FrancophonIA/ELRC3.0 huggingface dataset:
English: Table 6 Results from an open-label clinical trial with flexible dosing of Tresiba in type 2 diabetes mellitus
Danish: Tabel 6 Resultater fra et åbent klinisk studie med fleksibelt administrationstidspunkt af Tresiba med type 2-diabetes mellitus
English: The dose counter will show the exact number of units.
Danish: Dosistælleren viser det præcise antal enheder.
English: In the open-label trials the effect of Tresiba was tested in patients with type 1 diabetes mellitus (Table 3), in insulin naïve patients (insulin initiation in type 2 diabetes mellitus, Table 4) and in previous insulin users (insulin intensification in type 2 diabetes mellitus, Table 5) with fixed as well as flexible dosing time (Table 6), and the reduction in HbA1c from baseline to end of trial was confirmed to be non-inferior in all trials against all comparators (insulin detemir and insulin glargine (100 units/mL)).
Danish: I et åbent studie blev virkningen af Tresiba testet hos patienter med type 1-diabetes mellitus (tabel 3), insulinnaive patienter (initiering af insulin ved type 2-diabetes mellitus, tabel 4) og hos tidligere insulinbrugere (intensivering af insulin ved type 2-diabetes mellitus, tabel 5) med både faste og fleksible administrationstidspunkter (tabel 6), og non-inferioriteten af reduktionen af HbA1c fra baseline til studiets slutning blev bekræftet i alle studier i forhold til alle sammenligningsprodukter (insulin detemir og insulin glargin (100 enheder/ml)).
English: Pioglitazone: oral antidiabetic medicine used to treat type 2 diabetes mellitus.
Danish: Pioglitazon: lægemiddel i tabletform til behandling af type 2-diabetes.
English: The following substances may reduce the insulin requirement Oral antidiabetic medicinal products, GLP-1 receptor agonists, monoamine oxidase inhibitors (MAOI), beta-blockers, angiotensin converting enzyme (ACE) inhibitors, salicylates, anabolic steroids and sulfonamides.
Danish: Orale antidiabetika, GLP-1-receptoragonister, monoaminoxidasehæmmere (MAO-hæmmere), betablokkere, ACE-hæmmere, salicylater, anabolske steroider og sulfonamider.
English: • The dose counter of your pen shows the exact number of insulin units.
Danish: • Dosistælleren på din pen viser det præcise antal insulinenheder.
English: They may include cold sweats, cool pale skin, fatigue, nervousness or tremor, anxiousness, unusual tiredness or weakness, confusion, difficulty in concentration, drowsiness, excessive hunger, vision changes, headache, nausea and palpitation.
Danish: De kan omfatte koldsved, kold og bleg hud, udmattelse, nervøsitet eller tremor, ængstelse, usædvanlig træthed eller svaghed, konfusion, koncentrationsbesvær, døsighed, overdreven sult, synsforstyrrelser, hovedpine, kvalme og hjertebanken.
English: When your pen contains less than 80 units, the dose counter stops at the number of units left.
Danish: Når pennen indeholder mindre end 80 enheder, stopper dosistælleren ved det antal enheder, der er tilbage.
English: 1 In a once-daily regimen + insulin aspart to cover mealtime insulin requirements
Danish: 1 Regime med administration en gang dagligt + insulin aspart for at dække behovet for insulin ved måltiderne ± metformin ± pioglitazon
English: If you do not follow the instructions carefully, you may get too little or too much insulin, which can lead to too high or too low blood sugar level.
Danish: Hvis ikke du følger denne vejledning omhyggeligt, kan du risikere at få for lidt eller for meget insulin, hvilket kan føre til et for højt eller for lavt blodsukkerniveau.
English: The dose is provided in half the volume of 100 units/mL basal insulin products.
Danish: Dosis indgives ved brug af halvdelen af volumen i forhold til basalinsulinpræparater med 100 enheder/ml.
English: If you select and inject the wrong dose, your blood sugar level may get too high or too low.
Danish: Hvis du indstiller og injicerer en forkert dosis, kan dit blodsukkerniveau blive for højt eller for lavt.
English: Table 4 Results from open-label clinical trials in insulin naïve type 2 diabetes mellitus (insulin initiation)
Danish: Tabel 4 Resultater fra åbne kliniske studier med insulinnaiv type 2-diabetes mellitus (insulin initiering)
English: Re-use of needles may increase the risk of blocked needles leading to inaccurate dosing.
