FrancophonIA/ELRC3.0 huggingface dataset:
English: Darunavir Krka, co-administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (HIV-1) infection (see section 4.2).
Maltese: Darunavir Krka, mogħti flimkien ma' doża baxxa ta' ritonavir huwa indikat, flimkien ma' prodotti mediċinali antiretrovirali oħra, għall-kura ta' pazjenti b'infezzjoni bil-virus uman tal-immunodefiċjenza (HIV-1) (ara sezzjoni 4.2).
English: Coadministration of darunavir/cobicistat with weak to moderate CYP3A inducers (e.g. efavirenz, etravirine, nevirapine, boceprevir, fluticasone, and bosentan) is not recommended (see interaction table below).
Maltese: L-għoti ta' darunavir/cobicistat flimkien ma' indutturi ħfief jew moderati ta' CYP3A (eż. efavirenz, etravirine, nevirapine, boceprevir, fluticasone, u bosentan) mhuwiex irrakkomandat (ara ttabella ta' interazzjoni taħt).
English: The absolute oral bioavailability of a single 600 mg dose of darunavir alone was approximately 37% and increased to approximately 82% in the presence of 100 mg twice daily ritonavir.
Maltese: Il-bijodisponibiltà orali assoluta ta' doża waħda ta' 600 mg darunavir waħdu kienet ta' bejn wieħed u ieħor 37% u żdiedet għal madwar 82% fil-preżenza ta' 100 mg darbtejn kuljum ritonavir.
English: In a study conducted in rats, the number of corpora lutea and implantations were decreased in the presence of maternal toxicity.
Maltese: Fi studju li sar fil-firien, in-numru ta' corpora lutea u implantazzjonijiet kienu mnaqqsa fil-preżenza ta' tossiċità tal-omm.
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: Reproductive system and breast disorders uncommon gynaecomastia*
Maltese: Disturbi fis-sistema riproduttiva u fis-sider mhux komuni ġinekomastja*
English: Based on theoretical considerations darunavir is expected to increase alfuzosin plasma concentrations.
Maltese: Abbażi ta' konsiderazzjonijiet teoretiċi darunavir huwa mistenni li jżid ilkonċentrazzjonijiet ta' alfuzosin filplażma.
English: Life-threatening and fatal drug interactions have been reported in patients treated with colchicine and strong inhibitors of CYP3A and P-glycoprotein (P-gp; see sections 4.3 and 4.5).
Maltese: Interazzjonijiet tal-mediċina li kienu ta' periklu għall-ħajja u fatali ġew irrappurtati f'pazjenti kkurati b'colchicine u impedituri qawwija ta' CYP3A u P-glikoproteina (P-gp; ara sezzjonijiet 4.3 u 4.5).
English: based on published data with darunavir/ritonavir
Maltese: Riżultati darunavir/ ritonavir
English: 375 mg darunavir /50 mg ritonavir twice daily
Maltese: 375 mg darunavir/50 mg ritonavir darbtejn kuljum
English: In women receiving darunavir/ritonavir 800/100 mg once daily during the second trimester of pregnancy, mean intra-individual values for total darunavir Cmax, AUC24h and Cmin were 33%, 31% and 30% lower, respectively, as compared with postpartum; during the third trimester of pregnancy, total darunavir Cmax, AUC24h and Cmin values were 29%, 32% and 50% lower, respectively, as compared with postpartum.
Maltese: F'nisa li kienu qed jirċievu darunavir/ritonavir 800/100 mg darba kuljum waqt it-tieni trimestru tat-tqala, il-valuri medji intraindividwali għal Cmax, AUC24 siegħa u Cmin ta' darunavir totali kienu 33%, 31% u 30% inqas, rispettivament meta mqabbla ma' wara t-twelid; waqt it-tielet trimestru tat-tqala, il-valuri ta' Cmax, AUC24 siegħa u Cmin għal darunavir totali kienu 29%, 32% u 50% inqas, rispettivament, meta mqabbla ma' wara t-twelid.
