FrancophonIA/ELRC3.0 huggingface dataset:
English: Antiviral activity of Kaletra 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 Kaletra therapy, with respect to baseline viral genotype and phenotype, in 56 patients previous failing therapy with multiple protease inhibitors.
Maltese: L-attività antivirali ta' Kaletra f'pazjenti li qed ifallu fit-terapija ta' inibituri tal-protease Ir-rilevanza klinika tas-suxxettibilità in vitro għal lopinavir ġiet eżaminata billi ġie analizzat ir-respons viroloġiku tat-terapija b'Kaletra, fir-rigward tal-linja bażi tal-ġenotip u fenotip virali, fi 56 pazjent li qabel kienu qed ifallu t-terapija b'inibituri multipli tal-protease.
English: Polyvinyl alcohol, talc, titanium dioxide, macrogols type 3350, yellow ferric oxide E172.
Maltese: Polimer ta' l-alkoħol, talkum, dijossidu tat-titanju, macrogols tat-tip 3350, ossidu isfar tal-ħadid E172.
English: Increased plasma concentrations of avanafil (see sections 4.4 and 4.5).
Maltese: avanafil (ara sezzjoni 4.4 u 4.5).
English: Mean baseline CD4+ T-cell count was 259 cells/mm3 (range: 2 to 949 cells/ mm3) and mean baseline plasma HIV-1 RNA was 4.9 log10 copies/ml (range: 2.6 to 6.8 log10 copies/ml).
Maltese: Il-linja bażi medja tal-għadd ta' CD4+ T-cell kien ta' 259 ċelloli/mm3 (bejn 2 sa 949 cellola log10 kopji/ml) u l-linja bażi medja ta' HIV-1 RNA fil-plażma kienet ta' 4.9 log10 kopji/ml (minn: 2.6 sa 6.8 log10 kopji/ml).
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: 28 pazjent li kellhom ikkonfermat HIV RNA l-fuq min 400 kopja/ml, ma wera l-ebda mutazzjoni tal proteaż 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: Uncommon Gastrointestinal haemorrhage including gastrointestinal ulcer, duodenitis, gastritis and rectal haemorrhage, stomatitis and oral ulcers, faecal incontinence, constipation, dry mouth
Maltese: Emorraġija gastrointestinali li tinkludi ulċerazzjoni gastrointestinali, duodenite, gastrite u emorraġija min wara, stomatite u ulċerazzjoni fil-ħalq,inkontinenza ta' l-iskart tal-ġisem, konstipazzjoni, nixfa fil-ħalq
English: Concomitant administration of elbasvir/grazoprevir with Kaletra is contraindicated (see section
Maltese: elbasvir/grazoprevir ma' Kaletra huwa kontra-indikat (ara sezzjoni
English: Relevant examples are cytomegalovirus retinitis, generalised and/or focal mycobacterial infections, and Pneumocystis jiroveci pneumonia.
Maltese: Eżempji relevanti huma retinite ta' ċitomegalovirus, ġeneralizzata u/jew infezzjonijiet mikobakterjali, u pulmonite Pneumocystis jiroveci.
English: Based on known metabolic profiles, clinically significant interactions are not expected between Kaletra and dapsone, trimethoprim/sulfamethoxazole, azithromycin or fluconazole.
Maltese: Skont il-profili metaboliċi magħrufa, m'humiex mistennija interazzjonijiet li huma klinikament sinifikanti bejn Kaletra u dapsone, trimethoprim/sulfamethoxazole, azithromycin jew fluconazole.
English: Rivaroxaban (Ritonavir 600 mg twice daily)
Maltese: Rivaroxaban (Ritonavir 600 mg darbtejn kuljum)
English: Medicinal products within class
Maltese: Prodotti mediċinali f'din il klassi
English: Antiarrhythmics
Maltese: Antibijotiċi
English: In the absence of human serum, the mean IC50 of lopinavir against five different HIV-1 laboratory strains was 19 nM.
