FrancophonIA/ELRC3.0 huggingface dataset:
English: At week 48, the virologic response, defined as the percentage of patients with confirmed plasma viral load < 50 HIV-1 RNA copies/ml, was evaluated in 16 paediatric patients 15 kg to < 20 kg and 5 paediatric patients 10 kg to < 15 kg receiving PREZISTA/ritonavir in combination with other antiretroviral agents (see section 4.2 for dosage recommendations per body weight).
Maltese: HIV-1 RNA kopji/ml, ġie evalwat f'16-il pazjent pedjatriku li jiżnu minn 15 kg sa < 20 kg u 5 pazjenti pedjatriċi li jiżnu minn 10 kg sa < 15 kg li kienu qed jirċievu PREZISTA/ritonavir flimkien ma' mediċini antiretrovirali oħrajn (ara sezzjoni 4.2 għal rakkomandazzjonijiet dwar id-dożaġġ skont il-piż tal-ġisem).
English: Concomitant use of PREZISTA co-administered with low dose ritonavir and these antidepressants may increase concentrations of the antidepressant.
Maltese: L-użu ta' PREZISTA intensifikat u dawn l-antidepressanti jista' jżid ilkonċentrazzjonijiet tal-antidepressant.
English: It is not recommended to co-administer boosted PREZISTA with glecaprevir/pibrentasvir.
Maltese: Abbażi ta' konsiderazzjonijiet teoretiċi PREZISTA intensifikat jista' jżid lesponiment għal glecaprevir u pibrentasvir.
English: • ART-experienced with no darunavir resistance associated mutations (DRV-RAMs) and who have plasma HIV-1 RNA < 100,000 copies/ml and CD4+ cell count ≥ 100 cells x 10
Maltese: ● F'pazjenti b'esperjenza ta' trattament retrovirali (ART) mingħajr DRV-RAMs* u li għandhom < 100,000 kopja/ml ta' HIV-1/RNA fil-plażma u l-għadd ta' ċelluli ta' CD4+ ta' ≥ 100 ċellula x 10
English: 800 milligram (8 milliliter)
Maltese: 800 milligramma (8 millilitri) 100 milligramma (1.2 millilitri)
English: 600 mg PREZISTA/100 mg ritonavir once daily
Maltese: 600 mg PREZISTA/100 mg ritonavir darba kuljum
English: PREZISTA, co-administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infection in adult and paediatric patients from the age of 3 years and at least 15 kg body weight (see section 4.2).
Maltese: PREZISTA, mogħti flimkien ma' doża baxxa ta' ritonavir huwa indikat, flimkien ma' prodotti mediċinali antiretrovirali oħra, għall-kura ta' pazjenti b'infezzjoni bil-virus uman ta' l-immunodefiċjenza (HIV-1) f'pazjenti adulti u pazjenti pedjatriċi mill-età ta' 3 snin u li jkollhom piż tal-ġisem ta' mill-inqas 15 kg (ara sezzjoni 4.2).
English: PREZISTA/ ritonavir 600/100 mg twice daily N=298
Maltese: PREZISTA/ ritonavir 600/100 mg darbtejn kuljum N=298
English: PREZISTA 150 mg film-coated tablets
Maltese: 150 mg darba kuljum
English: Co-administration of PREZISTA with low dose ritonavir and alfuzosin is contraindicated (see section 4.3).
Maltese: PREZISTA mogħti flimkien ma' doża baxxa ta' ritonavir u alfuzosin huwa kontraindikat (ara sezzjoni 4.3).
English: Hepatobiliary disorders common increased alanine aminotransferase uncommon hepatitis, cytolytic hepatitis, hepatic steatosis, hepatomegaly, increased transaminase, increased aspartate aminotransferase, increased blood bilirubin, increased blood alkaline phosphatase, increased gamma-glutamyltransferase
Maltese: Disturbi fil-fwied u fil-marrara komuni żieda fl-alanine aminotransferase mhux komuni epatite, epatite ċitolitika, steatożi epatika, epatomegalija, żieda fit-transaminase, żieda flaspartate aminotransferase, żieda fil-bilirubin fiddemm, żieda fl-alkaline phosphatase fid-demm, żieda fil- gamma-glutamyltransferase
English: The recommended dose of PREZISTA with low dose ritonavir should not exceed the recommended adult dose (600/100 mg twice daily or 800/100 mg once daily).
