natgillin/translations-raw huggingface dataset:
Patients with HCV genotype 1a predominately had V36M and R155K single and combination variants, while patients with HCV genotype 1b predominately had V36A, T54A/S, and A156S/T/V variants.
Bolesnici s HCV genotipom 1a pretežno su imali jednu od V36M i R155K pojedinačnih varijanti ili njihove kombinacije, dok su bolesnici s HCV genotipom 1b pretežno imali V36A, T54A/S i A156S/T/V varijante.
Most laboratory values return to levels observed with peginterferon alfa and ribavirin by week 24, except platelet counts, which remain at levels lower than observed with peginterferon alfa and ribavirin until week 48 (see section 4.4).
Većina laboratorijskih vrijednosti vrati se na vrijednosti primijećene kod primjene peginterferona alfa i ribavirina do 24. tjedna, osim broja trombocita koji ostaje na vrijednosti nižoj od one primijećene uz peginterferon alfa i ribavirin do 48. tjedna (vidjeti dio 4.4).
(2.6-5.0 x ULN)
(2,6-5,0 x GGN)
Patients received INCIVO at a dosage of 750 mg every 8 hours.
Bolesnici su primali INCIVO u dozi od 750 mg svakih 8 sati.
break, or dissolve the tablets before you swallow them.
Nemojte ih žvakati, lomiti niti otapati prije nego što ih progutate.
Clinical drug-drug interaction studies with substrates of CYP2B6, CYP2C8, CYP2D6, CYP2C19 and UGT1A1, UGT2B7 and UGT1A3 indicate no clinically relevant impact of the suppression observed in vitro.
Klinička ispitivanja interakcija lijekova supstrata iz CYP2B6, CYP2C8, CYP2D6, CYP2C19 i UGT1A1, UGT2B7 i UGT1A3 upućuju da ne postoji klinički značajan utjecaj supresije zabilježene in vitro.
The resistance profile observed in Study HPC3008 in HCV/HIV-1 co-infected patients was similar to the resistance profile in mono-infected HCV patients.
Profil rezistencije zabilježen u Ispitivanju HPC3008 u HCV/HIV-1 koinficiranih bolesnika bio je sličan profilu rezistencije u bolesnika s HCV monoinfekcijom.
Voriconazole should not be administered to patients receiving telaprevir unless an assessment of the benefit/risk ratio justifies its use.
Vorikonazol se ne smije primjenjivati u bolesnika koji primaju telaprevir, osim ako procjena omjera koristi i rizika ne opravdava njegovu primjenu.
A lower ribavirin dose (600 mg/day) at initiation of INCIVO treatment is recommended (see section 5.1).
Na početku liječenja INCIVOM, preporučena je niža doza ribavirina (600 mg/dan) (vidjeti dio 5.1).
INCIVO may increase concentrations of the co-administered medicinal product and this may result in an increased risk of their associated cardiac adverse reactions.
INCIVO može povisiti koncentraciju istodobno primijenjenih lijekova, što može povećati rizik od srčanih nuspojava povezanih s tim lijekovima.
Rare side effects (affects less than 1 in 1,000 people): - a wide-spread severe rash with peeling skin which may be accompanied by fever, flu-like symptoms, blisters in the mouth, eyes, and/or genitals (Stevens-Johnson syndrome).
Rijetke nuspojave (javljaju se u manje od 1 na 1000 osoba): - prošireni, teški osip s ljuštenjem kože, koji može biti popraćen vrućicom, simptomima sličnima gripi, mjehurićima u ustima, na očima i/ili spolnim organima (Stevens-Johnsonov sindrom).
Based on population sequencing analyses of HCV in these 215 patients, the emergence of telaprevir-resistant HCV variants was detected in 105 (84%) virologic failures and in 55 (61%) relapsers, and wild-type virus was detected in 15 (12%) virologic failures and in 24 (27%) relapsers.
U tih 215 bolesnika, na temelju populacijskih analiza nukleotidnih sljedova genoma (engl. population sequencing analyses) HCV-a, otkrivena je pojava varijanti HCV-a rezistentnih na telaprevir u 105 (84%) bolesnika s virološkim neuspjehom i 55 (61%) bolesnika s relapsom, a divlji tip virusa otkrio se u 15 (12%) bolesnika s virološkim neuspjehom i 24 (27%) bolesnika s relapsom.
If INCIVO treatment is discontinued due to adverse drug reactions or because of insufficient virologic response, INCIVO treatment should not be reinitiated.
