FrancophonIA/ELRC3.0 huggingface dataset:
English: Before the first use store your medicine in a refrigerator (2°C - 8°C).
Danish: Opbevar lægemidlet i køleskabet (2°C-8°C), inden det tages i brug.
English: The infusion set (tubing and cannula) should be changed in accordance with the instructions in the product information supplied with the infusion set.
Danish: Infusionssættet (slange og kanyle) skal skiftes efter de instrukser, som er anført i brugervejledningen, der følger med infusionssættet.
English: Sodium hydroxide or hydrochloric acid may have been used to adjust the acidity.
Danish: Natriumhydroxid eller saltsyre kan være tilsat for at justere surhedsgraden (pH).
English: Insulin lispro Sanofi SoloStar is a disposable pre-filled pen containing 3 ml (300 units, 100 units/ml) of insulin lispro.
Danish: Insulin lispro Sanofi SoloStar er en fyldt engangspen, der indeholder 3 ml (300 enheder, 100 enheder/ml) insulin lispro.
English: You must think carefully about when to have your meals, how often to exercise and how much to do. You must also keep a close watch on your blood sugar levels by testing your blood glucose often.
Danish: Du skal også holde nøje øje med dit blodsukkerniveau ved ofte at måle dit blodsukker.
English: Mixing Insulin lispro Sanofi with longer-acting human insulins (see section 6.2)
Danish: Blanding af Insulin lispro Sanofi med længerevirkende human insulin (se pkt.
English: Before removing the needle from the vial, check the syringe for air bubbles that reduce the amount of Insulin lispro Sanofi in it.
Danish: Før nålen fjernes fra hætteglasset, undersøges sprøjten for luftbobler, da disse reducerer mængden af Insulin lispro Sanofi-opløsning.
English: • The 3 ml cartridge only fits the 3 ml pen.
Danish: • En 3 ml cylinderampul passer kun til en 3 ml pen.
English: The pre-filled pen simply has a built in cartridge.
Danish: Den fyldte pen har blot en indbygget cylinderampul.
English: • You should not normally mix Insulin lispro Sanofi with one of the mixtures of human insulins.
Danish: • Du bør almindeligvis ikke blande Insulin lispro Sanofi med blandinger af human insulin.
English: Insulin lispro Sanofi is suitable for use in adults and children.
Danish: Insulin lispro Sanofi kan bruges af voksne og børn.
English: Insulin lispro Sanofi should be mixed with longer-acting human insulins only on the advice of a doctor.
Danish: Insulin lispro Sanofi bør kun blandes med længerevirkende human insulin efter lægeordination.
English: Before first use
Danish: Før første anvendelse
English: The manufacturer's instructions with each individual pen must be followed for loading the cartridge, attaching the needle and administering the insulin injection
Danish: Fremstillerens instruktion til den enkelte pen skal følges for isætning af cylinderampul, påsætning af nål og injektion.
English: For example if you do need to inject a mixture, draw the Insulin lispro Sanofi into the syringe before the long acting insulin.
Danish: Hvis du skal injicere en blanding, skal Insulin lispro Sanofi trækkes op i sprøjten før det længerevirkende insulin.
English: Once the pre-filled pen is empty, do not use it again.
Danish: Når den fyldte pen er tom, skal du ikke bruge den mere.
English: • fruity smell on the breath
Danish: • frugtagtig ånde
English: Pharmacotherapeutic group: Drugs used in diabetes, insulins and analogues for injection, fast-acting, ATC code: A10AB04
Danish: Farmakoterapeutisk klassifikation: Antidiabetica, Insuliner og analoger til injektion, hurtigtvirkende.
English: One Insulin lispro Sanofi pre-filled pen contains multiple doses of insulin.
Danish: Én Insulin lispro Sanofi fyldt pen indeholder flere doser af insulin.
English: If mixing insulins, see section “Mixing Insulin lispro Sanofi with longer-acting human insulins” below and section 6.2.
Danish: Ved sammenblanding af insuliner bør instruktionerne i afsnittet ” Blanding af Insulin lispro Sanofi med længerevirkende human insulin” nedenfor samt pkt.
English: After injecting
Danish: Efter injektionen
English: Insulin requirements may be reduced in the presence of renal impairment.
