FrancophonIA/ELRC3.0 huggingface dataset:
English: Geometric mean Cmax, AUC of multiple doses of Viekirax 150 mg/100 mg/25 mg once daily with dasabuvir 250 mg twice daily with food in healthy volunteers
Maltese: Cmax medju ġeometriku, AUC ta' dożi multipli ta' Viekirax 150 mg/100 mg/25 mg darba kuljum ma' dasabuvir 250 mg darbtejn kuljum mal-ikel f'voluntiera b'saħħithom Cmax (ng/ml) (% CV)
English: NA ↔ ombitasvir/paritaprevir/dasabuvir (based on the crossstudy comparison)
Maltese: ↔ ombitasvir /paritaprevir/ /dasabuvir (bbażat fuq studju inkroċjat ta' tqabbil)
English: GT1a Arm A: Viekirax and dasabuvir + RBV Arm B: Viekirax and dasabuvir Peginterferon+ribavirin experienced -, without cirrhosis
Maltese: GT1a Fergħa A: Viekirax u dasabuvir + RBV Fergħa B: Viekirax u dasabuvir -esperjenza ta'Peginterferon+ribavirin, mingħajr ċirrożi
English: Lansoprazole
Maltese: Esomeprazole Lansoprazole
English: ↓ voriconazole ↑ paritaprevir
Maltese: ↑ voriconazole ↑ dasabuvir ↑ paritaprevir
English: 200 mg once daily/300 mg once daily
Maltese: 200 mg darba kuljum/ 3mf darba kuljum
English: The recommended dose of darunavir is 800 mg once daily, without ritonavir, when administered at the same time as Viekirax + dasabuvir (ritonavir dose in Viekirax will provide darunavir pharmacokinetic enhancement).
Maltese: Id-doża rrakkomandata ta' darunavir hija ta' 800 mg darba kuljum, mingħajr ritonavir, meta amministrat fl-istess ħin bħal Viekirax + dasabuvir, (doża ta' ritonavir f'Viekirax se tipprovdi żieda farmakokinetika ta'
English: Treated subjects (N = 63) had a median age of 51 years (range: 31 to 69); 24% of subjects were Black; 19% of subjects had compensated cirrhosis; 67% of subjects were HCV treatment-naïve; 33% of subjects had failed prior treatment with pegIFN/RBV; 89% of subjects had HCV genotype 1a infection.
Maltese: Individwi trattati (N=63) kellhom medja ta' età ta' 51-il sena (medda 31 sa 69); 24% tal-individwi kienu Suwed; 19% tal-individwi kellhom ċirrożi kkumpensata; 67% tal-individwi kienu naïve għall-kura ta' HCV; 33% tal-individwi fallew qabel it-trattament bi pegIFN/RBV; 89% tal-individwi kellhom infezzjoni tal-ġenotip 1a HCV.
English: Not Studied.
Maltese: Mhux studjat .
English: Alprazolam, diazepam for anxiety, panic attacks and trouble sleeping ciclosporin, tacrolimus to suppress the immune system cyclobenzaprine, carisoprodol for muscle spasms colchicine for patients whose kidney and liver function test are normal for treating gout attacks or familial Mediterranean fever digoxin, amlodipine, nifedipine, valsartan, diltiazem, verapamil, candesartan, losartan for heart problems or high blood pressure furosemide for the build-up of too much fluid in the body hydrocodone for pain levothyroxine for thyroid problems rilpivirine, darunavir, atazanavir for HIV infection omeprazole, lansoprazole, esomeprazole for stomach ulcers and other stomach problems imatinib for the treatment of some cancers of the blood fluvastatin, pitavastatin, pravastatin, rosuvastatin to lower blood cholesterol dabigatran to thin the blood fexofenadine for hay fever s-mephenytoin for epilepsy sulfasalazine for inflammatory bowel disease repaglinide for lowering blood sugar erythromycin for bacterial infections steroid or corticosteroid medicines (such as fluticasone)
Maltese: Colchicine, għall-pazjenti li testijiet tal-funzjoni tal-kliewi u fwied huma normali għat-trattament tal-attakki tal-gotta jew deni familjali tal-Mediterran digoxin, amlodipine, nifedipine, valsartan, diltiazem, verapamil, candesartan, losartan għall-problemi tal-qalb jew pressjoni għolja tad-demm furosemide għall-akkumulazzjoni ta' fluwidu fil ġisem hydrocodone għall-uġigħ levothyroxine għall-problemi tat-tirojde rilpivirine, darunavir, atazanavir għal infezzjoni tal-HIV
English: In a phase 2, multicentre, open-label, single arm study, 38 treatment-naïve or pegIFN/RBV treatment experienced, non-cirrhotic subjects with genotype 1 infection who were on stable doses of methadone (N=19) or buprenorphine +/- naloxone (N=19) received 12 weeks of Viekirax and dasabuvir with ribavirin.
