FrancophonIA/ELRC3.0 huggingface dataset:
English: (see also Table 2).
Maltese: (Tabella 2).
English: Expected: ↓ S-mephenytoin
Maltese: Mistenni: ↓ S-mephenytoin
English: Also see section 4.6.
Maltese: Ara wkoll sezzjoni 4.6.
English: HCV ANTIVIRAL Sofosbuvir
Maltese: ANTIVIRALI HCV Sofosbuvir
English: Desmethyl citalopram
Maltese: S-Desmethyl citalopram
English: No (for any parameter listed above) *AFP= serum alpha fetoprotein
Maltese: Le (għal kwalinkwa parametru elenkat hawn fuq) * AFP= serum alpha fetoprotein
English: ↔ ethinyl oestradiol
Maltese: ↔ ethinyl estradiol
English: HIV ANTIVIRALS: NON-NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS Rilpivirine2
Maltese: INIBITURI NON-NUCLEOTIDE REVERSE TRANSCRIPTASE Rilpivirine2
English: Lifepharma (Z.A.M.)
Maltese: Lifepharma (Z.A.M.) Ltd
English: See sections 4.8 and 5.1 for additional information.
Maltese: 4.8 u 5.1 għal informazzjoni addizzjonali.
English: Medicinal products transported by BCRP
Maltese: Prodotti mediċinali trasportati minn BCRP
English: ALT >5-20 × ULN* (Grade 3) >20 × ULN (Grade 4) Haemoglobin <100-80 g/L (grade 2) <80-65 g/L (grade 3) <65 g/L (Grade 4) Total bilirubin >3-10 × ULN (grade 3) >10 × ULN (grade 4) *ULN: Upper Limit of Normal
Maltese: ALT >5-20 × ULN* (Grad 3) >20 × ULN (Grade 4) Emoglobina <100-80 g/L (grad 2) <80-65 g/L (grad 3) <65 g/L (Grade 4) Bilirubin totali >3-10 × ULN (grad 3) >10 × ULN (grad 4) *ULN:
English: b. N=66 for the NS5B target.
Maltese: b. N=66 għall-mira NS5B.
English: Reduce pravastatin dose by 50%.
Maltese: NA Naqqas id-doża ta' pravastatin b'50%.
English: Dose normalised parameters reported for methadone, buprenorphine and naloxone.
Maltese: Dożi normalizzati parametric rapportati għal methadone, buprenorphine u naloxone.
English: Laboratory parameters
Maltese: Parametri tallaboratorju
English: Pitavastatin and fluvastatin
Maltese: Pitavastatin u fluvastatin
English: Use with tacrolimus, sirolimus and everolimus
Maltese: Użu ma' tacrolimus, sirolimus u everolimus
English: Race or ethnicity
Maltese: Razza jew Etniċità
English: − Tablet core: microcrystalline cellulose (E 460(i)), lactose monohydrate, copovidone, croscarmellose sodium, colloidal anhydrous silica (E 551), magnesium stearate (E 470b).
Maltese: − Qalba tal-pillola: microcrystalline cellulose (E 460(i)), lactose monohydrate, copovidone, croscarmellose sodium, colloidal anhydrous silica (E 551), magnesium stearate (E 470b).
English: Overall, 37 (97.4%) of 38 subjects achieved SVR12.
Maltese: Globalment, 37 (97.4%) minn 38 tal-individwi kisbu SVR12.
English: Other medicines and Exviera
Maltese: Mediċini oħra u Exviera
English: Relapse
Maltese: RILASSANTI
English: There is no pharmacokinetic information in patients >75 years.
Maltese: M'hemm l-ebda informazzjoni farmakokinetika f'pazjenti > 75 sena.
English: dasabu vir +
Maltese: dasabuvir +
English: Frequencies are defined as follows: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000) or very rare (<1/10,000).
Maltese: Il frekwenzi huma definiti bħala: 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); rari ħafna (<1/10,000).