Danish: Insulinbehovet kan være nedsat ved nedsat nyrefunktion.
English: • Never store your pen with the needle attached.
Danish: • Pennen må aldrig opbevares med påsat nål.
English: • tiredness
Danish: • svedtendens
English: Insulin lispro Sanofi takes effect rapidly and has a shorter duration of activity (2 to 5 hours) given subcutaneously as compared with regular insulin.
Danish: Insulin lispro Sanofi har en hurtigt indsættende virkning og en kortere virkningsvarighed (2-5 timer), ved subkutan injektion, end opløselig insulin.
English: Fertility Insulin lispro did not induce fertility impairment in animal studies (see section 5.3).
Danish: Fertilitet I dyrestudier medførte insulin lispro ikke nedsat fertilitet (se pkt.
English: Inject the liquid as soon as you have mixed it. Do the same thing every time.
Danish: Injicer væsken umiddelbart efter, at du har blandet den.
English: The pre-filled pen should not be stored with the needle attached.
Danish: Den fyldte pen må ikke opbevares med nålen påsat.
English: To ensure you get the accurate dose, the Insulin lispro Sanofi cartridges are to be used only with the following pens: - JuniorSTAR which delivers doses in steps of 0.5 units - Tactipen, AllStar and AllStar PRO which deliver doses in steps of 1 unit.
Danish: For at sikre, at du får den rigtige dosis, må Insulin lispro Sanofi cylinderampuller kun anvendes sammen med følgende penne: - JuniorSTAR, som afgiver Insulin lispro Sanofi i dosisintervaller på 0,5 enheder - Tactipen, AllStar og AllStar PRO, som afgiver Insulin lispro Sanofi i dosisintervaller på 1 enhed.
English: The pen with the inserted cartridge should not be stored with the needle attached.
Danish: Pennen med den monterede cylinderampul må ikke opbevares med nålen påsat.
English: If necessary, Insulin lispro Sanofi may also be administered intravenously, for example; for the control of blood glucose levels during ketoacidosis, acute illnesses or during intra and post operative periods.
Danish: Dette kan f.eks. være for at kontrollere blodglukoseniveauet under en ketoacidose, i forbindelse med akut sygdom eller under/efter en operation.
English: • Insulin lispro Sanofi in pre-filled pen is only suitable for injecting just under the skin.
Danish: • Insulin lispro Sanofi i en fyldt pen er kun egnet til injektion lige under huden.
English: Using Insulin lispro Sanofi in an infusion pump
Danish: Brug af Insulin lispro Sanofi i en infusionspumpe
English: Each pre-filled pen contains 3 ml.
Danish: Hver fyldt pen indeholder 3 ml.
English: • not using your Insulin lispro Sanofi or other insulin;
Danish: • at du ikke bruger Insulin lispro Sanofi eller anden insulin;
English: Insulin lispro Sanofi 100 units/ml solution for injection in vial This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Danish: Insulin lispro Sanofi 100 enheder/ml injektionsvæske, opløsning i hætteglas Dette lægemiddel må ikke blandes med andre lægemidler end dem, der er anført under pkt.
English: It doesn't matter which injection site you use, either upper arm, thigh, buttock or abdomen, your Insulin lispro Sanofi injection will still work quicker than soluble human insulin.
Danish: Uanset om du injicerer i overarmen, låret, balden eller maven, virker din Insulin lispro Sanofi injektion hurtigere end almindelig insulin.
English: Insulin lispro Sanofi (insulin lispro 100 units/ml) and another insulin lispro medicinal product (200 units/ml) in a pre-filled pen
Danish: Insulin lispro Sanofi (insulin lispro 100 enheder/ml) og et andet insulin lispro lægemiddel (200 enheder/ml) i fyldt pen
English: Do not mix any other insulin in an Insulin lispro Sanofi cartridge.
Danish: Bland ikke anden insulin i en Insulin lispro Sanofi cylinderampul.
English: SPECIAL STORAGE CONDITIONS Before first use:
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Før anbrud
English: When used with an insulin infusion pump, Insulin lispro Sanofi should not be mixed with any other insulin.
Danish: Når Insulin lispro Sanofi bruges i en insulininfusionspumpe, bør Insulin lispro Sanofi ikke blandes med anden insulin.
