FrancophonIA/ELRC3.0 huggingface dataset:
English: Anti-insulin antibodies: Limited data from a clinical trial with intraperitoneal administration of Insuman Implantable do not suggest that elevated levels of insulin antibodies are commonly associated with insulin antibody syndrome or serious adverse events (see section 4.4).
Croatian: Protutijela na inzulin: Malobrojni podaci iz kliničkog ispitivanja intraperitonejske primjene lijeka Insuman Implantable ne ukazuju na to da su povišene razine protutijela na inzulin često povezane sa sindromom protutijela na inzulin ili ozbiljnim štetnim događajima (vidjeti dio 4.4).
English: Medtronic MiniMed Implantable Pump
Croatian: Medtronic MiniMed pumpa za implantaciju
English: After flushing and refill of the pump with insulin, about 13 units of the sterile rinse buffer solution will remain in the distal portion of the side port catheter.
Croatian: Nakon ispiranja i punjenja pumpe inzulinom, u distalnom dijelu bočnog katetera ostat će približno 13 jedinica sterilne puferske otopine za ispiranje.
English: This training will be about this implantable insulin pump, how to use the pump and how to deal with special situations, such as hypoglycaemia or hyperglycaemia.
Croatian: Na obuci će biti riječi o ovoj pumpi za implantaciju, o tome kako je koristiti i kako postupiti u određenim situacijama, poput hipoglikemije ili hiperglikemije.
English: This happens when the tip of your catheter is fixed or in very close proximity to your liver.
Croatian: Do toga dolazi kada se vršak katetera nalazi unutar ili vrlo blizu jetre.
English: A calculated refill accuracy of less than 85% is indicative of insulin under-delivery.
Croatian: Izračunata preciznost nadopunjavanja manja od 85% ukazuje na primjenu premale doze inzulina.
English: o You need to carry alternative insulin and the means to administer it with you always.
Croatian: o Uvijek sa sobom morate nositi alternativni inzulin i pomagala za njegovu primjenu.
English: • Hyperglycaemia: If your blood sugar is too high, you may experience hyperglycaemia.
Croatian: • Hiperglikemija: Ako Vam je razina šećera u krvi previsoka, može nastupiti hiperglikemija.
English: All patients were naive to intraperitoneal insulin and had failed to improve their HbA1c within 3 months of intensive therapy with either multiple daily injection or continuous subcutaneous insulin infusion.
Croatian: Nitko od bolesnika prethodno nije primao inzulin intraperitonejski niti ostvario poboljšanje vrijednosti HbA1c unutar 3 mjeseca intenzivne terapije višestrukim svakodnevnim injekcijama ili kontinuiranom supkutanom infuzijom inzulina.
English: Rinsing may be performed earlier, for example if insulin under-delivery is revealed during a refill procedure or suspected due to insufficient blood glucose control.
Croatian: Ispiranje se može provesti i ranije, primjerice ako se tijekom nadopunjavanja pumpe utvrdi da se primjenjuje premala doza inzulina ili se na to posumnja zbog nedovoljne kontrole glukoze u krvi.
English: Hypersensitivity to titanium alloy, polysulfone or silicone materials used in the implanted components of the pump.
Croatian: Preosjetljivost na titanijevu leguru, polisulfon ili silikonske materijale koji se koriste u dijelovima pumpe namijenjenima za implantaciju.
English: The Medtronic MiniMed Implantable Pump should not be implanted in patients who have medical or mental conditions that make them unable to program modifications to the pump based on glucose readings or to take appropriate corrective actions in case of pump system problems.
Croatian: Medtronic MiniMed pumpa za implantaciju ne smije se implantirati bolesnicima s bolestima ili psihičkim stanjima koja im onemogućuju da unose izmjene u program pumpe u skladu s očitanjem razine glukoze u krvi ili da poduzmu odgovarajuće korektivne mjere u slučaju problema sa sustavom pumpe.
English: Insuman Basal").
Croatian: Basal").
English: Insuman Implantable 400 IU/ml presentation:
Croatian: Insuman Implantable 400 IU/ml:
English: Patients should be informed about the high concentration of insulin in Insuman Implantable (400 IU/ml) compared to other insulins in vials or cartridges (usually 100 IU/ml).
