FrancophonIA/ELRC3.0 huggingface dataset:
English: Two studies (LONG TERM and HIGH FH), involving a total of 2416 patients, were performed with a 150 mg every 2 weeks (Q2W) dose only.
Maltese: Żewġ studji (LONG TERM u HIGH FH), li kienu jinvolvu total ta' 2,416-il pazjent, saru biss bid-doża ta' 150 mg kull ġimagħtejn (Q2W).
English: Sometimes serious allergic reactions such as hypersensitivity (difficulties breathing), nummular eczema (reddish skin spots sometimes with blisters), and hypersensitivity vasculitis (which is a specific form of a hypersensitivity reaction with symptoms such as diarrhoea, with a rash, or purple-coloured skin spots on the skin) have occurred in clinical studies.
Maltese: Xi drabi reazzjonijiet allerġiċi serji bħal sensittività eċċessiva (problemi bit-teħid tan-nifs), ekżema b'forma tixbah munita (tbajja ħamranin fil-ġilda xi drabi bl-infafet), u vaskulite minn sensittività eċċessiva (li hija forma speċifika ta' reazzjoni ta' sensittività eċċessiva b'sintomi bħal dijarea, b'raxx, jew tbajja' ta' lewn vjola filġilda) seħħew fi studji kliniċi.
English: Patients had experienced an acute coronary syndrome (ACS) event 4 to 52 weeks prior to randomization and were treated with a lipid-modifying-therapy (LMT) regimen that was statin-intensive (defined as atorvastatin 40 or 80 mg, or rosuvastatin 20 or 40 mg) or at maximally tolerated dose of those statins, with or without other LMT.
Maltese: Il-pazjenti kellhom avveniment ta' sindrome koronarja akuta (ACS-acute coronary syndrome) 4 sa 52 ġimgħa qabel ma ġew magħżula b'mod arbitrarju u ġew ittrattati b'skeda ta' terapija li timmodifika l-lipidi (LMT-lipid modifying therapy) li kienet intensiva bl-użu ta' statins (definita bħala atorvastatin 40 jew 80 mg, jew rosuvastatin 20 jew 40 mg) jew bl-ogħla doża ttollerata ta' dawn l-istatins flimkien jew mingħajr LMT ieħor.
English: General allergic reactions were reported more frequently in the alirocumab group (8.1% of patients) than in the control group (7.0% of patients), mainly due to a difference in the incidence of pruritus.
Maltese: Reazzjonijiet allerġiċi ġenerali ġew irrappurtati b'mod aktar frekwenti fil-grupp ta' alirocumab (8.1% talpazjenti) milli fil-grupp ta' kontroll (7.0% tal-pazjenti), l-aktar minħabba differenza fl-inċidenza ta' prurite.
English: A concentration-dependent reduction in free PCSK9 and LDL-C is observed until target saturation is achieved.
Maltese: Jiġi osservat tnaqqis li jiddependi mill-konċentrazzjoni ta' PCSK9 ħieles u LDL-C sakemm tinkiseb is-saturazzjoni tal-mira.
English: Press the yellow safety cover on your skin at roughly a 90° angle.
Maltese: Agħfas l-għatu ta' sigurtà isfar mal-ġilda f'angolu ta' bejn wieħed u ieħor 90°.
English: Praluent helps lower your levels of “bad” cholesterol (also called “LDL cholesterol”).
Maltese: Praluent jgħin biex ibaxxi l-livelli ta' kolesterol “ħażin” tiegħek (imsejjaħ ukoll “kolesterol LDL”).
English: EU/1/15/1031/001 1 pre-filled pen EU/1/15/1031/002 2 pre-filled pens EU/1/15/1031/003 6 pre-filled pens
Maltese: EU/1/15/1031/001 EU/1/15/1031/002 EU/1/15/1031/003 EU/1/15/1031/004
English: At week 12 (before up-titration), 77.2% of patients reached an LDL-C of ˂70 mg/dL (˂1.81 mmol/L) as compared to 46.2% in the ezetimibe group.
Maltese: LDL-C ta' ˂70 mg/dL (≥1.81 mmol/L) meta mqabbla ma' 46.2% fil-grupp ta' ezetimibe.
