FrancophonIA/ELRC3.0 huggingface dataset:
English: Some patients with long-standing type 2 diabetes mellitus and heart disease or previous stroke who were treated with pioglitazone and insulin experienced the development of heart failure.
Danish: Nogle patienter med årelang type 2-diabetes mellitus og hjertesygdom eller tidligere slagtilfælde, der var i behandling med pioglitazon og insulin, udviklede hjertesvigt.
English: Hyperglycaemia, ketoacidosis and coma may develop within hours if the pump catheter is obstructed completely.
Danish: Hyperglykæmi, ketoacidose og koma kan udvikles i løbet af timer, hvis pumpekatetret tilstoppes helt.
English: Symptoms Insulin overdose may lead to severe and sometimes long-term and life-threatening hypoglycaemia.
Danish: Symptomer Insulinoverdosering kan medføre svær og til tider langvarig og livstruende hypoglykæmi.
English: You may have to perform the safety test several times before insulin is seen.
Danish: Det er muligt at sikkerhedstesten skal gentages flere gange, før der ses insulin på spidsen.
English: General disorders and administration site conditions Most minor reactions to insulins at the injection site usually resolve in a few days to a few weeks.
Danish: Almene symptomer og reaktioner på administrationsstedet De fleste mindre reaktioner over for insuliner på injektionsstedet forsvinder sædvanligvis i løbet af få dage til få uger.
English: If your blood sugar level falls too much you may become unconscious.
Danish: Hvis dit blodsukker falder for meget, kan du blive bevidstløs.
English: Severe allergic reactions to insulin may occur which may become life-threatening.
Danish: Alvorlige allergiske reaktioner overfor insulin kan forekomme, hvilket kan blive livstruende.
English: You should know these factors so that you are able to react correctly to changes in your blood sugar level and to prevent it from becoming too high or too low.
Danish: Du bør være bekendt hermed for at kunne handle korrekt i tilfælde af ændringer i dit blodsukker og for at forhindre, at blodsukkeret bliver for højt eller for lavt.
English: In the treatment of severe hyperglycaemia or ketoacidosis in particular, insulin administration is part of a complex therapeutic regimen which includes measures to protect patients from possible severe complications of a relatively rapid lowering of blood glucose.
Danish: Specielt ved behandling af alvorlig hyperglykæmi eller ketoacidose indgår insulin som en del af et komplekst behandlingsregime, der omfatter forholdsregler, der skal beskytte patienten mod mulige alvorlige komplikationer forårsaget af et relativt hurtigt fald i blodglucoseniveauet.
English: If you do not follow these instructions completely, you may get too much or too little insulin, which may affect your blood glucose.
Danish: Hvis ikke du følger denne brugsanvisning fuldstændig, kan du enten få for meget eller for lidt insulin, som kan påvirke dit blodsukker.
English: If you are concerned that your SoloStar may be damaged, use a new one.
Danish: Hvis du er bekymret for, om SoloStar kan være ødelagt, så brug en ny.
English: Severe hypoglycaemic attacks, especially if recurrent, may lead to neurological damage.
Danish: Alvorlige hypoglykæmiske episoder, især tilbagevendende, kan føre til neurologiske skader.
English: If you need a dose greater than 80 units, you should give it as two or more injections.
Danish: Hvis du behøver en dosis på mere end 80 enheder, skal det gives som to eller flere injektioner.
English: You normally should be able to recognise when your blood sugar is falling too much so that you can take the right actions.
Danish: Normalt bør du være i stand til at mærke når blodsukkeret falder for meget, så du kan tage de rette forholdsregler.
English: The acute toxicity was studied following subcutaneous administration in rats.
Danish: Akut toksicitet er undersøgt på rotter efter subkutan administration.
English: Speak to a doctor immediately if you are not able to control the hypoglycaemia or if it recurs.
Danish: Søg omgående læge, hvis du ikke kan få kontrol over din hypoglykæmi, eller hvis tilstanden kommer igen.
English: Pioglitazone should be discontinued if any deterioration in cardiac symptoms occurs.
Danish: Pioglitazon bør seponeres, hvis der sker en forværring i symptomer fra hjertet.
English: Special care before injection
Danish: Særlige forholdsregler inden injektion
English: The outer and inner needle caps should be removed.
Danish: Ydre og indre nålekapsel fjernes.
English: Only tetrafluoroethylene or polyethylene catheters must be used for infusion.
Danish: Kun tetrafluoretylen- eller polyethylenkatetre må anvendes til infusion.
English: Insulin that has been filled into the pump reservoir may be used for two weeks thereafter.
