FrancophonIA/ELRC3.0 huggingface dataset:
English: White to off-white, capsule shaped, biconvex film-coated tablets approximately 12.75 mm by 6.3 mm debossed with ‘M' on one side and ‘DV2' on the other side.
Maltese: Pilloli miksija b'rita bojod għal offwajt, b'forma ta' kapsula, imbuzzati fuq iż-żewġ naħat, ta' madwar 12.75 mm b'6.3 mm, imnaqqxa b'‘M' fuq naħa waħda u ‘DV2' fuq in-naħa l-oħra.
English: EU/1/16/1140/001 EU/1/16/1140/002 EU/1/16/1140/003 EU/1/16/1140/004 EU/1/16/1140/005
Maltese: EU/1/16/1140/001 EU/1/16/1140/002 EU/1/16/1140/003 EU/1/16/1140/004
English: Darunavir 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: Darunavir, 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: 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 farmakokinetiċi ta' darunavir amministrat flimkien ma' cobicistat jew ritonavir, ġie evalwati f'voluntiera adulti b'saħħithom u f'pazjenti infettati bl-HIV-1.
English: lopinavir AUC ↔ lopinavir Cmin ↑ 13% lopinavir Cmax ↑ 11% darunavir AUC ↓ 41% darunavir Cmin ↓ 55% darunavir Cmax ↓ 21% based upon non dose normalised values
Maltese: lopinavir AUC ↔ lopinavir Cmin ↑ 13% lopinavir Cmax ↑ 11% darunavir AUC ↓ 41% darunavir Cmin ↓ 55% darunavir Cmax ↓ 21%
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 darunavir/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' darunavir/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
English: V.J.
Maltese: IAS-USA
English: copies/ml at the week-8; rebound: HIV-1 RNA < 50 copies/ml followed by confirmed HIV-1 RNA to ≥ 400 copies/ml or confirmed > 1 log10 HIV-1 RNA increase from the nadir; discontinuations with HIV-1 RNA ≥ 400 copies/ml at last visit b IAS-USA lists c In GS-US216-130 baseline phenotype was not available
Maltese: Fallimenti viroloġiċi kienu ddefiniti bħala: qatt ma kienu soppressi: tnaqqis ikkonfermat ta'< 1 log10 ta' RNA ta' HIV-1 mill-linja bażi u ≥ 50 kopja/ml fil-ġimgħa 8; reġgħu ġew lura: < 50 kopja/ml ta' RNA ta' HIV-1 segwiti minn RNA ta' HIV-1 ikkonfermat sa ≥ 400 kopja/ml jew żieda kkonfermata ta' > 1 log10 ta' RNA ta' HIV-1 mill-inqas punt; ma komplewx b'≥ 400 copies/ml b'ta' RNA ta' HIV fl-aħħar vista b
English: darunavir/ ritonavir 800/100 mg once daily N=343
Maltese: Darunavir/ ritonavir 800/100 mg darba kuljum N=343
English: During the clinical development program (N=2,613 treatment-experienced subjects who initiated therapy with darunavir/ritonavir 600/100 mg twice daily), 51.3% of subjects experienced at least one adverse reaction.
Maltese: Waqt il-programm ta' żvilupp kliniku (N=2,613 individwu li kienu diġà ħadu kura qabel u li bdew terapija bi darunavir/ritonavir 600/100 mg darbtejn kuljum), 51.3% tal-individwi ħassew mill-anqas reazzjoni avversa waħda.
English: ≥ 1.0 log10 decrease from baseline in plasma viral load a
Maltese: ≥ 1.0 log10 tnaqqis mil-linja bażi fit-tagħbija virali filplażma a
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 epatite C) - Rifapentine, rifabutin (mediċini biex jikkuraw xi infezzjonijiet bħal ma hija t-tuberkulożi) - Saquinavir (infezzjoni bl-HIV).
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 darunavir 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 darunavir suspensjoni orali ma' doża baxxa ta' ritonavir darbtejn kuljum flimkien ma' mediċini antiretrovirali oħrajn.
