FrancophonIA/ELRC3.0 huggingface dataset:
English: Eyes or ears: pink eye; eye pain; deafness; trouble hearing; swelling around the eyelid; increased tearing; fluid draining from the ear or eye; abnormal feeling around the eye, red patch on the white of the eye; yellowing of the white part of the eyes or of the skin Mouth, nose or throat: hoarseness, dry throat or lips; painful or bleeding gums; sensitive tooth or toothache; tongue swollen, discoloured, or has sores; blistering by the tongue; severe pain when swallowing; chest pain close to the lungs; chest pain worsens when taking a deep breath; uncontrolled salivating; overactive thyroid gland Skin and hair: hives; open sore; intolerance to heat; markedly red face; pale face; yellow skin; rash due to sunlight; wound not healing normally Feet or hands or legs or arms: sensation of pain, numbness, tingling or prickling; blood clot in a vein; feeling cold in an arm or leg; painful inflammation of the joints most commonly in the foot (gout)
Croatian: Oči ili uši: suhe oči; zvonjenje u ušima; promjene vida Usta, nos ili grlo: bol u ustima, zubobolja; bol pri gutanju; krvarenje iz nosa, začepljen nos; promjene osjeta mirisa; bolne uzdignute površine u ustima; osjećaj jake žeđi uz suha usta ili suhu kožu; oticanje štitnjače, vrata ili glasnica; smanjena aktivnost štitnjače; bol ili otekline u ustima, osjećaj žarenja jezika; osjećaj napetosti ili začepljenosti u nosu, obrazima i iza očijuponekad uz pulsirajuću bol, vrućicu ili začepljen nos (sinusitis) Koža i kosa: bolni mjehurići obično nakon povišene temperature, trnci ili utrnulost kože; oslabljeni osjećaj ili osjet dodira; osip kože, mrljasti osip kože, crvenilo kože; crveni uzdignuti osip kože, ponekad s gnojnim mjehurićima; vruća, osjetljiva i crvena koža, ponekad uz vrućicu i zimicu; pojačano znojenje; kožna bolest sa zadebljalim crvenim mrljama na koži - često sa
English: Papilloedema
Croatian: Trombociti
English: Diarrhoea*, nausea*, vomiting* dry mouth, dysgeusia Abdominal pain*, abdominal pain upper*, constipation*, gastrooesophageal reflux disease*, haemorrhoids*, abdominal discomfort, abdominal distention, anorectal discomfort, aphthous stomatitis, cheilitis, dyspepsia, flatulence, glossodynia, mouth ulceration, oral pain, stomatitis, tooth disorder
Croatian: pleuralna bol*, plućna embolija*, suho grlo, disfonija, pojačana sekrecija gornjih dišnih putova, mjehurići u pleuralna fibroza*, ortopneja, zatajenje disanja proljev*, mučnina*, povraćanje*, suha usta, disgeuzija abdominalna bol*, bol u gornjem dijelu abdomena*, opstipacija*, gastroezofagealna refluksna bolest*, hemoroidi*, nelagoda u abdomenu, distenzija abdomena, anorektalna nelagoda, aftozni stomatitis, heilitis, dispepsija, flatulencija, glosodinija, ulceracije u ustima, bol u ustima,
English: 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).
Croatian: Relaps % (n/N) * Cijeli set analiza (FAS) obuhvaćao je sve randomizirane ispitanike (N= 98) koji su primili barem jednu dozu bilo kojeg studijskog lijeka (peginterferona alfa-2b, ribavirina ili lijeka Victrelis).
English: 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.
Croatian: Nakon jednokratne doze lijeka Victrelis od 800 mg, vezanje na proteine u plazmi u ljudi iznosi približno 75%.
English: No dose adjustment of omeprazole or Victrelis is recommended.
Croatian: Ne preporučuje se prilagođavati dozu omeprazola niti lijeka Victrelis.
English: 1 plasma HCV-RNA at
Croatian: 1 HCV-RNK u plazmi na kraju
English: The race distribution of subjects was as follows: 82% White, 18% Non-White, 14% Black, 3% Asian, and 1% Multiracial.
Croatian: Raspodjela ispitanika po rasama bila je kako slijedi: 82% bijelaca, 18% drugih rasa osim bijelaca: 14% crnaca, 3% Azijata, 1% miješane rase.
