FrancophonIA/ELRC3.0 huggingface dataset:
English: If you are breast-feeding, your doctor will advise you to discontinue breast-feeding or to discontinue Victrelis while breast-feeding.
Slovenian: Če dojite, vam bo zdravnik svetoval, da prenehate z dojenjem ali da prenehate jemati zdravilo Victrelis, dokler dojite.
English: As compared to the combination of boceprevir with peginterferon alfa-2b and ribavirin, the combination of boceprevir with peginterferon alfa-2a and ribavirin was associated with a higher rate of neutropenia (including grade 4 neutropenia) and a higher rate of infections.
Slovenian: V primerjavi s kombinacijo boceprevirja in peginterferona alfa-2b ter ribavirina je bila kombinacija boceprevirja s peginterferonom alfa-2a in ribavirinom povezana z večjim deležem nevtropenije (vključno z nevtropenijo stopnje 4) in večjim deležem okužb.
English: Combined use with peginterferon alfa-2a as compared to alfa-2b:
Slovenian: Sočasna uporaba s peginterferonom alfa-2a v primerjavi s sočasno uporabo s peginterferonom alfa-2b:
English: The concomitant use of Victrelis with doxazosin and tamsulosin is not recommended (see section 4.5).
Slovenian: Sočasna uporaba zdravila Victrelis z doksazosinom in tamsulozinom ni priporočljiva (glejte poglavje 4.5).
English: Administer peginterferon alfa and ribavirin and finish through TW 48.
Slovenian: 3. uporabljajte peginterferon alfa in ribavirin ter zaključite do konca 48.
English: If other HCV-RNA values were available after FW 24, the last available value in the period after FW 24 was used.
Slovenian: Če so bile na voljo druge vrednosti HCV-RNA po 24.
English: Patients receiving dabigatran should be monitored appropriately.
Slovenian: Bolnike, ki prejemajo dabigatran, je treba ustrezno spremljati.
English: If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking
Slovenian: Če kaj od naštetega velja za vas (ali če niste prepričani), se pred jemanjem zdravila Victrelis posvetujte z zdravnikom ali farmacevtom.
English: However, among poorly interferon-responsive patients to peginterferon alfa-2b/ribavirin during the 4-week lead-in period, the efficacy of boceprevir appeared to be reduced for those who had variants V36M, T54S, V55A or R155K detected at baseline.
Slovenian: Izmed bolnikov, ki so bili med 4-tedenskim uvajalnim obdobjem slabo odzivni na peginterferon alfa-2b/ribavirin, je bila učinkovitost boceprevirja zmanjšana pri tistih, pri katerih so na začetku zdravljenja zaznali variante V36M, T54S, V55A ali R155K.
English: Use in patients who have previously failed treatment with an HCV protease inhibitor
Slovenian: Uporaba pri bolnikih, pri katerih predhodno zdravljenje z enim od zaviralcev proteaze HCV ni bilo
English: Some cases have also been reported in patients coinfected with hepatitis B and C viruses treated with interferon (refer to the Summary of Product Characteristics for peginterferon alfa for more information on HBV reactivation in patients coinfected with HBV and HCV treated with interferon).
Slovenian: O primerih so poročali tudi pri bolnikih, sočasno okuženih z virusoma hepatitisa B in C, ki so se zdravili z interferonom (za več informacij o reaktivaciji HBV pri bolnikih, sočasno okuženih s HBV in HCV, ki se zdravijo z interferonom, glejte povzetek glavnih značilnosti zdravila za peginterferon alfa).
English: C-boceprevir, the most abundant circulating metabolites were a diasteriomeric mixture of ketone-reduced metabolites with a mean exposure approximately 4 fold greater than that of boceprevir.
Slovenian: Po enkratnem peroralnem odmerku 800 mg C-boceprevirja je bilo v obtoku največ presnovkov, ki so bili mešanica diastereomer ketonskih reduciranih presnovkov, s približno 4 krat večjo povprečno izpostavljenostjo, kot je izpostavljenost boceprevirju.
