FrancophonIA/ELRC3.0 huggingface dataset:
English: Keep the cartridge at room temperature for 1 or 2 hours before inserting it into the pen.
Danish: Cylinderampullen skal opbevares ved stuetemperatur i 1-2 timer, inden denne indsættes i pennen.
English: Before use, the filled cartridge must be kept at room temperature for 1 to 2 hours.
Danish: Det fyldte reservoir skal før anvendelse opbevares ved stuetemperatur i 1-2 timer.
English: Insuman Basal 40 IU/ml in a vial, Insuman Basal 100 IU/ml in a vial Insuman Basal must not be mixed with insulin human formulations designed specifically for use in insulin pumps.
Danish: Insuman Basal 40 IE/ml i hætteglas, Insuman Basal 100 IE/ml i hætteglas Insuman Basal må ikke blandes med human insulin formuleringer designet specifikt til brug i insulinpumper.
English: * Human insulin is produced by recombinant DNA technology in Escherichia coli.
Danish: *Human insulin fremstilles med rekombinant DNA-teknologi i Escherichia coli.
English: Insuman Rapid is a neutral insulin solution (regular insulin).
Danish: Insuman Rapid er en neutral insulinopløsning (regular insulin).
English: Look at the cartridge before you use it. Only use it if the solution is clear, colourless, with no solid particles visible, and has a water-like consistency.
Danish: Se på cylinderampullen, før du bruger den. Anvend den kun, når opløsningen er klar, farveløs, uden synlige faste partikler og har en vandlignende konsistens.
English: Later on, when the cartridge has been inserted into the pen, the insulin must be resuspended again prior to each injection.
Danish: Når cylinderampullen er placeret i pennen, skal insulinet resuspenderes inden hver injektion.
English: For Insuman Implantable administered via the intraperitoneal pump, the safety profile has not been established in pregnancy.
Danish: Sikkerhedsprofilen er endnu ikke etableret for insulin administreret med den intraperitoneale pumpe under graviditet.
English: Insuman Rapid is a solution for injection under the skin.
Danish: Insuman Rapid er en opløsning til injektion under huden.
English: Insuman Implantable must not be used with any other pumps (external or implantable) than the Medtronic MiniMed Implantable pump or with any other medical devices including syringes (see section 4.2).
Danish: Insuman Implantable må ikke anvendes med nogle andre pumper (eksterne eller implanterbare) end Medtronic MiniMed Implantable Pump eller med noget andet medicinsk udstyr inklusive sprøjter (se pkt.
English: SoloStar is a prefilled pen for the injection of insulin.
Danish: SoloStar er en engangspen til injektion af insulin.
English: Insuman Basal (an isophane insulin suspension) is an insulin with gradual onset and long duration of action.
Danish: Insuman Basal (en isophaninsulinsuspension) er et insulin med gradvist indsættende og langvarig virkning.
English: The first symptoms which alert you to hypoglycaemia ("warning symptoms") may change, be weaker or may be missing altogether if
Danish: - de første advarselssymptomer, som kan advare dig om hypoglykæmi, er svage eller helt mangler.
English: Side effects reported uncommonly (may affect up to 1 in 100 people)
Danish: Ikke almindelige bivirkninger (forekommer hos 1 ud af 100 patienter)
English: Only refill kit, refill needles, port locating template, 0.1 M sodium hydroxide sterile solution supplied by Medtronic MiniMed and sterile rinse buffer solution manufactured by Sanofi-Aventis Deutschland GmbH should be used with Insuman Implantable to rinse the pump.
Danish: Kun genopfyldningskit, genopfyldningsnåle, portlokaliseringsskabelon, 0,1 M natriumhydroxid sterilopløsning leveret af Medtronic MiniMed og steril skyllebufferopløsning fremstillet af SanofiAventis Deutschland GmbH må anvendes med Insuman Implantable for at skylle pumpen.
English: Not in-use pens:
Danish: Uanbrudte penne:
English: • Alarms and messages displayed by the device and the appropriate actions to take • Recognition of signs and symptoms of under or no delivery of insulin and the appropriate actions to take
Danish: • Alarmer og beskeder, som vises af det medicinske udstyr, samt hvilke passende foranstaltninger, der skal tages
English: Insuman Implantable must only be used in the Medtronic MiniMed implantable pump.
