FrancophonIA/ELRC3.0 huggingface dataset:
English: The medicinal product contains 30.5 mg sodium per reconstituted vial, equivalent to 1.5% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Danish: Dette lægemiddel indeholder 30,5 mg natrium per rekonstitueret hætteglas, svarende til 1,5% af det maksimale daglige indtag på 2 g natrium for voksne, som anbefales af WHO.
English: d Hepatic enzymes increased include alanine aminotransferase, aspartate aminotransferase, gamma-glutamyltransferase and bilirubin.
Danish: d Øgede hepatiske enzymer inkluderer alaninaminotranferase, aspartataminotransferase, gammaglutamyltransferase og bilirubin.
English: Treatment with NovoEight will be started by a doctor who is experienced in the care of patients with haemophilia A. Always use this medicine exactly as your doctor has told you.
Danish: Påbegyndelse af behandling med NovoEight skal foretages af en læge, som har erfaring med behandling af hæmofili A. Brug altid dette lægemiddel nøjagtigt efter lægens anvisning.
English: Turoctocog alfa (human coagulation factor VIII (rDNA)) is a purified protein that has 1,445 amino acids with an approximate molecular mass of 166 kDA.
Danish: Turoctocog alfa (human koagulationsfaktor VIII (rDNA)) er et oprenset protein, der har 1.445 aminosyrer og en molekylevægt på cirka 166 kDA.
English: Obese class II/III N=7
Danish: Svær overvægtig klasse II/III N=7
English: • Use a clean and germ free (aseptic) technique.
Danish: Anvend en ren og bakteriefri (aseptisk) metode.
English: Turoctocog alfa is a B-domain truncated recombinant human coagulation factor VIII (B-domain consists of 21 amino acids of the wild type B-domain) without any other modifications in the amino acid sequence.
Danish: Turoctocog alfa er en B-domæne trunkeret rekombinant human koagulationsfaktor VIII (B-domænet består af 21 aminosyrer fra vildtype B-domænet) uden nogen andre modifikationer i aminosyresekvensen.
English: If your dose requires more than one vial, repeat steps A to J with additional vials, vial adapters and pre-filled syringes until you have reached your required dose.
Danish: Hvis din dosis kræver mere end et hætteglas, gentages trinene A til J med yderligere hætteglas, hætteglasadapterer og fyldte sprøjter, indtil du når den nødvendige dosis.
English: Talk to your doctor before using NovoEight.
Danish: Kontakt lægen før du bruger NovoEight.
English: When infused into a haemophilia patient, factor VIII binds to endogenous von Willebrand Factor in the patient's circulation.
Danish: Under infusion i en hæmofili patient binder faktor VIII endogent til von Willebrand faktor i patientens cirkulation.
English: Do not use solutions that are cloudy or have deposits.
Danish: Brug ikke opløsninger der er uklare eller har bundfald.
English: An increase in dose may be required for underweight patients (BMI <18.5 kg/m2) and a decrease in dose may be required for obese patients (BMI ≥30 kg/m2), but there is insufficient data to recommend specific dose adjustments, see section 5.2.
Danish: En stigning i dosis kan være nødvendig for undervægtige patienter (BMI <18,5 kg/m2), og en reduktion i dosis kan være nødvendig for overvægtige patienter (BMI ≥30 kg/m2), men der er utilstrækkelige data til at anbefale specifikke dosisjusteringer, se pkt.
English: Data on Immune Tolerance Induction (ITI) has been collected in patients with haemophilia A who had developed inhibitors to factor VIII.
Danish: Data om immuntoleranceinduktion (ITI) er blevet indsamlet hos patienter med hæmofili A, der havde udviklet inhibitorer mod faktor VIII.
English: The reconstituted NovoEight must be injected into your vein (intravenous injection).
Danish: Det opblandede NovoEight skal injiceres i en vene (intravenøs injektion).
English: The amount to be administered and the frequency of administration should always be oriented to the clinical effectiveness in the individual case.
Danish: Dosis samt hyppigheden for indgivelse skal tilpasses det kliniske respons i hvert enkelt tilfælde.
English: Cmax (IU/dl)
Danish: Cmax (IE/dl)
English: The rate should be determined by the patient's comfort level.
Danish: Indgivelseshastigheden bør bestemmes, således patientens velbefindende sikres.
