FrancophonIA/ELRC3.0 huggingface dataset:
English: The pharmacokinetic properties of lopinavir co-administered with ritonavir have been evaluated in healthy adult volunteers and in HIV-infected patients; no substantial differences were observed between the two groups.
Maltese: Il-karatteristiċi farmakokinetiċi ta' lopinavir ko-amministrat ma ritonavir ġew evalwati f'voluntiera adulti f'saħħithom u f'pazjenti infettati bl-HIV; ma' ġiet innutata l-ebda differenza sostanzjali bejn iżżewg gruppi.
English: Adult Use
Maltese: Adultic a.
English: Due to CYP3A and P-gp inhibition by lopinavir/ritonavir.
Maltese: CYP3A u inibizzjoni ta' P-gp minn lopinavir/ritonavir.
English: Since increased concentrations of HMG-CoA reductase inhibitors may cause myopathy, including rhabdomyolysis, the combination of these agents with Kaletra is contraindicated (see section 4.3).
Maltese: HMG-CoA reductase jistgħu jikkawżaw mijopatija, inkluż rabdomilożi, it-taħlit ta' dawn laġenti flimkien ma' Kaletra huwa kontro-indikat (ara sezzjoni 4.3).
English: • colchicine (used to treat gout) if you have kidney and/or liver problems (see the section on
Maltese: - colchicine (jintuża għal trattament tal-gotta) - jekk għandek problemital-kliewi u/jew tal-fwied (ara t-taqsima dwar Mediċini oħra u Kaletra);
English: The 230/57.5 mg/m2 twice-daily regimen without nevirapine and the 300/75 mg/m2 twice-daily regimen with nevirapine provided lopinavir plasma concentrations similar to those obtained in adult patients receiving the 400/100 mg twice-daily regimen without nevirapine.
Maltese: Il- 230/57.5 mg/m2 dożaġġ darbtejn kuljum mingħajr nevirapine u t- 300/75 mg/m2 dożaġġ darbtejn kuljum b'nevirapine pprovdew konċentrazzjonijiet tal-plażma ta' lopinavir simili għal dawk ottenuti f'pazjenti adulti li kienu qed jirċievu 400/100 mg dożaġġ darbtejn kuljum mingħajr nevirapine.
English: Genotypic correlates of reduced phenotypic susceptibility to lopinavir in viruses selected by other protease inhibitors.
Maltese: Korrelati ġenotipiċi ta' suxxettibilità fenotipika mnaqqsa għal lopinavir fil-virus selezzjonati minn inibituri oħra tal-protease.
English: AUC: ↑ 4-fold
Maltese: AUC: ↑ 2.4-darbiet
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Oral solution - Carton containing 120 ml (2 bottles x 60 ml) oral solution
Maltese: Soluzzjoni orali- Kartuna li fih 120 ml (żewġ fliexken x 60ml) soluzzjoni orali
English: Events noted as having frequency “Not known” were identified via post-marketing surveillance.
Maltese: Avvenimenti li l-frekwenza tagħhom ġiet imnizzla bħala ‘mhux mgħarufa', kienu identifikati waqt sorveljanza ta' wara t-tqegħid fis-suq.
English: Medicinal product class
Maltese: Klassi tal-prodott mediċinali
English: The choice of Kaletra to treat protease inhibitor experienced HIV-1 infected patients should be based on individual viral resistance testing and treatment history of patients (see sections 4.4 and 5.1).
Maltese: L-għażla ta' Kaletra għat-trattament ta' pazjenti infettati b'HIV-1 li kienu diġà ġew trattati b'impedituri protejaż, għandha tkun ibbażata fuq testijiet individwali ta' reżistenza virali u fuq l-istorja ta' trattament tal-pazjenti (ara sezzjoni 4.4 u 5.1).
English: HIV RNA < 50 copies/ml*†
Maltese: HIV RNA < 400 kopji/ml* HIV RNA < 50 kopji/ml*†
English: In general, rebound isolates either retained (if cross-resistant at baseline) or developed significant cross-resistance to indinavir, saquinavir and atazanavir.