Danish: Insuman Implantable må kun anvendes i Medtronic MiniMed Implantable Pump.
English: For insulin human, no clinical data on exposed pregnancies are available.
Danish: Der foreligger ikke kliniske data om eksponering for human insulin under graviditet.
English: you are doing less exercise than usual, you are under stress (emotional distress, excitement), or you have an injury, are having an operation, have an infection or fever, you are taking or have taken certain other medicines (see section 2, "Other medicines and Insuman Implantable").
Danish: - dyrker mindre motion end sædvanlig eller er stresset (følelsesmæssigt ude af balance eller er ophidset), eller hvis du har en skade, er blevet opereret, har en infektion eller feber, - du tager eller har taget visse andre lægemidler (se punkt 2 ”Brug af anden medicin sammen med Insuman Implantable”).
English: Pump refill
Danish: Pumpe genopfyldning
English: Insuman Basal is administered subcutaneously.
Danish: Insuman Basal indgives subkutant.
English: The first symptoms which alert you to hypoglycaemia ("warning symptoms") may change, be weaker or may be missing altogether if - you are elderly, if you have had diabetes for a long time or if you suffer from a certain type of nervous disease (diabetic autonomic neuropathy), - you have recently suffered hypoglycaemia (for example the day before) or if it develops slowly, - you have almost normal or, at least, greatly improved blood sugar levels, - you have recently changed from an animal insulin to a human insulin such as Insuman, - you are taking or have taken certain other medicines (see section 2, "Other medicines and
Danish: De første symptomer på, at der er ved at opstå hypoglykæmi (”advarselssymptomer”), kan ændre sig, svækkes eller kan helt mangle, hvis: - du er ældre, hvis du har haft diabetes i lang tid eller hvis du lider af en bestemt form for sygdom i nervesystemet (diabetisk autonom neuropati), - du for nylig har haft hypoglykæmi (f.eks. dagen før), eller hvis tilstanden udvikles langsomt, - du har et næsten normalt eller i det mindste betydeligt forbedret blodsukker, - du for nylig er skiftet fra animalsk insulin til human insulin såsom Insuman, - du tager eller har taget visse andre lægemidler (se punkt 2 ”Brug af anden medicin sammen med
English: Substances that may reduce the blood-glucose-lowering effect include corticosteroids, danazol, diazoxide, diuretics, glucagon, isoniazid, oestrogens and progestogens (e.g. in oral contraceptives), phenothiazine derivatives, somatropin, sympathomimetic medicinal products (e.g. epinephrine [adrenaline], salbutamol, terbutaline), thyroid hormones, protease inhibitors and atypical antipsychotic medicinal products (e.g. olanzapine and clozapine).
Danish: Stoffer, som nedsætter den blodglucosesænkende effekt, omfatter kortikosteroider, danazol, diazoxid, diuretika, glukagon, isoniazid, østrogener og gestagener (f.eks. orale kontraceptiver), phenthiazinderivater, somatropin, sympatomimetiske lægemidler (f.eks. adrenalin, salbutamol, terbutalin), thyreoideahormoner, proteasehæmmere samt atypiske antipsykotiske lægemidler (f.eks. olanzapin og clozapin).
English: It inhibits glycogenolysis and gluconeogenesis, - increases lipogenesis in the liver and adipose tissue and inhibits lipolysis, - promotes the uptake of amino acids into cells and promotes protein synthesis,
Danish: Hæmmer glykogenolyse og glukoneogenese, - øger lipogenesen i lever og fedtvæv, og hæmmer lipolysen, - fremmer cellernes optagelse af aminosyrer og fremmer proteinsyntese,
English: Insuman SoloStar is white with a colour on the injection button.
Danish: Insuman Rapid SoloStar er hvid med en farvet doseringsknap.
English: Site of the pump implantation
Danish: Pumpeimplantationsstedet
English: After resuspension, the fluid must have a uniformly milky appearance.