Maltese: Fl assenza ta' serum uman, il-medja IC50 ta' lopinavir kontra ħames razzi differenti ta' HIV-1 tallaboratorju kien 19 nM.
English: A limited increase in total lopinavir concentrations of approximately 30% has been observed which is not expected to be of clinical relevance (see section 4.2).
Maltese: Ġiet osservata żieda limitata ta' bejn wieħed u ieħor 30% fil-konċentrazzjonijiet totali ta' lopinavir, li mhix mistennija li tkun ta' rilevanza klinika (ara sezzjoni 4.2).
English: The pharmacokinetics of Kaletra 100/25 mg tablet twice-daily weight-band dosing without nevirapine have been studied in a total of 53 paediatric patients.
Maltese: Il-farmakokinetika tal-pilloli Kaletra 100/25 mg darbtejn kuljum b'dożaġġ skont il-piż mingħajr nevirapine ġiet studjata f'total ta' 53 pazjent pedjatriku.
English: • severe or life threatening skin rashes and blisters (Stevens-Johnson syndrome and erythema multiforme).
Maltese: • Raxx u nfafet gravi jew ta' periklu għal ħajtek (sindromu ta' Stevens-Johnson u erythemamultiforme).
English: Study M98-863 was a randomised, double-blind trial of 653 antiretroviral treatment naïve patients investigating Kaletra (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 Kaletra (400/100 mg darbtejn kuljum) mqabbel ma' nelfinavir (750 mg tlett darbiet kuljum) stavudine u lamivudine.
English: Increased plasma concentrations of astemizole and terfenadine.
Maltese: Żieda fil-konċentrazzjonijiet fil-plażma ta' astemizole u terfenadine.
English: The treatment regimen was zidovudine plus lamivudine plus 300 mg lopinavir/75 mg ritonavir per m2 twice daily until 6 months of age, then 230 mg lopinavir/57.5 mg ritonavir per m2 twice daily.
Maltese: 300 mg lopinavir /75 mg ritonavir kull m2 darbtejn kuljum sa età ta' 6 xhur, imbagħad 230 mg lopinavir/57.5
English: Antidepressants and Anxiolytics Trazodone single dose
Maltese: Antidipressanti u Mediċini għal kontra l-ansjetà Trazodone doża waħda
English: Kaletra oral solution contains approximately 42% v/v alcohol.
Maltese: Is-soluzzjoni orali ta' Kaletra fih approssimament 42% v/v alkoħol.
English: • quetiapine (used to treat schizophrenia, bipolar disorder and major depressive disorder);
Maltese: - pimozide (użati biex jittrattaw skizofrenija); - quetiapine (użat biex jitratta skizofrenja, disturb bipolari u disturb dipressiv maġġuri);
English: Patients with advanced HIV disease may be at risk of elevated triglycerides and pancreatitis.
Maltese: Pazjenti bill-marda ta' l-HIV avvanzata jista' jkollom riskju ta' trigliċeridi elevati u pankreatite.
English: AUC: ↑ 52% Cmin: ↑ 74% Cmax: ↑ 29%
Maltese: Cmin:↑74% Cmax:↑29%
English: Antipsychotics/ Neuroleptics
Maltese: Mediċini AntiPsikotiċi/ Newrolettiċi
English: Median baseline CD4 cell count was 220 cells/mm3 (range13 to 1030 cells/mm3).
Maltese: Il-medjan tal linja bażi fl-għadd taċ-ċelluli CD4 kien 220 ċelluli/ml (limiti 13 għal 1030 ċelluli/ml).
English: The mean steady-state trough concentration prior to the morning dose was 8.1 ± 5.7 µg/ml.
Maltese: Il-medja steady state tal-konċentrazzjoni minima qabel id-doża ta' filgħodu kienet 8.1 ± 5.7 µg/ml.
English: Increased plasma concentrations of lomitapide (see section 4.5).
Maltese: lomitapide (ara sezzjoni 4.5).
