natgillin/translations-raw huggingface dataset:
No non-clinical studies assessing the potential toxicity of Insuman Implantable 400 IU/ml administered via intraperitoneal route were performed. 
Predkliničnih študij za oceno možne toksičnosti zdravila Insuman Implantable 400 i.e./ml, uporabljenega intraperitonealno, niso izvedli.
• in whom hypoglycaemia develops gradually, 
• se jim hipoglikemija razvije počasi,
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. 
Če morate za vzdrževanje koncentracije krvnega sladkorja zvišati insulin, ali se vam pojavi odporna hiperglikemija, je to lahko znak težav s črpalko.
Insuman Implantable is for intraperitoneal use only. 
Zdravilo Insuman Implantable je namenjeno samo za intraperitonealno uporabo.
• Implantable Insulin Pump system: Physician Manuals 
• Implantabilni sistem insulinske črpalke: priročniki za zdravnika
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). 
Uporaba pri pediatričnih bolnikih, ki še niso dosegli odrasle velikosti, zaradi velikosti črpalke (glejte poglavji 4.2 in 4.4).
Only after successful restoration of the stroke volume measurement can the catheter be flushed with the sterile rinse buffer solution and the pump refilled with insulin. 
Šele po izmerjeni uspešni obnovitvi pulznega volumna se sme kateter izprati s sterilno pufersko raztopino za izpiranje in črpalko ponovno napolniti z insulinom.
The prescription of this medicinal product is restricted to centres certified by Medtronic as having received adequate training in the use of the Medtronic MiniMed Implantable Pump. 
Predpisovanje tega zdravila je omejeno na centre, za katere družba Medtronic potrdi, da so bili deležni ustreznega usposabljanja za uporabo črpalke Medtronic MiniMed Implantable Pump.
If you have proliferative retinopathy (an eye disease related to diabetes) severe hypoglycaemic attacks may cause temporary loss of vision. 
Če imate proliferativno retinopatijo (očesno bolezen povezano s sladkorno boleznijo), lahko hud napad hipoglikemije povzroči začasno izgubo vida.
When used with an implantable insulin pump, Insuman Implantable will be continuously infused in your body and thus, may replace a long-acting insulin. 
Če je zdravilo Insuman Implantable uporabljeno z implantabilno insulinsko črpalko, ga ta stalno dovaja v telo in tako lahko nadomesti dolgodelujoči insulin.
Insuman Implantable is a high-concentrated insulin formulation Insuman Implantable contains 400 international units of insulin in each ml. 
Zdravilo Insuman Implantable je visoko koncentrirana oblika insulina Zdravilo Insuman Implantable vsebuje 400 mednarodnih enot insulina na mililiter.
Women of childbearing potential, implanted or candidates for implantation, should inform their physician if they are contemplating pregnancy. 
Ženske v rodni dobi, ki imajo vsajeno črpalko ali so kandidatke za vsaditev črpalke, morajo zdravnika obvestiti, če razmišljajo o nosečnosti.
with other insulin medicine other than Insuman Implantable. 
- skupaj s kakšnim drugim insulinskim zdravilom razen zdravila Insuman Implantable.
This happens when the tip of your catheter is fixed or in very close proximity to your liver. 
To se zgodi, če je konica katetra nameščena ali zelo blizu jeter.
If this happens, contact your doctor immediately. 
Če se to zgodi, se nemudoma posvetujte z zdravnikom.
• Rinse and flush procedure, stroke measurement and pump management including troubleshooting 
• Postopek izpiranja črpalke in katetra, meritev pulznega volumna in upravljanje s črpalko,
To prevent such pump problems, your doctor will schedule appointments at least every 6-months to rinse your pump. 
Za preprečitev takšnih težav s črpalko bo zdravnik za vas predvidel kontrolne preglede na vsaj 6 mesecev za izpiranje črpalke.
All solutions that will enter the pump must be properly degassed prior to filling the pump reservoir to avoid insulin aggregation and under-delivery. 
