FrancophonIA/ELRC3.0 huggingface dataset:
English: This co-administration might be considered on a case by case basis if deemed necessary, in patients with suppressed HIV viral loads and with HIV viral strain without any suspected resistance to the HIV regimen.
Slovenian: Takšna sočasna uporaba lahko pride v poštev pri posameznih bolnikih, ki imajo zmanjšano virusno breme virusa HIV in so okuženi s sevom virusa HIV, za katerega ni nobenega dvoma o rezistenci na režim zdravljenja HIV.
English: The SVR rates for those who received at least one dose of Victrelis (i.e. excluding patients who discontinued during PR lead-in) are 41% for null responders, 67% for partial responders and 96% for relapsers.
Slovenian: Pri tistih, ki so prejeli vsaj en odmerek zdravila Victrelis (tj. brez bolnikov, ki so izstopili med uvajalnim obdobjem s PR), so bili deleži SVR 41 % pri popolnoma neodzivnih bolnikih, 67 % pri delno odzivnih bolnikih in 96 % pri
English: Adverse reactions are listed by System Organ Class (see Table 3).
Slovenian: Neželeni učinki so navedeni po organskih sistemih (glejte preglednico 3).
English: All patients in this treatment arm were limited to 32 weeks of Victrelis.
Slovenian: Zdravljenje z zdravilom Victrelis je bilo pri vseh bolnikih v tej skupini omejeno na 32 tednov.
English: 1 plasma HCV-RNA at Follow-up Week (FW) 24.
Slovenian: 1 plazemska HCV-RNA v 24. tednu spremljanja (TS).
English: The most frequently reported adverse reactions were fatigue, anaemia (see section 4.4), nausea,
Slovenian: Neželeni učinki, o katerih so poročali najpogosteje, so bili: utrujenost, anemija (glejte poglavje 4.4),
English: • CYP3A4 inducer medicines (such as antibiotic medicine - rifampicin, and anticonvulsant medicines - carbamazepine, phenobarbital, phenytoin)
Slovenian: • zdravila, ki inducirajo CYP3A4 (kot so antibiotiki - rifampicin in antikonvulzivi karbamazepin, fenobarbital, fenitoin)
English: • difficulty breathing or swallowing, wheezing, hives, itching, swelling of your face, eyes, lips,
Slovenian: • težave z dihanjem ali požiranjem, piskajoče dihanje, koprivnico, srbenje, otekanje obraza, oči,
English: The race distribution of subjects was as follows: 77% White, 19% Black, and 4% others.
Slovenian: Porazdelitev preiskovancev po rasah je bila naslednja: 77 % belcev, 19 % črncev in 4 % ostalih.
English: Alternative contraceptives should be considered (see section 4.5).
Slovenian: Razmisliti je treba o uporabi drugih kontraceptivov (glejte poglavje 4.5).
English: In poorly interferon responsive patients (defined as < 1-log10 decline in HCV-RNA at TW 4) the use of triple therapy should be considered on a case by case basis, as the likelihood of achieving sustained virologic response (SVR) with triple therapy is lower in these patients (see section 5.1).
Slovenian: Pri bolnikih, slabo odzivnih na interferon (opredeljenih kot tisti, ki so imeli 4. teden zdravljenja < 1-log10 zmanjšanje HCV-RNA), je treba o zdravljenju s tremi zdravili razmisliti pri vsakem posameznem bolniku, ker je verjetnost za dosego trajnega virološkega odziva (SVRSustained Virologic Response) s tremi zdravili pri teh bolnikih manjša (glejte poglavje 5.1).
English: If you have any further questions on the use of this medicine, ask your doctor or pharmacist because
Slovenian: Če imate dodatna vprašanja o uporabi tega zdravila, se posvetujte z zdravnikom ali farmacevtom, ker vaše zdravljenje morda ne bo učinkovito.
English: • ‘ergot' type medicines, such as dihydro-ergotamine, ergonovine, ergotamine or methylergonovine - used for migraine and cluster headaches
Slovenian: • zdravila ergotskega tipa, npr. dihidroergotamin, ergonovin, ergotamin ali metilergonovin uporabljajo se za zdravljenje migrene in glavobolov v rafalih,
English: Food enhanced the exposure of boceprevir by up to 60% at the 800 mg three times daily dose when administered with a meal relative to the fasting state.
Slovenian: Hrana je pri uporabi odmerka 800 mg trikrat na dan povečala izpostavljenost boceprevirju za do 60 %, če je bil zaužit ob obroku, v primerjavi z zaužitjem na tešče.
