FrancophonIA/ELRC3.0 huggingface dataset:
English: INHALED BETA AGONISTS Salmeterol
Maltese: AGONIST TAR-RIĊETTUR BETA LI JINĠIBED MAN-NIFS Salmeterol
English: • trazodone, a medicine used to treat depression
Maltese: • trazodone, mediċina li tintuża għal trattament tad-dipressjoni
English: Randomisation was stratified by screening HIV-1 RNA level (≤ 100,000 copies/ml or > 100,000 copies/ml).
Maltese: L-għażla b'mod każwali ġiet stratifikata permezz ta' skrinjar tal-livell tal-HIV-1 RNA (≤ 100,000 kopja/mL jew > 100,000 kopja/mL).
English: However, a higher percentage of subjects in the cobicistat-boosted group had increases in total bilirubin > 2 x ULN than those in the ritonavir-boosted group (88.0% versus 80.9%).
Maltese: Madankollu, perċentwali ogħla ta' individwi fil-grupp imsaħħaħ minn cobicistat kellhom żidiet fil-bilirubina totali ta' > 2 x ULN minn dawk fil-grupp imsaħħaħ minn ritonavir (88.0% versus 80.9%).
English: • salmeterol, a medicine used to treat asthma
Maltese: • salmeterol, mediċina li tintużaw għal trattament tal-ażżma
English: At week 96 the mean change in serum creatinine was 0.07 ± 0.15 mg/dl and the mean change in eGFR by Cockcroft-Gault method was -6.2 ± 9.07 ml/min.
Maltese: F'ġimgħa 96 il-bidla medja tal-krejatinina fis-serum kienet ta' 0.07 ± 0.15 mg/dL u l-bidla medja f'eGFR bil-metodu ta' Cockcroft-Gault kienet ta' -6.2 ± 9.07 mL/min.
English: Cobicistat is a weak CYP2D6 inhibitor and is metabolised to a minor extent by CYP2D6.
Maltese: Cobicistat hu impeditur dgħajjef ta' CYP2D6 u jiġi metabolizzat, sa ċertu punt, minn CYP2D6.
English: Median baseline plasma HIV-1 RNA (range)
Maltese: Medjan ta' plażma fil-linja bażi HIV-1 RNA (medda) log10 kopji/mL
English: Atazanavir + cobicistat + emtricitabine and tenofovir disoproxil fumarate fixed-dose combination was non-inferior in achieving HIV-1 RNA < 50 copies/ml when compared to atazanavir + ritonavir + emtricitabine and tenofovir disoproxil fumarate fixed-dose combination.
Maltese: Atazanavir + cobicistat + kombinazzjoni ta' doża fissa ta' emtricitabine u tenofovir disoproxil fumarate ma kinux inferjuri fil-kisba ta' HIV-1 RNA < 50 kopja/mL meta mqabbla ma' atazanavir + ritonavir kif ukoll kombinazzjoni ta' doża fissa ta' emtricitabine u tenofovir disoproxil fumarate.
English: myalgia
Maltese: mijalġja
English: Some examples include, but are not limited to, etravirine, efavirenz, nevirapine, and bosentan (see Table 2).
Maltese: Xi eżempji jinkludu, iżda mhumiex limitati għal, etravirine, efavirenz, nevirapine, u bosentan (ara Tabella 2).
English: Co-administration of cobicistat with carbamazepine is contraindicated (see section 4.3).
Maltese: L-għoti flimkien ta' cobicistat ma' carbamazepine hu kontraindikat (ara sezzjoni 4.3).
English: • PDE-5 inhibitors: sildenafil for treatment of pulmonary arterial hypertension
Maltese: • impedituri ta' PDE-5: sildenafil għat-trattament ta' pressjoni għolja fl-arterja pulmonari
English: Inhibition of CYP3A-mediated metabolism by cobicistat enhances the systemic exposure of CYP3A substrates (such as atazanavir or darunavir) that have limited oral bioavailability and a short half-life due to CYP3A-dependent metabolism.
Maltese: L-inibizzjoni tal-metaboliżmu medjat minn CYP3A minn cobicistat ittejjeb lesponiment sistemiku ta' substrati ta' CYP3A (bħal atazanavir jew darunavir) li għandhom bijodisponibilità orali limitata u half-life qasira minħabba l-metaboliżmu dipendenti fuq CYP3A.
