FrancophonIA/ELRC3.0 huggingface dataset:
English: • check how your liver is working - tell your doctor straight away if you have any of the following signs of liver problems: loss of appetite; feeling or being sick; feeling tired or weak;
Danish: Fortæl det straks til lægen, hvis du får et eller flere af følgende tegn på leverproblemer: appetitløshed; kvalme eller opkastning; føler dig træt eller svag; får gulfarvning af huden eller øjnene; afføringens farve har ændret sig.
English: The dose of atorvastatin should not exceed a daily dose of 20 mg when co-administered with ZEPATIER.
Danish: Atorvastatin-dosis må ikke overstige 20 mg dagligt ved administration sammen med ZEPATIER.
English: Among genotype 1a-infected subjects, NS3 resistance-associated substitutions persisted at detectable levels at follow-up week 24 in 31% (4/13) of subjects.
Danish: Blandt genotype 1a-inficerede forsøgspersoner var NS3-resistens-associerede substitutioner persistente med detekterbare niveauer ved opfølgningsuge 24 hos 31% (4/13) af forsøgspersonerne.
English: • EBR/GZR + RBV† for 12 or 16 weeks (N=104 and respectively)
Danish: • EBR/GZR + RBV† i 12 eller 16 uger (N= hhv. 104 og 106)
English: GT 1, 4, 6 TN with or without cirrhosis HCV/HIV-1 co-infection
Danish: GT 1, 4, 6 TN med eller uden cirrose HCV/hiv 1-co-infektion
English: Grazoprevir is active in vitro against the following genotype 1b NS3 substitutions conferring resistance to other NS3/4A protease inhibitors: V36A/I/L/M, Q41L/R, F43S, T54A/C/G/S, V55A/I, Y56F, Q80L/R, V107I, S122A/G/R, R155E/K/N/Q/S, A156G/S, D168E/N/S, V170A/I/T.
Danish: Grazoprevir er aktivt in vitro mod følgende genotype 1b NS3-substitutioner, der giver resistens over for andre NS3/4Aproteasehæmmere: V36A/I/L/M, Q41L/R, F43S, T54A/C/G/S, V55A/I, Y56F, Q80L/R, V107I, S122A/G/R, R155E/K/N/Q/S, A156G/S, D168E/N/S og V170A/I/T.
English: Grazoprevir is active in vitro against the following genotype 1a NS3 substitutions which confer resistance to other NS3/4A protease inhibitors: V36A/L/M, Q41R, F43L, T54A/S, V55A/I, Y56F, Q80K/R, V107I, S122A/G/R/T, I132V, R155K, A156S, D168N/S, I170T/V.
Danish: Grazoprevir er aktivt in vitro mod følgende genotype 1a NS3-substitutioner, der giver resistens over for andre NS3/4A-proteasehæmmere: V36A/L/M, Q41R, F43L, T54A/S, V55A/I, Y56F, Q80K/R, V107I, S122A/G/R/T, I132V, R155K, A156S, D168N/S og I170T/V.
English: (8-24 mg/2-6 mg once daily)/ grazoprevir (200 mg once daily)
Danish: (8-24 mg/2-6 mg en gang dagligt)/grazoprevir (200 mg en gang dagligt
English: • EBR/GZR for 12 or 16 weeks (N=105 and respectively)
Danish: • EBR/GZR i 12 eller 16 uger (N= hhv. 105 og 105)
English: Efavirenz (600 mg once daily)/ elbasvir (50 mg once daily)
Danish: Efavirenz (600 mg en gang dagligt)/elbasvir (50 mg en gang dagligt)
English: In genotype 1b replicons, single NS5A substitutions L31F and Y93H reduced elbasvir antiviral activity by 17-fold.
Danish: I genotype 1b-replikoner reducerede enkeltsubstitutionerne L31F og Y93H i NS5A elbasvirs antivirale aktivitet 17 gange.