Maltese: Id-doża rakkomandata ta' PREZISTA ma' doża baxxa ta' ritonavir m'għandhiex taqbeż iddoża rakkomandata fl-adulti (600/100 mg darbtejn kuljum jew 800/100 mg darba kuljum).
English: Provided in a 200 ml amber glass bottle with polypropylene child resistant closure and a 6 ml low density polyethylene (LDPE) oral dosing pipette with 0.2 ml gradations.
Maltese: Ipprovduta fi flixkun tal-ħġieġ ta' 200 ml ta' lewn safrani b'tapp tal-polypropylene li ma jistax jinfetaħ mit-tfal u pipetta tad-dożaġġ orali ta' 6 ml talpolyethylene (LDPE) b'densità baxxa bi gradazzjonijiet ta' 0.2 ml.
English: prezista 150 mg (this is only applicable to the outer pack)
Maltese: prezista 150 mg (din tapplika biss għall-pakkett ta' barra)
English: 50 milligram (0.6 milliliter)
Maltese: 380 milligramma (3.8 millilitri) 50 milligramma (0.6 millilitri)
English: Musculoskeletal and connective tissue disorders uncommon myalgia, osteonecrosis, muscle spasms, muscular weakness, arthralgia, pain in extremity, osteoporosis, increased blood creatine phosphokinase rare musculoskeletal stiffness, arthritis, joint stiffness
Maltese: Disturbi muskolu-skeltriki u tat-tessuti konnettivi mhux komuni rari mijalġja, ostjonekrożi, spażmi fil-muskoli, dgħufija fil-muskoli, artralġja, uġigħ fl-idejn u ssaqajn, osteoporożi, żieda fil-creatine phosphokinase fid-demm ebusija muskoloskeletika, artrite, ebusija tal-ġog
English: PREZISTA/ritonavir 600/100 mg twice daily + OBR N=298
Maltese: PREZISTA/ritonavir 600/100 mg darbtejn kuljum + OBR N=298
English: One ritonavir a dose is between 15 and 30 kilograms
Maltese: Doża waħda ta' ritonavir a hija bejn 15 u 30 kilogramma
English: See the Summary of Product Characteristics for PREZISTA 100 mg/ml oral suspension, 75 mg, 150 mg, 300 mg or 600 mg tablets.
Maltese: Ara s-Sommarju tal-Karattesitiċi tal-Prodott għal PREZISTA 100 mg/ml suspensjoni orali, 75 mg, 150 mg, 300 mg jew 600 mg. * DRV-RAMs:
English: For dosage recommendations in children, see the Summary of Product Characteristics for PREZISTA 75 mg, 150 mg, 300 mg, 600 mg tablets and 100 mg/ml oral suspension.
Maltese: Għal rakkomandazzjonijiet dwar id-dożaġġ fi tfal, ara s-Sommarju tal-Karatteristiċi tal-Prodott għal PREZISTA 75 mg, 150 mg, 300 mg, 600 mg pilloli u 100 mg/ml suspensjoni orali.
English: Based on theoretical considerations PREZISTA is expected to increase alfuzosin plasma concentrations.
Maltese: Abbażi ta' konsiderazzjonijiet teoretiċi PREZISTA huwa mistenni li jżid ilkonċentrazzjonijiet ta' alfuzosin filplażma.
