FrancophonIA/ELRC3.0 huggingface dataset:
English: As limited information is available on the use of Symtuza in patients aged 65 and over, caution should be exercised, reflecting the greater frequency of decreased hepatic function and of concomitant disease or other therapy (see sections 4.2 and 5.2).
Maltese: Minħabba li hija disponibbli informazzjoni limitata dwar l-użu ta' Symtuza f'pazjenti li għandhom 65 sena u aktar, għandu jkun hemm kawtela, li tirrifletti l-frekwenza akbar ta' funzjoni mnaqqsa talfwied u ta' mard jew terapija oħra konkomittanti (ara sezzjonijiet 4.2 u 5.2).
English: Protocol Defined Rebound Rate (95% CI)
Maltese: Rata tal-Virus li Jfiġġ mill-Ġdid wara t-Trattament Ddefinita mill-Protokoll (95% CI)
English: While effective viral suppression with antiretroviral therapy (ART) has been proven to substantially reduce the risk of sexual transmission, a residual risk cannot be excluded.
Maltese: Filwaqt li soppressjoni virali effettiva b'terapjija antiretrovirali (ART, antiretroviral therapy) ġiet ippruvata li tnaqqas b'mod sostanzjali r-riskju ta' trasmissjoni sesswali, ma jistax jiġi eskluż riskju residwu.
English: Symtuza and sofosbuvir, sofosbuvir/ledipasvir, or daclatasvir can be used concomitantly without dose adjustment
Maltese: Symtuza u sofosbuvir, sofosbuvir/ledipasvir, jew daclatasvir jistgħu jintużaw flimkien mingħajr aġġustament fid-doża.
English: DRV/COBI is expected to increase alfusozin concentrations (CYP3A4 inhibition)
Maltese: Abbażi ta' konsiderazzjonijiet teoretiċi DRV/COBI huwa mistenni li jżid ilkonċentrazzjonijiet ta' alfusozin (inibizzjoni ta' CYP3A4)
English: Rifampicin to treat some infections such as tuberculosis Pimozide, lurasidone, quetiapine or sertindole to treat psychiatric conditions Ergot alkaloids like ergotamine, dihydroergotamine, ergometrine and methylergonovine to treat migraine headaches
Maltese: Rifampicin biex titratta xi infezzjonijiet bħat-tuberkulożi Pimozide, lurasidone, quetiapine jew sertindole biex titratta kundizzjonijiet psikjatriċi L-alkalojdi ergot bħal ergotamine, dihydroergotamine, ergometrine u methylergonovine biex titratta l-uġigħ ta' ras tal-emigranja
English: It is not known whether the co-administration of tenofovir alafenamide and xanthine oxidase inhibitors (e.g. febuxostat) would increase systemic exposure to tenofovir.
Maltese: Mhuwiex magħruf jekk l-għoti ta' tenofovir alafenamide u inibituri ta' xanthine oxidase (eż.febuxostat) iżidx l-esponiment sistemiku għal tenofovir.
English: Emtricitabine triphosphate inhibits HIV replication through incorporation into viral DNA by the HIV reverse transcriptase (RT), which results in DNA chain-termination.
Maltese: Emtricitabine triphosphate jinibixxi r-replikazzjoni tal-HIV permezz tal-inkorporazzjoni fid-DNA tal-virus minn reverse transcriptase (RT) tal-HIV, li twassal għal terminazzjoni tal-katina tad-DNA.
English: Weight and metabolic parameters
Maltese: Il-piż u parametri metaboliċi
English: In the Phase 2/3 trials in treatment-naïve patients, 12.7% (59/465) of patients receiving Symtuza experienced rash (most of which were grade 1), 1.5% (7/465) of patients discontinued treatment due to rash, of whom one for rash and hypersensitivity.