Ako se liječenje INCIVOM prekine zbog nuspojava ili nedovoljnog virološkog odgovora, liječenje INCIVOM se ne smije ponovno započeti.
In the description of the Phase 3 study outcomes for Study C211, HPC3008 and HPC3006, SVR12, considered virologic cure, was defined based on HCV RNA below the limit of quantification (25 IU/ml) using the last measurement in the visit window 12 weeks after the planned end of
Prema opisu ishoda faze III ispitivanja za Ispitivanje C211, HPC3008 i HPC3006, SVR12 koji se smatrao virološkim izlječenjem, definiran je na temelju procjene HCV RNK ispod granice kvantifikacije (25 IU/ml) s time da se koristilo posljednje mjerenje u vremenskom prozoru posjete 12 tjedana nakon planiranog završetka liječenja.
If your treatment is not working, your doctor may stop your medicines.
Ukoliko liječenje nije djelotvorno, liječnik ga može prekinuti.
INCIVO acts against the virus that causes hepatitis C infection and is used to treat chronic hepatitis C infection in adult patients (aged 18-65 years) in combination with peginterferon alfa and ribavirin.
INCIVO djeluje protiv virusa koji je uzročnik infekcije hepatitisa C i primjenjuje se za liječenje kronične infekcije hepatitisa C u odraslih bolesnika u kombinaciji s peginterferonom alfa i ribavirinom (u dobi od 18 do 65 godina).
It is not known whether telaprevir is excreted in human breast milk.
Nije poznato izlučuje li se telaprevir u majčino mlijeko u ljudi.
Within each frequency grouping, ADRs are presented in order of decreasing seriousness.
Unutar svake kategorije učestalosti, nuspojave su prikazane u padajućem nizu prema
Patients were randomised to 12 weeks of INCIVO (750 mg every 8 hours if taken in combination with atazanavir/ritonavir, tenofovir disoproxil fumarate, and emtricitabine or lamivudine OR 1,125 mg every 8 hours if taken in combination with efavirenz, tenofovir disoproxil fumarate, and emtricitabine) or placebo.
Bolesnici su bili randomizirani na 12 tjedana INCIVA (750 mg svakih 8 sati, ako se uzimao u kombinaciji s atazanavirom/ritonavirom, tenofovir dizoproksil fumaratom i emtricitabinom ili lamivudinom ILI 1125 mg svakih 8 sati, ako se uzimao u kombinaciji efavirenzom, tenofovir dizoproksil fumaratom i emtricitabinom) ili na placebo.
In Study HPC3008 (see sections 4.8 and 5.1), transient grade 3 (2.5 to ≤5 X ULN) and grade 4 (>5 X ULN) bilirubin increases during INCIVO treatment were seen in 39% and in 22% of the 59 patients on atazanavir/ritonavir, respectively.
U Ispitivanju HPC3008 (vidjeti dio 4.8 i 5.1), tijekom liječenja lijekom INCIVO, prolazni porasti bilirubina stupnja 3 (2,5 do ≤ 5 X GGN) i stupnja 4 (> 5 X GGN) zabilježeni su u 39% odnosno 22% od 59 bolesnika na atazanaviru/ritonaviru.
Chemistry evaluations (electrolytes, serum creatinine, uric acid, hepatic enzymes, bilirubin, TSH) are recommended as frequently as the haematology evaluations or as clinically indicated (see section 4.8).
Laboratorijske pretrage (elektroliti, kreatinin u serumu, mokraćna kiselina, jetreni enzimi, bilirubin, TSH) preporučuju se jednako često kao i hematološke pretrage ili prema kliničkoj indikaciji (vidjeti
Since it is highly unlikely that patients with inadequate viral responses will achieve a sustained virologic response (SVR), it is recommended that patients with HCV RNA > 1,000 IU/ml at week 4 or week 12 discontinue therapy (refer to table 1).
S obzirom da kod bolesnika s neadekvatnim virološkim odgovorom postizanje trajnog virološkog odgovora (engl. sustained virologic response, SVR) nije vjerojatno, preporučuje se da bolesnici s HCV RNK > 1000 IU/ml u 4. ili 12. tjednu prekinu terapiju (vidjeti Tablicu 1).
Sequence analyses of the telaprevir-resistant variants identified substitutions at 4 positions in the NS3-4A protease region, consistent with the mechanism of action for telaprevir (V36A/M, T54A/S, R155K/T, and A156S/T/V).
