FrancophonIA/ELRC3.0 huggingface dataset:
English: Darunavir FC was less than 10 for 90% of 3,309 clinical isolates resistant to amprenavir, atazanavir, indinavir, lopinavir, nelfinavir, ritonavir, saquinavir and/or tipranavir showing that viruses resistant to most PIs remain susceptible to darunavir.
Maltese: L-FC ta' darunavir kien anqas minn 10 għal 90% minn 3,309 virusis iżolati klinikament reżistenti għal amprenavir, atazanavir, indinavir, lopinavir, nelfinavir, ritonavir, saquinavir u/jew tipranavir li juri li l-virusis reżistenti għall-maġġoranza tal-PIs jibqgħu suxxettibbli għal darunavir.
English: Immune system disorders uncommon immune reconstitution inflammatory syndrome, (drug) hypersensitivity
Maltese: Disturbi fis-sistema immuni mhux komuni sindrome infjammatorju ta' rikostituzzjoni immuni, sensittività eċċessiva (għall-mediċina)
English: Alfuzosin to treat enlarged prostate
Maltese: Alfuzosin biex tikkura tkabbir tal-prostata
English: Astemizole or terfenadine to treat allergy symptoms
Maltese: Astemizole jew terfenadine biex tikkura sintomi tal-allerġija
English: Fluticasone: in a clinical study where ritonavir 100 mg capsules twice daily were co-administered with 50 μg intranasal fluticasone propionate (4 times daily) for 7 days in healthy subjects, fluticasone propionate plasma concentrations increased significantly, whereas the intrinsic cortisol levels decreased by approximately 86% (90% CI 82-89%).
Maltese: Fluticasone: fi studju kliniku fejn kapsuli ta' 100 mg ritonavir darbtejn kuljum ingħataw flimkien ma' 50 µg fluticasone propionate mogħti ġolimnieħer (4 darbiet kuljum) għal 7 ijiem f'pazjenti b'saħħithom, ilkonċentrazzjonijiet ta' fluticasone propionate fil-plażma żdiedu b'mod sinifikanti filwaqt li l-livelli intrinsiċi tal-cortisol naqsu b'bejn wieħed u ieħor 86% (90% CI 82 - 89%).
English: Darunavir Krka contains the active substance darunavir.
Maltese: - Is-sustanza attiva hija darunavir.
English: Second trimester of pregnancy (n=17)
Maltese: It-tieni trimestru tattqala (n=17)
English: (CYP450 induction)
Maltese: (induzzjoni ta' CYP450)
English: HIV-1 RNA < 50 copies/ml
Maltese: HIV-1 RNA < 50 kopja/ml
English: Regular assessment of virological response is advised.
Maltese: Hija rrakkomadata stima regolari tar-rispons viroloġiku.
English: The unbound fraction was also substantially reduced, including around 90% reductions of Cmin levels.
Maltese: Il-porzjon mhux marbut wkoll tnaqqas b'mod sostanzjali, inkluż tnaqqis ta' madwar 90% fil-livelli tas-Cmin.
English: ANTI-DIABETICS Metformin
Maltese: ANTIDIJABETIĊI Metformin
English: FC and by use of enfuvirtide (ENF): As treated analysis of the POWER and DUET trials.
Maltese: Bħala analizi trattata tal-provi POWER u DUET.
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: poliproteini Gag-Pol li fihom il-kowd ta' l-HIV fiċ-ċelluli infettati bil-virus, u permezz t'hekk ifixkel il-formazzjoni ta' biċċiet infettivi maturi tal-virus.
English: The table below shows the development of HIV-1 protease mutations and loss of susceptibility to PIs in virologic failures at endpoint in the ARTEMIS, ODIN and TITAN trials.
Maltese: It-tabella t'hawn taħt turi l-iżvilupp ta' mutazzjonijiet ta' protease tal-HIV-1 u telf ta' suxxettibbiltà għall-PIs fil-fallimenti viroloġiċi fl-aħħar tal-provi ARTEMIS, ODIN u TITAN.
