FrancophonIA/ELRC3.0 huggingface dataset:
English: (inhibition of CYP3A/efflux transporters)
Maltese: (Inibizzjoni tattrasportaturi/effluss ta' CYP3A)
English: Calcium channel blockers Felodipine, Nifedipine, and Nicardipine
Maltese: Imblukkaturi tal-kanali tal-kalċju Felodipine, Nifedipine, u Nicardipine
English: Pharmacokinetic differences due to race have not been identified.
Maltese: Ma' ġewx identifikati differenzi farmakokinetiċi relatati mar-razza.
English: Tablet contents:
Maltese: Kontenut tal-pillola:
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: effett fuq DAAs u lopinavir kien simili għal dak osservat meta lopinavir/ritonavir 400/100 mg BID kien amministrat (ara sezzjoni 4.3).
English: • lurasidone (used to treat depression);
Maltese: - lurasidone (użat biex jittratta dipressjoni);
English: AUC: ↑ 11-fold
Maltese: AUC: ↑ 11-il darba
English: The 16 viruses that displayed > 20-fold change in susceptibility all contained mutations at positions 10, 54, 63 plus 82 and/or 84.
Maltese: Is-16 -il virus li urew bidla ta' > 20 darba fis-suxxettibilità, kollha kien fihom mutazzjonijiet fil-pożizzjonijiet 10, 54, 63 u 82 u /jew 84.
English: Further stratification within each group was 1:1 (tablet versus soft capsule).
Maltese: Aktar stratifikazzjoni f'kull grupp ta' 1:1 (pillola versus kapsula ratba).
English: Monitor for ADRs related to afatinib.
Maltese: Issorvelja għall-ADRs relatati ma' afatinib.
English: Increased plasma concentrations of vardenafil (see sections 4.4 and 4.5)
Maltese: vardenafil (ara sezzjoni 4.4 u 4.5)
English: Increased plasma concentrations of fusidic acid.
Maltese: Żieda fil-konċentrazzjoni fil-plażma tal fusidic acid.
English: It is recommended that INR (international normalised ratio) be monitored.
Maltese: Huwa rrakkomandat li jiġi monitorjat l-INR (international normalised ratio).
English: Inhibition of HIV protease prevents cleavage of the gag-pol polyprotein resulting in the production of immature, non-infectious virus.
Maltese: Inibizjoni ta' HIV protease jipprevjeni il-qtugħ tal-poliproteina gag-pol, u b'hekk jirriżulta filproduzzjoni ta' virus immatur, mhux infettiv.
English: Table 7
Maltese: Tabella 7
English: Gastrointestinal disorders
Maltese: Disturbi Gastro-intestinali
English: AUC: ↑ 32% Cmax: ↔ Cmin: ↑ 51%
Maltese: ↑ 32% Cmax: ↔ Cmin: ↑ 51%
English: Increased plasma concentrations of pimozide.
Maltese: Żieda fil-konċentrazzjoni fil-plażma ta' pimozide.
English: Lopinavir AUC over a 12 hour dosing interval averaged 113.2 ± 60.5 µg•h/ml.
Maltese: Lopinavir AUC fuq intervall ta' dożaġġ ta' 12 il-siegħa kellu medja ta' 113.2 ± 60.5 µg/ml.
English: 3 tablets (300/75 mg) 4 tablets (400/100 mg) *weight based dosing recommendations are based on limited data
Maltese: 3 pilloli (300/75 mg) 4 pilloli (400/100 mg) * rakkomandazzjonijiet tad-dożaġġ fuq bażi tal-piż huma bbażati fuq data limitata
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-data farmakokinetika miġbura minn nisa tqal infettati bl-HIV li kienu qed jirċievu pilloli ta' 400/100mg lopinavir/ritonavir darbtejn kuljum hija ppreżentata f'Tabella 6 (ara sezzjoni 4.2).
English: Ελλάδα AbbVie ΦΑΡΜΑΚΕΥΤΙΚΗ Α.Ε.
