FrancophonIA/ELRC3.0 huggingface dataset:
English: Increased plasma concentrations of lovastatin and simvastatin; thereby, increasing the risk of myopathy including rhabdomyolysis (see section 4.5).
Maltese: Żieda fil-konċentrazzjoni fil-plażma ta' lovastatin u simvastatin; għalhekk, dan iżid ir-riskju ta' mijopatija, li jinkludi rabdomijoli (ara sezzjoni 4.5).
English: Plasma concentrations of lopinavir were measured over four 12-hour periods during second trimester (20-24 weeks gestation), third trimester before dose increase (30 weeks gestation), third trimester after dose increase (32 weeks gestation), and at 8 weeks post-partum.
Maltese: Il-konċentrazzjonijiet fil-plasma ta' lopinavir kienu mkejla waqt erbgħa perijodi ta' 12-il siegħa waqt it-tieni tlett xhur tat-tqala (20-24 ġimgħa tat-tqala), waqt it-tielet tlett xhur tat-tqala qabel ma tiżdied id-doża (30 ġimgħa tat-tqala), waqt it-tielet tlett xhur tat-tqala wara li tiżdied id-doża (32 ġimgħa tat-tqala), u 8 ġimgħat wara t-tqala.
English: AUC12 (µg•h/ml) Age ≥ 14 days to < 6 weeks cohort (N = 9):
Maltese: Età ≥ 14-il ġurnata sa < 6 ġimgħat cohort (N = 9):
English: The mean changes from baseline in PR interval ranged from 11.6 ms to 24.4 ms in the 12 hour interval post dose.
Maltese: Fl-intervall ta' 12-il siegħa ta' wara li ngħatat id-doża, it-tibdil medju mil-linja bażi fl-intervall PR varja minn 11.6 ms sa 24.4 ms.
English: Data from clinical trials in children below 2 years of age include the pharmacokinetics of Kaletra 300/75 mg/m2 twice daily studied in a total of 31 paediatric patients, ranging in age from 14 days to 6 months.
Maltese: Data minn provi kliniċi fi tfal ta' taħt is-sentejn età jinkludu farmakokinetika ta' Kaletra 300/75 mg/m2 darbtejn kuljum ġew studjati f'total ta' 31 pazjent pedjatriku li jvarjaw fl-età minn 14-il ġurnata sa 6 xhur.
English: The effective (peak to trough) half-life of lopinavir over a 12 hour dosing interval averaged 5 − 6 hours, and the apparent oral clearance (CL/F) of lopinavir is 6 to 7 l/h.
Maltese: Il-half-life effettiva ta' lopinavir (mill massimu sal-minimu) matul intervall ta' dożaġġ ta' 12 -il siegħa, kellu medja ta' 5 - 6 siegħat, u ttneħħija orali evidenti (CL/F) ta' lopinavir hi minn 6 sa 7 l/siegħa.
English: HIV RNA < 50 copies/ml (ITT)*
Maltese: HIV RNA < 400 kopji/ml (ITT)* HIV RNA < 50 kopji/ml (ITT)*
English: Systemic corticosteroid effects including Cushing's syndrome and adrenal suppression have been reported in patients receiving ritonavir and inhaled or intranasally administered fluticasone propionate; this could also occur with other corticosteroids metabolised via the P450 3A pathway e.g. budesonide and triamcinolone.
Maltese: Ġew irrappurtati effetti sistemiċi ta' kortikosterojdi li jinkludu s-sindromu ta' Cushing u soppressjoni adrenali f'pazjenti li jieħdu ritonavir u fluticasone propionate miġbud mill-imnifsejn jew applikat fl-imnieħer; dan jista' jiġri wkoll b'kortikosterojdi oħra metabbolizzati mill-proċess ta' P450 3A eż budesonide u triamcinolone.
English: The concomitant administration with alfuzosin is contraindicated (see section 4.5).
