FrancophonIA/ELRC3.0 huggingface dataset:
English: • Skin erosion: the movements of the pump can erode your skin
Croatian: • oštećenje kože: pomicanje pumpe može uzrokovati oštećenje kože
English: Following the change from an animal insulin to human insulin, dose reduction may be required in particular in patients who:
Croatian: Nakon prijelaza sa životinjskog inzulina na humani inzulin može biti potrebno smanjenje doze, naročito u bolesnika:
English: To avoid under-delivery which may occur when insulin deposits collect in the pumping mechanism inside the pump, it is recommended to follow a rinse procedure every 6 months.
Croatian: Kako bi se izbjegla primjena premale doze inzulina, do koje može doći kada se inzulin nataloži u mehanizmu za pumpanje unutar pumpe, preporučuje se provesti postupak ispiranja svakih 6 mjeseci.
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: Prijavljeni su slučajevi zatajivanja srca kod primjene pioglitazona u kombinaciji s inzulinom, osobito u bolesnika koji su imali rizične faktore za razvoj zatajivanja srca.
English: The pump is not connected to a glucose meter.
Croatian: Pumpa nije spojena s mjeračem glukoze.
English: • The most frequent side effect is hypoglycaemia (low blood sugar).
Croatian: • Najčešća nuspojava je hipoglikemija (niska razina šećera u krvi).
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: During a refill procedure, never push in the refill syringe plunger to fill the pump.
Croatian: Za vrijeme postupka nadopunjavanja, nikada ne smijete pritiskati klip štrcaljke za nadopunjavanje da biste nadopunili pumpu.
English: Insuman Rapid is a solution for injection under the skin or, in exceptional circumstances, into a vein (blood vessel).
Croatian: Insuman Rapid je otopina za injekciju koja se daje pod kožu ili, u iznimnim slučajevima, u venu (krvnu žilu).
English: • certain uncompensated endocrine disorders (e.g. in hypothyroidism and in anterior pituitary or adrenocortical insufficiency),
Croatian: • neke nekompenzirane endokrinološke poremećaje (npr. kod hipotireoze i insuficijencije adenohipofize ili kore nadbubrežne žlijezde)
English: Medical device change due to device malfunction Device blockage
Croatian: Operativni i medicinski postupci promjene na medicinskom proizvodu zbog kvara uređaja blokada uređaja
English: However, three studies were conducted in rats to assess the potential toxicity of administration of human insulin via the intraperitoneal route.
Croatian: Međutim, provedena su tri istraživanja u štakora u kojima se ispitivala potencijalna toksičnost primjene humanog inzulina intraperitonejskim putem.
English: Infection of the pump pocket
Croatian: Infekcija džepa za pumpu
English: This may require a change to your insulin dose (see section 4).
Croatian: To može zahtijevati promjenu doze inzulina (vidjeti dio 4.).
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 prilagodbe doze.
English: 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: Before you can use the Medtronic MiniMed Implantable Pump, you will be trained.
Croatian: Prije nego što počnete koristiti Medtronic MiniMed pumpu za implantaciju, proći ćete obuku.
English: (metabolic status, acid-base and electrolyte status, vital parameters etc.) in an intensive care unit or similar setting.
Croatian: Taj režim zahtijeva intenzivan nadzor (metabolički status, acido-bazni status i status elektrolita, vitalni parametri itd.) u jedinici intenzivnog liječenja ili u sličnom okruženju.
English: In another study, rats also received the same semi-synthetic insulin via an intraperitoneally implanted osmotic mini-pump infusion for up to 6 weeks.
Croatian: U drugom su ispitivanju štakori primali isti taj polusintetski inzulin u obliku infuzije intraperitonejski implantiranom osmotskom mini pumpom tijekom najviše 6 tjedana.