Maltese: M'hemm bżonn ta' l-ebda aġġustament fid-doża ta' Kaletra.
English: In children 14 days of age and older, the nature of the safety profile is similar to that seen in adults (see Table in section b).
Maltese: Fit-tfal ta' sentejn u ikbar, in-natura tal-profil ta' sigurta' huwa simili għal dak fl-adulti (ara t-tabella f'sezzjoni b).
English: Increased plasma concentrations of paritaprevir; thereby, increasing the risk of alanine transaminase (ALT) elevations (see section 4.5).
Maltese: Żieda fil-konċentrazzjonijiet ta' paritaprevir fil-plażma; b'hekk, jiżdied ir riskju ta' elevazzjonijiet ta' alanine transaminase (ALT) (ara sezzjoni 4.5).
English: Kaletra 200 mg/50 mg tablets
Maltese: Kaletra 200 mg/50 mg pilloli
English: Lipid-modifying agents HMG Co-A Reductase Inhibitors
Maltese: Impeditur ta' Reductase HMG CoA
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- il darba
English: Study P1060 was a randomised controlled trial of nevirapine versus lopinavir/ritonavir-based therapy in subjects 2 to 36 months of age infected with HIV-1 who had (Cohort I) and had not (Cohort II) been exposed to nevirapine during pregnancy for prevention of mother-to-child transmission.
Maltese: Studju P1060 kien prova kkontrollat fortuwitu ta' nevirapine kontra terapija ibbażata fuq lopinavir/ritonavir f'suġġetti b'età minn 2 sa 36-il xahar infettati bl-HIV-1 li kienu (Cohort I) u ma kienux (Cohort II) ġew esposti għal nevirapine waqt it-tqala għall-prevenzjoni ta' trażmissjoni bejn l omm u t-tarbija.
English: • Once-daily administration of lopinavir/ritonavir is not recommended for pregnant women due to the lack of pharmacokinetic and clinical data.
Maltese: • Amministrazzjoni ta' lopinavir/ritonavir darba kuljum mhux rrakkomandat f'nisa tqal minħabba nuqqas ta' data farmakokinetika u data klinika f'nisa tqal.
English: Rilpivirine (Lopinavir/ritonavir capsule 400/100 mg BID)
Maltese: Rilpivirine (Lopinavir/ritonavir kapsula 400/100mgBID)
English: They were randomised in a 1:1 ratio to receive either lopinavir/ritonavir 800/200 mg once daily (n = 300) or lopinavir/ritonavir 400/100 mg twice daily (n = 299).
Maltese: Huma ġew imqassma filproporzjon ta' 1:1 biex jirċievu jew lopinavir/ritonavir 800/200 mg darba kuljum (n = 300) jew lopinavir/ritonavir 400/100 mg darbtejn kuljum (n = 299).
English: Table 6
Maltese: Tabella 6
English: Based on weight (mg/kg)
Maltese: Skond il-piż (mg/kg)
English: Antifungals Ketoconazole and Itraconazole
Maltese: Ketoconazole u Itraconazole
English: Includes: alcohol, high fructose corn syrup, propylene glycol, glycerol, polyoxyl 40 hydrogenated castor oil, potassium (as acesulfame potassium).
Maltese: Fih fost oħrajn: alkoħol, high fructose corn syrup, propylene glycol, glycerol, polyoxyl 40 hydrogenated castor oil, potassju (bħala acesulfame potassium).
English: The lopinavir mean ± standard deviation steady-state AUC, Cmax and C12 were 112.5 ± 37.1 μg•h/ml, 12.4 ± 3.5 μg/ml and 5.71 ± 2.99 μg/ml, respectively.
Maltese: Il-medja ta' Lopinavir ± devjazzjoni standard fl--istat fiss ta' l-AUC, is-Cmax, u s-C12 ta' lopinavir kienu112.5 ± 37.1 μg•h/ml, 12.4 ± 3.5µg/ml u 5.71 ± 2.99 μg/ml rispettivament.