English: THYROID HORMONES Levothyroxin e
Maltese: ORMONI TAT-TIROJDE Levothyroxine
English: Arm B: Placebo
Maltese: Fergħa B: Plaċebo
English: ANTIMYCOBACTERIALS Rifampicin
Maltese: ANTIMIKOBATTERJALI Rifampicin
English: HCV genotype 1a
Maltese: Ġenotip 1a HCV
English: Overall SVR12
Maltese: SVR12 Globali
English: Exviera 250 mg tablets dasabuvir
Maltese: Exviera 250 mg pilloli dasabuvir
English: HIV ANTIVIRALS: INTEGRASE STRAND TRANSFER INHIBITOR Dolutegravir
Maltese: INIBITUR TA' INTEGRASE STRAND TRANSFER Dolutegravir
English: Dasabuvir has also been found to inhibit UGT1A4, 1A6 and intestinal UGT2B7 in vitro at in vivo relevant concentrations.
Maltese: Dasabuvir instab ukoll li jinibixxi UGT1A4, 1A6 u UGT2B7 intestinali in vitro f'konċentrazzjonijiet relevanti in vivo.
English: Purpose of the medicine carbamazepine, phenytoin, phenobarbital for epilepsy efavirenz, etravirine, nevirapine for HIV infection
Maltese: Għan tal-mediċina carbamazepine, phenytoin, phenobarbital għal epilessija efavirenz, etravirine, nevirapine għal infezzjoni tal-HIV
English: SAPPHIRE I and II PEARL II, III, and IV TURQUOISE II (subjects with cirrhosis)
Maltese: PEARL II, III, u IV TURQUOISE II
English: Q80K, although a highly prevalent polymorphism in NS3 (41.2% of samples), confers minimal resistance to paritaprevir.
Maltese: Q80K, għalkemm polimorfiżmu ferm prevalenti f'NS3 (41.2% tal-kampjuni), jikkonferixxi reżistenza minima għall-paritaprevir.
English: − Tablet film-coating: poly(vinyl alcohol) (E 1203), titanium dioxide (E 171), macrogol (3350), talc (E 553b), iron oxide yellow (E 172), iron oxide red (E 172) and iron oxide black (E 172).
Maltese: − Kisja b'rita tal-pillola: poly(vinyl alcohol) (E 1203), titanium dioxide (E 171), macrogol (3350), talc (E 553b), iron oxide yellow (E 172) , iron oxide red (E 172) u iron oxide black (E
English: Τηλ: +30 214 4165 555
Maltese: AbbVie ΦΑΡΜΑΚΕΥΤΙΚΗ Α.Ε. Τηλ: +30 214 4165 555
English: With RBV
Maltese: + RBV
English: Target Emergent amino acid substitutionsa
Maltese: Mira Sostituzzjonijiet tal-amino aċidi emerġentia
English: The AUC values of dasabuvir M1 metabolite were unchanged, 57% lower, and 77% higher, respectively.
Maltese: Il-valuri AUC tal-M1 metabolit ta' dasabuvir ma nbidlux, 57% inqas, u 77% ogħla, rispettivament.
English: Prior null response 100% (32/32)
Maltese: Qabel l-ebda rispons 100% (32/32)
English: Part 1 of the study was a Phase 2 pilot cohort consisting of 2 parts, Part 1a (63 subjects) and Part 1b (22 subjects).
Maltese: 2 li tikkonsisti f'2 partijiet, Parti 1a (63 suġġetti) u Parti 1b (22 suġġetti).
English: e. Observed in combination in 6% (4/67) of the subjects.
Maltese: Osservati flimkien ma' 6% (4/67) tal-individwi.
English: D168Y V36Ac, V36Mc, F43Lc, D168H, E357Kc
Maltese: V36Ac, V36Mc, F43Lc, D168H, E357Kc NS5A M28T
English: 12 or 24 weeks N = 380 n (%)
Maltese: 12 jew 24 ġimgħa N = 380 n (%)
English: SEDATIVES / HYPNOTICS Zolpidem
Maltese: SEDATIVI/IPNOTIĊI
English: CYP2C19 substrates evaluated in drug interaction studies include omeprazole and escitalopram (Table 2).