English: 300 mg once daily atazanavir AUC ↔ atazanavir Cmin ↑ 52% atazanavir Cmax ↓ 11% darunavir AUC ↔ darunavir Cmin ↔ darunavir Cmax ↔
Maltese: Impedituri ta' Protease (PIs) ta' HIV - mingħajr l-għoti addizzjonali ta' doża baxxa ta' ritonavir flimkien magħhom Atazanavir 300 mg darba kuljum atazanavir AUC ↔ atazanavir Cmin ↑ 52% atazanavir Cmax ↓ 11% darunavir AUC ↔ darunavir Cmin ↔ darunavir Cmax ↔
English: One PREZISTA dose is
Maltese: PREZISTA pilloli
English: The evidence of efficacy of PREZISTA/ritonavir 800/100 mg once daily is based on the analyses of 192 week data from the randomised, controlled, open-label Phase III trial ARTEMIS in antiretroviral treatment-naïve HIV-1 infected patients comparing PREZISTA/ritonavir 800/100 mg once daily with lopinavir/ritonavir 800/200 mg per day (given as a twice-daily or as a once-daily regimen).
Maltese: Effikaċja ta' PREZISTA 800 mg darba kuljum amministrat flimkien ma' 100 mg ritonavir darba kuljum f'pazjenti li qatt ma ħadu kura b'ART qabel L-evidenza tal-effikaċja ta' PREZISTA/ritonavir 800/100 mg darba kuljum hija bbażata fuq l-analiżi ta' dejta ta' 192 ġimgħa mill-prova tal-Fażi III, randomised, ikkontrollata, open-label ARTEMIS f'pazjenti infettati b'HIV-1 li qatt ma' ħadu kura b'ART qabel fejn PREZISTA/ritonavir 800/100 mg darba kuljum. tqabbel ma' lopinavir/ritonavir 800/200 mg kuljum (mogħti fi skeda ta' darbtejn kuljum jew darba kuljum).
English: Concomitant use of PREZISTA with low dose ritonavir and corticosteroids that are metabolised by CYP3A (e.g. fluticasone propionate or other inhaled or nasal corticosteroids) may increase the risk of development of systemic corticosteroid effects, including Cushing's syndrome and adrenal suppression.
Maltese: L-użu flimkien ta' PREZISTA intensifikat ma' kortikosterojdi li jiġu metabolizzati permezz ta' CYP3A (eż. fluticasone propionate jew kortikosterojdi oħra li jinġibdu man-nifs jew li jingħataw minn ġol-imnieħer) jista' jżid ir-riskju li jiżviluppaw effetti sistemiċi talkoritkosterojdi, inkluż is-sindrom ta' Cushing u soppressjoni talglandoli adrenali.
English: Talk to your doctor about the signs and symptoms of liver problems.
Maltese: Kellem lit-tabib tiegħekdwar is-sinjali u sintomi ta' problemi tal-fwied.
English: 90 film-coated tablets (3 bottles containing 30 tablets each) The bottles are not to be distributed individually.
Maltese: 90 pilloli miksijin b'rita (3 fliexken li fihom 30 pilloli kull wieħed) Il-fliexken m'għandhomx jitqassmu individwalment.
English: PREZISTA, co-administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (HIV-1) infection (see section 4.2).
Maltese: PREZISTA, mogħti flimkien ma' doża baxxa ta' ritonavir huwa indikat, flimkien ma' prodotti mediċinali antiretrovirali oħra, għall-kura ta' pazjenti b'infezzjoni bil-virus uman ta' limmunodefiċjenza (HIV-1) (ara sezzjoni 4.2).
English: In the 96 week analysis, the safety profile of PREZISTA/ritonavir 800/100 mg once daily in treatment-naïve subjects was similar to that seen with PREZISTA/ritonavir 600/100 mg twice daily in treatment-experienced subjects except for nausea which was observed more frequently in treatment-naïve subjects.
Maltese: Fis-96 ġimgħa ta' analiżi, il-profil ta' sigurtà ta' PREZISTA/ritonavir 800/100 mg darba kuljum f'individwi li qatt ma ħadu kura qabel kien jixbah lil dak li jidher bi PREZISTA/ritonavir 600/100 mg darbtejn kuljum f'pazjenti li jkunu diġà ħadu kura qabel minbarra t-tqalligħ li kien osservat aktar frekwenti f'individwi li qatt ma kienu ħadu kura qabel.
English: PREZISTA 75 mg film-coated tablets Tablet core
Maltese: PREZISTA 75 mg pilloli miksijin b'rita Qalba tal-pillola
English: Each film-coated tablet contains 75 mg darunavir (as ethanolate).
