FrancophonIA/ELRC3.0 huggingface dataset:
English: They can also spread around the injection site.
Danish: Disse kan brede sig til området omkring injektionsstedet.
English: Therefore, the safety and efficacy of Insuman Implantable (intraperitoneal use) have not been established in paediatric patients.
Danish: Sikkerheden og effekten af Insuman Implantable (intraperitoneal brug) er derfor ikke blevet klarlagt hos pædiatriske patienter.
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.
Danish: Efter intraperitoneal administration af Insuman Implantable 0,15 IE/kg var medianen for Tmax 0,54 timer og Cmax i serum var 210 ± 129 mikroIE/ml.
English: Other routes of administration (e.g. injection) are contraindicated.
Danish: Andre administrationsveje (f.eks. injektion) er kontraindiceret.
English: This can lead to obstruction of the implantable pump and under-delivery of insulin.
Danish: Dette kan føre til obstruktion af den implanterbare pumpe og underlevering af insulin.
English: There are no fixed rules for insulin dose regimen.
Danish: Der er ingen faste regler for insulindosisregime.
English: If you stop using your insulin this could lead to a very high blood sugar level.
Danish: Hvis du stopper med at tage din insulin kan det lede til et meget højt blodsukkerniveau.
English: This means that Insuman Implantable is more concentrated than standard insulin.
Danish: Det betyder, at Insuman Implantable er mere koncentreret end normal insulin.
English: To ensure that you read the dose correctly, hold the pen horizontally, with the needle on the left and the dosage selector to the right as shown in the illustrations below.
Danish: For at sikre, at du aflæser dosis korrekt, skal du holde pennen vandret med nålen til venstre og dosisskalaen til højre, som vist på illustrationen nedenfor.
English: Insuman Rapid is a solution for injection under the skin or, in exceptional circumstances, into a vein (blood vessel).
Danish: Insuman Rapid er en opløsning til injektion under huden eller, i særlige tilfælde, i en vene (blodåre).
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.
Danish: Alle patienterne var uden erfaring med intraperitoneal insulin og havde ikke forbedret deres HbA1c i løbet af 3 måneders intensiv terapi enten med adskillige daglige injektioner eller med kontinuert subkutan infusion af insulin.
English: The healthcare institution's standard sterile operating procedures for skin preparation must be followed to avoid microbial contamination and infection.
Danish: Sundhedsinstitutionens standard sterilprocedurer for forberedelse af huden skal overholdes for at undgå mikrobiel forurening og infektion.
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).
Danish: Medtronic MiniMed Implantable Pump er uegnet til brug i højder over 2439 meter (8000 fod) eller under 7,6 meter (25 fod).
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).
Danish: Hvis insulinunderlevering påvises i løbet af en genopfyldningsprocedure eller mistænkes grundet utilstrækkelig blodglucoseregulering skal diagnostiske procedurer udføres for at tjekke om problemet skyldes pumpen (dvs. fastklemt pumpemekanisme/tilbageløb) eller katetret (dvs. kateterokklusion).
English: This happens when the tip of your catheter is fixed or in very close proximity to your liver.
Danish: Dette sker når spidsen af dit kateter bliver sat fast i eller er meget tæt på din lever.
English: The catheter flush procedure should only be performed after confirming the stroke volume measurement.
Danish: Kateterskylleproceduren må kun udføres når måling af slagvolumen er bekræftet.
English: In case of hypoglycaemia, the insulin pump should temporarily be turned off, at least until the patient has recovered complete consciousness.
Danish: I tilfælde af hypoglykæmi skal insulinpumpen lukkes midlertidigt, som minimum indtil patienten er ved fuld bevidsthed.
English: The patient must be closely monitored for possible hypoglycaemia and administered intravenous glucose or glycogen as needed.
Danish: Patienten skal monitoreres tæt for mulig hypoglykæmi og have administreret intravenøs glucose eller glycogen efter behov.
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.
Danish: Patienter indskrevet i den kontinuerlige intraperitoneal infusionsgruppe modtog semi-syntetisk human insulin 400 IE/ml i 180 dage efterfulgt at Insuman Implantable 400 IE/ml i yderligere 180 dage.
English: If you have any questions about SoloStar or about diabetes, ask your doctor, pharmacist or nurse or call the local sanofi-aventis number on the front of this leaflet.
Danish: Hvis du har nogen spørgsmål vedrørende SoloStar eller vedrørende diabetes, så spørg dit sundhedspersonale eller ring til nummeret på den lokale repræsentant på forsiden af denne indlægsseddel.
English: Use of the pump at these altitudes may result in insulin over-delivery or under-delivery.
