FrancophonIA/ELRC3.0 huggingface dataset:
English: In phase 1 clinical studies, healthy subjects who received up to 100 mg once daily for up to 14 days or single doses up to 200 mg had no unexpected adverse reactions.
Maltese: Fi studji kliniċi ta' fażi 1, individwi b'saħħithom li rċivew sa 100 mg darba kuljum għal sa 14-il jum jew dożi waħdanin sa 200 mg ma kellhomx reazzjonijiet avversi mhux mistennija.
English: The AUC associated with this dose in males is 19-fold the clinical AUC exposure.
Maltese: L-AUC assoċjata ma' din id-doża fl-irġiel kienet ta' 19-il darba l-esponiment AUC klinika.
English: and very rare (<1/10,000).
Maltese: >1,000 nM), rispettivament.
English: Expected due to CYP3A4 induction by the anticonvulsant:
Maltese: Mistenni minħabba l-induzzjoni ta' CYP3A4 mill-antikonvulżant:
English: Patients with CP A or B cirrhosis GT 1 or 4
Maltese: Pazjenti b'ċirrożi CP A jew B GT 1 jew 4
English: Use of highly effective contraception should be continued for 5 weeks after completion of Daklinza therapy (see section 4.6).
Maltese: L-użu ta' kontraċezzjoni effettiva ħafna għandu jitkompla sa 5 ġimgħat wara li t-terapija b'Daklinza tkun intemmet (ara sezzjoni 4.6).
English: 79% of patients were white; 13% were black/African-American; 1% were Asian; 9% were Hispanic or Latino.
Maltese: sena); 77% tal-pazjenti kienu bojod; 19% kienu suwed/ Afrikani-Amerikani; 4% kienu Ispaniċi jew
English: Cardiac arrhythmias
Maltese: Koorti ċirrotika
English: Daklinza 90 mg: the film-coated tablet is light green, biconvex, round shape with "BMS" embossed on one side and "011" on the other side
Maltese: Daklinza 90 mg: il-pillola miksija b'rita hija ħadra ċara, imżaqqa fuq żewġ naħat, f'għamla tonda mnaqqxa b'“BMS” fuq naħa waħda u b'“011” fuq in-naħa l-oħra.
English: Patients with cirrhosis CP A or B
Maltese: CP A CP B CP C
English: SEDATIVES
Maltese: Tqala
English: Daklinza in combination with sofosbuvir
Maltese: Daklinza f'kombinazzjoni ma' sofosbuvir
English: mean median
Maltese: U KWANTITATTIVA
English: - If undetectable HCV RNA is achieved, but not at both treatment weeks 4 and 12, Daklinza should be discontinued at 24 weeks and peginterferon alfa and ribavirin continued for a total duration of 48 weeks.
Maltese: - Jekk HCV RNA li ma jinstabx jintlaħaq, iżda mhux fiż-żewġ ġimgħat 4 u 12 ta' kura, Daklinza għandu jitwaqqaf fl-24 ġimgħa u peginterferon alfa u ribavirin jitkomplew għal tul totali ta'
English: Light green biconvex round of dimension 10.16 mm diameter, embossed tablet with "BMS" on one side and "011" on the other side.
Maltese: 66 mm b'“BMS” imqabbża fuq naħa waħda u “011” fuq in-naħa l-oħra.
English: Table 13: Treatment outcomes, daclatasvir in combination with peginterferon alfa and ribavirin (pegIFN/RBV), treatment-naïve patients with HCV genotype 4
Maltese: Tabella 13: Riżultati tat-trattament, daclatasvir flimkien ma' peginterferon alfa u ribavirin
English: Palpitations
Maltese: ANTIBATTERIĊI
English: End of treatment HCV RNA undetectable
Maltese: Tmiem it-trattament HCV RNA mhux osservat
English: ANNEX II
Maltese: Ġenotip 2
English: In the cirrhosis cohort, 4 patients with hepatocellular carcinoma underwent liver transplantation after 1-71 days of treatment; 3 of the 4 patients received 12 weeks of post-liver transplant treatment extension and 1 patient, treated for 23 days before transplantation, did not receive treatment extension.
