FrancophonIA/ELRC3.0 huggingface dataset:
English: Lurasidone
Maltese: Lurasidine
English: In the absence and presence of 50% human serum, the mean IC50 of lopinavir against HIV-1IIIB in MT4 cells was 17 nM and 102 nM, respectively.
Maltese: Fl-assenza u fil-preżenza ta' 50% ta' serum uman, l-IC50 medja ta' lopinavir kontra HIV-1IIIB f'ċelluli MT4 kienet ta' 17 nM u 102 nM, rispettivament.
English: HCV protease inhibitors Boceprevir 800 mg three times daily
Maltese: Inibituri ta' HCV protease Boceprevir 800 mg tlett darbiet kuljum
English: Nucleoside/Nucleotide reverse transcriptase inhibitors (NRTIs) Stavudine, Lamivudine
Maltese: Inibituri nukleoside/nukleotide reverse transcriptase (NRTIs) Stavudine, Lamivudine Lopinavir: ↔
English: (see section 4.5); - riociguat is not recommended (see section 4.5); - vorapaxar is not recommended (see section 4.5); - fusidic acid in osteo-articular infections is not recommended (see section 4.5); - salmeterol is not recommended (see section 4.5); - rivaroxaban is not recommended (see section 4.5).
Maltese: (ara sezzjoni 4.5); - riociguat mhux irrakkomandat (ara sezzjoni 4.5); - vorapaxar mhux irrakkomandat (ara sezzjoni 4.5); - fusidic acid għal infezzjonijiet tal-għadam u l-ġoġi mhijiex rakkomandata (ara sezzjoni 4.5); - salmeterol mhijiex irrakomandata (ara sezzjoni 4.5); - rivaroxaban mhux irrakomandat (ara sezzjoni 4.5).
English: Ombitasvir/paritaprevir/rito navir + dasabuvir
Maltese: Ombitasvir/paritaprevir/ ritonavir + dasabuvir
English: EU/1/15/1067/001 EU/1/15/1067/002 EU/1/15/1067/003 EU/1/15/1067/004 EU/1/15/1067/005 EU/1/15/1067/006 EU/1/15/1067/007 EU/1/15/1067/008
Maltese: EU/1/15/1067/001 EU/1/15/1067/002 EU/1/15/1067/003 EU/1/15/1067/004
English: Opioids Buprenorphine, 16 mg QD Buprenorphine: ↔
Maltese: Buprenorphine, 16 mg QD
English: HIV RNA < 50 copies/ml
Maltese: HIV RNA < 50 kopji /ml
English: Table 6 Mean (%CV) Steady-State Pharmacokinetic Parameters of Lopinavir in HIV-Infected Pregnant Women
Maltese: Tabella 6 Medja (% CV) Parametri Farmakokinetiċi fl-Istat Fiss ta 'Lopinavir f'Nisa Tqal Infettati blHIV
English: In the QD group, 6/75 (8%) patients demonstrated new primary protease inhibitor mutations (codons 30, 32, 48, 50, 82, 84, 90), as did 12/77 (16%) patients in the BID group.
Maltese: Fil-grupp QD, 6/75 (8%) tal-pazjent urew mutazzjonijiet ġodda primarja talinibitur tal-protease (kodoni 30, 32, 48, 50, 82, 84, 90), kif għamlu 12/77 (16%) tal-pazjent fil-grupp BID.
