FrancophonIA/ELRC3.0 huggingface dataset:
English: Co-administration of Sovaldi with modafinil is expected to decrease the concentration of sofosbuvir, leading to reduced therapeutic effect of Sovaldi.
Danish: Administration af Sovaldi sammen med modafinil forventes at nedsætte koncentrationen af sofosbuvir og føre til en nedsat terapeutisk virkning af Sovaldi.
English: Adolescents (12 to 18 years of age) The recommended dose of Sovaldi is one tablet once daily with food (see section 5.2).
Danish: Den anbefalede dosis Sovaldi er en tablet en gang dagligt, som skal tages sammen med mad (se pkt.
English: Cirrhotic
Danish: Cirrose
English: Table 16: SVR12 rates for selected subgroups by genotype in study VALENCE
Danish: Tabel 16: SVR12-rater for udvalgte undergrupper efter genotype i VALENCE-studiet
English: No dose adjustment of sofosbuvir or methadone is required when sofosbuvir and methadone are used concomitantly.
Danish: Ingen dosisjustering af sofosbuvir eller methadon er nødvendig, når sofosbuvir og methadon anvendes samtidigt.
English: Clinical studies in patients with genotype 2 and 3 chronic hepatitis C Treatment-naïve adults - FISSION (study 1231)
Danish: Behandlingsnaive voksne - FISSION (studie 1231)
English: Otherc a. The efficacy analysis includes 3 patients with recombinant genotype 2/1 HCV infection.
Danish: Andetc a. Virkningsanalysen omfatter 3 patienter med rekombinant genotype 2/1 HCV-infektion.
English: SOF+PEG+RBV 12 weeks
Danish: SOF+PEG+RBV 12 uger
English: Yes a. The efficacy analysis includes 3 patients with recombinant genotype 2/1 HCV infection.
Danish: Cirrose Nej Ja a. Virkningsanalysen omfatter 3 patienter med rekombinant genotype 2/1 HCV-infektion.
English: The safety profile of sofosbuvir and ribavirin in HCV infected adult patients prior to liver transplantation was similar to that observed in patients treated with sofosbuvir and ribavirin in Phase 3 clinical studies (see section 5.1).
Danish: Sikkerhedsprofilen for sofosbuvir og ribavirin hos voksne patienter med HCV-infektion før levertransplantation var sammenlignelig med den observerede sikkerhedsprofil hos patienter, der blev behandlet med sofosbuvir og ribavirin i kliniske fase III-studier (se pkt.
English: Emtricitabine ↔ Cmax 0.97 (0.88, 1.07) ↔ AUC 0.99 (0.94, 1.05) ↔ Cmin 1.04 (0.98, 1.11)
Danish: Emtricitabin ↔ Cmax 0,97 (0,88; 1,07) ↔ AUC 0,99 (0,94; 1,05) ↔ Cmin 1,04 (0,98; 1,11)
English: No dose adjustment of sofosbuvir or raltegravir is required when sofosbuvir and raltegravir are used concomitantly.
Danish: Ingen dosisjustering af sofosbuvir eller raltegravir er nødvendig, når sofosbuvir og raltegravir anvendes samtidigt.
English: (eGFR ≥50
Danish: ≥ 50 og
English: Rilpivirine ↔ Cmax 1.05 (0.97, 1.15) ↔ AUC 1.06 (1.02, 1.09) ↔ Cmin 0.99 (0.94, 1.04)
Danish: Rilpivirin ↔ Cmax 1,05 (0,97; 1,15) ↔ AUC 1,06 (1,02; 1,09) ↔ Cmin 0,99 (0,94; 1,04)
English: S-methadone ↔ Cmax 0.95 (0.79, 1.13) ↔ AUC 0.95 (0.77, 1.17) ↔ Cmin 0.95 (0.74, 1.22)
Danish: S-methadon ↔ Cmax 0,95 (0,79; 1,13) ↔ AUC 0,95 (0,77; 1,17) ↔ Cmin 0,95 (0,74; 1,22)
English: Table 23: Outcomes by therapeutic regimen and treatment duration, a comparison across studies in genotype 4, 5 and 6 HCV infection
Danish: Tabel 23 Resultater for behandlingsprogram og behandlingsvarighed, en sammenligning af studier af HCV-genotype 4, 5 og 6-infektion
English: Sofosbuvir was studied in an open-label clinical study evaluating the safety and efficacy of 24 weeks of treatment with sofosbuvir and ribavirin in liver transplant recipients with chronic hepatitis C. Eligible patients were ≥18 years old and had undergone liver transplantation 6 to 150 months prior to screening.
