natgillin/translations-raw huggingface dataset:
Blandt genotype 1b-inficerede forsøgspersoner var NS3-resistens-associerede substitutioner persistente med detekterbare niveauer ved opfølgningsuge 24 hos 50% (1/2) af forsøgspersonerne.
Among genotype 1b-infected subjects, NS3 resistance-associated substitutions persisted at detectable levels at follow-up week 24 in 50% (1/2) of subjects.
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.
• 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;
Atorvastatin-dosis må ikke overstige 20 mg dagligt ved administration sammen med ZEPATIER.
The dose of atorvastatin should not exceed a daily dose of 20 mg when co-administered with ZEPATIER.
Blandt genotype 1a-inficerede forsøgspersoner var NS3-resistens-associerede substitutioner persistente med detekterbare niveauer ved opfølgningsuge 24 hos 31% (4/13) af forsøgspersonerne.
Among genotype 1a-infected subjects, NS3 resistance-associated substitutions persisted at detectable levels at follow-up week 24 in 31% (4/13) of subjects.
• EBR/GZR + RBV† i 12 eller 16 uger (N= hhv. 104 og 106)
• EBR/GZR + RBV† for 12 or 16 weeks (N=104 and respectively)
GT 1, 4, 6 TN med eller uden cirrose HCV/hiv 1-co-infektion
GT 1, 4, 6 TN with or without cirrhosis HCV/HIV-1 co-infection
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.
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.
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.
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.
(8-24 mg/2-6 mg en gang dagligt)/grazoprevir (200 mg en gang dagligt
(8-24 mg/2-6 mg once daily)/ grazoprevir (200 mg once daily)
• EBR/GZR i 12 eller 16 uger (N= hhv. 105 og 105)
• EBR/GZR for 12 or 16 weeks (N=105 and respectively)
Efavirenz (600 mg en gang dagligt)/elbasvir (50 mg en gang dagligt)
Efavirenz (600 mg once daily)/ elbasvir (50 mg once daily)
I genotype 1b-replikoner reducerede enkeltsubstitutionerne L31F og Y93H i NS5A elbasvirs antivirale aktivitet 17 gange.
In genotype 1b replicons, single NS5A substitutions L31F and Y93H reduced elbasvir antiviral activity by 17-fold.
69,85 mg) natrium pr. dosis.
ZEPATIER contains 3.04 mmol (or 69.85 mg) sodium per dose.
I genotype 4-replikoner reducerede enkeltsubstitutionerne D168A/V i NS3 grazoprevirs antivirale aktivitet 110 til 320 gange.
In genotype 4 replicons, single NS3 substitutions D168A/V reduced grazoprevir antiviral activity by 110to 320-fold.
Grazoprevir: I HCV-genotype 1a-replikoner reducerede enkeltsubstitutionerne D168A/E/G/S/V i NS3 grazoprevirs antivirale aktivitet 2 til 81 gange.
For grazoprevir, in HCV genotype 1a replicons, single NS3 substitutions D168A/E/G/S/V reduced grazoprevir antiviral activity by 2- to 81-fold.
Digoxin (0,25 mg enkeltdosis)/elbasvir (50 mg en gang dagligt)
Digoxin (0.25 mg single dose)/ elbasvir (50 mg once daily)
Disse ændringer er ikke klinisk relevante, og dosisjustering af elbasvir/grazoprevir på basis af race/etnisk oprindelse anbefales derfor ikke (se pkt.
These changes are not clinically relevant; therefore, no dose adjustment of elbasvir/grazoprevir is recommended based on race/ethnicity (see section 4.4).
• EBR/GZR i 12 uger (N=218)
• EBR/GZR for 12 weeks (N=218)
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.
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).
SYREREDUCERENDE MIDLER H2-receptorantagonister Famotidin (20 mg enkeltdosis)/elbasvir (50 mg enkeltdosis)/grazoprevir (100 mg enkeltdosis)
ACID REDUCING AGENTS H2-receptor antagonists Famotidine (20 mg single dose)/ elbasvir (50 mg single dose)/ grazoprevir (100 mg single dose)
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.
