FrancophonIA/ELRC3.0 huggingface dataset:
English: In long-term carcinogenicity studies with fosamprenavir in mice and rats, there were increases in hepatocellular adenomas and hepatocellular carcinomas in mice at exposure levels equivalent to 0.1 to 0.3-fold those in humans given 700 mg of fosamprenavir plus 100 mg ritonavir twice daily, and increases in hepatocellular adenomas and thyroid follicular cell adenomas in rats at exposure levels equivalent to 0.3 to 0.6-fold those in humans given 700 mg of fosamprenavir plus 100 mg ritonavir twice daily.
Maltese: Fi studji fit-tul dwar karċinoġeniċità b'fosamprenavir fi ġrieden u firien, kien hemm żidiet f'adenomi epatoċellulari u kanċer epatoċellulari fi ġrieden meta kienu esposti għall-livelli ekwivalenti għal 0.1 sa 0.3 darbiet dawk fi bnedmin li ħadu 700 mg ta' fosamprenavir u 100 mg ritonavir darbtejn kuljum, u żidiet f'adenomi epatoċellulari u adenomi follikulari tat-tirojde fi firien meta kienu esposti għall-livelli ekwivalenti għal 0.3 sa 0.6 darbiet dawk fi bnedmin li ħadu 700 mg ta'fosamprenavir u 100 mg ta' ritonavir darbtejn kuljum.
English: Renal impairment
Maltese: INALATI/NAŻALI
English: Repeat steps 4 to 8 in the same way until you have taken the whole dose.
Maltese: Irrepeti l-istruzzjonijiet minn 4 sa 8 bl-istess mod sakemm tkun ħadt id-doża kollha.
English: Additionally, both amprenavir, the active metabolite of fosamprenavir, and ritonavir are primarily metabolised in the liver by CYP3A4.
Maltese: Barra minn hekk, kemm amprenavir, il-metabolit attiv ta' fosamprenavir, u kemm ritonavir huma primarjament metabolizzati fil-fwied b'CYP3A4.
English: In subjects with severe hepatic impairment (Child-Pugh score of 10-13), a reduced dose of fosamprenavir 300 mg twice daily with a reduced dosing frequency of ritonavir 100 mg once daily delivered 19% lower plasma amprenavir Cmax, 23% lower AUC(0-12), and 38% lower C12 values, but similar unbound plasma amprenavir C12 values than achieved in subjects with normal hepatic function receiving the standard fosamprenavir with ritonavir 700 mg / 100 mg twice daily regimen.
Maltese: F'suġġetti b'indebboliment sever tal-fwied (Child-Pugh score ta' 10-13), doża mnaqqsa ta' fosamprenavir 300mg darbtejn kuljum bi frekwenza ta' dożaġġ ta' ritonavir imnaqqsa għal 100mg darba kuljum wassal 19% ta' amprenavir Cmax anqas fil-plażma, 23% anqas AUC (0-12), u 38% anqas fil-valur ta' C12, imma valuri simili ta' C12 ta' amprenavir fil-plażma minn dawk f'suġġetti b'funzjoni normali tal-fwied li ħadu sistema ta' kura standard b'fosamprenavir ma' ritonavir 700mg /
English: mechanism of interaction is CYP3A4 inhibition by fosamprenavir/ritonavir.
Maltese: Ilmekkaniżmu tal-interazzjoni huwa l-impediment ta' CYP3A4 permezz ta' fosamprenavir/ritonavir.
English: Subjects (%) with plasma HIV-1 RNA <50 copies/ml
Maltese: Individwi (%) b'RNA ta' HIV-1 <50 kopja/ml fil-plażma
English: Rhabdomyolysis: an increase in CPK, myalgia, myositis, and rarely, rhabdomyolysis, have been reported with protease inhibitors, more specifically in association with nucleoside analogues.
Maltese: Rabdomajoliżi: żieda ta' CPK, mijalġa, mijosite, u rarament ta' rabdomajoliżi ġew rappurtati ma' impedituri protease, speċifikament aktar f'assoċjazzjoni ma' analogi nuklejosidi.
English: Significant ↓ APV expected
Maltese: ↓ sinifikanti f'APV mistenni
English: Concomitant use of Telzir with simvastatin or lovastatin is contraindicated because of increased plasma concentrations of lovastatin and simvastatin which can increase the risk of myopathy, including rhabdomyolysis (see section 4.5).
