natgillin/translations-raw huggingface dataset:
I et ikke- sammenlignende studie fik 235 patienter med genotype 1 og lav virusmængde (< 600. 000 IU/ ml) PegIntron 1, 5 mikrogram/ kg subkutant en gang ugentlig i kombination med vægtjusteret ribavarin.
In a non-comparative trial, 235 patients with genotype 1 and low viral load (< 600,000 IU/ml) received PegIntron, 1.5 microgram/kg subcutaneously, once weekly, in combination with weight adjusted ribavirin.
Den totale vedvarende responsrate efter en 24 ugers behandlingsperiode var 50%.
The overall sustained response rate after a 24-week treatment duration was 50%.
Enogfyrre procent af forsøgspersonerne (97/ 235) havde plasma HCV- RNA niveauer under detektionsgrænsen ved behandlingens uge 4 og uge 24.
Forty-one percent of subjects (97/235) had nondetectable plasma HCV-RNA levels at Week 4 and Week 24 of therapy.
I denne undergruppe af patienter var der 92% (89/ 97) med vedvarende virologisk responsrate.
In this subgroup, there was a 92% (89/97) sustained virological response rate.
Begrænsede historiske data indikerer, at behandling i 48 uger kan være forbundet med en højere vedvarende responsrate (11/ 11) og en lavere risiko for relaps (0/ 11 i sammenligning med 7/ 96 efter 24 ugers behandling).
Limited historical data indicate that treatment for 48 weeks might be associated with a higher sustained response rate (11/11) and with a lower risk of relapse (0/11 as compared to 7/96 following 24 weeks of treatment).
Forudsigelighed med hensyn til vedvarende virologisk respons - Naive patienter Virologisk repons ved uge 12, defineret som en 2- log reduktion af virusmængden eller ikke påviselige værdier for HCV RNA, er vist som værende prædiktiv for vedvarende respons (se Tabel 8).
Predictability of sustained virological response – Naïve patients Virological reponse by week 12, defined as a 2-log viral load decrease or undetectable levels of HCV- RNA has been shown to be predictive for sustained response (Table 8).
Tabel 8
17 Table 8
Forudsigelighed med hensyn uge 12 og genotype *
Predictability of
til vedvarende respons efter viralt respons ved
sustained response by viral response at week 12 and genotype*
Behandling PegIntron 1, 5
Treatment PegIntron 1.5 + ribavirin (> 10.6 mg/kg) 48-week treatment PegIntron 1.5 +
Genotype
Genotype
Viralt respons ved Vedvarende respons Negativ uge 12 prædiktiv værdi
Viral response Sustained response Negative predictive value at week 12 1 Yes 75% (82/110) 71% (58/82) ---- No 25% (28/110) 0% (0/28) 100%
+ribavirin 800 – 1. 400 mg 24- ugers behandling
ribavirin 800-1,400 mg
Ja 99% (213/ 215) 83% (177/ 213) ---- Nej 1% (2/ 215) 50% (1/ 2) 50%
Yes 99% (213/215) 83% (177/213)
* viser patienter med 12 ugers resultat tilgængeligt
24-week treatment
Den negative prædiktive værdi for vedvarende respons hos patienter behandlet med PegIntron i monoterapi var 98%.
The negative predictive value for sustained response in patients treated with PegIntron in monotherapy was 98%.
Samtidig infektion med HCV/ HIV 18 Der har været udført to undersøgelser hos patienter med samtidig infektion af HCV og HIV.
HCV/HIV Co-infected patients Two trials have been conducted in patients co-infected with HIV and HCV.
Respons til behandlingen i begge af disse undersøgelser er repræsenteret i Tabel 9.
The response to treatment in both of these trials is presented in Table 9.
Patienterne blev randomiseret til enten at modtage PegIntron (1, 5 μg/ kg/ uge) plus ribavirin (800 mg/ dag) eller interferon alfa- 2b (3 MIE TIW) plus ribavirin (800 mg/ dag) i 48 uger med en opfølgningsperiode på 6 måneder.