Maltese: Ġeneralment iżolati li marru lura jew żammew (jekk reżistenti-inkroċjati fillinja bażi) jew żviluppaw cross-resistance għal indinavir, saquinavir u atazanavir.
English: (Ritonavir 200 mg twice daily)
Maltese: (Ritonavir 200 mg darbtejn kuljum)
English: If a patient is already taking St John's wort, stop St John's wort and if possible check viral levels.
Maltese: Jekk pazjent ikun diġà qiegħed jieħu l-fexfiex tar-raba' (St John's wort), waqqafulu u jekk ikun possibbli iċċekkja l livelli virali.
English: Patients with chronic hepatitis B or C and treated with combination antiretroviral therapy are at an increased risk for severe and potentially fatal hepatic adverse reactions.
Maltese: Pazjenti b'epatite kronika B jew Ċ u ttrattati b'terapija antiretrovirali kombinata qegħdin f'riskju akbar ta' reazzjonijiet avversi relatati mal-fwied, li huma serji ħafna u potenzjalment fatali.
English: Paediatric dosing guidelines for the dose 230/57.5 mg/m2 > 6 months to < 18 years
Maltese: Linji gwida ta' dożaġġ pedjatriku għad-doża ta' 230/57.5 mg/m2
English: Apalutamide is a moderate to strong CYP3A4 inducer and this may lead to a decreased exposure of lopinavir/ritonavir.
Maltese: Apalutamide huwa induttur moderat sa qawwi ta' CYP3A4 u dan jista' jwassal għal tnaqqis fl esponiment għal lopinavir/ritonavir.
English: Mean baseline CD4+ T-cell count was 216 cells/mm3 (range: 20 to 775 cells/mm3) and mean baseline plasma HIV-1 RNA was 5.0 log10 copies/ml (range: 1.7 to 7.0 log10 copies/ml).
Maltese: ċellola/mm3) u l-linja bażi fil-plażma HIV-1 RNA kienet ta' 5.0 log10 kopji/ml (tkopri minn 1.7 sa 7.0 log10 kopji/ml).
English: For adults and children weighing greater than 15 kg.
Maltese: Għall-adulti u tfal li jiżnu akbar minn 15 kg.
English: Kaletra is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infected adults, adolescents and children aged from 14 days and older.
Maltese: Kaletra huwa indikat flimkien ma' aġenti antiretrovirali oħra għat-trattament ta' adulti, adoloxxenti u tfal b'età minn 14-il ġurnata u 'il fuq infettati bil- human immunodeficiency virus (HIV-1).
English: In rats, embryofoetotoxicity (pregnancy loss, decreased foetal viability, decreased foetal body weights, increased frequency of skeletal variations) and postnatal developmental toxicity (decreased survival of pups) was observed at maternally toxic dosages.
Maltese: Fil-far, embrijofetotossiċita (telf ta' tqala, vijabilita' fetali imnaqqsa, piżijiet tal-korp fetali imnaqqsa, frekwenza akbar ta' varjazzjonijiet skeletali) u tossiċita' ta' l-iżvilupp ta' wara t-twelid (għixien imnaqqsa taż-żgħar) ġiet osservata f'dożaġġi tossiċi materni.
English: The concomitant administration with quetiapine is contraindicated (see section 4.5).
Maltese: L-amministrazzjoni konkomitanti ma' quetiapine huwa kontraindikat (ara sezzjoni 4.5).
English: Individual SmPCs should be consulted.
Maltese: Għandhom jiġu kkonsultati l-SmPCs individwali.
English: While rosuvastatin is poorly metabolised by CYP3A4, an increase of its plasma concentrations was observed.
Maltese: Filwaqt li huwa ammont żgħir ta' rosuvastatin li jiġi metabolizzat minn CYP3A4, ġiet osservata żieda fil-konċentrazzjoni tiegħu fil-plażma.
English: All patients were non-nucleoside reverse transcriptase inhibitor naïve.
Maltese: Il-pazjenti kollha kienu novizzi għal inibituri non-nucleoside reverse transriptase.
