FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients, whose blood glucose control is greatly improved, e.g. by intensified insulin therapy, may experience a change in their usual warning symptoms of hypoglycaemia and should be advised accordingly.
Danish: Patienter, hvis blodglucosekontrol er væsentligt forbedret, f.eks. ved intensiveret insulinbehandling, kan opleve ændringer i deres sædvanlige advarselssymptomer på hypoglykæmi og skal orienteres herom.
English: Fiasp can be used in adolescents and children from the age of 1 year (see section 5.1).
Danish: Fiasp kan anvendes til unge og børn fra 1 år (se pkt.
English: When your pen contains less than 80 units, the dose counter stops at the number of units left.
Danish: Når pennen indeholder færre end 80 enheder, stopper dosistælleren ved det antal enheder, der er tilbage.
English: To get the benefit of insulin infusion and to detect possible malfunction of the insulin pump, it is recommended that you measure your blood sugar level regularly.
Danish: For at få størst muligt udbytte af insulininfusionen og for at opdage eventuelle pumpesvigt anbefales det, at du måler dit blodsukker regelmæssigt.
English: If you notice these skin changes, tell your doctor or nurse.
Danish: Hvis du bemærker disse hudforandringer, skal du fortælle det til din læge eller sygeplejerske.
English: Tell your doctor immediately if you have signs of heart failure such as unusual shortness of breath, rapid increase in weight or localised swelling (oedema).
Danish: Fortæl det straks til din læge, hvis du oplever tegn på hjertesvigt, såsom usædvanlig kortåndethed, hurtig vægtstigning eller lokale væskeansamlinger (ødem).
English: If you have poor eyesight, please see section 3 ‘How to use Fiasp'.
Danish: Hvis du har nedsat syn, se punkt 3 ”Sådan skal du bruge Fiasp”.
English: • sympathomimetics such as epinephrine (adrenaline), salbutamol or terbutaline - for asthma
Danish: • sympatomimetika, såsom adrenalin, salbutamol og terbutalin - mod astma
English: • When you fill a new reservoir, do not leave large air bubbles in either the syringe or the tubing.
Danish: • Når du fylder en ny beholder, skal du kontrollere, at der ikke er store luftbobler i hverken sprøjte eller slange.
English: • Eye disorder - Fast improvements in blood sugar control may lead to a temporary worsening of diabetic eye disorder.
Danish: • Øjensygdom - Hurtigt forbedret blodsukkerkontrol kan være forbundet med en forbigående forværring af diabetisk øjensygdom.
English: 74.8% of patients treated with Fiasp reached a target HbA1c of < 7% compared to 75.9% of patients treated with NovoRapid.
Danish: 74,8% af de patienter, der blev behandlet med Fiasp, opnåede et target HbA1c på <7% sammenlignet med 75,9% af de patienter, der blev behandlet med NovoRapid.
English: The primary activity of Fiasp is the regulation of glucose metabolism.
Danish: Den primære virkning af Fiasp er en regulering af glucosemetabolismen.
English: • Do not drop your pen or knock it against hard surfaces.
Danish: • Undgå at tabe pennen eller slå den mod hårde overflader.
English: Novo Nordisk A/S Hallas Alle 4400 Kalundborg Denmark
Danish: Novo Nordisk A/S Hallas Allé DK-4400 Kalundborg Danmark
English: Data from two randomised controlled clinical trials conducted with insulin aspart (322 + 27 exposed pregnancies) do not indicate any adverse effect of insulin aspart on pregnancy or on the health of the foetus/new born when compared to soluble human insulin.
Danish: Data fra to randomiserede, kontrollerede kliniske forsøg med insulin aspart (322 + 27 eksponerede graviditeter) viser ingen bivirkninger af insulin aspart under graviditet eller på fosterets/det nyfødte barns helbred sammenlignet med opløseligt humant insulin.
English: In rare cases, the presence of such insulin antibodies may necessitate adjustment of the insulin dose in order to correct a tendency to hyper- or hypoglycaemia.