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).
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.
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.
• EBR/GZR i 12 uger (N=201)
• EBR/GZR for 12 weeks (N=201)
Darunavir/ritonavir (600 mg to gange dagligt)/ritonavir (100 mg to gange dagligt/elbasvir (50 mg en gang dagligt)
Darunavir/ritonavir (600 mg twice daily)/ ritonavir (100 mg twice daily/ elbasvir (50 mg once daily)
Baseret på in vitro-data hæmmer grazoprevir ikke P-gp.
Grazoprevir is not a P-gp inhibitor based on in vitro data.
Disse forskelle i eksponeringen for elbasvir og grazoprevir er ikke klinisk relevante.
These differences in elbasvir and grazoprevir exposure are not clinically relevant; therefore, elbasvir/grazoprevir may be taken without regard to food.
• EBR/GZR* i 12 uger (N=316)
• EBR/GZR* for 12 weeks (N=316)
(600 mg oral enkeltdosis)/elbasvir (50 mg enkeltdosis)
(600 mg PO single dose)/ elbasvir (50 mg single dose)
↔ Buprenorphin AUC 0,98 (0,81; 1,19) Cmax 0,90 (0,76; 1,07)
↔ Buprenorphine AUC 0.98 (0.81, 1.19) Cmax 0.90 (0.76, 1.07)
Tenofovirdisoproxilfumarat (300 mg en gang dagligt)/elbasvir (50 mg en gang dagligt)
Tenofovir disoproxil fumarate (300 mg once daily)/ elbasvir (50 mg once daily)
↔ Mycophenolsyre AUC 0,95 (0,87; 1,03) Cmax 0,85 (0,67; 1,07)
↔ Mycophenolic acid AUC 0.95 (0.87, 1.03) Cmax 0.85 (0.67, 1.07)
C-EDGE TE (ikke-blindet)
C-EDGE TE (open-label)
Raltegravir (400 mg enkeltdosis)/elbasvir (50 mg enkeltdosis)
Raltegravir (400 mg single dose)/ elbasvir (50 mg single dose)
↔ Naloxon AUC 0,88 (0,76; 1,02) Cmax 0,85 (0,66; 1,09)
↔ Naloxone AUC 0.88 (0.76, 1.02) Cmax 0.85 (0.66, 1.09)
• EBR* + GZR* + RBV† i 12 uger (N=14)
• EBR* + GZR* + RBV† for 12 weeks (N=14)
ZEPATIER indeholder:
What ZEPATIER contains
(20-150 mg en gang dagligt)/grazoprevir (200 mg en gang dagligt)
(20-150 mg once daily)/ grazoprevir (200 mg once daily)
I genotype 4replikoner reducerede enkeltsubstitutionerne L30S, M31V og Y93H i NS5A elbasvirs antivirale aktivitet 3 til 23 gange.
In genotype 4 replicons, single NS5A substitutions L30S, M31V, and Y93H reduced elbasvir antiviral activity by 3to 23-fold.
Hvis du har taget for meget ZEPATIER
If you take more ZEPATIER than you should
Disse ændringer er ikke klinisk relevante, og dosisjustering af elbasvir/grazoprevir på basis af køn anbefales derfor ikke (se pkt.
These changes are not clinically relevant; therefore, no dose adjustment of elbasvir/grazoprevir is recommended based on sex (see section 4.4).
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
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.
