FrancophonIA/ELRC3.0 huggingface dataset:
English: Very rare - Peripheral neuropathy (painful neuropathy)
Danish: Meget sjælden - Perifer neuropati (smertefuld neuropati)
English: Usually, the first symptoms of hyperglycaemia develop gradually over a period of hours or days.
Danish: De første symptomer på hyperglykæmi kommer normalt gradvist over en periode på timer eller dage.
English: Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Danish: • når risikostyringssystemet ændres, særlig som følge af, at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i risk/benefit-forholdet, eller som følge af, at en vigtig milepæl (lægemiddelovervågning eller risikominimering) er nået.
English: Paediatric population Protaphane can be used in children and adolescents.
Danish: Pædiatrisk population Protaphane kan anvendes til børn og unge.
English: Serious allergic reaction to Protaphane or one of its ingredients (called a systemic allergic reaction) is a very rare side effect, but it can potentially be life threatening.
Danish: Alvorlig allergisk reaktion på Protaphane eller et af de øvrige indholdsstoffer (også kaldet systemisk allergisk reaktion) er en meget sjælden bivirkning, men den kan være livstruende.
English: The maximum plasma concentration of the insulin is reached within 2-18 hours after subcutaneous administration.
Danish: Maksimal plasmakoncentration for insulinet opnås 2-18 timer efter subkutan indgivelsesmåde.
English: In intensive insulin therapy the suspension may be used as basal insulin (evening and/or morning injection) with fast-acting insulin given at meals.
Danish: Ved intensiv insulinbehandling kan suspensionen anvendes som basal insulin (injektion til aften og/eller morgen) med hurtigtvirkende insulin til måltiderne.
English: Protaphane is used to reduce the high blood sugar level in patients with diabetes mellitus (diabetes).
Danish: Protaphane anvendes til at sænke det høje blodsukkerniveau hos patienter med sukkersyge (diabetes mellitus).
English: You may recover more quickly from unconsciousness with an injection of the hormone glucagon by someone who knows how to use it.
Danish: Du kan genvinde bevidstheden hurtigere, hvis du får en injektion af hormonet glucagon af en person, der er instrueret i, hvordan det anvendes.
English: Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Danish: Ikke anvendt lægemiddel samt affald heraf bør bortskaffes i henhold til lokale retningslinier.
English: Protaphane contains less than 1 mmol sodium (23 mg) per dose, i.e. Protaphane is essentially ‘sodiumfree'.
Danish: Protaphane indeholder mindre end 1 mmol natrium (23 mg) per dosis, dvs. Protaphane er stort set natriumfrit.
English: If you have to mix two types of insulin
Danish: Hvis du skal blande to typer insulin
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 og reproduktions- og udviklingstoksicitet.
English: ► Every time you use a new Protaphane Penfill (before you put the cartridge into the insulin delivery system).
Danish: ► Hver gang du bruger en ny Protaphane Penfill (inden du anbringer cylinderampullen i insulininjektionssystemet).
English: Fast improvement in blood glucose control may be associated with acute painful neuropathy, which is usually reversible.
Danish: Hurtig forbedring af blodglucosekontrol kan være forbundet med akut, smertefuld neuropati, som sædvanligvis er reversibel.
English: Changes in strength, brand (manufacturer), type, origin (animal insulin, human insulin or insulin analogue) and/or method of manufacture (recombinant DNA versus animal source insulin) may result in a need for a change in dose.
Danish: Ændringer i styrke, mærke (fremstiller), type, oprindelse (animalsk insulin, humant insulin eller insulinanalog) og/eller fremstillingsmetode (rekombinant DNA i modsætning til insulin af animalsk oprindelse) kan medføre et behov for dosisændring.
English: • Severe hypoglycaemic episodes, where the patient has become unconscious, can be treated with glucagon (0.5 to 1 mg) given intramuscularly or subcutaneously by a trained person, or with glucose given intravenously by a healthcare professional.
Danish: • Svær hypoglykæmi, hvor patienten er blevet bevidstløs, kan behandles med glucagon (0,5 til 1 mg) indgivet intramuskulært eller subkutant af en instrueret person eller med glucose indgivet intravenøst af sundhedspersonale.
English: Patients must be instructed to always check the insulin label before each injection to avoid accidental mix-ups between Protaphane and other insulin products.
Danish: Patienter skal informeres om altid at kontrollere etiketten på insulinet før hver injektion, for at undgå utilsigtet forveksling mellem Protaphane og andre insulinpræparater.
English: Painful neuropathy (pain due to nerve damage): If your blood sugar level improves very fast, you may get nerve related pain.
Danish: Smertefuld neuropati (smerte på grund af beskadiget nerve): Hvis dit blodsukkerniveau forbedres meget hurtigt, kan du få nerverelateret smerte.
