FrancophonIA/ELRC3.0 huggingface dataset:
English: In patients who require high insulin doses because of the presence of insulin antibodies, transfer under medical supervision in a hospital or similar setting must be considered.
Danish: Hos patienter, som har behov for høje insulindoser pga. tilstedeværelse af insulinantistoffer, skal præparatomstilling under indlæggelse eller lignende overvejes.
English: The outside of the SoloStar can be cleaned by wiping it with a damp cloth.
Danish: Ydersiden af SoloStar pennen kan rengøres ved at tørre den af med en fugtig klud.
English: Shelf life after first use of the pen
Danish: Opbevaringstid efter første anvendelse af pennen
English: Inject the dose
Danish: Injektion af dosis
English: A. Check that the dose window shows “0” following the safety test.
Danish: A. Tjek at doseringsdisplayet viser ”0” efter sikkerhedstesten.
English: • Special caution must be taken to avoid accidental needle injury and transmission of infection.
Danish: • Der skal udvises forsigtighed for at undgå skader ved et uheld med nålen og overførsel af infektioner.
English: A marked change in glycaemic control may cause temporary visual impairment, due to temporary alteration in the turgidity and refractive index of the lens.
Danish: En udtalt ændring i den glykæmiske kontrol kan føre til midlertidige synsforstyrrelser, der skyldes forbigående ændring i linsens turgiditet og refraktionsindeks.
English: Insulin absorption and hence the blood-glucose-lowering effect of a dose may vary from one injection area to another (e.g. the abdominal wall compared with the thigh).
Danish: Insulinabsorptionen og den deraf følgende blodglucosesænkende virkning af en dosis kan variere mellem de forskellige injektionsfelter (f.eks. på abdomen i forhold til låret).
English: Insulin Human Winthrop Rapid is also suitable for the treatment of hyperglycaemic coma and ketoacidosis, as well as for achieving pre-, intra- and post-operative stabilisation in patients with diabetes mellitus.
Danish: Insulin Human Winthrop Rapid kan også anvendes til behandling af hyperglykæmisk koma og ketoacidose samt til præ-, per- og post-operativ stabilisering af patienter med diabetes mellitus.
English: Select a dose of 2 units.
Danish: Der vælges en dosis på 2 enheder.
English: For use in insulin pumps, which are suitable for insulins containing 100 IU/ml.
Danish: Til brug i insulinpumper, som er beregnet til insulin, som indeholder 100 IE/ml.
English: Before injection remove any air bubbles (see instructions for using the pen).
Danish: Før injektion fjernes alle luftbobler (se instruktion for brug af pennen).
English: In the elderly, progressive deterioration of renal function may lead to a steady decrease in insulin requirements.
Danish: Hos ældre kan en fremadskridende nedsættelse af nyrefunktionen føre til et stadigt nedsat insulinbehov.
English: It is advisable to test your blood sugar immediately after taking glucose to check that you really have hypoglycaemia.
Danish: Det anbefales, at kontrollere blodsukkeret umiddelbart efter indtagelsen af glucose, for at se om du virkelig har hypoglykæmi.
English: Why does hyperglycaemia occur?
Danish: Hvorfor opstår hyperglykæmi?
English: Immediate type allergic reactions to insulin or to the excipients may be life-threatening.
Danish: Type 1 allergiske reaktioner over for insulin eller over for hjælpestofferne kan være livstruende.
English: Always perform the safety test before each injection.
Danish: Udfør altid en sikkerhedstest før hver injektion.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Subcutaneous or intravenous use.
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Subkutan eller intravenøs anvendelse.
English: In many patients, the signs and symptoms of neuroglycopenia are preceded by signs of adrenergic counter-regulation.
Danish: Hos mange patienter ses tegn på adrenerg modregulation forud for tegn og symptomer på neuroglykopeni.
