FrancophonIA/ELRC3.0 huggingface dataset:
English: ART-naïve paediatric patients from the age of 12 years to < 18 years, and weighing at least 40 kg DIONE is an open-label, Phase II trial 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: Pazjenti pedjatriċi mill-età ta' 6 snin sa < 18-il sena u li jiżnu tal-anqas 20 kg b'esperjenza ta' ART DELPHI hija prova open-label tal-Fażi II li tevalwa l-farmakokinetika, is-sigurtà, it-tollerabilità u leffikaċja ta' darunavir flimkien ma' doża baxxa ta' ritonavir fi 80 pazjent tifel/tifla infettati b' HIV-1 li diġà ħadu kura b'ART qabel li għandhom minn 6 snin sa 17-il sena u li jiżnu mill-anqas 20 kg.
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 fil-prova ARTEMIS.
English: Talc
Maltese: RAMs
English: Dose for adults who have taken antiretroviral medicines before (your doctor will determine this) The dose is either: - 800 milligram darunavir (2 tablets containing 400 milligram of darunavir or 1 tablet containing 800 milligram of darunavir) together with 150 milligram cobicistat or 100 milligram ritonavir once daily.
Maltese: Id-doża hija jew: - 800 milligramma darunavir (2 pilloli li fihom 400 milligramma ta' darunavir jew pillola waħda li fiha 800 milligramma ta' darunavir) flimkien ma' 150 milligramma ta' cobicistat jew 100 milligramma ritonavir darba kuljum.
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-darunavir f'voluntiera b'saħħithom uriet li lmaġġoranza ta' radjuattività fil-plażma wara doża waħda ta' 400/100 mg darunavir ma' ritonavir kienet minħabba s-sustanza attiva oriġinali.
English: White to off-white, oval shaped, biconvex film-coated tablets approximately 21.2 mm by 10.6 mm, debossed with ‘M' on one side and ‘DV8' on the other side.
Maltese: Pillola miksija b'rita bojod għal offwajt, b'forma ovali, imbuzzati fuq iż-żewġ naħat, ta' madwar 21.2 mm b'10.6 mm, imnaqqxa b'‘M' fuq naħa waħda u ‘DV8' fuq in-naħa l-oħra.
English: At 48 weeks, virologic response, defined as the percentage of patients with plasma HIV-1 RNA level < 50 copies/ml, with darunavir/ritonavir 800/100 mg once daily treatment was demonstrated to be non-inferior (at the pre-defined 12% non-inferiority margin) compared to darunavir/ritonavir 600/100 mg twice daily for both ITT and OP populations.
Maltese: Fil-ġimgħa 48, rispons viroloġiku ddefinit bħala l-perċentwal ta' pazjenti b'livell ta' HIV-1 RNA < 50 kopja/ml fil-plażma, bi darunavir/ritonavir 800/100 mg darba kuljum intwera li ma kienx inferjuri (bil-marġini ta' non-inferjorità ta' 12% ddefiniti minn qabel) meta mqabbel ma' darunavir/ritonavir 600/100 mg darbtejn kuljum kemm għall-popolazzjonijiet ITT kif ukoll OP.
English: Each tablet contains 800 milligram of darunavir.
Maltese: Kull pillola fiha 800 milligramma ta' darunavir bħala ethanolate.
English: ODIN is a Phase III, randomised, open-label trial comparing darunavir/ritonavir 800/100 mg once daily versus darunavir/ritonavir 600/100 mg twice daily in ART-experienced HIV-1 infected patients with screening genotype resistance testing showing no darunavir RAMs (i.e. V11I, V32I, L33F, I47V, I50V, I54M, I54L, T74P, L76V, I84V, L89V) and a screening HIV-1 RNA > 1,000 copies/ml.
Maltese: Numru ta' tibdiliet ġenetiċi mill-lista ta' tibdiliet ġenetiċi assoċjati ma' nuqqas ta' rispons għall-darunavir/ritonavir (V11I, V32I, L33F, I47V, I50V, I54L jew M, T74P, L76V, I84V jew L89V)
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 tal-vleġġa għal kull parametru farmakokinetiku hija bbażata fuq il-confidence interval ta' 90% tal-proporzjon ġeometriku medju li jkun fil-medda (↔), taħt il-medda(↓) jew fuq il-medda (↑) minn firxa bejn 80-125% (ma tistax tittieħed stima bħala “ND”).