Maltese: Substrati ta' CYP2C19 evalwati fi studji ta' interazzjoni tal-mediċina jinkludu omeprazole u escitalopram (Tabella 2).
English: See additional information on specific hormonal contraceptives in sections 4.3 and 4.4.
Maltese: Ara l-informazzjoni addizzjonali dwar kontraċettivi ormonali speċifiċi fit-taqsimiet 4.3 u 4.4.
English: Exviera contains the active substance dasabuvir.
Maltese: Exviera fih is-sustanza attiva dasabuvir.
English: In Part 2, SVR12 was achieved by 27/28 (96.4%) subjects with HCV GT4/HIV-1 coinfection (95% CI: 82.3%, 99.4%) with no virologic failures.
Maltese: Fil-Parti 2, SVR12 inkiseb minn 27/28 (96.4%) suġġetti b' ko-infezzjoni ta' HCV GT4 / HIV-1 (95% CI: 82.3%, 99.4%) mingħajr fallimenti viroloġiċi.
English: Wort (hypericum perforatum)
Maltese: Fexfiex (Hypericum perforatum)
English: AbbVie Deutschland GmbH & Co. KG Tel: 00800 222843 33 (gebührenfrei) Tel: +49 (0) 611 / 1720-0
Maltese: KG, Tel: 00800 222843 33 (gebührenfrei) Tel: +49 (0) 611 / 1720-0
English: In Part 1b, SVR12 was achieved by 22/22 (100%) subjects (95% CI: 85.1%, 100%).
Maltese: Fil-Parti 1b, SVR12 inkiseb b'22/22 (100%) suġġetti (95% CI: 85.
English: Vistor hf. Tel: +354 535 7000
Maltese: Tel: +354 535 7000
English: Medicinal products metabolised by glucuronidation Dasabuvir is an inhibitor of UGT1A1 in vivo.
Maltese: Prodotti mediċinali metabolizzati minn glukuronidazzjoni Dasabuvir huwa inibitur ta' UGT1A1 in vivo.
English: PEARL II (open-label)
Maltese: PEARL II (tikketta miftuħa)
English: 12 weeks N = 509 n (%)
Maltese: N = 509 n (%)
English: GARNET (open-label)
Maltese: GARNET (tikketta miftuħa)
English: Multipack: 56 (4 packs of 14) film-coated tablets
Maltese: Pakkett multiplu: 56 (4 pakketti ta' 14) pillola miksija b'rita
English: The maximum daily dose of rosuvastatin should be 5 mg (see section 4.4).
Maltese: rosuvastatin għandha tkun 5 mg (ara sezzjoni 4.4).
English: The recommended tacrolimus dosing is 0.5 mg every 7 days.
Maltese: Id-doża rrakkomandata ta' tacrolimus hija 0.5 mg kull 7 ijiem.
English: Dasabuvir had reduced activity in biochemical assays against NS5B polymerases from HCV genotypes 2a, 2b, 3a and 4a (IC50 values ranging from 900 nM to >20 μM).
Maltese: Dasabuvir kellu attivita mnaqqsa f'testijiet biokemikali kontra NS5B polymerases min ġenotipi HCV 2a, 2b, 3a u 4a (valuri IC50 li jvarjaw min 900 nM sa >20 μM).
English: Medicinal products metabolised by CYP2D6 or CYP1A2
Maltese: Prodotti mediċinali metabolizzati minn CYP2D6 jew CYP1A2
English: Sulfamethoxazole, trimethoprim
Maltese: ANTIBIJOTIĊI (AMMINISTRAZZJONI SISTEMIKA) Sulfamethoxazole, trimethoprim
English: Table 18.
Maltese: Tabella 18.
English: AbbVie Spain, S.L.U.
