natgillin/translations-raw huggingface dataset:
In subjects who demonstrated interferon responsiveness by TW 4, treatment with the combination of Victrelis with peginterferon alfa-2b and ribavirin resulted in SVR rates of 79-81%, compared to 51% in subjects treated with standard of care.
TZ, je zdravljenje s kombinacijo zdravila Victrelis ter peginterferona alfa-2b in ribavirina povzročilo delež SVR od 79 do 81 %, v primerjavi z 51 % pri preiskovancih, zdravljenih s standardnim zdravljenjem.
Heart or circulation: fast or uneven heart-beat; high or low blood pressure Blood: drop in the number of blood platelets - the signs may include bleeding or bruising more easily than usual; high sugar (glucose) levels in the blood; high triglycerides levels in the blood; high uric acid levels in the blood; a combination of low platelet, red and white blood cell counts (pancytopenia); a severe drop of neutrophil count (agranulocytosis)
Prsni koš: težko dihanje, nelagodje v prsnem košu, bolečina v prsnem košu, občutek teže v prsnem košu s težkim dihanjem ali piskajočim dihanjem Srce in obtočila: hitro ali neredno bitje srca, visok ali nizek krvni tlak Kri: zmanjšanje števila trombocitov - med znaki so lahko krvavitve ali hitrejše pojavljanje modric kot po navadi, visoka vrednost sladkorja (glukoze) v krvi, visoka vrednost trigliceridov v krvi, visoka vrednost sečne kisline v krvi, kombinacija majhnega števila trombocitov, rdečih in belih krvnih celic (pancitopenija), močno zmanjšano število nevtrofilcev (agranulocitoza)
Victrelis in combination with ribavirin and peginterferon alfa is contraindicated in women who are
Zdravilo Victrelis v kombinaciji z ribavirinom in peginterferonom alfa je kontraindicirano pri
Patients who failed previous therapy: prior null responders, partial responders and relapsers to
Bolniki, pri katerih predhodno zdravljenje ni bilo uspešno: na predhodno zdravljenje z interferonom in ribavirinom popolnoma neodzivni bolniki, delno odzivni bolniki in bolniki z recidivom
- if you are a woman of childbearing age who is taking ribavirin: you must have a negative pregnancy test before treatment, each month during treatment, and for the 4 months after treatment is stopped.
Pri vas mora biti nosečnostni test negativen pred zdravljenjem, vsak mesec med zdravljenjem in še 4 mesece po zaključku zdravljenja.
No dose adjustment of digoxin or Victrelis is recommended.
Prilagoditev odmerka digoksina ali zdravila Victrelis ni potrebna.
**** Partial Responder: subject who failed to achieve SVR after at least 12 weeks of previous treatment with peginterferon alfa-2b and ribavirin, but demonstrated a ≥ 2 log10 reduction in HCVRNA by Week 12 and had detectable HCV-RNA at End of Treatment (EOT).
****Delno odzivni bolnik: preiskovanec, pri katerem po najmanj 12 tednih predhodnega zdravljenja s peginterferonom alfa-2b in ribavirinom ni bil dosežen SVR, je pa do 12. tedna bilo doseženo ≥ 2 log10 zmanjšanje HCV-RNA, in je ob koncu zdravljenja (KZ) imel zaznavno HCV-RNA.
Eleven subjects were missing TW 4 assessment (HCV-RNA) and were not included in the Lead-In
TZ manjkajoče izvide (HCV-RNA) in niso bili vključeni v rezultate
In C/C patients receiving tritherapy 89% in treatment naive were HCV-RNA undetectable by TW 8 and eligible for shorter duration of therapy as compared to 52% in treatment naïve non C/C.
TZ in zato možnost za krajše zdravljenje 89 % predhodno nezdravljenih bolnikov , v primerjavi z 52 % ne-C/C še ne zdravljenih bolnikov.
A secondary analysis of subjects who received at least one dose of Victrelis or placebo after the four-week lead-in with peginterferon alfa-2b and ribavirin (ModifiedIntent-to-Treat population) demonstrated SVR rates in the combined cohort of 67% to 68% Victreliscontaining arms vs. 40% PR48 control.
Sekundarna analiza preiskovancev, ki so po štiri-tedenskem obdobju uvajanja s peginterferonom alfa-2b in ribavirinom prejeli vsaj en odmerek zdravila Victrelis ali placeba (Modified-Intent-to-Treat population), je pokazala v kombinirani kohorti z zdravilom Victrelis delež SVR od 67 % do 68 %, v kontrolni skupini PR48 pa 40 %.