Vse raztopine, ki bodo prišle v črpalko, morajo biti pred polnjenjem rezervoarja črpalke ustrezno razplinjene, da bi preprečili agregacijo in nezadostno dajanje insulina.
Generally, the greater and more rapid the decline in blood glucose, the more marked is the phenomenon of counter-regulation and its symptoms. 
Praviloma so pojav protiregulacije in njegovi simptomi toliko izrazitejši, kolikor večje in hitrejše je znižanje koncentracije glukoze v krvi.
• Hyperglycaemia: If your blood sugar is too high, you may experience hyperglycaemia. 
• Hiperglikemija: Če imate previsok krvni sladkor, se vam lahko pojavi hiperglikemija.
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. 
Znano je, da lahko insulin, ki je izpostavljen kemičnim in/ali fizikalnim obremenitvam (npr. višjim temperaturam ali tresenju), tvori agregate, fibrile in gelaste strukture.
A number of substances affect glucose metabolism and may require dose adjustment of human insulin. 
Na presnovo glukoze vplivajo številne snovi in potrebna je lahko prilagoditev odmerka humanega insulina.
The Medtronic MiniMed Implantable Pump, which is implanted under the skin of your belly, infuses your insulin continuously (continuous intraperitoneal infusion). 
Črpalka Medtronic MiniMed Implantable Pump, ki vam jo vsadijo pod kožo na trebuhu, infundira insulin stalno (stalna intraperitonealna infuzija).
Focal hepatic steatosis 
Fokalna steatoza jeter
Diabetes mellitus is a disease where your body does not produce enough insulin to control the level of blood sugar. 
Sladkorna bolezen je bolezen, pri kateri v telesu ne nastaja insulina, da bi lahko uravnal koncentracijo krvnega sladkorja.
Hypoglycaemia, in general the most frequent adverse reaction of insulin therapy, may occur if the insulin dose is too high in relation to the insulin requirement. 
Hipoglikemija, ki je na splošno najpogostejši neželeni učinek zdravljenja z insulinom, se lahko pojavi, če je odmerek insulina prevelik glede na potrebe po insulinu.
If this occurs, you should contact your doctor immediately. 
Če se to zgodi, se morate nemudoma posvetovati z zdravnikom.
Acute toxicity of insulin human was studied following subcutaneous administration in rats. 
Akutno toksičnost humanega insulina so preučili po podkožni uporabi pri podganah.
The vials of insulin should be withdrawn from the refrigerator and stored at room temperature in the outer carton in order to protect from light for a minimum of 4 hours and no longer than 24 hours before use. 
Viale z insulinom je treba vzeti iz hladilnika in jih shraniti na sobni temperaturi (v zunanji ovojnini za zagotovitev zaščite pred svetlobo) vsaj 4 ure pred uporabo, a ne več kot 24 ur pred uporabo.
If you are using clear insulin (Insuman Rapid), do not use this pen if the insulin is cloudy, coloured or has particles. 
Če uporabljate bister insulin (Insuman Rapid), ne uporabite SoloStarja, če je insulin moten, obaravan ali so v njem delci.
Medication errors involving mix-up between subcutaneous Insuman formulations or other subcutaneous insulins have been reported. 
Opisane so bile napake pri uporabi zdravila, povezane z zamenjavo med podkožnimi oblikami insulina Insuman ali drugimi podkožno uporabljanimi insulini.
In addition, under the influence of sympatholytic medicinal products such as beta-blockers, clonidine, guanethidine and reserpine, the signs of adrenergic counter-regulation may be reduced or absent. 
Poleg tega se lahko pod vplivom simpatikolitičnih zdravil, npr. blokatorjev adrenergičnih receptorjev beta, klonidina, gvanetidina in rezerpina, znaki adrenergične protiregulacije zmanjšajo ali izginejo.
To avoid microbial contamination and infection, aseptic skin preparation should be performed according to the healthcare institution's standard sterile operating procedures. 
Da bi preprečili kontaminacijo z mikrobi in okužbo, je treba kožo aseptično pripraviti upoštevaje standardni operativni postopek za sterilno pripravo, ki velja v zdravstveni ustanovi.
