FrancophonIA/ELRC3.0 huggingface dataset:
English: The main study of Kymriah in B-cell ALL involved 92 children and young adults (3-25 years of age) whose cancer had come back after previous treatment or did not respond to treatment.
Croatian: U glavnom ispitivanju lijeka Kymriah sudjelovalo je 92 djece i odraslih (u dobi od tri do 25 godina) s akutnom limfoblastičnom leukemijom B-stanica u kojih se rak vratio nakon prethodnog liječenja ili nije reagirao na liječenje.
English: For the full list of side effects and restrictions with Kymriah, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja pri primjeni lijeka Kymriah potražite u uputi o lijeku.
English: (Invented)name Strength Pharmaceutical form
Croatian: Doza Farmaceutski oblik
English: The following graph shows the results from a study in patients:
Croatian: Sljedeći grafikon prikazuje rezultate ispitivanja na bolesnicima:
English: Elderly population (≥65 years old)
Croatian: Posebne populacije Stariji bolesnici (≥ 65 godina)
English: Be careful when you start or stop taking another medicine.
Croatian: Budite oprezni kada započinjete ili prestajete uzimati drugi lijek.
English: DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION
Croatian: DATUM PRVOG ODOBRENJA/DATUM OBNOVE ODOBRENJA
English: Your doctor will show you in which area of the skin you should inject Lantus.
Croatian: Liječnik će Vam pokazati u koje područje na koži trebate injicirati Lantus.
English: Do not stop Lantus without speaking to a doctor, who will tell you what needs to be done.
Croatian: Nemojte prestati primjenjivati Lantus bez savjetovanja s liječnikom koji će Vam reći što je potrebno napraviti.
English: Date of first use:……………
Croatian: EXP Datum prve uporabe:……………
English: The dose regimen (dose and timing) should be individually adjusted.
Croatian: Režim doziranja (doza i vrijeme) treba se individualno prilagoditi.
English: Date of first authorisation: 9 June 2000 Date of latest renewal: 17 February 2015
Croatian: Datum posljednje obnove: 17. veljače 2015.
English: Lantus with alcohol
Croatian: Lantus s alkoholom
English: Please, consult your doctor for further information.
Croatian: Obratite se svojem liječniku za dodatne informacije.
English: • Children below 2 years of age
Croatian: • Djeca mlađa od 2 godine
English: The safety and efficacy of Lantus have not been established.
Croatian: Sigurnost primjene i djelotvornost lijeka Lantus nisu ustanovljene.
English: To prevent the possible transmission of disease, never share your pen with anyone else.
Croatian: Kako bi se spriječio mogući prijenos bolesti, nikad nemojte dijeliti Vašu brizgalicu ni sa kim drugim.
English: Since Lantus is a solution, it does not require resuspension before use.
Croatian: Budući da je Lantus otopina, nije ga potrebno resuspendirati prije uporabe.
English: This medicinal product must not be mixed with other medicinal products.
Croatian: Ovaj lijek se ne smije miješati s drugim lijekovima.
English: You need one injection of Lantus every day, at the same time of the day.
Croatian: Potrebna Vam je jedna injekcija lijeka Lantus svakoga dana u isto vrijeme.
English: What Lantus is and what it is used for
Croatian: Što je Lantus i za što se koristi
English: To prevent the possible transmission of disease, each pen must be used by one patient only.
Croatian: Kako bi se spriječio mogući prijenos bolesti, svaku brizgalicu smije koristiti samo jedan bolesnik.
English: Generally, the greater and more rapid the decline in blood glucose, the more marked is the phenomenon of counter-regulation and its symptoms (see section 4.4).
Croatian: Općenito, što je veći i brži pad razine glukoze u krvi, to je izraženiji fenomen proturegulacije i njegovi simptomi (vidjeti dio 4.4).
English: Other medicines and Lantus
Croatian: Drugi lijekovi i Lantus
English: Low blood sugar means that there is not enough sugar in your blood.
