FrancophonIA/ELRC3.0 huggingface dataset:
English: Hypoglycaemia, the most frequent adverse reaction of insulin therapy, may occur if the insulin dose is too high in relation to the insulin requirement.
Danish: Hypoglykæmi, der normalt er den hyppigste bivirkning ved insulinbehandling, opstår, hvis insulindosis er for høj i forhold til insulinbehovet.
English: Side effects where the frequency cannot be estimated from the available data
Danish: Ikke kendte bivirkninger (kan ikke vurderes ud fra tilgængelige data)
English: Caution should be exercised when prescribing to pregnant women.
Danish: Apidra bør bruges med forsigtighed til gravide kvinder.
English: • Eye reactions
Danish: • Påvirkning af synet
English: B. Line up the needle with the pen, and keep it straight as you attach it (screw or push on,
Danish: B. Hold nålen vandret på linie med pennen, når du sætter nålen på (skru eller tryk nålen på afhængig af nåletypen).
English: Apidra should be used at a concentration of 1 Unit/ml insulin glulisine in infusion systems with sodium chloride 9 mg/ml (0.9%) solution for infusion with or without 40 mmol/l potassium chloride using coextruded polyolefin/polyamide plastic infusion bags with a dedicated infusion line.
Danish: Apidra bør anvendes i en koncentration på 1 enhed/ml insulin glulisin i infusionssystemer med natriumchlorid 9 mg/ml (0,9 %) infusionsvæske, med eller uden 40 mmol/l kaliumchlorid, under anvendelse af coextruderet polyolefin/polyamid plastikinfusionsposer med en dedikeret infusionslinie.
English: Limited pharmacokinetic data are available in elderly patients with diabetes mellitus.
Danish: Der foreligger begrænsede farmakokinetiske data vedrørende ældre patienter med diabetes mellitus.
English: Insulin glulisine for intravenous use at a concentration of 1 Unit/ml is stable between 15°C and 25°C for 48 hours (see section 6.6).
Danish: Insulin glulisin til intravenøs anvendelse med en koncentration på 1 enhed/ml er stabilt mellem 15°C og 25°C i 48 timer (se pkt.
English: Other medicines and Apidra
Danish: Brug af anden medicin sammen med Apidra
English: Type 1 diabetes mellitus-Adults
Danish: Type 1 diabetes mellitus-voksne
English: Your doctor may tell you to use it in combination with an intermediate, long-acting insulin, a basal insulin or with tablets used to treat high blood sugar levels.
Danish: Din læge kan eventuelt fortælle dig, at du skal tage det sammen med mellemvirkende eller langtidsvirkende insulin, med basal insulin eller med tabletter til behandling af for højt blodsukker.
English: Generalised allergy to insulin: Associated symptoms may include large-scale skin reactions (rash and itching all over the body), severe swelling of skin or mucous membranes (angioedema), shortness of breath, a fall in blood pressure with rapid heartbeat and sweating.
Danish: Generaliseret allergi over for insulin: Associerede symptomer kan inkludere omfattende hudreaktioner (udslæt og kløe overalt på kroppen), alvorlig hævelse af hud eller slimhinder (angioødem), åndenød, blodtryksfald med hurtig hjerterytme og svedudbrud.
English: Hypoglycaemia (low blood sugar) means that there is not enough sugar in the blood.
Danish: Hypoglykæmi (for lavt blodsukker) betyder, at der ikke er nok sukker i blodet.
English: What should you do if you experience hyperglycaemia?
Danish: Hvad skal du gøre, hvis du får hyperglykæmi?
English: CLINICAL PARTICULARS
Danish: Kliniske studier
English: Insulin glulisine shows low plasma protein binding, similar to human insulin.
Danish: Insulin glulisin har lav plasmaproteinbinding ligesom human insulin.
English: Insulin glulisine takes effect about twice as fast as regular human insulin and completes the glucose lowering effect about 2 hours earlier than regular human insulin.
Danish: Insulin glulisin virker ca. dobbelt så hurtigt som almindelig human insulin og opnår fuld glucosesænkede effekt ca. 2 timer tidligere end regular human insulin.
English: Subcutaneous injection in the abdominal wall ensures a slightly faster absorption than other injection sites (see section 5.2).
Danish: Absorptionen sker lidt hurtigere ved subkutan injektion i abdominalvæggen end ved brug af andre injektionssteder (se pkt.
English: Follow recommended safety measures for removal and disposal of needles (contact your doctor, pharmacist or nurse) in order to reduce the risk of accidental needle injury and transmission of infectious diseases.
