FrancophonIA/ELRC3.0 huggingface dataset:
English: Beta-blockers (used to treat high blood pressure) may weaken or suppress entirely the first warning symptoms which help you to recognise low blood sugar.
Danish: Betablokkere (til behandling af forhøjet blodtryk) kan svække eller fuldstændigt undertrykke de første advarselssignaler på lavt blodsukker.
English: • Oral contraceptives (birth control pills)
Danish: • Oral prævention (p-piller)
English: EXP/ During use or when carried as a spare: Use within 6 weeks
Danish: EXP/ Under brug eller medbragt som reserve: Bruges inden 6 uger
English: Pioglitazone should be discontinued if any deterioration in cardiac symptoms occurs.
Danish: Pioglitazon skal seponeres, hvis der sker en forværring af hjertesymptomer.
English: Keep the push-button fully depressed and let the needle remain under the skin for at least 6 seconds.
Danish: Hold trykknappen helt i bund, og lad nålen forblive under huden i mindst 6 sekunder.
English: On rare occasions, injection site reactions may require discontinuation of Actraphane.
Danish: I sjældne tilfælde kan reaktioner på injektionsstedet nødvendiggøre ophør af behandling med Actraphane.
English: Before travelling between different time zones, the patient should seek the doctor's advice since this may mean that the patient has to take the insulin and meals at different times.
Danish: Patienten skal informeres om at rådføre sig med sin læge før rejse mellem forskellige tidszoner, da dette kan betyde, at patienten skal tage insulin og mad på andre tidspunkter.
English: • Exercise more than usual.
Danish: • Motionerer mere end normalt.
English: Injection sites should always be rotated within the same region in order to reduce the risk of lipodystrophy.
Danish: Injektionsstederne skal altid varieres inden for samme område for at nedsætte risikoen for lipodystrofi.
English: Denmark Name and address of the manufacturers responsible for batch release
Danish: Danmark Navn og adresse på de fremstillere, der er ansvarlige for batchfrigivelse
English: See the big picture on top of this instruction.
Danish: Se det store billede i starten af denne brugervejledning.
English: Beta-blockers may mask the symptoms of hypoglycaemia.
Danish: Betablokkere kan maskere symptomerne på hypoglykæmi.
English: Avoidance of accidental mix-ups/medication errors
Danish: Undgå utilsigtet forveksling/medicineringsfejl
English: Very common - Hypoglycaemia*
Danish: Meget almindelig - Hypoglykæmi*
English: Paediatric population Actraphane can be used in children and adolescents.
Danish: Pædiatrisk population Actraphane kan anvendes til børn og unge.
English: You may stick yourself with the needle.
Danish: Du kan stikke dig på nålen.
English: Never try to put the inner needle cap back on the needle.
Danish: Forsøg aldrig at sætte den indre nålehætte tilbage på nålen.
English: Inadequate dosing or discontinuation of treatment, especially in type 1 diabetes, may lead to hyperglycaemia and diabetic ketoacidosis.
Danish: Utilstrækkelig dosering eller seponering af behandlingen, specielt hos type 1-diabetikere, kan føre til hyperglykæmi og diabetisk ketoacidose.
English: Before opening: Store in a refrigerator at 2°C - 8°C.
Danish: Før ibrugtagning: Opbevares i køleskab ved 2°C - 8°C.
English: A specific overdose of insulin cannot be defined, however, hypoglycaemia may develop over sequential stages if too high a dose relative to the patient's requirement is administered:
Danish: Der findes ingen specifikke definitioner på insulinoverdosering, men hypoglykæmi kan udvikles over sekventielle stadier, hvis der administreres større doser end svarende til patientens behov:
English: Very rare - Refraction disorders Uncommon - Diabetic retinopathy
Danish: Meget sjælden - Refraktionsanomalier Ikke almindelig - Diabetisk retinopati
English: ► If you drink alcohol, your need for insulin may change as your blood sugar level may either rise or fall.
Danish: ► Hvis du drikker alkohol, kan dit insulinbehov ændres, og dit blodsukkerniveau kan enten stige eller falde.
