FrancophonIA/ELRC3.0 huggingface dataset:
English: Methadone, 40-120 mg once daily individualized dose* (daclatasvir 60 mg once daily)
Maltese: Methadone, 40-120 mg doża individwalizzata li tingħata darba kuljum* (daclatasvir 60 mg darba kuljum)
English: ↑ Rosuvastatin AUC: 1.58 (1.44, 1.74) Cmax: 2.04 (1.83, 2.26)
Maltese: AUC: 1.58 (1.44, 1.74) Cmass: 2.04 (1.83, 2.26)
English: Prior telaprevir or boceprevir failures daclatasvir + sofosbuvir N=70
Maltese: Fallimenti qabel b'telaprevir jew boceprevir daclatasvir + sofosbuvir N=70
English: GT: Genotype; CP: Child Pugh * Includes patients co-infected with human immunodeficiency virus (HIV).
Maltese: GT: Ġenotip; CP: Child Pugh
English: Substitutions conferring daclatasvir resistance in genotypes 1-4 were observed in the N-terminal 100 amino acid region of NS5A in a cell-based replicon system.
Maltese: Sostituzzjonijiet li jikkonferixxu r-reżistenza għal daclatasvir f'ġenotipi 1-4 kienu osservati fir-reġjun terminali N ta' 100 aċidu amminiku ta' NS5A f'sistema replikon bażata fuq iċ-ċelluli.
English: Discontinue ribavirin
Maltese: ↔ Ribavirin
English: Vascular disorders common hot flush
Maltese: Disturbi vaskulari komuni fwawar
English: Patients who are identified as being at high risk of bradyarrhythmia should be continuously monitored for 48 hours in an appropriate clinical setting.
Maltese: Il-pazjenti li huma identifikati bħala li għandhom riskju għoli ta' bradiarritmija, għandhom jiġu ssorveljati b'mod kontinwu għal 48 siegħa f'ambjent kliniku xieraq.
English: In limited numbers of genotype 4-infected patients with non-response, substitutions L28M and L30H/S were detected at failure.
Maltese: b'nuqqas ta' rispons, ġew osservati is-sostituzzjonijiet L28M u L30H/S fil-falliment.
English: SVR12 was achieved by 99% patients with HCV genotype 1, 96% of those with genotype 2 and 89% of those with genotype 3 (see Tables 6 and 7).
Maltese: SVR12 intlaħaq minn 99% tal-pazjenti b'ġenotip 1 ta' HCV, 96% ta' dawk b'ġenotip 2 u 89% ta' dawk b'ġenotip 3 (ara Tabelli 6 u 7).
English: Genotype 3
Maltese: Ġenotip 3
English: AUC: 0.99 (0.95, 1.03) Cmax: 1.02 (0.95, 1.09)
Maltese: AUC: 0.99 (0.95, 1.03) Cmass: 1.02 (0.95, 1.09)
English: The mean score on the FibroTest (a validated non-invasive diagnostic assay) was 0.460 (range: 0.03 to 0.89).
Maltese: Il-punteġġ medju fuq il-Fibro Test (assaġġ dijanjostiku mhux invażiv ivvalidat) kien ta' 0.460 (medda: 0.03 sa 0.89).
English: Fusion inhibitor Enfuvirtide
Maltese: Impeditur ta' Fusjoni Enfuvirtide
English: The 211 patients had a median age of 54 years (range: 20 to 70); 83% were white; 12% were black/African-American; 2% were Asian; 20% were Hispanic or Latino.
Maltese: Il-211-il pazjent, kellhom età medjana ta' 54 sena (medda: 20 sa 70); 83% kienu bojod, 12% kienu suwed/Amerikani-Afrikani, 2% kienu Ażjatiċi; 20% kienu
English: The pharmacokinetics of daclatasvir following a single 30 mg oral dose were studied in non-HCV infected subjects with mild (Child-Pugh A), moderate (Child-Pugh B), and severe (Child-Pugh C) hepatic impairment compared with unimpaired subjects.
Maltese: Il-farmakokinetika ta' daclatasvir wara għotja orali waħda b'doża ta' 30 mg kienu studjati f'individwi mhux infettati b'HCV, li kellhom indeboliment tal-fwied ħafif (Child-Pugh A), moderat (Child-Pugh B), u sever (Child-Pugh C) meta mqabbla ma' individwi mhux indeboliti.