English: Alcohol, high fructose corn syrup, propylene glycol, purified water, glycerol, povidone, magnasweet110 flavour (mixture of monoammonium glycyrrhizinate and glycerol), vanilla flavour (containing p-hydroxybenzoic acid, p-hydroxybenzaldehyde, vanillic acid, vanillin, heliotropin, ethyl vanillin), polyoxyl 40 hydrogenated castor oil, cotton candy flavour (containing ethyl maltol, ethyl vanillin, acetoin, dihydrocoumarin, propylene glycol), acesulfame potassium, saccharin sodium, sodium chloride, peppermint oil, sodium citrate, citric acid, levomenthol.
Maltese: Alkoħol (42% v/v), high fructose corn syrup, propylene glycol, ilma ppurifikat, glycerol, povidone, magnasweet-110 flavour (taħlita ta' monoammonium glycyrrhizinate u glycerol), vanilla flavour (fih p hydroxybenzoic acid, p-hydroxybenzaldehyde, vanillic acid, vanillin, heliotropin, ethyl vanillin), polyoxyl 40 hydrogenated castor oil, cotton candy flavour (fih ethyl maltol, ethyl vanillin, acetoin, dihydrocoumarin, propylene glycol), acesulfame potassium, saccharin sodium, sodium chloride, peppermint oil, sodium citrate, citric acid, levomenthol.
English: Each 1 ml of Kaletra oral solution contains 356.3 mg of alcohol and 152.7 mg of propylene glycol.
Maltese: 356.3 mg ta' alkoħol u 152.7 mg ta' propylene glycol.
English: M98-940 was an open-label study of a liquid formulation of Kaletra in 100 antiretroviral naïve (44%) and experienced (56%) paediatric patients.
Maltese: M98-940 kien studju open-label ta' taħlita likwida orali ta' Kaletra f' 100 novizzi għat-terapji antiretrovirali (44%) u (56%) pazjenti pedjatriċi bl-esperjenza ta' dawn it-trattamenti.
English: Metabolism and nutrition disorders
Maltese: Disturbi fil-metaboliżmu u n nutrizzjoni
English: Lopinavir/ritonavir was not found to be mutagenic or clastogenic in a battery of in vitro and in vivo assays including the Ames bacterial reverse mutation assay, the mouse lymphoma assay, the mouse micronucleus test and chromosomal aberration assays in human lymphocytes.
Maltese: Lopinavir/ritonavir ma' instabx li hu mutaġeniku jew klastoġeniku f'serje sħiħa ta' provi in vitro u in vivo inklużi l-prova Ames bacterial reverse mutation, il-prova tal-limfoma fil-ġurdien, it-test mikronukleju fil-ġurdien u provi ta' aberrazzjoni kromosomatika fil-limfoċiti umani.
English: AUC: ↑ 5.7-fold Cmax: ↑ 3.5-fold
Maltese: AUC: ↑ 5.7-darbiet Cmax: ↑ 3.5-darbiet
English: • avanafil or vardenafil (used to treat erectile dysfunction);
Maltese: - avanafil jew vardenafil (użat biex jittratta disfunzjoni erettili);
English: Anaemia, leucopenia, neutropenia, lymphadenopathy
Maltese: Stenożi epatika, epatomegalite, kolanġite,
English: Monitor for ADRs related to abemaciclib.
Maltese: Issorvelja għall-ADRs relatati ma' abemaciclib.
English: M98-957 is a randomised, open-label study evaluating Kaletra treatment at two dose levels (400/100 mg and 533/133 mg, both twice daily) plus efavirenz (600 mg once daily) and nucleoside reverse transcriptase inhibitors in 57 multiple protease inhibitor experienced, non-nucleoside reverse transcriptase inhibitor naïve patients.
Maltese: M98-957 huwa studju fortuwitu open-label fejn it-terapija Kaletra ġiet evalwata f'żewġ livelli ta' dożi (400/100 mg u 533/133 mg, it-tnejn li huma darbtejn kuljum) u efavirenz (600 mg darba kuljum) u inibituri reverse nucleoside transcriptase f' 57 pazjenti b'esperjenza ta' inibituri tal-protease, imma novizzi għal inibituri ta' non- nucleoside reverse transcriptase.
