natgillin/translations-raw huggingface dataset:
If your female partner is not pregnant but is of childbearing age, she must be tested for pregnancy each month during treatment and for the 7 months after treatment has stopped.
Če vaša partnerka sicer trenutno ni noseča, a je v rodni dobi, mora opraviti nosečnostni test vsak mesec med vašim zdravljenjem in še 7 mesecev po koncu zdravljenja.
HBV screening should be performed in all patients before initiation of treatment.
Pred začetkom zdravljenja je treba vse bolnike testirati za HBV.
Partial responders**** in parent study
Delno odzivni bolniki**** v predhodni študiji
A genetic variant near the gene encoding interferon-lambda-3 (IL28B rs12979860, a C to T change) is a strong predictor of response to peginterferon alfa-2b/ribavirin.
Genetska varianta v bližini gena, ki kodira interferon-lambda-3 (IL28B rs12979860, sprememba iz C v T), je močan napovednik odziva na peginterferon alfa-2b/ribavirin.
Patients using oestrogens as hormone replacement therapy should be clinically monitored for signs of oestrogen deficiency.
Bolnike, ki uporabljajo estrogene za hormonsko nadomestno zdravljenje, je treba spremljati glede znakov pomanjkanja estrogena.
The Marketing Authorisation Holder shall ensure that all physicians who are expected to prescribe or use Victrelis are provided with a healthcare professional educational pack containing the following at
Imetnik dovoljenja za promet z zdravilom mora vsem zdravnikom, za katere pričakuje, da bodo predpisovali ali uporabljali zdravilo Victrelis, ob prihodu zdravila na trg priskrbeti komplet izobraževalnega gradiva, namenjenega zdravnikom, ki vsebuje:
Boceprevir has been shown to be a p-glycoprotein (P-gp) and breast cancer resistant protein (BCRP) substrate in vitro.
Pokazalo se je, da je boceprevir in vitro substrat p-glikoproteina (P-gp) in proteina odpornosti pri raku dojke (BCRP - breast cancer resistance protein).
Table 2 provides dosing recommendations as a result of drug interactions with Victrelis.
Preglednica 2 prikazuje priporočila za odmerjanje zaradi medsebojnega delovanja z zdravilom Victrelis.
Exploratory pharmacogenomic analysis of IL28B in phase 3 studies of Victrelis
Preiskovalna farmakogenomska analiza IL28B v kliničnih študijah faze 3 z zdravilom Victrelis
Victrelis contains the active ingredient boceprevir which helps to fight against hepatitis C infection by stopping the virus multiplying.
Zdravilo Victrelis vsebuje učinkovino boceprevir, ki pomaga zdraviti okužbo s hepatitisom C tako, da ustavi razmnoževanje virusa.
The antiviral activity of boceprevir was evaluated in a biochemical assay for slow binding inhibitors of NS3 protease and in the genotype 1a and 1b HCV replicon system.
Protivirusno aktivnost boceprevirja so ocenili v biokemičnem preizkusu za počasi vezoče zaviralce proteaze NS3 in v replikacijskem sistemu HCV genotipov 1a in 1b.
The subjects included 62% (104/168) genotype 1a and 38% (63/168) genotype 1b.
Med preiskovanci jih je bilo 62 % (104/168) z genotipom 1a in 38 % (63/168) z genotipom 1b.
Boceprevir/medicine derived material was shown to be transferred into the milk of lactating rats.
Pokazalo se je, da boceprevir/iz zdravila izvirajoče spojine prehajajo v mleko doječih podgan.
The concomitant use of Victrelis with doxazosin or tamsulosin may increase plasma concentrations of these medicines.
Sočasna uporaba zdravila Victrelis z doksazosinom ali tamsulozinom lahko poveča plazemske koncentracije teh zdravil.
Caution should be exercised with medicines known to prolong QT interval such as amiodarone, quinidine, methadone, pentamidine and some neuroleptics.
Previdnost je potrebna pri zdravilih, ki podaljšajo QT interval, kot so amiodaron, kinidin, metadon, pentamidin in nekateri nevroleptiki.
Do not use this medicine after the expiry date which is stated on the carton and blisterfoil after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in pretisnem omotu poleg oznake "Uporabno do" ali "EXP".
