FrancophonIA/ELRC3.0 huggingface dataset:
English: Light orange oval shaped tablet of 19.1 mm, debossed with “400MG” on one side and “TMC” on the other side.
Maltese: Pillola oranġjo ċara b'forma ovali ta' 19.1 mm, imnaqqxa b'“400MG” fuq naħa waħda u “TMC” fuq in-naħa l-oħra.
English: 600 mg (6 ml) PREZISTA/100 mg (1.2 ml) ritonavir once daily
Maltese: 600 mg (6 ml) PREZISTA/100 mg (1.2 ml) ritonavir darba kuljum
English: Darunavir/ritonavir (600/100 mg twice daily or 800/100 mg once daily) in combination with a background regimen was evaluated in a clinical trial of 36 pregnant women (18 in each arm) during the second and third trimesters, and postpartum.
Maltese: Darunavir/ritonavir (600/100 mg darbtejn kuljum jew 800/100 mg darba kuljum) flimkien ma' pjan terapewtiku fl-isfond ġie stmat fi prova klinika ta' 36mara tqila (18 f'kull fergħa) waqt it-tieni u t-tielet trimestri tat-tqala, u wara t-twelid.
English: 60 milligram (0.8 milliliter)
Maltese: 460 milligramma (4.6 millilitri) 60 milligramma (0.8 millilitri)
English: Excipient with known effect: Each tablet contains 1.375 mg sunset yellow FCF (E110).
Maltese: Kull pillola fiha 1.375 mg sunset yellow FCF (E110).
English: PREZISTA oral suspension Janssen Pharmaceutica NV Turnhoutseweg 30
Maltese: Janssen Pharmaceutica NV
English: - This medicine contains less than 1 mmol sodium (23 mg) per dosage unit, that is to say essentially ‘sodium-free'.
Maltese: - Din il-mediċina fiha inqas minn 1 mmol sodium (23 mg) f'kull unità tad-doża, li tista' tgħid hija essenzjalment ‘mingħajr sodium'.
English: The recommended dose of emtricitabine/tenofovir alafenamide is 200/10 mg once daily when used with boosted PREZISTA.
Maltese: Id-doża rrakkomandata ta' emtricitabine/tenofovir alafenamide hija 200/10 mg darba kuljum meta jintuża ma' PREZISTA intensifikat.
English: These results were confirmed in the analysis of data at 96 weeks of treatment in the TITAN trial, with 60.4% of patients in the PREZISTA/ritonavir arm having HIV-1 RNA < 50 copies/ml at week 96 compared to 55.2% in the lopinavir/ritonavir arm [difference: 5.2%, 95% CI (-2.8; 13.1)].
Maltese: Dawn ir-riżultati kienu kkonfermati fl-analiżi ta' dejta fis-96 ġimgħa ta' kura fil-prova TITAN, b'60.4% tal-pazjenti fil-fergħa ta' PREZISTA/ritonavir li kellhom HIV-1 RNA < 50 kopja/ml fis-96 ġimgħa meta kienu mqabbla ma' 55.2% fil-fergħa ta' lopinavir/ritonavir [differenza: 5.2%, 95% CI (-2.8; 13.1)].
English: Excipient with known effect: Each tablet contains 0.834 mg sunset yellow FCF (E110).
Maltese: Kull pillola fiha 0.834 mg sunset yellow FCF (E110).
English: Primary (major) PI mutations
Maltese: Mutazzjonijiet primarji (maġġuri) għall-PI
English: In a multiple dose study with PREZISTA co-administered with ritonavir (600/100 mg) twice daily, it was demonstrated that the total plasma concentrations of darunavir in subjects with mild (Child-Pugh Class A, n=8) and moderate (Child-Pugh Class B, n=8) hepatic impairment were comparable with those in healthy subjects.
Maltese: Fi studju b'dożi multipli ta' PREZISTA amministrat flimkien ma' ritonavir (600/100 mg) darbtejn kuljum, intwera bil-provi li lkonċentrazzjonijiet totali ta' darunavir fil-plażma f'individwi b'indeboliment epatiku ħafif (Child-Pugh Klassi A, n=8) u moderat (Child-Pugh Klass B, n=8) kienu kumparabbli ma dawk ta' individwi b'saħħithom.