Danish: Insulin, der er påfyldt pumpens reservoir, kan anvendes i op til 2 uger.
English: Patients should be advised to take precautions to avoid hypoglycaemia whilst driving.
Danish: Patienter skal rådes til at tage forholdsregler for at undgå hypoglykæmi i forbindelse med bilkørsel.
English: Only tetrafluoroethylene or polyethylene catheters must be used.
Danish: Kun tetrafluoretylen- eller polyetylenkatetre må anvendes.
English: A marked change (improvement or worsening) in your blood sugar control can disturb your vision temporarily.
Danish: En betydelig ændring (forbedring eller forværring) af din blodsukkerkontrol kan forbigående give synsforstyrrelser.
English: If the patient is concerned that the SoloStar may be damaged, he must use a new one.
Danish: Hvis patienten er bekymret for om SoloStar kan være ødelagt, skal patienten bruge en ny.
English: If necessary, more frequent blood sugar testing can help to identify mild hypoglycaemic episodes that may otherwise be overlooked.
Danish: Om nødvendigt kan en hyppigere blodsukkerkontrol hjælpe dig med at identificere milde tilfælde af hypoglykæmi, som måske ellers ville blive overset.
English: It is recommended that the date of the first use be noted on the label.
Danish: Det anbefales, at datoen for første brug noteres på hætteglassets etiket.
English: Intercurrent illness
Danish: Interkurrente sygdomme
English: Consequently, about 40% to 60% of the daily dose is administered at a basal rate, and the rest is given as bolus injections before meals.
Danish: Derfor administreres omkring 40 - 60% af døgndosis som "basalrate", mens den resterende del indgives i form af bolusinjektioner før måltider.
English: • Always attach a new needle before each use.
Danish: • Påsæt altid en ny nål før hver anvendelse.
English: C. Always put the pen cap back on the pen, then store the pen until your next injection.
Danish: C. Sæt altid penhætten tilbage på pennen og opbevar så pennen til næste injektion.
English: The patient should be informed on the injection technique by his health care professional.
Danish: Patienten skal trænes i injektionsteknik af sundhedspersonale.
English: • If still no insulin comes out, the needle may be blocked.
Danish: • Hvis der stadig ikke kommer insulin ud, kan nålen være tilstoppet.
English: Transferring a patient to another type or brand of insulin should be done under strict medical supervision.
Danish: Omstilling af en patient til en ny type insulin eller til et nyt brand (fremstiller) skal ske under omhyggelig medicinsk supervision.
English: You can clean the outside of your SoloStar by wiping it with a damp cloth.
Danish: Du kan rengøre ydersiden af din SoloStar ved at tørre den af med en fugtig klud.
English: Long-term improved glycaemic control decreases the risk of progression of diabetic retinopathy.
Danish: En forbedret glykæmisk kontrol over lang tid mindsker risikoen for progression af diabetisk retinopati.
English: Your blood sugar levels may either rise or fall if you drink alcohol.
Danish: Dit blodsukker kan enten stige eller falde, hvis du drikker alkohol
English: For further information on the side effects of low blood sugar or high blood sugar, see the box at the end of this leaflet.
Danish: Information om bivirkningerne ved lavt blodsukker eller højt blodsukker findes i den indrammede del sidst i indlægssedlen.
English: The most frequent side effect is hypoglycaemia (low blood sugar).
Danish: Den mest almindelige bivirkning er hypoglykæmi (lavt blodsukker).
English: If you have any questions about SoloStar or about diabetes, ask your doctor, pharmacist or nurseor call the local sanofi-aventis number on the front of this leaflet.
Danish: Hvis du har nogen spørgsmål vedrørende SoloStar eller vedrørende diabetes, så spørg dit sundhedspersonale eller ring på det lokale sanofi-aventis nummer på forsiden af denne indlægsseddel.
English: This should be kept in mind if treatment with the combination of pioglitazone and Insulin Human Winthrop is considered.
Danish: Dette skal tages i betragtning, hvis kombinationsbehandling med pioglitazon og Insulin Human Winthrop overvejes.
English: • If the needle is not kept straight while you attach it, it can damage the rubber seal and cause leakage, or break the needle.
Danish: • Hvis nålen ikke holdes lige, mens du påsætter den, kan gummistemplet blive ødelagt og give lækage, eller nålen kan blive ødelagt.
English: - If you are not eating enough, your blood sugar level may become too low (hypoglycaemia).
Danish: - Hvis du ikke spiser tilstrækkeligt, kan dit blodsukkerniveau blive for lavt (hypoglykæmi).
English: The following related adverse reactions from clinical investigations are listed below by system organ class and in order of decreasing incidence: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).