English: Adverse reactions from clinical trials and post-marketing experience in adult and paediatric patients:
Maltese: Reazzjonijiet avversi min studji kliniċi u esperjenza adulti u pedjatriċi warat-tqegħid fis-suq:
English: In HIV-infected patients with severe immune deficiency at the time of institution of combination antiretroviral therapy (CART), an inflammatory reaction to asymtomatic or residual opportunistic pathogens may arise and cause serious clinical conditions, or aggravation of symptoms.
Maltese: F'pazjenti infettati bl-HIV, b'immunodefiċenza serja ħafna meta tinbeda kombinazzjoni ta' trattament antiretrovirali (CART), reazzjoni inflammatorja għal patoġeni opportunistiċi asintomatiċi jew residwali tista toħroġ u tikkawża kundizzjonijiet kliniċi serji, jew aggravar tas-sintomi.
English: Once-daily dosing: the pharmacokinetics of once daily Kaletra have been evaluated in HIV-infected subjects naïve to antiretroviral treatment.
Maltese: Fit-tabella t'hawn taħt hawn imniżżla l-interazzjonijiet magħrufa u dawk teoretiċi ta' Kaletra ma' ċerti prodotti mediċinali antiretrovirali u oħrajn li m'humiex antiretrovirali.
English: Antiarrhythmics Amiodarone, Dronedarone
Maltese: Amiodarone, Dronedarone
English: Herbal products
Maltese: Prodotti mediċinali oħra
English: Phenytoin levels should be monitored when co-administering with Kaletra.
Maltese: Mhux rakkomandat li Kaletra u simeprevir jiġu amministrati flimkien.
English: Body Surface Area (m2)
Maltese: L-erja tas-superfiċje talġisem (m2)
English: Cmax: ↑ 6-fold
Maltese: Cmax: ↑ 5-darbiet
English: Patients were administered at least two nucleoside/nucleotide reverse transcriptase inhibitors selected by the investigator.
Maltese: Il-pazjenti ngħataw mill-inqas żewġ inibituri nucleoside/nucleotide reverse transcriptase magħżula mill-investigatur.
English: Interaction table
Maltese: Tabella ta' l-interazzjonijiet
English: Recommended lopinavir/ritonavir dosing (mg) twice daily.
Maltese: lopinavir/ritonavir (mg) darbtejn kuljum.
English: A dose reduction of the glucocorticoid should be considered with close monitoring of local and systemic effects or a switch to a glucocorticoid, which is not a substrate for CYP3A4 (e.g. beclomethasone).
Maltese: Għandu jiġi kkunsidrat tnaqqis fid-doża talglukokortikojd b'osservazzjoni mill-qrib tal-effetti lokali u sistemiċi jew qlib għal glukokortikojd li mhux substrat għal CYP3A4 (eż beclomethasone).
English: If treatment with a HMG-CoA reductase inhibitor is indicated, pravastatin or fluvastatin is recommended (see section 4.5).
Maltese: Jekk it-trattament b'inibitur HMG-CoA reductase huwa indikat, pravastatin jew fluvastatin huma rakkomandati (ara sezzjoni 4.5).
English: • The usual adult dose is 400 mg/100 mg twice a day i.e. every 12 hours, in combination with other anti-HIV medicines.
Maltese: - Id-doża li ssoltu tingħata għall-adulti hija 400 mg/100 mg darbtejn kuljum, jiġifieri kull 12 -il siegħa, flimkien ma' mediċini oħra għal kontra l-HIV.
English: • Kaletra is used by children 14 days of age and older, adolescents and adults who are infected with HIV, the virus which causes AIDS.
Maltese: - Kaletra jintuża minn tfal b'età ta'14-il ġurnata u ikbar, minn adoloxxenti u minn adulti li huma infettati bl-HIV, il-virus li jikkawża l-AIDS.
English: Do not transfer it to any other container.
Maltese: Titrassferihx għal kontenitur ieħor.
English: Total amounts of alcohol and propylene glycol from all medicines, including Kaletra oral solution, that are to be given to infants should be taken into account in order to avoid toxicity from these excipients (see section 4.4).