Maltese: L-amministrazzjoni konkomitanti ma' alfuzosin huwa kontraindikat (ara sezzjoni 4.5).
English: Protocol defined non-inferiority of once-daily dosing compared with twice-daily dosing was demonstrated if the lower bound of the 95% confidence interval for the difference in proportion of subjects responding (once daily minus twice daily) excluded -12% at Week 48.
Maltese: taħt ta' 95% intervall ta' fiduċja ghad-differenza fil-proporzjon ta' suggetti li kienu qed jirrisspondu għat-trattament (tnaqqas darbtejn kuljum minn darba kuljum) u teskludi -12% f' Ġimgħa 48.
English: Increased plasma concentrations of cisapride.
Maltese: Żieda fil-konċentrazzjoni fil-plażma ta' cisapride.
English: Cushing's syndrome has been reported in patients receiving ritonavir and inhaled or intranasally administered fluticasone propionate; this could also occur with other corticosteroids metabolised via the P450 3A pathway e.g. budesonide (see section 4.4 and 4.5).
Maltese: Is-sindromu ta' Cushing ġie rrapurtat f'pazjenti li kienu qed jirċievu ritonavir jew fluconazole propionate amministrat man-nifs jew mill imnieħer; dan jista jidher ukoll ma kortikosterojdi oħra li huma metabolizzati bis-sistema ta' P450 3A e.ż. budesonide (ara sezzjoni 4.4 u 4.5).
English: Kaletra contains lopinavir and ritonavir, both of which are inhibitors of the P450 isoform CYP3A.
Maltese: Kaletra fiha lopinavir u ritonavir, it-tnejn li huma inibituri ta' l-iżoforma P450 CYP3A.
English: Across studies, administration of Kaletra 400/100 mg twice daily yields mean steady-state lopinavir plasma concentrations 15 to 20-fold higher than those of ritonavir in HIV-infected patients.
Maltese: Tul studji, s-somministrazzjoni tal-Kaletra 400/100 mg darbtejn kuljum tagħti medja tal-konċentrazzjonijiet talplażma ta' lopinavir steady-state 15 sa 20-darba ogħla minn dawk ta' ritonavir f'pazjenti infettati blHIV.
English: Marked triglyceride elevation is a risk factor for development of pancreatitis.
Maltese: Elevazzjoni markata trigliċerida huwa fattur ta' riskju ta' żvillup ta' pankreatite.
English: There are limited pharmacokinetic data in children below 2 years of age.
Maltese: Hemm tagħrif farmakokinetiku limitat fi tfal ta' taħt is-sentejn età.
English: Anti-gout agents Colchicine single dose
Maltese: Mediċini għal kontra l-gotta Colchicine doża waħda
English: Outcomes at Week 24: Study P1030 Age: ≥ 14 days and < 6 weeks (N=10)
Maltese: Studju P1030 Età: ≥ 14-il ġurnata u
English: The pharmacokinetics of Kaletra 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' Kaletra 300/75 mg/m2 darbtejn kuljum u 230/57.5 mg/m2darbtejn kuljum ġew studjati f'total ta' 53 pazjent pedjatriku li jvarjaw fl-età minn 6 xhur sa 12 il-sena.
English: Kaletra oral solution is supplied in amber coloured multiple-dose polyethylene terephthalate (PET) bottles in a 60 ml size.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Kaletra soluzzjoni orali tiġi fi fliexken kulur ambra għal dożi multipli magħmulin minn polyethylene terephthalate (PET), ta' daqs ta' 60 ml.
English: For caution on parenterally administered midazolam, see section 4.5.
Maltese: Sabiex tiġi eżerċitata kawtela meta midazolam jiġi mgħoti parenteralment, ara sezzjoni 4.5.
English: Outcomes at Week 48: Study M98-863 Kaletra (N=326)
Maltese: Riżultati ta' ġimgħa 48: Studju M98-863
English: Belgique/Belgien Tél/Tel: +32 10 477811
Maltese: AbbVie Polska Sp. z o.o. Tel.: +48 22 37278 00
English: Lopinavir binds to both alpha-1-acid glycoprotein (AAG) and albumin however, it has a higher affinity for AAG.
