FrancophonIA/ELRC3.0 huggingface dataset:
English: • suffering from a psychiatric illness,
Croatian: • koji pate od neke psihijatrijske bolesti
English: There is no experience with Insuman Implantable in children and adolescents below 18 years.
Croatian: Nema iskustva s primjenom lijeka Insuman Implantable u djece i adolescenata mlađih od 18 godina.
English: • The potential for surgical and clinical complications and how to respond in the event any such complications arise.
Croatian: • mogućnosti kirurških i kliničkih komplikacija te o tome što napraviti u slučaju pojave takvih komplikacija.
English: Your SoloStar is designed to work accurately and safely.
Croatian: SoloStar je izrađen tako da radi točno i sigurno.
English: It is specially stabilised to minimise loss of efficacy which may result from mechanical and thermal stress in such pumps.
Croatian: Posebno je stabiliziran kako bi se minimizirao gubitak djelotvornosti do kojega bi moglo doći uslijed mehaničkog i toplinskog oštećenja u takvim pumpama.
English: It is recommended to perform the rinse procedure every 6 months.
Croatian: Preporučuje se provoditi postupak ispiranja svakih 6 mjeseci.
English: The mean pharmacokinetic profile is shown in figure 1.
Croatian: Srednji farmakokinetički profil prikazan je na slici 1.
English: Based on your needs, you may need to replace your insulin earlier.
Croatian: Ovisno o Vašim potrebama, inzulin ćete možda morati zamijeniti i ranije.
English: Skin erosion
Croatian: Erozija kože
English: It is recommended that the date of the first use be noted on the label.
Croatian: Preporučuje se na naljepnici naznačiti datum prve uporabe.
English: You may exceed this limit by programming only one bolus within 10 minutes.
Croatian: Možete prekoračiti navedeno ograničenje programiranjem samo jedne bolusne doze unutar 10 minuta.
English: The MAH shall ensure that the training programme for centres includes the following key elements:
Croatian: Nositelj odobrenja mora se pobrinuti da program obuke za centre obuhvati sljedeće ključne elemente:
English: These materials shall contain content closely similar to the mock-ups provided in the currently approved risk management plan annexes.
Croatian: Sadržaj tih materijala mora biti vrlo sličan nacrtima koji se nalaze u trenutno odobrenim dodacima plana upravljanja rizikom.
English: Refilling the pump is a sterile procedure which must be carried out in the hospital or clinic.
Croatian: Nadopunjavanje pumpe je sterilan postupak koji se mora provoditi u bolnici ili klinici.
English: This applies, for example, when changing from:
Croatian: To je, primjerice, potrebno pri prijelazu:
English: All procedures must be performed under sterile conditions.
Croatian: Svi postupci moraju se provoditi u sterilnim uvjetima.
English: The reservoir is completely filled (approximately 15 ml or 6,000 units of Insuman Implantable), independently of the patients needs.
Croatian: Spremnik se mora potpuno napuniti (približno 15 ml ili 6000 jedinica lijeka Insuman Implantable), neovisno o bolesnikovim potrebama.
English: In most cases you will need to see a doctor.
Croatian: U većini slučajeva ćete morati otići k liječniku.
English: No clinical symptoms, macroscopically visible changes or irritations in the abdominal cavity were observed.
Croatian: Nisu primijećeni klinički simptomi, makroskopski vidljive promjene niti iritacije u abdominalnoj šupljini.
English: Hyperglycaemia can become serious and lead to a serious condition (ketoacidosis).
Croatian: Hiperglikemija može postati ozbiljna i uzrokovati ozbiljno zdravstveno stanje (ketoacidozu).
English: This should be kept in mind if treatment with the combination of pioglitazone and Insuman is considered.
Croatian: Ovo treba imati na umu ako se razmatra liječenje kombinacijom pioglitazona i lijeka Insuman.
English: • were already controlled with relatively low blood glucose levels,
Croatian: • koji su već bili regulirani na relativno niskim razinama glukoze u krvi
English: SoloStar has to be used as recommended in these Instructions for Use (see section 6.6).
