natgillin/translations-raw huggingface dataset:
Among 302 patients who achieved SVR12 with daclatasvir + pegIFN/RBV with a median duration of post-SVR12 follow-up of 44 months, 2% (n=6) of patients relapsed.
Pri 302 bolnikih, ki so pri zdravljenju z daklatasvirjem + pegIFN/RBV dosegli SVR12, je v 44 mesecih (mediana vrednost trajanja spremljanja) po-SVR12 do ponovitve prišlo pri 2 % (n=6)
** The patient with virologic breakthrough met the original protocol definition of confirmed HCV RNA <LLOQ, detectable at treatment Week 8.
** Bolnik s povečanjem virusnega bremena med zdravljenjem (“virologic breakthrough”) je v 8. tednu zdravljenja dosegel s protokolom opredeljeno potrjeno vrednost HCV RNA < LLOQ.
Contraindications of concomitant use (see section 4.3) Daklinza is contraindicated in combination with medicinal products that strongly induce CYP3A4 and P-gp, e.g. phenytoin, carbamazepine, oxcarbazepine, phenobarbital, rifampicin, rifabutin, rifapentine, systemic dexamethasone, and the herbal product St John's wort (Hypericum perforatum), and thus may lead to lower exposure and loss of efficacy of Daklinza.
Kontraindikacije za sočasno uporabo (glejte poglavje 4.3) Uporaba zdravila Daklinza je kontraindicirana v kombinaciji z zdravili, ki močno inducirajo CYP3A4 in P-gp, npr. fenitoin, karbamazepin, okskarbazepin, fenobarbital, rifampicin, rifabutin, rifapentin, sistemski deksametazon in zdravila rastlinskega izvora, ki vsebujejo šentjanževko (Hypericum perforatum), saj se pri sočasni uporabi lahko zmanjša izpostavljenost zdravilu Daklinza in izgubi
Resistance in clinical studies
Odpornost v celični kulturi
Advanced cirrhosis and post-liver transplant (ALLY-1) In study ALLY-1, the regimen of daclatasvir, sofosbuvir, and ribavirin administered for 12 weeks was evaluated in 113 adults with chronic hepatitis C and Child-Pugh A, B or C cirrhosis (n=60) or HCV recurrence after liver transplantation (n=53).
Napredovala ciroza in stanje po presaditvi jeter (ALLY-1) V študiji ALLY-1 so režim uporabe daklatasvirja, sofosbuvirja in ribavirina 12 tednov proučevali pri 113 odraslih s kroničnim hepatitisom C in cirozo Child-Pugh A, B ali C (n=60) ali ponovitvijo HCV
Subjects with end-stage renal disease requiring haemodialysis had a 27% increase in daclatasvir AUC and a 20% increase in unbound AUC compared to subjects with normal renal function (see section 4.2).
Pri osebah s končno odpovedjo ledvic, ki potrebujejo zdravljenje s hemodializo, je bila vrednost AUC daklatasvirja večja za 27 %, vrednost AUC nevezanega daklatasvirja pa večja za 20 % kot pri osebah z normalnim delovanjem ledvic (glejte
Following multiple oral doses of daclatasvir 60 mg once daily in combination with peginterferon alfa and ribavirin in treatment-naïve patients with genotype 1 chronic HCV, the geometric mean (CV%) daclatasvir Cmax was 1534 (58) ng/ml, AUC0-24h was 14122 (70) ng•h/ml, and
Pri ponavljajočih se peroralnih odmerkih daklatasvirja v odmerku 60 mg enkrat na dan v kombinaciji s peginterferonom alfa in ribavirinom pri predhodno nezdravljenih bolnikih s kronično okužbo z genotipom 1 HCV so bile geometrijske srednje (KV %) vrednosti daklatasvirja naslednje: vrednost Cmax 1.534 (58) ng/ml, vrednost AUC0-24h 14.122 (70) ng•h/ml, vrednosti Cmin pa 232 (83) ng/ml.
