FrancophonIA/ELRC3.0 huggingface dataset:
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%).
Danish: Herudover resulterede brugen af Insuman Implantable ved kontinuert intraperitoneal infusion i stabil glykæmisk kontrol hos patienter med type 1-diabetes mellitus (per protokol population: gennemsnitlig reduktion: -0,25 ± 0,67; [95 % CI: -0,36; 0,11]) uden øgning af risikoen for svær hypoglykæmi sammenlignet med semi-syntetisk human insulin (14,3 % versus 13,1 %).
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.
Danish: Potentiel underlevering af insulin fra Medtronic MiniMed Implantable Pump kan resultere i en øgning af dagligt programmeret insulinforbrug, problemer med at vedligeholde euglykæmi, refraktorisk hyperglykæmi samt en faldende genopfyldningsnøjagtighed.
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.
Danish: Pumpens reservoir og sideportkateter skal tømmes for insulin og patienten skal selv administrere insulin ved subkutan injektion, så længe rejsen varer eller indtil pumpens reservoir bliver genopfyldt.
English: The pump reservoir stores about 6,000 units of insulin and requires a refill procedure every 40 to 45 days for insulin in-use stability reasons in the pump or earlier based on the insulin needs of the patients.
Danish: Pumpens reservoir indeholder omkring 6.000 IE insulin og har behov for genopfyldningsprocedure hver 40 til 45 dage grundet stabiliteten af insulin i brug i pumpen eller tidligere, baseret på patientens behov.
English: 4,000 IU/10 ml
Danish: 4.000 IE/10 ml
English: • Physician quick guides on the main programming functions
Danish: • ”Quick guides” til læger omhandlende hovedprogrammeringsfunktioner • ”Quick guides” til patienter omhandlende hovedprogrammeringsfunktioner
English: • Device programming
Danish: • Udstyrsprogrammering
English: Follow recommended safety measures for removal and disposal of needles (e.g. contact your doctor, pharmacist or nurse) in order to reduce the risk of accidental needle injury and transmission of infectious diseases.
Danish: Følg anbefalede retningslinjer for fjernelse og kassering af nåle (kontakt dit sundhedspersonale) for at reducere risikoen for skader med nålen ved uheld og overførsel af infektionssygdomme.
English: Hyperglycaemia, ketoacidosis or coma may develop within hours in case of malfunction of the pump system.
Danish: Hyperglykæmi, ketoacidose eller koma kan udvikle sig inden for få timer i tilfælde af funktionsfejl ved pumpens system.
English: Use of Insuman Implantable should be supervised by a physician experienced in diabetes and competent in using intraperitoneal insulin.
Danish: Brugen af Insuman Implantable skal overvåges af en læge, som har erfaring med diabetes og brugen af intraperitoneal insulin.
English: • Implantable Insulin Pump System: Patient manuals
Danish: • Implementerbart insulinpumpesystem: Manualer til patienter
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.
Danish: I et fase III-studium (HUBIN_L_05335) hos patienter med type 1-diabetes mellitus blev den farmakokinetiske profil for Insuman Implantable efter intraperitoneal administration af en insulinbolus vurderet hos 10 patienter efter intraperitoneal administration.
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.
Danish: Figur 1: Gennemsnitlig farmakokinetisk profil for seruminsulin hos patienter med type 1-diabetes mellitus efter en dosis på 0,15 IE/kg Insuman Implantable.
English: Side effects reported uncommonly (may affect up to 1 in 100 people) • Severe allergic reaction with low blood pressure (shock)
Danish: Ikke almindelige bivirkninger (forekommer hos 1 ud af 100 patienter) - Alvorlig allergisk reaktioner med lavt blodtryk (shock)
English: The risk of skin erosion at the pump implantation site can be reduced by selecting an appropriate implant site, maintaining good sterile technique during the implant procedure, prophylactic antibiotic therapy and by continuously wearing an abdominal binder until the capsule has formed (about 1 month) (see section 4.8).