Patients were randomized to receive either PegIntron (1.5 µg/kg/week) plus ribavirin (800 mg/day) or interferon alfa-2b (3 MIU TIW) plus ribavirin (800 mg/day) for 48 weeks with a follow-up period of 6 months.
Undersøgelse 2 (P02080) var en randomiseret, enkelt centerundersøgelse, der omfattede 95 tidligere ubehandlede voksne patienter med kronisk hepatitis C, der samtidig var inficeret med HIV.
Study 2 (P02080) was a randomized, single centre study that enrolled 95 previously untreated adult patients with chronic hepatitis C who were co- infected with HIV.
Patienterne blev randomiseret til enten at modtage PegIntron (100 eller 150 μg/ uge baseret på vægt) plus ribavirin (800- 1. 200 mg/ dag baseret på vægt) eller interferon alfa- 2b (3 MIE TIW) plus ribavirin (800- 1. 200 mg/ dag baseret på vægt).
Patients were randomized to receive either PegIntron (100 or 150 µg /week based on weight) plus ribavirin (800-1,200 mg/day based on weight) or interferon alfa-2b (3 MIU TIW) plus ribavirin (800-1,200 mg/day based on weight).
Behandlingsvarigheden var 48 uger med en opfølgningsperiode på 6 måneder med undtagelse af patienter, der var inficeret med genotyper 2 og 3 og viral load < 800. 000 IU/ ml (Amplicor), som blev behandlet i 24 uger med en 6 måneders opfølgningsperiode.
The duration of therapy was 48 weeks with a follow-up period of 6 months except for patients infected with genotypes 2 or 3 and viral load < 800,000 IU/ml (Amplicor) who were treated for 24 weeks with a 6-month follow-up period.
Tabel 9
18 Table 9
Vedvarende virologisk respons baseret på genotype efter PegIntron i kombination med Ribavirin hos patienter med samtidig infektion af HCV/ HIV Undersøgelse 11 Undersøgelse 22 PegIntron Interferon PegIntron Interferon (100 or alfa- 2b (1, 5 µg/ kg / alfa- 2b 150c µg/ uge) (3 MIE TIW) uge) + (3 MIE TIW) + + ribavirin + ribavirin ribavirin ribavirin p (800 - (800 - p (800 mg) (800 mg) værdia 1. 200 mg) d 1. 200 mg) d værdib
Sustained virological response based on genotype after PegIntron in combination with Ribavirin in HCV/HIV Co-infected patients Study 11 Study 22 PegIntron Interferon PegIntron Interferon (100 or alfa-2b (1.5 µg/kg/ alfa-2b 150c µg/week) (3 MIU TIW) week) + (3 MIU TIW) + + ribavirin + ribavirin
Alle Genotype 1, 4
All Genotype 1, 4
27% (56/ 205) 20% (41/ 205) 0, 047 44% (23/ 52) 21% (9/ 43) 0, 017 17% (21/ 125) 6% (8/ 129) 0, 006 38% (12/ 32) 7% (2/ 27) 0, 007
(41/205) 0.047 44% (23/52) 6% (8/129) 0.006 38% (12/32)
Genotype 2, 3
Genotype 2, 3
44% (35/ 80) 43% (33/ 76) 0, 88 53% (10/ 19) 47% (7/ 15)
53% (10/19)
MIE = millioner internationale enheder; TIW = tre gange ugentlig. a: p værdi baseret på Cochran- Mantel Haenszel Chi square test. b: p værdi baseret på chi- square test. c: forsøgspersoner < 75 kg fik 100 µg/ uge PegIntron og forsøgspersoner ≥ 75 kg fik 150 µg/ uge PegIntron. d: ribavirin dosis var 800 mg for patienter < 60 kg, 1. 000 mg for patienter 60- 75 kg, og 1. 200 mg for patienter > 75 kg.
MIU = million international units; TIW = three times a week. a: p value based on Cochran-Mantel Haenszel Chi square test. b: p value based on chi-square test. c: subjects < 75 kg received 100 µg/week PegIntron and subjects ≥ 75 kg received 150 µg/week PegIntron. d: ribavirin dosing was 800 mg for patients < 60 kg, 1,000 mg for patients 60-75 kg, and 1,200 mg for patients > 75 kg.