English: Expected due to CYP3A4 inhibition by the calcium channel blocker:
Maltese: CYP3A4 mill-imblokkatur tal-kanal tal-calcium hu mistenni li:
English: CYP3A4 inhibition by ritonavir
Maltese: Impediment ta' CYP3A4 b'ritonavir
English: The most resistant variants with single amino acid substitution in genotype 2a and genotype 3a were F28S (EC50 >300 nM) and Y93H (EC50 >1,000 nM), respectively.
Maltese: L-aktar varjanti reżistenti b'sostituzzjoni ta' aċidu amminiku wieħed f'ġenotip 2a u ġenotip 3a kienu F28S (EC50 >300 nM) u Y93H (EC50
English: Daklinza is indicated in combination with other medicinal products for the treatment of chronic hepatitis C virus (HCV) infection in adults (see sections 4.2, 4.4 and 5.1).
Maltese: Daklinza huwa indikat biex jingħata flimkien ma' prodotti mediċinali oħra għall-kura tal-infezzjoni kronika mill-virus ta' epatite Ċ (HCV) fl-adulti (ara sezzjonijiet 4.2, 4.4 u 5.1).
English: Skin and subcutaneous tissue disorders common rash, alopecia, pruritus, dry skin Musculoskeletal and connective tissue disorders common arthralgia, myalgia arthralgia, myalgia
Maltese: Disturbi muskolu-skeletriċi u tat-tessuti konnettivi komuni artralġja, mijalġja artralġja, mijalġja
English: Resistance in cell culture
Maltese: Reżistenza f'kultura ċellulari
English: CYP3A4 induction by rifampicin
Maltese: Sensibilizzazzjoni ta' CYP3A4 b'rifampicin
English: The most frequently detected NS5A RAVs included Q30E or Q30R in combination with L31M.
Maltese: NS5A RAVs misjuba b'mod komuni kienu jinkludu Q30E jew Q30R flimkien ma' L31M.
English: AUC: 1.12 (1.01, 1.26) Cmax: 1.14 (0.98, 1.32) Cmin: 1.23 (1.09, 1.38)
Maltese: AUC: 1.12 (1.01, 1.26) Cmass: 1.14 (0.98, 1.32) Cmin: 1.23 (1.09, 1.38)
English: Daklinza 30 mg film-coated tablets Daklinza 60 mg film-coated tablets Daklinza 90 mg film-coated tablets daclatasvir
Maltese: Daklinza 30 mg pilloli miksija b'rita Daklinza 60 mg pilloli miksija b'rita Daklinza 90 mg pilloli miksija b'rita
English: CYP3A4 inhibition by telaprevir
Maltese: Impediment ta' CYP3A4 minn telaprevir
English: Pack size of 28 film-coated tablets in non-perforated calendar blisters.
Maltese: Daqs tal-pakkett ta' 28 pillola miksija b'rita f'folji kalendarji mhux ipperforati.
English: 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 with HIV.
Maltese: AI444043 kien studju b'fergħa waħda, b'tikketta mikxufa, ta' daclatasvir ma' pegIFN/RBV f'adulti li qatt ma ġew ikkurati qabel b'infezzjoni kronika tal-ġenotip 1 tal-HCV li kienu ko-infettati bl-HIV.
English: The overall cure rate for genotype-3 infected patients who were treated for 12 weeks with sofosbuvir + daclatasvir (without ribavirin) in the presence and absence of the Y93H RAV was 7/13 (54%) and 134/145 (92%), respectively.
Maltese: Ir-rata ta' kura inġenerali għal pazjenti infettati bil-ġenotip 3 li kienu kkurati għal 12-il ġimgħa b'sofosbuvir + daclatasvir (mingħajr ribavirin) fil-preżenza u l-assenza ta' Y93H RAV kienet ta' 7/13 (54%) u 134/145 (92%), rispettivament.
English: Daklinza contains lactose
Maltese: Daklinza fih lactose.
English: AUC: 1.01 (0.95, 1.07) Cmax: 1.11 (1.02, 1.20)
Maltese: AUC: 1.01 (0.95, 1.07) Cmass: 1.11 (1.02, 1.20)
English: Interaction not studied.
Maltese: Interazzjoni mhux studjata.
