natgillin/translations-raw huggingface dataset:
No clinically relevant antiviral activity was observed against a variety of RNA and DNA viruses, including HIV, confirming that daclatasvir, which inhibits a HCV-specific target, is highly selective for HCV.
Klinično pomembne protivirusne aktivnosti proti različnim RNA in DNA virusom, vključno z virusom HIV, niso opazili, kar potrjuje, da je daklatasvir, ki zavira za HCV specifično tarčo, zelo selektiven za HCV.
If you accidentally take more Daklinza tablets than your doctor recommended, contact your doctor at once or contact the nearest hospital for advice.
Če ste pomotoma vzeli več tablet zdravila Daklinza kot bi smeli, se nemudoma posvetujte s svojim zdravnikom ali poiščite zdravniško pomoč v najbližji bolnišnici.
Daklinza must always be used together with other medicines against hepatitis C infection and must never be used by itself.
Zdravilo Daklinza je treba vedno uporabljati skupaj z drugimi zdravili proti okužbi z virusom hepatitisa C in se ga nikoli ne sme uporabljati samega.
Patients with Child-Pugh C liver disease
Bolniki z boleznijo jeter Child-Pugh C
The most frequently reported adverse reactions of at least Grade 3 severity (frequency of 1% or greater) were neutropenia, anaemia, lymphopenia and thrombocytopenia.
Najpogosteje poročani neželeni učinki jakosti vsaj stopnje 3 (pogostnost 1 % ali večja) so bili nevtropenija, anemija, limfopenija in trombocitopenija.
You may have to take your other medicines for different lengths of time.
Zdravljenje z drugimi zdravili lahko traja drugačen čas.
Administration of Daklinza may increase systemic exposure to medicinal products that are substrates of P-gp, OATP 1B1, OCT1 or BCRP, which could increase or prolong their therapeutic effect and adverse reactions.
Pri uporabi zdravila Daklinza se lahko poveča sistemska izpostavljenost zdravilom, ki so substrati za P-gp, OATP 1B1, OCT1 ali BCRP, kar lahko okrepi ali podaljša terapevtske in neželene učinke teh zdravil.
Due to the long half-life of amiodarone, appropriate monitoring should also be carried out for patients who have discontinued amiodarone within the past few months and are to be initiated on Daklinza in combination with sofosbuvir.
Zaradi dolge razpolovne dobe amiodarona je treba ustrezno spremljati tudi bolnike, ki so prekinili zdravljenje z amiodaronom v zadnjih nekaj mesecih in bodo začeli zdravljenje z zdravilom Daklinza v kombinaciji s sofosbuvirjem.
The median viral load was 6.42 log10 IU/ml, and 21% of patients had compensated cirrhosis.
Mediano virusno breme je bilo 6,42 log10 i.e./ml, 21 % bolnikov pa je imelo kompenzirano cirozo.
Regimen and duration HCV GT 1 or 4
Režim in trajanje GT 1 ali 4 HCV
Do not stop taking Daklinza unless your doctor told you to stop.
Ne prenehajte z jemanjem zdravila Daklinza, razen če vam tako naroči zdravnik.
All Genotype 3 N=18
Vsi genotip 3 N=18
Patients demographics and main disease characteristics are summarised in Table 8.
Demografske lastnosti bolnikov in glavne značilnosti bolezni so predstavljene v tabeli 8.
Antiviral activity in cell culture
Protivirusno delovanje v celični kulturi
Azithromycin Ciprofloxacin
Azitromicin Ciprofloksacin
Elimination Following single-dose oral administration of 14C-daclatasvir in healthy subjects, 88% of total radioactivity was recovered in feces (53% as unchanged drug) and 6.6% was excreted in the urine (primarily as unchanged drug).
Po enkratnem peroralnem odmerku z radioaktivnim izotopom 14C označenega daklatasvirja se je pri zdravih osebah 88 % celotne radioaktivnosti izločilo z blatom (53 % v obliki nespremenjenega zdravila), 6,6 % pa z urinom (v glavnem v nespremenjeni obliki).
Compassionate Use
Sočutna uporaba
Tell your doctor immediately if you are taking any medicines for heart problems and during treatment you experience:
Takoj obvestite zdravnika, če jemljete katero koli zdravilo za zdravljenje težav s srcem in med zdravljenjem opazite: zasoplost, omotico,
Population pharmacokinetic analysis of data from clinical studies indicated that age had no apparent effect on the pharmacokinetics of daclatasvir.
