natgillin/translations-raw huggingface dataset:
I PegIntron monoterapiundersøgelsen var livskvaliteten generelt mindre påvirket ved 0, 5 mikrogram/ kg PegIntron end ved enten 1, 0 mikrogram/ kg PegIntron en gang om ugen eller 3 MIE interferon alfa- 2b tre gange om ugen.
In the PegIntron monotherapy study, the Quality of Life was generally less affected by 0.5 microgram/kg of PegIntron than by either 1.0 microgram/kg of PegIntron once weekly or 3 MIU of interferon alfa-2b three times a week.
40 behandling
All Subjects
* Enhver patient med et ikke målbart HCV- RNA niveau ved besøget i opfølgningsuge 12 og manglende resultater ved besøget i opfølgningsuge 24 blev betragtet som vedvarende responder.
* Any subject with an undetectable HCV-RNA level at the Follow-Up Week 12 visit and missing data at the Follow- Up Week 24 visit was considered a sustained responder.
Tabel 8
40 Table 8
Forudsigelighed med hensyn uge 12 og genotype *
Predictability of sustained response by viral response at week 12 and genotype*
til vedvarende respons efter viralt respons ved
Treatment PegIntron 1.5 + ribavirin (> 10.6 mg/kg) 48-week treatment PegIntron 1.5 + ribavirin 800-1,400 mg
Viralt respons ved Vedvarende respons Negativ uge 12 prædiktiv værdi
Genotype 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% 2 and 3 Yes 99% (213/215) 83% (177/213) ----
+ribavirin (> 10, 6 mg/ kg) 48- ugers behandling PegIntron 1, 5
24-week treatment
Ja 75% (82/ 110) 71% (58/ 82) ---- Nej 25% (28/ 110) 0% (0/ 28) 100%
No 1% (2/215) 50% (1/2) 50%
+ribavirin 800 – 1. 400 mg 24- ugers behandling
* reflects patients
* viser patienter med 12 ugers resultat tilgængeligt
with 12 week data available
Samtidig infektion med HCV/ HIV 41 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.
Undersøgelse 1 (RIBAVIC; P01017) var en randomiseret, multicenterundersøgelse, der omfattede 412 tidligere ubehandlede voksne patienter med kronisk hepatitis C, der samtidig var inficeret med HIV.
Study 1 (RIBAVIC; P01017) was a randomized, multicentre study which enrolled 41 2 previously untreated adult patients with chronic hepatitis C who were co-infected with HIV.
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 6month follow-up period.
Tabel 9
41 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 res ponse 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
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 Peg Intron in combination with ribavirin.
42 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.
Tabel 10 Responsrater på genbehandling af patienter som ikke har responderet på tidligere behandling
42 Table 10 Rates of Response to retreatment in prior treatment failures
Respons% SVR% (n/ N) 12. uge (n/ N) 99% CI
Response SVR% (n/N) Week 12% 99% CI (n/N)
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
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).
43 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).
Renal udskillelse synes at være ansvarlig for 30% af total clearance af PegIntron.
Renal clearance appears to account for 30% of total clearance of PegIntron.
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 44 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.
Dosen af PegIntron i monoterapi bør reduceres hos patienter med moderat eller kraftigt nedsat nyrefunktion (se pkt.
44 for monotherapy should be reduced in patients with moderate or severe renal impairment (see sections 4.2 and 4.4).
Vand til injektionsvæsker.
45 Water for injections.
PegIntron 80 mikrogram leveres som:
PegIntron 80 micrograms is supplied as:
PegIntron leveres som et pulver peginterferon alfa- 2b i en styrke på 80 mikrogram til éndosis brug.
PegIntron is supplied as a powder of peginterferon alfa-2b at a strength of 80 micrograms for single use.
Den tilberedte opløsning har en koncentration på 80 mikrogram/ 0, 5 ml.
The reconstituted solution has a concentration of 80 micrograms/0.5 ml.
46 Som ved alle parenterale lægemidler, inspicer visuelt den tilberedte opløsning før indgift.
As for all parenteral medicinal products, inspect visually the reconstituted solution prior to administration.
Hvert hætteglas PegIntron, pulver til injektionsvæske, opløsning, indeholder 100 mikrogram peginterferon alfa- 2b målt på proteinbasis.
