natgillin/translations-raw huggingface dataset:
a) som udgør en forværring fra baseline og anses for bivirkninger hos HCV-inficerede patienter, der får INCIVOkombinationsbehandling, fra de poolede data fra de placebokontrollerede fase 2- og 3-studier Grad 3
a Grade ≥ 2) that represent a worsening from baseline and are considered adverse drug reactions in HCV-infected patients treated with INCIVO combination treatment from the pooled data from the placebo-controlled
Andet omfatter patienter med detekterbart HCV RNA på det faktiske tidspunkt for behandlingsafslutning, men som ikke opfyldte definitionen af virologisk svigt under behandlingen, samt patienter med manglende HCV RNAvurdering under den planlagte opfølgning.
Other includes patients with detectable HCV RNA at their actual end of treatment but who did not meet the definition of on-treatment virologic failure, and patients with a missing HCV RNA assessment during planned follow-up.
I placebokontrollerede fase 2- og 3-studier forekom alvorligt udslæt (primært eksematøst og kløende udslæt, der berører over 50% af legemsoverfladen) hos 4,8% af de patienter, der fik INCIVOkombinationsbehandling, sammenlignet med 0,4% af dem, der fik pegyleret interferon-alfa og ribavirin.
In placebo-controlled Phase 2 and 3 trials, severe rash (primarily eczematous, pruritic and involving more than 50% body surface area) was reported in 4.8% of patients who received INCIVO combination treatment compared to 0.4% receiving peginterferon alfa and ribavirin.
Andet omfatter patienter med detekterbart HCV-RNA på det planlagte tidspunkt for behandlingsafslutning, men som ikke fik et viralt gennembrud, samt patienter med manglende SVR-vurdering under den planlagte opfølgning.
Other includes patients with detectable HCV RNA at the planned end of treatment but who did not have viral breakthrough, and patients with a missing SVR assessment during planned follow-up.
Figur 1: Behandlingsvarighed for behandlingsnaive patienter og patienter med tilbagefald efter tidligere behandling (tidligere relapsers)
Figure 1: Duration of treatment for treatment-naïve patients and prior treatment
BEHOLDERENS ETIKET (pakning med 1 beholder)
BOTTLE LABEL (1-bottle pack)
Der kan gå flere uger, før udslættet er væk.
The rash may take several weeks to resolve.
Langtids-effektdata
5.3 Preclinical safety data
Er du i tvivl, så spørg lægen eller på apoteket.
If you need help, ask your doctor or pharmacist.
Samtidig brug af rifampicin og telaprevir er kontraindiceret.
Co-administration of rifampicin with telaprevir is contraindicated.
Sildenalfil eller vardenafil anbefales ikke anvendt sammen med telaprevir.
It is not recommended to co-administer sildenafil or vardenafil and telaprevir.
Anvendelse af pegyleret interferon-alfa-2a eller -2b To typer pegyleret interferon-alfa (2a og 2b) blev undersøgt i det åbne, randomiserede fase 2a-studie C208 hos behandlingsnaive patienter.
Use of peginterferon alfa 2a or 2b Two types of peginterferon alfa (2a and 2b) were studied in the Phase 2a open label, randomised
- For alle patienter med cirrose, uanset om de har ikke-detekterbart HCV-RNA (HCV-RNA ikke påvist) i uge 4 eller 12, anbefales supplerende behandling i 36 uger med pegyleret interferon-alfa og ribavirin alene, så den samlede behandlingsvarighed bliver 48 uger (se
- For all patients with cirrhosis irrespective of undetectable HCV RNA (target not detected) at weeks 4 or 12, an additional 36 weeks of peginterferon alfa and ribavirin alone for a total treatment duration of 48 weeks is recommended (see section 5.1).
