natgillin/translations-raw huggingface dataset:
Caution is recommended when prescribing INCIVO concurrently with medicinal products known to induce QT prolongation and which are CYP3A substrates such as erythromycin, clarithromycin, telithromycin, posaconazole, voriconazole, ketoconazole, tacrolimus, salmeterol (see section 4.5).
Pri predpisovanju zdravila INCIVO sočasno z drugimi zdravili, ki podaljšajo interval QT in so tudi substrati izoencima CYP3A, na primer z eritromicinom, klaritromicinom, telitromicinom, posakonazolom, vorikonazolom, ketokonazolom, takrolimusom ali salmeterolom, svetujemo previdnost (glejte poglavje 4.5).
The response rate in the Pbo/PR arm was higher than that seen in other clinical studies of peginterferon bitherapy (historical SVR rates < 36%).
Stopnja odziva v kraku Pbo/PR je bila, v primerjavi z drugimi kliničnimi študijami dvojnega zdravljenja s peginterferonom
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
↓ telaprevirja AUC 0,80 (0,76-0,85) Cmax 0,79 (0,74-0,84) Cmin 0,85 (0,75-0,98) ↑ atazanavirja AUC 1,17 (0,97-1,43) Cmax 0,85 (0,73-0,98) Cmin 1,85 (1,40-2,44) zaviranje CYP3A s telaprevirjem
During the INCIVO/placebo treatment phase, the most frequently reported ADRs of at least Grade 2 in severity in the INCIVO group (incidence ≥ 5.0%) were anaemia, rash, pruritus, nausea, and
V fazi zdravljenja z zdravilom INCIVO oz. s placebom so, v skupini, ki je prejemala zdravilo INCIVO, najpogosteje poročali o naslednjih neželenih učinkih jakosti najmanj 2. stopnje (pogostnost ≥ 5,0%): anemija, izpuščaj, pruritus, navzea in driska.
Some patients may experience fainting or problems with vision during INCIVO treatment.
Vpliv na sposobnost upravljanja vozil in strojev Pri nekaterih bolnikih se med zdravljenjem z zdravilom INCIVO lahko pojavi omedlevica ali motnje vida.
Telaprevir is a strong inhibitor of the important drug metabolising enzyme CYP3A4.
Telaprevir je močan zaviralec encima CYP3A4, ki je pomemben pri presnovi učinkovin.
If you have any questions about your medicines, please ask your doctor or pharmacist.
Če imate kakršnakoli vprašanja o vaših zdravilih, se posvetujte z zdravnikom ali s farmacevtom.
Recommendations for Monitoring of Cutaneous Reactions and Discontinuation of INCIVO, Ribavirin and Peginterferon alfa for Severe Rash
Priporočila za spremljanje kožnih reakcij in ukinitev zdravil INCIVO, ribavirin in peginterferon alfa v primeru hudega izpuščaja
Most drug-drug interaction studies have been performed with a telaprevir dose of 750 mg every 8 hours (q8h).
Večina študij medsebojnih delovanj z drugimi učinkovinami je bila izvedena z odmerkom 750 mg telaprevirja na 8 ur.
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.
V odprti študiji so imeli bolniki, ki predhodno niso bili zdravljeni, ki so prejemali peginterferon alfa-2a/ribavirin (n = 80) ali peginterferon alfa-2b/ribavirin (n = 81) v kombinaciji z zdravilom INCIVO primerljive stopnje SVR.
In placebo-controlled Phase 2 and 3 trials, anaemia (all grades) was reported in 32.1% of patients who received INCIVO combination treatment and in 14.8% of patients who received peginterferon alfa and ribavirin.
V s placebom nadzorovanih preskušanjih faze II in III so pri 32,1% bolnikov, ki so prejemali kombinirano zdravljenje z zdravilom INCIVO in pri 14,8% bolnikov, ki so prejemali peginterferon alfa in ribavirin poročali o anemiji (vseh stopenj).
Toxic epidermal necrolysis (TEN) including fatal outcome has been observed in post-marketing experience (see section 4.8).
Pri uporabi v obdobju trženja zdravila so opazili pojav toksične epidermalne nekrolize (TEN), vključno z enim smrtnim izidom (glejte poglavje 4.8).
No relevant inhibition by telaprevir of alcohol dehydrogenase was observed in vitro.
