natgillin/translations-raw huggingface dataset:
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.
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).
- 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).
• 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.
De fleste mindre reaktioner over for insulin forsvinder som regel i løbet af et par dage til få uger.
Most minor reactions to insulins usually resolve in a few days to a few weeks.
Derudover skal du læse og følge instruktionerne angivet i patientmanualen, der følger med Medtronic MiniMed Implantable Pump.
In addition, you should read and follow the instructions given in the patient manual accompanying the Medtronic MiniMed Implantable Pump.
Dette regime kræver tæt monitorering (metabolisk status, syre-base- og elektrolytstatus, vitale parametre etc.) på en intensivafdeling eller lignende.
(metabolic status, acid-base and electrolyte status, vital parameters etc.) in an intensive care unit or similar setting.
Insuman Basal er en isophaninsulinsuspension.
Insuman Basal is an isophane insulin suspension.
Hypersensitivitet over for titaniumlegering, polysulfon eller silikonematerialer brugt i de implanterede dele af pumpen.
Hypersensitivity to titanium alloy, polysulfone or silicone materials used in the implanted components of the pump.
Patienten skal læse og følge instruktionerne i patientmanualen som følger med infusionspumpen.
The patient should read and follow the instructions in the Patient Manual accompanying the infusion pump.
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.
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.
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.
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.
- hvis du bor permanent i højder over 2.439 meter (8.000 fod).
if you live permanently at heights above 2439 meters (8000 feet).
Infektioner omkring pumpeimplantationsstedet kan medføre behov for fjernelse af pumpen (pumpeeksplantation).
Infections around the pump implantation site may require the removal of your pump (explantation of the pump).
C. Tjek udseendet af din insulin.
C Check the appearance of your insulin.
Resterende insulin og ny insulin skal vejes for at udfylde genopfyldningsskemaet og beregne kriteriet for genopfyldningens nøjagtighed.
Residual insulin and new insulin must be weighed to record the refill worksheet and calculate the refill accuracy criterion.
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.
This is particularly important in those who have reduced or absent awareness of the warning symptoms of hypoglycaemia or have frequent episodes of hypoglycaemia.
Det er muligt at insulinen kan forårsage blokade af den implanterede pumpe.
It is possible that the insulin can cause blockage of the implantable pump.
Insuman Implantable må ikke bruges med nogen anden type injektionsudstyr (f.eks. sprøjter).
Insuman Implantable must not be used with any other type of injection devices (e.g. syringes).
Brug bestemte penne: Se indlægssedlen.
Use specific pens: see leaflet.
Der skal muligvis foretages ændringer i dosering af lægemidlet, kostplaner og fysisk aktivitet.
Adjustments in dose regimen of the medicinal product, meal patterns, or physical activity may be needed.
Insulinen i din pumpe skal udskiftes hver 40 til 45 dage med ny insulin.
The insulin in your pump must be replaced every 40 to 45 days with new insulin.
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.
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.
Medtronic MiniMed Implantable Pump, som er implanteret under huden på din mave, infunderer insulin kontinuert (kontinuert intraperitoneal infusion).
The Medtronic MiniMed Implantable Pump, which is implanted under the skin of your belly, infuses your insulin continuously (continuous intraperitoneal infusion).
• Information om registrering, herunder hvordan det gøres samt vigtigheden af at registrere patienterne
• Information on the registry including how to, and the importance of, entering patients in it • Surgical aspects of implantation
Holdbarhed i pumpen Op til 45 dage ved 37 °C.
Shelf life in the pump Up to 45 days at 37°C.
Før du skal ud at rejse, bør du tale med din læge.
Before travelling, consult your doctor.
- Hyperglykæmi: Hvis dit blodsukker er for højt kan du opleve hyperglykæmi.
• Hyperglycaemia: If your blood sugar is too high, you may experience hyperglycaemia.
B. Tag det ydre nålehylster af og behold det til at fjerne den brugte nål efter injektionen.
B. Take off the outer needle cap and keep it to remove the used needle after injection.
Du skal monitorere dit blodsukkerniveau tæt på genopfyldningsdage.
You must closely monitor your blood sugar level on refill days.
Kun efter vellykket reetablering af slagvolumenmålingen kan katetret skylles med steril skyllebufferopløsning og pumpen genopfyldes med insulin.
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.
Kontakt din læge øjeblikkeligt, hvis du er forhindret i at komme på hospitalet eller til en klinik, der kan udskifte insulinen i din pumpe.
Contact your doctor immediately if you are unable to go to the hospital or clinicto replace the insulin in your pump.
Focal leversteatose er observeret efter intraperitoneal administration af insulin, når kateteret var placeret meget tæt på eller i leverkapslen.
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.
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.
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.
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.
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.
Der blev ikke udført ikke-kliniske studier der vurderer potentiel toksicitet af Insuman Implantable 400 IE/ml administreret intraperitonealt.
No non-clinical studies assessing the potential toxicity of Insuman Implantable 400 IU/ml administered via intraperitoneal route were performed.
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.
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.
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.
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.
INSULINKONC - µIE/ml
INSULIN CONC - µIU/ml
Doseringsknappens farve varierer afhængig af hvilken formulering, Insuman insulinen er.
The injection button colour will vary based on the formulation of Insuman insulin used.
Insuman Implantable (400 IE/ml) indeholder 4 gange mere insulin i 1 ml end normal insulin (100 IE/ml).
Insuman Implantable (400 IU/ml) contains 4 times as much insulin in 1 ml as standard insulin (100 IU/ml).
Disse cylinderampuller bør ikke bruges med andre former for flergangspenne, da dosis-nøjagtigheden kun er vist med ovenstående penne.
These cartridges should not be used with any other reusable pen as the dosing accuracy has only been established with the listed pens.
Tidspunkt for genopfyldning af insulinpumpe
Time of refill of insulin pump
Underlevering forårsaget af okklusion i sideportens kateter kan forekomme brat eller gradvist.
Under-delivery of insulin caused by catheter occlusion Under-delivery caused by Side Port Catheter occlusion can occur either abruptly or gradually.
I sjældne tilfælde kræver forekomsten af sådanne anti-insulin-antistoffer justering af insulindosis for at korrigere for tendensen til hyper- eller hypoglykæmi.
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.
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.
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).
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.
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.
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).
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).
B. Hold nålen vandret på linje med pennen når du sætter nålen på (skru eller tryk nålen på afhængig af nåletypen).
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).
• Sikre at alle patienter modtager patientmanualen, patient ”quick guiden” og den vigtige indlægsseddel for det implementerbare Medtronic MiniMed insulinpumpesystem samt nødsituationsinformationskort til patienter
• 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
I genopfyldningsproceduren skal den resterende insulin fjernes fra pumpen, hvorefter pumpen skal genopfyldes med ny insulin.
In this refilling procedure the remaining insulin must be removed from the pump and the pump refilled with new insulin.
Skylning af pumpe for at undgå underlevering
Rinsing of pump to avoid insulin under-delivery
Fordi du har type 1-diabetes, en insulinkrævende diabetes mellitus, må du ikke afbryde insulinbehandlingen.
Because you have type 1 diabetes, an insulin dependent diabetes mellitus, do not stop your insulin.
Andre administrationsveje (f.eks. injektion).
Other routes of administration (e.g. injection).
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.
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.
Hvis du bruger en insulinsuspension (Insuman Basal eller Insumanblandinger) skal du vippe pennen frem og tilbage mindst 10 gange for at blande insulinen.
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.
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.
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.
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.
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.
• Implementerbart insulinpumpesystem: Manualer til læger
• Implantable Insulin Pump system: Physician Manuals
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.
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.
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.
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.
Derfor administreres omkring 40-60% af døgndosis som ”basalrate”, mens den resterende del indgives i form af bolusinjektioner før måltider.
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.
Patienter kan, afhængigt af deres insulinbehov, have brug for hyppigere genopfyldningsprocedurer.
Patients may require more frequent refill procedures based on their insulin needs.
Andre milde reaktioner ved injektionsstedet (f.eks. rødme, usædvanligt stærke smerter når der injiceres, kløe, hævelse eller betændelse) kan forekomme.
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.
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.
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.
I de fleste tilfælde skal du kontakte en læge.
In most cases you will need to see a doctor.
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.
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.
Insuman Rapid kan også gives intravenøst.
Insuman Rapid may also be administered intravenously.
Sørg for at kontakte lægen hurtigt.
Make sure that you contact a doctor quickly.
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.
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.
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).
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).
En kateter skylleprocedure skal udføres for at fjerne okklusionen.
A catheter flush procedure should be performed to clear the occlusion.
- andre omstændigheder opstår, som øger følsomheden over for hypo- eller hyperglykæmi (se pkt.
• other circumstances arise that may promote an increased susceptibility to hypo- or hyperglycaemia (see section 4.4).
Fremstillerens instruktioner for anvendelse af pennen skal følges nøje for isætning af cylinderampul, påsætning af nål og administration af insulin-injektionen.
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.
Søg omgående læge, hvis du ikke kan få kontrol over din hypoglykæmi, eller hvis tilstanden kommer igen.
Speak to a doctor immediately if you are not able to control the hypoglycaemia or if itcomes back.
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.
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.
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
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).
Insuman Implantable anvendes til at nedsætte for højt blodsukker hos voksne patienter med en bestemt form for diabetes (type 1-diabetes mellitus).
Insuman Implantable is used to reduce high blood sugar in adult patients with a certain form of diabetes (type 1 diabetes mellitus).
Insulinen i pumpen skal udskiftes for hver 40 til 45 dage med ny insulin eller tidligere baseret på dit insulinbehov.
The insulin in your pump must be replaced every 40 to 45 days with new insulin or earlier based on your insulin needs.
Når underlevering af insulin skyldes et problem med pumpen, skal skylleproceduren foretages.
• When under-delivery is caused by a problem with the pump, a rinse procedure should be performed.
► Bivirkninger indrapporteret ved insulin
► Side effects reported with the insulin
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.
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.
Du skal praktisere god insulinbehandling og teste din egne blodsukkerniveauer mindst fire gange dagligt for at tjekke dine blodsukkerniveauer og bestemme insulindosis.
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.
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.
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.
Hvis du oplever en hurtig stigning i blodsukkerniveau, som ikke reagerer på en bolusinsulindosis, skal du kontakte din læge omgående.
If you notice a rapid increase in blood sugar level which does not respond to a bolus dose of insulin, contact your doctor immediately.
Type 1 allergiske reaktioner (hypotension, angioneurotisk ødem, bronkospasmer, generaliserede hudreaktioner); antiinsulin-antistoffer
Immediate type allergic reactions (hypotension, angioneurotic oedema, bronchospasm, generalised skin reactions);
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).
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).