Maltese: Kull pillola miksija b'rita fiha 75 mg darunavir (bħala ethanolate).
English: POWER 1 and POWER 2 are randomised, controlled trials comparing PREZISTA co-administered with ritonavir (600/100 mg twice daily) with a control group receiving an investigator-selected PI(s) regimen in HIV-1 infected patients who had previously failed more than 1 PI containing regimen.
Maltese: POWER 1 u POWER 2 huma provi kkontrollati randomised li jqabblu PREZISTA mogħti flimkien ma' ritonavir (600/100 mg darbtejn kuljum) ma' grupp ta' kontroll li qed jirċievu skeda ta' għoti ta' dożi ta' PIs magħzula mill-investigatur f'pazjenti infettati bl-HIV-1 li qabel kienu fallew aktar minn skeda waħda ta' għoti ta' dożi li kien fih PI. OBR li kien jikkonsisti f'min ta' lanqas 2 NRTIs b'enfuvirtide (ENF) jew mingħajru intuża fiż-żewġ provi.
English: PREZISTA 800 mg film-coated tablets Each film-coated tablet contains 800 mg of darunavir (as ethanolate).
Maltese: PREZISTA 800 mg pilloli miksijin b'rita Kull pillola miksija b'rita fiha 800 mg ta' darunavir (bħala ethanolate).
English: - 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: - 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 - simvastatin, lovastatin u lomitapide (ara sezzjoni 4.5) - dabigatran, ticagrelor (ara sezzjoni 4.5).
English: Each ml of oral suspension contains 100 mg of darunavir (as ethanolate).
Maltese: Kull ml ta' suspensjoni orali fih 100 mg ta' darunavir (bħala ethanolate).
English: 6/l (see section 4.1) a regimen of 800 mg once daily with cobicistat 150 mg once daily or ritonavir 100 mg once daily taken with food may be used.
Maltese: 6/l fil-plażma (ara sezzjoni 4.1), tista' tintuża l-iskeda ta' għoti ta' dożi ta' 800 mg darba kuljum ma' cobicistat 150 mg darba kuljum jew ritonavir 100 mg darba kuljum mal-ikel.
English: Therapy with PREZISTA/cobicistat should not be initiated during pregnancy, and women who become pregnant during therapy with PREZISTA/cobicistat should be switched to an alternative regimen (see sections 4.2 and 4.4).
Maltese: Terapija bi PREZISTA/cobicistat m'għandhiex tinbeda waqt it-tqala, u nisa li joħorġu tqal waqt it-terapija bi PREZISTA/cobicistat għandhom jinqalbu għal skeda alternattiva (ara sezzjonjiet 4.2 u 4.4).
English: Nervous system disorders common headache, peripheral neuropathy, dizziness uncommon lethargy, paraesthesia, hypoaesthesia, dysgeusia, disturbance in attention, memory impairment, somnolence rare syncope, convulsion, ageusia, sleep phase rhythm disturbance
Maltese: Disturbi fis-sistema nervuża komuni uġigħ ta' ras, newropatija periferali, sturdament mhux komuni rari letarġija, paraestesija, ipoestesija, disgewżja, disturb fl-attenzjoni, indeboliment tal-memorja, ħeddla ta' rqad,
English: PREZISTA 150 mg film-coated tablets Each film-coated tablet contains 150 mg of darunavir (as ethanolate).
Maltese: PREZISTA 150 mg pilloli miksijin b'rita Kull pillola miksija b'rita fiha 150 mg ta' darunavir (bħala ethanolate).
English: ART-experienced paediatric patients from the age of 6 to < 18 years, and weighing at least 20 kg DELPHI is an open-label, Phase II trial evaluating the pharmacokinetics, safety, tolerability, and efficacy of PREZISTA with low dose ritonavir in 80 ART-experienced HIV-1 infected paediatric patients aged 6 to 17 years and weighing at least 20 kg.