Danish: Brugen af pumpen ved disse højder kan føre til insulinoverlevering eller underlevering.
English: It is advisable to test your blood sugar immediately after taking glucose to check that you really have hypoglycaemia.
Danish: Det anbefales at kontrollere blodsukkeret umiddelbart efter indtagelsen af glucose for at se, om du virkelig har hypoglykæmi.
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.
Danish: Efter intraperitoneal administration af 0,15 IE/kg Insuman Implantable blev insulin elimineret fra serum med en tilsyneladende gennemsnitlig halveringstid på 2,7 timer.
English: All solutions that will enter the pump must be properly degassed prior to filling the pump reservoir to avoid insulin aggregation and under-delivery.
Danish: Alle opløsninger, som skal ind i pumpen, skal afgasses korrekt før påfyldning af pumpens reservoir for at undgå insulinaggregering og underlevering.
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.
Danish: To hætteglas med Insuman Implantable (2 x 10 ml) er nødvendige for helt at genfylde pumpereservoiret og hindre luft i at trænge ind i pumpereservoiret i løbet af genopfyldningsproceduren.
English: Your doctor will tell you how to manage your blood glucose levels.
Danish: Din læge vil fortælle dig, hvordan du skal håndtere dine blodsukkerniveauer.
English: When used with an implantable insulin pump, Insuman Implantable will be continuously infused in your body and thus, may replace a long-acting insulin.
Danish: Når det anvendes sammen med en Insuman Implantable pumpe, vil Insuman Implantable kontinuerligt blive infunderet ind i din krop og kan derfor erstatte et langtidsvirkende insulin.
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.
Danish: Skylning kan foretages tidligere, for eksempel i tilfælde af underlevering af insulin, som er opdaget ved en genopfyldningsprocedure eller mistænkt grundet utilstrækkelig blodglucosekontrol.
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.
Danish: Du skal tjekke dit blodsukkerniveau mindst fire gange om dagen for at opdage og forebygge høje blodsukkerniveauer som skyldes, at pumpen ikke virker ordentligt.
English: • Severe allergic reactions to insulin may occur which may become life-threatening.
Danish: - Alvorlige allergiske reaktioner over for insulin kan forekomme, hvilket kan blive livstruende.
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%.
Danish: Årsagerne til initieringen af den kontinuerte, intraperitoneale insulininfusion (CIPII) var labil diabetes hos 62,7 %, hypoglykæmi hos 29,2 %, perifer insulinresistens hos 5,0 % samt hypoglykæmi og labil diabetes hos 3,1 %.
English: Insuman Infusat is therefore also suitable for continuous insulin infusion with other, conventional injection syringe pumps.
Danish: Insuman Infusat er derfor også velegnet til kontinuerlig insulininfusion med andre konventionelle injektion infusionspumper.
English: Low blood sugar levels (hypoglycaemia) may occur if you administer too much insulin.
Danish: Lave blodsukkerniveauer (hypoglykæmi) kan forekomme, hvis du administrerer for meget insulin.
English: Rinsing may be performed earlier, for example, when potential under-delivery is suspected based on a calculated refill accuracy of less than 85%.
Danish: Skylleproceduren kan foretages tidligere, for eksempel ved potentiel mistanke om underlevering af insulin baseret på en beregnet genopfyldningsnøjagtighed på under 85 %.
English: However, three studies were conducted in rats to assess the potential toxicity of administration of human insulin via the intraperitoneal route.
Danish: Imidlertid blev 3 undersøgelser udført på rotter for at vurdere potentiel toksicitet for administration af human insulin intraperitonealt.
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.
Danish: Ændringer til basal- og bolusdoser kontrolleres ved brug af en lille, håndholdt enhed (Personal Pump Communicator (PPC)), som kommunikerer med pumpen ved brug af radiobølger.
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).
Danish: Tal med din læge så du ved hvad du skal gøre hvis du planlægger at: - bo i en højde over 2.439 meter (8.000 fod), - rejse til en højde over 2.439 meter (8.000 fod) med andet end kommercielt fly, - dykke under 7,6 meter (25 fod).
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.
Danish: Denne træning vil omhandle den implanterede insulinpumpe, hvordan den bruges og hvordan særlige situationer håndteres såsom hypoglykæmi eller hyperglykæmi.
English: The unused insulin in the pump will be removed and the pump refilled with fresh insulin.
Danish: Det ubrugte insulin i pumpen vil blive fjernet og pumpen genopfyldt med frisk insulin.
English: The catheter is flushed by using 5-10 ml of sterile rinse buffer solution.
Danish: Katetret skylles ved brug af 5-10 ml steril skyllebufferopløsning.
