FrancophonIA/ELRC3.0 huggingface dataset:
English: - The CHMP considered the referral made under Article 31 of Directive 2001/83/EC, as amended, for medicinal products containing bromocriptine, cabergoline dihydroergocryptine, lisuride and pergolide,
Maltese: - Is-CHMP ikkunsidra r-referenza magħmula skond l-Artikolu 31 tad-Direttiva 2001/83/KE, kif emendat, għall-prodotti mediċinali li fihom bromocriptine, cabergoline dihydroergocryptine, lisuride u pergolide,
English: Neuropharmacol, 2006).
Maltese: Peralta et al., Movement Disorders 2006).
English: - Inclusion of cardiac valvulopathy (including regurgitation) and related disorders (pericarditis and pericardial effusion) as “very common” undesirable effects.
Maltese: - Inklużjoni ta' valvulopatija kardijaka (inkluża r-regurġitazzjoni) u disturbi relatati (perikardite u effużjoni perikardjali) bħala effetti mhux mixtieqa “komuni ħafna”.
English: The degree of 5-HT2B receptor agonism varies across ergot derived dopamine agonists and fits well with the difference in incidence rates of fibrotic events for the different ergot-products (C.Hofmann et al., Clin
Maltese: Ilgrad ta' agoniżmu ta' riċetturi 5-HT2B ivarja mal-medda ta' agonisti derivati minn ergot u jidħol sewwa mad-differenza fir-rati ta' inċidenza ta' episodji fibrotiċi għall-prodotti ergot differenti (C.Hofmann et al., Clin Neuropharmacol, 2006).
English: The Schade study reported higher adjusted incidence rate ratio (IRR) for symptomatic valvular regurgitation for cabergoline, and pergolide (in particular at doses > 3mg/day), compared to bromocriptine, lisuride, and non ergot derived dopamine agonists pramipexole and ropirinole for which no cases were reported.
Maltese: L-istudju Schade irrapporta proporzjon ta' rata ta' inċidenza (IRR) aġġustata ogħla għal regurġitazzjoni valvulari sintomatika għal cabergoline, u pergolide (b'mod partikolari f'dożi > 3mg/kuljum), meta mqabbla ma' bromocriptine, lisuride, u agonisti ta' dopamine mhux derivati minn ergot pramipexole u ropirinole għal liema l-ebda każ ma kien irrapportat.
English: Four main observational studies looked into the risk of cardiac valvulopathy in patients treated with dopamine agonists for Parkinson's disease (Zanettini et al., NEJM, 2007; Schade et al., NEJM 2007; Yamamoto et al., Neurology 2006; Peralta et al., Movement Disorders 2006).
Maltese: Schade et al., NEJM 2007; Yamamoto et al., Neurology 2006;
English: The CHMP reviewed all of the information made available by marketing authorisation holders (MAH) on the risk of fibrosis and cardiac valvulopathy from clinical trials, observational studies and spontaneous reports.
Maltese: Is-CHMP irreveda l-informazzjoni kollha magħmula disponibbli mid-detenturi ta' l-awtorizzazzjoni għat-tqegħid fis-suq (MAH) dwar ir-riskju ta' fibrożi u valvulopatija kardijaka minn provi kliniċi, studji osservattivi u rapporti spontanji.
English: Data from spontaneous reports indicate that subjects using carbergoline and pergolide are more at risk for fibrotic events and valvulopathy than subjects using bromocriptine, lisuride or dihydroergocryptine.
Maltese: Dejta minn rapporti spontanji indikaw li suġġetti li jużaw carbergoline u pergolide huma iktar f'riskju ta' episodji fibrotiċi u valvulopatija milli suġġetti li qegħdin jużaw bromocriptine, lisuride jew dihydroergocryptine.
English: Cases of fibrotic reactions and valvulopathy have been reported with cabergoline and pergolide during clinical trials (open label study and randomised controlled studies).
Maltese: Każijiet ta' reazzjonijiet fibrotiċi u valvulopatija ġew irrapportati b'cabergoline u pergolide waqt provi kliniċi (studji b'tikketta miftuħa u studji kkontrollati randomizzati).
English: At its June 2008 meeting, the CHMP concluded that the amount of evidence on the risk of fibrotic events, including valvulopathy, is not equal for all ergot-derived dopamine agonists.