Croatian: SoloStar se mora koristiti sukladno preporukama u tim Uputama za uporabu (vidjeti dio 6.6).
English: Other routes of administration (e.g. injection) are contraindicated.
Croatian: Drugi putovi primjene (npr. injekcijom) su kontraindicirani.
English: Injection needles are not included in the pack.
Croatian: Igle za injekciju nisu uključene u pakiranje.
English: • improved insulin sensitivity (e.g., by removal of stress factors),
Croatian: • poboljšanu osjetljivost na inzulin (npr. uklanjanjem čimbenika stresa)
English: o You need to carry the completed Patient Emergency Information Card with you always.
Croatian: o Uvijek sa sobom morate nositi ispunjenu karticu s informacijama o bolesniku za hitne slučajeve.
English: It is recommended to perform the rinse procedure every 6 months or as necessary based on the refill accuracy criterion.
Croatian: Postupak ispiranja se preporučuje provoditi svakih 6 mjeseci ili po potrebi, ovisno o parametru preciznosti nadopunjavanja.
English: The MAH shall ensure that all centres are adequately supplied with the following in the appropriate national language(s):
Croatian: Nositelj odobrenja mora se pobrinuti da svi centri budu adekvatno opskrbljeni sljedećim materijalima na odgovarajućem nacionalnom jeziku/jezicima:
English: • one human insulin preparation to another,
Croatian: • s jednog pripravka humanog inzulina na drugi,
English: • If you forget to have your pump refilled:
Croatian: • Ako zaboravite nadopuniti pumpu:
English: o You need to keep some form of fast-acting sugar with you at all times.
Croatian: o Uvijek sa sobom morate nositi neki oblik brzodjelujućeg šećera.
English: To avoid microbial contamination and infection, aseptic skin preparation should be performed according to the healthcare institution's standard sterile operating procedures.
Croatian: Kako bi se izbjegla kontaminacija mikrobima i infekcija, aseptičku pripremu kože treba provesti u skladu sa standardnim sterilnim operativnim postupcima koje propisuje zdravstvena ustanova.
English: Insulin does not cross the placental barrier.
Croatian: Inzulin ne prolazi kroz placentarnu barijeru.
English: Insuman Implantable should not be used during pregnancy unless the clinical condition of the woman requires treatment with Insuman Implantable.
Croatian: Insuman Implantable se ne smije koristiti u trudnoći osim ako kliničko stanje žene ne zahtijeva liječenje lijekom Insuman Implantable.
English: - In your body
Croatian: - u tijelu
English: Due to the size of the pump, adolescents who have not reached the adult size must not be implanted.
Croatian: Zbog veličine pumpe, ona se ne smije ugraditi adolescentima koji nisu dosegli odrasli stas.
English: Select your required dose (in the example below, the selected dose is 30 units).
Croatian: Odaberite potrebnu dozu (u primjeru prikazanom ispod, odabrana doza iznosi 30 jedinica).
English: Your doctor will tell you how to manage your blood glucose levels.
Croatian: Liječnik će Vam reći kako kontrolirati razine glukoze u krvi.
English: • Warnings and precautions when using an implantable pump
Croatian: • upozorenja i mjere opreza pri uporabi pumpe za implantaciju
English: The plunger will reach the end of the cartridge when the total of 300 units of insulin has been used.
Croatian: Klip će doći do kraja uloška kada se potroši svih 300 jedinica inzulina.
English: If normal or decreased values for glycated haemoglobin are noted, the possibility of recurrent, unrecognised (especially nocturnal) episodes of hypoglycaemia must be considered.
Croatian: Ako se uoče normalne ili snižene vrijednosti glikoziliranog hemoglobina, mora se uzeti u obzir mogućnost pojave opetovanih, neprepoznatih (posebice noćnih) epizoda hipoglikemije.
English: If you expect to have frequent medical imaging (e.g. MRI or ultrasound), talk to your doctor.
Croatian: Ako mislite da ćete često morati ići na medicinsko oslikavanje (npr. magnetsku rezonanciju ili ultrazvuk), obratite se svom liječniku.