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 ta' pilloli ta' darunavir ma' ritonavir ġew amministrati lil voluntiera b'saħħithom mingħajr l-ebda effetti sintomatiċi ħżiena.
English: ANTIBIOTIC Clarithromycin 500 mg twice daily clarithromycin AUC ↑ 57% clarithromycin Cmin ↑ 174% clarithromycin Cmax ↑ 26% darunavir AUC ↓ 13% darunavir Cmin ↑ 1% darunavir Cmax ↓ 17%
Maltese: ANTIBIJOTIKU Clarithromycin 500 mg darbtejn kuljum clarithromycin AUC ↑ 57% clarithromycin Cmin ↑ 174% clarithromycin Cmax ↑ 26% darunavir AUC ↓ 13% darunavir Cmin ↑ 1% darunavir Cmax ↓ 17% Konċentrazzjonijiet ta' 14-OHclarithromycin ma kinux b'tali mod li setgħu jiġu identifikati meta ngħata flimkien ma' darunavir ritonavir.
English: Marketing Authorisation Holder KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
Maltese: Manifattur KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Is-Slovenja
English: Cobicistat 150 mg given with darunavir 800 mg once daily enhances darunavir pharmacokinetic parameters in a comparable way to ritonavir (see section 5.2).
Maltese: Cobicistat 150 mg mogħti ma' darunavir 800 mg darba kuljum jintensifika lparametri farmakokinetiċi b'mod kumparabbli għal ritonavir (ara sezzjoni 5.2).
English: During the darunavir/ritonavir 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) ta' darunavir/ritonavir, l-epatite kienet irrappurtata f'0.5% tal-pazjenti li kienu qed jirċievu terapija antiretrovirali mħallta b'darunavir/ritonavir.
English: (not applicable for darunavir coadministered with ritonavir)
Maltese: (ma japplikax għal darunavir mogħti flimkien ma' ritonavir)
English: After day 23 of life, the exposure was comparable to that in adult rats.
Maltese: Wara t-23 jum ta' ħajja, l-esponiment kien komparabbli ma dak ta' firien adulti.
English: Digoxin 0.4 mg single dose digoxin AUC ↑ 61% digoxin Cmin ND digoxin Cmax ↑ 29% (↑ digoxin from probable inhibition of P
Maltese: Digoxin Doża waħda ta' 0.4 mg digoxin AUC ↑ 61% digoxin Cmin ND digoxin Cmax ↑ 29% (↑ digoxin x'aktarx minn impediment ta' P-gp)
English: silica, colloidal anhydrous ) and magnesium stearate (E470b)in the tablet core and poly(vinyl alcohol), macrogol, titanium dioxide (E171), talc (E553b), yellow iron oxide (E172) and red iron oxide (E172) in film coating.
Maltese: hydroxypropylcellulose, colloidal anhydrous silica; silicified microcrystalline cellulose (microcrystalline cellulose, colloidal anhydrous silica) u magnesium stearate (E470b) fil-qalba tal-pillola u poly(vinyl alcohol), macrogol, titanium dioxide (E171), talc (E553b), yellow iron oxide (E172) - għal 400 mg pilloli miksijin b'rita biss u red iron oxide (E172) fil-kisja tar-rita.
English: (CYP3A, CYP2D6 and/or P-gp inhibition)
Maltese: (inibizzjoni ta' CYP3A, CYP2D6 u/jew P-gp)
English: Darunavir may increase antifungal plasma concentrations and posaconazole, isavuconazole, itraconazole, or fluconazole may increase darunavir concentrations.
Maltese: Darunavir intensifikat jista' jżid ilkonċentrazzjonijiet tal-mediċina antifungali fil-plażma u posaconazole, isavuconazole, itraconazole jew fluconazole jistgħu jżidu lkonċentrazzjonijiet ta' darunavir.