Danish: I sjældne tilfælde vil tilstedeværelse af insulinantistoffer nødvendiggøre justering af insulindosis for at korrigere en tendens til hyper- eller hypoglykæmi.
English: If you have kidney or liver problems you may need to check your blood sugar level more often.
Danish: Hvis du har nyre- eller leverproblemer, kan det være nødvendigt at kontrollere dit blodsukker oftere.
English: • If you are conscious, treat your low blood sugar immediately with 15-20 g of fast-acting carbohydrate: eat glucose tablets or another high sugar snack, like fruit juice, sweets or biscuits (always carry glucose tablets or a high sugar snack, just in case).
Danish: • Hvis du er ved bevidsthed, skal du straks behandle dit lave blodsukker med 15-20 gram hurtigtvirkende kulhydrat: Spis glucosetabletter (druesukker) eller et andet meget sukkerholdigt produkt, såsom frugtjuice, slik eller kiks (medbring for en sikkerheds skyld altid glucosetabletter eller et meget sukkerholdigt produkt).
English: If you try to put it back on, you may accidentally prick or injure yourself with the needle.
Danish: Hvis du forsøger at sætte den på igen, kan du komme til at stikke eller skade dig selv med nålen.
English: • Once the needle is covered, carefully push the outer needle cap completely on.
Danish: • Når nålen er dækket, skubbes den ydre nålehætte forsigtigt helt på.
English: The duration of action was shorter for Fiasp compared to that of NovoRapid and lasted for 3-5 hours.
Danish: Virkningsvarigheden var kortere for Fiasp end for NovoRapid og varede 3-5 timer.
English: Insulins, including insulin aspart, the active ingredient in Fiasp, exert their specific action through binding to insulin receptors.
Danish: Insuliner, herunder insulin aspart, som er det aktive stof i Fiasp, udøver deres specifikke virkning ved at binde sig til insulinreceptorer.
English: 1 x 3 mL + 7 NovoFine Plus needles 1 x 3 mL + 7 NovoFine needles 1 x 3 mL + 7 NovoTwist needles 5 x 3 mL
Danish: 1 x 3 ml + 7 NovoFine Plus nåle 1 x 3 ml + 7 NovoFine nåle 1 x 3 ml + 7 NovoTwist nåle 5 x 3 ml
English: If it shows 80, at least 80 units are left in your pen.
Danish: Hvis den viser 80, er der mindst 80 enheder tilbage i pennen.
English: Always use this medicine exactly as your doctor has told you.
Danish: Brug altid lægemidlet nøjagtigt efter lægens anvisning.
English: If you drop it or suspect a problem, attach a new needle and check the insulin flow before you inject.
Danish: Hvis du taber pennen eller har mistanke om et problem, skal du sætte en ny nål på og kontrollere insulingennemløbet, før du injicerer.
English: Lipodystrophy (including lipohypertrophy, lipoatrophy) at the injection site was reported more often in this study with paediatric patients compared to studies in adults (see above).
Danish: Lipodystrofi (inklusive lipohypertrofi, lipoatrofi) på injektionsstedet blev i dette studie rapporteret oftere hos pædiatriske patienter sammenlignet med studier hos voksne (se ovenfor).
English: Fiasp is a fast-acting insulin aspart formulation.
Danish: Fiasp er en hurtigtvirkende insulin aspart-formulering.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and toxicity to reproduction after exposure to insulin aspart.
Danish: Prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, toksicitet efter gentagne doser, genotoksicitet samt reproduktionstoksicitet efter eksponering for insulin aspart.
English: Dose adjustment may be considered daily based on self-measured plasma glucose (SMPG) on the previous day(s) according to Table 1.
Danish: Daglig dosisjustering kan overvejes på baggrund af selvmålt plasmaglucose (SMPG) den/de foregående dag(e) i henhold til tabel 1.
English: Patients on basal-bolus treatment who forget a mealtime dose are advised to monitor their blood glucose level to decide if an insulin dose is needed.
Danish: Patienter i basal-bolus-behandling, som glemmer en måltidsdosis, rådes til at monitorere blodglucose for at afgøre, om en insulindosis er nødvendig.