Maltese: Fil-koorti taċ-ċirrożi, 4 pazjenti b'karċinoma epatoċellulari sarilhom trapjant tal-fwied wara jum sa 71 jum ta' kura; 3 mill4 pazjenti rċevew 12-il ġimgħa ta' estensjoni ta' kura ta' wara trapjant tal-fwied u pazjent wieħed, ikkurat għal 23 jum qabel it-trapjant, ma rċevewx estensjoni tal-kura.
English: End of treatment HCV RNA undetectable SVR12
Maltese: Tmiem tal-kura HCV RNA mhux osservat SVR12
English: The Cmax and AUC of total daclatasvir (free and protein-bound drug) were lower in subjects with hepatic impairment; however, hepatic impairment did not have a clinically significant effect on the free drug concentrations of daclatasvir (see section 4.2).
Maltese: Is-Cmass u l-AUC ta' daclatasvir totali (mediċina mhux marbuta u marbuta ma' proteina) kienu inqas f'individwi b'indeboliment tal-fwied, madanakollu, l-indeboliment tal-fwied ma kellux effett klinikament sinifikanti fuq il-konċentrazzjonijiet tal-mediċina mhix marbuta ta' daclatasvir (ara sezzjoni 4.2).
English: Daclatasvir is a very weak inducer of CYP3A4 and caused a 13% decrease in midazolam exposure.
Maltese: Daclatasvir huwa induttur dgħajjef ħafna ta' CYP3A4 u kkawża tnaqqis ta' 13% fl-esponiment ta' midazolam.
English: Response was rapid (at Week 4 91% of daclatasvir-treated patients had HCV RNA <LLOQ).
Maltese: Ir-rispons kien wieħed rapidu (f'Ġimgħa 4, 91% ta' pazjenti ttrattati b'daclatasvir kellhom HCV RNA<LLOQ).
English: For daclatasvirtreated patients with HCV RNA results at both follow-up Weeks 12 and 24, concordance of SVR12 and SVR24 was 97% for HCV genotype 1 and 100% for HCV genotype 4.
Maltese: Għal pazjenti b'HCV ittrattati b'daclatasvir riżultati ta' HCV RNA fiż-żewġ ġimgħat ta' segwiment, il-Ġimgħat 12 u 24, il-konkordanza ta' SVR12 u SVR 24 kienet 97% għal ġenotip 1 ta' HCV u 100% għal ġenotip 4 ta' HCV.
English: Integrase inhibitors Dolutegravir 50 mg once daily (daclatasvir 60 mg once daily)
Maltese: Dolutegravir 50 mg darba kuljum (daclatasvir 60 mg darba kuljum)
English: Each film-coated tablet contains daclatasvir dihydrochloride equivalent to 30 mg daclatasvir.
Maltese: Kull pillola miksija b'rita fiha daclatasvir dihydrochloride ekwivalenti għal 30 mg ta' daclatasvir.
English: 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.
Maltese: L-aktar reazzjonijiet avversi frekwenti rrapportati kienu għeja, uġigħ ta' ras, ħakk, anemija, mard bħal tal-influwenza, dardir, nuqqas ta' rqad, newtropenija, astenja, raxx, tnaqqis fl-aptit, ġilda xotta,
English: Daklinza has not yet been studied in children and adolescents.
Maltese: Daklinza għadu ma ġiex studjat fit-tfal u adolexxenti.
English: Each 30-mg film-coated tablet contains 58 mg of lactose (as anhydrous).
Maltese: Kull pillola miksija b'rita ta' 30 mg fiha 58 mg ta' lactose (bħala anidru).
English: Expected due to inhibition of OATP 1B1 and/or BCRP by daclatasvir:
Maltese: OATP 1B1 u/jew BCRP minn daclatasvir:
English: Data from study ALLY-3 (AI444218) support a 12-week treatment duration of Daklinza + sofosbuvir for treatment-naïve and -experienced patients with genotype 3 infection without cirrhosis.
