natgillin/translations-raw huggingface dataset:
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Strimvelis, including the appropriate precautions to be followed by healthcare professionals and patients. 
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
The dose depends on the bodyweight of the patient. 
Odmerek je odvisen od telesne mase bolnika.
Strimvelis contains cells derived from the patient's own bone marrow. 
Zdravilo Strimvelis vsebuje celice, pridobljene iz bolnikovega lastnega kostnega mozga.
For practical information about using Strimvelis, patients should read the package leaflet or contact their doctor or pharmacist. 
Za praktične informacije o uporabi zdravila Strimvelis naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
Strimvelis is a type of advanced therapy medicine called a ‘gene therapy product'. 
Zdravilo Strimvelis spada v skupino zdravil za napredno zdravljenje, ki se imenujejo „zdravila za gensko zdravljenje“.
Strimvelis can only be used to treat the same patient whose bone marrow was used to make the medicine. 
Zdravilo Strimvelis se uporablja le za zdravljenje bolnika, čigar kostni mozeg je bil uporabljen za izdelavo zdravila.
Strimvelis provides the opportunity of a cure that improves the working of the immune system for patients with ADA-SCID, which is a life-threatening condition. 
Zdravilo Strimvelis omogoča možnost zdravljenja, ki izboljšuje delovanje imunskega sistema pri bolnikih z ADA-SCID, ki je življenjsko nevarna bolezen.
A working gene for ADA is inserted into the CD34+ cells using a type of virus called a retrovirus, which has been altered genetically so that it can carry the ADA gene into cells and does not cause viral disease in humans. 
Gen, ki izdeluje ADA, se vstavi v celice CD34+ z uporabo vrste virusa, imenovanega retrovirus, ki je bil genetsko spremenjen, da lahko prenaša gen ADA v celice in ne povzroči virusnih bolezni pri ljudeh.
Some of the cells (called CD34+ cells) have been genetically modified to contain a working gene for ADA. 
Nekatere celice (imenovane celice CD34+) so bile gensko spremenjene, da vsebujejo gen, ki izdeluje ADA.
Strimvelis is a medicine used to treat severe combined immunodeficiency due to adenosine deaminase deficiency (ADA-SCID). 
Zdravilo Strimvelis se uporablja za zdravljenje hude kombinirane imunske pomanjkljivosti zaradi pomanjkanja adenozin deaminaze (ADA-SCID).
ADA-SCID is a rare inherited condition in which there is a change (mutation) in the gene needed to make an enzyme called adenosine deaminase (ADA). 
ADA-SCID je redka prirojena motnja, pri kateri gre za spremembo (mutacijo) gena, potrebnega za izdelovanje encima, imenovanega adenozin deaminaza (ADA).
Autologous CD34+ enriched cell fraction that contains CD34+ cells transduced with retroviral vector that encodes for the human ADA cDNA sequence 
Strimvelis avtologna, s CD34+ obogatena celična frakcija s celicami CD34+, transduciranimi z retrovirusnim vektorjem, ki kodira zaporedje človeške adenozin deaminaze (ADA) cDNA
Strimvelis is used in patients with ADA-SCID who cannot be treated by a bone-marrow transplant because they do not have a suitable, matched, related donor. 
Zdravilo Strimvelis se uporablja pri bolnikih z ADA-SCID, ki niso primerni za presaditev kostnega mozga, ker nimajo primernega, usklajenega, sorodnega dajalca.
Strimvelis can only be obtained with a prescription and treatment should only be given in a specialist transplant centre by a doctor who has experience in the treatment of ADA-SCID and the use of this type of medicine. 
Izdaja zdravila Strimvelis je le na recept in dati ga sme le zdravnik, ki ima izkušnje z zdravljenjem bolnikov z ADA-SCID in uporabo tovrstnih zdravil.
Before Strimvelis is given, patients receive conditioning (preparatory) treatment with another medicine, busulfan, to get rid of their abnormal bone marrow cells. 