English: #, a comparable systemic exposure to sildenafil was observed for a single intake of 100 mg sildenafil alone and a single intake of 25 mg sildenafil co-administered with PREZISTA and low dose ritonavir.
Maltese: #, esponiment sistemiku kumparabbli għal sildenafil kien osservat bit-teħid ta' doża unika ta' 100 mg sildenafil waħdu u teħid ta' doża unika ta' 25 mg sildenafil mogħti ma' PREZISTA flimkien ma' doża baxxa ta' ritonavir.
English: PREZISTA/ ritonavir 800/100 mg once daily N=343
Maltese: PREZISTA/ ritonavir 800/100 mg darba kuljum N=343
English: Clinical monitoring is recommended when co-administering PREZISTA with low dose ritonavir and clonazepam.
Maltese: Huwa rrakkomandat monitoraġġ kliniku meta PREZISTA intensifikat jingħata flimkien ma' clonazepam.
English: Tell your doctor if you take: - Phenobarbital, phenytoin (to prevent seizures) - Dexamethasone (corticosteroid) - Efavirenz (HIV infection) - Boceprevir (hepatitis C infection) - Rifapentine, rifabutin (medicines to treat some infections such as tuberculosis) - Saquinavir (HIV infection).
Maltese: Għid lit-tabib tiegħek jekk tieħu: - Phenobarbital, phenytoin (biex jilqgħu kontra attakki ta' epilessija) - Dexamethasone (kortikosterojd) - Efavirenz (għal infezzjoni bl-HIV) - Boceprevir (għal infezzjoni tal-epatite C) - Rifapentine, rifabutin (mediċini biex jikkuraw xi infezzjonijiet bħal ma hija t-tuberkulożi) - Saquinavir (infezzjoni bl-HIV).
English: For additional clinical study results in ART-experienced adults and paediatric patients, refer to the Summary of Product Characteristics for PREZISTA 75 mg, 150 mg, 300 mg or 600 mg tablets and 100 mg/ml oral suspension.
Maltese: Għal riżultati addizzjonali ta' studji kliniċi f'pazjenti adulti u pedjatriċi li digà ħadu ART, ara sSommarju ta' Karatterisiċi tal-Prodott għal pilloli ta' PREZISTA 75 mg, 150 mg, 300 mg jew 600 mg u suspensjoni orali ta' 100 mg/ml.
English: OR - 800 milligram PREZISTA together with 150 milligram cobicistat or100 milligram ritonavir once daily.
Maltese: JEW - 800 milligramma ta' PREZISTA flimkien ma' 150 milligramma ta' cobicistat jew
English: 200 ml bottle
Maltese: Flixkun ta' 200 ml
English: If parenteral midazolam is co-administered with boosted PREZISTA it may cause a large increase in the concentration of this benzodiazepine.
Maltese: Jekk midazolam parenterali jingħata flimkien ma' PREZISTA intensifikat huwa jista' jikkawża żieda kbira filkonċentrazzjoni ta' dan il-benzodiazepine.
English: The interaction trial showed a comparable daily systemic exposure for rifabutin between treatment at 300 mg once daily alone and 150 mg once every other day in combination with PREZISTA/ritonavir (600/100 mg twice daily) with an about 10-fold increase in the daily exposure to the active metabolite 25-O-desacetylrifabutin.
Maltese: Il-pova ta' interazzjoni wriet esponiment sistemiku kuljum għal rifabutin kumparabbli bejn kura bi 300 mg darba kuljum waħdu u b'150 mg ġurnata iva u oħra le flimkien ma' PREZISTA/ritonavir (600/100 mg darbtejn kuljum) b'żieda ta' madwar 10 darbiet aktar fl-esponiment ta' kuljum għall-metabolit attiv 25-O-desacetylrifabutin.
English: HIV-1 RNA < 50 copies/ml All patients
Maltese: HIV-1 RNA < 50 kopji/ml
English: Concomitant use of colchicine and boosted PREZISTA may increase the exposure to colchicine.
Maltese: L-użu konkomitanti ta' colchicine u PREZISTA intensifikat jista' jżid l-esponiment għal colchicine.