Croatian: Niska razina šećera u krvi znači da nema dovoljno šećera u Vašoj krvi.
English: It should be considered whether it is advisable to drive or use machines in these circumstances.
Croatian: Treba razmotriti je li preporučljivo u takvim okolnostima upravljati vozilom ili raditi sa strojevima.
English: Activity profile in patients with type 1 diabetes
Croatian: Profil aktivnosti u bolesnika sa šećernom bolešću tipa 1
English: Lantus should be administered once daily at any time but at the same time each day.
Croatian: Lantus se primjenjuje jedanput na dan, u bilo koje vrijeme, ali svaki dan u isto doba dana.
English: However, only very rarely, this will require a change to your insulin dose.
Croatian: Ipak, samo vrlo rijetko, ovo će uvjetovati promjenu Vaše doze inzulina.
English: Tell a doctor straight away if you notice signs of severe allergic reactions.
Croatian: Odmah se javite liječniku ukoliko primjetite znakove teških alergijskih reakcija.
English: This is a modified insulin, very similar to human insulin.
Croatian: To je modificirani inzulin, vrlo sličan ljudskom inzulinu.
English: These measures will help protect the environment.
Croatian: Ove će mjere pomoći će u očuvanju okoliša.
English: This should be kept in mind if treatment with the combination of pioglitazone and Lantus is considered.
Croatian: Ovo treba imati na umu ako se razmatra liječenje kombinacijom pioglitazona i lijeka Lantus.
English: This may constitute a risk in situations where these abilities are of special importance (e.g. driving a car or using machines).
Croatian: To može predstavljati rizik u situacijama u kojima su takve sposobnosti posebno važne (primjerice, vožnja ili rad sa strojevima).
English: The recovery of hypoglycaemia may be delayed because Lantus has a long action.
Croatian: Oporavak od hipoglikemije može potrajati jer Lantus ima dugotrajno djelovanje.
English: A. Check that the dose window shows “0” following the safety test.
Croatian: Provjerite da prozorčić za prikaz odabrane doze pokazuje "0" nakon testa sigurnosti.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, toksičnosti ponovljenih doza, genotoksičnosti, kancerogenosti i reproduktivne toksičnosti.
English: If you use more Lantus than you should
Croatian: Ako primijenite više lijeka Lantus nego što ste trebali
English: What Lantus looks like and contents of the pack
Croatian: Kako Lantus izgleda i sadržaj pakiranja
English: Your doctor may tell you to use it in combination with a short-acting insulin or with tablets used to treat high blood sugar levels.
Croatian: Liječnik će Vam možda reći da ga uzimate u kombinaciji s kratkodjelujućim inzulinom ili s tabletama koje se koriste za liječenje visoke razine šećera u krvi.
English: Use this medicine exactly as your doctor has told you.
Croatian: Koristite ovaj lijek točno onako kako Vam je rekao liječnik.
English: Very rare
Croatian: Rijetko Vrlo rijetko
English: Important information about some of the ingredients of Lantus
Croatian: Važne informacije o nekim sastojcima lijeka Lantus
English: Do not shake or mix it before use.
Croatian: Nemojte je tresti niti miješati prije uporabe.
English: Change the injection site with each injection to help prevent these skin changes.
Croatian: Promjenite mjesto injiciranja kod svake injekcije kako biste pomogli u sprečavanju takvih promjena na koži.
English: Your blood sugar levels may either rise or fall if you drink alcohol.
Croatian: Razina šećera u krvi može se povisiti ili sniziti ako pijete alkohol.
English: You can set the dose in steps of 1 unit, from a minimum of 1 unit to a maximum of 80 units.
Croatian: Doza se može odabrati u koracima od 1 jedinice, od najmanje 1 jedinice do najviše 80 jedinica.
English: Keep this possible problem in mind in all situations where you might put yourself and others at risk (such as driving a car or using machines).