As soon as patients notice a rapid increase in blood glucose, which does not respond to a bolus dose of insulin, the possibility of pump obstruction should be investigated by a physician trained to perform pump investigations. 
Čim bolnik opazi hitro zvišanje glukoze v krvi, ki se ne odzove na bolusni odmerek insulina, mora zdravnik, usposobljen za izvajanje preiskav črpalke, preučiti možnost zamašitve črpalke.
If you are allergic to this medicine or to animal insulins, talk to your doctor. 
Če ste alergični na to zdravilo ali na živalske insuline, se posvetujte s svojim zdravnikom.
Insulin administration via the pump can cause a fat infiltration of the liver at single, well-defined locations (called focal hepatic steatosis). 
Dajanje insulina s črpalko lahko povzroči maščobno infiltracijo jeter na posameznih, dobro omejenih mestih (to imenujemo žariščna (fokalna) steatoza jeter).
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). 
Zaradi velikosti implantabilne črpalke je uporaba zdravila Insuman Implantable kontraindicirana pri pediatričnih bolnikih, ki še niso dosegli odrasle velikosti (glejte poglavji 4.2 in 4.3).
Insuman Infusat may be infused by the subcutaneous route. 
Insuman Infusat se lahko infundira subkutano.
• Device components 
• Sestavni deli pripomočka.
• have a tendency to hypoglycaemia, 
• so nagnjeni k hipoglikemijam,
Detailed instructions on programming these limitations are contained in the Physician's Manual. 
Podrobna navodila o programiranju teh omejitev so navedena v priročniku za zdravnika.
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). 
Kaže, da je fokalna steatoza jeter po prenehanju infundiranja insulina oziroma odstranitvi ali spremembi položaja peritonealnega katetra reverzibilna in brez kliničnih posledic (glejte poglavje 4.8).
The solution must only be used if it is clear, colourless or almost colourless and practically free from visible particles. 
Raztopino se sme uporabiti le, če je bistra, brezbarvna ali skoraj brezbarvna in praktično brez vidnih delcev.
There is no clinical information with the use of Insuman Implantable in an implantable pump in pregnant women. 
Kliničnih podatkov o uporabi zdravila Insuman Implantable v implantabilni črpalki pri nosečnicah ni.
In case of insufficient glucose control or a tendency to hyper- or hypoglycaemic episodes, the patient's adherence to the prescribed treatment regimen and all other relevant factors must be reviewed before dose adjustment is considered. 
V primeru nezadostne urejenosti glukoze ali nagnjenosti k hiper- ali hipoglikemijam je treba pred spreminjanjem odmerka preveriti, ali bolnik upošteva predpisano shemo zdravljenja in vse druge pomembne dejavnike.
The physician must program specific limitations for insulin basal insulin rates, bolus delivery amounts. 
Zdravnik mora programirati specifične omejitve za bazalno hitrost insulina in bolusne odmerke.
Part of the daily insulin dose is infused continuously by the Medtronic MiniMed Implantable Pump and the remaining part of the daily dose is administered by you, using the same pump, as a bolus before meals. 
Del dnevnega odmerka insulina vam stalno infundira črpalka Medtronic MiniMed Implantable Pump, preostanek dnevnega odmerka pa si daste sami z uporabo iste črpalke, kot bolus pred obroki.
If you stop using Insuman Rapid 
Če ste prenehali uporabljati Insuman Rapid
If you experience severe low blood sugar levels, this may indicate a problem with your pump. 
Pojav zelo nizkega krvnega sladkorja je lahko znak težav s črpalko.
Immediate type allergic reactions to insulin or to the excipients may be life-threatening. 
Alergijske reakcije takojšnega tipa na insulin ali pomožne snovi so lahko smrtno nevarne.
Because you have type 1 diabetes, an insulin dependent diabetes mellitus, do not stop your insulin. 
Ker imate sladkorno bolezen tipa 1 (od insulina odvisno sladkorno bolezen), ne prenehajte uporabljati insulina.