English: Breast-feeding Patients with diabetes who are breast-feeding may require adjustments in insulin dose, diet or both.
Danish: Amning Diabetikere, der ammer, kan have behov for regulering af insulindosis og/eller diæt.
English: B Press the injection button all the way in. • When insulin comes out of the needle tip, your pen is working correctly.
Danish: • Når der kommer insulin ud af nålespidsen, fungerer pennen korrekt.
English: Insert the needle into the longer-acting insulin vial and inject the air.
Danish: Stik nålen i hætteglasset med længerevirkende insulin, og sprøjt luften ind i hætteglasset.
English: • You must not administer Insulin lispro Sanofi by the intravenous route (IV).
Danish: • Du må ikke injicere Insulin lispro Sanofi direkte i blodet (intravenøst (i.v.)).
English: Before using the pre-filled pen, the user manual included in the package leaflet must be read carefully.
Danish: Læs brugervejledningen, der ligger sammen med indlægssedlen, grundigt inden den fyldte pen tages i brug.
English: Hypersensitivity to insulin lispro or to any of the excipients listed in section 6.1.
Danish: Overfølsomhed over for insulin lispro eller over for et eller flere af hjælpestofferne anført i pkt.
English: Record the brand name (“Insulin lispro Sanofi”) and Lot number (included on the outer cartons and labels of each vial, cartridge and pre-filled pen) of the product you are using and provide this information when reporting any side effects.
Danish: Noter produktnavn (”Insulin lispro Sanofi”) og Lot-nummer (anført på yderkartonen og etiketten på alle hætteglas, cylinderampuller og fyldte penne), så du har det, hvis du skal indberette en bivirkning.
English: • Always keep spare syringes and a spare vial of Insulin lispro Sanofi
Danish: • Opbevar altid ekstra éngangssprøjter og et ekstra Insulin lispro Sanofi hætteglas.
English: • If you still find it hard to press in, get a new pen.
Danish: • Brug en ny pen, hvis du stadig har svært ved at trykke knappen ind.
English: Plunger
Danish: Balder
English: The 3 ml cartridge is only for use in 3 ml pens.
Danish: 3 ml cylinderampuller må kun anvendes i 3 ml insulinpenne.
English: Sanofi A/S Tlf: +45 45 16 70 00
Danish: Danmark sanofi-aventis Denmark A/SSanofi A/S Tlf: +45 45 16 70 00
English: • As soon as you have done the injection, take the needle off the pen using the outer needle cap. Do not share your needles.
Danish: • Umiddelbart efter at du har foretaget injektionen, skal du skrue nålen af pennen ved hjælp af nålens ydre hætte.
English: Do not store the vial in a refrigerator.
Danish: Opbevar det ikke i køleskabet.
English: Insulin lispro Sanofi in pre-filled pen is only suitable for injecting just under the skin (see also section 3).
Danish: Insulin lispro Sanofi i en fyldt pen er kun egnet til injektion lige under huden (se også punkt 3).
English: If you forget to use Insulin lispro Sanofi
Danish: Hvis du har glemt at bruge Insulin lispro Sanofi
English: One ml solution contains 100 units (equivalent to 3.5 mg) insulin lispro.
Danish: En ml indeholder 100 enheder (svarende til 3,5 mg) insulin lispro.
English: Put the needle through the rubber top of the Insulin lispro Sanofi vial and inject the air into the vial.
Danish: Stik nålen igennem gummimembranen på Insulin lispro Sanofi-hætteglasset og sprøjt luften ind i hætteglasset.
English: Making sure the tip of the needle is in the Insulin lispro Sanofi, withdraw the correct dose of Insulin lispro Sanofi into the syringe.
Danish: Sørg for at spidsen af nålen befinder sig i Insulin lispro Sanofi-opløsningen, og træk den korrekte dosis Insulin lispro Sanofi ind i sprøjten.
English: Insulin lispro Sanofi 100 units/ml solution for injection in a pre-filled pen Insulin lispro Each pre-filled pen delivers 1-80 units in steps of 1 unit.
Danish: Insulin lispro Sanofi 100 enheder/ml injektionsvæske, opløsning i fyldt pen insulin lispro Hver fyldt pen leverer 1-80 enheder i trin af 1 enhed.