English: • Severe allergic reactions to insulin may occur which may become life-threatening.
Croatian: • Mogu se javiti teške alergijske reakcije na inzulin koje mogu postati opasne po život.
English: Therefore, the safety and efficacy of Insuman Implantable (intraperitoneal use) have not been established in paediatric patients.
Croatian: Stoga sigurnost i djelotvornost lijeka Insuman Implantable (za intraperitonejsku primjenu) u pedijatrijskih bolesnika nisu ustanovljene.
English: • in whom hypoglycaemia develops gradually,
Croatian: • u kojih se hipoglikemija razvija postupno
English: In addition, antibiotic prophylactic measures are required before and after pump implantation to reduce the risk of pump pocket infection.
Croatian: Osim toga, prije i nakon implantacija pumpe neophodna je antibiotska profilaksa kako bi se smanjio rizik od infekcije džepa za pumpu.
English: Elderly population(≧65 years old)
Croatian: Stariji bolesnici (≧ 65 godina)
English: The patient blood glucose levels must be monitored at least every 15 minutes following the flush.
Croatian: Razine glukoze u krvi bolesnika moraju se provjeravati najmanje svakih 15 minuta nakon ispiranja.
English: Diagnostic procedures must be performed to check if the problem is due to the pump or catheter.
Croatian: Moraju se provesti dijagnostički postupci kako bi se utvrdilo nastaje li problem zbog pumpe ili katetera.
English: If the flush procedure is unsuccessful, catheter replacement surgery is usually performed.
Croatian: Ako postupak ispiranja ne uspije, obično se provodi kirurški zahvat zamjene katetera.
English: If you need to deliver one additional bolus, press “SEL” and then “ACT”.
Croatian: Ako trebate primijeniti jednu dodatnu bolusnu dozu, pritisnite ”SEL” i zatim ”ACT”.
English: Patients who plan to reside at or travel (other than by pressurised commercial aircraft) at elevations above 2439 meters (8000 feet) or to dive below 7.6 meters (25 feet) should be informed on the actions to be taken.
Croatian: Bolesnike koji namjeravaju živjeti ili putovati (osim komercijalnim zrakoplovima pod tlakom) na područja čija je nadmorska visina iznad 2439 metara ili roniti na dubini većoj od 7,6 metara treba upozoriti na mjere koje moraju poduzeti.
English: These limitations are necessary to provide some control over patients' ability to program their insulin regimens and to avoid the possibility of overdosing.
Croatian: Ta su ograničenja nužna kako bi se omogućila određena kontrola nad bolesnikovom mogućnošću programiranja vlastitog režima doziranja inzulina te tako izbjegla mogućnost predoziranja.
English: Keep this in mind in all situations where you might put yourself and others at risk (such as driving a car or using machines).
Croatian: Imajte to na umu u svim situacijama u kojima sebe i druge možete izložiti riziku (primjerice vožnja automobila ili rukovanje strojevima).
English: • Patient emergency information cards
Croatian: • karticama s informacijama o bolesniku za hitne slučajeve
English: Before initial pump implantation, 72.4% of these patients had been treated by continuous subcutaneous insulin infusion (CSII) and 17.8% by subcutaneous multi-injection.
Croatian: Prije prve implantacije pumpe, 72,4% navedenih bolesnika liječeno je kontinuiranom supkutanom infuzijom inzulina, a 17,8% višestrukim supkutanim injekcijama.
English: It is known that insulin can form aggregates, fibrils and gel-like structures when it is subjected to chemical and/or physical stress, e.g. increased temperatures and shaking.
Croatian: Poznato je da inzulin može tvoriti nakupine te vlaknaste i želatinozne strukture kada je izložen kemijskom i/ili fizičkom opterećenju, npr. povišenim temperaturama i trešnji.
English: The patient plays a significant role in diagnosing and correcting hyperglycemia linked to pump performance problems.
Croatian: Bolesnik igra značajnu ulogu u dijagnosticiranju i korigiranju hiperglikemije povezane s problemima u radu pumpe.
