FrancophonIA/ELRC3.0 huggingface dataset:
English: Antiviral activity in vitro: Saquinavir demonstrates antiviral activity against a panel of laboratory strains and clinical isolates of HIV-1 with typical EC50 and EC90 values in the range 1-10 nM and 5-50 nM, respectively, with no apparent difference between subtype B and non-B clades.
Maltese: Saquinavir juri attività antivirali kontra firxa ta' razez tal-laboratorju u iżolati kliniċi ta' HIV-1 b'valuri tipiċi ta' EC50 u EC90 fil-firxa ta' 1-10 nM u 5-50 nM rispettivament, bl-ebda differenza evidenti bejn il-gruppi tas-sottotip B u mhux B.
English: Increased alanine aminotransferase, increased aspartate aminotransferase, increased low density lipoprotein
Maltese: Żjieda ta' alanine aminotransferase, żjieda ta' aspartate aminotransferase, żjieda ta' lipoproteini ta' densità baxxa
English: Nervous System Disorder Common
Maltese: Disturbi fis-Sistema Nervuża
English: Medicinal products that are substrates of P-glycoprotein Digitalis glycosides
Maltese: Prodotti mediċinali li huma substrati ta' P-glycoprotein
English: Ibutilide
Maltese: Ibutilide Sotalol
English: Sildenafil Cmax ↑ 140 % Sildenafil AUC ↑ 210 %
Maltese: Sildenafil Cmax ↑ 140 % Sildenafil AUC ↑ 210 % - Sildenafil huwa substrat ta' CYP3A4.
English: The corresponding serum (50% human serum) adjusted EC50 ranged from 25-250 nM. Clinical isolates of HIV-2 demonstrated EC50 values in the range of 0.3-2.4 nM.
Maltese: L-EC50 korrispondenti aġġustat tasserum (50 % serum uman) varja minn 25-250 nM.
English: Glycerol triacetate, Iron oxide yellow and red (E172).
Maltese: Iron oxide isfar u aħmar (E172).
English: The frequency groupings according to MedDRA convention are: Very common (≥ 1/10); common (≥ 1/100 to <1/10); uncommon (≥ 1/1,000 to <1/100); rare (≥ 1/10,000 to <1/1,000); very rare (<1/10,000); not known (frequency cannot be estimated from the available data).
Maltese: Komuni ħafna (≥ 1/10); komuni (≥ 1/100 sa <1/10); mhux komuni (≥ 1/1,000 sa <1/100); rari (≥ 1/10,000 sa <1/1,000); rari ħafna (<1/10 000); mhux magħruf (frekwenza ma tistax tiġi stmata mid-dejta disponibbli).
English: Day 10
Maltese: Jum 10
English: Saquinavir is essentially completely metabolised by CYP3A4.
Maltese: Saquinavir huwa essenzjalment metabolizzat kompletament minn CYP3A4.
English: Methadone AUC ↓ 19 % (90 % CI 9 % to 29 %) None of the 12 patients experienced withdrawal symptoms.
Maltese: Methadone AUC ↓ 19 % (90 % CI 9 % sa 29 %) L-ebda wieħed mit-12-il pazjent ma kellu esperjenza ta' sintomi ta'
English: Invirase/ritonavir may increase concentrations of tricyclic antidepressants.
Maltese: Invirase/ritonavir jista' jżid ilkonċentrazzjonijiet ta' antidepressanti triċikliċi.
English: Nefazodone inhibits CYP3A4.
Maltese: Nefazodone jinibixxi lil CYP3A4.
English: In the “High Age Group”, the number of patients with a viral load <400 copies/mL at week 48 was 11 of 13.
Maltese: Fil-“Grupp ta' Età Akbar”, in-numru ta' pazjenti b'viral load ta' <400 kopja/mL wara 48 ġimgħa kien ta' 11 minn 13.
English: Anticonvulsants - Carbamazepine Phenobarbital Phenytoin (saquinavir/ritonavir)
Maltese: - Carbamazepine Phenobarbital Phenytoin (saquinavir/
English: Safety pharmacology: Cloned human cardiac potassium channel (hERG) trafficking in vitro was inhibited by 75% at 30μM of saquinavir.