English: H-2900 Komárom, Mylan utca 1
Maltese: Komárom, Mylan utca 1 L-Ungerija
English: ≥ 1.2 to < 1.4
Maltese: ≤ 1.2 sa < 1.4
English: Non-nucleoside reverse transcriptase inhibitors (NNRTIs) Efavirenz, 600 mg QD Lopinavir: AUC: ↓ 20%
Maltese: Inibituri non-nucleoside reverse transcriptase (NNRTIs): Efavirenz, 600 mg QD Lopinavir:
English: Increased plasma concentrations of vardenafil (see sections 4.4 and 4.5)
Maltese: Żieda fil-konċentrazzjoni fil-plażma ta' vardenafil (ara sezzjoni 4.4 u 4.5)
English: - The active substances are lopinavir and ritonavir - The other ingredients are sorbitan laurate, colloidal anhydrous silica, copovidone, sodium stearyl fumarate, hypromellose, titanium dioxide (E171), macrogol, hydroxypropylcellulose, talc, polysorbate
Maltese: - Is-sustanzi l-oħra huma sorbitan laurate, colloidal anhydrous silica, copovidone, sodium stearyl fumarate, hypromellose, titanium dioxide (E171), macrogol, hydroxypropylcellulose, talc, polysorbate 80.
English: Telaprevir 750 mg three times daily
Maltese: Telaprevir 750 mg tlett darbiet kuljum
English: simeprevir and telaprevir);
Maltese: (eż. boceprevir, simeprevir u telaprevir);
English: Lopinavir/ritonavir does not inhibit CYP2D6, CYP2C9, CYP2C19, CYP2E1, CYP2B6 or CYP1A2 at clinically relevant concentrations (see section 4.3).
Maltese: F'konċentrazzjoni klinika rilevanti, lopinavir/ritonavir ma jimpedixxix CYP2D6, CYP2C9, CYP2C19, CYP2E1, CYP2B6 jew CYP1A2 (ara sezzjoni 4.3).
English: ≥ 0.5 to < 0.9
Maltese: ≤ 0.5 sa < 0.9
English: ≥ 0.5 to < 0.8
Maltese: ≤ 0.5 sa < 0.8
English: KONCERT/PENTA 18 is a prospective multicentre, randomised, open-label study that evaluated the pharmacokinetic profile, efficacy and safety of twice-daily versus once-daily dosing of lopinavir/ritonavir 100 mg/25 mg tablets dosed by weight as part of combination antiretroviral therapy (cART) in virologically suppressed HIV-1 infected children (n=173).
Maltese: KONCERT/PENTA 18 huwa studju multicentre prospettiv, randomised u open -label li evalwa l-profil farmakokinetiku, l-effikaċja u s-sigurtà ta' dożaġġ ta' darbtejn kuljum versus darba kuljum ta' pilloli ta' lopinavir/ritonavir 100 mg/25 mg dożati skont il-piż bħala parti mit-terapija antiretrovirali kombinata (cART) fit-tfal infettati b'HIV-1 li huma soppressi viroloġikament (n = 173).
English: Omeprazole (40 mg QD) Omeprazole: ↔
Maltese: Aġenti li jnaqqsu l-aċidu Omeprazole (40 mg QD)
English: Fluticasone propionate, 50 μg intranasal 4 times daily:
Maltese: Fluticasone propionate, 50 mg applikat fl-imnieħer erba' darbiet kuljum::
English: Simeprevir 200 mg daily (ritonavir 100 mg BID)
Maltese: Simeprevir 200 mg kuljum (ritonavir 100 mg BID [darbtejn kuljum])
English: Herbal products St John's wort (Hypericum perforatum)
Maltese: Prodotti magħmulin mill-ħxejjex Fexfiex tar-Raba' (St John's wort) (Hypericum perforatum)
English: Increased plasma concentrations of avanafil (see sections 4.4 and 4.5)
Maltese: Żieda fil-konċentrazzjoni fil-plażma ta' avanafil (ara sezzjoni 4.4 u 4.5).
English: Mylan Hungary Kft
Maltese: Mylan Hungary Kft H-2900
English: Pack sizes available are:
Maltese: Id-daqsijiet disponibbli tal-pakketti huma:
English: Pharmacotherapeutic group: antivirals for systemic use, antivirals for treatment of HIV infections, combinations, ATC code: J05AR10
Maltese: Kategorija farmakoterapewtika: mediċina antivirali għal użu sistemikumediċina antivirali għattrattament ta' infezzjonijiet tal-HIV, kombinazzjonijiet, Kodiċi ATC:
English: The frequency category includes all reported events of moderate to severe intensity, regardless of the individual causality assessment.