Analiza nukleotidnih sljedova genoma varijanti rezistentnih na telaprevir pokazala je supstitucije na 4 položaja u NS3-4A regiji proteaze, u skladu s mehanizmom djelovanja telaprevira (V36A/M, T54A/S, R155K/T i A156S/T/V).
Patients with renal or hepatic impairment should not be given colchicine with INCIVO, due to the risk of colchicine toxicity.
Bolesnici s oštećenjem funkcije bubrega ili jetre ne smiju primati kolhicin s INCIVOM zbog rizika od toksičnosti kolhicina.
Severe rash: Extent of rash > 50% of body surface area or associated with vesicles,
Teški osip: Osip zahvaća > 50% površine tijela ili je povezan s vezikulama, bulama, i
Careful monitoring of therapeutic and adverse effects (including respiratory depression) is recommended when telaprevir is co-administered with alfentanil or fentanyl, including oral, buccal, nasal and extended-release transdermal or transmucosal preparations of fentanyl, especially at initiation of treatment.
Preporučuje se pažljivo praćenje terapijskog učinka i nuspojava (uključujući respiratornu depresiju) kada se telaprevir primijenjuje istodobno s alfentanilom ili fentanilom, uključujući pripravke fentanila koji se primjenjuju peroralno, putem sluznica, kroz nos i kod transdermalnih ili transmukoznih oblika s produženim otpuštanjem, posebno pri započinjanju liječenja.
All patients received ribavirin at a fixed dose of 800 mg/day.
Svi bolesnici su primili fiksnu dozu ribavirina od 800 mg/dan.
Tell your doctor if you have had or are going to have a liver or other organ transplant as INCIVO might not be right for you in this situation.
Obavijestite svoga liječnika ako imate transplantiranu ili će vam uskoro transplantirati jetru ili neki drugi organ, jer u tom slučaju INCIVO možda neće biti odgovarajući lijek za Vas.
In two double-blind, randomised, placebo- and active-controlled studies conducted to evaluate the effect on the QT interval, telaprevir monotherapy at a dose of 750 mg every 8 hours was not associated with a clinically relevant effect on QTcF interval.
Klinička ispitivanja koja su proučavala QT interval U dva dvostruko slijepa, randomizirana, placebom i djelatnom tvari kontrolirana ispitivanja provedena da bi se procijenio učinak na QT interval, monoterapija telaprevirom u dozi od 750 mg svakih 8 sati nije bila povezana s klinički važnim učinkom na QTcF interval.
Patients Co-infected with HIV-1
Bolesnici s istodobnom HIV-1 infekcijom
Increased plasma concentrations of quetiapine may lead to coma.
Povišene koncentracije kvetiapina u plazmi mogu dovesti do kome.
escitalopram, trazodone to treat mood disorders (antidepressants)
escitalopram, trazodon za liječenje poremećaja raspoloženja (antidepresivi)
Caution is recommended when prescribing INCIVO concurrently with medicinal products known to induce QT prolongation and which are CYP3A substrates such as erythromycin, clarithromycin, telithromycin, posaconazole, voriconazole, ketoconazole, tacrolimus, salmeterol (see section 4.5).
Preporučuje se oprez kad se INCIVO propisuje istodobno s lijekovima za koje se zna da izazivaju produljenje QT intervala i koji su supstrati CYP3A, kao što su eritromicin, klaritromicin, telitromicin, posakonazol, vorikonazol, ketokonazol, takrolimus i salmeterol (vidjeti dio 4.5).
What INCIVO looks like and contents of the pack Film-coated tablet.
Kako INCIVO izgleda i sadržaj pakiranja
to treat schizophrenia, bipolar disorder and major depressive disorder midazolam (taken by mouth), triazolam (taken to help you sleep and/or relieve anxiety (sedatives/hypnotics)
za liječenje shizofrenije, bipolarnog poremećaja i velikog depresivnog poremećaja midazolam (koji se uzima kroz usta), triazolam za spavanje i/ili ublažavanje tjeskobe (sedativi/hipnotici)
After oral administration, the apparent total clearance (Cl/F) was estimated to be 32.4 l/h with an inter-individual variability of 27.2%.
Nakon peroralne primjene, prividni ukupni klirens (Cl/F) iznosio je približno 32,4 l/sat uz varijabilnost između pojedinaca od 27,2%.
The most marked effects are expected on oral, nasal and buccal/sublingual fentanyl formulations.
