FrancophonIA/ELRC3.0 huggingface dataset:
English: Empty pens must never be re-used and must be properly discarded.
Danish: Tomme penne må aldrig genbruges, og skal bortskaffes på betryggende måde.
English: Skin erosion at pump implantation site (see section 4.4)
Danish: Huderosion ved pumpeimplantationssted (se pkt.
English: Proliferative retinopathy; Diabetic retinopathy;
Danish: Proliferativ retinopati, diabetisk retinopati, synsforstyrrelser
English: During a refill procedure, never push in the refill syringe plunger to fill the pump.
Danish: Skub aldrig til genopfyldningsstemplet under en genopfyldningsprocedure for at fylde pumpen.
English: Before the first withdrawal of insulin you must remove the safety tear-off lid on the vial.
Danish: Før du trækker insulin op første gang, skal du fjerne sikkerhedslåget, som sidder på hætteglasset.
English: Shelf life in the pump For in-use stability, see section 6.3.
Danish: Holdbarhed i pumpen For holdbarhed i brug, se pkt.
English: In case the pump does not work properly you must always have access to injection devices (e.g. syringe or pen) and insulin suitable for subcutaneous injection.
Danish: I tilfælde af at pumpen ikke virker ordentligt skal du altid have adgang til injektionsudstyr (f.eks. sprøjte eller pen) og insulin egnet til subkutan injektion.
English: For use in an infusion pump, Insuman Infusat is filled into the sterile cartridge of the pump.
Danish: Ved anvendelse i infusionspumpe fyldes Insuman Infusat i pumpens sterile reservoir.
English: The basal metabolic requirement is 40% to 60% of the total daily requirement.
Danish: Det basale metaboliske behov udgør 40-60 % af det totale døgnbehov.
English: • The important patient information leaflets for the Medtronic MiniMed implantable insulin pump system.
Danish: • Den vigtige indlægsseddel for det implementerbare Medtronic MiniMed insulinpumpesystem.
English: - enhances the uptake of potassium into cells.
Danish: - øger cellernes kaliumoptagelse.
English: Medical imaging technique
Danish: Medicinsk billeddiagnostik
English: You must contact your doctor immediately.
Danish: Du skal da øjeblikkeligt kontakte din læge.
English: Side effects reporting with a frequency not known
Danish: Bivirkninger, hvor hyppigheden ikke er kendt
English: Insuman Infusat has been developed for use in Hoechst Infusor and H-Tron.
Danish: Insuman Infusat er udviklet til brug i Hoechst Infusor og H-Tron.
English: If you use more Insuman Implantable than you should Your doctor will program maximum dose limits into your PPC.
Danish: Din læge vil programmere maksimale dosisgrænser ind i din PPC.
English: Insuman Implantable must only be used in the Medtronic MiniMed pump which is implanted under the skin of your belly and infuses your insulin continuously.
Danish: Insuman Implantable må kun anvendes med Medtronic MiniMed Pump, som er implanteret under huden i i din mave og infunderer din insulin kontinuerligt.
English: In patients with severe hepatic impairment, insulin requirements may be diminished due to reduced capacity for gluconeogenesis and reduced insulin metabolism.
Danish: Hos patienter med svært nedsat leverfunktion kan insulinbehovet mindskes pga. nedsat evne til gluconeogenese og nedsat insulinmetabolisme.
English: with other insulin medicine other than Insuman Implantable.
Danish: - med andre insuliner end Insuman Implantable.
English: It is advisable to inject immediately after mixing.
Danish: Injektion bør finde sted umiddelbart efter blandingen.
English: Insuman Implantable 400 IU/ml presentation:
Danish: Insuman Implantable 400 IE/ml:
English: Insulin deposits can cause blockage of the pump.
Danish: Insulinophobninger kan forårsage pumpeblokade.
English: The presence of antibodies has been reported in patients after treatment using the Medtronic MiniMed Implantable Pump.
Danish: Der er rapporteret tilstedeværelse af antistoffer hos patienter, der har været behandlet med Medtronic MiniMed Implantable Pump.
