FrancophonIA/ELRC3.0 huggingface dataset:
English: Change of estimated glomerular filtration rate calculated by Cockcroft-Gault method (eGFRCG) from baseline was observed within 7 days after start of treatment with cobicistat 150 mg among subjects with normal renal function (-9.9 ± 13.1 mL/min) and mild to moderate renal impairment (-11.9 ± 7.0 mL/min).
Maltese: Bidla fir-rata stmata ta' filtrazzjoni glomerulari kkalkulata bil-metodu Cockcroft-Gault (eGFRCG) mil-linja bażi kienet osservata fi żmien 7 ijiem wara l-bidu ta' trattament b'cobicistat 150 mg fost individwi b'funzjoni tal-kliewi normali (-9.9 ± 13.1 mL/min) u indeboliment tal-kliewi minn ħafif sa moderat (-11.9 ± 7.0 mL/min).
English: Co-administration of amiodarone, bepridil, dronedarone, ivabradine, quinidine, or ranolazine and REZOLSTA is contraindicated (see section 4.3).
Maltese: L-għoti flimkien ta' amiodarone, bepridil, dronedarone, ivabradine, quinideine, jew ranolazone u REZOLSTA huwa kontraindikat (ara sezzjoni 4.3).
English: (CYP3A inhibition, UGT/SULT induction)
Maltese: (Impediment ta' CYP3A, induzzjoni ta' UGT/SULT)
English: During the clinical development program (N = 3,063), hepatitis was reported in 0.5% of patients receiving combination antiretroviral therapy with darunavir/ritonavir.
Maltese: Waqt il-programm ta' żvilupp kliniku (N = 3,063), l-epatite kienet irrappurtata f'0.5% tal-pazjenti li kienu qed jirċievu terapija antiretrovirali mħallta b'darunavir/ritonavir.
English: Pharmacotherapeutic group: Antivirals for systemic use, antivirals for treatment of HIV infection, combinations ATC code: J05AR14
Maltese: Antivirali għall-użu sistemiku, antivirali għat-trattament ta' infezzjoni ta' HIV, kombinazzjonijiet Kodiċi ATC:
English: 6/l (see sections 4.2 and 4.4).
Maltese: 6/L (ara sezzjonijiet 4.2 u 4.4).
English: The most frequent adverse reactions reported in the pooled data of the Phase 3 study GS-US-216-130 and the REZOLSTA arm of Phase 3 study TMC114FD2HTX3001 were diarrhoea (23%), nausea (17%), rash (13%), and headache (10%).
Maltese: L-aktar reazzjonijiet avversi frekwenti rraportati f'ġabra ta' data mill-istudju tal-Fażi 3 GS-US-216130 u mill-fergħa ta' REZOLSTA fl-istudju tal-Fażi 3 TMC114FD2HTX3001 kienu dijarea (23%), dardir (17%), raxx (13%) u uġigħ ta' ras (10%).
English: Darunavir exhibits activity against laboratory strains and clinical isolates of HIV-1 and laboratory strains of HIV-2 in acutely infected T-cell lines, human peripheral blood mononuclear cells and human monocytes/macrophages with median EC50 values ranging from 1.2 to 8.5 nM (0.7 to 5.0 ng/mL).
Maltese: Darunavir juri attività kontra razez tal-laboratorju u ċelluli puri ta' virusis iżolati klinikament ta' HIV-1 u razez tal-laboratorju ta' HIV-2 f'razez ta' ċelluli T infettati b'mod akut, ċelluli mononukleari periferali tad-demm umani u makrofaġi/monoċiti umani b'medjan ta' valuri EC50 minn 1.2 sa 8.5 nM (0.7 sa 5.0 ng/mL).
English: Treatment-naïve darunavir/cobicistat 800/150 mg once daily + emtricitabine/tenofovir disoproxil fumarate N = 363
Maltese: Qatt ma ħadu trattament darunavir/cobicistat 800/150 mg darbakuljum + emtricitabine/tenofovir disoproxil fumarate N = 363
English: In GS-US-216-130 baseline phenotype was not available
Maltese: F'GS-US-216-130 fenotip fil-linja bażi ma kienx disponibbli
English: Darunavir is an inhibitor of CYP3A, a weak inhibitor of CYP2D6 and an inhibitor of P-gp.