English: Not known (frequency cannot be estimated from the available data) Skin and hair: 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); serious skin reaction, including blistering or peeling of the skin (a reaction called Stevens-Johnson syndrome)
Slovenian: Neznana pogostnost (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti) Koža in lasje: hud izpuščaj, ki ga lahko spremlja zvišana telesna temperatura, utrujenost, otekanje obraza ali limfnih žlez, povišana vrednost eozinofilcev (vrsta belih krvnih celic), učinki na jetra, ledvice ali pljuča (reakcija se imenuje DRESS), resne kožne reakcije, vključno z mehurji in luščenjem kože (reakcija, imenovana Stevens-Johnsonov sindrom) Ledvice: okvara ledvic (ki se po zaključku zdravljenja običajno popravi)
English: The ovulation suppression activity of oral contraceptives containing lower doses of norethindrone/ethinyl estradiol and of other forms of hormonal contraception during coadministration with Victrelis has not been established.
Slovenian: Zaviranja ovulacije s peroralnimi kontraceptivi z manjšimi odmerki noretindrona/etinilestradiola in z drugimi oblikami hormonske kontracepcije pri sočasni uporabi z zdravilom Victrelis niso dokazali.
English: † Rates for using ribavirin dose reduction versus erythropoietin in the management of anaemia in previously untreated subjects
Slovenian: † pri uporabi zmanjšanega odmerka ribavirina v primerjavi z eritropoetinom za obvladovanje anemije pri predhodno nezdravljenih preiskovancih
English: Decreased fertility was also observed in male rats, most likely as a consequence of testicular degeneration (no testicular degeneration has been observed in mice or monkeys).
Slovenian: Zmanjšano plodnost so opazili tudi pri podganjih samcih, najverjetneje zaradi degeneracije testisov.
English: Victrelis must not be used by itself.
Slovenian: Zdravila Victrelis se ne sme uporabiti
English: Table 5 presents sustained virologic response per treatment arm in previously untreated patients who were early responders and late responders and that received similar therapy up to treatment week 28.
Slovenian: Preglednica 5 prikazuje trajen virološki odziv v posamezni zdravljeni skupini pri predhodno nezdravljenih bolnikih z zgodnjim odzivom in s poznim odzivom, ki so bili podobno zdravljeni do 28. tedna zdravljenja.
English: The study included 5 subjects with cirrhosis and 4 were in the
Slovenian: Študija je vključevala 5 preiskovancev s cirozo, 4 so bili zdravljeni z zdravilom Victrelis.
English: Peelable blisters containing 12 hard capsules (3x4 capsule blister strip).
Slovenian: Odlepni pretisni omoti, ki vsebujejo 12 trdih kapsul (pretisni omot s 3 x 4 kapsulami).
English: Blood: low red blood cell count (anaemia), drop in the number of red blood cells - the signs may include feeling tired, headaches, being short of breath when exercising; low neutrophil count (neutropenia), low number of white blood cells - the signs may include getting more infections than usual - including fever, severe chills, a sore throat or mouth ulcers
Slovenian: Kri: znižano število rdečih krvnih celic (anemija), zmanjšano število rdečih krvnih celic - med znaki so lahko utrujenost, glavoboli, kratka sapa pri naporu, znižano število nevtrofilcev (nevtropenija), majhno število belih krvnih celic - med znaki so lahko pogostejše pojavljanje okužb kot po navadi - vključno z zvišano telesno temperaturo, hudo mrzlico, vnetjem žrela ali razjedami v ustih
English: Sustained Virologic Response (SVR) in patients receiving similar therapy up to treatment week 28
Slovenian: Trajen virološki odziv (SVR) pri bolnikih, ki so bili podobno zdravljeni do 28. tedna zdravljenja
English: In clinical trials, the proportion of subjects who received erythropoietin for the management of anaemia was 43% (667/1,548) of subjects in the Victrelis-containing arms compared to 24% (131/547) of subjects receiving peginterferon alfa-2b and ribavirin alone.
Slovenian: V kliničnih preskušanjih je bil delež preiskovancev, ki so prejeli eritropoetin za obvladovanje anemije, v skupinah z zdravilom Victrelis 43 % (667/1.548), med preiskovanci, ki so prejemali samo peginterferon alfa-2b in ribavirin, pa 24 % (131/547).
English: The efficacy of Victrelis as a treatment for chronic hepatitis C genotype 1 infection was assessed in approximately 1,500 adult subjects who were previously untreated (SPRINT-2) or who had failed previous therapy (RESPOND-2) in Phase III clinical studies.
Slovenian: Učinkovitost zdravila Victrelis za zdravljenje okužbe s kroničnim hepatitisom C genotip 1 so ocenili v kliničnih študijah III. faze pri približno 1.500 odraslih preiskovancih, ki predhodno še niso bili zdravljeni (SPRINT-2), ali pri katerih predhodno zdravljenje ni bilo uspešno (RESPOND-2).