V in vitro pogojih telaprevir ni pomembno zaviral alkoholdehidrogenaz.
Close monitoring of metformin efficacy and safety is recommended when starting or stopping INCIVO in patients receiving metformin.
Pri uvajanju in prekinjanju zdravljenja z zdravilom INCIVO je priporočljivo skrbno spremljanje učinkovitosti in varnosti metformina.
The following laboratory evaluations (complete blood count with white blood cell differential counts, electrolytes, serum creatinine, liver function tests, TSH, uric acid) must be conducted in all patients prior to initiating INCIVO combination treatment.
Pred uvedbo kombiniranega zdravljenja z zdravilom INCIVO je treba pri vseh bolnikih opraviti laboratorijske preiskave celotne krvne slike z diferencialno belo krvno sliko, določiti koncentracije elektrolitov, koncentracijo kreatinina v serumu, opraviti preiskave delovanja jeter, določiti koncentracijo TSH, določiti koncentracijo sečne kisline.
Study 107 was an open label, rollover study for patients who were treated in the control group (placebo, peginterferon alfa-2a, and ribavirin) of a Phase 2 study of telaprevir and who did not achieve SVR in the Phase 2 study.
Študija 107 je bila odprta obnovljena študija faze II uporabe telaprevirja pri bolnikih, ki so bili pred tem v kontrolni skupini (in so prejemali placebo, peginterferon alfa-2a in ribavirin) ter niso dosegli trajnega virološkega odziva v študiji druge faze.
For specific dosage instructions for peginterferon alfa and ribavirin, the Summary of Product Characteristics for these medicinal products should be consulted.
Za natančna navodila o odmerjanju peginterferona alfa in ribavirina preberite Povzetek glavnih značilnosti zdravila za obe zdravili.
Liver transplant patients without cirrhosis
Bolniki po preseditvi jeter brez ciroze
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,
Za podatke o uporabi zdravila INCIVO v kombinaciji s peginterferonom alfa in ribavirinom pri še nezdravljenih in že zdravljenih s HCV-1 okuženih bolnikih s presajenimi jetri, ki so prejemali stabilen odmerek imunosupresiva (takrolimus ali ciklosporin A), glejte poglavja 4.2 , 4.5, Imunosupresivi, 4.8 in 5.1.
All patients received 12 weeks of treatment with INCIVO in combination with peginterferon alfa-2a and ribavirin.
Vsi bolniki so se 12 tednov zdravili z zdravilom INCIVO v kombinaciji s peginterferonom alfa-2a in ribavirinom.
- severe rash, which may be accompanied by fever, fatigue, swelling of the face or lymph glands, increase of eosinophils (type of white blood cells), effects on liver, kidney or lung (a reaction called DRESS); - hives (urticaria) - dehydration.
- vnetje trebušne slinavke (pankreasa) - hud izpuščaj, ki ga lahko spremljajo zvišana telesna temperatura, utrujenost, otekanje obraza ali bezgavk, povečanje števila eozinofilcev (vrsta belih krvničk), učinki na jetra, ledvice ali pljuča
IL28B genotype CC
HCV genotip 1b
In clinical trials, the majority of these events (e.g., haemorrhoids, anorectal discomfort, anal pruritus, and rectal burning) were mild to moderate, very few led to treatment discontinuation and resolved after completion of INCIVO dosing.
V kliničnih preskušanjih je bila večina neželenih učinkov (npr. hemoroidi, anorektalne bolečine, analni pruritus in pekoč občutek v danki) blagih do zmernih.
HCV RNA > 1,000 IU/ml at week 12 of treatment
HCV RNK > 1.000 i.e./ml v 12. tednu zdravljenja
Antiretroviral therapy regimens included efavirenz, atazanavir/ritonavir, raltegravir, etravirine, or darunavir/ritonavir in combination with tenofovir or abacavir and either lamivudine or emtricitabine.
Vsi bolniki so prejeli fiksni, 800 mg odmerek ribavirina na dan. Protiretrovirusni režim zdravljenja je vključeval efavirenz, atazanavir/ritonavir, raltegravir, etravirin ali darunavir/ritonavir v kombinaciji z tenofovirjem ali abakavirjem, skupaj z lamivudinom ali
If the missed dose is noticed more than 4 hours after the time INCIVO should be taken, the missed dose should be skipped and the patient should resume the normal dosing schedule.