Maltese: Fil-provi ta' Fażi 2/3 f'pazjenti li qatt ma kienu ħadu trattament qabel, 12.7% (59/465) tal-pazjenti li kienu qed jirċievu Symtuza kellhom raxx (li filbiċċa l-kbira kien ta' grad 1), 1.5% (7/465) tal-pazjenti waqqfu t-trattament minħabba raxx, li persuna minnhom waqqfitu għal raxx u sensittività eċċessiva.
English: Following oral administration of Symtuza, the median terminal elimination half-life of emtricitabine is 17.2 hours.
Maltese: Wara l-għoti mill-ħalq ta' Symtuza, il-medjan tal-half-life terminali tal-eliminazzjoni ta' emtricitabine hija 17.2 sigħat.
English: In double-blind Phase 3 Trial TMC114FD2HTX3001 (AMBER), treatment-naïve patients were randomised to receive either Symtuza (N = 362) or a combination of fixed-dose combination of darunavir and cobicistat and fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate (F/TDF) (N = 363) once daily.
Maltese: Fil-Prova ta' Fażi 3 TMC114FD2HTX3001 (AMBER) fejn la l-investigaturi u lanqas l-individwi ma kienu jafu liema sustanza qed titntuża, pazjenti li qatt ma kienu ħadu trattament qabel intagħżlu b'mod arbitrarju biex jew jirċievu Symtuza (N = 362) jew kombinazzjoni ta' kombinazzjoni ta' doża fissa ta' darunavir u cobicistat u kombinazzjoni ta' doża fissa ta' emtricitabine u tenofovir disoproxil fumarate (F/TDF) (N = 363) darba kuljum.
English: They either switched to Symtuza (N = 763) or continued their treatment regimen (N = 378) (randomised 2:1).
Maltese: Huma jew għaddew għal Symtuza (N = 763) jew komplew l-iskeda ta' trattament tagħhom (N = 378) (magħżula b'mod arbitrarju 2:1).
English: C]-cobicistat, 99% of circulating radioactivity in plasma was unchanged cobicistat.
Maltese: C], 99% tarradjuattività li kienet tiċċirkola fil-plażma kien cobicistat mhux mibdul.
English: Treatment with darunavir/cobicistat (two of the components of Symtuza) 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 (tnejn mill-komponenti ta' Symtuza) 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: Cobicistat is a mechanism-based inhibitor of cytochrome P450 of the CYP3A subfamily.
Maltese: Cobicistat huwa inibitur ibbażat fuq il-mekkaniżmu taċ-ċitokrom P450 tas-sottofamilja CYP3A.
English: This difference is not clinically relevant.
Maltese: Din id-differenza ma kinitx rilevanti b'mod kliniku.
English: Over 96 weeks of treatment in the Phase 3 studies TMC114FD2HTX3001 (AMBER) in treatmentnaïve patients and TMC114IFD3013 (EMERALD) in virologically suppressed treatment-experienced patients, resistance testing was performed on samples from patients experiencing protocol-defined virologic failure (PDVF) and who had HIV-1 RNA ≥400 copies/mL at failure or at later time points.
Maltese: Fuq perjodu ta' 96 ġimgħa ta' trattament fl-istudji ta' Fażi 3 TMC114FD2HTX3001 (AMBER) f'pazjenti li qatt ma jkunu ħadu trattament qabel u TMC114IFD3013 (EMERALD) f'pazjenti b'soppressjoni viroloġika li jkunu ħadu trattament qabel, sar ittestjar dwar reżistenza fuq kampjuni minn pazjenti li kellhom falliment viroloġiku ddefinit mill-protokoll (PDVF, protocol-defined virologic failure) u li kellhom ≥400 kopja/mL ta' RNA ta' HIV-1 fil-falliment jew f'xi żmien wara.
English: In studies in treatment-naïve patients, Symtuza was associated with a lower impact on the estimated glomerular filtration rate by Cockcroft-Gault method compared to control group (DRV/COBI+F/TDF).