Maltese: Il-kategorija tal-frekwenza tinkudi lavvenimenti kolla li ġew irrapurtati b'intensita moderata għal severa, irrispettivament mill assessjar talkażijiet individuali.
English: ≥ 0.8 to < 1.2
Maltese: ≤ 0.8 sa < 1.2
English: The maximum mean (95% upper confidence bound) differences in QTcF from placebo were 3.6 (6.3) and 13.1(15.8) for 400/100 mg twice daily and supratherapeutic 800/200 mg twice daily LPV/r, respectively.
Maltese: Id-differenzi medji massimi (95% upper confidence bound) fil-QTcF mill-plaċebo kienu ta' 3.6 (6.3) u 13.1 (15.8) fil-każ fejn ingħatat doża ta' 400/100 mg LPV/r darbtejn kuljum u 800/200 mg LPV/r aktar milli jingħata fit-terapija darbtejn kuljum, rispettivament.
English: Dexamethasone
Maltese: Kortikosterojdi Dexamethasone
English: ≥ 0.9 to < 1.4
Maltese: ≤ 0.9 sa < 1.4
English: This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free'.
Maltese: Din prodotti mediċinali fiha inqas minn 1 mmol sodium (23 mg) kull pillola, jiġifieri essenzjalment ‘ħieles mis-sodium'.
English: After 48 weeks of treatment with lopinavir/ritonavir, efavirenz and nucleoside reverse transcriptase inhibitors, plasma HIV RNA ≤ 400 copies/ml was observed in 93% (25/27), 73% (11/15), and 25% (2/8) of patients with < 10-fold, 10 to 40-fold, and > 40-fold reduced susceptibility to lopinavir at baseline, respectively.
Maltese: Wara 48 ġimgħa ta' kura b'lopinavir/ritonavir, efavirenz u impedituri tannukleòside reverse transcriptase, il-plażma fl-HIV RNA < 400 kopja/ml kienet osservata fi 93% (25/27), fi 73% (11/15), u f'25% (2/8) ta' pazjenti b'suxxettibilità mnaqqsa għal liponavir fil-linja bażi ta' < 10 darbiet, minn 10 sa 40 darba, u > 40 darba, rispettivament.
English: For patients with renal impairment (CrCL < 30 ml/min) dose reduction of clarithromycin should be considered (see section 4.4).
Maltese: < 30 ml/min) għandu jiġi kkunsidrat tnaqqis fid-doża ta' clarithromycin (ara sezzjoni 4.4).
English: Tenofovir, 300 mg QD Tenofovir: AUC: ↑ 32%
Maltese: Tenofovir, 300 mg QD Tenofovir:
English: 30x1 Film-coated tablets
Maltese: 30x1 Pillola miksija b'rita
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: Ir-rekwiżiti tar- PSURs għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza talUnjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunke aġġornament sussegwenti ppubblikati fuq il-portal elettroniku Ewropew tal-mediċini.
English: Lopinavir AUC over a 24 hour dosing interval averaged 206.5 ± 89.7 μg h/ml.
Maltese: LAUC ta ' lopinavir fuq perjodu ta ' intervall tad-doża ta ' 24 siegħa kellha medja ta ' 206.5 ± 89.7 μg h/ml.
English: Resistance to nelfinavir, defined as the presence of the D30N or L90M mutation in protease, was observed in 41/96 (43%) patients.
Maltese: Ir-reżistenza għal nelfinavir, hekk definita bħala l-preżenza ta' mutazzjoni D30N jew L90M tal-proteaż, ġiet osservata f' 41/96 (43%) tal-pazjenti.
