natgillin/translations-raw huggingface dataset:
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 i kombination med 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 in combination with ribavirin.
84 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.
Efter enkeltdoser af PegIntron mellem 0, 25 og 2, 0 mikrogram/ kg/ uge, blev serum neopterin koncentrationen øget på en dosisafhængig måde.
Following single doses of Peg Intron between 0.25 and 2.0 micrograms/kg/week, serum neopterin concentration was increased in a dose- related manner.
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).
84 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).
Vedvarende virologisk
Sustained virological response (% patients HCV negative PegIntron monotherapy
respons (% patienter HCV negative) PegIntron monoterapi PegIntron + ribavirin 85
PegIntron + ribavirin
Genotype 2/ 3
85 Genotype 2/3
86 behandling
All Subjects
Tabel 8
86 Table 8
Samtidig infektion med HCV/ HIV 87 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.
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 thera py 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
87 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
Sustaine d 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
44% (35/ 80) 43% (33/ 76) 0, 88 53% (10/ 19) 47% (7/ 15)
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 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.
88 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
88 Table 10 Rates of Response to retreatment in prior treatment failures
73, 0 (135/ 185) 64, 6, 81, 4
73.0 (135/185) 6 4.6, 81.4
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).
89 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).
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 90 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.
90 for monotherapy should be reduced in patients with moderate or severe renal impairment (see sections 4.2 and 4.4).
Vand til injektionsvæsker.
91 Water for injections.
PegIntron 120 mikrogram leveres som:
PegIntron 120 micrograms is supplied as:
PegIntron leveres som et pulver peginterferon alfa- 2b i en styrke på 120 mikrogram til éndosis brug.
PegIntron is supplied as a powder of peginterferon alfa-2b at a strength of 120 micrograms for single use.
Den tilberedte opløsning har en koncentration på 120 mikrogram/ 0, 5 ml.
The reconstituted solution has a concentration of 120 micrograms/0.5 ml.
92 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 150 mikrogram peginterferon alfa- 2b målt på proteinbasis.
Each vial of PegIntron, powder for solution for injection contains 150 micrograms of peginterferon alfa- 2b as measured on a protein basis.
Hvert hætteglas giver 150 mikrogram/ 0, 5 ml peginterferon alfa- 2b efter tilberedning som anbefalet.
Each vial provides 150 micrograms/0.5 ml of peginterferon alfa-2b when reconstituted as recommended.
94 Kombinationsbehandling PegIntron 1, 5 mikrogram/ kg/ uge i kombination med ribavirin kapsler.
94 Combination therapy PegIntron 1.5 micrograms/kg/week in combination with ribavirin capsules.
95 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:
95 Duration of treatment - Retreatment Predictability of sustained virological response:
Doser til patienter, der foreskrives 0, 5 μg/ kg/ uge, skal således justeres ved volumen, som vist i Tabel 2.
The lowest vial or pen strength available is 50 μg/ 0.5 ml; therefore for patients prescribed 0.5 μ g/ kg/week, doses must be adjusted by volume as shown in Table 2.
96 Kombinationsbehandling - vejledninger for dosisreduktion
96 Combination Therapy Dose Reduction Guidelines
hvis: hvis:
dose to one -half dose if:
97 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.
97 Dose reduction for patients who use 0.5 μg/kg PegIntron monotherapy must be accomplished by reducing the prescribed volume by one-half.
hætteglas/ pen (μg/ 0, 5ml)
Dose (μg)
50 *
(μg/0.5ml)
15
(μg)
98 Anvendelse ved nedsat leverfunktion:
Use in hepatic impairment:
4. 3 Kontraindikationer
4.3 Contra indications
for et eller flere af hjælpestofferne;
98
Hvis en sådan reaktion udvikles 99 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:
99 Hydration:
Seponering af PegIntron bør overvejes hos patienter, som udvikler nye eller forværrede oftalmologiske lidelser.
Discontinuation of Peg Intron should be considered in patients who develop new or worsening ophthalmological disorders.
100 Mitokondriel toksicitet og mælkesyre acidose:
HCV/HIV Co-infection Mitochondrial toxicity and lactic acidosis:
Hæmatologiske anomalier hos HCV/ HIV co- inficerede patienter:
100 Haematological abnormalities in HCV/HIV co-infected patients:
101 • • •
• • •
102 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.