Maltese: Pazjenti pedjatriċi mill-età ta' 6 snin sa < 18-il sena u li jiżnu tal-anqas 20 kg b'esperjenza ta' ART DELPHI hija prova open-label tal-Fażi II li tevalwa l-farmakokinetika, is-sigurtà, it-tollerabilità u leffikaċja ta' PREZISTA flimkien ma' doża baxxa ta' ritonavir fi 80 pazjent tifel/tifla infettati b' HIV-1 li diġà ħadu kura b'ART qabel li għandhom minn 6 snin sa 17-il sena u li jiżnu mill-anqas 20 kg.
English: PREZISTA 600 mg film-coated tablets EU/1/06/380/002
Maltese: PREZISTA 600 mg pilloli miksijin b'rita EU/1/06/380/002
English: PREZISTA 300 mg film-coated tablets EU/1/06/380/001
Maltese: PREZISTA 300 mg pilloli miksijin b'rita EU/1/06/380/001
English: PREZISTA 400 mg film-coated tablets EU/1/06/380/003
Maltese: PREZISTA 400 mg pilloli miksijin b'rita EU/1/06/380/003
English: PREZISTA must always be given orally with low dose ritonavir as a pharmacokinetic enhancer and in combination with other antiretroviral medicinal products.
Maltese: PREZISTA għandu dejjem jingħata mill-ħalq flimkien ma doża baxxa ta' ritonavir li jservi ta' intensifikatur farmakokinetiku u flimkien ma' prodotti mediċinali antiretrovirali oħra.
English: For clinical trial results in ART-naïve paediatric patients aged 12 to 17 years, refer to the Summary of Product Characteristics for PREZISTA 400 mg and 800 mg tablets or PREZISTA 100 mg/ml oral suspension.
Maltese: Għar-riżultati mill-provi kliniċi f'pazjenti pedjatriċi bejn it-12 sa 17-il sena li ma ngħatawx kura b'ART, irreferi għas-Sommarju tal-Karatteristiċi tal-Prodott għal PREZISTA pilloli ta' 400 mg u 800 mg jew PREZISTA 100 mg/ml suspensjoni orali.
English: Number of subjects with virologic failure a and phenotype data that show resistance to PIs at endpoint c, n/N
Maltese: RAMs għall-PI Numru ta' individwi, b'falliment viroloġiku a u dejta ta' fenotip li juri reżistenza għall-PIs, fil-punt finali c, n/N
English: - PREZISTA 75 milligram and 150 milligram tablets and 100 milligram per milliliter oral suspension have been developed for use in children, but can also be used in adults in some cases.
Maltese: - Pilloli PREZISTA 75 milligramma u 150 milligramma u 100 milligramma għal kull millilitru ta' suspensjoni oral ġew żviluppati għall-użu fit-tfal, iżda f'xi każijiet jistgħu jintużaw ukoll fladulti.
English: PREZISTA 400 mg film-coated tablets 3 years
Maltese: PREZISTA 400 mg pilloli miksijin b'rita 3 snin
English: At least 3 oxidative metabolites of darunavir have been identified in humans; all showed activity that was at least 10-fold less than the activity of darunavir against wild type HIV.
Maltese: Ta' lanqas 3 sustanzi ossidattivi iffurmati millmetaboliżmu ta' darunavir kienu identifikati fil-bnedmin; kollha wrew attività li kienet ta' lanqas 10 darbiet anqas mill-attività ta' darunavir kontra l-HIV li jinstab fin-natura.
English: Film-coated tablet.
Maltese: Aħżen fil-pakkett oriġinali.
English: Boosted PREZISTA is expected to increase these antipsychotic plasma concentrations.
Maltese: PREZISTA intensifikat huwa mistenni li jżid il-konċentrazzjonijiet ta' dawn l-antipsikotiċi fil-plażma.