Each vial of PegIntron, powder for solution for injection contains 100 micrograms of peginterferon alfa- 2b as measured on a protein basis.
Hvert hætteglas giver 100 mikrogram/ 0, 5 ml peginterferon alfa- 2b efter tilberedning som anbefalet.
Each vial provides 100 micrograms/0.5 ml of peginterferon alfa-2b when reconstituted as recommended.
5. 1. * produceret ved hjælp af rDNA teknologi i E. coli celler indeholdende et genetisk fremstillet plasmahybrid med et interferon alfa- 2b gen fra humane leukocytter
For more information, see section 5.1. *produced by rDNA technology in E.coli cells harbouring a genetically engineered plasmid hybrid encompassing an interferon alfa-2b gene from human leukocytes
48 Kombinationsbehandling PegIntron 1, 5 mikrogram/ kg/ uge i kombination med ribavirin kapsler.
48 Combination therapy PegIntron 1.5 micrograms/kg/week in combination with ribavirin capsules.
Forudsigelighed af respons og non- respons ved HCV/ HIV co- infektion Tidlig virologisk respons i Uge 12, defineret som et 2 log viralt fald i load eller ikke- detekterbare niveauer af HCV- RNA, har vist sig at være forudsigeligt for et vedvarende respons.
Early virological response by Week 12, defined as a 2 log viral load decrease or undetectable levels of HCV-RN A, has been shown to be predictive for sustained response.
49 forudsigelig værdi på 50% (52/ 104; Undersøgelse 1) blev observeret for HCV/ HIV co- inficerede patienter, der modtog kombinationsbehandling.
A positive predictive value of 50% (52/104; Study 1) was observed for HCV/HIV co-infected patients receiving combination therapy.
Behandlingsvarighed – Genbehandling Forudsigelighed af vedvarende virologisk respons:
49 Duration of treatment - Retreatment Predictability of sustained virological response:
50 Kombinationsbehandling - vejledninger for dosisreduktion
50 Combination Therapy Dose Reduction Guidelines
< 25 x 109/ l 2, 5 x ULN ** > 4 mg/ dl (i > 4 uger)
< 25 x 109/l 2.5 x ULN** > 4 mg/dl (for > 4 weeks)
< 40
(μ g/0.5 ml)
25
(ml)
50 *
(μg)
0, 25
< 40
40- 50
50*
32
0.25
50
25
0, 3
40- 50
30
32
40 50 60
50
50 50 80
0.3
40 50 64
30
> 85
51-64 65-75 76-85 > 85
75
40 50 60 75
51 Tabel 3a Dosisjusteringsvejledninger for PegIntron monoterapi Laboratorieværdier
Table 3a Dose modification guidelines for PegIntron monotherapy
Dosisreduktion hos patienter, som anvender PegIntron 0, 5 μg/ kg som monoterapi, skal ske ved at reducere det foreskrevne volumen med halvdelen.
51 Dose reduction for patients who use 0.5 μg/kg PegIntron monotherapy must be accomplished by reducing the prescribed volume by one-half.
30- 35
(μ g/0.5ml)
52 Anvendelse ved nedsat leverfunktion:
Use in hepatic impairment:
for et eller flere af hjælpestofferne;
52
Hvis en sådan reaktion udvikles 53 under behandling med PegIntron, seponer behandlingen og indsæt omgående passende medicinsk behandling.
If such a reaction develops during treatment with PegIntron, discontinue treatment and institute appropriate medical therapy immediately.
Hydrering:
53 Hydration:
I sjældne tilfælde har patienter behandlet for kronisk hepatitis C med interferon alfa udviklet thyreoideaabnormaliteter, enten hypothyreoidisme eller hyperthyreoidisme.
Infrequently, patients treated for chronic hepatitis C with interferon alpha have developed thyroid abnormalities, ei ther hypothyroidism or hyperthyroidism.
54 Mitokondriel toksicitet og mælkesyre acidose:
HCV/HIV Co-infection Mitochondrial toxicity and lactic acidosis:
Hæmatologiske anomalier hos HCV/ HIV co- inficerede patienter:
54 Haematological abnormalities in HCV/HIV co-infected patients:
4. 5)
Patients treated with Peg Intron and ribavirin combination therapy and zidovudine are at increased risk of developing anaemia and therefore the concomitant use of this combination with zidovudine is not recommended (see section 4.5).