Maltese: Lopinavir jgħaqqad kemm mal-aċidu glikoproteina alpha-1(AAG) u mal-albumina, imma għandha affinita ogħla mal-AAG.
English: Initially, bosentan Cmin: ↑ by approximately 48-fold.
Maltese: Fil-bidu, bosentan Cmin:↑ bejn wieħed u ieħor b'48 darba.
English: Through Week 48, genotypic resistance testing results were available from 75 patients in the QD group and 75 patients in the BID group who had incomplete virologic response.
Maltese: Matul Ġimgħa 48, ir-riżultati ta' testijiet ta' reżistenza ġenotipika ħarġu minn 75 pazjent mill grupp QD u 75 pazjent mill grupp BID li ma kellhomx rispons viroloġiku komplut.
English: Each 1 ml of Kaletra oral solution contains 80 mg of lopinavir co-formulated with 20 mg of ritonavir as a pharmacokinetic enhancer.
Maltese: U KWANTITATTIVA Kull 1 ml Kaletra taħlita likwida li tittieħed mill-ħalq fiha 80 mg ta' lopinavir ko-formulata ma 20 mg ritonavir bħala mġiegħel farmakokinetiku.
English: This medicinal product contains up to 0.8 g of fructose per dose when taken according to the dosage recommendations.
Maltese: Dan il-prodott mediċinali fih sa 0.8 g fruktows kull doża meta jittieħed skond id-dożaġġ irrakkomandat.
English: Children less than 14 days of age and premature neonates Kaletra oral solution should not be administered to neonates before a postmenstrual age (first day of the mother's last menstrual period to birth plus the time elapsed after birth) of 42 weeks and a postnatal age of at least 14 days has been reached (see section 4.4).
Maltese: Tfal li għandhom inqas minn 14-il ġurnata u trabi tat-twelid prematuriKaletra soluzzjoni orali m'għandux jingħata lit-trabi tat-twelid qabel l-età ta' wara l-menstrwazzjoni (l-ewwel jum tal-aħħar menstrwazzjoni tal-omm sa t-twelid flimkien mal-ħin li jkun għadda wara t-twelid) ta' 42 ġimgħat u l età wara t-twelid ta' mill-inqas 14-il ġurnata ikun intlaħaq (ara sezzjoni 4.4 ).
English: A dose adjustment of Kaletra 400 mg/400 mg (i.e.
Maltese: Aġġustamet fid-doża ta' Kaletra 400 mg/400 mg (jiġifieri Kaletra
English: Each ml of Kaletra contains 80 mg of lopinavir and 20 mg of ritonavir.
Maltese: Kaletra fih 80 mg lopinavir u 20 mg ritonavir.
English: • medicines affecting the immune system (e.g. cyclosporin, sirolimus (rapamycin), tacrolimus);
Maltese: - mediċini li jaffetwaw is-sistema immunitarja (eż. cyclosporin, sirolimus (rapamycin),
English: Anxiety Uncommon Abnormal dreams, libido decreased
Maltese: Ansjeta Ħolm mhux normali, tnaqqis fil-libido
English: • ombitasvir/paritaprevir/ritonavir with or without dasabuvir (used to treat chronic hepatitis C
Maltese: - Ombitasvir/paritaprevir/ritonavir bi jew mingħajr dasabuvir (użati biex jittrattaw il-virus talepatite Ċ kronika [HCV]);
English: Other medicines and Kaletra
Maltese: Mediċini oħra u Kaletra
English: Antibiotics Clarithromycin
Maltese: Mediċini antibijotiċi
English: Lipid-modifying agents Lomitapide
Maltese: Aġenti li jimmodifikaw l-lipidi
English: The maximum mean (95% upper confidence bound) differences in QTcF from placebo were 3.6 (6.3) and
Maltese: Id-differenzi medji massimi (95% upper confidence bound) fil-QTcF
English: Resistance to lopinavir, defined as the presence of any primary or active site mutations in protease (see above), was observed in 0/51 (0%) patients.