Danish: Følg anbefalingerne for sikker fjernelse og bortskaffelse af nåle ( kontakt sundhedspersonalet) med henblik på at reducere risikoen for uheld med nåle og overførsel af smitsomme sygdomme.
English: - The active substance is insulin glulisine.
Danish: - Aktivt stof: insulin glulisin.
English: Serious hypoglycaemia may cause a heart attack or brain damage and may be life-threatening.
Danish: Alvorlig hypoglykæmi kan medføre hjerteanfald eller hjerneskade og kan være livstruende.
English: In an across study analysis of insulin glulisine in either healthy subjects or subjects with type 1 or type 2 diabetes mellitus the apparent half-life ranged from 37 to 75 minutes (interquartile range).
Danish: I en analyse af insulin glulisin til enten raske personer eller patienter med type 1 eller type 2 diabetes mellitus, foretaget på tværs af flere studier, varierede den tilsyneladende halveringstid fra 37 til 75 minutter (interkvartil spændvidde).
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.
Danish: De kan omfatte koldsved, kølig og bleg hud, træthed, nervøsitet eller tremor, ængstelse, usædvanlig træthed eller mathed, konfusion, koncentrationsbesvær, døsighed, overdreven sult, synsforstyrrelser, hovedpine, kvalme og palpitationer.
English: Studies in healthy volunteers and patients with diabetes demonstrated that insulin glulisine is more rapid in onset of action and of shorter duration of action than regular human insulin when given subcutaneously.
Danish: Studier med raske frivillige forsøgspersoner og patienter med diabetes har vist, at insulin glulisin har en hurtigere indsættende virkning og en kortere virkningsvarighed end regular human insulin ved subkutan administration.
English: Follow your doctor's instructions about the basal infusion rate and the mealtime insulin boluses to be taken.
Danish: Følg din læges vejledning om den grundlæggende infusionshastighed, og hvilke ekstra insulindoser du skal have i forbindelse med måltiderne.
English: If SoloStar is in cool storage, it should be taken out 1 to 2 hours before you inject to allow it to warm up.
Danish: Hvis SoloStar opbevares koldt, bør den tages ud 1-2 timer før injektion, for at varme den op til stuetemperatur.
English: This ensures that the full dose of insulin has been injected.
Danish: Dette sikrer, at hele insulindosen injiceres.
English: Insulin glulisine has a more rapid onset of action and a shorter duration of action than regular human insulin.
Danish: Insulin glulisin har en hurtigere indsættende virkning og en kortere virkningsvarighed end regular human insulin.
English: If your blood sugar is too high (hyperglycaemia), you may not have injected enough insulin.
Danish: HYPERGLYKÆMI (for højt blodsukker) Hvis blodsukkeret er for højt (hyperglykæmi), har du måske ikke injiceret nok insulin.
English: How to handle an infusion pump system
Danish: Håndtering af insulinpumpesystem
English: Air bubbles must be removed from the cartridge before injection (see instruction for using pen).
Danish: Eventuelle luftbobler skal fjernes fra cylinderampullen før injektionen (se brugsanvisningen for pennen).
English: Glucose must also be given intravenously, if the patient does not respond to glucagon within 10 to 15 minutes.
Danish: Hvis patienten ikke responderer på glucagon inden for 10-15 minutter, skal der altid gives glucose intravenøst.
English: This can quickly cause you to have high blood sugar and diabetic ketoacidosis (build-up of acid in the blood because the body is breaking down fat instead of sugar).
Danish: Dette kan hurtigt medføre, at du får højt blodsukker og diabetisk ketoacidose (ophobning af syre i blodet, da kroppen nedbryder fedt i stedet for sukker).
English: GLULISINE - pre REGULAR - pre
Danish: GLULISINE - før REGULAR - før
English: In addition, under the influence of sympatholytic medicinal products such as beta-blockers, clonidine, guanethidine and reserpine, the signs of adrenergic counter-regulation may be reduced or absent.
Danish: Under behandling med sympatolytika som f.eks. beta-blokkere, clonidin, guanethidin og reserpin kan symptomerne på adrenerg modregulation desuden være reduceret eller helt udeblive.
English: Read carefully all of this leaflet including the Instructions for Use of Apidra SoloStar, pre-filled pen, before using this medicine because it contains important information for you.
Danish: Læs denne indlægsseddel og brugsanvisningen for Apidra SoloStar, fyldt pen, grundigt, inden du begynder at tage dette lægemiddel.
English: Check if insulin comes out of the needle tip.
Danish: Kontroller om der kommer insulin ud af nålespidsen.
English: Hyperglycaemia can cause diabetic ketoacidosis (build-up of acid in the blood because the body is breaking down fat instead of sugar).