Danish: Sofosbuvir blev undersøgt i et åbent klinisk studie, der evaluerede sikkerheden og virkningen af 24 ugers behandling med sofosbuvir og ribavirin hos patienter med kronisk hepatitis C, der havde gennemgået en levertransplantation.
English: R-methadone ↔ Cmax 0.99 (0.85, 1.16) ↔ AUC 1.01 (0.85, 1.21) ↔ Cmin 0.94 (0.77, 1.14)
Danish: R-methadon ↔ Cmax 0,99 (0,85; 1,16) ↔ AUC 1,01 (0,85; 1,21) ↔ Cmin 0,94 (0,77; 1,14)
English: Consideration should be given to treating these patients, and potentially extending the duration of therapy with sofosbuvir, peginterferon alfa and ribavirin beyond 12 weeks and up to 24 weeks; especially for those subgroups who have one or more factors historically associated with lower response rates to interferon-based therapies (advanced fibrosis/cirrhosis, high baseline viral concentrations, black race, IL28B non CC genotype).
Danish: Det bør overvejes at behandle disse patienter, og muligvis forlænge behandlingsvarigheden med sofosbuvir, peginterferon alfa og ribavirin på over 12 uger og op til 24 uger, især for de undergrupper, der har en eller flere faktorer, der historisk er forbundet med lavere responsrater for interferon-baserede behandlinger (fremskreden fibrose/cirrose, høje virale koncentrationer ved baseline, sort race, IL28B non CC-genotype).
English: No dose adjustment of sofosbuvir or rilpivirine is required when sofosbuvir and rilpivirine are used concomitantly.
Danish: Ingen dosisjustering af sofosbuvir eller rilpivirin er nødvendig, når sofosbuvir og rilpivirin anvendes samtidigt.
English: b. Consideration should be given to potentially extending the duration of therapy beyond 12 weeks and up to 24 weeks; especially for those subgroups who have one or more factors historically associated with lower response rates to interferon-based therapies (e.g. advanced fibrosis/cirrhosis, high baseline viral concentrations, black race, IL28B non CC genotype, prior null response to peginterferon alfa and ribavirin therapy).
Danish: b. Det bør overvejes at forlænge behandlingsvarigheden på over 12 uger og op til 24 uger, især for de undergrupper, der har en eller flere faktorer, der historisk er forbundet med lavere responsrater for interferon-baserede behandlinger (f.eks. fremskreden fibrose/cirrose, høje virale koncentrationer ved baseline, sort race, IL28B non CC-genotype, tidligere nul-respons til peginterferon alfa og ribavirinbehandling).
English: PEG+RBV 24 weeks (n = 176)
Danish: PEG+RBV 24 uger (n = 176)
English: SOF+RBV 24 weeks
Danish: SOF+RBV 24 uger
English: SOF+RBV 24 weeks (n = 250)
Danish: SOF+RBV 24 uger (n = 250)
English: SOF+RBV 16 weeks
Danish: SOF+RBV 16 uger
English: Dosed 1 hr After Dialysis Sofosbuvir 1.6-fold↑ 2.1-fold↑ 2.7-fold↑ 1.3-fold↑ 1.6-fold↑ ~2-fold↑ 1.9-fold↑ GS331007 1.6-fold↑ 1.9-fold↑ 5.5-fold↑ ≥10-fold↑ ≥20-fold↑ ~7-fold↑ 21-fold↑
Danish: Sofosbuvir 1,6 gange↑ 2,1 gange↑ 2,7 gange↑ 1,3 gange↑
English: PEG+RBV 24 weeks (n = 243)
Danish: PEG+RBV 24 uger (n = 243)
English: a. See Table 4 for weight based ribavirin dosing recommendations b. Consideration should be given to potentially extending the duration of therapy beyond 12 weeks and up to 24 weeks; especially for those subgroups who have one or more factors historically associated with lower response rates to interferon based therapies (e.g. advanced fibrosis/cirrhosis, high baseline viral concentrations, black race, IL28B non CC genotype, prior null response to peginterferon alfa and ribavirin therapy).