Če se je na izpuščeni odmerek spomnil več kot 4 ure po času, ko bi ga moral vzeti, naj izpuščeni odmerek preskoči in nadaljuje z običajnim režimom jemanja zdravila.
On-treatment virologic failure was defined as meeting a virologic stopping rule and/or having viral breakthrough.
Virološki neuspeh med zdravljenjem je bil določen s kriterijem za prekinitev zdravljenja in/ali za virusni preboj.
Your doctor may request additional monitoring during your INCIVO treatment.
Med zdravljenjem z zdravilom INCIVO, bo zdravnik morda zahteval dodatno spremljanje.
If co-administered, no dose adjustment is required.
Pri sočasni uporabi prilagajanje odmerkov ni potrebno.
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.
Vključenih je bilo 74 bolnikov, mediana starost je bila 56 let (razpon: 43-68 let); 91,9% je bilo moških; 24,3% je imelo indeks telesne mase ≥ 30 kg/m2; 1,4% je bilo črncev; 95,9% je imelo začetne koncentracije HCV RNK ≥ 800.000 i.e./ml; 10,8% je imelo mostno fibrozo; nihče ni imel ciroze; 38,9% je imelo HCV genotip 1a; 58,3% je imelo HCV genotip 1b; 2,8% je imelo HCV genotip 1d; 21,6% je imelo IL28B genotip CC; 54,1% je imelo IL28B genotip CT; 24,3% je imelo IL28B genotip TT; 28,4% (n = 21) še ni prejemalo zdravil proti HCV; 71,6% (n = 53) se je že zdravilo proti HCV [pri 14,9% (n = 11) se je bolezen po predhodnjem zdravljenju ponovila; pri 40,5% (n = 30) ni bilo odziva na predhodnje zdravljenje; pri 16,2% (n = 12) odziva niso mogli opredeliti]; mediani čas od presaditve jeter je bil 2,5 let (razpon: 0,6-9,5 let); 67,6% (n = 50) je prejemalo takrolimus; 32,4%
There are no clinical data on re-treating patients who have failed an HCV NS3-4A protease inhibitor-based therapy (see section 5.1).
O ponovnem zdravljenju bolnikov, pri katerih je bilo zdravljenje z zaviralcem proteaze HCV NS3-4A neuspešno (glejte poglavje 5.1), ni kliničnih podatkov.
If your doctor stops INCIVO, it should not be restarted.
Če zdravnik prekine vaše zdravljenje z zdravilom INCIVO, ga ne smete ponovno začeti jemati.
BOTTLE LABEL (1-bottle pack)
NALEPKA NA PLASTENKI (1 plastenka)
Use in patients with advanced liver disease
Bolniki s presajenimi jetri
On-treatment virologic failure was defined as meeting a virologic stopping rule or having viral breakthrough.
Virološki neuspeh med zdravljenjem je bil določen s kriterijem za prekinitev zdravljenja ali za virusni preboj.
No or minimal fibrosis or portal fibrosis
Ni fibroze ali minimalna fibroza oziroma portalna fibroza
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.
Če se je na izpuščeni odmerek spomnil več kot 6 ur po času, ko bi ga moral vzeti, naj izpuščeni odmerek preskoči in nadaljuje z običajnim režimom jemanja zdravila.
)/PR: INCIVO 1,125 mg twice daily for 12 weeks with peginterferon alfa-2a and ribavirin for 24 or 48 weeks; T12(q8h)/PR: INCIVO 750 mg every 8 hours for 12 weeks with peginterferon alfa-2a and ribavirin for 24 or 48 weeks Patients with planned total treatment duration of 24 weeks.
)/PR: INCIVO 1.125 mg dvakrat na dan 12 tednov s peginterferonom alfa-2a in ribavirinom 24 ali 48 tednov; T12(q8h)/PR: INCIVO 750 mg na 8 ur 12 tednov s peginterferonom alfa-2a in ribavirinom 24 ali 48 tednov Bolniki z načrtovanim celokupnim trajanjem zdravljenja 24 tednov.
For moderate rash that progresses, permanent discontinuation of INCIVO should be considered.