English: Skin and subcutaneous tissue disorders common rash (including macular, maculopapular, papular, erythematous and pruritic rash), pruritus uncommon angioedema, generalised rash, allergic dermatitis, urticaria, eczema, erythema, hyperhidrosis, night sweats, alopecia, acne, dry skin, nail pigmentation rare
Maltese: Disturbi fil-ġilda u fit-tessuti ta' taħt il-ġilda komuni raxx (inkluż makulari, makulopapulari, papulari, raxx bil-ħmura u bil-ħakk), ħakk mhux komuni anġjoedima, raxx mifrux, dermatite allerġika, urtikarja, ekżema, ħmura, iperidrosi, għaraq billejl, alopeċja, akne, ġilda xotta, pigmentazzjoni fid-difer rari
English: PREZISTA oral suspension can be used in patients unable to swallow PREZISTA tablets.
Maltese: PREZISTA suspensjoni orali tista' tintuża f'pazjenti li ma jistgħux jibilgħu l-pilloli PREZISTA.
English: PHOSPHODIESTERASE, TYPE 5 (PDE-5) INHIBITORS For the treatment of erectile dysfunction Avanafil Sildenafil Tadalafil Vardenafil
Maltese: Għall-kura ta' anormalità erettili Avanafil Sildenafil Tadalafil Vardenafil
English: PREZISTA 75 mg film-coated tablets EU/1/06/380/005
Maltese: PREZISTA 75 mg pilloli miksijin b'rita EU/1/06/380/005
English: Boosted PREZISTA may increase antifungal plasma concentrations and posaconazole, isavuconazole, itraconazole or fluconazole may increase darunavir concentrations.
Maltese: PREZISTA intensifikat jista' jżid il-konċentrazzjonijiet talmediċina antifungali fil-plażma u posaconazole, isavuconazole, itraconazole jew fluconazole jistgħu jżidu lkonċentrazzjonijiet ta' darunavir.
English: Opaque, white, high density polyethylene (HDPE) plastic, 75 ml bottle containing 30 tablets, fitted with polypropylene (PP) child resistant closure.
Maltese: Flixkun opak abjad tal-plastik polyethylene ta' densità għolja (HDPE), flixkun ta' 75 ml li fih 30 pillola, magħluq b'għatu tal-polypropylene (PP) li ma' jinfetaħx mit-tfal.
English: PREZISTA may increase antifungal plasma concentrations and posaconazole, isavuconazole, itraconazole, or fluconazole may increase darunavir concentrations.
Maltese: PREZISTA jista' jżid ilkonċentrazzjonijiet tal-mediċina antifungali fil-plażma u posaconazole, isavuconazole, itraconazole jew fluconazole jistgħu jżidu lkonċentrazzjonijiet ta' darunavir.
English: These active substances include e.g.: - alfuzosin - amiodarone, bepridil, dronedarone, ivabradine, quinidine, ranolazine - astemizole, terfenadine - colchicine when used in patients with renal and/or hepatic impairment (see section 4.5) - ergot derivatives (e.g. dihydroergotamine, ergometrine, ergotamine, methylergonovine) - elbasvir/grazoprevir - cisapride - dapoxetine - domperidone - naloxegol - lurasidone, pimozide, quetiapine, sertindole (see section 4.5) - triazolam, midazolam administered orally (for caution on parenterally administered midazolam,
Maltese: Dawn is-sustanzi attivi jinkludu eż.: - alfuzosin - amiodarone, bepridil, dronedarone, ivabradine, quinidine, ranolazine - astemizole, terfenadine - colchicine meta jintuża f'pazjenti b'indeboliment tal-kliewi u/jew tal-fwied (ara sezzjoni 4.5) - derivattivi tal-ergot (eż. dihydroergotamine, ergometrine, ergotamine, methylergonovine) - elbasvir/grazoprevir - cisapride - dapoxetine - domperidone - naloxegol - lurasidone, pimozide, quetiapine, sertindole (ara sezzjoni 4.5) - triazolam, midazolam mogħti mill-ħalq (għal attenzjoni dwar midazolam li jingħata b'mod parenterali, ara sezzjoni 4.5) - sildenafil - meta jintuża għall-kura ta' pressjoni għolja fl-arterji tal-pulmun, avanafil
English: PREZISTA 400 mg or 800 mg must always be given orally with cobicistat or low dose ritonavir as a pharmacokinetic enhancer and in combination with other antiretroviral medicinal products (see section 5.2).
