FrancophonIA/ELRC3.0 huggingface dataset:
English: You will be admitted to the hospital to have the Medtronic MiniMed Implantable Pump surgically implanted in your belly.
Croatian: Bit ćete primljeni u bolnicu kako bi Vam se Medtronic MiniMed pumpa za implantaciju kirurški ugradila u trbuh.
English: Implant site infection (see section 4.4)
Croatian: Infekcije i infestacije infekcija na mjestu implantacije (vidjeti dio 4.4)
English: Unopened vials, unopened cartridges
Croatian: Neotvorene bočice, neotvoreni ulošci
English: Intraperitoneal insulin administration was similar to subcutaneous administration as demonstrated by change in HbA1c value from baseline (for continuous intraperitoneal administration: HbA1c value at Day 360 was 7.78 ± 1.04 versus 8.06 ± 0.77 at baseline; for subcutaneous administration: HbA1c value at Day 360 was 8.19 ± 0.87 versus 8.12 ± 0.76 at baseline).
Croatian: Promjena vrijednosti HbA1c u odnosu na početnu vrijednost bila je podjednaka kod intraperitonejske primjene i kod supkutane primjene inzulina (kontinuirana intraperitonejska primjena: vrijednost HbA1c 360. dana iznosila je 7,78 ± 1,04 naspram 8,06 ± 0,7 na početku ispitivanja;
English: Other medicines and Insuman Rapid
Croatian: Drugi lijekovi i Insuman Rapid
English: To prevent pump problems, your doctor will schedule appointments at least every 6-months to rinse your pump.
Croatian: Da bi se problemi s pumpom izbjegli, liječnik će Vam zakazati kontrolni pregled najmanje svakih 6 mjeseci kako bi isprao pumpu.
English: Insuman 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: Insuman 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: In patients who require high insulin doses because of the presence of insulin antibodies, transfer under medical supervision in a hospital or similar setting must be considered.
Croatian: U bolesnika kojima su potrebne visoke doze inzulina, zbog prisutnosti protutijela na inzulin, mora se razmotriti prijelaz pod liječničkim nadzorom u bolnici ili sličnom okruženju.
English: The pump is not connected to a glucose meter, and as such, patients are advised to practice good diabetes self management and test their own blood glucose levels at least four times daily to detect potential malfunction of the pump, to monitor glycaemic control and to determine required insulin doses.
Croatian: Budući da pumpa nije povezana s mjeračem glukoze, bolesnicima se savjetuje da dobro provode samokontrolu šećerne bolesti te da provjeravaju razinu glukoze u krvi najmanje četiri puta na dan kako bi se otkrio mogući kvar pumpe, nadzirala regulacija glikemije i odredile potrebne doze inzulina.
English: In literature, insulin pharmacokinetics are generally described to be reproducible in patients with type 1 diabetes mellitus receiving short-term and long-term continuous intraperitoneal insulin infusion.
Croatian: U stručnoj se literaturi navodi da je farmakokinetika inzulina u načelu ponovljiva u bolesnika sa šećernom bolešću tipa 1 koji primaju kratkotrajnu i dugotrajnu kontinuiranu intraperitonejsku infuziju inzulina.
English: Insuman Rapid").
Croatian: Rapid").
English: Other medicines and Insuman Implantable
Croatian: Drugi lijekovi i Insuman Implantable
English: Insuman Implantable administered in continuous intraperitoneal infusion was also similar to semi-synthetic human insulin as demonstrated by the refill accuracy criteria over the 4-refill cycles (per protocol population: mean difference: -3.15 ± 1.34; [95% CI: -5.81; -0.50]).
Croatian: Insuman Implantable primijenjen kontinuiranom intraperitonejskom infuzijom bio je sličan polusintetskom humanom inzulinu i kada je u pitanju parametar preciznosti nadopunjavanja tijekom 4 ciklusa nadopunjavanja (populacija prema protokolu: srednja razlika: -3,15 ± 1,34; [95% CI: -5,81; -0,50]).