Montelukast (10 mg enkeltdosis)/grazoprevir (200 mg enkeltdosis)
Montelukast (10 mg single dose)/ grazoprevir (200 mg single dose)
Rifampicin (600 mg intravenøs enkeltdosis)/elbasvir (50 mg enkeltdosis)
Rifampicin (600 mg IV single dose)/ elbasvir (50 mg single dose)
• EBR* + GZR* i 12 uger (N=122)
• EBR* + GZR* for 12 weeks (N=122)
Ketoconazol (400 mg oralt en gang dagligt)/ elbasvir (50 mg enkeltdosis)
Ketoconazole (400 mg PO once daily)/ elbasvir (50 mg single dose)
↔ Buprenorphin AUC 0,98 (0,89; 1,08) Cmax 0,94 (0,82; 1,08) C24 0,98 (0,88; 1,09)
↔ Buprenorphine AUC 0.98 (0.89, 1.08) Cmax 0.94 (0.82, 1.08) C24 0.98 (0.88, 1.09)
Ethinylestradiol (EE)/Levonorgestrel (LNG) (0,03 mg EE/0,15 mg LNG som enkeltdosis)/elbasvir (50 mg en gang dagligt)
Ethinyl oestradiol (EE) / Levonorgestrel (LNG) (0.03 mg EE/
Knogler, led, muskler og bindevæv: Almindelig
Musculoskeletal and connective tissue disorders: Common arthralgia, myalgia
AUC 1,11 (1,02; 1,22) Cmax 1,47 (1,25; 1,73)
↔ Digoxin AUC 1.11 (1.02, 1.22) Cmax 1.47 (1.25, 1.73)
Lopinavir/ritonavir (400 mg to gange dagligt)/ritonavir (100 mg to gange dagligt/elbasvir (50 mg en gang dagligt)
Lopinavir/ritonavir (400 mg twice daily)/ ritonavir (100 mg twice daily/ elbasvir (50 mg once daily)
Calciumacetat (2.668 mg enkeltdosis)/elbasvir (50 mg enkeltdosis)/ grazoprevir (100 mg enkeltdosis)
Calcium acetate (2,668 mg single dose)/ elbasvir (50 mg single dose)/ grazoprevir (100 mg single dose)
GT 1, 4, 6 TN med eller uden cirrose Behandling med opiatagonist
GT 1, 4, 6 TN with or without cirrhosis Opiate agonist therapy
(400 mg oralt en gang dagligt)/ grazoprevir (100 mg enkeltdosis)
(400 mg PO once daily)/ grazoprevir (100 mg single dose)
Protonpumpehæmmere Pantoprazol (40 mg en gang dagligt)/elbasvir (50 mg enkeltdosis)/grazoprevir (100 mg enkeltdosis)
Proton pump inhibitors Pantoprazole (40 mg once daily)/ elbasvir (50 mg single dose)/ grazoprevir (100 mg single dose)
(300 mg en gang dagligt)/ritonavir (100 mg en gang dagligt/elbasvir (50 mg en gang dagligt)
(300 mg once daily)/ ritonavir (100 mg once daily/ elbasvir (50 mg once daily)
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
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.
Sofosbuvir (400 mg enkeltdosis sofosbuvir)/elbasvir (50 mg en gang dagligt)/grazoprevir (200 mg en gang dagligt)
Sofosbuvir (400 mg single dose sofosbuvir)/ elbasvir (50 mg once daily)/ grazoprevir (200 mg once daily
Er du i tvivl, så spørg lægen eller apotekspersonalet.
If you have any questions about your medicines, please ask your doctor or pharmacist.
(600 mg intravenøs enkeltdosis)/grazoprevir (200 mg enkeltdosis)
(600 mg IV single dose)/ grazoprevir (200 mg single dose)
Begge forsøgspersoner, som ikke opnåede SVR af andre årsager end virologisk svigt, havde HCV-RNA ≤800.000 IE/ml ved baseline.
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.
