natgillin/translations-raw huggingface dataset:
Vedvarende virologisk respons baseret på genotype efter ViraferonPeg i kombination med Ribavirin hos patienter med samtidig infektion af HCV/ HIV Undersøgelse 11 Undersøgelse 22 ViraferonPeg Interferon ViraferonPeg 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 ViraferonPeg in combination with Ribavirin in HCV/HIV Co-infected patients Study 11 Study 22 ViraferonPeg Interferon ViraferonPeg Interferon (100 or alfa-2b (1.5 µg/kg/ alfa-2b 150c µg/week) (3 MIU TIW) week) + (3 MIU TIW) + + ribavirin + ribavirin ribavirin ribavirin p (800- (800- p (800 mg) (800 mg) valuea 1,200 mg) d 1,200 mg) d valueb
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% (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
44% (35/ 80) 43% (33/ 76) 0, 88 53% (10/ 19) 47% (7/ 15)
44% (35/80) 43% (33/76) 0.88 53% (10/19) 47% (7/15)
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 ViraferonPeg og forsøgspersoner ≥ 75 kg fik 150 µg/ uge ViraferonPeg. 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 ViraferonPeg and subjects ≥ 75 kg received 150 µg/week ViraferonPeg. 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.
Både Metavir score og Ishak graden faldt blandt forsøgspersoner, der blev behandlet med ViraferonPeg i kombination med ribavirin.
Both the Metavir score and Ishak grade decreased among subjects treated with ViraferonPeg in combination with ribavirin.
19 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 ViraferonPeg givet subkutant (1, 5 mikrogram/ kg/ uge) i kombination med ribavirin baseret på kropsvægt.
ViraferonPeg/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 ViraferonPeg, 1.5 microgram/kg subcutaneously, once weekly, in combination with weight adjusted ribavirin.
52, 5 (105/ 200) 43, 4, 61, 6
58.1 (200/344) 52.5 (105/200) 43.4, 61.6
44, 3 (54/ 122) 32, 7, 55, 8
48.6 (122/251) 44.3 (54/122) 32.7, 55.8
64, 9 (50/ 77) 50, 9, 78, 9
64.9 (50/77) 50.9, 78.9
44, 1 (26/ 59) 27, 4, 60, 7
44.1 (26/59) 27.4, 60.7
38, 6 (17/ 44) 19, 7, 57, 5
38.6 (17/44) 19.7, 57.5
60, 0 (9/ 15) 27, 4, 92, 6
60.0 (9/15) 27.4, 92.6
63, 5 (61/ 96) 50, 9, 76, 2
63.5 (61/96) 50.9, 76.2
50, 0 (6/ 12) 12, 8, 87, 2
50.0 (6/12) 12.8, 87.2
57, 7 (45/ 78) 43, 3, 72, 1
57.7 (45/78) 43.3, 72.1
51, 3 (40/ 78) 36, 7, 65, 9
51.3 (40/78) 36.7, 65.9
44, 8 (52/ 116) 32, 9, 56, 7
44.8 (52/116) 32.9, 56.7
20
LVL (≤600,000 IU/ml)
LVL (≤600. 000 48, 3 (269/ 557) IU/ ml)
48.3 (269/557)
HCV- RNA serum måles ved et videnskabeligt baseret kvantitativ polymerase kæde reaktions assay på et central laboratorium * Hensigt til at behandle- populationen inkluderer 7 patienter, hvor mindst 12 ugers tidligere behandling ikke er bekræftet.
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.
Langtidsvirkningsfulde data En stor undersøgelse med langtidsopfølgning inkluderede 567 patienter efter behandling i en tidligere undersøgelse med ViraferonPeg (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 ViraferonPeg (with or without ribavirin).
SVR resulterer, efter behandling af kronisk HCV med ViraferonPeg (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 ViraferonPeg (with or without ribavirin) results in long-term clearance of the virus providing resolution of the hepatic infection and clinical “cure” from chronic HCV.