Danish: a. Se tabel 4 angående anbefalet vægtbaseret ribavirindosering b. Det bør overvejes at forlænge behandlingsvarigheden fra 12 uger til op til 24 uger, især til de undergrupper, der har en eller flere faktorer, der historisk er forbundet med lavere responsrater i forbindelse med interferonbaserede behandlinger (f.eks. fremskreden fibrose/cirrose, høje virale koncentrationer ved baseline, sort etnisk oprindelse, IL28B non CC-genotype, tidligere nul-respons på behandling med peginterferon alfa og ribavirin).
English: Treated patients (n = 419) had a median age of 51 years (range: 19 to 74); 60% of the patients were male; median body mass index was 25 kg/m2 (range: 17 to 44 kg/m2); the mean baseline HCV RNA level was 6.4 log10 IU/mL; 21% had cirrhosis; 78% had HCV genotype 3; 65% were prior relapsers.
Danish: Behandlede patienter (n = 419) havde en gennemsnitsalder på 51 år (interval: 19 til 74); 60 % af patienter var mænd, gennemsnitlige body mass index var 25 kg/m2 (interval: 17 til 44 kg/m2), gennemsnitlige baseline HCV-rna-niveau var 6,4 log10 IE/ml, 21 % havde cirrose, 78 % havde HCVgenotype 3, 65 % havde tidligere recidiv.
English: SOF+RBV 16 weeks (n = 98)a
Danish: SOF+RBV 16 uger (n = 98)a
English: Monotherapy of Sovaldi is not recommended (see section 5.1).
Danish: Monoterapi med Sovaldi bør ikke anvendes (se pkt.
English: • diarrhoea, feeling sick (nausea), being sick (vomiting)
Danish: • diarré, kvalme, opkastning
English: SOF+RBV 12 weeks (n = 256)a
Danish: SOF+RBV 12 uger (n = 256)a
English: On-treatment virologic failure 0/207 Relapsea
Danish: Resultat for patienter uden SVR12 Virologisk svigt under behandling 0/327 Recidiva
English: No dose adjustment of sofosbuvir or tenofovir disoproxil is required when sofosbuvir and tenofovir disoproxil are used concomitantly.
Danish: Ingen dosisjustering af sofosbuvir eller tenofovirdisoproxil er nødvendig, når sofosbuvir og tenofovirdisoproxil anvendes samtidigt.
English: Consideration should be given to treating these patients, and potentially extending the duration of therapy with sofosbuvir, peginterferon alfa and ribavirin beyond 12 weeks and up to 24 weeks; especially for those subgroups who have one or more factors historically associated with lower response rates to interferon-based therapies (prior null response to peginterferon alfa and ribavirin therapy, advanced fibrosis/cirrhosis, high baseline viral concentrations, black race, IL28B non CC genotype).
Danish: Det bør overvejes at behandle disse patienter, og muligvis forlænge behandlingsvarigheden med sofosbuvir, peginterferon alfa og ribavirin på over 12 uger og op til 24 uger, især for de undergrupper, der har en eller flere faktorer, der historisk er forbundet med lavere responsrater for interferon-baserede behandlinger (tidligere nul-respons til peginterferon alfa og ribavirinbehandling, fremskreden fibrose/cirrose, høje virale koncentrationer ved baseline, sort race, IL28B non CC-genotype).
