FrancophonIA/ELRC3.0 huggingface dataset:
English: The unused insulin in the pump will be removed and the pump refilled with fresh insulin.
Slovenian: Neporabljeni insulin v črpalki bodo odstranili in črpalko napolnili s svežim insulinom.
English: Pushing insulin in this circumstance could result in unintended insulin delivery to the subcutaneous tissue around the pump fill port.
Slovenian: Potiskanje insulina lahko v takšnem primeru povzroči nenameren vstop insulina v podkožno tkivo okoli polnilnega nastavka črpalke.
English: Failure of the insulin to enter the pump may indicate that the pump reservoir is still full.
Slovenian: Če insulin ne gre v črpalko, to lahko pomeni, da je rezervoar črpalke še vedno poln.
English: You normally should be able to recognise when your blood sugar is falling too much so that you can take the right actions.
Slovenian: Običajno bi morali biti zmožni prepoznati, kdaj se vam krvni sladkor preveč zniža, tako da bi pravilno ukrepali.
English: This can lead to obstruction of the implantable pump and under-delivery of insulin.
Slovenian: To lahko povzroči zamašitev implantabilne črpalke in nezadostno dovajanje insulina.
English: No food effect is expected on Cmax, Tmax and AUC values following CIPII administration.
Slovenian: Po uporabi s CIPII ni pričakovati, da bi hrana vplivala na Cmax, tmax ali AUC.
English: In addition, use of Insuman Implantable in continuous intraperitoneal infusion resulted in stable glycaemic control in patients with type 1 diabetes mellitus (per protocol population: mean reduction: -0.25 ± 0.67; [95% CI: -0.36; 0.11]) without increasing the risk of severe hypoglycaemia compared to semi-synthetic human insulin (14.3% versus 13.1%).
Slovenian: Poleg tega je uporaba zdravila Insuman Implantable v stalni intraperitonealni infuziji pri bolnikih s sladkorno boleznijo tipa 1 dosegla stabilno urejenost glikemije (populacija po-protokolu: povprečno znižanje -0,25 ± 0,67, 95 % IZ: -0,36, 0,11]), ne da bi se povečalo tveganje za hude hipoglikemije v primerjavi s polsinteznim humanim insulinom (14,3 % v primerjavi s 13,1 %).
English: • Severe allergic reactions to insulin may occur which may become life-threatening.
Slovenian: • Pojavijo se lahko hude alergijske reakcije na insulin, ki lahko postanejo smrtno nevarne.
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).
Slovenian: Imetnik dovoljenja za promet z zdravilom (MAH) bo za zdravilo Insuman Implantable z jakostjo 400 i.e./ml raztopino za infundiranje izvajal sistem kontrolirane distribucije in bo poskrbel, da bo zdravilo na voljo le v centrih, ki imajo trenutno potrdilo družbe Medtronic, da ima center ustrezno infrastrukturo in osebje, ki je bilo deležno ustreznega usposabljanja za uporabo črpalke Medtronic MiniMed Implantable Pump in osebnega komunikatorja za črpalko (PPC - Personal Pump Communicator).
English: The stroke volume measurement procedure tests pump function, while a catheter flush procedure tests catheter patency.
Slovenian: Postopek merjenja pulznega volumna testira delovanje črpalke, postopek izpiranja katetra pa prehodnost katetra.
English: If insulin under-delivery is revealed during a refill procedure or suspected due to insufficient blood glucose control, diagnostic procedures must be performed to check if the problem is due to the pump (i.e. jammed pumping mechanism/backflow) or catheter (i.e. catheter occlusion).
Slovenian: Če se med ponovnim polnjenjem izkaže, da črpalka ne dovaja dovolj insulina, ali če sum na to obstaja zaradi nezadostne urejenosti glukoze v krvi, je treba opraviti diagnostične postopke, da bi ugotovili, ali je vzrok težav črpalka (tj. blokada črpalnega mehanizma/povratni tok) ali kateter (tj. zapora katetra).
English: EXP In the pump, the medicine is stable for 45 days at 37°C.
Slovenian: EXP V črpalki je zdravilo stabilno 45 dni pri temperaturi 37 °C.
English: • in whom glycaemic control is markedly improved,
Slovenian: • se jim urejenost glikemije občutno izboljša,
English: Use of Insuman Implantable should be supervised by a physician experienced in diabetes and competent in using intraperitoneal insulin.
Slovenian: Uporabo zdravila Insuman Implantable mora nadzorovati zdravnik, ki ima izkušnje s sladkorno boleznijo in je usposobljen za uporabo intraperitonealnega insulina.