English: Warning signs of low blood sugar - these may come on suddenly:
Danish: Advarselssignaler på for lavt blodsukker - de kan komme pludseligt:
English: • If you are given glucagon you will need sugar or a sugary snack as soon as you come round.
Danish: • Hvis du får glucagon, skal du også have glucose eller et sukkerholdigt produkt at spise, så snart du igen er ved bevidsthed.
English: Now turn over for information on how to use your FlexTouch.
Danish: Vend indlægssedlen for at få oplysninger om, hvordan du bruger din FlexTouch.
English: Never touch the dose counter when you inject.
Danish: Rør aldrig ved dosistælleren, når du injicerer.
English: If the dose counter does not return to 0, the full dose has not been delivered, which may lead to high blood sugar level.
Danish: Hvis dosistælleren ikke vender tilbage til 0, har du ikke fået den fulde dosis, hvilket kan medføre for højt blodsukker.
English: Combination of thiazolidinediones and insulin medicinal products Cases of congestive heart failure have been reported when thiazolidinediones were used in combination with insulin, especially in patients with risk factors for development of congestive heart failure.
Danish: Kombinationsbehandling med thiazolidindioner og insulinpræparater Tilfælde af kongestiv hjerteinsufficiens er blevet rapporteret, når thiazolidindioner har været brugt i kombination med insulin, særligt hos patienter med risikofaktorer for udvikling af kongestiv hjerteinsufficiens.
English: Fiasp can be used for CSII in pumps suitable for insulin infusion and will cover both the bolus insulin requirement (approximately 50%) and basal insulin.
Danish: Fiasp kan gives som CSII i pumper beregnet til insulininfusion og vil dække behovet for både bolusinsulin (cirka 50%) og basal-insulin.
English: In the three controlled clinical studies, 192 of 1,219 (16%) Fiasp treated patients with type 1 diabetes or type 2 diabetes were ≥ 65 years of age and 24 of 1,219 (2%) were ≥ 75 years of age.
Danish: I de tre kontrollerede kliniske studier var 192 af 1.219 (16%) Fiasp-behandlede patienter med type 1diabetes eller type 2-diabetes ≥65 år, og 24 af 1.219 (2%) var ≥75 år.
English: Observed rate of severe or BG confirmed hypoglycaemiaB per patient year of exposure (percentage of patients)
Danish: Observeret hyppighed af alvorlig eller BG-bekræftet hypoglykæmiB pr. patienteksponeringsår (procentdel af patienter)
English: Transferring a patient from another type, brand or manufacturer of insulin to Fiasp must be done under strict medical supervision and may result in the need for a change in dosage.
Danish: Præparatskift hos en patient fra en anden type, et andet mærke eller en anden fabrikant af insulin til Fiasp må kun ske under nøje lægekontrol og kan medføre et behov for ændring af dosis.
English: EXP During use: Use within 4 weeks (including time in a pump reservoir)
Danish: EXP Under brug: Anvendes inden 4 uger (inklusive opbevaringstiden i pumpens beholder)
English: Having low blood sugar can affect your ability to drive or use any tools or machines.
Danish: Hvis dit blodsukker er for lavt, kan det påvirke din evne til at køre bil og arbejde med værktøj eller maskiner.
English: After administration of Fiasp, the fast onset of appearance is maintained regardless of injection site.
Danish: Efter administration af Fiasp indtrådte virkningen hurtigt uanset injektionssted.
English: A 6-week, randomised (2:1), double-blind, parallel-group, active controlled trial evaluated compatibility of Fiasp and NovoRapid administered via CSII system in adult patients with type 1 diabetes.
Danish: Et 6-ugers randomiseret (2:1), dobbeltblindet, parallelgruppe, aktivt kontrolleret forsøg vurderede kompatibiliteten af Fiasp og NovoRapid indgivet via et CSII-system hos voksne patienter med type 1diabetes.
English: This can interrupt the injection.
Danish: Det kan afbryde injektionen.
English: Store below 30°C.
Danish: Opbevares ved temperaturer under 30°C.
English: Tubings in which the inner surface materials are made of polyethylene or polyolefin have been evaluated and found compatible with pump use.
