FrancophonIA/ELRC3.0 huggingface dataset:
English: In some patients with advanced HIV infection and a history of opportunistic infection, signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started.
Maltese: F'xi pazjenti b'infezzjoni avvanzata tal-HIV u storja ta' infezzjonjiet opportunistiċi, sinjali u sintomi ta' infjammazzjoni minn infezzjonijiet ta' qabel tista' sseħħ ftit wara li jinbeda trattament kontra l-HIV.
English: Concominant administration of boosted darunavir and lurasidone, pimozide or sertindole is contraindicated (see section 4.3).
Maltese: L-għoti flimkien ta' darunavir intensifikat u lurasidone, pimozide jew sertindole huwa kontraindikat (ara sezzjoni 4.3).
English: UROLOGICAL DRUGS Fesoterodine Solifenacin
Maltese: MEDIĊINI UROLOĠIĊI Fesoterodine
English: Buprenorphine/naloxone (medicines to treat opioid dependence) Salmeterol (medicine to treat asthma)
Maltese: Buprenorphine/naloxone (mediċini biex tikkura d-dipendenza fuq opjojdi) Salmeterol (mediċina biex tikkura l-ażma) Artemether/lumefantrine (mediċina kombinata għal kura tal-malarja)
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Maltese: Informazzjoni ddettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku talAġenzija Ewropea għall-Mediċini: http://www.ema.europa.eu
English: LABEL for bottle
Maltese: Lista tabularitar-reazzjonijietavversi
English: 600 mg darunavir/100 mg ritonavir once daily
Maltese: 600 mg darunavir/100 mg ritonavir darba kuljum
English: Virologic response was defined as a decrease in plasma HIV-1 RNA viral load of at least 1.0 log10 versus baseline.
Maltese: Ir-rispons viroloġiku kien infisser bħala tnaqqis fit-tagħbija virali ta' HIV-1 RNA ta' mill-inqas 1.0 log10 kontra l-linja bażi ta' riferiment.
English: darunavir/ ritonavir 800/100 mg once daily N=294
Maltese: darunavir/ ritonavir 800/100 mg darba kuljum N=294
English: and, therefore, higher plasma concentrations.
Maltese: analżeġiċi fil-plażma.
English: Concomitant use of darunavir/ritonavir and darunavir/cobicistat with lopinavir/ritonavir, rifampicin and herbal products containing St John's wort, Hypericum perforatum, is contraindicated (see section 4.5).
Maltese: rifampicin u prodotti magħmula mill-ħxejjex li fihom St John's wort, Hypericum perforatum, huwa kontraindikat (ara sezzjoni 4.5).
English: The combination may result in increased risk of cardiovascular adverse event with salmeterol, including QT prolongation, palpitations and sinus tachycardia.
Maltese: It-taħlita tista' twassal għal żieda fir-riskju ta' każijiet kardjovaskulari avversi b'salmeterol li jinkludu l-intervall QT jitwal, palpitazzjonijiet u takikardija tas-sinus.
English: In addition, pharmacokinetic modeling and simulation of darunavir exposures in paediatric patients across the ages of 3 to < 18 years confirmed the darunavir exposures as observed in the clinical studies and allowed the identification of weight-based darunavir/ritonavir once daily dosing regimens for paediatric patients weighing at least 15 kg that are either ART-naïve or treatment-experienced paediatric patients without DRV-RAMs* and who have plasma HIV-1 RNA < 100,000 copies/ml and CD4+ cell count ≥ 100 cells x 10
Maltese: Barra dan, l-immudellar farmakokinetiku u s-simulazzjoni farmakokinetika ta' esponimenti għal darunavir f'pazjenti pedjatriċi matul is-snin ta' 3 sa < 18-il sena kkonfermaw l-esponimenti għal darunavir kif kien osservat fl-istudji kliniċi u ppermettew l-identifikazzjoni ta' skedi ta' għoti ta' dożi abbażi tal-piż ta' darunavir/ritonavir darba kuljum għal pazjenti pedjatriċi li kienu jiżnu mill-inqas 15il kg li jew ikunu pazjenti pedjatriċi li ma jkunu qatt ħadu kura b'ART qabel jew li jkunu ħadu kura qabel li ma jkollhomx DRV-RAMs* u li fil-plażma jkollhom < 100,000 kopja/ml ta' RNA ta' HIV-1 u għadd ta' ≥ 100 ċellula x 10
English: 600 milligram Darunavir Krka (1 tablet containing 600 milligram of Darunavir Krka) together with 100 milligram ritonavir twice daily.