Maltese: PREZISTA 400 mg jew 800 mg għandu dejjem jingħata mill-ħalq flimkien ma' cobicistat jew doża baxxa ta' ritonavir bħala intensifikatur farmakokinetiku u flimkien ma' prodotti mediċinali antiretrovirali oħra (ara sezzjoni 5.2).
English: The metabolism of alfentanil is mediated via CYP3A, and may as such be inhibited by boosted PREZISTA.
Maltese: Il-metaboliżmu ta' alfentanil huwa medjat permezz ta' CYP3A, u fil-fatt jista' jiġi impedit minn PREZISTA intensifikat.
English: HIV-1 RNA < 50 copies/ml median CD4+ cell count change from baseline (x 10
Maltese: HIV-1 RNA < 50 kopja/ml il-medjan ta' tibdil fl-għadd ta' ċelluli CD4+ mill-linja bażi (x
English: Boosted PREZISTA can be expected to increase the plasma concentrations of calcium channel blockers.
Maltese: PREZISTA intensifikat jista' jkun mistenni li jżid ilkonċentrazzjonijiet ta' imblokkaturi talkanali tal-kalċju fil-plażma.
English: PREZISTA oral suspension is also available.
Maltese: PREZISTA suspensjoni orali
English: 675 mg PREZISTA/100 mg ritonavir once daily
Maltese: 675 mg PREZISTA/100 mg ritonavir darba kuljum
English: 600 mg (6 ml) PREZISTA/100 mg (1.2 ml) ritonavir twice daily ritonavir oral solution: 80 mg/ml rounded up for suspension dosing convenience
Maltese: 600 mg (6 ml) PREZISTA/100 mg (1.2 ml) ritonavir darbtejn kuljum soluzzjoni orali ta' ritonavir: 80 mg/ml miżjuda sal-eqreb numru sħiħ għall-konvenjenza tal-għoti tad-doża tas-suspensjoni
English: PREZISTA/ritonavir 800/100 mg once daily + OBR N=294
Maltese: PREZISTA/ritonavir 800/100 mg darba kuljum + OBR N=294
English: PREZISTA, co-administered with cobicistat is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infection in adult patients (see section 4.2).
Maltese: PREZISTA, mogħti flimkien ma' cobicistat huwa indikat, flimkien ma' prodotti mediċinali antiretrovirali oħra, għall-kura ta' infezzjoni bil-virus tal-immunodefiċjenza umana f'pazjenti adulti (ara sezzjoni 4.2).
English: PREZISTA 75 mg, 150 mg, 300 mg, and 600 mg tablets may be used to provide suitable dose regimens (see section 4.2):
Maltese: Il-pilloli PREZISTA 75 mg, 150 mg, 300 mg, u 600 mg jistgħu jintużaw biex jipprovdu skedi ta' għoti ta' dożi xierqa (ara sezzjoni 4.2):
English: Non-inferiority in virologic response to the PREZISTA/ritonavir treatment, defined as the percentage of patients with plasma HIV-1 RNA level < 50 copies/ml, was demonstrated (at the pre-defined 12% non-inferiority margin) for both Intent-To-Treat (ITT) and On Protocol (OP) populations in the 48 week analysis.
Maltese: Noninferjorità fir-rispons viroloġiku għall-kura bi PREZISTA/ritonavir, definita bħala l-perċentwali ta' pazjenti b'livell ta' HIV-1 RNA fil-plażma ta' < 50 kopja/ml, intweriet (fil-marġni ta' noninferjorità predefinita ta' 12%) għaż-żewġ popolazzjonijiet Intent-To-Treat (ITT) u On Protocol (OP) fl-analiżi ta' 48 ġimgħa.
English: Imputations according to the TLOVR algorithm Based on a normal approximation of the difference in % response NC=F
Maltese: Imputazzjonijiet skont l-algoriżmu TLOVR Ibbażat fuq l-approssimazzjoni normali tad-diferenza fil- % tar-rispons NC=F
English: 375 mg PREZISTA/50 mg ritonavir twice daily
Maltese: 375 mg PREZISTA/50 mg ritonavir darbtejn kuljum
English: Concominant administration of boosted PREZISTA and lurasidone, pimozide or sertindole is contraindicated (see section 4.3).
