FrancophonIA/ELRC3.0 huggingface dataset:
English: This means that Insuman Implantable is more concentrated than standard insulin.
Slovenian: To pomeni, da je zdravilo Insuman Implantable bolj koncentrirano kot standardni insulin.
English: • certain uncompensated endocrine disorders (e.g. in hypothyroidism and in anterior pituitary or adrenocortical insufficiency),
Slovenian: • določene nekompenzirane endokrine bolezni (npr. pri hipotiroidizmu in sprednji hipofizni ali adrenokortikalni insuficienci),
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%.
Slovenian: Razlogi za uvedbo stalnega intraperitonealnega infundiranja insulina (CIPII - continuous intra-peritoneal insulin infusion) so bili nestabilna sladkorna bolezen ("brittle diabetes") v 62,7 %, hipoglikemije v 29,2 %, periferna odpornost proti insulinu v 5,0 % ter hipoglikemije in nestabilna sladkorna bolezen v 3,1 %.
English: This should be kept in mind if treatment with the combination of pioglitazone and Insuman is considered.
Slovenian: To je potrebno upoštevati pri zdravljenju s kombinacijo pioglitazona in zdravila Insuman.
English: In most cases you will need to see a doctor.
Slovenian: Večinoma boste morali obiskati zdravnika.
English: • Recognition of signs and symptoms of severe hypoglycaemia and the appropriate actions to take
Slovenian: • Prepoznava znakov in simptomov hude hipoglikemije in ustrezno ukrepanje.
English: • previously required high insulin doses due to the presence of insulin antibodies.
Slovenian: • so pred tem potrebovali visoke odmerke insulina zaradi prisotnosti protiteles proti insulinu.
English: Before you can use the Medtronic MiniMed Implantable Pump, you will be trained.
Slovenian: Preden boste lahko uporabili črpalko Medtronic MiniMed Implantable Pump, boste deležni usposabljanja.
English: If you stop using your insulin this could lead to a very high blood sugar level.
Slovenian: Če prenehate uporabljati insulin, to lahko povzroči zelo visok krvni sladkor.
English: Insuman Implantable should not be used during pregnancy unless the clinical condition of the woman requires treatment with Insuman Implantable.
Slovenian: Med nosečnostjo se zdravila Insuman Implantable ne sme uporabljati, razen če klinično stanje ženske zahteva zdravljenje s tem zdravilom.
English: • Patient emergency information cards
Slovenian: • Informacijsko izkaznico bolnika za nujne primere.
English: Patients must be informed to closely monitor blood glucose levels on refill days (see section 6.6).
Slovenian: Bolnikom je treba naročiti, naj ob dneh ponovnega polnjenja skrbno kontrolirajo koncentracijo glukoze v krvi (glejte poglavje 6.6).
English: Depending on blood glucose values, an appropriate bolus amount must be programmed to remove the sterile rinse buffer solution from the catheter.
Slovenian: Odvisno od vrednosti glukoze v krvi je treba programirati ustrezen bolus za odstranitev sterilne puferske raztopine za izpiranje iz katetra.
English: The patient plays a significant role in diagnosing and correcting hyperglycemia linked to pump performance problems.
Slovenian: Bolnik ima pomembno vlogo pri prepoznavanju in odpravljanju hiperglikemije, povezane s težavami v delovanju črpalke.
English: • Infection of space where the pump has been implanted (pump pocket)
Slovenian: • Okužba mesta, kjer je vsajena črpalka (žepa črpalke)
English: o You need to keep some form of fast-acting sugar with you at all times.
Slovenian: o Vedno morate imeti pri sebi takšno ali drugačno obliko sladkorja, ki učinkuje hitro.
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.
Slovenian: Tretja študija, ki so jo izvedli pri diabetičnih podganah z uporabo drugega humanega insulina podobne oblike kot Insuman po katetru, fiksiranem v jetrno kapsulo, je pokazala, da lahko intraperitonealna uporaba visoke lokalne koncentracije insulina ob jetrni kapsuli povzroči reverzibilno fokalno steatozo jeter.
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.
