FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients with pre-existing liver dysfunction including chronic hepatitis have an increased frequency of liver function abnormalities during combination antiretroviral therapy and should be monitored according to standard practice.
Maltese: Pazjenti b'disfunzjoni tal-fwied ġa eżistenti, inkluża l-epatite kronika għandhom żieda fil-frekwenza funzjoni tal-fwied mhux normali waqt terapija kkombinata antiretrovirali, u għandhom ikunu monitorati kif titlob il-pratika standard.
English: Patients without prior antiretroviral therapy
Maltese: Pazjenti li qatt ma ħadu terapija antiretrovirali
English: If the benefit is considered to outweigh the risk and Kaletra must be used, reduce the ibrutinib dose to 140 mg and monitor patient closely for toxicity.
Maltese: Jekk ilbenefiċċju jitqies li huwa akbar mir-riskju u Kaletra għandu jintuża, naqqas id-doża ta' ibrutinib għal 140 mg u mmonetra mill-qrib il-pazjent għal tossiċità.
English: The lopinavir mean steadystate AUC, Cmax, and Cmin were 72.6 ± 31.1 µg•h/ml, 8.2 ± 2.9 µg/ml and 3.4 ± 2.1 µg/ml, respectively after Kaletra oral solution 230/57.5 mg/m2 twice daily without nevirapine (n=12), and were 85.8 ± 36.9 µg•h/ml, 10.0 ± 3.3 µg/ml and 3.6 ± 3.5 µg/ml, respectively after 300/75 mg/m2 twice daily with nevirapine (n=12).
Maltese: Il-medja fi steady-state tal-AUC, Cmax, u Cmin ta' lopinavir kien72.6± 31,1μg•h/ml, 8.2± 2.9µg•h/ml and 3.4± 2.1μg•h/ml rispettivament wara Kaletra
English: Sildenafil used to treat erectile dysfunction may be taken under doctor's supervision
Maltese: Sintomi infjammatorji għandhom jiġu evalwati u t-trattamenti mogħtija meta jkun neċessarju.
English: Modest decreases in amprenavir activity were noted with a median increase of IC50 from 3.7- to 8-fold in the baseline and rebound isolates, respectively.
Maltese: Tnaqqis modest f'attività ta' amprenavir ġew innutati b'żieda medjana ta' IC50 minn 3.7-il darba għal 8-il darba f'iżolati tal-linja bażi jew li marru lura rispettivament.
English: HIV-1 has been passaged in vitro with lopinavir alone and with lopinavir plus ritonavir at concentration ratios representing the range of plasma concentration ratios observed during Kaletra therapy.
Maltese: HIV-1 ġie mogħddi in vitro ma' lopinavir waħdu u ma' lopinavir flimkien ma ritonavir f'konċentrazzjonijiet proporzjonati, ;i jirrapreżentaw medda ta' konċentrazzjonijiet proporzjonati tal-plażma osservati waqt it-terapija b'Kaletra.
English: For children 2 weeks or older and weighing up to 15 kg
Maltese: Għat-tfal b'età ta' 2 ġimgħat jew ikbar u li jiżnu sa 15 kg
English: Lopinavir and ritonavir levels may increase on stopping St John's wort.
Maltese: lopinavir u ritonavir meta jitwaqqaf il-fexfiex tar-raba' (St John's wort).
English: Serum concentrations may be increased due to P-glycoprotein, BCRP and OATP1B inhibition by lopinavir/ritonavir.
Maltese: glycoprotein, BCRP u OATP1B/3 minn lopinavir/ritonavir.
English: Carcinogenicity studies in rats revealed no tumourigenic findings.
Maltese: Tarmix mediċini mal-ilma tad-dranaġġ.
English: Due to CYP3A4 inhibition by lopinavir/ritonavir.
Maltese: Konċentrazzjonijiet jistgħu jiżdiedu minħabba l-inibizzjoni ta' CYP3A4 minn lopinavir/ritonavir.
English: Concomitant administration with colchicine is contraindicated in patients with renal and/or hepatic impairment (see sections 4.3 and 4.5).