Maltese: L-għoti flimkien ta' PREZISTA intensifikat u lurasidone, pimozide jew sertindole huwa kontraindikat (ara sezzjoni 4.3).
English: 100 milligram (1.2 milliliter) between 30 and 40 kilograms 675 milligram (6.8 milliliter) 100 milligram (1.2 milliliter) more than 40 kilograms
Maltese: 675 milligramma (6.8 millilitri) 100 milligramma (1.2 millilitri)
English: Tell your doctor if you take: - Alfentanil (injectable strong and short-acting painkiller that is used for surgical procedures) - Digoxin (to treat certain heart disorders) - Clarithromycin (antibiotic) - Itraconazole, isavuconazole, fluconazole, posaconazole, clotrimazole (to treat fungal infections).
Maltese: - Digoxin (biex tikkura ċertu mard tal-qalb) - Clarithromycin (antibijotiku) - Itraconazole, isavuconazole, fluconazole, posaconazole, clotrimazole (biex tikkura infezzjonijiet fungali).
English: PREZISTA is an antiretroviral medicine used in the treatment of Human Immunodeficiency Virus (HIV) infection.
Maltese: PREZISTA fih is-sustanza attiva darunavir. PREZISTA huwa mediċina antiretrovirali użat għattrattament ta' infezzjoni bil-Virus Uman ta' l-Immunodefiċjenza (HIV).
English: OUTER CARTON / BOTTLE LABEL
Maltese: KARTUNA TA' BARRA/TIKKETTA TAL-FLIXKUN
English: Both arms used a fixed background regimen consisting of tenofovir disoproxil fumarate 300 mg once daily and emtricitabine 200 mg once daily.
Maltese: Iż-żewġ partijiet tal-istudju użaw kors fiss fl-isfond li kien jikkonsisti minn tenofovir disoproxil fumarate 300 mg darba kuljum u emtricitabine 200 mg darba kuljum.
English: PREZISTA/ritonavir should be used during pregnancy only if the potential benefit justifies the potential risk (see sections 4.4, 4.6 and 5.2).
Maltese: PREZISTA/ritonavir għandu jintuża biss waqt it-tqala jekk il-benefiċċju li jista' jkun hemm jiġġustifika r-riskju li jista' jkun hemm (ara sezzjonijiet 4.4, 4.6 u 5.2).
English: Gastrointestinal disorders very common diarrhoea common vomiting, nausea, abdominal pain, increased blood amylase, dyspepsia, abdominal distension, flatulence uncommon pancreatitis, gastritis, gastrooesophageal reflux disease, aphthous stomatitis, retching, dry mouth, abdominal discomfort, constipation, increased lipase, eructation, oral dysaesthesia rare stomatitis, haematemesis, cheilitis, dry lip, coated tongue
Maltese: Disturbi gastrointestinali komuni ħafna dijarea komuni rimettar, tqalligħ, uġigħ fl-addome, żieda flamylase fid-demm, dispepsja, nefħa fl-addome, gass mhux komuni rari pankreatite, gastrite, mard ta' rifluss gastroesofagali, stomatite bl-afte, taqligħ, ħalq xott, nefħa fl-addome, skonfort fl-addome, stitikezza, żieda fil-lipase, tifwieq, disastesija orali,
English: Drug-induced hepatitis (e.g. acute hepatitis, cytolytic hepatitis) has been reported with PREZISTA.
Maltese: Epatite ikkaġunata minn mediċina (eż. epatite akuta, epatite ċitolitika) kienet irrappurtata bi PREZISTA.
English: PREZISTA/cobicistat may, in contrast, increase methadone plasma concentrations (see cobicistat SmPC).
Maltese: B'kuntrast ma' dan, PREZISTA/cobicistat jista' iżid il-konċentrazzjonijiet ta' methadone fil-plażma (ara l-SmPC ta' cobicistat).