Analiza podatkov populacijske farmakokinetike iz kliničnih študij je pokazala, da starost ni opazno vplivala na farmakokinetiko daklatasvirja.
Other oral contraceptives have not been studied.
Drugih peroralnih kontraceptivov niso proučevali.
SVR12 was achieved by 74% of patients in this study (genotype 1a: 70%, genotype 1b: 79%).
V tej študiji je bil SVR12 dosežen pri 74 % bolnikov (genotip 1a: 70 %, genotip 1b: 79 %).
SVR12 was achieved by 83% (50/60) of patients in the cirrhosis cohort, with a marked difference between patients with Child-Pugh A or B (92-94%) as compared to those with Child-Pugh C and 94% of patients in the post-liver transplant cohort (Table 9).
SVR12 je bil dosežen pri 83 % (50/60) bolnikov v kohorti s cirozo, z izrazito razliko med bolniki s Child-Pugh A ali B (92-94 %) v primerjavi z bolniki s Child-Pugh C in pri 94 % bolnikov v kohorti po presaditivi jeter (tabela 9).
Daklinza must be administered in combination with other medicinal products.
Zdravilo Daklinza je treba uporabljati v kombinaciji z drugimi zdravili.
Medicinal products by therapeutic areas
Zdravila po terapevtskih področjih
The SVR rate for patients treated for 8 weeks was lower with this treatment duration as summarized in Table 11.
Pri bolnikih, ki so se zdravili 8 tednov, je bil delež SVR manjši, kot je povzeto v tabeli 11.
Conversion of the FibroTest score to the corresponding METAVIR score suggests that 35% of all patients (49% of patients with prior PI failure, 30% of patients with genotype 2 or 3) had ≥F3 liver fibrosis.
Pretvorba ocene FibroTesta v ustrezno METAVIR oceno kaže, da je 35 % vseh bolnikov (49 % bolnikov z neuspešnim predhodnim zdravljenjem z zaviralcem proteaze, 30 % bolnikov z genotipom 2 ali 3) imelo fibrozo jeter ≥ F3.
If the starting dose is well-tolerated, the dose can be titrated up to a maximum of 1,000-1,200 mg daily (breakpoint 75 kg).
Če bolnik začetni odmerek dobro prenaša, se odmerek lahko poveča do največ 1.000-1.200 mg na dan (omejeno s telesno maso 75 kg).
For detailed recommendations regarding pregnancy and contraception, refer to the Summary of Product Characteristics for ribavirin and peginterferon alfa.
Za podrobnejša priporočila glede nosečnosti in kontracepcije, glejte povzetek glavnih značilnosti zdravila za ribavirin in peginterferon alfa.
In rats, malformations mainly affected the brain, skull, eyes, ears, nose, lip, palate or limbs and in rabbits, the ribs and cardiovascular area.
Pri podganah so malformacije v glavnem prizadele možgane, lobanjo, oči, ušesa, nos, ustnice, nebo ali ude, pri kunčicah pa rebra in kardiovaskularni predel.
Cases are potentially life threatening, therefore amiodarone should only be used in patients on Daklinza and sofosbuvir when other alternative antiarrhythmic treatments are not tolerated or are contraindicated.
Primeri so lahko smrtno nevarni, zato se lahko amiodaron pri bolnikih, ki prejemajo zdravilo Daklinza in sofosbuvir, uporablja samo, če drugih nadomestnih antiaritmikov ne prenašajo ali če so ti pri njih kontraindicirani.
In order to evaluate the recurrence of hepatocellular carcinoma associated with Daklinza, the MAH shall conduct and submit the results of a prospective safety study using data deriving from a cohort of a well-defined group of patients, based on an agreed protocol.
Da bi lahko ugotovili ponovitev hepatocelularnega karcinoma, povezanega z zdravilom Daklinza, mora imetnik dovoljenja za promet z zdravilom izvesti in predložiti rezultate prospektivne študije varnosti s podatki, ugotovljenimi v kohortah natančno določenih skupin bolnikov, dogovorjenih v protokolu.
The duration of your treatment will depend on whether you have previously received treatment for your hepatitis C infection, the condition of your liver, and what other medicines you will take with Daklinza.
Trajanje zdravljenja je odvisno od predhodnega zdravljenja okužbe z virusom hepatitisa C, stanja jeter in vrste zdravil, ki jih jemljete skupaj z zdravilom Daklinza.
For 5 patients, cirrhosis status was indeterminate.
Pri 5 bolnikih stanje ciroze ni bilo določeno.