English: Pravastatin 40 mg single dose pravastatin AUC ↑ 81%¶
Maltese: Pravastatin Doża waħda ta' 40 mg pravastatin AUC ↑ 81%¶ pravastatin Cmin ND pravastatin Cmax ↑ 63%
English: One ritonavir a dose is between 15 and 30 kilograms
Maltese: Doża waħda ta' ritonavir a hija bejn 15-il kilogramma u 30 kilogramma
English: Rare myalgia, osteonecrosis, muscle spasms, muscular weakness, arthralgia, pain in extremity, osteoporosis, increased blood creatine phosphokinase musculoskeletal stiffness, arthritis, joint stiffness
Maltese: 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: 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)
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
English: Reproductive system and breast disorders Uncommon gynaecomastia*
Maltese: Disturbi fis-sistema riproduttiva u fis-sider Mhux komuni ġinekomastja*
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 darunavir/ritonavir (600/100 mg twice daily) with an about 10-fold increase in the daily exposure to the active metabolite 25O-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' darunavir/ritonavir (600/100 mg darbtejn kuljum) b'żieda ta' madwar 10 darbiet aktar fl-esponiment ta' kuljum għall-metabolit attiv 25-O-desacetylrifabutin.
English: Darunavir Mylan 150 mg film-coated tablets are available in blister packs containing 240 tablets and in plastic bottles containing 60 and 240 tablets.
Maltese: Darunavir Mylan 150 mg pilloli miksija b'rita huma disponibbli f'pakketti b'folji li fihom 240 pillola u fi fliexken tal-plastik li fihom 60 u 240 pillola.
English: Blister carton 30 film-coated tablets 60 film-coated tablets 120 film-coated tablets 120 x 1 film-coated tablets
Maltese: Kartuna bil-folji 30 pillola miksija b'rita 60 pillola miksija b'rita 120 pillola miksija b'rita 120 x 1 pillola miksija b'rita
English: ANTIMALARIALS Artemether/Lumefantrine 80/480 mg, 6 doses at 0, 8, 24, 36, 48, and 60 hours artemether AUC ↓ 16% artemether Cmin ↔ artemether Cmax ↓ 18% dihydroartemisinin AUC ↓ 18% dihydroartemisinin Cmin ↔ dihydroartemisinin Cmax ↓ 18% lumefantrine AUC ↑ 175% lumefantrine Cmin ↑ 126% lumefantrine Cmax ↑ 65% darunavir AUC ↔ darunavir Cmin ↓ 13% darunavir Cmax ↔
Maltese: AUC ta' artemether ↓ 16% Cmin ta' artemether ↔ Cmax ta' artemether↓ 18% AUC ta' dihydroartemisinin ↓ 18% Cmin ta' dihydroartemisinin ↔ Cmax ta' dihydroartemisinin ↓ 18% AUC ta' lumefantrine ↑ 175% Cmin ta' lumefantrine ↑ 126% Cmax ta' lumefantrine ↑ 65% AUC ta' darunavir ↔ Cmin ta' darunavir ↓ 13% Cmax ta' darunavir ↔
English: (CYP2D6 and/or CYP3A inhibition)
Maltese: (inibizzjoni ta' CYP2D6 u/jew CYP3A)
English: The film-coating contains polyvinyl alcohol partially hydrolysed, titanium dioxide (E171), macrogol and talc.
Maltese: Il-kisja tar-rita fiha polyvinyl alcohol parzjalment idrolizzat, titanium dioxide (E171), macrogol u terra.
English: Darunavir might increase the risk for elevated potassium levels by drospirenone.
Maltese: Darunavir jista' jżid ir-riskju ta' żieda fil-livelli tal-potassium minn drospirenone.
English: Darunavir Mylan 400 mg film-coated tablets Darunavir Mylan 800 mg film-coated tablets
Maltese: Darunavir Mylan 400 mg pilloli miksijin b'rita Darunavir Mylan 800 mg pilloli miksijin b'rita
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 darunavir/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 darunavir/ritonavir flimkien ma' mediċini antiretrovirali oħrajn (ara sezzjoni 4.2 għal rakkomandazzjonijiet dwar id-dożaġġ skont il-piż tal-ġisem).
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 - simvastatin, lovastatin u lomitapide (ara sezzjoni 4.5) - dabigatran, ticagrelor (ara sezzjoni 4.5).
English: The intravenous clearance of darunavir alone (150 mg) and in the presence of low dose ritonavir was 32.8 l/h and 5.9 l/h, respectively.