Maltese: JEW - 600 milligramma Darunavir Krka(pillola waħda li fiha 600 milligramma ta' Darunavir Krka ) flimkien ma' 100 milligramma ritonavir darbtejn kuljum.
English: Other corticosteroids: interaction not studied.
Maltese: Kortikosterojdi oħra: l-interazzjoni ma ġietx studjata.
English: Concomitant use of salmeterol and boosted darunavir may increase plasma concentrations of salmeterol.
Maltese: L-użu konkomitanti ta' salmeterol u darunavir intensifikat jista' jżid il-konċentrazzjonijiet ta' salmeterol fil-plażma.
English: Darunavir Krka 400mg film-coated tabletsareavailable in bottlescontaining 30 film-coated tablets (1 bottleof 30 film-coated tablets), 60 film-coated tablets (2 bottlesof 30 film-coated tablets), 90 filmcoated tablets (3 bottlesof 30 film-coated tablets)and 180 film-coated tablets (6 bottlesof 30 filmcoated tablets)in a box.
Maltese: Darunavir Krka 400 mg pilloli miksijin b'rita huma disponibbli fi fliexken li fihom 30 pillola miksijin b'rita (flixkun 1 ta' 30 pillola miksijin b'rita), 60 pillola miksijin b'rita (2 fliexken ta' 30 pillola miksjin b'rita), 90 pillola miksijin b'rita (3 fliexken ta' 30 pillola miksjin b'rita) u 180 pillola miksijin b'rita (6 fliexken ta' 30 pillola miksjin b'rita) f'kaxxa.
English: Increasing baseline darunavir fold change in EC50 (FC) was associated with decreasing virologic response.
Maltese: Il-linja bażi li tiżdied fid-drabi ta' tibdil fl-EC50 (FC) ta' darunavir kienet assoċjata ma' tnaqqis fir-rispons viroloġiku.
English: Blood and lymphatic system disorders uncommon rare thrombocytopenia, neutropenia, anaemia, leukopenia increased eosinophil count
Maltese: Disturbi tad-demm u tas-sistema limfatika mhux komuni rari tromboċitopenija, newtropenija, anemija, lewkopenija żieda fl-għadd ta' eosinofili
English: Co-administration of darunavir with low dose ritonavir and alfuzosin is contraindicated (see section 4.3).
Maltese: Darunavir mogħti flimkien ma' doża baxxa ta' ritonavir u alfuzosin huwa kontraindikat (ara sezzjoni 4.3).
English: (CYP2D6 and/or CYP3A inhibition).
Maltese: (inibizzjoni ta' CYP2D6 u/jew CYP3A)
English: Darunavir binds predominantly to α1-acid glycoprotein.
Maltese: Darunavir jintrabat b'mod predominanti mal-α1-glikoproteina aċida.
English: Pharmacokinetic results of total darunavir after administration of darunavir/cobicistat 800/150 mg once daily as part of an antiretroviral regimen, during the second trimester of pregnancy, the third trimester of pregnancy, and postpartum Pharmacokinetics of total darunavir (mean ± SD)
Maltese: Riżultati farmakokinetiċi ta' darunavir totali wara għoti ta' darunavir/cobicistat biddoża ta' 800/150 mg darba kuljum bħala parti minn skeda antiretrovirali, waqt ittieni trimestru tat-tqala, it-tielet trimestru tat-tqala u wara t-twelid Farmakokinetika ta' darunavir totali (medja ± SD)
English: Phenobarbital, phenytoin (to prevent seizures)
Maltese: Phenobarbital, phenytoin (biex jilqgħu kontra attakki ta' epilessija) Dexamethasone (kortikosterojd)
English: Systemic corticosteroid effects including Cushing's syndrome and adrenal suppression have been reported in patients receiving ritonavir and inhaled or intranasally administered fluticasone.