Danish: Genbrug af nåle kan øge risikoen for blokerede nåle,
English: FPG (mmol/L) End of trial Mean change from baseline
Danish: FPG (mmol/l) Forsøgsafslutning Middelændring fra baseline
English: Other medicines and Tresiba
Danish: Brug af anden medicin sammen med Tresiba
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 21 January 2013
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN
English: Tresiba must not be drawn from the cartridge of the pre-filled pen into a syringe (see section 4.4).
Danish: Tresiba må ikke udtages fra cylinderampullen tilhørende den fyldte pen og ind i en sprøjte (se punkt
English: Injecting your medicine
Danish: Injektion af lægemidlet
English: Always keep the cap on the pen when you are not using it in order to protect it from light.
Danish: Lad altid hætten sidde på pennen, når den ikke er i brug, for at beskytte den mod lys.
English: If you use too much insulin, your blood sugar may get too low (hypoglycaemia), see advice in section 4 ‘Too low blood sugar'.
Danish: Hvis du tager for meget insulin, kan dit blodsukker blive for lavt (hypoglykæmi) - se informationen i punkt 4 "For lavt blodsukker".
English: The signs may include: pain, redness, hives, swelling and itching.
Danish: Symptomerne kan være: smerter, rødme, udslæt, hævelse og kløe.
English: Dose button with smooth surface
Danish: Dosisknap med glat overflade
English: In addition, Tresiba 100 units/mL packaging and label are light green, and Tresiba 200 units/mL packaging and label are dark green with striping with a red box highlighting the formulation strength.
Danish: Derudover er Tresiba 100 enheder/ml pakningen og etiketten lysegrøn, og Tresiba 200 enheder/ml pakningen og etiketten er mørkegrøn med striber og med en rød boks, der fremhæver styrken af formuleringen.
English: • monoamine oxidase (MAO) inhibitors, for depression
Danish: • MAO-hæmmere (monoaminoxidasehæmmere), mod depression
English: PHARMACEUTICAL FORM AND CONTENTS Solution for injection (FlexTouch) Multipack: 6 (2 packs of 3) 3 mL pre-filled pens
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Injektionsvæske, opløsning (FlexTouch) Multipakning: 6 (2 pakker a 3) 3 mL pre-filled pens
English: The Poster for pharmacies/diabetic units shall contain the following key elements: - That Tresiba is available in 2 strengths; - Key differences in the design of the packages and the pre-filled pen devices; - When prescribing to make sure that the correct strength is mentioned in the prescription slip; - Always check the insulin label before dispensing to make sure the correct strength is delivered to the patient; - Always check the insulin label before each injection to avoid accidental mix-ups between the two different strengths of Tresiba; - Do not use outside of the pre-filled pen device (e.g. syringes); - Reporting of medication errors or any side effects.
Danish: - At Tresiba er tilgængelig i to styrker; - Nøgleforskelle i design af pakningerne og de fyldte pen enheder; - At sikre sig ved udskrivning at den rigtige styrke er nævnt på recepten; - Tjek altid insulinetiketten før dispensering for at sikre, at den korrekte styrke bliver givet til patienten; - Tjek altid insulinetiketten før hver injektion for at undgå fejltagelser mellem de to forskellige styrker af Tresiba; - Bruges kun i den fyldte penenhed, og ikke i f.eks. sprøjter; - Rapportér fejlmedicinering og alle bivirkninger.
English: If it shows less than 160, the number shown is the number of units left in your pen.
Danish: Hvis den viser mindre end 160, er det viste tal antallet af enheder, der er tilbage i pennen.
English: In type 2 diabetes mellitus, Tresiba may be used in combination with tablets for diabetes or with injectable antidiabetic medicines, other than insulin.
Danish: Ved type 2-diabetes mellitus, kan Tresiba bruges sammen med tabletter mod diabetes eller med injicérbart lægemiddel mod diabetes, udover insulin.
English: Headache; slurred speech; fast heartbeat; cold sweat, cool pale skin; feeling sick, feeling very hungry; tremor or feeling nervous or worried; feeling unusually tired, weak and sleepy; feeling confused, difficulty in concentrating; short-lasting changes in your sight.
Danish: Hovedpine, sløret tale, hurtig hjertebanken, koldsved, kold bleg hud, kvalme, usædvanlig stor sultfornemmelse, rysten, nervøsitet eller bekymring, unormal træthed, svaghed og døsighed, forvirring, koncentrationsbesvær, kortvarige synsforstyrrelser.