Maltese: Darunavir huwa impeditur ta' CYP3A, impeditur dgħajjef ta' CYP2D6 u impeditur ta' P-gp.
English: The antiretroviral effect of REZOLSTA is due to the darunavir component.
Maltese: L-effett antiretrovirali ta' REZOLSTA hu dovut għall-komponent darunavir.
English: OESTROGEN-BASED CONTRACEPTIVES Drospirenone (3 mg once daily)
Maltese: KONTRAĊETTIVI BBAŻATI FUQ L-ESTROĠENU Drospirenone (3 mg darba kuljum)
English: The combination of lurasidone, pimozide, quetiapine or sertindole and REZOLSTA is contraindicated (see section 4.3).
Maltese: Il-kombinazzjoni ta' lurasidone, pimozide, quetiapine jew sertindole u REZOLSTA hija kontraindikata (ara sezzjoni 4.3).
English: 30 film-coated tablets
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT 30 pillola
English: Second trimester of pregnancy N=7
Maltese: It-tieni trimestru tat-tqala N=7
English: Lovastatin, simvastatin, and lomitapide to lower cholesterol levels
Maltese: Lovastatin, simvastatin u lomitapide biex ibaxxu l-livelli tal-kolesterol
English: Medicinal products that induce CYP3A activity would be expected to increase the clearance of darunavir and cobicistat, resulting in lowered plasma concentrations of darunavir and cobicistat (e.g. efavirenz, carbamazepine, phenytoin, phenobarbital, rifampicin, rifapentine, rifabutin, St John's wort) (see section 4.3 and interaction table below).
Maltese: Prodotti mediċinali li jinduċu l-attività ta' CYP3A jkunu mistennija li jżidu t-tneħħija ta' darunavir u cobicistat bir-riżultat ta' konċentrazzjonijiet imnaqqsa ta' darunavir u cobicistat fil-plażma (eż. efavirenz, carbamazepine, phenytoin, phenobarbital, rifampicin, rifapentine, rifabutin, St John's wort) (ara sezzjoni 4.3 u tabella t'interazzjonijiet hawn isfel).
English: REZOLSTA might increase the risk for elevated potassium levels by drospirenone.
Maltese: REZOLSTA jista' jżid ir-riskju ta' żieda fil-livelli tal-potassium minn drospirenone.
English: Description of clinical studies of darunavir/ritonavir in adults
Maltese: Deskrizzjoni ta' studji kliniċi ta' darunavir/ritonavir f'adulti
English: The recommended dose of emtricitabine/tenofovir alafenamide is 200/10 mg once daily when used with REZOLSTA.
Maltese: Id-doża ta' emtricitabine/tenofovir alafenamide rrakkomandata hija ta' 200/10 mg darba kuljum meta jintuża ma' REZOLSTA.
English: Unchanged darunavir accounted for approximately 41.2% and 7.7% of the administered dose in faeces and urine, respectively.
Maltese: L-ammont ta' darunavir mhux mibdul kien ta' madwar 41.2% u 7.7% tad-doża amministrata fl-ippurgar u fl-awrina rispettivament.
English: Unlike ritonavir, cobicistat is not an inducer of CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19 or UGT1A1.
Maltese: B'mod kuntrarju għal ritonavir, cobicistat mhux induttur ta' CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19 jew UGT1A1.
English: Janssen-Cilag SpA Via C. Janssen Borgo San Michele 04100 Latina Italy
Maltese: Janssen Borgo San Michele 04100 Latina l-Italja
English: Reproductive system and breast disorders Uncommon gynaecomastia*
Maltese: Disturbi fis-sistema riproduttiva u fis-sider Mhux komuni ginekomastija*
English: The effect of cobicistat on serum creatinine was investigated in a Phase I trial in subjects with normal renal function (eGFR ≥ 80 mL/min, n = 12) and mild to moderate renal impairment (eGFR:50-79 mL/min, n = 18).
Maltese: L-effett ta' cobicistat fuq il-kreatinina fis-serum ġie mistħarreġ fi prova ta' Fażi I f'individwi b'funzjoni tal-kliewi normali (eGFR ≥ 80 mL/min, n = 12) u indeboliment tal-kliewi ħafif sa moderat (eGFR:50-79 mL/min, n = 18).