Danish: Risikoen for huderosion kan nedsættes ved at vælge et passende implantationssted, opretholde god, steril teknik under implantationsproceduren, anvende profylaktisk antibiotisk behandling og ved konstant at gå med et abdominalbælte indtil bindevævskapslen er dannet (cirka en måned) (se pkt.
English: • Refill procedure
Danish: • Genopfyldnigsprocedure
English: Patients must be informed to closely monitor blood glucose levels on refill days.
Danish: Patienter skal informeres om at monitorere blodglucoseniveauet nøje på genopfyldningsdage.
English: 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.
Danish: Infektion i pumpelommen (hvor din pumpe er placeret), hudafslidning hvor din pumpe er implanteret og dårlig heling af indstiksstedet i din hud kan forekomme.
English: Please refer to section 6.6 and the Physician's Manual, which describe how to diagnose potential pump system problems that may cause insulin under-delivery, and how to correct and prevent under-delivery.
Danish: 6.6 og lægens manual, som beskriver hvordan eventuelle problemer med pumpesystemet, som fører til underlevering af insulin, diagnosticeres samt hvordan underlevering forebygges.
English: The label on the insulin vial should be checked before use to make sure this is the correct insulin for the intended route of administration.
Danish: Etiketten på insulin-hætteglasset skal altid kontrolleres før brug for at sikre, at det er den korrekte insulin til den ønskede administrationsvej.
English: The MAH shall ensure that all patients receive training in the following key elements regarding the Insuman Implantable Pump 400 IU/ml:
Danish: Indehaveren af markedsføringstilladelsen skal sikre, at alle patienter modtager træning i følgende hovedelementer omhandlende Insuman Implantable Pump 400 IE/ml:
English: Women of childbearing potential, implanted or candidates for implantation, should inform their physician if they are contemplating pregnancy.
Danish: Kvinder i den fødedygtige alder som er implanteret eller skal have en implantation, skal informere deres læge, hvis de overvejer graviditet.
English: Dose adjustment may also be required, for example, if - the patient's weight changes, - the patient's life-style changes, - other circumstances arise that may promote an increased susceptibility to hypo- or hyperglycaemia (see section 4.4).
Danish: Dosisjustering kan også blive nødvendig, f.eks. hvis: - patientens vægt ændres, - patientens levevis ændres, - andre omstændigheder opstår, som øger følsomheden over for hypo- eller hyperglykæmi (se pkt.
English: • Skin changes at the injection site (lipodystrophy) If you inject your insulin too often at the same skin site, fatty tissue under the skin at this site may either shrink or thicken.
Danish: - Hudforandringer på injektionsstedet (lipodystrofi) Hvis du for ofte injicerer din insulin på samme sted på huden, kan fedtvævet under huden på dette sted svinde ind (lipoatrofi) eller blive tykkere (lipohypertrofi).
English: Most minor reactions to insulins usually resolve in a few days to a few weeks.
Danish: De fleste mindre reaktioner over for insulin forsvinder som regel i løbet af et par dage til få uger.
English: In addition, you should read and follow the instructions given in the patient manual accompanying the Medtronic MiniMed Implantable Pump.
Danish: Derudover skal du læse og følge instruktionerne angivet i patientmanualen, der følger med Medtronic MiniMed Implantable Pump.
English: (metabolic status, acid-base and electrolyte status, vital parameters etc.) in an intensive care unit or similar setting.
Danish: Dette regime kræver tæt monitorering (metabolisk status, syre-base- og elektrolytstatus, vitale parametre etc.) på en intensivafdeling eller lignende.
English: Insuman Basal is an isophane insulin suspension.
Danish: Insuman Basal er en isophaninsulinsuspension.
English: Hypersensitivity to titanium alloy, polysulfone or silicone materials used in the implanted components of the pump.
Danish: Hypersensitivitet over for titaniumlegering, polysulfon eller silikonematerialer brugt i de implanterede dele af pumpen.
English: The patient should read and follow the instructions in the Patient Manual accompanying the infusion pump.
