FrancophonIA/ELRC3.0 huggingface dataset:
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 ta' effikaċja ta' darunavir/ritonavir 800/100 mg darba kuljum hija bbażata fuq l-analiżi ta' dejta ta' 192 ġimgħa mill-prova każwali, ikkontrollata u bit-tikketta tingħaraf tal-Fażi III, 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: Hepatitis B and/or hepatitis C virus co-infection
Maltese: Pazjenti koinfettati bil-virus tal-epatite B u/jew Ċ
English: Co-administration of St John's wort and REZOLSTA is contraindicated (see section 4.3).
Maltese: L-għoti fl-istess waqt ta' St John's wort u REZOLSTA huwa kontraindikat (ara sezzjoni 4.3)
English: (CYP3A inhibition and/or P-gp inhibition)
Maltese: (impediment ta' CYP3A u/jew impediment ta' P-gp)
English: These decreases in eGFRCG were reversible after cobicistat was discontinued and did not affect the actual glomerular filtration rate, as determined by the clearance of probe drug iohexol.
Maltese: Dan it-tnaqqis f'eGFRCG kien riversibbli wara li cobicistat twaqqaf u m'affettwax ir-rata reali ta' filtrazzjoni glomerulari, kif stabbilit bit-tneħħija tal-mediċina sonda iohexol.
English: REZOLSTA should not be initiated in patients with creatinine clearance less than 70 mL/min when co-administered with one or more agent requiring dose adjustment based on creatinine clearance (e.g. emtricitabine, lamivudine, tenofovir disoproxil (as fumarate, phosphate or succinate) or adefovir dipivoxil) (see sections 4.2, 4.8 and 5.2).
Maltese: REZOLSTA m'għandux jiġi mibdi f'pazjenti bi tneħħija ta' kreatinina inqas minn 70 mL/min meta jingħata fl-istess waqt ma'sustanza waħda jew aktar li tkun teħtieġ aġġustament tad-doża minħabba t-tneħħija ta' kreatinina (eż. emtricitabine, lamivudine, tenofovir disoproxil (bħala fumarate, phosphate jew succinate) jew adefovir dipivoxil) (ara sezzjonijiet 4.4, 4.8 5u 5.2).
English: Amiodarone, bepridil, dronedarone, ivabradine, quinidine, ranolazine to treat certain heart disorders e.g. abnormal heart beat
Maltese: Amiodarone, bepridil, dronedarone, ivabradine, quinidine ranolazine biex tikkura ċerti disturbi tal-qalb eż. taħbit talqalb mhux normali Carbamazepine, phenobarbital u phenytoin biex jiġu evitati puplesiji Astemizole jew terfenadine biex tikkura sintomi tal-allerġija
English: Treatment-experienced darunavir/cobicistat 800/150 mg once daily + OBR N = 18
Maltese: Pazjenti esperjenzati bil-kura ta' darunavir/cobicistat 800/150 mg darba kuljum + OBR N = 18
English: Based on theoretical considerations REZOLSTA is expected to increase the plasma concentrations of fluvastatin, pitavastatin, pravastatin, lovastatin and simvastatin.
Maltese: Abbażi ta' konsiderazzjonijiet teoretiċi REZOLSTA hu mistenni li jgħolli lkonċentrazzjonijiet ta' fluvastatin, pitavastatin, pravastatin, lovastatin u simvastatin fil-plażma.
English: Rash occurred more commonly in treatment-experienced patients receiving regimens containing darunavir/ritonavir + raltegravir compared to patients receiving darunavir/ritonavir without raltegravir or raltegravir without darunavir/ritonavir (see section 4.8).
Maltese: Ir-raxx seħħ b'mod aktar komuni f'pazjenti esperjenzati bil-kura u li jkunu qed jirċievu skeda ta' kura li jkun fiha darunavir/ritonavir + raltegravir meta mqabbla ma' pazjenti li kienu qed jirċievu darunavir/ritonavir mingħajr raltegravir jew raltegravir mingħajr darunavir/ritonavir (ara sezzjoni 4.8).
English: No clinically relevant differences in cobicistat pharmacokinetics were observed between subjects with moderate impairment and healthy subjects.
Maltese: Ma ġew osservati l-ebda differenzi notevoli fil-farmakokinetiċi ta' cobicistat bejn individwi b'indeboliment tal-kliewi moderat u individwi b'saħħithom.
English: Primary (major) PI mutations PI RAMs
Maltese: RAMs PI
English: Patients should be instructed to take REZOLSTA within 30 minutes after completion of a meal (see sections 4.4, 4.5 and 5.2).