Maltese: AbbVie Spain, S.
English: Treatment:
Maltese: Trattament:
English: PROTON PUMP INHIBITORS Omeprazole
Maltese: TAL-PROTON-PUMP Omeprazole
English: 24 weeks (see section 5.1.)
Maltese: 24 ġimgħa (ara sezzjoni 5.1)
English: Raltegravir exposure is substantially increased (2-fold).
Maltese: L-espożizzjoni ta' raltegravir tiżdied sostanzjalment (2 darbiet).
English: Efavirenz/ emtricitabine / tenofovir disoproxil fumarate mg once daily
Maltese: Efavirenz/ emtricitabine/tenof ovir disoproxil fumarate
English: HIV ANTIVIRALS: NUCLEOSIDE INHIBITORS Abacavir/ lamivudine
Maltese: INIBITURI NUCLEOTIDE Abacavir/ lamivudine
English: See also Section 4.8 for discussion of safety information for RUBY-I.
Maltese: Ara wkoll is-Sezzjoni 4.8 għad-diskussjoni ta' informazzjoni dwar is-sigurtà għal RUBY-I.
English: Table 16.
Maltese: Tabella 16.
English: Medicinal products metabolised by CYP2C9
Maltese: Prodotti mediċinali metabolizzati minn CYP2C9
English: Use with statins
Maltese: Użu ma' statins
English: G558R and D559G/N were observed as treatment-emergent substitutions but the activity of dasabuvir against these variants could not be evaluated due to poor replication capacity.
Maltese: G558R u D559G/N kienu osservati bħala sostituzzjonijiet emerġenti għall-kura iżda l-attività ta' dasabuvir kontra dawn il-varjanti ma setgħetx tiġi evalwata minħabba kapaċità ta' replikazzjoni ħażina.
English: NNRTIs other than rilpivirine (efavirenz, etravirine, and nevirapine) are contraindicated (see section
Maltese: NNRTIs minbarra rilpivirine (efavirenz, etravirine u nevirapine) huma kontraindikati (ara sezzjoni
English: MUSCLE RELAXANTS Carisoprodol
Maltese: TAL-MUSKOLI Carisoprodol
English: Table 17.
Maltese: Tabella 17.
English: Table 15.
Maltese: Tabella 15.
English: Mechanism: possible enzyme induction by efavirenz.
Maltese: Induzzjoni ta' enżimi possibbli minn efavirenz.
English: Each carton contains 56 tablets (multipack carton containing 4 inner cartons of 14 tablets).
Maltese: Daqs ta' pakkett ta' 56 pillola (pakkett multiplu li fih 4 kartun interni ta' 14-il pillola.)
English: multicentre, open-label
Maltese: multiċentriku, open-label
English: Clinical monitoring and dose adjustment may be needed for other CYP1A2 substrates (e.g. ciprofloxacin, cyclobenzaprine, theophylline and caffeine).
Maltese: CYP1A2 (e.ż. ciprofloxacin, cyclobenzaprine, theophylline u kaffeina).
English: Table 11.
Maltese: Tabella 11.
English: 12 weeks N = 770 n (%)
Maltese: N = 770 n (%)
English: Frequency dasabuvir and ombitasvir/paritaprevir/ritonavir + ribavirin* N = 2,044
Maltese: Frekwenza dasabuvir u ombitasvir/paritaprevir/ritonavir + ribavirin* N = 2,044
English: Dasabuvir was greater than 99.5%, and M1 major metabolite of dasabuvir was 94.5% bound to human plasma proteins over a concentration range of 0.05 to 5 µg/mL.
Maltese: M1 ta' dasabuvir kien 94.5% marbut mal-proteini tal-plażma uman fuq firxa ta' konċentrazzjoni ta' 0.05 sa 5µg/mL.
English: Table 14.
Maltese: Tabella 14.
English: PVC/PE/PCTFE aluminium foil blister packs.
Maltese: Pakketti ta' folji tal-aluminju PVC/PE/PCTFE.