Maltese: Fil-fażi 2, multiċentriku, open-label, studju b'fergħha waħda, 38 li kienu naïve għall-kura jew blesperjenza fit-trattament ta' pegIFN/RBV, individwi mhux biċ-ċirrożi bl-infezzjoni tal-ġenotip 1 li kienu fuq doża stabbli ta' methadone (N=19) jew buprenorphine +/- naloxone (N=19) irċevew 12-il ġimgħa ta' Viekirax u dasabuvir ma' ribavirin.
English: Patients who are taking ethinylestradiol-containing medicinal products (i.e. most combined oral contraceptives or contraceptive vaginal rings) must switch to an alternative method of contraception (e.g., progestin only contraception or non-hormonal methods) prior to initiating Viekirax and dasabuvir therapy (see sections 4.3 and 4.5).
Maltese: Pazjenti li qed jieħdu prodotti mediċinali li fihom ethinylestradiol (jiġifieri ħafna mill-kontraċettivi orali kkombinati jew ċrieki vaġinali kontraċettivi) għandhom jaqilbu għal metodu alternattiv ta' kontraċezzjoni (pereżempju, kontraċezzjoni li tinvolvi progestin biss jew metodi li m'humiex ormonali) qabel tinbeda terapija b'Viekirax u dasabuvir (ara sezzjonijiet 4.3 u 4.5).
English: Purpose of the medicine alfuzosin for an enlarged prostate amiodarone, dronedarone used to correct irregular heartbeats astemizole, terfenadine for allergy symptoms.
Maltese: Għan tal-mediċina alfuzosin għal prostata mkabbra amiodarone, dronedarone użat biex jikkoreġi taħbit tal-qalb irregolari astemizole, terfenadine għal sintomi tal-allerġija.
English: Appropriate monitoring of serum digoxin levels is recommended.
Maltese: rrakkomandata sorveljanza xierqa ta' livelli ta' digoxin fis-serum.
English: Mechanism: CYP3A4/Pgp inhibition by ketoconazole and paritaprevir/ ritonavir/ ombitasvir
Maltese: Inibizzjoni ta' CYP3A4/Pgp minn ketoconazole u dasabuvir, paritaprevir/ ritonavir/omb itasvir
English: Asthenia Fatigue *Data set includes all genotype 1-infected subjects in Phase 2 and 3 trials including subjects with cirrhosis.
Maltese: *Is-sett ta' dejta jinkludi l-individwi infettati bil-ġenotip 1 fil-provi tal-Fażi 2 u 3 inkluż individwi b'ċirrożi.
English: Viekirax with weight-based ribavirin for 12 or 16 weeks Subjects had a median age of 56 years (range: 32 to 81); 50% were treatment-naïve, 28% were prior pegIFN/RBV null responders; 10% were prior pegIFN/RBV partial responders, 13% were prior pegIFN/RBV relapsers; 70% were male; 17% were Black; 73% had baseline HCV RNA levels of at least 800,000 IU per mL; 17% had platelet counts of less than 90 x 109 per L; and 4% had albumin less than 3.5 mg per dL.
Maltese: Individwi kellhom età medja ta' 56 sena (medda: 32-81); 50% kienu naïve għall-kura, 28% kienu qabel li ma rrispondewx għal pegIFN / RBV; 10% kienu qabel li irrispondew parzjalment għal pegIFN / RBV, 13% kienu qabel li kellhom rikaduta għal pegIFN / RBV; 70% kienu rġiel; 17% kienu Suwed; 73%
English: Use of ethinylestradiol-containing medicinal products such as those contained in most combined oral contraceptives or contraceptive vaginal rings (see section 4.4 and 4.5).
