FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients should practice good diabetes self care and check their blood glucose a minimum of 4 times daily to detect and prevent hyperglycemia and possible diabetic ketoacidosis due to pump under-delivery.
Danish: Patienter skal praktisere god diabetes egenomsorg og kontrollere deres blodglucoseniveau mindst 4 gange dagligt for at opdage og forebygge hyperglykæmi og potentiel ketoacidose grundet underlevering fra pumpen.
English: Consequently, about 40% to 60% of the daily dose is administered at a basal rate, and the rest is given as bolus injections before meals.
Danish: Derfor administreres omkring 40-60% af døgndosis som ”basalrate”, mens den resterende del indgives i form af bolusinjektioner før måltider.
English: Patients may require more frequent refill procedures based on their insulin needs.
Danish: Patienter kan, afhængigt af deres insulinbehov, have brug for hyppigere genopfyldningsprocedurer.
English: Other mild reactions at the injection site (such as injection site redness, unusually intense pain on injection site, itching, injection site swelling or injection site inflammation) may occur.
Danish: Andre milde reaktioner ved injektionsstedet (f.eks. rødme, usædvanligt stærke smerter når der injiceres, kløe, hævelse eller betændelse) kan forekomme.
English: Continuous infusion via the intraperitoneal and intravenous routes (combined data) resulted in higher plasma free insulin Cmax values than multiple daily subcutaneous injections and continuous subcutaneous insulin infusion via an external pump (combined data) in patients with type 1 diabetes mellitus.
Danish: Kontinuerlig infusion intraperitonealt og intravenøst (kombinerede data) resulterede i større frit plasma insulin Cmax-værdier end flere daglige subkutane injektioner og kontinuerlig subkutan insulin infusion via en ekstern pumpe (kombineret data) hos patienter med type 1-diabetes mellitus.
English: In most cases you will need to see a doctor.
Danish: I de fleste tilfælde skal du kontakte en læge.
English: In a single-dose study in rats, a semi-synthetic insulin human in a formulation with 400 IU/ml and excipients identical to the Insuman Implantable 400 IU/ml formulation was administered by intraperitoneal injection.
Danish: I en enkelt dosis undersøgelse i rotter blev et semi-syntetisk human insulin i en formulering med 400 IE/ml og identiske hjælpestoffer til Insuman Implantable 400 IE/ml-formuleringen administreret ved intraperitoneal injektion.
English: Insuman Rapid may also be administered intravenously.
Danish: Insuman Rapid kan også gives intravenøst.
English: Make sure that you contact a doctor quickly.
Danish: Sørg for at kontakte lægen hurtigt.
English: The purpose of this procedure is to dissolve insulin deposits within the pump reservoir, pumping mechanism and the side port catheter using 0.1 M sodium hydroxide sterile solution supplied by Medtronic MiniMed.
Danish: Formålet med denne procedure er at opløse insulinophobninger inde i pumpereservoiret, pumpemekanismen og sideportkatetret ved brug af 0,1 M natriumhydroxid sterilopløsning leveret af Medtronic MiniMed.
English: Patients should be informed about the high concentration of insulin in Insuman Implantable (400 IU/ml) compared to other insulins in vials or cartridges (usually 100 IU/ml).
Danish: Patienter skal informeres omkring den høje insulinkoncentration i Insuman Implantable (400 IE/ml) i forhold til andre insuliner i hætteglas eller cylinderampuller (normalt 100 IE/ml).
English: A catheter flush procedure should be performed to clear the occlusion.
Danish: En kateter skylleprocedure skal udføres for at fjerne okklusionen.
English: • other circumstances arise that may promote an increased susceptibility to hypo- or hyperglycaemia (see section 4.4).
Danish: - andre omstændigheder opstår, som øger følsomheden over for hypo- eller hyperglykæmi (se pkt.
English: The manufacturer's instructions for using the pen must be followed carefully for loading the cartridge, attaching the injection needle, and administering the insulin injection.