Maltese: Fi studji f'pazjenti li qatt ma kienu ħadu trattament qabel, Symtuza kien assoċjat ma' impatt inqas fuq l-istima tar-rata ta' filtrazzjoni mill-glomeruli permezz tal-metodu Cockcroft-Gault meta mqabbel malgrupp ta' kontroll (DRV/COBI+F/TDF).
English: Symtuza 800 mg/150 mg/200 mg/10 mg tablets darunavir/cobicistat/emtricitabine/tenofovir alafenamide
Maltese: Symtuza 800 mg/150 mg/200 mg/10 mg pilloli darunavir/cobicistat/emtricitabine/tenofovir alafenamide
English: The type of food is not important.
Maltese: It-tip ta' ikel li tieħu mhuwiex importanti.
English: Your doctor will consider if Symtuza is the right medicine for you.
Maltese: Din mhijiex lista sħiħa ta' mediċini.
English: The median terminal plasma half-life of cobicistat following administration of Symtuza is 3.6 hours.
Maltese: Il-medjan tal-half-life terminali ta' cobicistat fil-plażma wara l-għoti ta' Symtuza huwa 3.6 sigħat.
English: The absolute 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-bijodisponibbiltà assoluta ta' doża waħda ta' 600 mg ta' darunavir waħdu kienet madwar 37% u żdiedet għal madwar 82% fil-preżenza ta' 100 mg ta' ritonavir darbtejn kuljum.
English: (CYP3A and/or P-glycoprotein inhibition).
Maltese: (inibizzjoni ta' CYP3A u/jew talglikoproteina P).
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 sever tal-fwied fuq il-farmakokinetika ta' darunavir ma ġiex studjat (ara sezzjonijiet 4.2, 4.3 u 4.4).
English: For the treatment of pulmonary arterial hypertension Sildenafil Tadalafil
Maltese: Għat-tratament ta' pressjoni għolja fl-arterji tal-pulmuni Sildenafil Tadalafil
English: Patients had a median age of 46 years (range 19-78), 82% were male, 75.5% White, 20.9% Black, and 2.3% Asian.
Maltese: Il-pazjenti kellhom medjan ta' età ta' 46 sena (firxa minn 19-78), 82% kienu rġiel, 75.5% Bojod, 20.
English: If you forget to take Symtuza It is important not to miss a dose of Symtuza.
Maltese: Huwa importanti li ma taqbiżx doża ta' Symtuza.
English: There have been reports of increased bleeding, including spontaneous skin haematomas and haemarthrosis in patients with haemophilia type A and B treated with HIV PIs.
Maltese: Kien hemm rapporti ta' żieda fil-fsada, inkluż ematomi spontanji fil-ġilda u emartrożi f'pazjenti b'emofilja tat-tip A u B ttrattati b'PIs għall-HIV.
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'ħafna dożi b'darunavir/ritonavir (600/100 mg) darbtejn kuljum, intwera li l-konċentrazzjonijiet totali ta' darunavir fil-plażma f'individwi b'indeboliment ħafif (Klassi A ta' Child-Pugh, N = 8) u moderat (Klassi B ta' Child-Pugh, N = 8) tal-fwied kienu kumparabbli ma' dawk f'individwi f'saħħithom.
English: Tell your doctor if you take: - Bosentan (to treat high blood pressure in the pulmonary circulation) - Dexamethasone (injection) (corticosteroid) - Boceprevir (to treat hepatitis C virus infection) - Rifapentine, rifabutin (to treat bacterial infections) - Oxcarbazepine (to prevent seizures).
Maltese: Għid lit-tabib tiegħek jekk inti tieħu: - Bosentan (biex jittratta pressjoni għolja fiċ-ċirkulazzjoni tal-pulmuni) - Dexamethasone (injezzjoni) (kortikosterojd) - Boceprevir (biex jtitratta infezzjoni bil-virus tal-epatite Ċ) - Rifapentine, rifabutin (biex jitratta infezzjonijiet bil-batterji) - Oxcarbazepine (biex jevita aċċessjonijiet).