English: ethinylestradiol AUC ↓ 44% ethinylestradiol Cmin ↓ 62% ethinylestradiol Cmax ↓ 32% norethindrone AUC ↓ 14% norethindrone Cmin ↓ 30% norethindrone Cmax ↔ with darunavir/ritonavir
Maltese: AUC ta' ethinylestradiol ↓ 44% Cmin ta' ethinylestradiol ↓ 62% Cmax ta' ethinylestradiol ↓ 32% AUC ta' norethindrone ↓ 14% Cmin ta' norethindrone ↓ 30% Cmax ta' norethindrone ↔
English: Ritonavir inhibits the transporters P-glycoprotein, OATP1B1 and OATP1B3, and co-administration with substrates of these transporters can result in increased plasma concentrations of these compounds (e.g. dabigatran etexilate, digoxin, statins and bosentan; see the Interaction table below).
Maltese: Ritonavir jinibixxi t-trasportaturi OATP1B1 u OATP1B3 tal-glikoproteina P, u lgħoti flimkien ma' sustrati ta' dawn it-trasportaturi jista' jwassal għal żieda filkonċentrazzjonijiet ta'dawn is-sustanzi fil-plażma (eż. dabigatran etexilate, digoxin, statins u bosentan; ara t-Tabella ta' interazzjoni taħt).
English: In vitro experiments with human liver microsomes (HLMs) indicate that darunavir primarily undergoes oxidative metabolism.
Maltese: Esperimenti in vitro b'mikrosomi tal-fwied uman (HLMs) juru li darunavir jgħaddi primarjament minn metaboliżmu ossidattiv.
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) ta' 26 ġurnata jew 500mg/kg (doża ripetuta) mill-età ta' 23 sa 50 ġurnata, u l-esponimenti u l-profil ta' tossiċità kienu komparabbli ma' dawk osservati f'firien adulti.
English: A clinical study utilising a cocktail of medicinal products that are metabolised by cytochromes CYP2C9, CYP2C19 and CYP2D6 demonstrated an increase in CYP2C9 and CYP2C19 activity and inhibition of CYP2D6 activity in the presence of darunavir/ritonavir, which may be attributed to the presence of low dose ritonavir.
Maltese: Studju kliniku bl-użu ta' taħlita ta' prodotti mediċinali li jiġu mmetabolizzati miċċitokromi CYP2C9, CYP2C19 u CYP2D6 urew żieda fl-attività ta' CYP2C9 u CYP2C19 u impediment fl-attività ta' CYP2D6 fil-preżenza ta' darunavir/ritonavir, li tista' tkun attribwita għall-preżenza ta' doża baxxa ta' ritonavir.
English: Amlodipine, diltiazem, disopyramide, carvedilol, felodipine, flecainide, lidocaine,metoprolol, mexiletine, nifedipine, nicardipine, propafenone, timolol, verapamil (for heart disease) as the therapeutic effect or side effects of these medicines may be increased.
Maltese: Għid lit-tabib tiegħek jekk inti tieħu: - Amlodipine, diltiazem, disopyramide, carvedilol, felodipine,flecainide, lidocaine, metoprolol, mexiletine, nifedipine, nicardipine, propafenone, timolol, verapamil (għall-mard tal-qalb) minħabba li l-effett terapewtiku jew l-effetti sekondarji ta' dawn il-mediċini jistgħu jiżdiedu.
English: Patients received a weight-based twice daily treatment regimen, patients weighing 10 kg to < 15 kg received darunavir/ritonavir 25/3 mg/kg twice daily, and patients weighing 15 kg to < 20 kg received darunavir/ritonavir 375/50 mg twice daily.
Maltese: Il-pazjenti rċivew kors ta' kura darbtejn kuljum ibbażat fuq il-piż, pazjenti li jiżnu minn 10 kg sa < 15 kg irċivew darunavir/ritonavir 25/3 mg/kg darbtejn kuljum, u pazjenti li jiżnu minn 15 kg sa < 20 kg irċivew darunavir/ritonavir 375/50 mg darbtejn kuljum.