English: PREZISTA 75 mg film-coated tablets
Maltese: PREZISTA 75 mg pilloli miksijin b'rita
English: 800 mg PREZISTA/100 mg ritonavir once daily
Maltese: 800 mg PREZISTA/100 mg ritonavir darba kuljum
English: • 21 ART-experienced HIV-1 infected paediatric patients aged from 3 to < 6 years and weighing 10 kg to < 20 kg (16 participants from 15 kg to < 20 kg) who received PREZISTA oral suspension with low dose ritonavir twice daily in combination with other antiretroviral agents.
Maltese: • 21 pazjent pedjatriku infettati bl-HIV li kienu diġà ħadu kura b'ART qabel, li kellhom minn 3 sa < 6 snin u li kienu jiżnu minn 10 kg sa < 20 kg (16-il parteċipant li kienu jiżnu minn 15 kg sa < 20 kg) li rċivew PREZISTA suspensjoni orali ma' doża baxxa ta' ritonavir darbtejn kuljum flimkien ma' mediċini antiretrovirali oħrajn.
English: PREZISTA/ritonavir 600/100 mg twice daily + OBR N=296
Maltese: PREZISTA/ritonavir 600/100 mg darbtejn kuljum + OBR N=296
English: PREZISTA 75 mg film-coated tablets Each film-coated tablet contains 75 mg of darunavir (as ethanolate).
Maltese: PREZISTA 75 mg pilloli miksijin b'rita Kull pillola miksija b'rita fiha 75 mg ta' darunavir (bħala ethanolate).
English: ART-experienced paediatric patients from the age of 3 to < 6 years The pharmacokinetics, safety, tolerability and efficacy of PREZISTA/ritonavir twice daily in combination with other antiretroviral agents in 21 ART-experienced HIV-1 infected paediatric patients aged 3 to < 6 years and weighing 10 kg to < 20 kg was evaluated in an open-label, Phase II trial, ARIEL.
Maltese: Pazjenti pedjatriċi mill-età ta' 3 sa < 6 snin b'esperjrnza ta' ART Il-farmakokinetika, is-sigurtà, it-tollerabilità u l-effikaċja ta' PREZISTA/ritonavir darbtejn kuljum flimkien ma' mediċini antiretrovirali oħrajn f'21 pazjent pedjatriku infettati bl-HIV-1 li kienu diġà ħadu kura b'ART fil-passat, li kellhom minn 3 sa < 6 snin u li jiżnu minn 10 kg sa < 20 kg, ġew evalwati fi prova ta' Fażi
English: PREZISTA is also available as 75 milligram, 150 milligram, 300 milligram, 400 milligram, 600 milligram and 800 milligram film-coated tablets.
Maltese: PREZISTA hu disponibbli wkoll bħala 75 milligramma, 150 milligramma, 300 milligramma, 400 milligramma, 600 milligramma u 800 milligramma pilloli miksija b'rita.
English: PREZISTA/ ritonavir 800/100 mg once daily N=294
Maltese: PREZISTA/ ritonavir 800/100 mg darba kuljum N=294
English: Renal and urinary disorders uncommon acute renal failure, renal failure, nephrolithiasis, increased blood creatinine, proteinuria, bilirubinuria, dysuria, nocturia, pollakiuria rare decreased creatinine renal clearance
Maltese: Disturbi fil-kliewi u fis-sistema urinarja mhux komuni rari insuffiċjenza renali akuta, insuffiċjenza renali, nefrolitiażi, żieda fil-kreatinina fid-demm, proteinurja, bilirubinurja, disurja, nokturja, pollakijurja tnaqqis fit-tneħħija renali tal-kreatinina
English: The recommended dose of emtricitabine/tenofovir alafenamide is 200/10 mg once daily when used with PREZISTA with low dose ritonavir.
Maltese: Id-doża rrakkomandata ta' emtricitabine/tenofovir alafenamide hija 200/10 mg darba kuljum meta jintuża ma' PREZISTA b'doża baxxa ta' ritonavir.
English: Caution should be exercised when clarithromycin is combined with boosted PREZISTA.
Maltese: Għandu jkun hemm attenzjoni meta clarithromycin jingħata ma' PREZISTA intensifikat.
English: Therefore, protein displacement of medicinal products highly bound to 1-acid glycoprotein cannot be ruled out (see section 4.5).
