FrancophonIA/ELRC3.0 huggingface dataset:
English: In most cases you will need a doctor.
Danish: I de fleste tilfælde vil du have behov for en læge.
English: Tell your relatives, friends and close colleagues the following:
Danish: Fortæl familie, venner og nærmeste kolleger følgende:
English: Open here
Danish: Åbn her
English: This helps prevent:
Danish: Dette hjælper til at undgå:
English: • Contamination and/or infection
Danish: • Kontaminering og/eller infektion
English: Do not use this SoloStar.
Danish: Brug ikke denne SoloStar.
English: This ensures that you get an accurate dose by:
Danish: Dette sikrer at du får en korrekt dosis ved at:
English: It should be handled with care.
Danish: Den bør håndteres med forsigtighed.
English: Each pen contains multiple doses.
Danish: Hver pen indeholder adskillige doser.
English: Perform a safety test
Danish: Udfør en sikkerhedstest
English: The dose can then be selected.
Danish: Doseringen kan derefter vælges.
English: The pictures below are for illustrative purposes only.
Danish: Billederne nedenfor har udelukkende et illustrativt formål.
English: MedDRA system organ classes
Danish: MedDRA system organklasser
English: Slowly count to 10 before you withdraw the needle from the skin.
Danish: Tæl langsomt til 10 før du fjerner nålen fra huden.
English: • ensuring that pen and needle work properly
Danish: • Sikre at pen og nål virker korrekt
English: Make sure that you contact a doctor early.
Danish: Sørg for at kontakte lægen tidligt i forløbet.
English: No evidence of toxic effects was found.
Danish: Der fandtes ingen tegn på toksiske virkninger.
English: Problems with the pen?
Danish: Problemer med pennen?
English: Always carry some sugar (at least 20 grams) with you.
Danish: Du bør altid have noget sukker (mindst 20 gram) på dig.
English: The insulin requirement is often increased.
Danish: Insulinbehovet er ofte øget.
English: For these reasons, it must be done in a clinic or a similar setting.
Danish: Derfor skal det foregå på hospitalet eller et lignende sted.
English: It is specially stabilised to minimise loss of efficacy which may result from mechanical and thermal stress in such pumps.
Danish: Det er specielt stabiliseret for at formindske effekttabet, der skyldes de mekaniske og termiske stressvilkår i sådanne pumper.
English: Insulin that you inject in such a site may not work very well.
Danish: Insulin, der injiceres et sådant sted, virker måske ikke så godt.
English: Therefore, no specific frequency can be presented.
Danish: Derfor kan der ikke angives nogen specifik frekvens.
English: Many factors may influence your blood sugar level.
Danish: Mange faktorer kan påvirke blodsukkeret.
English: Your doctor or nurse should have discussed this with you previously.
Danish: Din læge eller sygeplejerske vil på forhånd have gennemgået dette med dig.
English: The puncture site within a given injection area must be changed regularly (generally, every 1 to 3 days).
Danish: Indstiksstedet for et bestemt injektionsfelt skal skiftes regelmæssigt (normalt med 1-3 dages mellemrum).
English: Schematic diagram of the pen
Danish: Skematisk diagram af pennen
English: Careful monitoring of glucose control is essential.
Danish: Omhyggelig glucosekontrol er vigtig.
English: Check your blood sugar frequently.
Danish: Kontrollér blodsukkeret hyppigt.
English: In this case, either you can inject what is remaining in the pen and complete your dose with a new SoloStar or use a new SoloStar for your full dose.
Danish: I dette tilfælde kan du enten injicere, hvad der er tilbage i pennen, og få resten af dosis fra en ny SoloStar eller anvende en ny SoloStar til hele din dosis.
English: This helps prevent contamination, and potential needle blocks.
Danish: Dette hjælper med at forebygge kontaminering og potentiel blokering af nålen.
English: These injections are justified even if it is not certain that you have hypoglycaemia.