English: Interactions between darunavir/ritonavir and antiretroviral and non-antiretroviral medicinal products are listed in the table below.
Maltese: Interazzjonijiet bejn darunavir/ritonavir u prodotti mediċinali antiretrovirali u li ma humiex antiretrovirali huma elenkati fit-tabella t'hawn taħt.
English: In cases of severe skin reaction see the warning in section 4.4.
Maltese: F'każijiet ta' reazzjoni qawwija fil-ġilda ara t-twissija f'sezzjoni 4.4.
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'darunavir/cobicistat 800/150 mg waqt it-tqala jwassal għal esponiment baxx għal darunavir (ara sezzjonijiet 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: Drug-induced hepatitis (e.g. acute hepatitis, cytolytic hepatitis) has been reported with darunavir.
Maltese: Epatite ikkaġunata minn mediċina (eż. epatite akuta, epatite ċitolitika) kienet irrappurtata b'darunavir.
English: ART-experienced paediatric patients from the age of 3 to < 6 years The pharmacokinetics, safety, tolerability and efficacy of darunavir/ritonavir twice daily in combination with other antiretroviral agents in 21 ART-experienced HIV-1 infected paediatric patients aged 3 to < 6 years and weighing 10 kg to < 20 kg was evaluated in an open-label, Phase II trial, ARIEL.
Maltese: Pazjenti pedjatriċimill-etàta'3snin sa,6sninb'esperjenza ta'ART Il-farmakokinetika, is-sigurtà, it-tollerabilità u l-effikaċja ta' darunavir/ritonavir darbtejn kuljum flimkien ma' mediċini antiretrovirali oħrajn f'21 pazjent pedjatriku infettati bl-HIV-1 li kienu diġà ħadu kura b'ART fil-passat, li kellhom minn 3 sa < 6 snin u li jiżnu minn 10 kg sa < 20 kg, ġew evalwati fi prova ta' Fażi
English: Darunavir with low dose ritonavir with triazolam or oral midazolam is contraindicated (see section 4.3)
Maltese: Darunavir ma' doża baxxa ta' ritonavir ma' triazolam jew midazolam orali huwa kontraindikat (ara sezzjoni 4.3)
English: Nilotinib
Maltese: Nifedipine
English: #, a comparable systemic exposure to sildenafil was observed for a single intake of 100 mg sildenafil alone and a single intake of 25 mg sildenafil co-administered with darunavir and low dose ritonavir.
Maltese: #, esponiment sistemiku kumparabbli għal sildenafil kien osservat bit-teħid ta' doża unika ta' 100 mg sildenafil waħdu u teħid ta' doża unika ta' 25 mg sildenafil mogħti ma' darunavir flimkien ma' doża baxxa ta' ritonavir.
English: Cobicistat decreases the estimated creatinine clearance due to inhibition of tubular secretion of creatinine.
Maltese: Cobicistat inaqqas it-tneħħija stmata tal-kreatinina minħabba inibizzjoni ta' sekrezzjoni tal-kreatinina mit-tubuli.
English: 600 mg darunavir /100 mg ritonavir twice daily with ritonavir oral solution: 80 mg/ml
Maltese: 600 mg darunavir/100 mg ritonavir darbtejn kuljum b'soluzzjoni orali ta' ritonavir: 80 mg/ml
English: Number of subjects with virologic failure and paired baseline/endpoint phenotypes, showing loss of susceptibility to PIs at endpoint compared to baseline, n/N PI darunavir amprenavir atazanavir indinavir lopinavir saquinavir tipranavir
Maltese: Numru ta' individwi b'falliment viroloġiku u fenotipi fl-aħħar tal-provi f'par mal-linja bażi, li juru telf ta' suxxettibbiltà għall-PIs fl-aħħar tal-prova meta mqabbla mal-linja bażi, n/N PI darunavir amprenavir atazanavir indinavir lopinavir saquinavir tipranavir
English: Medicinal products that may be affected by darunavir boosted with cobicistat
Maltese: Prodotti mediċinalilijistgħujiġuaffettwatiminndarunavirintensifikatb'cobicistat
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 farmakokinetiku ta' darunavir amministrat flimkien ma' cobicistat jew ritonavir, ġie evalwat f'voluntiera adulti b'saħħithom u f'pazjenti infettati bl-HIV-1.