RESPOND-2 (P05101) was a randomized, parallel-group, double-blinded study comparing two therapeutic regimens of Victrelis 800 mg orally three times daily in combination with PR [peginterferon alfa-2b 1.5 µg/kg/week subcutaneously and weight-based ribavirin (600 1,400 mg BID) orally divided twice daily] compared to PR alone in adult subjects with chronic hepatitis C HCV genotype 1 infection with demonstrated interferon responsiveness (as defined historically by a decrease in HCV-RNA viral load ≥ 2 log10 by Week 12 or undetectable HCV-RNA at end of prior treatment with a subsequent detectable HCV-RNA in plasma) and who failed prior treatment with peginterferon alfa and ribavirin.
Študija RESPOND-2 (P05101) je bila randomizirana, dvojno slepa študija vzporednih skupin, ki je primerjala dva režima zdravljenja z 800 mg zdravila Victrelis peroralno trikrat na dan v kombinaciji s PR [peginterferon alfa-2b 1,5 µg/kg/teden subkutano in ribavirin na podlagi telesne mase (600 1.400 mg dvakrat na dan) peroralno razdeljeno v dva dnevna odmerka] in samo PR pri odraslih preiskovancih z okužbo s kroničnim hepatitisom C HCV genotipa 1 ter dokazano odzivnostjo na interferon (v anamnezi opredeljeno z ≥ 2 log10 zmanjšanjem virusnega bremena HCV-RNA do 12. tedna ali nezaznavno HCV-RNA na koncu prejšnjega zdravljenja in s pozneje zaznavno HCVRNA v plazmi), pri katerih predhodno zdravljenje s peginterferonom alfa-2b in ribavirinom ni bilo uspešno.
No dose adjustment required for Victrelis or raltegravir.
Prilagoditev odmerka zdravila Victrelis ali raltegravirja ni potrebna.
Table 8 presents sustained virologic response per treatment arm in patients who had failed previous therapy that were early responders and late responders and that received similar therapy up to
Preglednica 8 prikazuje trajen virološki odziv v posameznih skupinah pri bolnikih, pri katerih predhodno zdravljenje ni bilo uspešno, z zgodnjim odzivom ali s poznim odzivom, ki so prejemali
Among the 314 subjects, 230 were infected with genotype 1a HCV and 84 were infected with genotype 1b HCV. Seventy percent (70%) (162/230) of genotype 1a subjects no longer had any RAVs detected at the boceprevir-resistance associated loci by population sequencing.
Med 314 preiskovanci je bilo 230 okuženih s HCV genotipa 1a in 84 s HCV genotipa 1b.
General: light-headedness, arthritis; increased tendency to bleed; swollen glands in neck or armpit or groin; intense burning or stabbing pain; increased sensitivity to light, sound, what is felt, or food one tastes; diabetes
Občasni (pojavijo se lahko pri največ 1 od 100 bolnikov) Splošno: omotičnost, artritis, povečana nagnjenost h krvavitvam, otekle bezgavke na vratu, v pazduhah ali dimljah, izrazita pekoča ali zbadajoča bolečina, večja občutljivost za svetlobo, zvok, dotike ali okuse hrane, sladkorna bolezen
The safety and efficacy of Victrelis alone or in combination with peginterferon alfa and ribavirin for the treatment of chronic hepatitis C genotype 1 infection in liver or other organ transplant recipients have not been studied (see section 4.5).
Varnost in učinkovitost zdravila Victrelis samega ali v kombinaciji s peginterferonom alfa in ribavirinom za zdravljenje kroničnega hepatitisa C genotipa 1 pri bolnikih, ki imajo presajena jetra ali druge organe, nista raziskani (glejte poglavje 4.5).
Human plasma protein binding is approximately 75% following a single dose of Victrelis 800 mg. Boceprevir is administered as an approximately equal mixture of two diastereomers which rapidly interconvert in plasma.
Boceprevir se uporablja kot približno enaka mešanica dveh diastereomer, ki se v plazmi hitro medsebojno pretvarjata.
The proportion of subjects with decreased neutrophils was higher in the Victrelis-containing arms compared to subjects receiving only peginterferon alfa-2b and ribavirin.
Delež preiskovancev z zmanjšanim številom nevtrofilcev je bil v skupinah, zdravljenih z zdravilom Victrelis, večji kot med preiskovanci, ki so prejemali samo peginterferon alfa-2b in ribavirin.