Preden se uporabi zdravilo Strimvelis, bo bolnik prejel predpripravo pred zdravljenjem z drugim zdravilom, busulfanom, da se odstranijo nenormalne celice kostnega mozga.
How is Strimvelis used? 
Kako se zdravilo Strimvelis uporablja?
Strimvelis must not be used in patients who have leukaemia (cancer of white blood cells) or myelodysplasia (a type of bone marrow disorder) or have had these conditions in the past. 
Zdravila Strimvelis ne smejo dobiti bolniki, ki imajo ali so v preteklosti imeli levkemijo (rak belih krvnih celic) ali mielodisplazijo (vrsto bolezni kostnega mozga).
To make Strimvelis, a sample of the patient's bone marrow is collected. 
Za izdelavo zdravila Strimvelis se odvzame vzorec bolnikovega kostnega mozga.
Once given back to the patient into a vein, Strimvelis is transported in the bloodstream to the bone marrow where the CD34+ cells start to grow and make normal lymphocytes that can produce ADA. 
Po dajanju zdravila Strimvelis v veno se zdravilo prenese po krvnem obtoku do kostnega mozga, kjer celice CD34+ začnejo rasti in izdelovati normalne limfocite, ki proizvajajo ADA. Ti limfociti izboljšajo bolnikovo zmožnost bojevanja proti okužbam in tako premagajo simptome bolezenskih stanj, ki so povezana z imunskim sistemom.
Then, CD34+ cells (cells that can make lymphocytes) are extracted from the bone marrow cells. 
Nato se iz celic kostnega mozga pridobijo celice CD34+ (celice, ki izdelujejo limfocite).
How does Strimvelis work? 
Kako zdravilo Strimvelis deluje?
Min, Max ND: Not determined 
Min, Max ND: ni bilo določeno
Do not take a double dose (two doses close together). 
Ne vzemite dvojnega odmerka (dveh odmerkov skupaj).
None of these effects have been observed in humans. 
Nobenega od teh učinkov niso opazili pri človeku.
Category/ Substitution, n (%) 
Kategorija/substitucija, n (%)
Ribavirin can harm your unborn baby. 
Ribavirin lahko škoduje nerojenemu otroku.
Loc. Fontana del Ceraso 03012 Anagni (FR) Italy 
Loc. Fontana del Ceraso 03012 Anagni (FR) Italija
End of treatment 
Konec zdravljenja
Black/African American Other 
Črnci/Afroameričani
The studies presented in Table 4 were conducted in healthy adult subjects unless otherwise noted. 
Študije, predstavljene v tabeli 4, so bile izvedene pri zdravih odraslih osebah, če ni navedeno drugače.
*Compared to historical data. 
* V primerjavi s preteklimi podatki.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 22 August 2014 
Datum prve odobritve: 22. avgust 2014
Excretion into milk 
Izločanje v mleko
The absolute bioavailability of the tablet formulation is 67%. 
Absolutna biološka uporabnost zdravila v obliki tablete je 67 %.
Not reported CP classes 
Ni podatka CP razredi
Patient population* 
Populacija bolnikov*
Relapse includes observations through follow-up Week 24. 
Ponovitev vključuje opazovanja med spremljanjem do 24. tedna.
and very rare (<1/10,000). 
< 1/1.000) in zelo redki (< 1/10.000).
Interaction not studied. 
Interakcij niso proučevali.
Ribavirin may be added based on clinical assessment of an individual patient. 
Ribavirin se lahko doda na osnovi klinične presoje pri vsakem bolniku posebej.
Treatment of overdose with daclatasvir should consist of general supportive measures, including monitoring of vital signs, and observation of the patient's clinical status. 
Zdravljenje prevelikega odmerjanja daklatasvirja mora obsegati splošne podporne ukrepe, vključno s spremljanjem vitalnih znakov in opazovanjem kliničnega stanja bolnika.
The relevance of including ribavirin as part of the 24-week regimen is unclear. 