Histologisk respons Leverbiopsier blev indhentet før og efter behandling i Undersøgelse 1 og var tilgængelige for 210 af de 412 forsøgspersoner (51%).
Histological response Liver biopsies were obtained before and after treatment in Study 1 and were available for 210 of the 412 subjects (51%).
Både Metavir score og Ishak graden faldt blandt forsøgspersoner, der blev behandlet med PegIntron i kombination med ribavirin.
Both the Metavir score and Ishak grade decreased among subjects treated with PegIntron in combination with ribavirin.
Dette fald var signifikant blandt de responderende (- 0, 3 for Metavir og - 1, 2 for Ishak) og stabilt (- 0, 1 for Metavir og - 0, 2 for Ishak) blandt de non- responderende.
This decline was significant among responders (-0.3 for Metavir and -1.2 for Ishak) and stable (-0.1 for Metavir and -0.2 for Ishak) among non-responders.
Steatosis var signifikant forbedret hos de patienter, der var inficeret med HCV Genotype 3.
Steatosis was significantly improved in patients infected with HCV Genotype 3.
PegIntron/ ribavirin genbehandling af patienter som ikke har responderet på tidligere behandling 2. 293 patienter i en ikke sammenligningsundersøgelse, som havde moderat til svær fibrose, hvor tidligere behandling med kombinationen af alfa interferon/ ribavirin var uden effekt, blev behandlet med PegIntron givet subkutant (1, 5 mikrogram/ kg/ uge) i kombination med ribavirin baseret på kropsvægt.
PegIntron/ribavirin retreatment of prior treatment failures In a non-comparative trial, 2,293 patients with moderate to severe fibrosis who failed previous treatment with combination alpha interferon/ribavirin were retreated with PegIntron, 1.5 microgram/kg subcutaneously, once weekly, in combination with weight adjusted ribavirin.
At tidligere behandling var uden effekt, blev defineret som værende relaps eller non respons (HCV- RNA positiv ved afslutningen på en 12 ugers behandling).
Failure to prior therapy was defined as relapse or non-response (HCV-RNA positive at the end of a minimum of 12 weeks of treatment).
19 Patienter som var HCV- RNA negative ved afslutningen af en 12 ugers behandling fortsatte behandlingen i alt 48 uger og blev overvåget i de næste 24 uger efter behandlingen var afsluttet.
Patients who were HCV-RNA negative at Treatment Week 12 continued treatment for 48 weeks and were followed for 24 weeks post-treatment.
12 ugers respons på behandlingen blev defineret som ikke målbart HCV- RNA efter 12 ugers behandling.
Response Week 12 was defined as undetectable HCV- RNA after 12 weeks of treatment.
Sustained virologisk respons (SVR) er defineret som ikke målbart HCV- RNA 24 uger efter endt behandling (Tabel 10).
Sustained Virologic Response (SVR) is defined as undetectable HCV-RNA at 24 weeks post-treatment (Table 10).