Maltese: Dejta mill-istudju ALLY-3 (AI444218) tappoġġja tul ta' kura ta' 12-il ġimgħa b'Daklinza + sofosbuvir għal pazjenti li qatt ma rċevew kura fil-passat u pazjenti li rċevew kura fil-passat, b'infezzjoni ta' ġenotip 3 mingħajr ċirrożi.
English: HCV genotype:
Maltese: Oħrajn Ġenotip HCV:
English: ACID REDUCING AGENTS H2-receptor antagonists Famotidine 40 mg single dose (daclatasvir 60 mg single dose)
Maltese: Antagonisti tar-riċettur H2 Famotidine 40 mg doża waħda
English: Lower rates of SVR were observed for patients with cirrhosis (see section 5.1).
Maltese: Rati aktar baxxi ta' SVR ġew osservati f'pazjenti b'ċirrożi (ara sezzjoni 5.1).
English: Daclatasvir was excreted into the milk of lactating rats with concentrations 1.7- to 2-fold maternal plasma levels.
Maltese: Daclatasvir kien eliminat fil-ħalib ta' firien li jreddgħu b'konċentrazzjonijiet ta' 1.7 sa 2 darbiet il livelli maternali fil-plażma.
English: Table 7: Treatment outcomes, daclatasvir in combination with sofosbuvir for 24 weeks, treatment-naïve patients with HCV genotype 2 or 3 in Study AI444040 Genotype 2
Maltese: Riżultati tat-trattament, daclatasvir flimkien ma' sofosbuvir għal 24 ġimgħa, pazjenti li ma ġewx ittrattati qabel b'HCV ġenotip 2 jew 3 fl-Istudju AI444040
English: In clinical studies of daclatasvir in combination with sofosbuvir or with peginterferon alfa and ribavirin, plasma HCV RNA values were measured using the COBAS TaqMan HCV test (version 2.0), for use with the High Pure System, with a lower limit of quantification (LLOQ) of 25 IU/ ml.
Maltese: Effikaċja klinika u sigurtà Fi studji kliniċi ta' daclatasvir flimkien ma' sofosbuvir jew ma' peginterferon alfa u ribavirin, il-valuri ta' HCV RNA fil-plażma tkejlu permezz tat-test COBAS TaqMan HCV (verżjoni 2.0), għal użu mal
English: CP A
Maltese: 24 ġimgħa
English: PK trough levels for peginterferon alfa in patients who received peginterferon alfa, ribavirin, and daclatasvir were similar to those in patients who received peginterferon alfa, ribavirin, and placebo.
Maltese: Livelli farmakokinetiċi i laktar baxxi għal peginterferon alfa f'pazjenti li rċivew peginterferon alfa, ribavirin, u daclatasvir kienu simili għal dawk f'pazjenti li rċivew peginterferon alfa, ribavirin, u plaċebo.
English: Discontinue peginterferon alfa and ribavirin (treatment with Daklinza is complete at week 24)
Maltese: IU/mL Waqqaf peginterferon alfa u ribavirin (kura b'Daklinza tkun lesta f'ġimgħa 24)
English: Bristol-Myers Squibb GmbH & Co. KGaA Tel: + 49 89 121 42-0
Maltese: KGaA Tel: + 49 89 121 42-0
English: Action
Maltese: Bojod
English: Elimination Following single-dose oral administration of 14C-daclatasvir in healthy subjects, 88% of total radioactivity was recovered in feces (53% as unchanged drug) and 6.6% was excreted in the urine (primarily as unchanged drug).
Maltese: Wara l-għoti mill-ħalq ta' doża waħda ta' 14Ċ-daclatasvir lil individwi b'saħħithom, 88% tarradjoattività kienet irkuprata fl-ippurgar (53% ta' mediċina mhux mibdula) u 6.6% kienet eliminata flawrina (prinċipalment bħala l-mediċina mhix mibdula).