English: Administration with an insulin delivery system
Danish: Administration med et insulindispenseringssystem
English: For every following injection, move the pen up and down between the two positions at least 10 times until the liquid appears uniformly white and cloudy.
Danish: Før hver efterfølgende injektion, skal du vende pennen op og ned mellem de to positioner mindst 10 gange, indtil al væsken er ensartet hvid og uklar.
English: Transferring a patient to another type or brand of insulin should be done under strict medical supervision.
Danish: Skift til en anden type eller mærke af insulin må kun foretages under tæt medicinsk kontrol.
English: If there is not enough insulin left, use a new one.
Danish: Hvis der ikke er nok insulin tilbage, skal du tage en ny i brug.
English: Ask your doctor, pharmacist or nurse for advice before taking this medicine while pregnant or breastfeeding.
Danish: Spørg din læge, apotekspersonalet eller sygeplejersken til råds, før du tager dette lægemiddel, hvis du er gravid eller ammer.
English: If prolonged severe low blood sugar is not treated, it can cause brain damage (temporary or permanent) and even death.
Danish: Hvis alvorligt lavt blodsukker forbliver ubehandlet i længere tid, kan det medføre hjerneskade (midlertidig eller varig) og i værste fald død.
English: Effects from diabetes High blood sugar (hyperglycaemia)
Danish: Følger af diabetes Højt blodsukker (hyperglykæmi)
English: The dose can be corrected either up or down by turning the dose selector in either direction until the correct dose lines up with the pointer.
Danish: Dosis kan korrigeres både op og ned ved at dreje dosisvælgeren frem eller tilbage, indtil den korrekte dosis står ud for markøren.
English: Blood glucose monitoring is recommended to achieve optimal glycaemic control.
Danish: For at opnå optimal glykæmisk kontrol anbefales monitorering af blodglucose.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction and development.
Danish: De prækliniske data viser ingen særlig risiko for mennesker vurderet ud fra konventionelle undersøgelser af sikkerhedsfarmakologi, toksicitet efter gentagne doser, genotoksicitet, karcinogenicitet samt reproduktions- og udviklingstoksicitet.
English: Actraphane is indicated for treatment of diabetes mellitus.
Danish: Actraphane er indiceret til behandling af diabetes mellitus.
English: Detailed information on this medicine is available on the European Medicines Agency website http://www.ema.europa.eu.
Danish: Du kan finde yderligere oplysninger om dette lægemiddel på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/.
English: Needle (example)
Danish: Nål (eksempel)
English: • Screw the needle straight and tightly onto your InnoLet (picture 1B).
Danish: • Skru nålen lige og stramt på din InnoLet (figur 1B).
English: During use or when carried as a spare: The product can be stored for a maximum of 6 weeks.
Danish: Under brug eller medbragt som reserve: Lægemidlet kan opbevares i højst 6 uger.
English: If the dose selector stops before it returns to 0, the full dose has not been delivered, which may result in too high blood sugar level.
Danish: Hvis dosisvælgeren stopper før den vender tilbage til 0, er den fulde dosis ikke blevet indgivet, hvilket kan resultere i et for højt blodsukkerniveau.
English: The frequencies of hypoglycaemia vary with patient population, dose regimens and level of glycaemic control, please see Description of selected adverse reactions below.
Danish: Frekvensen af hypoglykæmi varierer afhængigt af patientgruppe, dosisregime og niveau af glykæmisk kontrol, se Beskrivelse af udvalgte bivirkninger, nedenfor.
English: Small amounts of air may collect in the needle and cartridge during normal use.
Danish: Der kan samle sig små luftbobler i nål og cylinderampul under normal brug.
English: This may lead to too high blood sugar level.
Danish: Dette kan føre til et for højt blodsukkerniveau.
English: ► If InnoLet is dropped, damaged or crushed.
Danish: ► Hvis InnoLet tabes, beskadiges eller knuses.
English: • Be careful not to bend or damage the needle before use.