English: The pharmacokinetic data from HIV-1 infected pregnant women receiving lopinavir/ritonavir tablets 400/100 mg twice daily are presented in Table 6 (see section 4.2).
Maltese: Id-dejta farmakokinetika minn nisa tqal infettati bl-HIV-1 li kienu qed jirċievu pilloli lopinavir/ritonavir 400/100 mg darbtejn kuljum huma ppreżentati f'Tabella 6 (ara sezzjoni 4.2).
English: Study M98-863 was a randomised, double-blind trial of 653 antiretroviral treatment naïve patients investigating lopinavir/ritonavir (400/100 mg twice daily) compared to nelfinavir (750 mg three times daily) plus stavudine and lamivudine.
Maltese: Studju M98-863 kien fortuwitu u proċess double-blind bi 653 pazjenti ġodda għal trattament antiretrovirali fejn ġie investigat lopinavir/ritonavir (400/100 mg darbtejn kuljum) mqabbel ma' nelfinavir (750 mg tlett darbiet kuljum) u stavudine u lamivudine.
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1000 to < 1/100) and not known (cannot be estimated from the available data).
Maltese: F'kull grupp ta' frekwenza, effetti mhux mixtieqa huma murija f'ordni ta tnaqqis fis-serjeta': komuni ħafna (> 1/10), komuni (> 1/100 sa < 1/10), mhux komuni (> 1/1000 sa < 1/100) u mhux magħrufa (ma tistax tittieħed stima mid-data disponibbli).
English: Rilpivirine (Lopinavir/ritonavir capsule 400/100 mg BID)
Maltese: Rilpivirine (Lopinavir/ritonavir kapsula 400/100 mg BID)
English: HIV RNA < 400 copies/ml Mean increase from baseline in CD4+ T-cell count (cells/mm3)
Maltese: HIV RNA < 400 kopji/ml Żieda medja mill-lija bażi flgħadd ta' CD4+ T-cell (ċelloli/mm3)
English: Most tyrosine kinase inhibitors such as dasatinib and nilotinib, vincristine, vinblastine
Maltese: Il-biċċa l-kbira ta' inibituri ta' tyrosine kinase bħal dasatinib u nilotinib, vincristine, vinblastine
English: Mutations V82A, I54V and M46I emerged most frequently.
Maltese: L-aktar li tfaċċaw spiss kienu l-mutazzjonijiet V82A, I54V u M46I.
English: Lopinavir AUC over a 12 hour dosing interval averaged 113.2 ± 60.5 μg•h/ml.
Maltese: L-AUC ta' lopinavir fuq intervall ta' dożaġġ ta' 12 -il siegħa kellu medja ta' 113.2  60.5 g•h/ml.
English: Undesirable effects in clinical studies and post-marketing in adult patients System organ class
Maltese: Effetti mhux mixtieqa fi studji kliniċi u ta' wara t-tqegħid fis-suq f'pazjenti adulti Sistema tal-klassifika talorgani
English: The lopinavir mean steady-state AUC, Cmax, and Cmin were 72.6 ± 31.1 μg•h/ml, 8.2 ± 2.9 μg/ml and 3.4 ± 2.1 μg/ml, respectively after lopinavir/ritonavir oral solution 230/57.5 mg/m2 twice daily without nevirapine (n=12), and were 85.8 ± 36.9 μg•h/ml, 10.0 ± 3.3 μg/ml and 3.6 ± 3.5 μg/ml, respectively after 300/75 mg/m2 twice daily with nevirapine (n=12).
Maltese: ± 31,1μg•h/ml, 8.2 ± 2.9g•h/ml and 3.4± 2.1μg•h/ml rispettivament wara lopinavir/ritonavir soluzzjoni orali 230/57.5 mg/m2 darbtejn kuljum mingħajr nevirapine (n=12), u kienu 85.