Daklinza is not recommended for use in children and adolescents aged below 18 years because the safety and efficacy have not been established in this population.
Uporaba zdravila Daklinza pri otrocih in mladostnikih, mlajših od 18 let, ni priporočljiva, saj varnost in učinkovitost pri tej populaciji nista bili dokazani.
Important information about some of the ingredients in Daklinza Daklinza contains lactose.
Pomembne informacije o nekaterih sestavinah zdravila Daklinza Zdravilo Daklinza vsebuje laktozo.
In genotype 4, amino acid substitutions at 30 and 93 (EC50 < 16 nM) were frequently selected.
Pri genotipu 4 so bile pogosto izolirane aminokislinske substitucije na pozicijah 30 in 93 (EC50 < 16 nM).
General disorders and administration site conditions very common fatigue fatigue
Splošne težave in spremembe na mestu aplikacije zelo pogosti utrujenost utrujenost
In rats, no effect on mating or fertility was seen (see section 5.3).
Pri podganah niso opazili vpliva na parjenje ali plodnost (glejte poglavje 5.3).
The efficacy and safety of daclatasvir 60 mg once daily in combination with sofosbuvir 400 mg once daily in the treatment of patients with chronic HCV infection were evaluated in four open-label studies (AI444040, ALLY-1, ALLY-2 and ALLY-3).
Učinkovitost in varnost daklatasvirja v odmerku 60 mg enkrat na dan v kombinaciji s sofosbuvirjem v odmerku 400 mg enkrat na dan pri zdravljenju bolnikov s kronično okužbo s HCV so vrednotili v štirih odprtih študijah (AI444040, ALLY-1, ALLY-2 in ALLY-3).
It is used to treat adults with hepatitis C, an infectious disease that affects the liver, caused by the hepatitis C virus.
Daklatasvir uporabljamo za zdravljenje odraslih s hepatitisom C. Hepatitis C je nalezljiva bolezen, ki prizadene jetra in je posledica okužbe z virusom hepatitisa C.
Fusion inhibitor Enfuvirtide
Zaviralec fuzije Enfuvirtid
All 44 patients with HCV genotype 2 (n=26) or 3 (n=18) infection were treatment-naïve.
Vseh 44 bolnikov, okuženih z genotipom 2 (n=26) ali 3 (n=18) HCV, se predhodno še ni zdravilo.
If you take more Daklinza than you should
Če ste vzeli večji odmerek zdravila Daklinza, kot bi smeli
Table 4: Interactions and dose recommendations with other medicinal products
Tabela 4: Interakcije in priporočila za odmerjanje pri sočasni uporabi drugih zdravil
4.24 l/h.
je skupni očistek znašal 4,24 l/h.
The efficacy of Daklinza as part of a retreatment regimen in patients with prior exposure to a NS5A inhibitor has not been established.
Učinkovitosti zdravila Daklinza kot del režima ponovne uvedbe zdravljena pri bolnikih, predhodno zdravljenih z zaviralcem NS5A, niso ugotovili.
Response was rapid (at Week 4 91% of daclatasvir-treated patients had HCV RNA <LLOQ).
Odziv je bil hiter (v 4. tednu je imelo 91 % bolnikov, zdravljenih z daklatasvirjem, vrednost HCV RNA < LLOQ).
Table 10: Demographics and baseline characteristics in Study ALLY-2
Tabela 10: Demografske in izhodiščne lastnosti v študiji ALLY-2
In phase 1 clinical studies, healthy subjects who received up to 100 mg once daily for up to 14 days or single doses up to 200 mg had no unexpected adverse reactions.
V kliničnih študijah 1. faze uporaba odmerkov do 100 mg enkrat na dan v trajanju 14 dni ali enkratnih odmerkov do 200 mg pri zdravih osebah ni bila povezana s pojavom nepričakovanih neželenih učinkov.
If you stop taking Daklinza
Če ste prenehali jemati zdravilo Daklinza
All N=126
Vsi N=126
Coadministration of medicines that inhibit P-gp or OCT1 activity is likely to have a limited effect on daclatasvir exposure.
Zdravila, ki zavirajo delovanje P-gp ali OCT1, bodo pri sočasni uporabi verjetno imela omejen učinek na izpostavljenost daklatasvirju.
All Genotype 2 N=26
Vsi genotip 2 N=26
The SVR12 rate in genotype-3 infected patients with this RAV is reduced (in practice as relapse after end of treatment response), especially in patients with cirrhosis.