If serum haemoglobin concentrations continued to decrease to ≤ 8.5 g/dL, subjects could be treated with additional anaemia interventions, including the use of erythropoietin or ribavirin dose reduction.
Če se je vrednost serumskega hemoglobina še naprej zniževala do ≤ 8,5 g/dl, so pri preiskovancih anemijo lahko dodatno zdravili, vključno z eritropoetinom ali z zmanjšanim odmerkom ribavirina.
Continue with all three medicines (peginterferon alfa and ribavirin [PR] + Victrelis) and finish through Treatment Week 28 (TW 28).
2. nadaljujte z vsemi tremi zdravili (peginterferon alfa in ribavirin [PR] + Victrelis) in zaključite do konca 28. tedna zdravljenja (28.
A 3-year follow-up study of subjects who achieved SVR with a Victrelis-based regimen showed that > 99% (693/696) of patients maintained their SVR (no relapse) through the available follow-up period
3-letna študija spremljanja preiskovancev, ki so dosegli SVR z zdravljenjem z zdravilom Victrelis, je pokazala, da je > 99 % (693/696) bolnikov ohranilo SVR (brez recidiva) skozi celotno obdobje spremljanja (mediani čas spremljanja 3,4 leta).
• Peel back the tab to get to the capsule - do not push the capsule through the blister since pushing the capsule through the package may break the capsule.
• Odlepite zadnjo stran pretisnega omota, da boste razkrili kapsulo - ne potiskajte kapsule skozi pretisni omot, ker jo tako lahko poškodujete.
The clinical significance of the reductions in etravirine pharmacokinetic parameters and boceprevir Cmin in the setting of combination therapy with HIV antiretroviral medicines, which also affect the pharmacokinetics of etravirine and/or boceprevir, has not been directly assessed.
Klinični pomen zmanjšanja farmakokinetičnih parametrov etravirina in Cmin boceprevirja pri kombiniranem zdravljenju s HIV antiretrovirusnimi zdravili, ki vplivajo tudi na farmakokinetiko etravirina in/ali boceprevirja, ni bil neposredno ovrednoten.
Co-administration of atazanavir/ritonavir with boceprevir resulted in lower exposure of atazanavir which may be associated with lower efficacy and loss of HIV control.
Sočasna uporaba atazanavirja/ritonavirja z boceprevirjem je povzročila manjšo izpostavljenost atazanavirju, kar je lahko povezano z manjšo učinkovitostjo in izgubo nadzora nad HIV-om.
HBV/HCV co-infected patients are at risk of HBV reactivation, and should therefore be monitored and managed according to current
Pri bolnikih, sočasno okuženih s HBV/HCV, obstaja tveganje za reaktivacijo HBV, zato jih je treba spremljati in obravnavati v skladu s trenutnimi kliničnimi smernicami.
• have hepatitis C other than genotype 1
• če imate hepatitis C drugega genotipa kot 1,
The recommended dose of Victrelis is 800 mg administered orally three times daily (TID) with food (a meal or light snack).
Priporočeni odmerek zdravila Victrelis je 800 mg peroralno trikrat na dan s hrano (obrok ali lahek prigrizek).
An increase in plasma concentrations of substrates of the P-gp efflux transporter, such as digoxin or dabigatran, should be anticipated (see table 2).
Pričakovati je treba povečanje koncentracij substratov za efluksni transportni P-gp v plazmi, kot sta digoksin ali dabigatran (glejte preglednico 2).
However, since the clinical relevance of the boceprevir C8h decrease has not been established, increased clinical and laboratory monitoring for HCV suppression is recommended.
Ker pa kliničnega pomena znižanja C8ur boceprevirja niso dognali, priporočamo večji klinični nadzor in spremljanje laboratorijskih parametrov glede zaviranja HCV.
Dose adjustment of the benzodiazepine should be considered.
V poštev pride prilagoditev odmerka benzodiazepina.
If therapy is initiated, a very close monitoring for signs of infections and worsening liver function is warranted.
Če z zdravljenjem začnete, je treba bolnike zelo skrbno spremljati glede znakov okužb in poslabšanja delovanja jeter.
Alternative contraceptives should be considered for these patients.