If you are allergic to insulin or any of the other ingredients of this medicine (listed in section 6). 
če ste alergični na insulin ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
She/he is trained to perform pump procedures which are needed tomake sure your pump works properly. 
Vaša zdravnica/vaš zdravnik je usposobljen za izvedbo tistih postopkov s črpalko, ki so potrebni za zagotovitev njenega pravilnega delovanja.
You should contact your doctor for advice on driving if: you have frequent episodes of hypoglycaemia, the first warning symptoms which help you to recognise hypoglycaemia are reduced or absent. 
O upravljanju vozil se posvetujte z zdravnikom: če imate pogoste hipoglikemije, če so se vam prvi opozorilni simptomi, ki vam pomagajo prepoznati hipoglikemijo, zmanjšali ali so odsotni.
Insuman Infusat in a vial may also be used in other insulin pumps for which it has been shown that they are suitable for this insulin (see pump manual). 
Insuman Infusat v vložku se lahko uporablja tudi v drugih insulinskih črpalkah, za katere je dokazano, da so primerne za ta insulin (glejte priročnik črpalke).
Implantation of the pump in patients who reside permanently at elevations above 2439 meters (8000 feet) (see section 4.4). 
Vsaditev črpalke bolnikom, ki stalno živijo na nadmorski višini nad 2439 metrov (glejte poglavje 4.4).
Insuman Implantable has been designed only for intraperitoneal use with the Medtronic MiniMed Implantable Pump supplied by Medtronic MiniMed which delivers insulin directly into the peritoneal cavity. 
Zdravilo Insuman Implantable je izdelano le za intraperitonealno uporabo s črpalko Medtronic MiniMed Implantable Pump, ki jo dobavlja družba Medtronic MiniMed in ki dovaja insulin neposredno v peritonealno votlino.
The warning symptoms of hypoglycaemia may be changed, be less pronounced or be absent in certain risk groups. 
Opozorilni simptomi hipoglikemije se lahko v nekaterih ogroženih skupinah bolnikov spremenijo, tako da so manj izraziti ali jih sploh ni.
Solution for infusion 4,000 IU/10 ml 1 vial 
Raztopina za infundiranje 4,000 i.e./10 ml 1 viala
Elevated levels of antibodies to insulin are not commonly associated with a need to change your insulin dose or occurrence of serious side effects. 
Zvišano raven protiteles proti insulinu včasih spremlja potreba po spremembi odmerka insulina ali pojav resnih neželenih učinkov.
The insulin in your pump must be replaced every 40 to 45 days with new insulin or earlier based on your insulin needs. 
Insulin v črpalki je treba na 40 do 45 dni nadomestiti z novim insulinom (lahko pa že prej, odvisno od vaših potreb po insulinu).
For insulin human, no clinical data on exposed pregnancies are available. 
Za humani insulin ni na voljo kliničnih podatkov od nosečnic, ki so bile izpostavljene zdravilu.
In the following situations, the management of your diabetes may require extra care (e.g. urine and blood tests): - If you are ill or have a major injury then your blood sugar level may increase (hyperglycaemia). 
V naslednjih okoliščinah lahko vodenje vaše sladkorne bolezni zahteva dodatno skrb (npr. teste urina in krvi): - če ste bolni ali imate večjo poškodbo, se vam lahko krvni sladkor zviša (hiperglikemija).
In patients who require high insulin doses because of the presence of insulin antibodies, transfer under medical supervision in a hospital or similar setting must be considered. 
Pri bolnikih, ki zaradi protiteles proti insulinu potrebujejo velike odmerke insulina, je treba razmisliti o zdravljenju pod zdravniškim nadzorstvom v bolnišnici ali podobnem okolju.
Medical imaging technique 
Medicinska slikanja
• Refractory hyperglycaemia occurs. 
• se pojavi neodzivna hiperglikemija.
Infection of the pump pocket (where your pump is placed), erosion of the skin where your pump is implanted and poor healing of the incision site in your skin can occur. 