English: Lopinavir is extensively metabolised by the hepatic cytochrome P450 system, almost exclusively by isozyme CYP3A.
Maltese: Il-lopinavir huwa estensivament metabolizzat mis-sistema ċitokroma epatika P450, kważi esklussivament mill-iżożima CYP3A.
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: In addition, they contained a median of 3 mutations at amino acid positions 20, 24, 46, 53, 71 and 90.
Maltese: Madanakollu, kien fihom medjan ta' 3 mutazzjonijiet fil-pożizzjonijiet tal-amino aċidi 20, 24, 46, 53, 71 u 90.
English: Virologic failure* *Defined as confirmed plasma HIV-1 RNA level > 400 copies/ml at 24 weeks or viral rebound > 4000 copies/ml after Week 24.
Maltese: Falliment viroloġiku* *Iddefinit bħala livell ta' plażma ikkonfermat f'HIV-1 RNA > 400 kopji/ml wara 24 ġimgħa jew rikaduta virali > 4000 kopji/ml wara Ġimgħa 24.
English: • upper respiratory tract infection.
Maltese: − infezzjoni tal- apparat respiratorju ta' fuq.
English: Unchanged lopinavir accounted for approximately 2.2% and 19.8% of the administered dose in urine and faeces, respectively.
Maltese: Lopinavir mhux mibdul kien approssimattivament 2.2% u 19.8% tad-doża somministrata fl-urina u fl-iskart imneħħi mill-ġisem, rispettivament.
English: Renal impairment
Maltese: Insuffiċjenza Renali
English: Afatinib (Ritonavir 200 mg twice daily)
Maltese: Afatinib (Ritonavir 200 mg darbtejn kuljum)
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 studju in vitro kanali kardijaċi tal-potassju umani klonati (HERG) kienu inibiti bi 30% fl-ogħla konċentrazzjonijiet ta' lopinavir/ritonavir ippruvati, li kienu jikkorrispondu għal esponiment għal lopinavir ta' total ta' 7 darbiet u 15 il-darba livelli ta' plażma quċċata libera li ġew ottenuti fil-bniedem bid-doża terapewtika massima li ġiet irrikmandata.
English: • ranolazine (used to treat chronic chest pain [angina]);
Maltese: - ranolazine (użat biex jittratta uġigħ fis-sider kroniku [anġina]);
English: Administration of Kaletra with a high fat meal (872 kcal, 55.8% from fat) increased lopinavir AUC and Cmax by 96% and 43%, respectively, for soft capsules, and 130% and 56%, respectively, for oral solution.
Maltese: Is-somministrazzjoni ta' Kaletra flimkien ma' ikla b'kontenut għoli ta' xaħam (872 kcal, 55.8% mix-xaħam)żiedet l-AUC u Cmax ta' lopinavir bi 96% u 43%, rispettivament, għal kapsuli rotob, u 130% u 56%, rispettivament, għat-taħlita likwida orali.
English: 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 pazjent (8%) wrew mutazzjonijiet primarji ġodda għal inibitur tal-proteaż (codons 30, 32, 48, 50, 82, 84, 90), bħal ma għamlu 12/77 (16%) pazjent fil-grupp BID.
English: Ergot alkaloids Dihydroergotamine, ergonovine, ergotamine, methylergonovine
Maltese: Derivattivi tal-Ergotina Dihydroergotamine, ergonovine, ergotamine, methylergonovine
English: CD4+ T-cell count (cells/mm3)
Maltese: CD4+T-cell
English: Table 3
Maltese: Tabella 3
English: Antiretroviral Experienced (N=56)
Maltese: Dawk li ħadu mediċina antiretrovirali qabel (N=56)
English: PDE5 inhibitors
Maltese: Inibituri ta' PDE5
English: AUC: ↑ 11.86-fold Cmax: ↑ 6.31-fold C24: ↑ 20.70-fold
Maltese: AUC: ↑ 11.86- il darba Cmax: ↑ 6.31- darbiet C24: ↑ 20.70- il darba
English: For erectile dysfunction:
Maltese: Għal disfunzjoni erettili:
English: In addition, virologic response was observed in 91% (21/23), 71% (15/21) and 33% (2/6) patients with 0 − 5, 6 − 7, and 8 − 10 mutations of the above mutations in HIV protease associated with reduced in vitro susceptibility to lopinavir.