English: D Tap the insulin reservoir so that any air bubbles rise up towards the needle.
Danish: Bank på insulinbeholderen, således at eventuelle luftbobler stiger op mod nålen.
English: Insuman Infusat with alcohol
Danish: Brug af Insuman Infusat sammen med alkohol
English: Insulin treatment by continuous infusion in the body is likely to cause your body to produce antibodies to insulin (substances that act against insulin).
Danish: Insulinbehandling ved kontinuerlig infusion i kroppen vil sandsynligvis medføre, at din krop vil producere antistoffer over for insulin (stoffer der reagerer imod insulin).
English: 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.
Danish: Insuman Implantable er designet alene til brug i intraperitonealbehandling sammen med Medtronic MiniMed Implantable Pump, der leveres af Medtronic MiniMed, som udløser insulin direkte ind i bughulen.
English: Change to Insuman Implantable
Danish: Skift til Insuman Implantable
English: For further information on the side effects of low blood sugar or high blood sugar, see the box at the end of this leaflet.
Danish: Information om bivirkningerne ved lavt blodsukker eller højt blodsukker findes i det indrammede afsnit sidst i indlægssedlen.
English: 1 ml contains 40 IU (1.4 mg) insulin human.
Danish: 1 ml indeholder 40 IE (1,4 mg) human insulin.
English: Insuman Infusat may be infused by the subcutaneous route.
Danish: Insuman Infusat kan infunderes subkutant.
English: The active substance is insulin human.
Danish: - Aktivt stof: human insulin.
English: Insuman Rapid with alcohol
Danish: Brug af Insuman Rapid sammen med alkohol
English: In the following situations, the management of your diabetes may require a lot of care: - If you are ill or have a major injury then your blood sugar level may increase (hyperglycaemia).
Danish: I følgende situationer kan kontrollen af din diabetes kræve ekstra opmærksomhed: - Hvis du bliver syg eller kommer alvorligt til skade, kan dit blodsukkerniveau blive for højt
English: Sodium retention
Danish: Natriumretention
English: EXP In the pump, the medicine is stable for 45 days at 37°C.
Danish: EXP Lægemidlet er holdbart i 45 dage i pumpen ved 37 °C.
English: SoloStar is a pre-filled disposable pen containing insulin human.
Danish: SoloStar er en fyldt engangspen indeholdende human insulin.
English: If you stop using Insuman Basal
Danish: Hvis du holder op med at tage Insuman Basal
English: 1 ml contains 100 IU (3.5 mg) insulin human.
Danish: 1 ml indeholder 100 IE (3,5 mg) human insulin.
English: Should pump performance change, the patient would be able to detect a change in blood glucose levels.
Danish: Patienten ville være i stand til at detektere ændringer i blodglucose i tilfælde af ændringer i pumpens ydeevne.
English: Focal hepatic steatosis
Danish: Fokal leversteatose
English: Instructions for Use.
Danish: INSTRUKTIONER VEDRØRENDE ANVENDELSEN 16.
English: Transfer to Insuman Infusat
Danish: Omstilling til Insuman Infusat
English: When used in external portable insulin pumps, part of the daily insulin dose is infused continuously ("basal rate"), and the rest is administered in the form of bolus injections before meals.
Danish: I eksternt bærbare insulinpumper infunderes en del af døgndosis kontinuerligt (”basalrate”), mens den resterende del administreres som bolusinjektioner før måltider.
English: The following conditions of the MA refer to the Insuman Implantable 400 IU/ml strength solution for infusion.
Danish: Følgende betingelser for markedsføringstilladelsen omhandler Insuman Implantable 400 IE/ml infusionsvæske, opløsning.
English: One 10 ml vial of solution contains 4,000 IU insulin.
Danish: Et 10 ml hætteglas med opløsning indeholder 4000 IE insulin.
English: A part of the daily insulin dose ("basal rate") is infused continuously by the implantable pump and the remaining part of the daily dose is administered by the patient, using the same pump, as a bolus before meals.
