FrancophonIA/ELRC3.0 huggingface dataset:
English: Packs of 5 cartridges are available.
Croatian: Dostupna su pakovanja od 5 uložaka.
English: If you are breast--eeding consult your doctor as you may require adjustments in your insulin doses and your diet.
Croatian: Ako dojite, obratite se svom liječniku za savjet jer će možda biti potrebno prilagoditi dozu inzulina i prehranu.
English: Symptoms Insulin overdose may lead to severe and sometimes long-term and life-threatening hypoglycaemia.
Croatian: Predoziranje inzulinom može uzrokovati tešku, a katkada i dugotrajnu te po život opasnu hipoglikemiju.
English: For details on safety precautions in the use of insulin pumps see the operating manual.
Croatian: Za pojedinosti o mjerama sigurnosti kod primjene inzulinskih pumpi vidjeti priručnik za uporabu.
English: Fertility No clinical or animal data with insulin human on male or female fertility are available.
Croatian: Nema dostupnih podataka iz kliničkih ispitivanja niti ispitivanja na životinjama o učinku humanog inzulina na plodnost u muškaraca i žena.
English: This could lead to severe hyperglycaemia (very high blood sugar) and ketoacidosis (build-up of acid in the blood because the body is breaking down fat instead of sugar).
Croatian: To može dovesti do teške hiperglikemije (vrlo visoka razina šećera u krvi) i ketoacidoze (tijelo razgrađuje mast umjesto šećera pa dolazi do nakupljanja kiseline u krvi).
English: Only tetrafluoroethylene or polyethylene catheters must be used.
Croatian: Smiju se koristiti samo tetrafluoroetilenski i polietilenski kateteri.
English: Storage instructions
Croatian: Upute za čuvanje
English: Do not use SoloStar if it is damaged or not working properly (due to mechanical defects), 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: Such reactions to insulin or to the excipients can cause large-scale skin reactions (rash and itching all over the body); severe swelling of skin or mucous membranes (angiooedema), shortness of breath, a fall in blood pressure with rapid heart beat and sweating.
Croatian: Takve reakcije na inzulin ili pomoćne tvari mogu izazvati raširene kožne reakcije (osip i svrbež po cijelome tijelu), jako oticanje kože ili sluznica (angioedem), nedostatak zraka, pad krvnog tlaka s brzim otkucajima srca i znojenjem.
English: • removing air bubbles
Croatian: • odstraniti mjehuriće zraka
English: You may need to talk about - the availability of your insulin in the country you are visiting, - supplies of insulin, injection syringes etc., - correct storage of your insulin while travelling, - whom to contact in the event of technical problems with your pump, - timing of meals and insulin administration while travelling, - 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: Možda ćete morati porazgovarati o: - dostupnosti inzulina u zemlji koju posjećujete, - zalihama inzulina, štrcaljkama za injekciju i dr., - ispravnom čuvanju inzulina za vrijeme putovanja, - kome se obratiti u slučaju tehničkih poteškoća s pumpom, - rasporedu uzimanja obroka i inzulina za vrijeme putovanja, - 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: If SoloStar is in cool storage, it should be taken out 1 to 2 hours before injection to allow it to warm up.
Croatian: Ako se SoloStar čuva na hladnom, treba ga izvaditi 1 do 2 sata prije injekcije kako bi se ugrijao na sobnu temperaturu.
English: You may need to talk about - the availability of your insulin in the country you are visiting, - supplies of insulin, injection syringes etc., - correct storage of your insulin while travelling, - timing of meals and insulin administration while travelling, - 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: Možda ćete morati porazgovarati o: - dostupnosti inzulina u zemlji koju posjećujete, - zalihama inzulina, štrcaljkama za injekciju i dr., - ispravnom čuvanju inzulina za vrijeme putovanja, - rasporedu uzimanja obroka i inzulina za vrijeme putovanja, - 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: The pen should be turned gently to avoid foaming in the cartridge.
Croatian: Brizgalicu treba nježno okretati kako bi se izbjeglo pjenjenje u ulošku.