English: Grasp the plunger rod by the wide top end and take it out of the carton.
Danish: Tag stempelstangen i den brede ende og tag den ud af kartonen.
English: Musculoskeletal stiffness, arthropathy, pain in extremity, musculoskeletal pain
Danish: Muskuloskeletal stivhed, artropati, smerter i ekstremiteterne, muskuloskeletal smerte
English: During all clinical studies with NovoEight in previously treated patients, a total of 35 adverse reactions were reported in 23 of 242 patients exposed to NovoEight.
Danish: Under alle kliniske studier med NovoEight hos tidligere behandlede patienter blev der i alt reporteret 35 bivirkninger hos 23 af de 242 patienter eksponeret for NovoEight.
English: Table 1 Guide for dosing in bleeding episodes and surgery
Danish: Tabel 1 Vejledning til dosering ved blødningsepisoder og kirurgiske indgreb
English: Anti factor VIII antibody positive
Danish: Antifaktor VIIIantistofpositiv
English: In some cases, especially in younger patients, shorter dosage intervals or higher doses may be necessary.
Danish: I nogle tilfælde, specielt hos yngre patienter, kan det være nødvendigt med kortere dosisintervaller eller højere doser.
English: This medicine contains 30.5 mg sodium (main component of cooking/table salt) per reconstituted vial.
Danish: Dette lægemiddel indeholder 30,5 mg natrium (hovedbestanddel i køkken/bordsalt) per hætteglas efter opblanding.
English: Each pack of NovoEight contains a vial with white or slightly yellow powder, a 4 ml pre-filled syringe with a clear colourless solution, a plunger rod and a vial adapter.
Danish: Hver pakning af NovoEight indeholder et hætteglas med hvidt eller lettere gult pulver, en 4 ml fyldt sprøjte med en klar, farveløs opløsning, en stempelstang og en hætteglasadapter.
English: For storage at room temperature (≤30°C) or up to 40°C and storage conditions after reconstitution of the medicinal product, see section 6.3.
Danish: Vedrørende opbevaring ved stuetemperatur (≤30°C) eller ved op til 40°C samt opbevaringsforhold efter rekonstitution af præparatet, se pkt.
English: If a larger dose is needed, repeat steps A to J with additional vials, vial adapters and pre-filled syringes.
Danish: Hvis der er brug for en højere dosis gentages trin A til J med yderligere hætteglas, hætteglasadapterer og fyldte sprøjter.
English: Do not use any other way to heat the vial and pre-filled syringe.
Danish: Anvend ikke andre metoder til at opvarme hætteglasset og den fyldte sprøjte.
English: For long term prophylaxis against bleeding in patients below the age of 12, doses of 25-50 IU of factor VIII per kg body weight every second day or 25-60 IU of factor VIII per kg body weight 3 times weekly are recommended.
Danish: Til langtidsprofylakse mod blødninger hos patienter under 12 år anbefales dosis på 25-50 IE af faktor VIII per kg legemsvægt hver anden dag eller 25-60 IE af faktor VIII per kg legemsvægt 3 gange ugentlig.
English: Mean residence time (h) a BMI groups: Underweight: BMI <18.5 kg/m2, Normal weight: BMI 18.5-24.9 kg/m2, Overweight: BMI 25-29.9 kg/m2, Obese class I: BMI 30-34.9 kg/m2, Obese class II/III: BMI ≥35 kg/m2.
Danish: Middel opholdstid (time) a BMI-grupper: Undervægtig: BMI <18,5 kg/m2; Normalvægtig: BMI 18,5-24,9 kg/m2; Overvægtig: BMI 25-29,9 kg/m2; Svær overvægtig klasse I: BMI 30-34,9 kg/m2; Svær overvægtig klasse II/III: BMI ≥35 kg/m2.
English: NovoEight is given as an injection into a vein.
Danish: NovoEight gives som en injektion i en vene.
English: Patients should be informed of the early signs of hypersensitivity reactions including hives, generalised urticaria, tightness of the chest, wheezing, hypotension and anaphylaxis.
Danish: Patienter skal informeres om tidlige tegn på overfølsomhedsreaktioner, herunder nældefeber, generel urticaria, trykken for brystet, hiven efter vejret, hypotension og anafylaksi.