English: 3 tablets (300/75 mg) 4 tablets (400/100 mg)
Maltese: 3 pilloli (300/75 mg)
English: Monitor for ADRs related to afatinib
Maltese: Aġenti għal kontra l-kanċer Afatinib
English: Rosuvastatin, 20 mg QD Rosuvastatin: AUC: ↑ 2-fold
Maltese: Rosuvastatin, 20 mg QD Rosuvastatin:
English: INFORMATION IN BRAILLE Lopinavir/Ritonavir Mylan 200 mg/50 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Lopinavir/Ritonavir Mylan 200 mg/50 mg
English: M98-940 was an open-label study of a liquid formulation of lopinavir/ritonavir in 100 antiretroviral naïve (44%) and experienced (56%) paediatric patients.
Maltese: M98-940 kien studju open-label ta' taħlita likwida orali ta' lopinavir/ritonavir f' 100 novizzi għatterapji antiretrovirali (44%) u (56%) pazjenti pedjatriċi bl-esperjenza ta' dawn it-trattamenti.
English: AUC: ↑ 11.86-fold Cmax: ↑ 6.31-fold C24: ↑ 20.70-fold
Maltese: AUC: ↑ 11.86 darbiet Cmax: ↑ 6.31 darbiet C24: ↑ 20.
English: MARKETING AUTHORISATION NUMBER EU/1/15/1067/004 - 120 Film-coated tablets EU/1/15/1067/006 - 120x1 Film-coated tablets EU/1/15/1067/005 - 360 Film-coated tablets
Maltese: Pillola miksija b'rita EU/1/15/1067/006 - 120x1 Pillola miksija b'rita EU/1/15/1067/005 - 360 Pillola miksija b'rita
English: Mean age of patients enrolled was 41 years (range: 21 to 73); 51% were Caucasian and 66% were male.
Maltese: L-età medjana tal-individwi rreġistrati kienet ta' 41 sena (medda: 21 sa 73 sena), 51% kienu Kawkasi u 66% kienu rġiel.
English: Alpha1 adrenoreceptor antagonist Alfuzosin
Maltese: Mediċini li jimblukkaw ir-riċettur α1-Adrenoreceptor Alfuzosin
English: The median EC50 of lopinavir against isolates with 0 − 3, 4 − 5, 6 − 7 and 8 − 10 mutations at the above amino acid positions was 0.8, 2.7, 13.5 and 44.0-fold higher than the EC50 against wild type HIV, respectively.
Maltese: L-EC50 medjan ta' lopinavir kontra iżolati b'0-3, 4-5, 6-7 u 8-10 mutazzjonijiet fil-pożizzjonijiet ta' l-aċidu amminiku kif indikat hawn fuq, kien 0.8, 2.7 13.5 u 44.0 darba ogħla mill-EC50 kontra l-HIV tat-tip mhux ikkultivat, rispettivament.
English: Lopinavir/ritonavir has been shown in vivo to induce its own metabolism and to increase the biotransformation of some medicinal products metabolised by cytochrome P450 enzymes (including CYP2C9 and CYP2C19) and by glucuronidation.
Maltese: Ġie ppruvat li lopinavir/ritonavir in vivo, jinduċi l-metaboliżmu tiegħu nnifsu u jżid ilbiotrassformazzjoni ta' xi prodotti mediċinali metabolizzati mill-enżimi taċ-ċitokromju P450 (inklużi CYP2C9 u CYP2C19) u mill-glukorinidazzjoni.
English: INFORMATION IN BRAILLE Lopinavir/Ritonavir Mylan 100 mg/25 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Lopinavir/Ritonavir Mylan 100 mg/25 mg
English: Through 360 weeks of treatment, genotypic analysis of viral isolates was successfully conducted in 19 of 28 patients with confirmed HIV RNA above 400 copies/ml revealed no primary or active site mutations in protease (amino acids at positions 8, 30, 32, 46, 47, 48, 50, 82, 84 and 90) or protease inhibitor phenotypic resistance.