English: • Implantable Insulin Pump System: Patient manuals
Slovenian: • Implantabilni sistem insulinske črpalke: priročniki za bolnika
English: It is advisable to inject immediately after mixing
Slovenian: Mešanico je priporočljivo injicirati takoj po mešanju
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.
Slovenian: • Če je vzrok nezadostnega dovajanja insulina zapora katetra, je mogoče kateter s stranskim nastavkom izprati s 5 do 10 ml sterilne puferske raztopine za izpiranje.
English: o You need to program boluses and temporary basal rates with your PPC; o You need to replace the 1.5V AA battery in the PPC every 4 weeks.
Slovenian: o 1,5-voltno AA baterijo v PPC morate zamenjati vsake 4 tedne.
English: The catheter is flushed by using 5-10 ml of sterile rinse buffer solution.
Slovenian: Kateter se izpere z uporabo 5 do 10 ml sterilne puferske raztopine za izpiranje.
English: Hypersensitivity to titanium alloy, polysulfone or silicone materials used in the implanted components of the pump.
Slovenian: Preobčutljivost za titanove zlitine, polisulfonske ali silikonske materiale, uporabljene v implantiranih delih črpalke.
English: Your doctor will tell you if you have to mix insulin human preparations.
Slovenian: Zdravnik vam bo povedal, ali morate mešati humane insuline.
English: The insulin usage and clinical symptoms may be identical to those of pump under-delivery.
Slovenian: Poraba insulina in klinični simptomi so lahko enaki, kot če je vzrok črpalka.
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.
Slovenian: Po izpiranju in ponovnem polnjenju črpalke z insulinom ostane v distalnem delu katetra s stranskim nastavkom približno 13 enot sterilne puferske raztopine za izpiranje.
English: A rinse procedure using 0.1 M sodium hydroxide solution is performed to dissolve insulin deposits within the pump reservoir, pumping mechanism and the side port catheter.
Slovenian: Postopek izpiranja z 0,1 M raztopino natrijevega hidroksida se izvaja za raztapljanje odložkov insulina v rezervoarju črpalke, črpalnem mehanizmu in katetru s stranskim nastavkom.
English: The basal metabolic requirement is usually 40% to 60% of the total daily insulin requirement.
Slovenian: Bazalne presnovne potrebe po navadi predstavljajo od 40 do 60 % celotne dnevne potrebe po insulinu.
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.
Slovenian: Tega obdobja (45 dni) ne podaljšujte; če ne morete priti v bolnišnico ali ambulanto za nadomestitev insulina v črpalki, se nemudoma posvetujte z zdravnikom.
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).
Slovenian: Protitelesa proti insulinu: Omejeni podatki iz kliničnih preskušanj z intraperitonealno uporabo zdravila Insuman Implantable ne kažejo, da bi bilo zvišanje protiteles proti insulinu pogosto povezano s sindromom insulinskih protiteles ali resnimi neželenimi učinki (glejte poglavje 4.4).
English: if you live permanently at heights above 2439 meters (8000 feet).
Slovenian: - če stalno živite na višini nad 2439 metrov.
English: If the pump does not function well, you can draw the insulin from the cartridge into an injection syringe.
Slovenian: Če črpalka ne deluje dobro, lahko insulin iz vložka izvlečete v injekcijsko brizgo.
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.
Slovenian: Poleg tega bo PPC v primeru, da bolnik poskusi dati več kot 2,5-kratnik programiranega največjega bolusnega odmerka v obdobju ene ure, bolniku v opozorilo na zaslonu prikazal obvestilo "URNI MAKSIMUM PRESEŽEN" ("HOURLY MAX EXCEEDED").
English: Clinically relevant over-delivery of insulin was not observed during a 4 year period of evaluation of the Medtronic MiniMed Implantable Pump; however, this does not exclude the potential for such an occurrence.
Slovenian: Med 4-letnim obdobjem ocenjevanja črpalke Medtronic MiniMed Implantable Pump niso opazili klinično pomembnega prevelikega dovajanja insulina, vendar to ne izključuje možnosti, da se kaj takšnega zgodi.
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).
Slovenian: Med uporabo črpalke Medtronic MiniMed Implantable Pump so bili v dveh študijah III. faze (glejte poglavje 5.1) opisani naslednji povezani neželeni učinki.
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.
Slovenian: V študiji III. faze (HUBIN_L_05335) pri bolnikih s sladkorno boleznijo tipa 1 so farmakokinetični profil zdravila Insuman Implantable po intraperitonealni uporabi bolusa insulina ocenili pri 10 bolnikih po intraperitonealnem dajanju.