• EBR* + GZR* i 12 uger (N=14)
• EBR* + GZR* for 12 weeks (N=14)
(kombination af OATP1B- og CYP3Ahæmning)
(combination of OATP1B and CYP3A inhibition)
Atorvastatin (20 mg enkeltdosis)/grazoprevir (200 mg en gang dagligt)
Atorvastatin (20 mg single dose)/ grazoprevir (200 mg once daily)
Rilpivirin (25 mg en gang dagligt)/elbasvir (50 mg en gang dagligt)/grazoprevir (200 mg en gang dagligt)
Rilpivirine (25 mg once daily)/ elbasvir (50 mg once daily)/ grazoprevir (200 mg once daily)
Sevelamercarbonat (2.400 mg enkeltdosis)/elbasvir (50 mg enkeltdosis)/grazoprevir (100 mg enkeltdosis)
Sevelamer carbonate (2,400 mg single dose)/ elbasvir (50 mg single dose)/ grazoprevir (100 mg single dose)
(300 mg en gang dagligt)/elbasvir (50 mg en gang dagligt)/grazoprevir (100 mg en gang dagligt)
(300 mg once daily)/elbasvir (50 mg once daily)/grazoprevir (100 mg once daily)
Der er 2 x 7 stk. aluminiumblisterkort i hvert blisteromslag, hvilket giver i alt 28 tabletter.
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.
Disse ændringer er ikke klinisk relevante, og dosisjustering af elbasvir/grazoprevir på basis af alder anbefales derfor ikke (se pkt.
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).
GT 1 TE med HCVproteasehæmmerregime med eller uden cirrose
GT 1 TE with HCV protease inhibitor regimen
Mycophenolatmofetil (1.000 mg enkeltdosis)/elbasvir (50 mg en gang dagligt)/grazoprevir (200 mg en gang dagligt)
Mycophenolate mofetil (1,000 mg single dose)/ elbasvir (50 mg once daily)/ grazoprevir (200 mg once daily)
Midazolam (2 mg enkeltdosis)/grazoprevir (200 mg en gang dagligt)
Midazolam (2 mg single dose)/ grazoprevir (200 mg once daily)
Rosuvastatin (10 mg enkeltdosis)/grazoprevir (200 mg en gang dagligt)
Rosuvastatin (10 mg single dose)/ grazoprevir (200 mg once daily)
Pitavastatin (1 mg enkeltdosis)/grazoprevir (200 mg en gang dagligt)
Pitavastatin (1 mg single dose)/ grazoprevir (200 mg once daily)
Tal med lægen, før du tager dette lægemiddel, hvis du er på en diæt med lavt natriumindhold.
Talk to your doctor before taking ZEPATIER if you are breast-feeding.
4.2) Tidligere behandlingssvigt med boceprevir, telaprevir eller simeprevir i kombination med peg-IFN + RBV
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
(300 mg en gang dagligt)/ritonavir (100 mg en gang dagligt/grazoprevir (200 mg en gang dagligt)
(300 mg once daily)/ ritonavir (100 mg once daily/ grazoprevir (200 mg once daily)
Forsøgspersoner uden NS3polymorfismer ved baseline % (n/N)
Subjects without baseline NS3 polymorphisms, % (n/N)
Med cirrose
Cirrhotic
• EBR* + GZR* + RBV† i 8, 12 eller 18 uger (N= hhv.