Haemorrhagic diathesis, lymphadenopathy, lymphopenia
hemoragična diateza, limfadenopatija, limfopenija
Stomach and gut: diarrhoea; being sick (vomiting) Mental illness: feeling anxious; feeling of deep sadness or of being worthless (depression);
Duševne bolezni: občutek tesnobe, občutek globoke žalosti ali ničvrednosti (depresija), razdražljivost, napetost in nemir
Refer to the Summary of Product Characteristics for peginterferon alfa and ribavirin for baseline, ontreatment and post-treatment laboratory testing recommendations including haematology, biochemistry (including hepatic function tests), and pregnancy testing.
Glede priporočenih vrednosti laboratorijskih preiskav v izhodišču, med zdravljenjem in po zaključku zdravljenja, ki vključujejo hematologijo, biokemijo (vključno s preiskavami delovanja jeter), in glede preverjanja nosečnosti, glejte povzetek glavnih značilnosti zdravila za peginterferon alfa in ribavirin.
Previous Relapser = subject who failed to achieve SVR after at least 12 weeks of previous treatment with peginterferon alfa and ribavirin, but had undetectable HCV-RNA at the end of treatment.
Prej z recidivom = preiskovanci, ki niso dosegli SVR po vsaj 12 tednih predhodnega zdravljenja s peginterferonom alfa in ribavirinom, a so imeli na koncu zdravljenja nezaznavno HCV-RNA.
Clinical data (semen analyses and inhibin B levels - [a glycoprotein produced by Sertoli cells - used as a surrogate marker of testicular function]) showed no evidence of altered testicular function.
Klinični podatki (analiza semenske tekočine in koncentracija inhibina B [glikoproteina, ki nastaja v Sertolijevih celicah in se uporablja kot nadomestni označevalec delovanja mod]) niso pokazali znakov spremenjenega delovanja mod. Razpoložljivi farmakodinamični/toksikološki podatki pri podganah so pokazali učinke boceprevirja/presnovkov na plodnost; za te učinke se je pri samicah pokazalo, da so reverzibilni (glejte poglavje 5.3).
• were a patient who has previously failed treatment with an HCV protease inhibitor
• če je bilo pri vas predhodno zdravljenje z zaviralcem HCV proteaze neuspešno,
(CYP3A inhibition and/or P-gp
(zaviranje CYP3A in OATPB1)
Retinal ischaemia*, retinopathy*, abnormal sensation in eye, conjunctival haemorrhage, conjunctivitis, eye pain, eye pruritus, eye swelling, eyelid oedema, lacrimation increased, ocular hyperaemia, photophobia
možganska ishemija*, encefalopatija suho oko, mrežnični eksudati, zamegljen vid, okvara vida ishemija mrežnice*, retinopatija*, nenormalen občutek v očesu, veznična krvavitev, konjunktivitis, bolečina v očeh, srbenje oči, oteklost oči, edem očesne veke, močnejše solzenje, očesna hiperemija, fotofobija
If the patient has confirmed, detectable HCV-RNA at TW 24; then discontinue three-medicine
TZ potrjeno zaznavno HCV-RNA: ukinite zdravljenje s tremi zdravili.
(CYP3A inhibition - effect on quetiapine)
(zaviranje CYP3A - učinek na maravirok)
%(n/N) * The Intent-to-Treat (ITT) population consisted of all subjects (N=168) who received at least one dose of any study medicine (peginterferon alfa-2b, ribavirin, or Victrelis).
* Populacija z namenom zdravljenja (ITT populacija) vključuje vse preiskovance (N=168), ki so prejeli vsaj en odmerek katerega študijskega zdravila (peginterferon alfa-2b, ribavirin ali zdravilo Victrelis).
Coadministration of quetiapine with Victrelis is contraindicated (see section 4.3).
Sočasna uporaba kvetiapina z zdravilom Victrelis je kontraindicirana (glejte poglavje 4.3).
Relapse %(n/N) * The Full Analysis Set (FAS) consisted of all randomized subjects (N=98) who received at least one dose of any study medicine (peginterferon alfa-2b, ribavirin, or Victrelis).
Recidiv % (n/N) * Celotni nabor za analizo (FAS - Full Analysis Set) je obsegal vse randomizirane preiskovance (N=98), ki so prejeli vsaj en odmerek katerega koli raziskovanega zdravila (peginterferona alfa-2b, ribavirina ali zdravila Victrelis).
