FrancophonIA/ELRC3.0 huggingface dataset:
English: Follow closely the instructions for dose, monitoring (blood and urine tests), diet and physical activity (physical work and exercise) and injection technique, as discussed with your doctor.
Croatian: Pažljivo slijedite upute o doziranju, kontroli (pretrage krvi i mokraće), prehrani i tjelesnoj aktivnosti (fizički rad i tjelovježba) te tehnici injiciranja, o kojima ste razgovarali sa svojim liječnikom.
English: Severe allergic reactions may become life-threatening.
Croatian: Teške alergijske reakcije mogu postati opasne po život.
English: It is essential for patients with pre-existing or gestational diabetes to maintain good metabolic control throughout pregnancy to prevent adverse outcomes associated with hyperglycaemia.
Croatian: Neophodno je da bolesnice s postojećim ili gestacijskim dijabetesom održavaju dobru metaboličku kontrolu tijekom trudnoće, kako bi se spriječili štetni ishodi povezani s hiperglikemijom.
English: B Keep the needle straight and screw it onto the pen until fixed.
Croatian: B Držeći iglu ravno, navijte je na brizgalicu dok ne bude čvrsto pričvršćena.
English: You should test your blood sugar straight away after taking glucose to check that you really have hypoglycaemia.
Croatian: Izmjerite razinu šećera u krvi odmah nakon uzimanja glukoze kako biste provjerite imate li zaista hipoglikemiju.
English: The cumulative review of cutaneous amyloidosis included 29 cases of which 15 were well documented cases in which the event was confirmed with histopathology.
Croatian: Pregled kumulativnih podataka o kožnoj amiloidozi uključio je 29 slučajeva, uključujući 15 dobro dokumentiranih slučajeva u kojima je događaj potvrđen histopatološki.
English: • You are recovering from an illness or from fever.
Croatian: • oporavljate se od bolesti ili vrućice
English: Since Toujeo is a clear solution, it does not require resuspension before use.
Croatian: Budući da je Toujeo bistra otopina, nije ga potrebno resuspendirati prije uporabe.
English: Hypoglycaemia can be very serious and is very common with insulin treatment (may affect more than 1 in 10 people).
Croatian: Hipoglikemija može biti vrlo ozbiljna i vrlo je česta kod liječenja inzulinom (može se javiti u više od 1 na 10 osoba).
English: Fertility Animal studies do not indicate direct harmful effects with respect to fertility.
Croatian: Plodnost Ispitivanja na životinjama ne ukazuju na izravne štetne učinke na plodnost.
English: If you have poor eyesight, please see section 3.
Croatian: Ako ste slabovidni, pogledajte dio 3.
English: • For all injections, if no insulin comes out, the needle may be blocked.
Croatian: • Za sve injekcije, ako inzulin ne izlazi, igla je možda začepljena.
English: If you have any questions about your pen or about diabetes, ask your doctor, pharmacist or nurse or call sanofi-aventis number on the front of this leaflet.
Croatian: Ako imate bilo kakvih pitanja o svojoj brizgalici ili šećernoj bolesti, obratite se svom liječniku, ljekarniku ili medicinskoj sestri ili nazovite sanofi-aventis na broj naveden na prednjoj strani ove Upute.
English: Tabulated list of adverse reactions The following related adverse reactions from clinical investigations are listed below by system organ class and in order of decreasing incidence (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; not known: cannot be estimated from the available data).
Croatian: Sljedeće nuspojave povezane s primjenom lijeka zabilježene u kliničkim ispitivanjima prikazane su prema klasifikaciji organskih sustava i u padajućem nizu prema učestalosti (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; nepoznato: ne može se procijeniti na temelju dostupnih podataka).
English: • Only use your pen for up to 6 weeks after its first use.
Croatian: • Brizgalica se smije koristiti najviše 6 tjedana nakon prve uporabe.
English: This leaflet was last revised in Other source of information
Croatian: Ova uputa je zadnji puta revidirana u
English: • Always check the number in the dose window to make sure you dialled the correct dose
Croatian: • Uvijek provjerite broj u prozorčiću za prikaz doze kako biste bili sigurni da je doza ispravna.