Maltese: Ammonti totali ta' alkoħol u propylene glycol minn kull mediċina, inklużi Kaletra soluzzjoni orali, li jkunu se jingħataw lit-trabi għandhom jiġu kkunsiderati sabiex jiġi evitat tossiċità minn dawn leċċipjenti (ara sezzjoni 4.4).
English: Concomitant administration of Kaletra and ergot alkaloids are contraindicated as it may lead to acute ergot toxicity, including vasospasm and ischaemia (see section 4.3).
Maltese: L-għoti flimkien ta' Kaletra u derivattivi tal-ergotina huma kontra-indikati minħabba li jista' jwassal għal tossiċità akuta talergot, inkluż vażospażmu u iskemija (ara sezzjoni 4.3).
English: The adult dose of Kaletra tablets (400/100 mg twice daily) may be used in children 40 kg or greater or with a Body Surface Area (BSA)* greater than 1.4 m2. For children weighing less than 40 kg or with a BSA between 0.5 and 1.4 m2 and able to swallow tablets, please refer to the Kaletra 100 mg/25 mg tablets Summary of Product Characteristics.
Maltese: Id-doża tal-pilloli Kaletra għall-adulti (400/100 mg darbtejn kuljum) tista' tintuża fi tfal li jiżnu 40 kg jew aktar jew li għandhom l-Erja tas-Superfiċje tal-Ġisem (BSA)* akbar minn 1.4 m2. Fil-każ ta' tfal li jiżnu inqas minn 40 kg jew li għandhom l-erja tas-superfiċje tal-ġisem (BSA) bejn 0.5 u 1.4 m2 li jafu jibilgħu l-pilloli, irreferi għat-tabelli ta' linji gwida għad-dożaġġ imniżżla hawn taħt.
English: The dose of maraviroc should be decreased to 150 mg twice daily during co-administration with Kaletra 400/100 mg twice daily.
Maltese: Id-doża ta' maraviroc għanda tiġi mnaqqsa għal-150 mg darbtejn kuljum waqt ko-amministrazzjoni b' Kaletra 400/100 mg darbtejn kuljum.
English: Concomitant medicinal product levels increased Alpha1-adrenoreceptor antagonist
Maltese: Livelli aktar għoljin tal-prodotti mediċinali li jingħataw b'mod konkomitanti Mediċini li jimblukkaw ir-riċettur α1-Adrenoreceptor
English: Bedaquiline: AUC: ↑ 22%
Maltese: AUC:↑22%
English: Mean baseline CD4+ T-cell count was 838 cells/mm3 and mean baseline plasma HIV-1 RNA was 4.7 log10 copies/ml.
Maltese: Il-linja bażi medja fl għadd ta' ċelluli CD4+ T-cell kien 838 ċelluli/mm3 u l-medja linja bażi plazma HIV-1 RNA kienet
English: Based on the findings in a paediatric study (observed exposures were approximately 35% AUC12 and 75% lower Cmin than in adults), young children from 14 days to 3 months could have sub-optimal exposure with a potential risk of inadequate virologic suppression and emergence of resistance (see section 5.2).
Maltese: u 75% inqas Cmin milli fl-adulti), tfal żgħar minn 14-il jum sa 3 xhur jista' jkollhom esponiment subottimali b'riskju potenzjali ta' soppressjoni u emerġenza ta' reżistenza viroloġiċi inadegwati (ara sezzjoni 5.2).
English: The 5 bottle pack also contains five 5 ml syringes with 0.1 ml graduations.
Maltese: Il-5 pakketti tal- fliexken fihom ukoll 5 ml siringi bi gradazzjonijiet ta' 0.1 ml.
English: Strong CYP3A4 inhibitors such as protease inhibitors may increase bedaquiline exposure which could potentially increase the risk of bedaquiline-related adverse reactions.
Maltese: Inibituri qawwija ta'CYP3A4 bħal inibituri tal-protease jistgħu jżidu l-espożizzjoni ta'bedaquiline li potenzjalment tista' żżid ir-riskju ta'reazzjonijiet avversi relatati ma'bedaquiline.
English: Kaletra is likely to increase plasma concentrations of medicinal products that are primarily metabolised by CYP3A.