English: The concomitant use of Victrelis with potent CYP3A4 inducers (rifampicin, carbamazepine, phenobarbital, phenytoin) is not recommended (see section 4.5).
Slovenian: Sočasna uporaba zdravila Victrelis in močnih induktorjev CYP3A4 (rifampicina, karbamazepina, fenobarbitala, fenitoina) ni priporočljiva (glejte poglavje 4.5).
English: Sustained Virologic Response (SVR) in patients receiving similar therapy up to treatment week 36
Slovenian: Trajen virološki odziv (SVR) pri bolnikih, ki prejemajo podobno zdravljenje do 36. tedna
English: • The other ingredients are sodium lauryl sulfate, microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, pre-gelatinized starch, magnesium stearate, yellow iron oxide (E172), red iron oxide (E172), titanium dioxide (E171), gelatin, and shellac.
Slovenian: • Druge sestavine zdravila so natrijev lavrilsulfat, mikrokristalna celuloza, laktoza monohidrat, premreženi natrijev karmelozat, predgelirani škrob, magnezijev stearat, rumeni železov oksid (E 172), rdeči železov oksid (E 172), titanov dioksid (E 171), želatina in šelak.
English: Combination therapy of Victrelis, peginterferon alfa and ribavirin may influence some patients' ability to drive and use machines.
Slovenian: Kombinirano zdravljenje z zdravilom Victrelis, peginterferonom alfa in ribavirinom lahko pri nekaterih bolnikih vpliva na sposobnost vožnje in upravljanja strojev.
English: For data regarding drug-drug interactions with antiretroviral agents, see section 4.5.
Slovenian: Za podatke o medsebojnem delovanju z antiretrovirusnimi zdravili glejte poglavje 4.5.
English: The use of erythropoesis stimulating agents was associated with an increased risk of thromboembolic events including pulmonary embolism, acute myocardial infarction, cerebrovascular accident, and
Slovenian: Uporaba zdravil, ki stimulirajo eritropoezo, je bila povezana s povečanim tveganjem za nastanek tromboemboličnih zapletov, vključno s pljučno embolijo, akutnim miokardnim infarktom, cerebrovaskularnim insultom in globoko vensko trombozo.
English: Victrelis was associated with an additional decrease of approximately 1 g/dL in haemoglobin concentration (see section 4.4).
Slovenian: Zdravilo Victrelis je bilo povezano z dodatnim zmanjšanjem koncentracije hemoglobina za približno 1 g/dl (glejte poglavje 4.4).
English: How to take Victrelis
Slovenian: Kako jemati zdravilo Victrelis
English: Table 10 Sustained Virologic Response (SVR) rates by IL28B rs12979860 genotype
Slovenian: Preglednica 10 Deleži trajnega virološkega odziva (SVR) glede na IL28B rs12979860 genotip
English: Plasma concentrations of calcium channel blockers may increase when administered with Victrelis.
Slovenian: Plazemske koncentracije zaviralcev kalcijevih kanalčkov se lahko povečajo pri sočasni uporabi z zdravilom Victrelis.
English: Caution should be exercised in patients taking drospirenone-containing medicines with conditions that predispose them to hyperkalaemia or patients taking potassium-sparing diuretics.
Slovenian: Previdnost je potrebna pri bolnikih, ki prejemajo zdravila z drospirenonom, s stanji, ki povečujejo nagnjenost k hiperkaliemiji, ter pri bolnikih, ki prejemajo diuretike, ki varčujejo s kalijem.
English: • oral midazolam or oral triazolam - a sedative, given by mouth
Slovenian: • peroralni midazolam ali peroralni triazolam - pomirjevalo (sedativ), ki ga vzamete skozi usta,
English: A greater than 10-fold reduction in boceprevir susceptibility was conferred by the amino acid substitutions R155T and A156S.
Slovenian: Do več kot 10-kratnega zmanjšanja občutljivosti za boceprevir je prišlo ob zamenjavah aminokislin R155T in A156S.
English: The TW 4 response was a stronger predictor of SVR compared to response to previous treatment and allowed the determination of the subject's on-treatment interferon
Slovenian: TZ je bil močnejši napovednik SVR kot odziv na predhodno zdravljenje in je omogočil določitev preiskovančeve odzivnosti na interferon med
English: Seven percent of subjects receiving the combination of Victrelis with peginterferon alfa-2b and ribavirin had neutrophil counts of < 0.5 x 10
Slovenian: Sedem odstotkov preiskovancev, ki so prejemali kombinacijo zdravila Victrelis ter peginterferona alfa-2b in ribavirina, je imelo število nevtrofilcev < 0,5 x 10
English: Boceprevir, in combination with peginterferon alfa and ribavirin, was evaluated in a total of 98 patients (64 in the boceprevir arm) co-infected with Human Immunodeficiency Virus (HIV) and HCV genotype 1 who were previously untreated for chronic HCV infection (see section 4.8 and 5.1).
Slovenian: Boceprevir so v kombinaciji s peginterferonom alfa in ribavirinom ovrednotili pri skupno 98 bolnikih (64 jih je prejemalo boceprevir), ki so bili sočasno okuženi z virusom imunske pomanjkljivosti (HIV) in HCV genotipa 1, in se še niso zdravili zaradi kronične okužbe s HCV (glejte poglavji 4.8 in 5.1).
English: Hypoalbuminemia and low platelet count, as well as severe infections, have been identified as predictive factors of severe complications of liver disease.
Slovenian: Hipoalbuminemija in nizko število trombocitov, kot tudi hude okužbe, so se izkazali kot napovedni
English: Whether on treatment early viral response and/or IL28B genotype could reliably identify those patients who are unlikely to retrieve significant benefit of boceprevir (higher SVR rates or short course treatment duration) on top of the bitherapy is currently under investigation.
Slovenian: Trenutno še preiskujejo, ali lahko na podlagi zgodnjega virološkega odziva na zdravljenje in/ali IL28B genotipa zanesljivo identificiramo bolnike, pri katerih ne bo pomembne koristi zdravljenja z boceprevirjem (večjega deleža SVR ali krajšega zdravljenja) poleg dvojnega zdravljenja.
English: Boceprevir covalently, yet reversibly, binds to the NS3 protease active site serine (Ser139) through a (alpha)-ketoamide functional group to inhibit viral replication in HCV-infected host cells.
Slovenian: Boceprevir je zaviralec proteaze NS3 HCV. Boceprevir se z (alfa)-ketoamidno funkcionalno skupino kovalentno, vendar reverzibilno veže na serin (Ser139) v aktivno mesto proteaze NS3 in tako zavre razmnoževanje virusov v gostiteljskih celicah, okuženih s HCV.
English: The subjects were then continued on different regimens based on Treatment Week (TW) 8 response-guided therapy (Victrelis-RGT).
Slovenian: Potem so preiskovanci nadaljevali z različnimi režimi zdravljenja upoštevaje odziv v 8. tednu zdravljenja (TZ) (Victrelis-RTG - Response
English: Dizziness*, headache*
Slovenian: kašelj*, dispneja*
English: SVR rates with “missing=failure” approach were similar to those in the table: 69.9% (174/249) for subjects randomized to receive ribavirin dose reduction; 68.5% (172/251) for subjects randomized to receive
Slovenian: TS. Deleži SVR pristopom "manjkajoči = neuspeh" so bili podobni tistim v preglednici: 69,9 % (174/249) pri preiskovancih, randomiziranih v skupino z zmanjšanim odmerkom ribavirina; 68,5% (172/251) pri preiskovancih, randomiziranih v skupino, ki je prejemala eritropoetin.
English: • The Physician Educational Materials (PEM)
Slovenian: • izobraževalno gradivo za zdravnike,
English: Co-administration of Victrelis with medicines that induce or inhibit CYP3A4/5 could increase or decrease exposure to Victrelis (see section 4.4).
Slovenian: Sočasna uporaba zdravila Victrelis z zdravili, ki inducirajo ali zavirajo CYP3A4/5, lahko poveča ali zmanjša izpostavljenost zdravilu Victrelis (glejte
English: Table 11 Sustained Virologic Response (SVR) * and Relapse
Slovenian: Preglednica 11 Deleži trajnega virološkega odziva (SVR)* in deleži recidiva
English: Victrelis is a strong inhibitor of CYP3A4/5.
Slovenian: Zdravilo Victrelis je močan zaviralec CYP3A4/5.
English: • antiarrhythmic medicines- amiodarone, quinidine
Slovenian: • antiaritmike - amiodaron, kinidin
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Slovenian: Bolniki z redkimi dednimi motnjami, kot so intoleranca za galaktozo, laponska oblika zmanjšane aktivnosti laktaze ali malabsorpcija glukoze-galaktoze, ne smejo
English: Patients receiving prednisone and Victrelis should be monitored appropriately.
Slovenian: Bolnike, ki prejemajo prednizon in zdravilo Victrelis, je treba ustrezno spremljati.
English: Due to the combined treatment with peginterferon alfa and ribavirin, extreme care must be taken to avoid pregnancy in female patients or in female partners of male patients.
Slovenian: Zaradi kombiniranega zdravljenja s peginterferonom in ribavirinom je potrebna izjemna pazljivost, da bolnice ali partnerke bolnikov ne zanosijo.
English: You or your partner must use an effective birth control during the time you are taking ribavirin and for 7 months after stopping treatment.
Slovenian: Vi ali vaša partnerka morate uporabljati učinkovito kontracepcijsko zaščito v času jemanja ribavirina in še 7 mesecev po zaključku zdravljenja.
English: HCV-RNA levels should be monitored at Treatment Weeks 8, 12, and 24, and for other time points as
Slovenian: Vrednosti HCV-RNA je treba spremljati v 8., 12. in 24. tednu zdravljenja in v drugih časovnih obdobjih, kot je klinično primerno.
English: The addition of boceprevir to peginterferon alfa and ribavirin is associated with an additional decrease in haemoglobin concentrations of approximately 1 g/dL by Treatment Week 8 compared to standard of care (see section 4.8).
Slovenian: Dodatek boceprevirja peginterferonu alfa in ribavirinu je povezan z dodatnim zmanjšanjem koncentracije hemoglobina za približno 1g/dl do 8. tedna zdravljenja v primerjavi s standardnim zdravljenjem (glejte poglavje 4.8).
English: As a conservative measure in view of the limitations of the data, in treatment naïve patients-late responders, the treatment duration of the tritherapy is recommended to be prolonged to 32 weeks as compared to the tested 24 weeks duration of the tritherapy, for a total treatment duration of 48 weeks.
Slovenian: Kot konzervativni ukrep z vidika omejenega števila podatkov pri predhodno nezdravljenih bolnikih s poznim odzivom priporočamo, da se trajanje trojnega zdravljenja podaljša na 32 tednov v primerjavi s preizkušanim 24 tednov trajajočim trojnim zdravljenjem in naj tako celotno zdravljenje traja
English: Subjects randomized to receive erythropoietin (N=251)
Slovenian: Preiskovanci randomizirani v skupino, ki je prejemala eritropoetin (N=251)
English: You must use an effective birth control during the time you are taking ribavirin and for 4 months after stopping treatment.
Slovenian: Uporabljati morate učinkovito kontracepcijo medtem ko jemljete ribavirin in še 4 mesece po zaključku zdravljenja.
English: 9/L) was higher in boceprevir-treated patients (29%) than in placebo-treated patients (17%), in combination with peginterferon alfa-2b and ribavirin.
Slovenian: 9/l) je bil večji med bolniki, ki so prejemali boceprevir (29 %), kot med bolniki, ki so prejemali placebo (17 %), v kombinaciji s peginterferonom alfa-2b in ribavirinom.
English: Victrelis is partly metabolized by CYP3A4/5.
Slovenian: Zdravilo Victrelis se deloma presnavlja s CYP3A4/5.
English: In the limited number of co-infected subjects who did not achieve SVR and for whom population sequencing was performed, the prevalence of post-baseline RAVs was higher than that in mono
Slovenian: Pri omejenem številu preiskovancev s sočasno okužbo, ki niso dosegli SVR in pri katerih so izvedli populacijsko sekvenciranje, je bila prevalenca RAV po začetku zdravljenja višja kot pri preiskovancih
English: Victrelis may be co-administered with AKR inhibitors.
Slovenian: Zdravilo Victrelis se lahko uporablja z zaviralci AKR.
English: • Peginterferon alfa-2b + ribavirin for 48 weeks (PR48).
Slovenian: • Peginterferon alfa-2b + ribavirin 48 tednov (PR48).
English: Continue with all three medicines (PR + Victrelis) and finish through TW 36, and then
Slovenian: 2. nadaljujte z vsemi tremi zdravili (PR + Victrelis) in zaključite do konca 36.
English: Increased clinical and laboratory monitoring for HIV and HCV suppression is recommended.
Slovenian: Priporočamo večji klinični nadzor in spremljanje laboratorijskih parametrov glede zaviranja HIV in HCV.
