FrancophonIA/ELRC3.0 huggingface dataset:
English: When given intravenously the elimination half-life of insulin glargine and human insulin were comparable.
Danish: Efter intravenøs administration er eliminationshalveringstiden af insulin glargin sammenlignelig med human insulin.
English: Do not dilute it. Mixing or diluting may change the action of ABASAGLAR.
Danish: Blanding eller fortynding kan ændre virkningen af ABASAGLAR.
English: Step 14:
Danish: Trin 14:
English: - If you have injected too much ABASAGLAR, your blood sugar level may become too low (hypoglycaemia).
Danish: - Hvis du har injiceret for meget ABASAGLAR, kan dit blodsukker blive for lavt (hypoglykæmi).
English: Step 1:
Danish: Trin 1:
English: Shelf life after first use
Danish: Opbevaringstid efter første anvendelse
English: Do not throw it away.
Danish: Må ikke fortyndes.
English: - You should use a new needle for each injection and repeat the priming step.
Danish: - For hver indsprøjtning skal du bruge en ny nål og gentage kontrollen af insulinflowet.
English: 10 cartridges of 3 mL
Danish: 10 cylinderampuller a 3 ml.
English: Before travelling consult your doctor.
Danish: Du bør tale med din læge, før du skal ud at rejse.
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: clonidin, guanethidin og reserpin) kan endvidere svække eller helt undertrykke de første advarselssymptomer, som kan advare dig om hypoglykæmisk reaktion.
English: HYPERGLYCAEMIA (high blood sugar levels) If your blood sugar is too high (hyperglycaemia), you may not have injected enough insulin.
Danish: Hvis dit blodsukker er for højt (hyperglykæmi), har du måske ikke injiceret nok insulin.
English: Do not use ABASAGLAR KwikPen if it is damaged or not working properly, it has to be discarded and a new KwikPen has to be used.
Danish: Anvend ikke ABASAGLAR KwikPen, hvis den er skadet eller ikke virker ordentligt.
English: Each cartridge contains 3 mL of solution for injection, equivalent to 300 units.
Danish: Hver cylinderampul indeholder 3 ml injektionsvæske, opløsning svarende til 300 enheder.
English: • Turn the dose knob to select the number of units you need to inject.
Danish: • Indstil antallet af enheder, du skal indsprøjte, ved at dreje på doseringsknappen.
English: Each millilitre of the solution contains 100 units of the active substance insulin glargine (equivalent to 3.64 mg).
Danish: Hver ml opløsning indeholder 100 enheder af det aktive stof insulin glargin (svarende til 3,64 mg).
English: Visual impairment
Danish: Synsforstyrrelser
English: Pens in use must not be stored in the refrigerator.
Danish: Cylinderampuller i brug må ikke opbevares i køleskab.
English: The cartridge is sealed in a disposable pen injector.
Danish: Cylinderampullen er forseglet i en engangspen.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS CARTRIDGE LABEL
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER ETIKET CYLINDERAMPUL
English: The pen should be used as recommended in the information provided with the device.
Danish: Pennen skal anvendes som anbefalet i den brugermanual, der følger med pennen.
English: • Throw away the pen you are using after 28 days, even if it still has insulin left in it.
Danish: • Den pen, der er i brug, skal bortskaffes efter 28 dage.
English: The adverse reaction reports received from post marketing surveillance included relatively more frequent injection site reactions (injection site pain, injection site reaction) and skin reactions (rash, urticaria) in children and adolescents (≤ 18 years of age) than in adults.
Danish: Bivirkningsrapporter modtaget efter post marketing evaluering viser relativt flere reaktioner på indgivelsesstedet (smerte på injektionsstedet, reaktioner på injektionsstedet) og hudreaktioner (udslæt,
English: This leaflet was last revised in Other sources of information
Danish: Denne indlægsseddel blev senest ændret
English: ABASAGLAR 100 units/mL solution for injection in a cartridge is a clear and colourless solution.
