FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients using continuous subcutaneous insulin infusion pump therapy must be trained to administer insulin by injection and have alternative insulin delivery system available in case of pump system failure (see section 4.2 and 4.8).
Danish: Patienter, der får insulin som kontinuerlig subkutan infusion, skal være trænet i at administrere insulin som injektion og have et alternativt insulin-device tilgængeligt i tilfælde af pumpesvigt (se pkt.
English: Carry some information with you to show you are a person with diabetes.
Danish: Du bør altid have et kort eller lignende på dig, hvoraf det fremgår, at du har diabetes.
English: You may need to talk about - the availability of your insulin in the country you are visiting, - supplies of insulin, needles, 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, nåle 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: Comparable self-monitored blood glucose values were observed.
Danish: Blodglucoseværdier målt af patienterne selv var af samme størrelsesorden.
English: SPECIAL STORAGE CONDITIONS
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Uåbnet
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 action is generally maintained across a wide range of body mass indices (BMI), while total glucose lowering effect decreases with increasing obesity.
Danish: Et andet fase I studie med insulin glulisin og insulin lispro med 80 personer uden diabetes og med store forskelle i body mass index (18 til 46 kg/m2) har vist, at hurtig effekt generelt bevares trods store forskelle i body mass index (BMI), mens den totale glucosesænkende effekt bliver mindre ved forøget overvægt.
English: Based on your life-style and the results of your blood sugar (glucose) tests and your previous insulin usage, your doctor will determine how much Apidra you will need.
Danish: Din læge bestemmer hvor meget Apidra du har behov for på grundlag af din livsstil, resultaterne af dine blodsukkermålinger (glucose) og dit tidligere insulinforbrug.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PEN LABEL (pre-filled pen SoloStar)
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER PEN ETIKET (fyldt pen SoloStar)
English: However, insulin requirements may be reduced in the presence of renal impairment.
Danish: Insulinbehovet kan dog være reduceret ved nedsat nyrefunktion.
English: The product may be stored for a maximum of 4 weeks below 25°C away from direct heat or direct light.
Danish: Lægemidlet kan opbevares i maksimalt 4 uger under 25°C, væk fra direkte varme eller direkte lys.
English: A phase I study in 18 obese patients with type 2 diabetes mellitus (BMI between 35 and 40 kg/m2) with insulin glulisine and insulin lispro [90% CI: 0.81, 0.95 (p=<0.01)] has shown that insulin glulisine effectively controls diurnal postprandial blood glucose excursions.
Danish: 40 kg/m2) med insulin glulisin og insulin lispro [90 % CI: 0,81, 0,95 (p=<0,01)] har vist, at insulin glulisin effektivt kontrollerer døgnets postprandiale blodglucoseudsving.
English: Apidra is a short-acting insulin.
Danish: Apidra er et hurtigtvirkende insulinpræparat.
English: To ensure that you read the dose correctly, hold the pen horizontally, with the needle on the left and the dosage selector to the right as shown in the illustrations below.
Danish: Hold pennen vandret med nålen til venstre og dosis skalaen til højre, som vist på tegningen nedenfor, så du er sikker på at du aflæser dosis korrekt.
English: Your doctor has decided that SoloStar is appropriate for you based on your ability to handle SoloStar.
Danish: Sundhedspersonalet har besluttet, at SoloStar er den rigtige pen for dig.
English: When administered as a subcutaneous injection, Apidra must not be mixed with other medicinal products except NPH human insulin.
Danish: Når Apidra administreres som subkutan injektion, må det ikke blandes med andre lægemidler end NPH human insulin.
English: Apidra SoloStar 100 Units/ml solution for injection in a pre-filled pen EU/1/04/285/029-036
Danish: Apidra SoloStar 100 enheder/ml injektionsvæske, opløsning, i en fyldt pen EU/1/04/285/029-036
English: Administered immediately before a test meal, insulin glulisine provided better postprandial control than regular human insulin, as in adults (see section 5.1).
Danish: Ved indgivelse lige før et testmåltid gav insulin glulisin en bedre postprandial kontrol end regular human insulin, lige som hos voksne (se pkt.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (10 ml vial)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDERKARTON (10 ml hætteglas)
English: Each vial contains 10 ml solution (1000 Units).
Danish: Hvert hætteglas indeholder 10 ml opløsning (1.000 enheder).
English: Inspect the vial before use.
Danish: Undersøg hætteglasset før brug.
English: Apidra should be administered subcutaneously in the abdominal wall, thigh or deltoid or by continuous infusion in the abdominal wall.