English: Table 9: Treatment outcomes, daclatasvir in combination with sofosbuvir and ribavirin for 12 weeks, patients with cirrhosis or HCV recurrence after liver transplantation, Study ALLY-1
Maltese: Tabella 9: Riżultati tal-kura, daclatasvir f'kombinazzjoni ma' sofosbuvir u ribavirin għal 12-il ġimgħa, pazjenti b'ċirrożi jew rikorrenza HCV wara trapjant tal-fwied, Studju ALLY-1
English: Daklinza + sofosbuvir (without ribavirin) for 24 weeks
Maltese: Daklinza + sofosbuvir (mingħajr ribavirin) għal
English: In patients who received daclatasvir 60 mg tablet orally followed by 100 µg [13C,15N]-daclatasvir intravenous dose, the total clearance was
Maltese: F'pazjenti li rċivew pillola orali ta' daclatasvir 60 mg segwita minn doża ta' 100 µg ġol-vina ta' [13C,15N]-daclatasvir it-tneħħija totali kienet ta' 4.24 l/h.
English: Other medicines and Daklinza
Maltese: Mediċini oħra u Daklinza
English: Expected due to CYP3A4 induction by the antimycobacterial:
Maltese: Minħabba l-induzzjoni ta' CYP3A4 mill-antimikobatteriku:
English: ANTIVIRALS, HIV or HBV Protease inhibitors (PIs) Atazanavir 300 mg/ritonavir 100 mg once daily (daclatasvir 20 mg once daily)
Maltese: Atazanavir 300 mg/ritonavir 100 mg darba kuljum (daclatasvir 20 mg darba kuljum)
English: Treatmentexperienced*
Maltese: TAL-PRODOTT MEDIĊINALI
English: Missed doses
Maltese: Doża rakkomandata
English: 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).
Maltese: Tiħux Daklinza jekk qed tieħu xi waħda minn dawn il-mediċini li ġejjin: phenytoin, carbamazepine, oxcarbazepine jew phenobarbital, użati fit-trattament ta' attakki pupletiċi rifampicin, rifabutin jew rifapentine, antibijotiċi użati fil-kura ta' tuberkulosi dexamethasone, sterojde użat biex jittratta mard allerġiku u infjammatorju mediċini li jkun fihom St.
English: Patient disposition daclatasvir + sofosbuvir 12 weeks N = 153
Maltese: Dispożizzjoni tal-pazjent daclatasvir + sofosbuvir 12-il ġimgħa N=153
English: Light-headedness
Maltese: TAL-PRODOTT
English: ↔ Daclatasvir ↔ Warfarin
Maltese: Gwida għad-Dożaġġ b'Ribavirin
English: CP B
Maltese: CP A jew B
English: Pack size of 28 film-coated tablets in perforated unit dose blisters.
Maltese: L-interazzjoni ma ġietx studjata għal din il-pillola ta' kombinazzjoni b'doża fissa.
English: Close monitoring is recommended if this medicinal product is administered with Daklinza in combination with sofosbuvir (see sections 4.4 and
Maltese: Huwa rrakkomandat monitoraġġ mill-qrib jekk dan il-prodott mediċinali jingħata ma' Daklinza flimkien ma' sofosbuvir (ara s-sezzjonijiet 4.4 u 4.8).
English: If you forget to take Daklinza It is important not to miss a dose of this medicine.
Maltese: Jekk tinsa tieħu Daklinza Huwa importanti li ma taqbiżx doża ta' din il-mediċina.
English: Cases of severe bradycardia and heart block have been observed when Daklinza is used in combination with sofosbuvir and concomitant amiodarone and/or other drugs that lower heart rate (see sections 4.4 and 4.5).
Maltese: Każijiet ta' bradikardija severa u mblokkar tal-qalb ġew osservati meta Daklinza intuża flimkien ma' sofosbuvir u amiodarone konkomitanti u/jew mediċini oħrajn li jbaxxu r-rata ta' taħbit tal-qalb (ara s-sezzjonijiet 4.4 u 4.5). Popolazzjoni pedjatrika
English: The impact of baseline NS5A RAVs on cure rates of genotype 4 infection is not apparent.
Maltese: L-impatt ta' NS5A RAVs fil-linja bażi fuq ir-rati tal-kura tal-infezzjoni ta' ġenotip 4 mhuwiex apparenti.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 90 mg of daclatasvir (as dihydrochloride).
Maltese: Kull pillola miksija b'rita fiha 90 mg ta' daclatasvir (bħala dihydrochloride).