English: Beware: Artificial sweeteners and foods with artificial sweeteners (such as diet drinks) are of no help in treating hypoglycaemia.
Croatian: Oprez: Umjetni zaslađivači i hrana zaslađena umjetnim zaslađivačima (primjerice dijetalni napici) ne pomažu u slučaju hipoglikemije.
English: Your doctor will be handling the insulin vials and has the accessories (e.g. refill syringes and needles) and equipment required to fill your implantable pump.
Croatian: Za rukovanje bočicama inzulina zadužen je Vaš liječnik, koji ima sav pribor (npr. štrcaljke i igle za nadopunjavanje) i opremu potrebnu za nadopunjavanje pumpe za implantaciju.
English: If administration by syringe or intravenous injection is necessary, a vial should be used.
Croatian: Ako je potrebna primjena pomoću štrcaljke ili intravenske injekcije, potrebno je koristiti bočicu.
English: Packs of 5 cartridges are available.
Croatian: Dostupna su pakiranja od 5 uložaka.
English: In case of severe hypoglycaemia, patients should immediately contact their physician trained to perform pump investigations and the pump should then be investigated by the physician for possible catheter occlusion leading to accumulation of insulin with subsequent release of this accumulated insulin (see section 6.6).
Croatian: U slučaju teške hipoglikemije bolesnici se odmah moraju obratiti liječniku obučenom za ispitivanje pumpe, a liječnik tada mora provjeriti je li u pumpi možda došlo do začepljenja katetera koje dovodi do nakupljanja inzulina, nakon čega se nakupljeni inzulin mora ispustiti (vidjeti dio 6.6).
English: No non-clinical studies assessing the potential toxicity of Insuman Implantable 400 IU/ml administered via intraperitoneal route were performed.
Croatian: Nisu provedena neklinička istraživanja kojima bi se ocijenila potencijalna toksičnost intraperitonejski primijenjenog lijeka Insuman Implantable u dozi od 400 IU/ml.
English: Infection of the pump pocket (where your pump is placed), erosion of the skin where your pump is implanted and poor healing of the incision site in your skin can occur.
Croatian: Može doći do infekcije džepa za pumpu (gdje je postavljena Vaša pumpa), površinskog oštećenja kože na mjestu gdje je pumpa ugrađena ili slabog cijeljenja kože na mjestu gdje je napravljen kirurški rez.
English: Time of refill of insulin pump
Croatian: Vrijeme nadopunjavanja inzulinske pumpe
English: The patient must be closely monitored for possible hypoglycaemia and administered intravenous glucose or glycogen as needed.
Croatian: Bolesnika se mora pažljivo nadzirati zbog moguće pojave hipoglikemije te po potrebi primijeniti intravensku glukozu ili glikogen.
English: Insuman Infusat has been specially designed for use in external portable insulin pumps.
Croatian: Insuman Infusat posebno je namijenjen za primjenu u vanjskim prijenosnim inzulinskim pumpama.
English: Medication errors involving mix-up between subcutaneous Insuman formulations or other subcutaneous insulins have been reported.
Croatian: Prijavljene su medikacijske pogreške pri primjeni lijekova kada je došlo do zamjene sa supkutanim formulacijama lijeka Insuman ili drugim supkutanim inzulinima.
English: The patient should also be provided with alternative means of supplying insulin, e.g. provide the patient with 100 IU/ml insulin, devices, and supplies for subcutaneous injections.
Croatian: Bolesniku također treba dati alternativna sredstva za opskrbu inzulinom, npr. 100 IU/ml inzulina te pomagala i pribor za primjenu supkutanih injekcija.
English: Otherwise stroke volume values outside this range or the detection of backflow is indicative of a pump problem.
Croatian: Udarni volumeni izvan navedenog raspona ili povrat inzulina u spremnik ukazuju na problem s pumpom.