102 childbearing potential and their partners must each use an effective contraceptive during treatment and for 4 months after treatment has been concluded.
103 Tabel 4
Table 4
Meget almindelig:
103 Metabolism and nutrition disorders Very common:
104 Hyppighed ikke kendt:
Frequency not known:
Interstitiel lungesygdom
Interstitial lung disease 104
105 Sjælden:
Rare:
Bivirkninger var almindelige (≥ 1/ 100 til < 1/ 10) i kliniske undersøgelser hos patienter behandlet med PegIntron monoterapi.
These adverse reactions were common (≥1/100 to < 1/10) in clinical trials in patients treated with Peg Intron monother apy.
4. 4).
105 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).
106 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).
107 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.
Personer behandlet med PegIntron viste lette dosisrelaterede stigninger i legemstemperatur.
Subjects treated with Peg Intron showed mild dose-related elevations in body temperature.
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).
107 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 108
Peg Intron + ribavirin
Genotype 2/ 3
108 Genotype 2/3
109 behandling
All Subjects
Tabel 8
109 Table 8
Forudsigelighed med hensyn uge 12 og genotype *
Predictability of sustained response by viral response at week 12 and genotype *
Samtidig infektion med HCV/ HIV 110 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
110 Table 9
111 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
111 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).
112 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).
Gennemsnitlig (standard deviation) PegIntron eliminationshalveringstid er cirka 40 timer (13, 3 timer) med påviselig clearance på 22, 0 ml/ time· kg.
Mean (SD) Peg Intron elimin ation half-life is approximately 40 hours (13.3 hours), with apparent clearance of 22.0 ml/hr·kg.
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 113 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.
113 for monotherapy should be reduced in patients with moderate or severe renal impairment (see sections 4.2 and 4.4).
114 Saccharose, Polysorbat 80.
114 Water for injections.
PegIntron 150 mikrogram leveres som:
PegIntron 150 micrograms is supplied as:
PegIntron leveres som et pulver peginterferon alfa- 2b i en styrke på 150 mikrogram til éndosis brug.
PegIntron is supplied as a powder of peginterferon alfa-2b at a strength of 150 micrograms for single use.
Den tilberedte opløsning har en koncentration på 150 mikrogram/ 0, 5 ml.
The reconstituted solution has a concentration of 150 micrograms/0.5 ml.
115 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.
116 1.
116 1.
PegIntron 50 mikrogram pulver og solvens til injektionsvæske, opløsning i fyldt pen
PegIntron 50 micrograms, powder and solvent for solution for injection in pre-filled pen
Hver fyldt pen PegIntron 50 mikrogram indeholder en tilstrækkelig mængde peginterferon alfa- 2b målt på proteinbasis i et pulver til injektionsvæske, opløsning, og den tilsvarende mængde solvens til at give 50 mikrogram i 0, 5 ml peginterferon alfa- 2b efter tilberedning som anbefalet.
Each pre-filled pen of PegIntron 50 micrograms contains a sufficient amount of peginterferon alfa-2b as measured on a protein basis in a powder for solution for injection, and the corresponding amount of solvent, to provide 50 micrograms in 0.5 ml of peginterferon alfa-2b when reconstituted as recommended.
Pulver og solvens til injektionsvæske, opløsning i fyldt pen Hvidt pulver.
Powder and solvent for solution for injection in pre-filled pen White powder.
117 Kombinationsbehandling PegIntron 1, 5 mikrogram/ kg/ uge i kombination med ribavirin kapsler.
117 Combination therapy PegIntron 1.5 micrograms/kg/week in combination with ribavirin capsules.
118 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:
118 Duration of treatment - Retreatment Predictability of sustained virological response:
PegIntron monoterapi Ved monoterapi er PegIntron regimen 0, 5 eller 1, 0 mikrogram/ kg/ uge.
PegIntron monotherapy As monotherapy the PegIntron regimen is 0.5 or 1.0 microgram/k g/week.