Observed emergent NS5A resistance-associated variants are reported in Table 15.
Opažen pojav RAV NS5A je prikazan v tabeli 15.
Four patients discontinued the Daklinza regimen for adverse events, only one of which was considered
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
The dose of ribavirin, when combined with Daklinza, is weight-based (1,000 or 1,200 mg in patients <75 kg or ≥75 kg, respectively).
Pri kombiniranem zdravljenju z zdravilom Daklinza je odmerek ribavirina odvisen od telesne mase (1.000 mg pri bolnikih s telesno maso < 75 kg in 1.200 mg pri bolnikih s telesno maso ≥ 75 kg).
Treatmentexperienced* N=51
Predhodno že zdravljeni* N=51
Some other medicines can interact with Daklinza, affecting the levels of Daklinza in your body.
Nekatera druga zdravila lahko vplivajo na delovanje zdravila Daklinza in spremenijo količino zdravila Daklinza v telesu.
Coadministration with medicinal products that strongly induce cytochrome P450 3A4 (CYP3A4) and P-glycoprotein transporter (P-gp) and thus may lead to lower exposure and loss of efficacy of Daklinza.
Pri sočasni uporabi zdravil, ki so močni induktorji citokroma P450 3A4 (CYP3A4) in prenašalca P-glikoproteina (P-gp), se izpostavljenost zdravilu Daklinza lahko zmanjša in izgubi njegova učinkovitost.
Tell your doctor immediately if you are taking any medicines for heart problems and during treatment
Takoj obvestite zdravnika, če jemljete katero koli zdravilo za zdravljenje težav s srcem in med palpitacije (neprijetne občutke ob hitrem ali močnem utripanju srca),
Some diabetic patients have experienced low sugar levels in the blood (hypoglycaemia) after starting treatment with medicines
Nekateri sladkorni bolniki so imeli po začetku zdravljenja z zdravili, kot je zdravilo Daklinza, nizke ravni sladkorja v krvi (hipoglikemija).
Daklinza in combination with peginterferon alfa and ribavirin The most frequently reported adverse reactions were fatigue, headache, pruritus, anaemia, influenzalike illness, nausea, insomnia, neutropenia, asthenia, rash, decreased appetite, dry skin, alopecia, pyrexia, myalgia, irritability, cough, diarrhoea, dyspnoea and arthralgia.
Zdravilo Daklinza v kombinaciji s peginterferonom alfa in z ribavirinom Najpogosteje poročani neželeni učinki so bili utrujenost, glavobol, srbenje, anemija, gripi podobna bolezen, navzea, nespečnost, nevtropenija, astenija, izpuščaj, zmanjšanje apetita, suha koža, alopecija, zvišana telesna temperatura, bolečina v mišicah, razdražljivost, kašelj, driska, dispneja in bolečina v sklepih.
Ribavirin Dosing Guidelines
Smernice za odmerjanje ribavirina
* Mainly interferon-based therapy, but 7 patients received sofosbuvir + ribavirin and 2 patients received a ** Cirrhosis was determined by liver biopsy (METAVIR F4) for 14 patients, FibroScan >14.6 kPa for 11 patients or FibroTest score ≥0.75 and aspartate aminotransferase (AST): platelet ratio index (APRI) >2 for 7 patients.
7 bolnikov je prejemalo sofosbuvir + ribavirin, 2 bolnika pa ** Ciroza je bila pri 14 bolnikih določena z biopsijo jeter (METAVIR F4), pri 11 bolnikih z metodo FibroScan (> 14,6 kPa), pri 7 bolnikih pa z oceno FibroTesta ≥ 0,75 in indeksom razmerja med aspartataminotransferazo (AST) in trombociti (APRI) > 2.
24 weeks
12-tedensko zdravljenje
End of treatment HCV RNA undetectable
HCV RNA nezaznavna
Data to support the treatment of genotype 2 infection with Daklinza and sofosbuvir are limited.