Maltese: Waqt studji in vitro, l-ittraffikar fil-kanali kardijaċi tal-potassium umani (hERG) ikklonati kien impedut b'75% f'konċentrazzjoni ta' 30μM ta' saquinavir.
English: The number of patients with viral load <50 copies/mL was 9 of 13 for the same period.
Maltese: In-numru ta' pazjenti b'viral load ta' <50 kopja/mL kien ta' 9 minn 13 għall-istess perijodu.
English: - Delavirdine (unboosted saquinavir)
Maltese: - Delavirdine (saquinavir/
English: • medicines for gout, such as colchicine
Maltese: • mediċini għal gotta, bħal colchicine
English: Adverse reactions are presented according to the MedDRA system organ classification.
Maltese: Ir-reazzjonijiet avversi huma ppreżentati skont il-klassifika tas-sistemi u tal-organi MedDRA.
English: Efavirenz 600 mg qd (saquinavir/ritonavir 1600/200 mg qd, or saquinavir/ritonavir 1000/100 mg bid, or saquinavir/ritonavir 1200/100 mg qd)
Maltese: Efavirenz 600 mg qd (saquinavir/ritonavir 1600/200 mg qd, jew saquinavir/ritonavir 1000/100 mg bid, jew saquinavir/ritonavir 1200/100 mg qd)
English: Also contains lactose (monohydrate) 38.5 mg, colourants (titanium dioxide E 171, iron oxide E 172) and other constituents.
Maltese: Fih ukoll lactose (monohydrate) 38.5 mg, sustanzi koloranti (titanium dioxide E 171, iron oxide E 172) u kositwenti oħra.
English: The pharmacokinetic exposure parameters for the “High Age Group” are listed in Table 10.
Maltese: Il-parametri farmakokinetiċi ta' espożizzjoni għall-“Grupp ta' Età Akbar” huma elenkati f'Tabella 10 taħt.
English: Combination not recommended as may result in increased risk of cardiovascular adverse events associated with salmeterol, including QT prolongation, palpitations, and sinus tachycardia (see section 4,4).
Maltese: It-taħlita mhux irrakkomandata peress li tista' tirriżulta f'riskju akbar ta' avvenimenti kardjovaskulari avversi assoċjati ma' salmeterol, inkluż titwil ta' QT, palpitazzjonijiet, u takikardija tassinus (ara sezzjoni 4.4).
English: Rifampicin is contraindicated in combination with Invirase/ritonavir (see section 4.3).
Maltese: Rifampicin huwa kontra-indikat flimkien ma' Invirase/ritonavir (ara sezzjoni 4.3).
English: Oral contraceptives Ethinyl estradiol (saquinavir/ritonavir)
Maltese: Kontraċettivi orali Ethinyl estradiol (saquinavir/ritonavir)
English: Table 10: Pharmacokinetic parameters of saquinavir at steady-state in HIV-infected pediatric patients
Maltese: Parametri farmakokinetiċi ta' saquinavir fi stat fiss f'pazjenti pedjatriċi infettati b'HIV
English: Vasodilators (peripheral) Vincamine i.v.
Maltese: Vincamine i.v.
English: UNIQUE IDENTIFIER - 2D BARCODE Not applicable
Maltese: IDENTIFIKATUR UNIKU - BARCODE 2D Mhux applikabbli
English: Other medicinal products Alpha-1 adrenoreceptor antagonist Alfuzosin
Maltese: Antagonisti tal-adrenoriċetturi Alpha 1
English: The association between the number of these saquinavir-associated resistance mutations and virological response was confirmed in an independent clinical study (RESIST 1 and 2) involving a more heavily treatment experienced patient population, including 54% who had received prior saquinavir (p=0.0133, see Table 5).
Maltese: L-assoċazzjoni bejn in-numru ta' dawn il-mutazzjonijiet ta' reżistenza assoċjati ma' saquinavir u rispons viroloġiku kien ikkonfermat fi studju kliniku indipendenti (RESIST 1 u 2) li nvolva popolazzjoni ta' pazjenti b'esperjenza ta' kura aktar qawwija, inkluż 54 % li kienu rċevew saquinavir minn qabel (p=0.0133, ara Tabella 5).