Danish: Hyperglykæmi kan forårsage diabetisk ketoacidose (ophobning af syre i blodet, da kroppen nedbryder fedt i stedet for sukker).
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 Apidra 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: Please check the reverse (insulin) side of this leaflet for instructions on how to store SoloStar.
Danish: Læs venligst den modsatte side af denne indlægsseddel vedrørende opbevaring af SoloStar.
English: Thirst, increased need to urinate, tiredness, dry skin, reddening of the face, loss of appetite, low blood pressure, fast heart beat and glucose and ketone bodies in urine.
Danish: Tørst, øget vandladning, træthed, tør hud, ansigtsrødme, nedsat appetit, lavt blodtryk, hurtig puls og glucose og ketonstoffer i urinen.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 27 September 2004
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN
English: Pentamidine (used to treat some infections caused by parasites) may cause hypoglycaemia which may sometimes be followed by hyperglycaemia.
Danish: Pentamidin (anvendes til behandling af infektion forårsaget af parasitter) kan medføre for lavt blodsukker (hypoglykæmi), der undertiden kan efterfølges af for højt blodsukker (hyperglykæmi).
English: Hypoglycaemia is a very commonly reported side effect (may affect more than 1 on 10 people).
Danish: Hypoglykæmi er en meget almindelig bivirkning (forekommer hos flere end 1 ud af 10 patienter).
English: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products except NPH human insulin.
Danish: Da der ikke foreligger studier over eventuelle uforligeligheder, må dette lægemiddel ikke blandes med andre lægemidler end NPH human insulin.
English: When compared with soluble human insulin, if hypoglycaemia occurs after an injection with rapid acting analogues, it may occur earlier.
Danish: Hvis hypoglykæmi forekommer efter en injektion med hurtigtvirkende analoger, kan det forekomme tidligere sammenlignet med opløseligt human insulin.
English: Apidra 100 Units/ml solution for injection in a vial: Most of the cases were related to handling errors or pump system failure when Apidra was used with CSII.
Danish: (1) Apidra 100 enheder/ml injektionsvæske, opløsning, i et hætteglas: De fleste tilfælde var relateret til håndteringsfejl eller pumpesvigt, når Apidra blev givet som CSII.
English: To prevent any kind of contamination, the reusable pen should be used only by you.
Danish: For at undgå enhver form for forurening bør den genanvendelige pen kun benyttes af dig.
English: Hypoglycaemia (low blood sugar) can be very serious.
Danish: Alvorlige bivirkninger Hypoglykæmi (for lavt blodsukker) kan blive meget alvorlig.
English: Beta-blockers like other sympatholytic medicines (such as clonidine, guanethidine and reserpine) may weaken or suppress entirely the first warning symptoms which help you to recognise a hypoglycaemia.
Danish: Betablokkere og andre sympatikolytiske lægemidler (som f.eks. clonidin, guanethidin og reserpin) kan endvidere svække eller helt undertrykke de første advarselssymptomer på for lavt blodsukker (hypoglykæmi).
English: The glucose-lowering activities of insulin glulisine and regular human insulin are equipotent when administered by intravenous route.
Danish: Den glucosesænkende effekt af insulin glulisin og regular human insulin er ækvipotent ved intravenøs administration.
English: SoloStar is a pre-filled disposable pen containing insulin glulisine.
Danish: SoloStar er en fyldt engangspen, der indeholder insulin glulisin.
English: Apidra should be used in regimens that include an intermediate or long acting insulin or basal insulin analogue and can be used with oral hypoglycaemic agents.
Danish: Apidra kan bruges som led i behandlinger, der omfatter et mellemvirkende eller langtidsvirkende insulin eller en basal insulinanalog og kan bruges sammen med orale antidiabetika.
English: Do not put SoloStar next to the freezer compartment or a freezer pack.
Danish: SoloStar må ikke placeres op ad køleskabets køleelementer eller oven på fryseelementer.
English: Read and follow the instructions that come with your insulin infusion pump.
Danish: Læs og følg brugsanvisningen, der følger med pumpesystemet.
English: Apidra must not be mixed with any preparation other than NPH human insulin.
Danish: Apidra må ikke blandes med andre lægemidler end NPH human insulin.
English: In a study with 18 male subjects with diabetes mellitus type 1 aged 21 to 50 years, insulin glulisine displayed dose-proportional glucose lowering effect in the therapeutic relevant dose range 0.075 to 0.15 Units/kg, and less than proportional increase in glucose lowering effect with 0.3 Units/kg or higher, like human insulin.