Danish: Fremstillerens instruktioner for anvendelse af pennen skal følges nøje for isætning af cylinderampul, påsætning af nål og administration af insulin-injektionen.
English: Speak to a doctor immediately if you are not able to control the hypoglycaemia or if itcomes back.
Danish: Søg omgående læge, hvis du ikke kan få kontrol over din hypoglykæmi, eller hvis tilstanden kommer igen.
English: Table 1: Adverse reactions observed in HUBIN_L_05335 study with insulin human 400 IU/ml and clinical experience with insulin human 100 IU/ml and 40 IU/ml.
Danish: Tabel 1: Bivirkninger observeret i HUBIN_L_05335-studiet med human insulin og fra kliniske erfaringer med brugen af human insulin 100 IE/ml og 40 IE/ml.
English: In the following situations, the management of your diabetes may require extra care (e.g. urine and blood tests): - 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 (f.eks. urin og blodtests): - Hvis du bliver syg eller kommer alvorligt til skade, kan dit blodsukkerniveau blive for højt
English: Insuman Implantable is used to reduce high blood sugar in adult patients with a certain form of diabetes (type 1 diabetes mellitus).
Danish: Insuman Implantable anvendes til at nedsætte for højt blodsukker hos voksne patienter med en bestemt form for diabetes (type 1-diabetes mellitus).
English: The insulin in your pump must be replaced every 40 to 45 days with new insulin or earlier based on your insulin needs.
Danish: Insulinen i pumpen skal udskiftes for hver 40 til 45 dage med ny insulin eller tidligere baseret på dit insulinbehov.
English: • When under-delivery is caused by a problem with the pump, a rinse procedure should be performed.
Danish: Når underlevering af insulin skyldes et problem med pumpen, skal skylleproceduren foretages.
English: ► Side effects reported with the insulin
Danish: ► Bivirkninger indrapporteret ved insulin
English: As soon as patients notice a rapid increase in blood glucose, which does not respond to a bolus dose of insulin, the possibility of pump obstruction should be investigated by a physician trained to perform pump investigations.
Danish: Så snart patienterne opdager en hurtig stigning i blodglucose, som ikke reagerer på en bolusdosis af insulin, skal det undersøges af en læge, der er trænet i at udføre pumpeundersøgelser, hvorvidt der er obstruktion i pumpen.
English: You should practice good diabetes care and test your own blood sugar levels at least four times daily to check your blood sugar levels and determine insulin doses.
Danish: Du skal praktisere god insulinbehandling og teste din egne blodsukkerniveauer mindst fire gange dagligt for at tjekke dine blodsukkerniveauer og bestemme insulindosis.
English: A single-blind, randomised, 6-month controlled clinical study (HUBIN_L_05335) was conducted to evaluate the clinical efficacy and safety of Insuman Implantable compared to a semi-synthetic human insulin (400 IU/ml) administered via the Medtronic MiniMed Implantable Pump.
Danish: Et 6-måneders enkeltblindet, randomiseret, kontrolleret klinisk studium (HUBIN_L_05335) blev udført for at evaluere den kliniske virkning og sikkerhed af Insuman Implantable i forhold til et semi syntetisk humant insulin (400 IE/ml) administreret via Medtronic MiniMed Implantable Pump.
English: If you notice a rapid increase in blood sugar level which does not respond to a bolus dose of insulin, contact your doctor immediately.
Danish: Hvis du oplever en hurtig stigning i blodsukkerniveau, som ikke reagerer på en bolusinsulindosis, skal du kontakte din læge omgående.
English: Immediate type allergic reactions (hypotension, angioneurotic oedema, bronchospasm, generalised skin reactions);
Danish: Type 1 allergiske reaktioner (hypotension, angioneurotisk ødem, bronkospasmer, generaliserede hudreaktioner); antiinsulin-antistoffer
English: Particular caution should be exercised, and intensified blood glucose monitoring is advisable in patients in whom hypoglycaemic episodes might be of particular clinical relevance, such as in patients with significant stenoses of the coronary arteries or of the blood vessels supplying the brain (risk of cardiac or cerebral complications of hypoglycaemia) as well as in patients with proliferative retinopathy, particularly if not treated with photocoagulation (risk of transient amaurosis following hypoglycaemia).