Danish: Efter resuspendering skal væsken have et homogent mælkehvidt udseende.
English: From experience gained in a 6-month comparative phase III study (HUBIN_L_05335) with Insuman Implantable administered via the Medtronic MiniMed Implantable Pump in 84 patients aged 26 to 80 years (see section 5.1) and from clinical experience with insulin human 100 IU/ml and 40 IU/ml, the following adverse reactions were observed.
Danish: Følgende bivirkninger er observeret gennem et 6-måneders sammenlignende fase III studie (HUBIN_L_05335) med Insuman Implantable administreret gennem Medtronic MiniMed Implantable Pump hos 84 patienter i alderen 26 til 80 år (se pkt.
English: Insulin under-delivery
Danish: Insulinunderlevering
English: Other medicines and Insuman Basal
Danish: Brug af anden medicin sammen med Insuman Basal
English: The product may be stored for a maximum of 4 weeks not above 25°C and away from direct heat or direct light.
Danish: Opbevaringstid efter første anbrud af hætteglasset Produktet kan anvendes i op til 4 uger ikke over 25°C, væk fra direkte varme eller direkte lys.
English: The pen containing a cartridge or pens in-use must not be stored in the refrigerator.
Danish: Pen med ampul isat eller penne i brug må ikke opbevares i køleskab.
English: Abdominal pain Umbilical hernia
Danish: Abdominalsmerter; Navlebrok
English: In case your pump is damaged or your Personal Pump Communicator (PPC) is damaged or lost, review with your doctor what you should do in case your pump does not work correctly.
Danish: Du skal gennemgå med din læge, hvad du skal gøre, hvis din pumpe ikke virker korrekt, og din Personal Pump Communicator (PPC) er beskadiget eller tabt.
English: BRAILLE
Danish: Pendel
English: Units) of the active substance insulin human.
Danish: - Aktivt stof human insulin.
English: Insuman Comb 25 40 IU/ml in a vial, Insuman Comb 25 100 IU/ml in a vial Insuman Comb 25 must not be mixed with insulin human formulations designed specifically for use in insulin pumps.
Danish: Insuman Comb 25 40 IE/ml i hætteglas, Insuman Comb 25 100 IE/ml i hætteglas Insuman Comb 25 må ikke blandes med human insulin formuleringer designet specifikt til brug i insulinpumper.
English: Fertility No clinical or animal data with insulin human on male or female fertility are available.
Danish: human insulins påvirkning af mænd eller kvinders fertilitet.
English: Insulin administration via the intraperitoneal route can cause the body to produce antibodies to insulin (substances that act against insulin).
Danish: Insulin administreret intraperitonealt kan føre til, at kroppen danner antistoffer mod insulin (stoffer, der reagerer mod insulin).
English: Do NOT inject Insuman Basal into a vein (blood vessel).
Danish: Insuman Basal MÅ IKKE injiceres i en vene (blodåre).
English: After mixing, the suspension must have a uniform milky-white appearance.
Danish: Efter opblanding skal suspensionen have et ensartet mælkehvidt udseende.
English: Insuman Implantable can be used during breast-feeding.
Danish: Insuman Implantable kan anvendes under amning.
English: Insuman Rapid 40 IU/ml in a vial
Danish: Insuman Rapid 40 IE/ml i hætteglas
English: During a refill procedure, a very small amount of insulin may be deposited subcutaneously, possibly resulting in hypoglycemia.
Danish: Under en genopfyldningsprocedure kan en meget lille mængde insulin blive deponeret subkutant, hvilket kan resultere i hypoglykæmi.
English: The following related adverse reactions from clinical investigations are listed below by system organ class and in order of decreasing incidence: very common (1/10); common (1/100 to <1/10); uncommon (1/1,000 to <1/100); rare (1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).
