FrancophonIA/ELRC3.0 huggingface dataset:
English: Coadministration of Daklinza with St. John's wort or other strong inducers of CYP3A4 is contraindicated (see section 4.3).
Maltese: John's wort jew ma' indutturi qawwija oħra ta' CYP3A4 hu kontraindikat (ara sezzjoni 4.3).
English: 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).
Maltese: Fl-istudju ALLY-1, il-kors ta' daclatasvir, sofosbuvir, u ribavirin mogħtija għal 12-il ġimgħa kien evalwat f'113-il adult b'epatite C kronika u ċirrożi ta' Child-Pugh A, B jew C (n=60) jew rikorrenza HCV wara trapjant tal-fwied (n=53).
English: AUC: 1.10 (1.05, 1.15) Cmax: 0.95 (0.89, 1.02) Cmin: 1.17 (1.10, 1.24)
Maltese: AUC: 1.10 (1.05, 1.15) Cmass: 0.95 (0.89, 1.02) Cmin: 1.17 (1.10, 1.24)
English: These substitutions conferred low level resistance (EC50 <1 nM) for genotype 1b, and higher levels of resistance for genotype 1a (EC50 up to 350 nM).
Maltese: Dawn is-sostituzzjonijiet ikkonferixxew reżistenza ta' livell baxx (EC50 <1 nM) għal ġenotip 1b u livelli ogħla ta' reżistenza għal ġenotip 1a (EC50 sa 350 nM)
English: 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.
Maltese: 2, polypeptide tal-ko-trasportazzjoni ta' sodium taurocholate (NTCP), jew OATPs.
English: Inhibition of P-gp and BCRP by daclatasvir
Maltese: Impediment ta' P-gp b'daclatasvir
English: Expected due to CYP3A4 induction by etravirine or nevirapine:
Maltese: CYP3A4 minn etravirine jew nevirapine:
English: Daclatasvir is an inhibitor of HCV genotypes 1a and 1b replication in cell-based replicon assays with effective concentration (50% reduction, EC50) values of 0.003-0.050 and 0.001-0.009 nM, respectively, depending on the assay method.
Maltese: Attività antivirali fil-kultura ċellulari Daclatasvir huwa impeditur tar-replikazzjoni tal-ġenotipi ta' HCV 1a u 1b f'assaġġi ta' replikon bbażati fuq ċelluli b'valuri ta' konċentrazzjoni effettiva (tnaqqis ta' 50%, EC50) ta' 0.
English: Tabulated summary of interactions
Maltese: Sommarju f'Tabella tal-interazzjonijiet
English: All 44 patients with HCV genotype 2 (n=26) or 3 (n=18) infection were treatment-naïve.
Maltese: L-44 pazjent kollha kemm huma kellhom infezzjoni ta' HCV li kienet jew ta' ġenotip 2 (n=26) jew 3 (n=18) ma kinux ingħataw kura qabel.
English: Grade 3 adverse reactions were reported in less than 1% of patients, and no patients had a Grade 4 adverse reaction.
Maltese: Reazzjonijiet avversi ta' Grad 3 ġew irrapportati f'anqas minn 1% tal-pazjenti, u l-ebda pazjent ma kellu reazzjoni avversa ta' Grad 4.
English: SVR rates were comparable regardless of age, race, gender, IL28B allele status, or baseline HCV RNA level.
Maltese: Ir-rati ta' SVR kienu komparabbli irrispettivament milletà, ir-razza, is-sess, l-istatus allele IL28B, jew il-livell HCV RNA fil-linja bażi.
English: IMMUNOSUPPRESSANTS Cyclosporine 400 mg single dose (daclatasvir 60 mg once daily)
Maltese: IMMUNOSUPPRESSANTI Cyclosporine 400 mg doża waħda
English: Table 10: Demographics and baseline characteristics in Study ALLY-2
Maltese: Demografija u karatteristiċi tal-linja bażi fl-Istudju ALLY-2
English: The safety profile of daclatasvir in combination with peginterferon alfa and ribavirin was similar to that seen with peginterferon alfa and ribavirin alone, including among patients with cirrhosis.