English: No effects on the suckling child are anticipated.
Slovenian: Učinkov na dojenega otroka ni pričakovati.
English: You must contact your doctor immediately.
Slovenian: Nemudoma se morate posvetovati z zdravnikom.
English: Insuman Implantable (400 IU/ml) contains 4 times as much insulin in 1 ml as standard insulin (100 IU/ml).
Slovenian: Zdravilo Insuman Implantable (400 i.e./ml) vsebuje v 1 ml 4-krat toliko insulina kot standardni insulin (100 i.e./ml).
English: The insulin in your pump must be replaced every 40 to 45 days with new insulin.
Slovenian: Insulin v črpalki je treba na 40 do 45 dni nadomestiti z novim insulinom.
English: Under-delivery of insulin caused by catheter occlusion Under-delivery caused by Side Port Catheter occlusion can occur either abruptly or gradually.
Slovenian: Nezadostno dovajanje insulina zaradi zapore katetra Nezadostno dovajanje zaradi zapore katetra s stranskim nastavkom se lahko pojavi nenadoma ali postopoma.
English: Two vials of Insuman Implantable (2 x 10 ml) are required to completely refill the pump reservoir and exclude air from entering the pump reservoir during the refill procedure.
Slovenian: Za popolno napolnjenje rezervoarja črpalke sta potrebni dve viali zdravila Insuman Implantable (2 x 10 ml); preprečiti je treba, da bi med ponovnim polnjenjem v rezervoar črpalke prišel zrak.
English: Implantable").
Slovenian: Insuman Implantable").
English: The patient should be advised by the physician what needs to be done in case of travel, e.g. what to do if the pump malfunctions, availability of insulin and facility to replace the insulin, and who to contact in case of emergency.
Slovenian: Zdravnik mora bolniku povedati, kako naj ukrepa v primeru potovanja, npr. kako naj ravna v primeru okvare črpalke, ga seznaniti z dostopnostjo insulina in ustanovo za zamenjavo insulina, in mu povedati, na koga naj se obrne v nujnem primeru.
English: The pump refill procedure should be performed using sterile technique and this should take place in the centres certified by Medtronic.
Slovenian: Ponovno polnjenje črpalke je treba izvesti sterilno in v centrih, ki jih je certificirala družba Medtronic.
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.
Slovenian: Izpiranje se lahko opravi prej, na primer če se med postopkom ponovnega polnjenja ugotovi nezadostno dovajanje insulina, ali če zaradi nezadostne urejenosti glukoze v krvi obstaja sum na nezadostno dovajanje.
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.
Slovenian: Slika 1: Povprečni farmakokinetični profil insulina v serumu pri bolnikih s sladkorno boleznijo tipa 1 po odmerku 0,15 i.e./kg zdravila Insuman Implantable.
English: Insulins of different concentration (e.g. 100 IU per ml and 40 IU per ml) must not be mixed.
Slovenian: Insulinov različne koncentracije (npr. 100 i.e./ml in 40 i.e./ml) se ne sme mešati.
English: The majority of adverse reactions associated with the Medtronic MiniMed Implantable Pump can be prevented by the rinse procedure by physicians.
Slovenian: Večino neželenih učinkov, povezanih s črpalko Medtronic MiniMed Implantable Pump, je mogoče preprečiti tako, da zdravniki izvajajo postopek izpiranja.
English: Immediately take about 10 to 20 g sugar, such as glucose, sugar cubes or a sugar-sweetened beverage.Caution: Artificial sweeteners and foods with artificial sweeteners (such as diet drinks) are of no help in treating hypoglycaemia.
Slovenian: Nemudoma zaužijte približno 10 do 20 gramov sladkorja, v obliki glukoze, kock sladkorja ali s sladkorjem sladkane pijačePozor: Umetna sladila in hrana z umetnimi sladili (kot so dietne pijače) pri zdravljenju hipoglikemije ne pomagajo.
English: This regimen requires close monitoring
Slovenian: Takšna shema zahteva natančno kontrolo (presnovnega,
English: Before the first withdrawal of insulin you must remove the safety tear-off lid on the vial.
Slovenian: Pred prvim izvlekom insulina morate z viale odstraniti varnostni pokrovček.
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).
Slovenian: Zaradi prisotnosti takšnih protiteles je lahko potrebna prilagoditev odmerka insulina, da bi odpravili nagnjenost k hiper- ali hipoglikemiji (glejte poglavje 4.8).
English: Alternatively you can contact the Marketing Authorisation Holder listed at the end of this leaflet.