Maltese: Ir-reżistenza għal lopinavir, hekk definita bħala l-preżenza ta' mutazzjonijiet tal-proteaż fis-sit primarju jew attiv (ara hawn fuq), ġiet osservata f' 0/51 (0%) tal-pazjenti.
English: Higher tenofovir concentrations could potentiate tenofovir associated adverse events, including renal disorders.
Maltese: Konċentrazzjonijiet ogħla ta' tenofovir jistgħu jikkawżaw żieda fl-effetti avversi assoċjati ma' tenofovir, inklużi disturbi fil-kliewi.
English: Kaletra film-coated tablets are pale yellow debossed with [Abbott logo] and “KC”.
Maltese: Il-pilloli miksija b'rita Kaletra huma sofor ċari [bil-logow ta' Abbott] u “KC” imnaqqxa.
English: Particular caution must be used when prescribing Kaletra and medicinal products known to induce QT interval prolongation such as: chlorpheniramine, quinidine, erythromycin, clarithromycin.
Maltese: QT bħal chlorpheniramine, quinidine, erythromycin, clarithromycin.
English: A more pronounced effect on bedaquiline plasma exposures may be observed during prolonged co-administration with lopinavir/ritonavir.
Maltese: Effett aktar evidenti fuq esponimenti ta'bedaquiline fil plażma jista' jiġi osservat waqt ko-amministrazzjoni prolongata ma' lopinavir/ritonavir.
English: Nervous system disorders
Maltese: Disturbi fis-sistema nervuża Komuni
English: Kaletra oral solution comes in a multiple-dose 60 ml amber bottle.
Maltese: Is-soluzzjoni orali Kaletra tiġi fi fliexken kulur ambra għal dożi multipli, ta' daqs ta' 60 ml.
English: Effects on the electrocardiogram
Maltese: Effetti fuq l-elettrokardjogramm
English: In the QD group,
Maltese: Għalhekk,
English: Immune system disorders
Maltese: Disturbi fis-sistema imunitarja Komuni
English: In another open-label pharmacokinetic study, 19 HIV-infected pregnant women received lopinavir/ritonavir 400/100 mg twice daily as part of combination antiretroviral therapy during pregnancy from before conception.
Maltese: Fi studju farmakokinetiku open-labelieħor, 19-il mara tqal infettati bl-HIV rċevew lopinavir/ritonavir 400/100 mg darbtejn kuljum bħala parti mit-terapija antiretrovirali kkombinata waqt it-tqala minn qabel il-konċepiment.
English: Co-administration of ibrutinib and Kaletra may increase ibrutinib exposure which may increase the risk of toxicity including risk of tumor lysis syndrome.
Maltese: Ko-amministrazzjoni ta' ibrutinib u Kaletra jista' jżid l-espożizzjoni ta' ibrutinib li jista' jżid ir-riskju ta' tossiċità inkluż ir-riskju ta'
English: AUC: ↑ 13-fold Due to CYP3A inhibition by lopinavir/ritonavir.
Maltese: AUC: ↑ 11-il darba Minħabba li lopinavir/ritonavir jimpedixxi CYP3A.
English: One hundred patients were originally treated with Kaletra in the study (including 51 patients receiving 400/100 mg twice daily and 49 patients at either 200/100 mg twice daily or 400/200 mg twice daily).
Maltese: Flistudju, mitt pazjent oriġinarjament ġew ittrattati b'Kaletra (inkluż 51 pazjent li kienu qegħdin jirċievu 400/100 mg darbtejn kuljum u 49 pazjent li kienu qegħdin jirċievu jew 200/100 mg darbtejn kuljum jew 400/200 mg darbtejn kuljum).