Danish: Det er forsvarligt at give disse injektioner, også selv om det ikke er sikkert, at du har hypoglykæmi.
English: These symptoms often develop before the symptoms of a low sugar level in the brain.
Danish: Disse symptomer går ofte forud for symptomerne på lavt blodsukker i hjernen.
English: If you turn past your dose, you can turn back down.
Danish: Hvis du drejer forbi din dosis, kan du dreje tilbage igen.
English: This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Danish: Dette lægemiddel må ikke blandes med andre lægemidler end dem, der er anført under pkt 6.6.
English: Be careful when you start or stop taking another medicine.
Danish: Vær forsigtig, når du påbegynder eller holder op med at tage andre lægemidler
English: SoloStar has to be protected from dust and dirt.
Danish: SoloStar skal beskyttes mod støv og snavs.
English: However, the average insulin requirement is often 0.5 to 1.0 IU per kg body weight per day.
Danish: Det gennemsnitlige insulinbehov udgør dog ofte 0,5 - 1,0 IE pr. kg legemsvægt pr. døgn.
English: If the hypoglycaemia comes back again take another 10 to 20 g sugar.
Danish: Hvis du igen får hypoglykæmi, skal du indtage endnu 10 til 20 g sukker.
English: This is because the insulin may have lost some of its effectiveness.
Danish: Dette skyldes at insulinet kan have mistet noget af sin virkning.
English: Some medicines cause changes in the blood sugar level (decrease, increase or both depending on the situation).
Danish: Nogle lægemidler kan ændre blodsukkeret (få det til at falde, stige eller begge dele afhængig af situationen).
English: Insulin requirements may decrease during the first trimester and generally increase during the second and third trimesters.
Danish: Insulinbehovet kan falde i første trimester og stiger normalt i andet og tredje trimester.
English: Important information for use of SoloStar:
Danish: Vigtig information vedrørende anvendelse af Solostar:
English: They can also spread around the injection site.
Danish: De kan også brede sig til området omkring injektionsstedet.
English: Be familiar with your warning symptoms.
Danish: Vær fortrolig med dine advarselssymptomer.
English: Insulin must always be infused under aseptic conditions.
Danish: Insulin skal altid infunderes under aseptiske forhold.
English: If you are not able to use SoloStar or follow all the instructions completely on your own, you must use SoloStar only if you have help from a person who is able to follow the instructions completely.
Danish: Hvis du ikke selv er i stand til at følge alle instruktionerne fuldstændig, så brug kun SoloStar, hvis du har hjælp fra en person, som kan følge instruktionerne.
English: - In your body
Danish: - I kroppen
English: This may constitute a risk in situations where these abilities are of special importance (e.g. driving a car or using machines).
Danish: Dette kan udgøre en risiko i situationer, hvor disse evner er af særlig betydning (f.eks. ved bilkørsel eller ved betjening af maskiner).
English: It is essential for patients with pre-existing or gestational diabetes to maintain good metabolic control throughout pregnancy.
Danish: Det er meget vigtigt for patienter med kendt eller gestationel diabetes at opretholde en god metabolisk kontrol under graviditeten.
English: It should be considered whether it is advisable to drive or use machines in these circumstances.
Danish: I sådanne tilfælde bør det overvejes, om bilkørsel eller betjening af maskiner er tilrådeligt.
English: • If no insulin comes out, check for air bubbles and repeat the safety test two more times to remove them.
Danish: • Hvis der ikke kommer insulin ud, så tjek for luftbobler og gentag sikkerhedstesten to eller flere gange for at fjerne dem.
English: Generally, the greater and more rapid the decline in blood glucose, the more marked is the phenomenon of counter-regulation and its symptoms.
Danish: Generelt gælder det, at jo større og hurtigere faldet i blodglucose er, des mere udtalt er modregulationstilstanden og dens symptomer.