Croatian: Imajte to na umu u svim situacijama u kojima sebe i druge možete izložiti riziku (primjerice vožnja automobila ili upravljanje strojevima).
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 hyperglycemia.
Croatian: Vrlo je bitno da bolesnice s postojećim ili gestacijskim dijabetesom održavaju dobru metaboličku kontrolu tijekom trudnoće, kako bi se spriječili štetni ishodi povezani s hiperglikemijom.
English: Fertility Animal studies do not indicate direct harmful effects with respect to fertility.
Croatian: Istraživanja na životinjama ne ukazuju na izravne štetne učinke na plodnost.
English: Lantus is not the insulin of choice for the treatment of diabetic ketoacidosis.
Croatian: Lantus nije inzulin izbora za liječenje dijabetičke ketoacidoze.
English: -In your body
Croatian: -U tijelu
English: Patients with type 1 diabetes must continue to consume at least a small amount of carbohydrates on a regular basis, even if they are able to eat only little or no food, or are vomiting etc. and they must never omit insulin entirely.
Croatian: Bolesnici sa šećernom bolešću tipa 1 moraju nastaviti redovito uzimati barem male količine ugljikohidrata, čak i kad nisu u stanju jesti ili jedu vrlo malo, ili kad povraćaju i sl., a nikada ne smiju sasvim izostaviti inzulin.
English: What you need to know before you use Lantus
Croatian: Što morate znati prije nego počnete primjenjivati Lantus
English: Inform your doctor as soon as possible if you experience signs of heart failure such as unusual shortness of breath or rapid increase in weight or localised swelling (oedema).
Croatian: Čim prije obavijestite liječnika ako osjetite znakove srčanog zatajenja kao što je neuobičajen nedostatak zraka ili naglo povećanje tjelesne težine ili lokalizirano oticanje (edem).
English: Insulin glargine is metabolised into 2 active metabolites M1 and M2 (see section 5.2).
Croatian: Inzulin glargin se metabolizira u 2 aktivna metabolita M1 i M2 (vidjeti dio 5.2).
English: Inspect Lantus before use.
Croatian: Prije uporabe pregledajte Lantus.
English: - the possible effects of changing to different time zones, - possible new health risks in the countries to be visited, - what you should do in emergency situations when you feel unwell or become ill.
Croatian: - mogućim utjecajima promjene vremenskih zona, - mogućim novim rizicima po zdravlje u zemljama koje namjeravate posjetiti, - tome što trebate učiniti u hitnim slučajevima ako se ne osjećate dobro ili obolite.
English: In general, the safety profile for children and adolescents (≤18 years of age) is similar to the safety profile for adults.
Croatian: Općenito, profil sigurnosti primjene lijeka u djece i adolescenata (≤ 18 godina) sličan je profilu sigurnosti primjene u odraslih bolesnika.
English: A. Check the label on your SoloStar to make sure you have the correct insulin.
Croatian: Provjerite oznaku na Vašoj SoloStar brizgalici kako biste bili sigurni da imate ispravan inzulin.
English: - If you are allergic to insulin glargine or any of the other ingredients of this medicine (listed in section 6).
Croatian: Ako ste alergični na inzulin glargin ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: The use of Lantus may be considered during pregnancy, if clinically needed.
Croatian: Može se razmotriti primjena lijeka Lantus tijekom trudnoće, ako je to klinički opravdano.
English: Hypoglycaemia (low blood sugar) can be very serious and is very common with insulin treatment (may affect more than 1 in 10 people).
Croatian: Hipoglikemija (niska razina šećera u krvi) može biti vrlo ozbiljna i vrlo je česta uz liječenje inzulinom (može se javiti u više od 1 na 10 osoba).
English: Zinc chloride
Croatian: Cinkov klorid
English: - tell you when to check your blood sugar level, and whether you need to carry out urine tests, - tell you when you may need to inject a higher or lower dose of Lantus.