Maltese: Il-pazjenti għandhom jingħataw istruzzjonijiet biex jieħdu REZOLSTA fi żmien 30 minuta minn meta titlesta l-ikla (ara sezzjonijiet 4.4, 4.5 u 5.2).
English: Consideration should be given to official guidance on the appropriate treatment of tuberculosis in HIV infected patients.
Maltese: Konsiderazzjoni għandha wkoll tingħata għal gwida uffiċjali fuq it-trattament xieraq ta' tuberkolosi f'pazjenti infettati b'HIV.
English: Based on theoretical considerations REZOLSTA is expected to increase alfuzosin plasma concentrations.
Maltese: Abbażi ta' konsiderazzjonijiet teoretiċi RESOLSTA huwa mistenni li jżid ilkonċentrazzjonijiet ta' alfuzosin filplażma.
English: REZOLSTA should not be initiated in patients with creatinine clearance less than 70 mL/min, if any co-administered medicinal product (e.g. emtricitabine, lamivudine, tenofovir disoproxil (as fumarate, phosphate or succinate), or adefovir dipivoxil) requires dose adjustment based on creatinine clearance (see sections 4.4, 4.8 and 5.2).
Maltese: REZOLSTA m'għandux jiġi mibdi f'pazjenti bi tneħħija ta' kreatinina inqas minn 70 mL/min, jekk xi prodott mediċinali li jingħata fl-istess waqt (eż. emtricitabine, lamivudine, tenofovir disoproxil (bħala fumarate, phosphate jew succinate), jew adefovir dipivoxil) jeħtieġ aġġustament tad-doża minħabba t-tneħħija ta' kreatinina (ara sezzjonijiet 4.4, 4.8 u 5.2).
English: Based on theoretical considerations REZOLSTA is expected to increase these PDE-5 inhibitor plasma concentrations.
Maltese: Abbażi ta' konsiderazzjonijiet teoretiċi REZOLSTA jista' jgħolli l-konċentrazzjonijiet ta' analġeżiċi fil-plażma.
English: Based on theoretical considerations rifampin is expected to decrease darunavir and/or cobicistat plasma concentrations.
Maltese: Abbażi ta' konsiderazzjonijiet teoretiċi rifampin hu mistenni li jnaqqas il-konċentrazzjonijiet ta' darunavir u/jew cobicistat fil-plażma.
English: Concomitant use of salmeterol and REZOLSTA is not recommended.
Maltese: L-użu konkomitanti ta' salmeterol u REZOLSTA mhuwiex irrakkomandat.
English: HIV-1 infected patients who were eligible for this trial had a plasma HIV-1 RNA ≥ 1,000 copies/mL.
Maltese: Pazjenti infettati b'HIV-1 li kienu eliġibbli għal din il-prova kellhom ≥ 1,000 kopja/mL ta' RNA ta' HIV-1 fil-plasma.
English: Based on theoretical considerations, no mechanistic interaction is expected.
Maltese: Abbażi ta' konsiderazzjonijiet teoretiċi, lebda interazzjoni mekkanistika mhi mistennija
English: Therefore, REZOLSTA must not be used in patients with severe hepatic impairment (Child-Pugh Class C) (see sections 4.3, 4.4 and 5.2).
Maltese: Għalhekk, REZOLSTA m'għandux jintuża f'pazjenti b'indeboliment epatiku sever (Child-Pugh Klassi Ċ) (ara sezzjonijiet 4.3, 4.4 u 5.2).
English: Based on theoretical considerations clarithromycin is expected to increase darunavir and/or cobicistat plasma concentrations.
Maltese: Abbażi ta' konsiderazzjonijiet teoretiċi clarithromycin hu mistenni li jgħolli l-konċentrazzjonijiet ta' darunavir u/jew cobicistat fil-plażma.
English: One film-coated tablet of REZOLSTA 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: Pillola waħda ta' REZOLSTA miksija b'rita darba kuljum mal-ikel tista' tintuża f'pazjenti b'esponiment minn qabel ta' prodotti mediċinali antiretrovirali, imma mingħajr mutazzjonijiet assoċjati ma' reżistenza b'darunavir (DRV-RAMs)* u li għandhom < 100,000 kopja/mL ta' HIV-1 RNA u b'għadd ta' ċelluli CD4+ ta' ≥ 100 ċelluli x 10
English: Based on theoretical considerations co-administration of REZOLSTA with dabigatran or ticagrelor may increase concentrations of the anticoagulant.