English: After inserting a new cartridge:
Danish: Efter isætning af ny cylinderampul:
English: - certain uncompensated endocrine disorders (e.g. in hypothyroidism and in anterior pituitary or adrenocortical insufficiency), - concomitant treatment with certain other medicinal products.
Danish: - visse ukompenserede endokrine lidelser (f.eks. hypothyroidisme, hypofyseforlap- eller binyrebarkinsufficiens), - samtidig behandling med visse andre lægemidler.
English: Always use a new sterile needle for each injection.
Danish: Anvend altid en ny steril nål til hver injektion.
English: B. Take off the outer needle cap and keep it to remove the used needle after injection.
Danish: B. Tag den ydre nålekapsel af og behold den til at fjerne den brugte nål efter injektionen.
English: Take off the inner needle cap and discard it.
Danish: Tag den indre nålekapsel af og kasser den.
English: A. Select a dose of 2 units by turning the dosage selector.
Danish: A. Vælg en dosis på 2 ved at dreje dosisskalaen.
English: You should always consider the possibility of a technical problem if, in order to achieve the desired blood sugar levels, - you need additional insulin ("bolus doses") at larger doses or more often than usual, or - you need additional insulin ("bolus doses") at smaller doses or less often than usual.
Danish: Overvej altid, om der er opstået tekniske problemer, hvis du for at nå det ønskede blodsukker skal: - tage yderligere insulin ("bolus doser") i større doser eller oftere end normalt.
English: Following transfer from an animal insulin to human insulin, dose regimen reduction may be required in particular in patients who - were previously already controlled on rather low blood glucose levels, - have a tendency to hypoglycaemia, - previously required high insulin doses due to the presence of insulin antibodies.
Danish: Efter omstilling fra animalsk insulin til human insulin vil dosisreduktion især være påkrævet hos patienter, der: - allerede tidligere var indstillet på et relativt lavt blodglucoseniveau, - har tendens til hypoglykæmi, - tidligere havde behov for høje insulindoser pga. tilstedeværelse af insulinantistoffer.
English: Insulin Human Winthrop Rapid is a solution for injection under the skin or, in exceptional circumstances, into a vein (blood vessel).
Danish: Insulin Human Winthrop Rapid er en opløsning til injektion under huden eller, i særlige tilfælde, i en vene (blodåre).
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Danish: Indenfor hver gruppe af bivirkninger med samme frekvens er bivirkningerne opstillet efter faldende alvorlighed.
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: Beta-blokkere kan, som andre sympatolytiske lægemidler (såsom clonidin, guanethidin og reserpin), svække eller fuldstændig undertrykke de første advarselssymptomer, som kan advare dig om hypoglykæmisk reaktion.
English: If you are allergic to insulin or any of the other ingredients of this medicine (listed in section 6).
Danish: Hvis du er allergisk over for insulin eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i punkt 6).
English: You must use the pen as described in these Instructions for Use.
Danish: Du skal anvende pennen som beskrevet i brugsanvisningen.
English: Why does hypoglycaemia occur?
Danish: Hvorfor opstår hypoglykæmi?
English: If two different insulins have to be drawn into one single injection syringe, it is recommended that the shorter-acting insulin be drawn first to prevent contamination of the vial by the longer-acting preparation.
Danish: Når to forskellige insulintyper skal trækkes op i samme injektionssprøjte, tilrådes det at trække det korttidsvirkende insulin op først, så dets hætteglas ikke kontamineres med det langtidsvirkende præparat.
English: • Always have a spare SoloStar in case your SoloStar is lost or damaged.
Danish: • Opbevar altid en ekstra SoloStar i tilfælde af at din SoloStar bliver væk eller går i stykker
English: Such situations may result in severe hypoglycaemia (and possibly loss of consciousness) prior to the patient's awareness of hypoglycaemia.
Danish: Sådanne situationer kan føre til alvorlige tilfælde af hypoglykæmi (og eventuelt bevidsthedstab), uden at patienten forudgående har været bevidst om hypoglykæmien.