English: If you take more Sovaldi than you should
Danish: Hvis du har taget for meget Sovaldi
English: PEG+RBV 24 weeks (n = 67)
Danish: PEG+RBV 24 uger (n = 67)
English: The safety profile of sofosbuvir and ribavirin in liver transplant adult recipients with chronic hepatitis C was similar to that observed in patients treated with sofosbuvir and ribavirin in Phase 3 clinical studies (see section 5.1).
Danish: Patienter, der har gennemgået en levertransplantation Sikkerhedsprofilen for sofosbuvir og ribavirin hos voksne patienter med kronisk hepatitis C, der har gennemgået en levertransplantation, var sammenlignelig med den observerede sikkerhedsprofil hos patienter, der blev behandlet med sofosbuvir og ribavirin i kliniske fase III-studier (se pkt.
English: No dose adjustment of sofosbuvir or emtricitabine is required when sofosbuvir and emtricitabine are used concomitantly.
Danish: Ingen dosisjustering af sofosbuvir eller emtricitabin er nødvendig, når sofosbuvir og emtricitabin anvendes samtidigt.
English: SOF+RBV 12 weeks (n = 183)
Danish: SOF+RBV 12 uger (n = 183)
English: Table 20: Outcomes by therapeutic regimen and treatment duration, a comparison across studies in genotype 1 HCV infection
Danish: Tabel 20: Resultater for behandlingsprogram og behandlingsvarighed, en sammenligning af studier af HCV-genotype 1-infektion
English: • shortness of breath, cough
Danish: • stakåndethed, hoste
English: SOF+RBV 12 weeks (n = 103)a
Danish: SOF+RBV 12 uger (n = 103)a
English: SOF+RBV 12 weeks (n = 207)
Danish: SOF+RBV 12 uger (n = 207)
English: What Sovaldi is and what it is used for What you need to know before you take Sovaldi How to take Sovaldi
Danish: Det skal du vide, før du begynder at tage Sovaldi Sådan skal du tage Sovaldi Bivirkninger
English: Table 21: Outcomes by therapeutic regimen and treatment duration, a comparison across studies in genotype 2 HCV infection
Danish: Tabel 21: Resultater for behandlingsprogram og behandlingsvarighed, en sammenligning af studier af HCV-genotype 2-infektion
English: SOF+RBV 12 weeks
Danish: SOF+RBV 12 uger
English: SOF+RBV 12 weeks TN (n = 42)
Danish: SOF+RBV 12 uger TN (n = 42)
English: Treated patients (n = 278) had a median age of 54 years (range: 21 to 75); 54% of the patients were male; 91% were White; 5% were Black; 11% were Hispanic or Latino; mean body mass index was 28 kg/m2 (range: 18 to 53 kg/m2); 70% had baseline HCV RNA levels greater than 6 log10 IU/mL; 16% had cirrhosis; 49% had HCV genotype 3.
Danish: Behandlede patienter (n = 278) havde en gennemsnitsalder på 54 år (interval: 21 til 75), 54 % af patienterne var mænd, 91 % var hvide, 5 % var sorte, 11 % var af spansk eller latinamerikansk herkomst, gennemsnitligt body mass index var 28 kg/m2 (interval: 18 til 53 kg/m2), 70 % havde baseline HCV-rna-niveauer over 6 log10 IE/ml, 16 % havde cirrose, 49 % havde HCV-genotype 3.
English: SOF+RBV 12 weeks (n = 73)a
Danish: SOF+RBV 12 uger (n = 73)a
English: SOF+RBV 12 weeks TN (n = 26)
Danish: SOF+RBV 12 uger TN (n = 26)
English: Treated patients (n = 201) had a median age of 56 years (range: 24 to 70); 70% of the patients were male; 87% were White; 3% were Black; 9% were Hispanic or Latino; mean body mass index was 29 kg/m2 (range: 19 to 44 kg/m2); 73% had baseline HCV RNA levels greater than 6 log10 IU/mL; 34% had cirrhosis; 63% had HCV genotype 3; 75% were prior relapsers.