Maltese: Effetti sistemiċi tal-kortikosterojdi inkluż issindrome ta' Cushing u soppressjoni adrenali ġew irrappurtati f'pazjenti li kienu qed jirċievu ritonavir u
English: During the clinical development program (N=2,613 treatment-experienced subjects who initiated therapy with darunavir/ritonavir 600/100 mg twice daily), 51.3% of subjects experienced at least one adverse reaction.
Maltese: Waqt il-programm ta' żvilupp kliniku (N=2,613 individwu li kienu diġà ħadu kura qabel u li bdew terapija b'darunavir/ritonavir 600/100 mg darbtejn kuljum), 51.3% tal-individwi ħassew mill-anqas reazzjoni avversa waħda.
English: Concomitant use of boosted darunavir and these antidepressants may increase concentrations of the antidepressant.
Maltese: L-użu ta' darunavir intensifikat u dawn l-antidepressanti jista' jżid ilkonċentrazzjonijiet tal-antidepressant.
English: These EC50 values are well below the 50% cellular toxicity concentration range of 87 µM to > 100 µM.
Maltese: Dawn il-valuri EC50 huma ħafna anqas minn 50% tal-limiti minn 87 µM sa > 100 µM ta' konċentrazzjoni ta' tossiċità ċellulari.
English: The evidence of efficacy of darunavir/ritonavir 800/100 mg once daily is based on the analyses of 192 week data from the randomised, controlled, open-label Phase III trial ARTEMIS in antiretroviral treatment-naïve HIV-1 infected patients comparing darunavir/ritonavir 800/100 mg once daily with lopinavir/ritonavir 800/200 mg per day (given as a twice-daily or as a once-daily regimen).
Maltese: Effikaċja ta'darunavir800mgdarbakuljumamministratflimkienma'100mg ritonavirdarba kuljumf'pazjentiliqattmaħadukurab'ARTqabel L-evidenza tal-effikaċja ta' darunavir/ritonavir 800/100 mg darba kuljum hija bbażata fuq l-analiżi ta' dejta ta' 192 ġimgħa mill-prova tal-Fażi III, randomised, ikkontrollata, open-label ARTEMIS f'pazjenti infettati b'HIV-1 li qatt ma' ħadu kura b'ART qabel fejn darunavir/ritonavir 800/100 mg darba kuljum tqabbel ma' lopinavir/ritonavir 800/200 mg kuljum (mogħti fi skeda ta' darbtejn kuljum jew darba kuljum).
English: Cardiac disorders uncommon myocardial infarction, angina pectoris, prolonged electrocardiogram QT, tachycardia rare acute myocardial infarction, sinus bradycardia, palpitations
Maltese: Disturbi fil-qalb mhux komuni rari infart miokardijaku, angina pectoris, QT talelettrokardjogram imtawwal, takikardija,
English: darunavir/ritonavir N=80
Maltese: Riżultati fit-48 ġimgħa darunavir/ritonavir N=80
English: Darunavir dose is
Maltese: Mediċini oħra u Darunavir Krka
English: Co-administration of darunavir and ritonavir with medicinal products primarily metabolised by CYP2C9 (such as warfarin) and CYP2C19 (such as methadone) may result in decreased systemic exposure to such medicinal products, which could decrease or shorten their therapeutic effect.
Maltese: L-amministrazzjoni ta' darunavir u ritonavir flimkien ma' prodotti mediċinali primarjament immetabolizzati minn CYP2C9 (bħal warfarin) u CYP2C19 (bħal methadone) tista' twassal għal esponiment sistemiku mnaqqas għal dawn il-prodotti mediċinali, li jista' jnaqqas jew iqassar l-effett terapewtiku tagħhom.