English: During the third trimester of pregnancy, cobicistat Cmax, AUC24h, and Cmin, were 27%, 49%, and 83% lower, respectively, as compared with postpartum.
Maltese: Matul it-tielet trimestru tat-tqala, isCmax, l-AUC24h, u s-Cmin ta' cobicistat kienu 27%, 49%, u 83% aktar baxxi, rispettivament, meta mqabbla ma' wara t-twelid.
English: Glecaprevir/pibrentasvir,simeprevir (to treat hepatitis C infection) Fentanyl, oxycodone, tramadol(to treat pain)
Maltese: Glecaprevir/pibrentasvir, simeprevir (biex titratta infezzjoni tal-epatite C). Fentanyl, oxycodone, tramadol (biex jittrattaw l-uġigħ) Fesoterodine, solifenacin (biex jittrattaw disturbi uroloġiċi).
English: Amiodarone, bepridil, dronedarone, ivabradine, quinidine, ranolazine to treat certain heart disorders e.g. abnormal heart beat
Maltese: Amiodarone, bepridil, dronedarone, ivabradine, quinidine, ranolazine biex tikkura ċerti disturbi tal-qalb eż. taħbit talqalb mhux normali
English: See the Summary of Product Characteristics for Darunavir Krka 600 mg tablets (see section 4.5).
Maltese: Ara s-Sommarju tal-Karattersitiċi tal-Prodott għal Darunavir Krka pilloli ta' 600 mg (ara sezzjoni 4.5).
English: INHALED BETA AGONISTS Salmeterol
Maltese: BETA LI JINĠIBDU MAN-NIFS Salmeterol
English: Metabolism and nutrition disorders common anorexia, diabetes mellitus, hypercholesterolaemia, hypertriglyceridaemia, hyperlipidaemia
Maltese: Disturbi fil-metaboliżmu u n-nutrizzjoni komuni anoressija, dijabete mellitus, iperkolesterolemija, ipertrigliċeridemija,
English: The requirements for submission of PSURs for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: PSURs għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont lArtikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikat fuq il-portal elettroniku Ewropew tal-mediċini.
English: With Baseline CD4+ cell count (x 10
Maltese: B'għadd ta' ċelluli CD4+ (x 10
English: 400/100 mg twice daily
Maltese: 400/100 mg darbtejn kuljum
English: During the second trimester of pregnancy, cobicistat Cmax, AUC24h, and Cmin were 50%, 63%, and 83% lower, respectively, as compared with postpartum.
Maltese: Matul it-tieni trimestru tat-tqala, isCmax, l-AUC24h, u s-Cmin ta' cobicistat kienu 50%, 63%, u 83% aktar baxxi, rispettivament, meta mqabbla ma' wara t-twelid.
English: Darunavir Krka is an antiretroviral medicine used in the treatment of Human Immunodeficiency Virus (HIV) infection.
Maltese: Darunavir Krka huwa mediċina antiretrovirali użat għat-trattament ta' infezzjoni bil-Virus Uman talImmunodefiċjenza (HIV).
English: When used for birth control, alternative methods of nonhormonal contraception are recommended.
Maltese: Meta użati għallkontroll tat-twelid, metodi alternattivi ta' kontraċezzjoni mhux ormonali huma rrakkomandati.
English: The exposure-adjusted rates of rash (all causality) were 10.9, 4.2, and 3.8 per 100 patient-years (PYR), respectively; and for drug-related rash were 2.4, 1.1, and 2.3 per 100 PYR, respectively.
Maltese: 9, 4.2, u 3.8 għal kull 100 sena ta' pazjent (PYR), rispettivament; u għal raxx relatat mal-mediċina kienu 2.4, 1.1, u 2.3 għal kull 100
English: Nevirapine 200 mg twice daily nevirapine AUC ↑ 27% nevirapine Cmin ↑ 47% nevirapine Cmax ↑ 18% darunavir: concentrations were consistent with historical data (↑ nevirapine from CYP3A inhibition)
Maltese: Nevirapine 200 mg darbtejn kuljum nevirapine AUC ↑ 27% nevirapine Cmin ↑ 47% nevirapine Cmax ↑ 18% #darunavir: il-konċentrazzjonijiet kienu konsistenti ma' dejta storika (↑ nevirapine minn impediment ta' CYP3A)
English: Darunavir is primarily metabolised and eliminated by the liver.