Danish: De relaterede bivirkninger, som er forekommet i kliniske forsøg, er opstillet nedenfor efter organsystem og faldende hyppighed: meget almindelig (≥ 1/10); almindelig (≥ 1/100 til < 1/10);ikke almindelig (≥ 1/1.000 til < 1/100); sjælden (≥ 1/10.000 til < 1/1.000); meget sjælden (< 1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Insulin pen
Danish: Insulin beholder
English: Side effects reporting with a frequency not known (cannot be estimated from the available data)
Danish: Bivirkninger, hvor hyppigheden ikke er kendt (kan ikke estimeres ud fra forhåndenværende data) - Natriumretention - Påvirkning af synet
English: Transfer to Insuman Rapid
Danish: Omstilling til Insuman Rapid
English: The following adverse reactions from clinical investigations are listed below by system organ class and in order of decreasing incidence: very common (1/10); common (1/100 to <1/10); uncommon (1/1,000 to <1/100); rare (1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).
Danish: De relaterede bivirkninger, som er forekommet i kliniske forsøg, er opstillet nedenfor efter organsystem og faldende hyppighed: meget almindelig (≥1/10); almindelig (≥1/100 til <1/10); ikke almindelig (≥ 1/1.000 til < 1/100); sjælden (≥1/10.000 til <1/1.000); meget sjælden (< 1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Do not use the Medtronic MiniMed Implantable Pump if you are allergic to titanium alloy, polysulfone or silicone materials used in the implanted components of the pump.
Danish: - hvis du er allergisk over for titaniumlegering, polysulfon eller silikonematerialer som er anvendt i de implanterede dele af pumpen.
English: Insuman Rapid can be used during breast-feeding.
Danish: Insuman Rapid kan anvendes under amning.
English: Only the refill kit (syringe and stopcock), refill needles, port locating template supplied by Medtronic MiniMed and sterile rinse buffer solution manufactured by Sanofi-Aventis Deutschland GmbH should be used with Insuman Implantable to flush the catheter.
Danish: Kun genopfyldningskit (sprøjte og stophane), genopfyldningsnåle, portlokaliseringsskabelon leveret af Medtronic MiniMed og steril skyllebufferopløsning fremstillet af Sanofi-Aventis Deutschland GmbH må anvendes med Insuman Implantable til at skylle katetret.
English: If administration by syringe is necessary, a vial should be used.
Danish: Hvis administration med sprøjte er nødvendig, skal et hætteglas anvendes.
English: Only the refill kit (syringe and stopcock), refill needles, port locating template supplied by Medtronic MiniMed and sterile rinse buffer solution manufactured by Sanofi-Aventis Deutschland GmbH should be used with Insuman Implantable to refill the pump reservoir.
Danish: Kun genopfyldningskit (sprøjte og stophane), genopfyldningsnåle, portlokaliseringsskabelon leveret af Medtronic MiniMed og steril skyllebufferopløsning fremstillet af Sanofi-Aventis Deutschland GmbH må anvendes med Insuman Implantable til at genopfylde pumpereservoiret.
English: Insuman Rapid 100 IU/ml in a cartridge or Insuman rapid SoloStar 100 IU/ml in a pre-filled pen must not be mixed with any other insulin or with insulin analogues.
Danish: Insuman Rapid 100 IE/ml i cylinderampul eller Insuman Rapid SoloStar 100 IE/ml i fyldt pen må ikke blandes med andre insuliner eller med insulin-analoger.
English: Insuman Implantable 400 IU/ml infusion insulin human
Danish: Insuman Implantable 400 IE/ml infusion human insulin
English: What Insuman Implantable contains
Danish: Insuman Implantable indeholder natrium
English: What you need to know before you use Insuman Basal
Danish: Det skal du vide, før du begynder at tage Insuman Basal Tag ikke Insuman Basal
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).
Danish: (1) Bivirkninger observeret med et semi-syntetisk humant insulin (400 IE/ml) Følgende bivirkninger er rapporteret ved brug af Medtronic MiniMed Implantable Pump i de to fase III studier (se pkt.
English: Insuman Basal is injected under the skin 45 to 60 minutes before a meal.
Danish: Insuman Basal injiceres under huden 45 til 60 min. før et måltid.
English: • Training on how to set up the pump with the PPC; • Conduct of all procedures required for the correct management and maintenance of the
Danish: • Træning i, hvordan man sætter pumpen op sammen med PPC'en;
English: One ml contains 400 IU insulin human (equivalent to 14 mg).