Croatian: Bolesnike treba upozoriti na visoku koncentraciju inzulina u lijeku Insuman Implantable (400 IU/ml) u odnosu na druge inzuline u bočicama ili ulošcima (obično 100 IU/ml).
English: • missed meals,
Croatian: • propuštanje obroka
English: Combination of Insuman with pioglitazone
Croatian: Kombinacija lijeka Insuman i pioglitazona
English: The healthcare institution's standard sterile operating procedures for skin preparation must be followed to avoid microbial contamination and infection.
Croatian: Pri pripremi kože moraju se slijediti standardni sterilni operativni postupci koje propisuje zdravstvena institucija kako bi se izbjegla kontaminacija mikrobima i infekcija.
English: The patient should only be released once blood glucose levels are stable and within the safe range.
Croatian: Bolesnika se smije otpustiti tek kada se razine glukoze u krvi unutar sigurnog raspona.
English: When used with an implantable insulin pump, Insuman Implantable will be continuously infused in your body and thus, may replace a long-acting insulin.
Croatian: Kada se koristi u inzulinskoj pumpi za implantaciju, Insuman Implantable se kontinuirano ubrizgava u tijelo i stoga može zamijeniti dugodjelujući inzulin.
English: The injection button colour will vary based on the formulation of Insuman insulin used.
Croatian: Boja dugmeta za injiciranje ovisi o formulaciji lijeka Insuman koja se primjenjuje.
English: Alternatively you can contact the Marketing Authorisation Holder listed at the end of this leaflet.
Croatian: Osim toga, možete se obratiti nositelju odobrenja za stavljanje lijeka u promet navedenom na kraju ove upute.
English: The MAH shall implement a controlled distribution system for the Insuman Implantable 400 IU/ml strength solutions for infusion to ensure that the medicinal product is only available to centres with current certification by Medtronic as having the appropriate facilities and staff who have received adequate training in the use of the Medtronic MiniMed Implantable Pump and the Personal Pump Communicator (PPC).
Croatian: Nositelj odobrenja mora implementirati sustav kontrolirane distribucije za Insuman Implantable otopine za infuziju jačine 400 IU/ml kako bi osigurao da lijek bude dostupan samo centrima s važećim certifikatima tvrtke Medtronic, kojima se potvrđuje da ti centri imaju odgovarajuću opremu i osoblje adekvatno obučeno za uporabu Medtronic MiniMed pumpe za implantaciju i osobnog daljinskog upravljača za pumpu.
English: Insuman Implantable is used to reduce high blood sugar in adult patients with a certain form of diabetes (type 1 diabetes mellitus).
Croatian: Insuman Implantable se primjenjuje za snižavanje visoke razine šećera u krvi u odraslih bolesnika s određenim oblikom šećerne bolesti (šećernom bolešću tipa 1).
English: If you notice pain, redness, swelling in the area of your pump, contact your doctor.
Croatian: Ako primijetite bol, crvenilo ili oticanje na mjestu gdje se pumpa nalazi, obratite se svom liječniku.
English: The pump refill procedure should be performed using sterile technique and this should take place in the centres certified by Medtronic.
Croatian: Pumpa se mora nadopuniti primjenom sterilne tehnike u centrima koje je certificirao Medtronic.
English: • unaccustomed, increased or prolonged physical activity,
Croatian: • povećanu ili dugotrajnu tjelesnu aktivnost na koju bolesnik nije navikao
English: The refill procedure should be performed every 40 to 45 days.
Croatian: Pumpu treba nadopuniti svakih 40 do 45 dana.
English: Under-delivery due to a problem with the pump
Croatian: Primjena premale doze zbog problema s pumpom
English: Medication errors have been reported in which other Insuman formulations or other insulins have been accidentally administered.
Croatian: Prijavljene su medikacijske pogreške pri primjeni lijekova kada su slučajno primijenjene druge formulacije lijeka Insuman ili drugi inzulini.