English: Mean increase from baseline in CD4+ T-cell count (cells/mm3)
Maltese: Żieda medja mill-lija bażi flgħadd ta' CD4+T-cell (ċelloli/mm3)
English: Use the 5 ml oral dosing syringe to prepare a dose.
Maltese: − Uża s-siringa orali ta' 5 ml ipprovduta li tkejjel id-doża.
English: (combinations of mechanisms including CYP3A inhibition)
Maltese: (Taħlita ta' mekkaniżmi inkluż inibizzjoni ta' CYP3A) Lopinavir: ↔
English: Vasodilating agents Bosentan
Maltese: Minħabba li bosentan jinduċi
English: Due to CYP3A inhibition by lopinavir/ritonavir
Maltese: Livelli aktar baxxi tal-prodotti mediċinali lopinavir/ritonavir
English: At steady state, lopinavir protein binding remains constant over the range of observed concentrations after 400/100 mg Kaletra twice daily, and is similar between healthy volunteers and HIV-positive patients.
Maltese: Fi steady-state t-tagħqid tal-proteina ta' lopinavir jibqa kostanti fuq l-medda ta' konċentrazzjonijiet osservati wara 400/100 mg Kaletra darbtejn kuljum, u hija simili bejn volontiera b'saħħithom u pazjenti li huma HIV-posittivi.
English: AbbVie Deutschland GmbH & Co. KG, Knollstrasse, 67061 Ludwigshafen, Germany For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Maltese: KG, Knollstrasse, 67061 Ludwigshafen, Ġermanja Għal kull tagħrif dwar dan il-prodott mediċinali, jekk jogħġbok ikkuntattja lir-rappreżentant lokali tadDetentur ta' l-Awtorizzazzjoni għat-tqegħid fis-Suq:
English: Adult patients who have not previously taken other antiviral medicines can also take Kaletra tablets once daily as an 800 mg/200 mg dose.
Maltese: Pazjenti adulti li ma kienux ħadu mediċini antiretrovirali oħra qabel, jistgħu jieħdu l-pilloli Kaletra darba kuljum bħala doża ta' 800 mg/200 mg.
English: AUC: ↑ 5-fold
Maltese: AUC: ↑ 5 darbiet
English: Steady-state concentrations was moderately decreased due to CYP2C9 and CYP2C19 induction by lopinavir/ritonavir.
Maltese: Minħabba li lopinavir/ritonavir jinduċi CYP2C9 u CYP2C19,
English: Hepatitis C virus direct acting antivirals
Maltese: Virus tal-epatite Ċ li jaħdmu direttament kontra l-virali
English: Kaletra film-coated tablets are yellow debossed with [Abbott logo] and “KA”.
Maltese: Il-pilloli miksija b'rita Kaletra huma sofor u imnaqxin [bil-logo ta' Abbott] u “KA”.
English: Kaletra 100 mg/25 mg film-coated tablets are supplied in plastic bottles containing 60 tablets.
Maltese: Il-pilloli miksija b'rita Kaletra 100 mg/25 mg jiġu wkoll fi fliexken tal-plastik li fihom 60 pillola.
English: Co-administration of Kaletra with sildenafil is contraindicated (see section 4.3).
Maltese: Kaletra huwa kontro-indikat (ara sezzjoni 4.3).
English: Each film-coated tablet contains 200 mg of lopinavir co-formulated with 50 mg of ritonavir as a pharmacokinetic enhancer.
Maltese: Kull pillola miksija b'rita fiha 200 mg lopinavir ko-formulata ma' 50 mg ritonavir bħala qanqiel farmakokinetiku.
English: • enlargement of the lymph nodes;
Maltese: − tkabbir fil-lymph nodes;
English: • Kaletra contains the active substances lopinavir and ritonavir.
Maltese: - Kaletra fih is-sustanzi attivi lopinavir u ritonavir.
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: - salmeterol mhijiex irrakomandata (ara sezzjoni 4.5)); - rivaroxaban mhux irrakomandat (ara sezzjoni 4.5).