English: REZOLSTA contains the active substances darunavir and cobicistat.
Maltese: REZOLSTA fih is-sustanzi attivi darunavir u cobicistat.
English: ANTICOAGULANT/PLATELET AGGREGATION INHIBITOR Apixaban
Maltese: ANTIKOAGULANTI/IMPEDITUR TA' AGGREGAZZJONI
English: - Rifabutin (against bacterial infections) - Tadalafil, sildenafil, vardenafil (for erectile dysfunction or high blood pressure in the pulmonary circulation) - Amitriptyline, desipramine, imipramine, nortriptyline, paroxetine, sertraline, trazodone (to treat depression and anxiety) - Maraviroc (to treat HIV infection) - Colchicine (to treat gout or familial Mediterranean fever).
Maltese: - Rifabutin (kontra infezzjonijiet batterjali) - Tadalafil, sildenafil, vardenafil (għal impotenza jew pressjoni għolja fiċ-ċirkolazzjoni tal pulmuni) - Amitriptyline, desipramine, imipramine, nortriptyline, paroxetine, sertraline, trazodone (biex tikkura depressjoni u ansjetà) - Maraviroc (għal kura ta' infezzjoni bl-HIV) - Colchicine (għat-trattament tal-gotta jew tad-deni Mediterranju familjali).
English: Danmark Janssen-Cilag A/S Tlf: +45 4594 8282
Maltese: Danmark Janssen-Cilag A/S Tlf: +45 4594 8282 jacdk@its.jnj.com
English: Patients with severe (Child-Pugh Class C) hepatic impairment.
Maltese: Pazjenti b'indeboliment epatiku sever (Child-Pugh Klassi Ċ).
English: Darunavir is approximately 95% bound to plasma protein.
Maltese: Madwar 95% ta' darunavir huwa mwaħħal mal-proteini tal-plażma.
English: Population pharmacokinetic analysis in HIV infected patients showed that darunavir pharmacokinetics are not considerably different in the age range (18 to 75 years) evaluated in HIV infected patients (n = 12, age  65 years) (see section 4.4).
Maltese: Analiżi farmakokinetika ta' popolazzjoni f'pazjenti infettati b'HIV uriet li l-farmakokinetika ta' darunavir m'hijiex konsiderevolment differeni fil-medda tal-eta'(18 sa 75 sena) evalwati f'pazjenti infettati b'HIV (n = 12, età  65 sena) (ara sezzjoni 4.4).
English: OPIOID ANTAGONIST Naloxegol
Maltese: ANTAGONIST TAL-OPIOJDI
English: In the virologic failures of the GS-US-216-130 trial no cross-resistance with other HIV PIs was observed.
Maltese: Fil-fallimenti viroloġiċi tal-prova GS-US-216-130 l-ebda reżistenza inkroċjata ma' HIV PIs oħra ma kienu osservati.
English: Viruses selected in these conditions and showing decreased susceptibility to darunavir (range: 23-50-fold) harboured 2 to 4 amino acid substitutions in the protease gene.
Maltese: Virusis magħżula f'dawn il-kundizzjonijiet u li wrew suxxettibilità mnaqqsa għal darunavir (medda: 23-50 darba) kellhom fihom bejn 2 sa 4 sostituzzjonijiet tal-aċidu amminiku fil-ġene protease.
English: Genotypic testing should guide the use of REZOLSTA (see sections 4.2, 4.4 and 5.1).
Maltese: Testijiet ġenotipiċi għandhom iservu ta' gwida għall-użu ta' REZOLSTA (ara sezzjonijiet 4.2, 4.4, u 5.1).
English: Imputations according to the TLOVR algorithm Last Observation Carried Forward imputation
Maltese: Imputazzjonijiet skont l-algoritmu TLOVR Imputazzjoni tal-aħħar Osservazzjoni Miġjuba 'l Quddiem (Last Observation Carried Forward)
English: Pink oval shaped tablet of 23 mm x 11.5 mm, debossed with “800” on one side and “TG” on the other side.