Croatian: - Vam reći kada trebate provjeravati razinu šećera u krvi i trebate li napraviti pretrage mokraće - Vam reći kada ćete možda trebati injicirati veću ili manju dozu lijeka Lantus.
English: You must use the pen as described in these Instructions for Use.
Croatian: Brizgalicu morate koristiti kao što je opisano u uputama za uporabu.
English: Talk to your doctor, pharmacist or nurse before using Lantus.
Croatian: Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego primijenite Lantus.
English: Do NOT inject Lantus in a vein, since this will change its action and may cause hypoglycaemia.
Croatian: Lantus se NE SMIJE injicirati u venu jer će to promijeniti njegovo djelovanje i može uzrokovati hipoglikemiju.
English: These units are exclusive to Lantus 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 Lantus te nisu istovjetne internacionalnim jedinicama (IU) ili jedinicama koje se koriste za izražavanje jačine drugih inzulinskih analoga (vidjeti dio 5.1).
English: During the first weeks the reduction should, at least partially, be compensated by an increase in mealtime insulin, after this period the regimen should be adjusted individually.
Croatian: U prvim tjednima liječenja to smanjenje mora se barem djelomično nadoknaditi povećanjem doze inzulina u vrijeme obroka, a nakon tog početnoga razdoblja doziranje je potrebno individualno prilagoditi.
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: Read all of this leaflet carefully including the Instructions for Use of Lantus SoloStar, pre-filled pen, before you start using this medicine because it contains important information for you.
Croatian: Pažljivo pročitajte cijelu uputu, uključujući upute za uporabu napunjene brizgalice Lantus SoloStar, prije nego počnete primjenjivati ovaj lijek jer sadrže Vama važne podatke.
English: Follow recommended safety measures for removal and disposal of needles (contact your doctor, pharmacist or nurse) in order to reduce the risk of accidental needle injury and transmission of infectious diseases.
Croatian: Slijedite preporučene mjere za sigurno skidanje i uklanjanje igala (obratite se svom liječniku, ljekarniku ili medicinskoj sestri) kako biste umanjili rizik od slučajnog uboda iglom i prijenosa zaraznih bolesti.
English: C. Check the appearance of your insulin.
Croatian: C. Provjerite izgled inzulina.
English: Transferring a patient to another type or brand of insulin should be done under strict medical supervision.
Croatian: Prebacivanje bolesnika na drugu vrstu inzulina ili inzulin drugog proizvođača treba provesti pod strogim medicinskim nadzorom.
English: Changes in strength, brand (manufacturer), type (regular, NPH, lente, long-acting, etc.), origin (animal, human, human insulin analogue) and/or method of manufacture may result in the need for a change in dose.
Croatian: Promjene u jačini, nazivu inzulina (proizvođač), vrsti (obični, NPH, lente, dugodjelujući itd.), podrijetlu (životinjski, ljudski, analog ljudskog inzulina) i/ili načinu proizvodnje mogu rezultirati potrebom promjene doziranja.
English: Stomach pain, fast and deep breathing, sleepiness or even loss of consciousness may be signs of a serious condition (ketoacidosis) resulting from lack of insulin.
Croatian: Bol u trbuhu, brzo i duboko disanje, pospanost ili čak gubitak svijesti mogu biti znakovi ozbiljnog stanja (ketoacidoza) koje je nastalo zbog manjka inzulina.
English: Before taking a medicine ask your doctor if it can affect your blood sugar level and what action, if any, you need to take.
Croatian: Prije uzimanja nekog lijeka upitajte liječnika može li on utjecati na razinu šećera u krvi i što treba poduzeti bude li potrebno.
English: Although Lantus contains the same active substance as Toujeo (insulin glargine 300 units/ml), these medicines are not interchangeable.
Croatian: Iako Lantus sadrži istu djelatnu tvar kao Toujeo (inzulin glargin 300 jedinica/ml), ovi lijekovi nisu međusobno zamjenjivi.