Tabel 10 Responsrater på genbehandling af patienter som ikke har responderet på tidligere behandling
19 Table 10 Rates of Response to retreatment in prior treatment failures
Patienter med ikke målbart HCV- RNA efter 12 ugers behandling og SVR lige efter genbehandling Samlet
Patients with undetectable HCV–RNA at treatment Week 12 and SVR upon retreatement Overall
Interferon alfa/ ribavirin
interferon alpha/ribavirin
Peginterferon alfa/ ribavirin
peginterferon alpha/ribavirin
population *
Population*
Respons% 12. uge (n/ N)
Response Week 12% (n/N)
Respons% SVR% (n/ N) 12. uge (n/ N) 99% CI
Response SVR% (n/ N) Week 12% 99% CI (n/N)
Overordnet respons Tidligere respons
SVR% (n/N) 99% CI
38, 6 (549/ 1. 423)
Overall Prior Response
59, 4 (326/ 549) 54, 0, 64, 8
38.6 (549/1,423) 59.4 (326/549) 54.0,64.8
31, 5 (272/ 863) 50, 4 (137/ 272) 42, 6, 58, 2
31.5 (272/863) 50.4 (137/272) 42.6, 58.2
21, 7 (497/ 2. 293) 19, 5, 23, 9
21.7 (497/2,293) 19.5, 23.9
59, 6 (121/ 203) 50, 7, 68, 5
67.7 (203/300) 59.6 (121/203) 50.7, 68.5
58, 1 (200/ 344) 52, 5 (105/ 200) 43, 4, 61, 6
58.1 (200/344) 52.5 (105/200) 43.4, 61.6
37, 7 (243/ 645) 32, 8, 42, 6
37.7 (243/645) 32.8, 42.6
Genotype 1/ 4
Genotype 1/4
51, 2 (66/ 129) 39, 8, 62, 5
59.7 (129/216) 51.2 (66/129) 39.8, 62.5
48, 6 (122/ 251) 44, 3 (54/ 122) 32, 7, 55, 8
48.6 (122/251) 44.3 (54/122) 32.7, 55.8
28, 6 (134/ 468) 23, 3, 34, 0
28.6 (134/468) 23.3, 34.0
73, 6 (53/ 72) (60, 2, 87, 0)
73.6 (53/72) (60.2, 87.0)
83, 7 (77/ 92) 64, 9 (50/ 77) 50, 9, 78, 9
64.9 (50/77) 50.9, 78.9
61, 3 (106/ 173) 51, 7, 70, 8
61.3 (106/173) 51.7, 70.8
57, 0 (147/ 258) 49, 0, 64, 9
57.0 (147/258) 49.0, 64.9
12, 4 (59/ 476) 44, 1 (26/ 59) 27, 4, 60, 7
44.1 (26/59) 27.4, 60.7
13, 6 (188/ 1. 385) 11, 2, 15, 9
13.6 (188/1,385) 11.2, 15.9
51, 6 (69/ 182) 42, 1, 61, 2
51.6 (94/182) 42.1, 61.2
9, 9 (44/ 446) 38, 6 (17/ 44) 19, 7, 57, 5
38.6 (17/44) 19.7, 57.5
9, 9 (123/ 1. 242) 7, 7, 12, 1
9.9 (123/1,242) 7.7, 12.1
Genotype 2/ 3 Genotype
Genotype 2/3 Genotype
70, 3 (52/ 74) 56, 6, 84, 0
70.3 (52/74) 56.6, 84.0
53, 6 (15/ 28) 60, 0 (9/ 15) 27, 4, 92, 6
60.0 (9/15) 27.4, 92.6
46, 0 (63/ 137) 35, 0, 57, 0
46.0 (63/ 137) 35.0, 57.0
30, 2 (343/ 1. 135)
30.2 (343/1,135)
51, 3 (176/ 343) 44, 4, 58, 3
51.3 (176/343) 44.4, 58.3
23, 0 (162/ 704) 42, 6 (69/ 162) 32, 6, 52, 6
42.6 (69/162) 32.6, 52.6
14, 6 (270/ 1. 846) 12, 5, 16, 7
14.6 (270/1,846) 12.5, 16.7
73, 0 (135/ 185) 64, 6, 81, 4
73.0 (135/185) 64.6, 81.4
75, 6 (96/ 127) 63, 5 (61/ 96) 50, 9, 76, 2
75.6 (96/127)
4 METAVIR Fibrose score
4 METAVIR Fibrosis score
70, 6 (12/ 17) 42, 1, 99, 1
70.6 (12/17) 42.1, 99.1
44, 4 (12/ 27) 50, 0 (6/ 12) 12, 8, 87, 2
50.0 (6/12) 12.8, 87.2
28, 4 (19/ 67) 14, 2, 42, 5
28.4 (19/67) 14.2, 42.5
66, 8 (129/ 193) 58, 1, 75, 6
66.8 (129/193) 58.1, 75.6
33, 6 (78/ 232) 57, 7 (45/ 78) 43, 3, 72, 1
57.7 (45/78) 43.3, 72.1
29, 2 (191/ 653) 24, 7, 33, 8
29.2 (191/653) 24.7, 33.8
38, 0 (162/ 429)
38.0 (163/429)
62, 6 (102/ 163) 52, 8, 72, 3
62.6 (102/163) 52.8, 72.3
32, 4 (78/ 241) 51, 3 (40/ 78) 36, 7, 65, 9
51.3 (40/78) 36.7, 65.9
21, 9 (147/ 672) 17, 8, 26, 0
21.9 (147/672) 17.8, 26.0