English: Darunavir Mylan 75 mg film-coated tablets
Maltese: Darunavir Mylan 75 mg pilloli miksijin b'rita
English: Other strengths of Darunavir Mylan are available.
Maltese: Qawwiet oħra ta' Darunavir Mylan huma disponibbli.
English: In the 96 week analysis, the safety profile of darunavir/ritonavir 800/100 mg once daily in treatmentnaïve subjects was similar to that seen with darunavir/ritonavir 600/100 mg twice daily in treatmentexperienced subjects except for nausea which was observed more frequently in treatment-naïve subjects.
Maltese: Fis-96 ġimgħa ta' analiżi, il-profil ta' sigurtà ta' darunavir/ritonavir 800/100 mg darba kuljum f'individwi li qatt ma ħadu kura qabel kien jixbah lil dak li jidher bi darunavir/ritonavir 600/100 mg darbtejn kuljum f'pazjenti li jkunu diġà ħadu kura qabel minbarra t-tqalligħ li kien osservat aktar frekwenti f'individwi li qatt ma kienu ħadu kura qabel.
English: (CYP3A and/ or P-gp inhibition)
Maltese: (impediment ta' CYP3A u/jew tal-P-gp)
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: Bottle carton 480 film-coated tablets
Maltese: Kaxxa tal-kartun bi flixkun 480 pillola miksija b'rita
English: - Take darunavir always together with 150 milligram of cobicistat or 100 milligram of ritonavir.
Maltese: - Dejjem ħu darunavir flimkien ma' 150 milligramma ta' cobicistat jew 100 milligramma ta'
English: Otherc mean CD4+ cell count change from baseline (x 10
Maltese: Bidla medja fl-għadd taċ-ċelluli CD4+ millinja bażi (x 10
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 fil-firien adulti wara dożi komparabbli f'mg/kg bejn l-età ta' 5 u 11-il jum.
English: The terminal elimination half-life of darunavir was approximately 15 hours when combined with ritonavir.
Maltese: Il-half-life terminali ta' eliminazzjoni ta' darunavir kienet bejnwieħed u ieħor ta' 15-il siegħa meta kien flimkien ma' ritonavir.
English: Repeated administration of darunavir to rats caused hepatic microsomal enzyme induction and increased thyroid hormone elimination, which predispose rats, but not humans, to thyroid neoplasms.
Maltese: L-amministrazzjoni ripetuta ta' darunavir lill-firien ikkawżat induzzjoni ta' l-enzimi epatiċi mikrosomali u żiedet l-eliminazzjonni ta' l-ormon tat-tirojde, li jippredisponi lill-firien, iżda mhux lill-bnedmin, għal neoplażmi tat-tirojde.
English: and who have plasma HIV-1 RNA < 100,000
Maltese: B'HIV-RNA ta' < 100,000 fil-linja bażi
English: Rare myocardial infarction, angina pectoris, prolonged electrocardiogram QT, tachycardia acute myocardial infarction, sinus bradycardia, palpitations
Maltese: Rari infart miokardijaku, angina pectoris, QT ta' lelettrokardjogramm imtawwal, takikardija,
English: Darunavir Mylan 150 mg film-coated tablets darunavir
Maltese: Darunavir Mylan 150 mg pilloli miksijin b'rita darunavir
English: No new safety findings were identified in the 192 week analysis of the treatment-naïve subjects in which the mean treatment duration of darunavir/ritonavir 800/100 mg once daily was 162.5 weeks.
Maltese: Ma ġewx identifikati sejbiet oħra ta' sigurtà fil-192 ġimgħa ta' analiżi f'individwi li qatt ma ħadu kura qabel li kellhom medja ta' tul ta' kura bi darunavir/ritonavir 800/100 mg darba kuljum ta' 162.5 ġimgħat.