Maltese: Abbażi ta' konsiderazzjonijiet teoretiċi REZOLSTA hu mistenni li jgħolli dawn il-konċentrazzjonijiet antiarritmiċi fil-plażma.
English: Co-administration of REZOLSTA and other medicinal products that inhibit CYP3A may decrease the clearance of darunavir and cobicistat and may result in increased plasma concentrations of darunavir and cobicistat (e.g. azole antifungals such as clotrimazole).
Maltese: L-amministrazzjoni konġunta ta' REZOLSTA u prodotti mediċinali oħra li jimpedixxu CYP3A jista' jnaqqas it-tneħħija ta' darunavir u cobicistat u jista' jwassal għal konċentrazzjonijiet ogħla ta' darunavir u cobicistat fil-plażma (eż. antifungali azole bħal clotrimazole).
English: Based on theoretical considerations REZOLSTA is expected to increase concentrations of clonazepam.
Maltese: Abbażi ta' konsiderazzjonijiet teoretiċi REZOLSTA huwa mistenni li jżid ilkonċentrazzjonijiet ta' clonazepam.
English: The most frequent serious reactions are acute renal failure, myocardial infarction, immune reconstitution inflammatory syndrome, thrombocytopenia, osteonecrosis, diarrhoea, hepatitis, and pyrexia.
Maltese: Laktar reazzjonijiet frekwenti serji huma insuffiċjenza renali akuta, infart mijokardjali, sindrome infjammatorju ta' rikostituzzjoni immuni, tromboċitopenija, osteonekrosi, dijarea, epatite u deni.
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
English: If concomitant use of REZOLSTA with sildenafil, vardenafil or tadalafil is indicated, sildenafil at a single dose not exceeding 25 mg in 48 hours, vardenafil at a single dose not exceeding 2.5 mg in 72 hours or tadalafil at a single dose not exceeding 10 mg in 72 hours is recommended.
Maltese: Jekk ikun indikat l-użu konkomitanti ta' REZOLSTA ma' sildenafil, vardenafil, jew tadalafil hija rrakommandata doża waħda ta' sildenafil li ma' taqbiżx 25 mg f'48 siegħa, doża waħda ta' vardenafil li ma taqbiżx 2.5 mg f'72 siegħa jew doża waħda ta' tadalafil li ma' taqbiżx 10 mg f'72 siegħa.
English: Skin and subcutaneous tissue disorders Very common rash (including macular, maculopapular, papular, erythematous, pruritic rash, generalised rash, and allergic dermatitis)
Maltese: Disturbi fil-ġilda u fit-tessuti ta' taħt il-ġilda Komuni ħafna raxx (li jinkludi raxx makulari, makulopapulari, papulari, eritematosi, pruritiku, raxx ġeneralizzat, u dermatite allerġika)
English: Although darunavir has not been studied in patients with renal impairment, population pharmacokinetic analysis showed that the pharmacokinetics of darunavir were not significantly affected in HIV infected patients with moderate renal impairment (CrCl between 30-60 mL/min, n = 20) (see sections 4.2 and 4.4).
Maltese: Għalkemm darunavir ma ġiex studjat f'pazjenti b'indeboliment renali, analiżi farmakokinetika ta' popolazzjoni wriet li l-farmakokinetika ta' darunavir m'hijiex affettwata sinifikament fil-pazjenti infettati b'HIV u li għandhom indeboliment renali moderat (CrCl bejn 30 - 60 mL/min, n = 20)
English: In the 96 week analysis, the safety profile of darunavir/ritonavir 800/100 mg once daily in treatment-naïve subjects was similar to that seen with darunavir/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' darunavir/ritonavir 800/100 mg darba kuljum f'individwi li qatt ma ħadu kura qabel kien jixbah lil dak li jidher b'darunavir/ritonavir 600/100 mg darbtejn kuljum f'individwi esperjentati bil-kura minbarra d-dardir li kien osservat aktar frekwenti f'individwi li qatt ma kienu ħadu kura qabel.
English: β-BLOCKERS Carvedilol Metoprolol Timolol
Maltese: Imblokkaturi tar-riċetturi β Carvedilol
English: Co-administration of darunavir/cobicistat and medicinal products primarily metabolised by CYP3A may result in increased systemic exposure to such medicinal products, which could increase or prolong their therapeutic effect and adverse reactions.