Najuočljiviji učinci se očekuju uz formulacije fentanila koje se uzimaju peroralno, nazalno, putem bukalne sluznice/sublingvalno.
In that study, the following common adverse events were reported more frequently with the 1,875 mg every 8 hours regimen compared to the 750 mg every 8 hours regimen: nausea, headache, diarrhoea, decreased appetite, dysgeusia and vomiting.
U tom su ispitivanju prijavljene su sljedeće česte nuspojave, a one su bile češće zabilježene uz dozu od 1875 mg svakih 8 sati nego uz dozu od 750 mg svakih 8 sati: mučnina, glavobolja, proljev, smanjen apetit, disgeuzija i povraćanje.
Clonal sequencing analysis of a subset of patients who had wild-type HCV by population sequencing (n=20), comparing the frequency of resistant variants before the start of telaprevir treatment and at follow-up, showed that the HCV variant population in all patients had returned to pre-treatment levels.
Analizom klonskog nukleotidnog slijeda u podskupini bolesnika s divljim tipom HCV-a prema populacijskoj analizi nukleotidnih sljedova genoma (n = 20) i usporedbom učestalosti rezistentnih varijanti prije početka liječenja telaprevirom i tijekom praćenja, pokazalo se da se populacija HCV varijante u svih bolesnika vratila na vrijednosti prije liječenja.
No relevant inhibition by telaprevir of alcohol dehydrogenase was observed in vitro.
In vitro nije zabilježena značajna inhibicija alkoholne dehidrogenaze telaprevirom.
These active substances include alfuzosin, amiodarone, bepridil, quinidine, astemizole, terfenadine, cisapride, pimozide, ergot derivatives (dihydroergotamine, ergonovine, ergotamine, methylergonovine), lovastatin, simvastatin, atorvastatin, sildenafil or tadalafil (only when used for treatment of pulmonary arterial hypertension), quetiapine and orally administered midazolam or triazolam (see section 4.5).
Te djelatne tvari uključuju alfuzosin, amiodaron, bepridil, kinidin, astemizol, terfenadin, cisaprid, pimozid, ergot derivate (dihidroergotamin, ergonovin, ergotamin, metilergonovin), lovastatin, simvastatin, atorvastatin, sildenafil ili tadalafil (samo kad se koristi za liječenje plućne arterijske hipertenzije), kvetiapin i midazolam ili triazolam za peroralnu primjenu (vidjeti dio 4.5).
(< 350/mm potassium
(< 350/mm kalij
The active substance is telaprevir.
Djelatna tvar je telaprevir.
Any birth control method can fail, and, therefore, you and your partner must use at least two effective birth control methods during INCIVO therapy and afterwards.
Svaka metoda kontrole trudnoće može podbaciti, stoga za vrijeme i nakon liječenja INCIVOM vi i vaš partner/vaša partnerica morate koristiti najmanje dvije učinkovite metode zaštite od trudnoće.
INCIVO is available in packs containing 1 bottle (total of 42 film-coated tablets) or 4 bottles (total of
INCIVO je dostupan u pakiranjima s 1 bočicom (ukupno 42 filmom obložene tablete) ili 4 bočice (ukupno 168 filmom obloženih tableta).
Concomitant administration of INCIVO with active substances that strongly induce CYP3A e.g. rifampicin, St John's wort (Hypericum perforatum), carbamazepine, phenytoin and phenobarbital and thus may lead to lower exposure and loss of efficacy of INCIVO.
Istodobna primjena INCIVA s djelatnim tvarima koje snažno induciraju CYP3A, npr. rifampicin, gospina trava (Hypericum perforatum), karbamazepin, fenitoin i fenobarbital, i stoga mogu dovesti do smanjene izloženosti i prestanka djelotvornosti INCIVA.
DRESS presents as a rash with eosinophilia associated with one or more of the following features: fever, lymphadenopathy, facial oedema, and internal organ involvement (hepatic, renal, pulmonary).
DRESS se manifestira kao osip s eozinofilijom povezan s jednim ili više od sljedećih znakova: vrućica, limfadenopatija, edem lica i zahvaćenost unutarnjih organa (jetre, bubrega, pluća).
- 3 tablets of INCIVO twice daily (morning and evening) with food.
Preporučeni raspored uzimanja lijeka je: - 3 tablete INCIVA dva puta na dan (ujutro i navečer) uz hranu.