English: Acute toxicity of insulin human was studied following subcutaneous administration in rats.
Croatian: Akutna toksičnost humanog inzulina ispitana je nakon supkutane primjene u štakora.
English: • after transfer from animal insulin to human insulin,
Croatian: • koji su prešli sa životinjskog inzulina na humani inzulin
English: If you are breast-feeding consult your doctor as you may require adjustments in your insulin doses and your diet.
Croatian: Ako dojite, obratite se svome liječniku za savjet jer će možda biti potrebno prilagoditi dozu inzulina i prehranu.
English: Insulin may also cause sodium retention, particularly if previously poor metabolic control is improved by intensified insulin therapy
Croatian: Inzulin može dovesti i do retencije natrija, pogotovo ako je ranija slaba regulacija metabolizma poboljšana intenziviranim liječenjem inzulinom.
English: Pushing insulin in this circumstance could result in unintended insulin delivery to the subcutaneous tissue around the pump fill port.
Croatian: Uštrcavanje inzulina u takvim okolnostima može dovesti do istjecanja inzulina u supkutano tkivo oko otvora za nadopunjavanje pumpe.
English: Focal hepatic steatosis has been reported in few patients receiving the semi-synthetic human insulin, when the catheter was in very close proximity to the liver.
Croatian: Fokalna steatoza jetre prijavljena je u malog broja bolesnika koji su primali polusintetski humani inzulin Insuplant kada se kateter nalazio veoma blizu jetre.
English: Patients should practice good diabetes self care and check their blood glucose a minimum of 4 times daily to detect and prevent hyperglycemia and possible diabetic ketoacidosis due to pump under-delivery.
Croatian: Bolesnici moraju dobro provoditi samokontrolu šećerne bolesti i provjeravati razine glukoze u krvi najmanje 4 puta dnevno kako bi se otkrila i spriječila hiperglikemija i moguća dijabetička ketoacidoza uzrokovana primjenom premale doze pumpom.
English: What Insuman Implantable is and what it is used for
Croatian: Što je Insuman Implantable i za što se koristi
English: Insulin administration via the intraperitoneal route is likely to cause formation of anti-insulin antibodies.
Croatian: Postoji vjerojatnost da će primjena inzulina intraperitonejskim putem izazvati nastanak protutijela na inzulin.
English: Abdominal pain Umbilical hernia
Croatian: Poremećaji probavnog sustava bol u abdomenu pupčana hernija
English: Insuman Rapid may also be used for treating hyperglycaemic coma (coma caused by too much blood sugar) and ketoacidosis (build-up of acid in the blood because the body is breaking down fat instead of sugar) as well as for controlling blood sugar before, during and after surgery.
Croatian: Insuman Rapid može se primjenjivati i za liječenje hiperglikemijske kome (kome koju izaziva prevelika količina šećera u krvi) i ketoacidoze (nakupljanja kiseline u krvi do kojega dolazi zato što tijelo razgrađuje masti umjesto šećera) te za regulaciju šećera u krvi prije, za vrijeme i nakon kirurškog zahvata.
English: Transfer to Insuman Infusat
Croatian: Prijelaz na Insuman Infusat
English: Implantation of the pump in patients who reside permanently at elevations above 2439 meters (8000 feet) (see section 4.4).
Croatian: Implantacija pumpe u bolesnika koji stalno borave na nadmorskoj visini iznad 2439 metara (vidjeti dio 4.4).
English: If you are not sure whether you are taking one of those medicines, ask your doctor or nurse.
Croatian: Ako niste sigurni uzimate li jedan od tih lijekova, upitajte svog liječnika ili medicinsku sestru.
English: * Human insulin is produced by recombinant DNA technology in Escherichia coli.
Croatian: *Humani inzulin proizveden je tehnologijom rekombinantne DNK na bakteriji Escherichia coli.