English: 100 milligram more than 40 kilograms
Maltese: 100 milligramma bejn 30 u 40 kilogramma
English: Third trimester of pregnancy (n=12)
Maltese: It-tieni trimestru tattqala (n=12)
English: In a single arm trial investigating darunavir 800 mg once daily in combination with cobicistat 150 mg once daily and other antiretrovirals 2.2% of patients discontinued treatment due to rash.
Maltese: Fi prova b'fergħa waħda li investigat darunavir 800 mg darba kuljum flimkien ma' cobicistat 150 mg darba kuljum u antiretrovirali oħra 2.2% tal-pazjenti waqqfu l-kura minħabba raxx.
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 fil-pazjenti b'indeboliment renali, analiżi farmakokinetika ta' popolazzjoni wriet li l-farmakokinetika ta' darunavir m'hijiex affettwata sinifikament fil-pazjenti infettati bl-HIV u li għandhom indeboliment renali moderat (CrCl bejn 30 - 60 ml/min, n=20) (ara sezzjonijiet 4.2 u 4.4).
English: 675 mg darunavir/100 mg ritonavir once daily
Maltese: 675 mg darunavir/100 mg ritonavir darba kuljum
English: Musculoskeletal and connective tissue disorders uncommon myalgia, osteonecrosis, muscle spasms, muscular weakness, arthralgia, pain in extremity, osteoporosis, increased blood creatine phosphokinase rare musculoskeletal stiffness, arthritis, joint stiffness
Maltese: Disturbi muskoluskeltriċi u tat-tessuti konnettivi mhux komuni rari mijalġja, osteonekrożi, spażmi fil-muskoli, dgħufija fil-muskoli, artralġja, uġigħ fl-idejn u ssaqajn, osteoporożi, żieda fil-creatine phosphokinase fid-demm ebusija muskoloskeletrika, artrite, ebusija tal-ġog
English: Limited data are available in patients with HIV-1 clades other than B (see section 5.1).
Maltese: Hija disponibbli dejta limitata f'pazjenti bi grupp ta' HIV-1 ġejjin mill-istess antenat li mhumiex B (ara sezzjoni 5.1).
English: not known toxic epidermal necrolysis*, acute generalised exanthematous pustulosis*
Maltese: nekroliżi epidermali tossika, reazzjoni akuta ta'
English: Patients co-infected with hepatitis B and/or hepatitis C virus Among 1,968 treatment-experienced patients receiving darunavir co-administered with ritonavir 600/100 mg twice daily, 236 patients were co-infected with hepatitis B or C. Co-infected patients were more likely to have baseline and treatment emergent hepatic transaminase elevations than those without chronic viral hepatitis (see section 4.4).
Maltese: Pazjenti ko-infettati bil-virus tal-epatite B u/jew Ċ Fost 1,968 pazjent li kienu ħadu kura qabel u li kienu qed jirċievu darunavir flimkien ma' ritonavir 600 mg/100 mg darbtejn kuljum, 236 pazjent kienu co-infettati bl-epatite B jew Ċ.
English: Co-administration of boosted Clinical monitoring is recommended darunavir with clonazepam may increase concentrations of clonazepam.
Maltese: Huwa rrakkomandat monitoraġġ kliniku meta darunavir intensifikat jingħata flimkien ma' clonazepam.
English: In women receiving darunavir/ritonavir 600/100 mg twice daily during the second trimester of pregnancy, mean intra-individual values for total darunavir Cmax, AUC12h and Cmin were 28%, 26% and 26% lower, respectively, as compared with postpartum; during the third trimester of pregnancy, total darunavir Cmax, AUC12h and Cmin values were 18%, 16% lower and 2% higher, respectively, as compared with postpartum.