Maltese: It-tneħħija ta' darunavir waħdu (150 mg) wara amministrazzjoni fil-vina u fil-preżenza ta' doża baxxa ta' ritonavir kienet ta' 32.8 l/siegħa u 5.9 l/siegħa rispettivament.
English: Darunavir Mylan 75 mg film-coated tablets darunavir
Maltese: Darunavir Mylan 75 mg pilloli miksija b'rita darunavir
English: In some patients with advanced HIV infection and a history of opportunistic infection, signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started.
Maltese: F'xi pazjenti b'infezzjoni avvanzata ta' l-HIV u storja ta' infezzjonjiet opportunistiċi, sinjali u sintomi ta' infjammazzjoni minn infezzjonijiet ta' qabel tista' sseħħ ftit wara li jinbeda trattament kontra l-HIV.
English: ● 12 ART-naïve HIV-1 infected paediatric patients aged from 12 to 17 years and weighing at least 40 kg who received darunavir 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' darunavir ma' doża baxxa ta' ritonavir darba kuljum f'kombinazzjoni ma' sustanzi antiretrovirali (ara sezzjoni 5.1).
English: Therefore, protein displacement of medicinal products highly bound to α1-acid glycoprotein cannot be ruled out (see section 4.5).
Maltese: Għalhekk spostament ta' proteini ta' prodotti mediċinali li jintrabtu b'mod qawwi mal-1-glikoproteina aċida, ma jistax jiġi eskluż (ara sezzjoni 4.5).
English: The effects of high fluticasone systemic exposure on ritonavir plasma levels are unknown.
Maltese: L-effetti ta' esponiment sistemiku għoli għal fluticasone fuq illivelli ta' ritonavir fil-plażma mhumiex magħurfa.
English: Third Trimester of pregnancy (n=15)
Maltese: It-tielet trimestru tattqala (n=15)
English: Nevirapine 200 mg twice daily nevirapine AUC ↑ 27% nevirapine Cmin ↑ 47% nevirapine Cmax ↑ 18% darunavir: concentrations were consistent with historical data (↑ nevirapine from CYP3A inhibition)
Maltese: Nevirapine 200 mg darbtejn kuljum nevirapine AUC ↑ 27% nevirapine Cmin ↑ 47% nevirapine Cmax ↑ 18% darunavir: il-konċentrazzjonijiet kienu konsistenti ma' dejta storika.
English: Darunavir Mylan 800 mg film-coated tablets PVC/PE/PVDC-Al blister pack Do not store above 25°C.
Maltese: Darunavir Mylan 800 mg pilloli miksijin b'rita Pakkett bil-folji tal-PVC/PE/PVDC-Al Taħżinx f'temperatura 'l fuq minn 25°C.
English: Saquinavir: comparison of saquinavir/ritonavir 1,000/100 mg twice daily vs. saquinavir/darunavir/ritonavir 1,000/400/100 mg twice daily.
Maltese: Saquinavir: tqabbil ta' saquinavir/ritonavir 1,000/100 mg darbtejn kuljum ma' saquinavir/darunavir/ritonavir 1,000/400/100 mg darbtejn kuljum Darunavir: tqabbil ta' darunavir/ritonavir 400/100 mg darbtejn kuljum ma' darunavir/ritonavir 400/100 mg flimkien ma' saquinavir 1,000 mg darbtejn kuljum
English: Darunavir Mylan 150 mg film-coated tablets EU/1/16/1140/006
Maltese: Darunavir Mylan 150 mg pilloli miksijin b'rita EU/1/16/1140/006
English: Darunavir Mylan 800 mg film-coated tablets PVC/PE/PVDC-Al blister pack containing 30 tablets and 30x1 tablets.
Maltese: Darunavir Mylan 800 mg pilloli miksijin b'rita Pakkett bil-folji tal-PVC/PE/PVDC-Al li fih 30 pillola u 30x1 pillola.
English: For dosage recommendations in children, see the Summary of Product Characteristics for darunavir 75 mg, 150 mg, 300 mg, 600 mg tablets.
Maltese: Għal rakkomandazzjonijiet dwar id-dożaġġ fi tfal, ara s-Sommarju tal-Karatteristiċi tal-Prodott għal darunavir 75 mg, 150 mg, 300 mg, 600 mg pilloli.
English: During the darunavir/ritonavir clinical development program (N=3,063), severe skin reactions, which may be accompanied with fever and/or elevations of transaminases, have been reported in 0.4% of patients.
