FrancophonIA/ELRC3.0 huggingface dataset:
English: When used in external portable insulin pumps, part of the daily insulin dose is infused continuously ("basal rate"), and the rest is administered in the form of bolus injections before meals.
Croatian: Kada se primjenjuje u vanjskim prijenosnim inzulinskim pumpama, dio dnevne doze inzulina kontinuirano se infundira (“bazalna razina”), a ostatak se daje u obliku bolusnih injekcija prije obroka.
English: A dose of 2 units has to be selected.
Croatian: Mora se odabrati doza od 2 jedinice.
English: 3 cartridges of 3 ml 4 cartridges of 3 ml 5 cartridges of 3 ml 6 cartridges of 3 ml 9 cartridges of 3 ml 10 cartridges of 3 ml
Croatian: 3 uloška od 3 ml 4 uloška od 3 ml 5 uložaka od 3 ml 6 uložaka od 3 ml 9 uložaka od 3 ml 10 uložaka od 3 ml
English: • Always perform the safety test before each injection (see Step 3).
Croatian: • Prije svake injekcije treba provesti test sigurnosti (vidjeti 3. korak).
English: Particularly careful control of your diabetes, and prevention of hypoglycaemia, is important for the health of your baby.
Croatian: Vrlo pažljiva kontrola šećerne bolesti i sprječavanje hipoglikemije važni su za zdravlje Vašeg djeteta.
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 dosage.
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 prilagodbe doziranja.
English: After removing the cap, the needle should be carefully attached straight onto the pen.
Croatian: Nakon skidanja zatvarača, iglu treba pažljivo pričvrstiti ravno na brizgalicu.
English: In such a case, you may develop severe hypoglycaemia (and even faint) before you are aware of the problem.
Croatian: U takvim slučajevima možete razviti tešku hipoglikemiju (možete se čak i onesvijestiti) prije nego što postanete svjesni problema.
English: It is longer in patients with severe renal insufficiency.
Croatian: Poluvijek je dulji u bolesnika s teškom insuficijencijom bubrega.
English: Maintenance
Croatian: Održavanje
English: Transferring a patient to another type or brand of insulin should be done under strict medical supervision.
Croatian: Prijelaz bolesnika na drugu vrstu ili inzulin drugog proizvođača treba provesti pod strogim liječničkim nadzorom.
English: Pentamidine (used to treat some infections caused by parasites) may cause hypoglycaemia which may sometimes be followed by hyperglycaemia.
Croatian: Pentamidin (koristi se za liječenje nekih infekcija uzrokovanih parazitima) može uzrokovati hipoglikemiju, koja ponekad može biti praćena hiperglikemijom.
English: Continuous rotation of the injection site within the given injection area may help to reduce or prevent these reactions.
Croatian: Neprestano mijenjanje mjesta injiciranja unutar preporučenih područja injiciranja može pomoći u ublažavanju ili sprječavanju takvih reakcija.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Croatian: Nositelj odobrenja obavljat će dodatne farmakovigilancijske aktivnosti i intervencije, detaljno objašnjene u dogovorenom Planu upravljanja rizikom, a koji je opisan u Modulu 1.8.2 Odobrenja za stavljanje lijeka u promet, te svim sljedećim nadopunama Plana.
English: A number of substances affect glucose metabolism and may require dose adjustment of human insulin.
Croatian: Brojne tvari utječu na metabolizam glukoze i mogu zahtijevati prilagodbu doze humanog inzulina.
English: Patients should be aware of circumstances where warning symptoms of hypoglycaemia are diminished.
Croatian: Bolesnici bi trebali biti svjesni okolnosti u kojima su upozoravajući simptomi hipoglikemije slabije izraženi.
English: The cartridge must only be used once.
Croatian: Uložak se smije upotrijebiti samo jedanput.
English: The acute toxicity was studied following subcutaneous administration in rats.
Croatian: Akutna toksičnost ispitana je nakon supkutane primjene u štakora.
English: More severe episodes with coma, seizure, or neurologic impairment may be treated with intramuscular/subcutaneous glucagon or concentrated intravenous glucose.
Croatian: Teže epizode praćene komom, konvulzijama ili neurološkim oštećenjima mogu se liječiti intramuskularnom/supkutanom primjenom glukagona ili intravenskom primjenom koncentrirane glukoze.
English: This ensures that the full dose will be delivered.
Croatian: Tako ćete osigurati primjenu cijele doze.
English: Severe allergic reactions to insulin may occur which may become life-threatening.
Croatian: Mogu se javiti teške alergijske reakcije na inzulin koje mogu postati opasne po život.
