FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Maltese: Ġene li jaħdem għal ADA jiddaħħal fiċ-ċelluli CD34+ bl-użu ta' tip ta' virus li jissejjaħ retrovirus, li ġie mibdul ġenetikament sabiex ikun jista' jġorr il-ġene ADA fiċ-ċelluli u ma jikkawżax mard virali fil-bnedmin.
English: Category/ Substitution, n (%)
Maltese: Kategorija/ Sostituzzjoni, n (%)
English: The absolute bioavailability of the tablet formulation is 67%.
Maltese: Il-bijodisponibilità assoluta talformulazzjoni tal-pillola hi ta' 67%.
English: Atorvastatin Fluvastatin Simvastatin Pitavastatin Pravastatin
Maltese: Atorvastatin Fluvastatin Simvastatin Pitavastatin
English: Loc. Fontana del Ceraso 03012 Anagni (FR) Italy
Maltese: Fontana del Ceraso 03012 Anagni (FR) L-Italja
English: Belgique/België/Belgien
Maltese: Belgique/België/Belgien N.V.
English: See section 4.5.
Maltese: Ara sezzjoni 4.5.
English: Haemoglobin >12 g/dL
Maltese: Emoglobina >12 g/dL
English: Protease inhibitors (PIs) Boceprevir
Maltese: Impedituri ta' protease (Protease inhibitors, PIs) Boceprevir
English: Min, Max ND: Not determined
Maltese: ND (Not determined):
English: Age (years): median (range) Race:
Maltese: Età (snin): medjan (medda) Razza:
English: HERBAL SUPPLEMENTS St. John's wort (Hypericum perforatum)
Maltese: John's wort (Hypericum perforatum)
English: Uxbridge UB8 1DH United Kingdom
Maltese: Uxbridge UB8 1DH Ir-Renju Unit
English: Polyvinyl Chloride/poly-chloro-tri-fluoro-ethylene (PVC/PCTFE) clear blister/aluminum foil lidding.
Maltese: Polyvinyl Chloride/poly-chloro-tri-fluoro-ethylene (PVC/PCTFE) folja ċara/inforra bil-fojl talaluminju.
English: Anhydrous lactose Microcrystalline cellulose Croscarmellose sodium Silicon dioxide (E551) Magnesium stearate
Maltese: Il-qalba tal-pillola Anhydrous lactose Microcrystalline cellulose Croscarmellose sodium Silicon dioxide (E551) Magnesium stearate
English: ANTIBACTERIALS Clarithromycin Telithromycin
Maltese: Clarithromycin Telithromycin
English: HORMONAL CONTRACEPTIVES
Maltese: KONTRAĊETTIVI ORMONALI
English: Virologic breakthrough**
Maltese: Skoperta viroloġika**
English: Black/African American Other
Maltese: Suwed/AfrikaniAmerikani
English: 1b
Maltese: 1a 1b
English: >30 to ≤50 mL/min
Maltese: >30 sa ≤50 mL/min
English: Moderate inducers of CYP3A4
Maltese: Indutturi moderati ta' CYP3A4
English: Study AI444010
Maltese: Studju AI444010
English: Virologic failure
Maltese: Falliment viroloġiku
English: > 10 to ≤12 g/dL
Maltese: >10 sa ≤12 g/dL
English: Study AI444042
Maltese: Studju AI444042
English: In genotype 4, amino acid substitutions at 30 and 93 (EC50 < 16 nM) were frequently selected.
Maltese: F'ġenotip 4, sostituzzjonijiet ta' aċidu amminiku f'30 u 93 (EC50 <16 nM)
English: EU/1/14/939/001 EU/1/14/939/002 EU/1/14/939/003 EU/1/14/939/004 EU/1/14/939/005 EU/1/14/939/006
Maltese: EU/1/14/939/001 EU/1/14/939/002 EU/1/14/939/003 EU/1/14/939/004
English: Daclatasvir is an inhibitor of P-gp, organic anion transporting polypeptide (OATP) 1B1, OCT1 and breast cancer resistance protein (BCRP).
Maltese: Daclatasvir huwa impeditur ta' P-gp, polipeptid ta' trasport anijoniku u organiku (organic anion transporting polypeptide, OATP) 1B1, OCT1 u proteina ta' reżistenza tal-kanċer tas-sider (breast cancer resistance protein, BCRP).
