FrancophonIA/ELRC3.0 huggingface dataset:
English: Uncommon diabetes mellitus, dyslipidaemia, hyperglycaemia, hyperlipidaemia
Maltese: Mhux komuni anoreksja, iperkolesteremja, ipertrigliċeridemija dijabete mellitus, dislipidemija, ipergliċemija, iperlipidemija
English: Virologic failures selected for resistance testing were defined as: never suppressed: HIV-1 RNA < 1 log10 reduction from baseline and ≥ 50 copies/mL at week 8, confirmed at the following visit; 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 Virologic failures based on TLOVR non-VF censored algorithm (HIV-1 RNA > 50 copies/mL) IAS-USA lists
Maltese: Ikkonfermati fil-vista ta' wara; rebound: HIV-1 RNA <50 kopja/mL segwiti b'HIV-1 RNA għal ≥ 400 kopja /mL ikkonfermata jew >1 log10 HIV-1 RNA żieda kkonfermata mill-inqas livell; diskontinwazzjoni b'HIV-1 RNA ≥ 400 kopja/ml fl-aħħar viżita b Fallimenti viroloġiċi bażati fuq algoritmu ċensurat ta' TLOVR mhux VF (HIV-1 RNA >50 kopja/mL) Listi
English: Drug-induced hepatitis (e.g. acute hepatitis, cytolytic hepatitis) has been reported with darunavir/ritonavir.
Maltese: Epatite ikkaġunata minn mediċina (eż. epatite akuta, epatite ċitolitika) kienet irrappurtata b'darunavir/ritonavir.
English: REZOLSTA 800 mg/150 mg - film-coated tablets darunavir/cobicistat
Maltese: REZOLSTA 800 mg/150 mg - pilloli miksijin b'rita darunavir/cobicistat
English: REZOLSTA 800 mg/150 mg film-coated tablets
Maltese: REZOLSTA 800 mg/150 mg pilloli miksijin b'rita
English: The table below shows the efficacy data of the 48 week and 96 week analyses from the ARTEMIS trial:
Maltese: It-tabella ta' taħt turi d-dejta ta' effikaċja tal-analiżi ta' 48 ġimgħa u ta' 96 ġimgħa mill-prova ARTEMIS:
English: Each film-coated tablet contains 800 mg darunavir (as ethanolate) and 150 mg cobicistat.
Maltese: Kull pillola fiha 800 mg darunavir (bħala ethanolate) u 150 mg cobicistat.
English: The most frequent adverse reactions reported during the darunavir/ritonavir clinical development program and as spontaneous reports are diarrhoea, nausea, rash, headache, and vomiting.
Maltese: Ir-reazzjonijiet avversi li ġew irrappurtati l-aktar frekwenti matul il-programm ta' żvilupp kliniku ta' darunavir/ritonavir u bħala rapporti spontanji huma dijarea, dardir, raxx, uġigħ ta' ras u remettar.
English: Co-administration with the following medicinal products due to the potential for loss of therapeutic effect (see section 4.5): - carbamazepine, phenobarbital, phenytoin - rifampicin - lopinavir/ritonavir - St John's wort, (Hypericum perforatum).
Maltese: L-għoti flimkien mal-prodotti mediċinali li ġejjin minħabba l-potenzjal ta'nuqqas ta' effett terapewtiku (ara sezzjoni 4.5): - carbamazepine, phenobarbital, phenytoin - rifampicin - lopinavir/ritonavir - St.
English: Clinical monitoring is recommended when co-administering REZOLSTA with clonazepam.
Maltese: Huwa rrakkomandat monitoraġġ kliniku meta REZOLSTA jingħata flimkien ma' clonazepam.
English: HIV-RNA
Maltese: HIV PI
English: The pooled data of a single-arm trial investigating darunavir 800 mg once daily in combination with cobicistat 150 mg once daily and other antiretrovirals and one arm of a trial in which REZOLSTA 800/150 mg once daily and other antiretrovirals were administered, showed that 1.9% of patients discontinued treatment due to rash.