Danish: Behandlede patienter (n = 201) havde en gennemsnitsalder på 56 år (interval: 24 til 70), 70 % af patienterne var mænd, 87 % var hvide, 3 % var sorte, 9 % var af spansk eller latinamerikansk herkomst, gennemsnitligt body mass index var 29 kg/m2 (interval: 19 til 44 kg/m2), 73 % havde baseline HCV-rna-niveauer over 6 log10 IE/ml, 34 % havde cirrose, 63 % havde HCV-genotype 3, 75 % havde tidligere recidiv.
English: Treated patients (n = 327) had a median age of 54 years (range: 19 to 70); 64% of the patients were male; 79% were White; 17% were Black; 14% were Hispanic or Latino; mean body mass index was 29 kg/m2 (range: 18 to 56 kg/m2); 78% had baseline HCV RNA greater than 6 log10 IU/mL; 17% had cirrhosis; 89% had HCV genotype 1 and 11% had HCV genotype 4, 5 or 6.
Danish: Behandlede patienter (n = 327) havde en gennemsnitsalder på 54 år (interval: 19 til 70), 64 % af patienterne var mænd, 79 % var hvide, 17 % var sorte, 14 % var af spansk eller latinamerikansk herkomst, gennemsnitligt body mass index var 29 kg/m2 (interval: 18 til 56 kg/m2), 78 % havde baseline HCV-rna over 6 log10 IE/ml, 17 % havde cirrose, 89 % havde HCV-genotype 1 og 11 % havde HCV-genotype 4, 5 eller 6.
English: Table 22: Outcomes by therapeutic regimen and treatment duration, a comparison across studies in genotype 3 HCV infection
Danish: Tabel 22: Resultater for behandlingsprogram og behandlingsvarighed, en sammenligning af studier af HCV-genotype 3-infektion
English: No dose adjustment of sofosbuvir or efavirenz is required when sofosbuvir and efavirenz are used concomitantly.
Danish: Ingen dosisjustering af sofosbuvir eller efavirenz er nødvendig, når sofosbuvir og efavirenz anvendes samtidigt.
English: Sofosbuvir ↑ Cmax 1.45 (1.10, 1.92) ↑ AUC 1.34 (1.12, 1.59) Cmin (NA)
Danish: Sofosbuvir ↑ Cmax 1,45 (1,10; 1,92)
English: SOF+RBV 24 weeks TE (n = 13)
Danish: SOF+RBV 24 uger TE (n = 13)
English: SOF+RBV 12 weeks (n = 11)
Danish: SOF+RBV 12 uger (n = 11)
English: Treated patients (n = 499) had a median age of 50 years (range: 19 to 77); 66% of the patients were male; 87% were White; 3% were Black; 14% were Hispanic or Latino; mean body mass index was 28 kg/m2 (range: 17 to 52 kg/m2); 57% had baseline HCV RNA levels greater than 6 log10 IU/mL;
Danish: Behandlede patienter (n = 499) havde en gennemsnitsalder på 50 år (interval: 19 til 77), 66 % af patienterne var mænd, 87 % var hvide, 3 % var sorte, 14 % var af spansk eller latinamerikansk herkomst, gennemsnitligt body mass index var 28 kg/m2 (interval: 17 til 52 kg/m2), 57 % havde baseline HCV-rna-niveauer over 6 log10 IE/ml, 20 % havde cirrose, 72 % havde HCV-genotype 3.
English: SOF+RBV 16 weeks (n = 35)
Danish: SOF+RBV 16 uger (n = 35)
English: SOF+RBV 24 weeks TE (n = 15)
Danish: SOF+RBV 24 uger TE (n = 15)
English: • rash, itchy skin
Danish: • rygsmerter, muskelspasmer
English: SOF+RBV 12 weeks (n = 73)
Danish: SOF+RBV 12 uger (n = 73)
English: SOF+RBV 12 weeks (n = 64)
Danish: SOF+RBV 12 uger (n = 64)
English: SOF+RBV 16 weeks (n = 63)
Danish: SOF+RBV 16 uger (n = 63)
English: SOF+RBV 12 weeks (n = 39)
Danish: SOF+RBV 12 uger (n = 39)
English: Moderate RI
Danish: Moderat RI (eGFR
English: Hepatic impairment
Danish: • følelse af svimmelhed
English: If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Danish: Det er meget vigtigt, at du også læser indlægssedlerne for de andre lægemidler, som du vil tage sammen med det. Spørg lægen eller apotekspersonalet, hvis du har spørgsmål om dine lægemidler.