English: Subcutaneous or intravenous use.
Danish: Subkutan eller intravenøs anvendelse.
English: The basal metabolic requirement is 40% to 60% of the total daily requirement.
Danish: Det basale metaboliske behov udgør 40 - 60% af det totale døgnbehov.
English: Caution should be exercised when prescribing to pregnant women.
Danish: Der bør udvises forsigtighed ved ordinering til gravide.
English: Prior to each injection, a safety test has to be performed to ensure that pen and needle work properly and to remove air bubbles.
Danish: Før hver injektion skal der udføres en sikkerhedstest for at sikre at pennen og nålen virker rigtigt og for at fjerne luftbobler.
English: If the combination is used, patients should be observed for signs and symptoms of heart failure, weight gain and oedema.
Danish: Hvis kombinationen anvendes, skal patienterne observeres for tegn og symptomer på hjertesvigt, vægtstigning og ødem.
English: B. Select your required dose (in the example below, the selected dose is 30 units).
Danish: B. Vælg din dosis (i eksemplet nedenfor er der valgt en dosis på 30 enheder).
English: Special caution must be taken when removing and disposing of the needle.
Danish: Der skal udvises særlig forsigtighed ved fjernelse og bortskaffelse af nålen.
English: Follow these instructions completely each time you use SoloStar to ensure that you get an accurate dose.
Danish: Følg denne brugsanvisning fuldstændig hver gang du anvender SoloStar for at sikre, du får den nøjagtige dosis.
English: Refer to the manufacturer's instructions for using the pen.
Danish: Følg fremstillerens instruktioner for anvendelse af pennen.
English: However, it must be noted that the pharmacokinetics of insulin do not reflect its metabolic action.
Danish: Det skal imidlertid bemærkes, at insulins farmakokinetik ikke afspejler dets metaboliske virkning.
English: • Skin and allergic reactions
Danish: - Hud og allergiske reaktioner
English: The pen should be used as recommended in the information provided by the device manufacturer.
Danish: Pennen skal anvendes som anbefalet i informationen fra fremstilleren af pennen.
English: The warning symptoms of hypoglycaemia may be changed, be less pronounced or be absent in certain risk groups.
Danish: Advarselssymptomerne på hypoglykæmi kan være ændrede, mindre udtalte, eller ikke tilstede hos visse risikogrupper.
English: This regimen requires close monitoring (metabolic status, acid-base and electrolyte status, vital parameters etc.) in an intensive care unit or similar setting.
Danish: Dette regime kræver tæt monitorering (metabolisk status, syre-base- og elektrolytstatus, vitale parametre etc.) på en intensivafdeling eller lignende.
English: Your insulin dosage may need to be changed during pregnancy and after giving birth.
Danish: Din insulindosis skal muligvis justeres under graviditeten og efter fødslen.
English: Situations in which you must not start or continue to use insulin pumps are described in the operating manuals for these pumps.
Danish: De situationer, hvor du ikke må begynde eller fortsætte med at bruge insulinpumper er beskrevet i brugsanvisningen for disse pumper.
English: • Severe allergic reaction with low blood pressure (shock)
Danish: - Alvorlige allergiske reaktioner med lavt blodtryk (shock).
English: Severe hyperglycaemia or ketoacidosis must always be treated by a doctor, normally in a hospital.
Danish: Alvorlig hyperglykæmi eller ketoacidose skal altid behandles af en læge, og foregår normalt under hospitalsindlæggelse.
English: • Do not push the injection button while turning, as insulin will come out.
Danish: • Tryk ikke på dosisknappen mens du drejer, da der så vil komme insulin ud.
English: Most minor reactions to insulins usually resolve in a few days to a few weeks.
Danish: De fleste mindre reaktioner over for insulin forsvinder som regel i løbet af få dage til få uger.
English: SoloStar is designed to work accurately and safely.
Danish: SoloStar er designet til at virke præcist og sikkert.