English: Overall, the in vitro characterisation of phenotypic cross-resistance between lopinavir and other protease inhibitors suggest that decreased susceptibility to lopinavir correlated closely with decreased susceptibility to ritonavir and indinavir, but did not correlate closely with decreased susceptibility to amprenavir, saquinavir, and nelfinavir.
Maltese: Kollox ma kollox, il-karatterizazzjoni in vitro ta' cross resistance fenotipika bejn lopinavir u inibituri tal-protease oħrajn tissuġġerixxi li t-tnaqqis fis suxxettibilità għal lopinavir tikkorrelata mill-qrib ma tnaqqis fis-suxxettibilità għal ritonavir u indinavir, iżda ma tikkorrelatax mill-qrib ma tnaqqis fis-suxxettibilità għal amprenavir, saquinavir, u nelfinavir.
English: Tissue distribution studies conducted in the rat did not suggest significant cardiac retention of the active substance; 72-hour AUC in heart was approximately 50% of measured plasma AUC.
Maltese: Studji dwar id-distribuzzjoni tat-tessuti li saru fuq il-far ma ssuġġerewx żamma kardijaka sinifikanti tas-sustanza attiva; 72 siegħa AUC fil-qalb kienet approssimattivament 50% tal plażma AUC imkejjla.
English: Alpha1 adrenoreceptor antagonist Alfuzosin
Maltese: Mediċini li jimblukkaw ir-riċettur α1-Adrenoreceptor
English: Furthermore, polyoxol 40 hydrogenated castor oil and potassium present in Kaletra oral solution may cause only at high inadvertent doses gastrointestinal upset.
Maltese: Barra minn hekk, polyoxol 40 castor oil idroġenat u potassju preżenti fissoluzzjoni orali ta' Kaletra jistgħu jikkawżaw taqlib gastrointestinali f'dożi għolja meħudin involontarjament.
English: • Risk Management Plan (RMP)
Maltese: • Pjan tal-immaniġġar tar-riskju(RMP)
English: The nevirapine-based regimen was 160-200 mg/m2 once daily for 14 days, then 160-200 mg/m2 every 12 hours.
Maltese: Id-dożaġġ ibbażat fuq nevirapine kien 160-200 mg/m2 darba kuljum għal 14-il ġurnata, imbagħad 160-200 mg/m2 kull 12-il siegħa.
English: C24: ↑ 20.70-fold
Maltese: Cmax:↑ 4.7darbiet
English: Concomitant use of Kaletra and fluticasone or other glucocorticoids that are metabolised by CYP3A4, such as budesonide and triamcinolone, is not recommended unless the potential benefit of treatment outweighs the risk of systemic corticosteroid effects, including Cushing's syndrome and adrenal suppression (see section 4.5).
Maltese: bħal budesonide u triamcinolone,mhux irrikmandat sakemm il-benefiċċju potenzjali tat-trattament ma jkunx ikbar mir-riskju tal-effetti sistemiċi tal-kortikosterojdi, inklużi s-sindromu ta' Cushing u suppressjoni adrenali (ara sezzjoni 4.5).
English: The use of a once-daily dosing should be limited to those adult patients having only very few protease inhibitor (PI) associated mutations (i.e. less than 3 PI mutations in line with clinical trial results, see section 5.1 for the full description of the population) and should take into account the risk of a lesser sustainability of the virologic suppression (see section 5.1) and higher risk of diarrhoea (see section 4.8) compared to the recommended standard twice-daily dosing.
Maltese: L-użu ta' dożaġġ wieħed kuljum għandu jkun limitat għal dawk il-pazjenti adulti li jesperjenzaw biss ftit mutazzjonijiet assoċjati ma' inibituri tal-protejaż (PI) (jiġifieri inqas minn tliett mutazzjonijiet PI kif indikat fi studji kliniċi, ara sezzjoni 5.1 għal deskrizzjoni kompluta tal-popolazzjoni) u għandu jiġi kkunsidrat ir-riskju ta' nuqqas fis-sostenibilita' ta' supressjoni virali (ara sezzjoni 5.1) u riskju akbar ta' dijarrea (ara sezzjoni 4.8) meta mqabbel mad-dożaġġ rrakomandat ta' darbtejn kuljum.