English: OTHER SPECIAL WARNING(S), IF NECESSARY Mix thoroughly.
Danish: EVENTUELLE ANDRE SÆRLIGE ADVARSLER Blandes omhyggeligt.
English: Stomach pain, fast and deep breathing, sleepiness or even loss of consciousness may be signs of a serious condition (ketoacidosis) resulting from lack of insulin.
Danish: Mavesmerter, hurtig og dyb vejrtrækning, søvnighed eller endda bevidsthedstab kan være tegn på en alvorlig tilstand (ketoacidose), som er en følge af mangel på insulin.
English: Do not shake the vial vigorously as this may lead to changes in the suspension (giving the vial a frosted appearance; see below) and cause frothing.
Danish: Hætteglasset må ikke rystes kraftigt, da dette kan ændre suspensionen (giver injektionsvæsken et rimfrostagtigt udseende, se nedenfor) og forårsage skumdannelse.
English: Test your blood sugar level and your urine for ketones as soon as any of the above symptoms occur.
Danish: Kontroller dit blodsukker og undersøg urinen for ketonstoffer, så snart nogen af ovennævnte symptomer opstår.
English: Hold the pen as shown in this leaflet.
Danish: Hold pennen som anvist her i brugsanvisningen.
English: Other mild reactions at the injection site (such as injection site redness, unusually intense pain on injection site, itching, injection site swelling or injection site inflammation) may occur.
Danish: Andre milde reaktioner på injektionsstedet (f.eks. rødme på injektionsstedet, usædvanlig stærk smerte på injektionsstedet, kløe, hævelse af injektionsstedet eller betændelse på injektionsstedet) kan forekomme.
English: Injection sites within an injection area must be rotated from one injection to the next.
Danish: Injektionsstedet inden for det enkelte injektionsfelt skal skiftes fra injektion til injektion.
English: It must only be used in insulin pumps suitable for this insulin.
Danish: Det må kun bruges i insulinpumper, som er beregnet til dette insulin.
English: Do not use SoloStar if it is damaged or not working properly (due to mechanical defects), it has to be discarded and a new SoloStar has to be used.
Danish: Anvend ikke SoloStar, hvis den er skadet eller ikke virker ordentligt (pga. mekaniske fejl), den skal kasseres og en ny SoloStar tages i brug.
English: In case of insufficient glucose control or a tendency to hyper- or hypoglycaemic episodes, the patient's adherence to the prescribed treatment regimen, injection sites and proper injection technique and all other relevant factors must be reviewed before dose adjustment is considered.
Danish: I tilfælde af utilstrækkelig glucosekontrol eller ved tendens til udvikling af hyper- eller hypoglykæmi skal følgende vurderes inden en eventuel dosisjustering: hvorvidt patienten har overholdt den ordinerede behandlingsforskrift, har fulgt forskrifterne for injektionssteder, har anvendt korrekt injektionsteknik, samt hvorvidt øvrige relevante faktorer er opfyldt.
English: Mixing of insulins
Danish: Blanding af insuliner
English: Particularly careful control of your diabetes, and prevention of hypoglycaemia, is important for the health of your baby.
Danish: En ekstra omhyggelig diabeteskontrol og forebyggelse af hypoglykæmi er vigtig for dit barns sundhed.
English: Pentamidine may cause hypoglycaemia which may sometimes be followed by hyperglycaemia.
Danish: Pentamidin kan føre til hypoglykæmi, som til tider kan efterfølges af hyperglykæmi.
English: In patients with severe hepatic impairment, insulin requirements may be diminished due to reduced capacity for gluconeogenesis and reduced insulin metabolism.
Danish: Hos patienter med alvorlig nedsat leverfunktion kan insulinbehovet være nedsat pga. nedsat gluconeogenesekapacitet og nedsat insulinmetabolisme.
English: The used SoloStar must be discarded as required by your local authorities.
Danish: Den brugte SoloStar bør bortskaffes i overensstemmelse med lokale krav.