English: • Growth hormone (medicine for stimulation of skeletal and somatic growth and pronounced influence on the body's metabolic processes)
Danish: • Væksthormon (lægemiddel, der stimulerer væksten af skelet og legeme og har en udtalt effekt på kroppens metaboliske processer)
English: They must not give you any food or drink, because you may choke.
Danish: Du må ikke få noget at spise eller drikke, da du kan risikere at blive kvalt.
English: The amount or timing of insulin, food or exercise may need to be adjusted.
Danish: Tidspunktet for eller mængden af insulin, kost eller motion skal muligvis ændres.
English: If you are given glucagon you will need glucose or a sugar snack as soon as you are conscious.
Danish: Hvis du får glucagon, skal du også have glucose eller et sukkerholdigt produkt at spise, så snart du igen er ved bevidsthed.
English: Omission of a meal or unplanned strenuous physical exercise may lead to hypoglycaemia.
Danish: Udeladelse af et måltid eller ikke planlagt anstrengende fysisk aktivitet kan føre til hypoglykæmi.
English: If it is dropped, damaged or crushed, there is a risk of insulin leakage.
Danish: Hvis den tabes, ødelægges eller knuses, er der risiko for udsivning af insulin.
English: This leaflet was last revised in Other sources of information
Danish: Denne indlægsseddel blev senest ændret Yderligere information
English: Insulins and analogues for injection, intermediate-acting, insulin (human).
Danish: Insuliner og analoger til injektion, middellang virkningstid, insulin (humant).
English: Do not stop taking your insulin without speaking with a doctor, who will tell you what needs to be done.
Danish: Stop ikke med at tage dit insulin uden først at tale med en læge, der kan fortælle dig, hvad der skal gøres.
English: In case of hypoglycaemia or if hypoglycaemia is suspected, Protaphane must not be injected.
Danish: I tilfælde af hypoglykæmi eller ved mistanke herom, må Protaphane ikke injiceres.
English: Withdraw the needle from the skin then release the pressure on the push-button.
Danish: Træk nålen ud af huden og slip trykket på trykknappen.
English: You can select doses from 1 to 60 units in increments of 1 unit.
Danish: Du kan vælge en dosis på mellem 1 og 60 enheder i spring på 1 enhed.
English: Always use your insulin and adjust your dose exactly as your doctor has told you.
Danish: Tag altid dit insulin og tilpas din dosis nøjagtigt efter lægens anvisning.
English: Subcutaneous injection into the thigh results in a slower and less variable absorption compared to the other injection sites.
Danish: Subkutan injektion i låret giver langsommere og mindre variabel absorption end de øvrige injektionssteder.
English: Protaphane will start to lower your blood sugar about 1½ hours after you inject it, and the effect will last for approximately 24 hours.
Danish: Protaphane begynder at nedsætte blodsukkeret ca. 1½ time efter, at du har injiceret det, og virkningen varer i ca. 24 timer.
English: Detailed information on this medicine is available on the European Medicines Agency website http://www.ema.europa.eu.
Danish: Yderligere information om dette lægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: Do not use it if any damage is seen or if the rubber plunger has been drawn above the white label band at the bottom of the cartridge.
Danish: Brug den ikke hvis den er beskadiget, eller hvis gummistemplet er trukket ud over det hvide bånd i bunden af cylinderampullen.
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: What you need to know before you use Protaphane Do not use Protaphane
Danish: Det skal du vide, før du begynder at tage Protaphane Tag ikke Protaphane
English: Protaphane may be used alone or mixed with fast-acting insulin.
Danish: Protaphane kan tages alene eller blandes med hurtigtvirkende insulin.
English: Protaphane is administered subcutaneously by injection in the thigh, the abdominal wall, the gluteal region or the deltoid region.
Danish: Protaphane administreres subkutant ved injektion i låret, abdominal væggen, gluteal- eller deltoidregionen.
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: Hvad du skal gøre, hvis du oplever, at 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 you are treated with Protaphane Penfill and another insulin Penfill cartridge, you should use two insulin delivery systems, one for each type of insulin.
Danish: ► Hvis du behandles med Protaphane Penfill sammen med en anden insulin i Penfill cylinderampul, skal du anvende to injektionssystemer, ét til hver insulintype.
English: • Always make sure that a drop appears at the needle tip before injection (picture 1C).
Danish: • Kontrollér altid at der kommer en dråbe til syne på nålens spids før injektion (figur 1C).
English: Protaphane is indicated for treatment of diabetes mellitus.
Danish: Protaphane er indiceret til behandling af diabetes mellitus.
English: Protaphane can be used in elderly patients.
Danish: Protaphane kan anvendes til ældre patienter.
English: Dispose of it carefully and put the pen cap back on.
Danish: Kassér den omhyggeligt og sæt penhætten på.