Maltese: Barraminnhekk, rispons viroloġiku ġie osservat f'91% (21/23), f'71% (15/21) u fi 33% (2/6) tal-pazjenti b' 0−5, 6−7, u 8−10 mutazzjonijiet talmutazzjonijiet hawn fuq imsemmija fil-protejaż ta' l-HIV assoċjat mas-suxxettibilità in vitro imnaqqsa għal liponavir.
English: Cmax: ↑ 5-fold
Maltese: Cmax:↑ 5-darbiet
English: Kaletra 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 Kaletra in vivo, jinduċi l-metaboliżmu tiegħu nnifsu u jżid il-biotrassformazzjoni ta' xi prodotti mediċinali metabolizzati mill-enżimi taċ-ċitokromju P450 (inklużi CYP2C9 u CYP2C19) u mill-glukorinidazzjoni.
English: EU/1/01/172/005 - multipack: 120 (3 packs of 40) film-coated tablets EU/1/01/172/008 - carton of 120 film-coated tablets
Maltese: EU/1/01/172/008- kartuna ta' 120 pillola miksija b'rita
English: Overdoses with Kaletra oral solution have been reported (including fatal outcome).
Maltese: Doża eċċessivi tas-soluzzjoni orali ta' Kaletra kienu rrapurtati (inkluż riżultat fatali).
English: The combination may result in increased risk of cardiovascular adverse events associated with salmeterol, including QT prolongation, palpitations and sinus tachycardia.
Maltese: Il-kombinazzjoni tista' tirriżulta f'żieda fir-riskju ta' avvenimenti avversi kardjovaskulari assoċjati ma' salmeterol, inkluż dewmien tal-QT, palpitazzjoni u takikardija tas-sinus.
English: Refer to the afatinib SmPC for
Maltese: Irreferi għall-SmPC
English: Pharmaco-therapeutic group: antivirals for systemic use, antivirals for treatment of HIV infections, combinations, ATC code: J05AR10
Maltese: Kategorija farmakoterapewtika: mediċina antivirali għal użu sistemikumediċina antivirali għat trattament ta' infezzjonijiet tal-HIV, kombinazzjonijiet, Kodiċi ATC:
English: AbbVie Deutschland GmbH & Co. KG, Knollstrasse, 67061 Ludwigshafen, Germany
Maltese: KG, Knollstrasse, 67061 Ludwigshafen, Il-Ġermanja
English: The in vitro antiviral EC50 of lopinavir is approximately 10-fold lower than that of ritonavir.
Maltese: L-EC50 antivirali in vitro ta' lopinavir huwa bejn wieħed u ieħor 10 darbiet inqas minn dak ta' ritonavir.
English: Endocrine disorders
Maltese: Disturbi fis-sistema endokrinarja
English: Kaletra (80 mg + 20 mg) / ml oral solution
Maltese: Kaletra (80 mg + 20 mg) / ml soluzzjoni orali
English: At entry, median (range) HIV-1 RNA was 6.0 (4.7-7.2) log10 copies/ml and median (range) CD4+T-cell percentage was
Maltese: Maddħul, il-medjan (firxa) HIV-1 RNA kien 6.0 (4.7-7.2) log10 kopji/ml u l-medjan (firxa) tal-persentaġġ CD4 + T-cell kien 41 (16-59).
English: Study M05-730 was a randomised, open-label, multicentre trial comparing treatment with Kaletra 800/200 mg once daily plus tenofovir DF and emtricitabine versus Kaletra 400/100 mg twice daily plus tenofovir DF and emtricitabine in 664 antiretroviral treatment-naïve patients.