Maltese: F'nisa li kienu qed jirċievu darunavir/ritonavir 600/100 mg darbtejn kuljum waqt ittieni trimestru tat-tqala, il-valuri medji intraindividwali għal Cmax, AUC12-il siegħa u Cmin ta' darunavir totali kienu 28%, 26% u 26% inqas, rispettivament meta mqabbla ma' wara t-twelid; waqt it-tielet trimestru tat-tqala, il-valuri ta' Cmax, AUC12-il siegħa u Cmin għal darunavir totali kienu 18%, 16% inqas u 2% ogħla, rispettivament, meta mqabbla ma' wara t-twelid.
English: All ranges 0-2
Maltese: Informazzjoni għall-pazjent
English: Treatment with darunavir/cobicistat 800/150 mg once daily 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'darunavir/cobicistat 800/150 mg darba kuljum 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: In a multiple dose study with darunavir co-administered with 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 (ChildPugh Class B, n=8) hepatic impairment were comparable with those in healthy subjects.
Maltese: Fi studju b'dożi multipli ta' darunavir amministrat flimkien ma' ritonavir (600/100 mg) darbtejn kuljum, intwera bil-provi 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 kumparabbli ma dawk ta' individwi b'saħħithom.
English: At 48 weeks non-inferiority in virologic response to the darunavir/ritonavir treatment, defined as the percentage of patients with plasma HIV-1 RNA level < 400 and < 50 copies/ml, was demonstrated (at the pre-defined 12% non-inferiority margin) for both ITT and OP populations.
Maltese: Fit-48 ġimgħa in-nuqqas ta' inferjorità fir-rispons viroloġiku b'darunavir/ritonavir, definit bħala l-perċentwal ta' pazjenti b'livell ta' < 400 kopja/ml u < 50 ta' HIV-1 RNA fil-plażma, intwera (fil-marġini ta' 12% ddefinit minn qabel għan-nuqqas ta' inferjorità) kemm għal popolazzjonijiet ITT kif ukoll OP.
English: (CYP3A inhibition)
Maltese: (impediment ta' CYP3A)
English: These results were sustained up to 192 weeks of treatment in the ARTEMIS trial.
Maltese: Dawn ir-riżultati kienu sostnuti għal 192 ġimgħa ta' kura filprova ARTEMIS.
English: darunavir/ritonavir 600/100 mg twice daily + OBR N=296
Maltese: darunavir/ritonavir 600/100 mg darbtejn kuljum + OBR N=296
English: rifabutin Cmax darunavir AUC ↑ 53% darunavir Cmin ↑ 68% darunavir Cmax ↑ 39% sum of active moieties of rifabutin (parent drug + 25-O-desacetyl metabolite) 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 10fold increase in the daily exposure to the active metabolite 25-O-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-Odesacetylrifabutin.
English: United Kingdom Consilient Health (UK) Ltd. Tel: +44 (0)203 751 1888
Maltese: Tel: +44 (0)203 751 1888
English: Number of mutations from the list of mutations associated with a diminished response to darunavir/ritonavir (V11I, V32I, L33F, I47V, I50V, I54L or M, T74P, L76V, I84V or L89V)
Maltese: V11I, V32I, L33F, I47V, I50V, I54M, I54L, T74P, L76V, I84V, u L89V
English: Pharmacokinetic enhancer and concomitant medications Darunavir has different interaction profiles depending on whether the compound is boosted with ritonavir or cobicistat:
Maltese: Intensifikatur farmakokinetiku u mediċini oħra użati flimkien miegħu Darunavir jkollu profili differenti ta' interazzjoni skont jekk is-sustanza hijiex intensifikata b' ritonavir jew cobicistat:
English: Renal and urinary disorders uncommon acute renal failure, renal failure, nephrolithiasis, increased blood creatinine, proteinuria, bilirubinuria, dysuria, nocturia, pollakiuria rare decreased creatinine renal clearance
Maltese: Disturbi fil-kliewi u fis-sistema urinarja mhux komuni rari insuffiċjenza renali akuta, insuffiċjenza renali, nefrolitjażi, żieda fil-kreatinina fid-demm, proteinurja, bilirubinurja, disurja, nokturja, pollakijurja tnaqqis fit-tneħħija renali tal-kreatinina
English: Not studied with darunavir/ritonavir.