Danish: • Vær opmærksom på ikke at bøje eller ødelægge nålen før brug.
English: ► Always carry a spare Penfill cartridge in case the one in use is lost or damaged.
Danish: ► Medbring altid en reserve Penfill cylinderampul i tilfælde af, at den anden bliver væk eller beskadiget.
English: A number of medicinal products are known to interact with glucose metabolism.
Danish: Et antal lægemidler er kendt for at påvirke glucosemetabolismen.
English: The following substances may increase the patient's insulin requirement:
Danish: Følgende lægemidler kan øge patientens insulinbehov:
English: Pull off the big outer needle cap and keep it for later.
Danish: Fjern den store ydre nålehætte, og gem den til senere.
English: Uncommon - Urticaria, rash Very rare - Anaphylactic reactions*
Danish: Ikke almindelig - Urticaria, udslæt Meget sjælden - Anafylaktiske reaktioner*
English: It is a biphasic formulation containing both fast-acting and long-acting insulin.
Danish: Det er en bifasisk formulering, som indeholder både hurtigtvirkende og langtidsvirkende insulin.
English: Intensification of insulin therapy with abrupt improvement in glycaemic control may be associated with temporary worsening of diabetic retinopathy, while long-term improved glycaemic control decreases the risk of progression of diabetic retinopathy.
Danish: Intensivering af insulinbehandling med en hurtigt forbedret glykæmisk kontrol kan være forbundet med en forbigående forværring af diabetisk retinopati, hvorimod forbedret glykæmisk kontrol gennem længere tid nedsætter risikoen for forværring af diabetisk retinopati.
English: ► If you are going abroad, travelling over time zones may affect your insulin needs and the timing hereof.
Danish: ► Hvis du har planer om at rejse til udlandet, kan en eventuel tidsforskel påvirke insulinbehovet og injektionstidspunktet.
English: Summary of serious and very common side effects
Danish: Oversigt over alvorlige og meget almindelige bivirkninger
English: In clinical trials, the frequency of hypoglycaemia varied with patient population, dose regimens and level of glycaemic control.
Danish: I kliniske studier variererede frekvensen af hypoglykæmi afhængigt af patientgruppe, dosisregime og niveau af glykæmisk kontrol.
English: ► If you have such low blood sugar that it makes you pass out, if you have had the need for an injection of glucagon, or if you have experienced many incidents of low blood sugar, talk to a doctor.
Danish: ► Hvis du får så lavt blodsukker, at du besvimer, hvis du har haft behov for en injektion med glucagon, eller hvis du har haft gentagne tilfælde af lavt blodsukker, skal du tale med din læge.
English: During use or when carried as a spare: Do not refrigerate or freeze.
Danish: Under brug eller medbragt som reserve: Må ikke opbevares i køleskab eller fryses.
English: ► Always check the cartridge, including the rubber plunger at the bottom of the cartridge.
Danish: ► Kontrollér altid cylinderampullen, herunder gummistemplet i bunden af cylinderampullen.
English: Otherwise the liquid may leak out, which can cause inaccurate dosing.
Danish: Ellers kan væsken løbe ud, hvilket kan forårsage ukorrekt dosering.
English: This process is influenced by several factors (e.g. insulin dose, injection route and site, thickness of subcutaneous fat, type of diabetes).
Danish: Flere faktorer har indflydelse på denne proces (f.eks. insulindosis, injektionsmåde og -sted, tykkelsen af det subkutane fedtlag, diabetestype).
English: • Angiotensin converting enzyme (ACE) inhibitors (used to treat certain heart conditions or high blood pressure)
Danish: • Angiotensin konverterende enzym-hæmmere (ACE-hæmmere) (til behandling af visse hjertelidelser eller forhøjet blodtryk)
English: Actraphane is administered subcutaneously by injection in the thigh, the abdominal wall, the gluteal region or the deltoid region.
Danish: Actraphane administreres subkutant ved injektion i låret, maveregionen, gluteal- eller deltoideusregionen.
English: ► In insulin infusion pumps.
Danish: ► I insulininfusionspumper.