English: Kaletra 100 mg/25 mg tablets
Maltese: Pilloli Kaletra 100 mg/25 mg
English: Cmax: ↑ 4.7-fold Due to CYP3A inhibition by lopinavir/ritonavir.
Maltese: Cmax:↑ 4.7-darbiet Minħabba li lopinavir/ritonavir jimpedixxi CYP3A.
English: ≥ 0.9 to < 1.4
Maltese: ≥ 0.9 sa < 1.4
English: HIV RNA < 400 copies/ml
Maltese: HIV RNA < 400 kopji/ml
English: • impotence, abnormally heavy or extended menstrual flow or a lack of menstruation;
Maltese: − impotenza, menstruazzjoni tqila aktar mis-soltu jew imtawla jew nuqqas ta' menstruazzjoni;
English: PARTICULARS TO APPEAR ON THE INTERMEDIATE CARTON Inner carton of multipack of 120 (3 packs of 40) 200 mg/50 mg film-coated tablets) - without blue box
Maltese: KARTUNA TA' GEWWA TAL-PAKKETT TA' ĠEWWA TAL-PAKKETT TA' 120 PILLOLA (3 PAKKETTI TA' 40) 200 MG/50 MG PILLOLA MIKSIJA B'RITA - MINGĦAJR IL-KAXXA BLU
English: Serum concentrations of sofosbuvir, velpatasvir and voxilaprevir may be increased due to P-glycoprotein, BCRP and OATP1B1/3 inhibition by lopinavir/ritonavir.
Maltese: sofosbuvir, velpatasvir u voxilaprevir jistgħu jiżdiedu minħabba inibizzjoni ta' Pglycoprotein, BCRP u OATP1B/3 minn lopinavir/ritonavir.
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
Maltese: Il-medjan EC50 ta' lopinavir kontra l-iżolati bi 0-3, 4-5, 6-7 u 8-10 mutazzjonijiet fil pożizzjonijiet tal-amino aċidi kif indikat hawn fuq kienu 0.8, 2.7 13.5 u 44.
English: Acid reducing agents Omeprazole (40 mg QD)
Maltese: Omeprazole (40 mg QD)
English: • antifungals (e.g. ketoconazole, itraconazole, voriconazole);
Maltese: - mediċini għal kontra l-fungu (eż. ketoconazole, itraconazole, voriconazole); - mediċini għal kontra l-gotta (eż. colchicine)
English: Analgesics Fentanyl
Maltese: Mediċini analġeżiċi
English: In an open-label pharmacokinetic study, 12 HIV-infected pregnant women who were less than 20 weeks of gestation and on combination antiretroviral therapy initially received lopinavir/ritonavir 400 mg/100 mg (two 200/50 mg tablets) twice daily up to a gestational age of 30 weeks.
Maltese: Tqala u wara t-tqala Fi studju farmakokinetiku open-label, 12-il mara tqal infettati bl-HIV li kellhom anqas minn 20 ġimgħa ta' tqala u li kienu qed jirċievu terapija b'antiretrovirali kkominbinat, rċevew lopinavir/ritonavir 400 mg/100 mg (żewġ pilloli ta' 200/50 mg) darbtejn kuljum fil-bidu sat-30 ġimgħa tat-tqala.
English: Kaletra 100 mg/25 mg film-coated tablets lopinavir/ritonavir
Maltese: Kaletra 100 mg/25 mg pilloli miksija b'rita lopinavir/ritonavir
English: ≥ 0.5 to < 0.9
Maltese: ≥ 0.5 sa < 0.9
English: Patients were randomised to either 230 mg lopinavir/57.5 mg ritonavir per m2 or 300 mg lopinavir/75 mg ritonavir per m2. Naïve patients also received nucleoside reverse transcriptase inhibitors.
Maltese: mg ritonavir kull m2 jew 300 mg lopinavir/75 mg ritonavir kull m2. Pazjenti novizzi ingħataw inibituri nucleoside reverse transcriptase.