English: • Change of the pump due to malfunction
Croatian: • promjene na pumpi zbog kvara
English: • Physician quick guides on the main programming functions
Croatian: • brzim vodičima o glavnim funkcijama programiranja za liječnike
English: In the pump The medicine is stable in the pump for 45 days at 37°C.
Croatian: U pumpi Lijek u pumpi stabilan je tijekom 45 dana na temperaturi od 37°C.
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: Rinsing may be performed earlier, for example, when potential under-delivery is suspected based on a calculated refill accuracy of less than 85%.
Croatian: Ispiranje se može provesti i ranije, primjerice, ako se na temelju izračunate preciznosti nadopunjavanja manje od 85% posumnja na primjenu premale doze inzulina.
English: Residual insulin and new insulin must be weighed to record the refill worksheet and calculate the refill accuracy criterion.
Croatian: Rezidualni inzulin i novi inzulin moraju se izvagati kako bi se podaci unijeli u radni list o nadopunjavanju i kako bi se izračunao parametar preciznosti nadopunjavanja.
English: If you experience severe low blood sugar levels, this may indicate a problem with your pump.
Croatian: Izrazito niske razine šećera u krvi mogu ukazivati na problem s pumpom.
English: In case your pump is damaged or your Personal Pump Communicator (PPC) is damaged or lost, review with your doctor what you should do in case your pump does not work correctly.
Croatian: Ako se pumpa ošteti ili ako oštetite ili izgubite osobni daljinski upravljač za pumpu, razgovarajte s liječnikom o tome što morate učiniti ako pumpa ne radi ispravno.
English: Insuman Infusat with alcohol
Croatian: Insuman Infusat s alkoholom
English: The insulin in your pump must be replaced every 40 to 45 days with new insulin.
Croatian: Inzulin u pumpi mora se zamijeniti svakih 40 do 45 dana novim inzulinom.
English: Failure of the insulin to enter the pump may indicate that the pump reservoir is still full.
Croatian: Ako inzulin ne ulazi u pumpu, možda je spremnik pumpe još uvijek pun.
English: There is no clinical information with the use of Insuman Implantable in an implantable pump in pregnant women.
Croatian: Nema kliničkih informacija o primjeni lijeka Insuman Implantable u pumpi za implantaciju u trudnica.
English: The insulin usage and clinical symptoms may be identical to those of pump under-delivery.
Croatian: Potrošnja inzulina i klinički simptomi mogu biti jednaki kao i kod primjene premale doze zbog problema s pumpom.
English: Elevated levels of antibodies to insulin are not commonly associated with a need to change your insulin dose or occurrence of serious side effects.
Croatian: Povišene razine protutijela na inzulin ne povezuju se često s potrebom za prilagođavanjem doze inzulina niti pojavom ozbiljnih nuspojava.
English: • When under-delivery of insulin is due to catheter occlusion, the side port catheter may be flushed with 5-10 ml of sterile rinse buffer solution.
Croatian: • Ako je primjena nedovoljne količine inzulina posljedica začepljenja katetera, bočni se kateter može isprati s 5-10 ml sterilne puferske otopine za ispiranje.
English: Insuman Infusat").
Croatian: Infusat").
English: In a phase III study (HUBIN_L_05335) in patients with type 1 diabetes mellitus, the pharmacokinetic profile of Insuman Implantable after intraperitoneal administration of an insulin bolus was assessed in 10 patients after intraperitoneal administration.
Croatian: U ispitivanju faze III (HUBIN_L_05335) u bolesnika sa šećernom bolešću tipa 1, farmakokinetički profil lijeka Insuman Implantable nakon intraperitonejske primjene bolusnog inzulina ocijenjena je u 10 bolesnika nakon intraperitonejske primjene.
English: • Device programming
Croatian: • programiranje uređaja
English: • Refill procedure
Croatian: • postupak nadopunjavanja
English: • intercurrent illness (e.g. vomiting, diarrhoea),
Croatian: • interkurentnu bolest (npr. povraćanje, proljev)
English: What Insuman Basal contains
Croatian: Što Insuman Basal sadrži
English: Always put the pen cap back on the pen, then store the pen until your next injection.