Maltese: Il-ġabra ta' data minn prova bi grupp wieħed li stħarrġet darunavir 800 mg darba kuljum flimkien ma' cobicistat 150 mg darba kuljum u antiretrovirali oħrajn u grupp wieħed ta' prova li fiha REZOLSTA 800/150 mg u antiretrovirali oħrajn ingħataw darba kuljum, uriet li 1.9% talpazjenti waqfu t-trattament minħabba raxx.
English: REZOLSTA is indicated, in combination with other antiretroviral medicinal products, for the treatment of human immunodeficiency virus-1 (HIV-1) infection in adults aged 18 years or older.
Maltese: REZOLSTA huwa indikat, flimkien ma' prodotti mediċinali antiretrovirali oħra, għall-kura ta' pazjenti b'infezzjoni bil-virus ta' immunodefiċjenza umana (HIV-1) f'adulti li għalqu 18-il sena jew aktar.
English: ANTIMALARIALS Artemether/Lumefantrine
Maltese: MEDIĊINI KONTRA L-MALARJA Artemether/
English: - Ciclosporin, everolimus, tacrolimus, sirolimus (for dampening down your immune system) as the therapeutic effect or side effects of these medicines might be increased.
Maltese: - Ciclosporin, everolimus, tacrolimus, sirolimus (biex ittaffi l-qawwa tas-sistema immuni tiegħek) minħabba li l-effett terapewtiku jew l-effetti sekondarji ta' dawn il-mediċini jistgħu jiżdiedu.
English: Medicinal products that affect darunavir/cobicistat exposure
Maltese: Prodotti mediċinali li jaffettwaw l-esponiment ta' darunavir/cobicistat
English: The combination of rifampicin and REZOLSTA is contraindicated (see section 4.3).
Maltese: Il-kombinazzjoni ta' rifampicin u REZOLSTA hija kontraindikata (ara sezzjoni 4.3).
English: - Bosentan (to treat high blood pressure in the pulmonary circulation) - Buspirone, clorazepate, diazepam, estazolam, flurazepam, zolpidem, midazolam when used as injection (medicines to treat trouble with sleeping and/or anxiety) - Metformin (to treat type 2 diabetes) - Fentanyl, oxycodone, tramadol (to treat pain).
Maltese: - Bosentan (biex tikkura pressjoni għolja fiċ-ċirkolazzjoni pulmonarja) - Buspirone, clorazepate, diazepam, estazolam, flurazepam, zolpidem, midazolam meta jintuża bħala injezzjoni (mediċini biex jikkuraw problemi b'nuqqas ta' irqad u/jew ansjetà) - Metformin (għall-kura ta' dijabete ta' tip 2) - Fentayl, oxycodone, tramadol (għall-kura tal-uġigħ)
English: ANAESTHETIC Alfentanil
Maltese: Alfentanil
English: (CYP3A and/or CYP2D6 inhibition)
Maltese: (Impediment ta' CYP3A u/jew CYP2D6)
English: Co-administration of oral midazolam or triazolam and REZOLSTA is contraindicated (see section 4.3).
Maltese: L-għoti fl-istess waqt ta' midazolam orali jew triazolam u REZOLSTA huwa kontraindikat (ara sezzjoni 4.3)
English: - Buprenorphine/naloxone, methadone (medicines to treat opioid dependence) - Salmeterol (medicine to treat asthma) - Artemether/lumefantrine (a combination medicine to treat malaria) - Dasatinib, irinotecan, nilotinib, vinblastine, vincristine (medicines to treat cancer) - Perphenazine, risperidone, thioridazine (psychiatric medicines) - Clorazepate, diazepam, estazolam, flurazepam (medicines to treat sleeping disorders or anxiety) - Sildenafil, tadalafil, vardenafil (for erectile dysfunction or to treat a heart and lung disorder called pulmonary arterial hypertension) - Glecaprevir/pibrentasvir (to treat hepatitis C infection) - Fesoterodine, solifenacin (to treat urologic disorders).