55 • • •
• • •
Forsigtighed tilrådes derfor, når PegIntron behandling mod kronisk hepatitis initieres hos patienter der behandles med lægemidler med et snævert terapeutisk vindue og følsomhed for mild metabolisk svækkelse af leveren.
Caution is therefore advised when Peg Intron treatment is initiated for chronic hepatitis in patients treated with medication with a narrow therapeutic window and sensitive to mild metabolic impairment of the liver.
Fertile kvinder og deres partnere skal begge anvende en effektiv antikonception under behandling og i 4 måneder efter behandlingen er afsluttet.
56 childbearing potential and their partners must each use an effective contraceptive during treatment and for 4 months after treatment has been concluded.
57 Tabel 4
Table 4
Meget almindelig:
57 Metabolism and nutrition disorders Very common:
58 Hyppighed ikke kendt:
Frequency not known:
Interstitiel lungesygdom
Interstitial lung disease 58
59 Sjælden:
Rare:
Der var nogle tilfælde af mere alvorlig neutropeni hos patienter behandlet med de anbefalede doser af PegIntron i kombination med ribavirin (WHO grad 3:
There were some cases of more severe neutropenia in patients treated with the recommended doses of Peg Intron in combin ation with ribavirin (WHO grade 3:
4. 4).
59 Cardiovascular (CVS) adverse events, particularly arrhythmia, appeared to be correlated mostly with pre-existing CVS disease and prior therapy with cardiotoxic agents (see section 4.4).
60 Laboratorieværdier for samtidig infektion med HCV/ HIV Selvom hæmatologisk toksicitet af neutropeni, thrombocytopeni og anæmi forekom mere hyppigt hos patienter med samtidig infektion af HCV/ HIV, kunne hovedparten afhjælpes med en modificering af dosis og krævede sjældent for tidlig afbrydelse af behandling (se pkt.
Although haematological toxicities of neutropenia, thrombocytopenia and anaemia occurred more frequently in HCV/HIV co-infected patients, the majority could be managed by dose modification and rarely required premature discontinuation of treatment (see section 4.4).
61 Når først interferon er bundet til cellemembranen, så udløser det en kompleks række af intracellulære virkninger, som inkluderer induktion af visse enzymer.
Once bound to the cell membrane, interferon initiates a complex sequence of intracellular events that include the induction of certain enzymes.
Reduktion af antallet af neutrofile og hvide blodlegemer ved slutningen af uge 4 svarede til dosis af PegIntron.
Neutrophil and white cell count reductions at the end of week 4 correlated with the dose of Peg Intron.
PegIntron kliniske undersøgelser - Naive patienter To pivotale undersøgelser er blevet udført, en (C/ I97- 010) med PegIntron monoterapi; den anden (C/ I98- 580) med PegIntron i kombination med ribavirin.
Peg Intron clinical trials – Naïve patients Two pivotal trials have been conducted, one (C/I97-010) with PegIntron monotherapy; the other (C/I98-580) with PegIntron in combination with ribavirin.
Dette studie viste, at PegIntron var bedre end interferon alfa- 2b (Tabel 5).
This study showed that PegIntron was superior to interferon alfa-2b (Table 5).
I PegIntron kombinationsundersøgelsen blev 1. 530 naive patienter behandlet i et år med et af følgende kombinationsregimen: • PegIntron (1, 5 mikrogram/ kg/ uge) + ribavirin (800 mg/ dag), (n = 511). • PegIntron (1, 5 mikrogram/ kg/ uge i en måned efterfulgt af 0, 5 mikrogram/ kg/ uge i 11 måneder) + ribavirin (1. 000/ 1. 200 mg/ dag), (n = 514). • Interferon alfa- 2b (3 MIE tre gange om ugen) + ribavirin (1. 000/ 1. 200 mg/ dag) (n = 505).