English: • Do not inject a double dose to make up for a forgotten dose.
Croatian: • Nemojte injicirati dvostruku dozu da biste nadoknadili zaboravljenu dozu.
English: If you inject insulin too often at the same place, the skin may either shrink (lipoatrophy, may affect up to 1 in 100 people) or thicken (lipohypertrophy, may affect up to 1 in 10 people).
Croatian: Ako injicirate inzulin prečesto na istome mjestu, koža se na tom mjestu može stanjiti (lipoatrofija, može se javiti u do 1 na 100 osoba) ili zadebljati (lipohipertrofija, može se javiti u do 1 na 10 osoba).
English: Patients who forget a dose, should be advised to check their blood sugar and then resume their usual once-daily dosing schedule.
Croatian: Bolesnicima koji zaborave primijeniti dozu treba savjetovati da provjere razinu šećera u krvi, a zatim nastave s primjenom jedanput na dan prema uobičajenom rasporedu.
English: This is to avoid dosing errors and potential overdose which may lead to low blood sugar.
Croatian: Time se izbjegavaju pogreške u doziranju i moguće predoziranje koji mogu dovesti do niske razine šećera u krvi.
English: * Insulin glargine is produced by recombinant DNA technology in Escherichia coli.
Croatian: *Inzulin glargin proizveden je tehnologijom rekombinantne DNK na bakteriji Escherichia coli.
English: Changes in strength, brand (manufacturer), type (regular, NPH, lente, longacting, etc.), origin (animal, human, human insulin analogue) and/or method of manufacture may result in the need for a change in dose (see section 4.2).
Croatian: Promjene u jačini, nazivu (proizvođač), vrsti (obični, NPH, lente, dugodjelujući itd.), podrijetlu (životinjski, ljudski, analog ljudskog inzulina) i/ili načinu proizvodnje mogu dovesti do potrebe za promjenom doze (vidjeti dio 4.2)
English: Stomach
Croatian: trbuh
English: The insulin may not work very well.
Croatian: Može se dogoditi da inzulin ne djeluje dovoljno dobro.
English: Odd numbers are shown as a line between even numbers:
Croatian: Neparni su brojevi prikazani kao linija između parnih brojeva:
English: Switching from the 300 units/ml to the 100 units/ml concentration results in an increased risk of hypoglycaemic events, mainly in the first week after the switch.
Croatian: Prijelaz s koncentracije od 300 jedinica/ml na 100 jedinica/ml dovodi do povećanog rizika od hipoglikemijskih događaja, većinom u prvom tjednu nakon prijelaza.
English: The switch from one insulin therapy to another requires medical prescription, medical supervision and blood glucose monitoring.
Croatian: Prijelaz s jedne inzulinske terapije na drugu zahtijeva liječnički recept, liječnički nadzor i kontrolu razine glukoze u krvi.
English: Your doctor may tell you to use it with a short-acting insulin, or with other medicines for high blood sugar.
Croatian: Liječnik će Vam možda reći da ga uzimate u kombinaciji s kratkodjelujućim inzulinom ili drugim lijekovima za liječenje visoke razine šećera u krvi.
English: Physiological concentrations of endogenous IGF-1 may activate the mitogenic-proliferative pathway; however, the therapeutic concentrations found in insulin therapy,
Croatian: Fiziološke koncentracije endogenog IGF-1 proteina mogu aktivirati mitogeno-proliferativni put; međutim, terapijske koncentracije koje se postižu pri liječenju inzulinom,
English: • Change the place within the area you inject each day.
Croatian: • Svakodnevno mijenjajte mjesto u koje injicirate lijek.
English: • This pen is not recommended for use by people who are blind or have visual impairments without the assistance of a person trained in the proper use of the product.
Croatian: • Brizgalica nije preporučena za upotrebu u ljudi koji su slijepi ili imaju poremećaj vida bez pomoći osobe obučene za ispravno korištenje lijeka.
English: It can even hide or stop the first signs that your blood sugar is too low.