Maltese: Il-profil tas-sigurtà ta' daclatasvir flimkien ma' peginterferon alfa u ribavirin kien simili għal dak li deher b'peginterferon alfa u ribavirin waħidhom, inkluż fost pazjenti b'ċirrożi.
English: When Daklinza is used together with sofosbuvir and ribavirin, the following side effects have been reported.
Maltese: Meta Daklinza jintuża flimkien ma' sofosbuvir u ribavirin, ġew irrapportati l-effetti sekondarji li ġejjin.
English: ANTIMYCOBACTERIALS Rifampicin 600 mg once daily (daclatasvir 60 mg single dose)
Maltese: Rifampicin 600 mg darba kuljum (daclatasvir 60 mg doża waħda)
English: Patients with Child-Pugh C liver disease
Maltese: Pazjenti b'marda tal-fwied Child-Pugh C
English: ↔ Cyclosporine AUC: 1.03 (0.97, 1.09) Cmax: 0.96 (0.91, 1.02)
Maltese: AUC: 1.03 (0.97, 1.09) Cmass: 0.96 (0.91, 1.02)
English: ANTIFUNGALS Ketoconazole 400 mg once daily (daclatasvir 10 mg single dose)
Maltese: MEDIĊINI KONTRA L-MOFFA - ANTIFUNGALI Ketoconazole 400 mg darba kuljum (daclatasvir 10 mg doża waħda)
English: ↔ Ribavirin AUC: 0.94 (0.80, 1.11) Cmax: 0.94 (0.79, 1.11) Cmin: 0.98 (0.82, 1.17)
Maltese: AUC: 0.94 (0.80, 1.11) Cmass: 0.94 (0.79, 1.11) Cmin: 0.98 (0.82, 1.17)
English: Concerning recommended regimens with different HCV genotypes, see section 4.2.
Maltese: Rigward korsijiet rakkomandati b'ġenotipi differenti ta' HCV, ara sezzjoni 4.2.
English: The active transport is mediated by OCT1 and other unidentified uptake transporters.
Maltese: It-trasport attiv isir permezz ta' OCT1 u trasportaturi tal-assorbiment mhux identifikati oħrajn.
English: Daklinza + sofosbuvir + ribavirin for 12 weeks (see section 5.1)
Maltese: Daklinza + sofosbuvir + ribavirin għal 12-il ġimgħa (ara sezzjoni 5.1)
English: 28 x 1 film-coated tablet
Maltese: 28 pillola miksija b'rita 28 x 1 pillola miksija b'rita
English: In study AI444040, 211 adults with HCV genotype 1, 2, or 3 infection and without cirrhosis received daclatasvir and sofosbuvir, with or without ribavirin.
Maltese: Fl-istudju AI444040, 211-il adult b'infezzjoni bl-HCV ta' ġenotip 1, 2, jew 3 u mingħajr ċirrożi,
English: Post-LiverTransplant N=53
Maltese: Wara Trapjant tal-Fwied N=53
English: Strong inhibitors of CYP3A4 may increase the plasma levels of daclatasvir.
Maltese: Impedituri qawwija ta' CYP3A4 jistgħu jżidu l-livelli fil-plażma ta' daclatasvir.
English: At steady state, protein binding of daclatasvir in HCV-infected patients was approximately 99% and independent of dose at the dose range studied (1 mg to 100 mg).
Maltese: Fl-istadju fiss, l-irbit ta' daclatasvir ma' proteini f'pazjenti infettati b'HCV kien ta' madwar 99% u kien indipendenti mid-doża fil-firxa tad-dożi studjati (1 mg sa 100 mg).
English: Each 90-mg film-coated tablet contains 173 mg of lactose (as anhydrous).
Maltese: Kull pillola miksija b'rita ta' 90 mg fiha 173 mg ta' lactose (bħala anidru).