English: • HIV non-nucleoside reverse transcriptase inhibitor - efavirenz, etravirine
Slovenian: • nenukleozidne zaviralce HIV-reverzne transkriptaze - efavirenz, etravirin
English: Combined use with peginterferon alfa-2a see specific section in section 4.4.
Slovenian: Za sočasno uporabo s peginterferonom alfa-2a glejte ustrezno podpoglavje v poglavju 4.4.
English: If a patient has a serious adverse reaction potentially related to peginterferon alfa and/or ribavirin, the peginterferon alfa and/or ribavirin dose should be reduced.
Slovenian: Če se pojavijo resni neželeni učinki, ki bi lahko bili povezani s peginterferonom alfa in/ali ribavirinom, je treba odmerek peginterferona alfa in/ali ribavirina zmanjšati.
English: Use of ribavirin dose reduction versus erythropoietin in the management of anaemia in previously
Slovenian: Uporaba zmanjšanega odmerka ribavirina v primerjavi z eritropoetinom za obvladovanje anemije pri
English: Table 1 Duration of therapy using Response-Guided Therapy (RGT) guidelines in patients without cirrhosis who are previously untreated or who have failed previous therapy to interferon and ribavirin therapy
Slovenian: Preglednica 1 Smernice za trajanje zdravljenja glede na odziv (RGT - Response Guided Therapy) pri bolnikih brez ciroze, ki se še niso zdravili ali pri njih predhodno zdravljenje z interferonom in ribavirinom ni bilo uspešno
English: The safety profile represented by approximately 1,500 patients for the combination of Victrelis with peginterferon alfa-2b and ribavirin was based on pooled safety data in two clinical trials: one in patients who were previously untreated, and one in patients who had failed prior therapy (see
Slovenian: Varnostni profil pri približno 1.500 bolnikih, zdravljenih s kombinacijo zdravila Victrelis, peginterferona alfa-2b in ribavirina, temelji na kumulativnih podatkih o varnosti iz dveh kliničnih preskušanj: enega pri predhodno nezdravljenih bolnikih in enega pri bolnikih, pri katerih predhodno zdravljenje ni bilo uspešno (glejte poglavje 5.1).
English: Exposure of escitalopram was slightly decreased when co-administered with Victrelis.
Slovenian: Izpostavljenost escitalopramu se je nekoliko zmanjšala pri sočasni uporabi zdravila Victrelis.
English: SVR rates with “missing=failure” approach were 17/80 [21.3%] for PR48, 94/162 [58.0%] for Victrelis-RGT,
Slovenian: TS. Deleži SVR s pristopom "manjkajoči = neuspeh" so bili 17/80 [21,3 %] v skupini PR48, 94/162 [58,0 %] v skupini Victrelis-RGT, 106/161 [65,8 %] v skupini Victrelis-PR48.
English: In both treatment arms, patients with cirrhosis were at a higher risk to experience Grade 3-4 thrombocytopenia compared with non
Slovenian: V obeh skupinah so imeli bolniki s cirozo, v primerjavi z bolniki brez ciroze, večje tveganje za pojav trombocitopenije 3. do 4. stopnje.
English: Mean age of subjects randomized was 43.6 years.
Slovenian: Povprečna starost randomiziranih preiskovancev je bila 43,6 let.
English: Caution should be exercised in patients with conditions that predispose them to hyperkalaemia or patients taking potassiumsparing diuretics (see section 4.4).
Slovenian: Previdnost je potrebna pri bolnikih s stanji, ki povečujejo nagnjenost k hiperkaliemiji, in pri bolnikih, ki prejemajo diuretike, ki varčujejo s kalijem (glejte poglavje 4.4).
English: Mean age of subjects randomized was 49.1 years.
Slovenian: Povprečna starost randomiziranih preiskovancev je bila 49,1 leta.
English: Ten percent of subjects (17/168) were cirrhotic, including 3 (6%) prior null responders, 2 (7%) prior relapsers, and
Slovenian: Deset odstotkov preiskovancev (17/168) je imelo cirozo, med njimi so bili 3 (6 %) popolnoma neodzivni bolniki, 2 (7 %) bolnika s predhodnim recidivom in 12 (14 %) delno odzivnih bolnikov.
English: If there is no such value, the FW 12 value was carried forward.
Slovenian: Če takšne vrednosti ni, se je uporabila vrednost iz 12.
