FrancophonIA/ELRC3.0 huggingface dataset:
English: Hence, concomitant use of PREZISTA co-administered with low dose ritonavir and the combination product lopinavir/ritonavir is contraindicated (see section 4.3).
Maltese: Għalhekk, l-użu konkomitanti ta' PREZISTA intensifikat u t-taħlita tal-prodott lopinavir/ritonavir hija kontraindikata (ara sezzjoni 4.3).
English: PREZISTA 150 mg film-coated tablets Tablet core
Maltese: PREZISTA 150 mg pilloli miksijin b'rita Qalba tal-pillola
English: This can be seen in a blood test. - high blood pressure, flushing - red or dry eyes - fever, swelling of lower limbs due to fluids, malaise, irritability, pain - symptoms of infection, herpes simplex - erectile dysfunction, enlargement of breasts - sleeping problems, sleepiness, depression, anxiety, abnormal dreams, decrease in sexual drive
Maltese: - pressjoni għolja, fwawar - għajnejn ħomor jew xotti - deni, nefħa fir-riġlejn minħabba fluwidi, telqa mingħajr sinjal ta' mard, irritabilità, uġigħ - sintomi ta' infezzjoni, herpes simplex - abnormalità erettili, tkabbir tas-sider - problemi bl-irqad, xejra ta' ngħas, depressjoni, ansjetà, ħolm mhux normali, tnaqqis fil-ġibda sesswali
English: PREZISTA 800 mg film-coated tablets darunavir
Maltese: PREZISTA 800 mg pilloli miksijin b'rita darunavir
English: prezista 400 mg (this is only applicable to the outer pack)
Maltese: prezista 400 mg (din tapplika biss għall-pakkett ta' barra)
English: PREZISTA co-administered with low dose ritonavir can be expected to increase the plasma concentrations of calcium channel blockers.
Maltese: PREZISTA mogħti flimkien ma' doża baxxa ta' ritonavir jista' jkun mistenni li jżid il-konċentrazzjonijiet ta' imblokkaturi tal-kanali tal-kalċju filplażma.
English: (CYP3A and/ or P-gp inhibition)
Maltese: (inibizzjoni ta' CYP3A u/jew P-gp)
English: Opaque, white, high density polyethylene (HDPE) plastic, 160 ml bottle containing 120 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 120 pillola, magħluq b'għatu tal-polypropylene (PP) li ma' jinfetaħx mit-tfal.
English: Each film-coated tablet contains 800 mg darunavir (as ethanolate).
Maltese: Kull pillola miksija b'rita fiha 800 mg darunavir (bħala ethanolate).
English: The overall pharmacokinetic enhancement effect by ritonavir was an approximate 14-fold increase in the systemic exposure of darunavir when a single dose of 600 mg darunavir was given orally in combination with ritonavir at 100 mg twice daily (see section 4.4).
Maltese: titjib farmakokinetiku totali permezz ta' ritonavir kien ta' żieda ta' bejn wieħed u ieħor 14-il darba flesponiment sistemiku ta' darunavir meta doża waħda ta' darunavir 600 mg ingħatat mill-ħalq flimkien ma' ritonavir f'doża ta' 100 mg darbtejn kuljum (ara sezzjoni 4.4).
English: Pharmacokinetic results of total darunavir after administration of darunavir/ritonavir at 600/100 mg twice 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/ritonavir bid-doża ta' 600/100 mg darbtejn kuljum bħala parti minn kors antiretrovirali terapewtiku, waqt it-tieni trimestru tat-tqala, it-tielet trimestru tat-tqala u wara t-twelid Il-farmakokinetika ta' darunavir totali (medja ± SD)
English: PREZISTA 800 mg film-coated tablets
Maltese: PREZISTA 800 mg pilloli miksijin b'rita
English: PREZISTA 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 għandu dejjem jingħata mill-ħalq flimkien ma' doża baxxa ta' ritonavir bħala intensifikatur farmakokinetiku u flimkien ma' prodotti mediċinali antiretrovirali oħra (ara sezzjoni 5.2).
English: Imputations according to the TLOVR algorithm
Maltese: Imputazzjonijiet skont l-algoritmu TLOVR
English: PREZISTA 300 mg film-coated tablets
Maltese: PREZISTA 300 mg pilloli miksijin b'rita
English: For clinical trial results in ART-naïve adult patients, refer to the Summary of Product Characteristics for PREZISTA 400 mg and 800 mg tablets or 100 mg/ml oral suspension.