English: Failure to do so may result in pump pocket infection and subsequent pump explantation (see section 4.8).
Croatian: U protivnom može doći do infekcije džepa za pumpu i posljedične eksplantacije pumpe (vidjeti dio 4.8).
English: Beta-blockers like other sympatholytic medicines (such as clonidine, guanethidine, and reserpine) may weaken or stop the first warning symptoms which help you to recognise hypoglycaemia.
Croatian: Beta-blokatori, poput drugih simpatolitičkih lijekova (kao što su klonidin, gvanetidin i rezerpin), mogu oslabiti ili zaustaviti prve upozoravajuće simptome koji Vam pomažu prepoznati hipoglikemiju.
English: Because you have type 1 diabetes, an insulin dependent diabetes mellitus, do not stop your insulin.
Croatian: Budući da imate šećernu bolest tipa 1 (šećernu bolest ovisnu o inzulinu), ne smijete prestati primjenjivati inzulin.
English: Pack of 3 vials of 10 ml is available.
Croatian: Dostupna su pakiranja od 3 bočice od 10 ml.
English: The prescription of this medicinal product is restricted to centres certified by Medtronic as having received adequate training in the use of the Medtronic MiniMed Implantable Pump.
Croatian: Propisivanje ovog lijeka ograničeno je na centre koje je Medtronic certificirao nakon propisne obuke za uporabu Medtronic MiniMed pumpe za implantaciju.
English: • Training of patients and the key information that patients need to be aware of • Ensuring that each patient receives the patient manual, the patient quick guide and the important patient information leaflet for the Medtronic MiniMed implantable insulin pump system and the patient emergency information card
Croatian: • napomenu da svaki bolesnik mora dobiti priručnik za bolesnike, brzi vodič za bolesnike i letak za bolesnike s najvažnijim podacima o sustavu Medtronic MiniMed pumpe za implantaciju te karticu s informacijama o bolesniku za hitne slučajeve
English: Abnormal healing
Croatian: Abnormalno cijeljenje
English: Insuman Implantable is for intraperitoneal use only.
Croatian: Insuman Implantable namijenjen je isključivo za intraperitonejsku primjenu.
English: She/he is trained to perform pump procedures which are needed tomake sure your pump works properly.
Croatian: On je educiran za provođenje postupaka kojima će provjeriti radi li pumpa ispravno.
English: You must closely monitor your blood sugar level on refill days.
Croatian: Morate pažljivo pratiti razine šećera u krvi na dane nadopunjavanja pumpe.
English: Patients must be informed to closely monitor blood glucose levels on refill days.
Croatian: Bolesnike se mora upozoriti da moraju pažljivo nadzirati razine glukoze u krvi na dan nadopunjavanja pumpe.
English: Before the first withdrawal of insulin you must remove the safety tear-off lid on the vial.
Croatian: Prije prvog izvlačenja inzulina u štrcaljku morate s bočice skinuti sigurnosni zatvarač koji se otkida.
English: Part of the daily insulin dose is infused continuously by the Medtronic MiniMed Implantable Pump and the remaining part of the daily dose is administered by you, using the same pump, as a bolus before meals.
Croatian: Dio dnevne doze inzulina se kontinuirano ubrizgava Medtronic MiniMed pumpom za implantaciju, a ostatak dnevne doze dajete si sami, istom tom pumpom, u obliku bolusnih injekcija prije obroka.
English: The injection syringes must not contain any other medicinal product or residue (e.g. traces of heparin).
Croatian: Štrcaljke za injekciju ne smiju sadržavati nijedan drugi lijek niti ostatke lijekova (npr. heparin u tragovima).
English: No effects on the breastfed child are anticipated.
Croatian: Ne očekuje se da bi lijek mogao imati učinak na dojenče.
English: Frequent adjustments of insulin doses under strict medical supervision are often required for several weeks following pump implantation.