English: 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
Croatian: Manje česte (mogu se javiti se u do 1 na 100 osoba) Općenito: ošamućenost, artritis; povećana sklonost krvarenju; otečene žlijezde u vratu, pod pazuhom ili u preponama; jaka žareća ili probadajuća bol; pojačana osjetljivost na svjetlost, zvukove, dodir ili na okus hrane; šećerna bolest
English: 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).
Croatian: Nisu ispitivane sigurnost primjene i djelotvornost lijeka Victrelis primijenjenog samostalno ili u kombinaciji s peginterferonom alfa i ribavirinom u liječenju kroničnog hepatitisa C genotipa 1 u primatelja presatka jetre ili nekog drugog organa (vidjeti dio 4.5).
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).
Croatian: RAV-ovi su ustanovljeni u 6% ovih ispitanika, u usporedbi s 41% ispitanika u kojih je u 4. tjednu liječenja zabilježeno smanjenje virusnog opterećenja od < 1-log10 (ispitanici sa slabim odgovorom na
English: Null responders (as defined historically by a decrease in HCV-RNA viral load < 2 log10 by Week 12 to prior therapy) were excluded.
Croatian: Iz ispitivanja su isključeni bolesnici koji nisu odgovorili na prethodnu terapiju (što se uobičajeno definiralo kao smanjenje virusnog opterećenja HCV-RNK za < 2 log10 do 12. tjedna prethodnog liječenja).
English: diltiazem, felodipine, nicardipine, nifedipine, nisoldipine, verapamil)
Croatian: • lijek za snižavanje krvnog tlaka - blokatori kalcijevih kanala (npr. amlodipin, diltiazem, felodipin, nikardipin, nifedipin, nisoldipin, verapamil)
English: Victrelis must not be administered in the absence of peginterferon alfa and ribavirin.
Croatian: Victrelis se ne smije primijeniti bez peginterferona alfa i
English: Pregnancy must be avoided due to the use of Victrelis with ribavirin.
Croatian: Zbog primjene lijeka Victrelis s ribavirinom, trudnoća se mora izbjegavati.
English: • Store outside of the refrigerator at or below 30C for a period of not more than 3 months until expiry.
Croatian: • Čuvati izvan hladnjaka na temperaturi do 30C najdulje 3 mjeseca, ali ne dulje od isteka roka valjanosti.
English: 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).
Croatian: Cijeli set analiza (FAS) sastojao se od svih randomiziranih ispitanika (N= 403) koji su primili barem jednu dozu bilo kojeg studijskog lijeka (peginterferona alfa-2b, ribavirina ili lijeka Victrelis).
English: † Rates for using ribavirin dose reduction versus erythropoietin in the management of anaemia in previously untreated subjects
Croatian: Tablica 11 Stope trajnog virološkog odgovora (SVR)* i relapsa † kod snižavanja doze ribavirina u odnosu na primjenu eritropoetina za liječenje anemije u bolesnika koji prethodno nisu bili liječeni
English: 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
Croatian: Vrlo česte (mogu se javiti u više od 1 na 10 osoba) Općenito: glavobolja; zimica, vrućica; mučnina; simptomi nalik gripi; osjećaj omaglice; nedostatak energije; nemogućnost spavanja; slabi tek; smanjenje tjelesne težine; nedostatak zraka
English: Infections and infestations Common:
Croatian: Opći poremećaji i reakcije na mjestu primjene Vrlo često:
English: SVR § % (n/N) EOT % (n/N) Relapse
Croatian: SVR § % (n/N) EOT % (n/N)
English: Retinal ischaemia*, retinopathy*, abnormal sensation in eye, conjunctival haemorrhage, conjunctivitis, eye pain, eye pruritus, eye swelling, eyelid oedema, lacrimation increased, ocular hyperaemia, photophobia
Croatian: cerebralna ishemija*, encefalopatija suho oko, mrežnični eksudati, zamagljen vid, poremećaj ishemija mrežnice*, retinopatija*, neuobičajeni osjeti u oku, krvarenje iz očne spojnice, konjunktivitis, bol u oku, svrbež oka, oticanje oka, edem vjeđe, pojačano suzenje, očna hiperemija, fotofobija gluhoća*, nelagoda u uhu, oštećenje sluha
English: %(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).
Croatian: * Populacija koju se namjerava liječiti (ITT) obuhvaćala je sve ispitanike (N=168) koji su primili najmanje jednu dozu bilo kojeg studijskog lijeka (peginterferona alfa-2b, ribavirina ili lijeka Victrelis).
English: It is not recommended to co-administer lopinavir/ritonavir and Victrelis.
Croatian: Ne preporučuje se istodobna primjena lopinavira/ritonavira s lijekom Victrelis.