English: This may result in lowered plasma concentrations and potential decrease of efficacy of co-administered medicinal products.
Maltese: Dan jista' jirriżulta fi tnaqqis tal-konċentrazzjoni fil-plażma u tnaqqis potenzjali fl-effikaċja ta' prodotti mediċinali ko-amministrati.
English: Increased plasma concentrations of sildenafil.
Maltese: Żieda fil-konċentrazzjoni fil-plażma ta' sildenafil.
English: Delamanid: AUC: ↑ 22%
Maltese: AUC: ↑ 22%
English: HIV RNA < 400 copies/ml*
Maltese: HIV RNA < 400 kopji/ml*
English: Concomitant use of Kaletra with lomitapide is contraindicated (see prescribing information for lomitapide) (see section 4.3).
Maltese: L-użu konkomitanti ta' Kaletra ma' lomitapide huwa kontraindikat (ara l-informazzjoni dwar kif jiġi preskritt lomitapide) (ara sezzjoni 4.3).
English: Kaletra is not a cure for HIV infection or AIDS.
Maltese: Kaletra mhijiex trattament għall-infezzjoni ta' l-HIV jew AIDS.
English: The following events have been reported in association with unintended overdoses in preterm neonates: complete atrioventricular block, cardiomyopathy, lactic acidosis, and acute renal failure.
Maltese: kienu rrapurtati: interruzzjoni kompleta atrijo-ventrikulari, kardjomijopatija, lactic acidosis, u insuffiċjenza akuta tal-kliewi.
English: Kaletra 200 mg/50 mg film-coated tablets lopinavir/ritonavir
Maltese: Kaletra 200 mg/50 mg pilloli miksija b'rita lopinavir/ritonavir
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 Kaletra therapy, and mutations I47A and L76V have been observed in rebound isolates with reduced lopinavir susceptibility from patients receiving Kaletra therapy.
Maltese: f'iżolati li marru lura b'suxxettibilità mnaqqsa għal lopinavir fil-pazjenti b'esperjenza ta' inibituri talprotease li kienu jirċievu terapija ta' Kaletra u mutazzjonijiet I47A u L76V ġew osservati f'iżolati li marru lura b'suxxettibilità mnaqqsa għal lopinavir f' pazjenti li kienu jirċievu terapija ta' Kaletra.
English: virus [HCV]);
Maltese: (BPH));
English: Increased creatine phosphokinase (CPK), myalgia, myositis, and rarely, rhabdomyolysis have been reported with protease inhibitors, particularly in combination with nucleoside reverse transcriptase inhibitors.
Maltese: Gew rapurtati żieda ficreatine phosphokinase (CPK), mijalġja, mijożite u rarament rabdomijoliżi, ma inibituri tal-proteaż, speċjalment f'kombinazzjoni ma inibituri ta' nucleoside reverse transcriptase.
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: 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: Due to P-gp and/or CYP3A4 inhibition by ritonavir.
Maltese: P-gp u/jew CYP3A4.
English: Outcomes at Week 360: Study M97-720
Maltese: Studju M97-720
English: HIV RNA < 400 copies/ml* Median change from baseline in CD4+ T-cell count (cells/mm3)
Maltese: HIV RNA < 400 kopji/ml* Bidla medjana mil-linja bażi fl għadd ta' CD4+T-cell (ċelloli/mm3)
English: Due to the risk of bedaquiline related adverse events, the combination of bedaquiline and Kaletra should be avoided.
Maltese: Minħabba r-riskju ta' effetti avversi relatati ma' bedaquiline, il-kombinazzjoni ta' bedaquiline u Kaletra għandhatiġi evitata.
English: Kaletra film-coated tablets are supplied in packs containing 120 tablets (1 plastic bottle of 120 tablets) and multipacks comprising 3 plastic bottles each containing 120 tablets (360 tablets).
Maltese: Il-pilloli miksija b'rita Kaletra jiġuf'pakketti li fihom 120 pillola (flixkun tal-plastik b'120 pillola) u F'pakketti li fihom 3 fliexken tal-plastik ta' 120 pillola-il wieħed (360 pillola).