English: For both strengths, the needed dose is dialled in units.
Danish: For begge styrker indstilles den rette dosis i enheder.
English: Confirmed4
Danish: Bekræftet4
English: Nocturnal confirmed hypoglycaemia was defined as episodes between midnight and 6 a.m. b Episodes from week 16.
Danish: Bekræftet natlig hypoglykæmi blev defineret som episoder mellem midnat og kl. 6. b Episoder fra uge 16.
English: Glycerol, metacresol, phenol, zinc acetate, hydrochloric acid and sodium hydroxide (for pH adjustment) and water for injections
Danish: Glycerol, metacresol, phenol, zinkacetat, saltsyre/natriumhydroxid (til pH-justering) og vand til injektionsvæsker
English: Nocturnal severe2
Danish: Natlig alvorlig2
English: There is no clinical experience with flexibility in dosing time of Tresiba in children and adolescents.
Danish: Der er ingen klinisk erfaring med fleksibelt administrationstidspunkt af Tresiba hos børn og unge.
English: “Tresiba 100 units/mL” or “Tresiba 200 units/mL” is clearly marked on the pen label and packaging.
Danish: ”Tresiba 100 enheder/ml” eller ”Tresiba 200 enheder/ml” er tydeligt angivet på pen etiketten og pakningen.
English: Insulin glargine (100 units/mL) (N27) (CV%)
Danish: Insulin glargin (100 enheder/ml) (N27) (CV%)
English: The dose counter of the pre-filled pen shows the number of units of insulin to be injected.
Danish: Dosistælleren i den fyldte pen viser antallet af insulinenheder, der injiceres.
English: In rats, insulin degludec was secreted in milk; the concentration in milk was lower than in plasma.
Danish: Koncentrationen i mælk var lavere end i plasma.
English: 1 mL solution contains 200 units insulin degludec* (equivalent to 7.32 mg insulin degludec).
Danish: 1 ml af opløsningen indeholder 200 enheder insulin degludec* (svarende til 7,32 mg insulin degludec).
English: A drop of insulin should appear at the needle tip.
Danish: En dråbe insulin skal komme til syne på nålens spids.
English: Rate of hypoglycaemia (per patient year of exposure) Severe hypoglycaemia
Danish: Hyppighed af hypoglykæmi (pr. patientår med eksponering) Alvorlig hypoglykæmi
English: INFORMATION IN BRAILLE Tresiba cartridge 100
Danish: INFORMATION I BRAILLESKRIFT Tresiba cylinderampul 100
English: • if the pen is damaged or has not been stored correctly (see section 5 ‘How to store Tresiba').
Danish: • hvis pennen er beskadiget eller ikke har været opbevaret korrekt (se punkt 5 "Opbevaring").
English: Dispose of the needle safely after each use.
Danish: Kassér nålen sikkert efter brug.
English: Total
Danish: I alt
English: They include thirst, increased frequency of urination, nausea, vomiting, drowsiness, flushed dry skin, dry mouth, and loss of appetite as well as acetone odour of breath.
Danish: Symptomerne inkluderer tørst, hyppigere vandladning, kvalme, opkastning, døsighed, rødme og tør hud, mundtørhed, appetitløshed og acetoneånde.
English: Confirmed3
Danish: Bekræftet3
English: Pen label Dose counter Dose pointer
Danish: Penetikette Dosistæller Dosismarkør
English: It is used for once-daily dosing.
Danish: Det tages én gang dagligt.
English: EU/1/12/807/009 1 pen of 3 mL EU/1/12/807/006 1 pen of 3 mL and 7 NovoFine needles EU/1/12/807/010 1 pen of 3 mL and 7 NovoTwist needles EU/1/12/807/012 2 pens of 3 mL EU/1/12/807/013 3 pens of 3 mL EU/1/12/807/016 5 pens of 3 mL
Danish: EU/1/12/807/009 1 pen a 3 ml EU/1/12/807/006 1 pen a 3 ml og 7 NovoFine enagngsnåle EU/1/12/807/010 1 pen a 3 ml og 7 NovoTwist enagngsnåle EU/1/12/807/012 2 penne a 3 ml EU/1/12/807/013 3 penne a 3 ml EU/1/12/807/016 5 penne a 3 ml
English: INFORMATION IN BRAILLE Tresiba pre-filled pen 200 units/mL
Danish: INFORMATION I BRAILLESKRIFT Tresiba fyldt pen 200 enheder/ml
English: Nocturnal confirmed2
Danish: Bekræftet natlig2
English: The dose counter of your pen shows the exact number of insulin units.