English: AUC: 1.12 (1.02, 1.23) Cmax: 1.07 (0.99, 1.16)
Maltese: AUC: 1.12 (1.02, 1.23) Cmass: 1.07 (0.99, 1.16)
English: None
Maltese: JIS
English: AUC: 2.15 (1.87, 2.48) Cmax: 1.22 (1.04, 1.44)
Maltese: 2.15 (1.87, 2.48) Cmass: 1.22 (1.04, 1.44)
English: There was no Y93H RAV present at baseline for genotype-3 infected patients treated for 12-weeks with sofosbuvir + daclatasvir + ribavirin, and thus SVR outcomes cannot be assessed.
Maltese: Ma kienx hemm Y93H RAV preżenti fillinja bażi għal pazjenti infettati bil-ġenotip 3 ikkurati għal 12-il ġimgħa b'sofosbuvir + daclatasvir + ribavirin, u allura r-riżultati tal-SVR ma jistgħux jiġu vvalutati.
English: In dogs, bone marrow hypocellularity with correlating clinical pathology changes were observed at exposures 9-fold the clinical AUC exposure.
Maltese: Fil-klieb, lipoċellularità tal-mudullun b'tibdiliet tal-patoloġija klinika korrelati ġew osservati f'esponimenti li kienu 9 darbiet l-esponiment tal-AUC klinika.
English: 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.
Maltese: Fi studji kliniċi ta' Daklinza flimkien ma' sofosbuvir bi jew mingħajr ribavirin, 2% tal-pazjenti kellhom tnaqqis fl-emoglobina ta' Grad 3; dawn il-pazjenti kollha rċevew Daklinza + sofosbuvir + ribavirin.
English: Daclatasvir in combination with peginterferon alfa and ribavirin Baseline NS5A RAVs (at M28T, Q30, L31, and Y93 for genotype 1a; at L31 and Y93 for genotype 1b) increase the risk for non-response in treatment-naive patients infected with genotype 1a and genotype 1b infection.
Maltese: NS5A RAVs fil-linja bażi (f'M28T, Q30, L31, u Y93 għall-ġenotip 1a; f'L31 u Y93 għall-ġenotip 1b) iżidu r-riskju ta' nuqqas ta' rispons f'pazjenti li qatt ma ġew ikkurati qabel infettati b'infezzjoni ta'
English: NAME OF THE MARKETING AUTHORISATION HOLDER Bristol-Myers Squibb Pharma EEIG
Maltese: FIS-SUQ Bristol-Myers Squibb Pharma EEIG
English: 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).
Maltese: u P-gp huwa kontraindikat filwaqt li l-aġġustament fid-doża ta' Daklinza huwa rakkomandat meta jingħata flimkien ma' indutturi moderati jew CYP3A4 u P-gp (ara Tabella 4).
English: All Genotype 2 N=26
Maltese: Kollha N=26
English: AUC: 0.95 (0.82, 1.10) Cmax: 0.88 (0.78, 0.99) Cmin: 0.91 (0.71, 1.16)
Maltese: AUC: 0.95 (0.82, 1.10) Cmass: 0.88 (0.78, 0.99) Cmin: 0.91 (0.71, 1.16)
English: ↔ Alprazolam
Maltese: ↔ Triazolam ↔ Alprazolam
English: ↑ Dolutegravir AUC: 1.33 (1.11, 1.59) Cmax: 1.29 (1.07, 1.57) Cmin: 1.45 (1.25, 1.68)
Maltese: 1.33 (1.11, 1.59) Cmax: 1.29 (1.07, 1.57) Cmin: 1.45 (1.25, 1.68)
English: AI444010: Patients received daclatasvir 60 mg once daily (n=158) or placebo (n=78) plus pegIFN/RBV through Week 12.
Maltese: Pazjenti li rċivew daclatasvir 60 mg darba kuljum (n=158) jew plaċebo (n=78) flimkien ma' pegIFN/RBV matul Ġimgħa 12.
English: HCV replicons expressing daclatasvir-associated resistance substitutions remained fully sensitive to interferon alfa and other anti-HCV agents with different mechanisms of action, such as NS3 protease and NS5B polymerase (nucleoside and non-nucleoside) inhibitors.
Maltese: Replikons ta' HCV maħsuba għal sostituzzjonijiet dwar reżistenza assoċjata ma' daclatasvir baqgħu kompletament sensittivi għal interferon alfa u sustanzi oħra ta' kontra l-HCV b'mekkaniżmi differenti ta' azzjoni, bħal NS3 protease u NS5B polymerase (Impedituri nukleosidi u mhux nukleosidi).