Danish: I et studie med 18 mandlige patienter mellem 21 og 50 år med type 1 diabetes mellitus viste insulin glulisin proportional glucosesænkende effekt i de terapeutisk relevante doser fra 0,075 til 0,15 enheder/kg og mindre end proportional forøgelse i glucosesænkende effekt ved 0,3 enheder/kg eller højere ligesom human insulin.
English: In a study with 18 male subjects with diabetes mellitus type 1, aged 21 to 50 years, insulin glulisine displays dose-proportionality for early, maximum and total exposure in the dose range 0.075 to 0.4 Units/kg.
Danish: I et studie med 18 mandlige personer med type 1 diabetes mellitus mellem 21 og 50 år viste insulin glulisin dosisproportionalitet ved tidlig, maksimal og total indvirkning i doser fra 0,075 til 0,4 enheder/kg.
English: Insulin glulisine is a recombinant human insulin analogue that is equipotent to regular human insulin.
Danish: Insulin glulisin er en rekombinant human insulinanalog, der er ækvipotent med regular human insulin.
English: The Apidra cartridges are to be used only with the pens: ClikSTAR, Tactipen, Autopen 24, AllStar, AllStar PRO, JuniorSTAR.
Danish: Apidra cylinderampullerne må kun anvendes med pennene: ClikSTAR, Tactipen, Autopen 24, AllStar, AllStar PRO, JuniorSTAR.
English: • If your injection is given by another person, special caution must be taken by this person to avoid accidental needle injury and transmission of infection.
Danish: • Hvis en anden person giver dig injektionen, skal vedkommende være særlig opmærksom for af undgå skader fra nålen og overførsel af infektioner.
English: One unit of insulin glulisine has the same glucose-lowering activity as one unit of regular human insulin.
Danish: En enhed insulin glulisin har samme glucosesænkende effekt som en enhed regular human insulin.
English: Insulin glulisine given 2 minutes (GLULISINE pre) before the start of a meal compared to regular human insulin given 30 minutes (REGULAR 30 min) before the start of the meal (figure 1A) and compared to regular human insulin given 2 minutes (REGULAR pre) before a meal (figure 1B).
Danish: Insulin glulisin givet 2 minutter (GLULISINE pre) før start på et måltid sammenlignet med regular human insulin givet 30 minutter (REGULAR 30 min) før start på måltidet (figur 1A) og sammenlignet med regular human insulin givet 2 minutter (REGULAR pre) før et måltid (figur 1B).
English: Substances that may enhance the blood-glucose-lowering activity and increase susceptibility to hypoglycaemia include oral antidiabetic medicinal products, angiotensin converting enzyme (ACE) inhibitors, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors (MAOIs), pentoxifylline, propoxyphene, salicylates and sulphonamide antibiotics.
Danish: Stoffer, der kan øge den blodglucosesænkende effekt og øge følsomheden for hypoglykæmi, omfatter orale antidiabetika, angiotensin converting enzym-hæmmere (ACE-hæmmere), disopyramid, fibrater, fluoxetin, monoaminooxidasehæmmere (MAO-hæmmere), pentoxifyllin, propoxyphen, salicylater og antibiotika tilhørende sulfonamiderne.
English: Another phase I study with insulin glulisine and insulin lispro in a non-diabetic population in 80 subjects with a wide range of body mass indices (18-46 kg/m²) has demonstrated that rapid absorption and total exposure is generally maintained across a wide range of body mass indices.
Danish: Et andet fase I studie med insulin glulisin og insulin lispro med 80 personer uden diabetes og med store forskelle i body mass indeks (18 til 46 kg/m2) viste, at hurtig absorption og total påvirkning generelt opretholdes over et bredt område i body mass indeks.
English: When insulin glulisine was injected subcutaneously into abdomen, deltoid and thigh, the concentration-time profiles were similar with a slightly faster absorption when administered in the abdomen compared to the thigh.
Danish: Koncentration-tid-profilerne var ækvipotente, når insulin glulisin blev injiceret subkutant i abdomen, overarmen og låret med en lidt hurtigere absorption ved administration i abdomen sammenlignet med administration i låret.
English: These cartridges should not be used with any other reusable pen as the dosing accuracy has only been established with the listed pens (see section 4.2 and 6.6).
Danish: Disse cylinderampuller må ikke bruges sammen med andre former for flergangspenne, da dosisnøjagtighed kun er vist med ovenstående penne (se pkt.
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 and loss of consciousness.