Maltese: Matul 360 ġimgħa ta' trattament, analiżi ġenotipika ta' iżolati virali giet konkluża b'success f' 19 minn 28 pazjent li kellhom ikkonfermat HIV RNA l-fuq min 400 kopja/ml, ma wera l-ebda mutazzjoni talproteaż fis-sit primarju jew attiv (amino acids f'pużizzjonijiet 8, 30, 32, 46, 47, 48, 50, 82, 84 u 90) jew reżistenza fenotipika tal-proteaż.
English: AUC: ↑ 13-fold Parenteral Midazolam: AUC: ↑ 4-fold
Maltese: AUC: ↑ 13-il darba Midazolam Parenterali:
English: Cmax: ↑ 5-fold
Maltese: Cmax: ↑ 5-darbiet
English: Inhibition of HIV protease prevents cleavage of the gag-pol polyprotein resulting in the production of immature, non-infectious virus.
Maltese: L-impediment tal-protejaż ta' l-HIV jfixkel il-qsim tal-poliproteina gag-pol, u għalhekk ikun hemm il-produzzjoni ta' virus immatur, mhux infettiv.
English: Analgesics Fentanyl
Maltese: Mediċini analġeżiċi Fentanyl
English: AUC: ↑ 6.10-fold Cmax: ↑ 4.76-fold Ctrough: ↑ 12.33-fold
Maltese: AUC: ↑ 6.10 darbiet Cmax: ↑ 4.76 darbiet Ctrough: ↑ 12.33 darbiet (inibizzjoni ta '
English: Mean age of patients enrolled was 39 years (range: 19 to 71); 75% were Caucasian, and 78% were male.
Maltese: L-età medjana tal-individwi rreġistrati kienet ta' 39 sena (medda: 19 sa 71), 75% kienu Kawkasi u 78% kienu rġiel.
English: Effects on drug levels Geometric Mean Change (%) in AUC, Cmax, Cmin Mechanism of interaction
Maltese: Bidla fil-Medja Ġeometrika (%) f'AUC, Cmax, Cmin Mekkaniżmu ta' l-interazzjoni
English: − Lopinavir/ritonavir must not be taken once daily with efavirenz, nevirapine, carbamazepine, phenobarbital and phenytoin.
Maltese: - Lopinavir/ritonavir ma għandiex tittieħed darba kuljum jekk tingħata ma amprenavir, efavirenz, nevirapine, nelfinavir, carbamazepine, phenobarbital u phenytoin.
English: Patients were administered emtricitabine 200 mg once daily and tenofovir DF 300 mg once daily.
Maltese: Il-pazjenti ngħataw emtricitabine 200 mg darba kuljum u tenofovir DF 300 mg darba kuljum.
English: Around 85% of patients had a viral load of < 100,000 copies/ml.
Maltese: Madwar 85% tal-pazjenti kellhom ammont virali ta ' <100,000 kopja/ml.
English: Herbal preparations containing St John's wort (Hypericum perforatum) due to the risk of decreased plasma concentrations and reduced clinical effects of lopinavir and ritonavir (see section 4.5).
Maltese: Preparazzjonijiet mill-ħxejjex li fihom St John's wort (Hypericum perforatum) minħabba r-riskju ta' tnaqqis filkonċentrazzjoni fil-plażma u tnaqqis fleffetti kliniċi ta' lopinavir u ritonavir (ara sezzjoni 4.5).
English: Cmin: ↑ 3.5-fold
Maltese: Cmin: ↑ 3.5-darbiet
English: The effect on DAAs and lopinavir was similar to that observed when lopinavir/ritonavir 400/100 mg BID was administered (see section 4.3).
Maltese: Leffett fuq DAAs u lopinavir kien simili għal dak osservat meta ngħata lopinavir/ritonavir.400/100 mg BID (ara sezzjoni 4.3).