English: 500/125 mg
Maltese: 400/100 mg 500/125 mg
English: Hepatic impairment
Maltese: Problemi Epatiċi
English: Lopinavir/ritonavir was administered twice daily at 16/4 mg/kg for subjects 2 months to < 6 months, 12/3 mg/kg for subjects ≥ 6 months and < 15 kg, 10/2.5 mg/kg for subjects ≥ 6 months and ≥ 15 kg to < 40 kg, or 400/100 mg for subjects ≥ 40 kg.
Maltese: mg/kg għal suġġetti ≥ 6 xhur u <15 kg, 10/2.5 mg/kg għal suġġetti ≥ 6 xhur u ≥ 15 kg sa <40 kg, jew 400/100 mg għal suġġetti ≥ 40 kg.
English: After 48 weeks of treatment with Kaletra, 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: HIV RNA < 400 kopji/ml kienu osservati fi 93% (25/27), 73% (11/15), u 25%
English: Each bottle contains 120 tablets.
Maltese: 120 pillola.
English: Kaletra 400/100 mg + ritonavir 300 mg) twice daily has allowed compensating for the CYP 3A4 inducer effect of rifampicin.
Maltese: 400/100 mg + ritonavir 300 mg) darbtejn kuljum ikkumpensa għall-effett ta' rifamficin li jinduċi CYP 3A4.
English: M06-802 was a randomised open-label study comparing the safety, tolerability and antiviral activity of once-daily and twice-daily dosing of lopinavir/ritonavir tablets in 599 subjects with detectable viral loads while receiving their current antiviral therapy.
Maltese: Pazjenti li kellhom trattament antiretrovirali qabel M06-802 kien studju open-label li sar b'ordni addoċċli qabbel is-sigurtà, it-tollerabbilità u l-attività antivirali ta' dożaġġ ta' darba u darbtejn kuljum ta' pilloli lopinavir/ritonavir f'599 suġġett li kellhom ammonti virali li setgħu jiġu osservati fl-istess waqt li kienu qegħdin jirċievu t-terapija antivirali tagħhom.
English: Multiple dosing with 400/100 mg Kaletra twice daily for 2 weeks and without meal restriction produced a mean ± SD lopinavir peak plasma concentration (Cmax) of 12.3 ± 5.4 µg/ml, occurring approximately 4 hours after administration.
Maltese: Dużaġġ multiplu b' 400/100 mg Kaletra darbtejn kuljum għal ġimgħatejn u mingħajr restrizzjoni fuq likel ipproduċiet medja ± SD l-ogħla konċentrazzjoni ta' lopinavir fil-plażma lopinavir (Cmax) ta' 12.3 ± 5.4 µg/ml, li ntlaħqet approssimattivament 4 sigħat wara s-somministrazzjoni.
English: Due to induction of lamotrigine glucuronidation
Maltese: Minħabba l-induzzjoni ta' glucuronidation ta' lamotrigine
English: Oral solution contains: alcohol (42.4% v/v), high fructose corn syrup, propylene glycol (15.3% w/v), purified water, glycerol, povidone, magnasweet-110 flavour (mixture of monoammonium glycyrrhizinate and glycerol),
Maltese: high fructose corn syrup, propylene glycol (15.3% w/v), ilma ppurifikat, glycerol, povidone,
English: Infants should be monitored closely for toxicity related to Kaletra oral solution including: hyperosmolality, with or without lactic acidosis, renal toxicity, central nervous system (CNS) depression (including stupor, coma, and apnea), seizures, hypotonia, cardiac arrhythmias and ECG changes, and hemolysis.
Maltese: Trabi għandhom jiġu mmonitorjati mill-qrib għal tossiċità relatata mas-soluzzjoni orali ta' Kaletra inkluż: osmolarità għolja, bi jew mingħajr lactic acidosis, tossiċità fil-kliewi, depressjoni tassistema nervuża ċentrali (CNS) (inklużi sturdament, koma, u apneja), aċċessjonijiet, ipotonja, arritmiji kardijaċi u bidliet fl-ECG, u emolisi.