Maltese: - Perphenazine, risperidone, thioridazine (mediċini psikjatriċi) - Clorazepate, diazepam, estazolam, flurazepam (mediċini li jittrattaw disturbi tal-irqad jew l-ansjetà) - Sildenafil, tadalafil, vardenafil (minħabba impotenza jew sabiex tiġi kkurata disturbi fil-qalb jew fil-pulmun li tissejjaħ pressjoni għolja fl-arterji pulmonari) - Glecaprevir/pibrentasvir (għall-kura ta' infezzjoni tal-epatite C) - Fesoterodine, solifenacin (biex jitrattaw disturbi uroloġiċi)
English: Based on theoretical considerations St John's wort is expected to decrease darunavir and/or cobicistat plasma concentrations.
Maltese: Abbażi ta' konsiderazzjonijiet teoretiċi St John's wort hu mistenni li jnaqqas il-konċentrazzjonijiet ta' darunaviru/jew cobicistat fil-plażma.
English: Cobicistat is a mechanism based inhibitor of CYP3A, and a weak CYP2D6 inhibitor.
Maltese: Cobicistat huwa impeditur bażat fuq mekkaniżmu ta' CYP3A, u impeditur ta' CYP2D6 dgħajjef.
English: In women receiving REZOLSTA during the second trimester of pregnancy, mean intra-individual values for total darunavir Cmax, AUC24h and Cmin were 49%, 56% and 92% lower, respectively, as compared with postpartum; during the third trimester of pregnancy, total darunavir Cmax, AUC24h and Cmin values were 37%, 50% and 89% lower, respectively, as compared with postpartum.
Maltese: F'nisa li kienu qed jirċievu REZOLSTA matul it-tieni trimestru tat-tqala, valuri medji fl-istess individwu għas-Cmax, l-AUC24h u s-Cmin ta' darunavir totali kienu 49%, 56% u 92% aktar baxxi, rispettivament, meta mqabbla ma wara t-twelid; matul it-tielet trimestru tat-tqala, il valuri tas-Cmax, l-AUC24h u s-Cmin ta' darunavir totali kienu 37%, 50% u 89% aktar baxxi rispettivament, meta mqabbla ma' wara t-twelid.
English: A trial of the pharmacokinetics of cobicistat was performed in non-HIV-1 infected subjects with severe renal impairment (estimated creatinine clearance below 30 mL/min).
Maltese: Saret prova dwar il-farmakokinetiċi ta' cobicistat f'individwi li mhumiex infettati b'HIV-1 u b'indeboliment tal-kliewi sever (stima ta' tneħħija ta' kreatinina inqas minn 30 mL/min).
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea dwar għall-Mediċini: http://www.ema.europa.eu/.
English: With Baseline CD4+ cell count (x 10
Maltese: B'għadd ta' ċelluli ta' CD4+ (x 10
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 ta' darunavir/ritonavir (N = 3,063), reazzjonijiet qawwija fil-ġilda, li jistgħu akkumpanjati bid-deni u/jew livelli ta' transaminases li jogħlew, kienu rrappurtati f'0.4% tal-pazjenti.
English: The safety and efficacy of REZOLSTA in paediatric patients aged 3 to 17 years have not been established (see sections 4.4 and 5.3).
Maltese: Is-sigurtà u l-effikaċja ta' REZOLSTA f'pazjenti pedjatriċi li għandhom bejn 3 snin sa 17-il sena ma ġietx stabbilita (ara sezzjonijiet 4.4 u 5.3).
English: Uncommon pancreatitis acute, pancreatic enzymes increased
Maltese: Mhux komuni pankreatite akuta, żieda fl-enzimi tal-frixa
English: If REZOLSTA is co-administered with parenteral midazolam, it should be done in an intensive care unit or similar setting, which ensures close clinical monitoring and appropriate medical management in case of respiratory depression and/or prolonged sedation.