Croatian: Prvih nekoliko tjedana nakon ugradnje pumpe često je potrebno učestalo prilagođavanje doze inzulina pod strogim liječničkim nadzorom.
English: If you try to deliver more than 2.5 times the bolus maximum in one hour, the alarm “hourly max exceeded” will be displayed on your PPC screen.
Croatian: Ako u jednome satu pokušate primijeniti dozu koja je više od 2,5 puta veća od maksimalne doze, na osobnom daljinskom upravljaču za pumpu pojavit će se poruka upozorenja "hourly max exceeded" ("prekoračena maks. doza po satu").
English: For use in an infusion pump, Insuman Infusat is filled into the sterile cartridge of the pump.
Croatian: Za primjenu u infuzijskoj pumpi Insuman Infusat se stavlja u sterilni uložak pumpe.
English: Insuman Infusat must only be used in insulin pumps suitable for this insulin.
Croatian: Insuman Infusat smije se upotrebljavati samo u inzulinskim pumpama koje su prikladne za ovaj inzulin.
English: Skin erosion at pump implantation site (see section 4.4)
Croatian: Poremećaji kože i potkožnog tkiva erozija kože na mjestu implantacije pumpe (vidjeti dio 4.4)
English: The active substance is insulin human.
Croatian: - Djelatna tvar je humani inzulin.
English: Failure to do so may result in pump pocket infection and subsequent pump explantation (see section 4.4).
Croatian: U protivnom može doći do infekcije džepa za pumpu i posljedične eksplantacije pumpe (vidjeti dio 4.4).
English: Use of Insuman Implantable should be supervised by a physician experienced in diabetes and competent in using intraperitoneal insulin.
Croatian: Insuman Implantable mora se primjenjivati pod nadzorom liječnika s iskustvom u liječenju šećerne bolesti i osposobljenog za intraperitonejsku primjenu inzulina.
English: Most minor reactions to insulins usually resolve in a few days to a few weeks.
Croatian: Većina blagih reakcija na inzulin obično prolazi nakon nekoliko dana ili tjedana.
English: In case of severe hypoglycaemia, the pump should be investigated by the treating physician for possible catheter occlusion leading to accumulation of insulin with subsequent release of this accumulated insulin (see sections 4.4 and 6.6).
Croatian: U slučaju teške hipoglikemije liječnik mora provjeriti je li u pumpi možda došlo do začepljenja katetera koje dovodi do nakupljanja inzulina te ispustiti nakupljeni inzulin (vidjeti dijelove 4.4. i 6.6).
English: If you forget to use Insuman Implantable
Croatian: Ako ste zaboravili primijeniti Insuman Implantable
English: During this procedure, a very small amount of Insuman Implantable may be deposited under your skin, which may result in low blood sugar levels.
Croatian: Za vrijeme nadopunjavanja vrlo mala količina lijeka Insuman Implantable može dospjeti pod kožu, što može dovesti do niskih razina šećera u krvi.
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 sluznice (angioedem), nedostatak zraka, pad krvnog tlaka s brzim otkucajima srca i znojenjem.
English: Once in the pump, Insuman Infusat may be kept for up to 2 weeks.
Croatian: Insuman Infusat u pumpi može se čuvati najdulje 2 tjedna.
English: As soon as patients notice a rapid increase in blood glucose, which does not respond to a bolus dose of insulin, the possibility of pump obstruction should be investigated by a physician trained to perform pump investigations.
Croatian: Čim bolesnici primijete brzo povećanje razine glukoze u krvi koje nije posljedica primjene bolusne doze inzulina, liječnik obučen za ispitivanje pumpe mora provjeriti je li došlo do začepljenja pumpe.
English: The following 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 zabilježene u kliničkim ispitivanjima prikazane su prema organskim sustavima 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 iz dostupnih podataka).
English: Shelf life in the pump For in-use stability, see section 6.3.