English: Sinus tachycardia, acute myocardial infarction
Danish: Sinustakykardi, akut myokardieinfarkt
English: If you stop using NovoEight
Danish: Hvis du holder op med at bruge NovoEight
English: Three of these trials were performed in previously treated patients and the fourth in previously untreated patients.
Danish: Tre af disse studier blev udført med tidligere behandlede patienter,
English: For long term prophylaxis against bleeding in patients with severe haemophilia A. The usual recommended doses are 20-40 IU of factor VIII per kg body weight every second day or 20-50 IU of factor VIII per kg body weight 3 times weekly.
Danish: Til langtidsprofylakse mod blødninger hos patienter med svær hæmofili A. De normalt anbefalede doser er 20-40 IE af faktor VIII per kg legemsvægt hver anden dag eller 20-50 IE af faktor VIII per kg legemsvægt 3 gange ugentlig.
English: Non-clinical data reveal no special concern for humans based on conventional studies of safety pharmacology and repeated dose toxicity.
Danish: Ikke kliniske data baseret på konventionelle sikkerhedsstudier, farmakologi og gentagen dosistoksisitet tyder ikke på nogen speciel risiko for mennesker.
English: This is because if left, the medicine may no longer be sterile and could cause infections.
Danish: Hvis det opbevares, kan det være, at lægemidlet ikke længere er sterilt og det kan forårsage infektion.
English: A single dose pharmacokinetic trial (50 IU/kg) was performed in 35 haemophilia patients (≥18 years of age) in different BMI categories.
Danish: Der blev udført et farmakokinetisk studie med en enkeltdosis (50 IE/kg) hos 35 hæmofilipatienter (≥ 18 år) i forskellige Body Mass Index (BMI)-kategorier.
English: Minor surgery including tooth extraction
Danish: Kirurgi Mindre kirurgi inklusive tandudtræk 30-60
English: Do not stop using NovoEight without talking to your doctor.
Danish: Du må ikke holde op med at bruge NovoEight uden først at have talt med din læge om det.
English: 1 pre-filled syringe with solvent 1 plunger rod (placed under the syringe)
Danish: 1 fyldt sprøjte med solvens 1 stempelstang (placeret under sprøjten)
English: If you forget to use NovoEight
Danish: Hvis du har glemt at bruge NovoEight
English: The potency (IU) is determined using the European Pharmacopoeia (Ph. Eur) chromogenic assay.
Danish: Potensen (IE) er bestemt ved brug af chromogen assay i henhold til den Europæiske Farmakopé (Ph.
English: The maximum exposure (Cmax) and the total exposure (AUC) increase with increasing BMI indicating that dose adjustments may be required for underweight (BMI <18.5 kg/m2) and obese patients (BMI ≥30 kg/m2), see section 4.2.
Danish: Den maksimale eksponering (Cmax) og den totale eksponering (AUC) stiger med stigende BMI, hvilket indikerer, at dosisjusteringer kan være nødvendige for undervægtige (BMI <18,5 kg/m2) og overvægtige patienter (BMI ≥30 kg/m2), se pkt.
English: Repeat infusion every 12-24 hours for 3-4 days or more until pain and acute disability are resolved
Danish: Gentag infusionen hver 12.-24. time i 34 dage eller mere, indtil smerte og akut nedsat funktion er forsvundet
English: The most frequently reported adverse reaction was Factor VIII inhibition, see section 4.4.
Danish: Den hyppigst rapporterede bivirkning var faktor VIII-inhibering, se pkt.
English: Degree of haemorrhage/Type of surgical procedure
Danish: Blødningsgrad/Type af kirurgi
English: Known allergic reaction to hamster proteins.
Danish: 6.1 Allergisk reaktion overfor hamsterproteiner er kendt.
English: Severe symptoms, including difficulty in swallowing or breathing and red or swollen face or hands, require prompt emergency treatment.
Danish: Alvorlige symptomer inkluderer synke- eller åndedrætsbesvær, og rødt eller hævet ansigt eller hænder.
English: The trials included 298 exposed patients; 175 adolescents or adult patients without inhibitors from the age of 12 years (≥150 exposure days), 63 previously treated paediatric patients without inhibitors below 12 years of age (≥50 exposure days) and 60 previously untreated patients below 6 years of age.