English: 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.
Maltese: Konverżjoni mill-punteġġ tal-FibroTest għall-punteġġ korrispondenti ta' METAVIR tissuġġerixxi li 35% tal-pazjenti kollha (49% tal-pazjenti b'falliment ta' PI, 30% ta' pazjenti b'ġenotip 2 jew 3) kellhom fibrożi tal-fwied ta' ≥F3.
English: ↔ Daclatasvir AUC: 1.40 (1.29, 1.53) Cmax: 1.04 (0.94, 1.15) Cmin: 1.56 (1.41, 1.71)
Maltese: AUC: 1.40 (1.29, 1.53) Cmass: 1.04 (0.94, 1.15) Cmin: 1.56 (1.41, 1.71)
English: SVR rates were comparable regardless of HIV regimen, age, race, gender, IL28B allele status, or baseline HCV RNA level.
Maltese: Ir-rati ta' SVR kienu komparabbli irrispettivament mill-kors tal-HIV, l-età, ir-razza, is-sess, l-istatus allele IL28B, jew il-livell ta' HCV RNA fil-linja bażi.
English: ↔ Raltegravir
Maltese: ↔ Daclatasvir ↔ Raltegravir
English: Daklinza 60 mg: the film-coated tablet is light green, biconvex, pentagonal shape with "BMS" debossed on one side and "215" on the other side.
Maltese: Daklinza 60 mg: il-pillola miksija b'rita hija ħadra ċara, imżaqqa fuq żewġ naħat, f'għamla pentagonali mnaqqxa b'“BMS” fuq naħa waħda u b'“215” fuq in-naħa l-oħra.
English: Grade 3/4 increases in total bilirubin were observed in 5% of patients (all in patients with HIV coinfection who were receiving concomitant atazanavir, with Child-Pugh A, B, or C cirrhosis, or who were post-liver transplant).
Maltese: Kienu osservati żidiet ta' Grad 3/4 fil-bilirubina totali f'5% tal-pazjenti (kollha f'pazjenti b'koinfezzjoni tal-HIV li kienu qegħdin jirċievu atazanavir konkomittanti, b'ċirrożi ta' Child-Pugh A, B jew C, jew li kellhom trapjant tal-fwied).
English: There are no virologic treatment stopping rules that apply to the combination of Daklinza with sofosbuvir.
Maltese: Ma hemm ebda regola għall-waqfien tal-kura viroloġika li tapplika għall-kombinazzjoni ta' Daklinza ma' sofosbuvir.
English: The dose of daclatasvir was 60 mg once daily, with dose adjustments for concomitant antiretroviral use (see section 4.5).
Maltese: Id-doża ta' daclatasvir kienet ta' 60 mg darba kuljum, b'aġġustamenti fid-doża għal użu antiretrovirali konkomitanti (ara sezzjoni 4.5).
English: Daklinza must be administered in combination with other medicinal products.
Maltese: Daklinza jrid jingħata f'kombinazzjoni ma' prodotti mediċinali oħra.
English: HCV Treatmentnaïve N=101
Maltese: HCV* N=52
English: ↔ Darunavir AUC: 0.90 (0.73, 1.11) Cmax: 0.97 (0.80, 1.17) Cmin: 0.98 (0.67, 1.44)
Maltese: AUC: 0.90 (0.73, 1.11) Cmax: 0.97 (0.80, 1.17) Cmin: 0.98 (0.67, 1.44)
English: Frequency of baseline NS5A resistance-associated variants (RAVs) Baseline NS5A RAVs were frequently observed in clinical studies of daclatasvir.
Maltese: NS5A RAVs fil-linja bażi kienu osservati b'mod frekwenti fi studji kliniċi ta' daclatasvir.