Maltese: Fil-laqgħa tiegħu ta' Ġunju 2008, is-CHMP ikkonkluda li l-ammont ta' evidenza dwar ir-riskju ta' episodji fibrotiċi, inklużi valvulopatija, mhuwiex indaqs għall-agonisti kollha ta' dopamine derivati minn ergot.
English: No cases were reported for bromocriptine, dihydroergocryptine and lisuride by MAHs.
Maltese: L-ebda każ ma ġie rrapportat għal bromocriptine, dihydroergocryptine u lisuride millMAHs.
English: Cabergoline and pergolide belong to the class of ergot derived dopamine agonists, which also comprises bromocriptine, dihydroergocryptine and lisuride.
Maltese: Cabergoline u pergolide jappartjenu għall-klassi ta' agonisti ta' dopamine derivati minn ergot, li tinkludi wkoll bromocriptine, dihydroergocryptine u lisuride.
English: On 21 June 2007, the UK asked the CHMP, under article 31 of Directive 2001/83/EC, as amended, to review the risk of fibrosis and cardiac valvulopathy associated with the use of all ergot-derived dopamine agonists, and to provide an opinion on whether the marketing authorisations for all products of the class should be maintained, varied, suspended or withdrawn.
Maltese: Fil-21 ta' Ġunju 2007, ir-Renju Unit staqsa lis-CHMP, skond l-Artikolu 31 tad-Direttiva 2001/83/KE, kif emendata, biex jirrevedi r-riskju ta' fibrożi u valvulopatija kardijaka assoċjati ma' l-użu ta' agonisti ta' dopamine derivati minn ergot, u biex jipprovdi opinjoni dwar jekk l-awtorizzazzjonijiet għat-tqegħid fis-suq għall-prodotti kollha tal-klassi għandhomx jinżammu, jiġu varjati, sospiżi jew irtirati.
English: In view of the differences in the level risk amongst ergot derived dopamine agonists, the CHMP recommended that a separate opinion is issued for bromocriptine, dihydroergocryptine and lisuride.
Maltese: Minħabba d-differenzi fil-livell ta' riskju fost agonisti ta' dopamine derivati minn ergot, is-CHMP irrakkomanda li tinħareġ opinjoni separata għal bromocriptine, dihydroergocryptine u lisuride.
English: Ergot-derived dopamine agonists have been associated with an increased risk of fibrotic disorders and valvular heart disease.
Maltese: Agonisti ta' dopamine derivati minn ergot ġew assoċjati ma' żieda fir-riskju ta' disturbi fibrotiċi u mard valvulari tal-qalb.
English: For pergolide and cabergoline, the majority (about two thirds) of case reports of valvulopathy occurred with doses ≥ 3mg / day.
Maltese: Għal pergolide u cabergoline, il-maġġoranza (madwar żewġ terzi) tarrapporti ta' każijiet ta' valvulopatija seħħew b'dożi ≥ 3mg / kuljum.
English: For carbergoline and pergolide an increased risk of fibrotic events is considered well established.
Maltese: Għal carbergoline u pergolide żieda fir-riskju ta' episodji fibrotiċi hija kkunsidrata stabbilita sewwa.
English: ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARIES OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLETS PRESENTED BY THE EMEA
Maltese: ANNESS II KONKLUŻJONIJIET XJENTIFIĊI
English: The stimulation of the 5-HT2B receptor agonists is considered the most plausible mechanism that induces cardiac valvulopathy, although other mechanisms may be involved.
Maltese: L-istimulazzjoni ta' agonisti ta' riċetturi 5-HT2B hija kkunsidrata l-iktar mekkaniżmu plawżibbli li jinduċi valvulopatija kardijaka, għalkemm mekkaniżmi oħrajn jistgħu jkunu involuti.
English: For bromocriptine, dihydroergocryptine and lisuride an increased risk cannot be excluded based on the amount of evidence available.
Maltese: Għal bromocriptine, dihydroergocryptine u lisuride żieda fir-riskju ma tistax tiġi eskluża abbażi ta' l-ammont ta' evidenza disponibbli.
English: 8017 JV Zwolle NETHERLANDS
Maltese: 8017 JV Zwolle L-OLANDA
English: Contains lactose monohydrate.
Maltese: Fih lactose monohydrate.