Maltese: L-użu ta' prodotti mediċinali li fihom ethinylestradiol bħal dawk li jinsabu f'ħafna kontraċettivi orali kombinati jew ċrieki vaġinali kontraċettivi (ara sezzjoni 4.4 u 4.5).
English: TURQUOISE-III: treatment-naïve or pegIFN + RBV-experienced with compensated cirrhosis
Maltese: TURQUOISE-III: naïve għall-kura jew bl-esperjenza ta' pegIFN+RBV, b'ċirrożi kkumpensata Disinn:
English: Clinical trials in subjects with genotype 4 chronic hepatitis C PEARL- I- genotype 4, treatment-naïve or pegIFN + RBV experienced without cirrhosis Design:
Maltese: PEARL- I- naïve għall-kura, ġenotip 4 jew bl-esperjenza ta' pegIFN + RBV mingħajr ċirrożi Disinn:
English: In the presence of paritaprevir/ritonavir, dasabuvir exposures decreased by approximately 50% to 60% while ombitasvir exposures increased by 31-47%.
Maltese: Effett ta' paritaprevir/ritonavir fuq ombitasvir u dasabuvir Fil-preżenza ta' paritaprevir/ritonavir, l-espożizzjonijiet ta' dasabuvir naqsu b'madwar 50% sa 60% filwaqt l-espożizzjonijiet ta' ombitasvir żdiedu bi 31-47%.
English: HBV/HCV co-infected patients are at risk of HBV reactivation, and should therefore be monitored and managed according to current clinical guidelines.
Maltese: Pazjenti infettati bl-HBV/HCV f'daqqa qegħdin f'riskju għal attivazzjoni mill-ġdid ta' HBV, u għalhekk għandhom jiġu mmonitorjati u mmaniġjati skont il-linji gwida kliniċi kurrenti.
English: Ombitasvir is an inhibitor of HCV NS5A which is essential for viral replication.
Maltese: Ombitasvir huwa inibitur ta' HCV NS5A li huwa essenzjali għar-replikazzjoni virali.
English: Thirty four subjects (29 with HCV genotype 1a infection and 5 with HCV genotype 1b infection) were enrolled who had not received treatment for HCV infection after transplantation and had a METAVIR fibrosis score of F2 or less.
Maltese: Erbgħa u tletin individwi (29 b'infezzjoni tal-ġenotip 1a HCV u 5 b'infezzjoni tal-ġenotip 1b HCV) kienu rreġistrati li ma kienux irċevew trattament għall-infezzjoni ta' HCV wara t-trapjant u li kellhom punteġġ tal-fibrożi Metavir ta' F2 jew inqas.
English: Three interrupted Viekirax and dasabuvir for one to seven days, including one on ethinylestradiol.
Maltese: Tlieta interrompew Viekirax u dasabuvir għal perjodu minn wieħed sa sebat ijiem, inkluża waħda fuq ethinylestradiol.
English: 250 mg single dose
Maltese: 250 mg doża waħda Mekkaniżmu:
English: NAME OF THE MEDICINAL PRODUCT Viekirax 12.5 mg/75 mg/50 mg film-coated tablets
Maltese: Viekirax 12.5 mg/75 mg/50 mg pilloli miksijin b'rita
English: Viekirax 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: (CHC) f'adulti (ara sezzjonijiet 4.2, 4.4, u 5.1).
English: Patients should be informed that fatigue has been reported during treatment with Viekirax in combination with dasabuvir and ribavirin (see section 4.8).
Maltese: Dikompensazzjoni epatika, insuffiċjenza tal-fwied kienu osservati matul it-terapija b'Viekirax bi jew mingħajr dasabuvir u bi jew mingħajr ribavirin (ara sezzjoni 4.4).
English: Carisoprodol
Maltese: Carisoprodo l
English: Genotype 1b N=7 % (n)
Maltese: N=67b % (n)
English: ↑ naloxone
Maltese: Viekirax .
English: Coadministration with ethinylestradiol may increase the risk of ALT elevations (see sections 4.3 and 4.4).
Maltese: L-għoti flimkien ma' etinylestradiol jistgħu jżidu r-riskju ta' elevazzjonijiet ta' ALT (ara sezzjonijiet 4.3 u 4.4).