English: Pharmacotherapeutic group: Antivirals for systemic use; direct-acting antivirals, ATC code: J05AP09
Maltese: Antivirali b'azzjoni diretta, Kodiċi ATC: J05AP09 Mekkaniżmu ta' azzjoni
English: Table 13.
Maltese: Tabella 13.
English: C24:= concentration at 24 hours following single dose of cyclosporine, tacrolimus or sirolimus.
Maltese: 6. C24:= konċentrazzjoni wara 24 siegħa minn doża waħda ta' cyclosporine, tacrolimus jew sirolimus.
English: AbbVie Deutschland GmbH & Co. KG Knollstrasse
Maltese: AbbVie Deutschland GmbH & Co.
English: The M1 metabolite of dasabuvir had EC50 values of 39 and 8 nM against genotype 1a-H77 and 1bCon1 strains in HCV replicon cell culture assays, respectively, and the activity of the M1 metabolite was attenuated 3- to 4-fold in the presence of 40% human plasma.
Maltese: Il-metabolit M1 ta' dasabuvir kellu valuri ta' EC50 ta' 39 u 8 nM meta mqabbel ma' ġenotip 1a-H77 u 1b-Con1 f' testijiet ta' HCV replikon f'kultura taċ-ċelloli, rispettivament, u l- attivita tal-metabolit M1 kientet imnaqqsa minn 3- sa 4- darbiet fil-preżenza ta' 40% plasma umana.
English: Dasabuvir should not be used in patients with moderate to severe hepatic impairment (Child-Pugh B or C) (see sections 4.2, 4.3, 4.8 and 5.2).
Maltese: Dasabuvir m'għandux jintuża f'pazjenti b'indeboliment epatiku moderat għal serju (Child-Pugh B jew C) (ara sezzjonijiet 4.2, 4.3, 4.8 u 5.2).
English: 20-120 mg once daily8
Maltese: 20-120mg darba kuljum5
English: Exposures of cyclobenzaprine, a CYP1A2 substrate, were decreased.
Maltese: Espożizzjonijiet ta' cyclobenzaprine, substrat ta' CYP1A2, kienu imnaqsin.
English: 200 mg once daily followed by 200 mg twice daily
Maltese: 200 mg darba kuljum segwita minn 200 mg darbtejn kuljum
English: Patients with moderate to severe hepatic impairment (Child-Pugh B or C) (see section 5.2).
Maltese: Pazjenti b'indeboliment epatiku moderat għal sever (Child-Pugh B jew C) (ara sezzjoni 5.2).
English: Severe renal impairment or ESRD includes CKD Stage 4 defined as eGFR <30-15 mL/min/1.73 m2 or CKD Stage 5 defined as <15 mL/min/1.73 m2 or requiring haemodialysis.
Maltese: Indeboliment renali sever jew ESRD jinkludi CKD Stadju 4 definit bħala eGFR <30-15 mL/min/1.73 m2 jew CKD Stadju 5 definit bħala <15 mL/min/1.73 m2 jew li jeħtieġu emodijaliżi.
English: • Diarrhoea
Maltese: • Deidrazzjoni
English: Table 10.
Maltese: Tabella 10.
English: Dasabuvir is a non-nucleoside inhibitor of the HCV RNA-dependent RNA polymerase encoded by the NS5B gene, which is essential for replication of the viral genome.
Maltese: Dasabuvir huwa inibitur non-nucleoside tal-polymerase RNA dipendenti fuq HCV RNA dekodifikat mill-ġene N5SB, li huwa essenzjali għar-replikazzjoni tal-ġenomu virali.
English: Mechanism: CYP3A4 induction by apalutamide, enzalutamide or mitotane.
Maltese: induzzjoni ta' CYP3A4 minn apalutamide, enzalutamide, jew mitotane.