Croatian: Uvijek vratite zatvarač na brizgalicu, a zatim spremite brizgalicu do sljedeće injekcije.
English: After intraperitoneal administration of 0.15 IU/kg Insuman Implantable, insulin was eliminated from serum with an apparent mean half-life of 2.7 hours.
Croatian: Nakon intraperitonejske primjene lijeka Insuman Implantable u dozi od 0,15 IU/kg, inzulin se iz seruma eliminirao uz prividan poluvijek od 2,7 sati.
English: In this refilling procedure the remaining insulin must be removed from the pump and the pump refilled with new insulin.
Croatian: Tijekom tog postupka nadopunjavanja iz pumpe se mora ukloniti preostali inzulin, a zatim pumpu treba nadopuniti novim inzulinom.
English: The majority of adverse reactions associated with the Medtronic MiniMed Implantable Pump can be prevented by the rinse procedure by physicians.
Croatian: Većina nuspojava povezanih s Medtronic MiniMed pumpom za implantaciju može se spriječiti ako liječnici provedu postupak ispiranja.
English: Figure 1: Mean pharmacokinetic profile of serum insulin in patients with type 1 diabetes mellitus after a dose of 0.15 IU/kg Insuman Implantable.
Croatian: Slika 1: Srednji farmakokinetički profil inzulina u serumu u bolesnika sa šećernom bolešću tipa 1 nakon primjene lijeka Insuman Implantable u dozi od 0,15 IU/kg.
English: The pump reservoir and Side Port catheter must be emptied of insulin and the patients must self-administer insulin by subcutaneous injection for the duration of the trip and until their pump reservoir is refilled.
Croatian: Inzulin se mora ukloniti iz spremnika pumpe i bočnog katetera, a bolesnici si moraju samostalno davati inzulin supkutanom injekcijom za vrijeme trajanja putovanja, dok ponovno ne nadopune spremnik.
English: Patients with type 1 diabetes must continue to consume at least a small amount of carbohydrates (food or beverage) on a regular basis; even if they are able to eat only little or no food, or are vomiting, etc., and they must never omit insulin entirely.
Croatian: Bolesnici sa šećernom bolešću tipa 1 moraju nastaviti redovito uzimati barem male količine ugljikohidrata (hrane ili pića), čak i kad nisu u stanju jesti ili jedu vrlo malo, ili kad povraćaju itd., a nikada ne smiju sasvim izostaviti inzulin.
English: Insuman Implantable must not be used with any other type of injection devices (e.g. syringes).
Croatian: Insuman Implantable ne smije se koristiti ni s jednom drugom vrstom pomagala za injiciranje (npr. štrcaljkama).
English: Medical imaging technique
Croatian: Tehnika medicinskog oslikavanja
English: In addition, if patients are attempting to deliver more than 2.5 times the programmed maximum bolus amount within a one hour period, the PPC will display the “HOURLY MAX EXCEEDED” message to warn the patients.
Croatian: Osim toga, ako bolesnici unutar jednoga sata pokušaju primijeniti količinu lijeka koja je više od 2,5 puta veća od programirane maksimalne bolusne doze, na osobnom daljinskom upravljaču za pumpu pojavljuje se poruka s upozorenjem "PREKORAČENA MAKS.
English: The insulin in your pump must be replaced every 40 to 45 days with new insulin or earlier based on your insulin needs.
Croatian: Inzulin u pumpi mora se zamijeniti novim inzulinom svakih 40 do 45 dana ili ranije, ovisno o Vašim potrebama za inzulinom.
English: There was an additional 12-month open-label randomised controlled study (MIP 310) to assess the effect of intraperitoneal insulin administration versus subcutaneous insulin administration on glycaemic control and the frequency of severe hypoglycaemia.
Croatian: Provedeno je i dodatno 12-mjesečno, otvoreno, randomizirano, kontrolirano ispitivanje (MIP 310) u kojem se ocjenjivao učinak intraperitonejske primjene inzulina u usporedbi sa supkutanom primjenom inzulina na kontrolu glikemije i učestalost teške hipoglikemije.
English: Use of the pump at these altitudes may result in insulin over-delivery or under-delivery.