Croatian: Rok valjanosti u pumpi Za stabilnost lijeka u uporabi vidjeti dio 6.3.
English: Insuman Basal with alcohol
Croatian: Insuman Basal s alkoholom
English: The pump reservoir stores about 6,000 units of insulin and requires a refill procedure every 40 to 45 days for insulin in-use stability reasons in the pump or earlier based on the insulin needs of the patients.
Croatian: U spremnik pumpe stane približno 6000 jedinica inzulina, a treba ga nadopuniti svakih 40 do 45 dana kako bi se održala stabilnost inzulina u uporabi u pumpi.
English: If you stop using Insuman Rapid
Croatian: Ako prestanete primjenjivati Insuman Rapid
English: Do not use Insuman Rapid
Croatian: Nemojte primjenjivati Insuman Rapid
English: If your SoloStar is in cool storage, take it out 1 to 2 hours before you inject to allow it to warm up at room temperature.
Croatian: Ako SoloStar čuvate na hladnom, izvadite ga 1 do 2 sata prije injekcije kako bi se ugrijao na sobnu temperaturu.
English: One IU (International Unit) corresponds to 0.035 mg of anhydrous human insulin*.
Croatian: Jedna IU (internacionalna jedinica) odgovara 0,035 mg bezvodnog humanog inzulina*.
English: You should practice good diabetes care and test your own blood sugar levels at least four times daily to check your blood sugar levels and determine insulin doses.
Croatian: Morate dobro provoditi samokontrolu šećerne bolesti i mjeriti razine šećera u krvi najmanje četiri puta dnevno kako biste provjerili razinu šećera u krvi i odredili doze inzulina.
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 visoke razine šećera u krvi) i ketoacidoze (nakupljanja kiseline u krvi do kojega dolazi zato što tijelo razgrađuje masti umjesto šećera).
English: Make sure that you contact a doctor quickly.
Croatian: Javite se liječniku brzo.
English: 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: 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 svome liječniku za savjet o tome možete li voziti ako: - imate česte epizode hipoglikemije, - su Vam prvi upozoravajući znakovi hipoglikemije slabije izraženi ili izostaju.
English: You may feel symptoms of high blood sugar after you eat.
Croatian: Nakon obroka mogu se pojaviti simptomi visoke razine šećera u krvi.
English: If your pump has run out of insulin or is delivering less insulin than you need, you may feel symptoms of high blood sugar.
Croatian: Ako u pumpi nema više inzulina ili ako se njome primjenjuje doza inzulina manja od one koju trebate, mogu se pojaviti simptomi visoke razine šećera u krvi.
English: The vials of insulin should be withdrawn from the refrigerator and stored at room temperature in the outer carton in order to protect from light for a minimum of 4 hours and no longer than 24 hours before use.
Croatian: Bočice inzulina prije primjene treba izvaditi iz hladnjaka i čuvati na sobnoj temperaturi u vanjskom pakiranju, zaštićene od svjetlosti, tijekom najmanje 4 sata, ali ne dulje od 24 sata.
English: During the catheter flush procedure 13 units of insulin are manually pushed through the catheter and delivered to the patient.
Croatian: Tijekom postupka ispiranja katetera bolesniku se kroz kateter ručno ubrizgava 13 jedinica inzulina.
English: Under-delivery of insulin caused by catheter occlusion Under-delivery caused by Side Port Catheter occlusion can occur either abruptly or gradually.
Croatian: Primjena premale doze inzulina zbog začepljenja katetera Primjena premale količine zbog začepljenja bočnog katetera može nastupiti naglo ili postupno.
English: Do not use Insuman Implantable with any other syringes or pumps (external or implantable) than the implantable pump supplied by Medtronic MiniMed.
Croatian: Ne smijete primjenjivati Insuman Implantable u drugim štrcaljkama ili pumpama (za vanjsku primjenu ili za implantaciju) osim pumpe za implantaciju koju isporučuje Medtronic MiniMed.