English: HIV-1 RNA < 50 copies/ml CD4+ percent change from baseline CD4+ cell count mean change from baseline
Maltese: HIV-1 RNA < 50 kopja/ml Għadd taċ-ċelluli CD4+ bidla medja mill-linja bażi
English: Blood and lymphatic system disorders uncommon thrombocytopenia, neutropenia, anaemia, leukopenia rare increased eosinophil count
Maltese: Disturbi tad-demm u tas-sistema limfatika mhux komuni rari tromboċitopenija, newtropenija, anemija, lewkopenija żieda fl-għadd ta' eosinofili
English: prezista 75 mg (this is only applicable to the outer pack)
Maltese: prezista 75 mg (din tapplika biss għall-pakkett ta' barra)
English: At 48 weeks non-inferiority in virologic response to the PREZISTA/ritonavir treatment, defined as the percentage of patients with plasma HIV-1 RNA level < 400 and < 50 copies/ml, was demonstrated (at the pre-defined 12% non-inferiority margin) for both ITT and OP populations.
Maltese: Fit-48 ġimgħa in-nuqqas ta' inferjorità fir-rispons viroloġiku bi PREZISTA/ritonavir, definit bħala lperċentwal ta' pazjenti b'livell ta' < 400 kopja/ml u < 50 ta' HIV-1 RNA fil-plażma, intwera (filmarġini ta' 12% ddefinit minn qabel għan-nuqqas ta' inferjorità) kemm għal popolazzjonijiet ITT kif ukoll OP.
English: Administration of darunavir did not cause a statistically significant increase in the incidence of any other benign or malignant neoplasm in mice or rats.
Maltese: L-amministrazzjoni ta' darunavir ma kkawżatx żieda statistikament sinifikanti ta' kwalunkwe neoplażmu beninn jew malinn ieħor fil ġrieden u l-firien.
English: PREZISTA/ritonavir, the PREZISTA/ritonavir 600/100 mg twice daily regimen should be used (see section 4.4).
Maltese: Jekk efavirenz se jintuża flimkien ma' PREZISTA/ritonavir, għandha tintuża l-iskeda ta' għoti ta' dożi ta' PREZISTA/ritonavir 600/100 mg darbtejn kuljum (ara sezzjoni 4.4).
English: Boosted PREZISTA is expected to increase these antineoplastic plasma concentrations.
Maltese: PREZISTA intensifikat huwa mistenni li jżid il-konċentrazzjonijiet ta' dawn l-antineoplastiċi fil-plażma.
English: prezista 300 mg (this is only applicable to the outer pack)
Maltese: prezista 300 mg (din tapplika biss għall-pakkett ta' barra)
English: Based on theoretical considerations PREZISTA co-administered with cobicistat is expected to increase metformin plasma concentrations.
Maltese: Abbażi ta' konsiderazzjonijiet teoretiċi PREZISTA mogħti flimkien ma' cobicistat huwa mistenni li jżid il-konċentrazzjonijiet ta' metformin fil-plażma.
English: PREZISTA 600 mg film-coated tablets darunavir
Maltese: PREZISTA 600 mg pilloli miksijin b'rita darunavir
English: - In the evening, take 600 milligram PREZISTA together with 100 milligram ritonavir.
Maltese: - Filgħodu, ħu 600 milligramma PREZISTA flimkien ma' 100 milligramma ritonavir.
English: Opaque, white, high density polyethylene (HDPE) plastic, 160 ml bottle containing 480 tablets, fitted with polypropylene (PP) child resistant closure.
Maltese: Flixkun opak abjad tal-plastik polyethylene ta' densità għolja (HDPE), flixkun ta' 160 ml li fih 480 pillola, magħluq b'għatu tal-polypropylene (PP) li ma' jinfetaħx mit-tfal.
English: PREZISTA 300 mg film-coated tablets darunavir
Maltese: PREZISTA 300 mg pilloli miksijin b'rita darunavir
English: (CYP3A and/or P-gp inhibition)
Maltese: (impediment ta' CYP3A u/jew ta' P-gp)
English: Co-administration of domperidone with boosted PREZISTA is contraindicated.
Maltese: L-għoti ta' domperidone flimkien ma' PREZISTA intensifikat huwa kontraindikat.
English: • 12 ART-naïve HIV-1 infected paediatric patients aged from 12 to 17 years and weighing at least 40 kg who received PREZISTA tablets with low dose ritonavir once daily in combination with other antiretroviral agents (see section 5.1).