English: Most minor reactions to insulins usually disappear in a few days to a few weeks.
Croatian: Većina blagih reakcija na inzulin obično nestane nakon nekoliko dana ili tjedana.
English: A. Select a dose of 2 units by turning the dosage selector.
Croatian: Odaberite dozu od 2 jedinice okretanjem izbornika doze.
English: There is no experience in children under 2 years.
Croatian: Nema iskustva u djece mlađe od 2 godine.
English: SoloStar has to be used as recommended in these instructions for use (see section 6.6).
Croatian: SoloStar se mora koristiti sukladno preporukama u tim uputama za uporabu (vidjeti dio 6.6).
English: Most minor reactions to insulins at the injection site usually resolve in a few days to a few weeks.
Croatian: Većina blagih reakcija na inzulin na mjestu injiciranja obično se povlači u roku od nekoliko dana do nekoliko tjedana.
English: Via Valcanello, 4 03012 Anagni (FR) Italy
Croatian: ViaValcanello, 4 03012 Anagni (FR) Italija
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 načinu djelovanja inzulina koji se primjenjuju te se stoga može promijeniti s promjenom režima liječenja.
English: It is completely soluble at the acidic pH of the Lantus injection solution (pH 4).
Croatian: Potpuno je topljiv u kiselom mediju kakav je Lantus otopina za injekciju (pH 4).
English: Mixing or diluting can change its time/action profile and mixing can cause precipitation.
Croatian: Miješanjem ili razrjeđivanjem može se promijeniti trajanje i način djelovanja lijeka, a miješanje može uzrokovati precipitaciju.
English: Do not dilute it. Mixing or diluting may change the action of Lantus.
Croatian: Miješanje ili razrjeđivanje može promijeniti djelovanje lijeka Lantus.
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 može utjecati fizička aktivnost i drugi čimbenici.
English: Insulin treatment can cause the body to produce antibodies to insulin (substances that act against insulin).
Croatian: Liječenje inzulinom može uzrokovati da tijelo stvara protutijela na inzulin (tvari koje djeluju protiv inzulina).
English: Do not freeze or place next to the freezer or a freezer pack.
Croatian: Ne zamrzavati ili staviti neposredno uz zamrzivač ili rashladni uložak.
English: The exposure to M1 increases with the administered dose of Lantus.
Croatian: M1. Izloženost metabolitu M1 raste s primijenjenom dozom lijeka Lantus.
English: Insulin glargine injected once daily will reach steady state levels in 2-4 days after the first dose.
Croatian: Inzulin glargin injiciran jedanput na dan postići će stanje dinamičke ravnoteže 2-4 dana nakon prve doze.
English: SANOFI BULGARIA EOOD Тел.
Croatian: SANOFI BULGARIA EOOD
English: -In your brain
Croatian: -U mozgu
English: Physiological concentrations of endogenous IGF-1 may activate the mitogenic-proliferative pathway; however, the therapeutic concentrations found in insulin therapy, including in Lantus therapy, are considerably lower than the pharmacological concentrations required to activate the IGF-1 pathway.
Croatian: Fiziološke koncentracije endogenog IGF-1 proteina mogu aktivirati mitogeno-proliferativni put; međutim, terapijske koncentracije koje se postižu u liječenju inzulinom, uključujući i liječenje lijekom Lantus, su znatno niže od farmakoloških koncentracija potrebnih za aktivaciju IGF-1 metaboličkog puta.
English: Such situations may result in severe hypoglycaemia (and possibly loss of consciousness) prior to the patient's awareness of hypoglycaemia.
Croatian: Takve okolnosti mogu dovesti do teške hipoglikemije (i mogućeg gubitka svijesti) prije nego li bolesnik postane svjestan nastanka hipoglikemije.
English: More severe episodes with coma, seizure, or neurologic impairment may be treated with intramuscular/subcutaneous glucagon or concentrated intravenous glucose.