Maltese: Darunavir huwa primarjament metabolizzat u eliminat mill-fwied.
English: (CYP3A induction)
Maltese: (induzzjoni ta' CYP3A)
English: Lopinavir/ritonavir 400/100 mg twice daily + OBR N=297
Maltese: lopinavir/ritonavir 400/100 mg darbtejn kuljum + OBR N=297
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 fil-fsada spontanja fil-pazjenti morda bl-emofilja li qed jirċievu Impedituri ta' Protease antiretrovirali (ara sezzjoni 4.4).
English: Medicinal products that induce CYP3A activity would be expected to increase the clearance of darunavir and ritonavir, resulting in lowered plasma concentrations of darunavir and ritonavir (e.g. rifampicin, St John's wort, lopinavir).
Maltese: Prodotti mediċinali li jinduċu l-attività ta' CYP3A jkunu mistennija li jżidu t-tneħħija ta' darunavir u ritonavir bir-riżultat ta' konċentrazzjonijiet imnaqqsa ta' darunavir u ritonavir filplażma (eż. rifampicin, St John's wort, lopinavir).
English: How to take Darunavir Krka
Maltese: Kif taħżen Darunavir Krka
English: Interaction Geometric mean change (%)
Maltese: Interazzjoni Tibdil ġeometriku medju (%)
English: Co-administration of boosted darunavir and amiodarone, bepridil, dronedarone, ivabradine, quinidine, or ranolazine is contraindicated (see section 4.3).
Maltese: L-għoti ta' darunavir intensifikat flimkien ma' amiodarone, bepridil, dronedarone, ivabradine, quinidine, jew ranolazine huwa kontraindikat (ara sezzjoni 4.3).
English: Cmax, ng/mL AUC24h, ng.h/mL Cmin, ng/mL
Maltese: Cmax, ng/ml AUC24 siegħa, ng.siegħa/ml Cmin, ng/ml
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) (see section 4.4).
Maltese: Analiżi farmakokinetika ta' popolazzjoni f'pazjenti infettati bl-HIV uriet li lfarmakokinetika ta' darunavir m'hijiex konsiderevolment differeni fil-medda taleta'(18 sa 75 sena) evalwati f'pazjenti infettati bl-HIV (n=12, età 65) (ara sezzjoni 4.4).
English: Cmax, ng/ml AUC12h, ng.h/ml Cmin, ng/ml n=11 for AUC12h
Maltese: Cmax, ng/ml AUC12-il siegħa, ng.siegħa/ml Cmin, ng/ml n=11 għal AUC12-il siegħa
English: Immune reconstitution inflammatory syndrome
Maltese: Sindrome infjammatorjuta'rikostituzzjoniimmuni
English: Serious adverse reactions are diabetes mellitus, (drug) hypersensitivity, immune reconstitution inflammatory syndrome, rash and vomiting.
Maltese: Reazzjonijiet avversi serji huma diabetes mellitus, sensittivtà eċċessiva (għall-mediċina), sindrome infjammatorju ta' rikostituzzjoni immuni, raxx u rimettar.
English: Darunavir Krka 800 mg film-coated tablets (tablets):
Maltese: Darunavir Krka 800 mg pilloli miksjin b'rita (pilloli):
English: 150 mg twice daily darunavir AUC ↔ darunavir Cmin ↔ darunavir Cmax ↔
Maltese: 150 mg darbtejn kuljum darunavir AUC ↔ darunavir Cmin ↔ darunavir Cmax ↔
English: Viruses selected in these conditions and showing decreased susceptibility to darunavir (range: 23-50fold) harboured 2 to 4 amino acid substitutions in the protease gene.