Pomen vključitve ribavirina v 24-tedenski režim zdravljenja ni jasen.
Demographic and baseline characteristics of these 50 patients were generally comparable to those for patients who received 12 weeks of study treatment. 
Demografske in izhodiščne lastnosti teh 50 bolnikov so bile na splošno primerljive s tistimi pri bolnikih, ki so se v študiji zdravili 12 tednov.
* the effect of 60 mg daclatasvir on lopinavir may be higher. 
* učinek 60 mg daklatasvirja na lopinavir je lahko večji.
Patients who are identified as being at high risk of bradyarrhythmia should be continuously monitored for 48 hours in an appropriate clinical setting. 
Bolnike, pri katerih se ugotovi veliko tveganje za bradiaritmijo, je treba 48 ur neprekinjeno spremljati v ustrezni klinični ustanovi.
This lowers the amount of hepatitis C virus in your body and removes the virus from your blood over a period of time. 
Na ta način zmanjša količino virusa hepatitisa C v telesu in sčasoma virus odstrani iz krvi.
Carcinogenesis and mutagenesis 
Karcinogeneza in mutageneza
The HCV RNA thresholds that trigger discontinuation of treatment (i.e. treatment stopping rules) are presented in Table 3. 
Mejne vrednosti HCV RNA, ki so razlog za ukinitev zdravljenja (pravila za ukinitev zdravljenja), so predstavljena v tabeli 3.
The relevance of adding ribavirin to that regimen is unclear (see section 5.1). 
Pomen dodatka ribavirina k temu režimu zdravljenja ni jasen (glejte poglavje 5.1).
Resistance in clinical studies 
Odpornost v kliničnih študijah
Caution is advised. 
Priporočamo previdnost.
Study AI444010 
Študija AI444010
If you are taking any of these medicines, your doctor may decide to change your daily dose of Daklinza to ensure that the treatment is safe and effective for you. 
Če jemljete katero koli od teh zdravil, lahko zdravnik spremeni dnevni odmerek zdravila Daklinza, da zagotovi, da bo zdravljenje varno in učinkovito.
If you take any of these medicines, tell your doctor immediately. 
Če jemljete katero koli od teh zdravil, o tem nemudoma obvestite svojega zdravnika.
Do not use this medicine after the expiry date which is stated on the carton and blister after "EXP". 
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in pretisnem omotu poleg oznake “EXP”.
**GS-331007 is the major circulating metabolite of the prodrug sofosbuvir. 
**GS-331007 je glavni presnovek predzdravila sofosbuvirja v obtoku.
NARCOTIC ANALGESICS 
NARKOTIČNI ANALGETIKI
Concerning genotype-specific virological and clinical activity, see section 5.1. 
Za genotipsko specifično virološko in klinično aktivnost glejte poglavje 5.1.
Patients should be instructed to swallow the tablet whole. 
Bolniku je treba pojasniti, da mora tableto pogoltniti celo.
Long term efficacy data 
Podatki o dolgoročni učinkovitosti
Blood and lymphatic system disorders very common anaemia 
Bolezni krvi in limfatičnega sistema zelo pogosti anemija
Study AI444042 
Študija AI444042
In vitro studies indicate that daclatasvir is actively and passively transported into hepatocytes. 
In vitro študije kažejo, da daklatasvir aktivno in pasivno prehaja v hepatocite.
Outcomes by prior treatment experience are presented in Table 11. 
Izidi glede na predhodno zdravljenje so predstavljeni v tabeli 11.
The duration of your treatment with Daklinza will be either 12 or 24 weeks. 
Zdravljenje z zdravilom Daklinza lahko traja 12 ali 24 tednov.
The mean score on the FibroTest (a validated non-invasive diagnostic assay) was 0.460 (range: 0.03 to 0.89). 
Povprečna ocena FibroTesta (validirani neinvazivni diagnostični test) je znašala 0,460 (razpon: od 0,03 do 0,89).
The most frequently detected NS5A RAVs included Q30E or Q30R in combination with L31M. 