Croatian: Mogu čak i prikriti ili spriječiti prve znakove koji ukazuju na prenisku razinu šećera u krvi.
English: • You have had diabetes for a long time.
Croatian: • ako već dugo bolujete od šećerne bolesti
English: If you use more Toujeo than you should
Croatian: Ako primijenite više lijeka Toujeo nego što ste trebali
English: Together with the available evidence from literature and text books, this signal contains sufficient evidence to establish an association between insulin glargine and cutaneous amyloidosis.
Croatian: U kombinaciji s dostupnim dokazima iz literature i udžbenika, postoji dovoljno dokaza za taj signal da se utvrdi povezanost između inzulina glargina i kožne amiloidoze.
English: In such cases, you may develop severe hypoglycaemia (and even pass out) before you know what is happening.
Croatian: U takvim se slučajevima može razviti teška hipoglikemija (možete se čak i onesvijestiti) prije nego što uopće postanete svjesni što se događa.
English: Type 2 diabetic patients (n=194) received Toujeo once daily in the evening, either at the same time of the day (fixed time of administration) or within 3 hours before or after the usual time of administration (flexible dosing time).
Croatian: Bolesnici sa šećernom bolešću tipa 2 (n=194) primali su Toujeo jedanput na dan (navečer), svaki dan u isto vrijeme (fiksno vrijeme primjene) ili unutar 3 sata prije ili nakon uobičajena vremena primjene (fleksibilno vrijeme doziranja).
English: If you find it hard to press the injection button in, do not force it as this may break your pen.
Croatian: Ako Vam je teško pritisnuti dugme za injiciranje, nemojte ga pritiskati na silu jer biste mogli slomiti brizgalicu.
English: Taking into account the PRAC Assessment Report on the PSUR(s) for insulin glargine, the scientific conclusions of CHMP are as follows:
Croatian: Uzimajući u obzir PRAC-ovo izvješće o ocjeni periodičkog(ih) izvješća o neškodljivosti lijeka (PSUR) za inzulin glargin, znanstveni zaključci CHMP-a su sljedeći:
English: Always carry a spare pen and spare needles in case they get lost or stop working.
Croatian: Uvijek sa sobom nosite rezervnu brizgalicu i rezervne igle za slučaj da one u uporabi izgubite ili da prestanu raditi.
English: If you have an eye disorder related to diabetes called “proliferative retinopathy”, very low blood sugar attack may cause temporary loss of vision.
Croatian: Ako imate poremećaj oka povezan sa šećernom bolešću, koji se naziva 'proliferativna retinopatija', epizode vrlo niske razine šećera u krvi mogu uzrokovati privremen gubitak vida.
English: • If you do not follow all of these instructions, you may get too much or too little insulin.
Croatian: • Ako ne budete slijedili sve ove upute, možete primijeniti previše ili premalo inzulina.
English: Toujeo is not the insulin of choice for the treatment of diabetic ketoacidosis.
Croatian: Toujeo nije inzulin izbora za liječenje dijabetičke ketoacidoze.
English: The educational material for patient/carer guide (patient brochure) shall contain the following key elements:
Croatian: Edukacijski materijal za bolesnika/skrbnika (Vodič za bolesnika) sadržavat će sljedeće ključne elemente:
English: Please refer to the prescribing information of the medicinal product to which the patient is switching.
Croatian: Pročitajte informacije o lijeku na koji bolesnik prelazi.
English: Some medicines can change your blood sugar level.
Croatian: Neki lijekovi mogu promijeniti razinu šećera u krvi.
English: Antibody development was sparse and had no clinical impact.
Croatian: Stvaranje protutijela bilo je rijetko i nije imalo klinički učinak.
English: If you do not perform the safety test before each injection, you may get too little insulin.
Croatian: Ako ne napravite test sigurnosti prije svakog injiciranja, možete si dati premalo inzulina.
English: Do not soak, wash or lubricate your pen - this may damage it.
Croatian: Brizgalicu ne smijete namakati, prati niti podmazivati - tako biste je mogli oštetiti.