English: These include patients: - in whom glycaemic control is markedly improved, - in whom hypoglycaemia develops gradually, - who are elderly, - after transfer from animal insulin to human insulin, - in whom an autonomic neuropathy is present, - with a long history of diabetes, - suffering from a psychiatric illness, - receiving concurrent treatment with certain other medicinal products (see section 4.5).
Croatian: One obuhvaćaju bolesnike: - u kojih je regulacija glikemije izrazito poboljšana, - u kojih se hipoglikemija razvija postupno, - starije životne dobi, - koji su prešli sa životinjskog inzulina na humani inzulin, - u kojih je prisutna autonomna neuropatija, - koji već dugo boluju od šećerne bolesti, - koji pate od neke psihijatrijske bolesti, - koji se istodobno liječe određenim drugim lijekovima (vidjeti dio 4.5).
English: Turn the pen gently to avoid foaming in the cartridge.
Croatian: Brizgalicu okrećite nježno kako biste izbjegli stvaranje pjene u ulošku.
English: Breast-feeding women may require adjustments in insulin dose and diet.
Croatian: Dojiljama će možda biti potrebno prilagoditi dozu inzulina i prehranu.
English: Warning symptoms of hypoglycaemia
Croatian: Upozoravajući simptomi hipoglikemije
English: Always use a new sterile needle for each injection.
Croatian: Za svaku injekciju upotrijebite novu, sterilnu iglu.
English: Insulin with a gradual onset and long duration of action.
Croatian: Inzulin s postupnim početkom i dugim trajanjem djelovanja.
English: B. Take off the outer needle cap and keep it to remove the used needle after injection.
Croatian: Skinite vanjski zatvarač igle i sačuvajte ga radi uklanjanja upotrijebljene igle nakon injiciranja.
English: This is best done by gently tilting the cartridge back and forth (at least ten times).
Croatian: Najbolji način da se to učini je nježno naginjati uložak naprijed-natrag (najmanje deset puta).
English: A Use the injection method as instructed by your doctor, pharmacist or nurse.
Croatian: Primijenite tehniku injiciranja koju su Vam pokazali Vaš liječnik, ljekarnik ili medicinska sestra.
English: If your blood sugar is too high (hyperglycaemia), you may not have injected enough insulin.
Croatian: Ako Vam je razina šećera u krvi previsoka (hiperglikemija), možda niste injicirali dovoljno inzulina.
English: For information on the treatment of hyperglycaemia, see box at the end of this leaflet.
Croatian: Za informacije o liječenju hiperglikemije, pogledajte uokvireni tekst na kraju ove Upute o lijeku.
English: The dose can be set 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: HYPERGLYCAEMIA (high blood sugar levels)
Croatian: HIPERGLIKEMIJA (visoka razina šećera u krvi)
English: Aventis Pharma Norge AS Tlf: +47 67 10 71 00
Croatian: Norge sanofi-aventis Norge AS Tlf: +47 67 10 71 00
English: Other mild reactions at the injection site (such as injection site redness, unusually intense pain on injection site, itching, injection site swelling or injection site inflammation) may occur.
Croatian: Mogu se javiti i druge blage reakcije na mjestu injekcije (poput crvenila na mjestu injekcije, neuobičajeno jake boli na mjestu injekcije, svrbeža, oticanja na mjestu injekcije ili upale na mjestu injekcije).
English: These include: - change in the injection area, - improved insulin sensitivity (e.g. by removal of stress factors), - unaccustomed, increased or prolonged physical activity, - intercurrent illness (e.g. vomiting, diarrhoea), - inadequate food intake, - missed meals, - alcohol consumption, - certain uncompensated endocrine disorders (e.g. in hypothyroidism and in anterior pituitary or adrenocortical insufficiency), - concomitant treatment with certain other medicinal products.