ViraferonPeg er et velkarakteriseret polyethylenglycol- modificeret (“ pegyleret ”) derivat af interferon alfa- 2b og består hovedsageligt af monopegylerede sorter.
ViraferonPeg is a well characterized polyethylene glycol-modified (“pegylated”) derivative of interferon alfa-2b and is predominantly composed of monopegylated species.
Plasmahalveringstiden af ViraferonPeg er forlænget i sammenligning med ikke- pegyleret interferon alfa- 2b.
The plasma half-life of ViraferonPeg is prolonged compared with non-pegylated interferon alfa-2b.
ViraferonPeg har et potentiale for at depegylere til frit interferon alfa- 2b.
ViraferonPeg has a potential to depegylate to free interferon alfa-2b.
ViraferonPeg Cmax og AUC målinger stiger på en dosis- relateret måde.
ViraferonPeg Cmax and AUC measurements increase in a dose-related manner.
Gennemsnitlig (standard deviation) ViraferonPeg eliminationshalveringstid er cirka 40 timer (13, 3 timer) med påviselig clearance på 22, 0 ml/ time· kg.
Mean (SD) ViraferonPeg 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 ViraferonPeg påviselig udskillelse.
However, renal elimination may account for a minority (approximately 30%) of ViraferonPeg apparent clearance.
21 Nyrefunktion:
Renal function:
Renal udskillelse synes at være ansvarlig for 30% af total clearance af ViraferonPeg.
Renal clearance appears to account for 30% of total clearance of ViraferonPeg.
Efter gentagne doser af ViraferonPeg (1, 0 mikrogram/ kg indgivet subkutant hver uge i fire uger) reduceres clearance af ViraferonPeg 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 normal nyrefunktion.
Following multiple dosing of ViraferonPeg (1.0 microgram/kg subcutaneously administered every week for four weeks) the clearance of ViraferonPeg 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
Dosen af ViraferonPeg i monoterapi bør reduceres hos patienter med moderat eller kraftigt nedsat nyrefunktion (se pkt.
21 ViraferonPeg 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 ViraferonPeg 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 ViraferonPeg (see section 4.2)
Farmakokinetikken for ViraferonPeg efter en enkelt subkutan dosis på 1, 0 mikrogram/ kg var ikke påvirket af alder.
The pharmacokinetics of ViraferonPeg following a single subcutaneous dose of 1.0 microgram/kg were not affected by age.
ViraferonPeg er kun indiceret til behandling af kronisk hepatitis C i patienter som er 18 år eller ældre.
ViraferonPeg is indicated for the treatment of chronic hepatitis C only in patients 18 years of age or older.
Interferon neutraliserende faktor analyser blev udført på serum prøver fra patienter, som fik ViraferonPeg i den kliniske undersøgelse.
Interferon neutralising factor assays were performed on serum samples of patients who received ViraferonPeg in the clinical trial.
Den kliniske forekomst af neutraliserende faktorer hos patienter, der fik ViraferonPeg 0, 5 mikrogram/ kg er 1, 1%.
The clinical incidence of neutralising factors in patients who received ViraferonPeg 0.5 micrograms/kg is 1.1%.
Reproduktionsundersøgelser er ikke foretaget med ViraferonPeg.
Reproduction studies of ViraferonPeg have not been performed.
ViraferonPeg anses for sandsynligvis også at forårsage denne virkning.
ViraferonPeg is likely to also cause this effect.
Den relative non- toxicitet af monomethoxy- polyethylenglycol (mPEG), som frigøres fra ViraferonPeg ved metabolisme in vivo er blevet påvist i prækliniske akutte og subkroniske toksicitetsundersøgelser hos gnavere og aber, standard embryofoetale udviklingsundersøgelser og i in vitro mutagenicitetsforsøg.