Maltese: L-użu fl-istess ħin ta' Telzir ma' simvastatin jew lovastatin huwa kontraindikat minħabba żidiet filkonċentrazzjonijiet ta' lovastatin u simvastatin fil-plażma li jistgħu jżidu r-riskju ta' mijopatija, inkluż rhabdomyolisis (ara sezzjoni 4.5).
English: In patients with haemophilia type A and B, there have been reports of increased bleeding while taking protease inhibitors.
Maltese: Tip A u B kien hemm rapporti ta' żieda fil-fsada waqt l-użu ta' l-impedituri protease.
English: Mechanism unknown.
Maltese: Rakkomandati metodi ta'
English: This adjusted dose has not been evaluated in a clinical study and has been derived from extrapolation (see section 5.2).
Maltese: Din id-doża aġġustata ma ġietx evalwata fi studju kliniku u ġiet derivata minn estrapolazzjoni (ara sezzjoni 5.2).
English: In subjects with mild hepatic impairment (Child-Pugh score of 5-6), the dosage regimen of fosamprenavir 700 mg twice daily with a reduced dosing frequency of ritonavir 100 mg once daily provided slightly higher plasma amprenavir Cmax (17 %), slightly higher plasma amprenavir AUC(0-12) (22 %), similar plasma total amprenavir C12 values and approximately 117 % higher plasma unbound amprenavir C12 values compared to subjects with normal hepatic function receiving the standard fosamprenavir / ritonavir 700 mg /100 mg twice daily regimen.
Maltese: fosamprenavir 700 mg darbtejn kuljum flimkien ma' ritonavir 100mg bil-frekwenza tad-doża mnaqqsa għal darba kuljum waslet għal Cmax ta' amprenavir ġol-plażma kemm kemm ogħla (17 %), għal AUC (0-12) ta' amprenavir ġol-plażma kemm kemm ogħla (22 %), għall-livell simili ta' C12 ta' amprenavir totali fil-plażma u livell ta' C12 ta' amprenavir mhux marbut fil-plażma ta' bejn wieħed u ieħor 117 % ogħla meta mqabbla ma' dawk ta' suġġetti b'funzjoni tal-fwied normali li qegħdin jirċievu s-sistema ta' dożaġġ standard ta' fosamprenavir / ritonavir 700 mg /100 mg darbtejn kuljum.
English: Metabolic parameters: Weight and levels of blood lipids and glucose may increase during antiretroviral therapy (see section 4.4).
Maltese: Parametri metaboliċi: il-piż u l-livelli tal-lipidi u l-glucose fid-demm jistgħu jiżdiedu matul terapija antiretrovirali (ara sezzjoni 4.4).
English: Clinical experience with fosamprenavir boosted with ritonavir is mainly based on two open label studies one in antiretroviral naïve patients (study ESS100732), and one study in antiretroviral experienced patients (study APV30003).
Maltese: L-esperjenza klinika b'fosamprenavir imsaħħaħ b'ritonavir hi bażata l-aktar fuq żewġ studji openlabel, wieħed f'pazjenti li m'għandhomx esperjenza ta' terapija antiretrovirali (studju ESS100732), u studju wieħed f'pazjenti b'esperjenza antiretrovirali (studju APV30003).
English: Dose titration of paroxetine based on a clinical assessment of antidepressant response is recommended.
Maltese: assessjar kliniku ta' rispons ta' antidipressant.
English: Proportion with HIV-1 RNA < 50 copies/ml
Maltese: Proporzjon ta' pazjenti b'RNA ta' HIV-1 < 50 kopja/ml
English: Subjects with >1 log10 change from baseline in plasma HIV1 RNA
Maltese: Individwi b'tibdil >1 log10 mill-linja bażi fl-RNA ta' HIV-1 fil-plażma
English: Atorvastatin: Cmax ↑ 184% Atorvastatin: AUC ↑ 153% Atorvastatin: Cmin ↑ 73%
Maltese: Cmax ↑ 184% Atorvastatin:
English: Hepatitis C virus (HCV) Direct-Acting Antivirals: When hepatitis C virus direct-acting antiviral (DAA) drugs, which are metabolised by CYP3A4 or are inducers/inhibitors of CYP3A4, are coadministered with fosamprenavir/ritonavir, altered plasma concentrations of medications are expected due to inhibition or induction of CYP3A4 enzyme activity (see sections 4.3 and 4.5).