Croatian: Oni obuhvaćaju: - promjenu područja injiciranja, - poboljšanu osjetljivost na inzulin (npr. uklanjanjem čimbenika stresa), - povećanu ili dugotrajnu tjelesnu aktivnost na koju bolesnik nije navikao, - interkurentnu bolest (npr. povraćanje, proljev), - nedovoljan unos hrane, - propuštanje obroka, - konzumaciju alkohola, - neke nekompenzirane endokrinološke poremećaje (npr. kod hipotireoze i insuficijencije adenohipofize ili kore nadbubrežne žlijezde), - istodobno liječenje određenim drugim lijekovima.
English: Why does hypoglycaemia occur?
Croatian: Zašto dolazi do hipoglikemije?
English: Insulin Human Winthrop Rapid is also suitable for the treatment of hyperglycaemic coma and ketoacidosis, as well as for achieving pre-, intra- and post-operative stabilisation in patients with diabetes mellitus.
Croatian: Insulin Human Winthrop Rapid je također prikladan za liječenje hiperglikemijske kome i ketoacidoze te za postizanje stabilizacije u bolesnika sa šećernom bolešću prije, za vrijeme i nakon kirurškog zahvata.
English: A safety test must be performed before each injection.
Croatian: Prije svake injekcije morate provesti test sigurnosti.
English: Before withdrawing insulin from the vial for the first time, remove the plastic protective cap.
Croatian: Prije prvog izvlačenja inzulina iz bočice uklonite plastični zaštitni zatvarač.
English: Immediate type allergic reactions to insulin or to the excipients may be life-threatening.
Croatian: Reakcije preosjetljivosti tipa 1 na inzulin ili pomoćne tvari mogu biti opasne po život.
English: Follow closely the instructions for dosage, monitoring (blood and urine tests), diet and physical activity (physical work and exercise) as discussed with your doctor.
Croatian: Pažljivo slijedite upute o doziranju, kontroli (pretrage krvi i mokraće), prehrani i tjelesnoj aktivnosti (fizički rad i tjelovježba) o kojima ste razgovarali sa svojim liječnikom.
English: Only use injection needles that have been approved for use with SoloStar.
Croatian: Koristiti samo igle za injekciju koje su odobrene za uporabu s brizgalicom SoloStar.
English: Follow closely the instructions for dosage, monitoring (blood and urine tests), diet and physical activity (physical work and exercise), 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: Fur further details on handling, see section 6.6.
Croatian: Za dodatne informacije o rukovanju, vidjeti dio 6.6.
English: METHOD OF ADMINISTRATION Use specific pens: see leaflet.
Croatian: NAČIN PRIMJENE LIJEKA Koristiti odgovarajuće brizgalice: vidjeti Uputu.
English: MARKETING AUTHORISATION HOLDER Sanofi-Aventis Deutschland GmbH, D-65926 Frankfurt am Main, Germany
Croatian: NOSITELJ ODOBRENJA ZA STAVLJANJE GOTOVOG LIJEKA U PROMET Sanofi-Aventis Deutschland GmbH, D-65926 Frankfurt na Majni, Njemačka
English: C. Hold the pen with the needle pointing upwards.
Croatian: Držite brizgalicu iglom okrenutom prema gore.
English: Later, you must mix the insulin well again immediately before each injection.
Croatian: Kasnije ga morate ponovno dobro promiješati neposredno prije svake injekcije.
English: SoloStar is a prefilled pen for the injection of insulin.
Croatian: SoloStar je napunjena brizgalica za injiciranje inzulina.
English: - the patient's life-style changes, - other circumstances arise that may promote an increased susceptibility to hypo- or hyperglycaemia (see section 4.4).
Croatian: - se promijeni način života bolesnika, - nastanu druge okolnosti koje mogu dovesti do povećane podložnosti hipoglikemiji ili hiperglikemiji (vidjeti dio 4.4).
English: Remove and discard the needle
Croatian: 6. korak Skidanje i uklanjanje igle
English: Lipodystrophy
Croatian: HIPERGLIKEMIJA
English: For use in an infusion pump, Insulin Human Winthrop Infusat is filled into the sterile cartridge of the pump.
Croatian: Za primjenu u infuzijskoj pumpi Insulin Human Winthrop Infusat se stavlja u sterilni uložak pumpe.