Pri bolnikih z okužbo z genotipom 3 s to RAV je bil delež SVR12 manjši (v praksi kot ponovitev po končanem odzivu na zdravljenje), še posebej pri bolnikih s cirozo.
SVR12 was achieved in 90% of treatment-naïve patients and 86% of treatment-experienced patients.
SVR12 je bil dosežen pri 90 % predhodno še nezdravljenih bolnikov in 86 % predhodno že zdravljenih bolnikov.
Patients should be instructed that, if they miss a dose of Daklinza, the dose should be taken as soon as possible if remembered within 20 hours of the scheduled dose time.
Bolniku je treba pojasniti, da mora pozabljeni odmerek zdravila Daklinza vzeti takoj, ko se spomni, če od predvidenega časa še ni minilo več kot 20 ur.
The dose of daclatasvir was adjusted for concomitant antiretroviral use.
Odmerek daklatasvirja so prilagodili glede na sočasno uporabo protiretrovirusnih zdravil.
HCV Genotype 3 (ALLY-3)
Genotip 3 HCV (ALLY-3)
Dose modification, interruption and discontinuation Dose modification of Daklinza to manage adverse reactions is not recommended.
Prilagoditev odmerka, prekinitev in ukinitev zdravljenja Prilagoditev odmerka zdravila Daklinza z namenom obvladovanja neželenih učinkov ni priporočljiva.
Metabolism and nutrition disorders common decreased appetite
Presnovne in prehranske motnje pogosti zmanjšanje apetita
Elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate
Elvitegravir, kobicistat, emtricitabin, tenofovirdizoproksil fumarat
The dose of daclatasvir was 60 mg once daily, with dose adjustments for concomitant antiretroviral use (see section 4.5).
Odmerek daklatasvirja je bil 60 mg enkrat na dan, odmerek pa so prilagajali v skladu s sočasno uporabljenimi protiretrovirusnimi zdravili (glejte poglavje 4.5).
Pregnancy and contraception requirements
Nosečnost in potrebnost kontracepcije
It is important that you continue to take Daklinza during the whole treatment period.
Pomembno je, da zdravilo Daklinza ves čas zdravljenja jemljete redno.
Tell your doctor if you are pregnant, think you may be pregnant or are planning to become pregnant.
Če ste noseči, menite, da bi lahko bili noseči ali načrtujete zanositev, o tem obvestite zdravnika.
All patients receiving Daklinza and sofosbuvir in combination with amiodarone with or without other drugs that lower heart rate should also be warned of the symptoms of bradycardia and heart block and should be advised to seek medical advice urgently should they experience them.
Vse bolnike, ki prejemajo zdravilo Daklinza in sofosbuvir v kombinaciji z amiodaronom in drugimi zdravili, ki upočasnjujejo srčni utrip, ali brez njih, je treba prav tako opozoriti na simptome bradikardije in srčnega bloka ter jim svetovati, naj ob pojavu simptomov takoj poiščejo zdravniško pomoč.
12 weeks treatment duration
12-tedensko zdravljenje
At the 60 mg dose, exposure to daclatasvir was similar between healthy subjects and HCV-infected patients.
Pri uporabi 60 mg odmerka je bila izpostavljenost daklatasvirju pri zdravih osebah in bolnikih, okuženih s HCV, podobna.
Haemoglobin >12 g/dL
Hemoglobin > 12 g/dl
Interaction not studied for this fixed dose combination tablet.
Interakcij s to kombinacijo učinkovin v obliki tablete v fiksnem odmerku niso proučevali.
Treatment discontinuation in patients with inadequate on-treatment virologic response during treatment with Daklinza, peginterferon alfa and ribavirin It is unlikely that patients with inadequate on-treatment virologic response will achieve a sustained virologic response (SVR); therefore discontinuation of treatment is recommended in these patients.
Ukinitev zdravljenja pri bolnikih z nezadostnim virusnim odzivom med zdravljenjem z zdravilom Daklinza v kombinaciji s peginterferonom alfa in z ribavirinom Malo verjetno je, da bi bolniki z nezadostnim virusnim odzivom med zdravljenjem dosegli trajen virološki odziv (SVR - sustained virologic response), zato je pri teh bolnikih zdravljenje priporočljivo ukiniti.
Four patients discontinued the Daklinza regimen for adverse events, only one of which was considered related to study therapy.
Štirje bolniki so bili zaradi neželenih učinkov izključeni iz režima zdravljenja z zdravilom Daklinza, vendar pa so jih le pri enem bolniku opredelili kot povezane z zdravljenjem v študiji.