English: E After holding and slowly counting to 10, release the injection button.
Danish: E Slip injektionsknappen efter du har holdt den inde og langsom talt til 10.
English: Making sure the tip of the needle is in the insulin; withdraw the dose of longer-acting insulin.
Danish: Sørg for at spidsen af nålen befinder sig i insulinen, og træk dosis af længerevirkende insulin ind i sprøjten.
English: Subcutaneous administration of Insulin lispro Sanofi
Danish: Subkutan administration af Insulin lispro Sanofi
English: Pack sizes: 5 or 10 cartridges
Danish: Pakningsstørrelser: 5 eller 10 cylinderampuller.
English: Insulin lispro Sanofi 100 units/ml solution for injection in a pre-filled pen Type 1 colourless glass cartridge with a black plunger (bromobutyl rubber) and a flanged cap (aluminium) with a sealing disk (laminate of isoprene and bromobutyl rubber) sealed in a disposable pen injector (SoloStar).
Danish: Insulin lispro Sanofi 100 enheder/ml injektionsvæske, opløsning i fyldt pen Type 1 cylinderampul i klart glas med et sort stempel (bromobutylgummi) og en ombøjet hætte (aluminium) med en prop (laminat af isopren og bromobutylgummi), som er forseglet i en engangspen (SoloStar).
English: Insulin requirements may be reduced in patients with hepatic impairment due to reduced capacity for gluconeogenesis and reduced insulin breakdown; however, in patients with chronic hepatic impairment, an increase in insulin resistance may lead to increased insulin requirements.
Danish: Insulinbehovet kan være nedsat hos patienter med nedsat leverfunktion på grund af reduceret glukoneogenesekapacitet og reduceret insulinnedbrydning.
English: Each pre-filled pen contains 3 ml equivalent to 300 units insulin lispro.
Danish: Hver fyldt pen indeholder 3 ml svarende til 300 enheder insulin lispro.
English: Each vial contains 10 ml equivalent to 1,000 units insulin lispro.
Danish: Hvert hætteglas indeholder 10 ml svarende til 1.000 enheder insulin lispro.
English: Always use a new needle for each injection.
Danish: Brug en ny nål til hver injektion.
English: D Pull off the inner needle cap and throw away.
Danish: D Tag den indre nålehætte af, og kasser den.
English: Rubber seal
Danish: Gummipakning
English: Insulin lispro Sanofi solution for injection in a pre-filled pen (SoloStar) INSTRUCTIONS FOR USE
Danish: Insulin lispro Sanofi injektionsvæske, opløsning i fyldt pen (SoloStar) BRUGERVEJLEDNING
English: Draw air into the syringe equal to the amount of longer-acting insulin being taken.
Danish: Træk en mængde luft svarende til den ordinerede dosis af længerevirkende insulin op i sprøjten.
English: Keep your cartridge in use at room temperature (below 30°C) and dispose of after 4 weeks.
Danish: Den cylinderampul, der er i brug, opbevares ved stuetemperatur (under 30ºC) og kasseres efter 4 uger.
English: What you need to know before you use Insulin lispro Sanofi
Danish: Det skal du vide, før du begynder at bruge Insulin lispro Sanofi
English: • When used with an insulin infusion pump, Insulin lispro Sanofi should not be mixed with any other insulin.
Danish: • Når Insulin lispro Sanofi bruges i en insulininfusionspumpe, bør det ikke blandes med anden insulin.
English: Insulin lispro Sanofi 100 units/ml solution for injection in cartridge Type 1 colourless glass cartridge with a black plunger (bromobutyl rubber) and a flanged cap (aluminium) with a sealing disk (laminate of isoprene and bromobutyl rubber).
Danish: Insulin lispro Sanofi 100 enheder/ml injektionsvæske, opløsning i cylinderampul Type 1 cylinderampul i klart glas med et sort stempel (bromobutylgummi) og en ombøjet hætte (aluminium) med en prop (laminat af isopren og bromobutylgummi).
English: Insulin lispro in a pre-filled pen is available in two strengths.
Danish: Insulin lispro Sanofi i fyldt pen fås i to styrker.