English: Non-responders (non-SVR12) with baseline and postbaseline sequence with emergent NS5A RAVs M28: T Q30: H, K, R L31: I, M, V P32-deletion H58: D, P S62: L Y93: C, H, N Patient(s) lost to follow-up One patient considered a protocol failure (non-SVR) achieved SVR *** NS5A RAVs monitored at amino acid positions are 28, 29, 30, 31, 32, 58, 62, 92, and 93
Maltese: *** NS5A RAVs issorveljati f'pożizzjonijiet tal-aċidu amminiku huma 28, 29, 30, 31, 32, 58, 62, 92, u 93
English: NAME OF THE MEDICINAL PRODUCT Daklinza 90 mg tablets daclatasvir
Maltese: Daklinza 90 mg pilloli daclatasvir
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/939/005 28 tablets (calendar pack) EU/1/14/939/006 28 x 1 tablet
Maltese: EU/1/14/939/005 28 pillola (pakkett kalendarju) EU/1/14/939/006 28 x 1 pillola
English: 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).
Maltese: L-NS5A RAVs fil-linja bażi deskritti hawn fuq ma kellhom l-ebda impatt kbir fuq ir-rati ta' kura f'pazjenti kkurati b'sofosbuvir + daclatasvir +/- ribavirin, bl-eċċezzjoni tal-Y93H RAV fl-infezzjoni tal-ġenotip 3 (osservata f'16/192 [8%] tal-pazjenti).
English: Each film-coated tablet contains daclatasvir dihydrochloride equivalent to 90 mg daclatasvir.
Maltese: Kull pillola miksija b'rita fiha daclatasvir dihydrochloride ekwivalenti għal 90 mg ta' daclatasvir.
English: 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).
Maltese: Effetti teratoġeniċi u/jew embrijoċidali sinifikanti ġew osservati fi speċi ta' annimali esposti għal ribavirin, għalhekk għandha tingħata attenzjoni estrema sabiex tiġi evitata t-tqala f'pazjenti nisa u fi sħab nisa ta' pazjenti rġiel (ara s-Sommarju tal-Karatteristiċi tal-Prodott għal ribavirin).
English: In vitro and in vivo studies showed that daclatasvir is a substrate of P-gp.
Maltese: Studji in vitro u in vivo wrew li daclatasvir huwa sottostrat ta' P-gp.
English: There is limited experience of accidental overdose of daclatasvir in clinical studies.
Maltese: Hemm esperjenza limitata dwar doża eċċessiva aċċidentali ta' daclatasvir fi studji kliniċi.
English: At the 60 mg dose, exposure to daclatasvir was similar between healthy subjects and HCV-infected patients.
Maltese: Fid-doża ta' 60 mg, l-esponiment għal daclatasvir kien simili bejn individwi b'saħħithom u pazjenti infettati b'HCV.
English: For detailed recommendations regarding pregnancy and contraception, refer to the Summary of Product Characteristics for ribavirin and peginterferon alfa.
Maltese: Għal rakkomandazzjonijiet detalljati dwar it-tqala u l-kontraċezzjoni, irreferi għas-Sommarju tal-Karatteristiċi tal-Prodott għal ribavirin u peginterferon alfa.
English: 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.
Maltese: Fl-ogħla doża (100 mg/kg/jum), it-tossiċità maternali kienet tinkludi mortalità u distoċja, it tossiċità tal-iżvilupp kienet tinkludi tnaqqis baxx fil-vijabilità tal-wild fil-perijodi ta' waqt it-twelid u ftit wara t-twelid; u tnaqqis fil-piż tal-ġisem li ppersista għal sa meta kibru.
English: Simeprevir 150 mg once daily (daclatasvir 60 mg once daily)
Maltese: Simeprevir 150 mg darba kuljum (daclatasvir 60 mg darba kuljum)
English: Daklinza 30 mg film-coated tablets
Maltese: Daklinza 30 mg pilloli daclatasvir
English: CORTICOSTEROIDS Systemic dexamethasone
Maltese: KORTIKOSTEROJDI Dexamethasone sistemiku L-interazzjoni ma ġietx studjata.