English: If any of these apply, do not use Actraphane.
Danish: Hvis noget af ovenstående gør sig gældende, må du ikke bruge Actraphane.
English: • Make sure not to block the dose selector while injecting, as the dose selector must be allowed to return to 0 when you press the push-button.
Danish: • Sørg for, at du ikke blokerer for dosisvælgeren under injektion, da det er vigtigt, at den kan returnere frit til 0, når der trykkes på trykknappen.
English: Administration with InnoLet
Danish: Administration med InnoLet
English: Human insulin is reported to be degraded by insulin protease or insulin-degrading enzymes and possibly protein disulfide isomerase.
Danish: Humant insulin nedbrydes af insulinprotease eller insulinnedbrydende enzymer og muligvis af disulfidisomeraseproteinet.
English: Lead the needle into the big outer needle cap without touching it.
Danish: Før nålespidsen tilbage ind i den store ydre nålehætte uden at røre ved den.
English: With each injection, change the injection site within the particular area of skin that you use.
Danish: For hver injektion skal du vælge et nyt injektionssted inden for det bestemte hudområde, som du bruger.
English: • Dial the number of units required by turning the dose selector clockwise (picture 2).
Danish: • Indstil det ønskede antal enheder ved at dreje dosisvælgeren med uret (figur 2).
English: Disposable needle (example)
Danish: Engangsnål (eksempel)
English: Check that the dose selector is set at 0.
Danish: Kontrollér, at dosisvælgeren står på 0.
English: Close glucose monitoring is recommended during the transfer and in the initial weeks thereafter (see section 4.4).
Danish: Tæt glucosemonitorering anbefales i overgangsperioden og i de første behandlingsuger (se pkt.
English: • Complete the other stages of injection without delay.
Danish: • Fortsæt injektionsproceduren uden forsinkelse.
English: Do not use this medicinal product if you notice that the resuspended liquid is not uniformly white and cloudy.
Danish: Anvend ikke dette lægemiddel, hvis du bemærker, at den opblandede væske ikke er ensartet hvid og uklar.
English: • Inject too much insulin.
Danish: • Injicerer for meget insulin.
English: After stabilisation of the patient's blood glucose, adjustment of the dose should be considered (see sections 4.8 and 4.9).
Danish: Efter stabilisering af patientens blodglucose skal justering af dosis overvejes (se pkt.
English: If a drop of insulin still does not appear, the device is defective and must not be used.
Danish: Hvis der stadig ikke kommer en dråbe insulin til syne, er pennen defekt og må ikke bruges.
English: ► If you are allergic to human insulin or any of the other ingredients in this medicine, see section
Danish: ► Hvis du er allergisk over for humant insulin eller et af de øvrige indholdsstoffer i Actraphane, se under punkt 6.
English: Insulin suspensions should not be added to infusion fluids.
Danish: Insulinsuspensioner bør ikke tilsættes infusionsvæsker.
English: You cannot set a dose larger than the number of units remaining in the cartridge.
Danish: Du kan ikke indstille en dosis, som er højere end det antal enheder, der er tilbage i cylinderampullen.
English: Keep the push-button fully depressed until the needle has been withdrawn from the skin.
Danish: Hold trykknappen helt nede, indtil nålen er trukket ud fra huden.
English: This reduces the risk of too high or too low blood sugar level.
Danish: Dette reducerer risikoen for for højt eller for lavt blodsukkerniveau.
English: Use the injection technique advised by your doctor.
Danish: Anvend den injektionsteknik din læge har anbefalet.
English: When transferring from other intermediate or long-acting insulin medicinal products, adjustment of the Actraphane dose and timing of administration may be necessary.
Danish: Ved skift fra insulin med mellemlang virkningstid eller langtidsvirkende insulin kan dosisjustering af Actraphane og timing af administation være nødvendig.
English: You can carry it with you and keep it at room temperature (below 30°C) for up to 6 weeks.
Danish: Du kan have det med dig og opbevare det ved stuetemperatur (under 30°C) i op til 6 uger.