Maltese: Amministrazzjoni b'mod konkomitanti flimkien ma' colchicinehuwa kontraindikat, f'pazjenti b'indeboliment fil-kliewi u/jew fil-fwied (ara sezzjonijiet 4.3 u 4.5).
English: The recommended dosage of Kaletra is 5 ml of oral solution (400/100 mg) twice daily taken with food.
Maltese: Id-dużaġġ irrikmandat ta' Kaletra huwa ta' 5 ml ta' soluzzjoni orali (400/100 mg) darbtejn kuljum ma'
English: Due to BCRP (breast cancer resistance protein/ABCG2) and acute P-gp inhibition by lopinavir/ritonavir.
Maltese: ABCG2) u inibizzjoni akuta ta' P-gp minn lopinavir/ritonavir.
English: Caution should be exercised in administering carbamazepine or phenobarbital with Kaletra.
Maltese: nelfinavir, carbamazepine, phenobarbital u phenytoin.
English: Pancreatitis1, vomiting, gastrooesophageal reflux disease, gastroenteritis and colitis, abdominal pain (upper and lower), abdominal distension, dyspepsia, haemorrhoids, flatulence
Maltese: Dijarrea, nawsja Pankreatite1, rimettar, mard ta' refux gastro esofagali, gastroenterite u kolite, uġiegħ addominali (fuq u isfel), tinfiħ addominali, ħruq fl-istoku, morliti, gass
English: In HIV-infected patients with severe immune deficiency at the time of initiation of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic infections may arise.
Maltese: F'pazjenti infettati bl-HIV u li kellhom nuqqas serju ta' immunita meta inbeda trattament b' terapija antiretrovirali kkombinata (CART), jista jkun hemm reazzjoni infjammatorja għal infezzjoni li ma tidhirx jew li hi opportunistika fil-post.
English: Virologic Response of Study Subjects at Week 48 and Week 96 Week 48
Maltese: Rispons Viroloġiku ta' suġġetti studjati f'Ġimgħa 48 u f'Ġimgħa 96 Ġimgħa 48
English: Sustained virological response to Kaletra (in combination with nucleoside/nucleotide reverse transcriptase inhibitors) has been also observed in a small Phase II study (M97-720) through 360 weeks of treatment.
Maltese: Respons viroloġiku sostenut għal Kaletra (ikkombinat ma' inibituri nukleòside/nukleòtide reverse transcriptase ) ġie osservat anke fi studju Fażi
English: • Kaletra is not a cure for HIV infection or AIDS.
Maltese: − Kaletra mhuwiex trattament għall-infezzjoni tal-HIV jew tal-AIDS.
English: Study P1030 was an open-label, dose-finding trial evaluating the pharmacokinetic profile, tolerability, safety and efficacy of Kaletra oral solution at a dose of 300 mg lopinavir/75 mg ritonavir per m2 twice daily plus 2 NRTIs in HIV-1 infected infants ≥ 14 days and < 6 months of age.
Maltese: is-sigurtà u l-effikaċja ta' Kaletra soluzzjoni orali f'doża ta' 300 mg lopinavir/75 mg ritonavir kull m2 darbtejn kuljum flimkien ma' 2 NRTIs fi trabi infettati b'HIV-1 bl-età ta' ≥ 14 ġurnata u <6 xhur.
English: The 19 isolates demonstrated a 4.3-fold increase in IC50 compared to baseline isolates (from 6.2- to 43-fold, compared to wild-type virus).
Maltese: Id-19-il iżolati wrew żieda ta' 4.3-il darba f'IC50 meta mqabbla ma iżolati tal-linja bażi (minn 6.2-il darba għal 43-il darba, mqabbla ma virus tat tip mhux kkultivat).
English: Anticonvulsants Phenytoin
Maltese: Dawn il-prodotti mediċinali jinkludu
English: Each film-coated tablet contains 100 mg of lopinavir co-formulated with 25 mg of ritonavir as a pharmacokinetic enhancer.