English: Norgestromin ↔ Cmax 1.06 (0.93, 1.22)
Danish: ↔ Cmax 1,06 (0,93; 1,22)
English: Dialysis
Danish: Søvnløshed
English: Kidney problems
Danish: Nyreproblemer
English: • weight loss
Danish: • besvimelsesanfald
English: • Rifampicin (antibiotic used to treat infections, including tuberculosis); • St. John's wort (herbal medicine used to treat depression);
Danish: • Rifampicin (antibiotikum, der anvendes til behandling af infektioner, herunder tuberkulose)
English: GS-331007 ↓ Cmax 0.77 (0.70, 0.84) ↔ AUC 0.84 (0.76, 0.92) Cmin (NA)
Danish: GS-331007 ↓ Cmax 0,77 (0,70; 0,84)
English: Gilead Sciences Netherlands B.V. Tel: + 31 (0) 20 718 36 98
Danish: Tel: + 31 (0)20 718 36 98
English: Overall No cirrhosis
Danish: Samlet Uden cirrose Cirrose
English: Cirrhosis
Danish: Samletc
English: What should I do?
Danish: Hvad skal jeg gøre?
English: If your question is about:
Danish: Hvis dit spørgsmål handler om:
English: 80 times or more
Danish: 80 gange eller mere
English: • You may need to tap 80 times or more.
Danish: • Det kan være nødvendigt at slå 80 gange eller mere.
English: Where is the needle?
Danish: Hvor er nålen?
English: • Take your time.
Danish: • Giv dig god tid.
English: You do not see it before, during, or after using the pen.
Danish: Du kan ikke se den før, under eller efter brug af pennen.
English: 1b Wash your hands.
Danish: 1b Vask dine hænder.
English: • You will need enough time to complete all the steps without stopping.
Danish: • Du skal have tid nok til at færdiggøre alle trin uden at stoppe.
English: A. Look in the window.
Danish: A. Se på vinduet.
English: Number at Risk
Danish: Antal i risiko
English: The plunger may feel like it is springing back a little.
Danish: Det kan føles, som om stemplet springer lidt tilbage.
English: You may see or feel a small bump under the skin after your injection; it should go away after 4 to 8 weeks.
Danish: Du kan se eller føle en lille bule under huden efter din injektion; den burde gå væk efter 4 til 8 uger.
English: The powder inside is your medicine
Danish: Pulveret indeni er din medicin
English: You should not need to stop your treatment.
Danish: Det bør ikke være nødvendigt at stoppe behandlingen.
English: Date of first authorisation: 17 June 2011
Danish: Dato for første markedsføringstilladelse: 17. juni 2011
English: Pancreatitis can be a serious, potentially life-threatening medical condition.
Danish: Pancreatitis kan være en alvorlig og potentielt livstruende tilstand.
English: • loss of energy and strength
Danish: • manglende energi og styrke
English: This is also normal.
Danish: Det er også normalt.
English: (This question relates to the steps shown in sections 3a to 3d).
Danish: (Dette spørgsmål vedrører trinene, der vises i afsnit 3a til 3d).
English: • Follow these instructions step by step.
Danish: • Følg disse instruktioner trin for trin.
English: C. Wash your hands.
Danish: C. Vask dine hænder.
English: This guide is divided into sections:
Danish: Denne vejledning er inddelt i afsnit:
English: Do not try to unlock with excessive force or tools.
Danish: Forsøg ikke at låse op med overdreven kraft eller værktøj.
English: Please keep this possible problem in mind in all situations where you might put yourself and others at risk (e.g. driving a car or using machines).