English: AFP* < 20 ng/mL, platelets ≥ 90 x 109/L, AND albumin ≥ 35 g/L prior to treatment
Maltese: AFP* < 20ng/ml, plejtlets ≥ 90 x 109/L, U albumin ≥ 35 g/L qabel il-kura Iva (għal kull tliet parametri elenkati hawn fuq)
English: On-treatment VF
Maltese: Kura VF Rikaduta
English: Table 12.
Maltese: Tabella 12.
English: CYP2D6 substrates (e.g. desipramine, metoprolol and dextromethorphan) are not expected to require dose adjustments.
Maltese: Substrati ta' CYP2D6 (e.ż. desipramine, metoprolol u dextromethorphan) mhumiex mistennija li jeħtieġu aġġustamenti fid-doża.
English: A total of 129 subjects were treated, 84 with GT1a, 41 with GT1b, 1 with GT1 other, 3 with GT4 infection.
Maltese: GT1a, 41 bi GT1b, 1 bi GT1 oħrajn, 3 b'infezzjoni ta' GT4.
English: Genotype 1a N=67b % (n)
Maltese: N=67b % (n)
English: Laboratory abnormalities
Maltese: Abnormalitajiet tal-laboratorju
English: NAME OF THE MEDICINAL PRODUCT
Maltese: PRODOTTI MEDIĊINALI
English: Note: Doses used for dasabuvir + ombitasvir/paritaprevir/ritonavir were: ombitasvir 25 mg paritaprevir 150 mg, ritonavir 100 mg, once daily and dasabuvir 400 mg twice daily or 250 mg twice daily.
Maltese: Nota: Id-dożi użati għal dasabuvir + ombitasvir/paritaprevir/ritonavir kienu: ombitasvir 25 mg, paritaprevir 150 mg, ritonavir 100 mg darba kuljum u dasabuvir 400 mg darbtejn kuljum jew 250 mg darbtejn kuljum.
English: Main demographics in TURQUOISE-III Characteristics
Maltese: Demografiji ewlenin f' TURQUOISE-III
English: Overall, 61% had fibrosis stage F0-F1, 26% F2, 9% F3, and 4% F4.
Maltese: B'mod ġenerali, 61% kellhom stadju ta 'fibrożi F0-F1, 26% F2, 9% F3, u 4% F4. 61% kellhom esperjenza ta' trattament għal l-HCV qabel it-trapjant.
English: Resistance-associated variants at amino acid positions R155 and D168 in NS3 were rarely observed (less than 1%) at baseline.
Maltese: D168 fl-NS3 kienu osservati rarament (anqas minn 1%) fil-linja bażi.
English: L31F/V or Y93H in combination with L28M, L31F/V or P58S in genotype 1b; and NS5B variants Y448H in genotype 1a, and M414T and Y448H in genotype 1b.
Maltese: L31F/V jew Y93H flimkien ma' L28M, L31F/V jew P58S fil-ġenotip 1b; u l-varjanti f'NS5B Y448H fil ġenotip 1a, u M414T u Y448H fil-ġenotip 1b.
English: Note: For laboratory abnormalities refer to Table 4.
Maltese: Għal abnormalitajiet tal-laboratorju irreferi għat-Tabella 4 .
English: Exviera is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults (see sections 4.2, 4.4 and 5.1).
Maltese: Exviera hija indikata f'kombinazzjoni ma' prodotti mediċinali oħra għall-kura ta' epatite Ċ kronika (EĊK) f'adulti (ara sezzjonijiet 4.2, 4.4 u 5.1).
English: Hepatitis B virus reactivation
Maltese: Riattivazzjoni tal-virus tal-Epatite B
English: Transient elevations in total bilirubin >3 x ULN (mostly indirect) occurred in 17 (27.0%) subjects; 15 of these subjects were receiving atazanavir.
Maltese: Elevazzjonijiet temporanji fil bilirubin totali > 3 x ULN (l-aktar indiretti) seħħew f'17 (27.0 %) -il individwu; 15 minn dawn l-individwi kienu qed jirċievu atazanavir.