The number of subjects with cirrhosis is limited (where 40 subjects were treated with Victrelis of the
Število bolnikov s cirozo je majhno (40 od skupno53 bolnikov je bilo zdravljenih z zdravilom
PROVIDE (P05514) was an open-label, single-arm study of Victrelis 800 mg orally three times daily in combination with PR [peginterferon alfa-2b 1.5 µg/kg/week subcutaneously and weight-based ribavirin (600 1,400 mg BID) orally divided twice daily] in adult subjects with chronic hepatitis C (HCV) genotype 1 infection who did not achieve SVR while in the PR control arms of previous Phase 2 and 3 studies of combination therapy with Victrelis.
Študija PROVIDE (P05514) je bila odprta študija z eno skupino z zdravilom Victrelis 800 mg peroralno trikrat na dan v kombinaciji s PR [peginterferon alfa-2b 1,5 µg/kg/teden subkutano in ribavirin odvisno od telesne mase (600 - 1.400 mg dvakrat na dan) peroralno, razdeljeno v dva odmerka] pri odraslih bolnikih s kronično okužbo s hepatitisom C (HCV) genotipa 1, ki niso dosegli SVR v PR kontrolnih skupinah prejšnjih študij faze II in III s kombiniranim zdravljenjem z zdravilom Victrelis.
Interferon-responsiveness (as defined by ≥ 1-log10 decline in viral load at TW 4) was predictive of SVR.
Odzivnost na interferon (opredeljena kot ≥ 1-log10 zmanjšanje virusnega bremena v 4.
Chest discomfort*, chest pain*, malaise*, feeling of body temperature change, mucosal dryness, pain Feeling abnormal, impaired healing, non-cardiac chest
nelagodje v prsih*, bolečina v prsih*, splošno slabo počutje*, občutek spremenjene telesne temperature, suhost sluznic, bolečina
Treatment with pravastatin can be initiated at the recommended dose when co-administered with Victrelis.
Pri sočasni uporabi zdravila Victrelis se zdravljenje s pravastatinom lahko začne s priporočenim odmerkom.
Previous Partial Responder = subject who failed to achieve SVR after at least 12 weeks of previous treatment with peginterferon alfa and ribavirin, but demonstrated a ≥ 2 log10 reduction in HCV-RNA by Week 12 and had detectable HCV-RNA at End of Treatment (EOT).
Prej delno odzivni = preiskovanci, ki niso dosegli SVR po vsaj 12 tednih predhodnega zdravljenja s peginterferonom alfa in ribavirinom, a so do 12. tedna dosegli zmanjšanje HCV-RNA ≥ 2 log10 in so ob koncu zdravljenja (KZ) imeli zaznavno HCV-RNA.
Gelatin
šelak
T/T
TS.
† in previously untreated subjects with HIV co-infection
Bolniki s sočasno okužbo s HIV
The Full Analysis Set (FAS) consisted of all randomized subjects (N=1,097) who received at least one dose of any study medicine (peginterferon alfa-2b, ribavirin, or Victrelis).
Celotni nabor za analizo (FAS - Full Analysis Set) je obsegal vse randomizirane preiskovance (n = 1.097), ki so prejeli vsaj en odmerek kateregakoli raziskovanega zdravila (peginterferona alfa-2b, ribavirina ali zdravila Victrelis).
Co-administration of oral midazolam and oral triazolam with Victrelis is contraindicated (see section 4.3).
Sočasna uporaba peroralnega midazolama oz. peroralnega triazolama z zdravilom Victrelis je kontraindicirana (glejte poglavje 4.3).
The safety and efficacy of Victrelis alone or in combination with peginterferon alfa and ribavirin for the treatment of chronic hepatitis C genotypes other than genotype 1 have not been established.
Varnost in učinkovitost zdravila Victrelis samega ali v kombinaciji s peginterferonom alfa in ribavirinom za zdravljenje kroničnega hepatitisa C drugih genotipov kot genotipa 1 nista bili
In particular, do not take Victrelis if you are taking any of the following medicines: • alfuzosin and silodosin - used to treat symptoms of an enlarged prostate
• alfuzosin in silodozin - uporabljata se za zdravljenje simptomov povečane prostate,
If other HCVRNA values were available after FW 24, the last available value in the period after FW 24 was used.
TS, je bila uporabljena zadnja razpoložljiva vrednost po 24.