Najpogosteje odkrite RAV NS5A so vključevale Q30E ali Q30R v kombinaciji z L31M.
Clinically relevant increase in concentration is indicated as “↑”, clinically relevant decrease as “↓”, no clinically relevant change as “↔”. 
Klinično pomembno povečanje koncentracije je prikazano kot “↑”, klinično pomembno zmanjšanje kot “↓”, brez klinično pomembne spremembe pa kot “↔”.
Grade 3 adverse reactions were reported in less than 1% of patients, and no patients had a Grade 4 adverse reaction. 
O neželenih učinkih stopnje 3 so poročali pri manj kot 1 % bolnikov, o neželenih učinkih stopnje 4 pa niso poročali pri nobenem bolniku.
No dose adjustment of Daklinza or buprenorphine may be required, but it is recommended that patients should be monitored for signs of opiate toxicity. 
Odmerka zdravila Daklinza ali buprenorfina morda ni potrebno prilagajati, vendar je priporočljivo, da se bolnike spremlja na znake opiatne toksičnosti.
It is very important that you also read the package leaflets for the other medicines that you will be taking with Daklinza. 
Zelo pomembno je, da preberete tudi navodila za uporabo drugih zdravil, ki jih boste uporabljali skupaj z zdravilom Daklinza.
*results are dose-normalised to 60 mg dose. 
*Rezultati so normirani na 60-mg odmerek.
If the starting dose is not well-tolerated, the dose should be reduced as clinically indicated, based on haemoglobin and creatinine clearance measurements (see Table 2). 
Če bolnik začetnega odmerka ne prenaša dobro, je treba odmerek zmanjšati kot je to klinično indicirano na osnovi laboratorijskih vrednosti hemoglobina in kreatininskega očistka (glejte tabelo 2).
The active transport is mediated by OCT1 and other unidentified uptake transporters. 
Aktivni transport poteka s pomočjo OCT1 in z drugimi neznanimi prenašalci privzema.
Effect of food on oral absorption 
Vpliv hrane na absorpcijo pri peroralni uporabi
If available, ratios of geometric means are shown, with 90% confidence intervals (CI) in parentheses. 
Če so podatki na voljo, so v oklepaju prikazana razmerja geometrijskih sredin z 90-% intervali zaupanja (IZ).
Keep the tablet blister with you so that you can easily describe what you have taken. 
S seboj vzemite ovojnino zdravila, da boste zdravstvenemu osebju lažje pojasnili, kaj ste vzeli.
Mainly interferon-based therapy +/-NS3/4 PI. 
Večinoma z režimom na osnovi interferona +/-NS3/4 PI.
Age (years): median (range) Race: 
Starost (leta): mediana (razpon) Rasa:
If you are pregnant you must not take Daklinza. 
Če ste noseči, zdravila Daklinza ne smete jemati.
Uxbridge UB8 1DH United Kingdom 
Uxbridge UB8 1DH Velika Britanija
If you have any of these side effects, do not drive or use any tools or machines. 
primeru pojava takšnih neželenih učinkov ne smete voziti vozil ali upravljati z orodji ali s stroji.
This leaflet was last revised in <{MM/YYYY}>. 
Navodilo je bilo nazadnje revidirano dne <{MM/LLLL}>.
Pharmacotherapeutic group: Direct-acting antiviral, ATC code: J05AX14 
Farmakoterapevtska skupina: Zdravila z direktnim delovanjem na viruse, oznaka ATC: J05AX14
Other medicines and Daklinza 
Druga zdravila in zdravilo Daklinza
Daclatasvir in vitro did not inhibit (IC50 >40 µM) CYP enzymes 1A2, 2B6, 2C8, 2C9, 2C19, or 2D6. 
Daklatasvir in vitro ni zaviral (IC50 > 40 µM) encimov CYP 1A2, 2B6, 2C8, 2C9, 2C19 ali 2D6.