Maltese: Ma ġiex studjat b'darunavir/ritonavir.
English: Treatment of overdose with darunavir consists of general supportive measures including monitoring of vital signs and observation of the clinical status of the patient.
Maltese: It-trattament ta' doża eċċessiva ta' darunavir jikkonsisti f'miżuri ġenerali ta' għajnuna inkluż monitoraġġ tas-sinjali vitali u osservazzjoni tal-istat kliniku tal-pazjent.
English: Ritonavir may decrease plasma concentrations of voriconazole.
Maltese: Ritonavir jista' jnaqqas il-konċentrazzjonijiet ta' voriconazole fil-plażma.
English: Dapoxetine
Maltese: Pożoloġija
English: Second trimester of pregnancy (n=7)
Maltese: It-tieni trimestru tat-tqala (n=7)
English: In the table below the specific pharmacokinetic enhancer is specified when recommendations differ.
Maltese: Fit-tabella taħt il-farmakointensifikatur speċifiku huwa speċifikat meta rrakkomandazzjonijiet ikunu differenti.
English: darunavir/ ritonavir 800/100 mg once daily N=343
Maltese: darunavir/ ritonavir 800/100 mg darba kuljum N=343
English: The dose is either:
Maltese: Data ta' ftuħ:
English: Darunavir Krka 400 mg film-coated tablets Darunavir Krka 800 mg film-coated tablets darunavir
Maltese: Darunavir Krka 400 mg pilloli miksijin b'rita Darunavir Krka 800 mg pilloli miksijin b'rita darunavir
English: BOX
Maltese: KAXXA
English: Outcomes darunavir/ritonavir 800/100 mg once daily + OBR N=294
Maltese: Riżultati darunavir/ritonavir 800/100 mg darba kuljum + OBR N=294
English: At least 3 oxidative metabolites of darunavir have been identified in humans; all showed activity that was at least 10-fold less than the activity of darunavir against wild type HIV.
Maltese: Ta' lanqas 3 sustanzi ossidattivi iffurmati mill-metaboliżmu ta' darunavir kienu identifikati fil-bnedmin; kollha wrew attività li kienet ta' lanqas 10 darbiet anqas mill-attività ta' darunavir kontra l-HIV li jinstab fin-natura.
English: Darunavir Krka, co-administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (HIV-1) infection.
Maltese: Darunavir Krka, mogħti flimkien ma' doża baxxa ta' ritonavir huwa indikat, flimkien ma' prodotti mediċinali antiretrovirali oħra, għall-kura ta' pazjenti b'infezzjoni bil-virus uman tal-immunodefiċjenza (HIV-1).
English: Concomitant use of darunavir with low dose ritonavir and elbasvir/grazoprevir is contraindicated (see section 4.3).
Maltese: L-użu ta' darunavir flimkien ma' doża baxxa ta' ritonavir u elbasvir/grazoprevir huwa kontraindikat (ara sezzjoni 4.3).
English: The dose of simeprevir in this interaction study was 50 mg when co-administered in combination with darunavir/ritonavir, compared to 150 mg in the simeprevir alone treatment group.