English: B Pull off the pen cap.
Danish: B Tag penhætten af.
English: Making sure the tip of the needle is in the Insulin lispro Sanofi;withdraw the correct dose into the syringe.
Danish: Sørg for at spidsen af nålen befinder sig i Insulin lispro Sanofi-opløsningen, og træk den korrekte dosis ind i sprøjten.
English: Insulin lispro Sanofi solution for injection should be given by subcutaneous injection or by continuous subcutaneous infusion pump (see section 4.2) and may, although not recommended, also be given by intramuscular injection.
Danish: Insulin lispro Sanofi injektionsvæske, opløsning bør gives som subkutan injektion eller ved brug af kontinuerlig subkutan infusionspumpe (se pkt.
English: Insulin lispro maintains more rapid absorption when compared to soluble human insulin in patients with renal impairment.
Danish: Den hurtigere absorption af insulin lispro i forhold til opløselig human insulin opretholdes hos patienter med nedsat nyrefunktion.
English: Remove outer needle cap.
Danish: Fjern den ydre nålehætte.
English: You should only inject it into a muscle if your doctor has told you to.
Danish: Du bør kun injicere Insulin lispro Sanofi i en muskel, hvis din læge har sagt dette.
English: Always check the pack and the vial label for the name and type of the insulin when you get it from your pharmacy.
Danish: Kontrollér altid insulinens navn og type på pakningen og pennen etiket, når du får insulinen fra apoteket.
English: Once the cartridge is empty, do not use it again.
Danish: Når cylinderampullen er tom, skal du ikke bruge den mere.
English: The expiry date refers to the last day of that month.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på etiketten og pakningen efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
English: To prevent the possible transmission of disease, each pen must be used by you only, even if the needle is changed.
Danish: For at undgå overførsel af sygdomme må hver pen kun bruges af dig, også selvom nålen udskiftes.
English: To prevent the possible transmission of disease, each pen must be used by one patient only, even if the needle is changed.
Danish: For at undgå overførsel af sygdomme må hver pen kun bruges af den samme patient, også selvom nålen udskiftes.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABEL (cartridge)
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER ETIKET (cylinderampul)
English: Each pre-filled pen contains 3 ml of solution for injection, equivalent to 300 units.
Danish: Hver fyldt pen indeholder 3 ml injektionsvæske, opløsning svarende til 300 enheder.
English: Each vial contains 10 ml of solution for injection, equivalent to 1,000 units.
Danish: Hvert hætteglas indeholder 10 ml injektionsvæske, opløsning svarende til 1.000 enheder.
English: The Insulin lispro Sanofi in your pre-filled pen is the same as the Insulin lispro Sanofi, which comes in separate Insulin lispro Sanofi cartridges.
Danish: Insulin lispro Sanofi-insulinen i din fyldte pen er den samme insulin, som Insulin lispro Sanoficylinderampuller.
English: Remove the needle from the vial of Insulin lispro Sanofi and insert it into the vial of the longeracting insulin.
Danish: Fjern nålen fra hætteglasset med Insulin lispro Sanofi og før den ind i hætteglasset med den længerevirkende insulin.
English: • thyroid hormone replacement therapy,
Danish: • skjoldbruskkirtelhormon,
English: Each cartridge contains 3 ml equivalent to 300 units insulin lispro.
Danish: Hver cylinderampul indeholder 3 ml svarende til 300 enheder insulin lispro.
English: Insulin lispro Regular human insulin absorption and elimination when compared to soluble human insulin in patients with hepatic impairment.
Danish: Den hurtigere absorption og elimination af insulin lispro sammenlignet med opløselig human insulin opretholdes hos patienter med nedsat leverfunktion.
English: EU/1/17/1203/001 5 cartridges EU/1/17/1203/002 10 cartridges.
Danish: EU/1/17/1203/001 5 cylinderampuller EU/1/17/1203/002 10 cylinderampuller
English: Only your physician can administer Insulin lispro Sanofi by the intravenous route.
Danish: Det er kun din læge, der kan give dig Insulin lispro Sanofi direkte i blodet.
English: EU/1/17/1203/007 1 vial EU/1/17/1203/008 5 vials.