English: Darunavir binds predominantly to α1-acid glycoprotein.
Maltese: Darunavir jintrabat b'mod predominanti mal-1-glikoproteina aċida.
English: - high blood pressure, flushing - red or dry eyes - fever, swelling of lower limbs due to fluids, malaise, irritability, pain - symptoms of infection, herpes simplex - erectile dysfunction, enlargement of breasts - sleeping problems, sleepiness, depression, anxiety, abnormal dreams, decrease in sexual drive
Maltese: - għajnejn ħomor jew xotti - deni, nefħa fir-riġlejn minħabba fluwidi, telqa mingħajr sinjal ta' mard, irritabilità, uġigħ - sintomi ta' infezzjoni, herpes simplex - abnormalità erettili, tkabbir tas-sider - problemi bl-irqad, xejra ta' ngħas, depressjoni, ansjetà, ħolm mhux normali, tnaqqis fil-ġibda sesswali
English: Sildenafil
Maltese: Quetiapine
English: Darunavir Mylan 600 mg film-coated tablets darunavir
Maltese: Darunavir Mylan 600 mg pilloli miksijin b'rita darunavir
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 (see section 4.4).
Maltese: 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: Darunavir Mylan 75 mg film-coated tablets are white to off-white, oval shaped with two curved sides, marked with M on one side and DV1 on the other side.
Maltese: Darunavir Mylan 75 mg pilloli miksija b'rita huma bojod għal offwajt, b'forma ovali, imbuzzati fuq iż-żewġ naħat, imnaqqxa b'M fuq naħa waħda u DV1 fuq in-naħa l-oħra.
English: EU/1/16/1140/022 EU/1/16/1140/023 EU/1/16/1140/024 EU/1/16/1140/025 EU/1/16/1140/026 EU/1/16/1140/027 EU/1/16/1140/028 EU/1/16/1140/029
Maltese: EU/1/16/1140/026 EU/1/16/1140/027 EU/1/16/1140/028 EU/1/16/1140/029
English: Imputations according to the TLOVR algorithm.
Maltese: Imputazzjonijiet skont l-algoritmu TLOVR.
English: This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodiumfree'.
Maltese: Din il-mediċina fiha inqas minn 1 mmol sodium (23 mg) f'kull doża, jiġifieri hija prattikament ħielsa mis-sodium.
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 waħdu.
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' lanqas10 darbiet anqas mill-attività ta' darunavir kontra l-HIV li jinstab fin-natura.
English: Darunavir Mylan 300 mg film-coated tablets darunavir
Maltese: Darunavir Mylan 300 mg pilloli miksijin b'rita darunavir
English: Clinical monitoring for central nervous system toxicity associated with increased exposure to efavirenz may be indicated when darunavir co-administered with low dose ritonavir is given in combination with efavirenz.
Maltese: Fil-kelb, l-ebda sejbiet ta' tossiċità maġġuri jew organi mimsusa ma' kienu identifikati sa esponimenti ekwivalenti għal esponiment kliniku fid-doża rrakkomandata.
English: ● 80 ART-experienced HIV-1 infected paediatric patients aged from 6 to 17 years and weighing at least 20 kg who received darunavir tablets with low dose ritonavir twice daily in combination with other antiretroviral agents.
Maltese: ● 80 pazjent pedjatriku infettati b'HIV-1 li kienu diġà ħadu kura b'ART qabel li kellhom minn 6 snin sa 17-il sena u li kienu jiżnu mill-anqas 20 kg li rċievew pilloli darunavir flimkien ma' doża baxxa ta' ritonavir darbtejn kuljum flimkien ma' sustanzi antiretrovirali oħra.
English: At the highest tested doses, the systemic exposures (based on AUC) to darunavir were between 0.4- and 0.7-fold (mice) and 0.7- and 1-fold (rats), relative to those observed in humans at the recommended therapeutic doses.
Maltese: Fl-ogħla dożi ittestjati, lesponimenti sistemiċi (ibbażati fuq l-AUC) għal darunavir kienu bejn 0.4 darbiet u 0.7 darbiet (ġrieden) u 0.7 darbiet u darba aktar (fil-firien) meta mqabbla ma' dawk osservati fil-bnedmin fid-dożi terapewtiċi rrakkomandati.