English: Ezetimibe-controlled phase 3 study (on background statin) in patients with primary hypercholesterolaemia or mixed dyslipidaemia
Maltese: Studju ta' fażi 3 kkontrollat b'ezetimibe (fuq statin fl-isfond) f'pazjenti b'iperkolesterolemija primarja jew dislipidemija mħallta)
English: Cu mu lati ve inci den ce of eve nt
Maltese: MOD TA' KIF U MNEJN JINGĦATA
English: In the 2 studies in which patients were started and maintained on 150 mg every 2 weeks, the achieved mean reduction of LDL-C at week 12 was 62.6%.
Maltese: Fiż-2 studji li fihom il-pazjenti nbdew u komplew bid-doża ta' 150 mg kull ġimagħtejn, il-medja tat-tnaqqis fl-LDL-C li nkisbet f'ġimgħa 12 kienet 62.6%.
English: A slightly greater than dose proportional increase was observed, with a 2.1- to 2.7-fold increase in total alirocumab concentrations for a 2-fold increase in dose from 75 mg to 150 mg Q2W.
Maltese: Kienet osservata żieda kemxejn iktar minn dik fi proporzjon mad-doża, b'żieda ta' 2.1 sa 2.7 drabi filkonċentrazzjonijiet totali ta' alirocumab għal żieda ta' darbtejn fid-doża minn 75 mg sa 150 mg Q2W.
English: In published genetic studies as well as clinical and observational trials with lipid lowering therapies an increased risk of new onset of diabetes has been associated with lower levels of LDL-C.
Maltese: F'studji ġenetiċi ppubblikati kif ukoll f'provi ta' osservazzjoni u kliniċi b'terapiji li jnaqqsu l-livell tal-lipidi, żieda fir-riskju li toħroġ iddijabete ġiet assoċjata ma' livelli baxxi ta' LDL-C.
English: To give the 300 mg dose, give two 150 mg injections in a row at two different injection sites.
Maltese: Sabiex tagħti d-doża ta' 300 mg, agħti żewġ injezzjonijiet ta' 150 mg wara xulxin f'żewġ siti ta' injezzjoni differenti.
English: OUTER CARTON - Pre-filled syringe 150 mg
Maltese: KARTUNA TA' BARRA - Pinna mimlija għal-lest 150 mg
English: Monotherapy or as add-on to non-statin lipid-modifying therapy
Maltese: Monoterapija jew terapija miżjuda ma' terapija li timmodifika l-lipidi li mhijiex statin
English: Since alirocumab is a biological medicinal product, no pharmacokinetic effects of alirocumab on other medicinal products and no effect on cytochrome P450 enzymes are anticipated.
Maltese: Minħabba li alirocumab huwa prodott mediċinali bijoloġiku, ma huma antiċipati l-ebda effetti farmakokinetiċi ta' alirocumab fuq prodotti mediċinali oħra u ma huwa antiċipat l-ebda effett fuq l-enzimi taċ-ċitokroma P450.
English: A multicenter, double-blind, placebo-controlled, 52 week study included 311 patients categorised as very high CV risk and not at their pre-defined target LDL-C on a maximally tolerated dose of statin, with or without other lipid-modifying therapy.
Maltese: Studju ta' 52 ġimgħa, b'ħafna ċentri, kkontrollat bi plaċebo, fejn la l-investigatur u lanqas il-pazjenti ma kienu jafu liema sustanza qed tintuża kien jinkludi 311-il pazjent ikkategorizzati bħala li qegħdin f'riskju CV
English: 1 pre-filled pen 2 pre-filled pens 6 pre-filled pens
Maltese: 2 pinen mimlijin għal-lest 6 pinen mimlijin għal-lest
English: • cotton ball or gauze
Maltese: Mortalità minn kull kawża
English: Immunogenicity data are highly dependent on the sensitivity and specificity of the ADA assay.
Maltese: Dejta ta' immunoġeniċità tiddependi ħafna fuq is-sensittività u l-ispeċifiċità tal-assaġġ ta' ADA.
English: Dose adjustment in the alirocumab groups to 150 mg Q2W occurred at week 12 in patients with LDL-C ≥70 mg/dL or ≥100 mg/dL, depending on their level of CV risk, or in patients who did not have at least a 30% reduction of LDL-C from baseline.