Samtidig anvendelse af INCIVO og lægemidler, der hæmmer CYP3A og/eller P-gp, kan øge
Co-administration of INCIVO and medicinal products that inhibit CYP3A and/or P-gp may increase telaprevir plasma concentrations.
bosentan medfører induktion af CYP3A, telaprevis hæmmer CYP3A og organisk aniontransportpolypeptider (OATP)
CYP3A and organic anion transporter polypeptides (OATPs) by telaprevir
Se også indlægssedlen for pegyleret interferon-alfa og ribavirin.
See also the package leaflets for peginterferon alfa and ribavirin.
I det kliniske fase 3-studie C211 var der ingen forskel mellem den type varianter, der opstod hos patienter, som fik telaprevir 1.125 mg to gange dagligt, og typen hos patienter, som fik telaprevir 750 mg hver 8. time.
In the C211 Phase 3 clinical trial, there was no difference in the type of emerging variants between patients receiving telaprevir 1,125 mg twice daily (b.i.d.)
Patienterne i disse studier, 108, 111 og C216, havde kompenseret leversygdom, påviseligt HCV-RNA, og lever-histopatologi svarende til kronisk hepatitis C. Med mindre andet angives, blev INCIVO givet i en dosis på 750 mg hver 8. time.
Patients in these studies, 108, 111 and C216, had compensated liver disease, detectable HCV RNA, and liver histopathology consistent with chronic hepatitis C. Unless otherwise indicated, INCIVO was administered at a dosage of 750 mg every 8 hours (q8h); the peginterferon alfa-2a dose was 180 µg/week, and the ribavirin dose was 1,000 mg/day (patients weighing < 75 kg) or 1,200 mg/day (patients weighing ≥ 75 kg).
Relaps blev defineret som havende HCV RNA ≥ 25 IE/ml i opfølgningsperioden efter tidligere at have haft HCV RNA < 25 IE/ml på det planlagte tidspunkt for behandlingsafslutning og manglende opnåelse af SVR12.
Relapse was defined as having HCV RNA ≥ 25 IU/ml during the follow-up period after previous HCV RNA < 25 IU/ml at planned end of treatment and not achieving SVR12.
Alle patienter fik INCIVO plus pegyleret interferon alfa-2a og ribavirin i 12 uger, efterfulgt af pegyleret interferon alfa-2a og ribavirin i 36 uger (samlet behandlingsvarighed 48 uger).
All patients received 12 weeks of treatment with INCIVO plus peginterferon alfa-2a and ribavirin followed by 36 weeks of treatment with peginterferon alfa-2a and ribavirin (total treatment duration of 48 weeks).
In vitro fandtes ingen relevant hæmning af CYP1A2-, CYP2A6-, CYP2B6-, CYP2C8-, CYP2C9-,
No relevant inhibition by telaprevir of CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, and CYP2E1 isozymes was observed in vitro.
HCV-RNA > 1.000 IE/ml i uge 12 af behandlingen Behandling med INCIVO gennemført
HCV RNA > 1,000 IU/ml at week 12 of treatment
Tabel 1: Vejledning i seponering af behandling med INCIVO, pegyleret interferon-alfa og ribavirin
Table 1: Guidelines for discontinuation of INCIVO, Peginterferon Alfa, and Ribavirin treatment
- Lægen har ordineret INCIVO til dig personligt.
- This medicine has been prescribed for you only.
Andet omfatter patienter med detekterbart HCV RNA på det faktiske tidspunkt for behandlingsafslutning, men som ikke fik et viralt gennembrud, samt patienter med manglende HCV RNA-vurdering under den planlagte opfølgning.
Other includes patients with detectable HCV RNA at their actual end of treatment but who did not have viral breakthrough, and patients with a missing HCV RNA assessment during planned follow-up.
Pegyleret interferon-alfa-2a/pegyleret interferon-alfa-2b og ribavirin blev anvendt som angivet i de
Peginterferon alfa-2a/peginterferon alfa-2b and ribavirin were used according to their relevant Summary of Product Characteristics.