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 22 August 2014
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 22 ta' Awwissu 2014
English: 0.180/0.215/0.250 mg is recommended with Daklinza.
Maltese: 215/0.250 mg huwa rrakkomandat ma' Daklinza.
English: HCV/HIV co-infection (ALLY-2)
Maltese: Koinfezzjoni ta' HCV/HIV (ALLY-2)
English: TEL: +385 1 2078 508
Maltese: s r.o. Tel: +385 1 2078 508
English: Laboratory Value/Clinical Criteria
Maltese: Valur tal-Laboratorju/Kriterji Kliniċi
English: ↔ Daclatasvir ↔ Azithromycin or Ciprofloxacin
Maltese: ↔ Daclatasvir ↔ Azithromycin jew Ciprofloxacin
English: Daclatasvir in vitro did not inhibit (IC50 >40 µM) CYP enzymes 1A2, 2B6, 2C8, 2C9, 2C19, or 2D6.
Maltese: 5% tal-konċentrazzjoni tal-ġenitur.Daclatasvir in vitro ma impedixxix (IC50 >40 µM) l-enzimi ta' CYP 1A2, 2B6, 2C8, 2C9, 2C19, jew 2D6.
English: MELD score
Maltese: Punteġġ MELD
English: HCV Genotype 3 (ALLY-3)
Maltese: Ġenotip 3 tal-HCV (ALLY-3)
English: No antagonism of antiviral activity was observed.
Maltese: L-ebda antagoniżmu ta' attività antivirali ma ġiet osservata.
English: Tel: + 420 221 016 111
Maltese: s r.o. Tel: + 420 221 016 111
English: > 8.5 to ≤10 g/dL
Maltese: >8.5 sa ≤10 g/dL
English: pegIFN/RB V N=6
Maltese: pegIFN/RBV N=6
English: ≤30 mL/min or haemodialysis
Maltese: ≤30 mL/min jew emodijalisi
English: DATE OF REVISION OF THE TEXT {MM/YYYY}
Maltese: DATA TA' REVIŻJONI TAT-TEST
English: SVR12 was achieved by 74% of patients in this study (genotype 1a: 70%, genotype 1b: 79%).
Maltese: SVR12 intlaħaq minn 74% tal-pazjenti f'dan l-istudju (ġenotip 1a: 70%, ġenotip 1b: 79%).
English: pegIFN/RB V N=42
Maltese: pegIFN/RBV N=42
English: Daclatasvir is an inhibitor of nonstructural protein 5A (NS5A), a multifunctional protein that is an essential component of the HCV replication complex.
Maltese: Daclatasvir huwa impeditur ta' proteina mhux strutturali 5A (NS5A), proteina multifunzjonali li hi komponent essenzjali tal-kumpless ta' replikazzjoni ta' HCV.
English: (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000)
Maltese: komuni ħafna (≥1/10), komuni (≥1/100 sa <1/10), mhux komuni (≥1/1,000 sa <1/100), rari (≥1/10,000 sa <1/1,000) u rari ħafna (<1/10,000).
English: Tel: +386 1 2355 100
Maltese: s r.o. Tel: +386 1 2355 100
English: The majority of genotype 1a failures had emergent NS5A variants detected at Q30 (127/139 [91%]), and the majority of genotype 1b failures had emergent NS5A variants detected at L31 (37/49 [76%]) and/or Y93H (34/49 [69%]).
Maltese: Il maġġoranza ta' fallimenti ta' ġenotip 1a kellhom varjanti NS5A emerġenti osservati fi Q30 (127/139 [91%]) u l-maġġoranza ta' fallimenti ta' ġenotip 1b kellhom varjanti ta' NS5A emerġenti osservati f'L31 (37/49 [76%]) u jew Y93H (34/49 [69%]).
English: Maternal toxicity including mortality, abortions, adverse clinical signs, decreases in body weight and food consumption was noted in both species at exposures 25-fold (rat) and 72-fold (rabbit) the clinical AUC exposure.
Maltese: It-tossiċità materna inkluż il-mortalità, aborti, sinjali kliniċi avversi, tnaqqis fil-piż tal-ġisem u fil-konsum tal-ikel ġew innotati fiż-żewġ speċi f'esponimenti ta' 25 darba (firien) u 72 darba (fniek) l-esponiment tal-AUC klinika.
