FrancophonIA/ELRC3.0 huggingface dataset:
English: Adverse reactions are listed by system organ class (SOC) and frequency category.
Maltese: Ir-reazzjonijiet avversi huma elenkati skont is-sistema tal-klassifika ta' l-organi (SOC) u l-kategorija ta' frekwenza.
English: Baseline DRV FC
Maltese: Linja bażi ta' DRV FC
English: Imputations according to the TLOVR algorithm Last Observation Carried Forward imputation 95% confidence intervals.
Maltese: Imputazzjonijiet skont l-algoritmu TLOVR Imputazzjoni ta' Last Observation Carried Forward c Intervalli ta' kunfidenza ta' 95%.
English: Non-nucleo(s/t)ide reverse transcriptase inhibitors (NNRTIs) Efavirenz
Maltese: Impedituri tan-non-nucleo(s/t)ide reverse transcriptase (NNRTIs) Efavirenz
English: Pharmacokinetics of total darunavir (mean ± SD)
Maltese: Il-farmakokinetika ta' darunavir totali (medja ± SD)
English: (PHARMACAL) LIMITED Τηλ: + 357 24 651 882
Maltese: LIMITED Τηλ: + 357 24 651 882
English: 6/l (see section 4.2).
Maltese: 6/l (ara sezzjoni 4.2).
English: Dexamethasone (corticosteroid)
Maltese: Dexamethasone (sistemiku)
English: ≥ 15 kg to < 30 kg
Maltese: ≥ 15 kg sa < 30 kg
English: HEPATITIS C VIRUS (HCV) DIRECT-ACTING ANTIVIRALS NS3-4A protease inhibitors
Maltese: ANTIVIRALI LI JAĦDMU DIRETTAMENT FUQ VIRUS EPATITE C (HCV) impedituri tal-protease NS3-4A
English: Darunavir is an inhibitor of the dimerisation and of the catalytic activity of the HIV-1 protease (KD of 4.5 x 10
Maltese: Darunavir huwa impeditur tad-dimerizzazzjoni u l-attività katalittika tal-HIV-1 protease (KD ta' 4.5 x 10
English: Darunavir is extensively metabolised by the hepatic CYP system and almost exclusively by isozyme CYP3A4.
Maltese: Darunavir jiġi metabolizzat estensivament mis-sistema epatika CYP u kważi esklusivament mill-isożima CYP3A4.
English: Corticosteroids primarily metabolised by CYP3A (including betamethasone, budesonide, fluticasone, mometasone, prednisone, triamcinolone)
Maltese: KORTIKOSTEROJDI Kortikosterojdi mmetabolizzati primarjament minn CYP3A (inkluż betamethasone, budesonide, fluticasone, mometasone, prednisone, triamcinolone)
English: ║ based on published data with darunavir/ritonavir rosuvastatin AUC ↑ 93% rosuvastatin Cmax ↑ 277% rosuvastatin Cmin ND
Maltese: ibbażat fuq dejta pubblikata b'darunavir/ritonavir rosuvastatin AUC ↑ 93% rosuvastatin Cmax ↑ 277% rosuvastatin Cmin ND
English: ≥ 30 kg to < 40 kg
Maltese: ≥ 30 kg sa < 40 kg
English: POWER 1 and POWER 2 pooled data Week 48
Maltese: Tagħrif miġbur minn POWER 1 u POWER 2 Ġimgħa 48
English: sum of active moieties of rifabutin (parent drug + 25-O-desacetyl metabolite)
Maltese: total tan-nofsijiet attivi ta' rifabutin (mediċina oriġinali + il-metabolit 25-Odesacetyl)
English: CYP3A inducers that are contraindicated include rifampicin, St John's wort and lopinavir.
Maltese: Fost lindutturi ta' CYP3A li huma kontraindikati hemm rifampicin, St John's wort u lopinavir.
English: Ethinylestradiol (3 mg/0.02 mg once daily)
Maltese: Ethinylestradiol (3 mg/0.
English: Patients with severe (Child-Pugh Class C) hepatic impairment.