English: ► If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor 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 til råds, før du tager dette lægemiddel.
English: Frequency categories are defined according to the following convention: Very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100);
Danish: Frekvensenskategorierne er defineret i henhold til den følgende konvention: Meget almindelig (≥1/10), almindelig (≥1/100 til <1/10), ikke almindelig (≥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 tilgængelige data).
English: Always mix Protaphane and fast-acting insulin in the same sequence.
Danish: Bland altid Protaphane og hurtigvirkende insulin i samme rækkefølge.
English: Careful control of your diabetes, particularly prevention of hypoglycaemia, is important for the health of your baby.
Danish: Nøje kontrol med din diabetes specielt forebyggelse af hypoglykæmi (lavt blodsukker) er vigtigt for dit barns helbred.
English: Insulin suspensions are never to be administered intravenously.
Danish: Insulin suspensioner må ikke administreres intravenøst.
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: Vision problems: When you first start your insulin treatment, it may disturb your vision, but the disturbance is usually temporary.
Danish: Synsforstyrrelser: Når du påbegynder insulinbehandling, kan du opleve synsforstyrrelser, men forstyrrelsen er normalt midlertidig.
English: On rare occasions, injection site reactions may require discontinuation of Protaphane.
Danish: I sjældne tilfælde kan reaktioner på injektionsstedet nødvendiggøre seponering af Protaphane.
English: Close glucose monitoring is recommended during the transfer and in the initial weeks thereafter (see section 4.4).
Danish: Tæt monitorering af glucose anbefales i overgangsperioden og i de første behandlingsuger (se pkt.
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: In clinical trials, the frequency of hypoglycaemia varied with patient population, dose regimens and level of glycaemic control.
Danish: I kliniske studier varierede frekvensen af hypoglykæmi afhængigt af patientgruppe, dosisregime og niveauet af glykæmisk kontrol.
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, kan det medføre hjerneskade (midlertidig eller varig) og i værste fald død.
English: Lipodystrophy (including lipohypertrophy, lipoatrophy) may occur at the injection site.
Danish: Lipodystrofi (inklusive lipohypertrofi og lipoatrofi) kan forekomme på injektionsstedet.
English: The insulin will work more quickly if you inject into the waist (abdomen).
Danish: Insulinet vil virke hurtigere, hvis det injiceres i maveskindet (abdomen).
English: 12 units are marked on the residual scale.
Danish: På restdosisskalaen er 12 enheder markeret.
English: Be careful only to push the push-button when injecting.
Danish: Sørg for kun at trykke på trykknappen under injektionen.
English: If you only use one type of insulin
Danish: Hvis du kun tager én type insulin
English: Diabetes is a disease where your body does not produce enough insulin to control the level of your blood sugar.
Danish: Sukkersyge er en sygdom, hvor din krop ikke producerer nok insulin til at kontrollere niveauet af dit blodsukker.
English: The following substances may increase the patient's insulin requirement:
Danish: Følgende lægemidler kan øge patientens behov for insulin:
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 brug for en injektion med glucagon, eller hvis du har haft gentagne tilfælde af lavt blodsukker, skal du tale med din læge.
English: After resuspending, complete all of the following stages of injection without delay.
Danish: Efter opblanding gennemføres alle de følgende injektionsprocedurer uden forsinkelse.
English: Based on post-marketing sources and clinical trials, the frequency, type and severity of adverse reactions observed in the paediatric population do not indicate any differences to the broader experience in the general population.
Danish: Baseret på post-marketing erfaringer samt fra kliniske studier indikerer bivirkningernes frekvens, type og alvor, observeret i den pædiatriske population, ikke, at der er forskelle i forhold til den bredere erfaring i den generelle patientpopulation.
English: Uncommon - Urticaria, rash Very rare - Anaphylactic reactions*
Danish: Ikke almindelige - Urticaria, udslæt Meget sjælden - Anafylaktiske reaktioner*
English: Protaphane Penfill/Protaphane InnoLet/Protaphane FlexPen During use or when carried as a spare: The product can be stored for a maximum of 6 weeks.
Danish: Protaphane Penfill/Protaphane InnoLet/Protaphane FlexPen Under brug eller medbragt som reserve: Lægemidlet kan opbevares i højst 6 uger.
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: Check that the dose selector is set at 0.
Danish: Kontrollér at dosisvælgeren står på 0.
English: After removing Protaphane vial, cartridge or pre-filled pen from the refrigerator, it is recommended to allow the Protaphane vial, cartridge or pre-filled pen to reach room temperature before resuspending the insulin as instructed for first time use.
Danish: Efter at Protaphane hætteglas, cylinderampul eller fyldt pen er taget ud af køleskabet, anbefales det at lade Protaphane hætteglas, cylinderampul eller fyldt pen opnå stuetemperatur inden insulinet opblandes, som beskrevet ved første gangs brug.