English: 35 µg/250 µg once daily
Maltese: 35 µg/250 µg darba kuljum
English: ETHINYL-OESTRADIOL-CONTAINING PRODUCTS Ethinyloestradiol (EE)/Norgestimate
Maltese: PRODOTTI LI FIHOM ETHINYL-OESTRADIOL Ethinyloestradiol (EE)/Norgestimate
English: Table 4: Adverse reactions identified with Maviret Frequency
Maltese: Tabella 4: Reazzjonijiet avversi identifikati b'Maviret Frekwenza
English: HMG-COA REDUCTASE INHIBITORS Atorvastatin
Maltese: INIBITURI TA' HMG-COA REDUCTASE Atorvastatin
English: 6a NA = not available
Maltese: 6a NA = mhux disponibbli
English: EE/Levonorgestrel 20 µg/100 µg once daily
Maltese: EE/Levonorgestrel 20 µg/100 µg darba kuljum
English: norelgestromin ↑ norgestrel
Maltese: orelgestromin ↑ norgestrel
English: SURVEYOR-2d
Maltese: SURVEYOR-2
English: SOF+DCV 12 weeks N=115
Maltese: SOF+DCV 12-il ġimgħa N=115
English: (Inhibition of UGT1A1)
Maltese: (Inibizzjoni ta' UGT1A1)
English: Median EC50, nM (range)
Maltese: EC50 medjan, nM (medda)
English: Efavirenz/emtricitab ine/tenofovir disoproxil fumarate 600/200/300 mg once daily
Maltese: Efavirenz/emtricitab ine/tenofovir disoproxil fumarate 600/200/300 mg darba kuljum
English: Adults and adolescents aged 12 to <18 years
Maltese: Adulti u adolexxenti minn età ta' 12 sa <18-il sena
English: NA = not available
Maltese: NA = mhux disponibbli
English: HIV-ANTIVIRAL AGENTS Atazanavir + ritonavir
Maltese: GĦALL-HIV Atazanavir + ritonavir
English: P-gp, BCRP, and OATP1B1/3
Maltese: P-gp, BCRP, u OATP1B1/3
English: − Tablet film-coating: hypromellose (E464), lactose monohydrate, titanium dioxide, macrogol 3350, iron oxide red (E172).
Maltese: Kisja tal-pillola: hypromellose (E464), lactose monohydrate, titanium dioxide, macrogol 3350, iron oxide red (E172).
English: The overall prevalence of A30K and Y93H at baseline was 6.5% and 4.9%, respectively.
Maltese: Il-prevalenza globali ta' A30K u Y93H fil-linja bażi kienet ta' 6.5% u 4.9%, rispettivament.
English: Expected: ↑ fluvastatin and ↑ pitavastatin
Maltese: Mistenni: ↑ fluvastatin u ↑ pitavastatin
English: Maviret 8 weeks N=157
Maltese: Maviret 8 ġimgħat N=157
English: AbbVie Tél: +33 (0)1 45 60 13 00
Maltese: Tél: +33 (0)1 45 60 13 00
English: Significant inhibition of CYP1A2, CYP2C9, CYP2C19, CYP2D6, UGT1A6, UGT1A9, UGT1A4, UGT2B7, OCT1, OCT2, OAT1, OAT3, MATE1 or MATE2K are not expected.
Maltese: Mhijiex mistennija inibizzjoni sinifikanti ta' CYP1A2, CYP2C9, CYP2C19, CYP2D6, UGT1A6, UGT1A9, UGT1A4, UGT2B7, OCT1, OCT2, OAT1, OAT3, MATE1 jew MATE2K.
English: Each film-coated tablet contains 7.48 mg lactose (as lactose monohydrate).
Maltese: Kull pillola miksija b'rita fiha 7.48 mg lactose (bħala lactose monohydrate).
English: 67061 Ludwigshafen Germany
Maltese: 67061 Ludwigshafen
English: − Tablet core: copovidone (Type K 28), vitamin E polyethylene glycol succinate, silica, anhydrous colloidal, propylene glycol monocaprylate (type II), croscarmellose sodium, sodium stearyl fumarate.
Maltese: Qalba tal-pillola: copovidone (Type K 28), vitamin E polyethylene glycol succinate, silica, anhydrous colloidal, propylene glycol monocaprylate (type II), croscarmellose sodium, sodium stearyl fumarate.