English: Patients with type 1 diabetes must continue to consume at least a small amount of carbohydrates on a regular basis, even if they are able to eat only little or no food, or are vomiting etc. and they must never omit insulin entirely.
Danish: Type 1-diabetikere skal fortsætte med at indtage i det mindste små mængder af kulhydrater regelmæssigt, også selv om de kun kan spise lidt eller ingen føde, kaster op etc., og de må aldrig udelade insulin helt.
English: After removing the cap, the needle should be carefully attached straight onto the pen.
Danish: Efter fjernelse af hætten skal nålen omhyggeligt sættes lige på pennen.
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) ) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Danish: • Periodiske, opdaterede sikkerhedsindberetninger (PSUR'er) Indehaveren af markedsføringstilladelsen skal fremsende PSUR'er for dette lægemiddel i overensstemmelse med kravene på listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF og offentliggjort på den europæiske webportal for lægemidler.
English: Insulin does cross the placental barrier, although not in clinically significant amount.
Danish: Insulin passerer placentabarrieren, dog ikke i kliniske signifikante mængder.
English: To prevent the possible transmission of disease, each pen must be used by one patient only.
Danish: For at undgå overførsel af sygdomme, må pennen kun anvendes af den samme patient.
English: Avoid situations where SoloStar might be damaged.
Danish: Undgå situationer, hvor SoloStar kan blive ødelagt.
English: Studies of pharmacodynamic effects following subcutaneous administration in rabbits and dogs revealed the expected hypoglycaemic reactions.
Danish: Farmakodynamiske undersøgelser efter subkutan administration på kaniner og hunde viste de forventede hypoglykæmiske reaktioner.
English: If normal or decreased values for glycated haemoglobin are noted, the possibility of recurrent, unrecognised (especially nocturnal) episodes of hypoglycaemia must be considered.
Danish: Såfremt der observeres normale eller ligefrem nedsatte værdier af glykosyleret hæmoglobin, skal risikoen for tilbagevendende, ikke-erkendte (især natlige) hypoglykæmiske anfald tages i betragtning.
English: Intravenous insulin therapy must generally take place in an intensive care unit or under comparable monitoring and treatment conditions (see "Daily doses and timing of administration").
Danish: Intravenøs insulinbehandling bør som hovedregel foregå på en intensivafdeling eller under lignende monitorerings- og behandlingsforhold (se "Døgndosis og tidspunkt for administration").
English: OTHER SPECIAL WARNING(S), IF NECESSARY Use only clear and colourless solutions.
Danish: EVENTUELLE ANDRE SÆRLIGE ADVARSLER Kun klare og farveløse opløsninger må anvendes.
English: Change the needle and try again.
Danish: Erstat nålen og forsøg igen.
English: Please check section 6.4 for instructions on how to store SoloStar.
Danish: Læs venligst sektion 6.4 vedrørende opbevaringsbetingelser for SoloStar.
English: • Always perform the safety test before each injection (see Step 3).
Danish: • Udfør altid en sikkerhedstest før hver injektion (se trin 3).
English: • removing air bubbles
Danish: • Fjerne luftbobler
English: Changes in strength, brand (manufacturer), type (regular, NPH, lente, long-acting, etc.), origin (animal, human, human insulin analogue) and/or method of manufacture may result in the need for a change in dosage.
Danish: Ændringer i styrke, brand (fremstiller), type (regular, NPH, lente, langtidsvirkende, etc.), oprindelse (animalsk, human, human insulin analog) og/eller fremstillingmetode kan medføre, at det kan være nødvendigt at ændre dosis.
English: Immediately after delivery, insulin requirements decline rapidly (increased risk of hypoglycaemia).
Danish: Umiddelbart efter fødslen falder insulinbehovet hurtigt (øget risiko for hypoglykæmi).
English: Local tolerability studies following subcutaneous and intramuscular administration in rabbits gave no remarkable findings.