Maltese: Kaletra x'aktarx li jżid il-konċentrazzjoni fil-plażma ta' prodotti mediċinali li primarjament huma metabolizzati minn CYP3A.
English: Polyvinyl alcohol
Maltese: Polimer ta' l-alkoħol (Polyvinyl alcohol)
English: At the recommended adult dose(s) of this medicine, the estimated blood alcohol concentration in your body is about 0.002 - 0.01 g/dL.
Maltese: Fid-doża(i) rrakkomandata għall-adulti ta' din il-mediċina, il-konċentrazzjoni stmata ta' alkoħol fiddemm fil-ġisem tiegħek huwa dwar 0.002-0.01 g/dL.
English: Concomitant administration of elbasvir/grazoprevir with Kaletra is contraindicated (see section 4.3).
Maltese: L-użu ta' avanafil ma' Kaletra huwa kontraindikat (ara sezzjoni 4.3).
English: The adverse reactions are displayed by system organ class.
Maltese: Klassi tas-Sistema ta' lOrganu
English: Immune Reconstitution Inflammatory Syndrome
Maltese: Sindromi ta' Rikostituzzjoni Infjammatorja
English: Through Week 96, genotypic resistance testing results were available from 25 patients in the QD group and 26 patients in the BID group who had incomplete virologic response.
Maltese: Matul Ġimgħa 96, ir-riżultati ta' testijiet ta' reżistenza ġenotipika ħarġu minn 25 pazjent mill grupp QD u 26 pazjent mill grupp BID li ma kellhomx rispons viroloġiku komplut.
English: A series of blood samples were collected pre-dose and at intervals over the course of 12 hours in trimester 2 and trimester 3, at birth, and 4-6 weeks postpartum (in women who continued treatment post-delivery) for pharmacokinetic analysis of total and unbound levels of plasma lopinavir concentrations.
Maltese: Serje ta' kampjuni tad-demm kienu miġbura qabel d-doża u f'intervalli waqt it-12-il siegħa fit-tieni tlett xhur tat-tqala u fit-tielet tlett xhur tat-tqala, fit-twelid, u 4-6 ġimgħatwara ttqala(f'nisa li komplew it-trattament wara t-tqala) għal analiżi farmakokinetika tal-konċentrazzjonijiet fil-plasma tal-livelli ta' lopinavir totali u ta' lopinavirmhux magħqud mal-proteini.
English: Lack of resistance to lopinavir was confirmed by phenotypic analysis.
Maltese: Nuqqas ta' reżistenza għal lopinavir ġiet ikkonfermata b'analiżi fenotipika.
English: Rash including maculopapular rash, dermatitis/rash including eczema and seborrheic dermatitis, night sweats, pruritus
Maltese: dermatite/raxx li jinkludi ekżema u dermatite ta' seborreja, perspirazzjoni eċċessiva bil-lejl,
English: More frequent electrocardiogram monitoring and monitoring of transaminases is recommended (see section 4.5 and refer to the bedaquiline SmPC).
Maltese: Monitoraġġ aktar frekwenti b'elettrokardjogramma u l-monitoraġġ ta'transaminases huwa rrakkomandat(ara sezzjoni 4.5 u rreferi għall-SmPC ta'bedaquiline).
English: Therefore, the antiviral activity of Kaletra is due to lopinavir.
Maltese: Għalhekk, l-attività antivirali ta' Kaletra hija dovuta lil lopinavir.
English: Antianginal Ranolazine
Maltese: Frekwenza Reazzjoni Avversa
English: Potential for serious and/or life-threatening reactions in patients with renal and/or hepatic impairment (see sections 4.4 and 4.5).
Maltese: Potenzjal ta' reazzjonijiet serji u/jew ta' periklu għall-ħajja f'pazjenti b'indeboliment renali u/jew epatiku (ara sezzjonijiet 4.4 u 4.5).
English: Two pack sizes are available for Kaletra oral solution: - 120 ml (2 bottles x 60 ml) with 2 x 2 ml syringes with 0.1 ml graduations
Maltese: − 120 ml (2 fliexken x 60 ml) bi 2 x 2 ml siringi bi gradazzjonijiet ta' 0.1 ml.