Danish: De relaterede bivirkninger, som er forekommet i kliniske forsøg, er opstillet nedenfor efter organsystem og faldende hyppighed: meget almindelig: (≥1/10); almindelig: (≥1/100 til <1/10); Usædvanlig: (≥ 1/1.000 til < 1/100); sjælden:( ≥1/10.000 til <1/1.000); meget sjælden: (< 1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Before injection remove any air bubbles.
Danish: Før injektion fjernes alle luftbobler.
English: Do not store above 25°C and protect from direct heat and light.
Danish: Må ikke opbevares over 25°C og skal beskyttes mod direkte varme og lys.
English: This medicine contains less than 1 mmol (23 mg) sodium per dose, i.e. it is essentially ‘sodium-free'.
Danish: Dette lægemiddel indeholder mindre end 1 mmol (23 mg) natrium pr. dosis, d.v.s. det er i det væsentlige natriumfrit.
English: More severe episodes with coma, seizure, or neurologic impairment may be treated with intramuscular/subcutaneous glucagon or concentrated intravenous glucose.
Danish: Sværere tilfælde med koma, kramper eller neurologisk svækkelse kan behandles med intramuskulær/subkutan glucagon eller koncentreret intravenøs glucoseopløsning.
English: Patients should be aware of circumstances where warning symptoms of hypoglycaemia are diminished.
Danish: Patienterne skal være opmærksomme på situationer, hvor advarselssymptomerne på hypoglykæmi kan være nedsatte.
English: Prolonged or severe hypoglycaemic episodes may be life-threatening.
Danish: Lange eller alvorlige hypoglykæmiske episoder kan være livstruende.
English: Always remove the needle after each injection and store SoloStar without a needle attached.
Danish: Tag altid nålen af efter hver injektion og opbevar SoloStar uden nål påsat.
English: D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL
Danish: D. BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET
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: For at sikre, at du aflæser dosis korrekt, skal du holde pennen vandret med nålen til venstre, og dosisskalaen til højre, som vist på illustrationen til højre.
English: This helps prevent contamination and/or infection, entry of air into the insulin reservoir and leakage of insulin.
Danish: Dette forhindrer smitte og/eller infektion, at der kommer luftbobler i insulinen eller lækage af insulin.
English: There are no fixed rules for insulin dose regimen.
Danish: Der er ingen faste regler for insulindosering.
English: Diabetes mellitus is a disease where your body does not produce enough insulin to control the level of blood sugar.
Danish: Diabetes mellitus er en sygdom, som skyldes, at kroppen ikke danner tilstrækkeligt insulin til at kontrollere blodsukkeret.
English: Human insulin is produced by recombinant DNA technology in Escherichia coli.
Danish: Human insulin fremstilles med rekombinant DNA-teknologi i Escherichia coli.
English: 3 cartridges of 3 ml 4 cartridges of 3 ml 5 cartridges of 3 ml 6 cartridges of 3 ml 9 cartridges of 3 ml 10 cartridges of 3 ml
Danish: 3 cylinderampuller af 3 ml 4 cylinderampuller af 3 ml 5 cylinderampuller af 3 ml 6 cylinderampuller af 3 ml 9 cylinderampuller af 3 ml 10 cylinderampuller af 3 ml
English: Lipodystrophy may occur at the injection site and delay local insulin absorption.
Danish: Lipodystrofi kan opstå på injektionsstedet og forsinke den lokale insulinabsorption.
English: • Never use SoloStar if it is damaged or if you are not sure that it is working properly.
Danish: • Anvend aldrig SoloStar, hvis den er beskadiget eller hvis du er usikker på, om den virker korrekt.
English: After filling the cartridge of the pump keep it at room temperature for 1 to 2 hours before using it, so that you can see and remove any air bubbles which form during warming-up.
Danish: Efter påfyldning af pumpen skal denne opbevares i 1 - 2 timer ved stuetemperatur før anvendelse, så du kan se og fjerne alle luftbobler, som dannes under opvarmningen.
English: Check if insulin comes out of the needle tip.
Danish: Tjek om der kommer insulin ud af nålespidsen.
English: Froth can make it difficult for you to measure the correct dose.
Danish: Skum kan gøre det vanskeligt at afmåle den korrekte dosis.
English: If you are not sure whether you are taking one of those medicines ask your doctor or pharmacist.
Danish: Hvis du ikke er sikker på, om du tager et af disse lægemidler, bør du spørge din læge eller på apoteket.
English: This leaflet was last revised in {date}
Danish: Denne indlægsseddel blev senest ændret {MM/ÅÅÅÅ}
English: In each case, it may be necessary to adjust your insulin dosage to avoid blood sugar levels that are either too low or too high.