English: The strength“300” is highlighted in honey gold on the label (see section 4.4).
Croatian: Jačina '300' istaknuta je na naljepnici bojom meda (vidjeti dio 4.4).
English: Patients should be informed not to inject a double dose to make up for a forgotten dose.
Croatian: Bolesnike treba upozoriti da ne smiju injicirati dvostruku dozu kako bi nadoknadili zaboravljenu dozu.
English: • In an insulin infusion pump.
Croatian: • inzulinskom infuzijskom pumpom
English: What Toujeo is and what it is used for
Croatian: Što je Toujeo i za što se koristi
English: This should be kept in mind if treatment with the combination of pioglitazone and Toujeo is considered.
Croatian: Ovo treba imati na umu ako se razmatra liječenje kombinacijom pioglitazona i lijeka Toujeo.
English: Toujeo must not be used in insulin infusion pumps.
Croatian: Toujeo se ne smije primjenjivati u inzulinskim infuzijskim pumpama.
English: Instruct patients to perform a safety test as described in Step 3 of the Instructions for Use.
Croatian: Uputite bolesnika kako napraviti test sigurnosti kao što je opisano u koraku 3 uputa za uporabu.
English: No safety issues were identified with Toujeo with respect to adverse events and standard safety parameters.
Croatian: Nisu utvrđeni sigurnosni problemi s lijekom Toujeo s obzirom na štetne događaje i standardne sigurnosne parametre.
English: This will reduce the risk of skin shrinking or thickening (for more information, see “Other side effects” in section 4).
Croatian: Na taj ćete način smanjiti rizik od stanjivanja ili zadebljanja kože (pogledajte odlomak 'Druge nuspojave' u dijelu 4. za više informacija).
English: Patients must visually verify the number of selected units on the dose counter of the pen.
Croatian: Bolesnici moraju vizualno provjeriti broj odabranih jedinica na prozorčiću za prikaz doze na brizgalici.
English: The half-life of Toujeo after subcutaneous injection is 18-19 hours independent of dose.
Croatian: Poluvijek lijeka Toujeo nakon supkutane injekcije iznosi 18-19 sati, neovisno o dozi.
English: In the following situations, the management of your diabetes may require extra care (for example, blood and urine tests):
Croatian: Liječenje šećerne bolesti može zahtijevati dodatnu pozornost (npr. pretrage krvi i mokraće) u sljedećim situacijama:
English: • How to arrange the supply of insulin, needles and other items.
Croatian: • kako organizirati zalihe inzulina, igala i drugog pribora
English: Diabetes mellitus is an illness where your body does not make enough insulin to control your blood sugar.
Croatian: Šećerna bolest je vrsta bolesti kod koje tijelo ne stvara dovoljno inzulina za kontrolu razine šećera u krvi.
English: • If you are blind or have poor eye sight, do not use the pre-filled pen without help.
Croatian: • ako ste slijepi ili slabovidni, nemojte koristiti napunjenu brizgalicu bez nečije pomoći.
English: Stomach pain, fast and deep breathing, feeling sleepy or passing out (becoming unconscious) may be signs of a serious condition (ketoacidosis) resulting from lack of insulin.
Croatian: Bol u trbuhu, brzo i duboko disanje, pospanost ili gubitak svijesti biti znakovi ozbiljnog stanja (ketoacidoze) koje nastaje zbog manjka inzulina.
English: You should check your blood sugar level more than usual.
Croatian: Provjeravajte razinu šećera u krvi češće nego inače.
English: • You have severe kidney or liver disease, or some other disease such as hypothyroidism.
Croatian: • ako bolujete od teške jetrene ili bubrežne bolesti ili neke druge bolesti kao što je hipotireoza
English: • Use Toujeo once a day, preferably at the same time every day.
Croatian: • Primijenite Toujeo jedanput na dan, po mogućnosti svaki dan u isto vrijeme.
English: • Do not use the pen if the insulin looks cloudy, coloured or contains particles.
Croatian: • Nemojte upotrijebiti brizgalicu ako inzulin izgleda mutno, ako je promijenio boju ili ako sadrži čestice.