English: Please note: The needles shown are for illustrative purposes only.
Croatian: Napomena: Prikazane igle služe samo kao primjer.
English: Careful monitoring of glucose control is essential.
Croatian: Vrlo je važno strogo kontrolirati razinu glukoze.
English: Make sure that you contact a doctor early.
Croatian: Javite se liječniku na vrijeme.
English: Check if insulin comes out of the needle tip.
Croatian: Provjerite izlazi li inzulin kroz vrh igle.
English: - previously required high insulin doses due to the presence of insulin antibodies.
Croatian: - kojima su prethodno trebale visoke doze inzulina zbog prisutnosti protutijela na inzulin.
English: Situations in which you must not start or continue to use insulin pumps are described in the operating manuals for these pumps.
Croatian: Situacije u kojima ne smijete početi niti nastaviti s uporabom inzulinskih pumpi opisane su u priručniku za uporabu tih pumpa.
English: If you have type 1 diabetes (insulin dependent diabetes mellitus), do not stop your insulin and continue to get enough carbohydrates.
Croatian: Ako imate šećernu bolest tipa 1 (šećernu bolest ovisnu o inzulinu), nemojte prestati primjenjivati inzulin te nastavite uzimati dovoljno ugljikohidrata.
English: Each cartridge contains 3 balls (stainless steel).
Croatian: Jedan uložak sadrži 3 kuglice (nehrđajući čelik).
English: Do not mix insulins of different strengths (for example 100 IU per ml and 40 IU per ml).
Croatian: Nemojte miješati inzuline različitih jačina (primjerice, 100 IU/ml i 40 IU/ml).
English: It is advisable to test your blood sugar immediately after taking glucose to check that you really have hypoglycaemia.
Croatian: Preporučuje se da odmah nakon uzimanja glukoze izmjerite razinu šećera u krvi da provjerite imate li zaista hipoglikemiju.
English: How to handle SoloStar
Croatian: Kako rukovati brizgalicom SoloStar
English: Most minor reactions to insulins usually resolve in a few days to a few weeks.
Croatian: Većina manjih reakcija na inzulin na mjestu injiciranja obično se povlači u roku od nekoliko dana do nekoliko tjedana.
English: The first symptoms which alert you to hypoglycaemia ("warning symptoms") may change, be weaker or may be missing altogether if
Croatian: Prvi simptomi koji Vas mogu upozoriti na hipoglikemiju ("upozoravajući simptomi") mogu se promijeniti, biti manje izraženi ili potpuno izostati:
English: Adjustments in dose regimen of the medicinal product, meal patterns, or physical activity may be needed.
Croatian: Možda će biti potrebne prilagodbe doze lijeka, rasporeda obroka ili tjelesne aktivnosti.
English: Insulin treatment may cause temporary build-up of water in the body with swelling in the calves and ankles.
Croatian: Liječenje inzulinom može uzrokovati privremeno nakupljanje vode u tijelu, uz oticanje potkoljenica i gležnjeva.
English: The patient's ability to concentrate and react may be impaired as a result of hypoglycaemia or hyperglycaemia or, for example, as a result of visual impairment.
Croatian: Bolesnikova sposobnost koncentracije i reakcije može biti umanjena zbog hipoglikemije ili hiperglikemije ili, primjerice, zbog oštećenja vida.
English: In the treatment of severe hyperglycaemia or ketoacidosis in particular, insulin administration is part of a complex therapeutic regimen which includes measures to protect patients from possible severe complications of a relatively rapid lowering of blood glucose.
Croatian: U liječenju teške hiperglikemije i posebno ketoacidoze, primjena inzulina dio je složenog režima liječenja koji uključuje mjere zaštite bolesnika od mogućih teških komplikacija do kojih dolazi zbog relativno brzog snižavanja razine glukoze u krvi.
English: A marked change in glycaemic control may cause temporary visual impairment, due to temporary alteration in the turgidity and refractive index of the lens.
Croatian: Izražena promjena u regulaciji glikemije može uzrokovati privremeni poremećaj vida zbog privremene promjene napetosti i refrakcijskog indeksa leće.
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 pojave hipoglikemije.
English: • Special caution must be taken to avoid accidental needle injury and transmission of infection.
Croatian: • Mora se posebno paziti da se izbjegnu nehotične ozljede iglom i prijenos infekcije.
English: • Sodium retention
Croatian: • retencija natrija
English: Concerning incompatibility with other insulins, see section 6.2.