Danish: Slanger, hvis indre overflade er af polyethylen eller polyolefin, er blevet testet og fundet velegnet til anvendelse med en pumpe.
English: Postmeal dosing has not been investigated in patients with type 2 diabetes.
Danish: Administration efter et måltid er ikke blevet undersøgt hos patienter med type 2-diabetes.
English: • Do not expose your pen to dust, dirt or liquid.
Danish: • Udsæt ikke din pen for støv, snavs eller fugt.
English: Therefore, the requirement for patients to self-administer is that they can read the dose scale.
Danish: Derfor er det et krav til patienter, der selv administrerer Fiasp, at de kan aflæse dosisskalaen.
English: • if the insulin does not appear clear (e.g., cloudy) and colourless.
Danish: • Hvis insulinet ikke er klart og farveløst (men f.eks. er uklart).
English: • If 0 does not appear in the dose counter after continuously pressing the dose button, you may have used a blocked or damaged needle.
Danish: • Hvis dosistælleren ikke viser 0, når du bliver ved med at trykke på dosisknappen, har du måske brugt en tilstoppet eller beskadiget nål.
English: Avoidance of accidental mix-ups/medication errors Patients must be instructed to always check the insulin label before each injection to avoid accidental mix-ups between this medicinal product and other insulin medicinal products.
Danish: Forebyggelse af utilsigtet forveksling/medicineringsfejl Patienterne skal instrueres i altid at kontrollere etiketten på insulinet før hver injektion for at undgå utilsigtet forveksling af dette lægemiddel med andre insulinpræparater.
English: Furthermore, Fiasp has been studied in 777 paediatric subjects with type 1 diabetes in a randomised efficacy and safety trial (26 weeks of treatment).
Danish: Derudover er Fiasp blevet undersøgt hos 777 pædiatriske patienter med type 1-diabetes i et randomiseret virknings- og sikkerhedsstudie (26 ugers behandling).
English: If you have symptoms of low blood sugar, take actions immediately to increase your blood sugar level.
Danish: Hvis du har symptomer på for lavt blodsukker, skal du straks sørge for at øge dit blodsukker.
English: • your blood sugar got so low that you passed out
Danish: • dit blodsukker har været så lavt, at du er besvimet
English: Fiasp has been administered to elderly patients for the investigation of pharmacokinetic properties (see section 5.2).
Danish: Fiasp har været administreret til ældre patienter med henblik på undersøgelse af de farmakokinetiske egenskaber (se pkt.
English: Only the dose counter and dose pointer will show how many units you select per dose.
Danish: Kun dosistælleren og dosismarkøren viser, hvor mange enheder du vælger per dosis.
English: • Swelling around your joints - When you first start using your medicine, your body may keep more water than it should.
Danish: • Hævelse omkring leddene - Når du påbegynder behandling med Fiasp, kan kroppen tilbageholde mere vand, end den skal.
English: For intravenous use, it should be used at concentrations from 0.5 unit/mL to 1.0 unit/mL insulin aspart in infusion systems - using polypropylene infusion bags.
Danish: Til intravenøs anvendelse skal det anvendes i koncentrationer fra 0,5 enheder/ml til 1,0 enhed/ml insulin aspart i infusionssystemer - ved brug af polypropyleninfusionsposer.
English: The mean Cmax for a dose of 0.2 units/kg body weight is 298 pmol/L and comparable to NovoRapid.
Danish: Gennemsnitlig Cmax ved en dosis på 0,2 enheder/kg legemsvægt er 298 picomol/l og er sammenlignelig med NovoRapid.
English: Volume of distribution (Vd) after intravenous administration was 0.22 L/kg (e.g., 15.4 L for a 70 kg subject) corresponding to the extracellular fluid volume in the body.
Danish: Fordelingsvolumen (Vd) efter intravenøs administration var 0,22 l/kg (f.eks. 15,4 l for en person på 70 kg) svarende til kroppens ekstracellulære væskevolumen.