Maltese: • 12-il pazjent pedjatriku infettat ta' etajiet bejn 12 sa 17-il sena b'HIV-1 li ma kinux ikkurati qabel b'ART u li kienu jiżnu inqas minn 40 kg li rċevew pilloli ta' PREZISTA ma' doża baxxa ta' ritonavir darba kuljum f'kombinazzjoni ma' sustanzi antiretrovirali (ara sezzjoni 5.1).
English: No new safety findings were identified in the 192 week analysis of the treatment-naïve subjects in which the mean treatment duration of PREZISTA/ritonavir 800/100 mg once daily was 162.5 weeks.
Maltese: Ma ġewx identifikati sejbiet oħra ta' sigurtà fil-192 ġimgħa ta' analiżi f'individwi li qatt ma ħadu kura qabel li kellhom medja ta' tul ta' kura bi PREZISTA/ritonavir 800/100 mg darba kuljum ta' 162.5 ġimgħat.
English: Concomitant administration of boosted PREZISTA with dabigatran or ticagrelor is contraindicated (see section 4.3).
Maltese: L-għoti ta' PREZISTA intensifikat flimkien ma' dabigatran jew ticagrelor huwa kontraindikat (ara sezzjoni 4.3).
English: The use of carbamazepine with PREZISTA co-administered with cobicistat is contraindicated (see section 4.3).
Maltese: L-użu ta' carbamazepine ma' PREZISTA mogħti flimkien ma' cobicistat huwa kontraindikat (ara sezzjoni 4.3).
English: Boosted PREZISTA with triazolam or oral midazolam is contraindicated (see section 4.3)
Maltese: PREZISTA intensifikat flimkien ma' triazolam jew midazolam orali huwa kontraindikat (ara sezzjoni
English: Co-administration of darunavir and ritonavir with medicinal products primarily metabolised by CYP2C9 (such as warfarin) and CYP2C19 (such as methadone) may result in decreased systemic exposure to such medicinal products, which could decrease or shorten their therapeutic effect.
Maltese: L-amministrazzjoni ta' darunavir u ritonavir ma' prodotti mediċinali primarjament immetabolizzati minn CYP2C9 (bħal warfarin) u CYP2C19 (bħal methadone) tista' twassal għal esponiment sistemiku mnaqqas għal dawn il-prodotti mediċinali, li jista' jnaqqas jew iqassar l-effett terapewtiku tagħhom.
English: HIV-1 RNA < 50 copies/ml CD4+ percent change from baseline CD4+ cell count mean change from baseline ≥ 1.0 log10 decrease from baseline in plasma viral load
Maltese: HIV-1 RNA < 50 kopji/ml CD4+ bidla perċentwali mil-linja bażi CD4+ bidla medja tal-għadd taċ-ċelluli mil-linja bażi
English: 120 film-coated tablets
Maltese: 120 pilloli miksijin b'rita
English: PREZISTA is also available as 150 milligram, 300 milligram, 400 milligram, 600 milligram and 800 milligram film-coated tablets and 100 milligram per milliliter oral suspension.
Maltese: PREZISTA huwa disponibbli wkoll bħala pilloli miksija b'rita ta' 150 milligramma, 300 milligramma, 400 milligramma, 600 milligramma u 800 milligramma u 100 milligramma kull millilitru suspensjoni orali.
English: Pharmacokinetic results of total darunavir after administration of darunavir/cobicistat 800/150 mg once daily as part of an antiretroviral regimen, during the second trimester of pregnancy, the third trimester of pregnancy, and postpartum Pharmacokinetics of total darunavir (mean ± SD)
Maltese: Riżultati farmakokinetiċi ta' darunavir totali wara għoti ta' darunavir/cobicistat bid-doża ta' 800/150 mg darba kuljum bħala parti minn skeda antiretrovirali, waqt it-tieni trimestru tattqala, it-tielet trimestru tat-tqala u wara t-twelid Farmakokinetika ta' darunavir totali (medja ± SD)
English: PREZISTA 400 mg film-coated tablets darunavir
Maltese: PREZISTA 400 mg pilloli miksijin b'rita darunavir