Maltese: Id-doża ta' simeprevir f'dan l-istudju ta' interazzjoni kienet ta' 50 mg meta ngħatat flimkien ma' darunavir/ritonavir, meta mqabbla ma' 150 mg fil-grupp ta' kura b'simeprevir
English: Nervous system disorders common headache, peripheral neuropathy, dizziness uncommon lethargy, paraesthesia, hypoaesthesia, dysgeusia, disturbance in attention, memory impairment, somnolence rare syncope, convulsion, ageusia, sleep phase rhythm disturbance
Maltese: Disturbi fis-sistema nervuża komuni mhux komuni rari uġigħ ta' ras, newropatija periferali, sturdament letarġija, paraestesija, ipoestesija, disgewżja, disturb fl-attenzjoni, indeboliment tal-memorja, ħeddla ta' rqad,
English: CLINICAL PARTICULARS
Maltese: Riżultati kliniċi
English: The rash is usually mild to moderate.
Maltese: Ir-raxx huwa ġeneralment ħafif għal moderat.
English: Applicable to darunavir boosted with either ritonavir or cobicistat:
Maltese: Tapplika għal darunavir intensifikat b'ritonavir jew b'cobicistat:
English: Medicinal products that may be affected by darunavir boosted with ritonavir
Maltese: Prodotti mediċinali li jistgħu jiġu affettwati minn darunavir intensifikat b'ritonavir
English: Skin and subcutaneous tissue disorders common rash (including macular, maculopapular, papular, erythematous and pruritic rash), pruritus uncommon angioedema, generalised rash, allergic dermatitis, urticaria, eczema, erythema, hyperhidrosis, night sweats, alopecia, acne, dry skin, nail pigmentation rare
Maltese: Disturbi fil-ġilda u fit-tessuti ta' taħt il-ġilda komuni mhux komuni rari mhux magħruf raxx (inkluż makulari, makulopapulari, papulari, raxx bil-ħmura u bil-ħakk), ħakk anġjoedima, raxx mifrux, dermatite allerġika, urtikarja, ekżema, ħmura, iperidrosi, għaraq billejl, alopeċja, akne, ġilda xotta, pigmentazzjoni fiddifer
English: Do not combine Darunavir Krka with products that contain St John's wort (Hypericum perforatum).
Maltese: Tikkombinax Darunavir Krka ma' prodotti li fihom St John's wort (Hypericum perforatum).
English: 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)
Maltese: Dasatinib, everolimus, irinotecan, nilotinib, vinblastine, vincristine (biex tikkura l-kanċer) - Sildenafil, tadalafil, vardenafil(għall-impotenza jew biex tikkura disturb talqalb u tal-pulmun imsejjaħ pressjoni għolja fil-pulmuni tal-arterji).
English: darunavir/ ritonavir 600/100 mg twice daily N=296
Maltese: darunavir/ ritonavir 600/100 mg darbtejn kuljum N=296
English: Hepatobiliary disorders common increased alanine aminotransferase uncommon hepatitis, cytolytic hepatitis, hepatic steatosis, hepatomegaly, increased transaminase, increased aspartate aminotransferase, increased blood bilirubin, increased blood alkaline phosphatase, increased gamma-glutamyltransferase
Maltese: Disturbi fil-fwied u fil-marrara komuni mhux komuni żieda fl-alanine aminotransferase 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: HIV-1 RNA < 50 copies/ml CD4+ percent change from baseline CD4+ cell count mean change from baseline
Maltese: HIV-1 RNA < 50 kopji/ml CD4+ bidla perċentwali mil-linja bażi CD4+ bidla medja tal-għadd taċ-ċelluli millinja bażi
English: darunavir/ ritonavir 600/100 mg twice daily N=298
Maltese: darunavir/ ritonavir 600/100 mg darbtejn kuljum N=298
English: Concomitant use of colchicine and darunavir co-administered 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: 800 mg darunavir /100 mg ritonavir once daily
Maltese: 800 mg darunavir/100 mg ritonavir darba kuljum
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 iddożaġġ skont il-piż tal-ġisem).
English: Talk to your doctor about the signs and symptoms of liver problems.
Maltese: Kellem lit-tabib tiegħek dwar is-sinjali u sintomi ta' problemi tal-fwied.
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-α1glikoproteina aċida, ma jistax jiġi eskluż (ara sezzjoni 4.5).