Slovenian: Insuman Rapid je primeren tudi za zdravljenje hiperglikemične kome in ketoacidoze ter za doseganje pred-, med- in pooperacijske stabilizacije pri bolnikih z diabetesom mellitusom.
English: The patient must be closely monitored for possible hypoglycaemia and administered intravenous glucose or glycogen as needed.
Slovenian: Bolnika je treba skrbno nadzorovati glede morebitne hipoglikemije in mu je treba dati intravensko glukozo ali glikogen, kot je potrebno.
English: The co-primary endpoint was change in HbA1c from baseline and the pump refill accuracy after 4 refill cycles (162 ± 21 days).
Slovenian: Soprimarni opazovani dogodek je bila sprememba HbA1c od izhodišča in točnost ponovnega polnjenja črpalke po 4 ciklusih ponovnih polnjenj (162 ± 21 dni).
English: The patient should correct resistant hyperglycaemia with a standard dose of subcutaneous insulin.
Slovenian: Bolnik mora odporno hiperglikemijo korigirati s standardnim odmerkom podkožnega insulina.
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.
Slovenian: Vsi postopki v zvezi s črpalko (na primer ponovno polnjenje črpalke, izpiranje črpalke, preiskave črpalke za preverjanje, ali deluje pravilno) se izvajajo sterilno, da bi preprečili tveganje za okužbo.
English: • concomitant treatment with certain other medicinal products (see section 4.5).
Slovenian: • sočasno zdravljenje z določenimi drugimi zdravili (glejte poglavje 4.5).
English: If you expect to have frequent medical imaging (e.g. MRI or ultrasound), talk to your doctor.
Slovenian: Če pričakujete, da boste pogosto potrebovali medicinska slikanja (npr. magnetnoresonančno slikanje ali slikanje z ultrazvokom), se posvetujte z zdravnikom.
English: • A refill accuracy of less than 85% is calculated during a refill procedure.
Slovenian: • je med ponovnim polnjenjem izračunana točnost manjša od 85 %.
English: If this happens, immediately contact your doctor who is trained to perform pump investigations.
Slovenian: Če se to zgodi, se nemudoma posvetujte z zdravnikom, usposobljenim za izvajanje preiskav črpalke.
English: • Eye reactions
Slovenian: • Reakcije na očeh
English: • The most frequent side effect is hypoglycaemia (low blood sugar).
Slovenian: • Najpogostejši neželeni učinek je hipoglikemija (nizek krvni sladkor).
English: This leaflet was last revised in {date}
Slovenian: Navodilo je bilo nazadnje revidirano {datum}
English: Patients may require more frequent refill procedures based on their insulin needs.
Slovenian: Bolniki lahko glede na svoje potrebe po insulinu potrebujejo pogostejša ponovna polnjenja.
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).
Slovenian: Posvetujte se z zdravnikom, da boste izvedeli, kaj storiti, če načrtujete: - da boste živeli na višini nad 2439 metrov, - da boste potovali na višino nad 2439 metrov kako drugače kot s potniškim letalom, - da se boste potapljali v globino, večjo od 7,6 metra.
English: The frequency of this reaction varies with patient population and dose regimens.
Slovenian: Njena pogostnost se razlikuje med populacijami bolnikov in odmernimi shemami.
English: Combination of Insuman with pioglitazone
Slovenian: Kombinacija zdravila Insuman s pioglitazonom
English: No hepatic steatosis was observed.
Slovenian: Steatoze jeter niso opazili.
English: Your doctor or nurse should have talked to you about this before.
Slovenian: Zdravnik ali medicinska sestra sta se morala o tem že prej pogovoriti z vami.
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).
Slovenian: Če ne morete požirati ali ste nezavestni, boste potrebovali injekcijo glukoze ali glukagona (zdravila, ki zviša krvni sladkor).
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).
Slovenian: Preglednica 2: Neželeni učinki in tehnične reklamacije v zvezi z izdelkom, zabeleženi s sistemom za dajanje zdravila (vključno z neželenimi učinki, povezani z vsaditveno operacijo ali vzdrževanjem pripomočka).