Danish: Særlig forsigtighed bør udvises og intensiveret blodglucosekontrol tilrådes til patienter, hvor hypoglykæmi kan være af særlig klinisk betydning, f.eks. hos patienter med betydende stenoser i koronararterierne eller i hjernens forsyningskar (risiko for kardiale eller cerebrale hypoglykæmikomplikationer).
English: Do not use SoloStar if it is damaged or not working properly, it has to be discarded and a new SoloStar has to be used.
Danish: Anvend ikke SoloStar, hvis den er skadet eller ikke virker ordentligt (pga. mekaniske fejl), den skal kasseres og en ny SoloStar tages i brug.
English: When the refill needle is properly seated in the pump fill port, then the vacuum in the pump reservoir will passively draw the insulin from the syringe into the pump reservoir.
Danish: Når genopfyldningsnålen sidder korrekt i porten til pumpeopfyldningen vil vakuumet i pumpereservoiret passivt trække insulinet fra sprøjten og ind i pumpereservoiret.
English: SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGH AND REACH OF CHILDREN
Danish: SÆRLIG ADVARSEL OM, AT LÆGEMIDLET SKAL OPBEVARES UTILGÆNGELIGT FOR BØRN
English: Medication errors involving mix-up between subcutaneous Insuman formulations or other subcutaneous insulins have been reported.
Danish: Der er indrapporteret tilfælde af medicineringsfejl som omfatter forveksling med subkutane Insumanformuleringer eller andre subkutane insuliner.
English: The majority of adverse reactions associated with the Medtronic MiniMed Implantable Pump can be prevented by the rinse procedure by physicians.
Danish: Størstedelen af bivirkningerne associeret til brugen af Medtronic MiniMed Implantable Pump kan forebygges ved at gennemgå skylleproceduren som foretages af læger.
English: Your doctor will show you how and in which area of the skin you should infuse your insulin and how often you must change the puncture site within the particular area of skin where you are infusing the insulin.
Danish: Din læge vil vise dig hvordan og i hvilke hudområder, du skal injicere din insulin, og hvor ofte du skal skifte til et nyt injektionssted inden for det bestemte hudområde, som du bruger til at injicere dit insulin.
English: Unopened vials, unopened cartridges, not in-use pens Store in a refrigerator (2°C - 8°C).
Danish: Uanbrudte hætteglas, uanbrudte cylinderampuller, uanbrudte penne Opbevares i køleskab (2°C-8°C).
English: Do not administer insulin.
Danish: Tag ikke insulin.
English: Insuman Implantable administered in continuous intraperitoneal infusion was also similar to semi-synthetic human insulin as demonstrated by the refill accuracy criteria over the 4-refill cycles (per protocol population: mean difference: -3.15 ± 1.34; [95% CI: -5.81; -0.50]).
Danish: Kriteriet for genopfyldningens nøjagtighed over de 4 genopfyldninger var også lig den for Insuman Implantable administreret ved kontinuert intraperitoneal infusion i forhold til semi-syntetisk human insulin (per protokol population: gennemsnitlig forskel:3.15 ± 1,34; [95 % CI: -5,81; -0,50]).
English: The basal metabolic requirement is usually 40% to 60% of the total daily insulin requirement.
Danish: Det basale metaboliske behov udgør normalt 40-60 % af det totale daglige insulinbehov.
English: In patients who require high insulin doses because of the presence of insulin antibodies, transition under medical supervision in a hospital or similar setting must be considered.
Danish: Hos patienter som har behov for høje insulindoser pga. tilstedeværelsen af insulinantistoffer, skal det overvejes, om skiftet skal finde sted under medicinsk observation på et hospital eller lignende omstændigheder.