Maltese: Jekk REZOLSTA jingħata fl-istess waqt ma' midazolam, dan għandu jsir f'taqsima tal-kura intensiva jew ambjent simili, li jiżgura monitoraġġ kliniku mill-qrib u ġestjoni medika xierqa f'każ ta' depressjoni respiratorja u/jew sedazzjoni prolongata.
English: Limited information is available in this population, and therefore, REZOLSTA should be used with caution in patients above 65 years of age (see sections 4.4 and 5.2).
Maltese: Informazzjoni limitata hija disponibbli f'din il-popolazzjoni u għalhekk REZOLSTA għandu jintuża b'attenzjoni f'pazjenti li għandhom 65 sena t'età (ara sezzjonijiet 4.4 u 5.2).
English: C-cobicistat, 99% of circulating radioactivity in plasma was unchanged cobicistat.
Maltese: C-cobicistat, 99% tarradjoattività fiċ-ċirkolazzjoni fil-plażma baqgħet cobicistat li ma nbiddlitx.
English: The combination of avanafil and REZOLSTA is contraindicated (see section 4.3).
Maltese: Il-kombinazzjoni ta' avanafil u REZOLSTA hija kontraindikata (ara sezzjoni 4.3)
English: Darunavir/ritonavir may be considered as an alternative.
Maltese: Darunavir/ritonavir jista' jitqies bħala alternattiva.
English: Concomitant use of REZOLSTA and corticosteroids that are metabolised by CYP3A (e.g. fluticasone propionate or other inhaled or nasal corticosteroids) may increase the risk of development of systemic corticosteroid effects, including Cushing's syndrome and adrenal suppression.
Maltese: L-użu ta' REZOLSTA flimkien ma' kortikostrojdi li huma metabolizzati permezz ta' CYP3A (eż. fluticasone propionate jew kortikosterojdi oħra li jinġibdu man-nifs) jista' jżid ir-riskju ta' żvilupp ta' effetti sistemiċi talkortikosterojdi, inkluż is-sindrom ta' Cushing u soppressjoni talglandoli adrenali.
English: Rifampicin to treat some infections such as tuberculosis Lurasidone, pimozide, quetiapine or sertindole to treat psychiatric conditions Ergot alkaloids like ergotamine, dihydroergotamine, ergometrine and methylergonovine to treat migraine headaches
Maltese: Rifampicin biex jikkuraw xi infezzjonijiet bħat-tuberkulożi Lurasidone, pimozide, quetiapine jew sertindole biex tikkura kundizzjonijiet psikjatriċi Ergot alkaloids bħal ergotamine, dihydroergotamine, ergometrine u methylergonovine biex tikkura l-emigranja
English: A trial of the pharmacokinetics of cobicistat was performed in non-HIV-1 infected subjects with moderate hepatic impairment (Child-Pugh Class B).
Maltese: Saret prova dwar il-farmakokinetiċi ta' cobicistat f'individwi li mhumiex infettati b'HIV-1 u b'indeboliment tal-fwied moderat (ChildPugh Klassi B).
English: GS-US-216-130 is a single-arm, open-label, Phase III trial evaluating the pharmacokinetics, safety, tolerability, and efficacy of darunavir with cobicistat in 313 HIV-1 infected adult patients (295 treatment-naïve and 18 treatment-experienced).
Maltese: III, fi grupp uniku u bit-tikketta tingħaraf, li evalwat l-farmakokinetiċi, is-sigurtà, u l-effikaċja ta' darunavir ma' cobicistat fi 313-il pazjent adult infettat b'HIV (295 ma kinux trattati qabel u 18 b'esperjenza ta' trattament).
English: In some patients with advanced HIV infection and a history of unusual infections due to a weakened immune system (opportunistic infection), signs and symptoms of inflammation from previous infections may occur soon after HIV treatment is started.