Danish: Dosistælleren på pennen viser det præcise antal insulin enheder.
English: • Ensuring you use the right type of insulin - always check the insulin label before each injection to avoid accidental mix-ups between different strengths of Tresiba as well as other insulin products.
Danish: • Sikre dig, at du anvender den rigtige type insulin - kontrollér altid insulinetiketten før hver injektion for at undgå utilsigtet forveksling af forskellige Tresiba styrker såvel som andre insulinpræparater.
English: Discard the needle safely after each injection
Danish: Kassér nålen sikkert efter hver injektion
English: • Do not wash, soak or lubricate your pen.
Danish: • Pennen må ikke vaskes, iblødsættes eller smøres.
English: INFORMATION IN BRAILLE Tresiba pre-filled pen 100 units/mL
Danish: INFORMATION I BRAILLESKRIFT Tresiba fyldt pen 100 enheder/ml
English: 6 units selected
Danish: 6 enheder valgt
English: • Switching from other insulin medicines - the insulin dose may need to be changed if you switch from another type, brand or manufacturer of insulin.
Danish: • Skift fra andre insulinpræparater - hvis du skifter fra en anden type, et andet mærke eller en anden fabrikant af insulin kan det medføre et behov for ændring af dosis.
English: FPG (mmol/L) End of trial Mean change
Danish: FPG (mmol/l) Forsøgsafslutning Middelændring
English: A drop of insulin may appear at the needle tip.
Danish: En dråbe insulin kan komme til syne på nålens spids.
English: Before first use
Danish: Før ibrugtagning
English: Rate of hypoglycaemia (per 100 patient years of observation) Severe
Danish: N Hyppighed af hypoglykæmi (observering per 100 patientår)
English: If you split the dose wrong, you will inject too little or too much insulin, which can lead to too high or too low blood sugar level.
Danish: Hvis du opdeler din dosis forkert, kan du risikere at injicere for lidt eller for meget insulin, hvilket kan føre til et for højt eller for lavt blodsukkerniveau.
English: In type 1 diabetes mellitus, Tresiba must always be used in combination with meal-related rapid-acting insulin medicines.
Danish: Ved type 1-diabetes skal Tresiba altid kombineres med hurtigtvirkende insulin i forbindelse med måltiderne.
English: Tresiba 100 units/mL solution for injection in pre-filled pen EU/1/12/807/001
Danish: Tresiba 100 enheder/ml injektionsvæske, opløsning i fyldt pen EU/1/12/807/001
English: • Press and hold down the dose button until the dose counter returns to 0.
Danish: • Tryk på dosisknappen og hold den nede, indtil dosistælleren er tilbage på 0.
English: As with other basal insulin products, the prolonged effect of Tresiba may delay recovery from hypoglycaemia.
Danish: Den langvarige virkning af Tresiba kan som ved andre basalinsulinpræparater forsinke normalisering af blodsukkeret efter hypoglykæmi.
English: Tresiba can be used with meal-related rapid-acting insulin products.
Danish: Tresiba kan bruges med hurtigtvirkende insulinpræparater, der gives i forbindelse med et måltid.
English: • Once the needle is covered, carefully push the outer needle cap completely on. • Unscrew the needle and dispose of it carefully.
Danish: • Når nålen er dækket, skubbes den ydre nålehætte helt på.
English: If you experience eye problems, talk to your doctor.
Danish: Tal med din læge, hvis du oplever øjenproblemer.
English: 1 mL solution contains 100 units insulin degludec* (equivalent to 3.66 mg insulin degludec).
Danish: 1 ml af opløsningen indeholder 100 enheder insulin degludec* (svarende til 3,66 mg insulin degludec).
English: Can be stored in a refrigerator (2°C - 8°C).
Danish: Kan opbevares i et køleskab (2°C - 8°C).
English: Use of Tresiba in combination with GLP-1 receptor agonists in patients with type 2 diabetes mellitus When adding Tresiba to GLP-1 receptor agonists, the recommended daily starting dose is 10 units followed by individual dosage adjustments.
Danish: Når Tresiba gives i tillæg til GLP-1 receptoragonister, er den anbefalede startdosis 10 enheder dagligt.