English: Population pharmacokinetic analysis of data from clinical studies indicated that age had no apparent effect on the pharmacokinetics of daclatasvir.
Maltese: Analiżi farmakokinetika tal-popolazzjoni dwar tagħrif minn studji kliniċi indikaw li l-età ma kellix effett apparenti fuq il-farmakokinetika ta' daclatasvir.
English: Peginterferon alfa 180 µg once weekly and ribavirin 1000 mg or 1200 mg/day in two divided doses (daclatasvir 60 mg once daily)
Maltese: 1,000 mg jew 1,200 mg/day f'żewġ dożi maqsumin
English: BRISTOL-MYERS SQUIBB A.E. Τηλ: + 30 210 6074300
Maltese: Τηλ: + 30 210 6074300
English: AUC: 1.12 (1.06, 1.17) Cmax: 1.06 (0.99, 1.14)
Maltese: ↔ Norelgestromin AUC: 1.12 (1.06, 1.17) Cmass: 1.06 (0.99, 1.14)
English: In study ALLY-3, the combination of daclatasvir and sofosbuvir administered for 12 weeks was evaluated in 152 adults infected with HCV genotype 3; 101 patients were treatment-naïve and 51 patients had failed prior antiviral therapy.
Maltese: Fl-istudju ALLY-3, il-kombinazzjoni ta' daclatasvir u sofosbuvir mogħtija għal 12-il ġimgħa, ġiet evalwata f'152 adult infettati b'HCV ta' ġenotip 3; 101 pazjent qatt ma rċevew kura fil-passat u
English: Tablet core
Maltese: ↔ Tacrolimus
English: Observed emergent NS5A resistance-associated variants are reported in Table 14.
Maltese: Varjanti assoċjati mar-reżistenza ta' NS5A li żviluppaw li ġew osservati huma rrapportati fit-Tabella 14.
English: A third treatment group in study ALLY-2 included 50 HCV treatment-naïve HIV co-infected patients who received daclatasvir and sofosbuvir for 8 weeks.
Maltese: It-tielet grupp ta' kura fl-istudju ALLY-2 inkluda 50 pazjent koinfettati b'HIV li qatt ma ġew ikkurati qabel għal HCV li rċevew daclatasvir u sofosbuvir għal 8 ġimgħat.
English: Treatment outcomes in study AI444010 for patients with HCV genotype 4 are presented in Table 13.
Maltese: Ir-riżultati tat-trattament fi studju A1444010 għal pazjenti b'HCV ġenotip 4 huma ppreżentati f'Tabella 13.
English: 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.
Maltese: (CYP3A4) u trasportatur ta' P-glikoproteina (P-gp) u minħabba f'hekk jista' jikkaġuna esponiment aktar baxx u telf ta' effikaċja ta' Daklinza.
English: No dose adjustment of Daklinza 60 mg once daily or lopinavir/ritonavir is required.
Maltese: Daklinza 60 mg darba kuljum jew lopinavir/ritonavir mhu meħtieġ.
English: SVR12 rates were higher for patients with the IL-28B CC genotype than for those with non-CC genotypes and for patients with baseline HCV RNA less than 800,000 IU/ml but consistently higher in the daclatasvir-treated patients than for placebo-treated patients in all subgroups.
Maltese: Rati ta' SVR12 kienu ogħla għal pazjenti bil-ġenotip CC ta' IL-28B milli dawk għal ġenotipi mhux CC u għal pazjenti b'linja bażi ta' HCV RNA ta' 800,000 IU/mL imma b'mod konsistenti ogħla fil-pazjenti ttrattati b'daclatasvir milli għal pazjenti ttrattati bi plaċebo fis sottogruppi kollha.