Maltese: Meta l-mediċini antivirali li jaġixxu direttament (DAA) tal-virus tal-epatite Ċ, li huma metabolizzati minn CYP3A4 jew huma indutturi/inibituri ta' CYP3A4, jingħataw flimkien ma' fosamprenavir/ritonavir, huwa mistenni tibdil fil-konċentrazzjonijiet tal-plażma tal-mediċini minħabba l-inibizzjoni jew l-induzzjoni tal-attività talenzima CYP3A4
English: • doses of rifabutin greater than 150 mg every other day (an antibiotic)
Maltese: • dożi ta' rifabutin akbar minn 150mg ġurnata iva u ġurnata le (antibijotiku)
English: Subjects (%) with plasma HIV-1 RNA <400 copies/ml
Maltese: Individwi (%) b'RNA ta' HIV-1 <400 kopja/ml fil-plażma
English: APV29005 enrolled 30 patients aged 6 to 11 (the majority of whom were treated with fosamprenavir / ritonavir 18/3 mg/kg twice daily or the adult tablet regimen) and 40 patients aged 12 to 18 (the majority of whom were treated with the adult tablet regimen).
Maltese: APV29005 irreġistra 30 pazjent bejn is-6 u l-11 il-sena ( li l-maġġoranza tagħhom ġew trattati b'fosamprenavir/ritonavir 18/3mg/kg darbtejn kuljum jew bis-sistema ta' kura ta'pilloli ta' l-adulti) u
English: 225 ml oral suspension A 10 ml graduated dosing syringe and adapter are also provided in the pack
Maltese: 225 ml ta' suspensjoni orali Siringa ta' l-10 ml immarkata għad-dożaġġ u adapter huma wkoll provduti fil-pakkett
English: In the paediatric studies APV20003 and APV29005, 77 PI-experienced patients were treated with fosamprenavir / ritonavir-based regimens and 43 patients met study-defined virologic failure criteria through 48 weeks in APV29005 and up to 108 weeks in APV20003.
Maltese: Fl-istudji pedjatriċi APV20003 u APV29005, 77 pazjent b'esperjenza fil-PI ġew ikkurati b'korsijiet ibbażati fuq fosamprenavir/ritonavir u 43 pazjent issodisfaw il-kriterji ta' falliment viroloġiku definiti mill-istudju tul 48 ġimgħa b'APV29005 u sa 108 ġimgħat f'APV20003.
English: Herbal preparations containing St John's wort (Hypericum perforatum) must not be used while taking Telzir due to the risk of decreased plasma concentrations and reduced clinical effects of amprenavir (see section 4.5).
Maltese: Preparazzjonijiet tal-ħxejjex li fihom St John's wort (Hypericum perforatum) m'għandhomx jintużaw fl-istess waqt li qed jintuża Telzir minħabba r-riskju ta' tnaqqis fil-konċentrazzjoni fil-plażma u fl effetti klinici mnaqqsa ta' amprenavir (ara sezzjoni 4.5).
English: Lamivudine
Maltese: Lidocaine
English: Tenofovir disoproxil 245 mg once daily
Maltese: Tenofovir disoproxil
English: gskcyprus@gsk.com
Maltese: Infomed@viivhealthcare.com
English: When antineoplastic agents agents:
Maltese: Eżempji ta' aġenti antineoplastiċi::
English: Children 6 to 11 years of age (n=9) receiving fosamprenavir / ritonavir 18 / 3 mg/kg twice daily had 26 % higher AUC(0-24) and similar Cmax and Cmin values when compared to the historical adult population receiving fosamprenavir / ritonavir 700 / 100 mg twice daily.
Maltese: Tfal ta' bejn is-6 u l-11 il-sena (n=9) li kienu qed jieħdu fosamprenavir / ritonavir 18 / 3 mg/kg darbtejn kuljum kellhom valuri ta' AUC (0-24) aktar għolja b'26% u valuri simili għal Cmax u Cmin meta mqabbla ma' popolazzjoni adulta li fil-passat kienet qed tieħu fosamprenavir / ritonavir 700 / 100 mg darbtejn kuljum.