Maltese: F'xi pazjenti b'infezzjoni avvanzata ta' HIV u bi storja ta' infezzjonjiet mhux tas-soltu minħabba sistema immuni mdgħajfa (infezzjoni opportunistika), sinjali u sintomi ta' infjammazzjoni minn infezzjonijiet ta' qabel tista' sseħħ ftit wara li jinbeda trattament għal HIV.
English: HIV-1 infected patients who were eligible for this trial had a screening genotype showing no darunavir RAMs and plasma HIV-1 RNA ≥ 1,000 copies/mL.
Maltese: Pazjenti infettati b'HIV-1 li kienu eleġibbli għal din il-prova kellhom ġenotip skrinnjat li ma wera l-ebda RAMs għal darunavir u HIV-1 RNA ≥ 1,000 kopja/mL fil-plażma.
English: Clonazepam
Maltese: ANTIKONVULŻIVI Clonazepam
English: (inhibition of CYP3A)
Maltese: (impediment ta' CYP3A)
English: Use of other antiplatelets not affected by CYP inhibition or induction (e.g. prasugrel) is recommended (see section 4.3).
Maltese: L-użu ta' antiplatelets oħrajn mhux affettwati bl-impediment jew induzzjoni ta' CYP (eż. praugrel) huwa rakkomandat (ara sezzjoni 4.3).
English: Treatment-experienced darunavir/ritonavir 600/100 mg twice daily N = 296
Maltese: Pazjenti esperjenzati filkura ta' darunavir/riton avir 600/100 mg darbtejn kuljum N = 296
English: Based on theoretical considerations REZOLSTA may alter norethindrone plasma concentrations.
Maltese: Abbażi ta' konsiderazzjonijiet teoretiċi REZOLSTA jista' jibdel il-konċentrazzjonijiet ta' norethindrone fil-plażma.
English: The median terminal plasma half-life of cobicistat following administration of REZOLSTA is approximately 3-4 hours.
Maltese: Il-half-life terminali medjan ta' cobicistat fil-plażma wara l-għoti ta' REZOLSTA kien ta' madwar 3-4 sigħat.
English: The effect of severe hepatic impairment on the pharmacokinetics of darunavir has not been studied (see sections 4.2, 4.3 and 4.4).
Maltese: L-effett ta' indeboliment epatiku sever fuq il-farmakokinetiċi ta' darunavir għadu ma ġiex studjat (ara sezzjonijiet 4.2, 4.3 u 4.4).
English: darunavir/ ritonavir 800/100 mg once daily N = 343
Maltese: darunavir/ ritonavir 800/100 mg darba kuljum N = 343
English: Based on theoretical considerations REZOLSTA may alter warfarin plasma concentrations.
Maltese: Abbażi ta' konsiderazzjonijiet teoretiċi REZOLSTA jista' jaffettwa l-konċentrazzjonijiet ta' warfarin fil-plażma.
English: Tell your doctor if you take: - Bosentan (to treat heart disease) - Dexamethasone (injectable) (corticosteroid) - Efavirenz, etravirine, nevirapine (to treat HIV infection) - Rifapentine, rifabutin (to treat bacterial infections).
Maltese: Għid lit-tabib tiegħek jekk tieħu: - Bosentan (għal trattament ta' mard fil-qalb) - Dexamethasone (li jingħata b'injezzjoni) (corticosteroid) - Efavirenz, etravirine, nevirapine (għal trattament ta' infezzjoni bl-HIV) - Rifapentine, rifabutine (għal trattament ta' infezzjonijiet batteriċi).
English: Treatment with REZOLSTA during pregnancy results in low darunavir exposure (see sections 4.4 and 5.2).
Maltese: It-trattament b'REZOLSTA waqt it-tqala jwassal għal esponiment baxx għal darunavir (ara sezzjonijiet 4.4 u 5.2).
English: Uncommon side effects (may affect up to 1 in 100 people) - symptoms of infection or of autoimmune disorders (immune reconstitution inflammatory syndrome) - osteonecrosis (death of bone tissue caused by loss of blood supply to the bone) - enlargement of breasts - abnormal blood test results such as some tests for your pancreas, high level of sugar, abnormal levels of ‘lipids' (fats).