Maltese: Studju M05-730 kien fortuwitu, open-label u multicentre li jqabbel it-trattament b'Kaletra 800/200 mg darba kuljum flimkien ma tenofovir DF u emtricitabine versus Kaletra 400/100 mg darbtejn kuljum flimkien ma tenofovir DF u emtricitabine f' 664 pazjent li ma kienux ħadu trattament antiretrovirali qabel.
English: The steady state pharmacokinetic parameters of lopinavir in HIV-infected patients with mild to moderate hepatic impairment were compared with those of HIV-infected patients with normal hepatic function in a multiple dose study with lopinavir/ritonavir 400/100 mg twice daily.
Maltese: Il-parametri farmakokinetiċi steady-state ta' lopinavir f'pazjenti infettati bl-HIV bi problemi epatiċi minn ħfief għal moderati ġew mqabbla ma dawk ta' pazjenti infettati bl-HIV b'funzjoni epatika normali fi studju ta' dożi multipla b'lopinavir/ritonavir 400/100 mg darbtejn kuljum.
English: 120 ml (2 bottles x 60 ml) oral solution with two 2 ml oral dosing syringes.
Maltese: 120 ml (2 fliexken x 60ml) soluzzjoni orali bi żewġ 2 ml siringi għad-dożaġġ orali.
English: Postmarketing life-threatening cases of cardiac toxicity (including complete atrioventricular (AV) block, bradycardia, and cardiomyopathy), lactic acidosis, acute renal failure, CNS depression and respiratory complications leading to death have been reported, predominantly in preterm neonates receiving Kaletra oral solution (see sections 4.3 and 4.9).
Maltese: Każijiet ta' tossiċità kardijaka (inkluż interruzzjonikompleta atrijoventrikulari (AV), bradikardija, u kardjomijopatija), lactic acidosis, insuffiċjenza akuta tal-fwied, depressjoni tas-CNS u kumplikazzjonijiet respiratorji li jistgħu jwasslu għall-mewt, osservati wara ttqegħid tal-prodott fis-suq, kienu rrappurtati, l-aktar fi trabi li twieldu qabel iż-żmien u li qed jirċievu s soluzzjoni orali ta' Kaletra (ara sezzjonijiet 4.3 u 4.9).
English: • nausea;
Maltese: − dijarrea;
English: 1 See section 4.4: pancreatitis and lipids c. Description of selected adverse reactions
Maltese: 1 ara sezzjoni 4.4: pankreatite u lipidi c.
English: A dose adjustment of Kaletra 400 mg/400 mg (i.e. Kaletra 400/100 mg + ritonavir 300 mg) twice daily has allowed compensating for the CYP 3A4 inducer effect of rifampicin.
Maltese: 400 mg/400 mg (jiġifieri Kaletra 400/100 mg + ritonavir 300 mg) darbtejn kuljum ikkumpensa għall-effett ta' rifamficin li jinduċi CYP 3A4.
English: Trazodone: AUC: ↑ 2.4-fold
Maltese: Simeprevir: AUC:↑7.2 darbiet
English: AUC: ↑ 13-fold
Maltese: AUC: ↑ 13-il darba
English: The mean steady-state trough concentration prior to the morning dose was 5.5 ± 5.4 µg/ml.
Maltese: Listeady-state medju ta' konċentrazzjoni baxxa qabel id-doża ta' fil-għodu kienet 5.5 ± 5.4 µg/ml.
English: • anticoagulants (e.g. warfarin, rivaroxaban, vorapaxar);
Maltese: - mediċini għal kontra l-koagulazzjoni tad-demm (eż. warfarin, rivaroxaban, vorapaxar);
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 fil konċentrazzjoni fil-plażma u tnaqqis fl effetti kliniċi ta' lopinavir u ritonavir (ara sezzjoni 4.5).
English: Kaletra 800/200 mg was administered in combination with emtricitabine 200 mg and tenofovir DF 300 mg as part of a once-daily regimen.