Maltese: Virusis magħżula f'dawn ilkundizzjonijiet u li wrew suxxettibilità mnaqqsa għal darunavir (medda: 23-50 darba) kellhom fihom bejn 2 u 4 sostituzzjonijiet tal-aċidu amminiku fil-ġene protease.
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 fergħat użaw skeda fissa fl-isfond li kienet tikkonsisti f'tenofovir disoproxil fumarate 300 mg darba kuljum u emtricitabine 200 mg darba kuljum.
English: What Darunavir Krka looks like and contents of the pack Darunavir Krka 400 mg film-coated tablets (tablets):
Maltese: Kif jidher Darunavir Krka u l-kontenut tal-pakkett Darunavir Krka 400 mg pilloli miksjin b'rita (pilloli):
English: 800 mg darunavir/100 mg ritonavir once daily ritonavir oral solution: 80 mg/ml
Maltese: 800 mg darunavir/100 mg ritonavir darba kuljum soluzzjoni orali ta' ritonavir: 80 mg/ml
English: 450 mg darunavir /60 mg ritonavir twice daily
Maltese: 450 mg darunavir/60 mg ritonavir darbtejn kuljum
English: Amlodipine Diltiazem Felodipine Nicardipine Nifedipine Verapamil
Maltese: Darunavir intensifikat u didanosine jista' jintuża mingħajr aġġustamenti fid-doża.
English: The combination of avanafil and boosted darunavir is contraindicated (see section 4.3).
Maltese: Il-kombinazzjoni ta' avanafil u darunavir intensifikat hija kontraindikata (ara sezzjoni 4.3).
English: The recommended dose of emtricitabine/tenofovir alafenamide is 200/10 mg once daily when used with boosted darunavir.
Maltese: Id-doża rrakkomandata ta' emtricitabine/tenofovir alafenamide hija 200/10 mg darba kuljum meta jintuża ma' darunavir intensifikat.
English: Primary (major) PI mutations
Maltese: Mutazzjonijiet primarji (maġġuri) tal-PI
English: Saquinavir: comparison of saquinavir/ritonavir 1,000/100 mg twice daily vs. saquinavir/darunavir/ritonavir 1,000/400/100 mg twice daily Darunavir: comparison of darunavir/ritonavir 400/100 mg twice daily vs. darunavir/ritonavir 400/100 mg in combination with saquinavir 1,000 mg twice daily.
Maltese: Saquinavir: tqabbil ta' saquinavir/ritonavir 1,000/100 mg darbtejn kuljum ma' saquinavir/darunavir/ritonavir 1,000/400/100 mg darbtejn kuljum Darunavir: tqabbil ta' darunavir/ritonavir 400/100 mg darbtejn kuljum ma' darunavir/ritonavir 400/100 mg flimkien ma' saquinavir
English: (CYP3A and/or CYP2D6 inhibition)
Maltese: (impediment ta' CYP3A u/jew CYP2D6)
English: Proportion (%) of patients with response (HIV-1 RNA < 50 copies/ml at week 24) to darunavir coadministered with ritonavir (600/100 mg twice daily) by baseline genotype a, and baseline darunavir
Maltese: Proporzjon (%) ta' pazjenti b'rispons (HIV-1 RNA < 50 kopja/ml fl-24 ġimgħa) għal darunavir amministrat flimkien ma' ritonavir (600 mg/100 mg darbtejn kuljum) skont il-ġenotip fil-linja bażi a, u l-FC ta' darunavir fil-linja bażi u permezz tal-użu ta' enfuvirtide (ENF):
English: Medicinal products that affect darunavir exposure (cobicistat as pharmacoenhancer)
Maltese: Prodottimediċinali lijaffettwawl-esponiment għaldarunavir (cobicistat bħala farmakointensifikatur)
English: An increase of systemic exposure to darunavir was observed when darunavir co-administered with 100 mg ritonavir was co-administered with rifabutin (150 mg once every other day).