English: ALT elevations were typically asymptomatic, generally occurred during the first 4 weeks of treatment (mean time 20 days, range 8-57 days) and most resolved with ongoing therapy.
Maltese: Elevazzjonijit fl-ALT kienu tipikament asintomatiċi, ġeneralment seħħew matul lewwel 4 ġimgħat ta' trattament (ħin medju 20 ġurnata, medda 8-57 ijiem) u ħafna ġew solvuti b' terapija kontinwa.
English: Coadministration with enzyme inducers may increase the risk of adverse events and ALT elevations (see Table 2).
Maltese: L-għoti flimkien ma' indutturi ta' enżimi jistgħu jżidu r-riskju ta' reazzjonijiet avversi u elevazzjonijiet ta'ALT (ara Tabella 2).
English: ↑ midazolam or triazolam
Maltese: Mistenni: ↑ midazolam or triazolam
English: In contrast, the rate of ALT elevations in subjects using other types of estrogens as typically used in hormonal replacement therapy (i.e., oral and topical estradiol and conjugated estrogens) was similar to the rate observed in subjects who were not using estrogencontaining products (approximately 1% in each group).
Maltese: ALT f'individwi li jużaw tipi oħra ta' estroġeni kif tipikament jiġu użati fit-terapija bl-ormoni, bħala sostitut (jiġifieri estradiol orali u topiku u estroġeni konjugat ) kien simili għar-rata osservata f'pazjenti li ma kinux jużaw prodotti li fihom estroġenu (madwar 1% f'kull grupp) .
English: 0.035/0.25 mg once daily
Maltese: 0.35 mg darba kuljum
English: How to take Viekirax
Maltese: Tiħux Viekirax
English: IMMUNOSUPPRESSANTS
Maltese: IMBLOKKATURI
English: Mechanism: CYP2C19 induction by ritonavir
Maltese: Induzzjoni ta' CYP2CI9 minn ritonavir
English: Two patients discontinued Viekirax and dasabuvir due to elevated ALT, including one on ethinylestradiol.
Maltese: Żewġ pazjenti ma komplewx Viekirax u dasabuvir minħabba ALT elevat, inkluż wieħed fuq ethinylestradiol.
English: Mechanism: Intestinal Pgp inhibition by paritaprevir and ritonavir.
Maltese: Inibizzjoni intestinali ta' P-gp minn paritaprevir u ritonavir
English: The dasabuvir exposures obtained with the 400 mg formulation and the 250 mg tablet are similar.
Maltese: dasabuvir kienet 250 mg darbtejn kuljum.
English: No subjects experienced on-treatment virologic failure or relapse.
Maltese: Fuq trattament indeboliment viroloġiku
English: S-warfarin (0.85-1.08)
Maltese: ↑ ciclosporin 0.83
English: A pooled analysis of subjects with genotype 1 HCV infection, who were treated with ombitasvir, paritaprevir, and dasabuvir (a non-nucleotide NS5B inhibitor) with or without ribavirin in the Phase 2b and 3 clinical trials was conducted to explore the association between baseline NS3/4A, NS5A or NS5B substitutions/polymorphisms and treatment outcome in recommended regimens.
Maltese: Twettqet analiżi miġbura tal-individwi b'infezzjoni ta' HCV tal-ġenotip 1, li kienu trattati b' ombitasvir, paritaprevir, u dasabuvir (inibituri non-nukleotidi ta' NS5B ) bi jew mingħajr ribavirin fil-provi kliniċi tal-Fażi 2b u 3 ikkurati b'ABT-450, ombitasvir, u dasabuvir b'RBV jew mingħajru biex tiġi esplorata l assoċjazzjoni bejn is-sostituzzjonijiet/polimorfiżmi
English: Extreme caution must be taken to avoid pregnancy in female patients and female partners of male patients when Viekirax is taken in combination with ribavirin, see section 4.6 and refer to the Summary of Product Characteristics for ribavirin for additional information.
Maltese: pazjenti maskili meta Viekirax jintuża flimkien ma' ribavirin, ara sezzjoni 4.6 u rreferi għas-Sommarju tal-Karrateristiċi tal-Prodott ta' ribavirin għal informazzjoni addizzjonali.