English: This procedure should always be scheduled in advance of PPC “low reservoir” or “empty reservoir” messages with the patient.
Croatian: Ovaj postupak bi uvijek trebalo dogovoriti prije nego što se na osobnom daljinskom upravljaču za pumpu pojavi poruka "spremnik gotovo prazan" ("low reservoir") ili "spremnik prazan" ("empty reservoir").
English: o Running a diagnostic test of your pump system is needed if you think the pump may have been damaged by water, a sporting incident, electrotherapy (cardiac defibrillator), diagnostic ultrasound or radiation (X-ray).
Croatian: o Potrebno je provesti dijagnostičko ispitivanje sustava pumpe ako mislite da je pumpu možda oštetila voda, sportska nezgoda, elektroterapija (srčani defibrilator), dijagnostički ultrazvuk ili ozračivanje (rendgensko snimanje).
English: This can be reduced by continuously wearing an abdominal binder until the capsule has formed (about 1 month) and limiting patient activities immediately following device implant.
Croatian: To se može ublažiti stalnim nošenjem trbušnog steznika dok se ne formira ovojnica (približno 1 mjesec) te ograničavanjem bolesnikove tjelesne aktivnosti neposredno nakon implantacije uređaja.
English: • Recognition of signs and symptoms of severe hypoglycaemia and the appropriate actions to take
Croatian: • prepoznavanje znakova i simptoma teške hipoglikemije te odgovarajuće mjere koje treba poduzeti
English: • Infection of space where the pump has been implanted (pump pocket)
Croatian: • infekcija na području gdje je pumpa usađena (džep za pumpu)
English: o Every 40 to 45 days, a refill of insulin at the hospital is needed.
Croatian: o Svakih 40 do 45 dana potrebno je nadopuniti inzulin u bolnici.
English: Do not extend this period of time (45 days) and contact your doctor immediately if you are unable to go to the hospital or clinic to replace the insulin in your pump.
Croatian: Nemojte čekati dulje od navedenog razdoblja (45 dana) da nadopunite pumpu i odmah se obratite liječniku ako ne možete otići u bolnicu ili kliniku zamijeniti inzulin u pumpi.
English: Mean HbA1c value at baseline was 8.1%.
Croatian: Srednja vrijednost HbA1c na početku ispitivanja iznosila je 8,1%.
English: No hepatic steatosis was observed.
Croatian: Nije primijećena steatoza jetre.
English: Table 2: Adverse reactions and product technical complaints observed with the delivery system (including adverse reactions related to implantation surgery and or device maintenance).
Croatian: Tablica 2: Nuspojave i tehničke pritužbe na proizvod povezane sa sustavom za primjenu lijeka (uključujući nuspojave povezane s kirurškom implantacijom i/ili održavanjem uređaja).
English: Side effects reported uncommonly (may affect up to 1 in 100 people) • Severe allergic reaction with low blood pressure (shock)
Croatian: Manje često prijavljene nuspojave (mogu se javiti u manje od 1 na 100 osoba) • Teška alergijska reakcija praćena niskim krvnim tlakom (šok)
English: After stopping insulin infusion or removal or repositioning of the peritoneal catheter, focal hepatic steatosis seems to be reversible and without clinical consequence (see section 4.8).
Croatian: Nakon prekida infuzije inzulina ili uklanjanja ili ponovnog namještanja peritonealnog katetera, fokalna steatoza jetre čini se reverzibilnom i nema kliničke posljedice (vidjeti dio 4.8).
English: If you are not able to swallow or if you are unconscious, you will require an injection of glucose or glucagon (a medicine which increases blood sugar).
Croatian: ako ne možete gutati ili ako ste bez svijesti, treba Vam injekcija glukoze ili glukagona (lijek koji povisuje razinu šećera u krvi).
English: Unopened vials, unopened cartridges, not in-use pens Store in a refrigerator (2°C - 8°C).
Croatian: Neotvorene bočice, neotvoreni ulošci, neupotrijebljene brizgalice Čuvati u hladnjaku (2°C - 8°C).
English: Failure to do this may cause permanent damage to the pump.