Danish: EU/1/17/1203/007 1 hætteglas EU/1/17/1203/08 5 hætteglas
English: Always check the pack and the label cartridge for the name and type of the insulin when you get it from your pharmacy.
Danish: Kontrollér altid insulinens navn og type på pakningen og cylinderampullens etiket, når du får insulinen fra apoteket.
English: Each cartridge contains 3 ml.
Danish: Hver cylinderampul indeholder 3 ml.
English: • Read the instructions on how to use your pre-filled insulin pen.
Danish: • Læs brugervejledningen til din fyldte pen.
English: If you notice your skin thickening or pitting at the injection site, tell your doctor.
Danish: Fortæl det til din læge, hvis du bemærker, at din hud fortykkes eller får fordybninger ved injektionsstedet.
English: Each cartridge contains 3 ml of solution for injection, equivalent to 300 units.
Danish: Hver cylinderampul indeholder 3 ml injektionsvæske, opløsning svarende til 300 enheder.
English: Insulin lispro Sanofi in cartridges is only suitable for injecting just under the skin using a reusable pen (see also section 3).
Danish: Insulin lispro Sanofi i cylinderampuller er kun egnet til injektion lige under huden fra en flergangspen (se også punkt 3).
English: STEP 4: Select the dose
Danish: TRIN 5: Injektion af dosis
English: Keep the pre-filled pen in the outer carton in order to protect from light.
Danish: Opbevar den fyldte pen i yderkartonen for at beskytte mod lys.
English: Do not rub the area.
Danish: Undlad at gnide huden.
English: In patients with type 2 diabetes on maximum doses of sulphonyl urea agents, studies have shown that the addition of insulin lispro significantly reduces HbA1c compared to sulphonyl urea alone.
Danish: Studier har vist, at insulin lispro i kombination med sulfonylurinstoffer signifikant reducerer HbA1c sammenlignet med sulfonyurinstof alene hos type 2-diabetikere på den højeste dosis af sulfonyurinstoffer.
English: Do not put it near heat or in the sun. Do not keep your pen or the cartridges you are using in the fridge.
Danish: Læg den ikke nær varme eller i solen.
English: • Insulin lispro Sanofi is already dissolved in water, so you do not need to mix it.
Danish: • Insulin lispro Sanofi er allerede opløst i vand, så du behøver ikke at blande det. Du må dog kun bruge opløsningen, hvis den ser ud som vand.
English: The Insulin lispro Sanofi cartridges come in a pack of 5 or 10 cartridges.
Danish: Insulin lispro Sanofi i cylinderampul fås i pakninger med 5 eller 10 cylinderampuller.
English: Intravenous administration of Insulin lispro Sanofi Insulin lispro Sanofi 100 units/ml solution for injection in vial
Danish: Intravenøs administration af Insulin lispro Sanofi Insulin lispro Sanofi 100 enheder/ml injektionsvæske, opløsning, i et hætteglas
English: Insulin lispro Sanofi can be used in conjunction with a longer-acting insulin or oral sulphonylurea medicinal products, on the advice of a physician.
Danish: I samråd med en læge må Insulin lispro Sanofi bruges sammen med længerevirkende insulin eller orale sulfonylurinstoffer.
English: Each pre-filled pen contains 3 ml of solution.
Danish: Hver fyldt pen indeholder 3 ml opløsning.
English: NAME OF THE MEDICINAL PRODUCT Insulin lispro Sanofi 100 units/ml solution for injection in vial Insulin lispro Sanofi 100 units/ml solution for injection in cartridge Insulin lispro Sanofi 100 units/ml solution for injection in a pre-filled pen
Danish: Insulin lispro Sanofi 100 enheder/ml injektionsvæske, opløsning i hætteglas Insulin lispro Sanofi 100 enheder/ml injektionsvæske, opløsning i cylinderampul Insulin lispro Sanofi 100 enheder/ml injektionsvæske, opløsning i fyldt pen
English: If you use less Insulin lispro Sanofi than you need, a high blood sugar may occur.
Danish: Hvis du glemmer at tage Insulin lispro Sanofi, kan det ske, at dit blodsukker bliver for højt.
English: Do not use Insulin lispro Sanofi
Danish: Brug ikke Insulin lispro Sanofi: