FrancophonIA/ELRC3.0 huggingface dataset:
English: • in dogs, Dicural is used to treat acute (short-lived) infections of the bladder and to treat pyoderma (a skin infection with a rash and raised lumps).
Danish: • Til hunde anvendes Dicural til behandling af akutte (kortvarige) blæreinfektioner og til behandling af pyodermi (en hudinfektion med udslæt og pustler).
English: • in chickens and turkeys, Dicural is used to treat certain infections affecting the respiratory system (lungs and air sacs).
Danish: • Til kyllinger og kalkuner anvendes Dicural til behandling af bestemte infektioner, som påvirker luftvejene (lunger og luftsække).
English: • in cattle, Dicural is used to treat infections affecting the lungs and breathing (shipping fever and calf pneumonia).
Danish: • Til kvæg anvendes Dicural til behandling af infektioner, der påvirker lungerne og åndedrættet (viruspneumoni og kalvepneumoni).
English: What benefit has Dicural shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Dicural?
English: How does Dicural work?
Danish: Hvordan virker Dicural?
English: Dicural is only used in young turkeys of up to 2 kg body weight.
Danish: Dicural anvendes kun til unge kalkuner med en kropsvægt på op til 2 kg. Til både kyllinger og kalkuner gives lægemidlet i drikkevandet i fem dage
English: A further three trials looked at its effects in treating pyoderma: two compared it with enrofloxacin and one compared it with amoxicillin and clavulanic acid.
Danish: I to af disse blev Dicural sammenlignet med enrofloxacin, og i én blev det sammenlignet med amoxicillin og clavulansyre.
English: If this occurs:
Danish: Hvis dette sker:
English: Ελλάδα BGP Προϊόντα Μ.Ε.Π.Ε.
Danish: BGP Προϊόντα Μ.Ε.Π.Ε.
English: Elderly population (≥ 65 years old)
Danish: Ældre (≥ 65 år)
English: There may be new information.
Danish: Der kan være kommet ny information.
English: • The expiration date has not passed.
Danish: • udløbsdatoen ikke er overskredet.
English: • made of heavy duty plastic,
Danish: • er lavet af hård plast,
English: • upright and stable during use,
Danish: • er opretstående og stabil under brug,
English: Component of a multipack, can't be sold separately.
Danish: Komponent af en multipakning, må ikke sælges separat.
English: Use a new pen instead.
Danish: Brug i stedet en ny pen.
English: MedDRA system organ classes
Danish: MedDRA systemorganklasse
English: You will hear a “click” for each unit turned.
Danish: Du kan høre et “klik” for hver enhed.
English: • It is the correct insulin type.
Danish: • det er den rigtige type insulin.
English: It should be administered once daily at any time but at the same time each day.
Danish: Det kan gives på et hvilket som helst tidspunkt af dagen, men på samme tid hver dag.
English: Immediately take about 10 to 20 g sugar, such as glucose, sugar cubes or a sugar-sweetened beverage.
Danish: Tag omgående ca. 10-20 g sukker f.eks. som glucose, sukkerknald eller en sukkersødet drik.
English: You need one injection of Semglee every day, at the same time of the day.
Danish: Du skal have én injektion af Semglee hver dag på samme tid af dagen.
English: The exposure to M1 increases with the administered dose of Semglee.
Danish: Eksponeringen for M1 øges med den administrerede dosis af Semglee.
English: Small bubbles may still be visible.
Danish: Der kan stadig være små luftbobler.
English: Select and clean the injection site
Danish: Vælg og rengør injektionsstedet
English: This should be kept in mind if treatment with the combination of pioglitazone and Semglee is considered.
Danish: Dette skal tages i betragtning, hvis kombinationsbehandling med pioglitazon og Semglee overvejes.
English: • Do not soak or wash your pen.
Danish: • Du må ikke skylle eller vaske din pen.
English: In order to improve the traceability of biological medicinal products, the name and the batch number of the administered medicinal product should be clearly recorded.
Danish: For bedre at kunne spore biologiske lægemidler skal det administrerede lægemiddels navn og batch nummer noteres.
English: Do not stop Semglee without speaking to a doctor, who will tell you what needs to be done.
Danish: Afbryd ikke behandlingen med Semglee uden at tale med din læge, som vil fortælle dig, hvad der skal gøres.
English: The insulin may not work very well.
Danish: Insulinet virker måske ikke så godt.
English: • Check the pen label to make sure that you are taking the correct type of insulin.
Danish: • Kontrollér etiketten på pennen for at sikre, at du bruger den rigtige type insulin.
English: • Check the expiration date on the pen label.
Danish: • Kontrollér udløbsdatoen på pennens etiket.
English: You can inject 1 to 80 units in a single injection.
Danish: Du kan injicere 1-80 enheder i en enkelt injektion.
English: Do not shake or mix it before use.
Danish: Du skal ikke ryste eller blande opløsningen før brug.
English: Your doctor will show you in which area of the skin you should inject Semglee.
Danish: Din læge vil vise dig i hvilke hudområder, du skal injicere Semglee.
English: If you do not follow these instructions each time you use the pen, you may either get too much or too little insulin.
Danish: Hvis du ikke følger brugsanvisningen, hver gang du bruger pennen, kan du risikere enten at få for meget eller for lidt insulin.
English: Semglee is a biosimilar medicinal product.
Danish: Semglee er et biosimilært lægemiddel.
English: • Restart the process at step 2A to attach and prime a new needle.
Danish: • Gentag processen fra trin 2A for at påsætte og kontrollere en ny nål.
English: Since Semglee is a solution, it does not require resuspension before use.
Danish: Da Semglee er en opløsning, er resuspension ikke nødvendig før brug.
English: This may affect your blood sugar level.
Danish: Det kan påvirke dit blodsukker-niveau.
English: If the hypoglycaemia comes back again take another 10 to 20 g sugar.
Danish: Hvis du igen får hypoglykæmi, skal du indtage yderligere 10-20 g sukker.
English: This pen is not recommended for use by the blind or visually impaired without the help of someone trained to use the pen.
Danish: Denne pen anbefales ikke til blinde eller svagtseende uden hjælp fra en person, som er blevet trænet i at bruge pennen.
English: • The insulin looks clear and colourless.
Danish: • insulinet er klart og farveløst.
English: A - Inspect the pen: check the purple and white label on the pen to make sure:
Danish: A - Kontrol af din pen: kontrollér den lilla og hvide etiket på pennen for at sikre at:
English: • properly labelled to warn of hazardous waste inside the container.
Danish: • er mærket med en advarsel om, at den indeholder farligt affald.
English: The medicinal product may be stored for a maximum of 4 weeks not above 30°C and away from direct heat or direct light.
Danish: Lægemidlet kan opbevares i maksimalt 4 uger og ved temperaturer under 30°C og væk fra direkte varme eller direkte lys.
English: Remove the needle as described in Step 7, and discard the pen or return it to the pharmacist.
Danish: Fjern nålen som beskrevet i Trin 7, og kassér pennen eller lever den tilbage til apoteket.
English: The pen has a purple and white label and a purple injection button.
Danish: Pennen har en lilla og hvid etiket og en lilla injektionsknap.
English: F - Repeat steps 3B through 3E up to three more times until you see drops of insulin at the tip of the needle.
Danish: F - Gentag trin 3B til 3E op til tre gange, indtil der kommer insulin ud af nålespidsen.
English: Test your blood sugar level and your urine for ketones as soon as any of the above symptoms occur.
Danish: Kontrollér dit blodsukker, og undersøg urinen for ketonstoffer, så snart nogen af ovenstående symptomer opstår.
English: C - Put the needle in a sharps disposal container (see Step 8 for instructions on disposal)
Danish: C - Læg nålen i en kanyleboks (se Trin 8 for anvisninger vedrørende bortskaffelse).
English: Do not use the pen after the expiration date.
Danish: Brug ikke pennen efter udløbsdatoen.
English: United Kingdom Generics [UK] Ltd Tel: +44 1707 853000 This leaflet was last revised in {month YYYY}.
Danish: United Kingdom Generics [UK] Ltd Tel: +44 1707 853000 Denne indlægsseddel blev senest ændret {måned ÅÅÅÅ}.
English: The following related adverse reactions from clinical investigations are listed below by system organ class and in order of decreasing incidence (very common: ≥1/10; common: ≥1/100 to <1/10; uncommon: ≥1/1,000 to <1/100; rare: ≥1/10,000 to <1/1,000; very rare: <1/10,000).
Danish: Følgende relaterede bivirkninger, forekommet i kliniske studier, er nedenfor opstillet efter organsystem og faldende hyppighed (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).
English: If you do not have a sharps container, you may use a household container that is:
Danish: Hvis du ikke har en kanyleboks, kan du bruge en beholder, som:
English: B - Hold the pen body with one hand.
Danish: B - Hold pennen med den ene hånd.
English: The needle sizes compatible with this pen are: - 31G, 5 mm, - 32G, 4-6 mm, - 34G, 4 mm.
Danish: Følgende kanylestørrelser kan anvendes sammen med denne pen: - 31G, 5 mm, - 32G, 4-6 mm, - 34G, 4 mm.
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA PC: {number}
Danish: ENTYDIG IDENTIFIKATOR - MENNESKELIGT LÆSBARE DATA PC:
English: Hypoglycaemia (low blood sugar) can be very serious and is very common with insulin treatment (may affect more than 1 in 10 people).
Danish: Hypoglykæmi (lavt blodsukker) kan være meget alvorligt og er meget almindeligt ved insulinbehandling (kan forekomme hos flere end 1 ud af 10 personer).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - Packs of 1, 3, 5 and 10
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDERKARTON - pakninger af 1, 3, 5 og 10
English: Switch from other insulins to Semglee
Danish: Skift fra andre insuliner til Semglee
English: OTHER SPECIAL WARNING(S), IF NECESSARY Use only clear and colourless solutions.
Danish: EVENTUELLE ANDRE SÆRLIGE ADVARSLER Anvend kun klare og farveløse opløsninger.
English: *Insulin glargine is produced by recombinant DNA technology in Pichia pastoris.
Danish: *Insulin glargin er fremstillet ved rekombinant DNA-teknologi i Pichia pastoris.
English: To prevent the possible transmission of disease, each pen must be used by one patient only.
Danish: For at undgå overførsel af sygdomme må pennen kun anvendes af den samme patient.
English: After your injection
Danish: Efter injektionen
English: Do NOT inject Semglee in a vein, since this will change its action and may cause hypoglycaemia.
Danish: Semglee må IKKE injiceres i en blodåre, da dette vil ændre dets virkning, og kan forårsage hypoglykæmi.
English: • You can clean the outside of your pen by wiping it with a damp cloth.
Danish: • Du kan rengøre pennen ved at tørre den af med en fugtig klud.
English: Animal data do not indicate reproductive toxicity.
Danish: Data fra dyr viser ikke tegn på reproduktionstoksicitet.
English: Semglee is injected under the skin.
Danish: Semglee injiceres under huden.
English: The dose regimen (dose and timing) should be individually adjusted.
Danish: Doseringsregime (dosis og tidspunkt for dosering) skal tilpasses individuelt.
English: In patients with type 2 diabetes mellitus, Semglee can also be given together with orally active antidiabetic medicinal products.
Danish: Til patienter med type 2-diabetes mellitus kan Semglee også indgives sammen med oralt aktive antidiabetika.
English: A - Check that the dose window shows “0”.
Danish: A - Kontrollér at dosisvinduet viser “0”.
English: Do not put the pen back in the refrigerator after using it.
Danish: Du må ikke lægge pennen i køleskabet, efter du har brugt den.
English: • Keep your pen away from moisture, dust, direct sunlight and places where the temperature may get too high or low (see storage section at the beginning of these instructions)
Danish: • Opbevar pennen, så den ikke er udsat for fugt, støv, direkte sollys og steder, hvor det kan blive for varmt eller for koldt (se opbevaringsbetingelserne i starten af denne brugsanvisning)
English: Insulin glargine injected once daily will reach steady state levels in 2-4 days after the first dose.
Danish: Insulin glargin injiceret 1 gang daglig vil opnå steady state-niveauer 2-4 dage efter første dosis.
English: Over the course of this 6-year study, 42% of the insulin glargine group did not experience any hypoglycaemia.
Danish: I løbet af dette 6-års studie oplevede 42% af patienterne i insulin glargin-gruppen ingen hypoglykæmi.
English: • Go to Step 7 for instructions on safely removing the needle.
Danish: • Se Trin 7 for anvisninger om, hvordan nålen fjernes.
English: Very rare reported side effects (may affect up to 1 in 10,000 people) In very rare cases, dysgeusia (taste disorders) and myalgia (muscular pain) can occur.
Danish: Meget sjældne bivirkninger (kan forekomme hos op til 1 ud af 10.000 personer) I meget sjældne tilfælde kan der forekomme dysgeusia (smagsforstyrrelser) og myalgia (muskelsmerter).
English: The use of Semglee may be considered during pregnancy, if clinically needed.
Danish: Anvendelsen af Semglee til gravide kan overvejes, hvis det behandlingsmæssigt er nødvendigt.
English: • can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
Danish: • kan lukkes med et tætsiddende, punkterfrit låg, så skarpe genstande ikke kan falde ud,
English: Changes in strength, brand (manufacturer), type (regular, NPH, lente, long-acting, etc.), origin (animal, human, human insulin analogue) and/or method of manufacture may result in the need for a change in dose.
Danish: Ændringer i styrke, brand (fremstiller), type (regulær, NPH, lente, langtidsvirkende, etc.), oprindelse (animalsk, human, human insulinanalog) og/eller fremstillingsmetode kan medføre, at det kan være nødvendigt at ændre dosis.
English: It must only be used if the solution is clear, colourless, with no solid particles visible, and if it is of water-like consistency.
Danish: Opløsningen må kun anvendes, såfremt den er klar, farveløs, uden synlige partikler og har et vandlignende udseende.
English: You will need the outer needle cap later.
Danish: Du må ikke kassere den. Du får brug for den ydre nålehætte senere.
English: • Use an injection site that your healthcare provider has shown you.
Danish: • Anvend et af de injektionssteder, som lægen eller sundhedspersonalet har vist dig.
English: • Get a new pen and inject the full dose.
Danish: • Bruge en ny pen og injicere den fulde dosis.
English: 5 pens of 3 ml.
Danish: 5 penne á 3 ml.
English: The pen will not let you dial a dose more than the number of units left in the pen.
Danish: Pennen vil ikke lade dig vælge flere doser end der er tilbage i pennen.
English: Empty pens must never be reused and must be properly discarded.
Danish: Tomme penne må aldrig genbruges og skal bortskaffes på passende vis.
English: E - Store the pen at room temperature (under 30°C).
Danish: E - Pennen skal opbevares ved stuetemperatur (under 30°C).
English: It is completely soluble at the acidic pH of the Semglee injection solution (pH 4).
Danish: Det er fuldstændig opløseligt ved den sure pH i opløsningen af Semglee (pH 4).
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.
Danish: Prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, toksicitet efter gentagne doser, genotoksicitet, karcinogenicitet samt reproduktions- og udviklingstoksicitet.
English: Talk to your doctor, pharmacist or nurse before using Semglee.
Danish: Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før du bruger Semglee.
English: B - Push the needle straight into the skin as shown by your healthcare provider.
Danish: B - Tryk nålen lige ind i huden som vist af din læge eller sundhedspersonalet.
English: Do not push the injection button sideways or block the white dose knob with your fingers as this will stop you from injecting the medicine.
Danish: Du må ikke trykke skævt på knappen eller stoppe den hvide dosisvælger med dine finger, da det vil hindre, at medicinen udløses.
English: Semglee should not be administered intravenously.
Danish: Semglee må ikke gives intravenøst.
English: You may need to talk about - the availability of your insulin in the country you are visiting, - supplies of insulin, needles etc., - correct storage of your insulin while travelling, - timing of meals and insulin administration while travelling, - the possible effects of changing to different time zones, - possible new health risks in the countries to be visited, - what you should do in emergency situations when you feel unwell or become ill.
Danish: Du kan måske have behov for at tale om: - det er muligt at købe dit insulin i det land, som du skal besøge, - forsyninger af insulin, nåle etc., - korrekt opbevaring af dit insulin under rejsen, - tidspunkter for måltider og insulin-injektioner under rejsen, - eventuelle påvirkninger ved at skifte til andre tidszoner, - eventuelle nye sundhedsrisici i de lande, som du skal besøge, - hvad du skal gøre i krisesituationer, hvis du føler dig utilpas eller bliver syg.
English: Do not use alcohol, hydrogen peroxide, bleach, or any other liquids to clean your pen.
Danish: Anvend ikke alkohol, brintoverilte, blegemiddel eller andre rengøringsmidler til at rengøre din pen.
English: Keep twisting the needle until it comes off the pen.
Danish: Bliv ved med at dreje nålen, indtil den er fri af pennen.
English: These units are exclusive to Semglee and are not the same as IU or the units used to express the potency of other insulin analogues (see section 5.1).
Danish: Disse enheder gælder udelukkende for Semglee og er ikke det samme som IE eller enhederne, som angiver styrken på andre insulin-analoger (se pkt.
English: Due to more sustained basal insulin supply with Semglee, less nocturnal but more early morning hypoglycaemia can be expected.
Danish: På grund af et mere vedvarende tilskud af basalinsulin ved Semglee kan der forventes færre natlige men flere tidlig morgen hypoglykæmier.
English: • Do not share your pen with other people, even if the needle has been changed.
Danish: • Du må ikke dele din pen med andre, heller ikke selvom nålen udskiftes.
English: Do not force the dose knob to turn beyond 80 units.
Danish: Du må ikke tvinge dosisvælgerne til at dreje længere end til 80 enheder.
English: Based on your life-style and the results of your blood sugar (glucose) tests and your previous insulin usage, your doctor will - determine how much Semglee per day you will need and at what time, - tell you when to check your blood sugar level, and whether you need to carry out urine tests, - tell you when you may need to inject a higher or lower dose of Semglee.
Danish: Alt efter din levevis og resultatet af dine blodsukkermålinger (glucosemålinger) og din tidligere anvendelse af insulin vil din læge: - afgøre hvor meget Semglee du skal have per dag og på hvilket tidspunkt af dagen, - fortælle dig, hvornår du skal kontrollere dit blodsukker, og om det er nødvendigt at udføre urinprøver, - fortælle dig, hvornår du eventuelt skal have en større eller mindre dosis Semglee.
English: • Check that the medicine in the pen cartridge looks clear and colourless.
Danish: • Kontrollér at medicinen i cylinderampullen er klar og farveløs.
English: The used pen may be discarded in your household waste after you have removed the needle.
Danish: Du kan smide den brugte pen i skraldespanden, efter du har fjernet nålen.
English: You should change your injection site for each injection.
Danish: Du bør skifte injektionssted for hver injektion.
English: Semglee in pre-filled pen is only suitable for injecting just under the skin (see also section 3).
Danish: Semglee i en fyldt pen er kun egnet til injektion lige under huden (se også punkt 3).
English: There was less severe hypoglycaemia in the insulin glargine group as well.
Danish: Der var ligeledes færre alvorlige hypoglykæmier i insulin glargin-gruppen.
English: As you turn the white dose knob to set your dose, it will extend out and you will hear a “click” at each unit dialled.