F4 Baseline virus mængder
F4 Baseline Viral Load
49, 5 (95/ 192) 40, 2, 58, 8
49.5 (95/192) 40.2, 58.8
29, 7 (116/ 390) 44, 8 (52/ 116) 32, 9, 56, 7
44.8 (52/116) 32.9, 56.7
HVL (< 600. 000 IU/ ml)
HVL (> 600,000 IU/ml)
56, 1 (157/ 280) 48, 4, 63, 7
56.1 (157/280) 48.4, 63.7
41, 4 (63/ 152) 31, 2, 51, 7
41.4 (63/152) 31.2, 51.7
16, 6 (239/ 1. 441) 14, 1, 19, 1
16.6 (239/1,441) 14.1, 19.1
LVL (≤600. 000 48, 3 (269/ 557) IU/ ml)
LVL (≤600,000 IU/ml)
62, 8 (169/ 269) 55, 2, 70, 4
62.8 (169/269) 55.2, 70.4
61, 0 (72/ 118) 49, 5, 72, 6
61.0 (72/118) 49.5, 72.6
30, 2 (256/ 848) 26, 1, 34, 2
30.2 (256/848) 26.1, 34.2
Non- responders defineres som serum/ plasma HCV- RNA positive ved afslutning af mindst 12 ugers behandling.
Non-responder defined as serum/plasma HCV-RNA positive at the end of a minimum of 12 weeks of treatment.
HCV- RNA serum måles ved et videnskabeligt baseret kvantitativ polymerase kæde reaktions assay på et central laboratorium
Plasma HCV-RNA is measured with a research-based quantitative polymerase chain reaction assay by a central laboratory *Intent to treat population includes 7 patients for whom at least 12 weeks of prior therapy could not be confirmed.
36% (821/ 2. 286) af patienterne ikke målbart HCV- RNA plasma niveau i den 12. behandlings uge, målt ved hjælp af en videnskabelig baseret test (detektionsgrænse 125 IE/ ml).
20 Overall, approximately 36% (821/2,286) of patients had undetectable plasma HCV-RNA levels at Week 12 of therapy measured using a research-based test (limit of detection 125 IU/ml).
I denne undergruppe opretholdt 56% (463/ 823) den virologiske respons rate.
In this subgroup, there was a 56% (463/823) sustained virological response rate.
For patienter som tidligere har været behandlet med ikke- pegyleret interferon eller pegyleret interferon og som har været negative i 12. behandlings uge, var den fortsatte responsrate henholdsvis 59% og 50%.
For patients with prior failure on therapy with nonpegylated interferon or pegylated interferon and negative at Week 12, the sustained response rates were 59% and 50%, respectively.
Blandt 480 patienter med > 2 log viral reduktion, men målbar virus i uge 12, fortsatte sammenlagt 188 patienter behandlingen.
Among 480 patients with > 2 log viral reduction but detectable virus at Week 12, altogether 188 patients continued therapy.
Hos disse patienter var SVR 12%.
In those patients the SVR was 12%.
Non- responders som tidligere havde fået behandling med pegyleret interferon alfa/ ribavirin, var mindre tilbøjelige til at respondere i 12. uge på genbehandling end non- responders på ikke pegyleret interferon alfa/ ribavirin (12, 4% versus 28, 6%).
28.6%).
Hvis respons i 12. uge imidlertid var opnået, var der en lille forskel i SVR uanset tidligere behandling eller tidligere respons.
However, if a Week 12 response was achieved, there was little difference in SVR regardless of prior treatment or prior response.
Langtidsvirkningsfulde data En stor undersøgelse med langtidsopfølgning inkluderede 567 patienter efter behandling i en tidligere undersøgelse med PegIntron (med eller uden ribavirin).