Danish: 175 unge eller voksne patienter uden inhibitorer fra 12 år (≥150 udsatte dage), 63 tidligere behandlede pædiatriske patienter uden inhibitorer under 12 år (≥50 eksponeringsdage) og 60 ikke-tidligere behandlede patienter under 6 år.
English: In the trial with previously untreated patients, between 0 and 6 years of age, a total of 46 adverse reactions were reported in 33 of 60 patients exposed to NovoEight.
Danish: I studiet med ikke-tidligere behandlede patienter mellem 0 og 6 år blev der rapporteret i alt 46 bivirkninger hos 33 ud af 60 patienter, som fik NovoEight.
English: This incompatibility may prevent administration of the medicine and/or result in damage to the needleless connector.
Danish: Når forbindelse og sprøjte ikke passer sammen, kan det forhindre indgivelsen af lægemidlet og/eller resultere i, at forbindelsen uden nål beskadiges.
English: NovoEight has no influence on the ability to drive and use machines.
Danish: NovoEight påvirker ikke evnen til at føre motorkøretøj eller betjene maskiner.
English: Remove the plastic cap from the vial.
Danish: Fjern plastikhætten fra hætteglasset.
English: Therefore, factor VIII should be used during pregnancy and lactation only if clearly indicated.
Danish: Faktor VIII skal derfor kun anvendes på tvingende indikation til gravide og ammende kvinder.
English: The single dose pharmacokinetic parameters of NovoEight are listed in Table 4 for the one-stage clotting assay and in Table 5 for the chromogenic assay.
Danish: Parametrene for enkelt dosis farmakokinetik af NovoEight er angivet i Tabel 4 for et-trins koagulationsanalysen og i Tabel 5 for chromogen assay.
English: Calcium chloride dihydrate Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment)
Danish: Calciumchlorid dihydrat Natriumhydroxid (til pH-justering) Saltsyre (til pH-justering)
English: NovoEight is to be administered intravenously after reconstitution of the powder with the solvent supplied in the syringe.
Danish: NovoEight administreres intravenøst efter rekonstitution af pulveret med den medfølgende solvens i sprøjten.
English: Older children
Danish: Ældre
English: Mean residence time (h)
Danish: Middel opholdstid (time)
English: Stop pushing the plunger rod and let it move back on its own while the reconstituted solution fills the syringe.
Danish: Stop med at holde stempelstangen i bund og lad den trække sig tilbage af sig selv, mens den opblandede opløsning fyldes i sprøjten.
English: Uncommon side effects (may affect up to 1 in 100 people)
Danish: Ikke almindelige bivirkninger (kan forekomme hos 1 ud af 100 personer)
English: The analysis of plasma samples was conducted using both the one-stage clotting assay and the chromogenic assay.
Danish: Analysen af plasmaprøverne blev udført med både et-trins koagulationstest og chromogen assay.
English: In patients with haemophilia A, factor VIII is missing or not working properly.
Danish: Hos patienter med hæmofili A mangler eller virker faktor VIII ikke korrekt.
English: If you cannot use the reconstituted NovoEight solution immediately, it should be used within:
Danish: Hvis du ikke bruger NovoEight straks efter det er opblandet, skal det bruges indenfor:
English: See ‘Instructions on how to use NovoEight' for more information.
Danish: For yderligere information, se ‘NovoEight Brugervejledning'.
English: Each pack of NovoEight 250 IU, 500 IU, 1000 IU, 1500 IU, 2000 IU and 3000 IU powder and solvent for solution for injection contains:
Danish: Hver pakning af NovoEight 250 IE, 500 IE, 1000 IE, 1500 IE, 2000 IE og 3000 IE pulver og solvens til injektionsvæske, opløsning indeholder:
English: Management of such patients should be directed by physicians with experience in the care of haemophilia and factor VIII inhibitors.
Danish: Sådanne patienter skal behandles hos læger med ekspertise i hæmofilibehandling og faktor VIII inhibitorer.
English: Lightly squeeze the protective cap with your thumb and index finger as shown.
Danish: Tryk let på beskyttelseshætten med tommel- og pegefinger som vist.
