FrancophonIA/ELRC3.0 huggingface dataset:
English: Plasma HIV-1 RNA below 400 copies/ml
Maltese: HIV-1 RNA anqas minn 400 kopja/ml (%) fil-plażma
English: In this leaflet:
Maltese: Każijiet speċjali:
English: The studies evaluated Agenerase oral solution and capsules at doses of 15 mg/kg three times daily, 20 mg/kg three times daily, 20 mg/kg twice daily and 22.5 mg/kg twice daily although the majority received 20 mg/kg twice daily.
Maltese: L-istudji evalwaw is-soluzzjoni orali u kapsuli ta' Agenerase f'dożi ta' 15mg/kg tliet darbiet kuljum, 20mg/kg tliet darbiet kuljum, 20mg/kg darbtejn kuljum u 22.5mg/kg darbtejn kuljum għalkemm il-maġġoranza ngħataw 20mg/kg darbtejn kuljum.
English: Nelfinavir: the AUC, Cmin and Cmax of nelfinavir were increased by 15 %, 14 %, and 12 %, respectively, when given with amprenavir.
Maltese: Nelfinavir: l-AUC, Cmin u Cmax ta' nelfinavir żdiedu bi 15%, 14% u 12% rispettivament meta ġie mogħti flimkien ma' amprenavir.
English: Indinavir: the AUC, Cmin and Cmax of indinavir were decreased by 38 %, 27 %, and 22 %, respectively, when given with amprenavir.
Maltese: Indinavir: l-AUC, Cmin u Cmax ta' indinavir naqsu bi 38%, 27% u 22% rispettivament meta ġie mogħti flimkien ma' amprenavir.
English: HIV-1 isolates with a decreased susceptibility to amprenavir have been selected during in vitro serial passage experiments.
Maltese: Iżolati ta' HIV-1 b'suxxettibiltà mnaqqsa għal amprenavir ġew magħżula f'esperimenti serial passage in vitro.
English: When ritonavir is co-administered an increase in clarithromycin concentrations may occur.
Maltese: Meta jingħata ritonavir jistà jkun hemm żieda fil-konċentrazzjoni ta' clarithromycin.
English: Amprenavir levels may increase on stopping St John's wort.
Maltese: L-effett stimulanti jistà jdum għal ta' l-inqas ġimagħtejn wara li St.John's wort ikun twaqqaf.
English: Co-administration of amprenavir with methadone leads to a decrease of methadone concentrations.
Maltese: Meta jiġu mogħtija flimkien amprenavir u methadone jkun hemm tnaqqis fil-konċentrazzjoni ta' methadone fid-demm.
English: Atorvastatin is less dependent on CYP3A4 for metabolism.
Maltese: Atorvastatin jiddependi inqas fuq CYP3A4 sabiex ikun metabolizzat.
English: Agenerase oral solution is supplied in plastic bottles containing 240 ml of oral solution.
Maltese: Is-soluzzjoni orali ta' Agenerase tiġi fi fliexken li fihom 240 ml ta' soluzzjoni orali.
English: The capsule shell contains gelatin, glycerol, d-sorbitol and sorbitans solution, titanium dioxide and red printing ink.
Maltese: Qoxra tal-kapsula: gelatin, glycerol, taħlita likwida ta' d-sorbitol u sorbitans, titanium dioxide, red printing ink.
English: The AUC, Cmin, and Cmax of amprenavir were increased by 29 %, 27 %, and 47 % respectively.
Maltese: LAUC, Cmin u Cmax ta' amprenavir żdiedu bi 29%, 27% u 47% rispettivament.
English: Elevated triglycerides, elevated amylase, abnormal fat redistribution, anorexia
Maltese: livelli għoljin ta' trigliċeridi, livelli għoljin ta' amylase, lipodistrofija, anoressija
English: Agenerase is also available as capsules.
Maltese: Agenerase huwa disponibbli wkoll bħala kapsuli.
English: Agenerase belongs to a group of antiviral medicines called protease inhibitors.
Maltese: Agenerase jagħmel parti minn grupp ta' mediċini antivirali li jissejħu inibituri protease.
English: Alcohol and inhibitors of alcohol metabolism: Agenerase oral solution contains propylene glycol (550 mg/ml), which is primarily metabolised via alcohol dehydrogenase.
Maltese: Alkoħol u sustanzi li jinibixxu l-metaboliżmu ta' l-alkoħol: is-soluzzjoni orali ta' Agenerase fiha propylene glycol (550 mg/ml), li l-biċċa l-kbira minnu tiġi metabolizzata permezz ta' alcohol dehydrogenase.
English: The evidence of efficacy of Agenerase in combination with ritonavir 100 mg twice daily is based on study PRO30017, a randomized, open-label study, in which PI-experienced adults experiencing virological failure (viral load ≥1000 copies/ml) received either Agenerase (600 mg twice daily) in combination with ritonavir (100 mg twice daily) and nucleoside analogues (NRTI) or a standard of care (SOC) PI, predominantly boosted with low-dose RTV.
Maltese: L-evidenza ta' effikaċja ta' Agenerase flimkien ma' ritonavir 100mg darbtejn kuljum hija ibbażata fuq studju PRO30017, studju randomised open-label fejn pazjenti b'esperjenza PI li esperjenzaw falliment viroloġiku (viral load ≥1000 kopja/ml) irċevew jew Agenerase (600mg darbtejn kuljum) flimkien ma' ritonavir (100mg darbtejn kuljum) jew inkella analogi tan-nukleosidi (NRTI) jew PI standard ta' kura (SOC), l-aktar magħmul aktar qawwi b'doża baxxa ta' RTV.
English: As compared to a non-matched historical control group, co-administration of methadone and amprenavir resulted in a 30%, 27% and 25% decrease in serum amprenavir AUC, Cmax and Cmin respectively.
Maltese: F'paragun ma' grupp ta' kontroll storiku mhux imqabbel, kien hemm tnaqqis ta' 30%, 27% u 25% flAUC, Cmax u Cmin ta' amprenavir fis-serum, meta dan ġie mogħti flimkien ma' methadone.
English: When used with Agenerase with ritonavir, high doses (>200 mg/day) of ketoconazole or itraconazole are not recommended.
Maltese: Meta jintuża ma' Agenerase flimkien ma' ritonavir, m'humiex rakkomandati dożi għoljin (>200mg/kuljum) ta' ketoconazole u itraconazole.
English: NAME OF THE MEDICINAL PRODUCT Agenerase 150 mg soft capsules Amprenavir
Maltese: Agenerase 150 mg kapsuli rotob Amprenavir
English: Calcium-channel blockers: amprenavir may lead to increased serum concentrations of calcium channel blockers such as amlodipine, diltiazem, felodipine, isradipine, nicardipine, nifedipine, nimodipine, nisoldipine and verapamil, possibly resulting in enhanced activity and toxicity of these medicinal products.
Maltese: Imblokkaturi tal-kanali tal-kalċju: l-użu ta' amprenavir jistà jwassal għal żieda fil-konċentrazzjoni fisserum ta' imblokkaturi tal-kanali tal-kalċju bħal amlopidine, diltiazem, felodipine, isradipine,nicardipine, nifedipine, nimodipine, nisolpidine u verapamil, li possibilment jirriżulta f'attività u effetti tossiċi aktar qawwija minn naħa ta'dawn il-prodotti mediċinali.
English: - In some patients with advanced HIV infection (AIDS) and a history of opportunistic infection, signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started.
Maltese: - F'xi pazjenti b'infezzjoni avvanzata ta' l-HIV (AIDS), u li kellhom infezzjonijiet opportunistiċi fil-passat, jistgħu joħorġu sinjali u sintomi ta' infjammazzjoni minn infezzjonijiet ta' qabel ftit wara li jinbeda it-trattament kontra l-HIV.
English: Common: Uncommon:
Maltese: Komuni ħafna: Komuni:
English: In vivo a) ART-naïve or PI-naïve patients
Maltese: In vivo a) Pazjenti li m'għandhomx esperjenza ART jew PI,
English: Clarithromycin: the AUC and Cmin of clarithromycin were unaltered and the Cmax decreased by 10 % when given with amprenavir.