English: • some medicines affecting the immune system - such as ciclosporin, sirolimus (rapamycin),
Maltese: • xi mediċini b'effett fuq is-sistema immunitarja - bħal ciclosporin, sirolimus (rapamycin),
English: • certain heart medicines - such as calcium channel blockers, quinidine, digoxin
Maltese: • xi mediċini għall-qalb - bħal imblokkaturi tal-kanali tal-kalċju, quinidine, digoxin
English: The mean (% coefficient of variation in parentheses) values for saquinavir AUC0-12 and Cmax were 24.3 (102%) µg·hr/ml and 3.6 (83%) µg/ml, respectively, for HIV-infected patients with moderate hepatic impairment.
Maltese: Il-valuri medja (koeffiċjent % ta' varjazzjoni fil-parentesi) ta' l-AUC0-12 u Cmax għal saquinavir kienu 24.3 (102%) µg·hr/ml u 3.6 (83%) µg/ml, rispettivament, għall-pazjenti infettati bl-HIV b'indeboliment moderat tal-fwied.
English: Table 2: Incidences of Adverse Reactions and marked laboratory abnormalities in clinical studies and post-marketing experience in adult patients.
Maltese: Tabella 2: Inċidenza ta' Reazzjonijiet Avversi u anormalitajiet sinnifikanti tal-laboratorju minn studji kliniċi u esperjenza ta' wara t-tqegħid fis-suq f'pazjenti adulti.
English: • certain medicines for depression - amitriptyline, imipramine, trazodone, maprotiline
Maltese: • ċertu mediċini għad-depressjoni - amitriptyline, imipramine, trazodone, maprotiline
English: The proportion of patients with a reported PR interval prolongation > 200 ms in this study ranged from 3/22 (14%) (day 3) to 8/21 (38%) (day14).
Maltese: Ilproporzjon ta' pazjenti b'rapport ta' titwil fl-interval PR ta' > 200 ms f'dan l-istudju kien ivarja minn 3/22 (14%) (jum 3) sa 8/21 (38%) (jum 14).
English: The metabolism of saquinavir is mediated by cytochrome P450, with the specific isoenzyme CYP3A4 responsible for 90 % of the hepatic metabolism.
Maltese: Il-metaboliżmu ta' saquinavir huwa medjat miċ-ċitokromju P450 bl-iżoenżima speċifiku CYP3A4 responsabbli għal 90 % tal-metaboliżmu mill-fwied.
English: • certain medicines for HIV - such as atazanavir, lopinavir, rilpivirine
Maltese: • ċertu mediċini kontra l-HIV bħal atazanavir, lopinavir, rilpivirine
English: Antiviral activity according to baseline genotype and phenotype:
Maltese: Attività antivirali skond il-ġenotip u fenotip fil-linja bażi:
English: Change in Baseline Plasma HIV-1 RNA at Weeks 12-20
Maltese: Bidla fl-RNA ta' HIV-1 fil-Plażma fil-Linja Bażi f'Ġimgħa 12-20
English: Genotypic and phenotypic clinical cut-offs predicting the clinical efficacy of ritonavir boosted saquinavir have been derived from retrospective analyses of the RESIST 1 and 2 clinical studies and analysis of a large hospital cohort (Marcelin et al 2007).
Maltese: Punti kliniċi ġenotipiċi u fenotipiċi ta' waqfien li jbassru l-effikaċja klinika ta' saquinavir imsaħħaħ b'ritonavir ġew derivati minn analiżi retrospettiva ta' l-istudji kliniċi RESIST 1 u 2 u analiżi ta' ko-orti kbir ta' l-isptar (Marcelin et al 2007).
English: ANNEX II
Maltese: Tabella 10
English: The infants and young children were stratified into 2 groups: Group A “Low Age Group” 4 months to less than 2 years old (n=5) and Group B “High Age Group” children 2 years to less than 6 years old (n=13).
Maltese: Grupp A “Grupp ta' Età Żgħira” b'età minn 4 xhur sa inqas minn sentejn (n=5) u Grupp B “Grupp ta' Età Akbar” tfal b'età minn sentejn sa inqas minn 6 snin (n=13).
English: If a patient is already taking St. John's wort, stop St. John's wort, check viral levels and if possible saquinavir levels.
Maltese: John's wort, iċċekja l-livelli virali u jekk possibbli l-livelli ta' saquinavir.
English: N AUCτ (ng·h/ml) AUC0-24 (ng·h/ml) †
Maltese: N AUCτ (ng·h/ml)
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Maltese: Pazjenti bi problema rari ereditarji ta' intolleranza għall-galattosju, defiċjenza ta' Lapp lactase jew assorbiment ħażin ta' glukożju-galattosju n'għandhomx jieħdu din il-mediċina.
English: 6.5 Nature and contents of container Plastic bottles (HDPE) containing 120 tablets.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Fliexken tal-plastika (HDPE) li fihom 120 pillola.
English: Absolute bioavailability averaged 4 % (CV 73 %, range: 1 % to 9 %) in 8 healthy volunteers who received a single 600 mg dose (3 x 200 mg hard capsule) of Invirase following a heavy breakfast.
Maltese: Il-bijodisponibilità assoluta kienet medja ta' 4 % (CV 73 %, varjazzjoni: 1 % għal 9 %) fi 8 volontiera b'saħħithom li ngħataw doża waħda ta' 600 mg (3 x 200 mg kapsula iebsa) ta' Invirase wara kolazzjon kbira.
English: Antihistamines Terfenadine Astemizole (saquinavir/ritonavir)
Maltese: Antistaminiċi Terfenadine Astemizole (saquinavir/ritonavir)
English: Clarithromycin 500 mg bid (unboosted saquinavir 1200 mg tid)
Maltese: - Clarithromycin 500 mg bid (saquinavir mhux imsaħħaħ 1200 mg tid)
English: In a mass balance study using 600 mg 14C-saquinavir (n = 8), 88 % and 1 % of the orally administered radioactivity, was recovered in faeces and urine, respectively, within 4 days of dosing.
Maltese: Fi studju mass balance bl-użu ta' 600 mg ta' 14C-saquinavir (n = 8), 88 % u 1 % tar-radjuattività mogħtija mill ħalq, kienet irkuprata fl-ippurgar u fl-awrina, rispettivament, sa 4 ijiem mill-għotja tad-doża.
English: • other HIV medicines - such as nelfinavir, indinavir, nevirapine, delavirdine, efavirenz, maraviroc,
Maltese: • mediċini oħra għall-HIV - bħal nelfinavir, indinavir, nevirapine, delavirdine, efavirenz,
English: Somnolence, convulsions
Maltese: imipramine, clomipramine)
English: QT and PR prolongation on electrocardiogram: The effects of therapeutic (1000/100 mg twice daily) and supra-therapeutic (1500/100 mg twice daily) doses of Invirase/ritonavir on the QT interval were evaluated in a 4-way crossover, double-blind, placebo- and active-controlled (moxifloxacin 400 mg) study in healthy male and female volunteers aged 18 to 55 years old (N=59).
Maltese: L-effetti ta' dożi terapewtiċi (1000/100 mg darbtejn kuljum) u supra-terapewtiċi (1500/100 mg darbtejn kuljum) ta' Invirase/ritonavir fuq l-intervall QT kienu evalwati fi studju 4-way crossover, double-blind, ikkontrollat bil-plaċebo u b'mod attiva (400 mg moxifloxacin) f'voluntiera rġiel u nisa b'saħħithom b'età minn 18 sa 55 sena (N=59).
English: In this study, PR interval of > 200 msec was also observed in 40% and 47% of subjects receiving Invirase/ritonavir 1000/100 mg twice daily and 1500/100 mg twice daily, respectively, on Day 3.
Maltese: F'dan l-istudju, intervall PR ta' > 200 msec kien osservat ukoll f'40% u f'47% ta' l-individwi li rċevew Invirase/ritonavir 1000/100 mg darbtejn kuljum u 1500/100 mg darbtejn kulum, rispettivament, f'Ġurnata 3.
English: Immune System Disorders Common
Maltese: Disturbi fis-Sistema Immuni Komuni
English: Mechanism of action: The HIV protease is an essential viral enzyme required for the specific cleavage of viral gag and gag-pol polyproteins.
Maltese: Il-protease tal-HIV hija enżima virali essenzjali meħtieġa għall-qsim speċifiku tal-poliproteini virali gag u gag-pol.
English: Cobicistat is not recommended in combination with regimens containing ritonavir due to similar effects of cobicistat and ritonavir on CYP3A.
Maltese: programme ta' kura li fihom ritonavir minħabba effetti simili ta' cobicistat u ritonavir fuq CYP3A.
English: Based on in vitro studies, saquinavir is rapidly metabolised to a range of mono- and di-hydroxylated inactive compounds.
Maltese: saquinavir huwa metabolizzat malajr għal sustanzi inattivi tat-tip mono- u di-hydroxylated .
English: Streptogramin antibiotics such as quinupristin/dalfopristin inhibit CYP3A4.
Maltese: Anti-bijotiċi streptogramin bħal quinupristin/dalfopristin jinibixxu lil CYP3A4.
English: Limited safety data are available from a paediatric study (NV20911, n=18) in which the safety of saquinavir hard capsules (50 mg/kg bid, not to exceed 1000 mg bid) used in combination with low dose ritonavir oral solution (3 mg/kg bid for body weight from 5 to <15 kg, 2.5 mg/kg bid for body weight from 15 to 40 kg and 100 mg bid for body weight >40 kg) has been studied in paediatric patients aged 4 months to 6 years old.
Maltese: Hemm disponibbli dejta limitata dwar is-siġurta minn studju pedjatriku (NV20911, n=18) fejn issigurtà ta' kapsuli iebsin ta' saquinavir (50 mg/kg bid, mhux aktar minn 1000 mg bid) użati flimkien ma' doża baxxa ta' soluzzjoni orali ta' ritonavir (3 mg/kg bid għal piż tal-ġisem minn 5 sa <15-il kg, 2.5 mg/kg bid għal piż tal-ġisem minn 15 sa 40 kg u 100 mg bid għal piż tal-ġisem >40 kg) kienet studjata f'pazjenti pedjatriċi b'età minn 4 xhur sa 6 snin.
English: Saquinavir AUC ↑ 13% (90% CI: 27↓ - 74↑) Saquinavir Cmax ↑ 9% (90% CI: 27↓ - 61↑ ) Nelfinavir AUC ↓ 6% (90% CI: 28↓ - 22↑) Nelfinavir Cmax ↓ 5% (90% CI: 23↓ - 16↑)
Maltese: (90 % CI: 27↓ - 74↑) Saquinavir Cmax ↑ 9 % (90 % CI: 27↓ - 61↑ ) Nelfinavir AUC ↓ 6 % (90 % CI: 28↓ - 22↑) Nelfinavir Cmax ↓ 5 % (90 % CI: 23↓ - 16↑)
English: Erythromycin 250 mg qid (unboosted saquinavir 1200 mg tid)
Maltese: - Erythromycin 250 mg qid (saquinavir mhux imsaħħaħ 1200 mg tid)
English: There is limited experience of overdose with saquinavir.
Maltese: Hemm esperjenza limitata ta' doża eċċessiva b'saquinavir.
English: The following adverse events were reported with the highest severity (grades 3 and 4): anaemia, diabetes mellitus, diarrhoea, nausea, vomiting and fatigue.
Maltese: L-avvenimenti avversi li ġejjin kienu rrappurtati bl-ogħla severità (grad 3 u 4): anemija, dijabete mellitus, dijarea, tqalligħ, rimettar u għeja.
English: Patients with hepatic impairment: The effect of hepatic impairment on the steady state pharmacokinetics of saquinavir/ritonavir (1000 mg/100 mg twice daily for 14 days) was investigated in 7 HIV-infected patients with moderate liver impairment (Child Pugh Grade B score 7 to 9).
Maltese: L-effett ta' indeboliment tal-fwied fuq il-farmakokinetika fi stat fiss ta' saquinavir/ritonavir (1000 mg/100 mg darbtejn kuljum għal 14-il ġurnata) kien investigat f'7 pazjenti infettati bl-HIV b'indeboliment moderat tal-fwied (Child Pugh Grad B punteġġ 7 sa 9).
English: Histamine H2-receptor antagonist - Ranitidine
Maltese: Antagonisti tar-riċetturi H2 ta' l-istamina
English: Osteonecrosis: Although the aetiology is considered to be multifactorial (including corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index), cases of osteonecrosis have been reported particularly in patients with advanced HIV-disease and/or long-term exposure to combination antiretroviral therapy (CART).
Maltese: Għalkemm l-etjoloġija hija kkunsidrata bħala multifattorjali (inkluż użu ta' kortikosterojdi, konsum ta' alkoħol, immunosoppressjoni severa, indiċi tal-massa tal-ġisem għola), każijiet ta' osteonekrożi kienu rrappurtati speċjalment f'pazjenti b'marda ta' l-HIV avvanzata u/jew espożizzjoni fit-tul għal terapija antiretrovirali kombinata (CART).
English: High doses of ketoconazole (> 200 mg/day) are not recommended.
Maltese: Dożi għolja ta' ketoconazole (> 200 mg/kuljum) mhux irrakkomandati.
English: • certain medicines that may be used for a variety of things: cisapride, diphemanil, mizolastine,
Maltese: • ċertu mediċini li jistgħu jintużaw għal varjetà ta' affarijiet: cisapride, diphemanil, mizolastine,
English: In a clinical study 11 of 17 (65 %) healthy volunteers developed severe hepatocellular toxicity with transaminase elevations up to > 20fold the upper limit of normal after 1 to 5 days of co-administration.
Maltese: Fi studju kliniku 11 minn 17-il voluntier b'saħħithom (65 %) żviluppaw tossiċità epatoċellulari qawwija b'żjieda fit-transaminase sa > 20 darba l-għola limitu normali wara ġurnata sa 5 ġranet ta' għotja fl-istess waqt.
English: The mean steady-state volume of distribution following intravenous administration of a 12 mg dose of saquinavir was 700 l (CV 39 %).
Maltese: Il-medja tal-volum taddistribuzzjoni fi stat fiss wara l-għotja ġol-vini ta' doża ta' 12 mg ta' saquinavir kienet ta' 700 l (CV 39 %).
English: CDC Category C (%)
Maltese: N (%)
English: Saquinavir AUC ↓ 51 % Saquinavir Ctrough ↓ 49 % (8 hours post dose)
Maltese: - Saquinavir AUC ↓ 51 % Saquinavir Ctrough ↓ 49 % (8 sigħat wara d-doża) Saquinavir Cmax ↓ 54 %.
English: The primary study variable was maximal change from dense predose baseline in QTcF (ΔQTcFdense).
Maltese: Il-varjabbli primarja tal-istudju kienet il-bidla massima millinja bażi densa ta' qabel id-doża f'QTcF (ΔQTcFdense - change from dense predose baseline in QTcF).
English: Musculoskeletal and connective tissue disorders Common
Maltese: Disturbi muskolu-skeletriċi u tat-tessuti konnettivi Komuni
English: Saquinavir AUC ↓ 15% Saquinavir Cmax ↓ 9% Saquinavir Cmin ↓ 24% (remained above the target threshold for effective therapy.)
Maltese: Saquinavir AUC ↓ 15 % Saquinavir Cmax ↓ 9 % Saquinavir Cmin ↓ 24 % (baqgħet ilfuq mil-livell immirat għal terapija effettiva.)
English: • electrolyte disturbances, particularly uncorrected hypokalaemia
Maltese: • disturbi fl-elettroliti, speċjalment ipokalimja mhux ikkoreġuta
English: Baseline saquinavir phenotype (shift in susceptibility relative to reference, PhenoSense Assay) was shown to be a predictive factor of virological outcome.