Maltese: Kull pillola miksija b'rita fiha 100 mg lopinavir imħallat ma' 25 mg ritonavir biex iżid il farmakokinetika.
English: At least 13 lopinavir oxidative metabolites have been identified in man.
Maltese: Mill-inqas 13-il metabolita ossidattivi ta'lopinavir ġew identifikati fil-bniedem.
English: Of these, isolates from 96 nelfinavir-treated patients and 51 lopinavir/ritonavir-treated patients could be amplified for resistance testing.
Maltese: Min dawn, iżolati minn 96 pazjent trattat b' nelfinavir u 51 pazjent trattat b' lopinavir/ritonavir setgħu ġew studjati wkoll għal testijiet ta' reżistenza.
English: CYP3A4 inhibition likely due to lopinavir/ritonavir.
Maltese: Impedituri ta' CYP3A4 iżidu l esponiment ta' lomitapide,
English: Co-administration of encorafenib with Kaletra may increase encorafenib exposure which may increase the risk of toxicity, including the risk of serious adverse events such as QT interval prolongation.
Maltese: L-għoti ta' encorafenib flimkien ma' Kaletra jista' jżid l-esponiment għal encorafenib li jista' jżid irriskju ta' tossiċità, inkluż ir-riskju ta' avvenimenti avversi serji bħal titwil tal-intervall tal-QT.
English: The selection of resistance to lopinavir in patients having failed prior protease inhibitor therapy was characterised by analysing the longitudinal isolates from 19 protease inhibitor-experienced subjects in 2 Phase II and one Phase III studies who either experienced incomplete virologic suppression or viral rebound subsequent to initial response to Kaletra and who demonstrated incremental in vitro resistance between baseline and rebound (defined as emergence of new mutations or 2-fold change in phenotypic susceptibility to lopinavir).
Maltese: Dawn kienu esperjenzaw suppressjoni viroloġika mhux kompluta jew kellhom virus li ma baqax suppressat wara reazzjoni tal-bidu għal Kaletra jew ukoll li wrew reżistenza inkrementali in vitro bejn il-linja bażi u definit bħala t-tfaċċar ta' mutazzjonijiet ġodda jew bidla għal suxxettibilità fenotipika dopjja għal lopinavir).
English: Caution should be exercised in administering Kaletra with bosentan.
Maltese: Mhux rakkomandat liKaletra u simeprevir jiġu amministrati flimkien.
English: The co-administration of riociguat with Kaletra is not recommended (see section 4.4 and refer to riociguat SmPC).
Maltese: Il-frekwenza ta' dan mhux magħrufa (ara sezzjoni 4.4).
English: The median EC50 of lopinavir against isolates with 0 − 3, 4 − 5, 6 − 7 and 8 − 10 mutations at the above amino acid positions was 0.8, 2.7 13.5 and 44.0-fold higher than the EC50 against wild type HIV, respectively.
Maltese: 0.8, 2.7 13.5 u 44.0 darba ogħla mill-EC50 kontra l-HIV tat-tip mhux ikkultivat, rispettivament.
English: The median fold IC50 of lopinavir for these 18 isolates at baseline and rebound was 6.9- and 63-fold, respectively, compared to wild type virus.
Maltese: It-tinja tal-medjan IC50 ta' lopinavir ta' dawn it18-il iżolat fil-linja bażi u li marru lura kienet6.9-il darba u 63-il darba rispettivament, mqabbel ma virus tat-tip mhux ikkultivat.
English: Life-threatening and fatal drug interactions have been reported in patients treated with colchicine and strong inhibitors of CYP3A like ritonavir.
Maltese: Interazzjonijiet fatali tal-mediċina u ta' periklu għall-ħajja ġew irrappurtati f'pazjenti ttrattati b'colchicine u inibituri qawwija ta' CYP3A bħal ritonavir.
English: Cases of pancreatitis have been reported in patients receiving Kaletra, including those who developed hypertriglyceridaemia.
Maltese: Każijiet ta' pankreatite ġew irrapurtati f'pazjenti li qed jieħdu Kaletra, inklużi dawk li żvillupaw ipertrigliċeridimja.