Maltese: Fit-12-il ġimgħa, kien hemm aġġustament fid-doża fil-gruppi ta' alirocumab għal 150 mg Q2W f'pazjenti b'LDL-C ≥70 mg/dL jew ≥100 mg/dL, skont il-livell ta' riskju kardjovaskulari, jew f'pazjenti li ma kellhomx mill-inqas tnaqqis ta' 30 % f'LDL-C mil-linja bażi.
English: A few individuals have been reported, who carry PCSK9 loss-of-function mutations in two alleles and have profoundly low LDL-C levels, with HDL-C and TG levels in the normal range.
Maltese: • Billi jimblokka PCSK9, Praluent iżid in-numru ta' riċetturi disponibbli biex jgħin biex ineħħi lkolesterol “ħażin” - dan ibaxxi l-livelli tiegħek ta' kolesterol “ħażin”.
English: At week 24, the mean treatment difference for alirocumab 300 mg Q4W/150 mg Q2W from placebo in LDL-C percent change from baseline was -52.4% (97.5% CI: -59.8%, -45.0%; p-value: ˂ 0.0001).
Maltese: Q2W u plaċebo f'bidla perċentwali f'LDL-C mil-linja bażi kienet ta' -52.4.% (97.5% CI: -59.8%, -45.0%; pvalue: ˂ 0.0001).
English: The observed cases of pruritus were typically mild and transient.
Maltese: Il-każijiet osservati ta' prurite kienu tipikament ħfief u temporanji.
English: BLISTER - Pre-filled syringe 75 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Praluent 75 mg
English: At week 24, the mean percent change from baseline with alirocumab 300 mg Q4W/150 mg Q2W in LDL-C (ITT analysis) was -52.7% compared to -0.3% for placebo.
Maltese: Fl-24 ġimgħa, il-medja perċentwali ta' bidla mil-linja bażi b'alirocumab 300 mg Q4W/150 mg Q2W f'LDL-C (analiżi
English: LDL-C percent change from baseline was -31.6% (95% CI: -40.2%, -23.0%; p-value: ˂0.0001).
Maltese: 2%,23.0%; valur p: ˂0.0001).
English: Based on a population pharmacokinetic analysis, the median apparent half-life of alirocumab at steady state was 17 to 20 days in patients receiving alirocumab as monotherapy at subcutaneous doses of either 75 mg Q2W or 150 mg Q2W.
Maltese: Abbażi ta' analiżi farmakokinetika ta' popolazzjoni, il-medjan tal-half-life apparenti ta' alirocumab fl-istat fiss kienet minn 17 sa 20 jum f'pazjenti li kienu qed jirċievu alirocumab bħala monoterapija b'dożi ta' 75 mg
English: At low concentrations, the elimination is predominately through saturable binding to target (PCSK9), while at higher concentrations the elimination of alirocumab is largely through a non-saturable proteolytic pathway.
Maltese: F'konċentrazzjonijiet baxxi, l-eliminazzjoni hija l-aktar permezz ta' irbit saturabbli mal-mira (PCSK9), filwaqt li f'konċentrazzjonijiet ogħla l-biċċa lkbira tal-eliminazzjoni ta' alirocumab tkun permezz ta' sensiela ta' reazzjonijiet proteolitiċi mhux saturabbli.
English: Without Background Statin
Maltese: Ilma għall-injezzjonijiet
English: For study results with respect to effects on LDL-C, cardiovascular events and populations studied see section
Maltese: Għar-riżultati tal-istudji fir-rigward tal-effetti fuq LDL-C, avvenimenti kardjovaskulari u l-popolazzjonijiet li ġew studjati, ara sezzjoni 5
English: A multicenter, double-blind, ezetimibe-controlled, 24 week study included 248 patients with documented statin intolerance due to skeletal muscle-related symptoms.
Maltese: Studju ta' 24 ġimgħa, b'ħafna ċentri, ikkontrollat b'ezetimibe, fejn la l-investigatur u lanqas il-pazjenti ma kienu jafu liema sustanza qed tintuża kien jiġbor fih 248 pazjent b'intolleranza ddokkumentata għall-istatins minħabba sintomi marbuta mal-muskoli skeletriċi.
English: All-cause mortality, non-fatal MI, non-fatal ischemic stroke CHD Death
Maltese: Mewt CV Mortalità minn kwalunkwe kawża
English: BLISTER - Pre-filled syringe 150 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Praluent 150 mg
English: In analyses of pooled phase 3 studies that allowed up-titration, among the subgroup of patients up-titrated, an increase from 75 mg Q2W to 150 mg Q2W alirocumab at week 12 resulted in an additional 14% mean reduction in LDL-C in patients on a background statin.
Maltese: F'analiżi ta' ġabra ta' studji ta' fażi 3 li ħallew li ssir titrazzjoni 'l fuq, fost is-sottogrupp ta' pazjenti titrati 'l fuq, żieda minn 75 mg Q2W għal 150 mg Q2W alirocumab f'ġimgħa 12 wassal għal medja ta' tnaqqis addizzjonali ta' 14% fl-LDL-C f'pazjenti bi statin fl-isfond.
English: • Use a 90º angle if you can pinch 5 cm of skin.
Maltese: • Uża angolu ta' 90º jekk tista' toqros 5 ċm ta' ġilda.
English: Pharmacotherapeutic group: Other lipid modifying agents, ATC code: C10AX14.
Maltese: Sustanzi oħra li jbidlu l-lipidi Kodiċi ATC:
English: Green plunger
Maltese: X'inhu Praluent
English: Patients on 75 mg Q2W who had two consecutive LDL-C values below 15 mg/dL (0.39 mmol/L) were switched to placebo in a blinded fashion.
Maltese: 75 mg Q2W jew plaċebo miżjuda mat-terapija li timmodifika l-lipidi li kellhom diġà.
English: Nominal significance
Maltese: U KWANTITATTIVA
English: General allergic reactions
Maltese: Sensittività eċċessiva,
English: In pre-specified analyses before possible up-titration at week 12 in the 8 studies in which patients started with the 75 mg every 2 weeks dosing regimen, mean reductions in LDL-C ranging from 44.5% to 49.2% were achieved.
Maltese: F'analiżi speċifikati minn qabel, qabel ma seta jkun hemm titrazzjoni 'l fuq f'ġimgħa 12 fit-8 studji li fihom il-pazjenti bdew bl-iskeda ta' għoti ta' doża ta' 75 mg kull ġimagħtejn, inkisbet medja ta' tnaqqis li varja bejn 44.5% u 49.2% fl-LDL-C.
English: Patients in the alirocumab 300 mg every 4 weeks treatment group received alternating placebo injections to maintain blinding in regard to injection frequency.
Maltese: Pazjenti fil-grupp ta' trattament ta' alirocumab 300 mg kull 4 ġimgħat irċevew b'mod alternattiv injezzjonijiet ta' plaċebo sabiex il-frekwenza ta' injezzjonijiet tinżamm fl-għama.
English: At week 12 (before up-titration), 76.0% of patients in the alirocumab group reached an LDL-C of ˂70 mg/dL (˂ 1.81 mmol/L) as compared to 11.3% in the placebo group.
Maltese: ˂70 mg/dL (˂1.81 mmol/L) meta mqabbla ma' 11.3% fil-grupp ta' plaċebo.
English: For detailed results see Table 4.
Maltese: Għal riżultati ddettaljati ara Tabella 2.
English: At week 24, the mean treatment difference from ezetimibe in LDL-C percent change from baseline was -30.4% (95% CI: -36.6%, -24.2%; pvalue: ˂0.0001).
Maltese: Filġimgħa 24, il-medja tad-differenza tat-trattament minn ezetimibe fil-persentaġġ ta' bidla fl-LDL-C mill-linja bażi kienet -30.4% (95% CI: -36.6%, -24.
English: In a pool of ten placebo-controlled and active-controlled trials of patients treated with alirocumab 75 mg and/or 150 mg Q2W as well as in a separate clinical study of patients treated with alirocumab 75 mg Q2W or 300 mg every 4 weeks (including some patients with dose adjustment to 150 mg Q2W), the incidence of detecting ADA and NAb was similar to the results from the ODYSSEY OUTCOMES trial described above.
Maltese: jew 300 mg kull 4 ġimgħat (inkluż xi pazjenti b'aġġustamenti fid-doża għal 150 mg Q2W), l-inċidenza li jinstabu ADA u NAb kienet simili għar-riżultati mill-prova EFFETTI ODYSSEY deskritta aktar 'il fuq.
English: Eight studies were performed with a dose of 75 mg Q2W, and criteria-based up-titration to 150 mg Q2W at week 12 in patients who did not achieve their pre-defined target LDL-C based on their level of CV risk at week 8.
Maltese: Tmien studji saru bid-doża ta' 75 mg Q2W, u b'titrazzjoni 'l fuq abbażi ta' kriterji sa 150 mg Q2W f'ġimgħa 12 f'pazjenti li ma kisbux il-mira ta' LDL-C tagħhom iddefinita minn qabel abbażi tal-livell ta' riskju CV tagħhom f'ġimgħa 8.
English: Unstable Angina b f
Maltese: • Tpoġġix it-tapp il-blu lura f'postu.
English: • Use your thumb and first finger to pinch a fold of skin at the injection site.
Maltese: • Kull darba uża post differenti fil-parti fejn inti tinjetta.
English: • Check that you have the correct product and the correct dose (grey plunger for 150 mg/ml).
Maltese: • Iċċekkja li inti għandek il-prodott it-tajjeb u d-doża t-tajba (planġer griż għal 150 mg/ml).
English: Sometimes serious allergic reactions such as hypersensitivity (difficulties breathing), nummular eczema (reddish skin spots sometimes with blisters), and hypersensitivity vasculitis (which is a specific form of a hypersensitivity reaction with symptoms such as diarrhoea, with a rash, or purple-coloured skin spots on the skin) have occurred (may affect up to 1 in 1,000 people).
Maltese: Xi drabi seħħew reazzjonijiet allerġiċi serji bħal sensittività eċċessiva (problemi bit-teħid tan-nifs), ekżema b'forma tixbah munita (tbajja ħamranin fil-ġilda xi drabi bl-infafet), u vaskulite minn sensittività eċċessiva (li hija forma speċifika ta' reazzjoni ta' sensittività eċċessiva b'sintomi bħal dijarea, b'raxx, jew tbajja' ta' lewn vjola fil-ġilda) (jistgħu jaffettwaw sa persuna 1 minn kull 1,000).
English: 25 g / 25 g Solution for infusion
Maltese: 25 g / 25 g Soluzzjoni għallinfużjoni
English: Intravenous use bag (PVC)
Maltese: Użu għal ġol-vini borża (PVC)
English: #, angioedema,
Maltese: #, anġjoedima,
English: ANTIFUNGALS Clotrimazole Fluconazole Itraconazole Isavuconazole Posaconazole
Maltese: ANTIFUNGALI Clotrimazole Fluconazole Itraconazole Isavuconazole Posaconazole
English: IMMUNOSUPPRESSANTS Ciclosporin
Maltese: IMMUNOSOPPRESSANTI Ciclosporine
English: Polyvinyl alcohol- partially hydrolysed Macrogol 3350
Maltese: Poly(vinyl alkoħol) - parzjalment idrolizzat Macrogol 3350
English: ANTACIDS Aluminium/magnesium hydroxide
Maltese: ANTAĊIDI Aluminium/magnesium, hydroxide
English: Ethinylestradiol (0.02 mg once daily)
Maltese: Ethinylestradiol (0.02 mg darba kuljum)
English: HIV PI darunavir amprenavir atazanavir indinavir lopinavir saquinavir tipranavir
Maltese: darunavir amprenavir atazanavir indinavir lopinavir saquinavir tipranavir
English: * DRV-RAMs: V11I, V32I, L33F, I47V, I50V, I54M, I54L, T74P, L76V, I84V, L89V.
Maltese: V11I, V32I, L33F, I47V, I50V, I54M, I54L, T74P, L76V, I84V u L89V
English: TMC114FD2HTX3001 (darunavir/cobicistat arm)
Maltese: TMC114FD2HTX3001 (grupp ta' darunavir/cobicistat)
English: HIV ANTIRETROVIRALS Integrase strand transfer inhibitors Dolutegravir
Maltese: HIV Impedituri ta' integrase strand transfer Dolutegravir
English: Cobicistat inhibits the transporters p-glycoprotein (P-gp), BCRP, MATE1, OATP1B1 and OATP1B3.
Maltese: Cobicistat jimpedixxi t-trasportaturi ta' p-glycoprotein (P-gp), BCRP, MATE1, OATP1B1 u OATP1B3.
English: C-darunavir with ritonavir dose, approximately 79.5% and 13.9% of the administered dose of
Maltese: C-darunavir ma' ritonavir, madwar 79.5% u 13.9% tad-doża amministrata ta'
English: Imputations according to the Snapshot algorithm.
Maltese: Imputazzjonijiet skont l-algoritmu Snapshot.
English: (MATE1 inhibition)
Maltese: (Impediment ta' MATE1)
English: HIV Nucleo(s/t)ide reverse transcriptase inhibitors (NRTIs) Didanosine
Maltese: Impedituri ta' nucleo(s/t)ide reverse transcriptase (NRTIs) Didanosine
English: - Corticosteroids including betamethasone, budesonide, fluticasone, mometasone, prednisone,
Maltese: - Kortikosterojdi inkluż betamethasone, budesonide, fluticasone, mometasone, prednisone, triamcinolone.
English: CORTICOSTEROIDS Corticosteroids primarily metabolised by CYP3A (including betamethasone, budesonide, fluticasone, mometasone, prednisone, triamcinolone).
Maltese: KORTIKOSTEROJDI Kortikosterojdi primarjament immetabolizzati minn CYP3A (inkluż betamethasone, budesonide, fluticasone, mometasone, prednisone, triamcinolone).
English: Adverse reactions are listed by system organ class (SOC) and frequency category.
Maltese: Ir-reazzjonijiet avversi huma elenkati skont is-sistema tal-klassifika tal-organi (SOC) u l-kategorija ta' frekwenza.
English: Description of clinical studies of REZOLSTA in adults
Maltese: Deskrizzjoni ta' studji kliniċi b'REZOLSTA f'adulti
English: The film-coating contains polyvinyl alcoholpartially hydrolyzed, titanium dioxide, polyethylene glycol (macrogol), talc, iron oxide red, and iron oxide black.
Maltese: Il-kisja tar-rita fiha polyvinyl alkoħolparzjalment idrolizzat, titanium dioxide, polyethylene glycol (macrogol), terra, iron oxide red u iron oxide yellow.
English: (P-glycoprotein inhibition)
Maltese: (Impediment ta' P-glycoprotein)
English: MedDRA system organ class Frequency category
Maltese: Sistema tal-Klassifika tal-Organi ta' MedDRA
English: H2-RECEPTOR ANTAGONISTS Cimetidine
Maltese: H2 Cimetidine
English: 6/l (see section 4.2).
Maltese: 6/L (ara sezzjoni 4.2).
English: Darunavir is an inhibitor of the dimerisation and of the catalytic activity of the HIV-1 protease (KD of 4.5 x 10
Maltese: Darunavir huwa impeditur tad-dimerizzazzjoni u l-attività katalittika tal- HIV-1 protease (KD ta' 4.5 x 10
English: C-cobicistat, 86% and 8.2% of the dose were recovered in feces and urine, respectively.
Maltese: C-cobicistat, 86% u 8.2% tad-doża kienu rkuprati fl-ippurgar u fl-awrina rispettivament.
English: ANTI-DEPRESSANTS Herbal supplements St John's wort
Maltese: Supplimenti ta' ħxejjex St John's wort
English: Rare drug reaction with eosinophilia and systemic symptoms*
Maltese: Rari reazzjoni tal-mediċina b'eosinofilja u sintomi sistemiċi*
English: HIV Non-nucleo(s/t)ide reverse transcriptase inhibitors (NNRTIs) Efavirenz
Maltese: Impedituri HIV ta' non-nucleoside reverse transcriptase (NNRTIs) Efavirenz
English: - Atorvastatin, fluvastatin, pitavastatin, pravastatin, rosuvastatin (to lower cholesterol levels).
Maltese: - Atorvastatin, fluvastatin, pitavastatin, pravastatin, rosuvastatin (biex tnaqqas il-livelli ta' kolesterol fid-demm).
English: Cobicistat is a mechanism-based inhibitor of cytochromes P450 of the CYP3A subfamily.
Maltese: Cobicistat huwa impeditur bażat fuq mekkaniżmu ta' cytochromes P450 tas-sottofamilja ta' CYP3A.
English: Darunavir demonstrates antiviral activity in vitro against a broad panel of HIV-1 group M (A, B, C, D, E, F, G) and group O primary isolates with EC50 values ranging from < 0.1 to 4.3 nM.