Danish: Husk det i alle situationer, hvor du kan udsætte dig selv og andre for risiko (for eksempel i forbindelse med bilkørsel eller brug af maskiner).
English: Read the next steps carefully and look closely at the pictures.
Danish: Gennemlæs de næste trin omhyggeligt og se nøje på billederne.
English: You will hear a “click” when the injection begins.
Danish: Du vil høre et "klik", når injektionen begynder.
English: • is properly labelled to warn of hazardous waste inside the container.
Danish: • er mærket korrekt for at advare om farligt affald inde i beholderen.
English: This is how the parts should now look when they are connected.
Danish: Sådan skal delene se ud, når de er forbundet.
English: <-Exenatide favored
Danish: <-Exenatid favoriseret
English: Date of first authorisation: 17 June 2011 Date of latest renewal: 18 February 2016
Danish: Dato for første markedsføringstilladelse: 17. juni 2011 Dato for seneste fornyelse: 18. februar 2016
English: Wash your hands while the pen is warming up.
Danish: Vask dine hænder, mens pennen varmer op.
English: • You may need to turn the cap a few times before it loosens (if you hear clicking you are turning in the wrong direction).
Danish: • Det kan være, at du skal dreje hætten et par gange før den løsner sig (hvis du hører, at den klikker, drejer du den forkerte vej).
English: The medicine can still be fully mixed but it will take more shaking and more time.
Danish: Lægemidlet kan stadig blive helt blandet, men det vil tage mere omrystning og mere tid.
English: The clinical relevance of these findings is currently unknown.
Danish: Den kliniske relevans af disse fund er på nuværende tidspunkt ukendt.
English: Your step by step guide
Danish: Din trin for trin vejledning
English: You will need it later.
Danish: Du skal bruge den senere.
English: Why should I store my pen flat in the refrigerator?
Danish: Hvorfor skal jeg opbevare min pen liggende i køleskabet?
English: This medicine may reduce your appetite, the amount of food you eat, and your weight.
Danish: Dette lægemiddel kan nedsætte din appetit og dermed den mængde mad, som du spiser, og din vægt.
English: I am at step 4c.
Danish: Jeg er ved trin 4c.
English: When you remove the cover, you may see 1 or 2 drops of liquid.
Danish: Når du fjerner hætten, vil du muligvis kunne se 1 eller 2 dråber væske.
English: At the end of this period the pens must be used or discarded.
Danish: Efter denne periode skal pennen anvendes eller bortskaffes.
English: You will feel the needle go into your skin.
Danish: Du vil føle nålen komme ind i din hud.
English: STOP when you hear the click and the green label disappears.
Danish: STOP, når du hører et klik, og den grønne mærkat forsvinder.
English: Do not give this medicine to children and adolescents less than 18 years, as there is no experience with this medicine in this age group.
Danish: Børn og unge under 18 år må ikke få dette lægemiddel, da der ikke er nogen erfaring med dette lægemiddel til denne aldersgruppe.
English: All-cause mortality was the initial secondary endpoint assessed.
Danish: Dødelighed af alle årsager var det første sekundære endepunkt, der blev vurderet.
English: For more information, please see Figure N in Step 3B in the Instructions for the User.
Danish: For mere information, se Figur N i Trin 3B i brugervejledningen.
English: Additional reductions in postprandial concentrations were also observed.
Danish: Yderligere reduktioner af postprandiale koncentrationer blev også observeret.
English: Use a new pen for each injection.
Danish: Brug en ny pen for hver injektion.
English: -Placebo favored->
Danish: -Placebo favoriseret->
English: Includes follow-up within seventy days of the last dose received and extension period.
Danish: Inkluderer opfølgning inden for 70 dage efter den sidste modtagne dosis og forlængelsesperiode.
English: These pharmacokinetic characteristics of exenatide are independent of the dose.
Danish: Disse farmakokinetiske karakteristika for exenatid er uafhængige af dosis.
English: A. Inject and hold:
Danish: A. Insprøjt og hold: