FrancophonIA/ELRC3.0 huggingface dataset:
English: The maximum recommended dose in all ages is 7 mg of articaine per kg body weight, up to a maximum total dose of 500 mg in adults and 385 mg in children.
Maltese: Id-doża massima rakkomandata fl-etajiet kollha hija 7 mg ta' artikajna għal kull kg tal-piż tal-ġisem, sa doża totali massima ta' 500 mg fl-adulti u 385 mg fit-tfal.
English: The review of Septanest was initiated on 29 June 2018 at the request of the marketing authorisation holder, Septodont, under Article 30 of Directive 2001/83/EC.
Maltese: Ir-rieżami ta' Septanest inbeda fid-29 ta' Ġunju 2018 fuq talba tad-detentur tal-awtorizzazzjoni għattqegħid fis-suq, Septodont, skont l-Artikolu 30 tad-Direttiva 2001/83/KE.
English: After review of the available data, a number of other contraindications which were only valid in some countries were considered not to be supported by sufficient data or were considered redundant.
Maltese: Wara rieżami tad-data disponibbli, numru ta' kontraindikazzjonijiet oħra li kienu validi biss f'xi pajjiżi tqiesu li ma ġewx appoġġati minn data suffiċjenti, jew tqiesu li huma żejda.
English: On 4 June 2018, Septodont, the company that markets Septanest, referred the matter to EMA in order to harmonise the marketing authorisations for Septanest in the EU.
Maltese: Fl-4 ta' Ġunju 2018, Septodont, il-kumpanija li tqiegħed Septanest fis-suq, irreferiet il-kwistjoni lillEMA sabiex jiġu armonizzati l-awtorizzazzjonijiet għat-tqegħid fis-suq għal Septanest fl-UE.
English: After considering the available data on the use of Septanest, the Agency concluded that the SmPC should be harmonised.
Maltese: Wara li kkunsidrat id-data disponibbli dwar l-użu ta' Septanest, l-Aġenzija kkonkludiet li l-SmPC għandu jiġi armonizzat.
English: Septanest is a local anaesthetic (a medicine for preventing pain and discomfort in a part of the body during medical procedures).
Maltese: Septanest huwa anestetiku lokali (mediċina għall-prevenzjoni tal-uġigħ u l-iskumdità f'parti tal-ġisem matul proċeduri mediċi).
English: Septanest contains the active ingredient articaine together with adrenaline (epinephrine), which helps prolong articaine's effects and restrict it to a particular area of the body.
Maltese: Septanest fih l-ingredjent attiv, l-artikajna flimkien mal-adrenalina (epinefrina), li tgħin biex jiġu estiżi l-effettii tal-artikajna u tirrestrinġih għal żona partikolari tal-ġisem.
English: On 28 March 2019, the European Medicines Agency (EMA) completed a review of Septanest (also known by various other names) and recommended changes to the prescribing information in order to harmonise the way the medicine is used in the EU.
Maltese: Fit-28 ta' Marzu 2019, l-Aġenzija Ewropea għall-Mediċini (EMA) temmet rieżami ta' Septanest (magħruf ukoll b'diversi ismijiet oħra) u rrakkomandat tibdil fl-informazzjoni tal-preskrizzjoni sabiex jiġi armonizzat il-mod kif tintuża l-mediċina fl-UE.
English: Septanest must not be used in patients who are allergic to articaine or similar local anaesthetics (known as amide-type local anaesthetics) or to any other ingredient of the medicine.
Maltese: Septanest ma għandux jintuża f'pazjenti li huma allerġiċi għal artikajna jew għal anestetiċi lokali simili (magħrufa bħala anestetiċi lokali tat-tip ammid) jew għal kwalunkwe ingredjenti ieħor tal-mediċina.
English: Septanest has been authorised in the EU via national procedures.
Maltese: Septanest ġie awtorizzat fl-UE permezz ta' proċeduri nazzjonali.
English: This has led to inconsistency across Member States in the way the medicine is produced and can be used, as seen in the differences in the prescribing information - that is, the summary of product characteristics (SmPC), labelling and package leaflet - in the countries where the medicine is marketed.
Maltese: Dan wassal għal inkonsistenza fl-Istati Membri fil-mod ta' kif tiġi prodotta u kif tista' tintuża l-mediċina, kif jidher fid-differenzi fl-informazzjoni tal-preskrizzjoni - jiġifieri, is-sommarju tal-karatteristiċi tal-prodott (SmPC), it-tikkettar u l-fuljett ta' tagħrif - fil-pajjiżi fejn il-mediċina titqiegħed fis-suq.
English: In addition, parts of Module 3 of the medicine dossier (which describes how the medicine is produced and its quality controlled) have also been harmonised.
Maltese: Barra minn hekk, partijiet mill-Modulu 3 tad-dossier tal-mediċina (li jiddeskrivi kif tiġi prodotta lmediċina u kif tiġi kkontrollata l-kwalità tagħha) ukoll ġew armonizzati.
English: Septanest is now authorised for use as a local anaesthetic in dental procedures in adults, adolescents and children above 4 years of age (or weighing at least 20 kg).
Maltese: Septanest issa huwa awtorizzat għall-użu bħala anestetiku lokali fi proċeduri tas-snien fl-adulti, fladolexxenti u fit-tfal ta' 'l fuq minn 4 snin (jew li jiżnu minn tal-inqas 20 kg).
English: A European Commission decision valid throughout the EU was issued on 27/05/2019.
Maltese: Fis-27/05/2019 inħarġet deċiżjoni tal-Kummissjoni Ewropea valida fl-UE kollha.
English: Where justified by data, some of the previous contraindications have been included in section 4.4 (special warnings and precautions for use).
Maltese: Fejn ġie ġġustifikat middata, xi wħud mill-kontraindikazzjonijiet preċedenti ġew inklużi fis-sezzjoni 4.4 (Twissijiet speċjali u prekawzjonijiet għall-użu).
English: EMA/163092/2010 EMEA/H/C/212
Maltese: EMEA/H/C/212
English: This summary was last updated in 04-2010.
Maltese: Dan is-sommarju kien aġġornat l-aħħar fi: 04-2010.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Regranex to Janssen-Cilag International NV on 29 March 1999.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Regranex lil Janssen-Cilag International NV fid-29 ta' Marzu 1999.
English: Regranex is used on neuropathic ulcers up to 5 cm2 in size.
Maltese: Regranex jintuża f'ulċeri newropatiċi sa 5 cm2 fid-daqs.
English: This document is a summary of the European Public Assessment Report (EPAR) for Regranex.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Regranex.
English: Becaplermin is produced by a method known as ‘recombinant DNA technology': it is made by a yeast that has received a gene (DNA), which makes it able to produce human platelet-derived growth factor-BB. Becaplermin acts in the same way as the naturally produced growth factor by stimulating cell growth and helping the growth of normal tissue for healing.
Maltese: Becaplermin huwa prodott b'metodu magħruf bħala ‘teknoloġija tad-DNA rikombinanti': jiġifieri prodott mill-ħmira li tkun irċeviet ġene (DNA), li jagħmilha kapaċi li tipproduċi l-fattur tat-tkabbir BB derivat mill-plejtlits umani.
English: In the patients who used Regranex, 47% of the ulcers that were less than 5 cm2
Maltese: Fil-pazjenti li ħadu Regranex, 47% tal-ulċeri li kienu ta' daqs inqas minn 5 cm2 tfejqu.
English: Regranex is a gel that contains the active substance becaplermin.
Maltese: Regranex huwa ġell li fih is-sustanza attiva becaplermin.
English: In total, there were 922 ulcers in the studies.
Maltese: In-numru totali ta' ulċeri fl-istudji laħaq 922.
English: This compared to 35% in the patients using the placebo gel and 30% in the patients who were given only standard wound care.
Maltese: Dan ġie mqabbel mal-35% f'pazjenti li jużaw plaċebo u 30% tal-ulċeri ttrattati bil-kuri standard talferiti biss.
English: The active substance in Regranex, becaplermin, is a copy of a human protein called platelet-derived growth factor-BB. Growth factors are proteins that stimulate cells to multiply.
Maltese: Is-sustanza attiva f'Regranex, becaplermin, hija kopja tal-proteina umana li jisimha fattur tat-tkabbir BB derivat mill-plejtlits.
English: What is Regranex?
Maltese: X'inhu Regranex?
English: The most common side effects with Regranex (seen in more than 1 patient in 10) are infected skin ulcers and cellulitis (inflammation of the deep skin tissue).
Maltese: L-effetti komuni l-aktar komuni b'Regranex (li dehru f'iktar minn pazjenti 1 minn 10) huma infezzjoni fil-ġilda u ċellulite (infjammazzjoni tat-tessuti fondi tal-ġilda).
English: Regranex has been studied in one main study and three additional studies involving diabetic adults who had had at least one diabetic ulcer for at least eight weeks.
Maltese: Regranex ġie studjat fi studju ewlieni u fi tliet studji addizzjonali li involvew adulti dijabetiċi li żviluppaw tal-anqas ulċera dijabetika waħda għal tal-anqas tmien ġimgħat.
English: For more information about treatment with Regranex, read the Package Leaflet (also part of the EPAR).
Maltese: Ghal aktar informazzjoni dwar it-trattament b'Regranex, aqra l-Fuljett ta' Taghrif (ara parti mill-EPAR).
English: When the results of all four studies were looked at together, Regranex healed about 10% more ulcers than the placebo gel.
Maltese: Meta r-riżultati tal-erba' studi ġew analizzati f'daqqa, Regranex fejjaq madwar 10% iktar ulċeri mill-ġell bħala plaċebo.
English: Regranex was compared with placebo (a dummy treatment) and with no treatment, but all of the patients received standard wound care.
Maltese: Regranex tqabbel ma' plaċebo (trattament finta) u ma ebda trattament, iżda l-pazjenti kollha ġew ittrattati bil-kuri standard tal-feriti.
English: What benefit has Regranex shown during the studies?
Maltese: Liema benefiċċju wera Regranex waqt l-istudji mwettqa?
English: The full EPAR for Regranex can be found here.
Maltese: Għaliex ġie approvat Regranex?
English: What is the risk associated with Regranex?
Maltese: X'inhu r-riskju assoċjat ma' Regranex?
English: For the full list of side effects reported with Regranex, see the Package Leaflet.
Maltese: Għal-lista sħiħa ta' effetti sekondarji rrappurtati b'Regranex, ara l-Fuljett ta' Tagħrif.
English: Other information about Regranex:
Maltese: Aktar tagħrif dwar Regranex:
English: The main measure of effectiveness was the number of ulcers that had completely healed after 20 weeks.
Maltese: Il-kejl ewlieni tal-effikaċja kien in-numru ta' ulċeri li fejqu kompletament wara 20 ġimgħa.
English: Neuropathic ulcers are caused by a nerve problem, and not by a problem with the blood supply to the area affected.
Maltese: L-ulċeri ta' natura newropatika huma kkawżati minn problema tannervituri u mhux minn problema bil-provvista ta' demm fil-parti milquta.
English: Race/Ethnicity
Maltese: Razza/Etniċità
English: Number of isolates tested: a=5, b=4, c=14, d=10, e=9
Maltese: Numru ta' iżolati ttestjati: a=5, b=4, c=14, d=10, e=9 Reżistenza
English: STIMULANTS
Maltese: STIMULANTI
English: Weight/BMI
Maltese: Piż/BMI
English: ZEPATIER contains lactose monohydrate.
Maltese: ZEPATIER fih lactose monohydrate.
English: Each carton contains a total of 28 tablets.
Maltese: Kull kartuna fiha total ta' 28 pillola.
English: GT = Genotype
Maltese: GT = Ġenotip
English: Aluminium or magnesium hydroxide; calcium carbonate
Maltese: Aluminium jew magnesium hydroxide; calcium carbonate
English: Reference
Maltese: Referenza
English: ZEPATIER elbasvir/grazoprevir elbasvirum/grazoprevirum
Maltese: elbasvir/grazoprevir elbasvirum/grazoprevirum
English: Iron oxide yellow (E172) Iron oxide red (E172) Iron oxide black (E172) Carnauba wax
Maltese: Iron oxide isfar (E172) Iron oxide aħmar (E172) Iron oxide iswed (E172) Carnauba wax
English: Sodium laurilsulfate, vitamin E polyethylene glycol succinate, copovidone, hypromellose, microcrystalline cellulose, mannitol, lactose monohydrate, croscarmellose sodium, sodium chloride, colloidal anhydrous silica, magnesium stearate Film-coating:
Maltese: Sodium laurilsulfate, vitamina E polyethylene glycol succinate, copovidone, hypromellose, microcrystalline cellulose, mannitol, lactose monohydrate, croscarmellose sodium, sodium chloride, colloidal anhydrous silica, magnesium stearate
English: Normalised Ratio (INR) values is recommended.
Maltese: Normalised Ratio).
English: Table 2 provides a listing of assessed or potential medicinal product interactions.
Maltese: Tabella 2 tipprovdi lista ta' interazzjonijiet ivvalutati jew potenzjali ta' prodotti mediċinali.
English: Film-coating Lactose monohydrate Hypromellose Titanium dioxide Triacetin
Maltese: Lactose monohydrate Hypromellose Titanium dioxide Triacetin
English: Overall SVR
Maltese: SVR totali
English: Median EC50 (range) nM
Maltese: Medjan ta' EC50 (firxa) nM
English: D168C/E/G/N/V/Y
Maltese: D168C/E/G/N/V/Y V170I
English: Elbasvir and grazoprevir are extensively bound (> 99.9 % and 98.8 %, respectively) to human plasma proteins.
Maltese: Elbasvir u grazoprevir jintrabtu b'mod estensiv (> 99.9 % u 98.8 %, rispettivament) ma' proteini talplażma tal-bniedem.
English: † (Grade 3) >10.0 × ULN (Grade 4) Total Bilirubin (mg/dL) 2.6-5.0 × ULN (Grade 3) >5.0 × ULN (Grade 4)
Maltese: × ULN (Grad 4) Bilirubin Totali (mg/dL) 2.6-5.0 × ULN (Grad 3) >5.0
English: Interaction studied with elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (fixed-dose combination)
Maltese: L-interazzjoni ġiet studjata b'elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (doża fissa kkombinata)
English: Expected: ↔ Elbasvir ↔ Grazoprevir ↔ Lamivudine ↔ Abacavir ↔ Entecavir
Maltese: ↔ Elbasvir ↔ Grazoprevir ↔ Lamivudine ↔ Abacavir ↔ Entecavir
English: Carbamazepine Phenytoin
Maltese: ANTIKONVULŻIVI Carbamazepine Phenytoin
English: • feeling irritable
Maltese: • tħossok irritabbli
English: The tablet is 21 mm long and 10 mm wide.
Maltese: Il-pillola hija twila 21 mm u wiesa 10 mm.
English: ALT (IU/L) 5.1-10.0 × ULN
Maltese: 5.1-10.0 × ULN†
English: ZEPATIER N = 834 n (%)
Maltese: ZEPATIER* N = 834
English: Lactose monohydrate, hypromellose, titanium dioxide, triacetin, iron oxide yellow (E172), iron oxide red (E172), iron oxide black (E172), carnauba wax
Maltese: Lactose monohydrate, hypromellose, titanium dioxide, triacetin, iron oxide isfar (E172), iron oxide aħmar (E172), iron oxide iswed (E172), xemgħa carnauba
English: ZEPATIER with ribavirin
Maltese: ZEPATIER ma'ribavirin
English: Includes subjects from C-EDGE TN, C-EDGE COINFECTION, C-EDGE TE, C-WORTHY and C-SURFER.
Maltese: ¶Jinkludi individwi minn C-EDGE TN, C-EDGE COINFECTION, C-EDGE TE, C-WORTHY u C-SURFER.
English: Psychiatric disorders: Common insomnia, anxiety, depression
Maltese: Komuni insomnja, ansjetà, depressjoni
English: ZEPATIER contains sodium.
Maltese: ZEPATIER fih sodium.
English: Genotype 4 N = 5 % (n)
Maltese: Ġenotip 4 N = 5 % (n)
English: ZEPATIER contains 3.04 mmol (or 69.85 mg) sodium per dose.
Maltese: ZEPATIER fih 3.04 mmol (jew 69.85 mg) sodium f'kull doża.
English: Population pharmacokinetics estimates of exposure of elbasvir and grazoprevir were comparable between Whites and Black/African Americans.
Maltese: Stimi ta' farmakokinetika ta' popolazzjoni ta' esponiment għal elbasvir u grazoprevir kienu komparabbli bejn Bojod u Suwed/Amerikani Afrikani.
English: NS3 polymorphisms considered were any amino acid substitution at positions 36, 54, 55, 56, 80, 107, 122, 132, 155, 156, 158, 168, 170, and 175.
Maltese: ¶Il-polimorfiżmi ta' NS3 li ġew meqjusa kienu kwalunkwe sostituzzjoni ta' aċidu amminiku fil-pożizzjonijiet 36, 54, 55, 56, 80, 107, 122, 132, 155, 156, 158, 168, 170, u 175.
English: Elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (fixed-dose combination) elvitegravir (150 mg once daily)/cobicistat (150 mg once daily)/ emtricitabine (200 mg once daily)/ tenofovir disoproxil fumarate (300 mg once daily)/elbasvir (50 mg once daily)/ grazoprevir (100 mg once daily)
Maltese: OĦRAJN Elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (doża fissa kkombinata) elvitegravir (150 mg darba kuljum)/cobicistat (150 mg darba kuljum)/ emtricitabine (200 mg darba kuljum)/ tenofovir disoproxil fumarate (300 mg darba kuljum)/elbasvir (50 mg darba kuljum)/ grazoprevir (100 mg darba kuljum)
English: Musculoskeletal and connective tissue disorders: Common arthralgia, myalgia
Maltese: Disturbi muskoluskeletriċi u tat-tessuti konnettivi Komuni artralġja, mijalġja
English: • EBR* + GZR* for 8, 12, or 18 weeks (N=31, 136, and 63, respectively)
Maltese: • EBR* + GZR* għal 8, 12, jew 18-il ġimgħa (N=31, 136, u rispettivament)
English: Genotype 1a N = 37 % (n)
Maltese: Ġenotip 1a N = 37 % (n)
English: ZEPATIER contains lactose and sodium
Maltese: ZEPATIER fih lactose u sodium
English: ZEPATIER + RBV, 16 Weeks
Maltese: ZEPATIER + RBV, 16-il Ġimgħa
English: ZEPATIER is indicated for the treatment of chronic hepatitis C (CHC) in adults (see sections 4.2, 4.4 and 5.1).
Maltese: ZEPATIER huwa indikat għat-trattament ta' epatite Ċ kronika (CHC - chronic hepatitis C) fl-adulti (ara sezzjonijiet 4.2, 4.4 u 5.1).
English: C-WORTHY (open-label)
Maltese: C-WORTHY
English: Includes subjects from C-EDGE TN, C-EDGE COINFECTION, C-EDGE TE and C-SCAPE.
Maltese: ¶Jinkludi individwi minn C-EDGE TN, C-EDGE COINFECTION, C-EDGE TE, u C-SCAPE.
English: HMG-CoA REDUCTASE INHIBITORS
Maltese: INIBITURI TA' HMG-CoA REDUCTASE
English: A156G/V/M
Maltese: A156G/V/M V158A
English: • tacrolimus to prevent organ transplant rejection
Maltese: • tacrolimus biex jevita li trapjant ta' organu jiġi rifjutat
English: HIV ANTIVIRAL AGENTS: NON-NUCLEOSIDE HIV REVERSE TRANSCRIPTASE INHIBITORS
Maltese: INIBITURI MHUX NUCLEOSIDE TA' REVERSE TRANSCRIPTASE TAL-HIV
English: Genotype 1b N = 8 % (n)
Maltese: Ġenotip 1b N = 8 % (n)
English: Mean ratio (90 % confidence interval) for AUC, Cmax, C12 or C24 (likely mechanism of interaction)
Maltese: Medja tal-proporzjon (confidence interval ta' 90 %) tal-AUC, is-Cmax, is-C12 jew is-C24
English: The efficacy of ZEPATIER has not been demonstrated in HCV genotypes 2, 3, 5 and 6.
Maltese: L-effikaċja ta' ZEPATIER ma ntwerietx għall-ġenotipi 2, 3, 5 u 6 ta' HCV.
English: Table 3: Adverse reactions identified with ZEPATIER Frequency
Maltese: Tabella 3: Reazzjonjiet avversi identifikati b'ZEPATIER* Frekwenza
English: Higher rates of late ALT elevations occurred in females (2 % [11/652]), Asians (2 % [4/165]), and subjects aged ≥ 65 years (2 % [3/187]) (see sections 4.8 and 5.2).
Maltese: Rati ogħla ta' żidiet fil-livelli ta' ALT li damu biex ħarġu seħħew fin-nisa (2 % [11/652]), fl-Asjatiċi (2 % [4/165]), u f'individwi b'età ta' ≥ 65 sena (2 % [3/187]) (ara sezzjonijiet 4.8 u 5.2).
English: KINASE INHIBITOR
Maltese: INIBITUR TA' KINASE
English: Each film-coated tablet contains 87.02 mg of lactose (as monohydrate) and 3.04 mmol (or 69.85 mg) of sodium.
Maltese: Kull pillola miksija b'rita fiha 87.02 mg ta' lactose (bħala monohydrate) u 3.04 mmol (jew 69.85 mg) ta' sodium.
English: EBR with GZR
Maltese: • EBR/GZR
English: Based on in vitro data, clinically significant interactions with ZEPATIER as an inhibitor of other CYP enzymes, UGT1A1, esterases (CES1, CES2, and CatA), OAT1, OAT3, and OCT2 are not expected.
Maltese: Abbażi ta' dejta in vitro, mhumiex mistennija interazzjonijiet sinifikanti b'mod kliniku b'ZEPATIER bħala inibitur ta' enzimi oħra ta' CYP, UGT1A1, esterases (CES1, CES2, u CatA), OAT1, OAT3, u OCT2.
English: EBR with GZR + RBV
Maltese: EBR ma' GZR + RBV
English: Co-administration with inhibitors of organic anion transporting polypeptide 1B (OATP1B), such as rifampicin, atazanavir, darunavir, lopinavir, saquinavir, tipranavir, cobicistat or ciclosporin (see sections 4.4 and 4.5).
Maltese: L-għoti flimkien ma' inibituri tal-polypeptide 1B li jittrasporta l-anjoni organiċi (OATP1B - organic anion transporting polypeptide 1B), bħal rifampicin, atazanavir, darunavir, lopinavir, saquinavir, tipranavir, cobicistat jew ciclosporin (ara sezzjonijiet 4.4 u 4.5).
English: Ethinyl oestradiol (EE) / Levonorgestrel (LNG) (0.03 mg EE/
Maltese: Ethinyl oestradiol (EE) / Levonorgestrel (LNG) (doża waħda ta' 0.03 mg EE/ 0.15 mg LNG)/ elbasvir (50 mg darba kuljum)
English: OPIOID-SUBSTITUTION THERAPY
Maltese: TERAPIJA TA' SOSTITUZZJONI TAL-OPJOJDI
English: Elbasvir and grazoprevir are substrates of CYP3A and P-gp.
Maltese: Elbasvir u grazoprevir huma sustrati ta' CYP3A u P-gp.
English: • warfarin and other similar medicines called vitamin K antagonists used to thin the blood.
Maltese: • warfarin u mediċini oħra simili msejħa antagonisiti tal-vitamina K użati biex iraqqu d-demm.
English: R155I/K
Maltese: R155I/K A156T
English: Co-administration with inducers of cytochrome P450 3A (CYP3A) or P-glycoprotein (P-gp), such as efavirenz, phenytoin, carbamazepine, bosentan, etravirine, modafinil or St. John's wort (Hypericum perforatum) (see sections 4.4 and 4.5).
Maltese: L-għoti flimkien ma' indutturi taċ-ċitokrom P450 3A (CYP3A) jew tal-glikoproteina P (P-gp - Pglycoprotein), bħal efavirenz, phenytoin, carbamazepine, bosentan, etravirine, modafinil jew St.
English: • you are taking any of the following medicines: o rifampicin, usually given for tuberculosis o HIV protease inhibitors such as atazanavir, darunavir, lopinavir, saquinavir, or tipranavir o efavirenz or etravirine for HIV o elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate or elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide for HIV o ciclosporin to stop organ transplant rejection or to treat serious inflammatory illnesses of eyes, kidney, joints or skin o bosentan for pulmonary arterial hypertension o carbamazepine or phenytoin, mainly used for epilepsy and seizures o modafinil to help people who cannot stay awake o St. John's wort (Hypericum perforatum, a herbal medicine) for depression or other problems
Maltese: • inti qed tieħu xi waħda minn dawn il-mediċini li ġejjin: o rifampicin, li s-soltu jingħata għat-tuberkulożi o inibituri ta' HIV protease bħal atazanavir, darunavir, lopinavir saquinavir, jew tipranavir o efavirenz jew etravirine għall-HIV o elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate jew elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide għall-HIV o ciclosporin biex iwaqqaf trapjant ta' organu milli jiġi rifjutat mill-ġisem jew biex jitratta mard infjammatorju serju fl-għajnejn, fil-kliewi, fil-ġogi jew fil-ġilda o bosentan għall-pressjoni għolja fl-arterji tal-pulmun o carbamazepine jew phenytoin, li jintużaw l-aktar għall-epilessija u aċċessjonijiet o modafinil biex jgħin lil persuni li ma jistgħux jibqgħu imqajmin o St.
English: In pooled analyses of subjects who achieved SVR12 or met criteria for virologic failure, the prevalence and impact of NS5A polymorphisms (including M28T/A, Q30E/H/R/G/K/D, L31M/V/F, H58D, and Y93C/H/N) and NS3 polymorphisms (substitutions at positions 36, 54, 55, 56, 80, 107, 122, 132, 155, 156, 158, 168, 170, and 175) that confer greater than 5-fold reduction of elbasvir and grazoprevir antiviral activity respectively in vitro were evaluated.
Maltese: F'analiżi kollettiva ta' individwi li kisbu SVR12 jew issodisfaw kriterji għal falliment viroloġiku, ġew stmati l-prevalenza u l-impatt ta' polimorfiżmi ta' NS5A (inkluż M28T/A, Q30E/H/R/G/K/D, L31M/V/F, H58D, u Y93C/H/N) u polimorfiżmi ta' NS3 (sostituzzjonijiet fil-pożizzjonijiet 36, 54, 55, 56, 80, 107, 122, 132, 155, 156, 158, 168, 170, u 175) li jagħtu tnaqqis ta' aktar minn 5 darbiet flattività antivirali in vitro ta' elbasvir u grazoprevir rispettivament.
English: ↑ Lovastatin (CYP3A inhibition)
Maltese: ↑ Lovastatin (inibizzjoni ta' CYP3A)
English: In non-HCV-infected subjects with moderate hepatic impairment (Child-Pugh B [CP-B], score of 7-9), and severe hepatic impairment (Child-Pugh C [CP-C], score of 10-15) elbasvir AUC decreased by 28 % and 12%, respectively, while the grazoprevir steady-state AUC0-24 was increased 5-fold and 12-fold respectively, compared to matched healthy subjects (see sections 4.2 and 4.3).
Maltese: F'individwi mhux infettati b'HCV b'indeboliment moderat tal-fwied (Child-Pugh B [CP-B], punteġġ ta' 7-9) u b'indeboliment sever tal-fwied (Child-Pugh C [CP-C], punteġġ ta' 10-15) l-AUC ta' elbasvir naqset bi 28 % u 12 %, rispettivament, filwaqt li l-AUC0-24 ta' grazoprevir fi stat fiss żdiedet b'5 darbiet u 12-il darba rispettivament, meta mqabbla ma' individwi f'saħħithom b'karatteristiċi jaqblu (ara sezzjonijiet 4.2 u 4.3).
English: NS3 Any of the following NS3 substitutions: V36L/M, Y56F/H, V107I, R155I/K, A156G/M/T/V, V158A, D168A/C/E/G/N/V/Y, V170I
Maltese: V36L/M, Y56F/H, V107I, R155I/K, A156G/M/T/V, V158A, D168A/C/E/G/N/V/Y, V170I