FrancophonIA/ELRC3.0 huggingface dataset:
English: Based on post-marketing sources and clinical trials, the frequency, type and severity of adverse reactions observed in elderly patients and in patients with renal or hepatic impairment 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, oberserveret hos ældre patienter, og hos patienter med nedsat nyre- eller leverfunktion i forhold til den generelle patientgruppe, ikke, at der er forskelle i forhold til den bredere erfaring i den generelle patientpopulation.
English: Protaphane is administered by injection under the skin (subcutaneously).
Danish: Protaphane administreres ved injektion under huden (subkutant).
English: Hypoglycaemia may occur if the insulin dose is too high in relation to the insulin requirement.
Danish: Hypoglykæmi kan forekomme hvis insulindosis er for høj i forhold til insulinbehovet.
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 Protaphane, se punkt 6.
English: In elderly patients, glucose monitoring should be intensified and the insulin dose adjusted on an individual basis.
Danish: Monitorering af glucose skal intensiveres hos ældre patienter, og dosering af insulin skal tilpasses individuelt.
English: The occurrence of generalised hypersensitivity reactions (including generalised skin rash, itching, sweating, gastrointestinal upset, angioneurotic oedema, difficulty in breathing, palpitation and reduction in blood pressure) is very rare but can potentially be life threatening.
Danish: Generel overfølsomhed (inklusive hududslæt, kløe, svedtendens, gastrointestinalt ubehag, angioødem, åndedrætsbesvær, palpitationer og blodtryksfald) er meget sjælden, men kan være potentielt livstruende.
English: The best places to give yourself an injection are: the front of your waist (abdomen); your buttocks; the front of your thighs or upper arms.
Danish: De bedste steder til injektion er: Foran på maven, din balle, foran på låret eller overarmen.
English: During use or when carried as a spare: Store below 30°C.
Danish: Under brug eller medbragt som reserve: Opbevar under 30°C.
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: • Let the insulin reach room temperature before you use it.
Danish: • Lad insulinet opnå stuetemperatur inden du tager det.
English: leakage of insulin, blocked needles and inaccurate dosing.
Danish: udsivning af insulin, blokerede nåle og upræcis dosering.
English: • Move the cartridge up and down between positions a and b and back (see the picture) so that the glass ball moves from one end of the cartridge to the other at least 20 times.
Danish: • Bevæg cylinderampullen op og ned mellem position a og b (se tegningen), så glaskuglen bevæger sig fra den ene ende af cylinderampullen til den anden, mindst 20 gange.
English: Protaphane is an isophane (NPH) human insulin suspension.
Danish: Protaphane er en isophan (NPH) humant insulin suspension.
English: Protaphane contains sodium
Danish: Protaphane indeholder natrium
English: Protaphane vial (100 international units/ml), Penfill and FlexPen:
Danish: Protaphane hætteglas (100 internationale enheder/ml), Penfill og FlexPen:
English: Let the insulin reach room temperature before you use it.
Danish: Lad insulinet opnå stuetemperatur inden det tages i brug.
English: Do not use the pen if the resuspended insulin does not look uniformly white and cloudy.
Danish: Brug ikke pennen hvis det opblandede insulin ikke er ensartet hvidt og uklart.
English: Inject the air into the vial containing fast-acting insulin.
Danish: Injicér luften i hætteglasset med hurtigtvirkende insulin.
English: Always use the dose scale and the dose selector to see how many units you have selected before injecting the insulin.
Danish: Brug altid dosisskalaen og dosisvælgeren til at se, hvor mange enheder du har valgt, før du injicerer insulinet.
English: Other medicines and Protaphane
Danish: Brug af anden medicin sammen med Protaphane
English: ► Protaphane Penfill cartridges are designed to be used with Novo Nordisk insulin delivery systems and NovoFine or NovoTwist needles.
Danish: ► Protaphane Penfill cylinderampullerne er beregnet til anvendelse sammen med Novo Nordisk insulin-dispenseringssystemer og NovoFine eller NovoTwist engangsnåle.