English: Concomitant use of bosentan and boosted darunavir may increase plasma concentrations of bosentan.
Maltese: L-użu komkomitanti ta' bosentan u darunavir intensifikat jista' jżid il-konċentrazzjonijiet ta' bosentan filplażma.
English: ANTIPSYCHOTICS/NEUROLEPTICS Quetiapine
Maltese: ANTIPSIKOTIĊI/NEWROLETTIĊI
English: Darunavir Mylan 800 mg film-coated tablets darunavir
Maltese: Darunavir Mylan 800 mg pilloli miksijin b'rita darunavir
English: C-darunavir could be retrieved in faeces and urine, respectively.
Maltese: C-darunavir setgħet tinġabar lura mill-ipurgar u l-awrina, rispettivament.
English: Hence, concomitant use of darunavir co-administered with low dose ritonavir and the combination product lopinavir/ritonavir is contraindicated (see section 4.3).
Maltese: Għalhekk, l-użu konkomitanti ta' darunavir intensifikat u t-taħlita tal-prodott lopinavir/ritonavir hija kontraindikata (ara sezzjoni 4.3).
English: Darunavir Mylan 400 mg film-coated tablets darunavir
Maltese: Darunavir Mylan 400 mg pilloli miksijin b'rita darunavir
English: Darunavir has only been used in limited numbers of patients 65 years or older.
Maltese: Darunavir kien użat biss f'numru limitat ta' pazjenti ta' 65 sena jew aktar.
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 fluticasone li jinġibed man-nifs jew li jingħata minn ġolimnieħer.
English: As limited information is available on the use of darunavir in patients aged 65 and over, caution should be exercised in the administration of darunavir in elderly patients, 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 teżisti informazzjoni limitata dwar l-użu ta' darunavir f'pazjenti li għandhom 65 sena jew aktar, għandu jkun hemm attenzjoni meta darunavir jiġi ammministrat lill-pazjenti akbar fl-età, li tirrifletti il-frekwenza ogħla ta' funzjoni mnaqqsa tal-fwied u ta' mard konkomitanti jew terapiji oħra (ara sezzjonijiet 4.2 u 5.2).
English: No adjustment of methadone dosage is required when initiating co-administration with darunavir/ritonavir.
Maltese: Ma huwa rrakkomandat l-ebda aġġustament fid-doża għal darunavir/ritonavir.
English: Darunavir Mylan 400 mg and 800 mg tablets may be used to provide suitable dose regimens for the treatment of HIV-1 infection in adult and paediatric patients from the age of 3 years and at least 40 kg body weight who are:
Maltese: Il-pilloli Darunavir Mylan 400 mg u 800 mg jistgħu jintużaw biex jipprovdu skedi ta' għoti ta' dożi xierqa għat-trattament ta' infezzjoni ta' HIV-1 f'pazjenti adulti u pedjatriċi minn età ta' 3 snin u b'talanqas 40 kg ta' piż tal-ġisem li :
English: A dosage reduction of rifabutin by 75% of the usual dose of 300 mg/day (i.e. rifabutin 150 mg once every other day) and increased monitoring for rifabutin related adverse events is warranted in darunavir Cmax ↑ 39% ** sum of active moieties of rifabutin (parent drug + 25-O-desacetyl metabolite)
Maltese: Tnaqqis fid-dożaġġ ta' rifabutin b'75% mid-doża tas-soltu ta' 300 mg/kuljum (i.e. rifabutin 150 mg ġurnata iva u oħra le) u żieda fis-sorveljanza għal każijiet avversi relatati ma' rifabutin hija meħtieġa f'pazjenti li qed jirċievu din it-taħlita flimkien ma' darunavir mogħti flimkien ma' ritonavir.
English: Dose for children 3 years of age and above, weighing more than 40 kilograms who have not taken antiretroviral medicines before (your child's doctor will determine this) - The usual dose of darunavir is 800 milligram (2 tablets containing 400 milligram of darunavir or 1 tablet containing 800 milligram of darunavir) together with 100 milligram ritonavir once daily.