Maltese: Pazjenti b'indeboliment epatiku serju (Child-Pugh Klassi Ċ).
English: Your doctor might want to do some additional tests.
Maltese: Jista' jkun hemm bżonn ta' xi testijiet addizjonali.
English: Elimination After a 400/100 mg
Maltese: Eliminazzjoni Wara doża ta' 400/100 mg
English: TITAN Week 48
Maltese: TITAN Ġimgħa 48
English: ANTIANGINA/ANTIARRHYTHMIC
Maltese: ANTIANĠINA/ANTIARRITMIĊI
English: Pravastatin 40 mg single dose pravastatin AUC ↑ 81% pravastatin Cmin ND pravastatin Cmax ↑ 63%
Maltese: Pravastatin Doża waħda ta' 40 mg pravastatin AUC ↑ 81% pravastatin Cmin ND pravastatin Cmax ↑ 63%
English: Buprenorphine/naloxone 8/2 mg-16/4 mg once daily buprenorphine AUC ↓ 11% buprenorphine Cmin ↔ buprenorphine Cmax ↓ 8% norbuprenorphine AUC ↑ 46% norbuprenorphine Cmin ↑ 71% norbuprenorphine Cmax ↑ 36% naloxone AUC ↔ naloxone Cmin ND naloxone Cmax ↔
Maltese: Buprenorphine/naloxone 8/2 mg-16/4 mg darba kuljum buprenorphine AUC ↓ 11% buprenorphine Cmin ↔ buprenorphine Cmax ↓ 8% norbuprenorphine AUC ↑ 46% norbuprenorphine Cmin ↑ 71% norbuprenorphine Cmax ↑ 36% naloxone AUC ↔ naloxone Cmin ND naloxone Cmax ↔
English: Darunavir binds primarily to plasma α1-acid glycoprotein.
Maltese: Darunavir jeħel primarjament mal-glikoproteina α1-acid fil-plażma.
English: OPIOID ANTAGONIST Naloxegol
Maltese: ANTAGONIST TAL-OPIOJDI Naloxegol
English: Atorvastatin, pravastatin, rosuvastatin (to lower cholesterol levels).
Maltese: - Atorvastatin, pravastatin,rosuvastatin(biex tnaqqas il-livelli ta' kolesterol fiddemm).
English: Iron oxide, yellow (E172) - only for 400 mg film-coated tablets Iron oxide, red (E172)
Maltese: Iron oxide, yellow (E172) - għal 400 mg pilloli miksijin b'rita biss Iron oxide, red (E172)
English: Medicinal products that affect darunavir/ritonavir exposure Darunavir and ritonavir are metabolised by CYP3A.
Maltese: Prodotti mediċinali li jaffettwaw l-esponiment ta' darunavir/ritonavir Darunavir u ritonavir huma metabolizzati permezz ta' CYP3A.
English: (Rifabutin is an inducer and substrate of CYP3A.)
Maltese: (Rifabutin huwa induttur u substrat għal CYP3A).
English: Sedative/hypnotics are extensively metabolised by CYP3A.
Maltese: Sedattivi/ipnotiċi huma metabolizzati b'mod estensiv permezz ta' CYP3A.
English: Darunavir demonstrates antiviral activity in vitro against a broad panel of HIV-1 group M (A, B, C, D, E, F, G) and group O primary isolates with EC50 values ranging from < 0.1 to 4.3 nM.
Maltese: Darunavir juri attività antivirali in vitro kontra sezzjoni wiesa' ta' ċelluli puri tal-virusis iżolati primarjament ta' HIV-1 grupp M (A, B, C, D, E, F, G) u grupp O b'valuri EC50 minn < 0.1 to 4.3 nM.
English: Methadone individual dose ranging from 55 mg to 150 mg once daily
Maltese: Methadone doża individwali fuq firxa minn 55 mg sa 150 mg darba kuljum
English: Rifabutin 150 mg once every other day rifabutin AUC rifabutin Cmin
Maltese: 150 mg ġurnata iva u oħra le rifabutin AUC rifabutin Cmin
English: Oestrogen-based hormonal contraceptives and hormonal replacement therapy.