English: Repeat every 12 to 24 hours, at least 1 day, until the bleeding episode as indicated by pain is resolved or healing achieved
Danish: Gentag infusionen hver 12. til 24. time i mindst 1 dag, indtil blødningsepisoden, kendetegnet ved smerter, er gået i ro eller opheling er begyndt
English: Early haemarthrosis, muscle bleeding or oral bleeding
Danish: Tidlig hæmarthrose, muskelblødning eller oral blødning
English: Wipe the rubber stopper with a sterile alcohol swab and allow it to air dry for a few seconds before use to ensure that it is as germ free as possible.
Danish: Tør gummiproppen på hætteglasset af med en steril alkoholserviet og lad den lufttørre i nogle sekunder før brug, for at sikre at den er så bakteriefri som muligt.
English: - The ingredients in the solvent are sodium chloride and water for injections.
Danish: - Indholdsstofferne i solvensen: Natriumchlorid og vand til injektionsvæsker.
English: Underweight N=5
Danish: Undervægtig N=5
English: Injecting NovoEight via needleless connectors for intravenous (IV) catheters
Danish: Injektion af NovoEight via forbindelser uden nål til intravenøse (i.v.)
English: Excipient with known effect The medicinal product contains 30.5 mg sodium per reconstituted vial.
Danish: Hjælpestof, som behandleren skal være opmærksom på Dette lægemiddel indeholder 30,5 mg natrium per rekonstitueret hætteglas.
English: NovoEight in previously treated patients with severe haemophilia A (FVIII ≤1%).
Danish: administration af NovoEight 50 IE/kg hos tidligere behandlede patienter med svær hæmofili A (FVIII ≤ 1%).
English: For storage conditions of the reconstituted medicinal product see section 6.3.
Danish: For opbevaring af det rekonstituerede lægemiddel, se pkt.
English: Flushing, Thrombophlebitis superficial
Danish: Rødme, overfladisk tromboflebit
English: In the case of major surgical interventions in particular, precise monitoring of the substitution therapy by means of coagulation analysis (plasma factor VIII activity) is indispensable.
Danish: Nøjagtig overvågning af substitutionsbehandlingen med koagulationsanalyse (plasma faktor VIII-aktivitet), særligt i tilfælde af større kirurgiske indgreb, er ufravigelig.
English: The expiry date is printed after ‘EXP' on the outer carton, on the vial, on the vial adapter, and on the pre-filled syringe.
Danish: Udløbsdatoen står efter 'EXP' på kartonen, på hætteglasset, på hætteglasadapteren og på den fyldte sprøjte.
English: - The other ingredients are L-histidine, sucrose, polysorbate 80, sodium chloride, L-methionine,
Danish: - Øvrige indholdsstoffer: L-histidin, saccharose, polysorbat 80, natriumchlorid, L-methionin,
English: Push the plunger rod to inject all the solvent into the vial.
Danish: Pres stempelstangen for at injicere al solvensen ind i hætteglasset.
English: 1 vial with NovoEight powder 1 vial adapter
Danish: 1 hætteglas med NovoEight pulver 1 hætteglasadapter
English: Heart rate increased
Danish: Øget puls
English: Normal weight N=7
Danish: Normalvægtig N=7
English: Keep reconstituted NovoEight solution out of direct light.
Danish: Opblandet NovoEight opløsning må ikke opbevares i direkte lys.
English: Store in refrigerator (2°C - 8°C).
Danish: Opbevares i køleskab (2°C - 8°C).
English: calcium chloride dihydrate, sodium hydroxide and hydrochloric acid.
Danish: calciumchloriddihydrat, natriumhydroxid og saltsyre.
English: - 1 glass vial (type I) with powder and chlorobutyl rubber stopper - 1 sterile vial adapter for reconstitution - 1 pre-filled syringe of 4 ml solvent with backstop (polypropylene), a rubber plunger
Danish: - 1 hætteglas (type I) med pulver og chlorbutylgummiprop - 1 steril hætteglasadapter til rekonstitution - 1 fyldt sprøjte med 4 ml solvens med en bagstopper (polypropylen), et gummistempel (brombutyl) og en sprøjtehætte med en stopper (brombutyl) - 1 stempelstang (polypropylen)
English: It is recommended to use NovoEight immediately after reconstitution.
Danish: Det anbefales at bruge NovoEight straks efter rekonstitution.
English: Keep the plunger rod pushed completely in.