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 resterende antal enheder, der er i cylinderampullen.
English: Turn the dose selector to select the number of units you need to inject.
Danish: Indstil dosisvælgeren til det antal enheder du skal injicere.
English: Read carefully the Instructions on how to use Protaphane InnoLet included in this package leaflet.
Danish: Læs omhyggeligt brugervejledningen til Protaphane InnoLet, der er inkluderet i denne indlægsseddel.
English: Diabetic retinopathy (an eye disease related to diabetes which can lead to loss of vision): If you have diabetic retinopathy and your blood sugar level improves very fast, the retinopathy may get worse.
Danish: Diabetisk retinopati (en øjensygdom med relation til sukkersyge, som kan medføre synstab): Hvis du lider af diabetisk retinopati kan dette forværres, hvis dine blodsukkerniveauer forbedres meget hurtigt.
English: EXP/ During use or when carried as a spare: Use within 4 weeks
Danish: EXP/ Under brug eller medbragt som reserve: Bruges inden 4 uger
English: You cannot select a dose larger than the number of units left in the cartridge.
Danish: Du kan ikke indstille en dosis, som er højere end det antal enheder, der er tilbage i cylinderampullen.
English: Protaphane is a human insulin with gradual onset and long duration of action.
Danish: Protaphane er et humant insulin med gradvist indsættende effekt og lang virkningsvarighed.
English: If you take too much insulin your blood sugar gets too low (hypoglycaemia).
Danish: Hvis du har taget for meget insulin, bliver dit blodsukker for lavt (hypoglykæmi).
English: Instructions on how to use Protaphane suspension for injection in InnoLet Read the instructions carefully before using your InnoLet.
Danish: Brugervejledning til Protaphane injektionsvæske, suspension i InnoLet Læs denne brugervejledning omhyggeligt, inden du tager din InnoLet i brug.
English: Instructions on how to use Protaphane suspension for injection in FlexPen Read the following instructions carefully before using your FlexPen.
Danish: Brugervejledning til Protaphane injektionsvæske, suspension i FlexPen Læs denne brugervejledning omhyggeligt, inden du tager din FlexPen i brug.
English: You can clean your InnoLet by wiping it with a medicinal swab.
Danish: Din InnoLet kan renses udvendigt ved at tørre den med en alkoholserviet.
English: Protaphane can be used in children and adolescents.
Danish: Protaphane kan anvendes til børn og unge.
English: Draw into the syringe the same amount of air as the dose of Protaphane.
Danish: Træk en mængde luft ind i sprøjten svarende til dosis af Protaphane.
English: Needles, syringes, cartridges and pre-filled-pens must not be shared.
Danish: Nåle, sprøjter, cylinderampuller og fyldte penne må ikke deles med andre.
English: Always remove the needle after each injection and store your FlexPen without the needle attached.
Danish: Fjern altid nålen efter hver injektion og opbevar din FlexPen uden nålen påsat.
English: You must use the pen as described in the Instructions on how to use Protaphane FlexPen.
Danish: Du skal bruge pennen som beskrevet i brugervejledningen til Protaphane FlexPen.
English: Only use the resuspension if uniformly white and cloudy For use by one person only
Danish: Brug kun injektionsvæsken hvis den er ensartet hvid og uklar Må kun anvendes af én person
English: Turn the vial and syringe upside down and draw the correct insulin dose into the syringe.
Danish: Vend hætteglasset og sprøjten med bunden i vejret og træk den korrekte mængde insulin ind i sprøjten.
English: Inject the dose by pressing the push-button all the way in until 0 lines up with the pointer.
Danish: Injicér dosis ved at trykke på trykknappen indtil der står 0 ud for markøren.
English: Draw into the syringe the same amount of air as the dose of insulin you are going to inject.
Danish: Træk en mængde luft ind i sprøjten svarende til den mængde insulin, du vil injicere.
English: Resuspension of Protaphane
Danish: Oplanding af Protaphane
English: You must use the pen as described in the Instructions on how to use Protaphane InnoLet.