English: In case of severe hypoglycaemia, patients should immediately contact their physician trained to perform pump investigations and the pump should then be investigated by the physician for possible catheter occlusion leading to accumulation of insulin with subsequent release of this accumulated insulin (see section 6.6).
Danish: I tilfælde af alvorlig hypoglykæmi skal patienter omgående kontakte deres læge, der er trænet i at udføre undersøgelser af pumpen, og pumpen skal undersøges af lægen for eventuel kateterokklusion, som kan føre til ophobning af insulin og efterfølgende udløsning af den ophobede insulin (se pkt.
English: Antibodies to insulin
Danish: Antistoffer overfor insulin
English: If the pump does not function well, you can draw the insulin from the cartridge into an injection syringe.
Danish: Hvis insulinpumpen ikke fungerer tilfredsstillende, kan du trække insulin fra cylinderampullen op i en injektionssprøjte.
English: Do not use Insuman Implantable with any other syringes or pumps (external or implantable) than the implantable pump supplied by Medtronic MiniMed.
Danish: Brug ikke Insuman Implantable med nogen andre sprøjter eller pumper (eksterne eller implanterbare) end den implanterede pumpe leveret af Medtronic MiniMed.
English: Some patients with long-standing type 2 diabetes mellitus and heart disease or previous stroke who were treated with pioglitazone and insulin experienced the development of heart failure.
Danish: Nogle patienter med årelang type 2-diabetes mellitus og hjertesygdom eller tidligere slagtilfælde, der var i behandling med pioglitazon (oral antidiabetika, der anvendes til behandling af type 2-diabetes mellitus) og insulin, udviklede hjertesvigt.
English: Acute toxicity of insulin human was studied following subcutaneous administration in rats.
Danish: Akut toksicitet for human insulin er undersøgt på rotter efter subkutan administration.
English: Insulin treatment may cause temporary build-up of water in the body with swelling in the calves and ankles.
Danish: - Ødem Insulinbehandling kan føre til forbigående væskeophobning i kroppen med hævede ankler og lægge.
English: The presence of such insulin antibodies may necessitate adjustment of the insulin dose to correct a tendency for hyper- or hypoglycaemia (see section 4.8).
Danish: Tilstedeværelsen af sådanne antistoffer kan medføre behov for at justere insulindosis for at korrigere en tendens til hyper- eller hypoglykæmi (se pkt.
English: If you think you may have a problem with your insulin, have it checked by your doctor or pharmacist.
Danish: Hvis du tror, du kan have et problem med din insulin, bør du få det kontrolleret af din læge eller på apoteket.
English: Insulin may also cause sodium retention, particularly if previously poor metabolic control is improved by intensified insulin therapy
Danish: Insulin kan også forårsage natriumretention især hvis tidligere dårlig metabolisk kontrol er forbedret ved intensiveret insulinterapi - Påvirkning af synet
English: in adolescents who have not reached adult size.
Danish: - til unge som ikke er færdigudviklede.
English: Insuman Rapid may also be used for treating hyperglycaemic coma (coma caused by too much blood sugar) and ketoacidosis (build-up of acid in the blood because the body is breaking down fat instead of sugar) as well as for controlling blood sugar before, during and after surgery.
Danish: Insuman Rapid kan også anvendes til behandling af hyperglykæmisk koma (koma forårsaget af for højt blodsukker) og ketoacidose (ophobning af syre i blodet som følge af kroppens nedbrydning af fedt i stedet for sukker) samt til kontrol af blodsukker før, under og efter kirurgiske indgreb.
English: Examples of symptoms that indicate a low sugar level in the brain: headaches, intense hunger, nausea, vomiting, tiredness, sleepiness, sleep disturbances, restlessness, aggressive behaviour, lapses in concentration, impaired reactions, depression, confusion, speech disturbances (sometimes total loss of speech), visual disorders, trembling, paralysis, tingling sensations (paraesthesia), numbness and tingling sensations in the area of the mouth, dizziness, loss of self-control, inability to look after yourself, convulsions, loss of consciousness.