English: 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.
Croatian: Od bolesnika s genotipom C/C na trojnoj terapiji, 89% njih koji prethodno nisu bili liječeni imali su nemjerljivu razinu HCV-RNK do 8. tjedna
English: No dose adjustment of buprenorphine/naloxone or Victrelis is recommended.
Croatian: Ne preporučuje se prilagođavati dozu buprenorfina/naloksona niti lijeka Victrelis.
English: 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.
Croatian: Ispitanik s prethodnim relapsom = ispitanik koji nije postigao SVR nakon najmanje 12 tjedana prethodnog liječenja peginterferonom alfa i ribavirinom, ali je imao nemjerljivu razinu HCV-RNK
English: 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.
Croatian: RESPOND-2 (P05101) je bilo randomizirano, dvostruko slijepo, placebom kontrolirano ispitivanje paralelnih skupina u kojem su uspoređena dva režima liječenja: Victrelis 800 mg peroralno triput na dan u kombinaciji s PR-om [peginterferonom alfa-2b supkutano u dozi od 1,5 µg/kg/tjedno i ribavirinom u dozi prilagođenoj tjelesnoj težini bolesnika (600 1400 mg na dan) peroralno, podijeljeno u dvije doze] u usporedbi s primjenom samo PR-a u odraslih bolesnika s kroničnim hepatitisom C HCV genotipa 1 koji su odgovorili na liječenje interferonom (odgovorom se smatralo smanjenje virusnog opterećenja HCV-RNK za ≥ 2 log10 do 12. tjedna liječenja ili nemjerljiva razina HCV-RNK na kraju prethodnog liječenja uz kasnije mjerljivu HCV-RNK u plazmi), a koji nisu odgovorili na prethodnu terapiju peginterferonom alfa i ribavirinom.
English: Reminder: Please also read the “Pregnancy and breast-feeding” section of the Package Leaflets for peginterferon alfa and ribavirin before you start taking Victrelis.
Croatian: Podsjetnik: Prije nego počnete uzimati Victrelis, molimo pročitajte i dio "Trudnoća i dojenje" u Uputama o lijeku za peginterferon alfa i ribavirin.
English: 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 patients co-infected with hepatitis B virus
Croatian: Nisu ispitivane sigurnost primjene i djelotvornost lijeka Victrelis primijenjenog samostalno ili u kombinaciji s peginterferonom alfa i ribavirinom u liječenju kroničnog hepatitisa C genotipa 1 u bolesnika koji su istodobno zaraženi virusom hepatitisa B (HBV) i HCV-om.
English: A greater than 10-fold reduction in boceprevir susceptibility was conferred by the amino acid substitutions R155T and A156S.
Croatian: Aminokiselinske supstitucije R155T i A156S smanjile su osjetljivost na boceprevir više od 10 puta.
English: 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
Croatian: Psihičke bolesti: ljutnja; neprijateljski stav ili ponašanje; prijeteće ponašanje; problemi sa zlouporabom lijeka ili droga, neuobičajeno ponašanje; zbunjenost; razmišljanje o samoubojstvu; iznenadan intenzivan strah ili predosjećaj; osjećaj proganjanja; otežano rješavanje problema Mišići: bol u kostima; lokalizirana bol ili bol koja se širi
English: Also, tell your doctor or pharmacist if you are taking any of the following:
Croatian: Također recite liječniku ili ljekarniku ako uzimate neki od sljedećih lijekova: • lijekove za kontrolu začeća - drospirenon
English: Rectum or anus: anal itching; inability to pass stools or discoloured stools; more frequent
Croatian: Debelo crijevo ili anus: svrbež u analnom području; nemogućnost stolice ili promjena boje stolice; učestala stolica; krvarenje iz anusa
English: Other side effects include:
Croatian: Proaritmijski učinci:
English: P05411 was a phase II randomized, double-blind, placebo-controlled study comparing Victrelis 800 mg orally three times daily in combination with PR [peginterferon alfa-2b 1.5 µg/kg/week subcutaneously and weight-based dosing with ribavirin (600-1,400 mg/day orally)] to PR alone in subjects co-infected with HIV and HCV genotype 1 who were previously untreated for chronic HCV infection.