Maltese: Għal riżultati minn provi kliniċi f'pazjenti adulti li qatt ma ħadu kura b'ART qabel, irreferi għasSommarju tal-Karatteristiċi tal-Prodott tal-pilloli PREZISTA ta' 400 mg u 800 mg jew suspensjoni orali ta' 100 mg/ml.
English: Concominant administration of PREZISTA with low dose ritonavir and lurasidone, pimozide or sertindole is contraindicated (see section 4.3).
Maltese: L-għoti fl-istess waqt ta' PREZISTA flimkien ma' doża baxxa ta' ritonavir u lurasidone, pimozide jew sertindole huwa kontraindikat (ara sezzjoni 4.3).
English: ODIN is a Phase III, randomised, open-label trial comparing PREZISTA/ritonavir 800/100 mg once daily versus PREZISTA/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: Numru ta' tibdiliet ġenetiċi mill-lista ta' tibdiliet ġenetiċi assoċjati ma' nuqqas ta' rispons għall-PREZISTA/ritonavir (V11I, V32I, L33F, I47V, I50V, I54L jew M, T74P, L76V, I84V jew L89V) drabi ta' bidla fl-EC50
English: PREZISTA 400 mg film-coated tablets
Maltese: PREZISTA 400 mg pilloli miksijin b'rita
English: Opaque, white, high density polyethylene (HDPE) plastic, 160 ml bottle containing 240 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 240 pillola, magħluq b'għatu tal-polypropylene (PP) li ma' jinfetaħx mit-tfal.
English: Other severe side effects were diabetes (common) and inflammation of the pancreas (uncommon).
Maltese: Effetti sekondarji severi oħra kienu dijabete (komuni), u infjammazzjoni tal-frixa (mhux komuni).
English: Based upon the findings, the carbamazepine dose may need to be reduced by 25% to 50% in the presence of PREZISTA/ritonavir.
Maltese: Fuq bażi tas-sejbiet, id-doża ta' carbamazepine tista' tkun teħtieġ tnaqqis b'25% sa 50% fil-preżenza ta' PREZISTA/ritonavir.
English: Patients co-infected with hepatitis B and/or hepatitis C virus Among 1,968 treatment-experienced patients receiving PREZISTA co-administered with ritonavir 600/100 mg twice daily, 236 patients were co-infected with hepatitis B or C. Co-infected patients were more likely to have baseline and treatment emergent hepatic transaminase elevations than those without chronic viral hepatitis (see section 4.4).
Maltese: Fost 1,968 pazjent li kienu ħadu kura qabel u li kienu qed jirċievu PREZISTA flimkien ma' ritonavir 600 mg/100 mg darbtejn kuljum, 236 pazjent kienu co-infettati bl-epatite B jew Ċ.
English: - Tell your doctor if you have had problems with your liver before, including hepatitis B or C infection.
Maltese: - Għid lit-tabib tiegħek jekk fil-passat kellek problemi bil-fwied, inkluż infezzjoni tal-epatite B jew Ċ.
English: PREZISTA 600 mg film-coated tablets
Maltese: PREZISTA 600 mg pilloli miksijin b'rita
English: - slowing down of the thyroid gland function.
Maltese: milligramma ritonavir darba kuljum.
English: PREZISTA is also available as 75 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' 75 milligramma, 300 milligramma, 400 milligramma, 600 milligramma u 800 milligramma u 100 milligramma/ml suspensjoni orali.
English: - Take PREZISTA always together with 150 milligram of cobicistat or100 milligram of ritonavir.
Maltese: - Dejjem ħu PREZISTA flimkien ma' 150 milligramma ta' cobicistat jew 100 milligramma ta'
English: Opaque, white, high density polyethylene (HDPE) plastic, 160 ml bottle containing 60 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 60 pillola, magħluq b'għatu tal-polypropylene (PP) li ma' jinfetaħx mit-tfal.
English: Each film-coated tablet contains 150 mg darunavir (as ethanolate).
Maltese: Kull pillola miksija b'rita fiha 150 mg darunavir (bħala ethanolate).