Danish: Du skal bruge pennen som beskrevet i brugervejledningen til Protaphane InnoLet.
English: Suspension for injection 1 x 3 ml pre-filled pen 5 x 3 ml pre-filled pens 10 x 3 ml pre-filled pens
Danish: 1 x 3 ml fyldt pen 5 x 3 ml fyldte penne 10 x 3 ml fyldte penne
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 store ydre nålehætte.
English: There is no restriction on treatment with Protaphane during breast-feeding.
Danish: Der er ingen restriktioner for behandling med Protaphane under amning.
English: Read carefully the Instructions on how to use Protaphane FlexPen included in this package leaflet.
Danish: Læs omhyggeligt brugervejledningen til Protaphane FlexPen, der er inkluderet i denne indlægsseddel.
English: ► Needles and Protaphane FlexPen must not be shared.
Danish: ► Nåle og Protaphane FlexPen må ikke deles med andre.
English: SAS, 45 Avenue d'Orléans, F-28000 Chartres, France.
Danish: SAS, 45 Avenue d'Orléans, F-28000 Chartres, Frankrig.
English: Blood glucose monitoring is recommended to achieve optimal glycaemic control.
Danish: For at opnå optimal glykæmisk kontrol anbefales monitorering af blodglucose samt justering af insulindosis.
English: Your InnoLet is a simple, compact pre-filled pen able to deliver 1 to 50 units in increments of 1 unit.
Danish: Din InnoLet er en kompakt, fyldt insulinpen, som giver dig mulighed for at vælge en dosis mellem 1 og 50 enheder i spring på 1 enhed.
English: Talk to your doctor, pharmacist or nurse for advice.
Danish: Spørg lægen, apotekspersonalet eller sygeplejersken for rådgiving.
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Danish: Overfølsomhed over for det aktive stof eller et eller flere af hjælpestofferne anført under pkt.
English: Oral antidiabetic medicinal products, monoamine oxidase inhibitors (MAOI), beta-blockers, angiotensin converting enzyme (ACE) inhibitors, salicylates, anabolic steroids and sulfonamides.
Danish: Orale antidiabetiske lægemidler, monoaminoxidasehæmmere (MAO-hæmmere), betablokkere, ACEhæmmere, salicylater, anabolske steroider og sulfonamider.
English: Combination of Protaphane with pioglitazone
Danish: Kombinationsbehandling med Protaphane og pioglitazon
English: Then expel the air from the syringe and check that the dose is correct.
Danish: Pres luften ud af sprøjten og kontrollér at dosis er korrekt.
English: • After the injection, the needle should remain under the skin for at least 6 seconds to ensure that the full dose has been delivered.
Danish: • Efter injektion skal nålen forblive under huden i mindst 6 sekunder for at sikre, at hele dosis er injiceret.
English: In patients with renal or hepatic impairment, glucose monitoring should be intensified and the human insulin dose adjusted on an individual basis.
Danish: Monitorering af glucose skal intensiveres hos patienter med nedsat nyre- eller leverfunktion, og dosis af humant insulin skal tilpasses individuelt.
English: Priming to expel air prior to each injection
Danish: Klargøring for at fjerne luft inden hver injektion
English: Protaphane InnoLet is a pre-filled pen designed to be used with NovoFine or NovoTwist disposable needles up to a length of 8 mm. InnoLet delivers 1-50 units in increments of 1 unit.
Danish: Protaphane InnoLet er en fyldt pen beregnet til anvendelse sammen med NovoFine eller NovoTwist engangsnåle med en længde på op til 8 mm. InnoLet dispenserer 1-50 enheder i spring på 1 enhed.
English: Cartridge (type 1 glass) with a plunger (bromobutyl) and a rubber closure (bromobutyl/polyisoprene) containing 3 ml of suspension in a pre-filled multidose disposable pen made of polypropylene.