Podatki, ki podpirajo zdravljenje okužbe z genotipom 2 z zdravilom Daklinza in sofosbuvirjem, so
Most patients (71%, including 98% of prior PI failures) had IL-28B rs12979860 non-CC
Večina bolnikov (71 %, vključno z 98 % bolnikov z neuspešnim predhodnim zdravljenjem z zaviralcem proteaze) je imela ne-CC genotipe IL-28B rs12979860.
Ten percent of patients had compensated cirrhosis, and 75% of patients had IL-28B rs12979860 non-CC genotypes.
Deset odstotkov bolnikov je imelo kompenzirano cirozo, 75 % bolnikov pa je imelo ne-CC genotipe IL-28B rs12979860.
Among treatment-naïve patients with HCV RNA results at both follow-up Weeks 12 and 24, concordance between SVR12 and SVR24 was 99.5% independent of
Pri predhodno nezdravljenih bolnikih z ovrednoteno vrednostjo HCV-RNA pri obeh kontrolnih obiskih, to je v 12. in 24. tednu, je bila ugotovljena 99,5-% skladnost med SVR12 in SVR24, neodvisno od trajanja zdravljenja.
- Tablet core: anhydrous lactose (see section 2), microcrystalline cellulose, croscarmellose sodium, silicon dioxide (E551) and magnesium stearate - Film-coating: hypromellose, titanium dioxide (E171), macrogol 400, indigo carmine aluminum lake (E132), yellow iron oxide (E172)
- Filmska obloga: hipromeloza, titanov dioksid (E171), makrogol 400, indigotin (E132) in
How long to take Daklinza Make sure you take Daklinza for as long as your doctor has told you to take it.
Zdravilo Daklinza morate jemati tako dolgo, kot vam je to predpisal zdravnik.
Coadministration with strong inducers of CYP3A4 and P-gp is contraindicated while dose adjustment of Daklinza is recommended when coadministered with moderate inducers of CYP3A4 and P-gp (see Table 4).
Sočasna uporaba z močnimi induktorji CYP3A4 in P-gp je kontraindicirana, pri sočasni uporabi zmernih induktorjev CYP3A4 in P-gp pa je odmerek zdravila Daklinza priporočljivo prilagoditi (glejte tabelo 4).
Diabetics may experience improved glucose control, potentially resulting in symptomatic hypoglycaemia, after initiating HCV DAA treatment.
Pri sladkornih bolnikih se lahko po začetku zdravljenja okužbe s HCV z neposredno delujočim protivirusnim zdravilom izboljša nadzor nad sladkorjem, kar ima lahko za posledico simptomatsko hipoglikemijo.
Table 4: Interactions and dose recommendations with other medicinal products
Tabela 4: Interakcije in priporočila za odmerjanje pri sočasni uporabi drugih zdravil Priporočila pri sočasni uporabi
* Mainly interferon-based therapy +/-NS3/4 PI. ** Cirrhosis was determined by liver biopsy, FibroScan >14.6 kPa, or FibroTest score ≥0.75 and aspartate aminotransferase (AST): platelet ratio index (APRI) >2.
** Ciroza je bila določena z biopsijo jeter, z metodo FibroScan (> 14,6 kPa) ali z oceno FibroTesta ≥ 0,75 in indeksom razmerja med aspartat-aminotransferazo (AST) in trombociti (APRI) > 2.
Seven percent of patients had compensated cirrhosis; 92% had HCV genotype 1 (72% 1a and 20% 1b) and 8% had HCV genotype 4; 65% of patients had IL-28B rs12979860 non-CC genotypes.