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY
Danish: B. BETINGELSER FOR ELLER BEGRÆNSNINGER
English: The number in the dose window will return to “0” as you inject.
Danish: Nummeret i dosisdisplayet vil vise ”0” efter du har injiceret.
English: B Insert the needle into the skin.
Danish: B. Nålen stikkes ind i huden.
English: It may also be used in other insulin pumps for which it has been shown that they are suitable for this insulin and this type of cartridge (see pump manual).
Danish: Det kan også anvendes i andre insulinpumper, hvis disse er blevet testet og godkendt til anvendelse af dette insulin og denne type cylinderampuller (se brugsanvisning til pumpe).
English: You should contact your doctor for advice on driving if: - you have frequent episodes of hypoglycaemia, - the first warning symptoms which help you to recognise hypoglycaemia are reduced or absent.
Danish: Du bør kontakte din læge og få råd om bilkørsel hvis: - du har hyppige tilfælde af hypoglykæmi, - de første advarselssymptomer, som kan advare dig om hypoglykæmi er nedsatte eller helt mangler.
English: Dose adjustment may also be required, for example, if - the patient's weight changes, - the patient's life-style changes,
Danish: Dosisjustering kan også blive nødvendig, f.eks. hvis: - patientens vægt ændres, - patientens levevis ændres,
English: C. Deliver the dose by pressing the injection button in all the way.
Danish: C. Udløs dosis ved at trykke dosisknappen helt i bund.
English: One IU (International Unit) corresponds to 0.035 mg of anhydrous human insulin.
Danish: En IE (International Enhed) svarer til 0,035 mg vandfri human insulin.
English: Illnesses and injuries
Danish: Sygdomme og ulykkestilfælde
English: Remove and discard the needle
Danish: Fjernelse og bortskaffelse af nålen
English: The insulin is present as tiny crystals of insulin protamine.
Danish: Insulinet findes som små krystaller af protamininsulin.
English: Make sure that neither alcohol nor other disinfectants or other substances contaminate the insulin.
Danish: Sørg for, at hverken alkohol, andre desinficerende midler eller andre stoffer i øvrigt kommer i forbindelse med insulinet.
English: Each cartridge contains 3 balls (stainless steel).
Danish: Hver cylinderampul indeholder 3 kugler (rustfrit stål).
English: • SoloStar must never be used if it is damaged or if the patient is not sure if it is working properly.
Danish: • SoloStar må aldrig anvendes hvis den er gået i stykker, eller hvis patienten ikke er sikker på at den virker ordentligt.
English: A new sterile needle will be always used for each injection.
Danish: En ny steril nål skal altid bruges til hver injektion.
English: Do not soak, wash or lubricate the pen as this may damage it.
Danish: Skyl, vask eller smør aldrig pennen, da dette kan ødelægge den.
English: Empty pens must never be re-used and must be properly discarded.
Danish: Tomme penne må aldrig genbruges, og skal kasseres på betryggende vis.
English: The desired blood glucose levels, the insulin preparations to be used and the insulin dose regimen (doses and timings) must be determined individually and adjusted to suit the patient's diet, physical activity and life-style.
Danish: Det ønskede blodglucoseniveau, det anvendte insulin-præparat og insulin-doseringen (dosis og tidspunkt) fastlægges individuelt og skal tilpasses patientens kostvaner, fysiske aktivitet og levevis.
English: If insulin has been expelled through the needle tip, then the pen and the needle are working properly.
Danish: Hvis der afgives insulin ved nålespidsen, virker pennen og nålen korrekt.
English: Always use this medicine exactly as your doctor or pharmacist has told you.
Danish: Tag altid dette lægemiddel nøjagtigt efter lægens eller apotekspersonalets anvisninger.
English: HYPERGLYCAEMIA AND HYPOGLYCAEMIA
Danish: HYPERGLYKÆMI OG HYPOGLYKÆMI
English: A safety test must be performed before each injection.