Maltese: Clarithromycin: ma kien hemm l-ebda bidla fl-AUC u Cmin ta' clarithromycin, filwaqt li Cmax naqas b'10% meta ġie mogħti flimkien ma' amprenavir.
English: Amprenavir binds to the active site of HIV-1 protease and thereby prevents the processing of viral gag and gag-pol polyprotein precursors, resulting in the formation of immature non-infectious viral particles.
Maltese: Amprenavir jintrabat mas-sit attiv talprotease ta' HIV-1 u b'hekk ma jħallix l-ipproċessar tal-prekursuri virali tal-polyprotein gag u gagpol, li tirriżulta fil-formazzjoni ta' partiċelli mhux infettivi immaturi tal-vajrus.
English: The relationship between in vitro anti-HIV-1 activity of amprenavir and the inhibition of HIV-1 replication in humans has not been defined.
Maltese: Irrelazzjoni bejn l-attività in vitro anti-HIV-1 ta' amprenavir u l-impediment tar-replikazzjoni ta' HIV-1 fil-bniedem għada ma ġietx definita.
English: Amprenavir was not mutagenic or genotoxic in a battery of in vivo and in vitro genetic toxicity assays, including bacterial reverse mutation (Ames Test), mouse lymphoma, rat micronucleus, and chromosome aberration in human peripheral lymphocytes.
Maltese: Dawn kienu jinkludu bacterial reverse mutation (Ames Test), tumuri malinni fil-glandola limfatika tal-ġrieden, rat micronucleus u chromosome aberration fil-limfotiċi umani.
English: Excipients:
Maltese: Didanosine:
English: NAME OF THE MEDICINAL PRODUCT Agenerase 50 mg soft capsules Amprenavir
Maltese: Agenerase 50 mg kapsuli rotob Amprenavir
English: Agenerase must not be administered concurrently with medicinal products with narrow therapeutic windows that are substrates of cytochrome P450 3A4 (CYP3A4).
Maltese: Agenerase m'għandux jiġi mogħti ma' mediċini li għandhom meded terapewtiċi dojoq u li huma substrati taċ-citokromju P450 3A4 (CYP3A4).
English: The concentration of amprenavir in the cerebrospinal fluid is less than 1 % of plasma concentration.
Maltese: Ilkonċentrazzjoni ta' amprenavir fil-fluwidu ċerebrospinali hija inqas minn 1% ta' dik fil-plażma.
English: Mood disorders, depressive disorders Nervous system disorders Very Common:
Maltese: Tibdil tal-burdata, mard dipressiv Disturbi fis-sistema nervuża Komuni ħafna:
English: Agenerase is also available as an oral solution for use in children or adults unable to swallow capsules.
Maltese: Agenerase huwa disponibbli wkoll bħala soluzzjoni orali li tistà tintuża fi tfal jew adulti li m'humiex kapaċi jibilgħu kapsuli.
English: Agenerase oral solution contains vitamin E (46 IU/ml), therefore additional vitamin E supplementation is not recommended.
Maltese: Is-soluzzjoni orali ta' Agenerase fiha il-vitamina E (46
English: Resistance testing diagnostic companies have developed clinical phenotypic cut-offs for FPV/RTV that can be used to interpret resistance test results.
Maltese: Kumpaniji dijanjostiċi li jittestjaw ir-reżistenza żviluppaw cut-offs kliniċi fenotipiċi għal FPV/RTV li jistgħu jintużaw biex jinterpretaw riżultati ta' testijiet ta' reżistenza.
English: Amprenavir is a substrate of and inhibits CYP3A4.
Maltese: Amprenavir huwa substrat u inibitur ta' CYP3A4.
English: The amprenavir plasma Cmin values achieved with the combination of amprenavir (600 mg twice daily) in combination with Kaletra (400 mg lopinavir + 100 mg ritonavir twice daily) are approximately 4050% lower than when amprenavir (600 mg twice daily) is given in combination with ritonavir 100 mg twice daily.