Croatian: U protivnom bi moglo doći do trajnog oštećenja pumpe.
English: • an animal insulin (especially a bovine insulin) to human insulin,
Croatian: • sa životinjskog inzulina (osobito goveđeg inzulina) na humani inzulin,
English: The detailed operating instructions about the implantable pump, its functions and the necessary safety precautions are described in the Physician's Manual accompanying the infusion pump.
Croatian: Detaljne upute o rukovanju pumpom za implantaciju, njezinim funkcijama i nužnim mjerama opreza opisane su u Priručniku za liječnike, koji je priložen uz infuzijsku pumpu.
English: A stroke volume of between 0.42 μl to 0.58 μl without backflow is indicative of a catheter occlusion.
Croatian: Udarni volumen od 0,42-0,58 μl bez povrata inzulina u spremnik ukazuje na začepljenje katetera.
English: • Patients' responsibilities regarding insulin treatment as well as refill frequency and maintenance of the pump as outlined in the key messages in the patient information leaflet;
Croatian: • obvezama bolesnika povezanima s liječenjem inzulinom, kao i učestalošću nadopunjavanja i održavanjem pumpe, kao što je opisano u ključnim porukama u letku s informacijama za bolesnike;
English: If this happens, immediately contact your doctor who is trained to perform pump investigations.
Croatian: U tom se slučaju odmah obratite svom liječniku koji je educiran za provjeru pumpe.
English: The risk of skin erosion at the pump implantation site can be reduced by selecting an appropriate implant site, maintaining good sterile technique during the implant procedure, prophylactic antibiotic therapy and by continuously wearing an abdominal binder until the capsule has formed (about 1 month) (see section 4.8).
Croatian: Rizik od erozije kože na mjestu implantacije pumpe može se smanjiti odabirom prikladnog mjesta za implantaciju, održavanjem dobre sterilne tehnike za vrijeme implantacije, antibiotskom profilaksom te stalnim nošenjem trbušnog steznika dok se ne formira ovojnica oko pumpe (približno 1 mjesec) (vidjeti dio 4.8).
English: All pump procedures (such as pump refill, rinsing of the pump, pump investigations to check whether your pump works properly) are performed using sterile technique to avoid risk of infection.
Croatian: Svi postupci povezani s pumpom (poput nadopunjavanja i ispiranja te ispitivanja pumpe kojima se provjerava radi li ona ispravno) provode se primjenom sterilne tehnike kako bi se izbjegao rizik od infekcije.
English: • inadequate food intake,
Croatian: • nedovoljan unos hrane
English: Insulin under-delivery is suspected when:
Croatian: Na primjenu premale doze inzulina sumnja se kada:
English: All procedures should be performed using sterile technique.
Croatian: Svi postupci moraju se provoditi primjenom sterilne tehnike.
English: • in whom glycaemic control is markedly improved,
Croatian: • u kojih je regulacija glikemije izrazito poboljšana
English: The frequency of this reaction varies with patient population and dose regimens.
Croatian: Učestalost te reakcije varira s obzirom na populaciju bolesnika i režime doziranja.
English: Talk to your doctor to find out what you should do if you plan: to live at a height above 2439 meters (8000 feet) to travel to a height above 2439 meters (8000 feet) other than commercial aircraft to dive below 7.6 meters (25 feet).
Croatian: Razgovarajte s liječnikom kako biste saznali što morate učiniti ako namjeravate: - živjeti na nadmorskoj visini iznad 2439 metara, - putovati na područja nadmorske visine iznad 2439 metara bilo kojim prijevoznim sredstvom osim komercijalnim zrakoplovom, - roniti na dubini dubljoj od 7,6 metara.
English: Reservoir refilling must be performed by trained and qualified personnel in accordance with the instructions provided by the pump manufacturer.
Croatian: Postupak nadopunjavanja spremnika mora provoditi obučeno i kvalificirano osoblje u skladu s uputama proizvođača pumpe.
English: Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines.
Croatian: Obavijestite svoga liječnika ili medicinsku sestru ako uzimate ili ste nedavno uzeli ili biste mogli uzeti bilo koje druge lijekove.