Danish: Patienten skal læse og følge instruktionerne i patientmanualen som følger med infusionspumpen.
English: After filling the cartridge of the pump keep it at room temperature for 1 to 2 hours before using it, so that you can see and remove any air bubbles which form during warming-up.
Danish: Efter påfyldning af pumpen skal denne opbevares i 1-2 timer ved stuetemperatur før anvendelse, så du kan se og fjerne alle luftbobler, som dannes under opvarmningen.
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.
Danish: Patienter med en implanteret Medtronic MiniMed Implantable Pump skal have udførlig instruktion i brugen af pumpen og de nødvendige foranstaltninger i tilfælde af ildebefindende, hypoglykæmi og hyperglykæmi eller pumpesvigt.
English: if you live permanently at heights above 2439 meters (8000 feet).
Danish: - hvis du bor permanent i højder over 2.439 meter (8.000 fod).
English: Infections around the pump implantation site may require the removal of your pump (explantation of the pump).
Danish: Infektioner omkring pumpeimplantationsstedet kan medføre behov for fjernelse af pumpen (pumpeeksplantation).
English: C Check the appearance of your insulin.
Danish: C. Tjek udseendet af din insulin.
English: Residual insulin and new insulin must be weighed to record the refill worksheet and calculate the refill accuracy criterion.
Danish: Resterende insulin og ny insulin skal vejes for at udfylde genopfyldningsskemaet og beregne kriteriet for genopfyldningens nøjagtighed.
English: This is particularly important in those who have reduced or absent awareness of the warning symptoms of hypoglycaemia or have frequent episodes of hypoglycaemia.
Danish: Dette er af særlig betydning for patienter med nedsat eller manglende evne til at mærke advarselssymptomer på hypoglykæmi, eller hos patienter, som har hyppige anfald af hypoglykæmi.
English: It is possible that the insulin can cause blockage of the implantable pump.
Danish: Det er muligt at insulinen kan forårsage blokade af den implanterede pumpe.
English: Insuman Implantable must not be used with any other type of injection devices (e.g. syringes).
Danish: Insuman Implantable må ikke bruges med nogen anden type injektionsudstyr (f.eks. sprøjter).
English: Use specific pens: see leaflet.
Danish: Brug bestemte penne: Se indlægssedlen.
English: Adjustments in dose regimen of the medicinal product, meal patterns, or physical activity may be needed.
Danish: Der skal muligvis foretages ændringer i dosering af lægemidlet, kostplaner og fysisk aktivitet.
English: The insulin in your pump must be replaced every 40 to 45 days with new insulin.
Danish: Insulinen i din pumpe skal udskiftes hver 40 til 45 dage med ny insulin.
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.
Danish: Din læge vil håndtere hætteglassene med insulin og har det tilbehør (f.eks. genopfyldningssprøjter og kanyler), som er nødvendigt for at fylde din implanterbare pumpe.
English: The Medtronic MiniMed Implantable Pump, which is implanted under the skin of your belly, infuses your insulin continuously (continuous intraperitoneal infusion).
Danish: Medtronic MiniMed Implantable Pump, som er implanteret under huden på din mave, infunderer insulin kontinuert (kontinuert intraperitoneal infusion).
English: • Information on the registry including how to, and the importance of, entering patients in it • Surgical aspects of implantation
Danish: • Information om registrering, herunder hvordan det gøres samt vigtigheden af at registrere patienterne
English: Shelf life in the pump Up to 45 days at 37°C.
Danish: Holdbarhed i pumpen Op til 45 dage ved 37 °C.
English: Before travelling, consult your doctor.
Danish: Før du skal ud at rejse, bør du tale med din læge.
English: • Hyperglycaemia: If your blood sugar is too high, you may experience hyperglycaemia.
Danish: - Hyperglykæmi: Hvis dit blodsukker er for højt kan du opleve hyperglykæmi.
English: B. Take off the outer needle cap and keep it to remove the used needle after injection.
Danish: B. Tag det ydre nålehylster af og behold det til at fjerne den brugte nål efter injektionen.