English: • the patient's life-style changes,
Croatian: • se promjeni način života bolesnika
English: • Patient selection criteria
Croatian: • kriterije za odabir bolesnika
English: If you are ill or have mental problems that make you unable to make changes to your pump based on your blood glucose level or to take the appropriate actions if you have a problem with your pump, talk to your doctor.
Croatian: Ako ste bolesni ili imate psihičke tegobe koje Vam onemogućuju da unosite izmjene u pumpu na temelju izmjerenih razina glukoze u krvi ili da poduzmete odgovarajuće mjere u slučaju problema s pumpom, obratite se svom liječniku.
English: • When under-delivery is caused by a problem with the pump, a rinse procedure should be performed.
Croatian: • Ako je primjena nedovoljne količine inzulina posljedica problema s pumpom, treba provesti postupak ispiranja.
English: Please refer to section 6.6 and the Physician's Manual, which describe how to diagnose potential pump system problems that may cause insulin under-delivery, and how to correct and prevent under-delivery.
Croatian: Vidjeti dio 6.6 i Priručnik za liječnike, u kojima se opisuje kako dijagnosticirati moguće probleme sa sustavom pumpe koji mogu uzrokovati primjenu premale doze inzulina te kako ispraviti i spriječiti primjenu premale doze.
English: If this happens, contact your doctor immediately.
Croatian: Ako do toga dođe, odmah se obratite svom liječniku.
English: Two vials of Insuman Implantable (2 x 10 ml) are required to completely refill the pump reservoir and exclude air from entering the pump reservoir during the refill procedure.
Croatian: Potrebne su dvije bočice lijeka Insuman Implantable (2 x 10 ml) da bi se spremnik pumpe potpuno napunio i da bi se onemogućio ulazak zraka u spremnik za vrijeme nadopunjavanja.
English: The Medtronic MiniMed Implantable Pump is not designed for use at elevations above 2439 meters (8000 feet) or below 7.6 meters (25 feet).
Croatian: Medtronic MiniMed pumpa za implantaciju nije namijenjena za primjenu na nadmorskim visinama iznad 2439 metara niti na dubinama ispod 7,6 metara.
English: you are taking or have taken certain other medicines (see section 2, "Other medicines and Insuman Rapid").
Croatian: - ako uzimate ili ste uzimali neke druge lijekove (vidjeti dio 2. "Drugi lijekovi i Insuman Rapid").
English: For further details on handling see section 6.6 and instructions provided in the Physician's manual.
Croatian: Za više pojedinosti o rukovanju vidjeti dio 6.6 i upute u Priručniku za liječnike.
English: - In your brain
Croatian: - u mozgu
English: In addition, formation of a biofilm over the tip of the Side Port Catheter may cause latent hypoglycemia as the insulin programmed over time is trapped in the biofilm and is released after a sufficient volume of insulin has accumulated.
Croatian: Osim toga, stvaranje biofilma preko vrška bočnog katetera može uzrokovati latentnu hipoglikemiju jer se programirana količina inzulina s vremenom skuplja u biofilmu i zatim otpušta nakon što se nakupi dovoljna količina inzulina.
English: During the refill procedure it is important to fill out the refill worksheet and to calculate refill accuracy to evaluate system function.
Croatian: Za vrijeme nadopunjavanja važno je podatke o nadopunjavanju unijeti u radni list te izračunati preciznost nadopunjavanja kako bi se ocijenilo funkcioniranje sustava.
English: After intraperitoneal administration of Insuman Implantable 0.15 IU/kg, the median Tmax was 0.54 hours and Cmax in serum was 210 ± 129 microIU/ml.
Croatian: Nakon intraperitonejske primjene lijeka Insuman Implantable u dozi od 0,15 IU/kg, medijan vrijednosti Tmax iznosio je 0,54 sata, a Cmax u serumu bio je 210 ± 129 µIU/ml.
English: Insulin administration via the pump can cause a fat infiltration of the liver at single, well-defined locations (called focal hepatic steatosis).