English: Hepatitis B and/or hepatitis C virus co-infection
Maltese: Infezzjoni bil-virus tal-epatite B u/jew epatite Ċ ukoll
English: Black or African Heritage Asian
Maltese: Suwed jew ta' Nisel Afrikan
English: Median age, years (min-max)
Maltese: Karatteristiċi Demografiċi Medjan ta' età, snin (min-mas)
English: 150 mg once daily
Maltese: 150 mg darba kuljum
English: Cobicistat has no detectable antiviral activity against HIV-1, HBV or HCV and does not antagonise the antiviral effect of HIV inhibitors.
Maltese: Cobicistat m'għandu l-ebda attività antivirali li tista' tiġi osservata kontra l-HIV-1, HBV jew HCV u ma jantagonizzax l-effett antivirali ta' impedituri tal-HIV.
English: The active substance cobicistat is persistent in the environment.
Maltese: Is-sustanza attiva cobicistat hi persistenti fl-ambjent.
English: The safety and efficacy of cobicistat in children aged 0 to less than 18 years have not been established (see section 5.1).
Maltese: Is-sigurtà u l-effikaċja ta' cobicistat fit-tfal minn età ta' żero sa inqas minn 18-il sena ma ġewx determinati (ara sezzjoni 5.1).
English: The steady-state mean Cmax, AUCtau, and Ctrough (mean ± SD) following multiple doses of cobicistat in HIV-1 infected subjects (n = 68), respectively, were 1.2 ± 0.3 µg/ml, 10.9 ± 3.8 µg•h/ml, and 0.07 ± 0.07 µg/ml.
Maltese: Il-medja fl-istat fiss tas-Cmax, AUCtau, u Ctrough (medja ± SD) wara dożi multipli ta' cobicistat f'individwi infettati bl-HIV-1 (n = 68), rispettivament, kienu 1.2 ± 0.3 μg/mL, 10.
English: Increased plasma concentrations of medicinal products that are metabolised by CYP3A (including atazanavir and darunavir) are observed on co-administration with cobicistat.
Maltese: Żieda fil-konċentrazzjonijiet fil-plażma ta' prodotti mediċinali li jiġu metabolizzati minn CYP3A (li jinkludu atazanavir u darunavir) jiġu osservati mal-għoti flimkien ma' cobicistat.
English: Animal studies do not indicate direct or indirect harmful effects of cobicistat with respect to reproductive toxicity (see section 5.3).
Maltese: Studji f'annimali ma jurux effetti tossiċi diretti jew indiretti ta' cobicistat fuq is-sistema riproduttiva (ara sezzjoni 5.3).
English: CD4+ T-cell count (cells/mm3)b a Plus background regimen of emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg fixed-dose combination b Missing = excluded analysis
Maltese: T CD4+ (ċelluli/mm3)b a Flimkien ma' kors fl-isfond ta' kombinazzjoni ta' doża fissa ta' emtricitabine 200 mg u tenofovir disoproxil fumarate 300 mg b Neqsin = analiżi eskluża
English: • bosentan, a medicine used to treat pulmonary arterial hypertension
Maltese: • bosentan, mediċina li tintuża għal trattament ta' pressjoni għolja arterjali pulmonari
English: Cobicistat is metabolised via CYP3A (major)- and CYP2D6 (minor)-mediated oxidation and does not undergo glucuronidation.
Maltese: Cobicistat hu metabolizzat permezz ta' CYP3A (maġġuri) - u ossidazzjoni medjata minn CYP2D6 (minuri) u ma jgħaddix minn glukoronidazzjoni.
English: Cobicistat has not been studied in patients with severe hepatic impairment (Child-Pugh Class C).
Maltese: Cobicistat ma ġiex studjat f'pazjenti b'indeboliment epatiku sever (Child-Pugh Klassi Ċ).
English: log10 copies/ml
Maltese: HIV-1 RNA < 50 kopja/mL
English: The mean (± SD) change in estimated glomerular filtration rate (eGFR) by Cockcroft-Gault method after 144 weeks of treatment was -15.1 ± 16.5 ml/min in the cobicistat-boosted atazanavir plus emtricitabine and tenofovir disoproxil fumarate fixed-dose combination group and -8.0 ± 16.8 ml/min in the ritonavir-boosted atazanavir plus emtricitabine and tenofovir disoproxil fumarate fixed-dose combination group.