I T12/PR48-gruppen havde 3 forsøgspersoner (8%) brofibrose ved baseline, og 2 forsøgspersoner (5%) havde cirrose.
At baseline, 3 (8%) patients had bridging fibrosis and 2 (5%) patients had cirrhosis in the T12/PR48 arm.
Telaprevirs aktivitet mod hepatitis C
In vitro studies Activity of telaprevir against HCV
Behandling med INCIVO skal indledes i kombination med pegyleret interferon alfa og ribavirin i 12 uger efterfulgt af pegyleret interferon alfa og ribavirin alene i yderligere 36 uger, dvs. en samlet behandlingsvarighed på 48 uger.
Treatment with INCIVO must be initiated in combination with peginterferon alfa and ribavirin and administered for 12 weeks with an additional 36 weeks of peginterferon alfa and ribavirin alone for a total treatment duration of 48 weeks.
- INCIVO 750 mg hver 8. time sammen med pegyleret interferon-alfa-2b 1,5 g/kg/uge og
- INCIVO 750 mg every 8 hours with peginterferon alfa-2b 1.5 g/kg/week and ribavirin
Studie HPC3006 var et åbent fase 3b-studie, der omfattede behandlingsnaive og behandlingserfarne patienter med kronisk HCV-genotype 1-infektion, som var førstegangs-levertransplantatmodtagere i stabil behandling med de immunsupprimerende midler tacrolimus eller ciclosporin.
Study HPC3006 was an open-label, Phase 3b study in treatment- naïve and treatment-experienced chronic genotype 1 HCV- infected patients who were first time liver transplant recipients and were on a stable regimen of the immunosuppressants tacrolimus or cyclosporine A. No patients had cirrhosis of the liver graft.
Læs indlægssedlen for pegyleret interferon-alfa og ribavirin for at få yderligere oplysninger om dette.
You must read the package leaflets for peginterferon alfa and ribavirin for additional information.
Darunavir/ritonavir anbefales ikke anvendt sammen med telaprevir (se pkt.
It is not recommended to co-administer darunavir/ritonavir and telaprevir (see section 4.4).
Plasmakoncentrationen af HCV-RNA
Plasma HCV RNA values were measured using the COBAS
Tabel 17 viser de samlede responsrater hos behandlingsnaive og behandlingserfarne levertransplantatmodtagere med kronisk HCV-genotype 1-infektion samt efter undergruppe
Table 17 shows the overall response rates in treatment- naïve and treatment-experienced chronic genotype 1 HCV- infected liver transplant recipients and by subgroup (patients receiving tacrolimus or cyclosporine A).
Samtidig anvendelse af domperidon og INCIVO bør undgås (se pkt.
Co-administration of domperidone with INCIVO should be avoided (see section 4.4).
Det er ikke nødvendigt at ændre buprenorphindosis ved samtidig anvendelse af telaprevir.
No adjustment of the buprenorphine dose is required when co-administered with telaprevir.
Virologisk svigt i løbet af behandlingen omfatter patienter, som mødte en virologisk stopregel fastlagt i protokollen
On-treatment-virologic failure includes patients who met a protocol-defined virologic stopping rule and/or had viral
- INCIVO 1.125 mg hver 12. time sammen med pegyleret interferon-alfa-2b 1,5 g/kg/uge og
- INCIVO 1,125 mg every 12 hours with peginterferon alfa-2b 1.5 g/kg/week and ribavirin
etravirin*
phenytoin*
- INCIVO 1.125 mg hver 12. time sammen med pegyleret interferon-alfa-2a 180 g/uge og
- INCIVO 1,125 mg every 12 hours with peginterferon alfa-2a 180 g/week and ribavirin
Baseret på en populationsfarmakokinetisk model af eksponeringen for telaprevir ved steady state var ratioerne af middelværdierne (fundet ved mindste kvadraters metode; 90% CI) af 1.125 mg to gange dagligt versus 750 mg hver 8. time 1,08 (1,02; 1,13) for AUC24,ss, 0,878 (0,827; 0,930) for Ctrough,ss, og 1,18
versus 750 mg every 8 hours (q8h) were 1.08 (1.02; 1.13) for AUC24,ss, 0.878 (0.827; 0.930) for Ctrough,ss, and 1.18 (1.12;1.24) for Cmax,ss.