Danish: Eksempler på symptomer på lavt blodsukker i hjernen: Hovedpine, udtalt sultfornemmelse, kvalme, opkastning, træthed, søvnighed, søvnforstyrrelser, rastløshed, aggressiv adfærd, koncentrationsbesvær, nedsat reaktionsevne, depression, konfusion, taleforstyrrelser (til tider fuldstændig tab af talens brug), synsforstyrrelser, rysten, lammelser, prikkende og stikkende fornemmelse (paræstesi), følelsesløshed og prikken og stikken omkring munden, svimmelhed, manglende selvbeherskelse, hjælpeløshed, kramper og bevidstløshed.
English: Insuman Infusat has been specially designed for use in external portable insulin pumps.
Danish: Insuman Infusat er specielt udviklet til brug i eksterne transportable insulinpumper.
English: Only Insuman Implantable which has been specifically formulated for use in the Medtronic MiniMed Implantable Pump should be used to fill the sterile pump reservoir.
Danish: Kun Insuman Implantable der er specifikt formuleret til brug i Medtronic MiniMed Implantable Pump må bruges til at fylde det sterile pumpereservoir.
English: Pump blockage
Danish: Pumpeblokade
English: Use in paediatric patients who have not reached adult size due to the large size of the pump (see section 4.2 and 4.4).
Danish: Brug til pædiatriske patienter, der ikke er fuldt udvoksede, grundet pumpens størrelse (se pkt.
English: Beta-blockers, clonidine, lithium salts or alcohol may either potentiate or weaken the blood-glucose-lowering effect of insulin.
Danish: Beta-blokkere, clonidin, lithiumsalte eller alkohol kan enten øge eller hæmme insulins blodglucosesænkende effekt.
English: Detailed instructions on programming these limitations are contained in the Physician's Manual.
Danish: Detaljerede instruktioner om programmeringen af disse begrænsninger indgår i lægens manual.
English: Cases of cardiac failure have been reported when pioglitazone was used in combination with insulin, especially in patients with risk factors for development of cardiac heart failure.
Danish: Kombinationsbehandling med Insuman og pioglitazon Der er indrapporteret tilfælde af hjertesvigt ved anvendelse af pioglitazon i kombination med insulin, særligt hos patienter med risikofaktorer for udvikling af hjertesvigt.
English: It must be remembered that neutral regular insulin precipitates out at a pH of approximately 4.5 to 6.5.
Danish: Opmærksomheden henledes på, at neutral, opløselig insulin udfælder ved pH omkring 4,5-6,5.
English: Insulin administration via the pump can cause a fat infiltration of the liver at single, well-defined locations (called focal hepatic steatosis).
Danish: Insulinadministration via pumpen kan forårsage infiltration af fedt i leveren på enkelte veldefinerede steder (kaldet fedtlever).
English: Such reactions to insulin or to the excipients can cause large-scale skin reactions (rash and itching all over the body), severe swelling of skin or mucous membranes (angiooedema), shortness of breath, a fall in blood pressure with rapid heart beat and sweating.
Danish: Sådanne reaktioner overfor insulin eller hjælpestoffer kan forårsage omfattende hudreaktioner (udslæt og kløe overalt på kroppen), alvorlig hævelse af hud eller slimhinder (angioødem), åndenød, blodtryksfald med hurtig hjerterytme og svedudbrud.
English: Abnormal healing can occur at the surgical incision site after device implantation.
Danish: Der kan forekomme unormal heling ved det kirurgiske snit efter implantationen.
English: Your doctor will show you in which area of the skin you should inject your insulin.
Danish: Din læge vil vise dig i hvilke hudområder, du skal injicere din insulin.