Danish: En del af den daglige insulindosis (”basalrate”) bliver infunderet kontinuert af den implanterede pumpe og resten af den daglige dosis administreres af patienten ved brug af samme pumpe til bolus før måltiderne.
English: Implantable").
Danish: Insuman Implantable”).
English: Substances that may enhance the blood-glucose-lowering effect and increase susceptibility to hypoglycaemia include oral antidiabetic medicinal products, angiotensin converting enzyme (ACE) inhibitors, disopyramide, fibrates, fluoxetine, monoamine oxidase (MAO) inhibitors, pentoxifylline, propoxyphene, salicylates and sulphonamide antibiotics.
Danish: Stoffer, som kan forstærke den blodglucosesænkende effekt, og som kan øge risikoen for hypoglykæmi, omfatter orale antidiabetika, angiotensin converting enzyme (ACE)-hæmmere, disopyramid, fibrater, fluoxetin, monoaminoxidase (MAO)-hæmmere, pentoxifyllin, propoxyphen, salicylater og sulfonamidantibiotika.
English: If you stop using Insuman Implantable
Danish: Hvis du holder op med at bruge Insuman Implantable
English: • Sodium retention
Danish: - Natriumretention
English: Implant site infection (see section 4.4)
Danish: Infektion på implantationsstedet (se pkt.
English: Insuman Infusat must only be used in insulin pumps suitable for this insulin.
Danish: Insuman Infusat må kun anvendes i insulinpumper, der er beregnet til dette insulin.
English: 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).
Danish: Grundet den implantable pumpes store størrelse er brugen af Insuman Implantable kontraindiceret hos pædiatriske patienter, der ikke er fuldt udvoksede (se pkt.
English: For further details on handling see section 6.6 and instructions provided in the Physician's manual.
Danish: 6.6 og instruktionerne i lægens manual.
English: Beta-blockers like other sympatholytic medicines (such as clonidine, guanethidine, and reserpine) may weaken or suppress entirely the first warning symptoms which help you to recognise a hypoglycaemia.
Danish: Beta-blokkere og andre sympatolytiske lægemidler (som f.eks. clonidin, guanethidin og reserpin) kan endvidere svække eller helt undertrykke de første advarselssymptomer på for lavt blodsukker (hypoglykæmi).
English: Medical device change due to device malfunction Device blockage
Danish: Udskiftning af udstyret grundet funktionsfejl; Blokering af udstyret
English: • A refill accuracy of less than 85% is calculated during a refill procedure.
Danish: - Refraktær hyperglykæmi opstår - En genopfyldningsnøjagtighed mindre end 85 % er beregnet i løbet af en genopfyldningsprocedure.
English: You should know what these are so that you can react correctly to changes in your blood sugar level and prevent it from becoming too high or too low.
Danish: Du bør være bekendt med disse faktorer for at kunne handle korrekt i tilfælde af ændringer i dit blodsukker og for at forhindre, at blodsukkeret bliver for højt eller for lavt.
English: 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).
Danish: I tilfælde af svær hypoglykæmi skal pumpen undersøges af den tilknyttede læge for eventuel kateterokklusion, som kan føre til ophobning af insulin og efterfølgende udløsning af den ophobede insulin (se pkt.
English: 5 cartridges of 3.15 ml
Danish: 5 cylinderampuller af 3,15 ml
English: During this procedure, a very small amount of Insuman Implantable may be deposited under your skin, which may result in low blood sugar levels.
Danish: Ved en genopfyldningsprocedure kan en meget lille mængde Insuman Implantable blive deponeret under din hud, som kan resultere i lave blodsukkerniveauer.
English: One IU (International Unit) corresponds to 0.035 mg of anhydrous human insulin*.
Danish: En IE (International Enhed) svarer til 0,035 mg vandfri human insulin*.
English: Device occlusion; Catheter site pain
Danish: Okklusion af udstyret; Smerter ved kateteret
English: Use of other insulin medicinal products with the Medtronic MiniMed Implantable Pump.