The relative non-toxicity of monomethoxy-polyethylene glycol (mPEG), which is liberated from ViraferonPeg by metabolism in vivo has been demonstrated in preclinical acute and subchronic toxicity studies in rodents and monkeys, standard embryo-foetal development studies and in in vitro mutagenicity assays.
Dinatriumphosphat, vandfri Natriumdihydrogenphosphatdihydrat, Saccharose, Polysorbat 80.
Disodium phosphate, anhydrous, Sodium dihydrogen phosphate dihydrate, Sucrose, Polysorbate 80.
Solvens til parenteralt brug:
Solvent for parenteral use:
Vand til injektionsvæsker.
22 Water for injections.
ViraferonPeg 50 mikrogram leveres som:
ViraferonPeg 50 micrograms is supplied as:
ViraferonPeg leveres som et pulver peginterferon alfa- 2b i en styrke på 50 mikrogram til éndosis brug.
ViraferonPeg is supplied as a powder of peginterferon alfa-2b at a strength of 50 micrograms for single use.
Et lille volumen går tabt under færdigtilberedningen af ViraferonPeg til injektion, når dosen afmåles og injiceres.
A small volume is lost during preparation of ViraferonPeg for injection when the dose is measured and injected.
23 ViraferonPeg pulver for at sikre indgift af den anførte dosis i 0, 5 ml ViraferonPeg, injektionsvæske.
Therefore, each vial contains an excess amount of solvent and ViraferonPeg powder to ensure delivery of the labelled dose in 0.5 ml of ViraferonPeg, solution for injection.
Ved hjælp af en steril injektionssprøjte og kanyle injiceres 0, 7 ml vand til injektionsvæsker i hætteglasset med ViraferonPeg.
Using a sterilised injection syringe and injection needle, inject 0.7 ml of water for injections into the vial of ViraferonPeg.
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.
29. maj 2000 Dato for seneste fornyelse:
29 May 2000 Date of last renewal:
Hvert hætteglas ViraferonPeg, pulver til injektionsvæske, opløsning, indeholder 80 mikrogram peginterferon alfa- 2b målt på proteinbasis.
Each vial of ViraferonPeg, powder for solution for injection contains 80 micrograms of peginterferon alfa- 2b as measured on a protein basis.
25 Kombinationsbehandling ViraferonPeg 1, 5 mikrogram/ kg/ uge i kombination med ribavirin kapsler.
25 Combination therapy ViraferonPeg 1.5 micrograms/kg/week in combination with ribavirin capsules.
Den foreskrevne dosis ViraferonPeg 1, 5 μg/ kg til anvendelse i kombination med ribavirin kan indgives ifølge kategorier efter patientens vægt og styrken af pen/ hætteglas, som anført i Tabel 1.
The intended dose of 1.5 μg/kg of ViraferonPeg to be used in combination with ribavirin may be delivered in weight categories with the pen/vial strengths according to Table 1.
En
The negative predictive value for sustained response in HCV/HIV co-infected patients treated with ViraferonPeg in combination with ribavirin was 99% (67/68; Study 1) (see section 5.1).
26 positiv 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.
ViraferonPeg monoterapi Ved monoterapi er ViraferonPeg regimen 0, 5 eller 1, 0 mikrogram/ kg/ uge.
ViraferonPeg monotherapy As monotherapy the ViraferonPeg regimen is 0.5 or 1.0 microgram/kg/week.
ViraferonPeg monoterapi blev ikke undersøgt i HCV/ HIV co- inficerede patienter.
ViraferonPeg monotherapy was not studied in HCV/HIV co-infected patients.
halv dosis, hvis:
600 mg/day* if: < 10 g/dl
28 Tabel 3a Dosisjusteringsvejledninger for ViraferonPeg monoterapi Laboratorieværdier
Table 3a Dose modification guidelines for ViraferonPeg monotherapy
Dosisreduktion hos patienter, som anvender ViraferonPeg 0, 5 μg/ kg som monoterapi, skal ske ved at reducere det foreskrevne volumen med halvdelen.