English: Tresiba 100 units/mL solution for injection in pre-filled pen Tresiba 100 units/mL packaging and label are light green.
Danish: Tresiba 100 enheder/ml injektionsvæske, opløsning i fyldt pen Tresiba 100 enheder/ml pakning og etiket er lysegrøn.
English: • With Tresiba 200 units/mL a dose of 2-160 units per injection, in steps of 2 units, can be administered.
Danish: • Med Tresiba 200 enheder/ml kan der administreres en dosis på 2-160 enheder for hver injektion,
English: Tresiba 200 units/mL solution for injection in pre-filled pen Tresiba 200 units/mL packaging and label are dark green with striping with a red box highlighting the formulation strength.
Danish: Tresiba 200 enheder/ml injektionsvæske, opløsning i fyldt pen Tresiba 200 enheder/ml pakning og etiket er mørkegrøn med striber og med en rød boks, der fremhæver styrken af formuleringen.
English: HbA1c (%) End of trial Mean change
Danish: HbA1c (%) Forsøgsafslutning Middelændring
English: Tresiba 100 units/mL solution for injection in a cartridge Tresiba comes in a cartridge (Penfill) designed to be used with Novo Nordisk insulin delivery systems and NovoFine or NovoTwist injection needles.
Danish: Tresiba 100 enheder/ml injektionsvæske, opløsning i cylinderampul Tresiba leveres i en cylinderampul (Penfill), som er beregnet til anvendelse sammen med Novo Nordisk insulindispenseringssystemer og NovoFine eller NovoTwist engangsnåle.
English: Tresiba 100 units/mL solution for injection in cartridge The cartridge (Penfill) is designed to be used with Novo Nordisk delivery systems (durable devices for repeated use not included in the pack) and NovoFine/NovoTwist injection needles up to a length of 8 mm.
Danish: Tresiba 100 enheder/ml injektionsvæske, opløsning i cylinderampul Cylinderampullen (Penfill) er beregnet til anvendelse sammen med Novo Nordisk dispenseringssystemer (penne til flergangsbrug, medfølger ikke i pakningen) og NovoFine/NovoTwist engangsnåle med en længde på op til 8 mm.
English: End of treatment Rate of severe hypoglycaemia3
Danish: Behandlingsafslutning Hyppighed af alvorlig hypoglykæmi3 Vedligeholdelsesperiode
English: Based on your blood sugar level, your doctor may change your dose.
Danish: Lægen kan ændre din dosis ud fra dit blodsukkerniveau.
English: EU/1/12/807/001 1 pen of 3 mL EU/1/12/807/002 1 pen of 3 mL and 7 NovoFine needles EU/1/12/807/003 1 pen of 3 mL and 7 NovoTwist needles EU/1/12/807/004 5 pens of 3 mL
Danish: EU/1/12/807/001 1 pen a 3 ml EU/1/12/807/002 1 pen a 3 ml og 7 NovoFine enagngsnåle EU/1/12/807/003 1 pen a 3 ml og 7 NovoTwist engangsnåle EU/1/12/807/004 5 penne a 3 ml
English: Tresiba 100 units/mL and Tresiba 200 units/mL solution for injection in a pre-filled pen Tresiba is available in two strengths.
Danish: Tresiba 100 enheder/ml og Tresiba 200 enheder/ml injektionsvæske, opløsning i en fyldt pen Tresiba findes i to styrker.
English: - The 200 units/mL pre-filled pen delivers 2-160 units in steps of 2 units.
Danish: - Den fyldte pen med 200 enheder/ml leverer 2-160 enheder i trin af 2 enheder.
English: Hypersensitivity Urticaria
Danish: Overfølsomhed Urticaria
English: This medicine can cause allergic reactions such as hives, swelling of the tongue and lips, diarrhoea, nausea, tiredness and itching.
Danish: Sjældne bivirkninger (kan forekomme hos færre end 1 ud af 1.000 behandlede) Dette lægemiddel kan give allergiske reaktioner såsom udslæt, hævelse af tunge og læber, diarré, kvalme, træthed og kløe.
English: Nocturnal confirmed hypoglycaemia was defined as episodes between midnight and 6 a.m.
Danish: Bekræftet natlig hypoglykæmi var defineret som episoder mellem midnat og kl. 6.