Long-Term efficacy data A large long-term follow-up study enrolled 567 patients after treatment in a prior study with PegIntron (with or without ribavirin).
327 patienter fuldførte mindst 5 års langtidsopfølgning og kun 3 ud af 366 vedvarende responders fik tilbagefald under undersøgelsen.
327 patients completed at least 5 years of long-term follow-up and only 3 out of 366 sustained responders relapsed during the study.
Kaplan- Meier estimatet for fortsat vedvarende respons over 5 år for alle patienter er 99% (95% CI:
The Kaplan-Meier estimate for continued sustained response over 5 years for all patients is 99% (95% CI:
SVR resulterer, efter behandling af kronisk HCV med PegIntron (med eller uden ribavirin, i langtidsclearence af virus og giver resolution af den hepatiske infektion og klinisk ” helbredelse ” af kronisk HCV.
SVR after treatment of chronic HCV with PegIntron (with or without ribavirin) results in long-term clearance of the virus providing resolution of the hepatic infection and clinical “cure” from chronic HCV.
Dette udelukker imidlertid ikke forekomsten af hepatiske tilfælde hos patienter med cirrhose (inklusive hepatocarcinom).
However, this does not preclude the occurrence of hepatic events in patients with cirrhosis (including hepatocarcinoma).
PegIntron er et velkarakteriseret polyethylenglycol- modificeret (“ pegyleret ”) derivat af interferon alfa - 2b og består hovedsageligt af monopegylerede sorter.
PegIntron is a well characterized polyethylene glycol-modified (“pegylated”) derivative of interferon alfa-2b and is predominantly composed of monopegylated species.
Plasmahalveringstiden af PegIntron er forlænget i sammenligning med ikke- pegyleret interferon alfa- 2b.
The plasma half-life of PegIntron is prolonged compared with non-pegylated interferon alfa-2b.
PegIntron har et potentiale for at depegylere til frit interferon alfa- 2b.
PegIntron has a potential to depegylate to free interferon alfa-2b.
Den biologiske aktivitet af de pegylerede isomere er kvalitativt den samme, men svagere end frit interferon alfa- 2b.
The biologic activity of the pegylated isomers is qualitatively similar, but weaker than free interferon alfa-2b.
Efter subkutan indgift forekommer maksimale serumkoncentrationer mellem 15- 44 timer efter dosis, og vedvarer i op til 48- 72 timer efter dosis.
Following subcutaneous administration, maximal serum concentrations occur between 15-44 hours post-dose, and are sustained for up to 48-72 hours post-dose.
PegIntron Cmax og AUC målinger stiger på en dosis- relateret måde.
PegIntron Cmax and AUC measurements increase in a dose-related manner.
Gennemsnitlig påviselig fordelingsvolumen er 0, 99 l/ kg.
Mean apparent volume of distribution is 0.99 l/kg.
Efter flere doser er der en akkumulering af immunoreaktive interferoner.
Upon multiple dosing, there is an accumulation of immunoreactive interferons.
Der er imidlertid kun en beskeden stigning i biologisk aktivitet målt ved en bioassay.
There is, however, only a modest increase in biologic activity as measured by a bioassay.
Gennemsnitlig (standard deviation) PegIntron eliminationshalveringstid er cirka 40 timer (13, 3 timer) med påviselig clearance på 22, 0 ml/ time· kg.
Mean (SD) PegIntron elimination half-life is approximately 40 hours (13.3 hours), with apparent clearance of 22.0 ml/hr·kg.
Renal elimination kan imidlertid forklare en mindre del (cirka 30%) af PegIntron påviselig udskillelse.
However, renal elimination may account for a minority (approximately 30%) of PegIntron apparent clearance.
Renal udskillelse synes at være ansvarlig for 30% af total clearance af PegIntron.
Renal clearance appears to account for 30% of total clearance of Peg Intron.
I en enkeltdosisundersøgelse (1, 0 mikrogram/ kg) hos patienter med nedsat nyrefunktion, steg Cmax, AUC og halveringstiden i forhold til graden af nyrefunktionsforringelsen.