English: ZEPATIER contains 3.04 mmol (or 69.85 mg) sodium per dose.
Danish: 69,85 mg) natrium pr. dosis.
English: In genotype 4 replicons, single NS3 substitutions D168A/V reduced grazoprevir antiviral activity by 110to 320-fold.
Danish: I genotype 4-replikoner reducerede enkeltsubstitutionerne D168A/V i NS3 grazoprevirs antivirale aktivitet 110 til 320 gange.
English: For grazoprevir, in HCV genotype 1a replicons, single NS3 substitutions D168A/E/G/S/V reduced grazoprevir antiviral activity by 2- to 81-fold.
Danish: Grazoprevir: I HCV-genotype 1a-replikoner reducerede enkeltsubstitutionerne D168A/E/G/S/V i NS3 grazoprevirs antivirale aktivitet 2 til 81 gange.
English: Digoxin (0.25 mg single dose)/ elbasvir (50 mg once daily)
Danish: Digoxin (0,25 mg enkeltdosis)/elbasvir (50 mg en gang dagligt)
English: These changes are not clinically relevant; therefore, no dose adjustment of elbasvir/grazoprevir is recommended based on race/ethnicity (see section 4.4).
Danish: Disse ændringer er ikke klinisk relevante, og dosisjustering af elbasvir/grazoprevir på basis af race/etnisk oprindelse anbefales derfor ikke (se pkt.
English: • EBR/GZR for 12 weeks (N=218)
Danish: • EBR/GZR i 12 uger (N=218)
English: Co-administration of ZEPATIER with medicinal products that inhibit OATP1B transporters is contraindicated because it may result in a significant increase in the plasma concentration of grazoprevir (see sections 4.3 and 4.4).
Danish: Samtidig administration af ZEPATIER og lægemidler, som hæmmer OATP1B-transportører, er kontraindiceret, da det kan medføre en signifikant stigning i plasmakoncentrationen af grazoprevir (se pkt.
English: ACID REDUCING AGENTS H2-receptor antagonists Famotidine (20 mg single dose)/ elbasvir (50 mg single dose)/ grazoprevir (100 mg single dose)
Danish: SYREREDUCERENDE MIDLER H2-receptorantagonister Famotidin (20 mg enkeltdosis)/elbasvir (50 mg enkeltdosis)/grazoprevir (100 mg enkeltdosis)
English: ↔ R-Methadone AUC 1.09 (1.02, 1.17) Cmax 1.03 (0.96, 1.11)
Danish: ↔ R-methadon AUC 1,09 (1,02; 1,17) Cmax 1,03 (0,96; 1,11)
English: Co-administration of ZEPATIER and CYP3A or P-gp inducers is contraindicated because it may significantly decrease elbasvir and grazoprevir plasma concentrations and may lead to a reduced therapeutic effect of ZEPATIER (see sections 4.3, 4.5 and 5.2).
Danish: Samtidig administration af ZEPATIER og CYP3A- eller P-gp-induktorer er kontraindiceret, da det kan nedsætte plasmakoncentrationen af elbasvir og grazoprevir betydeligt og kan medføre reduceret terapeutisk virkning af ZEPATIER (se pkt.
English: Among genotype 1binfected subjects, NS5A resistance-associated substitutions persisted at detectable levels in 100% (7/7) of subjects at follow-up week 12 and in 100% (3/3) of subjects with follow-up week 24 data.
Danish: Blandt genotype 1b-inficerede forsøgspersoner var NS5A-resistensassocierede substitutioner persistente med detekterbare niveauer hos 100% (7/7) af forsøgspersonerne ved opfølgningsuge 12 og hos 100% (3/3) af forsøgspersonerne med data fra opfølgningsuge 24.