English: (CYP3A and/or P-glycoprotein inhibition)
Maltese: (inibizzjoni ta' CYP3A u/jew talglikoproteina P)
English: How to take Symtuza
Maltese: Mediċini oħra u Symtuza
English: In the Phase 3 trial in suppressed treatment-experienced patients (EMERALD Study TMC114IFD3013), 5.1% (39/763) of patients receiving Symtuza experienced rash (most of which were grade 1), none discontinued treatment due to rash.
Maltese: Fil-prova ta' Fażi 3 f'pazjenti soppressi li kienu ħadu trattament qabel (Studju EMERALD TMC114IFD3013), 5.1% (39/763) tal-pazjenti li kienu qed jirċievu Symtuza kellhom raxx (li fil-biċċa l-kbira kien ta' grad 1), l-ebda persuna ma waqqfet ittrattament minħabba raxx.
English: Based on theoretical considerations DRV/COBI is expected to increase these beta-blocker plasma concentrations.
Maltese: Abbażi ta' konsiderazzjonijiet teoretiċi DRV/COBI huwa mistenni li jżid dawn ilkonċentrazzjonijijiet ta' imblokkaturi beta fil-plażma.
English: The safety of emtricitabine and tenofovir alafenamide in combination with elvitegravir and cobicistat as a fixed-dose combination tablet was evaluated in approximately 70 HIV/HBV co-infected patients currently receiving treatment for HIV in an open-label clinical study (GS-US-292-1249).
Maltese: Is-sigurtà ta' emtricitabine u tenofovir alafenamide flimkien ma' elvitegravir u cobicistat bħala pillola kkombinata b'doża fissa kienet stmata f'madwar 70 pazjent koinfettati b'HIV/HBV li attwalment kienu qed jirċievu trattament għall-HIV fi studju kliniku fejn kemm il-pazjenti kif ukoll l-investigaturi kienu jafu liema sustanza qed tintuża (GS-US-292-1249).
English: 90 film-coated tablets (3 bottles containing 30 tablets each) The bottles are not to be distributed individually.
Maltese: 90 pillola miksija b'rita (3 fliexken li fihom 30 pillola l-wieħed) Il-fliexken m'għandhomx jitqassmu b'mod indiviwali.
English: Patients co-infected with hepatitis B and/or hepatitis C virus Limited information is available on the use of Symtuza components in patients co-infected with hepatitis B and/or C virus.
Maltese: Hija disponibbli informazzjoni limitata dwar l-użu tal-komponenti ta' Symtuza f'pazjenti li jkunu koinfettati bil-virus tal-epatite B u/jew C.
English: Based on theoretical considerations DRV/COBI is expected to increase these calcium channel blocker plasma concentrations.
Maltese: Abbażi ta' konsiderazzjonijiet teoretiċi DRV/COBI huwa mistenni li jżid dawn ilkonċentrazzjonijiet ta' imblokkaturi tal-kanali tal-kalċju fil-plażma.
English: Co-administration of St. John's wort and Symtuza is contraindicated (see section 4.3)
Maltese: John's wort flimkien ma' Symtuza huwa kontraindikat (ara sezzjoni 4.3)
English: (CYP3A induction) Symtuza is expected to increase bosentan plasma concentrations.
Maltese: (induzzjoni ta' CYP3A) Symtuza huwa mistenni li jżid ilkonċentrazzjonijiet ta' bosentan fil-plażma.
English: 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.
Maltese: Fost l-1,968 pazjent li kienu diġà ġew ittrattati qabel li kienu qed jirċievu darunavir mogħti flimkien ma' ritonavir 600/100 mg darbtejn kuljum, 236 pazjent kienu koinfettati bil-virus tal-epatite B jew C.
English: In vitro binding of tenofovir to human plasma proteins is < 0.7% and is independent of concentration over the range of 0.01-25 mcg/mL.