Danish: Apidra bør gives subkutant i abdominalvæggen, låret eller overarmen eller som kontinuerlig infusion i abdominalvæggen.
English: Apidra vials are for use with insulin syringes with the corresponding unit scale and for use with an insulin pump system.
Danish: Apidra hætteglas skal bruges sammen med insulinsprøjter med en passende enhedsskala eller gives via et insulinpumpesystem.
English: Insulin label must always be checked before each injection to avoid medication errors between insulin glulisine and other insulins.
Danish: Etiketten på insulinet skal altid kontrolleres før hver injektion for at undgå forveksling af insulin glulisin og andre insuliner.
English: It is a clear, colourless, aqueous solution with no particles visible.
Danish: Det er en klar, farveløs vandig opløsning uden synlige partikler.
English: Insulin label must always be checked before each injection to avoid medication errors between insulin glulisine and other insulins (see section 4.4).
Danish: Etiketten på insulinet skal altid kontrolleres før hver injektion for at undgå forveksling mellem insulin glulisin og andre insuliner (se pkt.
English: - If you have missed a dose of Apidra or if you have not injected enough insulin, your blood sugar level may become too high (hyperglycaemia).
Danish: Hvis du har glemt at tage Apidra - Hvis du har glemt at tage en dosis Apidra, eller hvis du ikke har injiceret nok insulin, kan blodsukkeret blive for højt (hyperglykæmi).
English: Apidra in cartridges is only suitable for injecting just under the skin using a reusable pen.
Danish: Apidra i cylinderampuller er kun egnet til indsprøjtning lige under huden ved hjælp af en genanvendelig pen.
English: In a 26-week phase III clinical study comparing insulin glulisine with insulin lispro both injected subcutaneously shortly (0-15 minutes) before a meal in patients with type 1 diabetes mellitus using insulin glargine as basal insulin, insulin glulisine was comparable to insulin lispro for glycaemic control as reflected by changes in glycated haemoglobin (expressed as HbA1c equivalent) from baseline to endpoint.
Danish: I et 26 ugers fase III klinisk studie med sammenligning af insulin glulisin og insulin lispro, begge injiceret subkutant kort tid (0-15 minutter) før et måltid, til patienter med type 1 diabetes mellitus, som brugte insulin glargin som basal insulin, kunne insulin glulisin sidestilles med insulin lispro med hensyn til glykæmisk kontrol afspejlet ved ændringer i glykosyleret hæmoglobin (udtrykt som HbA1c ækvivalent) fra baseline til endepunktet.
English: Apidra in cartridges is only suitable for injecting just under the skin using a reusable pen (see also section 3).
Danish: Apidra i cylinderampuller er kun egnet til indsprøjtning lige under huden ved hjælp af en genanvendelig pen (se også punkt 3).
English: In a study in patients with type 1 diabetes mellitus after subcutaneous administration of 0.15 Units/kg, for insulin glulisine the Tmax was 55 minutes and Cmax was 82 ± 1.3 µUnits/ml compared to a Tmax of 82 minutes and a Cmax of 46 ± 1.3 µUnits/ml for regular human insulin.
Danish: I et studie med patienter med type 1 diabetes mellitus var Tmax 55 minutter og Cmax 82 ± 1,3 µenheder/ml for insulin glulisin sammenlignet med en Tmax på 82 minutter og en Cmax på 46 ± 1,3 µ enheder/ml for regular human insulin efter subkutan administration af 0,15 enheder/kg.
English: INFORMATION IN BRAILLE Apidra SoloStar
Danish: Apidra SoloStar
English: This could lead to severe hyperglycaemia (very high blood sugar) and ketoacidosis (build-up of acid in the blood because the body is breaking down fat instead of sugar).
Danish: Dette kan medføre alvorlig hyperglykæmi (meget forhøjet blodsukker) og syreophobning i blodet, fordi kroppen nedbryder fedt i stedet for sukker (ketoacidose).
English: The product may be stored for a maximum of 4 weeks below 25°C.
Danish: Lægemidlet kan opbevares i maksimalt 4 uger under 25°C.
English: You must always check the insulin label before each injection to avoid mix-ups between Apidra and other insulins.
Danish: Husk altid at kontrollere etiketten på din insulin inden injektion for at undgå medicinforveksling mellem Apidra og andre insuliner.
English: A 12-week phase III clinical study performed in patients with type 1 diabetes mellitus receiving insulin glargine as basal therapy indicate that the immediate post-meal administration of insulin glulisine provides efficacy that was comparable to immediate pre-meal insulin glulisine (0-15 minutes) or regular insulin (30-45 minutes).
Danish: Et 12 ugers fase III klinisk studie med patienter med type 1 diabetes mellitus, som fik insulin glargin som basal behandling, tyder på, at indgivelse af insulin glulisin umiddelbart efter et måltid giver en effekt, der kan sidestilles med effekten af insulin glulisin (0-15 minutter) eller regular insulin (30-45 minutter) givet umiddelbart før et måltid.
English: In a clinical study performed in non-diabetic subjects covering a wide range of renal function (CrCl >80 ml/min, 30-50 ml/min, <30 ml/min), the rapid-acting properties of insulin glulisine were generally maintained.
Danish: (CrCl > 80 ml/min, 30-50 ml/min, < 30 ml/min) blev de hurtigtvirkende egenskaber for insulin glulisin som hovedregel bevaret.
English: Insulin glulisine given 15 minutes (GLULISINE post) after start of a meal compared to regular human insulin given 2 minutes (REGULAR pre) before start of the meal (figure 1C).
Danish: Insulin glulisin givet 15 minutter (GLULISINE post) efter start på et måltid sammenlignet med regular human insulin givet 2 minutter (REGULAR pre) før start på måltidet (figur 1C).
English: Hepatic impairment The pharmacokinetic properties have not been investigated in patients with impaired liver function.
Danish: De farmakokinetiske egenskaber er ikke undersøgt hos patienter med nedsat leverfunktion.
English: Absorption from deltoid sites was in-between (see section 4.2).
Danish: Absorptionen fra overarmen lå derimellem (se pkt.
English: METHOD OF ADMINISTRATION Use specific pens: see leaflet.
Danish: Brug bestemte penne: se indlægssedlen.
English: Substances that may reduce the blood-glucose-lowering activity include corticosteroids, danazol, diazoxide, diuretics, glucagon, isoniazid, phenothiazine derivatives, somatropin, sympathomimetic medicinal products (e.g. epinephrine [adrenaline], salbutamol, terbutaline), thyroid hormones, oestrogens, progestins (e.g. in oral contraceptives), protease inhibitors and atypical antipsychotic medicinal products (e.g. olanzapine and clozapine).
Danish: Stoffer, der kan nedsætte den blodglucosesænkende effekt, omfatter kortikosteroider, danazol, diazoxid, diuretika, glucagon, isoniazid, phenothiazinderivater, somatropin, sympatomimetika (f.eks. adrenalin, salbutamol, terbutalin), thyreoideahormoner, østrogener, gestagener (f.eks. i orale kontraceptiva), proteasehæmmere og atypiske antipsykotika (f.eks. olanzapin og clozapin).
English: Data indicated that insulin glulisine administered 2 minutes before the meal gives similar postprandial glycaemic control compared to regular human insulin given 30 minutes before the meal.
Danish: Data tydede på, at insulin glulisin givet 2 minutter før måltidet giver samme postprandiale glykæmiske kontrol som regular human insulin givet 30 minutter før måltidet.
English: The patient should be advised to read the instructions for use included in the package leaflet carefully before using SoloStar.
Danish: Brugsanvisningen i indlægssedlen skal læses omhyggeligt, før SoloStar anvendes.
English: In a study in patients with type 2 diabetes mellitus after subcutaneous administration of 0.2 Units/kg insulin glulisine, the Cmax was 91 µUnits/ml with the interquartile range from 78 to 104 µUnits/ml.
Danish: I et studie med patienter med type 2 diabetes mellitus var Cmax 91 µ-enheder/ml med en interkvartil spændvidde fra 78 til 104 µ-enheder/ml efter subkutan administration af 0,2 enheder/kg insulin glulisin.
English: Insulin reservoir
Danish: Insuinbeholder
English: - If you have injected too much Apidra, your blood sugar level may become too low (hypoglycaemia).
Danish: - Hvis du har taget for meget Apidra, kan dit blodsukker blive for lavt (hypoglykæmi).
English: A. Use the injection method as instructed by your doctor, pharmacist or nurse.
Danish: A. Anvend den injektionsteknik du er blevet instrueret i af sundhedspersonalet.
English: What you need to know before you use Apidra
Danish: Det skal du vide, før du begynder at tage Apidra Tag ikke Apidra:
English: Each cartridge contains 3 ml solution (300 Units).
Danish: Hver cylinderampul indeholder 3 ml opløsning (300 enheder).
English: Always use this medicine exactly as your doctor has told you.
Danish: Brug altid dette lægemiddel nøjagtigt efter lægens eller apotekspersonalets anvisning.
English: Check the insulin A. Check the label on your SoloStar to make sure you have the correct insulin.
Danish: A. Etiketten på din SoloStar skal kontrolleres for at sikre den indeholder den korrekte insulin.
English: Non-clinical data did not reveal toxicity findings others than those linked to the blood glucose lowering pharmacodynamic activity (hypoglycaemia), different from regular human insulin or of clinical relevance for humans.
Danish: Bortset fra toksicitet forbundet med den blodglucosesænkende farmakodynamiske effekt (hypoglykæmi) påviste ikke-kliniske sikkerhedsdata ikke andre former for toksicitet, end der ses ved behandling med regular human insulin.
English: To prevent any kind of contamination, the re-usable pen should be used by a single patient only.
Danish: For at undgå nogen form for kontaminering må den genanvendelige pen kun anvendes af den samme patient.
English: Insulin glulisine administered 15 minutes after starting the meal gives similar glycaemic control as regular human insulin given 2 minutes before the meal (see figure 1).
Danish: Insulin glulisin givet 15 minutter efter start på måltidet giver samme glykæmiske kontrol som regular human insulin givet 2 minutter før måltidet (se figur 1).
English: Patients administering Apidra by CSII must have an alternative insulin delivery system available in case of pump system failure (see section 4.4 and 4.8).
Danish: Patienter, der får Apidra vha. CSII, skal have et alternativt insulin-device tilgængeligt i tilfælde af pumpesvigt (se pkt.
English: The Apidra cartridges are to be used only in conjunction with the pens: ClikSTAR, Autopen 24, Tactipen, AllStar, AllStar PRO or JuniorSTAR (see section 4.2 and 4.4).
Danish: Apidra cylinderampullerne må kun anvendes i forbindelse med pennene: ClikSTAR, Autopen 24, Tactipen, AllStar, AllStar PRO eller JuniorSTAR (se pkt.
English: Do not use this medicine if it does not appear clear and colourless.
Danish: Anvend den kun hvis den er klar og farveløs.
English: The pen in use must not be stored in a refrigerator.
Danish: Ibrugtagne penne må ikke opbevares i køleskab.
English: Apidra 100 Units/ml solution for injection in a vial is a clear, colourless, aqueous solution with no particles visible.
Danish: Apidra 100 enheder/ml injektionsvæske, opløsning i et hætteglas er en klar, farveløs, vandig opløsning uden synlige partikler.
English: Packs of 1, 2, 4 and 5 vials are available.
Danish: Findes i pakninger med 1, 2, 4 og 5 hætteglas.
English: Apidra can be injected in the abdominal wall, the thigh or upper arm or by continuous infusion in the abdominal wall.
Danish: Apidra kan injiceres i maveskindet, i låret eller i overarmen eller ved en løbende injektion i maveskindet.
English: The pharmacokinetic properties of insulin glulisine are generally maintained in patients with renal impairment.
Danish: Som hovedregel bevares insulin glulisins farmakokinetiske egenskaber hos patienter med nedsat nyrefunktion.
English: Do not put Apidra next to the freezer compartment or a freezer pack.
Danish: Apidra må ikke komme i direkte berøring med frostboks eller fryseelementer.
English: Each ml of the solution contains 100 Units of insulin glulisine (equivalent to 3.49 mg).
Danish: Hver ml indeholder 100 enheder insulin glulisin (svarende til 3,49 mg).
English: Injection site reactions Local hypersensitivity reactions
Danish: Lokale overfølsomhedsreaktioner
English: Packs of 1, 3, 4, 5, 6, 8, 9 and 10 pens are available.
Danish: Findes i pakninger med 1, 3, 4, 5, 6, 8, 9 og 10 penne.
English: When used with a subcutaneous insulin infusion pump, Apidra must not be mixed with diluents or any other insulin.
Danish: Hvis Apidra gives via en subkutan insulin-infusionspumpe, må det ikke fortyndes, og det må ikke blandes med andre insuliner.
English: When given 2 minutes prior to meal, insulin glulisine provided better postprandial control than regular human insulin given 2 minutes before the meal.
Danish: Insulin glulisin givet 2 minutter før måltidet gav en bedre postprandial kontrol end regular human insulin givet 2 minutter før måltidet.
English: Only use needles that are compatible for use with SoloStar.
Danish: Anvend kun nåle som er kompatible til anvendelse med SoloStar
English: Apidra 100 Units/ml solution for injection in a cartridge EU/1/04/285/005-012
Danish: Apidra 100 enheder/ml injektionsvæske, opløsning, i en cylinderampul EU/1/04/285/005-012
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (PRE-FILLED PEN for SoloStar)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDERKARTON (fyldt pen SoloStar)
English: 5 vials of 10ml.
Danish: 5 hætteglas á 10 ml.
English: Refer to them before using your medicine.
Danish: Læs begge informationer igennem, inden du tager din medicin.
English: Once in use, the vial may be stored for a maximum of 4 weeks in the outer carton below 25°C away from direct heat or direct light.
Danish: Når hætteglasset er anbrudt, kan det opbevares i maksimalt 4 uger i den ydre karton under 25°C, væk fra direkte varme eller direkte lys.
English: It must only be used if the solution is clear, colourless, with no solid particles visible, and if it is of water-like consistency.
Danish: Den må kun anvendes, hvis opløsningen er klar, farveløs, uden synlige faste partikler og ligner vand.
English: Hypoglycaemia is also more likely to occur if: - you have just begun insulin treatment or changed to another insulin preparation, - your blood sugar levels are almost normal or are unstable, - you change the area of skin where you inject insulin (for example from the thigh to the upper arm), - you suffer from severe kidney or liver disease, or some other disease such as hypothyroidism.
Danish: - du lige er begyndt med insulinbehandling eller har skiftet til et andet insulinpræparat, - dit blodsukker er næsten normalt eller er ustabilt, - du skifter injektionssted fra ét hudområde på kroppen til et andet (f.eks. fra låret til overarmen),
English: Careful control of your diabetes, and prevention of hypoglycaemia, is important for the health of your baby.
Danish: Det er vigtigt for dit barns sundhed, at din diabetes kontrolleres omhyggeligt, og at du undgår at få for lavt blodsukker (hypoglykæmi).
English: The pen cap should be replaced on the pen.
Danish: Penhætten sættes på pennen igen.
English: After its first use, the product may be stored for a maximum of 4 weeks below 25°C.
Danish: Efter anbrud kan produktet opbevares i maksimalt 4 uger under 25 °C.
English: Medicines that may cause your blood sugar level to fall (hypoglycaemia) include: - all other medicines to treat diabetes, - angiotensin converting enzyme (ACE) inhibitors (used to treat certain heart conditions or high blood pressure), - disopyramide (used to treat certain heart conditions), - fluoxetine (used to treat depression), - fibrates (used to lower high levels of blood lipids), - monoamine oxidase (MAO) inhibitors (used to treat depression), - pentoxifylline, propoxyphene, salicylates (such as aspirin, used to relieve pain and lower fever), - sulphonamide antibiotics.
Danish: Blodsukkeret kan falde (hypoglykæmi), hvis du tager følgende medicin: - alle øvrige lægemidler til behandling af diabetes, - angiotensinkonverterende enzym (ACE) hæmmere (anvendes til behandling af visse hjertesygdomme eller højt blodtryk), - disopyramid (anvendes til behandling af visse hjertesygdomme), - fluoxetin (anvendes til behandling af depression), - fibrater (anvendes til at sænke et højt niveau af fedt (lipider) i blodet), - MAO-hæmmere (anvendes til behandling af depression), - pentoxifyllin, propoxyfen, salicylater (som f.eks. aspirin, anvendes som smertestillende midler og febernedsættende), - antibiotika af typen sulfonamider.
English: Apidra 100 Units/ml solution for injection in a vial EU/1/04/285/001-004
Danish: Apidra 100 enheder/ml injektionsvæske, opløsning, i et hætteglas EU/1/04/285/001-004
English: The cartridge is sealed in a disposable pre-filled pen.
Danish: Cylinderampullen er forseglet i en fyldt engangspen.
English: Each vial contains 10 ml of solution for injection, equivalent to 1000 Units.
Danish: Hvert hætteglas indeholder 10 ml injektionsvæske, opløsning, svarende til 1.000 enheder.
English: Apidra 100 Units/ml solution for injection in a vial Cases of hyperglycaemia have been reported with Apidra when used with CSII (see section 4.4) that has led to Diabetic Ketoacidosis (DKA); most of the cases were related to handling errors or pump system failure.
Danish: Apidra 100 enheder/ml injektionsvæske, opløsning, i et hætteglas Der er rapporteret tilfælde af hyperglykæmi, som har ført til diabetisk ketoacidose (DKA), når Apidra er blevet administreret som CSII (se pkt.
English: If administration by syringe, intravenous injection or infusion pump is necessary, a vial should be used (see section 4.4).
Danish: Hvis det er nødvendigt at anvende en sprøjte, intravenøs injektion eller infusionspumpe til administrationen, bør et hætteglas anvendes (se pkt.