English: • EBR/GZR for 12 weeks (N=201)
Danish: • EBR/GZR i 12 uger (N=201)
English: Darunavir/ritonavir (600 mg twice daily)/ ritonavir (100 mg twice daily/ elbasvir (50 mg once daily)
Danish: Darunavir/ritonavir (600 mg to gange dagligt)/ritonavir (100 mg to gange dagligt/elbasvir (50 mg en gang dagligt)
English: Grazoprevir is not a P-gp inhibitor based on in vitro data.
Danish: Baseret på in vitro-data hæmmer grazoprevir ikke P-gp.
English: These differences in elbasvir and grazoprevir exposure are not clinically relevant; therefore, elbasvir/grazoprevir may be taken without regard to food.
Danish: Disse forskelle i eksponeringen for elbasvir og grazoprevir er ikke klinisk relevante.
English: • EBR/GZR* for 12 weeks (N=316)
Danish: • EBR/GZR* i 12 uger (N=316)
English: (600 mg PO single dose)/ elbasvir (50 mg single dose)
Danish: (600 mg oral enkeltdosis)/elbasvir (50 mg enkeltdosis)
English: ↔ Buprenorphine AUC 0.98 (0.81, 1.19) Cmax 0.90 (0.76, 1.07)
Danish: ↔ Buprenorphin AUC 0,98 (0,81; 1,19) Cmax 0,90 (0,76; 1,07)
English: Tenofovir disoproxil fumarate (300 mg once daily)/ elbasvir (50 mg once daily)
Danish: Tenofovirdisoproxilfumarat (300 mg en gang dagligt)/elbasvir (50 mg en gang dagligt)
English: ↔ Mycophenolic acid AUC 0.95 (0.87, 1.03) Cmax 0.85 (0.67, 1.07)
Danish: ↔ Mycophenolsyre AUC 0,95 (0,87; 1,03) Cmax 0,85 (0,67; 1,07)
English: C-EDGE TE (open-label)
Danish: C-EDGE TE (ikke-blindet)
English: Raltegravir (400 mg single dose)/ elbasvir (50 mg single dose)
Danish: Raltegravir (400 mg enkeltdosis)/elbasvir (50 mg enkeltdosis)
English: ↔ Naloxone AUC 0.88 (0.76, 1.02) Cmax 0.85 (0.66, 1.09)
Danish: ↔ Naloxon AUC 0,88 (0,76; 1,02) Cmax 0,85 (0,66; 1,09)
English: • EBR* + GZR* + RBV† for 12 weeks (N=14)
Danish: • EBR* + GZR* + RBV† i 12 uger (N=14)
English: What ZEPATIER contains
Danish: ZEPATIER indeholder:
English: (20-150 mg once daily)/ grazoprevir (200 mg once daily)
Danish: (20-150 mg en gang dagligt)/grazoprevir (200 mg en gang dagligt)
English: In genotype 4 replicons, single NS5A substitutions L30S, M31V, and Y93H reduced elbasvir antiviral activity by 3to 23-fold.
Danish: I genotype 4replikoner reducerede enkeltsubstitutionerne L30S, M31V og Y93H i NS5A elbasvirs antivirale aktivitet 3 til 23 gange.
English: If you take more ZEPATIER than you should
Danish: Hvis du har taget for meget ZEPATIER
English: These changes are not clinically relevant; therefore, no dose adjustment of elbasvir/grazoprevir is recommended based on sex (see section 4.4).
Danish: Disse ændringer er ikke klinisk relevante, og dosisjustering af elbasvir/grazoprevir på basis af køn anbefales derfor ikke (se pkt.
English: Among genotype 1a-infected subjects, the median age was 54 years (range: 19 to 76); 71 % were male; 71 % were White; 22 % were Black or African American; 9% were Hispanic or Latino; 74% were treatment-naïve subjects; 26% were treatment-experienced subjects; mean body mass index was 27 kg/m2; 75 % had baseline HCV RNA levels greater than 800,000 IU/mL; 23 % had cirrhosis; 72% had non-C/C IL28B alleles (CT or TT); 30 % had HCV/HIV-1 co-infection.