English: Exposure in plasma, liver and brain was considerably higher than in adult rats after comparable doses in mg/kg between days 5 and 11 of age.
Maltese: Esponiment fil-plażma, fil-fwied u fil-moħħ kien konsiderevolment ogħla milli filfirien adulti wara dożi komparabbli f'mg/kg bejn l-età ta' 5 u 11-il jum.
English: This difference is not clinically relevant.
Maltese: Id-differenza m'hijiex klinikamnet rilevanti.
English: The metabolism of alfentanil is mediated via CYP3A, and may as such be inhibited by boosted darunavir.
Maltese: Il-metaboliżmu ta' alfentanil huwa medjat permezz ta' CYP3A, u fil-fatt jista' jiġi impedit minn darunavir intensifikat.
English: ANTIEMETICS Domperidone
Maltese: ANTIRETROVIRALI
English: Darunavir Krka 400 mg film-coated tablets darunavir
Maltese: Darunavir Krka 400 mg pilloli miksijin b'rita darunavir
English: Darunavir and ritonavir are metabolised by CYP3A.
Maltese: Darunavir u ritonavir huma metabolizzati permezz ta' CYP3A.
English: Concomitant use of darunavir with low dose ritonavir 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 flimkien ta' darunavir intensifikat ma' kortikosterojdi li jiġu metabolizzati permezz ta' CYP3A (eż. fluticasone propionate jew kortikosterojdi oħra li jinġibdu man-nifs jew li jingħataw minn ġol-imnieħer) jista' jżid ir-riskju li jiżviluppaw effetti sistemiċi tal-koritkosterojdi, inkluż is-sindrom ta' Cushing u soppressjoni tal-glandoli adrenali.
English: Co-administration with herbal preparations containing St John's wort (Hypericum perforatum) (see section 4.5).
Maltese: L-għoti flimkien ma' mediċini tal-ħxejjex li fihom St John's Wort (Hypericum perforatum) (ara sezzjoni 4.5).
English: Administration of darunavir did not cause a statistically significant increase in the incidence of any other benign or malignant neoplasm in mice or rats.
Maltese: L-amministrazzjoni ta' darunavir ma kkawżatx żieda statistikament sinifikanti ta' kwalunkwe neoplażmu beninn jew malinn ieħor fil-ġrieden u l-firien.
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 serju fuq il-farmakokinetika ta' darunavir għadu ma ġiex studjat (ara sezzjonijiet 4.2, 4.3 u 4.4).
English: Reporting suspected adverse reactions after authorisation of the medicinal product is important.
Maltese: Rappurtar ta' reazzjonijiet avversi suspettati Huwa importanti li jiġu rrappurtati reazzjonijiet avversi suspettati wara lawtorizzazzjoni tal-prodott mediċinali.
English: These active substances include e.g.: alfuzosin amiodarone, bepridil, dronedarone, ivabradine, quinidine, ranolazine astemizole, terfenadine colchicine when used in patients with renal and/or hepatic impairment (see section 4.5) ergot derivatives (e.g. dihydroergotamine, ergometrine, ergotamine, methylergonovine) elbasvir/grazoprevir cisapride dapoxetine domperidone naloxegol lurasidone, pimozide, quetiapine, sertindole (see section 4.5) triazolam, midazolam administered orally (for caution on parenterally administered midazolam, see section 4.5) sildenafil -when used for the treatment of pulmonary arterial hypertension, avanafil simvastatin, lovastatin and lomitapide (see section 4.5) dabigatran, ticagrelor (see section 4.5).
Maltese: Dawn is-sustanzi attivi jinkludu eż.: - alfuzosin - amiodarone, bepridil, dronedarone,ivabradine,quinidine, ranolazine - astemizole, terfenadine - colchicine meta jintuża f'pazjenti b'indeboliment tal-kliewi u/jew tal-fwied (ara sezzjoni 4.5) - derivattivi tal-ergot (eż. dihydroergotamine, ergometrine, ergotamine,
English: Darunavir must always be given orally with cobicistat or low dose ritonavir as a pharmacokinetic enhancer and in combination with other antiretroviral medicinal products (see section 5.2).