Danish: I hver enkelt situation kan det blive nødvendigt at justere insulindosis for at undgå for lavt eller for højt blodsukker.
English: Maintenance
Danish: Vedligeholdelse
English: Medication errors have been reported in which other Insulin Human Winthrop formulations or other insulins have been accidentally administered.
Danish: Der er indrapporteret tilfælde af medicineringsfejl hvor andre formuleringer af Insulin Human Winthrop eller andre insuliner utilsigtet er blevet administreret.
English: The label on the pen should be checked to make sure it contains the correct insulin.
Danish: Etiketten på pennen skal tjekkes for at sikre den indeholder den korrekte insulin.
English: In case of hypoglycaemia, the insulin pump should temporarily be turned off, at least until the patient has recovered complete consciousness.
Danish: I tilfælde af hypoglykæmi skal insulinpumpen lukkes midlertidigt, i det mindste indtil patienten på ny er ved fuld bevidsthed.
English: If you have proliferative retinopathy (an eye disease related to diabetes) severe hypoglycaemic attacks may cause temporary loss of vision.
Danish: Hvis du lider af proliferativ retinopati (en øjensygdom, der er relateret til diabetes) kan alvorlige tilfælde af hypoglykæmi medføre risiko for forbigående synstab.
English: • Entry of air into the insulin reservoir and leakage of insulin, which can cause inaccurate dosing.
Danish: • At der kommer luft i insulinbeholderen og lækage af insulin, som kan medføre forkert dosering
English: This is facilitated by the special equipment available for the insulin pumps (e.g. catheters, cannulas).
Danish: Dette gøres bedst ved anvendelse af det særlige udstyr, som findes til insulinpumper (f.eks. katetre, kanyler).
English: After resuspension, milky-white suspension.
Danish: Efter resuspension, mælkehvid suspension.
English: • Do not select a dose and/or press the injection button without a needle attached.
Danish: • Vælg ikke en dosis og/eller tryk ikke på dosisknappen uden nål påsat.
English: Special populations Elderly population (≧65 years old)
Danish: Ældre (≥65 år)
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
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 apoteket til råds, før du tager dette lægemiddel.
English: The patient should avoid situations where SoloStar may be damaged.
Danish: Patienten bør undgå situationer hvor SoloStar kan blive ødelagt.
English: Alternatively, it may emerge gradually over a period of several weeks.
Danish: I andre tilfælde kan behovet for dosisjustering udvikles gradvist i løbet af adskillige uger.
English: To reduce the risk of accidental needle injury, never replace the inner needle cap.
Danish: For at reducere risikoen for uheld med nålen må den indre nålekapsel aldrig sættes på igen.
English: The injection syringes must not contain any other medicinal product or residue (e.g. traces of heparin).
Danish: Injektionssprøjterne må ikke indeholde andre lægemidler eller rester heraf (f.eks. spor af heparin).
English: Factors increasing the susceptibility to hypoglycaemia require particularly close monitoring and may necessitate dose adjustment.
Danish: Faktorer, der øger risikoen for hypoglykæmi, kræver nøje kontrol, og dosisjustering kan blive nødvendig.
English: The pen must not be soaked, washed or lubricated as this may damage it.
Danish: Pennen må ikke skylles, vaskes eller smøres, da dette kan ødelægge den.
English: Keep this possible problem in mind in all situations where you might put yourself and others at risk (such as driving a car or using machines).
Danish: Vær opmærksom på dette mulige problem i alle situationer, hvor du kan bringe dig selv eller andre i fare (såsom ved bilkørsel eller ved betjening af maskiner).
English: With each injection, change the puncture site within the particular area of skin that you are using.
Danish: Ved hver injektion skal du skifte til et nyt injektionssted inden for det bestemte hudområde, som du bruger.
English: When used in external portable insulin pumps, part of the daily insulin dose is infused continuously ("basal rate"), and the rest is administered in the form of bolus injections before meals.
Danish: I eksternt bærbare insulinpumper infunderes en del af døgndosis kontinuerligt ("basalrate"), mens den resterende del administreres som bolusinjektioner før måltider.
English: Look at the cartridge before you use the pen.
Danish: Se på cylinderampullen, før du bruger pennen.
English: The pen cap must be put back on the pen after each injection in order to protect from light.
Danish: Penhætten skal sættes på pennen efter hver injektion for at beskytte mod lys.
English: Also do not use it in peristaltic pumps with silicone tubing.
Danish: Brug det ligeledes ikke i peristaltiske pumper med silikoneslanger.