English: • Patient quick guides on the main programming functions
Slovenian: • Hitri vodnik za bolnika o glavnih programskih funkcijah
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.
Slovenian: V primeru, da je vaša črpalka poškodovana ali, da se vam poškoduje osebni komunikator za črpalko (na kratko: PPC) ali ga izgubite, se z zdravnikom posvetujte, kako ravnati v primeru nepravilnega delovanja črpalke.
English: It is recommended to perform the rinse procedure every 6 months.
Slovenian: Postopek izpiranja je priporočljivo opraviti na 6 mesecev.
English: A calculated refill accuracy of less than 85% is indicative of insulin under-delivery.
Slovenian: Izračunana točnost ponovnega polnjenja, ki je manjša od 85 %, kaže na nezadostno dovajanje insulina.
English: During the catheter flush procedure 13 units of insulin are manually pushed through the catheter and delivered to the patient.
Slovenian: Med izpiranjem katetra se 13 enot insulina ročno potisne skozi kateter in jih dobi bolnik.
English: Residual insulin and new insulin must be weighed to record the refill worksheet and calculate the refill accuracy criterion.
Slovenian: Rezidualni insulin in novi insulin je treba stehtati, ju evidentirati na delovnem listu o ponovnem polnjenju in izračunati merilo točnosti ponovnega polnjenja.
English: For further details on handling see section 6.6 and instructions provided in the Physician's manual.
Slovenian: Za podrobnosti o ravnanju z zdravilom glejte poglavje 6.6 in navodila v priročniku za zdravnika.
English: These patients are not adequately controlled despite intensive injection of insulin under their skin (multiple daily injections or insulin pump therapy).
Slovenian: Ti bolniki bolezni nimajo ustrezno urejene kljub intenzivnemu injiciranju insulina pod kožo (več injekcij na dan ali zdravljenje z insulinsko črpalko).
English: Infections around the pump implantation site may require the removal of your pump (explantation of the pump).
Slovenian: Okužbe okrog mesta vsaditve črpalke lahko zahtevajo njeno odstranitev (eksplantacijo črpalke).
English: Infection of the pump pocket
Slovenian: Okužbe žepa črpalke
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.
Slovenian: Poleg tega lahko nastanek biofilma nad konico katetra s stranskim nastavkom povzroči latentno hipoglikemijo, ker se insulin, programiran skozi čas, ujame v biofilm in se sprosti, ko se nakopiči zadostna količina insulina.
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.
Slovenian: Po intraperitonealni uporabi zdravila Insuman Implantable 0,15 i.e./kg je bil mediani tmax 0,54 ure in Cmax v serumu 210 ± 129 mikro i.e./ml.
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.
Slovenian: Z vialami insulina bo ravnal vaš zdravnik, ki ima pripomočke (npr. brizge in igle za ponovno polnjenje) in opremo, potrebne za polnjenje vaše implantabilne črpalke.
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.
Slovenian: Bolnika je treba tudi oskrbeti z alternativnimi načini za uporabo insulina, npr. mu zagotoviti insulin 100 i.e./ml, pripomočke in opremo za podkožno injiciranje.
English: This may constitute a risk in situations where these abilities are of special importance (e.g. driving a car or using machines).
Slovenian: To lahko pomeni tveganje v okoliščinah, v katerih sta ti zmožnosti posebej pomembni (npr. pri vožnji avtomobila ali upravljanju s stroji).
English: • Physician quick guides on the main programming functions
Slovenian: • Hitri vodnik za zdravnika o glavnih programskih funkcijah
English: The insulin solution must be then degassed according to the degassing procedure described in the Physician's manual.
Slovenian: Raztopino insulina je treba razpliniti skladno s postopkom za razplinjenje, opisanim v priročniku za zdravnika.
English: In many cases, urine tests for ketones are indicated, and often it is necessary to adjust the insulin dose.
Slovenian: V številnih primerih je indicirano testiranje urina za ketone in pogosto je treba prilagoditi odmerek insulina.
English: Insuman (all presentations except Insuman Implantable): Medicinal product subject to medical prescription.
Slovenian: Insuman (vse oblike razen Insuman Implantable): Predpisovanje in izdaja zdravila je le na recept.