English: Insulin Human Winthrop Infusat must only be used in insulin pumps suitable for this insulin.
Croatian: Insulin Human Winthrop Infusat smije se upotrebljavati samo u inzulinskim pumpama koje su prikladne za ovaj inzulin.
English: Froth may interfere with the correct measurement of the dose.
Croatian: Pjena može ometati točno odmjeravanje doze.
English: Insulin Human Winthrop Rapid").
Croatian: Human Winthrop Rapid").
English: Refer to them before using your medicine.
Croatian: Pročitajte ih prije primjene lijeka.
English: Before injection remove any air bubbles (see instructions for using the pen).
Croatian: Prije injekcije uklonite mjehuriće zraka (vidjeti upute za uporabu brizgalice).
English: Pack of 3 vials of 10 ml is available.
Croatian: Dostupna su pakovanja od 3 bočice od 10 ml.
English: Following transfer from an animal insulin to human insulin, dose regimen reduction may be required in particular in patients who - were previously already controlled on rather low blood glucose levels, - have a tendency to hypoglycaemia,
Croatian: Nakon prijelaza sa životinjskog inzulina na humani inzulin može biti potrebno smanjenje doze, naročito u bolesnika: - koji su prethodno već bili regulirani na relativno niskim razinama glukoze u krvi, - koji su skloni hipoglikemiji,
English: Hypoglycaemia is also more likely to occur if: - you have just begun insulin treatment or changed to another insulin preparation, - your blood sugar levels are almost normal or are unstable, - you change the area of skin where you inject insulin (for example from the thigh to the upper arm), - you suffer from severe kidney or liver disease, or some other disease such as hypothyroidism.
Croatian: Hipoglikemija se također češće može pojaviti: - ako ste upravo započeli liječenje inzulinom ili ste prešli na drugi inzulinski pripravak, - ako Vam je razina šećera u krvi gotovo normalna ili nije stabilna, - ako promijenite područje na koži u koje injicirate inzulin (primjerice s bedra na nadlakticu), - ako bolujete od teške bubrežne ili jetrene bolesti ili neke druge bolesti kao što je hipotireoza.
English: The needle should always be removed after each injection and discarded.
Croatian: Nakon svake injekcije iglu treba skinuti i ukloniti je.
English: HYPOGLYCAEMIA (low blood sugar levels)
Croatian: HIPOGLIKEMIJA (niska razina šećera u krvi)
English: OTHER SPECIAL WARNING(S), IF NECESSARY Use only clear and colourless solutions.
Croatian: DRUGA POSEBNA UPOZORENJA, AKO JE POTREBNO Primijeniti samo bistru i bezbojnu otopinu.
English: Examples include: you have not injected your insulin or not injected enough, or if it has become less effective, for example through incorrect storage, your insulin pen does not work properly,
Croatian: Primjeri: - ako niste injicirali inzulin ili ako niste injicirali dovoljno inzulina ili ako je učinkovitost inzulina smanjena, primjerice zbog nepravilnog čuvanja, - ako Vam inzulinska pumpa ne radi ispravno,
English: C. Deliver the dose by pressing the injection button in all the way.
Croatian: Primijenite dozu tako što ćete pritisnuti dugme za injiciranje do kraja.
English: Only tetrafluoroethylene or polyethylene catheters must be used for infusion.
Croatian: Za infuziju se moraju koristiti samo tetrafluoroetilenski ili polietilenski kateteri.
English: Substances that may enhance the blood-glucose-lowering effect and increase susceptibility to hypoglycaemia include oral antidiabetic medicinal products, angiotensin converting enzyme (ACE) inhibitors, disopyramide, fibrates, fluoxetine, monoamine oxidase (MAO) inhibitors, pentoxifylline, propoxyphene, salicylates and sulphonamide antibiotics.