Maltese: Il-valuri ta' Cmin fil-plażma għal amprenavir milħuqa permezz tat-taħlita ta' amprenavir (600 mg darbtejn kuljum) flimkien ma' Kaletra (400 mg lopinavir + 100 mg ritonavir darbtejn kuljum) huma bejn wieħed u ieħor 40-50% anqas minn meta amprenavir (600 mg darbtejn kuljum) jiġi mogħti flimkien ma' 100 mg darbtejn kuljum ta' ritonavir.
English: PI-experienced adults, boosted Agenerase capsules
Maltese: Adulti b'esperjenza PI, kapsuli ta' Agenerase aktar qawwija
English: The AUC and Cmax of amprenavir were increased by 31 % and decreased by 16 % respectively.
Maltese: L-AUC u Cmax ta' amprenavir żdied b'31% u naqas b'16% rispettivament.
English: Some substances (e.g. lidocaine (by systemic route) and halofantrine) given with Agenerase may cause serious adverse reactions.
Maltese: Xi sustanzi (eż lidocaine (mill-vina) u halofantrine) meta jingħataw ma' Agenerase jista' jikkawżaw reazzjonijiet avversi serji.
English: The HMG-CoA reductase inhibitors lovastatin and simvastatin are highly dependent on CYP3A4 for metabolism, thus concomitant use of Agenerase with simvastatin or lovastatin is not recommended due to an increased risk of myopathy, including rhabdomyolysis.
Maltese: Il-mediċini lovastatin u simvastatin, li jinibixxu l'HMG-CoA reductase, jiddependu ħafna fuq CYP3A4 biex jiġu metabolizzati; għalhekk l-użu tagħhom fl-istess waqt ma' Agenerase m'huwiex rakkomandat minħabba riskju kbir ta'mijopatija, inkluż rhabdomyolysis.
English: Zidovudine: the AUC and Cmax of zidovudine were increased by 31 % and 40 %, respectively, when given with amprenavir.
Maltese: Zidovudine: l-AUC u Cmax ta' zidovudine żdiedu b'31% u 40% rispettivament meta ġie mogħti flimkien ma' amprenavir.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Agenerase oral solution contains 15 mg/ml of amprenavir.
Maltese: U KWANTITATTIVA Soluzzjoni orali ta' Agenerase li fiha 15 mg/ml ta' amprenavir.
English: Agenerase 150 mg soft capsules are supplied in a pack with two plastic bottles each containing 240 soft capsules.
Maltese: Agenerase 150 mg kapsuli rotob jiġu fi fliexken li kull wieħed fih 240 kapsula ratba.
English: Oblong, opaque, off-white to cream coloured, printed with ‘GX CC1'.
Maltese: Forma rettangolari, opaki, b'lewn abjad maħmuġ jkanġi għall-krema, stampati bl-ittri ‘GX CC1'.
English: Therefore, if paroxetine is co-administered with Agenerase and ritonavir, the recommended approach is a dose titration of paroxetine based on a clinical assessment of antidepressant response.
Maltese: Għalhekk jekk paroxetine jingħata flimkien ma' Agenerase u ritonavir, il-metodu rakkomandat huwa ta' titrazzjoni tad-doża ta' paroxetine fuq bażi ta' assessjar kliniku tar-rispons anti-dipressiv.
English: Hyperglycaemia, hypercholesterolaemia
Maltese: livelli għoljin ta' kolesterol fid-demm
English: Soft capsules
Maltese: Kapsuli rotob
English: Each Agenerase capsule contains 50 mg of amprenavir.
Maltese: Kull kapsula fiha 50 mg amprenavir.
English: What Agenerase looks like and contents of the pack Agenerase 50 mg soft capsules are supplied in plastic bottles containing 480 soft capsules.
Maltese: Agenerase 50 mg kapsuli rotob jiġu fi fliexken li kull wieħed fih 480 kapsula ratba.
English: On rare occasions, these muscle disorders have been serious (rhabdomyolysis).
Maltese: F'okkażjonijiet rari dawn kienu ta' natura serja (rhabdomyolysis).