In a single dose study (1.0 microgram/kg) in patients with impaired renal function, Cmax, AUC, and half- life increased in relation to the degree of renal impairment.
Efter gentagne doser af PegIntron (1, 0 mikrogram/ kg indgivet subkutant hver uge i fire uger) reduceres clearance af PegIntron med gennemsnitlig 17% hos patienter med moderat nedsat nyrefunktion (creatinin clearance 30- 49 ml/ minut) og med gennemsnitlig 44% hos patienter med kraftigt nedsat nyrefunktion (creatinin clearance 15- 29 ml/ minut) sammenlignet med personer med 21 normal nyrefunktion.
Following multiple dosing of PegIntron (1.0 microgram/kg subcutaneously administered every week for four weeks) the clearance of PegIntron is reduced by a mean of 17% in patients with moderate renal impairment (creatinine clearance 30-49 ml/minute) and by a mean of 44% in patients with severe renal impairment (creatinine clearance 15-29 ml/minute) compared to subjects with normal renal function.
Baseret på resultater med enkeltdosis var clearance den samme hos patienter med kraftigt nedsat nyrefunktion uden dialyse som hos patienter, der fik hæmodialyse.
The dose of PegIntron
Dosen af PegIntron i monoterapi bør reduceres hos patienter med moderat eller kraftigt nedsat nyrefunktion (se pkt.
21 for monotherapy should be reduced in patients with moderate or severe renal impairment (see sections 4.2 and 4.4).
4. 3).
Patients with creatinine clearance < 50 ml/minute must not be treated with PegIntron in combination with ribavirin (see section 4.3).
4. 2)
Because of marked inter-subject variability in interferon pharmacokinetics, it is recommended that patients with severe renal impairment be closely monitored during treatment with PegIntron (see section 4.2)
Ældre patienter ≥ 65 år:
Elderly patients ≥ 65 years of age:
Farmakokinetikken for PegIntron efter en enkelt subkutan dosis på 1, 0 mikrogram/ kg var ikke påvirket af alder.
The pharmacokinetics of PegIntron following a single subcutaneous dose of 1.0 microgram/kg were not affected by age.
Patienter under 18 år:
Patients under the age of 18 years:
Der er ikke foretaget specifikke farmakokinetiske undersøgelser med disse patienter.
Specific pharmacokinetic evaluations have not been performed on these patients.
PegIntron er kun indiceret til behandling af kronisk hepatitis C i patienter som er 18 år eller ældre.
PegIntron is indicated for the treatment of chronic hepatitis C only in patients 18 years of age or older.
Interferon neutraliserende faktorer:
Interferon neutralising factors:
Interferon neutraliserende faktor analyser blev udført på serum prøver fra patienter, som fik PegIntron i den kliniske undersøgelse.
Interferon neutralising factor assays were performed on serum samples of patients who received PegIntron in the clinical trial.
Interferon neutraliserende factorer er antistoffer, som neutraliserer den antivirale aktivitet af interferon.
Interferon neutralising factors are antibodies which neutralise the antiviral activity of interferon.
Den kliniske forekomst af neutraliserende faktorer hos patienter, der fik PegIntron 0, 5 mikrogram/ kg er 1, 1%.
The clinical incidence of neutralising factors in patients who received PegIntron 0.5 micrograms/kg is 1.1%.
Disse studier var begrænset til fire uger på grund af fremkomsten af anti- interferon antistoffer hos de fleste aber.
These studies were limited to four weeks due to the appearance of anti-interferon antibodies in most monkeys.
Reproduktionsundersøgelser er ikke foretaget med PegIntron.
Reproduction studies of PegIntron have not been performed.
Interferon alfa- 2b er vist at være abortfremkaldende i primater.
Interferon alfa-2b has been shown to be an abortifacient in primates.
PegIntron anses for sandsynligvis også at forårsage denne virkning.
PegIntron is likely to also cause this effect.
4. 6 for relevante humane data om graviditet og amning).
It is not known whether the components of this medicinal product are excreted into experimental animal or human milk (see section 4.6 for relevant human data on pregnancy and lactation).