Croatian: Uporaba pumpe na tim visinama može dovesti do primjene prevelike ili premale doze.
English: Focal hepatic steatosis has been observed after administration of insulin via the intra-peritoneal route, when the catheter was positioned very close to or in the liver capsule.
Croatian: Fokalna steatoza jetre primijećena je nakon primjene inzulina intraperitonejskim putem kada je kateter bio smješten veoma blizu ili unutar ovojnice jetre.
English: Patients implanted with a Medtronic MiniMed Implantable Pump must receive comprehensive instruction in the use of the pump, and the necessary actions in case of illness, hypoglycaemia and hyperglycaemia or pump failure.
Croatian: Bolesnici kojima se implantira Medtronic MiniMed pumpa za implantaciju moraju dobiti opsežne upute o uporabi pumpe i koracima koje moraju poduzeti u slučaju bolesti, hipoglikemije i hiperglikemije ili kvara pumpe.
English: From experience gained in a 6-month comparative phase III study (HUBIN_L_05335) with Insuman Implantable administered via the Medtronic MiniMed Implantable Pump in 84 patients aged 26 to 80 years (see section 5.1) and from clinical experience with insulin human 100 IU/ml and 40 IU/ml, the following adverse reactions were observed.
Croatian: Na temelju iskustva iz 6-mjesečnog usporednog ispitivanja faze III (HUBIN_L_05335) lijeka Insuman Implantable, koji se primjenjivao Medtronic MiniMed pumpom za implantaciju u 84 bolesnika u dobi od 26 do 80 godina (vidjeti dio 5.1), te na temelju kliničkog iskustva s primjenom humanog inzulina u dozama od 100 IU/ml i 40 IU/ml, primijećene su sljedeće nuspojave.
English: All of the findings suggest that continuous intraperitoneal insulin infusion in patients with type 1 diabetes mellitus, compared with continuous subcutaneous insulin infusion and multiple daily injections is more similar to the pharmacokinetics of endogenous insulin observed.
Croatian: Svi nalazi ukazuju na to da je kontinuirana intraperitonejska infuzija inzulina u bolesnika sa šećernom bolešću tipa 1, u usporedbi s kontinuiranom supkutanom infuzijom inzulina i višestrukim svakodnevnim injekcijama, sličnija primijećenoj farmakokinetici endogenog inzulina.
English: If you think you may have a problem with SoloStar, consult your doctor, pharmacist or nurse.
Croatian: Smatrate li da postoji problem sa SoloStar brizgalicom, obratite se liječniku, ljekarniku ili medicinskoj sestri.
English: Use in paediatric patients who have not reached adult size due to the large size of the pump (see section 4.2 and 4.4).
Croatian: Primjena u bolesnika koji nisu dosegli odrasli stas, zbog veličine pumpe (vidjeti dijelove 4.2 i 4.4).
English: If this happens, you may develop severe hypoglycaemia (and even faint) before you are aware of the problem.
Croatian: Ako se to dogodi, možete razviti tešku hipoglikemiju (možete se čak i onesvijestiti) prije nego što postanete svjesni problema.
English: Insuman Rapid may also be administered intravenously.
Croatian: Insuman Rapid može se primijeniti i intravenski.
English: The label on the insulin vial should be checked before use to make sure this is the correct insulin for the intended route of administration.
Croatian: Prije primjene treba provjeriti naljepnicu na bočici kako biste bili sigurni da je to pravi inzulin za namjeravani put primjene.
English: To prevent such pump problems, your doctor will schedule appointments at least every 6-months to rinse your pump.
Croatian: Da bi se takvi problemi izbjegli liječnik će Vam zakazati pregled najmanje svakih 6 mjeseci, kako bi isprao pumpu.
English: Detailed instructions on programming these limitations are contained in the Physician's Manual.
Croatian: Detaljnije upute o programiranju tih ograničenja nalaze se u Priručniku za liječnike.
English: The presence of such insulin antibodies may necessitate adjustment of the insulin dose to correct a tendency for hyper- or hypoglycaemia (see section 4.8).