English: L31V and Y93H were frequently observed resistance substitutions in genotype 1b, while M28T, L31V/M, Q30E/H/R, and Y93C/H/N were frequently observed resistance substitutions in genotype 1a.
Maltese: L31V u Y93H kienu sostituzzjonijiet ta' reżistenza osservati b'mod frekwenti f'ġenotip 1b, waqt li M28T, L31V/M, Q30E/H/R, u Y93C/H/N kienu sostituzzjonijiet ta' reżistenza osservati b'mod frekwenti f'ġenotip 1a.
English: Regimen and duration HCV GT 1 or 4
Maltese: Kors u tul HCV GT 1 jew 4
English: Buprenorphine/naloxone, 8/2 mg to 24/6 mg once daily individualized dose* (daclatasvir 60 mg once daily)
Maltese: Buprenorphine/naloxone, 8/2 mg sa 24/6 mg doża individwalizzata li tingħata darba kuljum* (daclatasvir 60 mg darba kuljum)
English: 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 and 5.2).
Maltese: (Child-Pugh A, punteġġ 5-6), moderat (Child-Pugh B, punteġġ 7-9) jew sever (Child-Pugh C, punteġġ ≥10) indeboliment tal-fwied (ara sezzjonijiet 4.4 u 5.2).
English: Genotype 1a Genotype 1b Genotype 2 Genotype 3 N=301
Maltese: Ġenotip 1a Ġenotip 1b Ġenotip 2 Ġenotip 3
English: Ethinylestradiol 35 μg once daily for 21 days + norgestimate
Maltese: Ethinylestradiol 35 μg darba kuljum għal 21 jum +
English: AUC*: 2.10 (1.95, 2.26) Cmax*: 1.35 (1.24, 1.47) Cmin*: 3.65 (3.25, 4.11)
Maltese: AUC*: 2.10 (1.95, 2.26) Cmass*: 1.35 (1.24, 1.47) Cmin*: 3.65 (3.25, 4.11)
English: Daclatasvir showed additive to synergistic interactions with interferon alfa, HCV nonstructural protein 3 (NS3) PIs, HCV nonstructural protein 5B (NS5B) non-nucleoside inhibitors, and HCV NS5B nucleoside analogues in combination studies using the cell-based HCV replicon system.
Maltese: HCV (nonstructural protein 3, NS3), impedituri mhux nukleosidi mhux strutturali 5B ta' HCV (ninstructural protein 5B, NS5B), u analogi ta' nukleosidi HCV NS5B fi studji ta' kombinazzjoni permezz tas-sistema replikon ta' HCV bbażata fuq ċelluli.
English: In vitro studies indicate that daclatasvir is actively and passively transported into hepatocytes.
Maltese: Studji in vitro jindikaw li daclatasvir huwa attivament u passivament trasportat fl-epatoċiti.
English: For HCV genotype 1, SVR12 rates were 64% (54% for 1a; 84% for 1b) for patients treated with daclatasvir + pegIFN/RBV and 36% for patients treated with placebo + pegIFN/RBV.
Maltese: Għal HCV ta' ġenotip 1, rati ta' SVR 12 kienu 64% (54% għal 1a; 84% għal 1b) għal pazjenti kkurati b'daclatasvir + pegIFN/RBV u 36% għal pazjenti ttrattati bi plaċebo + pegIFN/RBV.
English: Keep this leaflet.
Maltese: Popolazzjoni ta' pazjenti*
English: Each film-coated tablet contains 30 mg, 60 mg or 90 mg daclatasvir (as dihydrochloride) The other ingredients are - 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)
Maltese: Is-sustanzi l-oħra huma - Il-qalba tal-pillola: lactose anidru, (ara sezzjoni 2) microcrysalline cellulose, croscarmellose sodium, silicon dioxide (E551) u magnesium stearate - Il-kisi tar-rita: hypromellose, titanium dioxide (E171), macrogol 400, indigo carmine aluminum lake, (E132) yellow iron oxide (E172)
English: Calcium channel blockers Diltiazem
Maltese: Imblokkaturi tal-kanal tal-calcium Diltiazem
English: Cirrhosis was determined by liver biopsy, FibroScan >14.6 kPa, or FibroTest score ≥0.75 and aspartate aminotransferase (AST): platelet ratio index (APRI) >2.