Der er ilagt tørremiddel (en eller to
Desiccant (one pouch or two
Almindelige bivirkninger (forekommer hos færre end 1 ud af 10 behandlede) - svampeinfektion i munden - lavt antal blodplader, fald i lymfocytter (en type hvide blodlegemer), nedsat aktivitet af skjoldbruskkirtlen, forhøjet urinsyre i blodet, nedsat mængde kalium i blodet, forhøjet bilirubin i blodet
- low blood platelet count, decrease in lymphocytes (a type of white blood cell), decrease in thyroid gland activity, increase in uric acid in your blood, decrease in potassium in your blood,
Samtidig anvendelse af INCIVO og domperidon bør undgås (se pkt.
INCIVO co-administration with domperidone should be avoided (see section 4.5).
↑ triazolam
↑ alfentanil ↑ fentanyl
21,6% havde IL28Bgenotype CC, 54,1% havde IL28B-genotype CT, og 24,3% havde IL28B-genotype TT. 28,4% (n = 21) var HCV-behandlingsnaive, og 71,6% (n = 53) var behandlingserfarne [14,9% (n = 11) var tidligere relapsers, mens 40,5% (n = 30) var tidligere non-responders, og 16,2% (n = 12) kunne ikke klassificeres].
RNA levels ≥ 800,000 IU/ml; 10.8% had bridging fibrosis; none had cirrhosis; 38.9% had HCV genotype 1a; 58.3% had HCV genotype 1b; 2.8% had HCV genotype 1d; 21.6% had IL28B genotype CC; 54.1% had IL28B genotype CT; 24.3% had IL28B genotype TT; 28.4% (n = 21) were HCV treatment- naïve; 71.6% (n = 53) were treatment-experienced [14.9% (n = 11) were prior relapsers; 40.5% (n = 30) were prior non-responders; 16.2% (n = 12) could not be classified]; median time since liver transplantation was 2.5 years (range: 0.6 to 9.5 years); 67.6% (n = 50) received tacrolimus; 32.4% (n = 24) received cyclosporine A.
til at behandle psykiske lidelser (antipsykotika)
to treat fungal infections (antifungals)
Gå til kontrol hos din læge, og følg behandlingen i den anbefalede periode.
Please check with your doctor and follow
Den potentielle kliniske betydning af
The potential clinical significance of these findings is uncertain.
73,8% af patienterne (59 ud af 80) i den poolede pegyleret interferon-alfa-2a-gruppe opfyldte kriterierne (ikke-detekterbart HCV-RNA (HCV-RNA ikke påvist) fra uge 4 t.o.m.
73.8% (59/80) of patients in the pooled peginterferon alfa-2a group met the criteria (undetectable HCV RNA (target not detected) at week 4 through week 20) for the shortened 24 week peginterferon/ribavirin treatment duration versus 61.7% (50/81) of patients in the pooled
Naive patienter, der fik enten pegyleret interferon-alfa-2a/ribavirin (n = 80) eller pegyleret interferon-alfa
Naïve patients treated with either peginterferon alfa-2a/ribavirin (n = 80) or peginterferon alfa-2b/ribavirin (n = 81) in combination with INCIVO, in an open label study, had comparable SVR rates.