English: Therefore, female patients of childbearing potential must use an effective contraceptive during treatment and for 4 months after treatment has been concluded.
Slovenian: Zato morajo bolnice v rodni dobi uporabljati zanesljivo kontracepcijo med zdravljenjem in še štiri mesece po zaključku zdravljenja.
English: The race distribution of subjects was as follows: 85% White, 12% Black, 1% Asian, < 1% multiracial, < 1% Native Hawaiian or Other Pacific Islander.
Slovenian: Porazdelitev preiskovancev po rasah je bila naslednja: 85 % belcev, 12 % črncev, 1 % Azijcev, < 1 % večrasnih, < 1 % domorodcev Havajev ali drugih pacifiških otokov.
English: HIV Non-nucleoside Reverse Transcriptase Inhibitors (NNRTI)
Slovenian: Zaviralci HIV-nenukleozidne reverzne transkriptaze (NNRTI)
English: • intravenous sedatives - benzodiazepines (e.g., alprazolam, midazolam, triazolam)
Slovenian: • pomirjevala, ki jih dobite v žilo - benzodiazepine (npr. alprazolam, midazolam, triazolam)
English: Table 5 Sustained Virologic Response (SVR), End of Treatment (EOT), and Relapse in previously untreated patients (early and late responders)
Slovenian: Preglednica 5 Trajen virološki odziv (SVR), konec zdravljenja (KZ) in recidiv pri predhodno nezdravljenih bolnikih (bolniki z zgodnjim in poznim odzivom)
English: In subjects treated with boceprevir who did not achieve SVR and with post-baseline samples analysed for RAVs, interferon responsiveness was associated with detection of fewer RAVs, with 31% of these subjects having post-baseline RAVs compared to 69% of subjects with < 1-log10 decline in viral load at Treatment Week 4.
Slovenian: Pri preiskovancih, zdravljenih z boceprevirjem, ki niso dosegli SVR in so imeli opravljeno analizo RAV v vzorcih po začetku zdravljenja, je bila odzivnost na interferon povezana z odkritjem manj RAV: po začetku zdravljenja je imelo RAV 31 % teh preiskovancev v primerjavi z 69 % tistih, ki so imeli 4. teden zdravljenja < 1-log10 zmanjšanje virusnega bremena.
English: HIV Nucleoside Reverse Transcriptase Inhibitor (NRTI)
Slovenian: Zaviralec HIV-nukleozidne reverzne transkriptaze (NRTI)
English: A greater than 10-fold reduction in boceprevir susceptibility was conferred by the amino acid substitutions A156S/T/V, V170A, R155W+A156G and V36M+R155K.
Slovenian: Do več kot 10-kratnega zmanjšanja občutljivosti za boceprevir je prišlo ob zamenjavah aminokislin A156S/T/V, V170A, R155W+A156G in V36M+R155K.
English: Neuropathy peripheral*, cognitive disorder, hyperaesthesia, lethargy, loss of consciousness, mental impairment, neuralgia, presyncope
Slovenian: periferna nevropatija*, kognitivna motnja, hiperestezija, letargija, izguba zavesti, mentalna okvara, nevralgija,
English: The transfusion rate was 4% (10/249) in subjects randomized to receive ribavirin dose reduction and 2% (5/251) in subjects randomized to receive erythropoietin.
Slovenian: Delež transfuzije je bil 4 % (10/249) pri preiskovancih, randomiziranih v skupino z zmanjšanim odmerkom ribavirina, in 2 % (5/251) pri tistih, randomiziranih v skupino z
English: There is no specific antidote for overdose with Victrelis.
Slovenian: Za preveliko odmerjanje zdravila Victrelis ni specifičnega antidota.
English: If permanent discontinuation of ribavirin is required, then peginterferon alfa and Victrelis must also be discontinued.
Slovenian: Če je potrebna trajna ukinitev ribavirina, je treba prekiniti tudi uporabo peginterferona alfa in zdravila Victrelis.
English: In an in vitro dog Purkinje fiber study, boceprevir prolonged the action potential duration with inverse frequency dependence; the clinical relevance remains uncertain.
Slovenian: V in vitro študiji na pasjih Purkinijevih vlaknih je boceprevir podaljšal akcijski potencial obratno sorazmerno s frekvenco.