Danish: Brug af andre insulinholdige lægemidler sammen med Medtronic MiniMed Implantable Pump.
English: If you forget to use Insuman Implantable
Danish: Hvis du glemmer at tage Insuman Implantable
English: However, there is no experience with the use of Insuman Basal in pregnant women.
Danish: Erfaring savnes dog angående anvendelse af Insuman Basal til gravide.
English: Insuman Basal must never be injected intravenously.
Danish: Insuman Basal må aldrig injiceres intravenøst.
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.
Danish: Når underlevering af insulin skyldes kateterokklusion, kan sideportens kateter skylles med 5-10
English: Transfer to Insuman Basal
Danish: Omstilling til Insuman Basal
English: Insuman Infusat in a cartridge may also be used in other insulin pumps for which it has been shown that they are suitable for this insulin and this type of cartridge (see pump manual).
Danish: Insuman Infusat i cylinderampul kan også anvendes i andre insulinpumper, hvis disse er blevet testet og godkendt til anvendelse af dette insulin og denne type cylinderampuller (se brugsanvisning til pumpe).
English: The package leaflet is available in your national language on the European Medicines Agency web site: http://www.ema.europa.eu/.
Danish: Denne indlægsseddel er tilgængelig på dit sprog på det Europæiske Lægemiddelagenturs hjemmeside: http://www.ema.europa.eu/.
English: Shelf life after first use of the cartridge The product (cartridges in-use in the pump) may be stored for a maximum of 2 weeks.
Danish: Opbevaringstid efter første anbrud af cylinderampullen Cylinderampuller i brug (i pumpen) kan anvendes i op til 2 uger.
English: Empty pens must not be re-filled and must be properly discarded.
Danish: Tomme penne må ikke genfyldes, og skal kasseres på betryggende vis.
English: Insuman Basal can be used during breast-feeding.
Danish: Insuman Basal kan anvendes under amning.
English: However, use only those injection syringes which are designed for an insulin concentration of 100 IU (International Units) per ml.
Danish: Du må dog kun anvende injektionssprøjter, som er beregnet til insulin med en koncentration på 100 IE (Internationale Enheder) pr. ml.
English: Concerning incompatibility with other insulins, see section 6.2.
Danish: uforligelighed med andre insuliner, se pkt.
English: Insulin administration via the intraperitoneal route is likely to cause formation of anti-insulin antibodies.
Danish: Det er sandsynligt, at intraperitonealt administreret insulin kan forårsage dannelsen af anti-insulinantistoffer.
English: If administration by syringe or intravenous injection is necessary, a vial should be used.
Danish: Hvis administration med sprøjte eller intravenøs injektion er nødvendig, skal et hætteglas anvendes.
English: Insuman (all presentations except Insuman Implantable): Medicinal product subject to medical prescription.
Danish: Insuman (alle formuleringer undtagen Insuman Implantable):
English: 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).
Danish: Insuman Infusat i hætteglas kan også anvendes i andre insulinpumper, hvis disse er blevet testet og godkendt til anvendelse af dette insulin (se brugsanvisning til pumpe).
English: In the pump The medicine is stable in the pump for 45 days at 37°C.
Danish: Lægemidlet er holdbart i den implanterede insulinpumpe i 45 dage ved 37 °C.
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).
Danish: I tilfælde, hvor kateterspidsen er placeret i leverkapslen, er der øget risiko for fokal leversteatose ved intraperitoneal administration af insulin (se pkt.
English: Insuman Basal with alcohol
Danish: Brug af Insuman Basal sammen med alkohol
English: Do not use Insuman Rapid if you notice particles in it. Only use Insuman Rapid if the solution is clear, colourless and waterlike.
Danish: Anvend ikke Insuman Rapid, hvis du bemærker partikler i den. Anvend kun Insuman Rapid, når opløsningen er klar, farveløs, uden synlige faste partikler og med en vandlignende konsistens.