Danish: En ml indeholder 400 IE human insulin (svarende til 14 mg).
English: Insuman Comb 50 40 IU/ml in a vial, Insuman Comb 50 100 IU/ml in a vial Insuman Comb 50 must not be mixed with insulin human formulations designed specifically for use in insulin pumps.
Danish: Insuman Comb 50 40 IE/ml i hætteglas, Insuman Comb 50 100 IE/ml i hætteglas Insuman Comb 50 må ikke blandes med human insulin formuleringer designet specifikt til brug i insulinpumper.
English: Insuman Comb 30 with alcohol
Danish: Brug af Insuman Comb 30 sammen med alkohol
English: If your SoloStar is in cool storage, take it out 1 to 2 hours before you inject to allow it to warm up to room temperature.
Danish: Hvis SoloStar opbevares koldt, bør den tages ud 1-2 timer før injektion, for at varme den op. Kold insulin er mere smertefuldt at injicere.
English: Insuman Basal is a fluid (suspension) for injection under the skin.
Danish: Insuman Basal er en suspension til injektion under huden.
English: severe swelling of skin or mucous membranes (angiooedema), shortness of breath, a fall in blood pressure with rapid heart beat and sweating.
Danish: (udslæt og kløe overalt på kroppen), alvorlig hævelse af hud eller slimhinder (angioødem), åndenød, blodtryksfald med hurtig hjerterytme og svedudbrud.
English: What you need to know before you use Insuman Implantable
Danish: Det skal du vide, før du begynder at bruge Insuman Implantable Brug ikke Insuman Implantable
English: Talk to your doctor, pharmacist or nurse before using Insuman Basal.
Danish: Kontakt lægen, apotekspersonalet eller sundhedspersonalet før du tager Insuman Basal.
English: One ml of solution contains 400 IU insulin human* (equivalent to 14 mg).
Danish: En ml opløsning indeholder 400 IE human insulin* (svarende til 14 mg).
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER PEN-ETIKET
English: Each vial contains 5 ml of suspension for injection, equivalent to 500 IU insulin, or 10 ml of suspension for injection, equivalent to 1000 IU insulin.
Danish: Hvert hætteglas indeholder 5 ml injektionsvæske, suspension svarende til 500 IE insulin, eller 10 ml injektionsvæske, suspension svarende til 1.000 IE insulin.
English: If you are allergic to this medicine or to animal insulins talk to your doctor.
Danish: Tal med din læge, hvis du er allergisk over for dette lægemiddel eller animalske insuliner.
English: If you stop using Insuman Comb 30
Danish: Hvis du holder op med at tage Insuman Comb 30
English: Unopened vials: Store in a refrigerator.
Danish: Uanbrudte cylinderampuller: Opbevares i køleskab.
English: Insuman Rapid is injected subcutaneously 15 to 20 minutes before a meal.
Danish: Insuman Rapid injiceres subkutant 15-20 min. før et måltid.
English: What you need to know before you use Insuman Infusat
Danish: Det skal du vide, før du begynder at tage Insuman Infusat Tag ikke Insuman Infusat
English: Insulin label must always be checked before each administration to avoid medication errors between Insuman Implantable and other insulins (see section
Danish: Etiketten på insulinet skal altid kontrolleres før hver administration for at undgå forveksling mellem Insuman Implantable og andre insuliner (se pkt.
English: Insuman Comb 30 is a biphasic isophane insulin suspension consisting of 30% dissolved insulin and 70% crystalline protamine insulin.
Danish: Insuman Comb 30 er en bifasisk isophaninsulinsuspension med 30% opløst insulin og 70% krystallinsk protamininsulin.
English: Inspect the cartridge before use.
Danish: Læs indlægssedlen inden brug.
English: Other medicines and Insuman Implantable
Danish: Brug af anden medicin sammen med Insuman Implantable
English: After stopping insulin infusion or removal or repositioning of the peritoneal catheter, focal hepatic steatosis seems to be reversible and without clinical consequence (see section 4.8).