Maltese: Darunavir juri attività antivirali in vitro kontra sezzjoni wiesgħa ta' ċelluli puri tal-virusis iżolati primarjament ta' HIV-1 grupp M (A, B, C, D, E, F, G) u grupp O b'valuri EC50 minn < 0.1 to 4.3 nM.
English: HEPATITIS C VIRUS (HCV) DIRECT-ACTING ANTIVIRALS NS3-4A inhibitors
Maltese: ANTIVIRALI LI JAĦDMU DIRETTAMENT FUQ VIRUS EPATITE C (HCV) Impedituri tal-protease NS3-4A
English: DRESS (Drug Rash with Eosinophilia and Systemic Symptoms) and Stevens-Johnson syndrome has been rarely (< 0.1%) reported, and during post-marketing experience toxic epidermal necrolysis and acute generalised exanthematous pustulosis have been reported.
Maltese: DRESS (Drug Rash with Eosinophilia and Systemic Symtoms) u s-Sindrome ta' Stevens-Johnson kienu rrappurtat b'mod rari (< 0.1%), u waqt l-esperjenza ta' wara t-tqegħid fis-suq ġew irrappurtati nekroliżi epidermali tossika u reazzjoni akuta ta' nfafet b'materja mifruxa.
English: Darunavir is extensively metabolised by the hepatic CYP system and almost exclusively by isozyme CYP3A4.
Maltese: Darunavir jiġi metabolizzat estensivament mis-sistema epatika CYP u kważi esklussivament mill-isożima CYP3A4.
English: - Oestrogen-based hormonal contraceptives and hormone replacement therapy.
Maltese: - Kontraċettivi ormonali b'bażi ta' estroġenu jew terapija ta' sostituzzjoni tal-ormoni.
English: Darunavir After a 400/100 mg
Maltese: Darunavir Wara doża ta' 400/100 mg
English: Immune reconstitution inflammatory syndrome (IRIS)
Maltese: Sindrome infjammatorju ta' rikostituzzjoni immuni (Immune reconstitution inflammatory syndrome, IRIS)
English: - Clonazepam (to prevent seizures).
Maltese: - Clonazepam (biex jevita l-aċċessjonijiet).
English: A
Maltese: d
English: Darunavir contains a sulphonamide moiety.
Maltese: Darunavir fih moijetà ta' sulphonamide.
English: Uncommon hepatitis*, cytolytic hepatitis*
Maltese: Mhux komuni epatite*, epatite ċitolitika*
English: ODIN is a Phase III, randomised, open-label trial comparing darunavir/ritonavir 800/100 mg once daily versus darunavir/ritonavir 600/100 mg twice daily in ART-experienced HIV-1 infected patients with screening genotype resistance testing showing no darunavir RAMs (i.e. V11I, V32I, L33F, I47V, I50V, I54M, I54L, T74P, L76V, I84V, L89V) and a screening HIV-1 RNA > 1,000 copies/mL.
Maltese: ODIN hija prova, każwali, bit-tikketta tingħaraf tal-Fażi III li tqabbel darunavir/ritonavir 800/100 mg darba kuljum ma' darunavir/ritonavir 600/100 mg darbtejn kuljum f'pazjenti infettati b'HIV-1 li diġà ħadu ART b'testijiet li jeżaminaw reżistenza ġenotipka li ma wrew l-ebda RAMs (i.e. V11I, V32I, L33F, I47V, I50V, I54M, I54L, T74P, L76V, I84V, L89V) għal darunavir u b'eżami li juri HIV-1 RNA > 1,000 kopja/mL.
English: Cobicistat No clinically relevant pharmacokinetic differences due to gender have been identified for cobicistat.
Maltese: L-ebda differenza farmakokinetika klinikament rilevanti minħabba sess ma ġiet identifikata għal cobicistat.
English: No mechanistic interaction expected based on theoretical consideration.
Maltese: L-ebda interazzjoni mekkanistika abbażi ta' konsiderazzjoni teoretika.
English: - The other ingredients are hypromellose, silicified microcrystalline cellulose, colloidal silicon dioxide, crospovidone and magnesium stearate.
Maltese: - Is-sustanzi mhux attivi l-oħra huma hypromellose, silicified microcrystalline cellulose, colloidal silicon dioxide, crospovidone u magnesium stearate.