Če zmeren izpuščaj napreduje, je treba presoditi o prekinitvi zdravljenja z zdravilom INCIVO.
In the placebo-controlled Phase 2 and 3 trials, transfusions were reported during the INCIVO/placebo treatment phase in 2.5% of patients receiving INCIVO combination treatment and 0.7% in patients receiving peginterferon alfa and ribavirin alone.
V s placebom nadzorovanih preskušanjih faze II in III so v fazi zdravljena z zdravilom INCIVO/placebo pri 2,5% bolnikov, ki so prejemali kombinacijo z zdravilom INCIVO, in pri 0,7% bolnikov, ki so prejemali samo peginterferon alfa in ribavirin, poročali o transfuzijah.
Use INCIVO with caution in patients with: - a history of acquired QT prolongation; - clinically relevant bradycardia (persistent heart rate < 50 bpm); - a history of heart failure with reduced left-ventricular ejection fraction; - a requirement for medicinal products known to prolong the QT interval but the metabolism of which is not mainly CYP3A4 dependent (e.g. methadone, see section 4.5).
Zdravilo INCIVO je treba uporabljati previdno pri bolnikih: - ki imajo v pretekli anamnezi pridobljeno podaljšanje intervala QT; - ki imajo klinično pomembno bradikardijo (perzistentna srčna frekvenca < 50 utripov na minuto); - ki imajo v pretekli anamnezi srčno popuščanje z zmanjšanjem iztisne frakcije levega ventrikla;
The primary objective of the study was to assess the antiviral efficacy of INCIVO, peginterferon alfa-2a, and ribavirin in HCV/HIV-1 co-infected patients as measured by SVR12.
Primarni cilj študije je bilo s SVR12 oceniti protiretrovirusno učinkovitost zdravil INCIVO, peginterferona alfa-2a in ribavirina pri bolnikih, sočasno okuženih s HCV/HIV-1.
Ribavirin dose reductions were used for management of anaemia.
Pri zdravljenju anemije so zmanjšali odmerek ribavirina.
dexamethasone if taken by mouth or through to treat asthma or to treat inflammatory and autoimmune conditions (corticosteroids)
budezonid, flutikazon, ki ga vdihnete skozi usta ali nos, deksametazon, ki ga zaužijete skozi usta za zdravljenje astme ali za zdravljenje vnetnih ali avtoimunskih bolezni (kortikosteroidi)
Clinical monitoring is recommended.
Priporočljivo je tudi klinično spremljanje bolnika.
Table 11 shows the response rates for the recommended simultaneous start (T12/PR48) and the Pbo/PR48 arms.
V preglednici 11 so prikazane stopnje odziva za krak s priporočenim sočasnim začetkom zdravljenja (T12/PR48) in krak
Treatment-naive patients or prior relapsers who were non-cirrhotic and achieved extended rapid virologic response (eRVR) received 12 weeks of treatment with INCIVO plus peginterferon alfa-2a and ribavirin followed by 12 weeks of treatment with peginterferon alfa-2a and ribavirin (total treatment duration of 24 weeks).
Nezdravljeni bolniki ali bolniki brez ciroze, pri katerih se je bolezen ponovila in so dosegli hiter virološki odziv (eRVR- extended rapid virologic response), so prejeli 12-tedensko zdravljenje z zdravilom INCIVO, skupaj s peginterferonom alfa-2a in ribavirinom, sledilo mu je 12-tedensko zdravljenje s peginterferonom alfa-2a in ribavirinom (skupno trajanje zdravljenja 24 tednov).
Severe, potentially life-threatening and fatal skin reactions have been reported with INCIVO combination treatment.
Pri kombiniranem zdravljenju z zdravilom INCIVO so poročali o hudih, lahko življenju nevarnih in smrtnih kožnih reakcijah.
At week 12, INCIVO dosing ended and patients continued on peginterferon alfa-2a and ribavirin treatment.
Po 12 tednih so zaključili z jemanjem zdravila INCIVO in nadaljevali z zdravljenjem s peginterferonom alfa-2a in ribavirinom.
Purpose of the medicine flecainide, propafenone to treat certain heart disorders such as irregular heart beat (antiarrhythmics)
za zdravljenje določenih srčnih bolezni, na primer motenj srčnega ritma (antiaritmiki)
Since INCIVO treatment always needs to be used together with peginterferon alfa and ribavirin, please also check the package leaflets for the dosage instructions of these medicines.