Maltese: Effetti sekondarji mhux komuni (jistgħu jaffettwaw sa persuna 1 minn kull 100) - sintomi ta' infezzjoni jew ta' disturbi awtoimmuni (sindromu infjammatorju ta' rikostituzzjoni immuni) - osteonekrożi (mewt tat-tessut tal-għadam ikkaġunata minn nuqqas ta' provvista ta' demm lejn l-għadam) - tkabbir tas-sider - riżultati mhux normali ta' testijiet tad-demm bħal xi testijiet tal-frixa tiegħek, livell għoli ta' zokkor, livelli mhux normali ta' ‘lipidi' (xaħmijiet).
English: Changes were observed in liver (hepatocyte hypertrophy, vacuolation, increased liver enzymes) and thyroid (follicular hypertrophy).
Maltese: Bidliet ġew osservati fil-fwied (ipertrofija tal-epatoċiti, vakwolazzjoni, żieda fl-enzimi tal- fwied) u t-tirojde (ipertrofija follikulari).
English: In these pharmacokinetic trials, the exposure of darunavir 800 mg boosted with cobicistat 150 mg was consistent with that observed when boosted with ritonavir 100 mg. Darunavir as a component of REZOLSTA is bioequivalent to darunavir 800 mg once daily in combination with cobicistat 150 mg once daily co-administered as single medicinal products (see section 5.2).
Maltese: Darunavir bħala komponent ta' REZOLSTA huwa bijoekwivalenti għal darunavir 800 mg darba kuljum flimkien ma' cobicistat 150 mg darba kuljum li jittieħdu bħala prodott mediċinali wieħed (ara sezzjoni 5.2).
English: Therefore, protein displacement of medicinal products highly bound to 1-acid glycoprotein cannot be ruled out (see section 4.5).
Maltese: Għalhekk, spostament ta' proteini ta' prodotti mediċinali li jintrabtu b'mod qawwi ma' 1-glikoproteina aċida, ma jistax jiġi eskluż (ara sezzjoni 4.5).
English: With baseline CD4+ cell count ≥ 200 median CD4+ cell count change from baseline (x 10
Maltese: B'għadd taċċelluli CD4+ ≥ 200 fil-linja bażi medjan ta' tibdil fl-għadd taċċelluli CD4+ mill-linja bażi (x 10
English: (CYP2D6 and/or CYP3A inhibition)
Maltese: (Impediment ta'CYP2D6 u/jew CYP3A)
English: What is REZOLSTA?
Maltese: X'inhu REZOLSTA?
English: Gastrointestinal disorders Very common diarrhoea, nausea
Maltese: Disturbi gastrointestinali Komuni ħafna dijarea, dardir
English: Outcomes darunavir/ ritonavir 800/100 mg once daily N = 343
Maltese: Eżiti darunavir/ ritonavir 800/100 mg darba kuljum N = 343
English: Concomitant use of REZOLSTA with lovastatin and simvastatin is contraindicated (see section 4.3).
Maltese: L-użu konkomitanti ta' REZOLSTA ma' lovastatin u simvastatin huwa kontraindikat (ara sezzjoni 4.3).
English: Inhibition of CYP3A-mediated metabolism by cobicistat enhances the systemic exposure of CYP3A substrates, such as darunavir, where bioavailability is limited and half-life is shortened due to CYP3A-dependent metabolism.
Maltese: Impediment ta' metaboliżmu permezz ta' CYP3A b'cobicistat jintensifika aktar l-esponiment sistemiku ta' sottostrati ta' CYP3A bħal darunavir, meta l-bijodisponibilità hija ristretta u l-half-life huwa mqassar minħabba metaboliżmu dipendenti fuq CYP3A.
English: Darunavir was rapidly absorbed following oral administration of REZOLSTA in healthy volunteers.