English: It may also indicate that the refill needle is not properly seated in the pump inlet valve.
Slovenian: Pomeni lahko tudi, da polnilna igla ni pravilno nameščena v dovodno zaklopko črpalke.
English: This may require a change to your insulin dose (see section 4).
Slovenian: Zaradi tega je lahko potrebna sprememba odmerka insulina (glejte poglavje 4).
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.
Slovenian: Podrobna navodila za uporabo implantabilne črpalke, njenih funkcijah in potrebnih previdnostnih ukrepih glede varnosti so opisana v priročniku za zdravnika, priloženemu infuzijski črpalki.
English: Insulin under-delivery is suspected when:
Slovenian: Sum na nezadostno dovajanje insulina obstaja, če:
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).
Slovenian: Črpalka Medtronic MiniMed Implantable Pump ni načrtovana za uporabo na nadmorski višini nad 2439 metrov ali več kot 7,6 metrov pod gladino.
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.
Slovenian: Spremembe bazalnega in bolusnih odmerkov potekajo z uporabo majhne, ročne enote (osebnega komunikatorja za črpalko - PPC [Personal Pump Communicator]), ki s črpalko komunicira preko radijskih valov.
English: The patient should read and follow the instructions in the Patient Manual accompanying the infusion pump.
Slovenian: Bolnik mora prebrati in upoštevati navodila v priročniku za bolnika, priloženemu infuzijski črpalki.
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.
Slovenian: Če uporabljate suspenzijo insulina (Insuman Basal ali mešanice zdravila Insuman) pretresite injekcijski peresnik gor in dol vsaj 10-krat, da insulin ponovno suspendirate.
English: These include:
Slovenian: Med takšnimi dejavniki so:
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.
Slovenian: Po intraperitonealni uporabi 0,15 i.e./kg zdravila Insuman Implantable se je insulin odstranil iz seruma z navideznim povprečnim razpolovnim časom 2,7 ure.
English: The injection button colour will vary based on the formulation of Insuman insulin used.
Slovenian: Barva injekcijskega gumba se razlikuje glede na uporabljeno obliko insulina Insuman.
English: Insulin does not cross the placental barrier.
Slovenian: Insulin ne prestopa placentne pregrade.
English: • other circumstances arise that may promote an increased susceptibility to hypo- or hyperglycaemia (see section 4.4).
Slovenian: • če se pojavijo druge okoliščine, ki lahko sprožijo večjo nagnjenost k hipo- ali hiperglikemiji (glejte poglavje 4.4).
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.
Slovenian: Bolniki, vključeni v skupino s stalnim intraperitonealnim infundiranjem insulina so prejeli polsintezni humani insulin 400 i.e./ml 180 dni in nato zdravilo Insuman Implantable 400 i.e./ml nadaljnjih 180 dni.
English: In addition, antibiotic prophylactic measures are required before and after pump implantation to reduce the risk of pump pocket infection.
Slovenian: Poleg tega je pred vsaditvijo črpalke in po vsaditvi potrebna profilaktična uporaba antibiotika za zmanjšanje tveganja za okužbo žepa črpalke.
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.
Slovenian: Če črpalki zmanjka insulina ali daje manj insulina, kot ga potrebujete, lahko občutite simptome visokega krvnega sladkorja.
English: Contact your doctor immediately if you are unable to go to the hospital or clinicto replace the insulin in your pump.
Slovenian: Nemudoma se posvetujte z zdravnikom, če ne morete iti v bolnišnico ali ambulanto, da bi nadomestili insulin v črpalki.
English: The catheter flush procedure should only be performed after confirming the stroke volume measurement.
Slovenian: Izpiranje katetra je treba opraviti šele po potrditvi meritve pulznega volumna.
English: The implantable pump may erode through the skin, resulting in infection of the implant site and pump explantation.
Slovenian: Implantabilna črpalka lahko erodira skozi kožo, povzroči okužbo na mestu vsaditve in eksplantacijo črpalke.
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.