Table 12: SVR rates by extent of liver fibrosis at baseline: Study C216 T12/PR
Tablica 12: Stope SVR-a prema opsegu fibroze jetre na početku ispitivanja: Ispitivanje C216 T12/PR
Among patients treated with telaprevir, on-treatment virologic failure was more frequent in patients with genotype 1a than with genotype 1b and more frequent in prior null responders than in other populations (treatment-naïve, prior relapsers, prior partial responders; see section 5.1, Clinical Experience, Efficacy in Previously Treated Adults).
Među bolesnicima liječenima telaprevirom, virološki neuspjeh tijekom liječenja bio je češći u bolesnika s genotipom 1a nego s genotipom 1b i češći u bolesnika s prethodnim potpunim izostankom odgovora nego u drugih populacija bolesnika (koji prethodno nisu bili liječeni, imali su relaps ili djelomični odgovor; vidjeti dio 5.1, Kliničko iskustvo, Djelotvornost u odraslih bolesnika koji su prethodno bili liječeni).
to treat a heart and lung disorder called pulmonary arterial hypertension (endothelin receptor antagonist)
za liječenje poremećaja srca i pluća koji se zove plućna arterijska hipertenzija (antagonist endotelinskih receptora)
Your doctor will do blood tests before starting treatment and regularly during your treatment: - to see how much virus is in your blood and to determine if you have the type of virus (genotype 1) that can be treated with INCIVO.
- kako bi provjerio količinu virusa u vašoj krvi i kako bi odredio imate li tip virusa (genotip 1) koji se može liječiti INCIVOM.
- Adequately controlled thyroid function (TSH) - Calculated creatinine clearance ≥ 50 ml/min
- apsolutni broj neutrofila ≥ 1500/mm - odgovarajuće kontrolirana funkcija tiroidne žlijezde (TSH) - izračunati klirens kreatinina ≥ 50 ml/min
3) being treated with efavirenz or atazanavir/ritonavir in combination with tenofovir disoproxil fumarate and emtricitabine or lamivudine.
3) liječen efavirenzom ili atazanavirom/ritonavirom u kombinaciji s tenofovir dizoproksil fumaratom i emtricitabinom ili lamivudinom.
No adjustment of methadone dose is required when initiating co-administration of telaprevir.
Nije potrebna prilagodba doze metadona kad se istodobno počinje primjenjivati telaprevir.
The efficacy and safety of INCIVO in patients with genotype 1 chronic hepatitis C were evaluated in four Phase 3 studies: 3 in treatment-naïve patients and 1 in previously treated patients (relapsers, partial responders, and null responders).
Djelotvornost i sigurnost primjene INCIVA u bolesnika s kroničnim hepatitisom C uzrokovanim genotipom 1 procjenjivala se u fazi III četiri ispitivanja: 3 u bolesnika koji prethodno nisu bili liječeni i jednom u prethodno liječenih bolesnika (s relapsom, djelomičnim odgovorom ili izostankom odgovora).
Liver transplant patients without cirrhosis
Bolesnici s transplantiranom jetrom bez ciroze
Available data suggest that peginterferon alfa, and perhaps also ribavirin, may contribute to the frequency and severity of rash associated with INCIVO combination treatment.
Dostupni podaci sugeriraju da peginterferon alfa, a možda i ribavirin, mogu doprinijeti učestalosti i težini osipa koji je povezan s kombiniranim liječenjem INCIVOM.
The mean telaprevir Cmax and AUC were 10% and 21% greater, respectively, compared to healthy subjects (see section 4.2).
Prosječna vrijednost Cmax bila je 10% veća, a vrijednost AUC 21% veća od onih u zdravih ispitanika (vidjeti
Hypoalbuminaemia and low platelet counts have been identified as predictors of severe complications of liver disease as well as of interferon-based therapies (e.g., hepatic decompensation, serious bacterial infections).
Primjena u bolesnika s uznapredovalom bolešću jetre Hipoalbuminemija i nizak broj trombocita identificirani su kao prediktori za teške komplikacije jetrene bolesti kao i liječenja koja se temelje na interferonu (npr., dekompenzacija jetre, ozbiljne bakterijske infekcije).
No relevant effect of gender was identified.
Značajan utjecaj spola nije
Doses may need to be increased when combined with telaprevir.
Može biti potrebno povisiti dozu kad se primijenjuju istodobno s telaprevirom.