Danish: Hold stempelstangen presset helt ind.
English: • joint disease
Danish: • ledsygdomme
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Pre-filled syringe
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER Fyldt sprøjte
English: • Periodic Safety Update Reports (PSUR)
Danish: C. ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN • Periodiske, opdaterede sikkerhedsindberetninger (PSUR'er)
English: After injection, safely dispose of all unused NovoEight solution, the syringe with the infusion set, the vial with the vial adapter and other waste materials as instructed by your pharmacist.
Danish: Efter injektion kasséres alt ikke anvendt NovoEight opløsning, sprøjten med infusionssættet, hætteglasset med hætteglasadapteren samt andet affald, som instrueret af apotekspersonalet.
English: Wipe the rubber stopper on the vial with a sterile alcohol swab and allow it to air dry for a few seconds before use.
Danish: Afsprit gummipropperne med alkoholservietter, og lad dem lufttørre et par sekunder inden brug.
English: If you have a severe allergic reaction, your doctor may change your medicine.
Danish: Din læge kan ændre din medicin, hvis du har en alvorlig allergisk reaktion.
English: Push the plunger rod slowly until all air bubbles are gone.
Danish: Tryk forsigtigt på stempelstangen, indtil alle luftbobler er væk.
English: Haemarthrosis, Muscle haemorrhage
Danish: Hæmartrose, muskelblødning
English: If the plastic cap is loose or missing, do not use the vial.
Danish: Hvis plastikhætten er løs eller mangler, må hætteglasset ikke anvendes.
English: Pre-filled syringe with solvent
Danish: Fyldt sprøjte med solvens
English: Development of neutralising antibodies (inhibitors) may occur in patients with haemophilia A treated with factor VIII, including with NovoEight.
Danish: Der kan udvikles neutraliserende antistoffer (inhibitorer) hos patienter med hæmofili A, som behandles med faktor VIII, herunder med NovoEight.
English: • difficulty in breathing, shortness of breath or wheezing
Danish: • åndedrætsbesvær, åndenød eller hiven efter vejret
English: CL (ml/h/kg) t½ (h)
Danish: CL (ml/time/kg) t½ (time)
English: Grasp the plunger rod by the wide top and immediately connect the plunger rod to the syringe by turning it clockwise into the plunger inside the pre-filled syringe until resistance is felt.
Danish: Tag fat i den brede top af stempelstangen og forbind straks stempelstangen med sprøjten ved at dreje med uret ind i gummistemplet indeni den fyldte sprøjte, indtil der mærkes modstand.
English: Remove the protective paper from the vial adapter.
Danish: Fjern beskyttelsespapiret fra hætteglasadapteren.
English: NovoEight contains the active substance turoctocog alfa, human coagulation factor VIII.
Danish: NovoEight indeholder det aktive stof turoctocog alfa, human koagulationsfaktor VIII.
English: 0 − <6 years 6 − <12 years ≥12 years n=14
Danish: ≥12 år n=14
English: If you are not sure, talk to your doctor before using this medicine.
Danish: Hvis du er i tvivl, kontakt lægen, apoteket eller sundhedspersonalet før du bruger dette lægemiddel.
English: Syringe tip (under syringe cap)
Danish: Sprøjtespids (under sprøjtehætte)
English: NovoEight 250 IU powder and solvent for solution for injection NovoEight 500 IU powder and solvent for solution for injection NovoEight 1000 IU powder and solvent for solution for injection NovoEight 1500 IU powder and solvent for solution for injection NovoEight 2000 IU powder and solvent for solution for injection NovoEight 3000 IU powder and solvent for solution for injection
Danish: NovoEight 250 IE pulver og solvens til injektionsvæske, opløsning NovoEight 500 IE pulver og solvens til injektionsvæske, opløsning NovoEight 1000 IE pulver og solvens til injektionsvæske, opløsning NovoEight 1500 IE pulver og solvens til injektionsvæske, opløsning NovoEight 2000 IE pulver og solvens til injektionsvæske, opløsning NovoEight 3000 IE pulver og solvens til injektionsvæske, opløsning
English: Other medicines and NovoEight
Danish: Brug af anden medicin sammen med NovoEight
English: Frequencya in PUPs
Danish: Hyppigheda i PTPs Hyppigheda i PUPs