61 In the PegIntron combination trial, 1,530 naïve patients were treated for one year with one of the following combination regimens: • PegIntron (1.5 micrograms/kg/week) + ribavirin (800 mg/day), (n = 511). • PegIntron (1.5 micrograms/kg/week for one month followed by 0.5 microgram/kg/week for 11 months) + ribavirin (1,000/1,200 mg/day), (n = 514). • Interferon alfa-2b (3 MIU three times a week) + ribavirin (1,000/1,200 mg/day) (n = 505).
respons (% patienter HCV negative) PegIntron monoterapi PegIntron + ribavirin 62
PegIntron + ribavirin
P 1, 5 PegIntron 1, 5 mikrogram/ kg P 1, 0 PegIntron 1, 0 mikrogram/ kg P 0, 5 PegIntron 0, 5 mikrogram/ kg I Interferon alfa- 2b 3 MIE P 1, 5/ R P 0, 5/ R I/ R * **
P 1.5 PegIntron 1.5 micrograms/kg P 1.0 PegIntron 1.0 microgram/kg P 0.5 PegIntron 0.5 microgram/kg I Interferon alfa-2b 3 MIU P 1.5/R P 0.5/R I/ R * **
Genotype 2/ 3
62 Genotype 2/3
PegIntron (1, 5 mikrogram/ kg) + ribavirin (800 mg) PegIntron (1, 5 til 0, 5 mikrogram/ kg) + ribavirin (1. 000/ 1. 200 mg) Interferon alfa- 2b (3 MIE) + ribavirin (1. 000/ 1. 200 mg)
PegIntron (1.5 micrograms/kg) + ribavirin (800 mg) PegIntron (1.5 to 0.5 microgram/kg) + ribavirin (1,000/1,200 mg) Interferon alfa-2b (3 MIU) + ribavirin (1,000/1,200 mg)
63 behandling
All Subjects
Tabel 8
63 Table 8
Viralt respons ved Vedvarende respons Negativ uge 12 prædiktiv værdi
Genotype 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% 2 and 3 Yes 99% (213/215) 83% (177/213) ----
Samtidig infektion med HCV/ HIV 64 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.
Tabel 9
64 Table 9
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
27% (56/205) 20% 17% (21/125)
65 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.
Tabel 10 Responsrater på genbehandling af patienter som ikke har responderet på tidligere behandling
65 Table 10 Rates of Response to retreatment in prior treatment failures
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).
66 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).
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 Peg Intron apparent clearance.
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 67 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.
Dosen af PegIntron i monoterapi bør reduceres hos patienter med moderat eller kraftigt nedsat nyrefunktion (se pkt.
67 for monotherapy should be reduced in patients with moderate or severe renal impairment (see sections 4.2 and 4.4).
Vand til injektionsvæsker.
68 Water for injections.
Pulveret er påfyldt i et 2 ml hætteglas, Type I flint glas, med en butylgummiprop i et aftageligt aluminiumsegl med en polypropylenhætte.
The powder is contained in a 2 ml vial, Type I flint glass, with a butyl rubber stopper in an aluminium flip -off seal with a polypropylene bonnet.
PegIntron 100 mikrogram leveres som:
PegIntron 100 micrograms is supplied as:
PegIntron leveres som et pulver peginterferon alfa- 2b i en styrke på 100 mikrogram til éndosis brug.
PegIntron is supplied as a powder of peginterferon alfa-2b at a strength of 100 micrograms for single use.
Den tilberedte opløsning har en koncentration på 100 mikrogram/ 0, 5 ml.
The reconstituted solution has a concentration of 100 micrograms/0.5 ml.
69 Som ved alle parenterale lægemidler, inspicer visuelt den tilberedte opløsning før indgift.
As for all parenteral medicinal products, inspect visually the reconstituted solution prior to administration.
Hvert hætteglas PegIntron, pulver til injektionsvæske, opløsning, indeholder 120 mikrogram peginterferon alfa- 2b målt på proteinbasis.
Each vial of PegIntron, powder for solution for injection contains 120 micrograms of peginterferon alfa- 2b as measured on a protein basis.
Hvert hætteglas giver 120 mikrogram/ 0, 5 ml peginterferon alfa- 2b efter tilberedning som anbefalet.
Each vial provides 120 micrograms/0.5 ml of peginterferon alfa-2b when reconstituted as recommended.