Croatian: Tvari koje mogu pojačati učinak na snižavanje razine glukoze u krvi i povećati sklonost hipoglikemiji obuhvaćaju oralne antidijabetike, inhibitore angiotenzin konvertirajućeg enzima (ACE), dizopiramid, fibrate, fluoksetin, inhibitore monoamino-oksidaze (MAO), pentoksifilin, propoksifen, salicilate i sulfonamidske antibiotike.
English: It comes in cartridges designed for use in Hoechst Infusor and H-Tron (insulin pumps).
Croatian: Isporučuje se u ulošcima koji su namijenjeni za uporabu u pumpama Hoechst Infusor i H-Tron (inzulinske pumpe).
English: SoloStar delivers insulin in doses from 1 to 80 units in steps of 1 unit.
Croatian: Brizgalicom SoloStar može se odabrati doza inzulina u rasponu od 1 do 80 jedinica odmjeravanjem po 1 jedinice.
English: The outside of the SoloStar can be cleaned by wiping it with a damp cloth.
Croatian: Vanjski dio SoloStar brizgalice može se prebrisati vlažnom krpom.
English: Empty cartridges must not be refilled.
Croatian: Prazni ulošci ne smiju se ponovno puniti.
English: Insulin Human Winthrop Infusat is therefore also suitable for continuous insulin infusion with other, conventional injection syringe pumps.
Croatian: Insulin Human Winthrop Infusat je stoga prikladan i za kontinuiranu inzulinsku infuziju primjenom drugih, standardnih pumpi sa štrcaljkom.
English: The pen should be used as recommended in the information provided by the device manufacturer.
Croatian: Brizgalica se mora koristiti sukladno preporukama proizvođača tog medicinskog proizvoda.
English: Before using SoloStar, the Instructions for Use included in the Package Leaflet must be read carefully.
Croatian: Prije uporabe brizgalice SoloStar moraju se pažljivo pročitati Upute za uporabu koje su sastavni dio Upute o lijeku.
English: Keep the cartridge at room temperature for 1 or 2 hours before inserting it into the pen.
Croatian: Uložak držite na sobnoj temperaturi 1 do 2 sata prije nego što ga umetnete u brizgalicu.
English: You can clean the outside of your SoloStar by wiping it with a damp cloth.
Croatian: Vanjski dio svoje SoloStar brizgalice možete prebrisati vlažnom krpom.
English: Do not shake the vial vigorously as this could damage the insulin and cause froth to form.
Croatian: Bočicu nemojte snažno tresti jer može doći do oštećenja inzulina i pjenjenja.
English: SoloStar is a pre-filled disposable pen containing human insulin.
Croatian: SoloStar je napunjena brizgalica za jednokratnu uporabu koja sadrži humani inzulin.
English: Before use, the filled cartridge must be kept at room temperature for 1 to 2 hours.
Croatian: Prije primjene napunjeni uložak mora se čuvati na sobnoj temperaturi tijekom 1-2 sata.
English: This helps prevent contamination and/or infection, entry of air into the insulin reservoir and leakage of insulin.
Croatian: Tako će se spriječiti onečišćenje i/ili infekcija te ulazak zraka u spremnik s inzulinom i istjecanje inzulina, što može prouzročiti netočno doziranje.
English: Also, it must NOT be mixed with animal source insulins or insulin analogues.
Croatian: Osim toga, NE smije se miješati s inzulinima životinjskog podrijetla niti s inzulinskim analozima.
English: Insulin Human Winthrop Infusat has been specially designed for use in external portable insulin pumps.
Croatian: Insulin Human Winthrop Infusat posebno je namijenjen za primjenu u vanjskim prijenosnim inzulinskim pumpama.
English: After resuspension, the fluid must have a uniformly milky appearance.
Croatian: Nakon resuspenzije tekućina mora biti jednoliko mliječna.
English: Before travelling, consult your doctor.
Croatian: Obratite se svom liječniku za savjet prije putovanja.
English: Froth can make it difficult for you to measure the correct dose.
Croatian: Pjena može otežati točno odmjeravanje doze.
English: Insulin label must always be checked before each injection to avoid medication errors between insulin human and other insulins (see section 4.4).