Slovenian: Obrnete se lahko tudi na imetnika dovoljenja za promet z zdravilom, ki je naveden na koncu tega navodila.
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.
Slovenian: Insulin je treba izprazniti iz rezervoarja črpalke in katetra s stranskim nastavkom in bolnik si mora podkožno injicirati insulin med potovanjem in dokler rezervoar črpalke ni spet napolnjen.
English: In the pump The medicine is stable in the pump for 45 days at 37°C.
Slovenian: V črpalki V črpalki je zdravilo stabilno 45 dni pri temperaturi 37 °C.
English: Focal hepatic steatosis has been reported in few patients receiving the semi-synthetic human insulin, when the catheter was in very close proximity to the liver.
Slovenian: Fokalna steatoza jeter je bila opisana pri maloštevilnih bolnikih, ki so prejemali polsintezni humani insulin, če je bil kateter zelo blizu jeter.
English: If you notice a rapid increase in blood sugar level which does not respond to a bolus dose of insulin, contact your doctor immediately.
Slovenian: V primeru hitrega porasta krvnega sladkorja, ki se ne odzove na bolusni odmerek insulina, se nemudoma posvetujte z zdravnikom.
English: • Training of patients and the key information that patients need to be aware of • Ensuring that each patient receives the patient manual, the patient quick guide and the important patient information leaflet for the Medtronic MiniMed implantable insulin pump system and the patient emergency information card
Slovenian: • Zagotovitev, da vsak bolnik dobi priročnik za bolnika, hitri vodnik za bolnika in pomembno navodilo za uporabo implantabilnega sistema insulinske črpalke Medtronic MiniMed ter informacijsko izkaznico bolnika za nujne primere.
English: Insuman Infusat is therefore also suitable for continuous insulin infusion with other, conventional injection syringe pumps.
Slovenian: Zato je primeren tudi za trajno infundiranje insulina z drugimi, konvencionalnimi injekcijskimi črpalkami.
English: When the refill needle is properly seated in the pump fill port, then the vacuum in the pump reservoir will passively draw the insulin from the syringe into the pump reservoir.
Slovenian: Če je polnilna igla pravilno nameščena v polnilni nastavek črpalke, bo vakuum v rezervoarju črpalke pasivno potegnil insulin iz brizge v rezervoar črpalke.
English: More severe episodes with coma, seizure, or neurologic impairment may be treated with intramuscular/subcutaneous glucagon or concentrated intravenous glucose.
Slovenian: Hujše primere s komo, konvulzijami ali nevrološko prizadetostjo je mogoče zdraviti z glukagonom intramuskularno ali subkutano oz. s koncentrirano glukozo intravensko.
English: • intercurrent illness (e.g. vomiting, diarrhoea),
Slovenian: • sočasna bolezen (npr. bruhanje, driska),
English: You must check your blood sugar level at least four times daily to detect and prevent high blood sugar levels due to the pump not working properly.
Slovenian: Krvni sladkor si morate vsak dan izmeriti vsaj štirikrat na dan, da boste odkrili in preprečili visoko koncentracijo krvnega sladkorja zaradi nepravilnega delovanja črpalke.
English: Insuman Implantable is used to reduce high blood sugar in adult patients with a certain form of diabetes (type 1 diabetes mellitus).
Slovenian: Zdravilo Insuman Implantable uporabljamo za znižanje visokega krvnega sladkorja pri odraslih bolnikih z določeno vrsto sladkorne bolezni (sladkorna bolezen tipa 1).
English: You may feel symptoms of high blood sugar after you eat.
Slovenian: Po jedi se vam lahko pojavijo simptomi visokega krvnega sladkorja.
English: • a regimen with only regular insulin to one with a longer-acting insulin.
Slovenian: • s sheme z le enim navadnim insulinom na shemo z dolgodelujočim insulinom.
English: Use of the pump at these altitudes may result in insulin over-delivery or under-delivery.
Slovenian: Uporaba črpalke na takšni višini/globini lahko povzroči prekomerno ali nezadostno dovajanje insulina.
English: Insuman SoloStar is white with a colour on the injection button.
Slovenian: Insuman SoloStar je bele barve z obarvanim gumbom za injiciranje.
English: In this refilling procedure the remaining insulin must be removed from the pump and the pump refilled with new insulin.
Slovenian: Pri ponovnem polnjenju je treba preostanek insulina odstraniti iz črpalke in črpalko napolniti z novim insulinom.
English: If you notice pain, redness, swelling in the area of your pump, contact your doctor.