Maltese: Waqt il-programm ta' żvilupp kliniku (N=3,063) ta' darunavir/ritonavir, reazzjonijiet qawwija filġilda, li jistgħu jkunu imseħbin ma' deni u/jew livelli ta' transaminases li jogħlew, kienu rrappurtati f'0.4% tal-pazjenti.
English: CD4+ cell count mean change from baseline (x 106/l)b c c a
Maltese: Medja ta' tibdil fl-għadd taċ-ċelluli CD4+ mil-linja bażi (x 106/l)e d a
English: Uncommon increased alanine aminotransferase hepatitis, cytolytic hepatitis, hepatic steatosis, hepatomegaly, increased transaminase, increased aspartate aminotransferase, increased blood bilirubin, increased blood alkaline phosphatase, increased gamma-glutamyltransferase
Maltese: 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: Concomitant use of colchicine and darunavir coadministered with low dose ritonavir may increase the exposure to colchicine.
Maltese: L-użu konkomitanti ta' colchicine u darunavir intensifikat jista' jżid l-esponiment għal colchicine.
English: Each tablet contains 75 milligrams of darunavir.
Maltese: Kull pillola fiha 75 milligramma ta' darunavir
English: Changes were observed in liver (hepatocyte hypertrophy, vacuolation, increased liver enzymes) and thyroid (follicular hypertrophy).
Maltese: Bidliet ġew osservati fil-fwied (ipertrofija ta' l-epatoċiti, vakwolazzjoni, żieda fl-enzimi tal- fwied) u t-tirojde (ipertrofija follikulari).
English: Rosuvastatin 10 mg once daily rosuvastatin AUC ↑ 48%║ rosuvastatin Cmax ↑ 144% ║ based on published data with darunavir/ritonavir rosuvastatin AUC ↑ 93%§ rosuvastatin Cmax ↑ 277% rosuvastatin Cmin ND§
Maltese: ibbażat fuq dejta publikata b'darunavir/ritonavir rosuvastatin AUC ↑ 93% rosuvastatin Cmax ↑ 277%§ rosuvastatin Cmin ND
English: - Buprenorphine/naloxone (medicines to treat opioide dependence) - Salmeterol (medicine to treat asthma) - Artemether/lumefantrine (a combination medicine to treat malaria) - Dasatinib, everolimus, irinotecan, nilotinib, vinblastine, vincristine (to treat cancer) - Sildenafil, tadalafil, vardenafil (for erectile dysfunction or to treat a heart and lung disorder called pulmonary arterial hypertension) - Glecaprevir/pibrentasvir, simeprevir (to treat hepatitis C infection) - Fentanyl, oxycodone, tramadol (to treat pain) - Fesoterodine, solifenacin (to treat urologic disorders).
Maltese: - Buprenorphine/naloxone (mediċini biex tikkura d-dipendenza fuq opjojdi) - Salmeterol (mediċina biex tikkura l-ażma) - Artemether/lumefantrine (mediċina kombinata għal kura tal-malarja) - Dasatinib, everolimus, irinotecan, nilotinib, vinblastine, vincristine (biex tikkura l-kanċer) - Sildenafil, tadalafil, vardenafil (għall-impotenza jew biex tikkura disturb tal-qalb u tal-pulmun imsejjaħ pressjoni għolja fil-pulmuni tal-arterji) - Glecaprevir/pibrentasvir, simeprevir (biex titratta infezzjoni tal-epatite Ċ) - Fentanyl, oxycodone, tramadol (biex jittrattaw l-uġigħ).
English: Darunavir Mylan 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 Darunavir Mylan 75 mg, 150 mg, 300 mg, u 600 mg jistgħu jintużaw biex jipprovdu skedi ta' għoti ta' dożi xierqa (ara sezzjoni 4.2):
English: c a Imputations according to the TLOVR algorithm b Based on a normal approximation of the difference in % response c NC=F
Maltese: Ibbażat fuq l-approssimazzjoni normali tad-differenza fil-% tar-rispons c
English: HIV Protease inhibitors (PIs) - with co-administration of low dose ritonavir† Lopinavir/ritonavir
Maltese: Impedituri ta' Protease (PIs) ta' HIV - bl-għoti ta' doża baxxa ta' ritonavir flimkien magħhom † Lopinavir/ritonavir
English: Primary (major) PI mutations PI RAMs
Maltese: Mutazzjonijiet primarji (maġġuri) għall-PI
English: 800 mg darunavir/100 mg ritonavir once daily
Maltese: 800 mg darunavir/100 mg ritonavir darba kuljum
English: Blister carton 30 film-coated tablets 30 x 1 film-coated tablets
Maltese: Kartuna bil-folji 30 pillola miksija b'rita 30 x 1 pillola miksija b'rita
English: Tablet film-coat
Maltese: Differenza fil-kura
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: - The strong CYP3A inducers rifampicin and herbal preparations containing St John's wort (Hypericum perforatum).