Ker je treba zdravilo INCIVO vedno uporabljati skupaj s peginterferonom alfa in ribavirinom preberite tudi navodila za odmerjanje teh dveh zdravil.
Female patients of childbearing age and their male partners A hormonal contraceptive (‘the pill') may not be reliable during the treatment with INCIVO.
Hormonska kontracepcija (na primer tabletka) med zdravljenjem z zdravilom INCVIVO ni zanesljiva.
C - telaprevir and VRT-127394 towards total radioactivity recovered in faeces was 31.8% and 18.7%, respectively.
označenega telaprevirja k skupni količini radioaktivnosti, izmerjene v blatu, je znašal 31,8%, za VRT-127394 pa je znašal
You should contact your doctor immediately if you develop a rash or have a rash that gets worse.
Takoj se obrnite na svojega zdravnika tudi: - če se izpuščaj poslabša ALI
Steady-state exposure to telaprevir was 46% lower in subjects with moderate hepatic impairment (Child-Pugh Class B, score 7-9) compared to healthy subjects.
Izpostavljenost telaprevirju v stanju dinamičnega ravnovesja pri preiskovancih z blago okvaro jeter (razred A po Child-Pughu, ocena 5-6) je bila za 15% manjša kot pri zdravih preiskovancih, izpostavljenost telaprevirju v stanju dinamičnega ravnovesja pri preiskovancih z zmerno okvaro jeter (razred B po Child-Pughu, ocena 7-9) pa je bila za 46% manjša kot pri zdravih preiskovancih.
During the INCIVO/placebo treatment phase, the most frequently reported ADRs of at least Grade 3 in the INCIVO group (incidence ≥ 1.0%) were anaemia, rash, thrombocytopenia, lymphopenia,
V fazi zdravljenja z zdravilom INCIVO oz. placebom so najpogosteje poročali o naslednjih neželenih učinkih jakosti najmanj 3.stopnje, ki je prejemala zdravilo INCIVO (pogostnost ≥ 1,0%): anemija, izpuščaj, trombocitopenija, limfopenija, pruritus innavzea.
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.
Na osnovi populacijskega farmakokinetičnega modela izpostavljenosti telaprevirju v stanju dinamičnega ravnovesja je bila geometrična sredina razmerja najmanjših kvadratov (90% IZ) 1.125 mg dvakrat na dan v primerjavi s 750 mg na osem ur 1,08 (1,02; 1,13) za AUC24,ss, 0,878 (0,827; 0,930) za Cskozi,ss, in 1,18 (1,12;1,24) for Cmax,ss.
Each bottle contains one pouch or two pouches to keep the tablets dry (desiccant).
Vsaka plastenka vsebuje eno ali dve vrečki s sušilnim sredstvom.
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
V združeni skupini, ki je prejemala peginterferon alfa-2a je 73,8% (59/80) bolnikov v primerjavi z 61,7% (50/81) v združeni skupini, ki je prejemala peginterferon alfa-2b, doseglo kriterije za skrajšanje zdravljenja s peginterferonom/ribavirinom na 24 tednov (nezaznavna koncentracija HCV RNK (nezaznaven analit) med tedni 4 do 20).
Table 17: Treatment outcome in genotype 1 HCV-infected liver transplant recipients (Study HPC3006)
Preglednica 17: Izid zdravljenja pri z HCV genotipa 1 okuženih bolnikov s presajenimi jetri
Ελλάδα
Hud izpuščaj
Refer to the Summary of Product Characteristics for peginterferon alfa and ribavirin which must be
Preberite tudi Povzetek glavnih značilnosti zdravil peginterferon alfa in ribavirin, ki ju morate
Tell your doctor if you have had or are going to have a liver or other organ transplant as INCIVO might not be right for you in this situation.
Povejte zdravniku, če so vam ali vam bodo presadili jetra, ker v tem primeru zdravilo INCIVO
Consider consultation with a specialist in dermatology.
Presodite ali je potreben posvet z dermatologom.