English: Lopinavir provides the antiviral activity of Kaletra.
Maltese: Għalhekk l-attività antivirali tal-Kaletra hija dovuta għal-lopinavir.
English: Two pack sizes are available:
Maltese: Żewġ daqsijiet tal-pakkett huma disponibbli:
English: Patients should be informed that nausea has been reported during treatment with Kaletra (see section 4.8).
Maltese: Il-pazjenti għandhom jiġu infurmati li ġew irrappurtati każi ta' nawseja waqt it-trattatment b'Kaletra (ara sezzjoni 4.8).
English: If Kaletra is co-administered with parenteral midazolam, it should be done in an intensive care unit (ICU) or similar setting which ensures close clinical monitoring and appropriate medical management in case of respiratory depression and/or prolonged sedation.
Maltese: Jekk Kaletra jingħata flimkien ma' midazolam parenterali, dan għandu jsir f'post għall-kura intensiva (ICU) jew post simili fejn issir osservazzjoni klinika mill-qrib u fejn ikun hemm treġija medika adegwata f'każ illi jkun hemm deppressjoni respiratorja u/jew sedazzjoni twila aktar milli sippost.
English: It is not recommended to co-administer Kaletra and sofosbuvir/velpatasvir/ voxilaprevir.
Maltese: (eż. glecaprevir/pibrentasvir, simeprevir u sofosbuvir/velpatasir/voxilaprevir);
English: The 230/57.5 mg/m2 dosage might be insufficient in some children when co-administered with nevirapine or efavirenz.
Maltese: 230/57.5 mg/m2 darbtejn kuljum mingħajr nevirapine (n=12), u kienu 85.
English: In dogs, prominent U waves on the electrocardiogram have been observed associated with prolonged PR interval and bradycardia.
Maltese: Fil-klieb, mewġ U prominenti fuq l-elektrokardjogramma ġew osservati (bħala li kienu) assoċjati ma' intervall PR prolongat u mal-bradikardja.
English: At 30 weeks age of gestation, the dose was increased to 500/125 mg (two 200/50 mg tablets plus one 100/25 mg tablet) twice daily until subjects were 2 weeks postpartum.
Maltese: Fit-30 ġimgħa ta-tqala, d-doża kienet miżjuda għal 500/125 mg (żewġ pilloli ta' 200/50 mg flimkien ma' pillola ta' 100/25 mg) darbtejn kuljum sa' ġimgħatejn t-tqala.
English: In case of concomitant antiviral therapy for hepatitis B or C, please refer to the relevant product information for these medicinal products.
Maltese: F'każ li terapiji antiretrovirali jittieħdu flimkien għal epatite B jew Ċ, jekk jogħġbok irreferi għall-informazzjoni tal-prodott għal dawn il-prodotti mediċinali.
English: The pharmacokinetics of Kaletra 300/75 mg/m2 twice daily with nevirapine and 230/57.5 mg/ m2 twice daily alone have been studied in 53 paediatric patients ranging in age from 6 months to 12 years.
Maltese: Il-farmakokinetika ta' Kaletra 300/75 mg/m2 darbtejn kuljum b'nevirapine u 230/57.5 mg/m2
English: This is similar to an adult drinking 4-22 ml of beer or 1-4 ml of wine.
Maltese: birra jew 1-4 ml ta' inbid.
English: Concentrations are decreased due to CYP3A induction by phenytoin.
Maltese: Kaletra kienet dovuta għas-sustanza attiva oriġinali.
English: Erectile dysfunction, menstrual disordersamenorrhoea, menorrhagia
Maltese: Disturbi fl-erezzjoni, disturbi fil menstruazzjoni - amenorrea, menorraġia
English: Due to the risk of QTc prolongation associated with DM-6705, if co-administration of delamanid with Kaletra is considered necessary, very frequent ECG monitoring throughout the full delamanid treatment period is recommended (see section 4.4 and refer to the delamanid SmPC).