English: The time of occurrence of hypoglycaemia depends on the action profile of the insulins used and may, therefore, change when the treatment regimen is changed.
Croatian: Vrijeme nastupa hipoglikemije ovisi o profilu djelovanja inzulina koji se primjenjuju te se stoga može promijeniti s promjenom režima liječenja.
English: Insulin inhibits lipolysis in the adipocyte, inhibits proteolysis and enhances protein synthesis.
Croatian: Inzulin inhibira lipolizu u adipocitima, inhibira proteolizu i pojačava sintezu proteina.
English: Pharmacokinetic profiles were consistent with the pharmacodynamic activity of Toujeo.
Croatian: Farmakokinetički profili bili su sukladni farmakodinamičkoj aktivnosti lijeka Toujeo.
English: As with all insulins, the time course of action of insulin glargine may be affected by physical activity and other variables.
Croatian: Kao i kod svih inzulina, na duljinu djelovanja inzulina glargina mogu utjecati tjelesna aktivnost i drugi faktori.
English: When the signs of hypoglycaemia may be less clear:
Croatian: Kada bi znakovi hipoglikemije mogli biti manje izraženi:
English: • You have not injected your insulin or not injected enough.
Croatian: • niste injicirali inzulin ili niste injicirali dovoljno inzulina
English: • Toujeo is injected under the skin (subcutaneous use or “SC”).
Croatian: • Toujeo se injicira pod kožu (supkutana ili 's.c.' primjena).
English: Having too low or too high blood sugar or sight problems can affect your ability to drive and use tools or machines.
Croatian: Preniska ili previsoka razina šećera u krvi ili tegobe s vidom mogu utjecati na sposobnost upravljanja vozilima i rada s alatima ili strojevima.
English: Toujeo with alcohol
Croatian: Toujeo s alkoholom
English: Toujeo is available in two pre-filled pens.
Croatian: Toujeo je dostupan u dvije napunjene brizgalice.
English: Always do a safety test before each injection - this is to:
Croatian: Prije svake injekcije uvijek napravite test sigurnosti - tako ćete:
English: - If you are allergic to insulin glargine or to any of the other ingredients of this medicine (listed in section 6).
Croatian: Nemojte primjenjivati Toujeo: - ako ste alergični na inzulin glargin ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.)
English: Insulin glargine is metabolised into 2 active metabolites M1 and M2 (see section 5.2).
Croatian: Inzulin glargin metabolizira se u 2 aktivna metabolita - M1 i M2 (vidjeti dio 5.2).
English: Toujeo must not be mixed or diluted with any other insulin or other medicinal products.
Croatian: Toujeo se ne smije miješati ni razrjeđivati ni s jednim drugim inzulinom niti drugim lijekovima.
English: If you have kidney or liver problems, talk to your doctor as you may need a lower dose.
Croatian: Ako imate bubrežnih ili jetrenih tegoba, razgovarajte sa svojim liječnikom jer će Vam možda biti potrebna niža doza.
English: including in Toujeo therapy, are considerably lower than the pharmacological concentrations required to activate the IGF-1 pathway.
Croatian: uključujući liječenje lijekom Toujeo, znatno su niže od farmakoloških koncentracija potrebnih za aktivaciju IGF-1 metaboličkog puta.
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:
English: Steady state level within the therapeutic range is reached after 3-4 days of daily Toujeo administration.
Croatian: Stanje dinamičke ravnoteže unutar terapijskog raspona postiže se nakon 3-4 dana svakodnevne primjene lijeka Toujeo.
English: The frequency, type and severity of adverse reactions in the paediatric population do not indicate differences to the experience in the general diabetes population (see section 5.1).
Croatian: Učestalost, tip i težina nuspojava kod pedijatrijske populacije ne ukazuju na razlike u odnosu na iskustvo s općom populacijom dijabetičara (vidjeti dio 5.1).
English: What Toujeo looks like and contents of the pack
Croatian: Kako Toujeo izgleda i sadržaj pakiranja
English: Patients in the Toujeo arm included 73 children aged <12 years and 160 children aged ≥12 years.