Maltese: Doża għal tfal ta' 3 snin u aktar, li jiżnu tal-anqas 40 kilogramma li ma ħadux mediċini antiretrovirali qabel (it-tabib tal-tifel/tifla tiegħek ser jistabilixxi dan) - Id-doża rakkomandata tas-soltu għal Darunavir hija ta' 800 milligramma (2 pilloli li fihom 400 mg ta' darunavir jew pillola waħda1 li fiha 800 milligramma ta' darunavir) flimkien ma' 100 milligramma ritonavir darba kuljum.
English: Boosted darunavir is expected to increase these antiarrhythmic plasma concentrations.
Maltese: Darunavir intensifikat huwa mistenni li jżid dawn ilkonċentrazzjonijiet ta' antiarritmiċi filplażma.
English: Treatment-naïve darunavir/cobicistat 800/150 mg once daily + OBR N=295
Maltese: Qatt ma ħadu kura qabel darunavir/cobicistat 800/150 mg darba kuljum + OBR N=295
English: Increased concentrations of quetiapine may lead to coma (see section 4.3).
Maltese: Żieda filkonċentrazzjonijiet ta' quetiapine jistgħu jwasslu għal koma (ara sezzjoni 4.3).
English: There are currently inadequate data to determine whether co-administration of tenofovir disoproxil and cobicistat is associated with a greater risk of renal adverse reactions compared with regimens that include tenofovir disoproxil without cobicistat.
Maltese: Bħalissa m'hemmx dejta adegwata biex tistma jekk l-għoti flimkien ta' tenofovir disoproxil u cobicistat huwiex assoċjat ma' riskju akbar ta' reazzjonijiet avversi fil-kliewi meta mqabbla ma' skedi li jinkludu tenofovir disoproxil mingħajr cobicistat.
English: The usual dose of darunavir is 800 milligram (2 tablets containing 400 milligram of Darunavir Mylan or 1 tablet containing 800 milligram of Darunavir Mylan) once daily.
Maltese: Id-doża hija: - 800 milligramma darunavir (2 pilloli li fihom 400 milligramma ta' darunavir jew pillola waħda li fiha 800 milligramma ta' darunavir) flimkien ma' 100 milligramma ritonavir darba kuljum.
English: Mutations
Maltese: IMPEDITURI
English: Darunavir Mylan 800 mg film-coated tablets are white to off-white, oval shaped, with two curved sides, marked with M on one side and DV8 on the other side.
Maltese: Darunavir Mylan 800 mg pilloli miksija b'rita huma bojod għal offwajt, b'forma ovali, imbuzzati fuq iż-żewġ naħat, imnaqqxa b'M fuq naħa waħda u DV8 fuq in-naħa l-oħra.
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
Maltese: Riżultati farmakokinetiċi ta' darunavir totali wara għoti ta' darunavir/cobicistat bid-doża ta' 800/150 mg darba kuljum bħala parti minn skeda antiretrovirali, waqt it-tieni trimestru tattqala, it-tielet trimestru tat-tqala u wara t-twelid Farmakokinetika ta' darunavir totali (medja ± SD)
English: Based upon the findings, the carbamazepine dose may need to be reduced by 25% to 50% in the presence of darunavir/ritonavir.
Maltese: Fuq bażi tas-sejbiet, id-doża ta' carbamazepine tista' tkun teħtieġ tnaqqis b'25% sa 50% fil-preżenza ta' darunavir/ritonavir.
English: The marketing authorisation holder (MAH) shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent updates of the RMP.
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq (MAH) għandu jwettaq l-attivitajiet u l-interventi ta' farmakoviġilanza dettaljati fl-RMP maqbul ippreżentat fil-Modulu 1.8.2 tal-awtorizzazzjoni għattqegħid fis-suq u kwalunkwe aġġornamenti sussegwenti maqbul tal-RMP.