English: Patients who expect to need frequent or routine MRI or therapeutic ultrasound should not be implanted with the Medtronic MiniMed Implantable Pump.
Danish: Patienter, der forventes at have behov for hyppige- eller rutine-MR-scanninger eller terapeutisk ultralyd, må ikke få implanteret Medtronic MiniMed Implantable Pump.
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.
Danish: Insuman Implantable er indiceret til behandling af voksne patienter med type 1-diabetes mellitus, som ikke kan kontrolleres med subkutan insulinterapi (herunder pumpe), som forekommer med hyppig og ellers uforklarlig svær hyper- og/eller hypoglykæmi.
English: • Device components
Danish: • Udstyrskomponenter
English: If you try to deliver a second bolus, you will receive the hourly max exceeded alarm on your PPC screen again.
Danish: Hvis du prøver at indgive endnu en bolus, vil du se alarmen ”hourly max exceeded” på din PPC-skærm igen.
English: Medication errors have been reported in which other Insuman formulations or other insulins have been accidentally administered.
Danish: Der er indrapporteret tilfælde af medicineringsfejl, hvor andre formuleringer af Insuman eller andre insuliner utilsigtet er blevet administreret.
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.
Danish: Derudover kan dannelse af biofilm over spidsen på sideportens kateter forårsage latent glykæmi eftersom insulin akkumuleret over tid vil sætte sig fast i biofilmen og frigives når et tilstrækkeligt volumen insulin er akkumuleret.
English: These limitations are necessary to provide some control over patients' ability to program their insulin regimens and to avoid the possibility of overdosing.
Danish: Disse begrænsninger er nødvendige for at have nogen kontrol med patientens dosering af insulinen og for at undgå risikoen for overdosering.
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.
Danish: Patienter, der planlægger at opholde sig eller rejse (ud over med almindelige, kommercielle fly med kunstigt tryk) i højder på over 2439 meter (8000 fod) eller dykke under 7,6 meter (25 fod) skal informeres om de foranstaltninger, der skal tages.
English: Insuman Implantable is a high-concentrated insulin formulation Insuman Implantable contains 400 international units of insulin in each ml.
Danish: Insuman Implantable er en højkoncentreret insulinformulering Insuman Implantable indeholder 400 internationale enheder insulin i hver ml.
English: To prevent pump problems, your doctor will schedule appointments at least every 6-months to rinse your pump.
Danish: For at forebygge pumpeproblemer vil din læge planlægge aftaler mindst hver 6. måned for at skylle din pumpe.
English: Pushing insulin in this circumstance could result in unintended insulin delivery to the subcutaneous tissue around the pump fill port.
Danish: At tvinge insulin igennem under denne omstændighed kan resultere i utilsigtet insulintilførsel til det subkutane væv omkring pumpens fyldeport.
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.
Danish: Insuman Rapid kan også anvendes til behandling af hyperglykæmisk koma og ketoacidose samt til præ-, per- og post-operativ stabilisering af patienter med diabetes mellitus.
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).
Danish: Tabel 2: Bivirkninger og produktreklamationer observeret i forbindelse med leveringssystemet (herunder bivirkninger forbundet med implantationsoperationen og vedligeholdelse af udstyret).
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.
Danish: Efter gennemskylning og genopfyldning af pumpen med insulin vil der være omkring 13 enheder steril skyllebufferopløsning tilbage i den distale del af sideåbningskatetret.
English: At study initiation, half of the patients were switched to Insuman Implantable, while the other half remained on the semi-synthetic human insulin.
Danish: Ved studiets begyndelse skiftede halvdelen af patienterne til Insuman Implantable, imens den anden halvdel fortsatte behandlingen med semi-syntetisk human insulin.
English: If you notice pain, redness, swelling in the area of your pump, contact your doctor.
Danish: Hvis du oplever smerte, rødme, hævelse i området omkring din pumpe, skal du kontakte din læge.
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.
Danish: Medtronic MiniMed Implantable Pump må ikke implanteres i patienter, som har medicinske eller mentale tilstande, der gør dem ude af stand til at justere pumpens insulindosering baseret på glucosemålinger eller til at foretage passende korrigerende handlinger i tilfælde af problemer med pumpens system.
English: • Rinse and flush procedure, stroke measurement and pump management including troubleshooting
Danish: • Rense- og skylleprocedure, måling af slagvolumen samt håndtering af pumpe og fejlfinding
English: Before you can use the Medtronic MiniMed Implantable Pump, you will be trained.
Danish: Før du anvender Medtronic MiniMed Implantable Pump, vil du blive trænet.
English: Pentamidine may cause hypoglycaemia which may sometimes be followed by hyperglycaemia.
Danish: Pentamidin kan føre til hypoglykæmi, som til tider efterfølges af hyperglykæmi.