At the initiation and discontinuation of INCIVO treatment, doses of co-administered tacrolimus or cyclosporine A need to be markedly adjusted (see sections 4.4 and 4.5, Immunosuppressants).
Na početku i prilikom prekida liječenja INCIVOM, doze istodobno primjenjenog takrolimusa ili ciklosporina A, moraju se znatno prilagoditi (vidjeti djelove 4.4 i 4.5, Imunosupresivi).
Of a combined 255 treatment-naïve and previously treated patients from Phase 3 studies 108, 111, and C216 in whom telaprevir-resistant variants had emerged during treatment, 152 (60%) patients no longer had resistant variants detected by population sequencing (median follow-up of 10 months).
Od 255 bolesnika koji prethodno nisu bili liječeni i prethodno liječenih bolesnika iz faze III ispitivanja 108, 111 i C216, u kojih su se varijante rezistentne na telaprevir pojavile tijekom liječenja, 152 (60%) bolesnika više nije imalo rezistentne varijante otkrivene pomoću populacijske analize nukleotidnih sljedova (medijan praćenja od 10 mjeseci).
)/PR group was 74% (274/369) compared to 73% (270/371) in the T12(q8h)/PR group with 95% confidence interval of the difference: -4.9%, 12.0%.
Stopa SVR12 odgovora za T12(b.i.d.)/PR skupinu, bila je 74% (274/369) u usporedbi sa 73% (270/371) u T12(q8h)/PR skupini s 95%-tnim intervalom pouzdanosti razlike: -4,9%, 12,0%.
TSH levels should be determined before and during the course of INCIVO combination treatment and treated as clinically appropriate, including potential adjustment of thyroid replacement therapy in patients with pre-existing hypothyroidism (see section 4.4,
Vrijednosti TSH treba odrediti prije i tijekom kombiniranog liječenja s INCIVOM te liječiti ih klinički primjerenim načinom, uključujući moguću prilagodbu nadomjesnog liječenja tireoidnim hormonom u bolesnika s postojećom hipotireozom (vidjeti dio 4.4,
INCIVO can be used for patients with chronic hepatitis C infection who have never been treated before or can be used in patients with chronic hepatitis C infection who have been treated previously with an interferon-based regimen.
INCIVO se može primijeniti u bolesnika s kroničnom infekcijom hepatitisa C koji nikad prije nisu bili liječeni ili u bolesnika s kroničnom infekcijom hepatitisa C koji su prethodno bili liječeni interferonom.
Alternatively, 750 mg (two 375 mg tablets) can be taken orally every 8 hours (q8h) with food.
Alternativno, može se uzimati 750 mg (dvije tablete od 375 mg) peroralno svakih 8 sati uz obrok.
Table 6 shows SVR rates by IL28B genotype and the stage of liver fibrosis at baseline.
Tablica 6 pokazuje stope SVR uz IL28B genotipe i stadij fibroze jetre na početku ispitivanja.
If you are taking any of the above, ask your doctor about switching to another medicine.
Ako uzimate neki od gore navedenih lijekova, upitajte liječnika možete li ga zamijeniti nekim drugim
There are no clinical data on the use of INCIVO in patients on haemodialysis.
Nema kliničkih podataka o primjeni INCIVA u bolesnika na hemodijalizi.
The incidence of adverse drug reactions (ADRs) of at least moderate intensity (≥ Grade 2) was higher in the INCIVO group than in the placebo group.
Incidencija nuspojava barem umjerenog intenziteta (≥ 2. stupnja) bila je viša u skupini koja je primala INCIVO nego u skupini koja je primala placebo.
Prior non-responders includes prior partial responders and prior null responders.
Bez prethodnog odgovora uključuju one koji su prethodno djelomično odgovorili i one koji prethodno nisu uopće odgovorili.
filiāle Latvijā Mūkusalas iela 101
Janssen-Cilag Polska Sp. z o.o. filiāle Latvijā Mūkusalas iela 101
Because of the potential for adverse reactions in breastfed infants, due to the combined treatment of INCIVO with peginterferon alfa and ribavirin, breast-feeding must be discontinued prior to initiation of therapy.
Zbog mogućih nuspojava u dojenčadi kao posljedica kombiniranog liječenja INCIVOM, peginterferonom alfa i ribavirinom, dojenje se mora prekinuti prije početka liječenja.
Co-administration of oral midazolam or triazolam with telaprevir is contraindicated.
Istodobna primjena peroralnog midazolama ili triazolama s telaprevirom je kontraindicirana.