Danish: ABASAGLAR 100 enheder/ml injektionsvæske, opløsning i cylinderampul er en klar og farveløs opløsning.
English: Empty pens must not be re-filled and must be properly discarded.
Danish: Tomme penne må ikke fyldes igen og skal kasseres på betryggende vis.
English: No significant difference was seen in the progression of diabetic retinopathy when insulin glargine was compared to NPH insulin.
Danish: Det blev påvist, at insulin glargin ikke forværrede udviklingen af diabetisk retinopati sammenlignet med NPH-insulin.
English: Rarely, insulin may cause sodium retention and oedema particularly if previously poor metabolic control is improved by intensified insulin therapy.
Danish: Dette ses især hvis en tidligere dårlig metabolisk kontrol forbedres ved en intensiveret insulinbehandling.
English: - diuretics (used to treat high blood pressure or excessive fluid retention), - glucagon (pancreas hormone used to treat severe hypoglycaemia), - isoniazid (used to treat tuberculosis), - oestrogens and progestogens (such as in the contraceptive pill used for birth control), - phenothiazine derivatives (used to treat psychiatric disorders), - somatropin (growth hormone), - sympathomimetic medicines (such as epinephrine [adrenaline], salbutamol, terbutaline used to treat asthma), - thyroid hormones (used to treat thyroid gland disorders), - atypical antipsychotic medicines (such as clozapine, olanzapine), - protease inhibitors (used to treat HIV).
Danish: - kortikosteroider (såsom kortison, anvendes til behandling af betændelsestilstande), - danazol (medicin der virker på ægløsning), - diazoxid (anvendes til behandling af højt blodtryk), - vanddrivende lægemidler (anvendes til behandling af højt blodtryk eller overdreven væskeophobning) - glucagon (bugspytkirtelhormon, der anvendes til behandling af alvorlig hypoglykæmi), - isoniazid (anvendes til behandling af tuberkulose), - østrogener og gestagener (findes i f.eks. p-piller anvendes til forebyggelse af svangerskab), - phenthiazinderivater (anvendes til behandling af psykiatriske sygdomme), - somatropin (væksthormon), - sympatomimetika (såsom adrenalin, salbutamol eller terbutalin, anvendes til behandling af astma), - thyreoideahormoner (anvendes til behandling af sygdomme i skjoldbruskkirtlen), - atypiske antipsykotiske lægemidler (såsom clozapin, olanzapin) - proteasehæmmere (anvendes til behandling af HIV).
English: Step 10:
Danish: Trin 10:
English: Insulin administration may cause insulin antibodies to form.
Danish: Behandling med insulin kan føre til dannelse af antistoffer mod insulin.
English: Breast-feeding women may require adjustments in insulin dose and diet.
Danish: Det kan være nødvendigt at justere insulindosis og diæt hos kvinder, der ammer.
English: How to use ABASAGLAR
Danish: Sådan skal du tage ABASAGLAR
English: The ABASAGLAR cartridges are to be used only in conjunction with a Lilly reusable insulin pen (see section 4.4).
Danish: ABASAGLAR cylinderampullerne må kun anvendes sammen med en Lilly flergangspen (se pkt.
English: In-use pens
Danish: Penne i brug
English: Step 13:
Danish: Trin 13:
English: Packs of 5 and 10 cartridges.
Danish: Pakninger med 5 og 10 cylinderampuller.
English: Step 11:
Danish: Trin 11:
English: Step 9:
Danish: Trin 9:
English: Rubber Seal
Danish: Hætteklips Gummiforsegling Stempel
English: ATC Code: A10AE04.
Danish: insulin og insulin-analoger til injektion, langtidsvirkende, ATC-kode: A10AE04.
English: In healthy subjects and diabetic patients, insulin serum concentrations indicated a slower and much more prolonged absorption and showed a lack of a peak after subcutaneous injection of insulin glargine in comparison to human NPH insulin.