Maltese: L-irbit ta' tenofovir ma' proteini tal-plażma tal-bniedem in vitro hu < 0.7% u hu indipendenti millkonċentrazzjoni fuq firxa minn 0.
English: There were insufficient pharmacokinetic data in the clinical trials to determine the effect of hepatitis B and/or C virus infection on the pharmacokinetics of darunavir,cobicistat, emtricitabine, or tenofovir alafenamide (refer to sections 4.4 and 4.8).
Maltese: Koinfezzjoni bil-virus tal-epatite B u/jew l-epatite Ċ Ma kienx hemm dejta farmakokinetika biżżejjed fil-provi kliniċi biex tiddetermina l-effett ta' infezzjoni bil-virus tal-epatite B u/jew Ċ fuq il-farmakokinetika ta' darunavir, cobicistat, emtricitabine, jew tenofovir alafenamide (irreferi għas-sezzjonijiet 4.4 u 4.8).
English: PHOSPHODIESTERASE, TYPE 5 (PDE-5) INHIBITORS For the treatment of erectile dysfunction Sildenafil Tadalafil Vardenafil
Maltese: INIBITURI TA' PHOSPHODIESTERASE, TAT-TIP 5 (PDE-5)
English: Each film-coated tablet contains 800 mg of darunavir (as ethanolate), 150 mg of cobicistat, 200 mg of emtricitabine, and 10 mg of tenofovir alafenamide (as fumarate).
Maltese: Kull pillola miksija b'rita fiha 800 mg ta' darunavir (bħala ethanolate), 150 mg ta' cobicistat, 200 mg ta' emtricitabine, u 10 mg ta' tenofovir alafenamide (bħala fumarate).
English: The median baseline CD4+ cell count was 628 x 10
Maltese: Il-medjan tal-għadd taċ-ċelluli CD4+ fil-linja bażi kien 628 x 10
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
Maltese: L-għoti flimkien ma' dawn il-prodotti mediċinali li ġejjin minħabba l-possibbiltà ta' telf tal-effett terapewtiku (ara sezzjoni 4.5): - carbamazepine, phenobarbital, phenytoin - rifampicin - lopinavir/ritonavir - St.
English: Increased creatine phosphokinase (CPK), myalgia, myositis and rarely, rhabdomyolysis have been reported with the use of HIV protease inhibitors, particularly in combination with NRTIs.
Maltese: Żieda fil-creatine phosphokinase (CPK), mijalġja, mijosite u b'mod rari, rabdomijolisi ġew irrappurtati bl-użu ta' inibituri tal-protease tal-HIV, b'mod partikolari flimkien ma' NRTIs.
English: Patients co-infected with HIV and hepatitis B or C virus
Maltese: Pazjenti koinfettati bil-virus tal-HIV u tal-epatite B jew Ċ
English: Nervous system disorders very common headache common dizziness
Maltese: Disturbi fis-sistema nervuża komuni ħafna uġigħ ta' ras komuni sturdament
English: It is not recommended to co-administer Symtuza with glecaprevir/pibrentasvir.
Maltese: Abbażi ta' konsiderazzjonijiet teoretiċi DRV/COBI jista' jżid lesponiment għal glecaprevir u pibrentasvir.
English: In case of concomitant antiviral therapy for hepatitis B or C, please refer to the relevant product information for these medicinal products.
Maltese: F'każ ta' terapija antivirali konkomitanti għall-epatite B jew Ċ, jekk jogħġbok irreferi għall-informazzjoni rilevanti ta' dawn il-prodotti mediċinali.
English: This subject harbored a K103N mutation at screening, indicating transmitted NNRTI resistance.
Maltese: Dan l-individwu kellu mutazzjoni K103N fl-iscreening, li tindika reżistenza trasmessa għal NNRTI.
English: Metabolism is a major elimination pathway for tenofovir alafenamide in humans, accounting for > 80% of an oral dose.
Maltese: Il-metaboliżmu huwa r-rotta maġġuri tal-eliminazzjoni għal tenofovir alafenamide fil-bniedem, li jammonta għal > 80% ta' doża orali.