Maltese: Iċ-ċirrożi kienet iddeterminata minn bijopsija tal-fwied, FibroScan >14.6 kPa, jew punteġġ ta' FibroTest ≥0.75 u aspartate aminotransferase (AST): indiċi tal-proporzjon tal-plejtlits (APRI) >2.
English: The daclatasvir EC50 values in the replicon system were 0.003-1.25 nM for genotypes 3a, 4a, 5a and 6a, and 0.034-19 nM for genotype 2a as well as 0.020 nM for infectious genotype 2a (JFH-1) virus.
Maltese: Il-valuri ta' EC50 fis-sistema ta' replikon ta' daclatasvir kienu 0.003-1.25 nM għal ġenotipi 3a, 4a, 5a u 6a, u 0.034-19 nM għal ġenotipi 2a kif ukoll bħala 0.020 nM għal virus b'ġenotip 2a infettiv (JFH-1).
English: Luxembourg/Luxemburg N.V. Bristol-Myers Squibb Belgium S.A. Tél/Tel: + 32 2 352 76 11
Maltese: Bristol-Myers Squibb Belgium S.A. Tél/Tel: + 32 2 352 76 11
English: AUC: 3.00 (2.62, 3.44) Cmax: 1.57 (1.31, 1.88)
Maltese: AUC: 3.00 (2.62, 3.44) Cmass: 1.57 (1.31, 1.88)
English: Table 5: Adverse reactions in clinical studies System Organ Class
Maltese: Reazzjonijiet avversi fl-istudji kliniċi Sistema tal-Klassifika tal-Organi
English: All Genotype 3 N=18
Maltese: Kollha N=18
English: Potential for interaction with other medicinal products Daclatasvir is a substrate of CYP3A4, P-gp and organic cation transporter (OCT) 1.
Maltese: Daclatasvir huwa sottostrat ta' CYP3A4, P-gpu t-trasportatur katajoniku organiku (OCT) 1.
English: If available, ratios of geometric means are shown, with 90% confidence intervals (CI) in parentheses.
Maltese: Jekk disponibbli, proporzjonijiet ta' mezzi ġeometriċi huma murija, b'intervalli ta' kunfidenza ta' 90% (confidence interval, CI) fil-parentesi.
English: AUC: 0.21 (0.19, 0.23) Cmax: 0.44 (0.40, 0.48)
Maltese: AUC: 0.21 (0.19, 0.23) Cmass: 0.44 (0.40, 0.48)
English: Telaprevir 500 mg q12h (daclatasvir 20 mg once daily)
Maltese: Telaprevir 500 mg q12h (daclatasvir 20 mg darba kuljum)
English: Telaprevir 750 mg q8h (daclatasvir 20 mg once daily)
Maltese: Telaprevir 750 mg q8h (daclatasvir 20 mg darba kuljum)
English: *results are dose-normalised to 60 mg dose.
Maltese: *ir-riżultati huma normalizzati għaddoża sa doża ta' 60 mg.
English: No clinically relevant effects on the pharmacokinetics of either medicinal product are expected when daclatasvir is coadministered with any of the following: PDE-5 inhibitors, medicinal products in the ACE inhibitor class (e.g. enalapril), medicinal products in the angiotensin II receptor antagonist class (e.g. losartan, irbesartan, olmesartan, candesartan, valsartan), disopyramide, propafenone, flecainide, mexilitine, quinidine or antacids.
Maltese: L-ebda effett klinikament rilevanti fuq il-farmakokinetika ta' kwalunkwe prodott mediċinali mhu mistenni meta daclatasvir jingħata flimkien ma' xi wieħed minn dawn li ġejjin: impedituri ta' PDE-5, prodotti mediċinali fil-klassi ta' impeditur ta' ACE (eż. enalapril), prodotti mediċinali fil-klassi ta' antagonisti ta' riċettur ta' angiotensin II (eż. losartin, irbesartin, olmesartin, candesartin, valsartan), disopyramide, propafenone, flecainide, mexilitine, quinidine jew antaċidi.
English: In vitro daclatasvir is an inhibitor of renal uptake transporters, OAT1 and 3, and OCT2, but is not expected to have a clinical effect on the pharmacokinetics of substrates of these transporters.
Maltese: Daclatasvir in vitro huwa impeditur ta' trasportaturi ta' teħid mill-kliewi, OAT1 u 3, u OCT2, imma mhux mistenni li jkollu effett kliniku fuq il-farmakokinetika ta' sottostrati ta' dawn it-trasportaturi.