English: Co-administration of increased doses of fosamprenavir (1400 mg BID) with Kaletra (533/133 mg BID) to protease inhibitor-experienced patients resulted in a higher incidence of gastrointestinal adverse events and elevations in triglycerides with the combination regimen without increases in virological efficacy, when compared with standard doses of fosamprenavir/ritonavir.
Maltese: fosamprenavir (1400 mg BID) flimkien ma' Kaletra (533/133 mg BID) lil pazjenti li diġà kienu ngħataw inibituri talprotease wassal għal inċidenza akbar ta' effetti avversi gastro intestinali u żidiet fit-trigliċeridi mar-reġimen li ngħata miegħu mingħajr ma kien hemm żidiet fleffikaċja viroloġika.
English: In vitro experiments with human hepatic microsomes indicate that lopinavir primarily undergoes oxidative metabolism.
Maltese: Esperimenti in vitro b'mikrożomi epatiċi umani jindikaw illi primarjament lopinavir jgħaddi minn metaboliżmu ossidattiv.
English: • ergotamine, dihydroergotamine, ergonovine, methylergonovine (used to treat headaches);
Maltese: - ergotamine, dihydroergotamine, ergonovine, methylergonovine (użati biex jittrattaw l-uġigħ ta'
English: Concomitant Therapy: Efavirenz or Nevirapine
Maltese: Efavirenz jew Nevirapine
English: Concomitant Therapy: Efavirenz or nevirapine
Maltese: Efavirenz jew nevirapine
English: Decreased exposure of Kaletra may result in potential loss of virological response.
Maltese: Kaletra jista' jirriżulta f'telf potenzjali ta' rispons viroloġiku.
English: Patients were randomised in a 1:1 ratio to receive either Kaletra 800/200 mg once daily (n = 333) or Kaletra 400/100 mg twice daily (n = 331).
Maltese: Pazjenti kienu mqasssma b'mod fortuwitu ta' 1:1 sabiex jirċievu Kaletra 800/200 mg darba kuljum (n = 333) jew Kaletra 400/100 mg darbtejn kuljum (n = 331).
English: After a 400/100 mg 14C-lopinavir/ritonavir dose, approximately 10.4 ± 2.3% and 82.6 ± 2.5% of an administered dose of 14C-lopinavir can be accounted for in urine and faeces, respectively.
Maltese: Wara doża ta' 400/100 mg ta' 14C-lopinavir/ritonavir, bejn wieħed u ieħor 10.4 ± 2.3% u 82.6 ± 2.5% tad-doża meħuda ta' 14C-lopinavir, tinstab fl-awrina u fl-iskart imneħħi mill-ġisem, rispettivament.
English: Increased risk of alanine transaminase (ALT) elevations (see section 4.5).
Maltese: Żieda fir-riskju ta' elevazzjonijiet ta' alanine transaminase (ALT) (ara sezzjoni
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING 200 mg/50 mg Tablets - Carton of multipack containing 360 (3 bottles of 120) film-coated tablets - including blue box
Maltese: MG/50 MG - KARTUNA TA' PAKKETT LI FIH 260 (3 FLIEXKEN TA' 120) PILLOLI MIKSIJA B'RITA - INKLUŻA IL-KAXXA BLU
English: This leaflet was last revised in: {MM/YYYY}
Maltese: DATA TA' META ĠIET RIVEDUTA
English: If treatment with an HMG-CoA reductase inhibitor is indicated, pravastatin or fluvastatin is recommended (see section 4.5).
Maltese: Jekk ikun indikat trattament b'impeditur HMG-CoA reductase, pravastatin jew fluvastatin huma rrakkomandati (ara sezzjoni 4.5).
English: There were no reported events of failure attributed to therapy limiting toxicity.