Croatian: Primjena inzulina pumpom može uzrokovati masnu infiltraciju jetre na pojedinim, dobro ograničenim mjestima (stanje koje se naziva fokalnom steatozom jetre).
English: • concomitant treatment with certain other medicinal products (see section 4.5).
Croatian: • istodobno liječenje određenim drugim lijekovima (vidjeti dio 4.5)
English: Most minor reactions to insulins at the injection site 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: For Insuman Implantable administered via the intraperitoneal pump, the safety profile has not been established in pregnancy.
Croatian: Za Insuman Implantable primijenjen intraperitonejskom pumpom nije ustanovljen profil sigurnosti u trudnoći.
English: Depending on blood glucose values, an appropriate bolus amount must be programmed to remove the sterile rinse buffer solution from the catheter.
Croatian: Ovisno o vrijednostima glukoze u krvi, nužno je programirati primjenu određene količine u bolusu kako bi se sterilna puferska otopina za ispiranje uklonila iz katetera.
English: If you use more Insuman Implantable than you should Your doctor will program maximum dose limits into your PPC.
Croatian: Ako primijenite više lijeka Insuman Implantable nego što ste trebali Liječnik će u Vaš osobni daljinski upravljač za pumpu programirati ograničenja za maksimalnu dozu.
English: In a third study conducted in diabetic rats, administration of another human insulin with a formulation similar to Insuman via a catheter fixed to the liver capsule showed that intraperitoneal administration of high local insulin concentration at the liver capsule may induce reversible focal hepatic steatosis.
Croatian: U trećem ispitivanju provedenom u štakora sa šećernom bolešću, primjena drugog humanog inzulina, čija je formulacija slična onoj lijeka Insuman, kroz kateter pričvršćen za ovojnicu jetre pokazala je da intraperitonejska primjena visoke koncentracije inzulina lokalno u ovojnicu jetre može inducirati reverzibilnu fokalnu steatozu jetre.
English: Insuman SoloStar is white with a colour on the injection button.
Croatian: Insuman SoloStar je bijele boje s obojenim dugmetom za injiciranje.
English: In addition, use of Insuman Implantable in continuous intraperitoneal infusion resulted in stable glycaemic control in patients with type 1 diabetes mellitus (per protocol population: mean reduction: -0.25 ± 0.67; [95% CI: -0.36; 0.11]) without increasing the risk of severe hypoglycaemia compared to semi-synthetic human insulin (14.3% versus 13.1%).
Croatian: Osim toga, primjena lijeka Insuman Implantable kontinuiranom intraperitonejskom infuzijom dovela je do stabilne kontrole glikemije u bolesnika sa šećernom bolešću tipa 1 (populacija prema protokolu: srednje smanjenje: -0,25 ± 0,67; [95% CI: -0,36; 0,11]) bez povećanja rizika od teške hipoglikemije u usporedbi s polusintetskim humanim inzulinom (14,3% naspram 13,1%).
English: If you are using clear insulin (Insuman Rapid), do not use this pen if the insulin is cloudy, coloured or has particles.
Croatian: Ako primjenjujete bistar inzulin (Insuman Rapid), ne smijete upotrijebiti ovu brizgalicu ako je inzulin zamućen, obojen ili sadrži čestice.
English: The insulin solution must be then degassed according to the degassing procedure described in the Physician's manual.
Croatian: Otopina inzulina mora se zatim otpliniti u skladu s postupkom otplinjavanja opisanom u Priručniku za liječnike.
English: At study initiation, half of the patients were switched to Insuman Implantable, while the other half remained on the semi-synthetic human insulin.
Croatian: Na početku ispitivanja polovica je bolesnika prebačena na Insuman Implantable, a ostali su nastavili primati polusintetski humani inzulin.
English: The patient should be advised by the physician what needs to be done in case of travel, e.g. what to do if the pump malfunctions, availability of insulin and facility to replace the insulin, and who to contact in case of emergency.