Study conducted in patients with chronic HCV infection 
Študija, izvedena pri bolnikih s kronično okužbo s HCV
Treatment with Daklinza should be initiated and monitored by a physician experienced in the management of chronic hepatitis C. 
Zdravljenje z zdravilom Daklinza mora uvesti in spremljati zdravnik, ki ima izkušnje z zdravljenjem kroničnega hepatitisa C.
All 4 patients achieved SVR12. 
SVR12 je bil dosežen pri vseh 4 bolnikih.
In vitro and in vivo studies showed that daclatasvir is a substrate of P-gp. 
In vitro ter in vivo študije so pokazale, da je daklatasvir substrat za P-gp.
Because daclatasvir is highly protein bound (99%) and has a molecular weight >500, dialysis is unlikely to significantly reduce plasma concentrations of daclatasvir. 
Ker se daklatasvir močno veže na beljakovine (99 %), njegova molekulska masa pa je > 500, je malo verjetno, da bi dializa pomembneje zmanjšala koncentracije daklatasvirja v plazmi.
Resistance in cell culture 
Odpornost v celični kulturi
>30 to ≤50 mL/min 
> 30 do ≤ 50 ml/min
There are no data from the use of daclatasvir in pregnant women. 
Podatkov o uporabi daklatasvirja pri nosečnicah ni.
Not all packages may be marketed in your country. 
Na trgu morda ni vseh navedenih pakiranj.
Emerging resistance 
Pojav odpornosti
CCR5 receptor antagonist Maraviroc 
Antagonist receptorjev CCR5 Maravirok
Limited data are available from an ongoing follow-up study to assess durability of response up to 3 years after treatment with daclatasvir. 
Na voljo so omejeni podatki iz študije, ki trenutno še poteka in vrednoti trajanje odziva do 3 let po zdravljenju z daklatasvirjem.
Otherwise the medicine may not work against the hepatitis C virus. 
V nasprotnem zdravilo proti virusu hepatitisa C morda ne bo delovalo.
Tabulated summary of interactions 
Tabelarični pregled interakcij
This medicine works by stopping the hepatitis C virus from multiplying and infecting new cells. 
Zdravilo deluje tako, da virusu hepatitisa C prepreči razmnoževanje in okužbo novih celic.
If you have been told by your doctor that you have an intolerance to some sugars (e.g. lactose), talk to your doctor before taking Daklinza. 
Če vam je zdravnik povedal, da ne prenašate nekaterih sladkorjev (npr. laktoze), se pred začetkom jemanja zdravila Daklinza posvetujte s svojim zdravnikom.
Fibrosis stage F0 
Stopnja fibroze F0
↑ Daclatasvir ↔ Fluconazole 
↑ Daklatasvir ↔ Flukonazol
Treatment outcomes in study AI444042 are presented in Table 13. 
Izidi zdravljenja v študiji AI444042 so prikazani v tabeli 13.
In limited numbers of genotype 4-infected patients with non-response, substitutions L28M and L30H/S were detected at failure. 
Pri omejenem številu z genotipom 4 okuženih neodzivnih bolnikov, so ob neuspehu opazili substitucije L28M in L30H/S.
Table 4 provides information from drug interaction studies with daclatasvir including clinical recommendations for established or potentially significant drug interactions. 
V tabeli 4 so prikazane informacije iz študij medsebojnega delovanja med daklatasvirjem in drugimi zdravili, vključno s kliničnimi priporočili v primeru dokazanih ali možnih pomembnih interakcijah.
The serum digoxin concentrations should be monitored and used for titration of digoxin dose to obtain the desired clinical effect. 
Spremljati je treba koncentracije digoksina v serumu in odmerek digoksina titrirati do želenega kliničnega učinka.
What Daklinza is and what it is used for What you need to know before you take Daklinza How to take Daklinza 
Kaj je zdravilo Daklinza in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Daklinza Kako jemati zdravilo Daklinza
Daklinza is sometimes used together with ribavirin. 
Zdravilo Daklinza se včasih uporablja skupaj z ribavirinom.
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.