English: Daklinza + sofosbuvir +/- ribavirin for 24 weeks (see sections 4.4 and 5.1) HCV GT 3
Maltese: Daklinza + sofosbuvir +/- ribavirin għal 24 ġimgħa (ara sezzjoni 5.1)
English: ↔ Daclatasvir AUC: 1.05 (1.03, 1.07) Cmax: 1.07 (1.02, 1.12) Cmin: 1.10 (1.03, 1.19)
Maltese: AUC: 1.05 (1.03, 1.07) Cmass: 1.07 (1.02, 1.12) Cmin: 1.10 (1.03, 1.19)
English: Daklinza 60 mg film-coated tablets
Maltese: Daklinza 60 mg pilloli daclatasvir
English: Pharmacotherapeutic group: Direct-acting antiviral, ATC code: J05AX14
Maltese: Antivirali li jaġixxu b'mod dirett, Kodiċi ATC:
English: The sofosbuvir resistance-associated substitution S282T emerged in only 1 non-SVR12 patient infected with genotype 3.
Maltese: Is-sostituzzjoni ta' S282T ta' sofosbuvir assoċjata mar-reżistenza żviluppat f'pazjent wieħed mhux SVR12 infettat bil-ġenotip 3.
English: The dose of Daklinza should be increased to 90 mg once daily when coadministered with moderate inducers of CYP3A4.
Maltese: Id-doża ta' Daklinza għandha tiżdied għal 90 mg darba kuljum meta tingħata fl-istess ħin ma' indutturi moderati ta' CYP3A4.
English: HCV RNA undetectable SVR12*
Maltese: Tmiem il-kura HCV RNA mhux osservat SVR12
English: 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.
Maltese: CYP3A4 u P-gp, eż phenytoin, carbamazepine, oxcarbazepine, phenobarbital, rifampicin, rifabutin, rifapentine, dexamethasone sistemiku, u l-prodott mill-ħaxix ta' St John's wort (Hypericum perforatum), u għalhekk jistgħu jwasslu għal telf fl-esponiment u telf fl-effikaċja ta' Daklinza.
English: ↔ Midazolam AUC: 0.87 (0.83, 0.92) Cmax: 0.95 (0.88, 1.04)
Maltese: 87 (0.83, 0.92) Cmass: 0.95 (0.88, 1.04)
English: 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).
Maltese: Jekk id-doża talbidu hija tollerata sew, id-doża tista' tiġi titrata sa massimu ta' 1,000-1,200 mg kuljum (valur kritiku ta' 75 kg).
English: AUC: 0.84 (0.73, 0.96) Cmax: 0.64 (0.54, 0.77) Cmin: 0.92 (0.80, 1.05)
Maltese: AUC: 0.84 (0.73, 0.96) Cmass: 0.64 (0.54, 0.77) Cmin: 0.
English: In healthy subjects, administration of daclatasvir 60 mg tablet after a high-fat meal decreased daclatasvir Cmax and AUC by 28% and 23%, respectively, compared with administration under fasting conditions.
Maltese: Cmass u AUC bi 28% u 23% ta' daclatasvir, rispettivament, meta mqabbla mal-għoti f'kondizzjonijiet ta' sawm.
English: When Daklinza is used together with sofosbuvir (without ribavirin), the following side effects have been reported.
Maltese: Meta Daklinza jintuża flimkien ma' sofosbuvir (mingħajr ribavrin), ġew irrappurtati l-effetti sekondarji li ġejjin.
English: Recommendations concerning coadministration
Maltese: Impedituri ta' integrase
English: Patients with HCV genotype 1, 2, 3, 4, 5 or 6 infection were eligible to enroll.
Maltese: Il-pazjenti infettati bil-ġenotip 1, 2, 3, 4, 5 jew 6 tal-HCV kienu eliġibbli biex jirreġistraw.
English: Daklinza + sofosbuvir +/- ribavirin for 24 weeks (see sections 4.4 and 5.1)
Maltese: Daklinza + sofosbuvir +/- ribavirin għal 24 ġimgħa (ara sezzjonijiet 4.4 u 5
English: Relapse includes observations through follow-up Week 24.