English: At entry, median age was 0.7 years, median CD4 T-cell count was 1147 cells/mm3, median CD4 T-cell was 19%, and median HIV-1 RNA was > 750,000 copies/ml.
Maltese: T-cell kien 19%, u lmedjan ta' HIV 1 RNA kien > 750,000 kopji/ml. Fost 13-il suġġett b'falliment tal-virus bi grupp lopinavir/ritonavir bi data ta' reżistenza disponibbli l-ebda reżistenza għal lopinavir/ritonavir ma nstabet.
English: No pattern of birth defects suggestive of a common etiology was seen.
Maltese: Ma dehret l-ebda segwenza ta' difetti mat-twelid li jindikaw etjoloġija komuni.
English: Reduced serum thyroxin led to an increased release of TSH with resultant follicular cell hypertrophy in the thyroid glands of rats.
Maltese: Serum thyroxine imnaqqas wassal għall rilaxxament akbar ta' TSH li rriżulta f'ipertrofija taċ ċellula follikulari fil-glandola tajrod tal-far.
English: The in vitro antiviral activity of lopinavir against 112 clinical isolates taken from patients failing therapy with one or more protease inhibitors was assessed.
Maltese: L-attività antivirali in vitro ta' lopinavir kontra 112 iżolati klinici meħuda minn pazjenti li kienu qed ifallu t-terapija b'wieħed jew iżjed mill-inibituri tal-protease kienu analizzati.
English: More frequent electrocardiogram monitoring and monitoring of transaminases is recommended (see section 4.4 and refer to the bedaquiline SmPC).
Maltese: Monitoraġġ aktar frekwenti b'elettrokardjogramma u l monitoraġġ ta'transaminases huwa rrakkomandat (ara sezzjoni 4.4
English: Median baseline CD4 cell count was 349 cells/mm3 (range 72 to 807 cells/mm3) and median baseline plasma HIV-1 RNA was 4.0 log10 copies/ml (range 2.9 to 5.8 log10 copies/ml).
Maltese: 349 ċelluli/mm3 (limiti 72 għal 807 ċelluli/mm3) u l- linja bażi medjana tal-plażma HIV-1 RNA kienet
English: Given the pharmacokinetic interaction between Kaletra and tenofovir (see section 4.5), the results of this study might not be strictly extrapolable when other backbone regimens are used with Kaletra.
Maltese: Meta tqis l-interazzjoni farmakokinetika bejn Kaletra u tenofovir (ara sezzjoni 4.5), ir-rizultati ta' dan l-istudju mhux bil-fors jistgħu jiġu estensi meta dużaġġi oħra principali jiġu użati ma
English: • midazolam taken orally (taken by mouth), triazolam (used to relieve anxiety and/or trouble sleeping);
Maltese: - midazolam orali (mittieħed mill-ħalq), triazolam (użati għas-soljiev ta' anzjetà u/jew problemi ta' l-irqad);
English: Blisters packs - polyvinyl chloride (PVC) blisters with fluoropolymer foil backing Two pack sizes are available: - carton containing 120 film-coated tablets - multipack containing 120 (3 cartons of 40) film-coated tablets
Maltese: Wieħed isib ukoll pakketti b'folji li jkun fihom iżjed minn pakkett wieħed, li fihom 120 pillola (pakkett b'120 pillola jew 3 pakketti b'40 pillola-il wieħed).
English: The 4-oxo and 4-hydroxymetabolite epimeric pair are the major metabolites with antiviral activity, but comprise only minute amounts of total plasma radioactivity.
Maltese: Il-par (koppja) epimeriku/a 4-oxo u 4-idroximetabolita huma l-metaboliti maġġuri b'attività antivirali, imma jikkomprendu biss ammonti żgħar ħafna mit-total kollu tarradjoattivita tal-plażma.