English: No cirrhosis With cirrhosis** Genotype 1 1a 1b Genotype 2 Genotype 3 Genotype 4 Virologic failure Detectable HCV RNA at end of treatment Relapse Missing post-treatment data
Maltese: Infezzjoni b'HCV rikorrenti għal wara trapjant tal-fwied (GT 1, 3 jew 4) Pazjenti mingħajr ċirrożi
English: Bristol-Myers Squibb Gyógyszerkereskedelmi Kft. Tel: + 40 (0)21 272 16 00
Maltese: Slovenská republika Bristol-Myers Squibb spol. s r.o. Tel: + 421 2 59298411
English: In patients who received daclatasvir 60 mg tablet orally followed by 100 µg [13C,15N]-daclatasvir intravenous dose, estimated volume of distribution at steady state was 47 l. In vitro studies indicate that daclatasvir is actively and passively transported into hepatocytes.
Maltese: F'pazjenti li rċivew pillola orali ta' daclatasvir ta' 60 mg segwita minn doża ta' 100 µg ġol-vina ta' [13C,15N]-daclatasvir, il volum ta' distribuzzjoni stmat fi stadju fiss kien ta' 47 l.
English: Benzodiazepines Midazolam 5 mg single dose (daclatasvir 60 mg once daily)
Maltese: Escitalopram 10 mg darba kuljum (daclatasvir 60 mg darba kuljum)
English: AI444042: Patients received daclatasvir 60 mg once daily (n=82) or placebo (n=42) plus pegIFN/RBV for 24 weeks.
Maltese: Il-pazjenti rċivew daclatasvir 60 mg darba kuljum (n=82) jew plaċebo (n=42) flimkien ma'
English: With cirrhosis
Maltese: ↔ Cyclosporine
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 60 mg of daclatasvir (as dihydrochloride).
Maltese: Kull pillola miksija b'rita fiha 60 mg ta' daclatasvir (bħala dihydrochloride).
English: Table 14: Summary of noted newly emergent HCV NS5A substitutions on treatment or during follow-up in treated non-SVR12 subjects infected with HCV genotypes 1 through 3
Maltese: Sommarju ta' sostituzzjonijiet HCV NS5A li għadhom kif jiżviluppaw li ġew osservati fuq jew matul is-segwitu ta' individwi kkurati mingħajr SVR12 infettati b'HCV tal-ġenotipi 1 sa 3 Kategorija/ Sostituzzjoni, n (%)
English: Blood and lymphatic system disorders very common anaemia
Maltese: Disturbi tad-demm u tas-sistema limfatika komuni ħafna anemija
English: Ribavirin Dosing Guidelines The dose of ribavirin, when combined with Daklinza, is weight-based (1,000 or 1,200 mg in patients
Maltese: Id-doża ta' ribavirin, meta tiġi kkombinata ma' Daklinza, hija bbażata fuq il-piż (1,000 jew 1,200 mg f'pazjenti li jiżnu <75 kg jew ≥75 kg, rispettivament).
English: CCR5 receptor antagonist Maraviroc
Maltese: Antagonist tar-riċettur ta' CCR5
English: Table 4: Interactions and dose recommendations with other medicinal products Medicinal products by therapeutic areas
Maltese: Tabella 4: Interazzjonijiet u rakkomandazzjonijiet dwar id-doża ma' prodotti mediċinali oħra
English: Tacrolimus 5 mg single dose (daclatasvir 60 mg once daily)
Maltese: Tacrolimus 5 mg doża waħda
English: Study conducted in patients with chronic HCV infection
Maltese: Pazjenti infettati bl-HBV/HCV
English: Daclatasvir in combination with sofosbuvir
Maltese: Daclatasvir flimkien ma' sofosbuvir
English: CARDIOVASCULAR AGENTS Antiarrhythmics
Maltese: Prodotti mediċinali skont iżżoni terapewtiċi
English: LIPID LOWERING AGENTS HMG-CoA reductase inhibitors Rosuvastatin 10 mg single dose (daclatasvir 60 mg once daily)
Maltese: SUSTANZI LI JNAQQSU L-LIPIDI Impedituri ta' HMG-CoA reductase Rosuvastatin 10 mg doża waħda
English: 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).
Maltese: Individwi b'mard tal-kliewi fl-aħħar stadju li jeħtieġu emodijalisi, kellhom żieda ta' 27% fl-AUC ta' daclatasvir u żieda ta' 20% fl-AUC mhux imwaħħal, meta mqabbla ma' individwi b'funzjoni normali tal-kliewi
English: Fainting
Maltese: Manifattur
English: Relapse was defined as HCV RNA ≥LLOQ during follow-up after HCV RNA <LLOQ at end of treatment.