28 Dose reduction for patients who use 0.5 μg/kg ViraferonPeg monotherapy must be accomplished by reducing the prescribed volume by one-half.
Hos patienter, som anvender ViraferonPeg 1, 0 μg/ kg som monoterapi, kan dosisreduktion ske ved at reducere det foreskrevne volumen med halvdelen eller ved at bruge en lavere styrke, som vist i Tabel 3b.
For patients who use 1.0 μg/kg ViraferonPeg monotherapy, dose reduction may be accomplished by reducing the prescribed volume by one-half or by utilizing a lower dose strength as shown in Table 3b.
Tabel 3b – Reduceret ViraferonPeg dosis for 1, 0 μg/ kg monoterapiregimen
Table 3b – Reduced ViraferonPeg Dose for the 1.0 μg/kg Monotherapy Regimen
Hos patienter med moderat nedsat nyrefunktion (creatinin clearance 30- 50 ml/ minut) bør initialdosis af ViraferonPeg reduceres med 25%.
In patients with moderate renal dysfunction (creatinine clearance 30-50 ml/minute), the starting dose of ViraferonPeg should be reduced by 25%.
Patienter med kraftigt nedsat nyrefunktion (creatinin clearance 15- 29 ml/ minut) bør have initialdosis af ViraferonPeg reduceret med 50%.
Patients with severe renal dysfunction (creatinine clearance 15-29 ml/minute) should have the starting dose of ViraferonPeg reduced by 50%.
5. 2).
Data are not available for the use of ViraferonPeg in patients with creatinine clearance < 15 ml/minute (see section 5.2).
Patienter med creatinin clearance < 50 ml/ minut må ikke behandles med ViraferonPeg i kombination med ribavirin (se ribavirin SPC).
Patients with creatinine clearance < 50 ml/minute must not be treated with ViraferonPeg in combination with ribavirin (see ribavirin SPC).
- Initiering af ViraferonPeg er kontraindiceret i HCV/ HIV patienter med cirrhose og en Child -
- Initiation of ViraferonPeg is contraindicated in HCV/HIV patients with cirrhosis and a Child-Pugh
Hvis en sådan reaktion udvikles 30 under behandling med ViraferonPeg, seponer behandlingen og indsæt omgående passende medicinsk behandling.
If such a reaction develops during treatment with ViraferonPeg, discontinue treatment and institute appropriate medical therapy immediately.
Som med interferon alfa- 2b kræver patienter med tidligere hjerteinsufficiens, myokardieinfarkt og/ eller tidligere eller nuværende arytmilidelser, der får ViraferonPeg behandling, tæt monitoring.
As with interferon alfa-2b, patients with a history of congestive heart failure, myocardial infarction and/or previous or current arrhythmic disorders, receiving ViraferonPeg therapy require close monitoring.
31 Samtidig infektion med HCV/ HIV Mitokondriel toksicitet og mælkesyre acidose:
HCV/HIV Co-infection Mitochondrial toxicity and lactic acidosis:
32 Laboratorieundersøgelser:
Laboratory tests:
Resultater fra en multidosis undersøgelse, som vurderede P450 substrater hos kroniske hepatitis C patienter, som modtog ViraferonPeg (1, 5 µg/ kg) en gang ugentligt i 4 uger, viste en øgning i aktiviteten af CYP2D6 og CYP2C8/ 9.
32 Results from a multiple-dose probe study assessing P450 substrates in chronic hepatitis C patients receiving once weekly ViraferonPeg (1.5 µg/kg) for 4 weeks demonstrated an increase in activity of CYP2D6 and CYP2C8/9.
ViraferonPeg skal kun anvendes under graviditet, hvis den mulige fordel opvejer den mulige risiko for fosteret.