Maltese: Pillola roża b'għamla ovali ta' 23 mm x 11.5 mm, b' “800” intaljat fuq naħa waħda u “TG” fuq in-naħa l-oħra.
English: Cmax, ng/mL AUC24h, ng.h/mL Cmin, ng/mL
Maltese: Cmax, ng/mL AUC24h, ng.siegħa/mL 47,293 ± 19,058 47,991 ± 9,879 Cmin, ng/mL
English: No treatment related mortalities were noted in juvenile rats dosed at 1,000 mg/kg darunavir (single dose) on day 26 of age or at 500 mg/kg (repeated dose) from day 23 to 50 of age, and the exposures and toxicity profile were comparable to those observed in adult rats.
Maltese: L-ebda mortalitajiet relatati mal-kura ma ġew innutati fil-firien żgħażagħ li ngħataw doża ta' 1,000 mg/kg darunavir (doża waħda) f'jum 26 jew 500 mg/kg (doża ripetuta) mill-età ta' jum 23 sa 50, u l-esponimenti u l-profil ta' tossiċità kienu komparabbli ma' dawk osservati f'firien adulti.
English: While effective viral suppression with antiretroviral therapy has been proven to substantially reduce the risk of sexual transmission, a residual risk cannot be excluded.
Maltese: Filwaqt li ngħatat prova li soppressjoni virali b'terapija antiretrovirali effettiva tnaqqas b'mod sostanzjali r-riskju ta' trasmissjoni sesswali, riskju residwu ma jistax jiġi eskluż.
English: lopinavir/ ritonavir 800/200 mg per day N = 346
Maltese: lopinavir/ ritonavir 800/200 mg kuljum N = 346
English: There are other uses for sildenafil.
Maltese: Hemm użi oħra ta' sildenafil.
English: Co-administration with the following medicinal products due to the potential for serious and/or life-threatening adverse reactions (see section 4.5): - alfuzosin - amiodarone, bepridil, dronedarone, ivabradine, quinidine, ranolazine - astemizole, terfenadine - colchicine, when used in patients with renal and/or hepatic impairment (see section 4.5) - rifampicin - ergot derivatives (e.g. dihydroergotamine, ergometrine, ergotamine, methylergonovine) - cisapride - dapoxetine - domperidone - naloxegol - lurasidone, pimozide, quetiapine, sertindole (see section 4.5) - elbasvir/grazoprevir - triazolam, midazolam administered orally (for caution on parenterally administered midazolam,
Maltese: L-għoti flimkien mal-prodotti mediċinali li ġejjin huwa kontraindikat minħabba l-potenzjal ta' reazzjonijiet avversi serji u/jew li jistgħu jkunu ta' theddida għal ħajja (ara sezzjoni 4.5): - 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) - rifampicin - derivati ta' ergot (eż. dihydroergotamine, ergometrine, ergotamine, methylergonovine) - cisapride - dapoxetine - domperidone - naloxegol - lurasidone, pimozide, quetiapine, sertindole (ara sezzjoni 4.5) - elbasvir/grazoprevir - triazolam, midazolam li jingħata mill-ħalq (għal kawtela fuq midazolam li jingħata b'mod parenterali, ara sezzjoni 4.5) - sildenafil-meta jintuża għat-trattament ta' pressjoni għolja fl-arterja pulmonari, avanafil - simvastatin, lovastatin u lomitapide (ara sezzjoni 4.5) - dabigatran, ticagrelor.
English: There have been reports of increased spontaneous bleeding in haemophiliac patients receiving antiretroviral protease inhibitors (see section 4.4).
Maltese: Kien hemm rapporti ta' żieda fl-emorraġiji spontanji f'pazjenti emofiliċi li kienu qed jirċievu impedituri ta' Protease antiretrovirali (ara sezzjoni 4.4).
English: In the Phase III single-arm trial (GS-US-216-130), a decrease in eGFRCG was noted at week 2, which remained stable through week 48.
Maltese: III fi grupp wieħed (GS-US-216-130), tnaqqis f'eGFRCG ġie nnotat f'ġimgħa 2, li baqa' stabbli sa tul ġimgħa 48.