Eksempler på disse blodprøver: blodbillede, skjoldbruskkirtelhormoner (dannes i kirtel i halsen og regulerer stofskiftet), lever- og
Examples are: blood count levels, thyroid (a gland in your neck that controls your metabolism) levels, liver and kidney
T12/PR48: INCIVO i 12 uger efterfulgt af placebo i 4 uger i kombination med pegyleret interferon-alfa-2a og ribavirin i
T12/PR48: INCIVO for 12 weeks followed by placebo for 4 weeks, in combination with peginterferon alfa-2a and
Patienter, der tager INCIVO to gange dagligt, skal informeres om, at hvis de glemmer at tage en dosis INCIVO, og det opdages inden for 6 timer efter det sædvanlige tidspunkt, skal den foreskrevne dosis INCIVO tages hurtigst muligt sammen med føde.
), in case a dose of INCIVO is missed within 6 hours of the time it is usually taken, patients should be instructed to take the prescribed dose of INCIVO with food as soon as possible.
Salmeterol anbefales ikke anvendt sammen med telaprevir.
Concurrent administration of salmeterol and telaprevir is not recommended.
Janssen-Cilag SpA Via M.Buonarroti, 23
Manufacturer Janssen-Cilag SpA, Via C. Janssen,
In vitro fandtes der ingen relevant telaprevir-relateret hæmning af den organiske kation-transportør
No relevant inhibition by telaprevir of the organic cation transporter (OCT) OCT2 was observed in vitro.
For en oversigt over kontraindikationerne for pegyleret interferon-alfa og ribavirin henvises til produktresuméerne for disse, eftersom INCIVO skal anvendes i kombination med pegyleret
Refer to the Summary of Product Characteristics for peginterferon alfa and ribavirin for a list of their contraindications since INCIVO must be used in combination with peginterferon alfa and ribavirin.
- Patienter med detekterbart HCV-RNA i enten uge 4 eller 12 skal behandles i yderligere 36 uger med pegyleret interferon-alfa og ribavirin alene, så den samlede behandlingsvarighed bliver
- Patients with detectable HCV RNA at either weeks 4 or 12 receive an additional 36 weeks of peginterferon alfa and ribavirin alone for a total treatment duration of 48 weeks.
Kutane reaktioner - omfang og symptomer
Extent and features of Cutaneous Reactions
Tidligere partial responders Tidligere null responders omfatter kun data om patienter med resultater for HCV-RNA i uge 4
only includes data on patients who had week 4 HCV RNA available
Pbo/PR48: Placebo i 16 uger i kombination med pegyleret interferon-alfa-2a og ribavirin i 48 uger.
Pbo/PR48: placebo for 16 weeks in combination with peginterferon alfa-2a and ribavirin for 48 weeks
Hvis det først opdages mere end 6 timer efter det sædvanlige tidspunkt for indgift af INCIVO, skal den glemte dosis springes over, og det sædvanlige
If the missed dose is noticed more than 6 hours after the time INCIVO should be taken, the missed dose should be skipped and the patient should resume the normal dosing schedule.
til behandling af skizofreni, bipolar (maniodepressiv) sygdom og svære depressive episoder sovemidler og/eller angstdæmmende midler til at behandle epileptiske anfald (antiepileptika)
to treat schizophrenia, bipolar disorder and major depressive disorder midazolam (taken by mouth), triazolam (taken to help you sleep and/or relieve anxiety (sedatives/hypnotics)
Brugsanvisning
Absorption
Se også produktresuméerne for pegyleret interferon-alfa og ribavirin for alvorlige hudreaktioner i forbindelse
Refer also to the Summary of Product Characteristics for peginterferon alfa and ribavirin for severe skin reactions associated with
dabigatran
INCIVO
SVR-rater for patienter med eller uden cirrose
SVR rates for patients with or without cirrhosis Patients without cirrhosis 65.5% (38/58)
Klinisk kontrol og laboratorieundersøgelser for hyperbilirubinæmi anbefales (se pkt.
Clinical and laboratory monitoring for hyperbilirubinaemia is recommended (see section 4.4 and 4.8).