English: Darunavir contains a sulphonamide moiety.
Maltese: Darunavir fih parti li hija sulphonamide.
English: Cobicistat is not expected to induce CYP1A2, CYP3A4, CYP2C9, CYP2C19, UGT1A1, or P-gp (MDR1).
Maltese: Cobicistat mhuwiex mistenni li jinibixxi CYP1A2, CYP2B6, CYP2C8, CYP2C9 jew CYP2C19. Cobicistat mhuwiex mistenni li jinduċi CYP1A2, CYP3A4, CYP2C9, CYP2C19, UGT1A1, jew P-gp (MDR1).
English: There is an increased potential for sildenafil-associated adverse events (including visual disturbances, hypotension, prolonged erection and syncope).
Maltese: Hemm żieda fil-possibbiltà ta' avvenimenti avversi assoċjati ma' sildenafil (inkluż disturbi filvista, pressjoni baxxa, erezzjoni li tieħu fit-tul u sinkope).
English: The combination of rifampicin and Symtuza is contraindicated (see section 4.3).
Maltese: Rifampicin flimkien ma' Symtuza huwa kontraindikat (ara sezzjoni 4.3).
English: Based on theoretical considerations DRV/COBI is expected to increase these PDE-5 inhibitor plasma concentrations.
Maltese: Abbażi ta' konsiderazzjonijiet teoretiċi DRV/COBI huwa mistenni li jżid dawn ilkonċentrazzjonijiet ta' inibituri ta' PDE-5 fil-plażma.
English: Patients with chronic hepatitis B or C treated with antiretroviral therapy are at an increased risk for severe and potentially fatal hepatic adverse reactions.
Maltese: Il-pazjenti b'epatite B jew Ċ kronika ttrattati b'terapija antiretrovirali qegħdin f'riskju akbar għal reazzjonijiet avversi severi tal-fwied li jistgħu jkunu fatali.
English: No clinically relevant pharmacokinetic differences due to age have been identified for cobicistat, emtricitabine or tenofovir alafenamide in the age range ≤ 65 years.
Maltese: Ma ġew identifikati l-ebda differenzi farmakokinetiċi minħabba l-età li kienu rilevanti b'mod kliniku għal cobicistat, emtricitabine jew tenofovir alafenamide fil-firxa ta' etajiet ≤ 65 sena.
English: Lipid Parameter Baseline Median
Maltese: Tabella 3 Parametru tallipidi
English: C]-darunavir trial in healthy volunteers showed that a majority of the radioactivity in plasma after a single 400/100 mg darunavir with ritonavir dose was due to the parent active substance.
Maltese: C] f'voluntiera f'saħħithom uriet li l-biċċa l-kbira tar-radjuattività fil-plażma wara doża waħda ta' 400/100 mg darunavir b'ritonavir kienet minħabba s-sustanza attiva oriġinali.
English: C]-darunavir could be retrieved in faeces and urine, respectively.
Maltese: C] setgħet tinkiseb lura mill-ippurgar u mill-awrina, rispettivament.
English: Symtuza should not be administered concomitantly with medicinal products containing tenofovir disoproxil (e.g. fumarate, phosphate, or succinate), lamivudine, or adefovir dipivoxil used for the treatment of HBV infection.
Maltese: Symtuza m'għandux jingħata flimkien ma' prodotti mediċinali li fihom tenofovir disoproxil (eż. fumarate, phosphate, jew succinate), lamivudine, jew adefovir dipivoxil li jintużaw għat-trattament ta' infezzjoni b'HBV.
English: An open-label, Phase 2 trial (TMC114-C230) was conducted for evaluating the pharmacokinetics, safety, tolerability, and efficacy of darunavir with low dose ritonavir in 12 ART-naïve HIV-1 infected paediatric patients aged 12 to less than 18 years and weighing at least 40 kg.