Danish: Blandt genotype 1a-inficerede forsøgspersoner var medianalderen 54 år (19 til 76); 71% var mænd; 71% var kaukasere; 22% var negroide eller afroamerikanere; 9% var latinamerikanere; 74% var behandlingsnaive; 26% var behandlingserfarne; gennemsnitligt BMI var 27 kg/m2; 75% havde HCV
English: Montelukast (10 mg single dose)/ grazoprevir (200 mg single dose)
Danish: Montelukast (10 mg enkeltdosis)/grazoprevir (200 mg enkeltdosis)
English: ↔ Prednisone AUC 1.08 (1.00, 1.17) Cmax 1.05 (1.00, 1.10)
Danish: ↔ Prednison AUC 1,08 (1,00; 1,17) Cmax 1,05 (1,00; 1,10)
English: Rifampicin (600 mg IV single dose)/ elbasvir (50 mg single dose)
Danish: Rifampicin (600 mg intravenøs enkeltdosis)/elbasvir (50 mg enkeltdosis)
English: • EBR* + GZR* for 12 weeks (N=122)
Danish: • EBR* + GZR* i 12 uger (N=122)
English: Ketoconazole (400 mg PO once daily)/ elbasvir (50 mg single dose)
Danish: Ketoconazol (400 mg oralt en gang dagligt)/ elbasvir (50 mg enkeltdosis)
English: ↔ S-Methadone AUC 1.09 (0.94, 1.26) Cmax 1.09 (0.95, 1.25) C24 1.20 (0.98, 1.47)
Danish: ↔ S-methadon AUC 1,09 (0,94; 1,26) Cmax 1,09 (0,95; 1,25) C24 1,20 (0,98; 1,47)
English: ↔ Buprenorphine AUC 0.98 (0.89, 1.08) Cmax 0.94 (0.82, 1.08) C24 0.98 (0.88, 1.09)
Danish: ↔ Buprenorphin AUC 0,98 (0,89; 1,08) Cmax 0,94 (0,82; 1,08) C24 0,98 (0,88; 1,09)
English: Ethinyl oestradiol (EE) / Levonorgestrel (LNG) (0.03 mg EE/
Danish: Ethinylestradiol (EE)/Levonorgestrel (LNG) (0,03 mg EE/0,15 mg LNG som enkeltdosis)/elbasvir (50 mg en gang dagligt)
English: Musculoskeletal and connective tissue disorders: Common arthralgia, myalgia
Danish: Knogler, led, muskler og bindevæv: Almindelig
English: ↔ Digoxin AUC 1.11 (1.02, 1.22) Cmax 1.47 (1.25, 1.73)
Danish: AUC 1,11 (1,02; 1,22) Cmax 1,47 (1,25; 1,73)
English: ↔ R-Methadone AUC 1.03 (0.92, 1.15) Cmax 1.07 (0.95, 1.20) C24 1.10 (0.96, 1.26)
Danish: ↔ R-methadon AUC 1,03 (0,92; 1,15) Cmax 1,07 (0,95; 1,20) C24 1,10 (0,96; 1,26)
English: Lopinavir/ritonavir (400 mg twice daily)/ ritonavir (100 mg twice daily/ elbasvir (50 mg once daily)
Danish: Lopinavir/ritonavir (400 mg to gange dagligt)/ritonavir (100 mg to gange dagligt/elbasvir (50 mg en gang dagligt)
English: Calcium acetate (2,668 mg single dose)/ elbasvir (50 mg single dose)/ grazoprevir (100 mg single dose)
Danish: Calciumacetat (2.668 mg enkeltdosis)/elbasvir (50 mg enkeltdosis)/ grazoprevir (100 mg enkeltdosis)
English: GT 1, 4, 6 TN with or without cirrhosis Opiate agonist therapy
Danish: GT 1, 4, 6 TN med eller uden cirrose Behandling med opiatagonist