Croatian: P05411 je bilo randomizirano, dvostruko slijepo, placebom kontrolirano ispitivanje faze II u kojem je uspoređena primjena lijeka Victrelis 800 mg peroralno triput na dan u kombinaciji s PR-om [peginterferonom alfa-2b supkutano u dozi od 1,5 µg/kg/tjedno i ribavirinom u dozi prilagođenoj tjelesnoj težini bolesnika (600 -1400 mg/dan peroralno)] s primjenom samo PR-a u ispitanika istodobno zaraženih HIV-om i HCV-om genotipa 1 koji prethodno nisu bili liječeni zbog kronične HCV infekcije.
English: Neutrophils (see section 4.4)
Croatian: • U trudnoći (vidjeti dio 4.6).
English: 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).
Croatian: Ispitanik koji je prethodno djelomično odgovorio na terapiju = ispitanik koji nije postigao SVR nakon najmanje 12 tjedana prethodnog liječenja peginterferonom alfa i ribavirinom, ali je imao smanjenje razine HCV-RNK od ≥ 2 log10 do 12. tjedna i mjerljivu razinu HCV-RNK na kraju
English: Serious, acute hypersensitivity reactions (e.g., urticaria, angioedema) have been observed during combination therapy with Victrelis, peginterferon alfa, and ribavirin.
Croatian: Tijekom kombinirane terapije lijekom Victrelis, peginterferonom alfa i ribavirinom primijećene su ozbiljne, akutne reakcije preosjetljivosti (npr. urtikarija, angioedem).
English: Patients who failed previous therapy: prior null responders, partial responders and relapsers to
Croatian: Bolesnici koji nisu odgovorili na prethodnu terapiju: bolesnici koji su na prethodnu terapiju interferonom i ribavirinom odgovorili djelomično ili su doživjeli relaps
English: A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČ ODGOVORAN ZA PUŠTANJE SERIJE LIJEKA
English: If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking
Croatian: Ako se nešto od navedenog odnosi na Vas (ili niste sigurni), porazgovarajte s liječnikom ili ljekarnikom prije nego uzmete Victrelis.
English: Null responders*** in parent study
Croatian: Bolesnici bez ikakvog odgovora*** u izvornom ispitivanju
English: 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.
Croatian: PROVIDE (P05514) je bilo otvoreno ispitivanje s jednom skupinom u kojem se ispitivao Victrelis u peroralnoj dozi od 800 mg triput na dan u kombinaciji s PR-om [peginterferonom alfa-2b supkutano u dozi od 1,5 µg/kg/tjedno i ribavirinom u dozi prilagođenoj tjelesnoj težini bolesnika (600 1400 mg/dan) peroralno, podijeljeno u dvije doze] u odraslih ispitanika s kroničnom infekcijom hepatitisom C (HCV) genotipa 1 koji nisu postigli SVR dok su bili u PR kontrolnim skupinama u prethodnim ispitivanjima kombinirane terapije s lijekom Victrelis faze II i III.
English: 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 clinically appropriate.
Croatian: Treba napraviti kompletnu krvnu sliku (uz diferencijalnu bijelu krvnu sliku) prije početka liječenja te u 2., 4., 8. i 12. tjednu liječenja, a potrebno je i pažljivo praćenje u drugim vremenskim točkama, prema kliničkoj potrebi.
English: Chest discomfort*, chest pain*, malaise*, feeling of body temperature change, mucosal dryness, pain Feeling abnormal, impaired healing, non-cardiac chest
Croatian: nelagoda u prsištu*, bol u prsištu*, malaksalost*, osjećaj promjene tjelesne temperature, suhoća sluznice, bol
English: SPRINT-2 (P05216) was a randomized, double blinded, placebo-controlled 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 dosing with ribavirin (6001,400 mg/day orally divided twice daily)] to PR alone in adult subjects who had chronic hepatitis C HCV genotype 1 infection with detectable levels of HCV-RNA and were not previously treated with interferon alfa therapy.
Croatian: SPRINT-2 (P05216) je bilo randomizirano, dvostruko slijepo, placebom kontrolirano ispitivanje u kojem su uspoređena dva režima liječenja: Victrelis 800 mg peroralno triput na dan u kombinaciji s PR-om [peginterferonom alfa-2b supkutano u dozi od 1,5 µg/kg/tjedno i ribavirinom u dozi prilagođenoj tjelesnoj težini bolesnika (600 -1400 mg/dan peroralno, podijeljeno u dvije doze)] u usporedbi s primjenom samo PR-a u odraslih bolesnika s kroničnim hepatitisom C HCV genotipa 1 s mjerljivom razinom HCV-RNK i koji prethodno nisu bili liječeni interferonom alfa.