Maltese: Ir-rikaduta tinkludi osservazzjonijiet sa follow-up f'Ġimgħa 24.
English: What Daklinza looks like and contents of the pack Daklinza 30 mg: the film-coated tablet is green, biconvex, pentagonal shape with "BMS" debossed on one side and "213" on the other side.
Maltese: Daklinza 30 mg: il-pillola miksija b'rita hija ħadra, imżaqqa fuq żewġ naħat, f'għamla pentagonali mnaqqxa b'“BMS” fuq naħa waħda u b'“213” fuq in-naħa l-oħra.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/939/003 28 tablets (calendar pack) EU/1/14/939/004 28 x 1 tablet
Maltese: EU/1/14/939/003 28 pillola (pakkett kalendarju) EU/1/14/939/004 28 x 1 pillola
English: Most patients (61%) had IL-28B rs12979860 non-CC genotypes.
Maltese: 28B rs12979860 mhux CC.
English: The highest AUC value in unaffected females was 18-fold the clinical AUC exposure.
Maltese: L-ogħla valur ta' AUC f'nisa mhux affettwati kien ta' 18-il darba l-esponiment AUC klinika.
English: 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 Cmin was 232 (83) ng/ml.
Maltese: peginterferon alfa u ribavirin f'pazjenti li ma kinux ikkurati qabel b'HCV kroniku ta' ġenotip 1, il medja ġeometrika (CV%) ta' daclatasvir Cmass kienet 1,534 (58) ng/mL, AUC0-24 siegħa kienet ta'
English: daclatasvir + pegIFN/RBV
Maltese: daclatasvir + pegIFN/RBV N=12
English: *PK parameters for daclatasvir when administered with peginterferon alfa and ribavirin in this study were similar to those observed in a study of HCVinfected subjects administered daclatasvir monotherapy for 14 days.
Maltese: peginterferon alfa u ribavirin f'dan l istudju kienu simili għal dawk osservati fi studju ta' individwi infettati b'HCV li ngħataw monoterapija ta' daclatasvir għal 14il jum.
English: OTHER
Maltese: Pravastatin
English: The duration of your treatment with Daklinza will be either 12 or 24 weeks.
Maltese: Pazjent wieħed li ma kellux kura qabel kellu d-dejta ta' Ġimgħa 12 u 24 nieqsa.
English: The AUC value associated with this dose is 4-fold the clinical AUC exposure.
Maltese: 4 darbiet aktar (far) u 16-il darba (fenek) l-esponiment AUC klinika.
English: Discontinue Daklinza, peginterferon alfa and ribavirin
Maltese: peginterferon alfa u ribavirin
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/939/001 28 tablets (calendar pack) EU/1/14/939/002 28 x 1 tablet
Maltese: EU/1/14/939/001 28 pillola (pakkett kalendarju) EU/1/14/939/002 28 x 1 pillola
English: Common (may affect up to 1 in 10 people): decreased appetite difficulty sleeping, irritability dizziness 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
Maltese: Komuni ħafna (tista' taffettwa aktar minn persuna 1 f'10) tnaqqis fl-aptit diffikultà biex torqod uġigħ ta' ras nifsijiet qosra tqalligħ għeja mard bħal tal-influwenza deni ħakk, ġilda xotta, telf tax-xagħar mhux tas-soltu jew jirqaq ix-xagħar, raxx dijarea sogħla uġigħ fil-ġogi; muskoli li juġgħu jew teneri, mhux ikkaġunat bl-eżerċizzju; dgħufija mhux tas soltu irritabilità tnaqqis fiċ-ċelluli ħomor tad-demm (anemija), tnaqqis fiċ-ċelluli bojod tad-demm
English: No human data on the effect of daclatasvir on fertility are available.
Maltese: Ebda dejta umana dwar l-effett ta' daclatasvir fuq il-fertilità mhi disponibbli.