English: The implantable pump may erode through the skin, resulting in infection of the implant site and pump explantation.
Danish: Den implanterbare pumpe kan erodere gennem huden, hvilket kan føre til infektion af implantationsstedet og pumpeeksplantation.
English: Examples include: you have not administered your insulin or not administered enough, e.g. due to pump not working properly or catheter blockage.
Danish: - ikke har administreret din insulin eller ikke har administreret nok f.eks. grundet pumpe funktionsfejl eller kateterblokade.
English: Elevated levels of antibodies to insulin are not commonly associated with a need to change your insulin dose or occurrence of serious side effects.
Danish: Forhøjede niveauer af insulin-antistoffer er ikke sædvanligvis associeret med behov for at ændre din insulindosis eller forekomst af alvorlige bivirkninger.
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.
Danish: Patienten skal rådgives af lægen om hvilke foranstaltninger der skal tages i forbindelse med rejser, f.eks. hvad der skal gøres i tilfælde af funktionsfejl ved pumpen, tilgængeligheden af insulin og en institution der kan genopfylde pumpen samt information om, hvem der skal kontaktes i nødstilfælde.
English: Failure of the insulin to enter the pump may indicate that the pump reservoir is still full.
Danish: Hvis det ikke lykkedes insulinet at komme ind i pumpen kan det være en indikation af at pumpereservoiret stadig er fyldt.
English: Insuman Implantable is for intraperitoneal use only.
Danish: Insuman Implantable er kun til intraperitoneal anvendelse.
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.
Danish: Hvis din pumpe er løbet tør for insulin eller leverer mindre insulin end du har brug for, kan du føle symptomer på højt blodsukker.
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.
Danish: Overskrid ikke denne tidsperiode (45 dage) og kontakt din læge øjeblikkeligt hvis du er forhindret i at komme på hospitalet eller på en klinik, der kan udskifte insulinen i din pumpe.
English: The pump refill procedure should be performed using sterile technique and this should take place in the centres certified by Medtronic.
Danish: Pumpens genopfyldningsprocedure skal foregå ved en steril procedure og skal finde sted på behandlingscentre certificeret af Medtronic.
English: There is no clinical information with the use of Insuman Implantable in an implantable pump in pregnant women.
Danish: Der er ikke nogen klinisk information tilgængelig for brugen af Insuman Implantable i en implanterbar pumpe hos gravide kvinder.
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).
Danish: Baseret på ændringer i HbA1c-værdier fra udgangspunktet var intraperitoneal administration af insulin lig subkutan administration (for kontinuert intraperitoneal administration: HbA1c-værdi ved Dag 360 var 7,78 ± 1,04 versus 8,06 ± 0,77 ved udgangspunkt; for subkutan administration: HbA1c-værdi ved Dag 360 var 8,19 ± 0,87 versus 8,12 ± 0,76 ved udgangspunkt).
English: • concomitant treatment with certain other medicinal products (see section 4.5).
Danish: - samtidig behandling med visse andre lægemidler (se pkt.
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.
Danish: Hvis du prøver at indgive mere end 2,5 gange maksimum bolus i en time, vil alarmen ”hourly max exceeded” blive vist på din PPC-skærm.
English: Before taking a medicine ask your doctor if it can affect your blood sugar level, and what action, if any, you need to take.
Danish: Før du begynder at tage et lægemiddel, skal du spørge lægen, om det kan påvirke blodsukkeret, og hvilke forholdsregler du eventuelt skal tage.
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.
Danish: I en tredje undersøgelse gennemført i diabetiske rotter viste administration af et andet human insulin med en formulering lig Insuman via et kateter fastgjort til leverkapslen at intraperitoneal administration af høj lokal insulinkoncentration ved leverkapslen kan fremkalde reversibel fokal leversteatose.
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.
Danish: Der blev yderligere udført et 12-måneders ublindet, randomiseret, kontrolleret studie (MIP 310) for at vurdere effekten af intraperitoneal administration af insulin versus subkutan administration af insulin på glykæmisk kontrol og frekvensen af svær hypoglykæmi.
English: No hepatic steatosis was observed.
Danish: Ingen fokal leversteatose blev observeret.
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.
Danish: I litteraturen er insulins farmakokinetik generelt beskrevet til at være reproducerbar hos patienter med type 1-diabetes mellitus, der modtager kortvarig og længerevarende kontinuerlig intraperitoneal insulininfusion.
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.
Danish: Detaljerede instruktioner i brugen af den implanterbare pumpe, dens funktion og nødvendige sikkerhedsforanstaltninger er beskrevet i lægens manual, der følger med infusionspumpen.