Maltese: L-amministrazzjoni flimkien ta' darunavir/cobicistat u prodotti mediċinali oħra primarjament metabolizzati minn CYP3A tista' tirriżulta f'esponiment sistemiku ogħla għal prodotti mediċinali bħal dawn, li jista' jżid jew itawwal l-effett terapewtiku u r-reazzjonijiet avversi.
English: For the treatment of pulmonary arterial hypertension Sildenafil Tadalafil
Maltese: Għall-kura ta' pressjoni għolja fl-arterji pulmonari Sildenafil Tadalafil
English: ANTICONVULSANTS Carbamazepine Phenobarbital Phenytoin
Maltese: Alfuzosin biex jikkura tkabbir tal-prostata
English: The decreased susceptibility to darunavir of the emerging viruses in the selection experiment could not be explained by the emergence of these protease mutations.
Maltese: Is-suxxetibilità mnaqqsa ta' darunavir fil-virusis emerġenti fl-esperiment t'għażla ma setax jiġi spjegat bil-ħruġ ta' dawn il-mutazzjonijiet ta' protease.
English: Tell your doctor if you take: - Amlodipine, carvedilol, diltiazem, disopyramide, felodipine, flecainide, lidocaine, metoprolol, mexiletine, nicardipine, nifedipine, propafenone, timolol, verapamil (for heart disease) as the therapeutic effect or side effects of these medicines may be increased.
Maltese: Għid lit-tabib tiegħek jekk inti tieħu: - Amlodipine, carvedilol, diltiazem, disopyramide, felodipine, flecainide, lidocaine, metoprolol,
English: Osteonecrosis
Maltese: ANESTETIĊI
English: Your doctor will carefully consider whether to treat you with REZOLSTA.
Maltese: Jekk jogħġbok ara Mediċini oħra u REZOLSTA.
English: The combination of colchicine and REZOLSTA is contraindicated in patients with renal or hepatic impairment (see section 4.3).
Maltese: Il-kombinazzjoni ta' colchicine u REZOLSTA hi kontraindikata f'pazjenti b'indeboliment talkliewi jew tal-fwied (ara sezzjoni 4.3).
English: Based on theoretical considerations REZOLSTA is expected to increase salmeterol plasma concentrations.
Maltese: Abbażi ta' konsiderazzjonijiet teoretiċi REZOLSTA hu mistenni li jgħolli l-konċentrazzjonijiet ta' salmeterol fil-plażma.
English: (CYP3A induction) REZOLSTA is expected to increase bosentan plasma concentrations.
Maltese: (Induzzjoni ta' CYP3A) REZOLSTA hu mistenni li jgħolli l-konċentrazzjoni ta' bosentan fil-plażma.
English: Cobicistat has been shown to decrease estimated creatinine clearance due to inhibition of renal tubular secretion of creatinine.
Maltese: Cobicistat intwera li jnaqqas it-tneħħija ta' kreatinina stmata minħabba l-impediment ta' tnixxija ta' kreatinina mit-tubi renali.
English: Ex vivo rabbit studies and in vivo dog studies suggest that cobicistat has a low potential for QT prolongation, and may slightly prolong the PR interval and decrease left ventricular function at mean concentrations at least 10-fold higher than the human exposure at the recommended 150 mg daily dose.
Maltese: Studji fuq il-fniek eks vivo u fil-klieb in vivo jissuġerixxu li cobicistat għandu potenzjal baxx għal titwil tal-QT, u jista' jtawwal bi ftit l-intervall PR u jnaqqas il-funzjoni ventrikulari tax-xellug f'konċentrazzjonijiet medji ta' mill-anqas 10 darbiet mill-esponiment uman fid-doża rakkomandata ta' 150 mg kuljum.
English: Darunavir Results from a mass balance study with
Maltese: Darunavir Riżultati minn studju ta' bilanċ tal-massa b'
English: This recommendation is different from ritonavir-boosted darunavir.
Maltese: Din ir-rakkomandazzjoni hi differenti minn ritonavir imqawwi minn darunavir.
English: Inflammation of the pancreas (pancreatitis) has been reported in up to 1 patient in 100.
Maltese: L-infjammazzjoni tal-frixa (pankreatite) ġiet rapportata f'pazjent 1 f'100.
English: Based on theoretical considerations REZOLSTA is expected to increase lumefantrine plasma concentrations.
Maltese: Abbażi ta' konsiderazzjonijiet teoretiċi REZOLSTA hu mistenni li jgħolli l-konċentrazzjonijiet ta' lumefantrine fil-plażma.