Za te bolnice pridejo v poštev drugi kontraceptivi.
The concomitant use of Victrelis with rifampicin or anticonvulsants (such as phenytoin, phenobarbital or carbamazepine) may significantly reduce the plasma exposure of boceprevir.
Sočasna uporaba zdravila Victrelis in rifampicina ali antikonvulzivov (kot so fenitoin, fenobarbital ali karbamazepin) lahko pomembno zmanjša plazemsko izpostavljenost boceprevirju.
Boceprevir is eliminated with a mean plasma half-life (t½) of approximately 3.4 hours.
Boceprevir se izloča s povprečnim plazemskim razpolovnim časom (t1/2) približno 3,4 ure.
Victrelis should be administered with food.
Zdravilo Victrelis je treba zaužiti s hrano.
Clear polychlorotrifluoroethylene /PVC/aluminium blisters containing 4 hard capsules per blister cavity.
Pretisni omoti iz prozornega poliklorotrifluoroetilena/PVC/aluminija, ki vsebujejo 4 trde kapsule na jamico pretisnega omota.
If you are not sure, talk to your doctor or pharmacist before taking Victrelis.
Če ste negotovi, se posvetujte z zdravnikom ali farmacevtom, preden vzamete zdravilo Victrelis.
The frequency of severe or life threatening infections tends to be higher in boceprevir-containing arms than the control arm.
Pogostnost hudih ali življenjsko nevarnih okužb je malo večja v skupinah, ki prejemajo boceprevir, kot v kontrolni skupini.
After this period, the medicinal product should be disposed.
Po tem je treba zdravilo zavreči.
Subjects randomized to receive ribavirin dose reduction (N=249)
Preiskovanci, randomizirani v skupino z zmanjšanim odmerkom ribavirina (N=249)
• medicine used to treat symptoms of an enlarged prostate - doxazosin and tamsulosin
• zdravili za zdravljenje simptomov povečane prostate - doksazosin in tamsulozin
Do not take Victrelis in combination with peginterferon alfa and ribavirin if you: • are allergic to boceprevir or any of the other ingredients of this medicine (listed in section 6)
Ne jemljite zdravila Victrelis v kombinaciji s peginterferonom alfa in ribavirinom: • če ste alergični na boceprevir ali katero koli sestavino tega zdravila (navedeno v poglavju 6),
The European Medicines Agency has deferred the obligation to submit the results of studies with Victrelis in one or more subsets of the paediatric population in chronic viral hepatitis C (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je začasno odložila obvezo za predložitev rezultatov študij z zdravilom Victrelis za vse skupine pediatrične populacije s kroničnim virusnim hepatitisom C (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
In rats, boceprevir induced reversible effects on fertility and early embryonic development in female rats at exposures 1.2-fold the human exposure at the recommended therapeutic dose.
Pri podganah je boceprevir reverzibilno vplival na plodnost in zgodnji embrionalni razvoj pri podganjih samicah pri izpostavljenosti, ki je bila 1,2-krat tolikšna, kot je izpostavljenost človeka pri priporočenem terapevtskem odmerku.
Patients receiving digoxin should be monitored appropriately.
Bolnike, ki prejemajo digoksin, je treba ustrezno spremljati.
The degree of added value of Victrelis on top of the bitherapy in C/C patients will depend on the likelihood of achieving SVR with the bitherapy only.
Stopnja dodane vrednosti boceprevirja poleg dvojne terapije pri C/C bolnikih je odvisna od verjetnosti za dosego SVR z dvojno terapijo samo.
If a patient misses a dose and it is 2 or more hours before the next dose is due, the patient should take the missed dose with food and resume the normal dosing schedule.
Če bolnik pozabi vzeti odmerek in je do naslednjega odmerka 2 uri ali več, mora pozabljeni odmerek vzeti s hrano in nato nadaljevati jemanje po običajnem urniku.
Please see "Possible side effects" for more information.
Za več informacij, prosimo, glejte poglavje "Možni neželeni učinki".
Use in patients having HCV genotypes other than genotype 1
Uporaba pri bolnikih s HCV drugih genotipov kot genotipa 1
In a genotype 1a replicon, the IC50 and IC90 values for boceprevir were 900 nM and 1,400 nM, respectively.