English: Tabulated list of adverse reactions Adverse reactions are listed in Table 5 by regimen, system organ class and frequency: very common
Maltese: Elenku tabulat ta' reazzjonijiet avversi Reazzjonijiet avversi huma elenkati f'Tabella 5 skont il-kors, tas-sistema tal-organi u l-frekwenza:
English: Daclatasvir is an inhibitor of P-gp, OATP 1B1 and BCRP.
Maltese: Daclatasvir huwa impeditur ta' P-gp, OATP1B1 u BCRP.
English: Patients achieving virologic response [HCV RNA undetectable at weeks 4 and 12] completed therapy after 24 weeks while those who did not achieve virologic response received an additional 24 weeks of treatment with pegIFN/RBV, to complete a total of 48 weeks of study therapy.
Maltese: Il-pazjenti li jilħqu rispons viroloġiku [HCV RNA mhux osservat fil ġimgħat 4 u 12] lestew it-terapija wara 24 ġimgħa filwaqt li dawk li ma laħqux rispons viroloġiku rċevew 24 ġimgħa addizzjonali ta' kura b' pegIFN/RBV, biex ilestu total ta' 48 ġimgħa ta' terapija ta' studju.
English: Median age was 55 years (range: 24 to 73); 90% of patients were white; 4% were black/African-American; 5% were Asian; 16% were Hispanic or Latino.
Maltese: Il-medjan tal-età kien ta' 55 sena (medda: 24 sa 73); 90% tal-pazjenti kienu bojod; 4% kienu suwed/Amerikani-Afrikani; 5% kienu Asjatiċi;
English: AUC: 1.27 (1.20, 1.34) Cmax: 1.65 (1.52, 1.80) Cmin: 1.18 (1.09, 1.28)
Maltese: AUC: 1.27 (1.20, 1.34) Cmass: 1.65 (1.52, 1.80) Cmin: 1.18 (1.09, 1.28)
English: AI444042 enrolled patients with HCV genotype 4 infection and AI444010 enrolled patients with either genotype 1 or 4.
Maltese: A1444042 irreġistra pazjenti b'infezzjoni ta' HCV ġenotip 4 u A1444010 irreġistra pazjenti jew b'ġenotip 1 jew 4.
English: AUC: 1.05 (1.02, 1.08) Cmax: 1.00 (0.92, 1.08) Cmin: 1.10 (1.04, 1.16)
Maltese: AUC: 1.05 (1.02, 1.08) Cmass: 1.00 (0.92, 1.08) Cmin: 1.10 (1.04, 1.16)
English: Expected due to CYP3A4 inhibition by cobicistat:
Maltese: CYP3A4 minn cobicistat:
English: 600 mg daily
Maltese: 600 mg kuljum
English: Daclatasvir in combination with peginterferon alfa and ribavirin AI444042 and AI444010 were randomised, double-blind studies that evaluated the efficacy and safety of daclatasvir in combination with peginterferon alfa and ribavirin (pegIFN/RBV) in the treatment of chronic HCV infection in treatment-naïve adults with compensated liver disease (including cirrhosis).
Maltese: Daclatasvir f'kombinazzjoni ma' peginterferon alfa u ribavirin A1444042 u A1444010 kienu studji li fihom il-parteċipanti ntgħażlu b'mod każwali, u double-blind li evalwaw l-effikaċja u s-sigurtà ta' declatasvir flimkien ma' peginterferon alfa u ribavirin
English: Daclatasvir unbound AUC was estimated to be 18%, 39% and 51% higher for subjects with creatinine clearance (CLcr) values of 60, 30 and 15 ml/min, respectively, relative to subjects with normal renal function.
Maltese: L-AUC ta' daclatasvir mhix marbuta kienet stmata li hi ta' 18%, 39% u 51% ogħla għal individwi b'valuri ta' eliminazzjoni tal-kreatinina (CLcr) ta' 60, 30
English: Darunavir 800 mg/ritonavir 100 mg once daily (daclatasvir 30 mg once daily)
Maltese: Darunavir 800 mg/ritonavir 100 mg darba kuljum (daclatasvir 30 mg darba kuljum)
English: ↑ Simeprevir AUC: 1.44 (1.32, 1.56) Cmax: 1.39 (1.27, 1.52) Cmin: 1.49 (1.33, 1.67)
Maltese: AUC: 1.44 (1.32, 1.56) Cmass: 1.39 (1.27, 1.52) Cmin: 1.49 (1.33, 1.67)
English: Table 8: Demographics and main disease characteristics in Study ALLY-1
Maltese: Tabella 8: Demografija u karatteristiċi ewlenin tal-marda fl-Istudju ALLY-1
English: Other HCV antivirals
Maltese: MEDIĊINA ANTIVIRALI, HCV
English: Following multiple-dose administration of daclatasvir in HCV-infected patients, the terminal elimination half-life of daclatasvir ranged from 12 to 15 hours.