English: Tresiba 100 units/mL solution for injection in cartridge EU/1/12/807/007
Danish: Tresiba 100 enheder/ml injektionsvæske, opløsning i cylinderampul EU/1/12/807/007
English: - The 100 units/mL pre-filled pen delivers 1-80 units in steps of 1 unit.
Danish: - Den fyldte pen med 100 enheder/ml leverer 1-80 enheder i trin af 1 enhed.
English: Skin changes where you use the injection (lipodystrophy): Fatty tissue under the skin may shrink (lipoatrophy) or get thicker (lipohypertrophy).
Danish: Ikke almindelige bivirkninger (kan forekomme hos færre end 1 ud af 100 behandlede) Hudforandringer på det sted, hvor du injicerer (lipodystrofi): Fedtvævet under huden kan skrumpe ind (lipoatrofi) eller fortykkes (lipohypertrofi).
English: Tresiba 100 units/mL and Tresiba 200 units/mL solution for injection in a pre-filled pen Tresiba comes in a pre-filled pen (FlexTouch) designed to be used with NovoFine or NovoTwist injection needles.
Danish: Tresiba 100 enheder/ml og Tresiba 200 enheder/ml injektionsvæske, opløsning i en fyldt pen Tresiba leveres i en fyldt pen (FlexTouch), som er beregnet til anvendelse sammen med NovoFine eller NovoTwist engangsnåle.
English: Your pen is a pre-filled dial-a-dose insulin pen containing 600 units of insulin.
Danish: Pennen er en fyldt insulinpen med dosisindstilling og indeholder 600 enheder insulin.
English: • With Tresiba 100 units/mL a dose of 1-80 units per injection, in steps of 1 unit, can be administered.
Danish: • Med Tresiba 100 enheder/ml kan der administreres en dosis på 1-80 enheder for hver injektion,
English: PHARMACEUTICAL FORM AND CONTENTS Solution for injection (FlexTouch) Multipack: 10 (2 packs of 5) 3 mL pre-filled pens
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Injektionsvæske, opløsning (FlexTouch) Multipakning: 10 (2 pakninger a 5) 3 ml fyldte penne
English: Each mL of solution contains 100 units of insulin degludec.
Danish: Hver ml opløsning indeholder 100 enheder insulin degludec.
English: • Take a new needle and tear off the paper tab.
Danish: • Tag en ny nål, og riv forseglingen af.
English: 4 Inject your dose
Danish: 4 Injicer dosis
English: PHARMACEUTICAL FORM AND CONTENTS Solution for injection (FlexTouch) 3 x 3 mL.
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Injektionsvæske, opløsning (FlexTouch) 3 x 3 ml.
English: For detailed instructions for use, see the package leaflet.
Danish: Se detaljeret brugervejledning i indlægssedlen.
English: Time since injection (hours) Treatment
Danish: Tid efter injektion (timer) Behandling IDeg 0,6 enheder/kg
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION Tresiba 200 units/mL solution for injection insulin degludec
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ Tresiba 200 enheder/ml injektionsvæske, opløsning insulin degludec
English: MARKETING AUTHORISATION NUMBERS EU/1/12/807/007 5 cartridges of 3 mL EU/1/12/807/008 10 cartridges of 3 mL
Danish: MARKEDSFØRINGSTILLADELSESNUMRE EU/1/12/807/007 5 cylinderampuller a 3 ml EU/1/12/807/008 10 cylinderampuller a 3 ml
English: What Tresiba is and what it is used for What you need to know before you use Tresiba How to use Tresiba
Danish: Det skal du vide, før du begynder at tage Tresiba Sådan skal du tage Tresiba Bivirkninger
English: The pre-filled pen 100 units/mL can provide a dose of 1-80 units in one injection in steps of 1 unit.
Danish: Den fyldte Tresiba pen 100 enheder/ml kan levere en dosis på 1-80 enheder i én injektion i trin af 1 enhed.
English: The pre-filled pen 200 units/mL can provide a dose of 2-160 units in one injection in steps of 2 units.
Danish: Den fyldte Tresiba pen 200 enheder/ml kan levere en dosis på 2-160 enheder i én injektion i trin af 2 enheder.
English: There is no clinical experience with Tresiba during breast-feeding.
Danish: Der foreligger ingen kliniske erfaringer med anvendelse af Tresiba under amning.
English: Rate of hypoglycaemia (per Patient year of exposure) Severe
Danish: Hyppighed af hypoglykæmi (pr. patientår med eksponering) Svær