English: Hypersensitivity Anaphylactic reactions
Danish: Overfølsomhed Anafylaktiske reaktioner
English: Table 2 Adverse reactions from clinical trials MedDRA System Organ Class
Danish: Tabel 2 Bivirkninger fra kliniske forsøg MedDRAsystemorganklasse
English: • Pain due to nerve damage - If your blood sugar level improves very fast, you may get nerve related pain, this is usually temporary.
Danish: • Smerter på grund af nerveskader - Hvis dit blodsukker forbedres meget hurtigt, kan du få nerverelaterede smerter.
English: If not treated, this could lead to diabetic coma and eventually death.
Danish: Hvis ketoacidose ikke behandles, kan det resultere i diabetisk koma og i værste fald medføre døden.
English: If you stop using your insulin this could lead to a very high blood sugar level (severe hyperglycaemia) and ketoacidosis (a condition with too much acid in the blood which is potentially life-threatening).
Danish: Hvis du holder op med at bruge insulin, kan det føre til et meget højt blodsukker (alvorlig hyperglykæmi) og ketoacidose (en potentielt livstruende tilstand, hvor der er for meget syre i blodet).
English: Omission of a meal or unplanned, strenuous physical exercise may lead to hypoglycaemia.
Danish: Udeladelse af et måltid eller ikke planlagt anstrengende fysisk aktivitet kan medføre hypoglykæmi.
English: The potency of insulin analogues, including Fiasp, is expressed in units.
Danish: Styrken af insulinanaloger, herunder Fiasp, udtrykkes i enheder.
English: You may recover more quickly from passing out with an injection of glucagon.
Danish: Du kan genvinde bevidstheden hurtigere, hvis du får en injektion af glucagon.
English: The effect of gender on the pharmacokinetics of Fiasp was examined in an across-trial analysis of the pharmacokinetic studies.
Danish: Kønnets effekt på de farmakokinetiske egenskaber af Fiasp blev undersøgt i en analyse på tværs af de farmakokinetiske studier.
English: In the paediatric population lipodystrophy was reported with a frequency of 2.1% for Fiasp vs. 1.6% for NovoRapid.
Danish: Lipodystrofi blev hos den pædiatriske population rapporteret med en hyppighed på 2,1% for Fiasp versus 1,6% for NovoRapid.
English: Severe hypoglycaemia may lead to unconsciousness and/or convulsions and may result in temporary or permanent impairment of brain function or even death.
Danish: Svær hypoglykæmi kan medføre bevidstløshed og/eller kramper og kan resultere i midlertidig eller permanent hjerneskade eller i værste fald død.
English: 5 units selected
Danish: 5 enheder valgt
English: Total exposure of Fiasp was lower in children and adolescents compared to adults when dosed with 0.2 units/kg body weight, while the maximum serum insulin aspart concentration was similar between age groups.
Danish: Den totale eksponering af Fiasp var lavere hos børn og unge end hos voksne, når det blev doseret med 0,2 enheder/kg legemsvægt, mens den maksimale serumkoncentration af insulin aspart var den samme for alle aldersgrupper.
English: • Never share your pen or your needles with other people.
Danish: • Du må aldrig dele din pen eller dine nåle med andre.
English: The timing of hypoglycaemia usually reflects the time-action profile of the administered insulin formulation.
Danish: Tidspunktet for hypoglykæmi afspejler som regel tids-/virkningsprofilen for den administrerede insulinformulering.
English: A number of medicinal products are known to interact with the glucose metabolism.
Danish: Et antal lægemidler er kendt for at påvirke glucosemetabolismen.
English: Thiazolidinediones should be discontinued if any deterioration in cardiac symptoms occurs.
Danish: Thiazolidindioner skal seponeres, hvis hjertesymptomerne forværres.
English: The recommended starting dose in insulin naïve patients with type 1 diabetes is approximately 50% of the total daily insulin dose and should be divided between the meals based on the size and composition of the meals.
Danish: Den anbefalede startdosis hos insulinnaive patienter med type 1-diabetes er ca. 50% af den samlede daglige insulindosis, som fordeles på måltiderne ud fra deres størrelse og sammensætning.