200 mg every other day
200 mg vsak drugi dan
The clinical data to support the use of Daklinza and sofosbuvir in patients infected with HCV genotypes 4 and 6 are limited.
Klinični podatki, ki bi podpirali uporabo zdravila Daklinza in sofosbuvirja pri bolnikih, okuženih z genotipoma 4 in 6 HCV, so omejeni.
Coadministration of Daklinza can alter the concentration of other medicinal products and other medicinal products may alter the concentration of daclatasvir.
Sočasna uporaba zdravila Daklinza lahko spremeni koncentracijo drugih zdravil in druga zdravila lahko spremenijo koncentracijo daklatasvirja.
Discontinue peginterferon alfa and ribavirin (treatment with Daklinza is complete at week 24)
Ukinite zdravljenje s peginterferonom alfa in z ribavirinom (zdravljenje z zdravilom Daklinza se konča v 24. tednu)
Studies of daclatasvir in animals have shown embryotoxic and teratogenic effects (see section 5.3).
Študije z daklatasvirjem na živalih so pokazale embriotoksične in teratogene učinke (glejte poglavje 5.3).
Table 8: Demographics and main disease characteristics in Study ALLY-1 Cirrhotic cohort N = 60
Tabela 8: Demografske lastnosti bolnikov in glavne značilnosti bolezni v študiji ALLY-1 Kohorta s cirozo N = 60
The Cmax and AUC of total daclatasvir (free and protein-bound drug) were lower in subjects with hepatic impairment; however, hepatic impairment did not have a clinically significant effect on the free drug concentrations of daclatasvir (see section 4.2).
Vrednosti Cmax in AUC skupnega daklatasvirja (prosto in na beljakovine vezano zdravilo) so bile pri bolnikih z okvaro jeter manjše, vendar pa okvara jeter ni imela klinično pomembnega učinka na proste koncentracije daklatasvirja (glejte poglavje 4.2).
Daklinza should not be used during pregnancy or in women of childbearing potential not using contraception.
Zdravila Daklinza ne smete uporabljati pri nosečnicah in pri ženskah v rodni dobi, ki ne uporabljajo učinkovite kontracepcije.
Data from compassionate use programmes which included patients with genotype 3 infection and cirrhosis, support the use of Daklinza + sofosbuvir for 24 weeks in these patients.
Podatki iz programov sočutne uporabe zdravila, ki so vključevali bolnike z okužbo z genotipom 3 in s cirozo, podpirajo 24-tedensko uporabo zdravila Daklinza + sofosbuvirja pri teh bolnikih.
Virologic breakthrough**
Povečanje virusnega bremena med zdravljenjem (“virologic breakthrough”)**
Warnings and precautions Talk to your doctor or pharmacist before taking Daklinza.
Opozorila in previdnostni ukrepi Pred začetkom jemanja zdravila Daklinza se posvetujte z zdravnikom ali farmacevtom.
The active transport is mediated by OCT1 and other unidentified uptake transporters, but not by organic anion transporter (OAT) 2, sodium-taurocholate cotransporting polypeptide (NTCP), or OATPs.
Aktivni transport poteka s pomočjo OCT1 in z drugimi neznanimi prenašalci privzema, ne pa tudi s prenašalcem organskih anionov (OAT - organic anion transporter) 2, polipeptidnim soprenašalcem za natrijev tavroholat (NTCP - sodium-taurocholate cotransporting polypeptide) ali polipeptidnimi prenašalci organskih anionov (OATP - organic anion transporting polypeptide).
HCV/HIV co-infection (ALLY-2)
Sočasna okužba s HCV/HIV (ALLY-2)
There are no clinical data in patients with genotype 5 (see section 5.1).
Pri bolnikih, okuženih z genotipom 5, kliničnih podatkov ni (glejte poglavje 5.1).
The pharmacokinetic properties of daclatasvir were evaluated in healthy adult subjects and in patients with chronic HCV.
Farmakokinetične lastnosti daklatasvirja so vrednotili pri zdravih odraslih osebah in bolnikih s kronično okužbo s HCV.
The baseline NS5A RAVs described above had no major impact on cure rates in patients treated with sofosbuvir + daclatasvir +/- ribavirin, with the exception of the Y93H RAV in genotype 3 infection (seen in 16/192 [8%] of patients).