Croatian: Skupina bolesnika koja je primala lijek Toujeo uključivala je 73 djece mlađe od 12 godina te 160 djece u dobi od 12 godina ili starije.
English: you may get too much or too little insulin.
Croatian: Možete dobiti previše ili premalo inzulina.
English: If you have kidney or liver problems
Croatian: Ako imate bubrežnih ili jetrenih tegoba
English: These units are exclusive to Toujeo and are not the same as IU or the units used to express the potency of other insulin analogues (see section 5.1).
Croatian: Ove se jedinice odnose isključivo na Toujeo te nisu istovjetne internacionalnim jedinicama (IU) ni jedinicama koje se koriste za izražavanje jačine drugih inzulinskih analoga (vidjeti dio 5.1).
English: Paediatric population Population pharmacokinetic analysis was conducted for Toujeo based on concentration data of its main metabolite M1 using data from 75 pediatric subjects (6 to <18 years of age) with type 1 diabetes.
Croatian: Populacijska farmakokinetička analiza za lijek Toujeo provedena je na osnovi podataka o koncentraciji njegovog glavnog metabolita M1 koristeći podatke dobivene od 75 pedijatrijskih ispitanika (u dobi od 6 do ispod 18 godina) sa šećernom bolešću tipa
English: When needed, patients can administer Toujeo up to 3 hours before or after their usual time of administration (see section 5.1).
Croatian: Bolesnici po potrebi mogu primijeniti Toujeo do 3 sata prije ili nakon uobičajena vremena primjene (vidjeti dio 5.1).
English: Results from a study on progression of diabetic retinopathy
Croatian: Rezultati ispitivanja progresije dijabetičke retinopatije
English: In the elderly, progressive deterioration of renal function may lead to a steady decrease in insulin requirements (see section 4.8 and 5.1).
Croatian: U starijih osoba progresivno pogoršanje bubrežne funkcije može dovesti do postupnog i ravnomjernog smanjenja potrebe za inzulinom (vidjeti dijelove 4.8 i 5.1).
English: Patients who are blind or have poor vision should be instructed to get help/assistance from another person who has good vision and is trained in using the insulin device.
Croatian: Bolesnicima koji su slijepi ili slabovidni treba savjetovati da zatraže pomoć druge osobe koja dobro vidi i obučena je za uporabu pomagala za primjenu inzulina.
English: If you have injected too much of this medicine, your blood sugar level may become too low.
Croatian: Ako ste injicirali previše ovog lijeka, razina šećera u krvi može postati preniska.
English: • Your insulin has become less effective - for example because it was not stored properly.
Croatian: • djelotvornost inzulina je smanjena - npr. zbog nepravilna čuvanja
English: Pregnancy There is no clinical experience with use of Toujeo in pregnant women.
Croatian: Trudnoća Nema kliničkog iskustva s primjenom lijeka Toujeo u trudnica.
English: Such reactions to insulin (including insulin glargine) or the excipients may, for example, be associated with generalised skin reactions, angio-oedema, bronchospasm, hypotension and shock, and may be life-threatening.
Croatian: Takve reakcije na inzulin (uključujući inzulin glargin) ili pomoćne tvari mogu, primjerice, biti povezane s generaliziranim kožnim reakcijama, angioedemom, bronhospazmom, hipotenzijom i šokom te mogu ugroziti život.
English: • Perform a safety test as described in Step 3 of the Instructions for Use.
Croatian: • Napravite test sigurnosti kako je opisano u 3. KORAKU uputa za uporabu.
English: See also section 4.2 under “Method of administration”.
Croatian: Vidjeti i odlomak „Način primjene“ u dijelu 4.2.
English: • Keep your pen and needles out of the sight and reach of children
Croatian: • Čuvajte brizgalicu i igle izvan pogleda i dohvata djece.
English: • Talk to your doctor, pharmacist or nurse if you think you have problem with your pen.
Croatian: • obratite se svom liječniku, ljekarniku ili medicinskoj sestri ako mislite da postoji problem s brizgalicom