Anvendelse af INCIVO i kombination med peginterferon og ribavirin anbefales ikke til patienter med
INCIVO in combination with peginterferon and ribavirin is not recommended in patients with platelets < 90,000/mm
methadon til afvænning fra opioidmisbrug (narkotikamisbrug)
metformin to treat diabetes (antidiabetics)
Seponeres permanent behandling med INCIVO, pegyleret interferon-alfa og ribavirin.
INCIVO treatment completed Permanently discontinue treatment with INCIVO, peginterferon alfa, and ribavirin.
parenteral anvendelse af midazolam*
tenofovir disoproxil fumarate*
58% af patienterne var mænd, 23% havde et body mass index ≥ 30 kg/m2, 9% var sorte, 11% var af latinamerikansk afstamning, 77% havde HCV-RNA ≥ 800.000 IE/ml ved baseline, 15% havde brofibrose, 6% havde cirrose, 59% havde HCV af genotype 1a og 40% havde HCV af genotype 1b.
The 1,088 enrolled patients had a median age of 49 years (range: 18 to 69); 58% of the patients were male; 23% had a body mass index ≥ 30 kg/m2; 9% were Black; 11% were Hispanic or Latino; 77% had baseline HCV RNA levels ≥ 800,000 IU/ml; 15% had bridging fibrosis; 6% had cirrhosis; 59% had HCV genotype 1a; and 40% had HCV genotype 1b.
Hvis du holder op med at tage INCIVO
If you take more INCIVO than you should
INCIVO skal anvendes i kombination med pegyleret interferon-alfa og ribavirin.
INCIVO must be used in combination with peginterferon alfa and ribavirin.
Virkningen på koncentrationer af ubundet telaprevir er
Discontinuation of INCIVO combination treatment is not
4.5 skal følges nøje.
Drug interactions need to be carefully taken into account, see sections 4.4 and 4.5.
Hos patienter med HCV-RNA mellem 100 IE/ml og 1.000 IE/ml i uge 12 opnåedes SVR hos 2 ud af 8 patienter (25%).
In patients with HCV RNA between 100 IU/ml and 1,000 IU/ml at week 12,
Behandlingen med INCIVO skal indledes i kombination med pegyleret interferon-alfa og ribavirin og gives i 12 uger (se figur 1).
Duration of treatment - Treatment-naïve adults and prior treatment relapsers Treatment with INCIVO must be initiated in combination with peginterferon alfa and ribavirin and administered for 12 weeks (see figure 1).
Se produktresuméerne for pegyleret interferon-alfa og ribavirin, som skal gives sammen med
Refer to the Summary of Product Characteristics for peginterferon alfa and ribavirin which must be
Dosismodifikation af INCIVO er ikke nødvendig, når lægemidlet anvendes til patienter med hepatitis C og let nedsat leverfunktion
Dose modification of INCIVO is not required when administered to hepatitis C patients with mild hepatic impairment (Child-Pugh A, score 5-6).
Behandling med INCIVO skal indledes i kombination med pegyleret interferon-alfa og ribavirin og gives i 12 uger, hvorefter der behandles med pegyleret interferon-alfa og ribavirin alene (uden INCIVO), indtil den samlede behandlingsvarighed er 48 uger (se figur 2).
Duration of treatment - Previously treated adults with prior partial or prior null response Treatment with INCIVO must be initiated in combination with peginterferon alfa and ribavirin and administered for 12 weeks, followed by peginterferon alfa and ribavirin therapy alone (without INCIVO) for a total treatment duration of 48 weeks (see figure 2).
60% af patienterne var mænd, 32% havde et body mass index ≥ 30 kg/m2, 14% var sorte, 10% var af latinamerikansk afstamning, 82% havde HCV-RNA ≥ 800.000 IE/ml ved baseline, 16% havde brofibrose, 11% havde cirrose, 72% havde HCV af genotype 1a og 27% havde HCV af genotype 1b.