English: Indeed, Kaletra could increase concentrations of the co-administered medicinal products and this may result in an increase of their associated cardiac adverse reactions.
Maltese: Tassew, Kaletra jista iżid il-konċentrazzjonjiiet ta' prodotti mediċinali ko-amministrati u dan jista' jirriżulta f'żieda fir-reazzjonijiet avversi kardijaċi assoċjati.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Maltese: • Kull meta s-sistema tal-ġestjoni tar-riskju tiġi modifikata speċjalment minħabba li tasal informazzjoni ġdida li tista' twassal għal bidla sinifikanti fil-profil tal-benefiċċju/riskju jew minħabba li jintlaħaq għan importanti (farmakoviġilanza jew minimizzazzjoni tar-riskji).
English: The requirements for submission of periodic safety update reports 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: • Rapporti Perjodiċi Aġġornati dwar is-Sigurtà Ir-rekwiżiti biex jiġu ppreżentati rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (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: triamcinolone).
Maltese: delamanid).
English: Between week 24 and 48, patients randomised to a dose of 400/100 mg were converted to a dose of 533/133 mg.
Maltese: Bejn il-ġimgħa 24 u 48, pazjenti fortuwitament mogħtija doża ta' 400/100 mg kienu konvertiti għal doża ta' 533/133 mg.
English: Rationale
Maltese: Linji
English: Uncommon Alopecia, capillaritis, vasculitis
Maltese: Telf tax-xagħar, kapillarite, vaskulite
English: 96 week arm (N=13)
Maltese: < 6 xhur (N=21)
English: HIV, respectively.
Maltese: HIV tat-tip mhux ikkultivat, rispettivament.
English: Glecaprevir/pibrentasvir Serum concentrations may be increased due to P-glycoprotein, BCRP and OATP1B inhibition by lopinavir/ritonavir.
Maltese: Glecaprevir/pibrentasvir Konċentrazzjonijiet fis-serum jistgħu jiżdiedu minħabba inibizzjoni ta' P-glycoprotein, BCRP u OATP1B minn lopinavir/ritonavir.
English: For Kaletra oral solution, the corresponding increases in lopinavir AUC and Cmax were 80% and 54%, respectively.
Maltese: AUC u Cmax kienu 80% u 54%, rispettivament.
English: 300/75 mg/m2 (corresponding to 3.75 ml/m2)
Maltese: 300/75 mg/m2
English: Mean increase from baseline in CD4+ T-cell count (cells/mm3) * intent to treat analysis where patients with missing values are considered virologic failures
Maltese: Żieda medja mill-lija bażi flgħadd ta' CD4+T-cell (ċelloli/mm3) * intenzjoni li tiġi ttrattata analiżi fejn pazjenti b'valuri nieqsa huma kkunsidrati fallimenti viroloġiċi
English: The in vitro antiviral activity of lopinavir against laboratory and clinical HIV strains was evaluated in acutely infected lymphoblastic cell lines and peripheral blood lymphocytes, respectively.
Maltese: Attività antiviraliin vitro L-attività antivirali in vitro ta' lopinavir kontra razzi ta' l-HIV tal-laboratorju u kliniċi kienet evalwata f'linji ta' ċelluli limfoblastiċi infettati b'mod akut, u limfoċiti tad-demm periferali, rispettivament.
English: The standard recommended dosage of Kaletra tablets is 400/100 mg (two 200/50 mg) tablets twice daily taken with or without food.
Maltese: Id-doża adulta tal-pilloli ta' Kaletra, 2 pilloli (400/100 mg darbtejn kuljum), tista tingħata fi tfal li jiżnu