English: Fiasp pre-filled pen and needle (example) (FlexTouch)
Danish: Fiasp fyldt pen og nål (eksempel) (FlexTouch)
English: • Keep the needle in your skin after the dose counter has returned to 0 and count slowly to 6.
Danish: • Lad nålen forblive i huden, efter dosistælleren er tilbage på 0, og tæl langsomt til 6.
English: • Never share your pen with other people.
Danish: • Du må aldrig dele din pen med andre.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per dose i.e. essentially ‘sodiumfree'.
Danish: Dette lægemiddel indeholder mindre end 1 mmol natrium (23 mg) per dosis, hvilket betyder, at det stort set er natriumfrit.
English: 24 units selected
Danish: 24 enheder valgt
English: A specific overdose for insulin cannot be defined, however, hypoglycaemia may develop over sequential stages if a patient is dosed with more insulin than required:
Danish: En specifik overdosis af insulin kan ikke defineres, men hypoglykæmi kan udvikles over sekventielle faser, hvis der administreres større doser end svarende til patientens behov:
English: Patients using CSII should be instructed in the use of the pump and use the correct reservoir and tubing for pump (see section 6.6).
Danish: Patienter, som anvender CSII, skal instrueres i brugen af pumpen og skal anvende den korrekte beholder og slange til pumpen (se pkt.
English: They may include cold sweats, cool pale skin, fatigue, nervousness or tremor, anxiousness, unusual tiredness or weakness, confusion, difficulty in concentration, drowsiness, excessive hunger, vision changes, headache, nausea and palpitation (see sections 4.4 and 5.1).
Danish: De kan omfatte koldsved, kold bleg hud, udmattelse, nervøsitet eller tremor, ængstelse, usædvanlig træthed eller svaghed, konfusion, koncentrationsbesvær, døsighed, overdreven sult, synsforstyrrelser, hovedpine, kvalme og palpitationer (se pkt.
English: Turn until it is on tight.
Danish: Drej, indtil nålen sidder fast.
English: Total insulin aspart exposure and maximum concentration following administration of Fiasp was 30% higher in elderly subjects compared to younger adult subjects.
Danish: Den totale eksponering for insulin aspart og den maksimale koncentration efter administration af Fiasp var 30% højere hos ældre end hos yngre voksne.
English: Beta-blocking agents may mask the symptoms of hypoglycaemia.
Danish: Betablokkere kan maskere symptomerne på hypoglykæmi.
English: The use of inadequate doses or discontinuation of treatment, especially in patients requiring insulin, may lead to hyperglycaemia and diabetic ketoacidosis; conditions which are potentially lethal.
Danish: Anvendelse af utilstrækkelige doser eller afbrydelse af behandlingen, navnlig hos patienter, som har behov for insulin, kan medføre hyperglykæmi og diabetisk ketoacidose, som er potentielt dødelige tilstande.
English: Do not store above 30°C.
Danish: Må ikke opbevares ved temperaturer over 30°C.
English: Fiasp administered at mealtime was non-inferior to NovoRapid in reducing HbA1c, and the improvement in HbA1c was statistically significant in favour of Fiasp.
Danish: Fiasp indgivet i forbindelse med et måltid var non-inferiørt i forhold til NovoRapid med hensyn til reduktion af HbA1c, og forbedringen af HbA1c var statistisk signifikant til fordel for Fiasp.
English: Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.
Danish: Du kan finde yderligere oplysninger om dette lægemiddel på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: The treatment effect of Fiasp in achieving glycaemic control was assessed when administered at mealtime or postmeal.
Danish: Behandlingseffekten af Fiasp til opnåelse af glykæmisk kontrol blev vurderet, når det blev indgivet i forbindelse med eller efter et måltid.
English: Fiasp is recommended to be administered subcutaneously in the abdominal wall or the upper arm (see section 5.2).
Danish: Det anbefales, at Fiasp indgives subkutant i abdominalvæggen eller overarmen (se pkt.
English: Baseline  End of trial Adjusted change from baseline Estimated treatment difference
Danish: Baseline  Forsøgsafslutning Justeret ændring fra baseline Estimeret behandlingsforskel