English: • At the request of the European Medicines Agency; • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Croatian: • Uoči svake izmjene sustava za upravljanje rizicima, a naročito kada je ta izmjena rezultat primitka novih informacija koje mogu voditi ka značajnim izmjenama omjera korist/rizik, odnosno kada je omjer korist/rizik rezultat ostvarenja nekog važnog cilja (u smislu farmakovigilancije ili smanjenja rizika).
English: Any unused insulin should be disposed of in accordance with local requirements and should not be reused.
Croatian: Neupotrijebljeni inzulin mora se zbrinuti u skladu s lokalnim propisima i ne smije se ponovno upotrijebiti.
English: The following related adverse reactions have been reported with the use of the Medtronic MiniMed Implantable Pump in the two phase III studies (see section 5.1).
Croatian: Sljedeće nuspojave povezane s lijekom primijećene su kod primjene Medtronic MiniMed pumpe za implantaciju u dva ispitivanja faze III (vidjeti dio 5.1).
English: Should pump performance change, the patient would be able to detect a change in blood glucose levels.
Croatian: Ako dođe do promjena u radu pumpe, bolesnik može primijetiti promjenu u razini glukoze u krvi.
English: • The patient reports an increase in insulin use to maintain euglycaemia.
Croatian: • bolesnik prijavi povećanu primjenu inzulina za održavanje euglikemije.
English: Continuous rotation of the injection site within the given injection area may help to reduce or prevent these reactions.
Croatian: Neprestano mijenjanje mjesta injiciranja unutar preporučenih područja injiciranja može pomoći u ublažavanju ili sprečavanju takvih reakcija.
English: The catheter flush procedure should only be performed after confirming the stroke volume measurement.
Croatian: Postupak ispiranja katetera smije se provesti tek nakon što se potvrdi izmjerena vrijednost udarnog volumena.
English: Insuman Implantable with alcohol Your blood sugar levels may either rise or fall if you drink alcohol.
Croatian: Insuman Implantable s alkoholom Razina šećera u krvi može porasti ili pasti ako pijete alkohol.
English: • the patient's weight changes,
Croatian: • se promjeni tjelesna težina bolesnika
English: It may also indicate that the refill needle is not properly seated in the pump inlet valve.
Croatian: Međutim, to također može značiti i da igla za nadopunjavanje nije pravilno sjela u dovodni ventil pumpe.
English: You must contact your doctor immediately.
Croatian: Odmah se morate obratiti svom liječniku.
English: Contact your doctor immediately if you are unable to go to the hospital or clinicto replace the insulin in your pump.
Croatian: Odmah se obratite svom liječniku ako ne možete otići u bolnicu ili kliniku zamijeniti inzulin u pumpi.
English: No food effect is expected on Cmax, Tmax and AUC values following CIPII administration.
Croatian: Ne očekuje se utjecaj hrane na vrijednosti Cmax, Tmax i AUC-a nakon kontinuirane intraperitonejske infuzije inzulina.
English: • other circumstances arise that may promote an increased susceptibility to hypo- or hyperglycaemia (see section 4.4).
Croatian: • nastanu druge okolnosti koje mogu dovesti do povećane podložnosti hipoglikemiji ili hiperglikemiji (vidjeti dio 4.4).
English: If the rinse procedure fails to restore the stroke volume and accurate delivery, an extended rinse procedure needs to be performed.
Croatian: Ako se postupkom ispiranja ne uspiju ponovno uspostaviti udarni volumen i precizna primjena doze, treba provesti produljeni postupak ispiranja.
English: This can be verified by checking the insulin daily history on the PPC at each visit.
Croatian: To se može provjeriti pregledom povijesti dnevne primjene inzulina na osobnom daljinskom upravljaču za pumpu pri svakom posjetu,
English: The study included 168 patients with type 1 diabetes mellitus, previously treated with the semi-synthetic human insulin.
Croatian: Ispitivanje je obuhvatilo 168 bolesnika sa šećernom bolešću tipa 1 koji su prethodno liječeni polusintetskim humanim inzulinom.