English: Novo Nordisk Production SAS 45, Avenue d'Orléans F-28000 Chartres France
Danish: Novo Nordisk Production SAS 45, Avenue d'Orléans F-28000 Chartres Frankrig
English: Be careful not to bend or damage the needle before use.
Danish: Vær opmærksom på ikke at bøje eller ødelægge nålen før brug.
English: If your doctor has switched you from one type or brand of insulin to another, your dose may have to be adjusted by your doctor.
Danish: Hvis lægen ændrer dit insulin til en anden insulintype eller et andet insulinmærke, er det muligt, at dosis skal justeres af din læge.
English: ► Check the label to make sure it is the right type of insulin.
Danish: ► Kontrollér på etiketten, at det er den rigtige insulintype.
English: Keep away from the cooling element.
Danish: Må ikke opbevares tæt på køleelementet.
English: Changes at the injection site (lipodystrophy): The fatty tissue under the skin at the injection site may shrink (lipoatrophy) or thicken (lipohypertrophy).
Danish: Forandringer på injektionsstedet (lipodystrofi): Fedtvævet under huden på injektionsstedet kan skrumpe ind (lipoatrofi) eller fortykkes (lipohypertrofi).
English: After you have resuspended the insulin, complete all the following steps of injection without delay.
Danish: Efter du har opblandet insulinet, gennemføres følgende injektionsprocedure uden forsinkelse.
English: • If you suddenly feel unwell, and you: start sweating; start being sick (vomiting); have difficulty in breathing; have a rapid heartbeat; feel dizzy.
Danish: • Hvis du pludselig føler dig utilpas, og du begynder at svede, kaster op, får åndedrætsbesvær,
English: If not, talk to your doctor.
Danish: Hvis det ikke forsvinder, skal du tale med din læge.
English: This reduces the risk of contamination, infection, leakage of insulin, blocked needles and inaccurate dosing.
Danish: Dette reducerer risikoen for forurening, infektion, udsivning af insulin, blokerede nåle og upræcis dosering.
English: List of other side effects Uncommon side effects
Danish: Oversigt over andre bivirkninger Ikke almindelige bivirkninger
English: • Put the pen cap back on your InnoLet to protect the insulin from light.
Danish: • Sæt penhætten tilbage på din InnoLet for at beskytte insulinet mod lys.
English: Never share your pen or your needles with other people.
Danish: Del aldrig din pen og nåle med andre.
English: Both hypoglycaemia and hyperglycaemia, which can occur in inadequately controlled diabetes therapy, increase the risk of malformations and death in utero.
Danish: Både hypoglykæmi og hyperglykæmi, som kan optræde ved utilstrækkeligt kontrolleret diabetesbehandling, øger risikoen for fosterskader og -død.
English: • Glucocorticoids (such as ‘cortisone' used to treat inflammation)
Danish: • Glukokortikoider (såsom "cortison" til behandling af inflammation (vævsirritation))
English: You can carry it with you and keep it at room temperature (below 25°C) for up to 6 weeks.
Danish: Du kan have det med dig og opbevare det ved stuetemperatur (under 25°C) i op til 6 uger.
English: What you need to know before you use Actraphane Do not use Actraphane
Danish: Det skal du vide, før du begynder at tage Actraphane Tag ikke Actraphane
English: This may indicate a blocked or damaged needle.
Danish: Dette kan betyde, at nålen er blokeret eller ødelagt.
English: Always ensure you use the correct pen before you inject your insulin.
Danish: Kontrollér altid, at det er den korrekte pen, du bruger, før du injicerer dit insulin.
English: If you stop taking your insulin
Danish: Hvis du holder op med at tage insulin
English: When patients are transferred between different types of insulin medicinal products, the early warning symptoms of hypoglycaemia may change or become less pronounced than those experienced with their previous insulin.
Danish: Skift til et præparat med en anden type insulin kan betyde, at de tidlige advarselssymptomer på hypoglykæmi kan ændres eller blive mindre udtalte end dem, patienten oplevede med den tidligere insulin.
