natgillin/translations-raw huggingface dataset:
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).
Close clinical monitoring for respiratory depression and/or prolonged sedation should be exercised during co-administration of Victrelis with intravenous benzodiazepines (alprazolam, midazolam, triazolam). 
Med sočasno uporabo zdravila Victrelis in intravenskih benzodiazepinov (alprazolama, midazolama, triazolama) je treba bolnika natančno klinično spremljati glede depresije dihanja in/ali dolgotrajne sedacije.
Refer to the Summary of Product Characteristics for peginterferon alfa and ribavirin for additional information about how to reduce and/or discontinue the peginterferon alfa and/or ribavirin dose. 
Za dodatne informacije o zmanjšanju odmerka oz. prenehanju uporabe peginterferona alfa in/ali ribavirina glejte povzetek glavnih značilnosti zdravila za peginterferon alfa in ribavirin.
Complete blood counts (with white blood cell differential counts) should be obtained at pretreatment, and at Treatment Weeks 2, 4, 8, 12 and should be monitored closely at other time points, as clinically appropriate. 
Preiskavo popolne krvne slike (z diferencialno sliko belih krvnih celic) je treba opraviti pred zdravljenjem in 2., 4., 8. ter 12. teden zdravljenja in jo skrbno spremljati, ko je klinično primerno.
Very common (may affect more than 1 in 10 people) General: headache; chills, fever; feeling sick (nausea); flu-like symptoms; feeling dizzy, low energy; not being able to sleep; low appetite, weight loss; shortness of breath Mouth, nose or throat: cough; dry mouth; funny taste Skin and hair: dry skin, itching, rash; hair loss or thinning of hair Joints and muscles: unusual weakness; painful, swollen joints; muscle ache not caused by exercise 
Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov) Splošno: glavobol, mrzlica, zvišana telesna temperatura, siljenje na bruhanje (navzea), gripi podobni simptomi, omotica, pomanjkanje energije, nespečnost, slab apetit, hujšanje, težko dihanje (kratka sapa)
Gastroenteritis*, pneumonia*, staphylococcal infection*, candidiasis, ear infection, fungal skin infection, nasopharyngitis, onychomycosis, pharyngitis, respiratory tract infection, rhinitis, skin infection, urinary tract 
Neželeni učinek bronhitis*, celulitis*, herpes simpleks, gripa, glivična okužba v ustih, sinuzitis gastroenteritis*, pljučnica*, stafilokokna okužba*, kandidoza, okužba ušesa, glivična okužba kože, nazofaringitis, onihomikoza, faringitis, okužba dihal, rinitis, okužba kože, okužba sečil epiglotitis*, vnetje srednjega ušesa, sepsa Benigne, maligne in neopredeljene neoplazme (vključno s cistami in polipi) neoplazma na ščitnici (vozliči)
Epistaxis, nasal congestion, oropharyngeal pain, respiratory tract congestion, sinus congestion, wheezing Pleuritic pain*, pulmonary embolism*, dry throat, dysphonia, increased upper airway secretion, oropharyngeal blistering 
plevralna bolečina*, pljučna embolija*, suho žrelo, disfonija, močnejša sekrecija v zgornjih dihalih, orofaringealni mehurji
• Peginterferon alfa-2b + ribavirin for 4 weeks followed by Victrelis 800 mg three times daily + peginterferon alfa-2b + ribavirin for 44 weeks (Victrelis-PR48). 
• Peginterferon alfa-2b + ribavirin 4 tedne in nato 800 mg zdravila Victrelis trikrat na dan + peginterferon alfa-2b + ribavirin 44 tednov (Victrelis-PR48).
• 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.
• Peginterferon alfa-2b + ribavirin for 4 weeks followed by Victrelis 800 mg three times daily + peginterferon alfa-2b + ribavirin for 32 weeks. 
• Peginterferon alfa-2b + ribavirin 4 tedne in nato 800 mg zdravila Victrelis trikrat na dan + peginterferon alfa-2b + ribavirin 32 tednov.
Reminder: Please also read the “Do not use” 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 "Ne jemljite zdravila" v navodilu za uporabo za peginterferon alfa in ribavirin.
Subjects were randomized in a 2:1 ratio and stratified based on cirrhosis/fibrosis and baseline HCV-RNA (< 800,000 IU/mL vs. ≥ 800,000 IU/mL). 
Preiskovanci so bili randomizirani v razmerju 2:1 ter razdeljeni glede na cirozo/fibrozo in HCV-RNA v izhodišču
Table 4 
RESPOND-2
Sexual: missing menstrual period; heavy or prolonged menstrual period; uterine bleeding (i.e., prolonged >7 days or excessive bleeding at irregular or more frequent than normal intervals, bleeding occurring in menopausal women at least 6 months to 1 year after cessation of cycles) Mental illness: anger; hostile attitude or behaviour; threatening behaviour; substance abuse problems, abnormal behaviour; feeling of confusion; thoughts of suicide; sudden intense fear or apprehension; feeling you are being persecuted; difficulty solving problems Muscles: pain in your bones; local or widespread pain 
Duševne bolezni: jeza, sovražnost ali sovražno obnašanje, grozeče obnašanje, težave z zlorabo substanc, nenormalno obnašanje, občutek zmedenosti, razmišljanje o samomoru, nenaden močan strah ali bojazen, preganjavica, težave pri reševanju problemov Mišice: bolečina v kosteh, lokalna ali široko razširjena bolečina
Pharmacotherapeutic group: antivirals for systemic use, protease inhibitors, ATC code: J05AE12 
Farmakoterapevtska skupina: zdravila za sistemsko zdravljenje virusnih infekcij, zaviralci proteaz,
Stomach and gut: pain in stomach and in the upper right side of the stomach or back; a burning feeling in the stomach, upset stomach; feeling bloated, burping (belching) Anus: wind (flatulence); piles (haemorrhoids); difficulty passing stools (constipation) Urinary: going to the toilet to urinate more often than usual Sexual: a decrease in sex drive; difficulty getting or keeping an erection Mental illness: changes in mood, feeling agitated; memory loss, trouble concentrating Chest: difficulty breathing; chest discomfort, chest pain; heavy feeling in the chest, with 
Želodec in črevo: bolečina v želodcu in zgornji desni strani trebuha ali hrbta, pekoč občutek v želodcu, razdražen želodec, napihnjenost, spahovanje Zadnjik: vetrovi (flatulenca), zlata žila (hemoroidi), težave pri iztrebljanju blata (zaprtje) Sečila: pogostejše uriniranje kot po navadi
Relapser: subject who failed to achieve SVR after at least 12 weeks of previous treatment with peginterferon alfa-2b and ribavirin, but had undetectable HCV-RNA at the end of treatment. 
Bolnik z recidivom: preiskovanec, pri katerem po najmanj 12 tednih predhodnega zdravljenja s peginterferonom alfa-2b in ribavirinom ni bil dosežen SVR, je pa imel nezaznavno HCV-RNA ob
Refer to the Summary of Product Characteristics for ribavirin for information regarding dose reduction and/or discontinuation of ribavirin. 
Za informacijo o zmanjšanju odmerka in/ali prekinitvi oz. ukinitvi uporabe ribavirina glejte povzetek glavnih značilnosti zdravila za ribavirin.