Maltese: Wara l-għoti ta' dożi multipli ta' daclatasvir f'pazjenti infettati bl-HCV, il-half-life tal-eliminazzjoni terminali ta' daclatasvir varjat bejn 12 u 15-il siegħa.
English: SVR12 was achieved in 90% of treatment-naïve patients and 86% of treatment-experienced patients.
Maltese: SVR12 inkiseb f'90% tal-pazjenti li qatt ma rċevew kura fil-passat u f'86% tal-pazjenti li rċevew kura fil-passat.
English: 200 mg daily
Maltese: 200 mg kuljum
English: In 9 phase 2/3 studies with daclatasvir in combination with peginterferon alfa + ribavirin or in combination with sofosbuvir +/- ribavirin, the following frequencies of such RAVs were seen at baseline: 7% in genotype 1a infection (M28T, Q30, L31, and/or Y93), 11% in genotype 1b infection (L31 and/or Y93H), 51% in genotype 2 infection (L31M), 8% in genotype 3 infection (Y93H) and 64% in genotype 4 infection (L28 and/or L30).
Maltese: (M28T, Q30, L31, u/ jew Y93), 11% f'infezzjoni tal-ġenotip 1b (L31 u/jew Y93H), 51% fl-infezzjoni tal-ġenotip 2 (L31M), 8% fl-infezzjoni tal-ġenotip 3 (Y93H) u 64% f'infezzjoni tal-ġenotip 4 (L28 u/jew L30).
English: Lopinavir 400 mg/ritonavir 100 mg twice daily (daclatasvir 30 mg once daily)
Maltese: Lopinavir 400 mg/ritonavir 100 mg darbtejn kuljum (daclatasvir 30 mg darba kuljum)
English: Table 6: Treatment outcomes, daclatasvir in combination with sofosbuvir, HCV genotype 1 in Study AI444040
Maltese: Tabella 6: Riżultati tat-trattament, daclatasvir fimkien ma' sofosbuvir, HCV ġenotip 1 fl-Istudju
English: ↔ Tacrolimus AUC: 1.00 (0.88, 1.13) Cmax: 1.05 (0.90, 1.23)
Maltese: AUC: 1.00 (0.88, 1.13) Cmass: 1.05 (0.90, 1.23)
English: AUC: 1.10 (1.01, 1.21) Cmax: 1.06 (0.98, 1.15) Cmin: 1.15 (1.02, 1.30)
Maltese: AUC: 1.10 (1.01, 1.21) Cmass: 1.06 (0.98, 1.15) Cmin: 1.15 (1.02, 1.30)
English: AUC: 1.37 (1.24, 1.52) Cmax: 1.30 (1.03, 1.64) Cmin: 1.17 (1.03, 1.32)
Maltese: ↑ Buprenorphine AUC: 1.37 (1.24, 1.52) Cmax: 1.30 (1.03, 1.64) Cmin: 1.17 (1.03, 1.32)
English: Expected due to CYP3A4 and P-gp inhibition by verapamil:
Maltese: CYP3A4 u P-gp minn verapamil:
English: oxcarbazepine, phenobarbital, rifampicin, rifabutin, rifapentine, systemic dexamethasone, and the herbal product St John's wort (Hypericum perforatum).
Maltese: Dawn is-sustanzi attivi jinkludu imma mhumiex limitati għal phenytoin, carbamazepine, oxcarbazepine, phenobarbital, rifampicin, rifabutin, rifapentine, dexamethasone sistemiku, u l-prodott tal-ħxejjex bis- St John's wort (Hypericum perforatum).
English: The overall safety profile of daclatasvir is based on data from 2215 patients with chronic HCV infection who received Daklinza once daily either in combination with sofosbuvir with or without ribavirin (n=679, pooled data) or in combination with peginterferon alfa and ribavirin (n=1536, pooled data) from a total of 14 clinical studies.