English: Increased bleeding may occur while taking protease inhibitors (such as Telzir).
Maltese: Jista' jkollok tnixxija ta' demm aktar waqt li tkun qed tieħu inibituri tal-protease (bħal Telzir).
English: Amprenavir metabolism is inhibited by ritonavir, via inhibition of CYP3A4, resulting in increased plasma concentrations of amprenavir.
Maltese: amprenavir hu impedit b'ritonavir, permezz ta' l-impeditur CYP3A4, u dan jirriżulta f'konċentrazzjonijiet ogħla ta' amprenavir fil-plażma.
English: Both of these studies compared fosamprenavir/ritonavir with lopinavir / ritonavir.
Maltese: Iż-żewġ studji qabblu fosamprenavir/ritonavir ma' lopinavir/ritonavir.
English: PDE5 inhibitors: ↑ expected (CYP3A4 inhibition by FPV/RTV)
Maltese: Inibituri PDE5: ↑ mistennija (Inibizzjoni CYP3A4 minn FPV/RTV)
English: Proportion with HIV-1 RNA < 400 copies/ml
Maltese: Proporzjon ta' pazjenti b'RNA ta' HIV-1 < 400 kopja/ml
English: Lovastatin: ↑ expected Simvastatin: ↑ expected (CYP3A4 inhibition by FPV/RTV)
Maltese: Lovastatin: ↑ mistennija Simvastatin: ↑ mistennija (Inibizzjoni CYP3A4 minn FPV/RTV)
English: NAME OF THE MEDICINAL PRODUCT Telzir 700 mg film-coated tablets
Maltese: Informazzjoni għall-utent Telzir 700 mg Pilloli miksijin b'rita
English: ViiV Healthcare SAS Tél: + 33 (0)1 39 17 6969 Infomed@viivhealthcare.com
Maltese: ViiV Healthcare SAS Tél: + 33 (0)1 39 17 6969
English: Telzir in combination with low dose ritonavir is indicated for the treatment of Human Immunodeficiency Virus Type 1 (HIV-1) infected adults, adolescents and children of 6 years and above in combination with other antiretroviral medicinal products.
Maltese: Telzir flimkien ma' doża żgħira ta' ritonavir hu indikat fil-kura ta' adulti, adolexxenti u tfal ta' 6 snin u aktar infettati bil-Virus ta' l-Immunodefiċjenza tal-Bniedem Tip 1 (HIV-1) flimkien ma' prodotti mediċinali antiretrovirali oħra.
English: Paroxetine: Cmax ↓ 51% Paroxetine: AUC ↓ 55%
Maltese: Cmax ↓ 51% Paroxetine:
English: This is based on safety data from a total of 864 patients exposed to fosamprenavir/ritonavir in these three studies.
Maltese: Dan huwa bbażat fuq dejta ta' sigurtà minn total ta' 864 pazjent esposti għal fosamprenavir/ritonavir f'dawn l-istudji.
English: Ranitidine 300 mg single dose
Maltese: 300 mg darba kuljum
English: When fosamprenavir and ritonavir are co-administered, the ritonavir metabolic drug interaction profile may predominate because ritonavir is a more potent CYP3A4 inhibitor.
Maltese: Interazzjoni ma' prodotti mediċinali oħra u forom oħra ta' interazzjoni Meta fosamprenavir u ritonavir jingħataw flimkien, il-profil ta' interazzjoni metabolika taddroga ta' ritonavir jista' jkun predominanti għaliex ritonavir hu impeditur CYP3A4 aktar potenti.
English: It may cause serious adverse reactions (see section 4.4).
Maltese: Jista' jkun hemm il-bżonn ta' aktar tnaqqis fid-doża (ara sezzjoni 4.5).
English: Angioedema
Maltese: ADRENORIĊETTUR
English: No clinically significant interaction is expected.
Maltese: L-ebda interazzjoni klinikament sinifikanti mistennija.
English: Administration of fosamprenavir 700 mg twice daily with ritonavir 100 mg twice daily results in plasma amprenavir concentrations (data from study APV30003 in antiretroviral experienced patients) which results in protein adjusted median ratios of Cmin/IC50 and Cmin/IC95 of 21.7 (range 1.19-240) and 3.21 (range 0.26-30.0), respectively.