English: ↑ diltiazem, verapamil
Maltese: Mistenni: ↑ diltiazem, verapamil ↑ paritaprevir
English: The safety summary is based on pooled data from phase 2 and 3 clinical trials in more than 2,600 subjects who received Viekirax and dasabuvir with or without ribavirin.
Maltese: Is-sommarju tas-sigurtà huwa bbażat fuq dejta miġbura minn provi kliniċi ta' fażi 2 u 3 f'aktar minn 2,600 individwu li ngħataw Viekirax u dasabuvir ma' ribavirin jew mingħajru.
English: Effect of dasabuvir on paritaprevir/ritonavir and ombitasvir In the presence of dasabuvir, paritaprevir exposures increased by 50% to 65% while there was no change in ombitasvir exposures.
Maltese: Effett ta' dasabuvir fuq paritaprevir/ritonavir u ombitasvir Fil-preżenza ta' dasabuvir, paritaprevir l-espożizzjonijiet żdiedu bi 50% sa 60% filwaqt ma kienx hemm ebda bidla fl- espożizzjonijiet t' ombitasvir.
English: A 10 kg change in body weight from 76 kg (median weight in the Phase 3 studies) would results in <10% change in ombitasvir exposures, and no change in paritaprevir exposures.
Maltese: Bidla ta' 10 kg fil-piż tal-ġisem minn 76 kg (piż medjan fil-studji Fażi 3) se jiriżulta f' bidla ta' < 10% fl-espożizzjonijiet ta' ombitasvir, u l-ebda bidla fil-espożizzjonijiet ta' paritaprevir.
English: For dosing recommendations with HIV antiviral agents, refer to section 4.4 (Treatment of patients with HIV co-infection) and section 4.5.
Maltese: Għal rakkomandazzjonijiet ta' dożaġġ f'aġenti antivirali tal-HIV, irreferi għal sezzjoni 4.4 (Trattament ta' pazjenti b' ko-infezzjoni ta' HIV) u sezzjoni 4.5.
English: 10 of 34 subjects (29.4%) dose modified ribavirin due to decrease in haemoglobin and 2.9% (1/34) had an interruption of ribavirin.
Maltese: 10 individwi (29.4%) kellhom mill-inqas linja ta' bażi waħda ta' emoglobina ta'inqas minn 10 g / dL. 10 individwi minn 34 (29.4%) kellhom doża ta' ribavirin modifikata minħabba tnaqqqis fl-emoglobina u 2.9% (1/34) kellhom interruzzjoni ta' ribavirin.
English: Mechanism: CYP3A4 inhibition by cobicistat
Maltese: inibizzjoni ta' CYP3A4 minn cobicistat
English: Similar effect expected as observed with Viekirax + dasabuvir.
Maltese: Effett simili hu mistenni kif osservat b'Viekirax + dasabuvir.
English: Dose normalized cyclosporine ratios are shown for interaction with Viekirax with or without dasabuvir.
Maltese: Dożi normalizzati tal-proporzjonijiet ta' cyclosporine huma murija għal interazzjoni ma' Viekirax bi jew mingħajr dasabuvir.
English: In patients with renal or hepatic impairment, use of colchicine with Viekirax with or without dasabuvir is contraindicated (see section 4.3 and 4.5).
Maltese: F'pazjenti b'indeboliment renali jew epatiku l'użu ta' colchicine ma' Viekirax bi jew mingħajr dasabuvir huwa kontraindikat (ara sezzjoni 4.3 u 4.5).
English: Mechanism: CYP3A4 induction enzalutamide or mitotane.
Maltese: induzzjoni induzzjoni ta' CYP3A4 minn enzalutamide jew mitotane.
English: Co-administration with other direct-acting antivirals against HCV
Maltese: Ritonavir mhuwiex attiv kontra HCV.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 12.5 mg of ombitasvir, 75 mg of paritaprevir and 50 mg of ritonavir.
Maltese: Kull pillola miksija b'rita fiha 12.5 mg ta' ombitasvir, 75 mg ta' paritaprevir u 50 mg ta' ritonavir.
English: Co-administration of Viekirax with or without dasabuvir with medicinal products primarily metabolized by CYP3A may result in increased plasma concentrations of these medicinal products.