V eni replikacijski enoti genotipa 1a sta bili IC50 za boceprevir 900 nM in IC90 1.400 nM.
As liver function may change during treatment with Victrelis, a close monitoring of International Normalised Ratio (INR) values is recommended in patients treated with vitamin K antagonists.
Ker se delovanje jeter v času zdravljenja z zdravilom Victrelis lahko spremeni, se pri bolnikih, ki se zdravijo z antagonisti vitamina K, priporoča natančno spremljanje vrednosti mednarodnega normaliziranega razmerja (INR).
In medicine interaction trials conducted with AKR inhibitors diflunisal and ibuprofen, boceprevir exposure did not increase to a clinically significant extent.
V preskušanjih medsebojnega delovanja, izvedenih z zaviralci AKR diflunisalom in ibuprofenom, se izpostavljenost beceprevirju ni povečala do klinično pomembne vrednosti.
%, (n/N) 73 (80/110) 79 (90/114) EOT %, (n/N) 86 (95/110) 89 (101/114) Relapse
SVR (n/N) KZ % (n/N) 86 (95/110) 89 (101/114)
• have a condition called ‘autoimmune hepatitis'
• če imate bolezen, imenovano "avtoimunski hepatitis",
Evaluation of varying combinations of boceprevir and interferon alfa-2b that produced 90% suppression of replicon RNA showed additivity of effect; no evidence of synergy or antagonism was
Ocena različnih kombinacij boceprevirja in interferona alfa-2b, ki so povzročile 90 % supresijo replikacijske enote RNA, je pokazala aditiven učinek; sinergije ali antagonizma niso ugotovili.
Patients without cirrhosis who are previously untreated or who have failed previous therapy The following dosing recommendations differ for some subgroups from the dosing studied in the Phase 3 trials (see section 5.1).
Bolniki brez ciroze, ki so predhodno nezdravljeni ali s predhodnim neuspešnim zdravljenjem Naslednja priporočila za odmerjanje se za nekatere podskupine razlikujejo od odmerjanja, ki je bilo preučevano v kliničnih preskušanjih faze 3 (glejte poglavje 5.1).
IL28B rs12979860 was genotyped in 653 of 1,048 (62%) subjects in SPRINT-2 (previously untreated) and 259 of 394 (66%) subjects in RESPOND-2 (previous treatment failure) [see section 5.1 for the clinical trial descriptions].
Varianta IL28B rs12979860 je bila genotipizirana pri 653 od 1.048 (62 %) preiskovancev v študiji SPRINT-2 (predhodno nezdravljeni) in pri 259 od 394 (66 %) preiskovancev v študiji RESPOND-2 (predhodno neuspešno zdravljenje) [glejte poglavje 5.1 za opis kliničnih študij].
In 2-year carcinogenicity studies, no carcinogenicity was observed, but there was an increased incidence of hepatocellular adenomas in mice, which was not statistically significant, at systemic exposures 5.7-fold higher than those in humans at the recommended therapeutic dose.
V 2-letnih študijah kancerogenosti niso opazili kancerogenih učinkov, vendar pa se je pojavnost hepatocelularnih adenomov pri miših povečala ob sistemskih izpostavljenostih, ki so bile 5,7-krat večje kot pri človeku med uporabo priporočenega terapevtskega odmerka, kar pa ni bilo statistično značilno.
Boceprevir has not been studied in patients with decompensated cirrhosis (see section 5.2).
Boceprevir ni bil raziskan pri bolnikih z dekompenzirano cirozo (glejte poglavje 5.2).
Decreases in neutrophil counts may require dose reduction of peginterferon alfa or discontinuation of therapy.
Zmanjšanje števila nevtrofilcev lahko zahteva zmanjšanje odmerka peginterferona alfa ali ukinitev zdravljenja.
This is due to liver function changes during treatment with Victrelis.
Razlog za to so spremembe delovanja jeter pri zdravljenju z zdravilom Victrelis.
If haemoglobin is < 10 g/dL (or < 6.2 mmol/L) management of anaemia may be warranted (see
Če je hemoglobin < 10 g/dl (oz. < 6,2 mmol/l), je lahko treba urediti anemijo (glejte poglavje 4.8).