Maltese: L-għoti ta' 700 mg fosamprenavir darbtejn kuljum ma' 100 mg ritonavir darbtejn kuljum tirriżulta f'konċentrazzjonijiet amprenavir fil-plażma (data mill-istudju APV30003 f'pazjenti b'esperjenza ta' kura antiretrovirali) li tirriżulta fil-medja ta' proporzjon aġġustata ta' proteina ta' Cmin/IC50 u Cmin/IC95
English: • raltegravir (used to treat HIV infection)
Maltese: • raltegravir (jintuża għall-kura ta' infezzjoni bl-HIV)
English: • dolutegravir (used to treat HIV infection)
Maltese: • dolutegravir (jintuża biex jikkura infezzjoni tal-HIV)
English: Clinical chemistry abnormalities: clinical chemistry abnormalities (Grade 3 or 4) potentially related to treatment with fosamprenavir with ritonavir and reported in greater than or equal to 1 % of adult patients, included: increased ALT (common), AST (common), serum lipase (common) and triglycerides (common).
Maltese: Anormalitajiet kliniċi ta' kimika: anormalitajiet kliniċi ta' kimika (Grad 3 jew 4) li setgħu kienu relatati ma' kura b'fosamprenavir b'ritonavir u li ġew rappurtati f'1% jew aktar ta' pazjenti adulti, kienu jinkludu: żieda ta' ALT (komuni), ta' AST (komuni), ta' serum lipase (komuni) u ta' trigliċeridi
English: No new safety concerns were identified from analyses of 48 week data from studies APV29005 or APV20002, in which 54 subjects 4 weeks to <2 years of age received twice daily fosamprenavir / ritonavir with background nucleoside reverse transcriptase inhibitor therapy and 5 subjects received only single doses of fosamprenavir with or without ritonavir.
Maltese: APV29005 jew APV20002, li fihom 54 individwu minn 4 ġimgħat sa <sentejn irċivew fosamprenavir/ritonavir darbtejn kuljum ma' terapija ta' inibitur nucleoside reverse transcriptase ta'
English: In pregnant rats and rabbits there were no major effects on embryo-foetal development.
Maltese: F'firien u fniek tqal ma kienx hemm effetti sinifikanti fuq l-iżvilupp embrijo-fetali.
English: Itraconazole: ↑ expected (CYP3A4 inhibition by FPV/RTV)
Maltese: Itraconazole: ↑ mistennija (Inibizzjoni ta' CYP3A4 minn FPV/RTV)
English: While effective viral suppression with antiretroviral therapy has been proven to substantially reduce the risk of sexual transmission, a residual risk cannot be excluded.
Maltese: trasmissjoni sesswali, riskju residwu ma jistax jiġi eskluż.
English: For adults with moderate hepatic impairment (Child-Pugh score: 7-9) the recommended dose is 450 mg fosamprenavir twice daily with 100 mg ritonavir once daily.
Maltese: Id-doża rakkomandata għall-adulti b'indeboliment tal-fwied moderat (Child-Pugh score: 7-9) hija ta' 450 mg fosamprenavir darbtejn kuljum ma' 100 mg ritonavir darba kuljum.
English: For adults with mild hepatic impairment (Child-Pugh score: 5-6) the recommended dose is 700 mg fosamprenavir twice daily with 100 mg ritonavir once daily.
Maltese: Id-doża rakkomandata għall-adulti b'indeboliment tal-fwied ħafif (Child-Pugh score: 5-6) hija ta' 700 mg fosamprenavir darbtejn kuljum ma' 100 mg ritonavir darba kuljum.
English: Some people taking combination therapy for HIV develop a condition called osteonecrosis.
Maltese: Xi nies fuq terapija kombinata għal HIV jiżviluppaw kondizzjoni li tissejjaħ ostejonekrożi.
English: The plasma amprenavir pharmacokinetics were evaluated in a 14 day repeat-dose study in HIV-1 infected adult subjects with mild, moderate, or severe hepatic impairment receiving fosamprenavir with ritonavir compared to matched control subjects with normal hepatic function.