Note that the virologic stopping rules taken into account in this treatment outcome analysis are actual stopping rules, i.e., those derived from disposition and exposure data, as opposed to mathematical stopping rules, i.e., derived from the
Opomba: v analizi zdravljenja so upoštevani dejanski kriteriji za prekinitev zdravljenja (kriteriji na osnovi bolezni in podatkov o izpostavljenosti) in ne kriterijev določenih na osnovi podatkov o koncentraciji HCV RNK.
Other medicinal products associated with severe cutaneous reactions should be used with caution during administration of INCIVO combination treatment to avoid potential confusion as to which medicinal product could be contributing to a severe cutaneous reaction.
Da bi se izognili morebitnim dvomom o tem katero zdravilo je povzročilo hudo kožno reakcijo je med kombiniranim zdravljenjem z zdravilom INCIVO pri uporabi drugih zdravil, povezanih s hudimi kožnimi reakcijami potrebna previdnost.
Among patients treated with telaprevir, on-treatment virologic failure was more frequent in patients with genotype 1a than with genotype 1b and more frequent in prior null responders than in other populations (treatment-naïve, prior relapsers, prior partial responders; see section 5.1, Clinical Experience, Efficacy in Previously Treated Adults).
Tudi pri bolnikih, ki se prej niso odzvali na zdravljenje, je bila pogostejša kot pri drugih populacijah (pri še nezdravljenih bolnikih, pri bolnikih, ki so imeli predhodno ponovitev bolezni ali pri tistih, ki so se prej le delno odzvali na zdravljenje; glejte poglavje 5.1, Klinične izkušnje in Učinkovitost pri predhodno
In vitro studies Activity of telaprevir against HCV
Klinične študije za proučevanje intervala QT
These guidelines may not perform similarly when a lead-in treatment with peginterferon alfa and ribavirin has been used prior to starting INCIVO therapy (see section 5.1).
Te smernice morda ne bodo enako učinkovite če se pred uvedbo zdravljenja z zdravilom INCIVO bolnik zdravi s peginterferonom alfa in ribavirinom (glejte
5.8% of patients discontinued INCIVO alone due to rash events and 2.6% of patients discontinued INCIVO combination treatment for rash events compared to none of those receiving peginterferon
Zdravljenje z zdravilom INCIVO v monoterapiji je bilo zaradi pojava izpuščaja ukinjeno pri 5,8% bolnikov, kombinirano zdravljenje z zdravilom INCIVO je bilo zaradi pojava izpuščaja ukinjeno pri 2,6% bolnikov, v primerjavi z bolniki, ki so prejemali samo peginterferon alfa in ribavirin, pri katerih ni bilo nobene ukinitve zdravljenja zaradi pojava izpuščaja.
Refer to section 4.3 for HMG-CoA reductase inhibitors that are contraindicated with INCIVO.
Zaviralci reduktaze HMG-CoA, ki so kontraindicirani pri uporabi zdravila INCIVO, so navedeni v poglavju 4.3.
Examples are: blood count levels, thyroid (a gland in your neck that controls your metabolism) levels, liver and kidney
Primeri so: število nekaterih krvnih celic, koncentracije ščitničnih (žleza v vratu, ki uravnava presnovo) hormonov, preiskave delovanja
Not applicable.
Podatki niso na voljo.
The denominator when calculating the relapse rate represents the number of patients with end-of-treatment response (HCV RNA < 25 IU/ml).
Število bolnikov z odzivom ob zaključku zdravljenja (HCV RNA < 25 IU/ml) predstavlja imenovalec pri izračunu stopnje relapsa.
- 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.
- Bolniki z zaznavno koncentracijo HCV RNK v 4. ali v 12. tednu naj prejemajo samo peginterferon alfa in ribavirin še dodatnih 36 tednov, do skupnega trajanja zdravljenja 48 tednov.
Telaprevir exposure was similar regardless of whether the total daily dose of 2,250 mg was administered as 750 mg every 8 hours (q8h) or 1,125 mg twice daily (b.i.d.).
Ne glede na to, ali je bil dnevni odmerek 2.250 mg zaužit kot 750 mg na osem ur ali kot 1.125 mg dvakrat na dan, je bila celokupna izpostavljenost telaprevirju podobna.
No adjustment of methadone dose is required when initiating co-administration of telaprevir.
Ob uvedbi zdravljenja s telaprevirjem ni potrebna prilagoditev odmerka metadona.