Maltese: L-għoti flimkien ta' Viekirax bi jew mingħajr dasabuvir ma' prodotti mediċinali primarjament metabolizzat minn CYP3A jista' jirriżulta f'żieda ta' konċentrazzjonijiet fil-plażma ta' dawn il-prodotti mediċinali.
English: 2a
Maltese: Ġenotip 1a
English: SVR12 for genotype 1b-infected peginterferon+ribavirin-experienced subjects in PEARL II
Maltese: SVR12 għal individwi li esperjenzaw kura, infettati bil-ġenotip 1b f'PEARL II
English: Genotype 1a N=67
Maltese: Fergħa B 24 Ġimgħa
English: Outcome for subjects without SVR12 On-treatment VFa
Maltese: Tabella 18 SVR12 għal Individwi
English: (0.81-0.96) (0.88-1.02) monitoring of INR is recommended with all vitamin K antagonists.
Maltese: Il-maġġoranza (86.8%) kellhom livelli ta' HCV RNA tal linja ta' bażi ta' mill-inqas 800,000
English: Use with colchicine
Maltese: Użu ma' colchicine
English: Table 3 lists adverse reactions for which a causal relationship between paritaprevir/ombitasvir/ritonavir, in combination with dasabuvir and/or ribavirin, and the adverse event is at least a reasonable possibility.
Maltese: Tabella 3 telenka r-reazzjonijiet avversi li għalihom, relazzjoni kawżali bejn ombitasvir/paritaprevir/ritonavir, flimkien ma' dasabuvir ma' jew mingħajr ribavirin, u l-avveniment avvers hija tal-anqas possibbiltà raġonevoli.
English: Clinical monitoring and lower doses of imatinib are recommended.
Maltese: Monitoraġġ kliniku u dożi aktar baxxi ta ' imatinib huma rrakkomandati .
English: global multicentre, open-label
Maltese: multiċentriku globali, tikketta miftuħa
English: Mechanism: OATP1B1 inhibition by paritaprevir.
Maltese: OATP1B1/1B3 minn paritaprevir u emoliżi indotta minn ribavirin.
English: PVC/PE/PCTFE aluminium foil blister packs.
Maltese: Pakketti ta' folji tal-aluminju PVC/PE/PCTFE 56 pilloli (kartuna multiplika fiha 4 kartun intern ta' 14 pilloli kull waħda).
English: (≤25% difference in the Least Square Means ratio) for Viekirax with or without dasabuvir, unless otherwise noted.
Maltese: (differenza ta' 25% fil-proporzjon tal-Anqas Mezzi Kwadri) għal Viekirax ma' dasabuvir jew mingħajru,
English: Mechanism: CYP3A4 induction by carbamazepine
Maltese: Induzzjoni ta' CYP3A4 minn carbamazepin e paritaprevir
English: < 90, n (%)
Maltese: N = 509 n (%)
English: Mechanism:
Maltese: Tel:
English: Mechanism: P-gp inhibition by paritaprevir, ritonavir and dasabuvir.
Maltese: inibizzjoni ta' P-gp minn dasabuvir, paritaprevir, ritonavir u dasabuvir
English: In the presence of ombitasvir, paritaprevir exposures were minimally affected (5% to 27% change) while dasabuvir exposures increase by approximately 30%.
Maltese: Effett ta' ombitasvir fuq paritaprevir/ritonavir jew dasabuvir Fil- preżenza ta' ombitasvir, paritaprevir l-espożizzjonijiet kienu affettwati minimament (5% sa 27% bidla) filwaqt l-espożizzjonijiet ta' dasabuvir żdiedu b'madwar 30%.
English: Concomitant use is contraindicated (See section
Maltese: Użu konkomitanti huwa kontraindikat (ara sezzjoni
English: Viekirax without ribavirin and without dasabuvir was also evaluated in genotype 1b infected subjects in Phase 2 studies M13-393 (PEARL-I) and M12-536.
Maltese: M13-393 (PEARL-I) u M12-536.
English: Mechanism: BCRP inhibition by paritaprevir, ritonavir and dasabuvir.
Maltese: inibizzjoni ta'BCRP minn paritaprevir, ritonavir u dasabuvir.
English: Mechanism: CYP3A4 inhibition by ritonavir
Maltese: Inibizzjoni ta' CYP3A4 minn ritonavir
English: CYP3A4 inhibition by ritonavir and increase in paritaprevir exposures may be due to OATP/BCRP/ P-gp inhibition by ciclosporin.