Croatian: Prisutnost takvih protutijela na inzulin može uvjetovati prilagođavanje doze inzulina kako bi se umanjila sklonost hiperglikemiji odnosno hipoglikemiji (vidjeti dio 4.8).
English: Side effects reported with a frequency not known (cannot be estimated from the available data)
Croatian: Nuspojave prijavljene s nepoznatom učestalošću (ne može se procijeniti iz dostupnih podataka)
English: You should know these factors so that you are able to react correctly to changes in your blood sugar level and to prevent it from becoming too high or too low.
Croatian: Morate ih poznavati kako biste mogli ispravno odgovorili na promjene razine šećera u krvi i spriječiti da ona postane previsoka ili preniska.
English: Liver reaction
Croatian: Jetrene reakcije
English: Insuman Infusat is therefore also suitable for continuous insulin infusion with other, conventional injection syringe pumps.
Croatian: Insuman Infusat je stoga prikladan i za kontinuiranu inzulinsku infuziju primjenom drugih, standardnih pumpi sa štrcaljkom.
English: Solution for infusion 4,000 IU/10 ml 1 vial
Croatian: Otopina za infuziju 4000 IU/10 ml 1 bočica
English: ► Side effects reported with the implantable pump (including side effects related to implantation of the pump and or pump maintenance)
Croatian: Nuspojave prijavljene kod uporabe pumpe za implantaciju (uključujući nuspojave povezane s ugradnjom i/ili održavanjem pumpe)
English: A single-blind, randomised, 6-month controlled clinical study (HUBIN_L_05335) was conducted to evaluate the clinical efficacy and safety of Insuman Implantable compared to a semi-synthetic human insulin (400 IU/ml) administered via the Medtronic MiniMed Implantable Pump.
Croatian: Provedeno je jednostruko slijepo, randomizirano, 6-mjesečno kontrolirano kliničko ispitivanje (HUBIN_L_05335) u kojem su se ocjenjivale klinička djelotvornost i sigurnost lijeka Insuman Implantable primijenjenoga u Medtronic MiniMed pumpi za implantaciju u usporedbi s polusintetskim humanim inzulinom (400 IU/ml).
English: The Medtronic MiniMed Implantable Pump, which is implanted under the skin of your belly, infuses your insulin continuously (continuous intraperitoneal infusion).
Croatian: Medtronic MiniMed pumpa za implantaciju, koja se ugrađuje ispod kože na području trbuha, kontinuirano ubrizgava inzulin (kontinuirana intraperitonejska infuzija).
English: Due to the large size of the implantable pump, use of Insuman Implantable in paediatric patients who have not reached adult size is contraindicated (see section 4.2 and 4.3).
Croatian: Zbog veličine pumpe za implantaciju, primjena lijeka Insuman Implantable u bolesnika koji nisu dosegli odrasli stas je kontraindicirana (vidjeti dijelove 4.2 i 4.3).
English: The need to adjust (e.g. reduce) the dose may become evident immediately after transfer.
Croatian: Potreba za prilagođavanjem (npr. smanjenjem) doze može može se ukazati odmah nakon prijelaza ili se može pojaviti postupno tijekom razdoblja od nekoliko tjedana.
English: Solution for infusion (infusion).
Croatian: OBLIK Otopina za infuziju (infuzija).
English: If you need to increase your insulin to maintain your blood sugar level, if you experience refractory hyperglycaemia, this may indicate a problem with the pump.
Croatian: Ako morate povećavati dozu inzulina da biste održali razinu šećera u krvi ili je uporno prisutna hiperglikemija, to može ukazivati na problem s pumpom.
English: Insuman Infusat in a cartridge may also be used in other insulin pumps for which it has been shown that they are suitable for this insulin and this type of cartridge (see pump manual).
Croatian: Insuman Infusat u ulošku može se primjenjivati i u drugim inzulinskim pumpama za koje je utvrđeno da su prikladne za ovaj inzulin i ovu vrstu uloška (vidjeti priručnik za uporabu pumpe).
English: If the pump does not function well, you can draw the insulin from the cartridge into an injection syringe.
Croatian: Ako pumpa ne radi ispravno, inzulin se može iz uloška uvući u štrcaljku za injekciju.