Maltese: Darunavir għandu dejjem jingħata mill-ħalq flimkien ma' doża baxxa ta' ritonavir bħala intensifikatur farmakokinetiku u flimkien ma' prodotti mediċinali antiretrovirali oħra (ara sezzjoni 5.2).
English: The strong CYP3A inducers rifampicin and herbal preparations containing St John's wort (Hypericum perforatum).
Maltese: - L-indutturi qawwija ta' CYP3A rifampicin u l-preparazzjonijiet magħmula millħxejjex li fihom St John's wort (Hypericum perforatum).
English: Darunavir Krka 400 mg film-coated tablets Darunavir Krka 800 mg film-coated tablets
Maltese: Darunavir Krka 400 mg pilloli miksijin b'rita Darunavir Krka 800 mg pilloli miksijin b'rita
English: The combination product lopinavir/ritonavir (see section 4.5).
Maltese: Il-frekwenza m'hijiex magħrufa (ara sezzjoni 4.4).
English: 20 mg once daily darunavir AUC ↔ darunavir Cmin ↔ darunavir Cmax ↔
Maltese: 20 mg darba kuljum darunavir AUC ↔ darunavir Cmin ↔ darunavir Cmax ↔
English: Darunavir Krka 600 mg film-coated tablets darunavir
Maltese: Darunavir Krka 600 mg pilloli miksijin b'rita darunavir
English: ANTIPSYCHOTICS/NEUROLEPTICS Quetiapine
Maltese: ANTIANĠINA/ANTIARRITMIĊI Disopyramide
English: Do not use this medicine after the expiry date which is stated on the packaging after EXP.
Maltese: Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq l-ippakkjar wara EXP.
English: There were no new clinically relevant safety findings compared with the known safety profile of darunavir/ritonavir in HIV-1 infected adults (see sections 4.2, 4.4 and 5.2).
Maltese: Ma kien hemm lebda sejbiet ġodda rilevanti b'mod kliniku dwar sigurtà meta mqabbla mal-profil ta' sigurtà magħruf ta' darunavir/ritonavir f'individwi adulti infettati b'HIV-1 (ara sezzjonijiet 4.2, 4.4 u 5.2).
English: Rifapentine and rifampicin are strong CYP3A inducers and have been shown to cause profound decreases in concentrations of other protease inhibitors, which can result in virological failure and resistance development (CYP450 enzyme induction).
Maltese: Rifapentine u rifampicin huma indutturi qawwija ta' CYP3A u ntwerew li jikkawżaw tnaqqis kbir fil-konċentrazzjonijiet ta' impedituri ta' protease oħra, li jista' jwassal għal falliment viroloġiku u żvilupp ta' reżistenza (induzzjoni talenzima CYP450).
English: The direction of the arrow for each pharmacokinetic parameter is based on the 90% confidence interval of the geometric mean ratio being within (↔), below (↓) or above (↑) the 80-125% range (not determined as “ND”).
Maltese: Id-direzzjoni talvleġġa għal kull parametru farmakokinetiku hija bbażata fuq il-confidence interval ta' 90% tal-proporzjon ġeometriku medju li jkun fil-medda (↔), taħt ilmedda(↓) jew fuq il-medda (↑) minn firxa bejn 80-125% (ma tistax tittieħed stima bħala “ND”).
English: Darunavir Krka 800 mg film-coated tablets:
Maltese: Darunavir Krka 800 mg pilloli miksijin b'rita:
English: Indinavir: comparison of indinavir/ritonavir 800/100 mg twice daily vs. indinavir/darunavir/ritonavir 800/400/100 mg twice daily.
Maltese: Indinavir: tqabbil ta' indinavir/ritonavir 800/100 mg darbtejn kuljum ma' indinavir/darunavir/ritonavir 800/400/100 mg darbtejn kuljum.