Maltese: 1 ± 16.5 mL/min fil-grupp ta' atazanavir imsaħħaħ minn cobicistat u kombinazzjoni ta' doża fissa ta' emtricitabine u tenofovir disoproxil fumarate u -8.0 ± 16.8 mL/min fil-grupp ta' atazanavir imsaħħaħ minn ritonavir u kombinazzjoni ta' doża fissa ta' emtricitabine u tenofovir disoproxil fumarate.
English: AUC: ↑ 822% Cmax: ↑ 1785%
Maltese: AUC: ↑ 822% Cmax: ↑ 1785% Cmin: NC
English: Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs) Efavirenz (600 mg single dose) Co-administration of efavirenz and cobicistat is expected to decrease cobicistat plasma concentrations.
Maltese: Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs) Efavirenz (600 mg doża waħda)
English: depression, sleep disorder Nervous system disorders: Common:
Maltese: dipressjoni, disturb fl-irqad Disturbi fis-sistema nervuża:
English: Tybost is indicated as a pharmacokinetic enhancer of atazanavir 300 mg once daily or darunavir 800 mg once daily as part of antiretroviral combination therapy in human immunodeficiency virus-1 (HIV-1) infected adults.
Maltese: Tybost hu indikat bħala enhancer biex itejjeb il-valur farmakokinetiku ta' atazanavir 300 mg darba kuljum jew darunavir 800 mg darba kuljum bħala parti minn terapija ta' kombinazzjoni antiretrovirali fl-adulti infettati bil-virus tal-immunodefiċjenza uman 1 (HIV-1).
English: AUC: ↔ Cmax: ↓ 13% Cmin: ND
Maltese: AUC: ↔ Cmax: ↓ 13% Cmin: MS
English: IMMUNOSUPPRESSANTS Ciclosporin
Maltese: Ciclosporin Sirolimus
English: In Study GS-US-216-0114, decreases in estimated creatinine clearance occurred early in treatment with cobicistat, after which they stabilised.
Maltese: Fl-Istudju GS-US-216-0114, tnaqqis fit-tneħħija stmata tal-krejatinina seħħet kmieni fil-kura b'cobicistat, u wara t-tnaqqis stabbilizza ruħu.
English: Tybost 150 mg film-coated tablets cobicistat
Maltese: Tybost 150 mg pilloli miksija b'rita cobicistat
English: Patients were randomised in a 1:1 ratio to receive either atazanavir 300 mg + cobicistat 150 mg once daily or atazanavir 300 mg + ritonavir 100 mg once daily, each administered with a fixed background regimen containing tenofovir disoproxil fumarate 300 mg and emtricitabine 200 mg administered as a fixed-dose combination tablet.
Maltese: Pazjenti ntgħażlu b'mod każwali fi proporzjon ta' 1:1 biex jirċievu jew atazanavir 300 mg + cobicistat 150 mg darba kuljum jew atazanavir 300 mg + ritonavir 100 mg darba kuljum, kull wieħed mogħti b'kors fiss fl-isfond li kien fih tenofovir disoproxil fumarate 300 mg u emtricitabine 200 mg mogħtija bħala pillola kombinata ta' doża fissa.
English: Clinical experience
Maltese: Esperjenza klinika
English: Table 5: Pharmacokinetic parameters [mean ± SD (%CV)] of darunavir 800 mg co-administered with cobicistat 150 mg or ritonavir 100 mg once daily
Maltese: Parametri farmakokinetiċi [medja ± SD (%CV)] ta' darunavir 800 mg mogħti flimkien ma' cobicistat 150 mg jew ritonavir 100 mg darba kuljum
English: Cobicistat is primarily metabolised and eliminated by the liver.
Maltese: Cobicistat jiġi metabolizzat u eliminat prinċipalment mill-fwied.
English: AUC: ↑ 290% Cmax: ↑ 319%
Maltese: AUC: ↑ 290% Cmax: ↑ 319% Cmin: NC
English: See sections 4.2, 4.8 and 5.2.