Croatian: Prije svake injekcije uvijek se mora provjeriti naljepnica na inzulinu kako ne bi došlo do pogrešaka u primjeni zbog zamjene humanog inzulina i drugih inzulina (vidjeti dio 4.4).
English: Following transfer from an animal insulin to human insulin, dose regimen reduction may be required in particular in patients who - were previously already controlled on rather low blood glucose levels, - have a tendency to hypoglycaemia, - previously required high insulin doses due to the presence of insulin antibodies.
Croatian: Nakon prijelaza sa životinjskog inzulina na humani inzulin može biti potrebno smanjenje doze, naročito u bolesnika: - koji su prethodno već bili regulirani na relativno niskim razinama glukoze u krvi, - koji su skloni hipoglikemiji, - kojima su prethodno trebale visoke doze inzulina zbog prisutnosti protutijela na inzulin.
English: Air bubbles must be removed before starting the infusion (see the operator's manual for the pump).
Croatian: Prije početka infuzije moraju se ukloniti mjehurići zraka (vidjeti priručnik za uporabu pumpe).
English: Always perform the safety test before each injection.
Croatian: Prije svake injekcije uvijek treba provesti test sigurnosti.
English: The manufacturer's instructions for using the pen must be followed carefully for loading the cartridge, attaching the injection needle, and administering the insulin injection.
Croatian: Moraju se pažljivo slijediti upute proizvođača za umetanje uloška, pričvršćivanje igle za injekciju te primjenu injekcije inzulina.
English: Adherence of the patient to the dose regimen and dietary regimen, correct insulin administration and awareness of hypoglycaemia symptoms are essential to reduce the risk of hypoglycaemia.
Croatian: Za smanjenje rizika od hipoglikemije neophodno je da se bolesnik pridržava režima doziranja i prehrane, da pravilno primjenjuje inzulin te da prepoznaje simptome hipoglikemije.
English: What should you do if you experience hypoglycaemia
Croatian: Što trebate učiniti u slučaju hipoglikemije
English: Make sure that neither alcohol nor other disinfectants or other substances contaminate the insulin.
Croatian: Pazite da alkohol i druga sredstva za dezinfekciju ili druge tvari ne onečiste inzulin.
English: Insulin pump faults
Croatian: Kvar inzulinske pumpe
English: Packs of 3 vials are available.
Croatian: Dostupna su pakovanja od 3 bočice.
English: • Eye reactions
Croatian: • poremećaji oka
English: However, use only those injection syringes which are designed for an insulin concentration of 100 IU (International Units) per ml.
Croatian: Međutim, smijete koristiti samo štrcaljke za injekciju koje su namijenjene za koncentraciju inzulina od 100 IU (internacionalnih jedinica) po mililitru.
English: Take off the inner needle cap and discard it.
Croatian: Skinite unutarnji zatvarač igle i bacite ga u otpad.
English: For details on safety precautions in the use of insulin pumps, refer to the operator's manual.
Croatian: Za pojedinosti o mjerama sigurnosti kod primjene inzulinskih pumpi pročitajte priručnik za uporabu.
English: How to handle the cartridges
Croatian: Kako rukovati ulošcima
English: Shelf life after first use of the pen
Croatian: Rok valjanosti nakon prve uporabe brizgalice
English: Diabetic retinopathy; Visual impairment
Croatian: Poremećaji oka proliferativna retinopatija; dijabetička retinopatija; poremećaj vida
English: D-65926 Frankfurt / Main Germany
Croatian: D-65926 Frankfurt na Majni Njemačka
English: Each ml contains 100 IU insulin human (equivalent to 3.5 mg).
Croatian: Jedan ml sadrži 100 IU humanog inzulina (što odgovara 3,5 mg).
English: For information on the treatment of hypoglycaemia, see box at the end of this leaflet.
Croatian: Za informacije o liječenju hipoglikemije, pogledajte uokvireni tekst na kraju ove Upute o lijeku.
English: Insulin Human Winthrop Infusat with alcohol
Croatian: Insulin Human Winthrop Infusat s alkoholom