Maltese: QTc assoċjati ma' DM 6705, jekk l-ko-amministrazzjoni ta' delamanid ma' lopinavir / ritonavir huwa kkunsidrat neċessarju, huwa rrakkomandat monitoraġġ ta' ECG frekwenti ħafna matul il-perjodu kollu tattrattament ta' delamanid (ara sezzjoni 4.4 u rreferi għall-SmPC
English: Undesirable effects in clinical studies and post-marketing in adult patients System organ class
Maltese: Effetti mhux mixtieqa fi studji kliniċi u ta' wara t-tqegħid fis-suq f'pazjenti adulti
English: Use the 2 ml oral dosing syringe to prepare a dose.
Maltese: - Uża s-siringa orali ta' 2 ml ipprovduta li tkejjel id-doża.
English: Uncommon Hepatic steatosis, hepatomegaly, cholangitis, hyperbilirubinemia
Maltese: Anemija, lewkopenija, newtropenja, limfadenopatija
English: Kaletra 200 mg film-coated tablets and Kaletra 100 mg/25 mg film-coated tablets: AbbVie Deutschland GmbH & Co. KG, Knollstrasse, 67061 Ludwigshafen, Germany
Maltese: lopinavir/ritonavir 100 mg/25 mg dożati skont il-piż bħala parti mit-terapija antiretrovirali kombinata(cART) fit-tfal infettati b'HIV-1 li huma soppressi viroloġikament (n = 173).
English: In the absence of human serum, the mean IC50 of lopinavir was 6.5 nM against several HIV-1 clinical isolates.
Maltese: ta' lopinavir kien 6.5 nM kontra bosta iżolati kliniċi HIV-1.
English: It is important to note that cases of pancreatitis have been reported in patients receiving Kaletra, including those who developed hypertriglyceridaemia.
Maltese: Huwa importanti li ninutaw li każi ta' pankreatite ġew rappurtati f'pazjenti li qed jieħdu Kaletra, inklużi dawk li żvillupaw ipertrigliċeridemija.
English: The plasma levels of ritonavir are less than 7% of those obtained after the ritonavir dose of 600 mg twice daily.
Maltese: Il livelli fil-plażma ta' ritonavir huma inqas minn 7% ta' dawk miksuba wara d-doża ta' ritonavir ta' 600mg darbtejn kuljum.
English: Co-administration of ibrutinib and Kaletra should be avoided.
Maltese: Ko-amministrazzjoni ta' ibrutinib u
English: The co-administration of vorapaxar with Kaletra is not recommended (see section 4.4 and refer to the vorapaxar SmPC).
Maltese: L-użu ta' rivaroxaban mhux rakkomandat f' pazjenti li qed jirċievu trattament konkomitanti b' Kaletra (ara sezzjoni 4.4).
English: Lopinavir/ritonavir plasma concentrations may decrease due to CYP3A4 induction by bosentan.
Maltese: Minħabba li lopinavir/ritonavir jimpedixxi CYP3A4.
English: The efficacy data favouring the twice-daily regimen are reinforced by a differential in pharmacokinetic parameters significantly favouring the twice-daily regimen (see section 5.2).
Maltese: Id-data dwar l-effikaċja li tiffavorixxir-reġimen ta' darbtejn kuljum hija msaħħa minn differenzjal fil-parametri farmakokinetiċi li jiffavorixxi b'mod sinifikattiv ir-reġimenta' darbtejn kuljum (ara sezzjoni 5.2).
English: • swelling or inflammation of the stomach, intestines and colon;
Maltese: − nefħa jew infjammazzjoni tal-istonku, intestini u colon;
English: Serum concentrations may be increased due to CYP3A inhibition by lopinavir/ritonavir, resulting in increased risk of tumor lysis syndrome at the dose initiation and during the ramp-up phase (see section 4.3 and refer to the venetoclax SmPC).
Maltese: Il-konċentrazzjonijiet tas-serum jistgħu jiżdiedu minħabba inibizzjoni ta' CYP3A minn lopinavir/ritonavir, li jirriżulta f'żieda fir-riskju tas-sindromu ta' lisi tat-tumur meta tinbeda d-doża u matul il-fażi ta' żieda fid-doża (ara sezzjoni 4.3 u irreferi għall- SmPC
English: The use of rivaroxaban is not recommended in patients receiving concomitant treatment with Kaletra (see section 4.4).