English: Expected due to CYP3A4 induction by dexamethasone:
Maltese: CYP3A4 b'dexamethasone:
English: AUC: 2.32 (2.06, 2.62) Cmax: 1.46 (1.28, 1.66)
Maltese: AUC: 2.32 (2.06, 2.62) Cmass: 1.46 (1.28, 1.66)
English: All N=126
Maltese: Kollha N=126
English: For HCV genotype specific activity, see sections 4.4 and 5.1.
Maltese: Għal attività speċifika ta' ġenotip ta' HCV, ara sezzjonijiet 4.4 u 5
English: INFORMATION IN BRAILLE Daklinza 90 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Daklinza 90 mg
English: In case of non-response to therapy with daclatasvir + peginterferon alfa + ribavirin, NS5A RAVs generally emerged at failure (139/153 genotype 1a and 49/57 genotype 1b).
Maltese: F'każ ta' nuqqas ta' rispons għat-terapija b'daclatasvir + peginterferon alfa + ribavirin, NS5A RAVs ħarġu b'mod ġenerali meta kien hemm falliment (139/153 ġenotip 1a u 49/57 ġenotip 1b).
English: All 4 patients achieved SVR12.
Maltese: L-4 pazjenti kollha kisbu SVR12.
English: SVR rates were >94% across combination antiretroviral therapy (cART) regimens, including boosted-PI-, NNRTI-, and integrase inhibitor (INSTI)-based therapies.
Maltese: Ir-rati ta' SVR kienu >94% fil-korsijiet ta' terapija antiretrovirali kombinata (combination antiretroviral therapy, cART) kollha, inkluż terapiji msaħħa bbażati inibituri fuq PI-, NNRTI-, u integrase msaħħa (integrase strand transfer inhibitor, INSTI).
English: INFORMATION IN BRAILLE Daklinza 60 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Daklinza 60 mg
English: Overall, SVR12 was achieved by 97% (149/153) of patients administered daclatasvir and sofosbuvir for 12 weeks in ALLY-2.
Maltese: B'mod ġenerali, SVR12 inkiseb minn 97% (149/153) tal-pazjenti mogħtija daclatasvir u sofosbuvir għal 12-il ġimgħa f'ALLY-2.
English: There are no clinical data in patients with genotype 5 (see section 5.1).
Maltese: M'hemm ebda dejta klinika f'pazjenti b'ġenotip 5 (ara sezzjoni 5.1).
English: INFORMATION IN BRAILLE Daklinza 30 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Daklinza 30 mg
English: 400 mg daily
Maltese: 400 mg kuljum
English: Mainly interferon-based therapy, but 7 patients received sofosbuvir + ribavirin and 2 patients received a cyclophilin inhibitor.
Maltese: Prinċiparjament terapija bbażata fuq interferon, iżda 7 pazjenti rċevew sofosbuvir + ribavirin, u 2 pazjenti rċevew inibitur ta' cyclophilin.
English: Toxicology
Maltese: Tossikoloġija
English: * Evaluated in opioid-dependent adults on stable buprenorphine/naloxone maintenance therapy.
Maltese: * Evalwat f'adulti dipendenti fuq l-opjojdi fuq terapija stabbli ta' manteniment ta' buprenorphine/naloxone.
English: The most frequently reported adverse reactions of at least Grade 3 severity (frequency of 1% or greater) were neutropenia, anaemia, lymphopenia and thrombocytopenia.
Maltese: L-aktar reazzjonijiet avversi frekwenti rrapportati tal-anqas b'severità ta' Grad 3 (frekwenza ta' 1% jew aktar) kienu newtropenja, anemija, limfopenja u tromboċitopenija.
English: The efficacy and safety of daclatasvir 60 mg once daily in combination with sofosbuvir 400 mg once daily in the treatment of patients with chronic HCV infection were evaluated in four open-label studies (AI444040, ALLY-1, ALLY-2 and ALLY-3).
Maltese: L-effikaċja u s-sigurtà ta' daclatasvir 60 mg darba kuljum flimkien ma' sofosbuvir 400 mg darba kuljum fil-kura ta' pazjenti b'infezzjoni kronika bl-HCV, ġew evalwati erba' studji b'tikketta mikxufa (AI444040, ALLY-1, ALLY-2 u ALLY-3).