The 540 enrolled patients had a median age of 51 years (range: 19 to 70); 60% of the patients were male; 32% had a body mass index ≥ 30 kg/m2; 14% were Black; 10% were Hispanic or Latino; 82% had baseline HCV RNA levels > 800,000 IU/ml; 16% had bridging fibrosis; 11% had cirrhosis; 72% had HCV genotype 1a; and 27% had HCV genotype 1b.
abacavir zidovudin
abacavir
4.2, 4.5, Immunsupprimerende midler, 4.8 og 5.1 for oplysninger om brugen af INCIVO i kombination med pegyleret interferon alfa og ribavirin til behandlingsnaive og behandlingserfarne HCV-1-inficerede patienter, som var levertransplantatmodtagere og i stabil behandling med de immunsupprimerende midler tacrolimus eller ciclosporin.
For information on the use of INCIVO in combination with peginterferon alfa and ribavirin in treatment-naïve and treatment-experienced HCV-1 infected patients who were liver transplant recipients and were on a stable regimen of the immunosuppressants tacrolimus or cyclosporine A, see sections 4.2,
clarithromycin, erythromycin, telithromycin, troleandomycin til at behandle bakterielle infektioner (antibiotika) blodfortyndende midler til at forebygge blodpropper (antikoagulantia) til at behandle humørforandringer (antidepressiva) til at behandle diabetes (sukkersyge) (antidiabetika) til at behandle kvalme og opkastning (antiemetika) til at behandle svampeinfektioner (antimykotika)
clarithromycin, erythromycin, telithromycin, troleandomycin to treat bacterial infections (antibacterials)
Tabel 3: Bivirkninger af INCIVO (taget i kombination med pegyleret interferon-alfa og ribavirin) hos HCV-inficerede patienter i kliniske studier a og efter markedsføring Bivirkninger
Table 3: Adverse drug reactions to INCIVO (taken in combination with peginterferon alfa and ribavirin) in HCV-infected patients in clinical trials a and post-marketing Adverse Drug Reactions INCIVO, peginterferon alfa, and ribavirin combination therapy oral candidiasis anaemia thrombocytopenia b, lymphopenia hypothyroidism hyperuricaemia b, hypokalaemia gout dysgeusia, syncope
Forsigtighed tilrådes, og klinisk kontrol med laboratorieundersøgelser anbefales.
Caution is warranted, laboratory and clinical monitoring is recommended.
INCIVO i kombination med pegyleret interferon alfa og ribavirin blev evalueret hos 74 HCV-1inficerede levertransplanterede patienter uden cirrose, som fik enten tacrolimus eller ciclosporin.
INCIVO in combination with peginterferon alfa and ribavirin was evaluated in 74 HCV-1 infected, post-liver transplant patients without cirrhosis receiving either tacrolimus or cyclosporine A. At the initiation of INCIVO treatment, doses of co-administered tacrolimus or cyclosporine A need to be markedly reduced, including a prolongation in the dosing interval for tacrolimus, in order to maintain therapeutic plasma concentrations of the immunosuppressant.
Hæmoglobinværdier < 8,5 g/dl blev observeret hos 8%, der fik INCIVO
Haemoglobin values of < 8.5 g/dl were observed in 8% of INCIVO combination treatment compared to 2% of patients receiving peginterferon alfa and ribavirin.
Anæmi
Elderly
filiāle Latvijā
Hispanic Latino
Levertransplantatmodtagere
IMMUNOSUPPRESSANTS
AUC 1,17 (0,97-1,43) Cmax 0,85 (0,73-0,98) Cmin 1,85 (1,40-2,44) telaprevis hæmmer CYP3A
AUC 0.80 (0.76-0.85) Cmax 0.79 (0.74-0.84) Cmin 0.85 (0.75-0.98) ↑ atazanavir AUC 1.17 (0.97-1.43) Cmax 0.85 (0.73-0.98) Cmin 1.85 (1.40-2.44) inhibition of CYP3A by telaprevir