Maltese: - Kontraċettivi ormonali b'bażi ta' estroġenu u terapija ta' sostituzzjoni talormoni.
English: (CYP3A and OATP1B inhibition)
Maltese: (inibizzjoni ta' CYP3A u OATP1B)
English: 375 milligram darunavir + 50 milligram ritonavir twice a day between 30 and 40 kilograms
Maltese: 375 milligramma darunavir + 50 milligramma ritonavir darbtejn kuljum bejn 30 u 40 kilogramma
English: Atorvastatin 10 mg once daily atorvastatin AUC ↑ 3-4 fold atorvastatin Cmin ↑ ≈5.5-10 fold atorvastatin Cmax ↑ ≈2 fold darunavir/ritonavir
Maltese: Atorvastatin 10 mg darba kuljum atorvastatin AUC ↑ 3-4 drabi aktar atorvastatin Cmin ↑ ≈5.5-10 drabi aktar atorvastatin Cmax ↑ ≈2 drabi aktar darunavir/ritonavir
English: 100 milligram ritonavir oral solution: 80 milligram per milliliter
Maltese: 100 milligramma a soluzzjoni orali ta' ritonavir: 80 milligramma f'kull millilitru
English: Indinavir 800 mg twice daily indinavir AUC ↑ 23% indinavir Cmin ↑ 125% indinavir Cmax ↔ darunavir AUC ↑ 24% darunavir Cmin ↑ 44% darunavir Cmax ↑ 11%
Maltese: Indinavir 800 mg darbtejn kuljum indinavir AUC ↑ 23% indinavir Cmin ↑ 125% indinavir Cmax ↔ darunavir AUC ↑ 24% darunavir Cmin ↑ 44% darunavir Cmax ↑ 11%
English: CALCIUM CHANNEL BLOCKERS Amlodipine
Maltese: TAL-KALĊJU Amlodipine
English: Sertraline 50 mg once daily
Maltese: Sertraline 50 mg darba kuljum
English: Etravirine 100 mg twice daily etravirine AUC ↓ 37% etravirine Cmin ↓ 49% etravirine Cmax ↓ 32% darunavir AUC ↑ 15% darunavir Cmin ↔ darunavir Cmax ↔
Maltese: Etravirine 100 mg darbtejn kuljum etravirine AUC ↓ 37% etravirine Cmin ↓ 49% etravirine Cmax ↓ 32% darunavir AUC ↑ 15% darunavir Cmin ↔ darunavir Cmax ↔
English: * DRV-RAMs: V11I, V32I, L33F, I47V, I50V, I54M, I54L, T74P, L76V, I84V and L89V
Maltese: V11I, V32I, L33F, I47V, I50V, I54M, I54L, T74P, L76V, I84V u L89V
English: DRESS (Drug Rash with Eosinophilia and Systemic Symptoms) and Stevens-Johnson Syndrome has been rarely (< 0.1%) reported, and during post-marketing experience toxic epidermal necrolysis and acute generalised exanthematous pustulosis have been reported.
Maltese: DRESS (Drug Rash with Eosinophilia and Systemic Symtoms) u s-Sindrome ta' Stevens-Johnson kien irrappurtat b'mod rari (< 0.1%), u waqt l-esperjenza ta' wara t-tqegħid fis-suq ġew irrappurtati nekroliżi epidermali tossika u reazzjoni akuta ta' bżieżaq b'materja mifruxa.
English: Lovastatin, simvastatin and lomitapide to lower cholesterol levels
Maltese: Lovastatin, simvastatin u lomitapide biex tbaxxi l-livelli tal-kolesterol
English: Saquinavir 1,000 mg twice daily darunavir AUC ↓ 26% darunavir Cmin ↓ 42% darunavir Cmax ↓ 17% saquinavir AUC ↓ 6% saquinavir Cmin ↓ 18% saquinavir Cmax ↓ 6%
Maltese: Saquinavir 1,000 mg darbtejn kuljum darunavir AUC ↓ 26% darunavir Cmin ↓ 42% darunavir Cmax ↓ 17% saquinavir AUC ↓ 6% saquinavir Cmin ↓ 18% saquinavir Cmax ↓ 6%
English: Response (HIV-1 RNA < 50 copies/ml at week 24) %, n/N
Maltese: Rispons (HIV-1 RNA < 50 kopja/ml fil-ġimgħa 24) %, n/N
English: If a patient is already taking St John's wort, stop St John's wort and if possible check viral levels.