English: • atazanavir (for HIV infection)
Maltese: • atazanavir (għal infezzjoni tal-HIV)
English: MAGELLAN-1e
Maltese: MAGELLAN-1
English: Follow the dosing recommendations in Tables 1 and 2.
Maltese: Segwi r-rakkomandazzjonijiet dwar id-dożaġġ f'Tabelli 1 u 2.
English: No clinically significant interactions are expected with tenofovir disoproxil fumarate.
Maltese: Mhumiex mistennija interazzjonijiet klinikament sinifikanti ma' tenofovir disoproxil fumarate.
English: PVC/PE/PCTFE aluminium foil blister packs.
Maltese: Pakketti ta' folji tal-PVC/PE/PCTFE fojl tal-aluminju.
English: Table 3: Interactions between Maviret and other medicinal products
Maltese: Tabella 3: Interazzjonijiet bejn Maviret u prodotti mediċinali oħra
English: • carbamazepine, phenobarbital, phenytoin, primidone (normally used for epilepsy)
Maltese: • carbamazepine, phenobarbital, phenytoin, primidone (ġeneralment użati għallepilessija)
English: 47 subjects were enrolled in DORA (Part 1).
Maltese: Ġew irreġistrati 47 individwu f'DORA (Parti 1).
English: GT 1, 2, 4, 5, 6 8 weeks
Maltese: GT 1, 2, 4, 5, 6
English: Immunosuppressants allowed for co-administration were ciclosporin ≤100 mg/day, tacrolimus, sirolimus, everolimus, azathioprine, mycophenolic acid, prednisone, and prednisolone.
Maltese: L-immunosoppressanti permessi għall-għoti fl-istess ħin kienu ciclosporin ≤100 mg / jum, tacrolimus, sirolimus, everolimus, azathioprine, mycophenolic acid, prednisone, u prednisolone.
English: Pibrentasvir AUC was similar in Child-Pugh A subjects, 26% higher in Child-Pugh B subjects, and 114% higher in Child-Pugh C subjects.
Maltese: L-AUC ta' pibrentasvir kienet simili f'individwi Child-Pugh A, 26% ogħla f'individwi Child-Pugh B, u 114% ogħla f'individwi ChildPugh C.
English: AbbVie GmbH Tel: +43 1 20589-0
Maltese: Österreich AbbVie GmbH Tel: +43 1 20589-0
English: • dabigatran etexilate (to prevent blood clots)
Maltese: • dabigatran etexilate (għall-prevenzjoni tal-emboli)
English: Glecaprevir and pibrentasvir are weak inhibitors of cytochrome P450 (CYP) 3A and uridine glucuronosyltransferase (UGT) 1A1 in vivo.
Maltese: Glecaprevir u pibrentasvir huma inibituri dgħajfa taċ-ċitokromu P450 (CYP) 3A u tal-uridine glucuronosyltransferase (UGT) 1A1 in vivo.
English: The overall SVR12 rate was 100% (47/47).
Maltese: Ir-rata SVR12 globali kienet 100 % (47/47).
English: Tmax (h)a
Maltese: Assorbiment Tmax (h)
English: Substrate of transporter
Maltese: Trasport Substrat tat-trasportatur
English: Additional drug-drug interaction studies were performed with the following medical products and showed no clinically significant interactions with Maviret: abacavir, amlodipine, buprenorphine, caffeine, dextromethorphan, dolutegravir, emtricitabine, felodipine, lamivudine, lamotrigine, methadone, midazolam, naloxone, norethindrone or other progestin-only contraceptives, rilpivirine, tenofovir alafenamide and tolbutamide.
Maltese: Twettqu studji addizzjonali tal-interazzjoni bejn il-mediċini bil-prodotti mediċinali li ġejjin u ma wrew l-ebda interazzjoni klinikament sinifikanti ma' Maviret: abacavir, amlodipine, buprenorphine, kafeina, dextromethorphan, dolutegravir, emtricitabine, felodipine, lamivudine, lamotrigine, methadone, midazolam, naloxone, norethindrone jew kontraċettivi oħra ta' progestin biss, rilpivirine, tenofovir alafenamide u tolbutamide.
English: 0.5 mg single dose
Maltese: 0.5 mg
English: Maviret 12 weeks N=233
Maltese: Maviret 12-il ġimgħa N=233
English: 15 IU/mL (except for SURVEYOR-1 and SURVEYOR-2 which used the Roche COBAS TaqMan real-time reverse transcriptase-PCR (RT-PCR) assay v. 2.0 with an LLOQ of 25 IU/mL).