English: (OATP1B and CYP3A inhibition)
Maltese: (inibizzjoni ta' OATP1B u CYP3A)
English: The table below shows the development of HIV-1 protease mutations and loss of susceptibility to HIV PIs in virologic failures at endpoint in the GS-US-216-130, ARTEMIS and ODIN trials.
Maltese: It-tabella t'hawn taħt turi l-iżvilupp ta' mutazzjonijiet ta' protease ta' HIV-1 u telf ta' suxxettibbiltà għall-PIs ta' HIV fil-fallimenti viroloġiċi fl-punti aħħarin ta' GS-US-216-130, ARTEMIS u ODIN.
English: In the darunavir/cobicistat fixed-dose combination treament arm, 363 HIV-1 infected, adult, treatment-naïve patients were treated.
Maltese: Fil-grupp ta' trattament bil-kombinazzjoni ta' doża fissa ta' darunavir/cobicistat ġew ittrattati 363 pazjent adult, infettati b'HIV-1, li qatt ma kienu ġew ttrattati qabel.
English: It selectively inhibits the cleavage of HIV encoded Gag-Pol polyproteins in virus infected cells, thereby preventing the formation of mature infectious virus particles.
Maltese: Huwa selettivament jimpedixxi l-qasma ta' poliproteini Gag-Pol li fihom il-kodiċi tal-HIV fiċ-ċelluli infettati bil-virus, u permezz t'hekk ifixkel il-formazzjoni ta' biċċiet infettivi maturi tal-virus.
English: Date of first authorisation: 19 November 2014 Date of latest renewal: 31 July 2019
Maltese: Data tal-aħħar tiġdid: 31 Lulju 2019
English: Life-threatening and fatal drug interactions have been reported in patients treated with colchicine and strong inhibitors of CYP3A and P-glycoprotein (see section 4.5).
Maltese: Interazzjonijiet tal-mediċina li kienu ta' periklu għall-ħajja u fatali ġew irrappurtati f'pazjenti kurati b'colchicine u impedituri qawwija ta' CYP3A u P-glikoproteina (ara sezzjoni 4.5).
English: HIV-1 RNA (copies/mL)
Maltese: HIV-1 RNA < 50 kopja/mL B'HIV-1 RNA (kopja/mL)
English: Tenofovir disoproxil *
Maltese: Tenofovir disoproxil* *l-istudju sar b'tenofovir disoproxil fumarate
English: Concomitant use of REZOLSTA with elbasvir/grazoprevir is contraindicated (see section 4.3).
Maltese: L-użu ta' REZOLSTA flimkien ma' elbasvir/grazoprevir huwa kontraindikat (ara sezzjoni 4.3).
English: Third trimester of pregnancy N=6
Maltese: It-tielet trimestru tat-tqala N=6
English: Cobicistat has no detectable antiviral activity against HIV-1 and does not antagonise the antiviral effect of darunavir.
Maltese: Cobicistat ma kellu ebda attività antivirali osservata kontra HIV-1 u ma jantagonizzax l-effett antivirali ta' darunavir.
English: When also taking into account the clinical trial data of DRV/COBI/emtricitabine/tenofovir alafenamide, StevensJohnson syndrome occurred rarely (in 1 out of 2,551 subjects) consistent with the DRV/rtv clinical trial program (see Severe skin reactions in Section 4.4).
Maltese: Meta wieħed iqis ukoll id-data mill-prova klinika ta' DRV/COBI/emtricitabine/tenofovir alafenamide, is-sindrome ta' Stevens-Johnson seħħ b'mod rari (f'1 minn 2,551 individwu) li huwa konsistenti mal-programm tal-prova klinika ta' DRV/rtv (ara Reazzjonijiet qawwija fil-ġilda fis-Sezzjoni 4.4).
English: Common vomiting, abdominal pain, abdominal distension, dyspepsia, flatulence
Maltese: Komuni remettar, uġigħ addominali, distenzjoni abdominali, dispepsja, gass
English: Not known toxic epidermal necrolysis*, acute generalised exanthematous pustulosis*
Maltese: Mhux magħruf nekrolisi epidermali tossika*, pustulosi eksantematuża akuta mifruxa*
English: Cobicistat does not select any HIV resistance mutations, due to its lack of antiviral activity.