Danish: Du skal udføre en sikkerhedstest før hver injektion.
English: • If no insulin comes out after changing the needle, your SoloStar may be damaged.
Danish: • Hvis der ikke kommer insulin ud efter erstatning af nålen, kan SoloStar være ødelagt.
English: - Do not take a double dose to make up for a forgotten dose.
Danish: - Du må ikke tage en dobbeltdosis, som erstatning for en glemt dosis.
English: Particular caution should be exercised, and intensified blood glucose monitoring is advisable in patients in whom hypoglycaemic episodes might be of particular clinical relevance, such as in patients with significant stenoses of the coronary arteries or of the blood vessels supplying the brain (risk of cardiac or cerebral complications of hypoglycaemia) as well as in patients with proliferative retinopathy, particularly if not treated with photocoagulation (risk of transient amaurosis following hypoglycaemia).
Danish: Særlig forsigtighed bør udvises og intensiveret monitorering af blodglucose tilrådes til patienter, hvor hypoglykæmi kan være af særlig klinisk betydning, f.eks. hos patienter med betydende stenoser i koronararterierne eller i hjernens forsyningskar (risiko for kardielle eller cerebrale hypoglykæmikomplikationer).
English: The need to adjust (e.g. reduce) the dose may become evident immediately after transfer.
Danish: Dosisjustering (f.eks. reduktion) kan være nødvendig umiddelbart efter præparatomstilling.
English: Handling of the pen
Danish: Anvendelse af pennen
English: Insulin Human Winthrop Infusat is therefore also suitable for continuous insulin infusion with other, conventional injection syringe pumps.
Danish: Insulin Human Winthrop Infusat er derfor også velegnet til kontinuerlig insulininfusion med andre konventionelle injektion infusionspumper.
English: Froth may interfere with the correct measurement of the dose.
Danish: Skum kan vanskeliggøre en korrekt afmåling af dosis.
English: SoloStar is a prefilled pen for the injection of insulin.
Danish: SoloStar er en fyldt pen til injektion af insulin.
English: If you think you may have a problem with your insulin, have it checked by your doctor or pharmacist.
Danish: Hvis du tror, du kan have et problem med din insulin, bør du få det kontrolleret af Deres læge eller på apoteket.
English: Do not use the pen after this time period.
Danish: Pennene må ikke anvendes efter denne periode.
English: 40 IU (International Units) of the active substance insulin human.
Danish: (Internationale Enheder) af det aktive stof human insulin.
English: OTHER After inserting a new cartridge: You must check that your insulin pen is working properly before you inject the first dose.
Danish: ANDET Efter isætning af ny cylinderampul: Kontrollér, at din insulinpen fungerer rigtigt, før den første injektion foretages.
English: Proliferative retinopathy; Diabetic retinopathy;
Danish: Proliferativ retinopati, diabetisk retinopati,
English: 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: 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: Mild episodes of hypoglycaemia can usually be treated with oral carbohydrates.
Danish: Milde tilfælde af hypoglykæmi kan sædvanligvis behandles ved indtagelse af kulhydrater.
English: The pen cap should be replaced on the pen.
Danish: Penhætten bør sættes på pennen igen.
English: Other side effects include (frequency cannot be estimated from the available data)
Danish: Andre bivirkninger inkluderer (hyppigheden kan ikke fastlægges ud fra de tilgængelige data)
English: It is designed for use in the Hoechst Infusor and H-Tron insulin pumps.
Danish: Det er udviklet til brug i Hoechst Infusor og H-Tron insulinpumper.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 17 January 2007 Date of latest renewal: 17 January 2012
Danish: Dato for første tilladelse: 17. januar 2007 Dato for seneste fornyelse: 17. januar 2012
English: Do not use this SoloStar if insulin is cloudy, coloured or has particles.
Danish: Brug ikke SoloStar hvis insulinen er tåget, farvet eller indeholder partikler.