English: Failure to do so may result in pump pocket infection and subsequent pump explantation (see section 4.4).
Danish: Mangel på disse foranstaltninger kan føre til infektion pumpens lomme og resultere i pumpeeksplantation (se pkt.
English: Turn the pen gently to avoid foaming in the cartridge.
Danish: Pennen skal vippes forsigtigt for at undgå skumdannelse i cylinderampullen.
English: For further information on side effects of high blood sugar, see the box at the end of this leaflet.
Danish: For yderligere information om bivirkningerne af højt blodsukker findes i det indrammede afsnit sidst i indlægssedlen.
English: However, there is no experience with the use of Insuman Infusat in pregnant women.
Danish: Erfaring savnes dog angående anvendelse af Insuman Infusat til gravide.
English: TEXT TO APPEAR ON THE ALUMINIUM FOIL WHICH IS USED FOR SEALING TRANSPARENT PLASTIC TRAY CONTAINING THE CARTRIDGE
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP TEKST, SOM SKAL ANFØRES PÅ ALUMINIUMSFOLIEN, DER FORSEGLER DEN GENNEMSIGTIGE PLASTIKBEHOLDER MED CYLINDERAMPULLEN LÆGEMIDLETS NAVN
English: You may need to adjust your insulin dose to avoid blood sugar levels that are either too low or too high.
Danish: Du kan have brug for at justere insulindosis for at undgå for lavt eller for højt blodsukker.
English: Adherence of the patient to the dose regimen and dietary regimen, correct insulin administration and awareness of hypoglycaemia symptoms are essential to reduce the risk of hypoglycaemia.
Danish: For at mindske risikoen for hypoglykæmi er det vigtigt, at patienten overholder dosering og diæt, administrerer insulinen korrekt, og er opmærksom på symptomer på hypoglykæmi.
English: If you stop using Insuman Infusat
Danish: Hvis du holder op med at tage Insuman Infusat
English: Other medicines and Insuman Rapid
Danish: Brug af anden medicin sammen med Insuman Rapid
English: Insuman Rapid is administered subcutaneously.
Danish: Insuman Rapid indgives subkutant.
English: These include patients: - in whom glycaemic control is markedly improved, - in whom hypoglycaemia develops gradually, - who are elderly, - after transfer from animal insulin to human insulin, - in whom an autonomic neuropathy is present, - with a long history of diabetes, - suffering from a psychiatric illness, - receiving concurrent treatment with certain other medicinal products (see section 4.5).
Danish: Disse omfatter: - patienter, hvor den glykæmiske kontrol er forbedret betydeligt, - patienter, hvor hypoglykæmi udvikles gradvist, - som er ældre patienter, - efter skift fra animalsk insulin til human insulin, - patienter, som lider af autonom neuropati, - patienter, med en lang diabetes-anamnese, - patienter, som har en psykisk lidelse, - patienter, som er i samtidig behandling med visse andre lægemidler (se pkt.
English: 1 vial of 5 ml 5 vials of 5 ml 1 vial of 10 ml 5 vials of 10 ml
Danish: 1 hætteglas af 5 ml 5 hætteglas af 5 ml 1 hætteglas af 10 ml 5 hætteglas af 10 ml
English: Later on, the insulin must be resuspended again prior to each injection.
Danish: Herefter skal insulinet resuspenderes igen før hver injektion.
English: Do not use Insuman Rapid in insulin pumps - special insulin preparations are available for use in such devices.
Danish: Brug ikke Insuman Rapid i insulinpumper - særlige insulin-præparater er tilgængelige til brug i sådanne apparater.
English: Abnormal healing
Danish: Anormal heling
English: Insuman Implantable is a neutral insulin solution (regular insulin).
Danish: Insuman Implantable er en neutral insulinopløsning (regular insulin).
English: Insuman Infusat must NOT be mixed with any other insulin preparations.
Danish: Insuman Infusat må IKKE blandes med andre insulinpræparater.