Slovenian: Črpalke Medtronic MiniMed Implantable Pump se ne sme vsaditi bolnikom s takšnimi zdravstvenimi ali duševnimi motnjami, ki bi jim onemogočile prilagoditev programa črpalke na podlagi izvidov merjenja glukoze ali ustrezno izvajanje korektivnih ukrepov v primeru težav s črpalnim sistemom.
English: If you use more Insuman Implantable than you should Your doctor will program maximum dose limits into your PPC.
Slovenian: Če ste uporabili večji odmerek zdravila Insuman Implantable, kot bi smeli Zdravnik bo v PPC programiral meje največjega odmerka.
English: • after transfer from animal insulin to human insulin,
Slovenian: • so prešli z živalskega na humani insulin,
English: • the patient's weight changes,
Slovenian: • če se spremeni bolnikova telesna masa,
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.
Slovenian: Opravljena je bila dodatna 12-mesečna odprta randomizirana kontrolirana študija (MIP 310) za primerjalno oceno vpliva intraperitonealne in podkožne uporabe insulina na urejenost glikemije in pogostnost hudih hipoglikemij.
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.
Slovenian: V literaturi je farmakokinetika insulina na splošno opisana kot ponovljiva pri bolnikih s sladkorno boleznijo tipa 1, ki prejemajo kratkotrajno in dolgotrajno stalno intraperitonealno infuzijo insulina.
English: • Information on the registry including how to, and the importance of, entering patients in it • Surgical aspects of implantation
Slovenian: • Informacije o registru, vključno z informacijami o tem, kako bolnike vnesti v register, in o pomembnosti vnosa bolnikov v register.
English: However, three studies were conducted in rats to assess the potential toxicity of administration of human insulin via the intraperitoneal route.
Slovenian: Izvedene pa so bile tri študije na podganah za oceno morebitne toksičnosti intraperitonealno uporabljenega humanega insulina.
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.
Slovenian: Možno nezadostno dovajanje insulina s črpalko Medtronic MiniMed Implantable Pump lahko povzroči večjo dnevno programirano porabo insulina, težave pri vzdrževanju evglikemije, neodzivno hiperglikemijo in stalno zmanjševanje točnosti ponovnega polnjenja.
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.
Slovenian: Zdravilo Insuman Implantable je indicirano za zdravljenje odraslih bolnikov s sladkorno boleznijo tipa 1, pri katerih urejenosti ni mogoče doseči s podkožno uporabo insulina (vključno s črpalko) in imajo pogoste, sicer nepojasnjene hude hiper- in/ali hipoglikemije.
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).
Slovenian: Bolnike je treba seznaniti z visoko koncentracijo insulina v zdravilu Insuman Implantable (400 i.e./ml) v primerjavi z drugimi insulini v vialah ali vložkih (po navadi 100 i.e./ml).
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).
Slovenian: Intraperitonealno dajanje insulina je bilo podobno podkožnemu dajanju sodeč po spremembi HbA1c od izhodišča (stalna intraperitonealna uporaba: vrednost HbA1c 360. dan je bila 7,78 ± 1,04 in izhodiščno 8,06 ± 0,77; podkožna uporaba: vrednost HbA1c 360. dan je bila 8,19 ± 0,87 in izhodiščno
English: In addition, you should read and follow the instructions given in the patient manual accompanying the Medtronic MiniMed Implantable Pump.
Slovenian: Poleg tega morate prebrati in upoštevati navodila v priročniku za bolnika, ki je priložen črpalki Medtronic MiniMed Implantable Pump.
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.
Slovenian: Nobeden od bolnikov pred tem še ni prejemal intraperitonealnega insulina, HbA1c pa se jim ni izboljšal v 3 mesecih intenzivnega zdravljenja z večkratnimi dnevnimi injekcijami ali stalnim podkožnim infundiranjem insulina.
English: Do not use the Medtronic MiniMed Implantable Pump if you are allergic to titanium alloy, polysulfone or silicone materials used in the implanted components of the pump.
Slovenian: Ne uporabljajte črpalke Medtronic MiniMed Implantable Pump če ste alergični na titanove zlitine, polisulfonske ali silikonske snovi, uporabljene v vsajenih delih črpalke.