Croatian: Liječnik mora savjetovati bolesnika o tome što učiniti u slučaju putovanja, npr. što učiniti ako se pumpa pokvari, o dostupnosti inzulina i ustanovama u kojima ga može zamijeniti te o tome kome se mora obratiti u hitnom slučaju.
English: Infections around the pump implantation site may require the removal of your pump (explantation of the pump).
Croatian: Infekcije na mjestu ugradnje pumpe mogu zahtijevati uklanjanje pumpe (eksplantaciju pumpe).
English: Do not extend this period of time.
Croatian: Nemojte čekati dulje od toga.
English: The patient should correct resistant hyperglycaemia with a standard dose of subcutaneous insulin.
Croatian: Bolesnik mora korigirati rezistentnu hiperglikemiju standardnom dozom inzulina za supkutanu primjenu.
English: The PPC prompts you with messages on the screen.
Croatian: Osobni daljinski upravljač za pumpu obavještava Vas o tome porukom na zaslonu.
English: Patients must be informed to closely monitor blood glucose levels on refill days (see section 6.6).
Croatian: Bolesnike treba upozoriti da moraju pažljivo pratiti razine glukoze u krvi na dan nadopunjavanja pumpe (vidjeti dio 6.6).
English: • a regimen with only regular insulin to one with a longer-acting insulin.
Croatian: • s režima doziranja u kojem se primjenjuje samo običan inzulin na režim u kojem se primjenjuje inzulin s duljim djelovanjem.
English: Potential under-delivery of insulin by the Medtronic MiniMed Implantable Pump may result in an increase in daily programmed insulin usage, difficulty maintaining euglycaemia, refractory hyperglycaemia, and steady decrease in refill accuracy.
Croatian: Moguća primjena premale doze inzulina Medtronic MiniMed pumpom za implantaciju može dovesti do povećanja u programiranoj dnevnoj primjeni inzulina, poteškoća u održavanju euglikemije, refrakterne hiperglikemije i stalnoga smanjenja preciznosti nadopunjavanja.
English: • Patient quick guides on the main programming functions
Croatian: • brzim vodičima o glavnim funkcijama programiranja za bolesnike
English: • Device components
Croatian: • dijelove uređaja
English: Women of childbearing potential, implanted or candidates for implantation, should inform their physician if they are contemplating pregnancy.
Croatian: Žene reproduktivne dobi kojima je pumpa implantirana ili su kandidatkinje za implantaciju moraju obavijestiti liječnika ako razmišljaju o trudnoći.
English: If you are using a suspension insulin (Insuman Basal or Insuman mixtures), turn the pen up and down at least 10 times to resuspend the insulin.
Croatian: Ako primjenjujete suspenziju inzulina (Insuman Basal ili mješavine lijeka Insuman), okrenite brizgalicu gore-dolje najmanje deset puta da biste promiješali inzulin.
English: Changes in basal and bolus doses are controlled by means of a small, hand held unit (Personal Pump Communicator (PPC)) which communicates with the pump via radio waves.
Croatian: Promjene bazalnih i bolusnih doza kontroliraju se malom, ručnom jedinicom (osobnim daljinskim upravljačem za pumpu) koja se s pumpom povezuje radiovalovima.
English: Reasons for initiation of continuous intra-peritoneal insulin infusion (CIPII) were brittle diabetes in 62.7%, hypoglycaemia in 29.2%, insulin peripheral resistance in 5.0% and hypoglycaemia and brittle diabetes in 3.1%.
Croatian: Razlozi za uvođenje kontinuirane intraperitonejske infuzije inzulina bili su nestabilna šećerna bolest u 62,7% bolesnika, hipoglikemija u 29,2% bolesnika, periferna rezistencija na inzulin u 5,0% bolesnika te hipoglikemija i nestabilna šećerna bolest u 3,1% bolesnika.