English: You must closely monitor your blood sugar level on refill days.
Danish: Du skal monitorere dit blodsukkerniveau tæt på genopfyldningsdage.
English: 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.
Danish: Kun efter vellykket reetablering af slagvolumenmålingen kan katetret skylles med steril skyllebufferopløsning og pumpen genopfyldes med insulin.
English: Contact your doctor immediately if you are unable to go to the hospital or clinicto replace the insulin in your pump.
Danish: Kontakt din læge øjeblikkeligt, hvis du er forhindret i at komme på hospitalet eller til en klinik, der kan udskifte insulinen i din pumpe.
English: Focal hepatic steatosis has been observed after administration of insulin via the intra-peritoneal route, when the catheter was positioned very close to or in the liver capsule.
Danish: Focal leversteatose er observeret efter intraperitoneal administration af insulin, når kateteret var placeret meget tæt på eller i leverkapslen.
English: You should always consider the possibility of a technical problem if, in order to achieve the desired blood sugar levels, - you need additional insulin ("bolus doses") at larger doses or more often than usual, or - you need additional insulin ("bolus doses") at smaller doses or less often than usual.
Danish: Overvej altid, om der er opstået tekniske problemer, hvis du for at nå det ønskede blodsukker skal: - tage yderligere insulin (”bolus doser”) i større doser eller oftere end normalt.
English: 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.
Danish: I tilfælde af utilstrækkelig glucosekontrol eller ved tendens til udvikling af hyper- eller hypoglykæmiske episoder skal det undersøges, hvorvidt patienten har overholdt det ordinerede behandlingsregime og alle andre relevante faktorer, inden en eventuel dosisjustering overvejes.
English: No non-clinical studies assessing the potential toxicity of Insuman Implantable 400 IU/ml administered via intraperitoneal route were performed.
Danish: Der blev ikke udført ikke-kliniske studier der vurderer potentiel toksicitet af Insuman Implantable 400 IE/ml administreret intraperitonealt.
English: 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.
Danish: Hætteglassene med insulin skal tages ud af køleskabet og opbevares ved stuetemperatur, i den ydre karton for at beskytte mod lys, i mindst 4 timer og ikke længere end 24 timer inden anvendelse.
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.
Danish: Patienten skal også forsynes med en alternativ måde at få insulin på, f.eks. kan patienten forsynes med 100 IE/ml insulin og medicinsk udstyr til subkutan administration af insulin.
English: INSULIN CONC - µIU/ml
Danish: INSULINKONC - µIE/ml
English: The injection button colour will vary based on the formulation of Insuman insulin used.
Danish: Doseringsknappens farve varierer afhængig af hvilken formulering, Insuman insulinen er.
English: Insuman Implantable (400 IU/ml) contains 4 times as much insulin in 1 ml as standard insulin (100 IU/ml).
Danish: Insuman Implantable (400 IE/ml) indeholder 4 gange mere insulin i 1 ml end normal insulin (100 IE/ml).
English: These cartridges should not be used with any other reusable pen as the dosing accuracy has only been established with the listed pens.
Danish: Disse cylinderampuller bør ikke bruges med andre former for flergangspenne, da dosis-nøjagtigheden kun er vist med ovenstående penne.
English: Time of refill of insulin pump
Danish: Tidspunkt for genopfyldning af insulinpumpe
English: Under-delivery of insulin caused by catheter occlusion Under-delivery caused by Side Port Catheter occlusion can occur either abruptly or gradually.
Danish: Underlevering forårsaget af okklusion i sideportens kateter kan forekomme brat eller gradvist.
English: In rare cases, the presence of such anti-insulin antibodies may necessitate adjustment of the insulin dose in order to correct a tendency to hyper- or hypoglycaemia.
Danish: I sjældne tilfælde kræver forekomsten af sådanne anti-insulin-antistoffer justering af insulindosis for at korrigere for tendensen til hyper- eller hypoglykæmi.
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).