Maltese: Effett fuq ciclosporin li ġejj min inibizzjoni ta' CYP3A4 b' ritonavir u żieda f'espożizzjoni ta' paritaprevir li tista' tkun minħabba inibizzjoni ta' OATP/BCRP/ P-gp b' ciclosporin.
English: 7 of 7 subjects with genotype 1b infection and 51 of 56 subjects with genotype 1a infection achieved SVR12.
Maltese: 7 minn 7 individwi b'infezzjoni tal-ġenotip 1b u 51 minn 56 individwi b'infezzjoni tal-ġenotip 1a kisbu SVR12. 5 minn 6 individwi b'ċirrożi kkumpensata f'kull fergħa kisbu SVR12.
English: The assay had a lower limit of quantification (LLOQ) of 25 IU per mL.
Maltese: L-analiżi kellha limitu aktar baxx ta' kwantifikazzjoni (LLOQ) ta' 25 IU għal kull mL.
English: Paritaprevir, ritonavir and dasabuvir are inhibitors of BCRP in vivo.
Maltese: Prodotti mediċinali li huma trasportati minn BCRP Paritaprevir, ritonavir u dasabuvir huma inibitturi ta' BCRP in vivo.
English: Concomitant use with efavirenz is contraindicated (see section 4.3).
Maltese: lopinavir / ritonavir) huma kontraindikati (ara sezzjoni 4.3).
English: For subjects who received ribavirin, the ribavirin dose was 1000 mg per day for subjects weighing less than 75 kg or 1200 mg per day for subjects weighing greater than or equal to 75 kg.
Maltese: Għal individwi li rċevew ribavirin, id-doża ta' ribavirin kienet 1000 mg kuljum għal individwi li jiżnu anqas minn 75 kg jew 1200 mg kuljum għal individwi li jiżnu
English: 600 mg twice daily
Maltese: 200 mg darbtejn kuljum
English: Elimination
Maltese: Is-sostituzzjonijiet
English: See section 4.2 for dosing recommendations in HCV/HIV-1 co-infected patients.
Maltese: Ara sezzjoni 4.2 għal rakkomandazzjonijiet ta' dożaġġ f'pazjenti b' ko-infezzjoni ta' HCV/HIV.
English: SVR12 rates for recommended treatment regimens by patient population HCV Genotype 1b Viekirax and dasabuvir
Maltese: Jekk l-aġġustamenti fid-doża ta' prodotti mediċinali konkomitanti jsiru minħabba l-kura b'Viekirax jew
English: Use of colchicine is contraindicated with Viekirax with or without dasabuvir in patients with renal or hepatic impairment (see sections 4.3 and 4.4).
Maltese: colchicine hu kontraindikat b'Viekirax bi jew mingħajr dasabuvir f'pazjenti b'indeboliment renali jew epatiku (ara sezzjonijiet 4.3 u 4.4
English: Concomitant use is contraindicated (see section 4.3).
Maltese: Użu konkomitanti huwa kontraindikat (ara sezzjoni 4.3).
English: In Phase 3 clinical trials, 1075 subjects (including 181 with compensated cirrhosis) with genotype 1 HCV infection received the recommended regimen (see section 4.2).
Maltese: Fi provi kliniċi tal-Fażi 3, 1075 individwu (inkluż 181 b'ċirrożi kkumpensata) b'infezzjoni ta' HCV talġenotip 1 irċevew ir-reġim irrakkomandat (ara sezzjoni 4.2).Tabella 15 turi r-rati SVR għal dawn l individwi.
English: • There may also be a risk for birth defects if ribavirin is taken by a male patient, whose female partner becomes pregnant.
Maltese: • Jista' jkun hemm ukoll riskju għal difetti tat-twelid jekk ribavirin huwa meħud minn pazjent, li lpartner femminili tiegħu toħroġ tqila.
English: In genotype 1b, substitutions L28T, L31F/V, as well as Y93H alone or in combination with L28M, R30Q, L31F/M/V or P58S in HCV NS5A reduced susceptibility to ombitasvir.
Maltese: L28M, R30Q, L31F/M/V jew P58S f'HCV NS5A naqqsu s-suxxettibbiltà għal ombitasvir.