Maltese: Jekk pazjent ikun diġà qed jieħu St John's wort, waqqaf is-St John's wort u jekk possibbli ċċekkja l-livelli virali.
English: Study was conducted with tenofovir disoproxil fumarate 300 mg once daily.
Maltese: L-istudju sar b'tenofovir disoproxil fumarate 300 mg darba kuljum.
English: The recommendations for darunavir boosted with ritonavir are adequate also for darunavir boosted with cobicistat with regard to substrates of CYP3A4, CYP2D6, P-glycoprotein, OATP1B1 and OATP1B3 (see contraindications and recommendations presented in the section above).
Maltese: Ir-rakkomadazzjonijiet għal darunavir intensifikat b'ritonavir huma adegwati anke għal darunavir intensifikat b'cobicistat għal dawk li huma sustrati ta' CYP3A4, CYP2D6, glikoproteina P, OATP1B1 u OATP1B3 (ara kontraindikazzjonijiet u rakkomandazzjonijiet ippreżentati fis-sezzjoni fuq).
English: Darunavir exhibits activity against laboratory strains and clinical isolates of HIV-1 and laboratory strains of HIV-2 in acutely infected T-cell lines, human peripheral blood mononuclear cells and human monocytes/macrophages with median EC50 values ranging from 1.2 to 8.5 nM (0.7 to 5.0 ng/ml).
Maltese: Darunavir juri attività kontra razez tal-laboratorju u ċelluli puri ta' virusis iżolati klinikament ta' HIV-1 u razez tal-laboratorju ta' HIV-2 f'linji ta' ċelluli T infettati b'mod akut, ċelluli mononukleari periferali tad-demm umani u makrofaġi/monoċiti umani b'medjan ta' valuri EC50 minn 1.2 sa 8.5 nM (0.7 sa 5.0 ng/ml).
English: ANTIMALARIALS Artemether/Lumefantrine 80/480 mg, 6 doses at 0, 8, 24, 36, 48, and 60 hours artemether AUC ↓ 16% artemether Cmin ↔ artemether Cmax ↓ 18% dihydroartemisinin AUC ↓ 18% dihydroartemisinin Cmin ↔ dihydroartemisinin Cmax ↓ 18% lumefantrine AUC ↑ 175% lumefantrine Cmin ↑ 126% lumefantrine Cmax ↑ 65% darunavir AUC ↔ darunavir Cmin ↓ 13% darunavir Cmax ↔
Maltese: Artemether/ Lumefantrine 80/480 mg, 6 dożi wara 0, 8, 24, 36, 48, u 60 siegħa artemether AUC ↓ 16% artemether Cmin ↔ artemether Cmax ↓ 18% dihydroartemisinin AUC ↓ 18% dihydroartemisinin Cmin ↔ dihydroartemisinin Cmax ↓ 18% lumefantrine AUC ↑ 175% lumefantrine Cmin ↑ 126% lumefantrine Cmax ↑ 65% darunavir AUC ↔ darunavir Cmin ↓ 13% darunavir Cmax ↔
English: (CYP2D6 inhibition)
Maltese: (inibizzjoni ta' CYP2D6)
English: Boceprevir 800 mg three times daily boceprevir AUC ↓ 32% boceprevir Cmin ↓ 35% boceprevir Cmax ↓ 25% darunavir AUC ↓ 44% darunavir Cmin ↓ 59% darunavir Cmax ↓ 36%
Maltese: Boceprevir 800 mg tlett darbiet kuljum boceprevir AUC ↓ 32% boceprevir Cmin ↓ 35% boceprevir Cmax ↓ 25% darunavir AUC ↓ 44% darunavir Cmin ↓ 59% darunavir Cmax ↓ 36%
English: Colchicine (if you have kidney and/or liver problems)
Maltese: Colchicine (jekk inti għandek problemi filkliewi u/jew fil-fwied)
English: Daily doses of 150, 450 and 1,000 mg/kg were administered to mice and doses of 50, 150 and 500 mg/kg were administered to rats.