Maltese: waqt follow-up wara HCV RNA < LLOQ fi tmiem ta' trattament.
English: The safety and efficacy of Daklinza in children and adolescents aged <18 years have not yet been established.
Maltese: Is-sigurtà u l-effikaċja ta' Daklinza fit-tfal u adolexxenti li m'għalqux 18-il sena ma ġewx determinati s'issa.
English: Among patients who achieved SVR12 with daclatasvir and sofosbuvir (± ribavirin) with a median duration of post-SVR12 follow-up of 15 months, no relapses have occurred.
Maltese: Fost pazjenti li kisbu SVR12 b'daclatasavir u sofosbuvir (± ribavirin) b'tul ta' żmien medjan ta' segwiment wara SVR12 ta' 15-il xahar, ma kien seħħ l-ebda rkadar.
English: Mainly interferon-based therapy +/-NS3/4 PI.
Maltese: HCV RNA osservat fi tmiem il-kura Rikaduta Dejta ta' wara l-kura nieqsa Prinċipalment terapija bbażata fuq interferon +/-NS3/4 PI.
English: Relapse
Maltese: Azzjoni
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 30 mg of daclatasvir (as dihydrochloride).
Maltese: Kull pillola miksija b'rita fiha 30 mg ta' daclatasvir (bħala dihydrochloride).
English: Daclatasvir inhibits both viral RNA replication and virion assembly.
Maltese: Ittabella mhijiex waħda li inklussiva għal kollox.
English: No clinically relevant antiviral activity was observed against a variety of RNA and DNA viruses, including HIV, confirming that daclatasvir, which inhibits a HCV-specific target, is highly selective for HCV.
Maltese: Ma ġiet osservata l-ebda attività klinika rilevanti kontra varjetà ta' viruses ta' RNA u DNA, li jinkludu
English: ↑ Concentration of statin
Maltese: Sturdament Palpitazzjonijiet
English: MA (EU) number
Maltese: Numru tal-MA (EU) Isem ivvintat
English: Pharmaceutical Form
Maltese: Qawwa Għamla farmaċewtika
English: Route of administration Immediate Packaging Pack size
Maltese: Il-pakkett li jmiss malprodott
English: Attenuated feline panleucopenia virus (PLI IV): at least 3.5 log 10 CCID50 per dose
Maltese: 50 flixkun ta' doża (lajofiliżejt) u 50 flixkun ta' ml (solvent)
English: CCID50 per dose
Maltese: Għamla Farmaċewtika
English: Attenuated feline rhinotracheitis herpesvirus (FVH F2 strain): at least 4.9 log 10 CCID50 per dose Inactivated feline Calicivirosis antigens (FCV 431 and FCV G1 strains): at least 2.0 ELISA U per doses
Maltese: 10 fliexken ta' doża (lajofiliżejt) u 10 fliexken ta' ml (solvent)
English: Target species
Maltese: Qawwa
English: 90 (3 x 30) tablets
Maltese: Flixkun(HDPE) 90 (3 x 30) pillola
English: MA (EU) number (Invented) name
Maltese: Numru talawtorizzazzjoni għat-tqegħid fissuq (EU)
English: Pack size
Maltese: Prodott
English: Packaging Package size l t o r
Maltese: Mnejn jingħata Il-pakkett
English: It is available as tablets (25, 50 and 100 mg).
Maltese: Jiġi f'pilloli (25, 50 u 100 mg).
English: The full EPAR for Xelevia can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The active substance in Xelevia, sitagliptin, is a dipeptidyl-peptidase-4 (DPP-4) inhibitor.
Maltese: Is-sustanza attiva f'Xelevia, is-sitagliptina, hija inibitur tad-dipeptidil-peptidażi-4 (DPP 4).
English: This summary was last updated in 08-2012.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'08-2012.
English: EPAR summary for the public sitagliptin
Maltese: Sommarju tal-EPAR għall-pubbliku sitagliptina