English: The solution must only be used if it is clear, colourless or almost colourless and practically free from visible particles.
Danish: Opløsningen må kun anvendes hvis den klar, farveløs eller næsten farveløs og praktisk taget fri for visuelle partikler.
English: Part of the daily insulin dose is infused continuously by the Medtronic MiniMed Implantable Pump and the remaining part of the daily dose is administered by you, using the same pump, as a bolus before meals.
Danish: En del af den daglige insulindosis infunderes kontinuerligt af Medtronic MiniMed Implantable Pump og den resterende del af den daglige dosis administreres af dig ved brug af den samme pumpe som bolus før måltider.
English: You should know these factors so that you are able to react correctly to changes in your blood sugar level and to 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 lavt.
English: If you are ill or have mental problems that make you unable to make changes to your pump based on your blood glucose level or to take the appropriate actions if you have a problem with your pump, talk to your doctor.
Danish: Tal med din læge hvis du er syg eller har mentale problemer, som gør dig ude af stand til at foretage ændringer til din pumpe baseret på dit blodsukkerniveau eller til at træffe de rigtige beslutninger, hvis du har et problem med din pumpe.
English: Failure to properly degas all fluids may introduce air in the pump causing insulin aggregation and under-delivery.
Danish: Hvis opløsningerne ikke afgasses korrekt kan der komme luft i pumpen, hvilket kan føre til insulinaggregering og underlevering.
English: If this occurs, you should contact your doctor immediately.
Danish: Hvis det sker, skal du kontakte din læge øjeblikkeligt.
English: Patients who reside permanently at elevations above 2439 meters (8000 feet) must not be implanted (see section 4.3).
Danish: Patienter, der opholder sig permanent i højder over 2439 meter (8000 fod), må implanteres (se pkt.
English: Follow closely the instructions for dose, monitoring (blood and/or urine tests), diet and physical activity (physical work and exercise) as discussed with your doctor.
Danish: Følg nøje instruktionerne for dosis, monitorering (blod- og/eller urinprøver), diæt og fysisk aktivitet (fysisk arbejde og træning) som diskuteret med din læge.
English: The physician must program specific limitations for insulin basal insulin rates, bolus delivery amounts.
Danish: Lægen skal programmere specifikke begrænsninger for den basale insulindosis og mængden af insulin i en bolusdosis.
English: Patients must be informed to closely monitor blood glucose levels on refill days (see section 6.6).
Danish: Patienter skal informeres om at overvåge deres blodglucoseniveau nøje på genopfyldningsdage (se pkt.
English: Insuman Implantable will be prescribed by a doctor who has received training in the use of the Medtronic MiniMed Implantable Pump.
Danish: Insuman Implantable vil blive udskrevet af en læge, som har fået træning i brugen af Medtronic MiniMed Implantable Pump.
English: Liver reaction
Danish: Leverreaktion
English: Implantation of the pump in patients who reside permanently at elevations above 2439 meters (8000 feet) (see section 4.4).
Danish: Implantation af pumpen hos patienter der permanent bor i højder over 2439 meter (8000 fod) (se pkt.
English: o Running a diagnostic test of your pump system is needed if you think the pump may have been damaged by water, a sporting incident, electrotherapy (cardiac defibrillator), diagnostic ultrasound or radiation (X-ray).
Danish: o Hver 40.-45. dag er det nødvendigt at genopfylde med insulin på hospitalet o Udførelse af diagnosetest af dit pumpesystem er nødvendigt, hvis du mener, at pumpen er beskadiget af vand, under udførelse af sport, af elektroterapi (hjertedefibrillator), af diagnostisk ultralyd eller stråling (røntgen).
English: Beware: Artificial sweeteners and foods with artificial sweeteners (such as diet drinks) are of no help in treating hypoglycaemia.
Danish: OBS: Husk, at kunstige sødemidler og madvarer indeholdende kunstige sødemidler (såsom light sodavand) ikke kan anvendes til behandling af hypoglykæmi.