Danish: Cylinderampul (type 1-glas) med et stempel (brombutyl) og en gummiprop (brombutyl/polyisopren) indeholdende 3 ml suspension i en fyldt engangspen til flergangsbrug lavet af polypropylen.
English: Protaphane vial (100 international units/ml) 1 vial contains 10 ml equivalent to 1,000 international units.
Danish: Protaphane hætteglas (100 internationale enheder/ml ) 1 hætteglas indeholder 10 ml svarende til 1000 internationale enheder.
English: Just before use, roll the vial of Protaphane between your hands until the liquid is uniformly white and cloudy.
Danish: Umiddelbart før brug rulles hætteglasset med Protaphane mellem hænderne, indtil væsken er ensartet hvid og uklar.
English: 1 ml suspension contains 40 international units isophane (NPH) insulin human* (equivalent to 1.4 mg).
Danish: 1 ml suspension indeholder 40 internationale enheder isophan (NPH) humant insulin* (svarende til 1,4 mg).
English: Protaphane FlexPen is a pre-filled pen designed to be used with NovoFine or NovoTwist disposable needles up to a length of 8 mm. FlexPen delivers 1-60 units in increments of 1 unit.
Danish: Protaphane FlexPen er en fyldt pen beregnet til anvendelse sammen med NovoFine eller NovoTwist engangsnåle med en længde på op til 8 mm. FlexPen dispenserer 1-60 enheder i spring på 1 enhed.
English: ► There are no restrictions on treatment with Protaphane during breast-feeding.
Danish: ► Der er ingen begrænsninger ved behandling med Protaphane under amning.
English: Always check if there is enough insulin left (at least 12 units) in the cartridge to allow even resuspension.
Danish: Kontrollér altid, at der er insulin tilbage i cylinderampullen (mindst 12 enheder), for at sikre ensartet opblanding.
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 den med dig og opbevare den ved stuetemperatur (under 30°C) i op til 6 uger.
English: Protaphane vial (100 international units/ml) EU/1/02/234/003
Danish: Protaphane hætteglas (100 internationale enheder/ml) EU/1/02/234/003
English: 1 ml suspension contains 100 international units isophane (NPH) insulin human* (equivalent to 3.5 mg).
Danish: 1 ml suspension indeholder 100 internationale enheder isophan (NPH) humant insulin* (svarende til 3,5 mg).
English: ► Needles and Protaphane Penfill must not be shared.
Danish: ► Nåle og Protaphane Penfill må ikke deles med andre.
English: Draw into the syringe the same amount of air as the dose of fast-acting insulin.
Danish: Træk en mængde luft ind i sprøjten svarende til dosis af hurtigtvirkende insulin.
English: Suspension for injection 1 x 3 ml cartridge 5 x 3 ml cartridges 10 x 3 ml cartridges
Danish: 1 x 3 ml cylinderampul 5 x 3 ml cylinderampuller 10 x 3 ml cylinderampuller
English: As with any insulin therapy, injection site reactions may occur and include pain, redness, hives, inflammation, bruising, swelling and itching.
Danish: Som ved al anden insulinbehandling, kan der opstå reaktioner på injektionsstedet og medføre smerte, rødmen, udslæt, inflammation, blå mærker, hævelse og kløe.
English: ► If FlexPen is dropped, damaged or crushed.
Danish: ► Hvis du taber, skader eller knuser din FlexPen.
English: Each ml contains 100 IU of human insulin.
Danish: Hver ml indeholder 100 IE humant insulin.
English: Protaphane vial (40 international units/ml) EU/1/02/234/001
Danish: Protaphane hætteglas (40 internationale enheder/ml) EU/1/02/234/001
English: The patient should be advised to discard the needle and syringe after each injection.
Danish: Patienten skal informeres om at kassere nålen efter hver injektion.
English: You can carry it with you and keep it at room temperature (below 25°C) for up to 4 weeks.
Danish: Du kan have det med dig og opbevare det ved stuetemperatur (under 25°C) i op til 4 uger.