Sedem odstotkov bolnikov je imelo kompenzirano cirozo jeter, 92 % bolnikov je imelo genotip 1 HCV (72 % 1a in 20 % 1b) ter 8 % bolnikov genotip 4 HCV. 65 % bolnikov je imelo
Daklinza contains less than 1 mmol sodium (23 mg) per maximum dose of 90 mg, that is to say
Bolniki na dieti z nadzorovanim vnosom natrija Zdravilo Daklinza vsebuje manj kot 1 mmol (23 mg) natrija na največji odmerek 90 mg, kar v bistvu
You may need closer monitoring of your blood glucose levels and/or adjustment of your diabetes medication after starting Daklinza.
Po začetku jemanja zdravila Daklinza morda potrebujete skrbno spremljanje ravni sladkorja v krvi in/ali prilagoditev zdravila za zdravljenje sladkorne bolezni.
Respiratory, thoracic and mediastinal disorders dyspnoea, dyspnoea exertional, cough, nasal diarrhoea, vomiting, abdominal pain, gastrooesophageal reflux disease, constipation, dry mouth, flatulence nausea, diarrhoea, abdominal pain
Bolezni dihal, prsnega koša in mediastinalnega prostora dispneja, dispneja pri telesnem naporu, kašelj, kongestija nosne sluznice driska, bruhanje, bolečina gastroezofagealna refluksna bolezen, zaprtost, suha usta,
If you have been told by your doctor that you have an intolerance to some sugars (e.g. lactose), talk to
Če vam je zdravnik povedal, da ne prenašate nekaterih sladkorjev (npr. laktoze), se pred začetkom jemanja zdravila Daklinza posvetujte s svojim zdravnikom.
Administration of Daklinza with any of these calcium channel blockers may result in increased concentrations of daclatasvir.
Pri sočasni uporabi zdravila Daklinza in katerega koli zaviralca kalcijevih kanalčkov se koncentracije daklatasvirja lahko povečajo.
Table 14: Treatment outcomes, daclatasvir in combination with peginterferon alfa and ribavirin (pegIFN/RBV), treatment-naïve patients with HCV genotype 4
Tabela 14: Izidi zdravljenja, daklatasvir v kombinaciji s peginterferonom alfa in ribavirinom (pegIFN/RBV), predhodno nezdravljeni bolniki z genotipom 4 HCV
These active substances include but are not limited to phenytoin, carbamazepine, oxcarbazepine, phenobarbital, rifampicin, rifabutin, rifapentine, systemic dexamethasone, and the herbal product St John's wort (Hypericum perforatum).
Med te zdravilne učinkovine med drugim spadajo fenitoin, karbamazepin, okskarbazepin, fenobarbital, rifampicin, rifabutin, rifapentin, sistemski deksametazon in zdravila rastlinskega izvora, ki vsebujejo šentjanževko (Hypericum perforatum).
* 2 patients had detectable HCV RNA at end of treatment; 1 of these patients achieved SVR.
* 2 bolnika sta ob koncu zdravljenja imela zaznavno raven HCV RNA.
Table 2: Ribavirin dosing guidelines for coadministration with Daklinza regimen for patients with cirrhosis or post-transplant
Tabela 2: Smernice za odmerjanje ribavirina pri sočasni uporabi z zdravilom Daklinza pri bolnikih s cirozo ali po presaditvi jeter
AI444043 was an open-label, single-arm study of daclatasvir with pegIFN/RBV in treatment-naïve adults with chronic HCV genotype 1 infection who were co-infected
Študija AI444043 je bila odprta, enoskupinska študija uporabe daklatasvirja v kombinaciji s pegIFN/RBV pri zdravljenju predhodno še nezdravljenih odraslih bolnikov s kronično okužbo z genotipom 1 HCV in sočasno okužbo z virusom HIV.
No dose adjustment of Daklinza is required for patients with mild (Child-Pugh A, score 5-6), moderate (Child-Pugh B, score 7-9) or severe (Child-Pugh C, score ≥10) hepatic impairment (see sections 4.4
Pri bolnikih z blago (Child-Pugh A, ocena 5-6), zmerno (Child-Pugh B, ocena 7-9) ali s hudo (Child-Pugh C, ocena ≥ 10) okvaro jeter odmerka zdravila Daklinza ni treba prilagajati.