• EBR* + GZR* + RBV† for 8, 12, or 18 weeks (N=60, 152, and 65, respectively)
(dels på grund af OATP1B- og CYP3A-hæmning)
(due in part to OATP1B and CYP3A inhibition)
Tacrolimus (2 mg enkeltdosis)/elbasvir (50 mg en gang dagligt)/ grazoprevir (200 mg en gang dagligt)
Tacrolimus (2 mg single dose)/ elbasvir (50 mg once daily)/ grazoprevir (200 mg once daily)
(10 mg enkeltdosis)/elbasvir (50 mg en gang dagligt)/grazoprevir (200 mg en gang dagligt)
(10 mg single dose)/ elbasvir (50 mg once daily) / grazoprevir (200 mg once daily)
(300 mg en gang dagligt)/grazoprevir (200 mg en gang dagligt)
(300 mg once daily)/ grazoprevir (200 mg once daily)
Brug af anden medicin sammen med ZEPATIER Fortæl altid lægen eller apotekspersonalet, hvis du tager anden medicin eller har gjort det for nylig.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
HIV-ANTIVIRALE MIDLER: INTEGRASEHÆMMERE (AF GENOMOVERFØRSEL)
HIV ANTIVIRAL AGENTS: INTEGRASE STRAND TRANSFER INHIBITORS
Uden cirrose
‡ with or without cirrhosis
Det skal du vide, før du begynder at tage ZEPATIER Sådan skal du tage ZEPATIER Bivirkninger
What ZEPATIER is and what it is used for What you need to know before you take ZEPATIER How to take ZEPATIER
Forsøgspersoner med NS3polymorfismer ved baseline % (n/N)
Subjects with baseline NS3 polymorphisms, % (n/N)
(600 mg to gange dagligt)/ritonavir (100 mg to gange dagligt/grazoprevir (200 mg en gang dagligt)
(600 mg twice daily)/ ritonavir (100 mg twice daily/ grazoprevir (200 mg once daily)
ANTIMYKOTIKA
ANTIARRHYTHMICS
Ciclosporin (400 mg enkeltdosis)/elbasvir (50 mg en gang dagligt)/grazoprevir (200 mg en gang dagligt)
Ciclosporin (400 mg single dose)/ elbasvir (50 mg once daily)/ grazoprevir (200 mg once daily)
(400 mg to gange dagligt)/ritonavir (100 mg to gange dagligt/grazoprevir (200 mg en gang dagligt)
(400 mg twice daily)/ ritonavir (100 mg twice daily/ grazoprevir (200 mg once daily)
Forsøgspersoner uden NS5Apolymorfismer ved baseline, % (n/N)
Subjects without baseline NS5A polymorphisms, % (n/N)
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.
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).
Dolutegravir (50 mg enkeltdosis)/elbasvir (50 mg en gang dagligt)/grazoprevir (200 mg en gang dagligt)
Dolutegravir (50 mg single dose)/ elbasvir (50 mg once daily)/ grazoprevir (200 mg once daily)
(600 mg en gang dagligt)/grazoprevir (200 mg en gang dagligt)
(600 mg once daily)/ grazoprevir (200 mg once daily)
Gentagelse af behandling
Retreatment
(400 mg to gange dagligt)/grazoprevir (200 mg en gang dagligt)
(400 mg twice daily)/ grazoprevir (200 mg once daily)
(OATP1B-hæmning og CYP3Ainduktion)
(OATP1B inhibition and CYP3A induction)
Pravastatin (40 mg enkeltdosis)/elbasvir (50 mg en gang dagligt)/grazoprevir (200 mg en gang dagligt)
Pravastatin (40 mg single dose)/ elbasvir (50 mg once daily)/ grazoprevir (200 mg once daily)
Prednison (40 mg enkeltdosis)/elbasvir (50 mg en gang dagligt)/grazoprevir (200 mg en gang dagligt)
Prednisone (40 mg single dose)/ elbasvir (50 mg once daily)/ grazoprevir (200 mg once daily
(600 mg oral enkeltdosis)/grazoprevir (200 mg en gang dagligt)
(600 mg PO single dose)/ grazoprevir (200 mg once daily)
Forsøgspersoner med NS5Apolymorfismer ved baseline, % (n/N)
Subjects with baseline NS5A polymorphisms, % (n/N)
Population
Gender
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.
The highest dose of grazoprevir was 1,000 mg once daily for 10 days, and a single dose of 1,600 mg.
Pruritus, alopeci
• muscle aches
Undgå kontakt med øjnene.
Avoid contact with eyes.
En hvid suspension.
A white suspension.
• Tag en pipette ud af æsken.
• Take out one pipette from the box.
Bør ikke anvendes hos hunde med generaliseret demodecose.
Do not use in dogs with generalised demodecosis.
ATCvet-kode: QS02 CA03
ATCvet code: QS02CA03.
I sådanne tilfælde bør behandlingen stoppes.
In this case, treatment should be stopped.
Tryk forsigtigt men fast på midten af pipettens krop.
Squeeze gently but firmly in the middle of the body of the pipette.