English: Bottle carton 60 film-coated tablets 240 film-coated tablets
Maltese: Kartuna bi flixkun 60 pillola miksija b'rita 240 pillola miksija b'rita
English: Baseline genotype or phenotype and virologic outcome Baseline genotype and darunavir FC (shift in susceptibility relative to reference) were shown to be a predictive factor of virologic outcome.
Maltese: Linja bażi ġenotipika jew fenotipika u l-effetti viroloġiċi Il-ġenotip u l-FC ta' darunavir fil-linja bażi (bidla fis-suxxettibilità fejn għandha x'taqsam marriferenza) intwerew li kienu fattur ta' tbassir għall-effetti viroloġiċi.
English: Last Observation Carried Forward imputation c
Maltese: Imputazzjonijiet skont l-algoriżmu TLOVR b Imputazzjoni ta' Last Observation Carried Forward c
English: Concomitant use of darunavir coadministered with low dose ritonavir and these antidepressants may increase concentrations of the antidepressant.
Maltese: L-użu ta' darunavir intensifikat u dawn lantidepressanti jista' jżid ilkonċentrazzjonijiet tal-antidepressant.
English: Rash considered by the investigator to be drug-related occurred at similar rates.
Maltese: Ir-raxx li kien ikkunsidrat mill-investigatur li kien relatat mal-mediċina, seħħ f'rati simili.
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: l-għoti flimkien ta' darunavir/cobicistat ma' prodotti mediċinali li huma indutturi qawwija ta' CYP3A (eż. St.
English: Reproductive system and breast disorders Uncommon erectile dysfunction, gynaecomastia General disorders and administration site conditions Common
Maltese: Disturbi fis-sistema riproduttiva u fis-sider Mhux komuni disfunzjoni tal-erezzjoni, ġinekomastja
English: - In the evening, take two 300 milligram darunavir tablets together with 100 milligram ritonavir.
Maltese: - Filgħodu, ħu żewġ pilloli ta' 300 milligramma darunavir flimkien ma' 100 milligramma ritonavir.
English: If concomitant use of darunavir co-administered with low dose ritonavir with sildenafil, vardenafil or tadalafil is indicated, sildenafil at a single dose not exceeding 25 mg in 48 hours, vardenafil at a single dose not exceeding 2.5 mg in 72 hours or tadalafil at a single dose not exceeding 10 mg in 72 hours is recommended.
Maltese: Jekk ikun indikat l-użu konkomitanti ta' darunavir intensifikat flimkien ma' sildenafil, vardenafil, jew tadalafil hija rrakommandata doża waħda ta' sildenafil li ma' taqbiżx 25 mg f'48 siegħa, doża waħda ta' vardenafil li ma taqbiżx 2.5 mg f' 72 siegħa jew doża waħda ta' tadalafil li ma' taqbiżx 10 mg f'72 siegħa.
English: Darunavir Mylan 300 mg film-coated tablets are available in blister packs containing 30, 60 and 120 tablets and in plastic bottles containing 30 and 120 tablets.
Maltese: Darunavir Mylan 300 mg pilloli miksija b'rita huma disponibbli f'pakketti b'folji li fihom 30, 60 u 120 pillola u fi fliexken tal-plastik li fihom 30 u 120 pillola
English: Pharmacokinetic results of total darunavir after administration of darunavir/ritonavir at 600/100 mg twice daily as part of an antiretroviral regimen, during the second trimester of pregnancy, the third trimester of pregnancy and postpartum
Maltese: Riżultati farmakokinetiċi ta' darunavir totali wara għoti ta' darunavir/ritonavir bid-doża ta' 600/100 mg darbtejn kuljum bħala parti minn kors antiretrovirali terapewtiku, waqt it-tieni trimestru tat-tqala, it-tielet trimestru tat-tqala u wara t-twelid Il-farmakokinetika ta' darunavir totali (medja ± SD)
English: BOTTLE LABEL
Maltese: Mhux applikabbli
English: zoldipem (sedative agents) - Perphenazine, risperidone, thioridazine (to treat psychiatric conditions).
Maltese: - Fesoterodine, solifenacin (biex jittrattaw disturbi uroloġiċi).