Maltese: IU/mL (ħlief għal SURVEYOR-1 u SURVEYOR-2 li uża r-Roche COBAS TaqMan real-time reverse transcriptase-PCR (RT-PCR) assay v.
English: MAGELLAN-2 Maviret for 12 weeks (n=100) Adolescent subjects (12 to <18 years) GT1-6
Maltese: MAGELLAN-2 Maviret għal 12-il ġimgħa (n=100) Individwi adolexxenti (12 sa <18-il sena) GT1-6
English: Medicinal products that inhibit OATP1B1/3 (e.g. elvitegravir, ciclosporin, darunavir, lopinavir) increase systemic concentrations of glecaprevir.
Maltese: Prodotti mediċinali li jinibixxu OATP1B1/3 (eż. elvitegravir, ciclosporin, darunavir, lopinavir) iżidu l-konċentrazzjonijiet sistemiċi ta' glecaprevir.
English: Rosuvastatin 5 mg once daily
Maltese: Rosuvastatin 5 mg darba kuljum
English: The overall SVR12 rates were 97.2% (352/362) and 99.4% (159/160) in VOYAGE-1 and VOYAGE-2, respectively.
Maltese: B'mod ġenerali r-rati ta' SVR12 kienu 97.2% (352/362) u 99.4% (159/160) f'VOYAGE-1 u VOYAGE-2, rispettivament.
English: VITAMIN K ANTAGONISTS Vitamin K antagonists
Maltese: K Antagonisti talvitamina K
English: The overall safety profile in HCV/HIV-1 co-infected subjects (ENDURANCE-1 and EXPEDITION2) was comparable to that observed in HCV mono-infected subjects.
Maltese: Il-profil ta' sigurtà globali f'individwi koinfettati b'HCV / HIV-1 (ENDURANCE-1 u EXPEDITION2) kien komparabbli ma' dak osservat f'individwi mono-infettati b'HCV.
English: Glecaprevir is also a substrate of the hepatic uptake transporters OATP1B1/3.
Maltese: Glecaprevir huwa substrat ukoll tat-trasportaturi tal-uptake epatiku OATP1B1/3.
English: Patients with severe hepatic impairment (Child-Pugh C) (see sections 4.2, 4.4, and 5.2).
Maltese: Pazjenti b'indeboliment sever tal-fwied (Child-Pugh C) (ara sezzjonijiet 4.2, 4.4, u 5.2).
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), very rare (< 1/10,000) or not known (cannot be estimated from the available data).
Maltese: Ilfrekwenzi huma definiti kif ġej: 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) ) jew mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: Some combinations of substitutions in genotypes 1a and 3a (including A30K+Y93H in genotype 3a) showed reductions in susceptibility to pibrentasvir.
Maltese: Xi kombinazzjonijiet ta' sostituzzjonijiet fil-ġenotipi 1a u 3a (inkluża A30K+Y93H filġenotip 3a) urew tnaqqis fis-suxxettibilità għal pibrentasvir.
English: • rifampicin (for infections)
Maltese: • rifampicin (għall-infezzjonijiet)
English: ANTICOAGULANTS Dabigatran etexilate 150 mg single dose
Maltese: Dabigatran etexilate doża waħda ta' 150 mg
English: The overall SVR12 rate was 97.6% (82/84).
Maltese: Ir-rata globali ta' SVR12 kienet ta' 97.6% (82/84).
English: Glecaprevir is a pan-genotypic inhibitor of the HCV NS3/4A protease, which is necessary for the proteolytic cleavage of the HCV encoded polyprotein (into mature forms of the NS3, NS4A, NS4B, NS5A, and NS5B proteins) and is essential for viral replication.
Maltese: Glecaprevir huwa inibitur pan-ġenotipiku tal-protease HCV NS3/4A, li huwa meħtieġ għall-qsim proteolitiku tal-poliproteina kodifikata tal-HCV (f'forom maturi tal-proteini NS3, NS4A, NS4B, NS5A, u NS5B) u huwa essenzjali għar-replikazzjoni virali.
English: Glecaprevir and pibrentasvir are substrates of the efflux transporters P-gp and/or BCRP.