English: SoloStar delivers insulin in doses from 1 to 80 units in steps of 1 unit.
Danish: SoloStar indgiver insulin i doser fra 1 til 80 enheder i trin af 1 enhed.
English: Not all of these pens may be marketed in your country.
Danish: Ikke alle penne er nødvendigvis markedsført i alle lande.
English: • If your injection is given by another person, or if you are giving an injection to another person, special caution must be taken by this person when removing and disposing of the needle.
Danish: • Hvis din injektion gives af en anden person, skal denne person udvise speciel forsigtighed når nålen fjernes og kasseres.
English: The dose window must show “0” following the safety test.
Danish: Doseringsvinduet skal vise ”0” efter sikkerhedstesten.
English: While holding the pen with the needle pointing upwards, the insulin reservoir should be tapped gently with the finger so that any air bubbles rise up towards the needle.
Danish: Imens pennen holdes med nålen opad, bankes forsigtigt med en finger på insulinbeholderen, således at eventuelle luftbobler stiger op mod nålen.
English: • The patient must always have a spare SoloStar available in case the SoloStar is lost or damaged.
Danish: • Patienten skal altid have en ekstra SoloStar tilgængelig i tilfælde af, at SoloStar pennen bliver væk eller går i stykker.
English: Hypoglycaemia; Sodium retention
Danish: Hypoglykæmi; natriumretention
English: D.
Danish: B.
English: It is longer in patients with severe renal insufficiency.
Danish: Halveringstiden er forlænget hos patienter med svær nyreinsufficiens.
English: This is particularly important in those who have reduced or absent awareness of the warning symptoms of hypoglycaemia or have frequent episodes of hypoglycaemia.
Danish: Dette er af særlig betydning hos patienter med nedsat eller manglende evne til at mærke advarselssymptomer på hypoglykæmi, eller hos patienter, som har hyppige anfald af hypoglykæmi.
English: A. Remove the protective seal from a new needle.
Danish: A. Fjern folieforseglingen fra en ny nål
English: Talk with your doctor, pharmacist or nurse about proper injection technique before using SoloStar.
Danish: Tal med dit sundhedspersonale om korrekt injektionsteknik før anvendelse af SoloStar.
English: METHOD OF ADMINISTRATION Use specific pens: see leaflet.
Danish: ADMINISTRATIONSMÅDE Brug bestemte penne: Se indlægssedlen.
English: Secondary dose adjustment
Danish: Sekundær dosisjustering
English: Dose adjustment may also be required, for example, if - the patient's weight changes,
Danish: Dosisjustering kan også blive nødvendig, f.eks. hvis: - patientens vægt ændres,
English: Like all medicines, this medicine can cause side effects, although not everybody gets them.
Danish: Dette lægemiddel kan som al anden medicin, give bivirkninger, men ikke alle får bivirkninger.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, Before taking a medicine ask your doctor if it can affect your blood sugar level, and what action, if any, you need to take.
Danish: Fortæl altid lægen eller på apoteket, hvis du tager anden medicin eller har gjort det for nylig..Før du begynder at tage et lægemiddel, skal du spørge lægen, om det kan påvirke dit blodsukkerniveau, og hvilke forholdsregler du eventuelt skal tage.
English: How to handle SoloStar
Danish: Håndtering af SoloStar
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 3.15 ml
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 3,15 ml
English: Beta-blockers, clonidine, lithium salts or alcohol may either potentiate or weaken the blood-glucose-lowering effect of insulin.
Danish: Betablokkere, clonidin, lithiumsalte eller alkohol kan enten forstærke eller nedsætte insulins blodglucosesænkende virkning.
English: Do not inject insulin.
Danish: Tag ikke insulin.
English: The desired blood glucose levels and the insulin dose regimen must be determined individually and adjusted to suit the patient's diet, physical activity and life-style.
Danish: Det ønskede blodglucoseniveau og insulin-doseringen fastlægges individuelt og skal tilpasses patientens kostvaner, fysiske aktivitet og levevis.
English: If no insulin appears at the needle tip, step 3 should be repeated until insulin appears at the needle tip.
Danish: Hvis der ikke afgives insulin ved nålespidsen, skal trin 3 gentages indtil der afgives insulin på nålespidsen.
English: Mix the insulin well and check it before you insert it into the pen.
Danish: Bland insulinet omhyggeligt og kontrollér det inden det sættes i pennen.
English: Italia Sanofi S.p.A. Tel: 800 13 12 12 (domande di tipo tecnico) 800 536389 (altre domande)
Danish: Tel: 800 13 12 12 (domande di tipo tecnico) 800 536389 (altre domande)