English: At the highest tested doses, the systemic exposures (based on AUC) to darunavir when co-administered with ritonavir were between 0.4- and 0.7-fold (mice) and 0.7- and 1-fold (rats), relative to those observed in humans at the recommended therapeutic doses.
Maltese: Fl-ogħla dożi ittestjati, l-esponimenti sistemiċi (ibbażati fuq l-AUC) għal darunavir meta mogħtija flimkien ma' ritonavir kienu bejn 0.4 darbiet u 0.7 darbiet (ġrieden) u 0.7 darbiet u darba aktar (fil-firien) meta mqabbla ma' dawk osservati fil-bnedmin fid-dożi terapewtiċi rrakkomandati.
English: Postpartum (6-12 weeks) N=6
Maltese: Wara t-twelid (6 ġimgħat-12-il ġimgħa) N=6
English: Based on theoretical considerations REZOLSTA is expected to increase these calcium channel blocker plasma concentrations.
Maltese: Abbażi ta' konsiderazzjonijiet teoretiċi REZOLSTA hu mistenni li jgħolli l-konċentrazzjonijiet ta' dawn l-imblokkaturi tal-kanali tal-kalċju fil-plażma.
English: (CYP3A inhibition) Concentrations of clarithromycin may be increased upon co-administration with REZOLSTA.
Maltese: (impediment ta' CYP3A) Konċentrazzjonijiet ta' clarithromycin jistgħu jiżdiedu bl-għoti fl-istess waqt ta' REZOLSTA (impediment ta' CYP3A)
English: REZOLSTA 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: REZOLSTA 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: Darunavir was evaluated for carcinogenic potential by oral gavage administration to mice and rats up to 104 weeks.
Maltese: Darunavir ġie evalwat għal potenzjal kanċeroġeniku permezz ta' amministrazzjoni b'tubu mill-ħalq lill-ġrieden u l-firien sa 104 ġimgħat.
English: Based on theoretical considerations REZOLSTA may increase the exposure to grazoprevir.
Maltese: Abbażi ta' konsiderazzjonijiet teoretiċi REZOLSTA jista' jżid l-esponiment għal grazoprevir.
English: Treatment with darunavir/cobicistat 800/150 mg during pregnancy results in low darunavir exposure (see section 5.2), which may be associated with an increased risk of treatment failure and an increased risk of HIV transmission to the child.
Maltese: It-trattament b'REZOLSTA waqt it-tqala jwassal għal esponiment baxx għal darunavir (ara sezzjoni 5.2) li jista' jiġi assoċjat ma' żieda fir-riskju ta' falliment viroloġiku u żieda fir-riskju ta' trasmissjoni tal-infezzjoni tal-HIV lit-tarbija.
English: How to take REZOLSTA
Maltese: Mediċini oħra u REZOLSTA
English: (CYP3A, CYP2D6 and/or P-gp inhibition)
Maltese: (impediment ta' CYP2D6 u/jew CYP3A)
English: With ritonavir-boosted darunavir, a small decrease in methadone plasma concentrations was observed.
Maltese: B'darunavir imqawwi b'ritonavir, tnaqqis żgħir fil-konċentrazzjonijiet ta' methadone fil-plażma kienet osservata.
English: Combinations with optimised background regimens (OBRs) other than ≥ 2 NRTIs have not been studied in this population.
Maltese: Kombinazzjoni ta' programmi ta' kura ottimizzati fl-isfond (optimized background regimens, OBRs) li mhumiex ≥ 2 NRTIs ma ġewx studjati f'din il-popolazzjoni.
English: * These adverse drug reactions have not been reported in clinical trial experience with darunavir/cobicistat but have been noted with darunavir/ritonavir treatment and could be expected with darunavir/cobicistat too.
Maltese: * Dawn ir-reazzjonijiet avversi ta' mediċina ma ġewx rapportati fl-esperjenza ta' provi kliniċi b'darunavir/cobicistat imma ġew innotati bi trattament ta' darunavir/ritonavir u jistgħu jseħħu b'darunavir/cobicistat ukoll.
English: Co-administration of REZOLSTA with alfuzosin is contraindicated (see section 4.3).
Maltese: L-għoti ta' RESOLSTA flimkien ma' alfuzosin huwa kontraindikat (ara sezzjoni 4.3).
English: What REZOLSTA contains - The active substances are darunavir and cobicistat.
Maltese: X'fih REZOLSTA - Is-sustanzi attivi huma darunavir u cobicistat.