Danish: Lokale toleranceforsøg efter subkutan og intramuskulær administration på kaniner viste ingen bemærkelsesværdige fund.
English: The insulin cartridge of the pump must be sterile and must be used once only.
Danish: Pumpens insulinpatron skal være steril og må kun anvendes en gang.
English: Intercurrent illness requires intensified metabolic monitoring.
Danish: Interkurrente sygdomme kræver en intensiveret metabolisk kontrol.
English: The cartridge must only be used once.
Danish: Reservoiret må kun anvendes én gang.
English: Always tell people who are caring for you or treating you that you require insulin.
Danish: Fortæl altid de personer, som passer eller behandler dig, at du skal have insulin.
English: Immediately take about 10 to 20 g sugar, such as glucose, sugar cubes or a sugar-sweetened beverage.
Danish: Tag omgående ca. 10 til 20 g sukker som glucose, hugget sukker eller en sukkersødet drik.
English: Do not force the dosage selector to turn.
Danish: Tving ikke doseringsskalaen til at dreje.
English: If you are not confident about recognising your warning symptoms, avoid situations (such as driving a car) in which you or others would be put at risk by hypoglycaemia.
Danish: Hvis du ikke er fortrolig med dine advarselssymptomer, bør du undgå situationer (såsom bilkørsel), hvor du selv eller andre kan bringes i fare på grund af risikoen for hypoglykæmi.
English: A limited amount of data on pregnant women (less than 300 pregnancy outcomes reported) exposed to marketed insulin human indicates no safety issues in use of insulin human in pregnancy.
Danish: En begrænset mængde data for gravide kvinder (mindre end 300 graviditetsudfald rapporteret) behandlet med markedsført human insulin viser ingen sikkerhedsproblemer ved brug af human insulin under graviditet.
English: Before travelling, consult your doctor.
Danish: Før du skal ud at rejse, skal du tale med din læge.
English: • You cannot turn the dosage selector past the number of units left in the pen.
Danish: • Du kan ikke dreje doseringsskalaen forbi antallet af enheder, der er tilbage i pennen.
English: Whenever the patient notices a rapid increase in blood glucose which does not respond to a bolus dose, a check must be made for possible catheter obstruction.
Danish: Hvis en patient bliver opmærksom på hurtigt stigende blodglucose, som ikke responderer på en bolusdosis, skal muligheden for kateterobstruktion undersøges.
English: SoloStar has to be used as recommended in these Instructions for Use (see section 6.6).
Danish: SoloStar skal anvendes som anbefalet i denne brugsanvisning (se pkt.
English: This ensures that the full dose will be delivered.
Danish: Dette sikrer, at hele dosis er udløst.
English: No effects on the suckling child are anticipated.
Danish: Der forventes ingen påvirkning af børn, der bliver ammet.
English: Date of latest renewal: 17 January 2012
Danish: Dato for seneste fornyelse: 17. januar 2012
English: - In your brain
Danish: - I hjernen
English: Your doctor will tell you if you have to mix insulin human preparations.
Danish: Din læge vil fortælle dig, om, du skal blande human insulin-præparater.
English: However, only very rarely, this will require a change to your insulin dosage.
Danish: Dette vil dog kun yderst sjældent gøre det nødvendigt at ændre din insulindosis.
English: Close metabolic monitoring is recommended during the transition and in the initial weeks thereafter.
Danish: Omhyggelig metabolisk monitorering anbefales under præparatomstillingen og i de efterfølgende uger.
English: In many cases, urine tests for ketones are indicated, and often it is necessary to adjust the insulin dose.
Danish: Urintests for ketonstoffer er indiceret i mange tilfælde, og det er ofte nødvendigt at justere insulindosis.
English: In healthy subjects, the serum half-life of insulin is approximately 4 to 6 minutes.