Maltese: Il-farmakokinetiċi ta' amprenavir fil-plażma ġew evalwati fi studju ta' 14-il ġurnata b'doża ripetuta f'suġġetti adulti bl-infezzjoni HIV-1 u b'indeboliment tal-fwied ħafif, moderat jew sever li qegħdin jirċievu fosamprenavir flimkien ma' ritonavir u dawn ġew mqabbla ma' suġġetti simili b'funzjoni talfwied normali bħala kontroll.
English: The median durations of prior exposure to protease inhibitors were 149 weeks for patients receiving fosamprenavir with ritonavir twice daily (49 % received ≥ 2 prior PIs) and 130 weeks for patients receiving lopinavir/ritonavir (40 % received ≥2 prior PIs).
Maltese: It-tul medju ta' esponimenti ta' qabel għal impedituri protease kien ta' 149 ġimgħa għal pazjenti li kienu jieħdu fosamprenavir b'ritonavir darbtejn kuljum (49% ħadu ≥2 PIs minn qabel) u ta' 130 ġimgħa għal pazjenti li kienu jieħdu lopinavir/ritonavir (40% ħadu ≥ PIs minn qabel).
English: Combination of rifampicin with Telzir with concomitant low-dose ritonavir is contraindicated (see section 4.5).
Maltese: Il-kumbinazzjoni ta' rifampicin u Telzir flimkien ma' doża baxxa ta' ritonavir hija kontraindikata (ara sezzjoni 4.5).
English: Itraconazole No drug interaction studies.
Maltese: L-ebda studji ta' interazzjoni fuq mediċini.
English: Halofantrine: ↑ expected (CYP3A4 inhibition by FPV/RTV)
Maltese: Halofantrine: ↑ mistennija (Inibizzjoni CYP3A4 minn FPV/RTV)
English: Greater effects may be expected when fluticasone propionate is inhaled.
Maltese: Jistgħu ikunu mistennija benefiċċji akbar meta ikun inalat fluticasone propionate.
English: Not recommended.
Maltese: infjammazzjoni.
English: Study performed with amprenavir.
Maltese: ta' dawk osservati minn amprenavir.
English: The median durations of prior exposure to protease inhibitors were 149 weeks for patients receiving fosamprenavir with ritonavir twice daily (49 % received ≥ 2 prior PIs) and 130 weeks for patients receiving lopinavir/ritonavir (40 % received ≥ 2 prior PIs).
Maltese: It-tul medjan ta' esponimenti ta' qabel għal impedituri protease kien ta' 149 ġimgħa għal pazjenti li kienu jieħdu fosamprenavir b'ritonavir darbtejn kuljum (49% ħadu ≥2 PIs minn qabel) u ta' 130 ġimgħa għal pazjenti li kienu jieħdu lopinavir/ritonavir (40% ħadu ≥ PIs minn qabel).
English: ANTICONVULSANTS Phenytoin
Maltese: Phenytoin
English: Remove the bottle cap and keep it safely.
Maltese: withdrawal bħala prekawzjoni.
English: Pimozide: ↑ expected (CYP3A4 inhibition by FPV/RTV)
Maltese: Pimozide: ↑ mistennija (Inibizzjoni CYP3A4 minn FPV/RTV)
English: The median durations of prior exposure to NRTIs were 257 weeks for patients receiving fosamprenavir with ritonavir twice daily (79 % had ≥ 3 prior NRTIs) and 210 weeks for patients receiving lopinavir/ritonavir (64 % had ≥ 3 prior NRTIs).
Maltese: It-tul medju ta' esponimenti ta' qabel għal NRTIs kien ta' 257 ġimgħa għal pazjenti li kienu jieħdu fosamprenavir b'ritonavir darbtejn kuljum (79% ħadu ≥3 NRTIs minn qabel) u ta' 210 ġimgħa għal pazjenti li kienu jieħdu lopinavir/ritonavir (64% ħadu ≥3 NRTIs minn qabel).
English: Anti-mycobacterial: Rifabutin
Maltese: Anti-mikobatteriċi:
English: Osteonecrosis
Maltese: Ostejonekrożi
English: If you have severe liver disease the dose is 6 ml Telzir oral suspension (300 mg fosamprenavir) twice daily with 100 mg ritonavir only once daily.
Maltese: Jekk tbati minn mard sever tal-fwied id-doża hija ta' 6ml suspensjoni orali ta' Telzir (300mg fosamprenavir) darbtejn kuljum ma' 100mg ritonavir darba kuljum biss.