Maltese: Ara sezzjonijiet 4.2, 4.8
English: Co-administration of Tybost and antiretroviral medicinal products Tybost must be co-administered with either atazanavir 300 mg once daily or with darunavir 800 mg once daily (see section 4.2).
Maltese: L-għoti flimkien ta' Tybost u prodotti mediċinali antiretrovirali Tybost irid jingħata flimkien jew ma' atazanavir 300 mg darba kuljum jew ma' darunavir 800 mg darba kuljum (ara sezzjoni 4.2).
English: Baseline characteristics and treatment outcomes at weeks 48 and 144 for Study GS-US-216-0114 are presented in Tables 6 and 7, respectively.
Maltese: Il-karatteristiċi fil-linja bażi u r-riżultati tat-trattament f'ġimgħat 48 u 144 għall-Istudju GS-US-216-0114 huma ppreżentati f'Tabelli 6 u 7, rispettivament.
English: Tybost contains sunset yellow FCF aluminium lake which may cause allergic reactions.
Maltese: Tybost fih sunset yellow FCF aluminium lake li jista' jikkawża reazzjonijiet allerġiċi.
English: A study of the pharmacokinetics of cobicistat was performed in non-HIV-1 infected subjects with moderate hepatic impairment (Child-Pugh Class B).
Maltese: Studju dwar il-farmakokinetika ta' cobicistat twettaq f'individwi b'indeboliment epatiku moderat (Child-Pugh Klassi B) li ma kinux infettati b'HIV-1.
English: Cmax: ↑ 277% Cmin: NC
Maltese: AUC: ↑ 93% Cmax: ↑ 277% Cmin: NC
English: Antimycobacterials Rifabutin (150 mg every other day)/Elvitegravir (150 mg once daily)/Cobicistat (150 mg once daily)
Maltese: Antimikobatteriċi Rifabutin (150 mg kull jumejn)/Elvitegravir (150 mg darba kuljum)/Cobicistat (150 mg darba kuljum)
English: • atorvastatin, fluvastatin, pitavastatin, pravastatin and rosuvastatin, medicines used to lower cholesterol
Maltese: • atorvastatin, fluvastatin, pitavastatin, pravastatin u rosuvastatin, mediċini li jintużaw biex ibaxxu l-kolesterol fid-demm
English: The following pack sizes are available: outer cartons containing 1 bottle of 30 film-coated tablets and 90 (3 bottles of 30) film-coated tablets.
Maltese: Id-daqsijiet tal-pakketti li ġejjin huma disponibbli: kartun ta' barra li fihom flixkun wieħed ta' 30 pillola miksija b'rita, u 90 (3 fliexken ta' 30) pillola miksija b'rita.
English: Table 8: Changes in CD4+ cell counts through weeks 48 and 144 in Study GS-US-216-0114 Week 48
Maltese: Tabella 8: Bidliet fl-għadd taċ-ċelluli CD4+ sat-48 u l-144 ġimgħa fl-Istudju GS-US-216-0114
English: Date of first authorisation: 19 September 2013 Date of latest renewal: 26 July 2018
Maltese: Data tal-aħħar tiġdid: 26 Lulju 2018
English: Table 3: Tabulated summary of adverse reactions to cobicistat-boosted atazanavir based on experience of 144 weeks from phase 3 Study GS-US-216-0114
Maltese: Tabella 3: Sommarju tabulat ta' reazzjonijiet avversi għal atazanavir imsaħħaħ minn cobicistat ibbażati fuq l-esperjenza ta' 144 ġimgħa mill-Istudju ta' fażi 3 GS-US-216-0114
English: A study of the pharmacokinetics of cobicistat was performed in non-HIV-1 infected subjects with severe renal impairment (estimated creatinine clearance below 30 ml/min).
Maltese: Studju dwar il-farmakokinetika ta' cobicistat twettaq f'individwi li ma kinux infettati bl-HIV-1 b'indeboliment renali sever (stima ta' tneħħija tal-krejatinina taħt 30 mL/min).
English: Contains sunset yellow FCF aluminium lake (E110), see leaflet for further information.
Maltese: TA' EĊĊIPJENTI Fih sunset yellow FCF aluminium lake (E110), ara l-fuljett ta' tagħrif għal aktar informazzjoni.