English: Please refer to the Summary of Product Characteristics for peginterferon alfa.
Slovenian: Prosimo, glejte povzetek glavnih značilnosti zdravila za peginterferon alfa.
English: As a conservative measure in view of limitations of the data, in treatment experienced patients early responders, the total treatment duration is recommended to be prolonged to 48 weeks as compared to the tested 36 weeks total treatment duration (tested RGT), with a 12 weeks of peginterferon ribavirin consolidation phase after the end of the tritherapy at week 36.
Slovenian: Kot konzervativni ukrep z vidika omejenega števila podatkov pri že zdravljenih bolnikih z zgodnjim odzivom priporočamo podaljšanje zdravljenja na 48 tednov in to tako, da po koncu trojne terapije v 36. tednu (kolikor je trajalo zdravljenje v kliničnih študijah v skupinah RTG) sledi 12 tedenska utrjevalna faza zdravljenja s peginterferonom in ribavirinom.
English: Mean age of subjects randomized was 49 years.
Slovenian: Srednja starost randomiziranih preiskovancev je bila 49 let.
English: If permanent discontinuation of peginterferon alfa is required, then ribavirin and Victrelis must also be discontinued.
Slovenian: Če je potrebna trajna ukinitev peginterferona alfa, je treba prekiniti tudi uporabo ribavirina in zdravila Victrelis.
English: Victrelis, in combination with peginterferon alfa and ribavirin, is used for chronic hepatitis C virus infection in adults (also called HCV infection).
Slovenian: Zdravilo Victrelis se v kombinaciji s peginterferonom alfa in ribavirinom uporablja za zdravljenje kroničnega hepatitisa C (to okužbo imenujemo tudi okužba s HCV) pri odraslih.
English: Anaemia*, neutropenia* Leukopenia*, thrombocytopenia*, pancytopenia,
Slovenian: anemija*, nevtropenija* levkopenija*, trombocitopenija*, pancitopenija, agranulocitoza
English: Effects on fertility and Sertoli cells have been observed in rats but not in mice and monkeys.
Slovenian: Pri podganah, ne pa tudi pri miših in opicah, so opazili učinke na plodnost in na Sertolijeve celice.
English: Null responders (as defined historically by a decrease in HCV-RNA viral load < 2 log10 by Week 12 to prior therapy) were excluded.
Slovenian: Izključeni so bili popolnoma neodzivni bolniki (opredeljeni anamnestično z < 2 log10 zmanjšanjem virusnega bremena HCV-RNA do 12. tedna pred zdravljenjem).
English: If a patient misses a dose and it is less than 2 hours before the next dose is due, the missed dose
Slovenian: Če bolnik pozabi vzeti odmerek, do naslednjega odmerka pa je manj kot 2 uri, mora pozabljeni
English: While taking the combination of Victrelis with ribavirin and peginterferon alpha, serious allergic reactions have been reported.
Slovenian: Pri kombiniranem zdravljenju z zdravilom Victrelis, ribavirinom in peginterferonom alfa so poročali o resnih alergijskih reakcijah.
English: The number of subjects with cirrhosis is limited (where 39 subjects were treated with Victrelis of
Slovenian: Število preiskovancev s cirozo je omejeno (39 od skupno 49 bolnikov je bilo zdravljenih z zdravilom
English: 938/non-Black and Cohort 2 /Black N=159) and stratified by HCV genotype (1a or 1b) and by HCVRNA viral load (≤ 400,000 IU/mL vs. > 400,000 IU/mL) to one of the following three treatment arms:
Slovenian: Preiskovanci so bili v razmerju 1:1:1 randomizirani v dve kohorti (kohorta 1 N=938/bolniki, ki niso bili črnci, in kohorta 2/črnci N=159) ter stratificirani po genotipu HCV (1a ali 1b) in virusnem bremenu HCV-RNA (≤ 400.000 i.e./ml v primerjavi z > 400.000 i.e./ml) v eno od naslednjih treh skupin zdravljenja:
English: Since Victrelis is prescribed with peginterferon alfa and ribavirin, please also refer to the respective Summary of Product Characteristics of peginterferon alfa and ribavirin.
Slovenian: Ker se zdravilo Victrelis predpisuje skupaj s peginterferonom alfa in ribavirinom, glejte tudi povzetek glavnih značilnosti zdravila za peginterferon alfa in ribavirin.