English: If efavirenz is to be used in combination with darunavir /ritonavir, the darunavir/ritonavir 600/100 mg twice daily regimen should be used (see section 4.4).
Maltese: Jekk efavirenz se jintuża flimkien ma' darunavir/ritonavir, għandha tintuża l-iskeda ta' għoti ta' dożi ta' darunavir/ritonavir 600/100 mg darbtejn kuljum (ara sezzjoni 4.4).
English: Co-administration of darunavir and ritonavir and other medicinal products that inhibit CYP3A may decrease the clearance of darunavir and ritonavir and may result in increased plasma concentrations of darunavir and ritonavir (e.g. indinavir, azole antifungals like clotrimazole).
Maltese: L-amministrazzjoni ta' darunavir u ritonavir flimkien ma' prodotti mediċinali oħra li jimpedixxu CYP3A jistgħu jnaqqsu t-tneħħija ta' darunavir u ritonavir u jistgħu jwasslu għal konċentrazzjonijiet ogħla ta' darunavir u ritonavir fil-plażma (eż. indinavir, antifungali azoles bħal clotrimazole).
English: ANTIGOUT MEDICINES Colchicine
Maltese: IL-PRODOTT MEDIĊINALI
English: Uncommon side effects (may affect up to 1 in 100 people) chest pain, changes in electrocardiogram, rapid heart beating decreased or abnormal skin sensibility, pins and needles, attention disturbance, loss of memory, problems with your balance difficulty breathing, cough, nosebleed,throat irritation inflammation of the stomach or mouth, heartburn, retching, dry mouth, discomfort of the abdomen, constipation, belching kidney failure, kidney stones, difficult discharge of urine, frequent or excessive passage of urine, sometimes at night urticaria, severe swelling of the skin and other tissues (most often the lips or the eyes), eczema, excessive sweating, night sweats, hair loss, acne, scaly skin, colouration of nails muscle pain, muscle cramps or weakness, pain in extremity, osteoporosis slowing down of the thyroid gland function.
Maltese: Effetti sekondarji mhux komuni (jistgħu jaffettwaw sa persuna 1 minn kull 100) uġigħ fis-sider, tibdil fl-elettrokardjogram, qalb tħabbat tgħaġġel - sensibilità fil-ġilda mnaqqsa jew mhux normali, tingiż fil-partijiet talġisem minħabba li jorqdu, disturb fl-attenzjoni, telf tal-memorja, problemi bil-bilanċ diffikultà biex tieħu n-nifs, sogħla, tifġir tal-imnieħer, irritazzjoni fil-gerżuma - infjammazzjoni tal-istonku, jew il-ħalq, ħruq ta' stonku, taqligħ, ħalq xott, skonfort tal-addome, stitikezza, tifwieq - falliment tal-kliewi, ġebelfil-kliewi, diffikultà biex tgħaddil-awrina, tgħaddi l-awrina b'mod frekwenti jew eċċessiv, xi kultant bil-lejl - urtikarja, nefħa qawwijafil-ġilda u tessuti oħra (l-aktar ix-xufftejn jewlgħajnejn), ekżema, togħroq iż-żejjed, ixoqq l-għaraq bil-lejl, jaqa' x-xagħar, akne, ġilda taqa' qxur qxur, tbajja' fid-dwiefer uġigħ fil-muskoli, bugħawwieġ jew dgħufija fil-muskoli, uġigħ fl-idejn u ssaqajn, osteoporożi glandola tat-tirojde taħdem aktar bil-mod.
English: POWER 1 and POWER 2 are randomised, controlled trials comparing darunavir co-administered with ritonavir (600/100 mg twice daily) with a control group receiving an investigator-selected PI(s) regimen in HIV-1 infected patients who had previously failed more than 1 PI containing regimen.