English: Tablet film-coat
Maltese: fil-linja bażi
English: The resistance profile of REZOLSTA is supported by two Phase III trials conducted with darunavir/ritonavir in treatment-naïve (ARTEMIS) and treatment-experienced (ODIN) patients and the analysis of 48 week data from trial GS-US-216-130 in treatment-naïve and treatment-experienced patients.
Maltese: III li saru b'darunavir/ritonavir f'pazjenti li ma kinux kurati qabel (ARTEMIS) u pazjenti b'esperjenza ta' kura qabel (ODIN) u l-analiżi ta' tagħrif minn 48 ġimgħa minn prova GS-US-216-130 f'pazjenti li ma kinux kkurati qabel u b'esperjenza fil-kura.
English: The terminal elimination half-life of darunavir was approximately 15 hours when combined with ritonavir.
Maltese: Il-half-life terminali ta' eliminazzjoni ta' darunavir kienet madwar ta' 15-il siegħa meta kien flimkien ma' ritonavir.
English: It is recommended that the international normalised ratio (INR) be monitored when warfarin is co-administered with REZOLSTA.
Maltese: Huwa rrakkomandat li lproporzjon internazzjonali normalizzat (INR) jiġi mmonitorjat meta warfarin jingħata flimkien ma' REZOLSTA.
English: ANTIPSYCHOTICS/NEUROLEPTICS Perphenazine
Maltese: ANTIPSIKOTIĊI/NEWROLETTIĊI
English: The evidence of efficacy of REZOLSTA once daily is based on the analysis of 48 week data from trial GS-US-216-130 in ART-naïve and ART-experienced patients, trial TMC114FD2HTX3001 in ART-naïve patients, and two Phase III trials ARTEMIS and ODIN conducted with darunavir/ritonavir 800/100 mg q.d.
Maltese: L-evidenza ta' effikaċja ta' REZOLSTA darba kuljum hi bażata fuq l-analiżi ta' tagħrif minn 48 ġimgħa mill-prova GS-US-216-130 f'pazjenti li ma kinux kkurati qabel b'ART u pazjenti b'esperjenza ta' ART, prova TMC114FD2HTX3001 f'pazjenti li ma kinux kkurati qabel b'ART, u żewġ provi ta' Fażi
English: Diazepam
Maltese: Dasatinib
English: Based on theoretical considerations REZOLSTA may increase methadone plasma concentrations.
Maltese: Abbażi ta' konsiderazzjonijiet teoretiċi REZOLSTA jista' jgħolli l-konċentrazzjonijiet ta' methadone fil-plażma.
English: Treatment-experienced darunavir/ritonavir 800/100 mg once daily N = 294
Maltese: Pazjenti esperjenzati filkura ta' darunavir/riton avir 800/100 mg darba kuljum N = 294
English: Patients using oestrogens as hormone replacement therapy should be clinically monitored for signs of oestrogen deficiency.
Maltese: Pazjenti li jkunu qed jużaw lestroġeni bħala terapija tas-sostituzzjoni tal-ormoni, għandhom jiġu mmonitorjati klinikament għal sinjali ta' defiċjenza tal-estroġenu.
English: In clinical trials with darunavir/ritonavir and darunavir/cobicistat, rash was mostly mild to moderate, often occurring within the first four weeks of treatment and resolving with continued dosing (see section 4.4).
Maltese: Fi provi kliniċi b'darunavir/ritonavir u darunavir/cobicistat, ir-raxx kien prinċipalment ħafif sa moderat, li ħafna drabi seħħ fl-ewwel erba' ġimgħat tal-kura u fieq meta tkomplew jittieħdu aktar dożi (ara sezzjoni 4.4).
English: Treatment with REZOLSTA will improve your immune system (your body's natural defences) and reduce the risk of developing illnesses linked to HIV infection, but REZOLSTA is not a cure for HIV infection.
Maltese: It-trattament b'REZOLSTA jtejjeb is-sistema immuni tiegħek (id-difiża naturali ta' ġismek) u jnaqqas ir-riskju li tiżviluppa mard li għandu x'jaqsam ma' infezzjoni b'HIV, iżda REZOLSTA mhux kura għal infezzjoni ta' HIV.
English: Clinical monitoring is recommended when co-administering REZOLSTA perphenazine, risperidone or thioridazine.
Maltese: Monitoraġġ kliniku hu rakkomandat meta REZOLSTA jiġi amministrat fl-istess waqt ma' perphenazine, risperidone jew thioridazine.