English: (400 mg PO once daily)/ grazoprevir (100 mg single dose)
Danish: (400 mg oralt en gang dagligt)/ grazoprevir (100 mg enkeltdosis)
English: Proton pump inhibitors Pantoprazole (40 mg once daily)/ elbasvir (50 mg single dose)/ grazoprevir (100 mg single dose)
Danish: Protonpumpehæmmere Pantoprazol (40 mg en gang dagligt)/elbasvir (50 mg enkeltdosis)/grazoprevir (100 mg enkeltdosis)
English: (300 mg once daily)/ ritonavir (100 mg once daily/ elbasvir (50 mg once daily)
Danish: (300 mg en gang dagligt)/ritonavir (100 mg en gang dagligt/elbasvir (50 mg en gang dagligt)
English: Among genotype 4-infected subjects, the median age was 51 years (range: 28 to 75); 66 % were male; 88 % were White; 8 % were Black or African American; 11% were Hispanic or Latino; 77% were treatment-naïve subjects; 23% were treatment-experienced subjects; mean body mass index was 25 kg/m2; 56 % had baseline HCV RNA levels greater than 800,000 IU/mL; 22 % had cirrhosis; 73% had non-C/C IL28B alleles (CT or TT); 40 % had HCV/HIV-1 co-infection.
Danish: Blandt genotype 4-inficerede forsøgspersoner var medianalderen 51 år (28 til 75); 66% var mænd; 88% var kaukasere; 8% var negroide eller afroamerikanere; 11% var latinamerikanere; 77% var behandlingsnaive; 23% var behandlingserfarne; gennemsnitligt BMI var 25 kg/m2; 56% havde HCV
English: ↔ Emtricitabine AUC 1.07 (1.03, 1.10) Cmax 0.96 (0.90, 1.02) C24 1.19 (1.13, 1.25)
Danish: ↔ Emtricitabin AUC 1,07 (1,03; 1,10) Cmax 0,96 (0,90; 1,02) C24 1,19 (1,13; 1,25)
English: Sofosbuvir (400 mg single dose sofosbuvir)/ elbasvir (50 mg once daily)/ grazoprevir (200 mg once daily
Danish: Sofosbuvir (400 mg enkeltdosis sofosbuvir)/elbasvir (50 mg en gang dagligt)/grazoprevir (200 mg en gang dagligt)
English: If you have any questions about your medicines, please ask your doctor or pharmacist.
Danish: Er du i tvivl, så spørg lægen eller apotekspersonalet.
English: ↔ Rilpivirine AUC 1.13 (1.07, 1.20) Cmax 1.07 (0.97, 1.17) C24 1.16 (1.09, 1.23)
Danish: ↔ Rilpivirin AUC 1,13 (1,07; 1,20) Cmax 1,07 (0,97; 1,17) C24 1,16 (1,09; 1,23)
English: (600 mg IV single dose)/ grazoprevir (200 mg single dose)
Danish: (600 mg intravenøs enkeltdosis)/grazoprevir (200 mg enkeltdosis)
English: Both relapsers had baseline HCV RNA >800,000 IU/mL Both subjects who failed to achieve SVR for reasons other than virologic failure had baseline HCV RNA <=800,000 IU/mL.
Danish: Begge forsøgspersoner, som ikke opnåede SVR af andre årsager end virologisk svigt, havde HCV-RNA ≤800.000 IE/ml ved baseline.
English: • EBR* + GZR* for 12 weeks (N=14)
Danish: • EBR* + GZR* i 12 uger (N=14)
English: (combination of OATP1B and CYP3A inhibition)
Danish: (kombination af OATP1B- og CYP3Ahæmning)
English: Atorvastatin (20 mg single dose)/ grazoprevir (200 mg once daily)
Danish: Atorvastatin (20 mg enkeltdosis)/grazoprevir (200 mg en gang dagligt)
English: Rilpivirine (25 mg once daily)/ elbasvir (50 mg once daily)/ grazoprevir (200 mg once daily)
Danish: Rilpivirin (25 mg en gang dagligt)/elbasvir (50 mg en gang dagligt)/grazoprevir (200 mg en gang dagligt)
English: Sevelamer carbonate (2,400 mg single dose)/ elbasvir (50 mg single dose)/ grazoprevir (100 mg single dose)
Danish: Sevelamercarbonat (2.400 mg enkeltdosis)/elbasvir (50 mg enkeltdosis)/grazoprevir (100 mg enkeltdosis)
English: (300 mg once daily)/elbasvir (50 mg once daily)/grazoprevir (100 mg once daily)
Danish: (300 mg en gang dagligt)/elbasvir (50 mg en gang dagligt)/grazoprevir (100 mg en gang dagligt)
English: The tablets are packaged into a carton containing two (2) cardboard cards, each cardboard card containing (2) 7-count aluminium blisters sealed in a cardboard card for a total of 28 tablets.
Danish: Der er 2 x 7 stk. aluminiumblisterkort i hvert blisteromslag, hvilket giver i alt 28 tabletter.
English: These changes are not clinically relevant; therefore, no dose adjustment of elbasvir/grazoprevir is recommended based on age (see sections 4.2 and 4.4).
Danish: Disse ændringer er ikke klinisk relevante, og dosisjustering af elbasvir/grazoprevir på basis af alder anbefales derfor ikke (se pkt.
English: GT 1 TE with HCV protease inhibitor regimen
Danish: GT 1 TE med HCVproteasehæmmerregime med eller uden cirrose
English: Mycophenolate mofetil (1,000 mg single dose)/ elbasvir (50 mg once daily)/ grazoprevir (200 mg once daily)
Danish: Mycophenolatmofetil (1.000 mg enkeltdosis)/elbasvir (50 mg en gang dagligt)/grazoprevir (200 mg en gang dagligt)
English: Midazolam (2 mg single dose)/ grazoprevir (200 mg once daily)
Danish: Midazolam (2 mg enkeltdosis)/grazoprevir (200 mg en gang dagligt)
English: Rosuvastatin (10 mg single dose)/ grazoprevir (200 mg once daily)
Danish: Rosuvastatin (10 mg enkeltdosis)/grazoprevir (200 mg en gang dagligt)
English: Pitavastatin (1 mg single dose)/ grazoprevir (200 mg once daily)
Danish: Pitavastatin (1 mg enkeltdosis)/grazoprevir (200 mg en gang dagligt)
English: Talk to your doctor before taking ZEPATIER if you are breast-feeding.
Danish: Tal med lægen, før du tager dette lægemiddel, hvis du er på en diæt med lavt natriumindhold.
English: RBV was administered at a total daily dose of 800 mg to 1,400 mg based on weight (see section 4.2) Failed prior treatment with boceprevir, telaprevir, or simeprevir in combination with peg-IFN + RBV
Danish: 4.2) Tidligere behandlingssvigt med boceprevir, telaprevir eller simeprevir i kombination med peg-IFN + RBV
English: (300 mg once daily)/ ritonavir (100 mg once daily/ grazoprevir (200 mg once daily)
Danish: (300 mg en gang dagligt)/ritonavir (100 mg en gang dagligt/grazoprevir (200 mg en gang dagligt)
English: Subjects without baseline NS3 polymorphisms, % (n/N)
Danish: Forsøgspersoner uden NS3polymorfismer ved baseline % (n/N)
English: Cirrhotic
Danish: Med cirrose
English: • EBR* + GZR* + RBV† for 8, 12, or 18 weeks (N=60, 152, and 65, respectively)
Danish: • EBR* + GZR* + RBV† i 8, 12 eller 18 uger (N= hhv.