Croatian: Teže epizode popraćene komom, konvulzijama ili neurološkim oštećenjima mogu se liječiti intramuskularnom/supkutanom primjenom glukagona ili intravenskom primjenom koncentrirane glukoze.
English: The switch from one insulin therapy to another requires medical prescription, medical supervision and blood glucose monitoring.
Croatian: Za prijelaz s jedne inzulinske terapije na drugu potrebna je liječnička preporuka i nadzor te praćenje koncentracije glukoze u krvi.
English: Cases of cardiac failure have been reported when pioglitazone was used in combination with insulin, especially in patients with risk factors for development of cardiac heart failure.
Croatian: Zabilježeni su slučajevi zatajivanja srca kod primjene pioglitazona u kombinaciji s inzulinom, osobito u bolesnika koji su imali rizične faktore za razvoj zatajivanja srca.
English: Due to more sustained basal insulin supply with Lantus, less nocturnal but more early morning hypoglycaemia can be expected.
Croatian: Zbog ravnomjernije opskrbe bazalnim inzulinom kod primjene lijeka Lantus, može se očekivati manje noćnih no više ranojutarnjih epizoda hipoglikemije.
English: For further details on handling, see section 6.6.
Croatian: Za dodatne informacije o rukovanju, vidjeti dio 6.6.
English: Do not use SoloStar if it is damaged or not working properly, it has to be discarded and a new SoloStar has to be used.
Croatian: Ne smijete upotrijebiti SoloStar brizgalicu ako je oštećena ili ne radi ispravno; treba je ukloniti i upotrijebiti novu SoloStar brizgalicu.
English: With improved metabolic control and resulting increase in insulin sensitivity a further adjustment in dose regimen may become necessary.
Croatian: Zbog poboljšane metaboličke regulacije i posljedičnog povećanja inzulinske osjetljivosti možda će biti potrebna daljnja prilagodba režima doziranja.
English: Do not use this SoloStar if the insulin is cloudy, coloured or has particles.
Croatian: Ne smijete upotrijebiti ovu SoloStar brizgalicu ako je inzulin zamućen, obojen ili sadrži čestice.
English: Participants were randomised (1:1) to receive insulin glargine (n=6264), titrated to reach FPG ≤95 mg/dl (5.3 mM), or standard care (n=6273).
Croatian: Sudionici su randomizirani (1:1) da primaju inzulin glargin (n=6264), titriran kako bi se postigla razina glukoze u plazmi natašte od ≤ 95 mg/dl (5,3 mmol/l), ili standardno liječenje (n=6273).
English: Combination of Lantus with pioglitazone
Croatian: Kombinacija lijeka Lantus i pioglitazona
English: This can spread around the injection site.
Croatian: Ove se reakcije mogu proširiti i oko mjesta injiciranja.
English: Examples of symptoms that indicate a low sugar level in the brain: headaches, intense hunger, nausea, vomiting, tiredness, sleepiness, sleep disturbances, restlessness, aggressive behaviour, lapses in concentration, impaired reactions, depression, confusion, speech disturbances (sometimes total loss of speech), visual disorders, trembling, paralysis, tingling sensations (paraesthesia), numbness and tingling sensations in the area of the mouth, dizziness, loss of self-control, inability to look after yourself, convulsions, loss of consciousness.
Croatian: Sljedeći simptomi ukazuju na nisku razinu šećera u mozgu: glavobolje, jaka glad, mučnina, povraćanje, umor, pospanost, poremećaji spavanja, nemir, agresivno ponašanje, poteškoće s koncentracijom, slabije reakcije, depresija, smetenost, poremećaji govora (ponekad potpun gubitak sposobnosti govora), poremećaji vida, drhtavica, paraliza, trnci (parestezije), utrnulost i trnci u području usta, omaglica, gubitak samokontrole, nesposobnost vođenja brige o samome sebi,