Maltese: - rivaroxaban mhux irrakomandat (ara sezzjoni 4.5).
English: Each ml contains lopinavir 80 mg and ritonavir 20 mg.
Maltese: Kull ml ta' Kaletra soluzzjoni orali fihlopinavir 80 mg u ritonavir 20 mg.
English: Concomitant administration of Kaletra with colchicine in patients with renal and/or hepatic impairment is contraindicated due to a potential increase of colchicine-related serious and/or life-threatening reactions such as neuromuscular toxicity (including rhabdomyolysis) (see sections 4.3 and 4.4).
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: AUC: ↑ 7.2-fold Cmax: ↑ 4.7-fold Cmin: ↑ 14.4-fold
Maltese: AUC: ↑ 2.17- darbiet Cmax: ↑ 2.04- darbiet Ctrough: ↑ 2.36- darbiet
English: The concomitant administration with lurasidone is contraindicated (see section 4.3).
Maltese: sildenafil huwa kontraindikat (ara sezzjoni 4.3).
English: Concomitant administration of Kaletra and quetiapine is contraindicated as it may increase quetiapine-related toxicity.
Maltese: Amministrazzjoni konkomitanti ta' Kaletra ma' quetiapine huwa kontraindikat għax jista' jżid it tossiċità relatata ma' quetiapine.
English: Lovastatin and Simvastatin Lovastatin, Simvastatin: Markedly increased plasma concentrations due to CYP3A inhibition by lopinavir/ritonavir.
Maltese: Żieda kbira fil-konċentrazzjoni fil-plażma minħabba li lopinavir/ritonavir jimpedixxi CYP3A.
English: • lomitapide (used to lower blood cholesterol);
Maltese: - lomitapide (użat biex inaqqas il-kolesterol fid-demm);
English: dosage adjustment recommendations.
Maltese: Mhux applikabbli.
English: Amiodarone, Dronedarone Amiodarone, Dronedarone: Concentrations may be increased due to CYP3A4 inhibition by lopinavir/ritonavir.
Maltese: - amiodarone, dronedarone(użat biex jittratta taħbita mhux normali tal-qalb); - lovastatin, simvastatin (użati biex inaqqsu l-kolesterol fid-demm);
English: One-hundred thirteen nelfinavir-treated patients and 74 lopinavir/ritonavir-treated patients had an HIV RNA above 400 copies/ml while on treatment from Week 24 through Week 96.
Maltese: RNA il-fuq min 400 kopja/ml waqt li kienu fuq trattament min ġimgħa 24 sa ġimgħa 96.
English: Cases of osteonecrosis have been reported, particularly in patients with generally acknowledged risk factors, advanced HIV disease or long-term exposure to combination antiretroviral therapy (CART).
Maltese: osteonekrożi ġew irrappurtati partikolarment f'pazjenti fi stat avvanzat ta' HIV u/jew esposizzjoni twila għal terapija antiretrovirali (CART).
English: After multiple dosing, less than 3% of the lopinavir dose is excreted unchanged in the urine.
Maltese: 3% tad-doża ta' lopinavir hija mneħħija mhux mibdula fl-urina.
English: Co-administration of delamanid with a strong inhibitor of CYP3A (as lopinavir/ritonavir) may increase exposure to delamanid metabolite, which has been associated with QTc prolongation.
Maltese: L-għoti ta' delamanid flimkien ma' inibitur qawwi ta' CYP3A (bħal lopinavir/ritonavir) jista' jżid lespożizzjoni għall-metabolit ta' delamanid, li ġie assoċjat mat-titwil tal-QTc.
English: Other
Maltese: kontra
English: The twice-daily weight-band dosing without nevirapine provided lopinavir plasma concentrations similar to those obtained in adult patients receiving the 400/100 mg twice-daily regimen without nevirapine.