English: (due in part to OATP1B and CYP3A inhibition)
Danish: (dels på grund af OATP1B- og CYP3A-hæmning)
English: Tacrolimus (2 mg single dose)/ elbasvir (50 mg once daily)/ grazoprevir (200 mg once daily)
Danish: Tacrolimus (2 mg enkeltdosis)/elbasvir (50 mg en gang dagligt)/ grazoprevir (200 mg en gang dagligt)
English: (10 mg single dose)/ elbasvir (50 mg once daily) / grazoprevir (200 mg once daily)
Danish: (10 mg enkeltdosis)/elbasvir (50 mg en gang dagligt)/grazoprevir (200 mg en gang dagligt)
English: (300 mg once daily)/ grazoprevir (200 mg once daily)
Danish: (300 mg en gang dagligt)/grazoprevir (200 mg en gang dagligt)
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicin sammen med ZEPATIER Fortæl altid lægen eller apotekspersonalet, hvis du tager anden medicin eller har gjort det for nylig.
English: HIV ANTIVIRAL AGENTS: INTEGRASE STRAND TRANSFER INHIBITORS
Danish: HIV-ANTIVIRALE MIDLER: INTEGRASEHÆMMERE (AF GENOMOVERFØRSEL)
English: ‡ with or without cirrhosis
Danish: Uden cirrose
English: What ZEPATIER is and what it is used for What you need to know before you take ZEPATIER How to take ZEPATIER
Danish: Det skal du vide, før du begynder at tage ZEPATIER Sådan skal du tage ZEPATIER Bivirkninger
English: Subjects with baseline NS3 polymorphisms, % (n/N)
Danish: Forsøgspersoner med NS3polymorfismer ved baseline % (n/N)
English: (600 mg twice daily)/ ritonavir (100 mg twice daily/ grazoprevir (200 mg once daily)
Danish: (600 mg to gange dagligt)/ritonavir (100 mg to gange dagligt/grazoprevir (200 mg en gang dagligt)
English: ANTIARRHYTHMICS
Danish: ANTIMYKOTIKA
English: Ciclosporin (400 mg single dose)/ elbasvir (50 mg once daily)/ grazoprevir (200 mg once daily)
Danish: Ciclosporin (400 mg enkeltdosis)/elbasvir (50 mg en gang dagligt)/grazoprevir (200 mg en gang dagligt)
English: (400 mg twice daily)/ ritonavir (100 mg twice daily/ grazoprevir (200 mg once daily)
Danish: (400 mg to gange dagligt)/ritonavir (100 mg to gange dagligt/grazoprevir (200 mg en gang dagligt)
English: Subjects without baseline NS5A polymorphisms, % (n/N)
Danish: Forsøgspersoner uden NS5Apolymorfismer ved baseline, % (n/N)
English: Placebo-controlled study in subjects with CKD Stage 4 (eGFR 15-29 mL/min/1.73 m2) or Stage 5 (eGFR < 15 mL/min/1.73 m2), including subjects on hemodialysis, Subjects were randomised in a 1:1 ratio to one of the following treatment groups: EBR + GZR for 12 weeks (ITG) or placebo for 12 weeks followed by open-label treatment with EBR/GZR for 12 weeks (DTG).
Danish: Placebokontrolleret studie med forsøgspersoner med kronisk nyresygdom (CKD) i stadium 4 (eGFR 1529 ml/min/1,73 m2) eller stadium 5 (eGFR <15 ml/min/1,73 m inklusive forsøgspersoner i hæmodialyse.