English: Always check there are at least 12 units of insulin left in the cartridge to allow resuspension.
Danish: Kontrollér altid at der er mindst 12 enheder insulin tilbage i cylinderampullen for at sikre ensartet opblanding.
English: Protaphane vial (40 international units/ml) and InnoLet:
Danish: Protaphane hætteglas (40 internationale enheder/ml) og InnoLet:
English: Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.
Danish: Fortæl det altid til lægen, apotekspersonalet eller sygeplejersken, hvis du bruger anden medicin eller har gjort det for nylig.
English: ► Always use a new needle for each injection to prevent contamination.
Danish: ► Brug altid en ny nål til hver injektion for at beskytte mod forurening.
English: If there are less than 12 units left, use a new InnoLet.
Danish: Brug en ny InnoLet, hvis der er mindre end 12 enheder tilbage
English: InnoLet is designed to be used with NovoFine or NovoTwist disposable needles up to a length of 8 mm. As a precautionary measure, always carry a spare insulin delivery device in case your InnoLet is lost or damaged.
Danish: InnoLet er beregnet til anvendelse sammen med NovoFine eller NovoTwist engangsnåle med en længde på op til 8 mm. Medbring for en sikkerheds skyld altid et ekstra injektionssystem i tilfælde af, at din InnoLet der mistes eller ødelægges.
English: The needle should be kept under the skin for at least 6 seconds to make sure the entire dose is injected.
Danish: Efter injektionen bør nålen forblive under huden i mindst 6 sekunder for at sikre, at hele dosis er injiceret.
English: zinc chloride, glycerol, metacresol, phenol, disodium phosphate dihydrate, sodium hydroxide/hydrochloric acid for pH adjustment, protamine sulfate and water for injections
Danish: zinkchlorid, glycerol, metacresol, phenol, dinatriumphosphatdihydrat, natriumhydroxid/saltsyre til justering af pH, protaminsulfat og vand til injektionsvæsker
English: If there is not enough insulin left, use a new one.
Danish: Brug en ny, hvis der ikke er nok insulin tilbage.
English: • Keeping the needle upwards, press the push-button and the dose selector returns to 0.
Danish: • Hold fortsat nålen opad, og tryk trykknappen ind, hvorved dosisvælgeren nulstilles.
English: Each ml contains 40 IU of human insulin.
Danish: Hver ml indeholder 40 internationale enheder humant insulin.
English: Push the needle into the vial of Protaphane, turn the vial and syringe upside down and draw out the dose you have been prescribed.
Danish: Stik nu nålen ind i hætteglasset med Protaphane, vend derefter hætteglasset og sprøjten med bunden i vejret og træk den dosis ud som du har fået ordineret.
English: They include thirst, increased frequency of urination, nausea, vomiting, drowsiness, flushed dry skin, dry mouth, loss of appetite as well as acetone odour of breath.
Danish: De indbefatter tørst, hyppig vandladning, kvalme, opkastning, døsighed, rødme og tørhed af huden, mundtørhed, appetitløshed og acetoneånde.
English: FlexPen is designed to be used with NovoFine or NovoTwist disposable needles up to a length of 8 mm. As a precautionary measure, always carry a spare insulin delivery device in case your FlexPen is lost or damaged.
Danish: FlexPen er beregnet til anvendelse sammen med NovoFine eller NovoTwist engangsnåle med en længde på op til 8 mm. Medbring for en sikkerheds skyld altid et ekstra injektionssystem i tilfælde af, at din FlexPen mistes eller ødelægges.
English: Protaphane Penfill is only suitable for subcutaneous injections from a reusable pen.
Danish: Protaphane Penfill er kun egnet til subkutan injektion fra en genanvendelig pen.
English: Expel any air from the syringe and check that the dose is correct.
Danish: Pres resten af luften ud af sprøjten og kontrollér at dosis er korrekt.
English: At the beginning of the insulin treatment, refraction anomalies, oedema and injection site reactions (pain, redness, hives, inflammation, bruising, swelling and itching at the injection site) may occur.
Danish: I starten af insulinbehandlingen kan der forekomme refraktionsanomalier, ødemer og reaktioner på injektionsstedet (smerte, rødmen, udslæt, inflammation, blå mærker, hævelser og kløe på injektionsstedet).
English: You will hear clicks as the dose selector returns to 0.
Danish: Der høres en klikkende lyd, når dosisvælgeren nulstilles.
English: ► After each injection, be sure to remove and discard the needle and store Protaphane without the needle attached.
Danish: ► Husk at fjerne nålen efter hver injektion og kassér nålen og opbevar Protaphane uden nålen påsat.
English: Roll the vial between your hands until the liquid is uniformly white and cloudy.
Danish: Rul hætteglasset mellem hænderne indtil væsken er ensartet hvid og uklar.
English: Protaphane vials are for use with insulin syringes with a corresponding unit scale.
Danish: Protaphane i hætteglas er beregnet til anvendelse med insulininjektionssprøjter, der har en passende enhedsskala.
English: See the big picture on top of this instruction.
Danish: Se figuren øverst i brugervejledningen.
English: Protaphane InnoLet is only suitable for subcutaneous injections.
Danish: Protaphane InnoLet er kun egnet til subkutan injektion.
English: After resuspension, the liquid should appear uniformly white and cloudy.
Danish: Efter opblanding, skal væsken fremstå ensartet hvid og uklar.
English: Protaphane FlexPen is a pre-filled disposable pen containing human insulin as isophane (NPH).
Danish: Protaphane FlexPen er en fyldt engangspen til flergangsbrug, der indeholder humant insulin som isophan (NPH).
English: How to handle Protaphane InnoLet
Danish: Sådan bruger du Protaphane InnoLet
English: Check with your doctor, pharmacist or nurse if you are not sure.
Danish: Spørg lægen, apotekspersonalet eller sygeplejersken, hvis der er noget du er i tvivl om.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER WRAPPER LABEL ON MULTIPACK (VIAL - with blue box)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE ETIKET PÅ MULTIPAKNING (HÆTTEGLAS - med blue box)
English: Pack sizes of 1 or 5 vials of 10 ml or a multipack of 5 packs of 1 x 10 ml vial.
Danish: Pakningsstørrelser med 1 eller 5 hætteglas a 10 ml eller i en multipakning med 5 pakker med 1 x 10 ml hætteglas.
English: Pack sizes of 1, 5 and 10 pre-filled pens.
Danish: Pakninger a 1, 5 og 10 fyldte penne.
English: They include: increased urination; feeling thirsty; losing your appetite; feeling sick (nausea or vomiting); feeling drowsy or tired; flushed, dry skin; dry mouth and a fruity (acetone) smell of the breath.
Danish: De omfatter: Hyppig vandladning, tørst, appetitløshed, kvalme eller opkastning, døsighed eller træthed, rød, tør hud, mundtørhed og en frugtagtig (acetonelugtende) ånde.
English: Resuspend according to instructions
Danish: Opblandes som angivet i indlægssedlen
English: How to handle Protaphane FlexPen
Danish: Sådan bruger du Protaphane FlexPen
English: If you do not resuspend the insulin, this may cause inaccurate dosing, which can lead to too high or too low blood sugar level.
Danish: Hvis ikke du opblandet insulinet, kan det forårsage upræcis dosering, som kan føre til et for højt eller for lavt blodsukkerniveau.
English: ► Protaphane Penfill is only suitable for injecting under the skin using a reusable pen.
Danish: ► Protaphane Penfill er kun egnet til indsprøjtning under huden ved hjælp af en genanvendelig pen.
English: Protaphane Penfill is only suitable for injecting under the skin using a reusable pen.
Danish: Protaphane Penfill er kun egnet til indsprøjtning under huden ved hjælp af en genanvendelig pen.
English: Protaphane FlexPen is only suitable for subcutaneous injections.
Danish: Protaphane FlexPen er kun egnet til subkutan injektion.