Maltese: Kaletra 800/200 mg ġiet amministrata flimkien ma emtricitabine 200 mg u tenofovir DF 300 mg bhala parti minn dużaġġ ta'
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: Increased plasma concentrations of amiodarone and dronedarone.
Maltese: Żieda fil-konċentrazzjoni fil-plażma ta' amiodarone u dronedarone.
English: A 14C-lopinavir study in humans showed that 89% of the plasma radioactivity after a single 400/100 mg Kaletra 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 Kaletra kienet dovuta għas-sustanza attiva prinċipali.
English: d. Paediatric populations
Maltese: d. Popolazzjoni Pedjatrika
English: The concomitant administration with fusidic acid is contraindicated in dermatological infections (see section 4.5).
Maltese: L-amministrazzjoni konkomitanti ma' fusidic acid huwa kontraindikat f'infezzjonijiet dermatoloġiċi (ara sezzjoni 4.5).
English: Thirty-nine patients (39%) discontinued the study, including 16 (16%) discontinuations due to adverse events, one of which was associated with a death.
Maltese: Disgħa u tletin pazjent (39%) ma komplewx l-istudju, li jinkudu 16 (16%) waqfiet minħabba avvenimenti avversi, u li waqfa minnhom kienet assoċjata ma mewt.
English: • anticancer medicines (e.g. abemaciclib, afatinib, apalutamide, ceritinib, encorafenib, ibrutinib, venetoclax, most tyrosine kinases inhibitors such as dasatinib and nilotinib, also vincristine and vinblastine);
Maltese: - anti-bijotiċi (eż. rifabutin, rifampicin, clarithromycin); - mediċini għal kontra l-kanċer (eż. abemaciclib, afatinib, apalutamide, ceritinib, encorafenib, ibrutinib, venetoclax, il-biċċa l-kbira ta' inibituri ta' tyrosine kinase bħal dasatinib u nilotinib, kif ukoll vincristine u vinblastine);
English: Adultc a. Kaletra oral solution 230/57.5 mg/m2 twice daily regimen without nevirapine b. Kaletra oral solution 300/75 mg/m2 twice daily regimen with nevirapine c. Kaletra film-coated tablets 400/100 mg twice daily at steady state
Maltese: Kaletra soluzzjoni orali 230/57.5 mg/m2 dożaġġ darbtejn kuljum mingħajr nevirapine b. Kaletra soluzzjoni orali 300/75 mg/m2 dożaġġ darbtejn kuljum ma' nevirapine c.
English: HIV-1 isolates with reduced susceptibility to lopinavir have been selected in vitro.
Maltese: Iżolati HIV-1 b'suxxettibilità mnaqqsa għal lopinavir ġew mgħażula in vitro.
English: Experienced patients received nevirapine plus up to two nucleoside reverse transcriptase inhibitors.
Maltese: Pazjenti b'esperjenza ingħataw nevirapine u sa żewġ inibituri nucleoside reverse transcriptase.
English: Kaletra contains lopinavir and ritonavir, both of which are inhibitors of the P450 isoform CYP3A in vitro.
Maltese: Kaletra fih lopinavir u ritonavir, it-tnejn li huma impedituri ta' l-iżoforma ta' P450, CYP3A in vitro.
English: Use in adults
Maltese: Użu mill-adulti
English: AUC: ↑ 2-fold
Maltese: AUC: ↑ 2-darbiet
English: − Keep this leaflet.
Maltese: follikulite u furunklu.
English: Etravirine (Lopinavir/ritonavir tablet 400/100 mg BID)
Maltese: Etravirine (Lopinavir/ritonavir pillola 400/100mgBID)
English: No clinical relevant interaction expected.
Maltese: Ma hi mistennija l-ebda interazzjoni li hi klinikament rilevanti.
English: Mutations L33F, I50V and V32I combined with I47V/A were also observed.
Maltese: V32I kkombinati ma' I47V/A.
English: Weight and metabolic parameters
Maltese: Parametri tal-metaboliċi