Injection-site reactions have not been included since Victrelis is administered orally.
Reakcije na mestu injiciranja niso bile vključene, ker se zdravilo Victrelis uporablja peroralno.
For additional information on use of Victrelis in patients with advanced liver disease, see section 4.4.
Za dodatne informacije glede uporabe zdravila Victrelis pri bolnikih z napredovalo boleznijo jeter glejte poglavje 4.4.
Boceprevir has a mean total body clearance (CL/F) of approximately 161 l/hr.
Boceprevir ima povprečen celotni telesni očistek (CL/F) približno 161 l/uro.
However, the combination therapy of Victrelis, peginterferon alfa and ribavirin may make you feel tired, faint, a sensation of your head spinning, changes in blood pressure, confused or difficulty seeing clearly.
Vendar pa lahko kombinacija zdravila Victrelis ter peginterferona alfa in ribavirina povzroči utrujenost, omotico, občutek vrtenja v glavi, spremembe krvnega tlaka, zmedenost ali težave z vidom.
Boceprevir was not genotoxic in a battery of in vitro or in vivo assays, including bacterial mutagenicity, human peripheral blood lymphocyte and mouse micronucleus assays.
Boceprevir ni bil genotoksičen v skupini preizkusov in vitro ali in vivo, vključno s preizkusom mutagenosti pri bakterijah, preizkusom na humanih limfocitih periferne krvi in mikrojedrnim
In a study comparing the use of ribavirin dose reduction and erythropoesis stimulating agents in the management of treatment-emergent anaemia, the use of erythropoesis stimulating agents was associated with an increased risk of thromboembolic events (see section 5.1).
V študiji, v kateri so primerjali uporabo zmanjšanega odmerka ribavirina in zdravil za stimulacijo eritropoeze za obvladovanje med zdravljenjem nastale anemije, je bila uporaba zdravil za stimulacijo eritropoeze povezana s povečanim tveganjem za nastanek tromboemboličnih zapletov (glejte
No data are available; therefore, the combination of boceprevir with these medicines is not-recommended (see section 4.4).
Podatkov ni na voljo, zato kombinacija boceprevirja in teh zdravil ni priporočljiva (glejte poglavje 4.4).
No gender-related pharmacokinetic differences in the phase III studies have been observed in adult patients.
Spol Pri odraslih bolnikih v študijah faze III niso ugotovili s spolom povezanih farmakokinetičnih razlik.
• Store in a refrigerator until expiry.
• Shranjujte v hladilniku do izteka roka uporabnosti.
• Store in a refrigerator (2C - 8C) until expiry.
• Shranjujte v hladilniku (2 C - 8 C) do izteka roka uporabnosti.
Boceprevir/metabolites are excreted in rat milk (see section 5.3).
Boceprevir/presnovki se izločajo v mleku podgan (glejte poglavje 5.3).
Male patients or their female partners must use an effective contraceptive during treatment and for 7 months after treatment has been concluded.
Moški bolniki in njihove partnerke morajo uporabljati učinkovito kontracepcijo med zdravljenjem in še 7 mesecev po zaključku
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Za vse dodatne informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za
Heart or circulation: abnormal or rapid heart rate; heart disease caused by poor blood flow in
Srce in obtočila: nenormalno ali hitro bitje srca, bolezen srca zaradi slabega pretoka krvi skozi
• antimicrobial medicine - pentamidine
• protimikrobna zdravila - pentamidin
Population pharmacokinetic analysis of Victrelis indicated that race had no apparent effect on exposure.
Populacijska farmakokinetična analiza zdravila Victrelis je pokazala, da rasa nima nobenega opaznega vpliva na izpostavljenost.
In both studies, the addition of Victrelis to the current standard of care (peginterferon alfa and ribavirin) significantly increased sustained virologic response (SVR) rates compared to the current standard of care alone.
V obeh študijah je dodatek zdravila Victrelis trenutnemu standardnemu zdravljenju (s peginterferonom alfa in z ribavirinom) značilno povečal deleže trajnega virološkega odziva (SVR) v primerjavi s samim trenutnim standardnim zdravljenjem.
Use in patients with rare hereditary disorders
Uporaba pri bolnikih z redkimi dednimi motnjami
Each capsule contains 56 mg of lactose monohydrate.