Maltese: Dożi kuljum ta' 150, 450 u 1,000 mg/kg kienu mogħtija lill-ġrieden u dożi ta' 50, 150 u 500 mg/kg kienu mogħtija lill-firien.
English: 300 mg once daily atazanavir AUC ↔ atazanavir Cmin ↑ 52% atazanavir Cmax ↓ 11% darunavir AUC ↔ darunavir Cmin ↔ darunavir Cmax ↔
Maltese: 300 mg darba kuljum atazanavir AUC ↔ atazanavir Cmin ↑ 52% atazanavir Cmax ↓ 11% darunavir AUC ↔ darunavir Cmin ↔ darunavir Cmax ↔
English: Imputations according to the TLOVR algorithm Based on a normal approximation of the difference in % response NC=F
Maltese: Imputazzjonijiet skont l-algoritmu TLOVR Ibbażat fuq l-approssimazzjoni normali tad-diferenza fil-% tar-rispons NC=F
English: Lopinavir/ ritonavir 800/200 mg per day N=346
Maltese: Lopinavir/ ritonavir 800/200 mg kuljum N=346
English: Atorvastatin 10 mg once daily atorvastatin AUC ↑ 3-4 fold atorvastatin Cmin ↑ ≈5.5-10 fold atorvastatin Cmax ↑ ≈2 fold darunavir/ritonavir atorvastatin AUC ↑ 290% atorvastatin Cmax ↑ 319% atorvastatin Cmin ND
Maltese: Atorvastatin 10 mg darba kuljum atorvastatin AUC ↑ 3-4 drabi aktar atorvastatin Cmin ↑ ≈5.5-10 drabi aktar atorvastatin Cmax ↑ ≈2 drabi aktar darunavir/ritonavir atorvastatin AUC ↑ 290% atorvastatin Cmax ↑ 319% atorvastatin Cmin ND
English: With HIV-1 clade Type B
Maltese: Bi grupp ta' HIV-1 ġej mill-istess antenat Tip B
English: DRESS, Stevens-Johnson syndrome, erythema multiforme, dermatitis, seborrhoeic dermatitis, skin lesion, xeroderma not known toxic epidermal necrolysis, acute generalised exanthematous pustulosis
Maltese: DRESS, sindrome ta' Stevens-Johnson, eritema multiforme, dermatite, dematite tas-saborrea, ġerħa fil-ġilda, kserodema.
English: (induction of CYP450 enzymes)
Maltese: (induzzjoni tal-enzimi CYP450)
English: Baseline genotype or phenotype and virologic outcome
Maltese: Linja bażi ġenotipika jew fenotipika u l-effetti viroloġiċi
English: With Baseline HIV-1 RNA (copies/ml)
Maltese: B'HIV-1 RNA (kopja/ml)
English: According to the TLOVR non-virologic failure censored algorithm 24 (30.0%) patients experienced virological failure, of which 17 (21.3%) patients were rebounders and 7 (8.8%) patients were nonresponders.
Maltese: Skont l-algoritmu ċċensurat ta' falliment mhux viroloġiku ta' TLOVR 24 (30.0%) pazjent esperjenzaw falliment viroloġiku, li minnhom 17 -il pazjent (21.3%) reġgħu lura għal li kienu u 7 (8.8%) pazjenti ma rrispondewx għallkura.
English: ≥ 30 kg-< 40 kg 675 mg darunavir /100 mg ritonavir once daily
Maltese: ≥ 30 kg-< 40 kg 675 mg darunavir/100 mg ritonavir darba kuljum
English: Increased plasma concentrations of lovastatin or simvastatin may cause myopathy, including rhabdomyolysis.