Zgoraj opisane izhodiščne RAV NS5A niso imele pomembnega vpliva na delež ozdravitev pri bolnikih, ki so se zdravili s sofosbuvirjem + daklatasvirjem +/- ribavirinom, z izjemo RAV Y93H pri okužbi z genotipom 3 (opažena pri 16/192 [8 %] bolnikov).
At the highest dose (100 mg/kg/day), maternal toxicity included mortality and dystocia; developmental toxicity included slight reductions in offspring viability in the peri- and neonatal periods; and reductions in birth weight that persisted into adulthood.
Pri največjem odmerku (100 mg/kg/dan) je toksičnost za matere vključevala pogine in distokijo, toksičnost za razvoj pa nekoliko zmanjšano sposobnost mladičev za preživetje v perinatalnem in postnatalnem obdobju ter manjšo telesno maso mladičev ob kotitvi, ki se je ohranila v odraslo dobo.
SVR12 rates were higher for patients with the IL-28B CC genotype than for those with non-CC genotypes and for patients with baseline HCV RNA less than 800,000 IU/ml but consistently higher in the daclatasvir-treated patients than for placebo-treated patients in all subgroups.
Pri bolnikih s CC genotipi IL-28B so bili deleži SVR12 višji kot pri bolnikih z ne-CC genotipi in bolnikih z izhodiščno vrednostjo HCV RNA manjšo od 800.000 i.e./ml, vendar v vseh podskupinah dosledno višji pri bolnikih, ki so se zdravili z daklatasvirjem, kot pri bolnikih, ki so prejemali placebo.
Patients who had missing data at follow-up Week 12 were considered responders if their next available HCV RNA value was <LLOQ.
Bolniki z manjkajočim podatkom pri obisku v 12. tednu so bili obravnavani kot bolniki z odzivom, če je bila naslednja razpoložljiva vrednost HCV RNA manjša od LLOQ.
In clinical studies of daclatasvir in combination with sofosbuvir or with peginterferon alfa and ribavirin, plasma HCV RNA values were measured using the COBAS TaqMan HCV test (version 2.0), for use with the High Pure System, with a lower limit of quantification (LLOQ) of 25 IU/ ml.
V kliničnih študijah daklatasvirja v kombinaciji s sofosbuvirjem ali peginterferonom alfa in ribavirinom, so vrednosti HCV RNA v plazmi izmerili s testom COBAS TaqMan HCV (različica 2.0) v visoko prečiščenem sistemu, s spodnjo mejo kvantifikacije (LLOQ - lower limit of quantification) 25 i.e./ml.
Relapse was defined as HCV RNA ≥LLOQ during follow-up after HCV RNA <LLOQ at end of treatment.
Ponovitev je bila opredeljena kot vrednost HCV RNA ≥ LLOQ med spremljanjem po vrednosti HCV RNA < LLOQ na koncu zdravljenja.
Patients with HCV genotype 1, 2, 3, 4, 5, or 6 infection were eligible to enroll, including patients with compenstated cirrhosis (ChildPugh A).
Bolniki z okužbo z genotipom 1, 2, 3, 4, 5 ali 6 HCV so izpolnjevali pogoje za vključitev, vključno z bolniki s kompenzirano cirozo (Child-Pugh A).
How long to take Daklinza Make sure you take Daklinza for as long as your doctor has told you to take it.
Kako dolgo jemati zdravilo Daklinza Zdravilo Daklinza morate jemati tako dolgo, kot vam je to predpisal zdravnik.
Among the 167 patients with HCV genotype 1 infection, 126 were treatment-naïve and 41 had failed prior therapy with a PI regimen (boceprevir or telaprevir).
Od 167 bolnikov z okužbo z genotipom 1 HCV se 126 bolnikov predhodno še ni zdravilo, pri 41 bolnikih pa predhodno zdravljenje z režimom, ki je vključeval PI (boceprevir ali telaprevir), ni bilo uspešno.
Available pharmacokinetic and toxicological data in animals have shown excretion of daclatasvir and metabolites in milk (see section 5.3).
Razpoložljivi farmakokinetični in toksikološki podatki pri živalih kažejo na izločanje daklatasvirja in njegovih presnovkov v živalsko mleko (glejte poglavje 5.3).
Refer to the Summary of Product Characteristics of ribavirin.
Glejte povzetek glavnih značilnosti zdravila za ribavirin.
Modest increases in concentrations of daclatasvir are expected, but no dose adjustment of Daklinza or fluconazole is required.
Pričakujemo zmerno povečanje koncentracij daklatasvirja, vendar pa odmerka zdravila Daklinza ali flukonazola ni treba prilagajati.