English: Medtronic MiniMed Implantable Pump and the PPC, including rinsing procedures and instructions as to how to handle messages, alarms and routine warnings issued by the PPC;
Danish: hvordan man håndterer beskeder, alarmer og rutinemæssige advarsler udstedt af PPC'en;
English: It must be remembered that - insulin protamine crystals dissolve in an acid pH range, - the soluble insulin part precipitates out at a pH of approximately 4.5 to 6.5.
Danish: Opmærksomheden henledes på, - at protamininsulinkrystaller opløses i sur pH, - det opløselige insulin udfældes ved pH 4,5-6,5.
English: Insuman Infusat must not be used in peristaltic pumps with silicone tubing.
Danish: Insuman Infusat må ikke bruges i peristaltiske pumper med silikoneslanger.
English: In case of malfunction of the pump, patients should always have available injection devices (syringe or pen) and insulin suitable for subcutaneous injection.
Danish: I tilfælde af funktionsfejl ved pumpen skal patienter altid have tilgang til injektionsanordninger (kanyle eller pen) og insulin egnet til subkutan injektion.
English: If you stop using Insuman Rapid
Danish: Hvis du holder op med at tage Insuman Rapid
English: Rinsing of the pump
Danish: Skylning af pumpen
English: During a refill procedure, a very small amount of Insuman Implantable may be deposited subcutaneously, which might result in low blood sugar levels.
Danish: Ved en genopfyldningsprocedure kan en meget lille mængde Insuman Implantable blive deponeret subkutant, hvilket kan resultere i lave blodsukkerniveauer.
English: o You need to carry alternative insulin and the means to administer it with you always.
Danish: o Du skal altid opbevare det udfyldte nødsituationskort til patienter på dig o Du skal altid medbringe alternativ insulin samt midler til at administrere det o Du skal altid medbringe en form for hurtigtvirkende sukker
English: Not all of these pens may be marketed in your country (see section 4.2 and 6.6).
Danish: Ikke alle penne er nødvendigvis markedsført i alle lande (see pkt.
English: Insuman rapid SoloStar 100 IU/ml in a pre-filled pen The pen in-use or carried as a spare may be stored for a maximum of 4 weeks not above 25°C and away from direct heat or direct light.
Danish: Insuman Rapid SoloStar 100 IE/ml i en fyldt pen Penne i brug eller taget med som reserve kan anvendes i op til 4 uger ikke over 25°C og væk fra direkte varme eller direkte lys.
English: A.
Danish: E.
English: Solution for infusion 4,000 IU/10 ml 1 vial
Danish: Infusionsvæske, opløsning 4000 IE/10 ml 1 hætteglas
English: Insuman Rapid is injected under the skin 15 to 20 minutes before a meal.
Danish: Insuman Rapid injiceres under huden 15 til 20 min. før et måltid.
English: Each ml contains 40 IU insulin human (equivalent to 1.4 mg).
Danish: Hver ml indeholder 40 IE human insulin (svarende til 1,4 mg).
English: Insuman Rapid must not be used in external or implanted insulin pumps or in peristaltic pumps with silicone tubing.
Danish: Insuman Rapid må ikke bruges i eksterne eller implanterede insulinpumper eller i peristaltiske pumper med silikoneslanger.
English: Most serious side effects Side effects reported commonly (may affect up to 1 in 10 people)
Danish: Mest alvorlige bivirkninger Ikke almindelige bivirkninger (forekommer hos 1 ud af 100 patienter)
English: Other medicines and Insuman Infusat
Danish: Brug af anden medicin sammen med Insuman Infusat
English: • The patient reports an increase in insulin use to maintain euglycaemia.
Danish: Insulinunderlevering mistænkes når: - Patienten rapporterer om en stigning i insulinforbrug til at vedligeholde euglykæmi.
English: Colourless glass vial (type I) closed with flanged cap made of aluminium with tear-off lid and inserted sealing disk made of chlorobutyl rubber.
Danish: Farveløse hætteglas (type 1) med ombøjet hætte af aluminium med aftageligt låg og indsat tætningsskive af chlorbutylgummi.