71 Kombinationsbehandling PegIntron 1, 5 mikrogram/ kg/ uge i kombination med ribavirin kapsler.
71 Combination therapy PegIntron 1.5 micrograms/kg/week in combination with ribavirin capsules.
72 forudsigelig værdi på 50% (52/ 104; Undersøgelse 1) blev observeret for HCV/ HIV co- inficerede patienter, der modtog kombinationsbehandling.
A positive predictive value of 50% (52/104; Study 1) was observed for HCV/HIV co-infected patients receiving combination therapy.
Behandlingsvarighed – Genbehandling Forudsigelighed af vedvarende virologisk respons:
72 Duration of treatment - Retreatment Predictability of sustained virological response:
73 Kombinationsbehandling - vejledninger for dosisreduktion
73 Combination Therapy Dose Reduction Guidelines
mængde (μg)
(μg/0.5 ml)
74 Tabel 3a Dosisjusteringsvejledninger for PegIntron monoterapi Laboratorieværdier
Table 3a Dose modification guidelines for PegIntron monotherapy
Dosisreduktion hos patienter, som anvender PegIntron 0, 5 μg/ kg som monoterapi, skal ske ved at reducere det foreskrevne volumen med halvdelen.
74 Dose reduction for patients who use 0.5 μg/kg PegIntron monotherapy must be accomplished by reducing the prescribed volume by one-half.
30- 35
(μg/0.5ml)
75 Anvendelse ved nedsat leverfunktion:
Use in hepatic impairment:
for et eller flere af hjælpestofferne;
75
Hvis en sådan reaktion udvikles 76 under behandling med PegIntron, seponer behandlingen og indsæt omgående passende medicinsk behandling.
If such a reaction develops during treatment with PegIntron, discontinue treatment and institute appropriate medical therapy immediately.
Hydrering:
76 Hydration:
77 Mitokondriel toksicitet og mælkesyre acidose:
HCV/HIV Co-infection Mitochondrial toxicity and lactic acidosis:
Hæmatologiske anomalier hos HCV/ HIV co- inficerede patienter:
77 Haematological abnormalities in HCV/HIV co-infected patients:
For de antiretrovirale lægemidler, der skal tages samtidig med HCV- behandling, henvises der til disses respektive produktresuméer for kendskab og håndtering af toksicitet, der er specifik for det enkelte produkt samt potentialet for overlappende toksiciteter med PegIntron og ribavirin.
Please refer to the respective Summary of Product Characteristics of the antiretroviral medicinal products that are to be taken concurrently with HCV therapy for awareness and management of toxicities specific for each product and the potential for overlapping toxicities with Peg Intron and ribavirin.
78 • • •
• • •
Disse fund kan delvist være relaterede til forbedret metabolisk kapacitet, som følge af reduceret hepatisk inflammation hos patienter i behandling med PegIntron.
These findings may partly relate to improved metabolic capacity due to reduced hepatic inflammation in patients undergoing treatment with Peg Intron.
79 4. 6 Graviditet og amning
4.6 Pregnancy and lactation
Fertile kvinder og deres partnere skal begge anvende en effektiv antikonception under behandling og i 4 måneder efter behandlingen er afsluttet.
79 childbearing potential and their partners must each use an effective contraceptive during treatment and for 4 months after treatment has been concluded.
80 Tabel 4
Table 4
Meget almindelig:
80 Metabolism and nutrition disorders Very common:
81 Hyppighed ikke kendt:
Frequency not known:
Interstitiel lungesygdom
Interstitial lung disease 81
82 Sjælden:
Rare:
4. 4).
82 Cardiovascular (CVS) adverse events, particularly arrhythmia, appeared to be correlated mostly with pre-existing CVS disease and prior therapy with cardiotoxic agents (see section 4.4).
83 Laboratorieværdier for samtidig infektion med HCV/ HIV Selvom hæmatologisk toksicitet af neutropeni, thrombocytopeni og anæmi forekom mere hyppigt hos patienter med samtidig infektion af HCV/ HIV, kunne hovedparten afhjælpes med en modificering af dosis og krævede sjældent for tidlig afbrydelse af behandling (se pkt.
Although haematological toxicities of neutropenia, thrombocytopenia and anaemia occurred more frequently in HCV/HIV co-infected patients, the majority could be managed by dose modification and rarely required premature discontinuation of treatment (see section 4.4).