General: difficult breathing and swallowing; tumour of the thyroid; infection of the blood; swelling or lumps in organs of the body; disease which leads to increasing muscle paralysis; disease of the brain - signs may include headache and fever, paralysis of a part of the body, a stiff neck or being sensitive to light
Redki (pojavijo se lahko pri največ 1 od 1.000 bolnikov) Splošno: težko dihanje in požiranje, tumor ščitnice, okužba krvi, oteklost ali bule v telesnih organih, bolezen, ki povzroči naraščajočo ohromelost mišic, bolezen možganov - med znaki so lahko glavobol in zvišana telesna temperatura, ohromelost dela telesa, tog vrat ali občutljivost
• Store outside of the refrigerator at or below 30°C for a period of not more than 3 months until expiry.
• Shranjujte izven hladilnika pri temperaturi do 30 °C ne več kot 3 mesece in do izteka roka uporabnosti.
General disorders and administration site conditions Asthenia*, chills, fatigue*, pyrexia*, influenza-like
astenija*, mrzlica, utrujenost*, pireksija*, gripi podobna bolezen
Table 3 Adverse reactions in combination with Victrelis with peginterferon alfa-2b and ribavirin reported during clinical trials
Neželeni učinki pri kombinaciji zdravila Victrelis s peginterferonom alfa-2b in ribavirinom, o katerih
• Store outside of the refrigerator at or below 30C for a period of not more than 3 months until
• Shranjujte izven hladilnika pri temperaturi do 30 C ne več kot 3 mesece in do izteka roka
Boceprevir was shown to be devoid of embryonic or teratogenic potential in both rats and rabbits at maternotoxic dose levels.
Pokazalo se je, da boceprevir pri odmerkih, ki so toksični za matere, nima vpliva na plod ali teratogenega potenciala ne pri podganah ne pri kuncih.
The Full Analysis Set (FAS) consisted of all randomized subjects (N=403) who received at least one dose of any study medicine (peginterferon alfa-2b, ribavirin, or Victrelis).
Celotni nabor za analizo (FAS - Full Analysis Set) je obsegal vse randomizirane preiskovance (n = 403), ki so prejeli vsaj en odmerek kateregakoli raziskovanega zdravila (peginterferona alfa-2b, ribavirina ali zdravila Victrelis).
Complete blood counts (with white blood cell differential counts) should be obtained at pretreatment, and at Treatment Weeks 2, 4, 8, and 12, and should be monitored closely at other time points, as
Celotno krvno sliko (z diferencialno sliko belih krvnih celic) je treba pregledati pred začetkom zdravljenja, v 2., 4., 8. in 12. tednu zdravljenja in jo skrbno spremljati v drugih časovnih obdobjih, kot
Victrelis does not inhibit or induce the other enzymes
Zdravilo Victrelis ne zavira in
Reminder: Please also read the “Pregnancy and breast-feeding” section of the Package Leaflets for peginterferon alfa and ribavirin before you start taking Victrelis.
Opozorilo: Preden začnete jemati zdravilo Victrelis, prosimo, preberite tudi poglavje "Nosečnost in dojenje" v navodilih za uporabo za peginterferon alfa in ribavirin.
Lead-In Response (Viral Load Reduction)
Odziv med uvajalnim obdobjem (zmanjšanj e virusnega bremena)
diltiazem, felodipine, nicardipine, nifedipine, nisoldipine, verapamil)
• zdravilo za znižanje krvnega tlaka - zaviralci kalcijevih kanalčkov (npr. amlodipin, diltiazem, felodipin, nikardipin, nifedipin, nizoldipin, verapamil)
(tacrolimus 0.5 mg single dose + Victrelis 800 mg three times daily multiple doses)
(enkraten peroralni odmerek 4 mg + zdravilo Victrelis 800 mg trikrat na dan)
Rilpivirine* (rilpivirine 25 mg every 24 hours + Victrelis 800 mg three times daily)
Etravirin* (etravirin 200 mg vsakih 12 ur + zdravilo Victrelis 800 mg trikrat na dan)
Dysuria, nocturia Renal impairment
dizurija, nikturija
Boceprevir has a mean apparent volume of distribution (Vd/F) of approximately 772 l at steady state.
Povprečni navidezni volumen porazdelitve boceprevirja (Vd/F) je v stanju dinamičnega ravnovesja približno 772 l. Vezava na humane beljakovine v plazmi je po enkratnem odmerku 800 mg zdravila Victrelis približno 75 %.
The addition of Victrelis to the peginterferon alfa-2b and ribavirin therapy significantly increased the SVR rates compared to peginterferon alfa-2b and ribavirin therapy alone (59% to 66% Victreliscontaining arms vs. 21% PR48 control) for randomized subjects who received at least one dose of any study medicine (Full-Analysis-Set population) and decreased the length of therapy to 36 weeks for many previous treatment failures (see Table 7).