Maltese: Cobicistat ma jagħżilx mutazzjonijiet ta' reżistenza ta' HIV, minħabba n-nuqqas ta' attività antivirali tiegħu.
English: Psychiatric disorders Common abnormal dreams
Maltese: Disturbi psikjatriċi Komuni ħolm abnormali
English: Manufacturer Janssen-Cilag SpA, Via C. Janssen, Borgo San Michele, 04100 Latina, Italy
Maltese: Janssen, 04010 Borgo San Michele, Latina, l-Italja
English: Single doses up to 3,200 mg of darunavir as oral solution alone and up to 1,600 mg of the tablet formulation of darunavir in combination with ritonavir have been administered to healthy volunteers without untoward symptomatic effects.
Maltese: Dożi uniċi sa' 3,200 mg darunavir bħala mistura waħedha u sa 1,600 mg fl-għamla ta' pilloli ta' darunavir flimkien ma' ritonavir ġew amministrati lil voluntiera b'saħħithom mingħajr l-ebda effetti sintomatiċi ħżiena.
English: darunvir/ritonavir 600/100 mg twice daily + OBR N = 296
Maltese: darunavir/ritonavir 600/100 mg darbtejn kuljum + OBR N = 296
English: Both arms used a fixed background regimen consisting of tenofovir disoproxil fumarate 300 mg once daily and emtricitabine 200 mg once daily.
Maltese: Iż-żewġ friegħi użaw skeda fissa fl-isfond li kienet tikkonsisti f'tenofovir disoproxil fumarate 300 mg darba kuljum u emtricitabine 200 mg darba kuljum.
English: Serious adverse reactions were diabetes mellitus, (drug) hypersensitivity, immune reconstitution inflammatory syndrome, rash, Stevens-Johnson syndrome, and vomiting.
Maltese: Reazzjonijiet avversi serji kienu dijabete mellitus, sensittivita eċċessiva (minħabba l-mediċina), sindrome infjammatorju ta' rikostituzzjoni immuni, raxx, sindrome ta' Stevens-Johnson u remettar.
English: Tell your doctor if you take: - Alfentanil (injectable, strong and short-acting, painkiller that is used for surgical procedures) - Digoxin (to treat certain heart disorders) - Clarithromycin (antibiotic) - Clotrimazole, fluconazole, itraconazole, isavuconazole, posaconazole (against fungal infections).
Maltese: Għid lit-tabib tiegħek jekk tieħu: - Alfentanil (mediċina li ttaffi l-uġigħ li tingħata b'injezzjoni, qawwija li taġixxi għal perijodu qasir li tintuża fi proċeduri kirurġiċi) - Digoxin (biex tikkura ċertu mard tal-qalb) - Clarithromycin (antibijotiku) - Clotrimazole, fluconazole, itraconazole, isavuconazole, posaconazole (kontra infezzjonijiet fungali).
English: With baseline CD4+ cell count < 200
Maltese: B'għadd taċċelluli CD4+ < 200 fil-linja bażi
English: Cobicistat is primarily metabolised and eliminated by the liver.
Maltese: Cobicistat huwa prinċipalment metabolizzat u eliminat mill-fwied.
English: Expected interactions between REZOLSTA and antiretroviral and non-antiretroviral medicinal products are listed in the table below and are based on the identified interactions with darunavir/ritonavir, darunavir/cobicistat and with cobicistat.
Maltese: Interazzjonijiet mistennija bejn REZOLSTA u prodotti mediċinali antiretrovirali u mhux antiretrovirali huma elenkati fit-tabella t'hawn taħt u huma bbażati fuq l-interazzjonijiet identifikati b'darunavir/ritonavir, darunavir/cobicistat u b'cobicistat.
English: Based on theoretical considerations nevirapine is expected to decrease darunavir and/or cobicistat plasma concentrations, (CYP3A induction).
Maltese: Abbażi ta' konsiderazzjonijiet teoretiċi nevirapine hu mistenni li jnaqqas il-konċentrazzjonijiet ta' darunavir u/jew cobicistat fil-plażma, (induzzjoni ta' CYP3A).
English: In a multiple dose trial with darunavir/ritonavir (600/100 mg) twice daily, it was demonstrated that the total plasma concentrations of darunavir in subjects with mild (Child-Pugh Class A, n = 8) and moderate (Child-Pugh Class B, n = 8) hepatic impairment were comparable with those in healthy subjects.