English: The steady-state pharmacokinetic parameters of atazanavir were comparable when boosted with cobicistat versus ritonavir (see Table 4).
Maltese: Il-parametri farmakokinetiċi ta' atazanavir fl-istat fiss kienu komparabbli meta ssaħħu b'cobicistat versus ritonavir (ara Tabella 4).
English: Vinblastine
Maltese: Vinblastine Vincristine
English: Norgestimate/Ethinyloestradiol Interaction not studied.
Maltese: Norgestimate/Ethinyloestra diol
English: AUC: ↔ Cmax: ↑ 41% Cmin: ND
Maltese: AUC: ↔ Cmax: ↑ 41% Cmin: MS
English: • sildenafil and vardenafil, medicines used to treat impotence, and tadalafil, a medicine used to treat impotence and pulmonary hypertension
Maltese: • sildenafil u vardenafil, mediċini li jintużaw għat-trattament ta' impotenza, u tadalafil, mediċina li tintuża għat-trattament ta' impotenza u pressjoni għolja pulmonari
English: The steady-state pharmacokinetic parameters of darunavir were comparable when boosted with cobicistat versus ritonavir (see Table 5).
Maltese: Il-parametri farmakokinetiċi ta' darunavir fl-istat fiss kienu komparabbli meta ssaħħu b'cobicistat versus ritonavir (ara Tabella 5).
English: No data are available on which to make a dose recommendation for patients over the age of 65 years (see section 5.2).
Maltese: M'hemmx informazzjoni fuqhiex wieħed jista' jagħti rakkomandazzjoni għall-pazjenti ta' 'l fuq minn 65 sena (ara sezzjoni 5.2).
English: Co-administration with cobicistat can increase plasma concentrations of medicinal products that are metabolised by CYP2D6 (see sections 4.3 and 4.4).
Maltese: Lgħoti flimkien ma' cobicistat jista' jżid il-konċentrazzjonijiet fil-plażma ta' prodotti mediċinali li jiġu metabolizzati minn CYP2D6 (ara sezzjonijiet 4.3 u 4.4).
English: Co-administration with cobicistat can increase plasma concentrations of medicinal products that are metabolised by CYP2D6 (see sections 4.3 and 4.5).
Maltese: Lgħoti flimkien ma' cobicistat jista' jżid il-konċentrazzjonijiet fil-plażma ta' prodotti mediċinali li jiġu metabolizzati minn CYP2D6 (ara sezzjonijiet 4.3 u 4.5).
English: No dose adjustment of cobicistat is required in patients with mild (Child-Pugh Class A) or moderate hepatic impairment (Child-Pugh Class B).
Maltese: L-ebda aġġustament fid-doża ta' cobicistat mhu meħtieġ f'pazjenti b'indeboliment epatiku ħafif (Child-Pugh Klassi A) jew moderat (Child-Pugh Klassi B).
English: ANTICOAGULANTS Dabigatran
Maltese: ANTIDIJABETIĊI ORALI
English: Table 6: Demographic and baseline disease characteristics of antiretroviral treatment-naïve HIV-1 infected adult subjects in Study GS-US-216-0114
Maltese: Tabella 6: Karatteristiċi demografiċi u tal-marda fil-linja bażi ta' individwi adulti infettati blHIV-1 li qatt ma ngħataw trattament b'mediċini antiretrovirali fil-passat fl-Istudju
English: Co-administration of cobicistat with medicinal products that are strong inducers of CYP3A (such as St. John's wort (Hypericum perforatum), rifampicin, carbamazepine, phenobarbital, phenytoin) may result in decreased plasma concentrations of cobicistat and consequently that of atazanavir or darunavir being boosted, leading to loss of therapeutic effect and possible development of resistance (see section 4.3).
Maltese: John's wort (Hypericum perforatum), rifampicin, carbamazepine, phenobarbital, phenytoin) jista' jirriżulta fi tnaqqis tal-konċentrazzjonijiet fil-plażma ta' cobicistat u konsegwentement li atazanavir jew darunavir jiġu msaħħa, li jwasslu għat-telf tal-effett terapewtiku u possibbilment l-iżvilupp ta' reżistenza (ara sezzjoni 4.3).
English: Adverse reactions to cobicistat-boosted atazanavir during 144 weeks of clinical trial experience from Study GS-US-216-0114 are listed in Table 3, below, by body system organ class and frequency.
Maltese: Reazzjonijiet avversi għal atazanavir imsaħħaħ minn cobicistat matul il-144 ġimgħa ta' esperjenza talistudji kliniċi mill-Istudju GS-US-216-0114 huma elenkati f'Tabella 3, hawn taħt, skont il-klassi ta' sistema tal-organi fil-ġisem u skont il-frekwenza.
English: Metabolism and nutrition disorders: Common:
Maltese: Disturbi fil-metaboliżmu u n-nutrizzjoni:
English: The safety and efficacy of cobicistat with atazanavir in HIV-1 infected patients were evaluated in the randomised, double-blind, active-controlled phase 3 Study GS-US-216-0114 in HIV-1 infected patients with baseline estimated creatinine clearance above 70 ml/min who were treatment-naïve (n = 692).
Maltese: F'pazjenti infettati bl-HIV-1 li qatt ma rċivew trattament fil-passat Is-sigurtà u l-effikaċja ta' cobicistat ma' atazanavir f'pazjenti infettati bl-HIV-1 ġew evalwati flIstudju ta' fażi 3 li fih il-parteċipanti ntgħażlu b'mod każwali, double-blind, ikkontrollat b'mod attiv GS-US-216-0114 f'pazjenti infettati bl-HIV-1 bi tneħħija stmata tal-krejatinina fil-linja bażi ta' aktar minn 70 mL/min li qatt ma rċivew kura fil-passat (n = 692).
English: Pharmacokinetics of cobicistat have not been fully evaluated in hepatitis B and/or C virus co-infected subjects.
Maltese: Il-farmakokinetika ta' cobicistat ma ġietx evalwata b'mod sħiħ f'soġġetti infettati wkoll b'virus talepatite B u/jew Ċ.
English: Each film-coated tablet contains 150 mg cobicistat.
Maltese: Kull pillola miksija b'rita fiha 150 mg ta' cobicistat.
English: Atorvastatin (10 mg single dose)/Darunavir (800 mg)/Cobicistat (150 mg once daily)
Maltese: Atorvastatin (10 mg doża waħda)/Darunavir (800 mg)/Cobicistat (150 mg darba kuljum)
English: K65R or K70E, or any primary resistance substitution associated with protease inhibitors.
Maltese: L-ebda individwu ma żviluppa ssostituzzjonijiet ta' reżistenza K65R jew K70E, assoċjati ma' tenofovir jew kwalunkwe sostituzzjoni ta' reżistenza primarja assoċjata ma' inibituri tal-proteases.
English: In an analysis of treatment-failure subjects in Study GS-US-216-0114 through week 144, evaluable genotypic data from paired baseline and treatment-failure isolates were available for all 21 virologic failures in the cobicistat group.
Maltese: F'analiżi ta' individwi li fihom il-kura ma rnexxietx fl-Istudju GS-US-216-0114 sa ġimgħa 144, dejta ġenotipika li setgħet tiġi evalwata minn iżolati paired fil-linja bażi u ta' kura ma rnexxietx kienu disponibbli għall-21 falliment viroloġiku kollha fil-grupp ta' cobicistat.
English: Atorvastatin (10 mg single dose)/Atazanavir (300 mg)/Cobicistat (150 mg once daily)
Maltese: Atorvastatin (10 mg doża waħda)/Atazanavir (300 mg)/Cobicistat (150 mg darba kuljum)
English: The effect of cobicistat on serum creatinine and eGFR in patients switching from ritonavir to cobicistat in Study GS-US-236-0118 was consistent with the effect in treatmentnaïve patients in Study GS-US-216-0114.
Maltese: L-effett ta' cobicistat fuq il-krejatinina fis-serum u eGFR f'pazjenti li jaqilbu minn ritonavir għal cobicistat fl-Istudju GS-US-236-0118 kien konsistenti mal-effett f'pazjenti li qatt ma rċivew kura fil-passat fl-Istudju GS-US-216-0114.