English: ↔ GS-331007** AUC: 1.0 (0.95, 1.08) Cmax: 0.8 (0.77, 0.90) Cmin: 1.4 (1.35, 1.53)
Maltese: 1.0 (0.95, 1.08) Cmass: 0.8 (0.77, 0.90) Cmin: 1.4 (1.35, 1.53)
English: Table 3: Treatment stopping rules in patients receiving Daklinza in combination with peginterferon alfa and ribavirin with inadequate on-treatment virologic response
Maltese: Tabella 3: Regoli ta' waqfien tal-kura f'pazjenti li jkunu qed jirċievu Daklinza f'kombinazzjoni ma' peginterferon alfa u ribavirin b'rispons viroloġiku waqt ilkura mhux adegwat
English: Each film-coated tablet contains daclatasvir dihydrochloride equivalent to 60 mg daclatasvir.
Maltese: Kull pillola miksija b'rita fiha daclatasvir dihydrochloride ekwivalenti għal 60 mg ta' daclatasvir.
English: Proton pump inhibitors Omeprazole 40 mg once daily (daclatasvir 60 mg single dose)
Maltese: Impedituri tal-proton-pump Omeprazole 40 mg darba kuljum (daclatasvir 60 mg doża waħda)
English: Dose recommendation for concomitant medicines Strong inhibitors of cytochrome P450 enzyme 3A4 (CYP3A4) The dose of Daklinza should be reduced to 30 mg once daily when coadministered with strong inhibitors of CYP3A4.
Maltese: Rakkomandazzjoni tad-doża għal mediċini li jittieħdu fl-istess ħin Inibituri qawwijin tal-enzima 3A4 ta' ċitokrom P450 (CYP3A4)
English: P-gp inhibition by daclatasvir
Maltese: P-gp b'daclatasvir:
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Maltese: Pazjenti bi problemi ereditarji rari ta' intolleranza għal gallatosju, defiċjenza ta' lattosju ta' Lapp jew assorbiment ħażin ta' glukosju-gallatosju m'għandhomx jieħdu din il-mediċina.
English: The pharmacokinetics of daclatasvir following a single 60 mg oral dose were studied in non-HCV infected subjects with renal impairment.
Maltese: Il-farmakokinetika ta' daclatasvir wara doża orali waħda ta' 60 mg kienet studjata f'individwi b'indeboliment tal-kliewi infettati mhux b'HCV.
English: Patients with CP C cirrhosis
Maltese: Pazjenti b'ċirrożi CP C
English: Nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) Tenofovir disoproxil fumarate 300 mg once daily (daclatasvir 60 mg once daily)
Maltese: Tenofovir disoproxil fumarate 300 mg darba kuljum (daclatasvir 60 mg darba kuljum)
English: 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.
Maltese: L-għoti ta' Daklinza jista' jżid l-esponiment sistemiku għal prodotti mediċinali li huma sottostrati ta' P-gp, OATP 1B1, OCT1 jew BCRP, li jistgħu jżidu jew itawwlu leffett terapewtiku tagħhom u r-reazzjonijiet avversi.
English: Each 60-mg film-coated tablet contains 116 mg of lactose (as anhydrous).
Maltese: Kull pillola miksija b'rita ta' 60 mg fiha 116 mg ta' lactose (bħala anidru).
English: In study ALLY-2, the combination of daclatasvir and sofosbuvir administered for 12 weeks was evaluated in 153 adults with chronic hepatitis C and HIV co-infection; 101 patients were HCV treatment-naïve and 52 patients had failed prior HCV therapy.
Maltese: Fl-Istudju ALLY-2, il-kombinazzjoni ta' daclatasvir u sofosbuvir mogħtija għal 12-il ġimgħa kienet evalwata f'153 adult b'koinfezzjoni kronika tal-epatite C u HIV; 101 pazjent qatt ma ġew ikkurati qabel għal HCV u 52 pazjent fallew terapija HCV qabel.