Maltese: 2 (TMC114-C230) fejn kemm l-investigaturi kif ukoll l-individwi kienu jafu liema sustanza qed tintuża biex tevalwa l-farmakokinetika, is-sigurtà, it-tollerabbiltà u l-effikaċja ta' darunavir flimkien ma' doża baxxa ta' ritonavir fi 12 il-pazjent pedjatriku infettati bl-HIV-1 li għandhom minn 12-il sena sa inqas minn18-il sena u jiżnu mill-inqas 40 kg.
English: Based on theoretical considerations (systemic) dexamethasone is expected to decrease darunavir and/or cobicistat plasma concentrations.
Maltese: Abbażi ta' konsiderazzjonijiet teoretiċi dexamethasone (sistemiku) huwa mistenni li jnaqqas il-konċentrazzjonijiet ta' darunavir u/jew ta' cobicistat filplażma.
English: No mechanistic interaction expected based on theoretical considerations.
Maltese: Ma hija mistennija l-ebda interazzjoni mekkanistika abbażi ta' konsiderazzjonijiet teoretiċi.
English: ANTICOAGULANT/PLATELET AGGREGATION INHIBITOR Apixaban
Maltese: ANTIKOAGULANT/INIBITUR TA' TAGĦQID TAL-PLEJTLITS Apixaban
English: Any child exposed in utero to nucleoside and nucleotide analogues, even HIV negative children, should have clinical and laboratory follow-up and should be fully investigated for possible mitochondrial dysfunction in case of relevant signs or symptoms.
Maltese: Kwalunkwe wild espost in utero għal analogi ta' nucleosid u nucleotid, anke tfal negattivi għall-HIV, għandhom jkollhom segwitu kliniku u tal-laboratorju u għandhom jiġu investigati b'mod komplut għal disfunzjoni mitokondrijali f'każ ta' sinjali jew sintomi rilevanti.
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 jinibixxi b'mod selettiv il-qsim tal-poliproteini Gag-Pol magħmulin b'kowd mill-HIV f'ċelluli infettati bil-virus, b'hekk jevita l-formazzjoni ta' partiċelli maturi infettivi tal-virus.
English: HEPATITIS C VIRUS (HCV) DIRECT-ACTING ANTIVIRALS NS3-4A inhibitors
Maltese: GĦALL-VIRUS TAL-EPATITE C (HCV, HEPATITIS C
English: HIV-1 isolates with reduced susceptibility to tenofovir alafenamide express a K65R mutation in HIV-1 RT; in addition, a K70E mutation in HIV-1 RT has been transiently observed.
Maltese: Iżolati ta' HIV-1 b'suxxettibbiltà mnaqqsa għal tenofovir alafenamide jesprimu mutazzjoni K65R flRT ta' HIV-1 ; barra minn hekk, ġiet osservata mutazzjoni K70E f'RT ta' HIV-1 b'mod temporanju.
English: Based on theoretical considerations DRV/COBI is expected to increase these antifungal plasma concentrations, and darunavir, cobicistat and/or tenofovir alafenamide plasma concentrations may be increased by the antifungals.
Maltese: Abbażi ta' konsiderazzjonijiet teoretiċi DRV/COBI huwa mistenni li jżid dawn ilkonċentrazzjonijiet ta' antifungali fil-plażma, u l-konċentrazzjonijiet ta' darunavir, cobicistat u/jew tenofovir alafenamide jistgħu jiżdiedu permezz tal-antifungali.
English: Metabolism and nutrition disorders common diabetes mellitus, anorexia, hypercholesterolaemia, low density lipoprotein increased, hypertriglyceridaemia, hyperlipidaemia, dyslipidaemia uncommon hyperglycaemia
Maltese: Distubi fil-metaboliżmu u n-nutrizzjoni komuni dijabete mellitus, anoreksja, iperkolesterolimja, żieda fil-lipoproteina ta' densità baxxa, ipertrigliċeridimja, iperlipidimja, dislipidimja mhux komuni ipergliċemija