Maltese: prodotti mediċinali li jintrabtu b'mod qawwi mal-1-glikoproteina aċida, ma jistax jiġi eskluż (ara sezzjoni 4.5).
English: PREZISTA 150 mg film-coated tablets darunavir
Maltese: PREZISTA 150 mg pilloli miksijin b'rita darunavir
English: Rash considered by the investigator to be drug-related occurred at similar rates.
Maltese: Ir-raxx li kien ikkunsidrat millinvestigatur li kien relatat mal-mediċina, seħħ f'rati simili.
English: Concomitant use of boosted PREZISTA and elbasvir/grazoprevir is contraindicated (see section 4.3).
Maltese: L-użu ta' PREZISTA intensifikat flimkien ma' elbasvir/grazoprevir huwa kontraindikat (ara sezzjoni 4.3).
English: The pharmacokinetic properties of darunavir, co-administered with cobicistat or ritonavir, have been evaluated in healthy adult volunteers and in HIV-1 infected patients.
Maltese: Il-tagħrif farmakokinetiku ta' darunavir amministrat flimkien ma' cobicistat jew ritonavir, ġie evalwati f'voluntiera adulti b'saħħithom u f'pazjenti infettati bl-HIV-1.
English: PREZISTA 150 mg film-coated tablets EU/1/06/380/004
Maltese: PREZISTA 150 mg pilloli miksijin b'rita EU/1/06/380/004
English: 800 mg (8 ml) PREZISTA/100 mg (1.2 ml) ritonavir once daily ritonavir oral solution: 80 mg/ml rounded up for suspension dosing convenience
Maltese: 800 mg (8 ml) PREZISTA/100 mg (1.2 ml) ritonavir darba kuljum soluzzjoni orali ta' ritonavir: 80 mg/ml miżjuda sal-eqreb numru sħiħ għall-konvenjenza tal-għoti tad-doża tas-suspensjoni
English: PREZISTA/ ritonavir 600/100 mg twice daily N=296
Maltese: PREZISTA/ ritonavir 600/100 mg darbtejn kuljum N=296
English: The clinical trial data from ART-experienced patients (TITAN trial and the pooled analysis of the POWER 1, 2 and 3 and DUET 1 and 2 trials) showed that virologic response to PREZISTA co-administered with low dose ritonavir was decreased when 3 or more darunavir RAMs (V11I, V32I,
Maltese: Dejta minn provi kliniċi minn pazjenti li diġà ħadu kura b'ART qabel (prova TITAN u l-analiżi miġbura minn POWER 1, 2 u 3 u l-provi DUET 1 u 2 ) urew li r-rispons viroloġiku għall-PREZISTA mogħti flimkien ma' doża baxxa ta' ritonavir tnaqqas meta 3 RAMs
English: In addition, pharmacokinetic modeling and simulation of darunavir exposures in paediatric patients across the ages of 3 to < 18 years confirmed the darunavir exposures as observed in the clinical studies and allowed the identification of weight-based PREZISTA/ritonavir once daily dosing regimens for paediatric patients weighing at least 15 kg that are either ART-naïve or treatment-experienced paediatric patients without DRV-RAMs* and who have plasma HIV-1 RNA < 100,000 copies/ml and CD4+ cell count ≥ 100 cells x 10
Maltese: Barra dan, l-immudellar farmakokinetiku u s-simulazzjoni farmakokinetika ta' esponimenti għal darunavir f'pazjenti pedjatriċi matul is-snin ta' 3 sa < 18-il sena kkonfermaw leponimenti għal darunavir kif kien osservat fl-istudji kliniċi u ppermettew l-identifikazzjoni ta' skedi ta' għoti ta' dożi abbażi tal-piż ta' PREZISTA/ritonavir darba kuljum għal pazjenti pedjatriċi li kienu jiżnu mill-inqas 15-il kg li jew ikunu pazjenti pedjatriċi li ma jkunu qatt ħadu kura b'ART qabel jew li jkunu ħadu kura qabel li ma jkollhomx DRV-RAMs* u li fil-plażma jkollhom < 100,000 kopja/ml ta' RNA ta' HIV-1 u għadd ta' ≥ 100 ċellula x 10