English: Metabolism and nutrition disorders common diabetes mellitus, hypertriglyceridaemia, hypercholesterolaemia, hyperlipidaemia uncommon gout, anorexia, decreased appetite, decreased weight, increased weight, hyperglycaemia, insulin resistance, decreased high density lipoprotein, increased appetite, polydipsia, increased blood lactate dehydrogenase
Maltese: mhux komuni gotta, anoreksja, tnaqqis fl-aptit, tnaqqis fil-piż, żieda fil-piż, ipergliċemija, reżistenza għallinsulina, tnaqqis fil-lipoproteina ta' densità għolja, żieda fl-aptit, polidipsja, żieda fil-lactate dehydrogenase fid-demm
English: The pharmacokinetics of darunavir in combination with ritonavir taken once daily in 12 ART-naïve paediatric patients, aged 12 to < 18 years and weighing at least 40 kg, showed that PREZISTA/ritonavir 800/100 mg once daily results in darunavir exposure that was comparable to that achieved in adults receiving PREZISTA/ritonavir 800/100 mg once daily.
Maltese: Il-farmakokinetiċi ta' darunavir flimkien ma' ritonavir li ttieħed darbta kuljum fi 12-il pazjent pedjatriku mhux ikkurati b'ART, ta' bejn 12 sa < 18-il sena u li kienu jiżnu inqas minn 40 kg, urew li PREZISTA/ritonavir 800/100 mg darba kuljum irriżulta f'esponiment għal darunavir li kien komparabbli ma dak miksub f'adulti li rċevew PREZISTA/ritonavir 800/100 mg darba kuljum.
English: Boosted PREZISTA is expected to increase these antiarrhythmic plasma concentrations.
Maltese: PREZISTA intensifikat huwa mistenni li jżid dawn ilkonċentrazzjonijiet ta' antiarritmiċi filplażma.
English: Furthermore, AUC of the sum of active moieties of rifabutin (parent drug + 25-O-desacetyl metabolite) was increased 1.6-fold, while Cmax remained comparable.
Maltese: Barra minn hekk, l-AUC tat-total tan-nofsijiet attivi ta' rifabutin (mediċina oriġinali + il-metabolit 25-O-desacetyl) żdiedet b'1.6 drabi aktar, filwaqt li s-Cmax baqgħet kumparabbli.
English: - PREZISTA 75 milligram and 150 milligram tablets and 100 milligram per milliliter oral suspension have been developed for use in children weighing less than 40 kilograms, but can also be used in some cases.
Maltese: - Pilloli PREZISTA 75 milligramma u 150 milligramma u suspensjoni orali ta' 100 milligramma għal kull millilitru ġew żviluppati għall-użu fit-tfal li jiżnu anqas minn 40 kilogramma, iżda jistgħu jintużaw ukoll f'xi każijiet.
English: Concominant use of everolimus or irinotecan and boosted PREZISTA is not recommended.
Maltese: L-użu flimkien ta' everolimus jew irinotecan u PREZISTA intensifikat mhuwiex irrakkomandat.
English: Co-administration of boosted PREZISTA with clonazepam may increase concentrations of clonazepam.
Maltese: L-għoti ta' PREZISTA intensifikat flimkien ma' clonazepam jista' jżid il-konċentrazzjonijiet ta' clonazepam.
English: (↑ efavirenz from CYP3A inhibition) (↓ darunavir from CYP3A induction)
Maltese: (↑ nevirapine minn impediment ta' CYP3A)
English: - In the evening, take two 300 milligram PREZISTA tablets together with 100 milligram ritonavir.
Maltese: - Filgħaxija, ħu żewġ pilloli ta' 300 milligramma PREZISTA flimkien ma' 100 milligramma ritonavir.
English: 600 milligram PREZISTA + 100 milligram ritonavir twice a day * For children aged 12 or more and weighing at least 40 kilograms, your child's doctor will determine if PREZISTA
Maltese: 600 milligramma PREZISTA + 100 milligramma ritonavir darbtejn kuljum * Għal tfal ta' 12-il sena jew aktar u li jiżnu tal-anqas 40 kilogramma, it-tabib tat-tifel jew tifla tiegħek ser jistabilixxi jekk tistax tintuża d-doża ta' PREZISTA 800 milligramma darba kuljum.
English: Medicinal products that affect darunavir exposure (ritonavir as pharmacoenhancer) Darunavir and ritonavir are metabolised by CYP3A.
Maltese: Prodotti mediċinali li jaffettwaw l-esponiment għal darunavir (ritonavir bħala farmokointensifikatur)
English: Co-administration of boosted PREZISTA and naloxegol is contraindicated.