Pojavijo se lahko okužba žepa črpalke (tj. mesta, kjer je vsajena črpalka), erozija kože na mestu, kjer je vsajena črpalka, ali slabo celjenje reza na koži.
For use in an infusion pump, Insuman Infusat is filled into the sterile cartridge of the pump. 
Za uporabo v infuzijski črpalki se Insuman Infusat napolni v sterilni vložek črpalke.
Insuman Implantable must not be used with any other type of injection devices (e.g. syringes). 
Zdravila Insuman Implantable ne smete uporabljati z nobenim drugim pripomočkom za injiciranje (npr. z brizgami).
Continuous infusion via the intraperitoneal and intravenous routes (combined data) resulted in higher plasma free insulin Cmax values than multiple daily subcutaneous injections and continuous subcutaneous insulin infusion via an external pump (combined data) in patients with type 1 diabetes mellitus. 
Stalno intraperitonealno in intravensko infundiranje (kombinirani podatki) je pri bolnikih s sladkorno boleznijo tipa 1 povzročilo večjo Cmax prostega insulina v plazmi kot večkratne dnevne podkožne injekcije ali stalno podkožno infundiranje insulina z zunanjo črpalko (kombinirani podatki).
No effects on the breastfed child are anticipated. 
Učinki na dojenčke niso pričakovani.
Patients should practice good diabetes self care and check their blood glucose a minimum of 4 times daily to detect and prevent hyperglycemia and possible diabetic ketoacidosis due to pump under-delivery. 
Bolniki morajo izvajati dobro samooskrbo sladkorne bolezni in morajo glukozo v krvi meriti vsaj 4-krat na dan, da bi odkrili in preprečili hiperglikemijo ter možno diabetično ketoacidozo zaradi nezadostnega dovajanja insulina.
Failure to properly degas all fluids may introduce air in the pump causing insulin aggregation and under-delivery. 
Nepravilno razplinjenje vseh tekočin lahko v črpalko vnese zrak, povzroči agregacijo insulina in nezadostno dovajanje insulina.
Insuman Implantable administered in continuous intraperitoneal infusion was also similar to semi-synthetic human insulin as demonstrated by the refill accuracy criteria over the 4-refill cycles (per protocol population: mean difference: -3.15 ± 1.34; [95% CI: -5.81; -0.50]). 
V stalni intraperitonealni infuziji uporabljeno zdravilo Insuman Implantable je bilo podobno polsinteznemu humanemu insulinu tudi sodeč po točnosti ponovnega polnjenja v 4 ciklusih ponovnega polnjenja (populacija po-protokolu: povprečna razlika: -3,15 ± 1,34, 95 % IZ:
There are no fixed rules for insulin dose regimen. 
Za odmerjanje insulina ni trdnih pravil.
For further details on handling see section 6.6. 
Za podrobnosti o ravnanju z zdravilom glejte poglavje 6.6.
Insuman Implantable with alcohol Your blood sugar levels may either rise or fall if you drink alcohol. 
Zdravilo Insuman Implantable skupaj z alkoholom Če pijete alkoholne pijače, se vam krvni sladkor lahko zviša ali zniža.
• Alarms and messages displayed by the device and the appropriate actions to take • Recognition of signs and symptoms of under or no delivery of insulin and the appropriate actions to take 
• Prepoznava znakov in simptomov nezadostnega dovajanja ali nedovajanja insulina in ustrezno ukrepanje.
Insuman Infusat must only be used in insulin pumps suitable for this insulin. 
Insuman Infusat morate uporabljati samo v insulinskih črpalkah, primernih za ta insulin.
Solution for infusion (infusion). 
FARMACEVTSKA OBLIKA Raztopina za infundiranje (infuzija).
Rinsing may be performed earlier, for example, when potential under-delivery is suspected based on a calculated refill accuracy of less than 85%. 
Izpiranje se lahko opravi prej, na primer če zaradi izračunane točnosti ponovnega polnjenja, manjše od 85 %, obstaja sum na nezadostno dovajanje insulina.
The patient blood glucose levels must be monitored at least every 15 minutes following the flush. 