English: The treatment discontinuation rate due to anaemia was 2% (5/249) in subjects randomized to receive ribavirin dose reduction and 2% (6/251) in subjects randomized to receive erythropoietin.
Slovenian: Delež prekinitve zdravljenja zaradi anemije je bil 2 % (5/249) pri preiskovancih, randomiziranih v skupino z zmanjšanim odmerkom ribavirina, in 2 % (6/251) pri preiskovancih, randomiziranih v skupino z eritropoetinom.
English: Victrelis contains lactose
Slovenian: Zdravilo Victrelis vsebuje laktozo
English: Subjects with these baseline variants and reduced response to peginterferon alfa-2b/ribavirin represented approximately 1% of the total number of
Slovenian: Preiskovanci s temi variantami na začetku zdravljenja in z zmanjšanim odzivom na peginterferon alfa-2b/ribavirin so predstavljali približno 1 % celotnega števila preiskovancev, zdravljenih z boceprevirjem.
English: In a pooled analysis of subjects who were previously untreated and subjects who have failed previous therapy who received four weeks of peginterferon alfa-2b and ribavirin followed by boceprevir 800 mg three times daily in combination with peginterferon alfa-2b and ribavirin in two Phase III studies, post-baseline RAVs were detected in 15% of all subjects.
Slovenian: V kumulativni analizi predhodno še nezdravljenih preiskovancev in preiskovancev, pri katerih predhodno zdravljenje ni bilo uspešno, ki so v dveh študijah III. faze štiri tedne prejemali peginterferon alfa-2b in ribavirin, nato pa 800 mg boceprevirja trikrat na dan v kombinaciji s peginterferonom alfa-2b in ribavirinom, so v obdobju po začetku zdravljenja odkrili RAV pri 15 % preiskovancev.
English: The IC50 and IC90 values for boceprevir against different genotype 1b replicons ranged from 200 to 600 nM and 400 to 900 nM, respectively, in a 72-hour cell culture assay.
Slovenian: V 72-urnem preizkusu na celični kulturi je bila IC50 boceprevirja proti različnim replikacijskim enotam genotipa 1b od 200 do 600 nM in njegova IC90 od 400 do 900 nM.
English: * The Full Analysis Set (FAS) consisted of all subjects who became anaemic (serum haemoglobin of approximately ≤10 g/dL within the treatment period) and were randomized to using either ribavirin dose reduction or erythropoietin (N=500).
Slovenian: ‡ % (n/N) Recidiv % (n/N) *Celotni nabor za analizo (FAS - Full Analysis Set) je obsegal vse preiskovance, ki so postali anemični (vrednost serumskega hemoglobina med zdravljenjem je bila približno ≤10 g/dl) in so bili randomizirani v skupino, ki je prejemala zmanjšan odmerek ribavirina, ali v skupino, ki je prejemala eritropoetin (N=500).
English: The following double amino acid substitutions conferred more than 10-fold reduced sensitivity to boceprevir: V55A+I170V, T54S+R155K, R155K+D168N, R155T+D168N and
Slovenian: Naslednje dvojne zamenjave aminokislin so prinesle več kot 10-krat zmanjšanje občutljivosti za boceprevir: V55A+I170V, T54S+R155K, R155K+D168N, R155T+D168N in V36M+R155K.
English: • birth control medicines - drospirenone
Slovenian: • kontraceptive - drospirenon
English: The addition of boceprevir to peginterferon alfa-2b and ribavirin resulted in higher incidences of neutropenia and Grade 3-4 neutropenia compared with peginterferon alfa-2b and ribavirin alone (see section 4.8).
Slovenian: Dodatek boceprevirja peginterferonu alfa-2b in ribavirinu je povzročil večjo pojavnost nevtropenije in nevtropenijo stopnje 3-4 v primerjavi z zdravljenjem samo s peginterferonom alfa-2b in ribavirinom (glejte poglavje 4.8)
English: Each capsule has a yellowish-brown, opaque cap with an "MSD" logo imprinted in red ink and offwhite, opaque body with the code "314" imprinted in red ink.
Slovenian: Pokrovček kapsule je rumenkasto-rjav, neprozoren in ima z rdečim črnilom natisnjeno oznako "MSD", telo kapsule pa je sivo-belo, neprozorno in ima z rdečim črnilom natisnjeno kodo "314".
English: If the patient has hepatitis C virus ribonucleic acid (HCV-RNA) results greater than or equal to 1,000 IU/mL at TW 8; then discontinue three-medicine regimen.