However, if the missed dose is remembered more than 20 hours after the scheduled dose, the dose should be skipped and the next
Če pa je od predvidenega časa minilo že več kot 20 ur, mora pozabljeni odmerek izpustiti in vzeti le naslednji odmerek ob običajnem času.
Warnings and precautions Talk to your doctor or pharmacist before taking Daklinza.
Pred začetkom jemanja zdravila Daklinza se posvetujte z zdravnikom ali farmacevtom.
No dose adjustment of Daklinza is required for patients with any degree of renal impairment (see
Pri bolnikih s katero koli stopnjo okvare ledvic odmerka zdravila Daklinza ni treba prilagajati (glejte
Missed doses
Okvara ledvic
If treatment interruption of components in the regimen is necessary because of adverse reactions, Daklinza must There are no virologic treatment stopping rules that apply to the combination of Daklinza with
Če je treba zdravljenje z drugimi zdravili v režimu zdravljenja zaradi pojava neželenih učinkov prekiniti, se zdravila Daklinza ne sme uporabljati v monoterapiji.
Daklinza 30 mg film-coated tablets Daklinza 60 mg film-coated tablets daclatasvir
Daklinza 30 mg filmsko obložene tablete Daklinza 60 mg filmsko obložene tablete
PK trough levels for peginterferon alfa in patients who received peginterferon alfa, ribavirin, and daclatasvir were received peginterferon alfa, ribavirin,
Pri bolnikih, ki so prejemali peginterferon alfa, ribavirin prejemali peginterferon alfa, ribavirin
No data are available.
V tabeli niso navedene
Post-LiverTransplant N=53
Po presaditvi jeter N = 53
Daklinza 30 mg: the film-coated tablet is green, biconvex, pentagonal shape with "BMS" debossed on one side and "213" on the other side.
Daklinza 30 mg: zelena, obojestransko izbočena, peterokotna filmsko obložena tableta z vtisnjeno oznako “BMS” na eni in “213” na drugi strani.
The table is not all-inclusive.
Navedba smiselno ni potrebna.
In clinical studies of Daklinza in combination with sofosbuvir with or without ribavirin, 2% of patients had Grade 3 haemoglobin decreases; all of these patients received Daklinza + sofosbuvir + ribavirin.
V kliničnih študijah zdravila Daklinza v kombinaciji s sofosfubovirjem, z ribavirinom ali brez njega, so pri 2 % bolnikov poročali o zmanjšanju vrednosti hemoglobina stopnje 3.
*PK parameters for daclatasvir when administered with peginterferon alfa and ribavirin in this study were similar to those observed in a study of HCV
*V tej študiji so bili farmakokinetični parametri za daklatasvir pri uporabi s peginterferonom alfa in ribavirinom študiji pri bolnikih, okuženih s HCV,
The film-coated tablet should not be chewed or crushed due the unpleasant taste of the
Zaradi neprijetnega okusa zdravilne učinkovine se filmsko obložene tablete ne sme žvečiti ali drobiti.
Significant teratogenic and/or embryocidal effects have been demonstrated in all animal species exposed to ribavirin; therefore, extreme care must be taken to avoid pregnancy in female patients and in female partners of male patients (see the Summary of Product Characteristics for ribavirin).
Posebno skrb je tako treba nameniti preprečitvi nosečnosti pri bolnicah in partnerkah bolnikov (glejte povzetek glavnih značilnosti zdravila za
Follow guidelines above for haemoglobin 200 mg every other day Discontinue ribavirin
600 mg na dan 400 mg na dan 200 mg na dan ukinite ribavirin upoštevajte zgornje smernice za hemoglobin 200 mg vsak drugi dan ukinite ribavirin
SVR rates were >94% across combination antiretroviral therapy (cART) regimens, including boosted-PI-, NNRTI-, and integrase inhibitor (INSTI)-based therapies.