Maltese: Id-dożaġġ skont il-piż darbtejn kuljum mingħajr nevirapine pprovdakonċentrazzjoni fil-plażma ta' lopinavir simili għal dik milħuqa f'pazjenti adulti li kienu qegħdin jirċievu dożaġġ ta' 400/100 mg darbtejn kuljum mingħajr nevirapine. .
English: Lopinavir: AUC: ↔
Maltese: AUC:↔
English: HIV RNA < 50 copies/ml
Maltese: HIV RNA < 400 kopji/ml HIV RNA < 50 kopji /ml
English: Each tablet of Kaletra contains 200 mg of lopinavir and 50 mg of ritonavir
Maltese: Kull pillola Kaletra fihalopinavir 200 mg u ritonavir 50 mg.
English: Concomitant administration of Kaletra with fusidic acid is contraindicated in dermatological indications due to the increased risk of adverse events related to fusidic acid, notably rhabdomyolysis (see section 4.3).
Maltese: Il-piż u l-livelli ta' lipidi u glukożju fid-demm jistgħujiżdiedu matul it-terapija antiretrovirali (ara sezzjoni 4.4).
English: Kaletra oral solution contains up to 0.3 g of glycerol per dose.
Maltese: Is-soluzzjoni oralo ta' Kaletra fih daqs 0.3g ta' glycerol għal kull doża.
English: Please refer to the Aptivus Summary of Product Characteristics for additional information on the use of tipranavir, including genotypic predictors of response, in treatment of lopinavir-resistant HIV-1 infection.
Maltese: Kaletra huwa indikat flimkien ma' aġenti antiretrovirali oħra għat-trattament ta' adulti, adoloxxenti u tfal il-fuq minn sentejn infettati b il- human immunodeficiency virus (HIV-1).
English: • fusidic acid used to treat long-term infections of the bones and joints (e.g. osteomyelitis);
Maltese: fusidic acid għal infezzjonijiet tal-għadam u l-ġoġi mhijiex rakkomandata (ara sezzjoni 4.5);
English: • levothyroxine (used to treat thyroid problems);
Maltese: − vorapaxarmhux irrakkomandat (ara sezzjoni 4.5);
English: Concomitant administration of Kaletra and pimozide is contraindicated as it may increase the risk of serious haematologic abnormalities or other serious adverse effects from this agent (see section 4.3)
Maltese: pimozide huwa kontra-indikat minħabba li jista' jżid ir-riskju ta' anormalitajiet ematoloġiċi serji jew effetti avversi serji oħra minn dan l-aġent (ara sezzjoni 4.3)
English: adverse events, including renal disorders.
Maltese: żieda fl-effetti avversi.
English: However, if it is judged necessary to resort to solid oral dosage form for children weighing less than 40 kg or with a BSA between 0.5 and 1.4 m2 and able to swallow tablets, Kaletra 100 mg/25 mg tablets may be used.
Maltese: Minkejja dan, jekk jiġi meqjus neċessarju rikorriment għall-forma solida ta' dużaġġ orali fi tfal li jiżnu inqas minn 40 kg jew b'BSA ta' bejn 0.5 u 1.4 m2 u huma kapaċi jibilgħu l-pilloli, jistgħu jintużaw pilloli ta' Kaletra100 mg/25 mg.
English: Virologic Response of Study Subjects at Week 48 Study 802 QD BID Difference [95% CI]
Maltese: Rispons Viroloġiku ta' suġġetti studjati f'Ġimgħa 48 ta' Studju 802
English: Pancreatitis should be considered if clinical symptoms (nausea, vomiting, abdominal pain) or abnormalities in laboratory values (such as increased serum lipase or amylase values) suggestive of pancreatitis should occur.
Maltese: Il-pankreatite għandha tiġi kkunsidrata jekk sintomi kliniċi (nawseja, rimettar, uġigħ addominali) jew valuri tal-laboratorju mhux normali (bħal żieda fis-serum lipase u fil-valuri ta' l-amylase) li jissuġġerixxu l-eżistenza tal-pankreatite, iseħħu.