119 Kombinationsbehandling - vejledninger for dosisreduktion
119 Combination Therapy Dose Reduction Guidelines
Blodplader Bilirubin – direkte Bilirubin - indirekte
Platelets Bilirubin – direct Bilirubin – indirect
120 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.
120 Dose reduction for patients who use 0.5 μg/kg PegIntron monotherapy must be accomplished by reducing the prescribed volume by one-half.
121 Anvendelse ved nedsat leverfunktion:
Use in hepatic impairment:
Der er ingen påviselige aldersrelaterede virkninger på farmakokinetikken for PegIntron.
There are no apparent age -related effects on the pharmacokinetics of PegIntron.
4. 4);
in the previous six months (see section 4.4); 121
Hvis en sådan reaktion udvikles 122 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:
122 Hydration:
Regelmæssige synsundersøgelser anbefales under PegIntron behandling, især hos patienter med sygdomme, der kan være forbundet med retinopati, såsom diabetes mellitus eller hypertension.
Periodic visual examinations are recommended during Peg Intron therapy, particularly in patients with disorders that may be associated with retinopathy, such as diabetes mellitus or hypertension.
123 Mitokondriel toksicitet og mælkesyre acidose:
HCV/HIV Co-infection Mitochondrial toxicity and lactic acidosis:
Hæmatologiske anomalier hos HCV/ HIV co- inficerede patienter:
123 Haematological abnormalities in HCV/HIV co-infected patients:
124 • • •
• • •
125 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.
125 childbearing potential and their partners must each use an effective contraceptive during treatment and for 4 months after treatment has been concluded.
126 Tabel 4
Table 4
Meget almindelig:
126 Metabolism and nutrition disorders Very common:
127 Hyppighed ikke kendt:
Frequency not known:
Interstitiel lungesygdom
Interstitial lung disease 127
128 Sjælden:
Rare:
4. 4).
128 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).
Bivirkningerne, der har været rapporteret i undersøgelserne med en hyppighed > 5%, var oral candidiasis (14%), pådraget lipodystrofi (13%), nedsat CD4- lymfocytter (8%), nedsat appetit (8%), øget gamma - glutamyltransferase (9%), rygsmerte (5%), øget amylase i blodet (6%), øget mælkesyre i blodet (5%), cytolytisk hepatitis (6%), øget lipase (6%) og smerte i lemmerne (6%).
HCV/HIV co-infected patients For HCV/HIV co-infected patients receiving Peg Intron in combination with ribavirin, other undesirable effects (that were not reported in mono-infected patients) which have been reported in the larger studies with a frequency > 5% were: oral candidiasis (14%), lipodystrophy acquired (13%), CD4 lymphocytes decreased (8%), appetite decreased (8%), gamma-glutamyltransferase increased (9%), back pain (5%), blood amylase increased (6%), blood lactic acid increased (5%), cytolytic hepatitis (6%), lipase increased (6%) and pain in limb (6%).
129 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).
Anvendelsen af PegIntron i kombination med ribavirin havde ingen observerbar negativ indvirkning på kontrollen af HIV- viræmi under behandling eller opfølgning.
The use of Peg Intron in combination with ribavirin had no observable negative impact on the control of HIV viraemia during therapy or follow-up.
130 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.
PegIntron Farmakodynamikken af PegIntron blev undersøgt i en undersøgelse med stigende enkeltdoser i raske forsøgspersoner ved at undersøge ændringer i mundtemperatur, koncentrationer af effektorproteiner såsom serum neopterin og 2’ 5 ’ - oligoadenylat syntetase (2’ 5 ’ - OAS), og ligeledes antal hvide blodlegemer og neutrofile.
Peg Intron PegIntron pharmacodynamics were assessed in a rising single-dose trial in healthy subjects by examining changes in oral temperature, concentrations of effector proteins such as serum neopterin and 2’5’- oligoadenylate syn thetase (2’5’-OAS), as well as white cell and neutrophil counts.
Efter enkeltdoser af PegIntron mellem 0, 25 og 2, 0 mikrogram/ kg/ uge, blev serum neopterin koncentrationen øget på en dosisafhængig måde.
Following single doses of PegIntron between 0.25 and 2.0 micrograms/kg/week, serum neopterin concentration was increased in a dose-related manner.