English: Volume of oral solution twice daily taken with food (80 mg lopinavir/20 mg ritonavir per ml)**
Maltese: (80 mg lopinavir/20 mg ritonavir kull ml)**
English: Patients with prior antiretroviral therapy
Maltese: Pazjenti li kellhom trattament antiretrovirali qabel
English: • lovastatin, simvastatin (used to lower blood cholesterol);
Maltese: - lovastatin, simvastatin (użati biex inaqqsu l-kolesterol fid-demm);
English: Multipack: 120 (3 packs of 40) film-coated tablets 120 film-coated tablets
Maltese: Pakkett li fih aktar minn pakkett wieħed: 120 (3 pakketti ta' 40)pillola miksija b'rita 120 pillola miksija b'rita
English: *Proportion of subjects who had HIV-1 < 400 copies/ml and had remained on study treatment
Maltese: *Proporzjon ta' individwi li kellhom HIV-1 <400 kopja/ml u kienu baqgħu fuq l-istudju ta' trattament
English: Fluvastatin or Pravastatin
Maltese: Rabdomijoliżi, osteonekrożi
English: Sedatives/hypnotics Oral midazolam, triazolam Increased plasma concentrations of oral midazolam and triazolam.
Maltese: Żieda fil-konċentrazzjoni fil-plażma ta' midazolam mittieħed mill-ħalq u triazolam.
English: • A history of liver problems as patients with a history of liver disease, including chronic hepatitis B or C are at increased risk of severe and potentially fatal liver side effects.
Maltese: - Storja ta' problemi tal-fwied,peress li pazjenti bi storja ta' mard tal-fwied, inkluża l-epatite kronika tat-tip B u Ċ huma f'riskju akbar ta' effetti sekondarji serji ħafna u li jistgħu jkunu fatali.
English: Along with nucleoside reverse transcriptase inhibitors (NRTIs), in some studies, Kaletra was used in combination with efavirenz or nevirapine.
Maltese: Bħal inibituri oħra ta' nucleoside reverse transcriptase (NRTIs), f'xi ftit studji, Kaletra kien użat ikkombinat ma' efavirenz jew nevirapine.
English: Concomitant use of avanafil or vardenafil and lopinavir/ritonavir is contraindicated (see section 4.3).
Maltese: L-għoti flimkien ta' Kaletra u ranolazine huwa kontraindikat (ara sezzjoni 4.3).
English: Тел.
Maltese: ml.
English: Kaletra oral solution is contraindicated in children below the age of 14 days, pregnant women, patients with hepatic or renal failure and patients treated with disulfiram or metronidazole due to the potential risk of toxicity from the excipient propylene glycol (see section 4.4).
Maltese: Is-soluzzjoni orali ta' Kaletra hija kontr-indikata fi tfal taħt l'età ta' 14-il ġurnata, nisa tqal, pazjenti b'disfunzjoni tal-fwied jew kliewi u pazjenti li huma trattati b'disulfiram jew metronidazole, minħabba tossiċita potenzjali mill-eċċipjent propylene glycol (ara sezzjoni 4.4).
English: • If the dose is between 2 ml and 5 ml - use the 5 ml oral dosing syringe to prepare a dose.
Maltese: − Jekk id-doża hija bejn 2 ml u 5 ml - uża s-siringa tad-dożaġġ orali ta' 5 ml biex tipprepara doża.
English: BATCH NUMBER
Maltese: Numru rrakkomandat ta'
English: Healthcare professionals should be aware that Kaletra oral solution is highly concentrated and contains 42.4% alcohol (v/v) and 15.3% propylene glycol (w/v).
Maltese: Informazzjoni importanti dwar xi wħud mis-sustanzi ta' Kaletra Kaletra fih 42% v/v alkoħol u 15% propylene glycol w/v.
English: See further the detailed description of the clinical studies.
Maltese: Ara deskrizzjoni aktar iddettaljata tal-istudji kliniċi.
English: • You must not take Kaletra with sildenafil used to treat pulmonary arterial hypertension (high blood pressure in the pulmonary artery) (see also Do not take Kaletra section above).
Maltese: - M'għandekx tieħu Kaletra ma' sildenafil użat għtll-trattament ta' ipertensjoni arterjali pulmonari (pressjoni għolja fl-arterja tal-pulmun)(ara s-sezzjoni hawn fuq ta' Tieħux Kaletra)