English: Dolutegravir (50 mg single dose)/ elbasvir (50 mg once daily)/ grazoprevir (200 mg once daily)
Danish: Dolutegravir (50 mg enkeltdosis)/elbasvir (50 mg en gang dagligt)/grazoprevir (200 mg en gang dagligt)
English: (600 mg once daily)/ grazoprevir (200 mg once daily)
Danish: (600 mg en gang dagligt)/grazoprevir (200 mg en gang dagligt)
English: Retreatment
Danish: Gentagelse af behandling
English: (400 mg twice daily)/ grazoprevir (200 mg once daily)
Danish: (400 mg to gange dagligt)/grazoprevir (200 mg en gang dagligt)
English: (OATP1B inhibition and CYP3A induction)
Danish: (OATP1B-hæmning og CYP3Ainduktion)
English: Pravastatin (40 mg single dose)/ elbasvir (50 mg once daily)/ grazoprevir (200 mg once daily)
Danish: Pravastatin (40 mg enkeltdosis)/elbasvir (50 mg en gang dagligt)/grazoprevir (200 mg en gang dagligt)
English: Prednisone (40 mg single dose)/ elbasvir (50 mg once daily)/ grazoprevir (200 mg once daily
Danish: Prednison (40 mg enkeltdosis)/elbasvir (50 mg en gang dagligt)/grazoprevir (200 mg en gang dagligt)
English: (600 mg PO single dose)/ grazoprevir (200 mg once daily)
Danish: (600 mg oral enkeltdosis)/grazoprevir (200 mg en gang dagligt)
English: Subjects with baseline NS5A polymorphisms, % (n/N)
Danish: Forsøgspersoner med NS5Apolymorfismer ved baseline, % (n/N)
English: Gender
Danish: Population
English: The highest dose of grazoprevir was 1,000 mg once daily for 10 days, and a single dose of 1,600 mg.
Danish: Den højeste dosis af grazoprevir var 1.000 mg en gang dagligt i 10 dage og en enkeltdosis på 1.600 mg. I disse studier med raske frivillige var bivirkningerne sammenlignelige med de bivirkninger, der blev rapporteret i placebogrupperne, med hensyn til hyppighed og sværhedsgrad.
English: • muscle aches
Danish: Pruritus, alopeci
English: Avoid contact with eyes.
Danish: Undgå kontakt med øjnene.
English: A white suspension.
Danish: En hvid suspension.
English: • Take out one pipette from the box.
Danish: • Tag en pipette ud af æsken.
English: Do not use in dogs with generalised demodecosis.
Danish: Bør ikke anvendes hos hunde med generaliseret demodecose.
English: ATCvet code: QS02CA03.
Danish: ATCvet-kode: QS02 CA03
English: In this case, treatment should be stopped.
Danish: I sådanne tilfælde bør behandlingen stoppes.
English: 1180 Wien
Danish: A-1180 Wien
English: Squeeze gently but firmly in the middle of the body of the pipette.
Danish: Tryk forsigtigt men fast på midten af pipettens krop.
English: Do not use this veterinary medicinal product after the expiry date, which is stated on the label.
Danish: Brug ikke dette veterinærlægemiddel efter den udløbsdato, der står på etiketten efter EXP.
English: Use only accordingly to the benefit-risk assessment by the responsible veterinarian.
Danish: Må kun anvendes i overensstemmelse med den ansvarlige dyrlæges vurdering af benefit-risk forholdet.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 20/11/2008.
Danish: DATO FOR FØRSTE TILLADELSE/FORNYELSE AF TILLADELSEN Dato for første markedsføringstilladelse:20/11/2008
English: 1 dose / ear / day for 5 days
Danish: ins 1 dosis / øre / dag i 5 dage
English: 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary ins1 dose / ear / day for 5 days
Danish: 4.10 Overdosering (symptomer, nødforanstaltninger, modgift), om nødvendigt ins 1 dosis / øre / dag i 5 dage
English: • To open: hold up the pipette upright and break the top of the cannula.
Danish: • For at åbne: hold pipetten lodret og knæk den øverste del af kanylen.
English: Since many bacterial strains may be involved in otitis externa in dogs, the mechanisms of resistance can vary.
Danish: Eftersom mange bakterielle stammer kan være involveret i betændelse i øregangen hos hunde, kan resistensmekanismerne variere.