Maltese: Fenotip ta' saquinavir fil-linja bażi (bidla fis-suxxettibilità relattiva għar-referenza, PhenoSense Assay) intwera li huwa fattur ta' tbassir għar-riżultat virloġiku.
English: Day 3 mg (n=22)
Maltese: Jum 3 mg (n=22)
English: Use with caution due to possible cardiac arrhythmias.
Maltese: Uża b'attenzjoni minħabba l-possibbiltà ta' arritmiji kardijaċi.
English: Invirase is prescribed for use in combination with ritonavir (Norvir) and other antiretroviral medicines.
Maltese: Invirase huwa preskritt biex jintuża flimkien ma' ritonavir (Norvir) u mediċini antiretrovirali oħrajn.
English: Saquinavir Cmin ↓ 78% Dual-boosted protease inhibitor combination therapy in multipletreatment experienced HIV-positive adults.
Maltese: Saquinavir Cmin ↓ 78 % Terapija kombinata imsaħħa b'żewġ inibituri tal-protease f'pazjenti adulti bl-HIV b'esperjenza ta' kura multipla.
English: Combination not recommended.
Maltese: Kombinazzjoni mhux rakkomandata.
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.
Maltese: Effetti sistemiċi tal-kortikosterojdi inkluż issindrome ta' Cushing u soppressjoni adrenali kienu irrapportati f'pazjenti li ngħataw ritonavir u fluticasone propionate mogħti man-nifs mill-ħalq jew mill-imnieħer; dan jista' jseħħ wkoll ma' kortikosterojdi oħra metabolizzati mir-rotta ta' P450 3A eż. budesonide.
English: The mean residence time of saquinavir was 7 hours (n = 8).
Maltese: Il-ħin ta' residenza medja ta' saquinavir kien ta' 7 sigħat (n = 8).
English: Use with caution.
Maltese: Uża b'attenzjoni.
English: Increased CPK, myalgia, myositis and rarely, rhabdomyolysis have been reported with protease inhibitors, particularly in combination with nucleoside analogues.
Maltese: Żjieda f'CPK, mijalġja, mijosite u rarament, rhabdomyolysis kienu rrappurtati b'inibituri tal-protease, speċjalment f'taħlita ma' analogy ta' nucleoside.
English: Rifabutin 150 mg q3d (saquinavir/ritonavir 1000/100 mg bid) in healthy volunteers
Maltese: Rifabutin 150 mg q3d (saquinavir/ritonavir 1000/100 mg bid) f'voluntiera f'saħħithom
English: There have been reports of muscle pain, tenderness or weakness, particularly with combination antiretroviral therapy including protease inhibitors and nucleoside analogues.
Maltese: Kien hemm rapporti ta' uġigħ fil-muskoli, uġigħ mal-mess jew dgħjufija, speċjalment b'terapija antiretrovirali kkombinata li tinkludi inibituri tal-protease u analogi tan-nucleoside.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 04 October 1996
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 4 ta' Ottubru 1996
English: At present, there is only limited information on the use of Invirase/ritonavir in children and in adults over the age of 60 years.
Maltese: Fil-preżent, hemm biss informazzjoni limitata dwar l-użu ta' Invirase/ritonavir fi tfal u f'adulti b'età 'l fuq minn 60 sena.
English: Vomiting, abdominal distension, abdominal pain, upper abdominal pain, constipation, dry mouth, dyspepsia, eructation, flatulence, lip dry, loose stools
Maltese: Rimettar, nefħa addominali, uġigħ addominali, uġigħ fin-naħa ta' fuq tal-addome, stitikezza, ħalq xott, dispepsja, tifwieq, gass, xufftejn xotti,
English: Narcotic analgesics Methadone 60-120 mg qd (saquinavir/ritonavir 1000/100 mg bid)
Maltese: Analġeżiċi narkotiċi Methadone 60-120 mg qd (saquinavir/ritonavir 1000/100 mg bid)
English: Each film-coated tablet contains lactose (monohydrate) 38.5 mg.
Maltese: Kull pillola miksija b'rita fiha 38.5mg lactose (monohydrate).