For total daily doses >60 dose steps/day, Suliqua must not be used.
Croatian: • Za ukupnu dnevnu dozu koja je >60 odmjernih koraka/dan, Suliqua se ne smije koristiti.
English: • Your blood sugar levels are almost normal or are unstable.
Croatian: • ako Vam je razina šećera u krvi gotovo normalna ili nije stabilna.
English: The cartridge should be inspected before use.
Croatian: Uložak treba pregledati prije uporabe.
English: The incidence of MACE was similar between LANTUS and standard care in ORIGIN [Hazard Ratio (95% CI) for MACE; 1.02 (0.94, 1.11)].
Croatian: Incidencija MACE-a bila je slična između LANTUSA i standardnog liječenja u ispitivanju ORIGIN [omjer hazarda (95% IP) za MACE; 1,02 (0,94, 1,11)].
English: Patients should be advised to take precautions to avoid hypoglycaemia while driving and using machines.
Croatian: Bolesnicima treba savjetovati da poduzmu mjere opreza kako bi izbjegli hipoglikemiju tijekom vožnje i rada sa strojevima.
English: This will reduce the risk of developing dents or lumps at the site (for more information, see “Other side effects” in section 4).
Croatian: To će smanjiti rizik od razvoja udubljenja ili kvržica na mjestu injiciranja (za više informacija pogledajte 'Druge nuspojave' u dijelu 4).
English: • How to arrange the supply of your medicine, needles and other items.
Croatian: • tome kako osigurati zalihu lijeka, igala i drugih predmeta
English: Speak to a doctor straight away if you are not able to control the hypoglycaemia, or it comes back again.
Croatian: Odmah se obratite liječniku ako niste u stanju kontrolirati hipoglikemiju ili ako se ona ponavlja.
English: To avoid medication errors, the prescriber must make sure that the correct strength and number of dose steps is stated in the prescription (see section 4.4).
Croatian: Kako bi se izbjegle medikacijske pogreške, propisivač mora biti siguran da je na receptu navedena točna jačina lijeka i broj odmjernih koraka (vidjeti dio 4.4).
English: You might then need to eat something (such as bread or pasta) that will raise your blood sugar over a longer time, especially if your next meal is not due.
Croatian: Zatim pojedite nešto (primjerice kruh ili tjesteninu) što će povisiti šećer u krvi na dulje vrijeme, posebno ako još nije vrijeme idućeg obroka.
English: Patients adjusting the amount or timing of dosing should only do so under medical supervision with appropriate glucose monitoring (see section 4.4).
Croatian: Bolesnici koji prilagođavaju količinu ili vrijeme doziranja smiju to raditi samo pod medicinskim nadzorom uz prikladno praćenje glukoze (vidjeti dio 4.4).
English: If pancreatitis is suspected, Suliqua should be discontinued; if acute pancreatitis is confirmed, lixisenatide should not be restarted.
Croatian: Posumnja li se na pankreatitis, primjenu lijeka Suliqua treba prekinuti; ako se akutni pankreatitis potvrdi, liječenje liksisenatidom ne smije se ponovno započinjati.
English: ** Severe symptomatic hypoglycaemia was an event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions.
Croatian: ** Teška simptomatska hipoglikemija bio je događaj koji je zahtijevao pomoć drugih osoba kako se primijenili ugljikohidrati, glukagon ili druge mjere oživljanja.
English: Excipient(s) with known effects: Each ml contains 2.7 milligrams of metacresol.
Croatian: Pomoćna(e) tvar(i) s poznatim učinkom: Jedan ml sadrži 2,7 miligrama metakrezola.
English: Preferably inject Suliqua before the same meal every day, when you have chosen the most convenient way.
Croatian: Poželjno je injicirati lijek Suliqua prije istog obroka svaki dan, nakon što ste odabrali najprikladniji način.
English: C. Place your thumb on the injection button.
Croatian: Postavite svoj palac na dugme za injiciranje.
English: Store below 25°C.
Croatian: Čuvati ispod 25°C.
English: If blood glucose levels are still too low (<4 mmol/L) or hypoglycaemia comes back take another 15 to 20 gram of sugar.
Croatian: Ako je razina glukoze u krvi i dalje preniska (<4 mmol/L) ili ako se hipoglikemija ponovno javi, opet uzmite 15 do 20 g šećera.