English: The implantable pump may erode through the skin, resulting in infection of the implant site and pump explantation.
Croatian: Pumpa za implantaciju može erodirati kroz kožu te tako uzrokovati infekciju na mjestu implantacije i eksplantaciju pumpe.
English: Patients enrolled in the continuous intraperitoneal insulin infusion group received The semi-synthetic human insulin 400 IU/ml for 180 days followed by Insuman Implantable 400 IU/ml for a further 180 days.
Croatian: Bolesnici u skupini liječenoj kontinuiranom intraperitonejskom infuzijom inzulina primali su polusintetski humani inzulin u dozi od 400 IU/ml tijekom 180 dana, a nakon toga Insuman Implantable u dozi od 400 IU/ml još 180 dana.
English: When the refill needle is properly seated in the pump fill port, then the vacuum in the pump reservoir will passively draw the insulin from the syringe into the pump reservoir.
Croatian: Kada igla za nadopunjavanje pravilno sjedne u otvor za nadopunjavanje pumpe, vakuum iz spremnika pumpe pasivno će povući inzulin iz štrcaljke u spremnik pumpe.
English: Focal hepatic steatosis
Croatian: Fokalna steatoza jetre
English: Always use this medicine exactly as your doctor or nurse has told you.
Croatian: Uvijek primijenite ovaj lijek točno onako kako su Vam rekli Vaš liječnik ili medicinska sestra.
English: Insuman Implantable is indicated for the treatment of adult patients with type 1 diabetes mellitus that cannot be controlled with subcutaneous insulin (including pump) therapy, presenting with frequent, otherwise unexplained severe hyper-and/or hypoglycaemia.
Croatian: Insuman Implantable je indiciran za liječenje odraslih bolesnika sa šećernom bolešću tipa 1 u kojih se glikemija ne može regulirati liječenjem inzulinom za supkutanu primjenu (uključujući pumpu) i u kojih se često javlja neobjašnjiva i teška hiperglikemija i/ili hipoglikemija.
English: • A refill accuracy of less than 85% is calculated during a refill procedure.
Croatian: • se tijekom postupka nadopunjavanja izračuna preciznost nadopunjavanja manja od 85%.
English: Insert the needle into the skin.
Croatian: Ubodite iglu u kožu.
English: When the catheter tip is fixed in the liver capsule, administration of insulin via the intra-peritoneal route is associated with an increased risk of focal hepatic steatosis (see section 4.4).
Croatian: Kad se vršak katetera nalazi u ovojnici jetre, primjena inzulina intraperitonejskim putem povezana je s povećanim rizikom od fokalne steatoze jetre (vidjeti dio 4.4).
English: The stroke volume measurement procedure tests pump function, while a catheter flush procedure tests catheter patency.
Croatian: Postupkom mjerenja udarnog volumena ispituje se funkcija pumpe, a postupkom ispiranja katetera ispituje se prohodnost katetera.
English: The basal metabolic requirement is usually 40% to 60% of the total daily insulin requirement.
Croatian: Bazalna metabolička potreba obično iznosi 40% do 60% ukupne dnevne potrebe za inzulinom.
English: This seems to be reversible when your catheter is repositioned or your insulin infusion stopped and without consequences on your health (see section 4).
Croatian: Čini se da se ovo stanje povlači kada se kateter premjesti ili kada se prekine infuzija inzulina, a ne ostavlja posljedice na zdravlje (vidjeti dio 4.).
English: Clinically relevant over-delivery of insulin was not observed during a 4 year period of evaluation of the Medtronic MiniMed Implantable Pump; however, this does not exclude the potential for such an occurrence.
Croatian: Tijekom 4-godišnjeg razdoblja ocjene Medtronic MiniMed pumpe za implantaciju nije primijećena klinički značajna primjena prevelike doze inzulina; međutim, to ne isključuje mogućnost da se to dogodi.