Maltese: L-għoti ta' PREZISTA intensifikat flimkien ma' naloxegol huwa kontraindikat.
English: Cmax, ng/ml AUC24h, ng.h/ml Cmin, ng/ml
Maltese: Cmax, ng/mL
English: Recommended dose for treatment-naïve paediatric patients (3 to 17 years) with PREZISTA tablets and ritonavir
Maltese: Doża rakkomandata għal pazjenti pedjatriċi (minn 3 snin sa 17-il sena) li diġà ħadu kura bi PREZISTA u ritonavir
English: • 80 ART-experienced HIV-1 infected paediatric patients aged from 6 to 17 years and weighing at least 20 kg who received PREZISTA tablets with low dose ritonavir twice daily in combination with other antiretroviral agents.
Maltese: • 80 pazjent pedjatriku infettati b'HIV-1 li kienu diġà ħadu kura b'ART qabel li kellhom minn 6 snin sa 17-il sena u li kienu jiżnu mill-anqas 20 kg li rċievew pilloli PREZISTA flimkien ma' doża baxxa ta' ritonavir darbtejn kuljum flimkien ma' sustanzi antiretrovirali oħra.
English: The pharmacokinetics of darunavir in combination with ritonavir taken twice daily in 74 treatment-experienced paediatric patients, aged 6 to 17 years and weighing at least 20 kg, showed that the administered weight-based doses of PREZISTA/ritonavir resulted in darunavir exposure comparable to that in adults receiving PREZISTA/ritonavir 600/100 mg twice daily (see section 4.2).
Maltese: Il-farmakokinetika ta' darunavir meta ngħata flimkien ma' ritonavir li ttieħed darbtejn kuljum f'74 pazjent tifel/tifla li kienu diġà ħadu kura qabel, li kellhom minn 6 snin sa 17-il sena u kienu jiżnu mill-anqas 20 kg, uriet li d-dożi ta' PREZISTA/ritonavir mogħtija skont il-piż irriżultaw f'esponiment għal darunavir li jaqbel ma' dak fl-adulti li kienu qed jirċievu PREZISTA/ritonavir 600/100 mg darbtejn kuljum (ara sezzjoni 4.2).
English: Pharmacokinetic results of total darunavir after administration of darunavir/ritonavir at 800/100 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/ritonavir bid-doża ta' 800/100 mg darba kuljum bħala parti minn kors terapewtiku antiretrovirali, waqt it-tieni trimestru tat-tqala, it-tielet trimestru tat-tqala u wara t-twelid Il-farmakokinetika ta' darunavir totali (medja ± SD)
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.
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).
English: PREZISTA 300 mg film-coated tablets Tablet core
Maltese: PREZISTA 300 mg pilloli miksijin b'rita Qalba tal-pillola
English: OR - 600 milligram PREZISTA (2 tablets containing 300 milligram of PREZISTA or 1 tablet containing 600 milligram of PREZISTA) together with 100 milligram ritonavir twice daily.
Maltese: (2 tablets pilloli li fihom 300 milligramma ta' PREZISTA jew pillola 1 li fiha 600 milligramma ta' PREZISTA) flimkien ma' 100 milligramma ritonavir darbtejn kuljum.
English: PREZISTA is also available as 75 milligram, 150 milligram, 300 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' 75 milligramma, 150 milligramma, 300 milligramma, 600 milligramma u 800 milligramma u 100 milligramma/millilitru suspensjoni orali.
English: 6/l (see section 4.1) a regimen of 800 mg once daily with ritonavir 100 mg once daily taken with food may be used.
Maltese: 6/l (ara sezzjoni 4.1) skeda ta' 800 mg darba kuljum b'100 mg ritonavir darba kuljum mal-ikel tista' tiġi segwita.
English: PREZISTA is also available as 75 milligram, 150 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' 75 milligramma, 150 milligramma, 400 milligramma, 600 milligramma u 800 milligramma 100 milligramma/millilitru suspensjoni orali.