Maltese: Fi prova b'dożi multipli ta' darunavir/ritonavir (600/100 mg) darbtejn kuljum, intwera li l-konċentrazzjonijiet totali ta' darunavir fil-plażma f'individwi b'indeboliment epatiku ħafif (Child-Pugh Klassi A, n = 8) u moderat (Child-Pugh Klass B, n = 8) kienu komparabbli ma dawk ta' individwi b'saħħithom.
English: In the REZOLSTA arm of Phase III trial TMC114FD2HTX3001, mean eGFRCG change from baseline was -11.1 mL/min at week 48 and mean eGFRcystatin C change from baseline was +2.9 mL/min/1.73 m² at week 48.
Maltese: III, il-bidla medja tal-eGFRCG mil-linja bażi kienet -11.1 mL/min f'ġimgħa 48 u l-bidla medja fl-eGFRcystatin C mil-linja bażi kienet +2.9 mL/min/1.73 m² f'ġimgħa 48.
English: EU/1/14/967/001
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/14/967/001
English: The mean eGFRCG change from baseline was -9.6 mL/min at week 2, and -9.6 mL/min at week 48.
Maltese: Il-bidla f'eGFRCG medju mil-linja bażi kienet ta' -9.6 mL/min f'ġimgħa 2, u -9.6 mL/min f'ġimgħa 48.
English: (CYP3A and/or P-glycoprotein inhibition).
Maltese: (Impediment ta' CYP3A u/jew P-glikoproteina).
English: However, unbound darunavir concentrations were approximately 55% (Child-Pugh Class A) and 100% (Child-Pugh Class B) higher, respectively.
Maltese: A) u 100% (Child-Pugh Klassi B) ogħla rispettivament.
English: Cobicistat is 97 to 98% bound to human plasma proteins and the mean plasma to blood-drug concentration ratio was approximately 2.
Maltese: Cobicistat jeħel minn 97% sa 98% ma' proteini fil-plażma u l-proporzjon tal-konċentrazzjoni medja tal-plażma għad-demm kienet ta' madwar 2.
English: Darunavir The absolute oral bioavailability of a single 600 mg dose of darunavir alone is approximately 37%.
Maltese: Darunavir Il-bijodisponibiltà orali assoluta ta' doża waħda ta' 600 mg darunavir waħdu kienet ta' madwar 37%.
English: 6/l (see section 4.1).
Maltese: 6/L fil-plażma (ara sezzjoni 4.1).
English: Based on theoretical considerations (systemic) dexamethasone is expected to decrease darunavir and/or cobicistat plasma concentrations.
Maltese: Abbażi ta' konsiderazzjonijiet teoretiċi dexamethasone (sistemiku) hu mistenni li jnaqqas il-konċentrazzjonijiet ta' darunavir u/jew cobicistat fil-plażma.
English: HIV-1 RNA < 50 copies/mL mean HIV-1 RNA log change from baseline (log10 copies/mL) CD4+ cell count mean change from baseline
Maltese: HIV-1 RNA < 50 kopja/mL Bidla log medja ta' HIV-1 RNA mil-linja bażi (log10 kopji/mL)
English: Interaction trials with darunavir/cobicistat, darunavir/ritonavir and with cobicistat have only been performed in adults.
Maltese: Provi ta' interazzjoni b'darunavir/cobicistat, darunavir/ritonavir u b'cobicistat saru biss f'adulti.
English: REZOLSTA has only been used in limited numbers of patients 65 years or older.
Maltese: REZOLSTA kien użat biss f'numru limitat ta' pazjenti ta' 65 sena jew aktar.
English: The table below shows the 48-week efficacy data of the darunavir/cobicistat arm of the TMC114FD2HTX3001 trial:
Maltese: It-tabella taħt turi d-data ta' effikaċja ta' 48 ġimgħa fil-grupp ta' darunavir/cobicistat tal-prova TMC114FD2HTX3001:
English: REZOLSTA 800 mg/150 mg tablets darunavir/cobicistat
Maltese: REZOLSTA 800 mg/150 mg pilloli miksijin b'rita darunavir/cobicistat