Slovenian: Če se pojavi bolečina, pordelost ali oteklost v predelu črpalke, se posvetujte z zdravnikom.
English: Unopened vials, unopened cartridges, not in-use pens Store in a refrigerator (2°C - 8°C).
Slovenian: Neodprte viale, neodprti vložki, injekcijski peresniki, ki jih ne uporabljate Shranjujte v hladilniku (2°C - 8°C).
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.
Slovenian: Bolnike z vsajeno črpalko Medtronic MiniMed Implantable Pump je treba izčrpno poučiti o uporabi črpalke, potrebnih ukrepih v primeru bolezni, hipoglikemije, hiperglikemije ali odpovedi črpalke.
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.
Slovenian: Bolniki s sladkorno boleznijo tipa 1 morajo še naprej redno uživati vsaj malo ogljikovih hidratov (s hrano ali pijačo), čeprav zmorejo užiti le malo ali nič hrane ali če bruhajo itn., ter ne smejo nikoli povsem opustiti insulina.
English: Insuman Infusat has been specially designed for use in external portable insulin pumps.
Slovenian: Insuman Infusat je posebej pripravljen za uporabo v zunanjih prenosnih insulinskih črpalkah.
English: Insuman Rapid may also be administered intravenously.
Slovenian: Insuman Rapid lahko apliciramo tudi intravensko.
English: Some medicines cause changes in the blood sugar level (decrease, increase or both depending on the situation).
Slovenian: Nekatera zdravila povzročijo spremembe koncentracije krvnega sladkorja (znižanje,zvišanje ali oboje, odvisno od okoliščin).
English: If you get severe hyperglycemia (very high blood sugar) or ketoacidosis (build up of acid in the blood because the body is breaking down fat instead of sugar) or coma, this may indicate a problem with the pump.
Slovenian: Če se vam pojavi huda hiperglikemija (zelo visok krvni sladkor) ali ketoacidoza (kopičenje kisline v krvi, ker telo razgrajuje maščobe namesto sladkorja) ali koma, je to lahko znak težav s črpalko.
English: Do not mix insulin with any other medicines except with insulin human preparations as detailed below.
Slovenian: Insulina ne mešajte z nobenimi drugimi zdravili, razen s humanimi insulini, navedenimi spodaj.
English: The purpose of this procedure is to dissolve insulin deposits within the pump reservoir, pumping mechanism and the side port catheter using 0.1 M sodium hydroxide sterile solution supplied by Medtronic MiniMed.
Slovenian: Namen tega je raztopitev odložkov insulina v rezervoarju črpalke, črpalnem mehanizmu in katetru s stranskim nastavkom z uporabo 0,1 M sterilne raztopine natrijevega hidroksida, ki jo dobavlja družba Medtronic MiniMed.
English: Do not store above 25°C and protect from direct heat and light.
Slovenian: Shranjujte pri temperaturi do 25°C in zaščitite pred neposredno toploto in svetlobo.
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.
Slovenian: Na usposabljanju se boste seznanili z implantabilno insulinsko črpalko, njeno uporabo in obvladovanjem posebnih okoliščin, na primer hipoglikemije ali hiperglikemije.
English: o Every 40 to 45 days, a refill of insulin at the hospital is needed.
Slovenian: o Na 40 do 45 dni morate opraviti ponovno polnjenje z insulinom v bolnišnici.
English: When the catheter tip is fixed in the liver capsule, administration of insulin via the intra-peritoneal route is associated with an increased risk of focal hepatic steatosis (see section 4.4).
Slovenian: Če je konica katetra nameščena v kapsuli jeter, intraperitonealno dajanje insulina spremlja večje tveganje za fokalno steatozo jeter (glejte poglavje 4.4).
English: The active substance is insulin human.
Slovenian: Zdravilna učinkovina je humani insulin.
English: If you try to deliver more than 2.5 times the bolus maximum in one hour, the alarm “hourly max exceeded” will be displayed on your PPC screen.
Slovenian: Če boste poskušali dati več kot 2,5-kratni največji bolus v eni uri, se bo na zaslonu PPC pojavil alarm "urni maksimum presežen".
English: Frequent adjustments of insulin doses under strict medical supervision are often required for several weeks following pump implantation.
Slovenian: Pogosto so več tednov po vsaditvi črpalke potrebna pogosta prilagajanja odmerkov insulina pod strogim zdravniškim nadzorstvom.
English: Medication errors have been reported in which other Insuman formulations or other insulins have been accidentally administered.
Slovenian: O napakah zdravljenja so poročali, ko so bile druge oblike zdravila Insuman ali drugi insulini pomotoma aplicirani.