Maltese: Żieda fil-konċentrazzjonijiet ta' lovastatin jew simvastatin filplażma tista' tikkawża mijopatija, inkluż rabdomijalisi.
English: Darunavir is approximately 95% bound to plasma protein.
Maltese: Bejn wieħed u ieħor 95% ta' darunavir huwa mwaħħal mal-proteini talplażma.
English: Tenofovir disoproxil 245 mg once daily tenofovir AUC ↑ 22% tenofovir Cmin ↑ 37% tenofovir Cmax ↑ 24% darunavir AUC ↑ 21% darunavir Cmin ↑ 24% darunavir Cmax ↑ 16% (↑ tenofovir from effect on MDR-1 transport in the renal tubules)
Maltese: Tenofovir disoproxil 245 mg darba kuljum tenofovir AUC ↑ 22% tenofovir Cmin ↑ 37% tenofovir Cmax ↑ 24% darunavir AUC ↑ 21% darunavir Cmin ↑ 24% darunavir Cmax ↑ 16% (↑ tenofovir mill-effett fuq it-trasport b'MDR-1 fit-tubi ż-żgħar tal-kilwa)
English: 150 mg twice daily maraviroc AUC ↑ 305% maraviroc Cmin ND maraviroc Cmax ↑ 129% darunavir, ritonavir concentrations were consistent with historical data
Maltese: 150 mg darbtejn kuljum maraviroc AUC ↑ 305% maraviroc Cmin ND maraviroc Cmax ↑ 129% konċentrazzjonijiet ta' darunavir, ritonavir kienu konsistenti ma' dejta storika
English: Strong CYP3A inducers include e.g. carbamazepine, phenobarbital and phenytoin (see sections 4.4 and 4.5).
Maltese: Indutturi qawwija ta' CYP3A jinkludu eż. carbamazepine, phenobarbital u phenytoin (ara sezzjonijiet 4.4 u 4.5).
English: Darunavir was not mutagenic or genotoxic in a battery of in vitro and in vivo assays including bacterial reverse mutation (Ames), chromosomal aberration in human lymphocytes and in vivo micronucleus test in mice.
Maltese: Darunavir ma kienx mutaġeniku jew ġenotossiku f'għadd ta' analiżi in vitro u in vivo inkluż mutazzjoni batterjali bil-kuntrarju (Ames), aberrazzjoni talkromożomi fil-limfoċit uman u t-test in vivo tal-mikronukleju fil-ġrieden.
English: Rilpivirine 150 mg once daily rilpivirine AUC ↑ 130% rilpivirine Cmin ↑ 178% rilpivirine Cmax ↑ 79% darunavir AUC ↔ darunavir Cmin ↓ 11% darunavir Cmax ↔
Maltese: Rilpivirine 150 mg darba kuljum rilpivirine AUC ↑ 130% rilpivirine Cmin ↑ 178% rilpivirine Cmax ↑ 79% darunavir AUC ↔ darunavir Cmin ↓ 11% darunavir Cmax ↔
English: TLOVR non-VF censored algorithm based on HIV-1 RNA < 50 copies/ml, except for TITAN (HIV-1 RNA < 400 copies/ml) IAS-USA lists
Maltese: Algoritmu ċċensurat TLOVR mhux-VF ibbażat fuq HIV-1 RNA < 50 kopja/ml, minbarra għal TITAN (HIV-1 RNA < 400 kopja/ml) IAS-listi tal-USA
English: Cmax, ng/ml AUC24h, ng.h/ml Cmin, ng/ml
Maltese: Cmax, ng/mL AUC24h, ng.siegħa/mL Cmin, ng/mL
English: During the Phase III clinical trial GS-US-216-130 with darunavir/cobicistat (N=313 treatment-naïve and treatment-experienced subjects), 66.5% of subjects experienced at least one adverse reaction.
Maltese: III tal-prova klinika GS-US-216-130 b'darunavir/cobicistat (N=313-il individwu li qatt ma ħadu kura qabel u li kienu diġà ħadu kura qabel), 66.5% talindividwi kellhom mill-inqas reazzjoni avversa waħda.