Maltese: Il-profil ta-sigurtà globali ta' daclatasvir hu bbażat fuq tagħrif minn 2,215 pazjent b'infezzjoni kronika tal-HCV li rċivew Daklinza darba kuljum jew f'kombinazzjoni ma' sofobuvir bi jew mingħajr ribavirin (n=679, dejta miġbura) jew f'kombinazzjoni ma' peginterferon alfa u ribavirin (n=1,536
English: The safety and efficacy of Daklinza in the treatment of HCV infection in patients with Child-Pugh C liver disease have been established in the clinical study ALLY-1 (AI444215, Daklinza + sofosbuvir + ribavirin for 12 weeks); however, SVR rates were lower than in patients with Child-Pugh A and B. Therefore, a conservative treatment regimen of Daklinza + sofosbuvir +/- ribavirin for 24 weeks is proposed for patients with Child-Pugh C (see sections 4.2 and 5.1).
Maltese: Is-sigurtà u l-effikaċja ta' Daklinza fit-trattament ta' infezzjoni b'HCV f'pazjenti bil-marda tal-fwied Child-Pugh C ġie stabbilit fl-istudju kliniku ALLY-1 (AI444215, Daklinza + sofosbuvir + ribavirin għal 12-il ġimgħa); madankollu, ir-rati SVR kienu aktar baxxi milli f'pazjenti b'Child-Pugh A u B.
English: AUC: 0.82 (0.70, 0.96) Cmax: 0.56 (0.46, 0.67) Cmin: 0.89 (0.75, 1.06)
Maltese: 82 (0.70, 0.96) Cmass: 0.56 (0.46, 0.67) Cmin: 0.89 (0.75, 1.06)
English: Table 11: Treatment outcomes, daclatasvir in combination with sofosbuvir in patients with HCV/HIV co-infection in Study ALLY-2
Maltese: Tabella 11: Riżultati tal-kura, daclatasvir f'kombinazzjoni ma' sofosbuvir f'pazjenti b'koinfezzjoni HCV/HIV fl-Istudju ALLY-2
English: Daklinza must be administered in combination with other medicinal products for the treatment of chronic HCV infection (see sections 4.1 and 4.2).
Maltese: Daklinza għandu jingħata flimkien ma' prodotti mediċinali oħra għall-kura ta' infezzjoni kronika ta' HCV (ara sezzjonijiet 4.1 u 4.2).
English: Daklinza + sofosbuvir + ribavirin for 12 weeks Daklinza + sofosbuvir +/- ribavirin for 24 weeks
Maltese: Daklinza + sofosbuvir + ribavirin għal 12-il ġimgħa Daklinza + sofosbuvir +/- ribavirin għal 24 ġimgħa
English: Clinically relevant increase in concentration is indicated as “↑”, clinically relevant decrease as “↓”, no clinically relevant change as “↔”.
Maltese: Żieda klinikament rilevanti fil-konċentrazzjoni hija indikata b' “↑”, tnaqqis klinikament rilevanti bħala “↓”, l-ebda bidla klinikament rilevanti bħala “↔”.
English: ANTIVIRALS, HCV Nucleotide analogue polymerase inhibitor Sofosbuvir 400 mg once daily (daclatasvir 60 mg once daily) Study conducted in patients with chronic HCV infection
Maltese: Impeditur ta' polymerase analogu nukleotide (Nucleotide analogu polymerase inhibitor) Sofosbuvir 400 mg darba kuljum (daclatasvir 60 mg darba kuljum)
English: Because daclatasvir is highly protein bound (99%) and has a molecular weight >500, dialysis is unlikely to significantly reduce plasma concentrations of daclatasvir.
Maltese: Peress li daclatasvir jintrabat sew mal-proteini (99%) u għandu piż molekulari >500, id-dijalisi mhix probabbli tnaqqas b'mod sinifikanti l konċentrazzjonijiet ta' daclatasvir.
English: In male rats, effects on reproductive endpoints were limited to reduced prostate/seminal vesicle weights, and minimally increased dysmorphic sperm at 200 mg/kg/day; however, neither finding adversely affected fertility or the number of viable conceptuses sired.
Maltese: effetti fuq punti aħħarin ta' riproduzzjoni kienu limitati għal piżijiet mnaqqsa fil-bużżieqa talprostata/seminali, u żieda minima fi sperma dismorfika f'doża ta' 200 mg/kg/jum; madanakollu, lebda riżultat ma affettwa l-fertilità jew l-għadd ta' konċepimenti vijabbli magħmula.