Dodatek zdravila Victrelis zdravljenju s peginterferonom alfa-2b in ribavirinom je pri randomiziranih preiskovancih, ki so prejeli vsaj en odmerek kateregakoli raziskovanega zdravila (Full Analysis Set population) značilno povečal deleže SVR v primerjavi z zgolj kombinacijo peginterferona alfa-2b in ribavirina (59 % do 66 % v skupinah z zdravilom Victrelis v prim.
The most common reason for dose reduction was anaemia, which occurred more frequently in subjects receiving the combination of Victrelis with peginterferon alfa-2b and ribavirin than in subjects receiving peginterferon alfa-2b and ribavirin alone.
Anemija je bila pogostejša pri preiskovancih, ki so prejemali zdravilo Victrelis in peginterferon alfa-2b in ribavirin, kot pri preiskovancih, ki so prejemali samo peginterferon alfa-2b in ribavirin.
o Subjects with undetectable HCV-RNA at TW 8 (early responders) and TW 12
TZ nezaznavno HCV-RNA (zgodnji odziv) in so bili HCV-RNA negativni do 24.
lopinavir AUC ↓ 34% lopinavir Cmax ↓ 30% lopinavir Cmin ↓ 43%
etravirin AUC ↓ 23 % etravirin Cmax ↓ 24 % etravirin Cmin ↓ 29 %
Hypotension*, hypertension Deep vein thrombosis*, flushing, pallor, peripheral
globoka venska tromboza*, zardevanje, bledica, mrzli periferni deli telesa
Concomitant administration of Victrelis with sirolimus requires significant dose reduction and prolongation of the dosing interval for sirolimus, with close monitoring of sirolimus blood concentrations and frequent assessments of renal function and sirolimus-related side effects.
Sočasna uporaba zdravila Victrelis s sirolimusom zahteva bistveno zmanjšanje odmerka in podaljšanje intervala odmerjanja sirolimusa.
Aggression*, homicidal ideation*, panic attack*, paranoia*, substance abuse*, suicidal ideation*, abnormal behaviour, anger, apathy, confusional state, mental status changes, restlessness Bipolar disorder*, completed suicide*, suicide attempt*, hallucination auditory, hallucination visual, psychiatric
hipokaliemija*, motnja apetita, sladkorna bolezen, protin, hiperkalciemija anksioznost*, depresija*, nespečnost, razdražljivost čustvena labilnost, agitacija, motnja libida, spremembe razpoloženja, motnje spanja agresivnost*, homicidno razmišljanje*, napad panike*, paranoja*, zloraba opojnih substanc*, samomorilno razmišljanje*, nenormalno vedenje, jeza, apatija, stanje zmedenosti, spremembe duševnega stanja, nemir bipolarna motnja*, dovršen samomor*, poskus samomora*, slušne halucinacije, vidne halucinacije, psihiatrična dekompenzacija omotica*, glavobol* hipestezija*, parestezije*, sinkopa*, amnezija, motnje pozornosti, okvara spomina, migrena, parozmija, tremor,
Refer to the Summary of Product Characteristics for peginterferon alfa and ribavirin for additional
Za dodatne informacije glejte povzetka glavnih značilnosti zdravila za peginterferon alfa in ribavirin.
Concomitant administration of Victrelis with tacrolimus requires significant dose reduction and prolongation of the dosing interval of tacrolimus, with close monitoring of tacrolimus blood concentrations and frequent assessments of renal function and tacrolimus-related side effects.
Sočasna uporaba zdravila Victrelis s takrolimusom zahteva bistveno zmanjšanje odmerka in podaljšanje intervala odmerjanja takrolimusa.
Table 6 Sustained Virologic Response (SVR)*, End of Treatment (EOT) and HCV Relapse Rates
Preglednica 6 Trajen virološki odziv (SVR)*, konec zdravljenja (KZ) in HCV recidiv † - deleži pri preiskovancih s sočasno okužbo s HIV, ki se še niso zdravili
Serious, acute hypersensitivity reactions (e.g., urticaria, angioedema) have been observed during combination therapy with Victrelis, peginterferon alfa, and ribavirin.
Med kombiniranim zdravljenjem z zdravilom Victrelis, peginterferonom alfa in ribavirinom so opazili resne, akutne preobčutljivostne reakcije (npr. urtikarijo, angioedem).