Bolniku je treba po izpiranju vsaj na 15 minut kontrolirati koncentracijo glukoze v krvi.
Perform a safety test 
3. korak Opravite varnostni preizkus.
In patients with severe hepatic impairment, insulin requirements may be diminished due to reduced capacity for gluconeogenesis and reduced insulin metabolism. 
Pri bolnikih s hudo okvaro jeter se lahko potreba po insulinu zmanjša zaradi zmanjšane zmožnosti za glukoneogenezo in zmanjšane presnove insulina.
If your SoloStar is in cool storage, take it out 1 to 2 hours before you inject to allow it to warm up at room temperature. 
Če imate SoloStar shranjen na hladnem, ga vzemite ven 1 do 2 uri pred injiciranjem, da se ogreje na sobno temperaturo.
Transfer to Insuman Infusat 
Prehod na Insuman Infusat
In case of severe hypoglycaemia, the pump should be investigated by the treating physician for possible catheter occlusion leading to accumulation of insulin with subsequent release of this accumulated insulin (see sections 4.4 and 6.6). 
V primeru hude hipoglikemije mora lečeči zdravnik črpalko preiskati glede možne zapore katetra, ki povzroči kopičenje insulina in posledično sprostitev tega nakopičenega insulina (glejte poglavji 4.4 in
You should practice good diabetes care and test your own blood sugar levels at least four times daily to check your blood sugar levels and determine insulin doses. 
Izvajati morate dobro vodenje sladkorne bolezni in si koncentracijo krvnega sladkorja meriti vsaj štirikrat na dan, da boste preverjali raven krvnega sladkorja in določili odmerke insulina.
Shelf life in the pump Up to 45 days at 37°C. 
Rok uporabnosti v črpalki Do 45 dni pri temperaturi 37 °C.
To prevent pump problems, your doctor will schedule appointments at least every 6-months to rinse your pump. 
Za preprečitev težav s črpalko bo zdravnik predvidel kontrolne preglede na vsaj 6 mesecev za izpiranje črpalke.
This seems to be reversible when your catheter is repositioned or your insulin infusion stopped and without consequences on your health (see section 4). 
Kot kaže, po premestitvi katetra ali prenehanju infundiranja insulina ta sprememba izgine, ne da bi imela kakšne posledice za vaše zdravje (glejte poglavje 4).
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. 
Vsi izsledki kažejo, da je stalno intraperitonealno infundiranje insulina pri bolnikih s sladkorno boleznijo tipa 1 bolj podobno opaženi farmakokinetiki endogenega insulina kot stalno podkožno infundiranje insulina ali večkratno dnevno injiciranje.
Insuman Rapid with alcohol 
Zdravilo Insuman Rapid z alkoholom
However, use only those injection syringes which are designed for an insulin concentration of 100 IU (International Units) per ml. 
Vendar uporabite le injekcijske brizge, namenjene za insulin s koncentracijo 100 i.e. (mednarodnih enot) na ml.
She/he is trained to perform pump investigations. 
Vaša zdravnica/vaš zdravnik je usposobljen za izvajanje preiskav črpalke.
Examples include: you have not administered your insulin or not administered enough, e.g. due to pump not working properly or catheter blockage. 
Med možnimi vzroki so: niste si dali insulina, ali ga niste dali dovolj, npr. zaradi nepravilnega delovanja črpalke ali zamašitve katetra.
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. 
Izpiranje črpalke za preprečitev nezadostnega dovajanja insulina Da bi preprečili nezadostno dovajanje insulina, ki se lahko pojavi v primeru nabiranja odložkov insulina v črpalnem mehanizmu, je priporočljivo vsakih 6 mesecev opraviti izpiranje.
During this procedure, a very small amount of Insuman Implantable may be deposited under your skin, which may result in low blood sugar levels. 
Med tem postopkom lahko zelo majhna količina zdravila Insuman Implantable pride pod kožo; to lahko povzroči nizek krvni sladkor.
Transfer to Insuman Rapid 
Prehod na Insuman Rapid