ViraferonPeg is to be used during pregnancy only if the potential benefit justifies the potential risk to the foetus
Ribavirin behandling er kontraindiceret hos kvinder, der er gravide.
33 contraindicated in women who are pregnant.
Sinuitis, bronkitis, dysfoni, næseblod, rhinitis, respiratorisk lidelse, forstoppet næse, rhinorrhea, tør hoste
Sinusitis, bronchitis, dysphonia, epistaxis, rhinitis, respiratory disorder, nasal congestion, rhinorrhea, nonproductive cough 35
I en klinisk undersøgelse rapporterede cirka 1, 2% af patienter behandlet med ViraferonPeg eller interferon alfa- 2b i kombination med ribavirin livstruende psykiatriske bivirkninger under behandling.
36 In a clinical trial, approximately 1.2% of patients treated with ViraferonPeg or interferon alfa-2b in combination with ribavirin reported life-threatening psychiatric events during treatment.
Der er set doser op til 10, 5 gange den tilsigtede dosis.
37 Doses up to 10.5 times the intended dose have been reported.
I ViraferonPeg monoterapiundersøgelsen blev i alt 916 naive kroniske hepatitis C patienter behandlet med ViraferonPeg (0, 5, 1, 0 eller 1, 5 mikrogram/ kg/ uge) i et år med en opfølgningsperiode på seks måneder.
38 In the ViraferonPeg monotherapy trial, a total of 916 naïve chronic hepatitis C patients were treated with ViraferonPeg (0.5, 1.0 or 1.5 micrograms/kg/week) for one year with a follow-up period of six months.
39 Tabel 5
Table 5
Vedvarende virologisk respons (% patienter HCV negative) ViraferonPeg monoterapi ViraferonPeg + ribavirin
Sustained virological response (% patients HCV negative) Viraferon Peg monotherapy ViraferonPeg + ribavirin
I ViraferonPeg monoterapiundersøgelsen var livskvaliteten generelt mindre påvirket ved 0, 5 mikrogram/ kg ViraferonPeg end ved enten 1, 0 mikrogram/ kg ViraferonPeg en gang om ugen eller 3 MIE interferon alfa- 2b tre gange om ugen.
In the ViraferonPeg monotherapy study, the Quality of Life was generally less affected by 0.5 microgram/kg of ViraferonPeg than by either 1.0 microgram/kg of ViraferonPeg once weekly or 3 MIU of interferon alfa-2b three times a week.
40 ViraferonPeg 1, 5 μg/ kg en gang ugentlig plus Ribavirin 800 - 1. 400 mg/ dag
of Treatment Response
I et ikke- sammenlignende studie fik 235 patienter med genotype 1 og lav virusmængde (< 600. 000 IU/ ml) ViraferonPeg 1, 5 mikrogram/ kg subkutant en gang ugentlig i kombination med vægtjusteret ribavarin.
40 In a non-comparative trial, 235 patients with genotype 1 and low viral load (< 600,000 IU/ml) received ViraferonPeg, 1.5 microgram/kg subcutaneously, once weekly, in combination with weight adjusted ribavirin.
til vedvarende respons efter viralt respons ved
Treatment ViraferonPeg 1.5 + ribavirin (> 10.6 mg/kg) 48-week treatment ViraferonPeg 1.5 + ribavirin 800-1,400 mg
+ribavirin (> 10, 6 mg/ kg) 48- ugers behandling ViraferonPeg 1, 5
24-week treatment
41 Den negative prædiktive værdi for vedvarende respons hos patienter behandlet med ViraferonPeg i monoterapi var 98%.
The negative predictive value for sustained response in patients treated with ViraferonPeg in monotherapy was 98%.
42 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 ViraferonPeg givet subkutant (1, 5 mikrogram/ kg/ uge) i kombination med ribavirin baseret på kropsvægt.
ViraferonPeg/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 ViraferonPeg, 1.5 microgram/kg subcutaneously, once weekly, in combination with weight adjusted ribavirin.