Danish: Når du drejer den hvide dosisvælger for at indstille din dosis, bevæger den sig og du vil høre et “klik” for hver dosisenhed.
English: This could damage the pen.
Danish: Det kan beskadige den.
English: INFORMATION IN BRAILLE Semglee
Danish: INFORMATION I BRAILLESKRIFT Semglee
English: Correspondingly, the incidences of nocturnal hypoglycaemia were 32% in the insulin glargine / lispro group versus 52% in the NPH / regular group.
Danish: Modsat var incidensen af natlige hypoglykæmier 32% i insulin glargin/lispro-gruppen versus 52% i NPH/regulær-gruppen.
English: Semglee in pre-filled pen is only suitable for subcutaneous injections.
Danish: Semglee i fyldt pen er kun egnet til subkutane injektioner.
English: Remove the needle after the injection and store the pen without the needle.
Danish: Fjern kanylen efter injektion og opbevar pennen uden kanyle.
English: You may give other people serious infection or get a serious infection from them.
Danish: Du kan risikere at give andre en alvorlig infektion eller få en alvorlig infektion fra andre.
English: If you accidentally turn past 2 units, turn back the dose knob in the opposite direction to the correct number of units.
Danish: Hvis du ved et uheld drejer forbi 2 enheder, kan du dreje tilbage igen, indtil du når det korrekte antal enheder.
English: After subcutaneous injection of Semglee in diabetic patients, insulin glargine is rapidly metabolized at the carboxyl terminus of the Beta chain with formation of two active metabolites M1 (21A-Gly-insulin) and M2 (21A-Gly-des-30B-Thr-insulin).
Danish: Efter subkutan injektion af Semglee til diabetespatienter bliver insulin glargin hurtigt metaboliseret ved carboxylenden af beta-kæden under dannelse af to aktive metabolitter M1 (21A-Gly-insulin) og M2 (21A-Gly-des-30B-Thr-insulin).
English: • Sterile disposable hypodermic needle compatible with this pen
Danish: • Steril hypodermisk nål til engangsbrug, som passer til denne pen
English: IGF-1 receptor binding: The affinity of insulin glargine for the human IGF-1 receptor is approximately 5 to 8-fold greater than that of human insulin (but approximately 70 to 80-fold lower than the one of IGF-1), whereas M1 and M2 bind the IGF-1 receptor with slightly lower affinity compared to human insulin.
Danish: IGF-1-receptorbinding: affiniteten af insulin glargin til den humane IGF-1-receptor er omkring 5-8 gange højere end human insulins affinitet (men omkring 70-80 gange lavere end affiniteten af IGF-1), hvorimod M1 og M2 bindes til IGF-1-receptoren med en lidt lavere affinitet end humant insulin.
English: Shelf-life after first use of the pen
Danish: Opbevaringstid efter første anbrud af pennen
English: In a randomised, controlled clinical study, paediatric patients (age range 6 to 15 years) with type 1 diabetes (n=349) were treated for 28 weeks with a basal-bolus insulin regimen where regular human insulin was used before each meal.
Danish: I et randomiseret kontrolleret klinisk studie blev pædiatriske patienter (i alderen fra 6-15 år) med type 1-diabetes (n=349) behandlet i 28 uger med et basal bolus insulin regime, hvor regulær humant insulin blev anvendt før hvert måltid.
English: Only use needles that are compatible with Semglee pen (see “Instructions for Use”).
Danish: Anvend kun nåle som er kompatible til brug i Semglee pennen (se ”Brugsanvisning”).
English: Needles to be obtained separately: Needle sizes compatible with this pen:
Danish: Nåle som skal anskaffes separat: Følgende nålestørrelser passer til denne pen:
English: Only use needles that are compatible for use with this pre-filled pen.
Danish: Anvend kun kanyler, der er kompatible til brug med denne fyldte pen.
English: If you stop using Semglee
Danish: Hvis du holder op med at bruge Semglee
English: Semglee is administered subcutaneously.
Danish: Administration Semglee indgives subkutant.