Danish: Efter subkutan injektion af insulin glargin til raske forsøgspersoner og diabetespatienter indikerer serumkoncentrationen af insulin en langsommere og en forlænget absorption uden koncentrationstoppe sammenlignet med NPH-insulin.
English: Keep the cartridge in the outer carton in order to protect from light.
Danish: Opbevar cylinderampullen i den ydre karton for at beskytte mod lys.
English: 5sec
Danish: 5 sek
English: - A drop of insulin at the needle tip is normal.
Danish: - Det er normalt at se en dråbe insulin ved nålens spids.
English: Medicinal product subject to medical prescription
Danish: Lægemidlet er receptpligtigt
English: Empty cartridges must not be refilled and must be properly discarded.
Danish: Tomme cylinderampuller må ikke fyldes igen og skal bortskaffes på betryggende måde.
English: Posology
Danish: Papirflig
English: Nervous system disorders
Danish: Nervesystem
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Danish: Yderligere information om dette lægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: • To prime your pen, turn the dose knob to select 2 units.
Danish: • For at kontrollere insulinflowet indstil 2 enheder ved at dreje doseringsknappen.
English: Examples include: - you have not injected your insulin or not injected enough, or if it has become less effective, for example through incorrect storage, - your insulin pen does not work properly, - you are doing less exercise than usual, you are under stress (emotional distress, excitement), or you have an injury, operation, infection or fever, - you are taking or have taken certain other medicines (see section 2, "Other medicines and
Danish: Hvis du for eksempel: - ikke har injiceret din insulin eller ikke har injiceret nok, eller hvis det har mistet noget af sin virkning f.eks. på grund af forkert opbevaring, - din insulinpen ikke fungerer tilfredsstillende, - dyrker mindre motion end sædvanlig eller er stresset (følelsesmæssigt ude af balance, ophidselse),
English: carbohydrates), - you lose carbohydrates due to vomiting or diarrhoea, - you drink alcohol, particularly if you are not eating much, - you are doing more exercise than usual or a different type of physical activity, - you are recovering from an injury or operation or other stress, - you are recovering from an illness or from fever, - you are taking or have stopped taking certain other medicines (see section 2, "Other medicines and ABASAGLAR").
Danish: Hvis du for eksempel: - tager for meget insulin, - springer måltider over eller udsætter dem, - ikke spiser nok eller spiser mad, der indeholder færre kulhydrater end normalt (sukker og sukkerlignende stoffer kaldes kulhydrater; kunstige sødemidler er imidlertid IKKE kulhydrater), - mister kulhydrater på grund af opkastning og diarré, - drikker alkohol, især hvis du ikke spiser ret meget, - får mere motion end normalt eller udøver en anden form for fysisk aktivitet, - er ved at komme dig efter en skade eller operation eller andre former for stress, - er ved at komme dig efter en sygdom eller feber, - tager eller er holdt op med at tage visse andre lægemidler (se punkt 2, "Brug af anden medicin sammen med ABASAGLAR").
English: Before using ABASAGLAR solution for injection in pre-filled pen, the instructions for use included in the package leaflet must be read carefully (see section 6.6).
Danish: Brugermanualen i indlægssedlen skal læses omhyggeligt før ABASAGLAR injektionsvæske, opløsning i fyldt pen anvendes (se pkt.
English: Pharmacotherapeutic group: Drugs used in diabetes, insulins and analogues for injection, long-acting.
Danish: Farmakoterapeutisk klassifikation: Lægemidler anvendt til diabetes.
English: EU/1/14/944/008 5 pens EU/1/14/944/013 5 pens
Danish: EU/1/14/944/008 5 penne EU/1/14/944/013 5 penne
English: Recap the pen after use to protect from light.
Danish: Opbevar pennen med penhætten påsat for at beskytte mod lys.
English: EU/1/14/944/007 5 pens EU/1/14/944/012 5 pens
Danish: EU/1/14/944/007 5 penne EU/1/14/944/012 5 penne
English: The pharmacokinetic and pharmacodynamic findings indicate that the effect of the subcutaneous injection with insulin glargine is principally based on exposure to M1. Insulin glargine and the metabolite M2 were not detectable in the vast majority of subjects and, when they were detectable their concentration was independent of the administered dose of insulin glargine.
Danish: De farmakokinetiske og farmakodynamiske fund indikerer, at effekten af en subkutan injektion af insulin glargin hovedsageligt skyldes eksponering for M1.
English: The prolonged duration of action of insulin glargine is dependent on its injection into subcutaneous tissue.
Danish: Subkutan injektion af insulin glargin er en forudsætning for den lange virkningsvarighed.
English: Instructions for use KwikPen ABASAGLAR 100 units/mL solution for injection in a pre-filled pen Insulin glargine
Danish: Brugermanual KwikPen ABASAGLAR 100 enheder/ml injektionsvæske, opløsning, i en fyldt pen insulin glargin
English: Package leaflet: Information for the user ABASAGLAR 100 units/mL solution for injection in a pre-filled pen insulin glargine
Danish: INDLÆGSSEDDEL: INFORMATION TIL BRUGEREN ABASAGLAR 100 enheder/ml injektionsvæske, opløsning, i fyldt pen insulin glargin
English: Do not use if it has been frozen.
Danish: Brug ikke en pen, der har været udsat for frost.
English: Package leaflet: Information for the user ABASAGLAR 100 units/mL solution for injection in a cartridge insulin glargine
Danish: Indlægsseddel: information til brugeren ABASAGLAR 100 enheder/ml injektionsvæske, opløsning, i cylinderampul insulin glargin
English: Store in original package in order to protect from light.
Danish: Opbevares i den ydre emballage for at beskytte mod lys.
English: ABASAGLAR 100 units/mL injection KwikPen insulin glargine
Danish: ABASAGLAR 100 enheder/ml, injektionsvæske KwikPen insulin glargin s.c. anvendelse
English: - corticosteroids (such as "cortisone" used to treat inflammation), - danazol (medicine acting on ovulation), - diazoxide (used to treat high blood pressure),
Danish: - disopyramid (anvendes til behandling af visse hjetesygdomme), - fluoxetin (anvendes til behandling af depression), - fibrater (anvendes til at sænke høje niveauer af lipider i blodet),
English: Needles are not included in the pack.
Danish: Nåle medfølger ikke.
English: Dose Window
Danish: Doseringsvindue Doseringsknap
English: The ABASAGLAR cartridges are to be used only in Lilly insulin pens to ensure you get the correct dose.
Danish: For at sikre, at du får den korrekte dosis, må ABASAGLAR-cylinderampuller kun anvendes sammen med Lilly insulinpenne.
English: Plasma trough levels of insulin glargine and its main M1 and M2 metabolites were measured in children treated with insulin glargine, revealing plasma concentration patterns similar to adults, and providing no evidence for accumulation of insulin glargine or its metabolites with chronic dosing.
Danish: Plasma-dal-koncentrationen af insulin glargin og dets vigtigste M1- og M2metabolitter blev målt hos børn behandlet med insulin glargin.
English: If you use more ABASAGLAR than you should
Danish: Hvis du har taget for meget ABASAGLAR
English: A 24-week parallel group study was conducted in 125 children with type 1 diabetes mellitus aged 2 to 6 years, comparing insulin glargine given once daily in the morning to NPH insulin given once or twice daily as basal insulin.
Danish: Studiet sammenlignede insulin glargin administreret én gang daglig om morgenen med NPH-insulin administreret én eller to gange daglig som basal-insulin.
English: ABASAGLAR 100 units/mL injection insulin glargine
Danish: ABASAGLAR 100 enheder/ml injektionsvæske insulin glargin s.c. anvendelse
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - Cartridge.
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDERKARTON - Cylinderampul.
English: In-use pen
Danish: Uanbrudte penne
English: Solution for injection.
Danish: Injektionsteknik
English: Do not add any other insulin to the cartridge.
Danish: Brug ikke cylinderampullen til andre insuliner.
English: In patients with proliferative retinopathy, particularly if not treated with photocoagulation, severe hypoglycaemic episodes may result in transient amaurosis.
Danish: Alvorlige hypoglykæmiske episoder kan medføre forbigående amaurose hos patienter med proliferativ retinopati, især hvis denne ikke er laserbehandlet.
English: Look at the cartridge before you use it. Only use it if the solution is clear, colourless and water-like, and has no visible particles in it. Do not shake or mix it before use.
Danish: Opløsningen må kun bruges, hvis den er klar, farveløs og ligner vand, og ikke indeholder synlige partikler.
English: Pen Body
Danish: Pennens base
English: ABASAGLAR 100 units/mL solution for injection in a cartridge and pre-filled pen
Danish: ABASAGLAR 100 enheder/ml injektionsvæske, opløsning i cylinderampul og fyldt pen
English: Similar effects on glycohaemoglobin and the incidence of symptomatic hypoglycaemia were observed in both treatment groups, however fasting plasma glucose decreased more from baseline in the insulin glargine group than in the NPH group.
Danish: Der blev vist ens effekt på glycohæmoglobin og incidensen af symptomatisk hypoglykæmi i begge behandlingsgrupper.
English: ABASAGLAR 100 units/mL solution for injection in a pre-filled pen
Danish: ABASAGLAR 100 enheder/ml injektionsvæske, opløsning, i en fyldt pen
English: Retinopathy
Danish: Indsprøjtning
English: • Push the dose knob all the way in
Danish: • Tryk doseringsknappen helt ind.
English: - 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), - somatostatin analogues (such as octreotide, used to treat an uncommon condition in which you make too much growth hormone), - sulphonamide antibiotics.
Danish: disopyramid (anvendes til behandling af visse hjetesygdomme), fluoxetin (anvendes til behandling af depression), fibrater (anvendes til at sænke høje niveauer af lipider i blodet), monoaminoxidasehæmmere (MAO-hæmmere) (anvendes til behandling af depression), pentoxifyllin, propoxyphen, salicylater (såsom.
English: EU/1/14/944/003 5 cartridges EU/1/14/944/009 10 cartridges
Danish: EU/1/14/944/003 5 cylinderampuller EU/1/14/944/009 10 cylinderampuller
English: Priming your pen Prime before each injection.
Danish: Kontrol af insulinflow fra pennen Kontroller insulinflowet før hver indsprøjtning.
English: Ask your doctor or pharmacist for advice before taking any medicine.
Danish: - Spørg lægen eller apotekspersonalet eller sundhedspersonalet, hvis der er mere, du vil vide.
English: Frequency of administration
Danish: Reaktioner på administrationsstedet
English: ABASAGLAR 100 units/mL solution for injection in a pre-filled pen insulin glargine
Danish: ABASAGLAR 100 enheder/ml injektionsvæske, opløsning i fyldt pen insulin glargin
English: Troubleshooting
Danish: Bortskaf
English: In use:
Danish: Lot:
English: Plunger
Danish: Penhætte
English: Zinc oxide
Danish: Zinkoxid
English: Inform your doctor if you are planning to become pregnant, or if you are already pregnant.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge eller apotekspersonalet til råds, før du tager dette lægemiddel.
English: Boehringer Ingelheim Pharma GmbH & Co. KG Tel: +49 (0) 800 77 90 900
Danish: KG Tel: +49 (0) 800 77 90 900
English: ABASAGLAR 100 units/mL solution for injection in a cartridge insulin glargine
Danish: ABASAGLAR 100 enheder/ml injektionsvæske, opløsning i cylinderampul insulin glargin
English: In general, to prevent hypoglycaemia you must eat more food and monitor your blood sugar.
Danish: Indtagelse af mere mad og kontrol af blodsukkeret kan almindeligvis forebygge udvikling af hypoglykæmi.
English: How to store ABASAGLAR Contents of the pack and other information
Danish: Pakningsstørrelser og yderligere oplysninger
English: - If you need help deciding how to divide up your dose, ask your healthcare professional.
Danish: - Spørg sundhedspersonalet til råds, hvis du er nødt til at opdele din dosis.
English: There may be new information.
Danish: Yderligere oplysninger om håndtering findes under pkt.
English: 16 January 2014 EMA/35464/2014
Danish: Den 16. januar 2014 EMA/35464/2014
English: Tel. +44 (0)20 7418 8427 E-mail: press@ema.europa.eu
Danish: Tlf. +44 (0)20 7418 8427 E-mail: press@ema.europa.eu
English: Not yet known1
Danish: Kendes endnu ikke1
English: Contact our press officers Monika Benstetter or Martin Harvey
Danish: Kontakt vores pressesekretærer Monika Benstetter eller Martin Harvey
English: 1 Further studies are ongoing or planned to collect sufficient data to estimate the risk for these products.
Danish: 1 Yderligere undersøgelser pågår eller er planlagt med henblik på at samle tilstrækkelige data til beregning af risikoen med disse produkter.
English: The classification as ‘second, third or fourth generation' is however not science-based and not standardised, and may differ between institutions and publications.
Danish: Klassificeringen som “anden, tredje eller fjerde generation” er imidlertid ikke videnskabeligt baseret og ikke standardiseret og kan være forskellig i forskellige institutioner og publikationer.
English: The review of combined hormonal contraceptives was initiated in February 2013 at the request of France, under Article 31 of Directive 2001/83/EC.
Danish: Gennemgangen af kombinerede hormonale præventionsmidler blev indledt i februar 2013 på anmodning af Frankrig i henhold til artikel 31 i direktiv 2001/83/EF.
English: But it is important that you are aware of the risk of blood clots associated with these medicines, even though it is very low.
Danish: Det er dog vigtigt, at du kender til den risiko for blodpropper, der er forbundet med disse lægemidler, selv om den er meget lav.
English: If you develop any of these signs and symptoms you should seek medical advice immediately.
Danish: Får du nogen af disse tegn og symptomer, skal du straks søge læge.
English: • You should discuss with your doctor or nurse what is the most appropriate type of contraception for you.
Danish: • Du skal drøfte med lægen eller sygeplejersken, hvilken type præventionsmiddel der er bedst egnet til dig.
English: • If you have been taking CHCs without any problem, there is no reason for you to stop taking them on the basis of this review.
Danish: • Hvis du har taget kombinerede hormonale præventionsmidler uden problemer, er der ingen grund til at holde op med at bruge dem på baggrund af denne gennemgang.
English: This risk is very low and there is no evidence for a difference in the level of risk between products depending on the type of progestogen.
Danish: Denne risiko er meget lav, og der er ikke tegn på en forskel i risiko mellem produkterne afhængig af den type progestogen, de indeholder.
English: The review has reinforced the importance of ensuring that clear and up-to-date information is provided to women who use these medicines and to the healthcare professionals giving advice and clinical care.
Danish: Gennemgangen fremhæver betydningen af klar, opdateret information til kvinder, der anvender disse lægemidler, og til de sundhedspersoner, der yder rådgivning og klinisk behandling.
English: • You should also be aware of the factors that increase your risk of a clot and be aware of how these may change over time.
Danish: • Du skal desuden kende til de faktorer, der øger din risiko for blodpropper, og være klar over, hvordan de ændrer sig med tiden.
English: The CHMP opinion was forwarded to the European Commission, which issued a final decision on 16 January 2014.
Danish: CHMP's udtalelse blev overgivet til Europa-Kommissionen, som vedtog en retligt bindende beslutning den 16. januar 2014.
English: • Because a woman's individual risk factors will change over time, there is a need to regularly reassess the suitability of her contraceptive.
Danish: • Da den enkelte kvindes risikofaktorer ændrer sig med tiden, bør egnetheden af hendes kontraceptivum regelmæssigt revurderes.