Po režimih kombiniranega protiretrovirusnega zdravljenja (cART - combination antiretroviral therapy), vključno z zdravljenji na osnovi okrepljenega PI, NNRTI in zaviralca integraze
Light green biconvex pentagonal of dimensions 9.1 mm x 8.9 mm, debossed tablet with "BMS" on one
Svetlo zelena, obojestransko izbočena, peterokotna tableta, velikosti 9,1 mm x 8,9 mm, z vtisnjeno oznako “BMS” na eni in “215” na drugi strani.
Refer to the respective Summary of Product Characteristics for drug interaction information for other medicinal products in the regimen.
Za podatke o interakcijah drugih zdravil, uporabljenih v režimu zdravljenja, glejte ustrezne povzetke
12 weeks therapy HCV Treatmentnaïve N=101
HCV, brez predhodnega zdravljenja N=101
* One treatment-experienced patient achieved SVR12 per local HCV RNA results.
* Pri enem predhodno že zdravljenem bolniku je bila SVR12 dosežena v skladu z lokalnimi rezultati
One treatment-naïve patient was missing both post-treatment Weeks 12
Pri enem predhodno nezdravljenem bolniku so manjkali podatki tako v 12. kot 24. tednu po zdravljenju.
↑ Digoxin AUC: 1.27 (1.20, 1.34)
↔ Daklatasvir AUC: 1,40 (1,29; 1,53)
and you notice within 20 hours of the time you usually take Daklinza, you must take the tablet as soon as possible.
in od običajnega časa, ko vzamete zdravilo Daklinza, še ni minilo več kot 20 ur, tableto vzemite takoj, ko je to mogoče, nato pa vzemite naslednji odmerek ob običajnem času.
Since Daklinza is used in combination with other agents, the contraindications and warnings for those
Ker se zdravilo Daklinza uporablja v kombinaciji z drugimi zdravili, je treba upoštevati tudi kontraindikacije in opozorila za uporabo teh zdravil.
Pravastatin
Predhodno
The sofosbuvir resistance-associated substitution S282T emerged in only 1 non-SVR12 patient Emergent daclatasvir resistance-associated substitutions have been shown to persist for 3 years posttreatment and beyond for patients treated with daclatasvir-based regimens.
Substitucija S282T, povezana z odpornostjo proti sofosbuvirju, se je pojavila le pri 1 bolniku, okuženem z genotipom 3, pri katerem SVR12 ni bil dosežen.
No dose adjustment of midazolam, other benzodiazepines or other CYP3A4 substrates is required when coadministered with Daklinza.
Pri sočasni uporabi zdravila Daklinza odmerka midazolama, drugih benzodiazepinov ali drugih substratov za CYP3A4 ni treba prilagajati.
Dizziness has been reported during treatment with Daklinza in combination with sofosbuvir, and dizziness, disturbance in attention, blurred vision and reduced visual acuity have been reported during treatment with Daklinza in combination with peginterferon alfa and ribavirin.
Pri zdravljenju z zdravilom Daklinza v kombinaciji s sofosbuvirjem so poročali o pojavu omotice, pri zdravljenju z zdravilom Daklinza v kombinaciji s sofosbuvirjem in peginterferonom alfa ter ribavirinom pa o omotici, motnjah pozornosti, zamegljenem vidu in zmanjšani ostrini vida.
Daklinza in combination with sofosbuvir
Zdravilo Daklinza v kombinaciji s sofosbuvirjem
Do not take Daklinza if you are taking any of the following medicines: phenytoin, carbamazepine, oxcarbazepine or phenobarbital, used to treat epileptic seizures rifampicin, rifabutin or rifapentine, antibiotics used to treat tuberculosis dexamethasone, a steroid used to treat allergic and inflammatory diseases medicines containing St. John's wort (Hypericum perforatum, a herbal preparation).