Danish: Anti-insulin antistoffer: Begrænsede data fra et klinisk studium med intraperitoneal administration af Insuman Implantable tyder ikke på, at forhøjede værdier af insulinantistoffer ofte er forbundet med insulinantistofsyndrom eller andre alvorlige bivirkninger (se pkt.
English: 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.
Danish: Alle resultaterne tyder på at kontinuerlig intraperitoneal insulininfusion hos patienter med type 1diabetes mellitus sammenlignet med kontinuerlig subkutan insulininfusion og flere daglige injektioner er mere lig farmakokinetikken observeret for endogent insulin.
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).
Danish: Indehaveren af markedsføringstilladelsen skal implementere et kontrolleret distributionssytem for Insuman Implantable 400 IE/ml infusionsvæske, opløsning for at sikre, at lægemidlet kun er tilgængeligt for centre med gældende certificering fraMedtronic som havende hensigtsmæssige faciliteter og personale, der har modtaget tilstrækkelig træning i brug af Medtronic MiniMed Implantable Pump og Personal Pump Communicator (PPC).
English: B. Line up the needle with the pen, and keep it straight as you attach it (screw or push on, depending on the needle type).
Danish: B. Hold nålen vandret på linje med pennen når du sætter nålen på (skru eller tryk nålen på afhængig af nåletypen).
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
Danish: • Sikre at alle patienter modtager patientmanualen, patient ”quick guiden” og den vigtige indlægsseddel for det implementerbare Medtronic MiniMed insulinpumpesystem samt nødsituationsinformationskort til patienter
English: In this refilling procedure the remaining insulin must be removed from the pump and the pump refilled with new insulin.
Danish: I genopfyldningsproceduren skal den resterende insulin fjernes fra pumpen, hvorefter pumpen skal genopfyldes med ny insulin.
English: Rinsing of pump to avoid insulin under-delivery
Danish: Skylning af pumpe for at undgå underlevering
English: Because you have type 1 diabetes, an insulin dependent diabetes mellitus, do not stop your insulin.
Danish: Fordi du har type 1-diabetes, en insulinkrævende diabetes mellitus, må du ikke afbryde insulinbehandlingen.
English: Other routes of administration (e.g. injection).
Danish: Andre administrationsveje (f.eks. injektion).
English: Continuous intraperitoneal insulin infusion results in earlier, shorter and higher peaks of plasma free insulin than continuous subcutaneous insulin infusion in patients with type 1 and type 2 diabetes mellitus.
Danish: Kontinuerlig intraperitoneal insulininfusion resulterer i tidligere, kortere og højere toppe af frit plasma insulin end kontinuerlig subkutan insulin infusion hos patienter med type 1- og type 2-diabetes mellitus.
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.
Danish: Hvis du bruger en insulinsuspension (Insuman Basal eller Insumanblandinger) skal du vippe pennen frem og tilbage mindst 10 gange for at blande insulinen.
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.
Danish: Hvis du får alvorlig hyperglykæmi (meget højt blodsukker) eller ketoacidose (ophobning af syre i blodet fordi kroppen nedbryder fedt i stedet for sukker) eller koma, kan dette tyde på et problem med pumpen.
English: The pump is not connected to a glucose meter, and as such, patients are advised to practice good diabetes self management and test their own blood glucose levels at least four times daily to detect potential malfunction of the pump, to monitor glycaemic control and to determine required insulin doses.
Danish: Pumpen er ikke forbundet til et glukometer eller lignende, og patienterne opfordres derfor til at praktisere god egenomsorg af diabetes og måle deres blodglucoseniveau mindst fire gange dagligt for at detektere potentielle funktionsfejl ved pumpen, monitorere glykæmisk kontrol samt bestemme de nødvendige insulindoser.
English: • Implantable Insulin Pump system: Physician Manuals
Danish: • Implementerbart insulinpumpesystem: Manualer til læger
English: 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.
Danish: Udskrivelsen af dette produkt er begrænset til centre, som er certificerede af Medtronic til at have modtaget tilstrækkelig træning i brugen af Medtronic MiniMed Implantable Pump.