Slovenian: TZ vrednost ribonukleinske kisline virusa hepatitisa C (HCV-RNA) večjo ali enako 1.000 i.e./ml: ukinite zdravljenje s tremi zdravili.
English: tacrolimus AUC ↑ 1610% tacrolimus Cmax ↑ 890%
Slovenian: takrolimus AUC ↑ 1610 % takrolimus Cmax ↑ 890 %
English: A limited number of subjects (n=12) received ≤ 200mg/day of ribavirin for at least
Slovenian: Omejeno število preiskovancev (n=12) je vsaj 14 dni prejemalo ≤ 200 mg/dan.
English: Concomitant administration of pravastatin with Victrelis increased exposure to pravastatin.
Slovenian: Pri sočasni uporabi pravastatina z zdravilom Victrelis se je povečala izpostavljenost pravastatinu.
English: • Detailed information about the risk of haematological disorders (notably anaemia) associated with Victrelis, consisting of factual description of the haematological disorders in terms of frequency and time to onset and related clinical symptoms
Slovenian: • Natančne informacije o tveganju za hematološke motnje (še posebej anemijo) povezane z zdravilom Victrelis.
English: • However, if it is less than 2 hours before your next dose is due, skip the missed dose.
Slovenian: • Če pa je do naslednjega odmerka manj kot 2 uri, pozabljeni odmerek izpustite.
English: Achievement of SVR was associated with the subject's response to peginterferon alfa-2b and ribavirin therapy, whether defined by classification of response to previous treatment, or by a decrease in HCVRNA at TW 4 (see Table 7).
Slovenian: Doseganje SVR je bilo povezano z odzivom preiskovanca na zdravljenje s peginterferonom alfa-2b in ribavirinom, opredeljenim bodisi z odzivom na predhodno zdravljenje bodisi z zmanjšanjem HCV-RNA 4.
English: Tel: 0800 673 673 673 (+49 (0) 89 4561 2612)
Slovenian: MSD SHARP & DOHME GMBH Tel: 0800 673 673 673 (+49 (0) 89 4561 2612) e-mail@msd.de
English: Each blister cavity is heat sealed closed with the peelable lidding in a configuration of 3 blister cavities per blister card and packaged.
Slovenian: Vsaka jamica je s toplotnim pečatenjem zaprta z odstranljivo prevleko; na
English: Increased clinical and laboratory monitoring for HIV suppression is warranted.
Slovenian: Potrebna sta večji klinični nadzor in spremljanje laboratorijskih parametrov glede zaviranja HIV.
English: Victrelis contains lactose.
Slovenian: Zdravilo Victrelis vsebuje laktozo.
English: In healthy subjects who received 800 mg three times daily alone, boceprevir medicine exposure was characterized by AUC(т) of 6,147 ng
Slovenian: Pri zdravih preiskovancih, ki so prejemali samo 800 mg trikrat na dan, so izpostavljenost boceprevirju opredeljevale AUC(т) 6.147 ng.h/ml, Cmax 1.913 ng/ml in Cmin 90 ng/ml.
English: • Victrelis is always taken in combination with peginterferon alfa and ribavirin.
Slovenian: • Zdravilo Victrelis se vedno jemlje v kombinaciji s peginterferonom alfa in ribavirinom.
English: HMG CoA REDUCTASE INHIBITORS Atorvastatin* (atorvastatin 40 mg single dose + Victrelis 800 mg three times daily)
Slovenian: INHIBITORJI HMG CoA REDUKTAZE Atorvastatin* (atorvastatin 40 mg enkratni odmerek + zdravilo Victrelis 800 mg trikrat na dan)
English: Dose modifications due to anaemia/haemolytic anaemia occurred twice as often in patients treated with the combination of Victrelis with peginterferon alfa-2b and ribavirin (26%) compared to peginterferon alfa-2b and ribavirin alone (13%).
Slovenian: Prilagoditve odmerka zaradi anemije/hemolitične anemije so bile dvakrat pogostejše pri bolnikih, zdravljenih z zdravilom Victrelis ter peginterferonom alfa-2b in ribavirinom (26 %), kot pri tistih, ki so prejemali samo peginterferon alfa-2b in ribavirin (13 %).
English: No dose adjustment of Victrelis or rilpivirine is recommended.
Slovenian: Prilagoditev odmerka zdravila Victrelis ali rilpivirina ni potrebna.