English: Inhibition of OATP 1B1 and BCRP by daclatasvir
Maltese: Impediment ta' OATP1B1, u BCRP b'daclatasvir
English: 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.
Maltese: Seba' fil-mija tal-pazjenti kellhom ċirrożi kkumpensata; 92% kellhom ġenotip 1 (72% 1a u 20% 1b) u 8% kellhom ġenotop 4 ta' HCV; 65% talpazjenti kellhom ġenotipi mhux CC ta' IL-28B rs12979860.
English: ≥ F3 liver fibrosis
Maltese: ≥ fibrożi tal-fwied F3
English: Creatinine Clearance >50 mL/min
Maltese: >50 mL/min
English: Most patients (71%, including 98% of prior PI failures) had IL-28B rs12979860 non-CC genotypes.
Maltese: (71%, li jinkludu 98% b'fallimenti ta' PI ta' qabel) kellhom IL-28B rs12979860 mhux ġenotipi CC.
English: NARCOTIC ANALGESICS
Maltese: ANALĠESIĊI NARKOTIĊI
English: AUC*: 0.68 (0.60, 0.78) Cmax*: 0.83 (0.76, 0.92) Cmin*: 0.41 (0.34, 0.50)
Maltese: AUC*: 0.68 (0.60, 0.78) Cmass*: 0.83 (0.76, 0.92) Cmin*: 0.41 (0.34, 0.50)
English: No dose adjustment of Daklinza 60 mg once daily, darunavir/ritonavir (800/100 mg once daily or 600/100 mg twice daily) or darunavir/cobicistat is required.
Maltese: Daklinza 60 mg darba kuljum, darunavir/ritonavir (800/100 mg darba kuljum jew 600/100 mg darbtejn kuljum) jew darunavir/cobicistat mhu rakkomandat.
English: * Evaluated in opioid-dependent adults on stable methadone maintenance therapy.
Maltese: * Evalwat f'adulti dipendenti fuq l-opjojdi fuq terapija stabbli ta' manteniment ta' methadone.
English: Induction of CYP3A4 by efavirenz
Maltese: Induzzjoni ta' CYP3A4 b'efavirenz
English: Daklinza 30 mg, 60 mg and 90 mg film-coated tablets are available in packs of 28 tablets in nonperforated calendar blisters and perforated unit dose blisters.
Maltese: Daklinza 30 mg, 60 mg u 90 mg pilloli miksija b'rita huma disponibbli f'pakketti ta' 28 pilloli f'folji kalendarji mhux ipperforati u folji pperforati ta' doża waħda.
English: Green biconvex pentagonal of dimensions 7.2 mm x 7.0 mm, debossed tablet with "BMS" on one side and "213" on the other side.
Maltese: Pillola ta' lewn ħadrani pentagonali mżaqqa fuq żewġ naħat b'dimensjonijiet ta' 7.2 mm x 7.0 mm imnaqqxa b'“BMS” fuq naħa waħda u “213” fuq in-naħa l-oħra.
English: An oral contraceptive containing ethinylestradiol 35 μg and norgestimate
Maltese: Kontraċettiv orali li fih ethinylestradiol 35 μg u norgestimate 0.180/0.
English: Light green biconvex pentagonal of dimensions 9.1 mm x 8.9 mm, debossed tablet with "BMS" on one side and "215" on the other side.
Maltese: Pillola ta' lewn ħadrani ċar pentagonali mżaqqa fuq żewġ naħat b'dimensjonijiet ta' 9.1 mm x 8.9 mm imnaqqxa b'“BMS” fuq naħa waħda u “215” fuq in-naħa l-oħra.
English: Expected due to CYP3A4 inhibition by boceprevir:
Maltese: CYP3A4 minn boceprevir:
English: The HCV RNA thresholds that trigger discontinuation of treatment (i.e. treatment stopping rules) are presented in Table 3.
Maltese: Illimiti ta' HCV RNA li jagħtu bidu għall-waqfien tal-kura (i.e. regoli ta' twaqqif tal-kura) huma ppreżentati f'Tabella 3.
English: Ribavirin can harm your unborn baby.
Maltese: Ribavirin jista' jiżdied abbażi ta'
English: Treatment outcomes in study AI444042 are presented in Table 13.
Maltese: Riżultati ta' trattament fl-istudju A1444042 huma ppreżentati f'Tabella 13.