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: Prior to each injection small amounts of air may collect in the cartridge during normal use.
Danish: Før hver injektion kan der samle sig små luftbobler i cylinderampullen under normal brug.
English: When transferring from other intermediate or long-acting insulin medicinal products, adjustment of the Protaphane dose and timing of administration may be necessary.
Danish: Ved skift fra insulin med middellang virksningstid eller langtidsvirkende insulin kan dosisjustering af Protaphane og timing af administation være nødvendig.
English: If a drop of insulin still does not appear, the pen is defective, and you must use a new one.
Danish: Hvis der stadig ikke kommer en dråbe insulin til syne, er pennen defekt, og du skal derfor tage en ny i brug.
English: If you forget to take your insulin your blood sugar may get too high (hyperglycaemia).
Danish: Hvis du glemmer at tage dit insulin, kan dit blodsukker blive for højt (hyperglykæmi).
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: Use the injection technique advised by your doctor or nurse and as described in your pen manual.
Danish: Anvend den injektionsteknik din læge eller sygeplejerske har anbefalet og som beskrevet i instruktionerne for anvendelse af pennen.
English: • Glucocorticoids (such as ‘cortisone' used to treat inflammation)
Danish: • Glukokortikoider (såsom 'cortison' til behandling af inflammation (vævsirritation))
English: Inject the air into the vial containing Protaphane and pull out the needle.
Danish: Injicér luften i hætteglasset med Protaphane, og træk nålen ud.
English: Protaphane is often given in combination with fast-acting insulin preparations.
Danish: Protaphane gives ofte i kombination med hurtigtvirkende insulinpræparater.
English: Protaphane can be used during pregnancy.
Danish: Protaphane kan tages under graviditet.
English: Treatment with Protaphane helps to prevent complications from your diabetes.
Danish: Behandling med Protaphane hjælper med at forebygge komplikationer som skyldes din diabetes.
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 op til 8 mm
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 injektionsvæsken ikke er ensartet hvid og uklar.
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
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: • Hold your InnoLet with the needle upwards and tap the cartridge gently with your finger a few times (picture 1C) to make any air bubbles collect at the top of the cartridge.
Danish: • Hold din InnoLet med nålen opad, og bank let på cylinderampullen med fingeren et par gange (figur 1C), så eventuelle luftbobler samles i toppen af cylinderampullen.
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: Move the pen up and down twenty times between the two positions as shown, so the glass ball moves from one end of the cartridge to the other.
Danish: Vend pennen, som vist, op og ned 20 gange mellem de to positioner, så glaskuglen bevæger sig fra den ene til den anden ende i cylinderampullen.
English: Insulin suspensions should not be added to infusion fluids.
Danish: Insulinsuspensioner bør ikke tilsættes til infusionsvæsker.
English: Preparing your Protaphane FlexPen
Danish: Klargøring af din Protaphane FlexPen
English: Protaphane with alcohol
Danish: Brug af Protaphane sammen med alkohol
English: The following substances may reduce the patient's insulin requirement:
Danish: Følgende lægemidler kan reducere patientens behov for insulin:
English: During use or when carried as a spare: The product can be stored for a maximum of 4 weeks.
Danish: Under brug eller medbragt som reserve: Lægemidlet kan opbevares i højst 4 uger.
English: If you suspect that the cartridge is damaged, take it back to your supplier.
Danish: Hvis du mistænker, at cylinderampullen er beskadiget, skal den returneres til apoteket.
English: Insulin suspensions are not to be used in insulin infusion pumps.
Danish: Insulin suspensioner må ikke anvendes i insulininfusionspumper.
English: Patients transferred to Protaphane from another type of insulin may require an increased number of daily injections or a change in dose from that used with their usual insulin medicinal products.
Danish: Patienter, der skifter til Protaphane fra en anden insulintype, skal muligvis have øget antallet af daglige injektioner eller ændret dosis i forhold til dosis af deres sædvanlige insulinpræparater.
English: Protaphane Penfill is designed to be used with Novo Nordisk insulin delivery systems and NovoFine or NovoTwist needles.
Danish: Protaphane Penfill er beregnet til anvendelse sammen med Novo Nordisk insulindispenseringssystemer og NovoFine eller NovoTwist nåle.
English: Inject the air into the vial.
Danish: Injicér luften i hætteglasset.
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 præparart med en anden type insulin kan betyde, at de tidlige advarselssymptomer på hypoglykæmi kan ændres eller blive mindre udtalte end dem, der oplevedes med tidligere insulin.
English: Contents of the pack and other information What Protaphane contains
Danish: Pakningsstørrelser og yderligere oplysninger Protaphane indeholder
English: * see Description of selected adverse reactions
Danish: * se Beskrivelse af udvalgte bivirkninger nedenfor.