English: Caution: Artificial sweeteners and foods with artificial sweeteners (such as diet drinks) are of no help in treating hypoglycaemia.
Danish: OBS: Husk at kunstige sødemidler og madvarer indeholdende kunstige sødemidler (såsom light sodavand) ikke kan anvendes til behandling af hypoglykæmi.
English: These cartridges should not be used with any other reusable pen as the dosing accuracy has only been established with the listed pens.
Danish: Disse cylinderampuller bør ikke bruges med andre former for flergangspenne, da dosisnøjagtighed kun er vist med ovenstående penne.
English: D-65926 Frankfurt / Main Germany
Danish: D-65926 Frankfurt/ Main Tyskland
English: Serious hypoglycaemia may cause a heart attack or brain damage and may be life-threatening.
Danish: Alvorlig hypoglykæmo kan give hjerteanfald eller hjerneskade og kan være livstruende.
English: increases the transport of glucose into cells as well as the formation of glycogen in the muscles and the liver, and improves pyruvate utilisation.
Danish: - øger glucosetransporten ind i cellerne, fremmer glykogendannelsen i muskler og lever, og forbedrer udnyttelsen af pyruvat.
English: Travel
Danish: Rejser
English: B Line up the needle with the pen, and keep it straight as you attach it (screw or push on, depending on the needle type).
Danish: B. Hold nålen vandret på linje med pennen når du sætter nålen på (skru eller tryk nålen på afhængig af nåletypen).
English: It is advisable to inject immediately after mixing.
Danish: Injektion bør foretages umiddelbart efter blandingen.
English: If you have liver or kidneys problems or if you are elderly, speak to your doctor as you may need a lower dose.
Danish: Tal med din læge, hvis du har lever- eller nyreproblemer, eller hvis du er ældre, da du kan have behov for en lavere dosis.
English: - other circumstances arise that may promote an increased susceptibility to hypo- or hyperglycaemia (see section 4.4).
Danish: - andre omstændigheder opstår, som øger følsomheden over for hypoglykæmi eller hyperglykæmi (se pkt.
English: Particularly careful control of your diabetes, and prevention of hypoglycaemia, is important for the health of your baby..
Danish: En ekstra omhyggelig diabeteskontrol og forebyggelse af hypoglykæmi er vigtig for dit barns sundhed
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Sanofi-Aventis Deutschland GmbH
Danish: NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Sanofi-Aventis Deutschland GmbH
English: You must check that your insulin pen is working properly before you inject the first dose.
Danish: Kontrollér, at din insulinpen fungerer rigtigt, før den første injektion foretages.
English: Such reactions to insulin or to the excipients can cause large-scale skin reactions (rash and itching all over the body); severe swelling of skin or mucous membranes (angiooedema), shortness of breath, a fall in blood pressure with rapid heart beat and sweating.
Danish: Sådanne reaktioner overfor insulin eller hjælpestoffer kan forårsage omfattende hudreaktioner (udslæt og kløe over hele kroppen), alvorlig hævelse af hud eller slimhinder (angioødem), åndenød, blodtryksfald med hurtig hjerterytme og svedudbrud.
English: Adjustments in dose regimen of the medicinal product, meal patterns, or physical activity may be needed.
Danish: Der skal muligvis foretages ændringer i dosering af lægemidlet, samt i kostplanerne og den fysiske aktivitet.
English: A. Put the outer needle cap back on the needle, and use it to unscrew the needle from the pen.
Danish: A. Sæt den ydre nålekapsel tilbage på nålen og brug den til at tage nålen af pennen.
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Danish: Hvis du vil have yderligere oplysninger om dette lægemiddel, skal du henvende dig til den lokale repræsentant for indehaveren af markedsføringstilladelsen.
English: You can set doses from 1 to 80 units in steps of 1 unit.
Danish: Du kan sætte dosis fra 1 til 80 Enheder i trin af 1 Enhed.