Croatian: Za inkompatibilnosti s drugim inzulinima vidjeti dio 6.2.
English: If you have any questions about SoloStar or about diabetes, ask your doctor, pharmacist or nurse or call the local sanofi-aventis number on the front of this leaflet.
Croatian: Ako imate bilo kakvih pitanja o SoloStar brizgalici ili o šećernoj bolesti, obratite se svom liječniku, ljekarniku ili medicinskoj sestri ili nazovite broj lokalnog sanofi-aventis ureda naveden na početku ove upute.
English: This should be kept in mind if treatment with the combination of pioglitazone and Insulin Human Winthrop is considered.
Croatian: Ovo treba imati na umu ako se razmatra liječenje kombinacijom pioglitazona i lijeka Insulin Human Winthrop.
English: If insulin has been expelled through the needle tip, then the pen and the needle are working properly.
Croatian: Ako inzulin izlazi kroz vrh igle, brizgalica i igla rade ispravno.
English: In this case, either you can inject what is remaining in the pen and complete your dose with a new SoloStar or use a new SoloStar for your full dose.
Croatian: U tom slučaju možete ili injicirati dozu koja je preostala u brizgalici i upotpuniti je dozom iz nove SoloStar brizgalice, ili upotrijebiti novu SoloStar brizgalicu za primjenu cijele doze.
English: Local tolerability studies following subcutaneous and intramuscular administration in rabbits gave no remarkable findings.
Croatian: U ispitivanjima lokalne podnošljivosti nakon supkutane i intramuskularne primjene u kunića nisu dobiveni nikakvi značajni nalazi.
English: A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČ(I) BIOLOŠKE DJELATNE TVARI I PROIZVOĐAČ(I) ODGOVORAN(ODGOVORNI) ZA PUŠTANJE SERIJE LIJEKA U PROMET
English: • Oedema
Croatian: • edem
English: The patient should be informed on the injection technique by his health care professional.
Croatian: Zdravstveni djelatnik treba objasniti bolesniku tehniku injiciranja.
English: Prolonged or severe hypoglycaemic episodes may be life-threatening.
Croatian: Epizode produljenih ili teških hipoglikemija mogu biti opasne po život.
English: Your doctor or nurse should have discussed this with you previously.
Croatian: O tome ste prethodno trebali razgovarati sa svojim liječnikom ili medicinskom sestrom.
English: These changes sometimes give the vial a frosted appearance.
Croatian: Zbog tih promjena uložak ponekad može izgledati zamrznuto.
English: Insulin may cause sodium retention and oedema, particularly if previously poor metabolic control is improved by intensified insulin therapy.
Croatian: Inzulin može dovesti do retencije natrija i edema, pogotovo ako je ranija slaba regulacija metabolizma poboljšana intenziviranim liječenjem inzulinom.
English: Read these instructions carefully before using your SoloStar.
Croatian: Pažljivo pročitajte ove upute prije uporabe brizgalice SoloStar.
English: Perform a safety test
Croatian: 3. korak Provođenje testa sigurnosti
English: OTHER SPECIAL WARNING(S), IF NECESSARY Mix thoroughly.
Croatian: DRUGA POSEBNA UPOZORENJA, AKO JE POTREBNO Dobro promiješati.
English: Before use of needle, carefully read the “Instructions for Use” accompanying the needles.
Croatian: Prije uporabe igle pažljivo pročitajte „Upute za uporabu“ koje su priložene uz igle.
English: In clinical studies and during marketed use, the frequency varies with patient population and dose regimens.
Croatian: U kliničkim ispitivanjima i nakon stavljanja lijeka u promet učestalost varira s obzirom na skupinu bolesnika i režim doziranja.
English: The injection syringes must not contain any other medicines or traces of medicines (such as traces of heparin).
Croatian: Štrcaljke za injekciju ne smiju sadržavati nijedan drugi lijek niti ostatke lijekova (poput tragova heparina).
English: For insulin human, no clinical data on exposed pregnancies from controlled clinical studies are available.
Croatian: Nema dostupnih kliničkih podataka o trudnicama izloženim humanom inzulinu u kontroliranim kliničkim ispitivanjima.
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: Pentamidine may cause hypoglycaemia which may sometimes be followed by hyperglycaemia.
Croatian: Pentamidin može uzrokovati hipoglikemiju, koja ponekad može biti praćena hiperglikemijom.
English: Dose adjustment may also be required, for example, if - the patient's weight changes,
Croatian: Prilagodba doze može također biti potrebna, primjerice, ako: - se promijeni tjelesna težina bolesnika,
English: The pictures below are for illustrative purposes only.