Maltese: Glecaprevir u pibrentasvir huma substrati tat-trasportaturi tal-effluss P-gp u/jew BCRP.
English: The SVR12 rate was 95.7% (22/23) for GT5-infected subjects and 98.4% (60/61) for GT6-infected subjects.
Maltese: Ir-rata ta' SVR12 kienet ta' 95.7% (22/23) għal individwi infettati b'GT5 u 98.4% (60/61) għal individwi infettati b'GT6.
English: Baseline polymorphisms in NS3 were detected in 1.1% (9/845), 0.8% (3/398), 1.6% (10/613), 1.2% (2/164), 41.9% (13/31), and 2.9% (1/34) of subjects with HCV genotype 1, 2, 3, 4, 5, and 6 infection, respectively.
Maltese: Instabu polimorfiżmi tal-linja bażi f'NS3 f'1.1% (9/845), 0.8% (3/398), 1.6% (10/613), 1.2% (2/164), 41.9% (13/31), u 2.9% (1/34) talindividwi b'infezzjoni tal-ġenotip 1, 2, 3, 4, 5, u 6 tal-HCV, rispettivament.
English: Pack containing 84 (4 x 21) film-coated tablets.
Maltese: Pakkett li fih 84 (4 x 21) pillola miksijin b'rita.
English: All subjects (15/15) with Y93H and 75% (15/20) with A30K in NS5A at baseline achieved SVR12.
Maltese: L-individwi kollha (15/15) b'Y93H u 75% (15/20) b'A30K f'NS5A fil-linja bażi kisbu SVR12.
English: AbbVie AB Tel: +46 (0)8 684 44 600
Maltese: Tel: +46 (0)8 684 44 600
English: Substitutions important for the HCV protease inhibitor class at positions 36, 43, 54, 55, 56, 155, 166, or 170 in NS3 had no impact on glecaprevir activity.
Maltese: Is-sostituzzjonijiet importanti għall-klassi tal-inibitur tal-protease tal-HCV fil-pożizzjonijiet 36, 43, 54, 55, 56, 155, 166, jew 170 f'NS3 ma kellhom ebda impatt fuq l-attività ta' glecaprevir.
English: GT1, 2, 4, 5, 6 EXPEDITION-8 Maviret for 8 weeks (n=280) (TN only) Subjects with CKD stage 3b, 4 and 5 with or without cirrhosis GT1-6
Maltese: GT1, 2, 4, 5, 6 EXPEDITION-8 Maviret għal 8 ġimgħat (n=280) (TN biss) Individwi b'CKD tal-istadju 3b, 4 u 5 bi jew mingħajr ċirrożi GT1-6
English: Baseline polymorphisms in NS5A were detected in 26.8% (225/841), 79.8% (331/415), 22.1% (136/615), 49.7% (80/161), 12.9% (4/31), and 54.1% (20/37) of subjects with HCV genotype 1, 2, 3, 4, 5, and 6 infection, respectively.
Maltese: Instabu polimorfiżmi tallinja bażi f'NS5A f'26.8% (225/841), 79.8% (331/415), 22.1% (136/615), 49.7% (80/161), 12.9% (4/31), u 54.1% (20/37) tal-individwi b'infezzjoni tal-ġenotip 1, 2, 3, 4, 5, u 6 tal-HCV, rispettivament.
English: (Inhibition of OATP1B1/3)
Maltese: (Inibizzjoni ta' OATP1B1/3)
English: The overall SVR12 rate was 97.9% (274/280).
Maltese: Ir-rata totali ta' SVR12 kienet 97.9% (274/280).
English: Of the genotype 3-infected subjects with end stage renal disease enrolled in EXPEDITION-4, 100% (11/11) achieved SVR12.
Maltese: Mill-individwi infettati bil-ġenotip 3 b'mard renali tal-aħħar stadju rreġistrati f'EXPEDITION-4, 100% (11/11) kisbu SVR12.
English: The pharmacokinetic properties of the components of Maviret are provided in Table 11.
Maltese: Il-proprjetajiet farmakokinetiċi tal-komponenti ta' Maviret huma pprovduti f'Tabella 11.