Maltese: Żieda fl-esponiment sistemiku għal darunavir kienet osservata meta darunavir mogħti flimkien ma' 100 mg ritonavir ingħata flimkien ma' rifabutin (150 mg ġurnata iva u oħra le).
English: TITAN is a randomised, controlled, open-label Phase III trial comparing darunavir co-administered with ritonavir (600/100 mg twice daily) versus lopinavir/ritonavir (400/100 mg twice daily) in ARTexperienced, lopinavir naïve HIV-1 infected adult patients.
Maltese: TITAN hija prova tal-Fażi III randomised, ikkontrollata, open-label, li tqabbel darunavir mogħti flimkien ma' ritonavir (600/100 mg darbtejn kuljum) versus lopinavir/ritonavir (400/100 mg darbtejn kuljum) f'pazjenti adulti infettati bl-HIV1 li ġieli ħadu ART qabel iżda qatt ma ħadu lopinavir.
English: Ear and labyrinth disorders uncommon vertigo
Maltese: Disturbi fil-widnejn u fis-sistema labirintika mhux komuni vertigo
English: Pharmacotherapeutic group: antivirals for systemic use, protease inhibitors, ATC code: J05AE10.
Maltese: Antivirali għall-użu sistemiku, inibituri talprotease, Kodiċi ATC:
English: Several of the interaction studies (indicated by
Maltese: Diversi mill-istudji ta' interazzjoni (indikati b'
English: The effects of high fluticasone systemic exposure on ritonavir plasma levels are
Maltese: L-effetti ta' esponiment sistemiku għoli għal fluticasone fuq il-livelli ta' ritonavir filplażma mhumiex magħurfa.
English: (↑ clarithromycin from CYP3A inhibition and possible P-gp inhibition)
Maltese: (↑clarithromycin minn impediment ta' CYP3A u x'aktarx minn impediment ta' P-gp)
English: The type of food does not affect the exposure to darunavir (see sections 4.4, 4.5 and 5.2).
Maltese: It-tip ta' ikel ma jaffettwax lesponiment għal darunavir (ara sezzjonijiet 4.4, 4.5 u 5.2).
English: Darunavir/ritonavir (600/100 mg twice daily or 800/100 mg once daily) in combination with a background regimen was evaluated in a clinical trial of 36 pregnant women (18 in each arm) during the second and third trimesters, and postpartum.
Maltese: Darunavir/ritonavir (600/100 mg darbtejn kuljum jew 800/100 mg darba kuljum) flimkien ma' pja terapewtiku fl-isfond ġie stmat fi prova klinika ta' 36 mara tqila (18 f'kull fergħa) waqt it-tieni u t-tielet trimestri tat-tqala, u wara t-twelid.
English: The intravenous clearance of darunavir alone (150 mg) and in the presence of low dose ritonavir was 32.8 l/h and 5.9 l/h, respectively.
Maltese: It-tneħħija ta' darunavir waħdu (150 mg) wara amministrazzjoni fil-vina u filpreżenza ta' doża baxxa ta' ritonavir kienet ta' 32.8 l/siegħa u 5.9 l/siegħa rispettivament.
English: These results were confirmed in the analysis of data at 96 weeks of treatment in the TITAN trial, with 60.4% of patients in the darunavir/ritonavir arm having HIV-1 RNA < 50 copies/ml at week 96 compared to 55.2% in the lopinavir/ritonavir arm [difference: 5.2%, 95% CI (-2.8; 13.1)].
Maltese: Dawn ir-riżultati kienu kkonfermati fl-analiżi ta' dejta fis-96 ġimgħa ta' kura fil-prova TITAN, b'60.4% talpazjenti fil-fergħa ta' darunavir/ritonavir li kellhom HIV-1 RNA < 50 kopja/m fis-96 ġimgħa meta kienu mqabbla ma' 55.2% fil-fergħa ta' lopinavir/ritonavir [differenza: 5.2%, 95% CI (-2.8; 13.1)].