English: If insulin under-delivery is revealed during a refill procedure or suspected due to insufficient blood glucose control, diagnostic procedures must be performed to check if the problem is due to the pump (i.e. jammed pumping mechanism/backflow) or catheter (i.e. catheter occlusion).
Croatian: Ako se tijekom postupka nadopunjavanja otkrije ili posumnja na primjenu premale doze inzulina na temelju nedostatne kontrole glukoze u krvi, moraju se provesti dijagnostički postupci kako bi se utvrdilo je li problem u pumpi (zaglavljen mehanizam za pumpanje/povrat inzulina u spremnik) ili kateteru (začepljenje katetera).
English: The MAH shall ensure that all patients receive training in the following key elements regarding the Insuman Implantable Pump 400 IU/ml:
Croatian: Nositelj odobrenja mora se pobrinuti da svi bolesnici prođu obuku o sljedećim ključnim elementima povezanima s Insuman Implantable 400 IU/ml pumpom za implantaciju:
English: You must check your blood sugar level at least four times daily to detect and prevent high blood sugar levels due to the pump not working properly.
Croatian: Morate provjeravati razinu šećera u krvi najmanje četiri puta na dan kako biste uočili i spriječili visoke razine šećera u krvi uzrokovane nepravilnim radom pumpe.
English: Important information about some of the ingredients of Insuman Implantable This medicine contains less than 1 mmol (23 mg) sodium per dose, i.e. it is essentially ‘sodium-free'.
Croatian: Važne informacije o nekim sastojcima lijeka Insuman Rapid Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po dozi, tj. zanemarive količine natrija.
English: Before use of the 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 addition, you should read and follow the instructions given in the patient manual accompanying the Medtronic MiniMed Implantable Pump.
Croatian: Osim toga, morate pročitati i pridržavati se uputa navedenih u Priručniku za bolesnike koji je priložen uz Medtronic MiniMed pumpu za implantaciju.
English: The co-primary endpoint was change in HbA1c from baseline and the pump refill accuracy after 4 refill cycles (162 ± 21 days).
Croatian: Dvije primarne mjere ishoda bile su promjena vrijednosti HbA1c u odnosu na početnu vrijednost te preciznost nadopunjavanja pumpe nakon 4 ciklusa nadopunjavanja (162 ± 21 dana).
English: Insuman Rapid with alcohol
Croatian: Insuman Rapid s alkoholom
English: These cartridges should not be used with any other reusable pen as the dosing accuracy has only been established with the listed pens (see section 4.2 and 6.6).
Croatian: Ovi ulošci ne smiju se upotrebljavati niti s jednom drugom brizgalicom za višekratnu primjenu jer je preciznost doziranja utvrđena samo s navedenim brizgalicama (vidjeti dio 4.2 i 6.6).
English: The patient should read and follow the instructions in the Patient Manual accompanying the infusion pump.
Croatian: Bolesnik mora pročitati i slijediti upute navedene u Priručniku za bolesnike, koji je priložen uz infuzijsku pumpu.
English: • Rinse and flush procedure, stroke measurement and pump management including troubleshooting
Croatian: • postupke ispiranja, mjerenje udarnog volumena i rukovanje pumpom, uključujući otkrivanje problema
English: Insuman Implantable is a high-concentrated insulin formulation Insuman Implantable contains 400 international units of insulin in each ml.
Croatian: Insuman Implantable je formulacija s visokom koncentracijom inzulina Insuman Implantable sadrži 400 internacionalnih jedinica inzulina u jednome mililitru.
English: • Information on the registry including how to, and the importance of, entering patients in it • Surgical aspects of implantation
Croatian: • informacije o registru, uključujući podatke o načinu i važnosti unošenja bolesnika u registar
English: The catheter is flushed by using 5-10 ml of sterile rinse buffer solution.
Croatian: Kateter se ispire s 5-10 ml sterilne puferske otopine za ispiranje.