English: Daclatasvir Cmax, AUC, and Cmin increased in a near dose-proportional manner.
Maltese: Daclatasvir Cmass, AUC, u Cmin żdiedu f'manjiera kważi proporzjonali mad-doża.
English: SVR was the primary endpoint to determine the HCV cure rate, which was defined as HCV RNA less than LLOQ at 12 weeks after the end of treatment (SVR12) for studies AI444040, ALLY-1 (AI444215), ALLY-2 (AI444216), ALLY-3 (AI444218), AI444042 and AI444043 and as HCV RNA undetectable at 24 weeks after the end of treatment (SVR24) for study AI444010.
Maltese: għall-istudji A1444040, ALLY-1 (AI444215), ALLY-2 (AI444216), ALLY-3 (AI444218), A1444042
English: Expected due to CYP3A4 inhibition by atazanavir/cobicistat: ↑ Daclatasvir
Maltese: CYP3A4 minn atazanavir/cobicistat:
English: Digoxin 0.125 mg once daily (daclatasvir 60 mg once daily)
Maltese: Digoxin 0.125 mg darba kuljum (daclatasvir 60 mg darba kuljum)
English: 0.180/0.215/0.250 mg once daily for 7/7/7 days (daclatasvir 60 mg once daily)
Maltese: 215/0.250 mg darba kuljum għal 7/7/7 ijiem
English: AUC: 1.96 (1.84, 2.10) Cmax: 1.50 (1.39, 1.62) Cmin: 2.68 (2.42, 2.98)
Maltese: AUC: 1.96 (1.84, 2.10) Cmass: 1.50 (1.39, 1.62) Cmin: 2.68 (2.42, 2.98)
English: All N=41
Maltese: Kollha N=41
English: ANTICONVULSANTS
Maltese: ANTIKOAGULANTI
English: Metabolism and nutrition disorders common decreased appetite
Maltese: Disturbi fil-metaboliżmu u n-nutrizzjoni komuni nuqqas ta' aptit
English: CYP3A4 inhibition by ketoconazole
Maltese: Impediment ta' CYP3A4 b'ketoconazole
English: Table 1: Recommended treatment for Daklinza interferon-free combination therapy
Maltese: Tabella 1: Kura rakkomandata għal terapija kombinata b'Daklinza mingħajr interferon
English: No evidence of mutagenic or clastogenic activity was observed in in vitro mutagenesis (Ames) tests, mammalian mutation assays in Chinese hamster ovary cells, or in an in vivo oral micronucleus study in rats.
Maltese: L-ebda evidenza ta' attività mutaġenika jew klastoġenika ma ġiet osservata f'testijiet ta' mutaġenisi (Ames), analiżi ta' mutazzjoni mammifera fiċ ċelluli tal-ovarji tal-ħemster Ċiniż in vitro, jew fi studju tal-mikronuklueju orali fil-firien in vivo.
English: The concomitant use of amiodarone was limited through the clinical development of sofosbuvir plus direct-acting antivirals (DAAs).
Maltese: L-użu konkomitanti ta' amiodarone kien limitat permezz tal-iżvilupp kliniku ta' sofosbuvir flimkien ma' antivirali li jaġixxu direttament (DAAs).
English: Severe bradycardia and heart block
Maltese: Bradikardija Severa u Mblokkar tal-Qalb
English: AUC: 0.94 (0.84, 1.04) Cmax: 1.01 (0.89, 1.14)
Maltese: AUC: 0.94 (0.84, 1.04) Cmass: 1.01 (0.89, 1.14)
English: Among the 167 patients with HCV genotype 1 infection, 126 were treatment-naïve and 41 had failed prior therapy with a PI regimen (boceprevir or telaprevir).
Maltese: Fost il-167 pazjent b'infezzjoni ta' ġenotip 1 ta' HCV, 126 ma kinux ħadu kura qabel u 41 kienu ħadu terapija b'korsb'PI (boceprevir jew telaprevir) li ma rnexxietx.
English: 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).
Maltese: SVR12 inkiseb minn 83% (50/60) tal-pazjenti fil-koorti taċ-ċirrożi, b'differenza kbira bejn pazjenti b'Child-Pugh A jew B (92-94%) meta mqabbel ma' dawk b'Child-Pugh C u 94% tal-pazjenti filkoorti ta' wara trapjant tal-fwied (Tabella 9).