English: Coadministration of Daklinza with rifampicin, rifabutin, rifapentine or other strong inducers of CYP3A4 is contraindicated (see section 4.3).
Maltese: L-għoti fl-istess ħin ta' Daklinza ma' rifampicin, rifabutin, rifapentine jew indutturi qawwija oħra ta' CYP3A4 huwa kontraindikat (ara sezzjoni 4.3).
English: Data to support the treatment of genotype 2 infection with Daklinza and sofosbuvir are limited.
Maltese: Dejta biex tappoġġja l-kura ta' infezzjoni ta' ġenotip 2 b'Daklinza u sofosbuvir hija limitata.
English: In vitro and in vivo studies demonstrate that daclatasvir is a substrate of CYP3A, with CYP3A4 being the major CYP isoform responsible for the metabolism.
Maltese: Bijotrasformazzjoni Studji in vitro u in vivo wrew li daclatasvir huwa sottostrat ta' CYP3A, b'CYP3A4 ikun l-isoforma ta'
English: Tell your doctor if you take any of the following medicines: amiodarone or digoxin, used to treat irregular heart beats atazanavir/ritonavir, atazanavir/cobicistat, elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate combination tablet, etravirine, nevirapine or efavirenz, used to treat HIV infection boceprevir or telaprevir, used to treat hepatitis C infection clarithromycin, telithromycin or erythromycin, used to treat bacterial infections dabigatran etexilate, used to to prevent blood clots ketoconazole, itraconazole, posaconazole or voriconazole, used to treat fungal infections verapamil, diltiazem, nifedipine or amlodipine, used to decrease blood pressure rosuvastatin, atorvastatin, fluvastatin, simvastatin, pitavastatin or pravastatin, used to lower blood cholesterol oral contraceptives
Maltese: boceprevir jew telaprevir, użati għat-trattament ta' infezzjoni tal-epatite Ċ clarithromycin, telithromycin jew erythromycin, użati fit-trattament ta' infezzjonijiet batteriċi dabigatran etexilate, użat biex jevita l-emboli tad-demm ketoconazole, itraconazole, posaconazole jew voriconazole użati fil-kura ta' infezzjonijiet bil moffa verapamil, diltiazem, nifedipine jew amlodipine, użati biex ibaxxu l-pressjoni tad-demm rosuvastatin, atorvastatin, fluvastatin, simvastatin, pitavastatin jew pravastatin użati biex ibaxxu lkolesterol fid-demm kontraċettivi orali B'xi wħud minn dawn il-mediċini, it-tabib tiegħek jista' jkollu bżonn jaġġusta d-doża tiegħek ta'
English: In repeat-dose toxicology studies in animals, hepatic effects (Kupffer-cell hypertrophy/ hyperplasia, mononuclear cell infiltrates and bile duct hyperplasia) and adrenal gland effects (changes in cytoplasmic vacuolation and adrenal cortical hypertrophy/hyperplasia) were observed at exposures similar or slightly higher than the clinical AUC exposure.
Maltese: Fi studji tat-tossikoloġija b'doża ripetuta fl-annimali, effetti fuq il-fwied (ipertrofija taċ-ċelluli ta' Kupffer/iperplasja, infiltrati ta' ċelluli mononukleari u iperplasja tal-passaġġ biljari) u effetti filglandola adrenali (bidliet fil-vakulazzjoni ċitoplasmika u ipertrofija kortikali adrenali/iperplasja) ġew osservati f'esponmenti simili jew kemmxejn ogħla mill-esponiment tal-AUC klinika.
English: Patients assigned to daclatasvir 60 mg once-daily treatment group who had HCV RNA <LLOQ at Week 4 and undetectable at Week 10 were then randomised to receive another 12 weeks of daclatasvir 60 mg + pegIFN/RBV or placebo + pegIFN/RBV for a total treatment duration of 24 weeks.
Maltese: Il-pazjenti kienu assenjati fuq daclatasvir 60 mg darba kuljum fil grupp ta' kura li kellu HCV RNA <LLOQ f'Ġimgħa 4 u mhux osservat f'Ġimgħa 10 kienu mbagħad magħżula b'mod każwali biex jirċievu 12-il ġimgħa oħra ta' daclatasvir 60 mg + pegIFN/RBV jew plaċebo + pegIFN/RBV għal tul totali ta' trattament ta' 24 ġimgħa.