Maltese: Ma kienx hemm irrappurtati avvenimenti ta' falliment attribwiti f'terapija bi tossiċità limitata.
English: 300 ml (5 bottles x 60 ml) oral solution with five 5 ml oral dosing syringes.
Maltese: 300 ml (5 fliexken X 60 ml) ta' soluzzjoni orali bi ħames 5ml siringi għad-dożaġġ orali
English: The effects of Kaletra (in combination with other antiretroviral agents) on biological markers (plasma HIV RNA levels and CD4+ T-cell counts) have been investigated in controlled studies of Kaletra of 48 to 360 weeks duration.
Maltese: HIV RNA u għadd ta' CD4+ T-cell) ġew investigati fi studji kkontrollat ta' Kaletra li damu 48 għal 360 ġimgħa.
English: Cardiac events have been reported with Kaletra in preclinical studies; therefore, the potential cardiac effects of Kaletra cannot be currently ruled out (see sections 4.8 and 5.3).
Maltese: Avvenimenti kardijaċi ġew irrappurtati fi studji ta' qabel l-użu kliniku, allura, l-effeti kardijaċi potenzjali ta' Kaletra ma jistgħuwx jkunu esklużi (ara sezzjoni 4.8 u 5.3).
English: • fusidic acid (used to treat skin infections caused by Staphylococcus bacteria such as impetigo and infected dermatitis).
Maltese: - fusidic acid (użat biex jittratta infezzjonijiet fil-ġilda, bħal impetigo u dermatite infettiva, li huma kkawzati minn batterji Staphylococcus).
English: M97-765 is a randomised, double-blind trial evaluating Kaletra at two dose levels (400/100 mg and 400/200 mg, both twice daily) plus nevirapine (200 mg twice daily) and two nucleoside reverse transcriptase inhibitors in 70 single protease inhibitor experienced, non-nucleoside reverse transcriptase inhibitor naïve patients.
Maltese: Kaletra f'żewġ livelli ta' dożi (400/100 mg u 400/200 mg, it-tnejn li huma darbtejn kuljum) u nevirapine (200 mg darbtejn kuljum) u żewġ inbituri ta' reverse transcriptase f' 70 pazjenti b'esperjenza ta' inibituri tal-protease, imma novizzi għal inibituri ta' non- nucleoside reverse transcriptase.
English: Multiple dosing of 800/200 mg Kaletra once daily for 2 weeks without meal restriction (n=16) produced a mean ± SD lopinavir peak plasma concentration (Cmax) of 14.8 ± 3.5 µg/ml, occurring approximately 6 hours after administration.
Maltese: Dużaġġ multiplu ta' 800/200 mg Kaletra darba kuljum għal ġimgħatejn mingħajr restrizzjoni fuq l-ikel (n=16) ipproduċu medja ± SD ta' koncentrazzjoni massima ta' lopinavir filplażma (Cmax) ta' 14.8 ± 3.5 µg/ml, li tiġri bejn wieħed u ieħor 6 sigħat wara l-amministratazzjoni.
English: • alfuzosin (used in men to treat symptoms of an enlarged prostate (benign prostatic hyperplasia (BPH));
Maltese: - alfuzosin (użat fl-irġiel biex jittratta sintomi ta' prostata li kibret (benign prostatic hyperplasia
English: Each ml contains: lopinavir 80 mg and ritonavir 20 mg.
Maltese: Kull ml fih: lopinavir 80 mg u ritonavir 20 mg.
English: Clinical results
Maltese: Rizultati kliniċi
English: * intent to treat analysis where patients with missing values are considered virologic failures Paediatric Use
Maltese: * bl-intenzjoni li tkun trattata l-analiżi fejn pazjenti b'valuri nieqsa huma kkunsidrati fallimenti viroloġiċi
English: Each tablet of Kaletra contains 100 mg of lopinavir and 25 mg of ritonavir
Maltese: Kull pillola Kaletra fiha 100 mg lopinavir u 25 mg ritonavir.