Maltese: POWER 1 u POWER 2 huma provi kkontrollati randomised li jqabblu darunavir mogħti flimkien ma' ritonavir (600/100 mg darbtejn kuljum) ma' grupp ta' kontroll li qed jirċievu skeda ta' għoti ta' dożi ta' PIs magħzula mill-investigatur f'pazjenti infettati bl-HIV-1 li qabel kienu fallew aktar minn skeda waħda ta' għoti ta' dożi li kien fih PI. OBR li kien jikkonsisti f'min ta' lanqas 2 NRTI b'enfuvirtide (ENF) jew mingħajru intuża fiż-żewġ provi.
English: The Darunavir Krka 400 and 800 milligram tablets are used to treat adults and children (3 years of age and above, at least 40 kilograms body weight) who are infected by HIV and who have not used antiretroviral medicines before.
Maltese: Il-pilloli ta' Darunavir Krka 400, 800 milligramma jintużaw għat-trattament ta' adulti u tfal (3 snin u aktar, tal-anqas b'piż tal-ġisem ta' 40 kilogramma) li huma infettati blHIV u li qatt ma kienu użaw mediċini antiretrovirali qabel.
English: The total mean treatment duration for subjects was 95.3 weeks.
Maltese: It-tul ta' żmien globali medju ta' kura għall-individwi kien ta' 95.3 ġimgħat.
English: Outcomes darunavir/ritonavir 600/100 mg twice daily + OBR N=298
Maltese: Effetti darunavir/ritonavir 600/100 mg darbtejn kuljum + OBR N=298
English: -The other ingredients arecellulose, microcrystalline;crospovidone, hydroxypropylcellulose;
Maltese: - Is-sustanzi mhux attivi l-oħra huma microcrystalline cellulose, crospovidone,
English: Imputations according to the TLOVR algorithm.
Maltese: Imputazzjonijiet skont l-algoritmu TLOVR
English: 400 mg film-coated tablets:
Maltese: 400 mg pilloli miksjin b'rita:
English: Darunavir boosted with cobicistat is more sensitive to CYP3A induction than ritonavir-boosted darunavir: co-administration of darunavir/cobicistat with medicinal products that are strong inducers of CYP3A (e.g. St John's wort, rifampicin, carbamazepine, phenobarbital, and phenytoin) is contraindicated (see section 4.3).
Maltese: Darunavir intensifikat b'cobicistat huwa aktar sensittiv għal induzzjoni minn CYP3A milli darunavir intensifikat b'ritonavir: lgħoti flimkien ta' darunavir/cobicistat ma' prodotti mediċinali li huma indutturi qawwija ta' CYP3A (eż. St.
English: OTHER LIPID MODIFYING AGENTS Lomitapide
Maltese: SUSTANZI OĦRA LI JIMMODIFIKAW IL-LIPIDI Lomitapide
English: Darunavir given with low dose ritonavir may be considered as an alternative.
Maltese: Darunavir/ritonavir jista' jitqies bħala alternattiva.
English: Outcomes darunavir/ ritonavir 800/100 mg once daily N=343
Maltese: Effetti darunavir/ ritonavir 800/100 mg darba kuljum N=343
English: Boosted darunavir is expected to increase these antiarrhythmic plasma concentrations.
Maltese: Darunavir intensifikat huwa mistenni li jżid dawn il-konċentrazzjonijiet ta' antiarritmiċi fil-plażma.
English: Darunavir is metabolised by the hepatic system.
Maltese: Darunavir huwa mmetabolizzat permezz tas-sistema epatika.
English: Voriconazole should only be taken after medical evaluation.
Maltese: Voriconazole għandu jittieħed biss wara evalwazzjoni medika.
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 (N=3,063) ta' darunavir/ritonavir, reazzjonijiet qawwija fil-ġilda, li jistgħu jkunu imseħbin ma' deni u/jew livelli ta' transaminases li jogħlew, kienu rrappurtati f'0.4% tal-pazjenti.
English: HIV-1 RNA < 50 copies/ml CD4+ cell count mean change from baseline
Maltese: HIV-1 RNA < 50 kopja/ml Għadd taċ-ċelluli CD4+ bidla medja mil-linja bażi