Maltese: - L-indutturi qawwija ta' CYP3A rifampicin u l-preparazzjonijiet magħmula mill-ħxejjex li fihom St John's wort (Hypericum perforatum).
English: The recommended dose of darunavir 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 rrakkomandata ta' darunavir ma' doża baxxa ta' ritonavir m'għandhiex taqbeż id-doża rrakkomandata fl-adulti (600/100 mg darbtejn kuljum jew 800/100 mg darba kuljum).
English: The evidence of efficacy of darunavir/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 darunavir/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: L-evidenza tal-effikaċja ta' darunavir/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 darunavir/ritonavir 800/100 mg darba kuljum. tqabbel ma' lopinavir/ritonavir 800/200 mg kuljum (mogħti fi skeda ta' darbtejn kuljum jew darba kuljum).
English: Darunavir Mylan 600 mg film-coated tablets PVC/PE/PVDC-Al blister pack containing 30 and 60 tablets and 60x1 tablets.
Maltese: Darunavir Mylan 600 mg pilloli miksijin b'rita Folja tal-PVC/PE/PVDC-Al li fiha 30 u 60 pillola u 60 x1 pillola.
English: There were no new clinically relevant safety findings compared with the known safety profile of darunavir/ritonavir in HIV-1 infected adults (see sections 4.2, 4.4 and 5.2).
Maltese: Ma kien hemm l-ebda sejbiet ġodda rilevanti b'mod kliniku dwar sigurtà meta mqabbla mal-profil ta' sigurtà magħruf ta' darunavir/ritonavir f'individwi adulti infettati b'HIV-1 (ara sezzjonijiet 4.2, 4.4 u 5.2).
English: Indinavir: comparison of indinavir/ritonavir 800/100 mg twice daily vs. indinavir/darunavir/ritonavir 800/400/100 mg twice daily.
Maltese: Indinavir: tqabbil ta' indinavir/ritonavir 800/100 mg darbtejn kuljum ma' indinavir/darunavir/ritonavir 800/400/100 mg darbtejn kuljum
English: - Darunavir Mylan 75 milligram and 150 milligram tablets have been developed for use in children, but can also be used in adults in some cases.
Maltese: - Pilloli Darunavir Mylan 75 milligramma u 150 milligramma ġew żviluppati għall-użu fit-tfal, iżda f'xi każijiet jistgħu jintużaw ukoll fl-adulti.
English: Cobicistat as a pharmacokinetic enhancer of darunavir should, therefore, not be initiated in patients with creatine clearance less than 70 ml/min if any co-administered agent requires dose adjustment based on creatinine clearance: e.g. emtricitabine, lamivudine, tenofovir disoproxil (as fumarate, phosphate or succinate) or adefovir dipovoxil.
Maltese: Cobicistat bħala intensifikatur farmakokinetiku ta' darunavir għandu, għalhekk, ma jinbediex f'pazjenti bi tneħħija tal-kreatinina inqas minn 70 ml/min jekk kwalunkwe waħda mis-sustanzi mogħtija miegħu tkun teħtieġ aġġustament fid-doża abbażi ta' tneħħija tal-kreatinina: eż. emtricitabine, lamivudine, tenofovir disoproxil (bħala fumarate, phosphate jew succinate) jew adefovir dipovoxil.
English: copies/ml) b IAS-USA lists
Maltese: IAS-listi tal-USA
English: Darunavir/ritonavir 600/100 mg twice daily + OBR N=296
Maltese: Darunavir/ritonavir 600/100 mg darbtejn kuljum + OBR N=296
English: ANTIGOUT MEDICINES Colchicine
Maltese: Prodotti mediċinali skont loqsma terapewtiċi