60, 0 (9/ 15) 27, 4, 92, 6
60.0 (9/ 15) 27.4, 92.6
43
LVL (≤600,000 IU/ml)
HCV- RNA serum måles ved et videnskabeligt baseret kvantitativ polymerase kæde reaktions assay på et central laboratorium * Hensigt til at behandle- populationen inkluderer 7 patienter, hvor mindst 12 ugers tidligere behandling ikke er bekræftet.
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.
44 Nyrefunktion:
Renal function:
Dosen af ViraferonPeg i monoterapi bør reduceres hos patienter med moderat eller kraftigt nedsat nyrefunktion (se pkt.
44 ViraferonPeg for monotherapy should be reduced in patients with moderate or severe renal impairment (see sections 4.2 and 4.4).
ViraferonPeg 80 mikrogram leveres som:
ViraferonPeg 80 micrograms is supplied as:
ViraferonPeg leveres som et pulver peginterferon alfa- 2b i en styrke på 80 mikrogram til éndosis brug.
ViraferonPeg is supplied as a powder of peginterferon alfa-2b at a strength of 80 micrograms for single use.
46 ViraferonPeg pulver for at sikre indgift af den anførte dosis i 0, 5 ml ViraferonPeg, injektionsvæske.
Therefore, each vial contains an excess amount of solvent and ViraferonPeg powder to ensure delivery of the labelled dose in 0.5 ml of ViraferonPeg, solution for injection.
Hvert hætteglas ViraferonPeg, pulver til injektionsvæske, opløsning, indeholder 100 mikrogram peginterferon alfa- 2b målt på proteinbasis.
Each vial of ViraferonPeg, powder for solution for injection contains 100 micrograms of peginterferon alfa-2b as measured on a protein basis.
48 Kombinationsbehandling ViraferonPeg 1, 5 mikrogram/ kg/ uge i kombination med ribavirin kapsler.
48 Combination therapy ViraferonPeg 1.5 micrograms/kg/week in combination with ribavirin capsules.
49 positiv 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.
51 Tabel 3a Dosisjusteringsvejledninger for ViraferonPeg monoterapi Laboratorieværdier
Table 3a Dose modification guidelines for ViraferonPeg monotherapy
Dosisreduktion hos patienter, som anvender ViraferonPeg 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 ViraferonPeg monotherapy must be accomplished by reducing the prescribed volume by one-half.
Hvis en sådan reaktion udvikles 53 under behandling med ViraferonPeg, seponer behandlingen og indsæt omgående passende medicinsk behandling.
If such a reaction develops during treatment with ViraferonPeg, discontinue treatment and institute appropriate medical therapy immediately.
54 Samtidig infektion med HCV/ HIV Mitokondriel toksicitet og mælkesyre acidose:
HCV/HIV Co-infection Mitochondrial toxicity and lactic acidosis:
55 Laboratorieundersøgelser:
Laboratory tests:
Resultater fra en multidosis undersøgelse, som vurderede P450 substrater hos kroniske hepatitis C patienter, som modtog ViraferonPeg (1, 5 µg/ kg) en gang ugentligt i 4 uger, viste en øgning i aktiviteten af CYP2D6 og CYP2C8/ 9.
55 Results from a multiple-dose probe study assessing P450 substrates in chronic hepatitis C patients receiving once weekly ViraferonPeg (1.5 µg/kg) for 4 weeks demonstrated an increase in activity of CYP2D6 and CYP2C8/9.
Ribavirin behandling er kontraindiceret hos kvinder, der er gravide.
56 contraindicated in women who are pregnant.
Sinuitis, bronkitis, dysfoni, næseblod, rhinitis, respiratorisk lidelse, forstoppet næse, rhinorrhea, tør hoste
Sinusitis, bronchitis, dysphonia, epistaxis, rhinitis, respiratory disorder, nasal congestion, rhinorrhea, nonproductive cough 58