English: BOTTLE LABEL FOR ORAL SUSPENSION
Maltese: TIKKETTA TAL-FLIXKUN GĦAL SUSPENSJONI ORALI
English: PREZISTA/ritonavir 800/100 mg once daily in ART-experienced patients should not be used in patients with one or more darunavir resistance associated mutations (DRV-RAMs) or HIV-1 RNA ≥ 100,000 copies/ml or CD4+ cell count < 100 cells x 10
Maltese: PREZISTA/ritonavir 800/100 mg darba kuljum f'pazjenti li diġà ħadu ART m'għandux jintuża f'pazjenti b'mutazzjoni waħda jew aktar assoċjati ma' reżistenza għal darunavir (DRV-RAMs) jew HIV-1 RNA ≥ 100,000 kopja/ml jew għadd ta' ċelluli CD4+ < 100 ċelluli x 10
English: Adverse reactions observed with darunavir/cobicistat in adult patients
Maltese: Prodotti mediċinali li jaffettwaw l-esponiment għal darunavir (cobicistat bħala farmakointensifikatur)
English: Pack includes a 6 ml dosing pipette with 0.2 ml gradations.
Maltese: Il-pakkett jinkludi pipetta ta' 6 ml tad-dożaġġ li fiha gradazzjonijiet ta' 0.2 ml.
English: Each film-coated tablet contains 300 mg darunavir (as ethanolate).
Maltese: Kull pillola miksija b'rita fiha 300 mg darunavir (bħala ethanolate).
English: PREZISTA 800 mg film-coated tablets Tablet core
Maltese: PREZISTA 800 mg pilloli miksijin b'rita Qalba tal-pillola
English: PREZISTA 75 mg, 150 mg, 300 mg, and 600 mg tablets can be used to construct the twice daily 600 mg regimen.
Maltese: Il-pilloli PREZISTA 75 mg, 150 mg, 300 mg, u 600 mg jistgħu jintużaw biex tgħaqqad l-iskeda ta' għoti ta' doża ta' 600 mg darbtejn kuljum.
English: Clinical monitoring for central nervous system toxicity associated with increased exposure to efavirenz may be indicated when PREZISTA co-administered with low dose ritonavir is given in combination with efavirenz.
Maltese: Fil-kelb, l-ebda sejbiet ta' tossiċità maġġuri jew organi mimsusa ma' kienu identifikati sa esponimenti ekwivalenti għal esponiment kliniku fid-doża rrakkomandata.
English: Each tablet contains 75 milligram of darunavir (as ethanolate).
Maltese: Kull pillola fiha 75 milligramma ta' darunavir bħala ethanolate.
English: The PREZISTA 800 milligram tablet is used to treat adults and children (3 years of age and above, at least 40 kilograms body weight) who are infected by HIV and - who have not used antiretroviral medicines before.
Maltese: Il-pillola PREZISTA 800 milligramma tintuża għat-trattament ta' adulti u tfal (3 snin u aktar, tal-anqas b'piż tal-ġisem ta' 40 kilogramma)li huma infettati bl-HIV u - li qatt ma kienu użaw mediċini antiretrovirali qabel.
English: Treatment-experienced darunavir/cobicistat 800/150 mg once daily N=18
Maltese: Pazjenti li kienu diġà ħadu kura qabel darunavir/cobicistat 800/150 mg darba kuljum N=18
English: A dose regimen of 800 mg once daily with cobicistat 150 mg once daily or ritonavir 100 mg once daily taken with food may be used in patients with prior exposure to antiretroviral medicinal products but without 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: Skeda ta' kura b'doża ta' 800 mg darba kuljum ma' cobicistat 150 mg darba kuljum jew ritonavir 100 mg darba kuljum meħuda mal-ikel użata f'pazjenti b'esponiment minn qabel għalprodotti mediċinali antiretrovirali iżda mingħajr reżistenza għal darunavir assoċjata ma' mutazzjonijiet (DRV-RAMs)* u li għandhom < 100,000 kopja/ml ta' HIV-1 RNA fil-plażma u għadd ta' ċelluli CD4+ ≥ 100 ċelluli x 10
English: PREZISTA 600 mg film-coated tablets Tablet core
Maltese: PREZISTA 600 mg pilloli miksijin b'rita Qalba tal-pillola
English: Based on theoretical considerations boosted PREZISTA may increase plasma concentrations of these analgesics.
Maltese: Abbażi ta' konsiderazzjonijiet teoretiċi PREZISTA intensifikat jista' jżid ilkonċentrazzjonijiet ta' dawn l-analżeġiċi fil-plażma.