English: (Induction of Pgp/CYP3A)
Maltese: (Induzzjoni talP‑gp/CYP3A)
English: 16 weeks (GT3 TE only) (n=3)
Maltese: 16-il ġimgħa (GT3 TE biss) (n=3)
English: Activity of glecaprevir and pibrentasvir against HCV genotypes 1-6 replicon cell lines
Maltese: Attività ta' glecaprevir u pibrentasvir kontra linji ta' ċelloli replikon tal-ġenotipi 1-6 tal-HCV
English: Luxembourg/Luxemburg
Maltese: Luxembourg/Luxemburg AbbVie SA
English: Raltegravir 400 mg twice daily
Maltese: Raltegravir 400 mg darbtejn kuljum
English: Co-administration with Maviret may increase plasma concentrations of medicinal products that are substrates of P-gp (e.g. dabigatran etexilate, digoxin), BCRP (e.g. rosuvastatin), or OATP1B1/3 (e.g. atorvastatin, lovastatin, pravastatin, rosuvastatin, simvastatin).
Maltese: L-għoti flistess ħin ma' Maviret jista' jżid il-konċentrazzjonijiet fil-plażma ta' prodotti mediċinali li huma substrati tal-P-gp (eż. dabigatran etexilate, digoxin), BCRP (eż. rosuvastatin), jew OATP1B1/3 (eż. atorvastatin, lovastatin, pravastatin, rosuvastatin, simvastatin).
English: VF=virologic failure a. Percent of subjects with prior treatment experience to PRS is 26%, 14%, 24%, 0%, and 13% for genotypes 1, 2, 4, 5, and 6, respectively.
Maltese: Il-perċentwal ta' individwi b'esperjenza ta' kura preċedenti b'PRS huwa 26%, 14%, 24%, 0%, u 13% għallġenotipi 1, 2, 4, 5, u 6, rispettivament.
English: Glecaprevir EC50, nM Pibrentasvir EC50, nM
Maltese: Sottotip tal-HCV EC50 ta' glecaprevir, nM EC50 ta' pibrentasvir, nM 1a
English: Safety in HCV/HIV-1 Co-infected Subjects
Maltese: Sigurtà f'individwi ko-infettati b'HCV/HIV-1
English: Maviret 100 mg/40 mg tablets glecaprevir/pibrentasvir
Maltese: Maviret 100 mg/40 mg pilloli glecaprevir/pibrentasvir
English: A166S or Q168R were present at baseline and post-treatment in 5 subjects.
Maltese: A166S jew Q168R kienu preżenti fil-linja bażi u wara l-kura f'5 individwi.
English: Glecaprevir and pibrentasvir AUC were similar with and without dialysis (≤ 18% difference) in dialysis-dependent non-HCV infected subjects.
Maltese: L-AUC ta' glecaprevir u pibrentasvir kienu simili bi jew mingħajr dijalisi (differenza ta' ≤ 18%) f'individwi mhux infettati bl-HCV dipendenti fuq dijalisi.
English: Genotype 2 Genotype 4 Genotype 5 Genotype 6
Maltese: Ġenotip 4 Ġenotip 5 Ġenotip 6
English: Treatment difference -1.2%; 95% confidence interval (-5.6% to 3.1%) Treatment difference -0.4%; 97.5% confidence interval (-5.4% to 4.6%) Outcome for subjects without SVR12 On-treatment VF Relapsea Otherb a. Relapse is defined as HCV RNA ≥ LLOQ after end-of-treatment response among those who completed treatment.
Maltese: Differenza bejn il-kuri -1.2%; Intervall ta' kunfidenza ta' 95% (-5.6% sa 3.1%) Differenza bejn il-kuri -0.4%; Intervall ta' kunfidenza ta' 97.5% (-5.4% sa 4.6%) Riżultat għal individwi mingħajr SVR12 VF waqt il-kura Rikaduta Oħrajn 1 Rikaduta hija definita bħala HCV RNA ≥ LLOQ wara r-rispons fi tmiem il-kura fost dawk li temmew il-kura.
English: (Inhibition of OATP1B1/3, P-gp, BCRP, CYP3A)
Maltese: (Inibizzjoni ta' OATP1B1/3, P-gp, BCRP, CYP3A)
English: Biliary excretion Biliary excretion t1/2 (h) at steady-state % of dose excreted in urinec % of dose excreted in faecesc
Maltese: Eskrezzjoni biljari Eskrezzjoni biljari t1/2 (h) fiss % tad-doża mneħħija fl-awrina c