English: Heavily pre-treated children, unboosted Agenerase
Maltese: Tfal trattati ħafna minn qabel, Agenerase mhux aktar qawwi
English: Caution is advised when Agenerase is used concomitantly with PDE5 inhibitors (e.g. sildenafil and vardenafil) (see section 4.5).
Maltese: Hi rrakkomandata l-kawtela meta Agenerase jintuża flimkien ma' inibituri ta' PDE5 (eż sildenafil u vardenafil) (ara sezzjoni 4.5)
English: 6.5 Nature and contents of container White High Density Polyethylene (HDPE) bottles containing 480 capsules.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Fliexken bojod magħmula mil-propilin ta' densità għolja (HDPE) u fihom 480 kapsula l-wieħed.
English: A connection between visceral lipomatosis and protease inhibitors and lipoatrophy and nucleoside reverse transcriptase inhibitors has been hypothesised.
Maltese: Teżisti ipoteżi dwar rabtà possibli bejn ilvisceral lipomatosis, il-inibituri protease, il-lipoatrophy u inibituri nuklejosajd rivers transkriptejż.
English: Tricyclic antidepressants: careful monitoring of the therapeutic and adverse reactions of tricyclic antidepressants is recommended when they (for example desipramine and nortriptyline) are concomitantly administered with Agenerase (see section 4.4).
Maltese: Antidepressanti triċikliċi: monitoraġġ tajjeb ta' l-effetti terapewtiċi u l-effetti avversi ta' antidepressanti triċikliċi hu rakkomandat meta dawn (per eżempju desipramine u nortriptyline) jingħataw flimkien ma' Agenerase (ara sezzjoni 4.4).
English: Midazolam: midazolam is extensively metabolized by CYP3A4.
Maltese: Midazolam jiġi mmetaboliżżat b'mod estensiv minn CYP3A4.
English: Efavirenz: efavirenz has been seen to decrease the Cmax, AUC and Cmin,ss of amprenavir by approximately 40 % in adults.
Maltese: Efavirenz: ġie muri li efavirenz inaqqas is-Cmax, AUC u Cmin,ss ta' amprenavir b'madwar 40% f'pazjenti adulti.
English: You may need additional factor VIII to control
Maltese: Xi wħud minn dawn il-pazjenti ingħataw aktar factor VIII.
English: In study PROAB3006, seven cases (3 %) were reported in 245 NRTI-experienced subjects treated with amprenavir and in 27 (11 %) of 241 subjects treated with indinavir, in combination with various NRTIs for a median duration of 56 weeks (p< 0.001).
Maltese: Fl-istudju PROAB3006 kien hemm sebgħa każi (3%), minn total ta' 245 pazjent li kienu diġà ngħataw kura permezz tal-inibituri protease u li kienu qed jirċievu amprenavir, u 27 (11%) minn 241 pazjent li kienu qed jirċievu indinavir flimkien ma' diversi mediċini oħra tat-tip NRTIs għal medja ta' 56 ġimgħa (p<0.
English: Only one case (a buffalo hump) was reported in 113 (< 1 %) antiretroviral naive subjects treated with amprenavir in combination with lamivudine/zidovudine for a median duration of 36 weeks.
Maltese: Kien hemm każ wieħed biss (buffalo hump) irraportat f'113-il pazjent li qatt ma kienu ngħataw kura permezz ta' mediċini antiretrovirali u li kienu qed jingħataw amprenavir flimkien ma' lamivudine/zidovudine għal medja ta' madwar 36 ġimgħa.
English: Associations contraindicated (see section 4.3)
Maltese: Assoċjazzjonijiet kontraindikati (ara sezzjoni 4.3)
English: Very Common: Uncommon: Rare:
Maltese: Mhux komuni Rari:
English: The AUC, Cmin and Cmax of amprenavir were decreased by 32 %, 14 %, and 37 %, respectively.
Maltese: LAUC, Cmin u Cmax ta' amprenavir naqsu bi 32%, 14% u 37% rispettivament.
English: In PI experienced patients receiving Agenerase capsules 600 mg twice daily and low dose ritonavir, 100 mg twice daily, the nature and frequency of adverse events (grade 2-4) and Grade 3/4 laboratory abnormalities were similar to those observed with Agenerase alone, with the exception of elevated triglyceride levels, and elevated CPK levels which were very common in patients receiving Agenerase and low dose ritonavir.
Maltese: F'pazjenti li kienu diġà ngħataw kura permezz tal-inibituri protease u li kienu qed jirċievu kapsuli ta' Agenerase 600 mg darbtejn kuljum, flimkien ma' doża baxxa ta' ritonavir, 100 mg darbtejn kuljum, ittip u l-frekwenza ta' l-effetti mhux mixtieqa (grade 2-4) u ta' Grade 3/4 anormalitajiet tal-laboratorju kienu jixxiebħu ma' dawk li tfaċċaw b'Agenerase waħdu, minbarra iż-żieda fil-livell tat-trigliċeridi u tas-CPK li kienu ferm komuni fil-pazjenti li kienu qegħdin jirċievu Agenerase u doża baxxa ta' ritonavir.
English: Slovenská republika GlaxoSmithKline Slovakia s. r. o. Tel: + 421 (0)2 49 10 33 11 recepcia.sk@gsk.com
Maltese: Tel: + 421 (0)2 49 10 33 11 recepcia.sk@gsk.com
English: Hepatobiliary disorders Common:
Maltese: Sustanzi mhux attivi:
English: When amprenavir and ritonavir are co-administered, the ritonavir metabolic drug interaction profile may predominate because ritonavir is a more potent CYP3A4 inhibitor.
Maltese: Meta amprenavir u ritonavir jiġu mogħtija flimkien, il-profil ta' l-interazzjonijiet metaboliċi ta' ritonavir jippredomina minħabba l-fatt li ritonavir huwa inibitur aktar b'saħħtu ta' CYP3A4.
English: Each Agenerase capsule contains 150 mg of amprenavir.
Maltese: Kull kapsula fiha 150 mg amprenavir.
English: The active substance is amprenavir
Maltese: Sustanzi mhux attivi
English: MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH RELEASE
Maltese: Analiżi bbażata fuq testijiet ta' reżistenza ġenotipika
English: Metronidazole: Agenerase oral solution is contraindicated in patients treated with metronidazole (see section 4.3).
Maltese: Metronidazole: is-soluzzjoni orali ta' Agenerase hija kontra-indikata f'dawk il-pazjenti li qed jingħataw metronidazole (ara 4.3).
English: Relevant examples are cytomegalovirus retinitis, generalised and/or focal mycobacterium infections, and Pneumocystis carinii pneumonia.
Maltese: Eżempji rilevanti jinkludu retinite ċitomegalovirus, infezzjonijiet mikobatterjali lokali jew mifruxa, u pulmonite b'Pneumocystis carinii.
English: New onset of diabetes mellitus, hyperglycaemia or exacerbations of existing diabetes mellitus have been reported in patients receiving antiretroviral therapy, including protease inhibitors.
Maltese: Każijiet ġodda ta' dijabete, ipergliċemija jew taħrix ta' każi eżistenti ta' dijabete ġew irrapurtati f'pazjenti li kienu qed jirċievu terapija antiretrovirali, inkluż bil-inibituri protease.
English: DATE OF THE REVISION OF THE TEXT Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http://www.emea.europa.eu
Maltese: Informazzjoni dettaljata dwar dan il-prodott tinsab fuq il-website ta' l-Aġenzija Ewropeja dwar ilMediċini (EMEA) http://www.emea.europa.eu/.
English: The in vitro antiviral activity observed with fosamprenavir is due to the presence of trace amounts of amprenavir.
Maltese: L-attivita' antivirali in vitro osservata b'fosamprenavir hija minħabba l-preżenza ta' traċċi ta' amprenavir.
English: Children (4 to 12 years) and patients less than 50 kg body weight: the recommended dose of Agenerase capsules is 20 mg/kg body weight twice a day, in combination with other antiretroviral agents, without exceeding a total daily dose of 2400 mg (see section 5.1).