English: Cmax:↑ 3.5-fold
Maltese: Cmax: ↑ 3.5-darbiet
English: In the absence of human serum, the mean IC50 of lopinavir against five different HIV-1 laboratory strains was 19 nM.
Maltese: Flassenza tas-serum uman, l-IC50 medja ta' lopinavir kontra ħames razez differenti tal-laboratorju ta' HIV-1 kienet ta' 19 nM.
English: In addition, they contained a median of 3 mutations at amino acid positions 20, 24, 46, 53, 71 and 90.
Maltese: Barraminnhekk, dawn kien fihom medjan ta' 3 mutazzjonijiet filpożizzjonijiet ta' l-aċidi amminiċi 20, 24, 46, 53, 71 u 90.
English: Increased plasma concentrations of sildenafil.
Maltese: Żieda filkonċentrazzjoni fil-plażma ta' sildenafil.
English: The pharmacokinetics of lopinavir/ritonavir oral solution 300/75 mg/m2 twice daily and 230/57.5 mg/m2 twice daily have been studied in a total of 53 paediatric patients, ranging in age from 6 months to 12 years.
Maltese: Il-farmakokinetika ta' lopinavir/ritonavir soluzzjoni orali 300/75 mg/m2 darbtejn kuljum u 230/57.5 mg/m2 darbtejn kuljum ġew studjati f'total ta' 53 pazjent pedjatriku li jvarjaw fl-età minn 6 xhur sa 12 il-sena.
English: Etravirine (Lopinavir/ritonavir tablet 400/100 mg BID)
Maltese: Etravirine (Lopinavir/ritonavir pillola 400/100 mg BID)
English: During in vitro studies, cloned human cardiac potassium channels (HERG) were inhibited by 30% at the highest concentrations of lopinavir/ritonavir tested, corresponding to a lopinavir exposure 7-fold total and 15-fold free peak plasma levels achieved in humans at the maximum recommended therapeutic dose.
Maltese: Waqt studji in vitro li saru, kanali kardijaċi tal-potassju umani li ġew maħluqa permezz tal-cloning (HERG) kienu inibiti bi 30% fl-ogħla konċentrazzjoni ta' lopinavir/ritonavir ippruvata, li tikkorrispondi ma' esponiment għal lopinavir ta' total ta' 7 darbiet aktar u 15 -il darba aktar mill-ogħla livelli liberi filplażma li ġew milħuqa fil-bniedem bid-doża terapewtika massima rrakkomandata.
English: Due to BCRP (breast cancer resistance protein/ABCG2) and acute P-gp inhibition by lopinavir/ritonavir
Maltese: Minħabba l-BCRP (proteina reżistenti għall-kanċer tas-sider/ ABCG2) u inibizzjoni akuta ta' P-gp minn lopinavir/ritonavir.
English: Lopinavir/Ritonavir Mylan tablets contain lopinavir and ritonavir, both of which are inhibitors of the P450 isoform CYP3A in vitro.
Maltese: Lopinavir/ritonavir fih lopinavir u ritonavir, it-tnejn li huma impedituri ta' l-iżoforma ta' P450, CYP3A in vitro.
English: AUC: ↑ 7.2-fold Cmax: ↑ 4.7-fold Cmin: ↑ 14.4-fold
Maltese: AUC: ↑ 7.2 darbiet Cmax: ↑ 4.7 darbiet Cmin: ↑ 14.
English: Based on known metabolic profiles, clinically significant interactions are not expected between Lopinavir/Ritonavir Mylan and dapsone, trimethoprim/sulfamethoxazole, azithromycin or fluconazole.
Maltese: Skont il-profili metaboliċi magħrufa, m'humiex mistennija interazzjonijiet li huma klinikament sinifikanti bejn Lopinavir/Ritonavir Mylan u dapsone, trimethoprim/sulfamethoxazole, azithromycin jew fluconazole.