English: SELECTIVE SEROTONIN REUPTAKE INHIBITORS (SSRIS)
Maltese: TAT-TEHID LURA TA' SEROTONINA(SSRIS)
English: In subjects with moderate hepatic impairment (Child-Pugh score of 7-9), a reduced dose of fosamprenavir 450 mg twice daily with a reduced dosing frequency of ritonavir 100 mg once daily is predicted to deliver similar plasma amprenavir Cmax and AUC(0-12), but approximately 35 % lower plasma total amprenavir C12 values and approximately 88 % higher plasma unbound amprenavir C12 values than achieved in subjects with normal hepatic function receiving the standard fosamprenavir with ritonavir 700 mg / 100 mg twice daily regimen.
Maltese: F'suġġetti b'indeboliment tal-fwied moderat (Child-Pugh score ta' 7-9), huwa stmat li doża mnaqqsa ta' fosamprenavir 450 mg darbtejn kuljum flimkien ma' ritonavir 100mg bil-frekwenza tad-doża mnaqqsa għal darba kuljum twassal għal-livell simili ta' Cmax u AUC (0-12) ta' amprenavir ġol-plażma, imma twassal għal-livell ta' C12 ta' amprenavir totali fil-plażma ta' bejn wieħed u ieħor 35% iżjed baxx u livell ta' C12 ta' amprenavir mhux marbut fil-plażma ta' bejn wieħed u ieħor 88 % ogħla min dik milqugħa f'suġġetti b'funzjoni tal-fwied normali li qed jirċievu s-sistema ta' dożaġġ standard ta'
English: Haemophiliac patients: there have been reports of increased spontaneous bleeding in haemophiliac patients receiving antiretroviral protease inhibitors (see section 4.4).
Maltese: Pazjenti bl-emofilja: kien hemm rapporti ta' żieda fil-fsada spontanja f'pazjenti bl-emofilja meta dawn kienu qed jirċievu impedituri antiretrovirali ta' protease (ara sezzjoni 4.4).
English: Predicted exposures are based on extrapolation from data observed following administration of fosamprenavir 300 mg twice daily with ritonavir 100 mg once daily in subjects with moderate hepatic impairment.
Maltese: Esponimenti mbassra huma bbażati fuq estrapolazzjoni minn dejta osservata wara l-għoti ta' fosamprenavir 300 mg darbtejn kuljum flimkien ma' ritonavir 100 mg darba kuljum f'individwi b'indeboliment moderat tal-fwied.
English: Lidocaine: ↑ expected (CYP3A4 inhibition by FPV/RTV)
Maltese: Lidocaine: ↑ mistennija (InibizzjoniCYP3A4 minn FPV/RTV)
English: • injectable midazolam (used to treat anxiety)
Maltese: • injezzjoni ta' midazolam (użati għal kura ta' l-ansjeta')
English: The recommended dose is 700 mg fosamprenavir twice daily with 100 mg ritonavir twice daily.
Maltese: Id-doża rakkomandata hi ta' 700 mg fosamprenavir darbtejn kuljum ma' 100 mg ritonavir darbtejn kuljum.
English: An increase in weight and in levels of blood lipids and glucose may occur during antiretroviral therapy.
Maltese: Żieda fil-piż u fil-livelli ta' lipidi u glucose fid-demm tista' sseħħ matul terapija antiretrovirali.
English: → Use an alternative non-hormonal type of contraception such as a condom.
Maltese: →Uża tip ta' kontraċezzjoni ieħor mhux ormonali bħal kondom.
English: Blood cholesterol increased Blood triglycerides increased Alanine aminotransferase increased
Maltese: Żjieda f'Alanine aminotransferase
English: Paediatric / other populations
Maltese: Popolazzjoni pedjatrika/popolazzjonijiet oħra
English: Ritonavir: Cmax ↑ 63%* Ritonavir: AUC ↑ 45%* * compared to historical data
Maltese: Cmax ↑63%* Ritonavir:
English: Each ml of oral suspension contains 50 mg fosamprenavir as fosamprenavir calcium (equivalent to approximately 43 mg amprenavir).
Maltese: Kull ml tas-suspensjoni fih 50 mg fosamprenavir bħala fosamprenavir calcium (ekwivalenti għal madwar 43 mg amprenavir).