Brug ikke dette veterinærlægemiddel efter den udløbsdato, der står på etiketten efter EXP.
Do not use this veterinary medicinal product after the expiry date, which is stated on the label.
Må kun anvendes i overensstemmelse med den ansvarlige dyrlæges vurdering af benefit-risk forholdet.
Use only accordingly to the benefit-risk assessment by the responsible veterinarian.
DATO FOR FØRSTE TILLADELSE/FORNYELSE AF TILLADELSEN Dato for første markedsføringstilladelse:20/11/2008
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 20/11/2008.
ins 1 dosis / øre / dag i 5 dage
1 dose / ear / day for 5 days
4.10 Overdosering (symptomer, nødforanstaltninger, modgift), om nødvendigt ins 1 dosis / øre / dag i 5 dage
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary ins1 dose / ear / day for 5 days
• For at åbne: hold pipetten lodret og knæk den øverste del af kanylen.
• To open: hold up the pipette upright and break the top of the cannula.
Eftersom mange bakterielle stammer kan være involveret i betændelse i øregangen hos hunde, kan resistensmekanismerne variere.
Since many bacterial strains may be involved in otitis externa in dogs, the mechanisms of resistance can vary.
Interaktion med andre lægemidler og andre former for interaktion: Der er ikke fastlagt kompatibilitet med ørerens.
Interaction with other medicinal products and other forms of interaction: Compatibility with ear cleaners has not been demonstrated.
Diesterne omdannes i hudens struktur til C17 monoester, der er ansvarlige for potensen af den terapeutiske klasse.
The diesters are transformed inside the skin structures in C17 monoesters responsible for the potency of the therapeutic class.
Som præsenteret gør produktet det muligt at behandle hunde, der lider af bilateral øregangsbetændelse.
The product as presented allows treating a dog suffering from bilateral otitis.
Hos hunde, der blev behandlet med den terapeutiske dosis i ti sammenhængende dage, faldt niveauet af serum-cortisol fra dag fem og derefter og vendte tilbage til normale værdier indenfor ti dage efter endt behandling.
In dogs treated at the therapeutic dose for ten consecutive days, serum cortisol levels decreased from five days onward and returned to normal values within ten days after the end of treatment.
Den luftløse pumpe gør det muligt at dosere præparatet uanset flaskens position.
The airless pump allows the product to be administered whatever the position of the bottle is.
I alle tilfælde fortsatte behandlingen med veterinærlægemidlet og alle hunde blev raske uden særlig behandling.
In all cases, treatment with the veterinary medicinal product was not discontinued and all dogs recovered without any specific therapy.
Uanset hundens størrelse
Whatever the size
Let til moderat rødme i øret er hyppig (2,4 % af de behandlede hunde).
Mild to moderate redness of the ear was common (2.4% of treated dogs).
Uanset flaskens position
Whatever the position
• Ryst pipetten grundigt før brug.
• Shake the pipette thoroughly before use.
Se afsnit 4.5 i produktresuméet.
See section 4.5 of the SPC.
FREMSTILLERENS BATCHNUMMER Lot
MANUFACTURER'S BATCH NUMBER Lot {number}
[Enkeltdosisbeholder:]
[Single-dose container:]
Diestererne er fedtopløselige komponenter, der sikrer en forbedret penetration gennem huden sammen med lavere systemisk biotilgængelighed.
The diesters are lipophilic components ensuring an enhanced penetration into the skin associated with low systemic bioavailability.
Gentamicin er kendt for at være forbundet med ototoxicitet når det anvendes systemisk i højere doser.
Gentamicin is known to be associated with ototoxicity when administered by the systemic route at higher doses.
Alle isolerede Escherichia coli var fuldt modtagelige for gentamicin.
All Escherichia coli isolates were fully susceptible to gentamicin.
Flydende paraffin.
Liquid paraffin.
Papeldannelse er sjælden (mindre end 1 % af de behandlede hunde).
Papules were observed uncommonly (less than 1% of treated dogs).