Croatian: Slike u nastavku služe samo kao primjer.
English: If you are concerned that your SoloStar may be damaged, use a new one.
Croatian: Ako sumnjate da je Vaš SoloStar možda oštećen, uklonite ga i upotrijebite novi.
English: Long-term improved glycaemic control decreases the risk of progression of diabetic retinopathy.
Croatian: Dugoročno poboljšanje regulacije glikemije smanjuje rizik od napredovanja dijabetičke retinopatije.
English: • Do not select a dose and/or press the injection button without a needle attached.
Croatian: • Nemojte odabirati dozu i/ili pritiskati dugme za injiciranje bez pričvršćene igle.
English: - other circumstances arise that may promote an increased susceptibility to hypo- or hyperglycaemia (see section 4.4).
Croatian: - nastanu druge okolnosti koje mogu dovesti do povećane podložnosti hipoglikemiji ili hiperglikemiji (vidjeti dio 4.4).
English: If the insulin pen is damaged or not working properly (due to mechanical defects) it has to be discarded, and a new insulin pen has to be used.
Croatian: Ako je inzulinska brizgalica oštećena ili ne radi ispravno (zbog mehaničkih oštećenja), treba je ukloniti i upotrijebiti novu inzulinsku brizgalicu.
English: The need to adjust (e.g. reduce) the dose may become evident immediately after transfer.
Croatian: Potreba za prilagođavanjem (npr. smanjenjem) doze može se ukazati odmah nakon prijelaza ili se može pojaviti postupno tijekom razdoblja od nekoliko tjedana.
English: This helps prevent contamination, and potential needle blocks.
Croatian: To pomaže da se spriječi onečišćenje i moguće začepljenje igle.
English: If necessary, more frequent blood sugar testing can help to identify mild hypoglycaemic episodes that may otherwise be overlooked.
Croatian: Ako je potrebno, češće mjerite razinu šećera u krvi jer Vam to može pomoći u prepoznavanju blagih epizoda hipoglikemije, koje biste inače previdjeli.
English: • The patient must always have a spare SoloStar available in case the SoloStar is lost or damaged.
Croatian: • Bolesnik uvijek mora na raspolaganju imati rezervni SoloStar u slučaju da se SoloStar koji koristi izgubi ili ošteti.
English: To ensure that you read the dose correctly, hold the pen horizontally, with the needle on the left and the dosage selector to the right as shown in the illustrations below.
Croatian: Kako biste točno očitali dozu, držite brizgalicu vodoravno, tako da je igla na lijevoj, a izbornik doze na desnoj strani, kako prikazuju slike u nastavku.
English: Follow recommended safety measures for removal and disposal of needles (e.g. 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: Mix the insulin well and check it before you insert it into the pen.
Croatian: Dobro promiješajte inzulin i pregledajte ga prije nego što ga umetnete u brizgalicu.
English: Medication errors have been reported in which other Insulin Human Winthrop formulations or other insulins have been accidentally administered.
Croatian: Prijavljene su medikacijske pogreške kada su slučajno primijenjene druge formulacije lijeka Insulin Human Winthrop ili drugi inzulini.
English: Other side effects include (frequency cannot be estimated from the available data)
Croatian: Druge nuspojave uključuju (učestalost se ne može procijeniti iz dostupnih podataka)
English: Each pen contains multiple doses.
Croatian: Jedna brizgalica sadrži više doza lijeka.
English: You should contact your doctor for advice on driving if: - you have frequent episodes of hypoglycaemia, - the first warning symptoms which help you to recognise hypoglycaemia are reduced or absent.
Croatian: Morate se obratiti svom liječniku za savjet o tome možete li voziti: - ako imate česte epizode hipoglikemije, - ako su Vam prvi upozoravajući znakovi hipoglikemije slabije izraženi ili izostaju.
English: • If still no insulin comes out, the needle may be blocked.
Croatian: • Ako inzulin i dalje ne izlazi, igla je možda začepljena.
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 potpuni gubitak sposobnosti govora), poremećaji vida, drhtavica, paraliza, osjećaj trnaca (parestezija), utrnulost i trnci u području usta, omaglica, gubitak samokontrole, nesposobnost vođenja brige o samome sebi, konvulzije, gubitak svijesti.
English: • Entry of air into the insulin reservoir and leakage of insulin, which can cause inaccurate dosing.
Croatian: • ulazak zraka u spremnik s inzulinom i istjecanje inzulina, što može prouzročiti netočno doziranje.
English: Refer to the technical manual for contraindications relating to the use of insulin pumps.
Croatian: Vidjeti tehnički priručnik za kontraindikacije vezane uz primjenu inzulinskih pumpi.
English: For further information on the side effects of low blood sugar or high blood sugar, see the box at the end of this leaflet.
Croatian: Za dodatne informacije o nuspojavama niske ili visoke razine šećera u krvi, pogledajte uokvireni tekst na kraju ove Upute o lijeku.
English: Shelf life after first use of the cartridge The product (cartridges in-use in the pump) may be stored for a maximum of 2 weeks.
Croatian: Rok valjanosti nakon prve uporabe uloška Lijek (ulošci u uporabi koji se nalaze u pumpi) se može čuvati najdulje 2 tjedna.
English: The most frequent side effect is hypoglycaemia (low blood sugar).
Croatian: Najčešća nuspojava je hipoglikemija (niska razina šećera u krvi).
English: A dose should not be selected and/or the injection button should not be pressed without a needle attached.
Croatian: Ne smije se odabirati dozu i/ili pritiskati dugme za injiciranje bez pričvršćene igle.
English: If no insulin appears at the needle tip, step 3 should be repeated until insulin appears at the needle tip.
Croatian: Ako se na vrhu igle ne pojavljuje inzulin, treba ponoviti korak 3 još dva puta dok se na vrhu igle ne pojavi inzulin.
English: • Always have a spare SoloStar in case your SoloStar is lost or damaged.
Croatian: • Uvijek morate imati rezervni SoloStar u slučaju da se SoloStar koji koristite izgubi ili ošteti.
English: Travel
Croatian: Putovanje
English: No effects on the suckling child are anticipated.
Croatian: Ne očekuje se da bi lijek mogao imati učinak na dojenče.
English: A marked change (improvement or worsening) in your blood sugar control can disturb your vision temporarily.
Croatian: Izrazite promjene (poboljšanje ili pogoršanje) razine šećera u krvi mogu uzrokovati prolazno pogoršanje vida.
English: The needle should be inserted into the skin.
Croatian: Iglu treba ubosti u kožu.
English: Recommended safety measures for removal and disposal of needles must be followed (e.g. a one handed capping technique) in order to reduce the risk of accidental needle injury and transmission of infectious diseases.
Croatian: Moraju se slijediti preporučene mjere za sigurno skidanje i uklanjanje igala (npr. tehnika vraćanja zatvarača na iglu jednom rukom) kako bi se umanjio rizik od slučajnog uboda iglom i prijenosa zaraznih bolesti.
English: Insulin that has been filled into the pump reservoir may be used for two weeks thereafter.
Croatian: Inzulin koji je stavljen u spremnik pumpe može se primjenjivati sljedeća dva tjedna.
English: • If the needle is not kept straight while you attach it, it can damage the rubber seal and cause leakage, or break the needle.
Croatian: • Ako iglu prilikom stavljanja ne držite ravno, to može oštetiti gumeni zatvarač te izazvati istjecanje lijeka ili se igla može slomiti.
English: Prior to each injection, a safety test has to be performed to ensure that pen and needle work properly and to remove air bubbles.
Croatian: Prije svake injekcije mora se provesti test sigurnosti kako bi se provjerilo rade li brizgalica i igle ispravno te uklonili mjehurići zraka.
English: Your ability to concentrate or react may be reduced if: - you have hypoglycaemia (low blood sugar levels), - you have hyperglycaemia (high blood sugar levels), - you have problems with your sight.
Croatian: Vaša sposobnost koncentracije i reagiranja može biti oslabljena ako: - imate hipoglikemiju (nisku razinu šećera u krvi), - imate hiperglikemiju (visoku razinu šećera u krvi), - imate problema s vidom.
English: Some patients with long-standing type 2 diabetes mellitus and heart disease or previous stroke who were treated with pioglitazone and insulin experienced the development of heart failure.
Croatian: U nekih bolesnika koji dugo boluju od šećerne bolesti tipa 2 i imaju srčanu bolest ili su imali moždani udar, a liječeni su pioglitazonom i inzulinom, došlo je do razvoja srčanog zatajivanja.
English: While holding the pen with the needle pointing upwards, the insulin reservoir should be tapped gently with the finger so that any air bubbles rise up towards the needle.
Croatian: Držeći brizgalicu iglom okrenutom prema gore, treba kucnuti prstom po spremniku inzulina kako bi se mjehurići zraka popeli prema igli.
English: Do not mix insulin with any other medicines.
Croatian: Nemojte miješati inzulin s drugim lijekovima.