English: Subjects were randomized in a 1:2:2 ratio and stratified based on response to their previous qualifying regimen (relapsers vs. partial responders) and by HCV subtype (1a vs. 1b) to one of the following treatment arms:
Slovenian: Preiskovanci so bili randomizirani v razmerju 1:2:2 in stratificirani glede na odziv na njihov prejšnji režim zdravljenja (bolniki z recidivom v primerjavi z delno odzivnimi) in glede na podtip HCV (1a v primerjavi z 1b) v
English: • If you forget a dose and it is more than 2 hours before your next dose is due, take the missed dose with food.
Slovenian: • Če ste pozabili vzeti odmerek, do naslednjega odmerka pa je več kot 2 uri, vzemite pozabljeni odmerek s hrano.
English: Among the variants, 91% of V36M, 98% of T54A, 71% of T54S, 78% of V55A, 76% of R155K, 92% of A156S, 96% of I/V170A, 77% of R155K+T54S and 95% of R155K+V36M were undetectable by population sequencing.
Slovenian: Med variantami je bilo s populacijskim sekveniranjem nezaznavnih 91 % V36M, 98 % T54A, 71 % T54S, 78 % V55A, 76 % R155K, 92 % A156S, 96 % I/V170A, 77 % R155K+T54S in 95 % R155K+V36M.
English: 1 plasma HCV-RNA at
Slovenian: 1 HCV-RNA
English: • antifungal medicines - ketaconazole, itraconazole, posaconazole, voriconazole
Slovenian: • protiglivna zdravila - ketokonazol, itrakonazol, posakonazol, vorikonazol
English: In subjects treated with boceprevir, interferon responsiveness (as defined by ≥ 1-log10 decline in viral load at Treatment Week 4) was associated with detection of fewer RAVs, with 6% of these subjects having RAVs compared to 41% of subjects with < 1-log10 decline in viral load at Treatment Week 4 (poorly interferon responsive).
Slovenian: Pri preiskovancih, zdravljenih z boceprevirjem, je bila odzivnost na interferon (opredeljena kot ≥ 1-log10 zmanjšanje virusnega bremena 4. teden zdravljenja) povezana z odkritjem manj RAV: RAV je imelo 6 % teh preiskovancev v primerjavi z 41 % tistih, ki so imeli 4. teden zdravljenja < 1-log10 zmanjšanje virusnega bremena (slabo odzivni na interferon).
English: All cirrhotic patients and null responders - Recommended treatment duration is 48 weeks: 4 weeks of bitherapy with peginterferon alfa+ ribavirin + 44 weeks of tritherapy with peginterferon alfa + ribavirin + Victrelis.
Slovenian: Vsi bolniki s cirozo in popolnoma neodzivni bolniki - Priporočeno trajanje zdravljenja je 48 tednov: 4 tedne dvojno zdravljenje s peginterferonom alfa in ribavirinom + 44 tednov trojno zdravljenje s peginterferonom alfa, ribavirinom in zdravilom Victrelis.
English: In clinical trials with the combination of Victrelis, peginterferon alfa-2b and ribavirin compared to peginterferon alfa-2b and ribavirin alone, the median time from the initiation of therapy to onset of haemoglobin less than 10 g/dL was similar (71 days with a range of 15-337 days, and 71 days with a range of 8-337 days, respectively).
Slovenian: V kliničnih preskušanjih s kombinacijo zdravila Victrelis, peginterferona alfa-2b in ribavirina v primerjavi s samo peginterferonom alfa-2b in ribavirinom je bil mediani čas od začetka zdravljenja do pojava padca hemoglobina pod 10 g/dl podoben (71 dni z razponom od 15-337 dni oz. 71 dni z razponom od 8-337 dni).
English: When co-administration is required, starting with the lowest possible dose of atorvastatin should be considered with titration up to desired clinical effect while monitoring for safety, without exceeding a daily dose of 20 mg. For patients currently taking atorvastatin, the dose of atorvastatin should not exceed a daily dose of 20 mg during co-administration with Victrelis.
Slovenian: Če je potrebna sočasna uporaba, je treba razmisliti o začetku zdravljenja z najnižjim možnim odmerkom atorvastatina in titraciji do želenega kliničnega učinka ob spremljanju varnosti, ne da bi presegli dnevni odmerek 20 mg.
English: Pleural fibrosis*, orthopnoea, respiratory failure
Slovenian: plevralna fibroza*, ortopneja, odpoved dihanja
English: No effects on foetal development have been observed in rats and rabbits (see section 5.3).
Slovenian: Pri podganah in kuncih niso opazili učinkov na razvoj ploda (glejte poglavje 5.3).