Pomožna snov z znanim učinkom Ena kapsula vsebuje 56 mg laktoze monohidrata.
Co-administration of Victrelis with an oral contraceptive containing ethinyl estradiol and at least 1 mg of norethindrone is unlikely to alter the contraceptive effectiveness.
Malo verjetno je, da bi sočasna uporaba zdravila Victrelis s peroralnim kontraceptivom, ki vsebuje etinilestradiol in vsaj 1 mg noretindrona, spremenila učinkovitost kontracepcije.
It is possible that boceprevir is excreted in human milk.
Mogoče je, da se boceprevir izloča v materino mleko.
Mean age of subjects randomized was 52.7 years.
Povprečna starost randomiziranih preiskovancev je bila 52,7 let.
If such reaction occurs, combination therapy should be discontinued and appropriate medical therapy immediately instituted
Če se takšna reakcija pojavi, je treba kombinirano zdravljenje prekiniti in nemudoma začeti z ustrezno terapijo (glejte poglavji 4.3 in
Croscarmellose sodium Pre-gelatinized starch Magnesium stearate
premreženi natrijev karmelozat predgelirani škrob magnezijev stearat
Based on results of clinical studies, Victrelis must not be used alone due to the high probability of increased resistance without combination anti-HCV therapies (see section 5.1).
Na podlagi izsledkov kliničnih študij se zdravila Victrelis ne sme uporabljati samega, ker brez kombinirane uporabe zdravil za hepatitis C obstaja velika verjetnost povečanja odpornosti (glejte poglavje 5.1).
Given the incremental risk of adverse events with Victrelis (anaemia notably); in case the patient cannot tolerate the treatment, consideration could be given to pursue with 12 weeks of bitherapy for the final 12 weeks of treatment instead of tritherapy (see sections 4.8 and 5.1).
Glede na povečano tveganje za neželene učinke pri zdravilu Victrelis (najopazneje anemije) lahko po lastni presoji, če bolnik ne prenaša zdravljenja, zadnjih 12 tednov zdravljenja namesto trojnega zdravljenja uporabite dvojno zdravljenje (glejte poglavji 4.8 in 5.1).
Population pharmacokinetic analysis of Victrelis indicated that age had no apparent effect on exposure.
Populacijska farmakokinetična analiza zdravila Victrelis je pokazala, da starost nima nobenega opaznega vpliva na izpostavljenost.
• HIV protease inhibitors - atazanavir, darunavir, lopinavir, ritonavir
• zaviralce HIV proteaze - atazanavir, darunavir, lopinavir, ritonavir
Treatment with Victrelis should be initiated and monitored by a physician experienced in the
Zdravljenje z zdravilom Victrelis mora uvesti in spremljati zdravnik z izkušnjami z zdravljenjem
Indeed, serum progesterone, luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels indicated that ovulation was suppressed during coadministration of norethindrone 1 mg/ethinyl estradiol 0.035 mg with Victrelis (see section 4.6).
Pravzaprav so serumske koncentracije progesterona, luteinizirajočega hormona (LH) in folikle stimulirajočega hormona (FSH) pokazale, da je bila med sočasno uporabo noretindrona 1 mg/ etinilestradiola 0,035 mg in zdravila Victrelis ovulacija zavrta (glejte poglavje 4.6).
Victrelis contains lactose (a type of sugar).
Zdravilo Victrelis vsebuje laktozo (vrsto sladkorja).
No human data on the effect of Victrelis on fertility are available.
Podatkov o vplivu zdravila Victrelis na plodnost pri človeku ni na voljo.
Boceprevir concentrations are not likely to be affected by maraviroc co-administration (based on elimination pathway of boceprevir).
Malo verjetno je, da sočasna uporaba maraviroka vpliva na koncentracije boceprevirja (glede na pot izločanja boceprevirja).
These blood tests are done for a number of reasons:
Zdravnik vas bo napotil na redne preiskave krvi, ki jih je treba opraviti iz več razlogov:
RAVs were detected in 8% of patients at baseline by population sequencing.
RAV so bile s populacijskim sekveniranjem na začetku zdravljenja odkrite pri 8 % bolnikov.