Danish: Eksempler på symptomer på lavt blodsukker i hjernen er: Hovedpine, udtalt sultfornemmelse, kvalme, opkastning, træthed, søvnighed, søvnforstyrrelser, rastløshed, aggressiv adfærd, koncentrationsbesvær, nedsat reaktionsevne, depression, konfusion, taleforstyrrelser (til tider fuldstændigt tab af talens brug), synsforstyrrelser, skælven, lammelser, prikkende og stikkende fornemmelse (paræstesi), følelsesløshed og prikken og stikken omkring munden, svimmelhed, manglende selvbeherskelse, hjælpeløshed, kramper og bevidstløshed.
English: A phase I study in patients with type 1 diabetes mellitus assessed the glucose lowering profiles of insulin glulisine and regular human insulin administered subcutaneously at a dose of 0.15 Units/kg, at different times in relation to a 15-minute standard meal.
Danish: I et fase I studie med patienter med type 1 diabetes mellitus undersøgtes profilerne for den glucosesænkende effekt af insulin glulisin og regular human insulin givet subkutant i en dosis på 0,15 enheder/kg på forskellige tidspunkter i forhold til et 15 minutters standardmåltid.
English: A 26-week phase III clinical study followed by a 26-week extension safety study was conducted to compare insulin glulisine (0-15 minutes before a meal) with regular human insulin (30-45 minutes before a meal) injected subcutaneously in patients with type 2 diabetes mellitus also using NPH insulin as basal insulin.
Danish: Et 26 ugers fase III klinisk studie efterfulgt af et 26 ugers forlængelsesstudie vedrørende sikkerhed blev udført for at sammenligne insulin glulisin (0-15 minutter før et måltid) med regular human insulin (30-45 minutter før et måltid) injiceret subkutant hos patienter med type 2 diabetes mellitus, som også brugte NPH insulin som basal insulin.
English: The pharmacokinetic properties of insulin glulisine have not been investigated in patients with decreased liver function.
Danish: Insulin glulisins farmakokinetiske egenskaber er ikke undersøgt hos patienter med nedsat leverfunktion.
English: When used with an insulin infusion pump, Apidra must not be mixed with other medicinal products.
Danish: Hvis Apidra gives via en insulin-infusionspumpe, må Apidra ikke blandes med andre lægemidler.
English: Each pen contains 3 ml solution, equivalent to 300 Units.
Danish: Hver pen indeholder 3 ml opløsning, svarende til 300 enheder.
English: You may need to talk about - the availability of your insulin in the country you are visiting, - supplies of insulin, injection syringes etc, - correct storage of your insulin while travelling, - timing of meals and insulin administration while travelling, - the possible effects of changing to different time zones, - possible new health risks in the countries to be visited, - what you should do in emergency situations when you feel unwell or become ill.
Danish: Tal med din læge, inden du skal ud at rejse, om: - muligheden for at købe din insulin i det land, som du skal besøge, - forsyninger af insulin, sprøjter etc., - korrekt opbevaring af din insulin under rejsen, - tidspunkter for måltider og injektion af insulin under rejsen, - mulige påvirkninger ved at skifte til andre tidszoner, - eventuelle nye sundhedsrisici i de lande, som du skal besøge.
English: Apidra in a pre-filled pen is only suitable for injecting just under the skin.
Danish: Apidra i fyldte penne er kun egnet til indsprøjtning lige under huden.
English: However, insulin requirements may be reduced in the presence of renal impairment (see section 5.2).
Danish: Insulinbehovet kan dog være reduceret ved nedsat nyrefunktion (se pkt.
English: - The other ingredients are: metacresol (see section 2 under “Apidra contains metacresol”), sodium chloride (see section 2 under “Important information about some of the ingredients of Apidra”), trometamol, polysorbate 20, concentrated hydrochloric acid, sodium hydroxide, water for injections.
Danish: - Øvrige indholdsstoffer: metacresol (se afsnit 2 under ”Apidra indeholder metacresol”), natriumchlorid (se afsnit 2 ”Vigtig information om nogen af de øvrige indholdsstoffer i Apidra”), trometamol, polysorbat 20, koncentreret saltsyre, natriumhydroxid, vand til injektionsvæsker.
English: Your blood sugar level may either rise or fall if you take: - beta-blockers (used to treat high blood pressure), - clonidine (used to treat high blood pressure), - lithium salts (used to treat psychiatric disorders).
Danish: Blodsukkeret kan enten stige eller falde, hvis du tager: - betablokkere (anvendes til behandling af højt blodtryk), - clonidin (anvendes til behandling af højt blodtryk), - lithiumsalte (anvendes til behandling af psykiske sygdomme).
English: Apidra in a pre-filled pen is only suitable for injecting just under the skin (see also section 3).
Danish: Apidra i fyldte penne er kun egnet til indsprøjtning lige under huden (se også punkt 3).