Maltese: Tfal (minn 4 sa 12-il sena) u pazjenti li għandhom piż tal-ġisem inqas minn 50 kg: id-doża rakkomandata ta' kapsuli ta' Agenerase hija ta' 20 mg għal kull kilogramm ta' piż tal-gisem darbtejn kuljum, flimkien ma' mediċini antiretrovirali oħra, mingħajr ma tinqabeż id-doża totali ta' 2400 mg kuljum (ara sezzjoni 5.1).
English: Oral anticoagulants: a reinforced monitoring of the International Normalised Ratio is recommended in case of administration of Agenerase with warfarin or other oral anticoagulants, due to a possible decrease or increase of their antithrombotic effect (see section 4.4).
Maltese: Anti-koagulanti orali: monitoraġġ rinfurzat tal-Proporzjon Internazzjonali Normalizzathu rakkomandat f'każi ta' l-għoti ta' Agenerase ma' warfarin jew xi anti-koagulanti oħra, minħabba lpossibiltà ta' xi tnaqqis jew żieda ta' l-effett anti-trombotiku tagħhom (ara sezzjoni 4.4).
English: Clinically validated phenotypic interpretation systems may be used in association with the genotypic data to estimate the activity of amprenavir / ritonavir or fosamprenavir / ritonavir in patients with PIresistant isolates.
Maltese: Sistemi ta' interpretazzjoni fenotipika validata klinikament tista' tintuża flimkien ma' data ġenotipika biex tagħmel stima ta' l-attività ta' amprenavir / ritonavir jew fosamprenavir / ritonavir f'pazjenti b'iżolati reżistenti għal PI.
English: Genotypic analysis of isolates from 13 of 14 paediatric patients exhibiting virological failure among the 59 PI-naïve patients enrolled, demonstrated resistance patterns similar to those observed in adults.
Maltese: Analiżi ġenotipika ta' iżolati minn 13 minn 14-il pazjent pedjatriku li wrew falliment viroloġiku fost il-59 pazjent mingħajr esperjenza PI li ħadu sehem, urew mudell ta' reżistenza simili ta' dawk osservati fl-adulti.
English: Additional mutations observed which may contribute to resistance were: L10V/F/R, I13V, K20R/T, L33F/V, M36I, M46I/L, I47V/L Q58E, I62V, L63P, V77I, I85V, and I93L.
Maltese: Mutazzjonijiet oħra osservati li jistgħu iwasslu għal reżistenza kienu : L10V/F/R, II3V, K20R/T, L33F/V, M361, M461/L, 147V/L Q58E, 162V, L63P, V771, 185V, u 193L.
English: The evidence of efficacy of unboosted Agenerase was based on two uncontrolled clinical studies involving 288 HIV infected children aged between 2 and 18 years, 152 of whom were PI experienced.
Maltese: L-evidenza ta' effikaċja ta' Agenerase mhux qawwi kienet ibbażata fuq żewġ studji kliniċi mhux ikkontrollati b'288 tifel u tifla ta' bejn is-2 u t-18 il-sena infettati bl-HIV, li 152 minnhom kellhom esperjenza PI.
English: Analysis of the virological failure samples across these regimens defined four main resistance pathways: V32I+I47V, I50V, I54L/M and I84V.
Maltese: V32I+I47V, I50V, I54L/M and I84V.
English: Elevated transaminases
Maltese: TAL-PRODOTT MEDIĊINALI
English: Other medicinal products, listed below, including examples of substrates, inhibitors or inducers of CYP3A4, may lead to interactions when administered with Agenerase.
Maltese: Prodotti mediċinali oħra, msemmija hawn taħt u li jinkludu substrati, inibituri jew stimulanti ta' CYP3A4, jistgħu jwasslu għal interazzjonijiet meta jingħataw ma' Agenerase.
English: Abdominal pain, abdominal discomfort, dyspeptic symptoms, loose stools
Maltese: Uġigħ jew skumdità addominali, sintomi ta' diġestjoni ħażina, ippurgar maħlul