English: 480 film-coated tablets
Maltese: 480 pilloli miksijin b'rita
English: OR - 800 milligram PREZISTA (2 tablets containing 400 milligram of PREZISTA or 1 tablet containing 800 milligram of PREZISTA) together with 100 milligram ritonavir once daily.
Maltese: (2 pilloli li fihom 400 milligramma ta' PREZISTA jew pillola waħda li fiha 800 milligramma ta' PREZISTA) flimkien ma' 100 milligramma ritonavir darba kuljum.
English: Dose for adults who have taken antiretroviral medicines before (your doctor will determine this) The dose is either: - 800 milligram PREZISTA (2 tablets containing 400 milligram of PREZISTA or 1 tablet containing 800 milligram of PREZISTA) together with 150 milligram cobicistat or 100 milligram ritonavir once daily.
Maltese: (2 pilloli li fihom 400 milligramma ta' PREZISTA jew pillola waħda li fiha 800 milligramma ta' PREZISTA) flimkien ma' 150 milligramma ta' cobicistat jew 100 milligramma ritonavir darba kuljum.
English: PREZISTA is also available as 75 milligram, 150 milligram, 300 milligram, 400 milligram and 600 milligram film-coated tablets and 100 milligram per milliliter oral suspension.
Maltese: PREZISTA huwa disponibbli wkoll bħala pilloli miksija b'rita ta' 75 milligramma, 150 milligramma, 300 milligramma, 400 milligramma u 600 milligramma u 100 milligramma/millilitru suspensjoni orali.
English: Number of subjects with virologic failure and paired baseline/endpoint genotypes, developing mutations b at endpoint, n/N Primary (major) PI mutations PI RAMs Number of subjects with virologic failure and paired baseline/endpoint phenotypes, showing loss of susceptibility to PIs at endpoint compared to baseline, n/N PI
Maltese: Numru ta' individwi, b'falliment viroloġiku a u dejta ta' ġenotip li jiżviluppa mutazzjonijiet b,fil-punt finali, n/N
English: Efavirenz in combination with PREZISTA/ritonavir 800/100 mg once daily may result in sub-optimal darunavir Cmin.
Maltese: Dawn il-pazjenti rċevew PREZISTA/ritonavir 800/100 mg darbtejn kuljum f'kombinazzjoni ma sustanzi antiretrovirali oħra.
English: Co-administration of boosted PREZISTA and alfuzosin is contraindicated (see section 4.3).
Maltese: L-għoti ta' PREZISTA intensifikat flimkien ma' alfuzosin huwa kontraindikat (ara sezzjoni 4.3).
English: The efficacy and safety of the use of PREZISTA with 100 mg ritonavir and any other HIV PI (e.g. (fos)amprenavir, nelfinavir and tipranavir) has not been established in HIV patients.
Maltese: L-effikaċja u s-sigurtà tal-użu ta' PREZISTA flimkien ma' 100 mg ritonavir u kwalunkwe PI ta' HIV ieħor (eż. (fos)amprenavir, nelfinavir u tipranavir) ma ġewx stabbiliti f'pazjenti bl-HIV.
English: Each film-coated tablet contains 600 mg darunavir (as ethanolate).
Maltese: Kull pillola miksija b'rita fiha 600 mg darunavir (bħala ethanolate).
English: At 48 weeks, virologic response, defined as the percentage of patients with plasma HIV-1 RNA level < 50 copies/ml, with PREZISTA/ritonavir 800/100 mg once daily treatment was demonstrated to be non-inferior (at the pre-defined 12% non-inferiority margin) compared to PREZISTA/ritonavir 600/100 mg twice daily for both ITT and OP populations.
Maltese: Fil-ġimgħa 48, rispons viroloġiku ddefinit bħala l-perċentwal ta' pazjenti b'livell ta' HIV-1 RNA < 50 kopja/ml fil-plażma, bi PREZISTA/ritonavir 800/100 mg darba kuljum intwera li ma kienx inferjuri (bil-marġini ta' non-inferjorità ta' 12% ddefiniti minn qabel) meta mqabbel ma' PREZISTA/ritonavir 600/100 mg darbtejn kuljum kemm għall-popolazzjonijiet ITT kif ukoll OP.
English: prezista 800 mg (this is only applicable to the outer pack)
Maltese: prezista 800 mg (din tapplika biss għall-pakkett ta' barra)
English: 240 film-coated tablets
Maltese: 240 pilloli miksijin b'rita