English: • Each tablet contains 250 mg of dasabuvir (as sodium monohydrate).
Maltese: • Kull pillola fiha 250 mg dasabuvir (bħala sodium monoidrat).
English: The proportion of subjects who permanently discontinued treatment due to adverse reactions was 0.2% (5/2,044) and 4.8% (99/2,044) of subjects had ribavirin dose reductions due to adverse reactions.
Maltese: Il-proporzjon ta' individwi li waqqfu l-kura b'mod permanenti minħabba avvenimenti avversi kien 0.2% (5/2,044) u 4.8% (99/2,044) tal-individwi kellhom tnaqqis fid-doża ta' ribavirin minħabba reazzjonijiet avversi.
English: Part 2 was a Phase 3 cohort consisting of 233 subjects.
Maltese: IlParti 2 kienet ko-orti ta' Fażi 3 li tikkonsisti minn 233 suġġett.
English: The overall safety profile in HCV/HIV-1 co-infected subjects was similar to that observed in HCV mono-infected subjects.
Maltese: Il-profil ta' sigurtà globali f'individwi ko-infettati b'HCV/HIV-1 kien simili għal dak osservat f'individwi infettati b'HCV biss.
English: randomised, global multicentre, double-blind, placebo-controlled
Maltese: ‘randomised', ‘multicentre' globali, ‘double-blind', ikkontrollat bil-plaċebo
English: Primary SVR12 Assessment for Part 2, Subjects with HCV GT1/HIV-1 co-infection in TURQUOISE-I
Maltese: Valutazzjoni SVR12 Primarja għall-Parti 2, Suġġetti b'HCV GT1/HIV-1 ko infezzjoni fit-TURQUOISE Tabella 17.
English: For hepatitis C virus (HCV) genotype specific activity, see sections 4.4 and 5.1.
Maltese: Għall-attività speċifika marbuta mal-ġenotip tal-virus ta' epatite Ċ (HCV), ara sezzjonijiet 4.4 u 5.1.
English: In vitro studies show that dasabuvir is not an inhibitor of organic cation transporters (OCT2), organic anion transporters (OAT3), or multidrug and toxin extrusion proteins (MATE1 and MATE2K) at clinically relevant concentrations.
Maltese: Studji in vitro juru li dasabuvir mhuwiex inibitur tattrasportaturi cation organiċi (OCT2), it-trasportaturi anion organiċi (OAT3), jew diversi mediċini u proteini li jestrudu tossini (MATE1 u MATE2K) f'konċentrazzjonijiet klinikament rilevanti.
English: Exviera tablets are beige, ovaloid film-coated tablets, of dimensions of 14.0 mm x 8.0 mm, marked with “AV2”.
Maltese: Pilloli Exviera huma beige, ovali miksijin b'rita, b'daqs ta' 14.0 mm x 8.0 mm immarkati bi “AV2”.
English: Such medicinal products include sulfasalazine, imatinib and some of the statins (see Table 2).
Maltese: Prodotti mediċinali bħal dawn jinkludu sulfasalazine, imatinib u wħud mill-istatins (ara t-Tabella 2).
English: Plasma HCV RNA values were measured during the clinical trials using the COBAS TaqMan HCV test (version 2.0), for use with the High Pure System (except GARNET which used COBAS AmpliPrep/COBAS TaqMan HCV Test v2.0).
Maltese: Il-valuri HCV RNA fil-plażma tkejlu matul il-provi kliniċi permezz tat-test COBAS TaqMan HCV (verżjoni 2.0), għall-użu mas-Sistema High Pure (minbarra GARNET fejn intuża COBAS AmpliPrep/COBAS TaqMan HCV Test v2.0).
English: ombitas vir/parit aprevir/r itonavir atazanavir dasabuvir ombitasvir paritaprevir
Maltese: dasabuvir ombitasvir/ paritaprevi r/ritonavir atazanavir dasabuvir ombitasvir paritaprevir
English: Not studied.