Danish: Fokal leversteatose lader til at være reversibel og uden kliniske konsekvenser ved ophør af insulininfusionen eller ved fjernelse eller flytning af det peritoneale kateter (se pkt.
English: Do not add any other insulin to the cartridge.
Danish: Tilsæt ikke andet insulin til cylinderampullen.
English: Dose Based on your life-style and the results of your blood sugar (glucose) tests, your doctor will determine how much Insuman Implantable per day you will need, tell you when to check your blood sugar level, and whether you need to carry out urine tests.
Danish: Baseret på din livsstil og resultater fra blodsukkermålinger vil din læge - afgøre hvor meget Insuman Implantable du har brug for per dag, - fortælle dig, hvornår du skal kontrollere dit blodsukker, og hvis du skal udføre urinprøver.
English: What you need to know before you use Insuman Rapid
Danish: Det skal du vide, før du begynder at tage Insuman Rapid Tag ikke Insuman Rapid
English: 3.15 ml solution in a cartridge (type 1 colourless glass) with a plunger (fluoropolymer coated rubber (type 1, mixture of chlorobutyl and natural rubber)), a flanged cap (aluminium) and a stopper with hole (bromobutyl rubber (type 1), a Luer cone attachment (colourless polyethylene) and a Luer cap (colourless polyethylene).
Danish: 3,15 ml opløsning i cylinderampul (type 1 farveløst glas) med et stempel (fluoropolymerovertrukken gummi (type 1, blanding af chlorbutyl- og naturgummi)), ombøjet hætte (aluminium), en prop med hul (bromobutylgummi (type 1)), Luer beskyttelseshætte (farveløs polyethylen) og Luerlåg (farveløs polyethylen).
English: Follow closely the instructions for dose, monitoring (blood and urine tests), diet and physical activity (physical work and exercise) as discussed with your doctor.
Danish: Overhold nøje lægens anvisninger vedrørende dosering, kontrol (blod- og urinprøver), kostplan og fysisk aktivitet (fysisk arbejde og motion).
English: For further details on handling, see section 6.6.
Danish: For yderligere information omkring håndtering, se pkt.
English: Insuman Infusat is a neutral insulin solution (regular insulin).
Danish: Insuman Infusat er en neutral insulinopløsning (regular insulin).
English: Use only with Medtronic MiniMed Implantable Pump.
Danish: Må kun anvendes med Medtronic MiniMed Implantable Pump.
English: Insuman Rapid must not be mixed with insulin human formulations designed specifically for use in insulin pumps.
Danish: Insuman Rapid må ikke blandes med human insulin formuleringer designet specifikt til brug i insulinpumper.
English: Insuman Rapid in pre-filled pen is only suitable for injecting just under the skin.
Danish: Insuman Rapid i fyldte penne er kun egnet til indsprøjtning lige under huden.
English: If administration by syringe or intravenous injection is necessary, a vial should be used (see section 4.4).
Danish: Hvis administration med sprøjte eller intravenøs injektion er nødvendig, skal et hætteglas anvendes (se pkt.
English: Transfer to Insuman Comb 30
Danish: Omstilling til Insuman Comb 30
English: However, there is no experience with the use of Insuman Rapid in pregnant women.
Danish: Erfaring savnes dog angående anvendelse af Insuman Rapid til gravide.
English: Talk to your doctor, pharmacist or nurse before using Insuman Infusat.
Danish: Kontakt lægen, apotekspersonalet eller sundhedspersonalet før du tager Insuman Infusat.
English: Pharmacodynamic effects Insuman Implantable is an insulin with rapid onset and short duration of action.
Danish: Farmakodynamisk virkning Insuman Implantable er et insulin med hurtigt indsættende og kortvarig virkning.
English: Each cartridge or pen contains 3 ml of suspension for injection, equivalent to 300 IU insulin.
Danish: Hver cylinderampul eller pen indeholder 3 ml injektionsvæske, suspension svarende til 300 IE insulin.
English: However, there is no experience with the use of Insuman Comb 25 in pregnant women.
Danish: Erfaring savnes dog angående anvendelse af Insuman Comb 25 til gravide.