Danish: Hos raske personer er insulins serum-halveringstid omkring 4 - 6 minutter.
English: Read these instructions carefully before using your SoloStar.
Danish: Læs denne brugsanvisning omhyggeligt før du anvender SoloStar.
English: In clinical studies and during marketed use, the frequency varies with patient population and dose regimens.
Danish: I kliniske forsøg og under anvendelse efter markedsføring varierer hyppigheden mellem patientpopulation og doseringsregimer.
English: C. OTHER CONDITIONS AND REQUIREMENTS OF THE
Danish: C. ANDRE FORHOLD OG BETINGELSER FOR
English: Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Danish: Læs denne indlægsseddel grundigt inden du begynder at tage dette lægemiddel, da den indeholder vigtige informationer.
English: Please check the reverse (insulin) side of this leaflet for instructions on how to store SoloStar.
Danish: Læs venligst den modsatte (insulin) side af denne indlægsseddel vedrørende hvordan SoloStar opbevares
English: Insulin administration into a vein for example to treat severe hyperglycaemia and ketoacidosis, requires experience and special safety precautions.
Danish: Injektion af insulin i en vene, for eksempel ved behandling af alvorlig hyperglykæmi og ketoacidose, kræver erfaring og særlige sikkerhedsforanstaltninger.
English: If a dose greater than 80 units is required, it should be given as two or more injections.
Danish: Hvis der kræves en dosis på mere end 80 enheder, skal det gives som to eller flere injektioner.
English: Stop your insulin infusion (if necessary, by withdrawing the needle) at least until you feel that you are fully alert again.
Danish: Stop insulininfusionen (om nødvendigt ved at tage nålen ud) i det mindste indtil du føler, at du er dig selv igen.
English: In such a case, you may develop severe hypoglycaemia (and even faint) before you are aware of the problem.
Danish: I sådanne tilfælde kan du udvikle alvorlig hypoglykæmi (og endda besvime), før du selv bliver klar over problemet.
English: Continuous rotation of the injection site within the given injection area may help to reduce or prevent these reactions.
Danish: Stadig skift af injektionssted, inden for et givet injektionsfelt, kan mindske eller forhindre disse reaktioner.
English: Then the injection button should be held down 10 seconds before withdrawing the needle.
Danish: Derefter holdes dosisknappen inde i 10 sekunder før nålen trækkes ud.
English: • Skin changes at the injection site (lipodystrophy) If you inject your insulin too often at the same skin site, fatty tissue under the skin at this site may either shrink or thicken.
Danish: - Hudforandringer på injektionsstedet (lipodystrofi) Hvis du for ofte injicerer din insulin på samme sted i huden, kan fedtvævet under huden på dette sted enten svinde eller blive tykkere.
English: • Before each use, a new needle must always be carefully attached and a safety test must be performed.
Danish: • Før hver anvendelse skal en ny nål påsættes og sikkerhedstest udføres.
English: A number of substances affect glucose metabolism and may require dose adjustment of human insulin.
Danish: En række stoffer har indflydelse på glucosemetabolismen og kan nødvendiggøre dosisjustering af human insulin.
English: Daily doses and timing of administration
Danish: Døgndosis og tidspunkt for administration
English: In rare cases, the presence of such anti-insulin antibodies may necessitate adjustment of the insulin dose in order to correct a tendency to hyper- or hypoglycaemia.
Danish: I sjældne tilfælde kræver forekomsten af sådanne anti-insulin-antistoffer justering af insulindosis for at korrigere for tendensen til udvikling af hyper- eller hypoglykæmi.
English: The patient's ability to concentrate and react may be impaired as a result of hypoglycaemia or hyperglycaemia or, for example, as a result of visual impairment.
Danish: Patientens koncentrations- og reaktionsevne kan være nedsat som følge af hypoglykæmi eller hyperglykæmi, eller f.eks. på grund af nedsat syn.
English: Shock
Danish: Chok