English: Unchanged darunavir accounted for approximately 41.2% and 7.7% of the administered dose in faeces and urine, respectively.
Maltese: L-ammont ta' darunavir mhux mibdul kien ta' bejn wieħed u ieħor 41.2% u 7.7% tad-doża amministrata fl-ippurgar u fl-awrina rispettivament.
English: Following intravenous administration, the volume of distribution of darunavir alone was 88.1 ± 59.0 l (Mean ± SD) and increased to 131 ± 49.9 l (Mean ± SD) in the presence of 100 mg twice-daily ritonavir.
Maltese: Wara amministrazjoni fil-vini, il-volum ta' distribuzzjoni ta' darunavir waħdu kien ta' 88.1 ± 59.0 l (Medja ± SD) u żdied għal 131 ± 49.9 l (Medja ± SD) filpreżenza ta'100 mg ritonavir darbtejn kuljum.
English: 450 milligram darunavir + 60 milligram ritonavir twice a day more than 40 kilograms*
Maltese: 450 milligramma darunavir + 60 milligramma ritonavir darbtejn kuljum aktar minn 40 kilogramma*
English: Lopinavir/ritonavir 533/133.3 mg twice daily lopinavir AUC ↑ 9% lopinavir Cmin ↑ 23% lopinavir Cmax ↓ 2% darunavir AUC ↓ 38% darunavir Cmin ↓ 51% darunavir Cmax ↓ 21% lopinavir AUC ↔ lopinavir Cmin ↑ 13% lopinavir Cmax ↑ 11% darunavir AUC ↓ 41% darunavir Cmin ↓ 55% darunavir Cmax ↓ 21% based upon non dose normalised values
Maltese: Lopinavir/ritonavir 533/133.3 mg darbtejn kuljum lopinavir AUC ↑ 9% lopinavir Cmin ↑ 23% lopinavir Cmax ↓ 2% darunavir AUC ↓ 38% darunavir Cmin ↓ 51% darunavir Cmax ↓ 21% lopinavir AUC ↔ lopinavir Cmin ↑ 13% lopinavir Cmax ↑ 11% darunavir AUC ↓ 41% darunavir Cmin ↓ 55% darunavir Cmax ↓ 21%
English: Elbasvir/grazoprevir to treat hepatitis C infection
Maltese: Elbasvir/grazoprevir biex titratta infezzjoni tal-epatite Ċ
English: The clinical relevance of the increase in norbuprenorphine pharmacokinetic parameters has not been established.
Maltese: Ir-rilevanza klinika taż-żieda filparametri farmakokinetiċi ta' norbuprenorphine ma ġietx stabbilita.
English: In most cases, Darunavir Krka can be combined with anti-HIV medicines belonging to another class [e.g. NRTIs (nucleoside reverse transcriptase inhibitors), NNRTIs (non-nucleoside reverse transcriptase inhibitors), CCR5 antagonists and FIs (fusion inhibitors)].
Maltese: F'ħafna mill-każi Darunavir Krka jista' jittieħed flimkien ma' mediċini li jagħmlu parti minn klassi oħra [eż. NRTI's (impedituri tan-nucleoside reverse transcriptase), NNRTI's (impedituri tan-non nucleoside reverse transcriptase), antagonisti ta' CCR5 u FIs (impedituri ta' fużjoni)].
English: HIV RNA < 50 copies/ml
Maltese: HIV RNA < 50 kopja/mla
English: ≥ 15 kg-< 30 kg 600 mg darunavir/100 mg ritonavir once daily
Maltese: ≥ 15 kg-< 30 kg 600 mg darunavir/100 mg ritonavir darba kuljum
English: - The other ingredients are cellulose, microcrystalline; crospovidone, hydroxypropylcellulose; silica, colloidal anhydrous; silicified microcrystalline cellulose (cellulose, microcrystalline; 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) - only for 400 mg film-coated tablets and red iron oxide (E172) in film coating.
Maltese: - Is-sustanzi mhux attivi l-oħra huma microcrystalline cellulose, crospovidone, 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) u red iron oxide (E172) fil-kisja tar-rita.