Ne jemljite zdravila Daklinza, če jemljete katero koli od naslednjih zdravil: fenitoin, karbamazepin, okskarbazepin ali fenobarbital, ki se uporabljajo za zdravljenje rifampicin, rifabutin ali rifapentin, antibiotiki za zdravljenje tuberkuloze.
Other None
Ελλάδα
If you have any questions about your medicines, please ask your doctor or
Če imate o predpisanih zdravilih kakršno koli vprašanje, se posvetujte z
Coadministration of Daklinza with rifampicin, rifabutin, rifapentine or other strong inducers of CYP3A4 is contraindicated (see section 4.3).
Sočasna uporaba zdravila Daklinza z rifampicinom, rifabutinom, rifapentinom ali drugimi močnimi induktorji CYP3A4 je kontraindicirana (glejte poglavje 4.3).
Daclatasvir in combination with sofosbuvir
Daklatasvir v kombinaciji s sofosbuvirjem
migraine shortness of breath, cough, nasal congestion (blocked nose) hot flush dry skin, unusual hair loss or thinning, rash, itching diarrhoea, vomiting, abdominal pain, constipation, heartburn, excessive gas in the stomach or bowel dry mouth joint pain, aching or tender muscles, not caused by exercise
suha koža, neobičajno izpadanje ali redčenje las, izpuščaj, srbenje driska, bruhanje, bolečina v trebuhu, zaprtost, zgaga, nabiranje plinov v želodcu ali črevesu bolečina v sklepih, bolečina ali občutljivost v mišicah, ki nista posledica telesne aktivnosti
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,
Post-Liver Transplant N = 53
Po presaditvi jeter N=53
With some of these medicines, your doctor may need to adjust your dose of Daklinza.
Pri sočasni uporabi nekaterih navedenih zdravil bo zdravnik odmerek zdravila Daklinza morda moral
Table 3: Treatment stopping rules in patients receiving Daklinza in combination with peginterferon alfa and ribavirin with inadequate on-treatment virologic response
Tabela 3: Pravila za ukinitev zdravljenja pri bolnikih z nezadostnim virusnim odzivom med zdravljenjem z zdravilom Daklinza v kombinaciji s peginterferonom alfa in z
If you become pregnant, stop taking Daklinza and tell your doctor immediately.
Če med zdravljenjem z zdravilom Daklinza zanosite, takoj prenehajte jemati zdravilo in o tem nemudoma
*Comparison for daclatasvir was to a studies of daclatasvir 60 mg once daily with peginterferon alfa and ribavirin).
*Primerjava podatkov za daklatasvir s peginterferonom alfa in ribavirinom).
Expected due to CYP3A4 induction by
Pričakovano zaradi indukcije CYP3A4
↔ Ethinylestradiol AUC: 1.01 (0.95, 1.07) Cmax: 1.11 (1.02, 1.20)
↔ Daklatasvir AUC: 1,41 (1,32; 1,50) Cmax: 0,77 (0,70; 0,85)
Patients originally assigned to placebo and those in the daclatasvir group who did not achieve HCV RNA <LLOQ at Week 4 and undetectable at Week 10 continued pegIFN/RBV
Bolniki, ki so bili prvotno razporejeni v skupino s placebom in bolniki v skupini z daklatasvirjem, ki v 4. tednu niso dosegli vrednost HCV RNA < LLOQ in nezaznavne ravni v 10. tednu, so nadaljevali zdravljenje s pegIFN/RBV celotno 48-tedensko obdobje zdravljenja.
Green biconvex pentagonal of dimensions 7.2 mm x 7.0 mm, debossed tablet with "BMS" on one side
Zelena, obojestransko izbočena, peterokotna tableta, velikosti 7,2 mm x 7,0 mm, z vtisnjeno oznako “BMS” na eni in “213” na drugi strani.