Maltese: Mhux studjat.
English: In genotype 1a, substitutions C316Y, M414T, Y448H, A553T, G554S, S556G/R, and Y561H in HCV NS5B reduced susceptibility to dasabuvir.
Maltese: Fil-ġenotip 1a, is-sostituzzjonijiet C316Y, M414T, Y448H, A553T, G554S, S556G/R, u Y561H f'HCV NS5B naqqsu s-suxxettibbiltà għal dasabuvir.
English: Dasabuvir administered with ombitasvir/paritaprevir/ritonavir did not affect the exposures of the CYP2D6 /CYP1A2 substrate duloxetine.
Maltese: Dasabuvir amministrat ma' ombitasvir/paritaprevir/ritonavir ma affetwatx l-espożizzjonitas-substrat tal-CYP2D6/CYP1A2, duloxetine.
English: In the genotype 1a replicon, the activity of dasabuvir was reduced 21- to 32-fold by the M414T, S556G or Y561H substitutions; 152- to 261-fold by the A553T, G554S or S556R substitutions; and 1472- and 975-fold by the C316Y and Y448H substitutions, respectively.
Maltese: Fir-replikon tal-ġenotip 1a, l-attività ta' dasabuvir tnaqqset b'21 sa 32 darba mis-sostituzzjonijiet M414T, S556G jew Y561H; b'152 sa 261 darba mis-sostituzzjonijiet A553T, G554S jew S556R; u b'1472 u 975 darba mis-sostituzzjonijiet
English: Ethinyloestradiol is contraindicated in combination with dasabuvir (see section 4.3).
Maltese: Ethinyloestradiol huwa kontraindikat flimkien ma' dasabuvir (ara sezzjoni 4.3).
English: See leaflet for further information.
Maltese: Prodott ta' ribavirin għal informazzjoni addizzjonali.
English: ANTIARRYTHMICS Digoxin
Maltese: Digoxin dasabuvir digoxin
English: Co-administration of dasabuvir with medicinal products that inhibit CYP2C8 (e.g. teriflunomide, deferasirox) may increase dasabuvir plasma concentrations.
Maltese: Ko-amministrazzjoni ta' dasabuvir ma' prodotti mediċinali li jinibixxu CYP2C8 (e.ż. teriflunomide, deferasirox) jistgħu jżidu l-konċentrazzjonijiet ta' dasabuvir fil-plażma.
English: The mean EC50 of dasabuvir against replicons containing NS5B from a panel of treatment-naïve genotype 1a and 1b isolates in the HCV replicon cell culture assay was 0.77 nM (range 0.4 to 2.1 nM; n=11) and 0.46 nM (range 0.2 to 2 nM; n=10), respectively.
Maltese: L-EC50 medju ta' dasabuvir kontra replikons li fihom NS5B minn penil ta' iżolati ta' ġenotip 1a u 1b li qatt ma ħadu l-kura qabel fit-testijiet fuq kulturi ta' ċelloli HCV replikon kienu 0.77 nM (firxa ta' 0.4 sa 2.1 nM; n=11) u 0.46 nM (firxa ta' 0.2 sa 2 nM; n=10), rispettivament
English: Other pegIFN/RBV failures
Maltese: Fallimenti oħra b pegIFN/RBV
English: • St. John's Wort (Hypericum perforatum)
Maltese: • Fexfiex (Hypericum perforatum)
English: The persistence of dasabuvir, ombitasvir and paritaprevir resistance-associated amino acid substitutions in NS5B, NS5A and NS3, respectively, was assessed in genotype 1a-infected subjects in Phase 2b trials.
Maltese: Il-persistenza ta' sostituzzjonijiet ta' aċidi amminiċi assoċjati ma' reżistenza għal dasabuvir, ombitasvir and paritaprevir f'NS3, NS5A, u NS5B, rispettivament, kienet ivvalutata fl-individwi infettati bil-ġenotip 1a fil-provi tal-Fażi 2b.