English: In the virologic failures of the GS-US-216-130 trial no cross-resistance with other HIV PIs was observed.
Maltese: Fil-fallimenti viroloġiċi tal-prova GS-US-216-130 ma kienet osservata l-ebda reżistenza inkroċjata ma' PIs ta' HIV oħra.
English: Silicified microcrystalline cellulose (Cellulose, microcrystalline; Silica, colloidal anhydrous) Magnesium stearate (E470b)
Maltese: Silicified microcrystalline cellulose (Cellulose, microcrystalline; Silica, colloidal anhydrous)
English: Carbamazepine 200 mg twice daily carbamazepine AUC ↑ 45% carbamazepine Cmin ↑ 54% carbamazepine Cmax ↑ 43% darunavir AUC ↔ darunavir Cmin ↓ 15%
Maltese: Carbamazepine 200 mg darbtejn kuljum carbamazepine AUC ↑ 45% carbamazepine Cmin ↑ 54% carbamazepine Cmax ↑ 43% darunavir AUC ↔ darunavir Cmin ↓ 15%
English: 600 mg once daily efavirenz AUC ↑ 21% efavirenz Cmin ↑ 17% efavirenz Cmax ↑ 15% darunavir AUC ↓ 13% darunavir Cmin ↓ 31% darunavir Cmax ↓ 15% (↑ efavirenz from CYP3A inhibition) (↓ darunavir from CYP3A induction)
Maltese: 600 mg darba kuljum efavirenz AUC ↑ 21% efavirenz Cmin ↑ 17% efavirenz Cmax ↑ 15% darunavir AUC ↓ 13% darunavir Cmin ↓ 31% darunavir Cmax ↓ 15% (↑ efavirenz minn impediment ta' CYP3A) (↓ darunavir minn induzzjoni ta' CYP3A)
English: PROTON PUMP INHIBITORS Omeprazole
Maltese: TAL-POMPA TAL-PROTON Omeprazole
English: 400 mg once daily didanosine AUC ↓ 9% didanosine Cmin ND didanosine Cmax ↓ 16% darunavir AUC ↔ darunavir Cmin ↔ darunavir Cmax ↔
Maltese: didanosine AUC ↓ 9% didanosine Cmin ND didanosine Cmax ↓ 16% darunavir AUC ↔ darunavir Cmin ↔ darunavir Cmax ↔
English: For full information on interactions with other medicinal products see section 4.5.
Maltese: Għal informazzjoni sħiħa dwar interazzjonijiet ma' prodotti mediċinali oħra ara sezzjoni 4.5.
English: (inhibition of CYP450 enzymes)
Maltese: (impediment tal-enzimi CYP450)
English: ANTICOAGULANT/PLATELET AGGREGATION INHIBITOR Apixaban
Maltese: ANTIKOAGULANTI/INIBITUR TAL-AGGREGAZZJONI
English: Darunavir co-administered with low dose ritonavir and amiodarone, bepridil, dronedarone, ivabradine, quinidine, or ranolazine is contraindicated (see section 4.3).
Maltese: Darunavir mogħti flimkien ma' doża baxxa ta' ritonavir u amiodarone, bepridil, dronedarone, ivabradine, quinidine, jew ranolazine huwa kontraindikat (ara sezzjoni 4.3).
English: Frequency categories are defined as follows: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000) and not known (frequency cannot be estimated from the available data).
Maltese: Il-kategoriji ta' frekwenza huma definiti kif ġej: komuni ħafna (≥ 1/10), komuni (≥ 1/100 sa < 1/10), mhux komuni (≥ 1/,000 sa < 1/100), rari (≥ 1/10,000 sa < 1/1,000) u mhux magħruf (il-frekwenza ma tistax tiġi stmata mid-data disponibbli).
English: Darunavir is primarily metabolised by CYP3A.
Maltese: Darunavir huwa mmetabolizzat primarjament mis-CYP3A.
English: 4.5 Interaction with other medicinal products and other forms of interaction
Maltese: Interazzjonijiet ma' prodotti mediċinali u forom oħra ta' interazzjoni