English: Relapse rate was the proportion of subjects with undetectable HCV-RNA at End of Treatment (EOT) and detectable HCV-RNA at End of Follow-up (EOF) among subjects who were undetectable at EOT and not missing EOF data.
Croatian: Stopa relapsa je udio ispitanika s nemjerljivom razinom HCV-RNK na kraju liječenja (EOT), ali mjerljivom HCV-RNK na kraju razdoblja praćenja (EOF) među ispitanicima s nemjerljivom razinom na EOT za koje su postojali podaci na EOF.
English: 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).
Croatian: Full Analysis Set, FAS) obuhvaćao je sve randomizirane ispitanike (N= 1097) koji su primili barem jednu dozu bilo kojeg studijskog lijeka (peginterferona alfa-2b, ribavirina ili lijeka Victrelis).
English: Reporting of side effects
Croatian: Dugoročni podaci o djelotvornosti
English: • Peginterferon alfa-2b + ribavirin for 4 weeks followed by Victrelis 800 mg three times daily + peginterferon alfa-2b + ribavirin for 44 weeks (Victrelis-PR48).
Croatian: • Peginterferon alfa-2b + ribavirin tijekom 4 tjedna, a zatim Victrelis 800 mg triput na dan + peginterferon alfa-2b + ribavirin tijekom 44 tjedna (Victrelis-PR48).
English: • Peginterferon alfa-2b + ribavirin for 4 weeks followed by Victrelis 800 mg three times daily + peginterferon alfa-2b + ribavirin for 32 weeks.
Croatian: • Peginterferon alfa-2b + ribavirin tijekom 4 tjedna, a zatim Victrelis 800 mg triput na dan + peginterferon alfa2b + ribavirin tijekom 32 tjedna.
English: Boceprevir also undergoes, to a lesser extent, oxidative metabolism
Croatian: Boceprevir je, također, u manjoj mjeri podložan oksidativnom metabolizmu posredovanom enzimom CYP3A4/5.
English: **** 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).
Croatian: ***Ispitanik bez odgovora: ispitanik u kojega je smanjenje vrijednosti HCV-RNK do 12. tjedna liječenja peginterferonom alfa-2b i ribavirinom bilo manje od 2-log10 **** Ispitanik s djelomičnim odgovorom: ispitanik koji nije uspio postići SVR nakon najmanje 12 tjedana prethodnog liječenja peginterferonom alfa-2b i ribavirinom, ali u kojega je zabilježeno smanjenje vrijednosti HCV-RNK ≥ 2 log10 do 12. tjedna i koji je imao mjerljive razine HCV-RNK na
English: 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
Croatian: Kompletnu krvnu sliku (s diferencijalnom krvnom slikom leukocita) potrebno je odrediti prije liječenja te u 2., 4., 8. i 12. tjednu liječenja, a pomno je nadzirati u drugim vremenskim točkama,
English: • Peginterferon alfa-2b + ribavirin for 4 weeks followed by Victrelis 800 mg three times daily + peginterferon alfa-2b + ribavirin for 24 weeks.
Croatian: • Peginterferon alfa-2b + ribavirin tijekom 4 tjedna, a zatim Victrelis 800 mg triput na dan + peginterferon alfa-2b + ribavirin tijekom 24 tjedna.
English: **Relapse rate was the proportion of subjects with undetectable HCV-RNA at End of Treatment (EOT) and detectable HCV-RNA at End of Follow-up (EOF) among subjects who were undetectable
Croatian: **Stopa relapsa je udio bolesnika s nemjerljivom razinom HCV-RNK na kraju liječenja (EOT), ali mjerljivom razinom HCV-RNK na kraju razdoblja praćenja (EOF) među ispitanicima s nemjerljivom razinom na EOT za koje su postojali podaci na EOF.
English: HMG CoA REDUCTASE INHIBITORS Atorvastatin* (atorvastatin 40 mg single dose + Victrelis 800 mg three times daily)
Croatian: Midazolam* (peroralna primjena) (pojedinačna peroralna doza od 4 mg + Victrelis 800 mg triput na dan)
English: No dose adjustment of dabigatran is recommended.
Croatian: Ne preporučuje se prilagođavati dozu dabigatrana.
English: Reminder: Please also read the “Do not use” section of the Package Leaflets for peginterferon alfa and ribavirin before you start taking Victrelis.
Croatian: Podsjetnik: Prije nego počnete uzimati Victrelis, pročitajte i dio "Nemojte uzimati" u Uputama o lijeku za peginterferon alfa i ribavirin.