Maltese: Darunavir ġie assorbit malajr wara l-għoti orali ta' REZOLSTA f'voluntieri b'saħħithom.
English: PHOSPHODIESTERASE, TYPE 5 (PDE-5) INHIBITORS For the treatment of erectile dysfunction Sildenafil Tadalafil Vardenafil
Maltese: TA' PHOSPHODIESTERASE, TAT-TIP 5 (PDE-5)
English: Following oral administration of REZOLSTA in healthy volunteers, maximum plasma concentrations of cobicistat were observed 2 to 5 hours post-dose.
Maltese: Wara teħid orali ta' REZOLSTA f'voluntieri b'saħħithom, il-konċentrazzjonijiet massimi fil-plażma ta' cobicistat kienu osservati minn 2 sa 5 sigħat wara d-doża.
English: Outcomes darunvir/ritonavir 800/100 mg once daily + OBR N = 294
Maltese: Eżiti darunavir.ritonavir 800/100 mg darba kuljum + OBR N = 294
English: Efficacy of darunavir/cobicistat fixed-dose combination 800/150 mg once daily in ART-naïve patients TMC114FD2HTX3001 is a randomized, active-controlled, double blind, Phase III trial to evalate the efficacy and safety of darunavir/cobicistat/emtricitabine/tenofovir alafenamide versus darunavir/cobicistat fixed-dose combination + emtricitabine/tenofovir disoproxil fumarate.
Maltese: III, fejn la linvestigaturi u lanqas l-individwi ma kienu jafu liema sustanza qed tintuża biex tevalwa l-effikaċja u ssigurtà ta' darunavir/cobicistat/emtricitabine/tenofovir alafenamide versus kombinazzjoni ta' doża fissa ta' darunavir/cobicistat + emtricitabine/tenofovir disoproxil fumarate.
English: Treatment with darunavir/cobicistat 800/150 mg during the second and third trimester has been shown to result in low darunavir exposure, with a reduction of around 90% in Cmin levels (see section 5.2).
Maltese: It-trattament b'REZOLSTA matul it-tieni u t-tielet trimestru ntwera li jwassal għal esponiment baxx għal darunavir, bi tnaqqis ta' madwar 90% fil-livelli tas-Cmin (ara sezzjoni 5.2).
English: Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe sustanza mhux attiva elenkata fis-sezzjoni 6.1.
English: An increase in serum creatinine due to the inhibitory effect of cobicistat generally does not exceed 0.4 mg/dl.
Maltese: Kull żieda fil-kreatinina fis-serum minħabba l-effett impeditorju ta' cobicistat ġeneralment ma jaqbiżx 0.4 mg/dL.
English: All subjects darunavir/cobicistat 800/150 mg once daily + OBR N = 313
Maltese: L-individwi kollha darunavir/cobicistat 800/150 mg darba kuljum + OBR N = 313
English: C-darunavir with ritonavir showed that approximately 7.7% of the administered dose of darunavir is excreted in the urine unchanged.
Maltese: C-darunavir ma' ritonavir wera li madwar 7.7% tad-doża ta' darunavir amministrata titneħħa fl-awrina mingħajr ma tinbidel.
English: At 48 weeks, virologic response, defined as the percentage of patients with plasma HIV-1 RNA level < 50 copies/mL, with darunavir/ritonavir 800/100 mg once daily treatment was demonstrated to be non-inferior (at the pre-defined 12% non-inferiority margin) compared to darunavir/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 < 50 kopja/mL ta' HIV-1 RNA fil-plażma, bi darunavir/ritonavir 800/100 mg darba kuljum intwera li ma kienx inferjuri (bil-marġini ta' non-inferjorità ta' 12% ddefiniti minn qabel) meta mqabbel ma' darunavir/ritonavir 600/100 mg darbtejn kuljum kemm għall-popolazzjonijiet ITT kif ukoll OP.
English: Musculoskeletal and connective tissue disorders Common
Maltese: Disturbi muskoluskeletriċi u tat-tessuti konnettivi Komuni mijalġja