English: Due to the risk of bedaquiline related adverse events, the combination of bedaquiline and Lopinavir/Ritonavir Mylan should be avoided.
Maltese: Minħabba r-riskju ta' effetti avversi relatati ma' bedaquiline, il-kombinazzjoni ta' bedaquiline u Lopinavir/Ritonavir Mylan għandha tiġi evitata.
English: MARKETING AUTHORISATION NUMBER EU/1/15/1067/001 - 60 Film-coated tablets EU/1/15/1067/002 - 60x1 Film-coated tablets
Maltese: Pillola miksija b'rita EU/1/15/1067/002 - 60x1 Pillola miksija b'rita
English: (Lopinavir/ritonavir 400/100 mg BID, multiple dose)
Maltese: (Lopinavir/ritonavir 400/100mg BID (darbtej kuljum), dożi multipli)
English: Concomitant Therapy: Efavirenz or nevirapine
Maltese: Terapija Mogħtija fl-Istess Ħin: Efavirenz jew nevirapine
English: A 14C-lopinavir study in humans showed that 89% of the plasma radioactivity after a single 400/100 mg lopinavir/ritonavir dose was due to parent active substance.
Maltese: Studji ta' 14C-lopinavir fil-bniedem urew illi 89% tar-radjoattività fil-plażma wara doża unika ta' 400/100 mg lopinavir/ritonavir kienet dovuta għas-sustanza attiva prinċipali.
English: In addition to the mutations described above, mutations V32I and I47A have been observed in rebound isolates with reduced lopinavir susceptibility from protease inhibitor experienced patients receiving lopinavir/ritonavir therapy, and mutations I47A and L76V have been observed in rebound isolates with reduced lopinavir susceptibility from patients receiving lopinavir/ritonavir therapy.
Maltese: Mal-mutazzjonijiet deskritti hawn fuq, kienu ukoll osservati l-mutazzjonijiet V321 u I47A f'iżolati li marru lura b'suxxettibilità mnaqqsa għal lopinavir f'pazjenti b'esperjenza ta' impeditur protejaż li kienu qegħdin jirċievu terapija b'lopinavir/ritonavir u mutazzjonijiet I47A u L76V ġew osservati f'iżolati li marru lura b'suxxettibilità mnaqqsa għal lopinavir f' pazjenti li kienu jirċievu terapija ta' lopinavir/ritonavir.
English: Antiviral activity of lopinavir/ritonavir in patients failing protease inhibitor therapy The clinical relevance of reduced in vitro susceptibility to lopinavir has been examined by assessing the virologic response to lopinavir/ritonavir therapy, with respect to baseline viral genotype and phenotype, in 56 patients previous failing therapy with multiple protease inhibitors.
Maltese: Ir-rilevanza klinika tas-suxxettibilità in vitro mnaqqsa għal lopinavir ġiet eżaminata billi ġie evalwat irrispons viroloġiku għat-terapija b'lopinavir/ritonavir, fir-rigward tal-ġenotip u fenotip virali fil-linja bażi, f'56 pazjent li qabel ma kellhomx rispons għat-terapija b'diversi impedituri protejaż.
English: Mean increase from baseline in CD4+ T-cell count (cells/mm3)
Maltese: Żieda medja mill-lija bażi fl-għadd ta' CD4+ T-cell (ċelloli/mm3)
English: Multipack: 120 (4 cartons of 30) Film-coated tablets Multipack: 120x1 (4 cartons of 30x1) Film-coated tablets Multipack: 360 (12 cartons of 30) Film-coated tablets
Maltese: Pakkett multiplu: 120 (4 kartuni ta '30) Pillola miksija b'rita Pakkett multiplu: 120x1 (4 kartuni ta '30x1)
English: Mylan Healthcare SIA Tel: +371 676 055 80
Maltese: BGP Products SIA Tel: +371 676 055 80