English: Uncommon - Lipodystrophy*
Danish: Ikke almindelig - Lipodystrofi*
English: Your blood sugar level may rise (hyperglycaemia) if you take:
Danish: Dit blodsukkerniveau kan stige (hyperglykæmi), hvis du tager:
English: Designed to be used with NovoFine or NovoTwist disposable needles up to a length of 8 mm
Danish: Beregnet til anvendelse sammen med NovoFine eller NovoTwist engangsnåle med en længde på op til 8 mm
English: Vision problems: When you first start your insulin treatment, it may disturb your vision, but the disturbance is usually temporary.
Danish: Synsproblemer: Når du påbegynder insulinbehandling, kan du opleve synsforstyrrelser, men forstyrrelsen er normalt midlertidig.
English: If you forget to take your insulin your blood sugar may get too high (hyperglycaemia).
Danish: Hvis du glemmer at tage insulin, kan dit blodsukker blive for højt (hyperglykæmi).
English: The following substances may reduce the patient's insulin requirement:
Danish: Følgende lægemidler kan reducere patientens insulinbehov:
English: If you forget to take your insulin
Danish: Hvis du har glemt at tage insulin
English: Do not refrigerate or freeze.
Danish: Må ikke opbevares i køleskab eller fryses.
English: What to do if you experience high blood sugar: ► If you get any of the above signs: test your blood sugar level, test your urine for ketones if you can, then seek medical advice immediately.
Danish: Du skal gøre følgende, hvis du får højt blodsukker: ► Hvis du oplever nogle af ovennævnte signaler: Mål dit blodsukkerniveau, kontrollér om muligt urinen for ketonstoffer og søg straks lægehjælp.
English: ► If FlexPen is dropped, damaged or crushed.
Danish: ► Hvis FlexPen tabes, beskadiges eller knuses.
English: Insulin suspensions are not to be used in insulin infusion pumps.
Danish: Insulinsuspensioner må ikke anvendes i insulininfusionspumper.
English: In type 1 diabetes, untreated hyperglycaemic events eventually lead to diabetic ketoacidosis, which is potentially lethal.
Danish: Hos type 1-diabetikere fører ubehandlede hyperglykæmiske tilfælde i sidste instans til diabetisk ketoacidose, som kan medføre døden.
English: Always keep your pen and needles out of sight and reach of others, especially children.
Danish: Opbevar altid din pen og nåle utilgængeligt for andre, specielt børn.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION
Danish: LÆGEMIDLETS NAVN, STYRKE OG ADMINISTRATIONSVEJ
English: The advisability of driving should be considered in these circumstances.
Danish: I disse tilfælde bør det nøje vurderes, om motorkørsel kan tilrådes.
English: Do not refill your InnoLet.
Danish: Genopfyld aldrig din InnoLet.
English: Upon regaining consciousness, administration of oral carbohydrates is recommended for the patient in order to prevent a relapse.
Danish: Når patienten har genvundet bevidstheden, anbefales det at give kulhydrater oralt for at forhindre et tilbagefald.
English: Setting the dose • Always check that the push-button is fully depressed and the dose selector is set to 0.
Danish: Indstilling af dosis • Kontrollér altid, at trykknappen er helt i bund, og at dosisvælgeren står på 0.
English: The cartridge contains a glass ball to facilitate resuspension.
Danish: Cylinderampullen indeholder en glaskugle, der letter opblandingen.
English: Hold your FlexPen with the needle pointing upwards and tap the cartridge gently with your finger a few times to make any air bubbles collect at the top of the cartridge.
Danish: Hold din FlexPen, så nålen vender opad, og bank let på cylinderampullen med fingeren et par gange, så eventuelle luftbobler samles i toppen af cylinderampullen.
English: - If the second and third characters are H7 or T6, the manufacturer is Novo Nordisk Production
Danish: - Hvis andet og tredje skrifttegn er H7 eller T6, så er fremstilleren Novo Nordisk Production SAS, 45
English: The suspension is cloudy, white and aqueous.
Danish: Suspensionen er uklar, hvid og vandig.