English: ANTI-NEOPLASTICS Dasatinib
Maltese: 4.1 Indikazzjonijiet terapewtiċi
English: Orange, round, biconvex, film-coated tablet of diameter 10.3 mm, debossed with “GSI” on one side of the tablet and plain-faced on the other side of the tablet.
Maltese: 3 mm, b'“GSI” imnaqqxa fuq naħa waħda tal-pillola u xejn fuq in-naħa l-oħra tal-pillola.
English: Tybost should not be used in combination with other medicinal products containing cobicistat or with ritonavir due to similar effects of cobicistat and ritonavir on CYP3A.
Maltese: Tybost m'għandux jintuża flimkien ma' prodotti mediċinali oħrajn li fihom cobicistat jew ma' ritonavir minħabba effetti simili ta' cobicistat u ritonavir fuq CYP3A.
English: Cmax: ↑ 958% Cmin: NC
Maltese: AUC: ↑ 242% Cmax: ↑ 958% Cmin: NC
English: alfuzosin, used to treat an enlarged prostate gland amiodarone, quinidine, used to correct irregular heartbeats dabigatran, used to prevent and treat blood clots carbamazepine, phenobarbital, phenytoin, used to prevent seizures rifampicin, used to prevent and treat tuberculosis and other infections dihydroergotamine, ergometrine, ergotamine, used to treat migraine headache
Maltese: • Jekk qed tieħu mediċini li fihom xi waħda minn dawn: alfuzosin, jintuża għal trattament ta' glandola mkabbra tal-prostata amiodarone, quinidine, jintużaw biex jikkoreġu taħbit irregolari tal-qalb dabigatran, jintuża għall-prevenzjoni u t-trattament ta' emboli tad-demm carbamazepine, phenobarbital, phenytoin, jintużaw għal prevenzjoni ta' aċċessjonijiet rifampicin, jintuża għal prevenzjoni u trattament ta' tuberkulosi u infezzjonijiet oħrajn dihydroergotamine, ergometrine, ergotamine, jintużaw għal trattament ta' uġigħ ta' emigranja fir-ras
English: The median terminal plasma half-life of cobicistat following administration of Tybost is approximately 3-4 hours.
Maltese: Il-medjan tal-half-life terminali fil-plażma ta' cobicistat wara l-għoti ta' Tybost hu ta' madwar 3-4 sigħat.
English: Tybost film-coated tablets are orange, round, biconvex tablets, debossed on one side with “GSI” and plain-faced on the other side of the tablet.
Maltese: Tybost pilloli miksija b'rita huma oranġjo, tondi u bikonvessi, b'“GSI” imnaqqxa fuq naħa waħda talpillola u xejn fuq in-naħa l-oħra tal-pillola.
English: No clinically relevant differences in cobicistat pharmacokinetics were observed between subjects with moderate impairment and healthy subjects.
Maltese: L-ebda differenzi klinikament rilevanti fil-farmakokinetika ta' cobicistat ma ġew osservati bejn individwi b'indeboliment moderat u individwi b'saħħithom.
English: • dasatinib, nilotinib, vinblastine and vincristine, medicines used to treat cancer • corticosteroids including betamethasone, budesonide, fluticasone, mometasone,
Maltese: • dasatinib, nilotinib, vinblastine u vincristine, mediċini li jintużaw għal trattament tal-kanċer
English: Uncommon side effects
Maltese: Rappurtar tal-effetti sekondarji
English: Package leaflet: Information for the patient Tybost 150 mg film-coated tablets cobicistat
Maltese: Informazzjoni għall-pazjent Tybost 150 mg pilloli miksija b'rita cobicistat
English: When clarithromycin is co-administered with darunavir/cobicistat, consult the darunavir Summary of Product Characteristics for dosing recommendations.
Maltese: Meta clarithromycin jingħata flimkien ma' darunavir/cobicistat, ikkonsulta sSommarju tal-Karatteristiċi tal-Prodott ta' darunavir għal rakkomandazzjonijiet dwar id-dożaġġ.
English: Tybost contains sunset yellow FCF aluminium lake (E110) Tell your doctor if you have an allergy to sunset yellow FCF aluminium lake (E110).
Maltese: Għid lit-tabib tiegħek jekk għandek allerġija għal sunset yellow FCF aluminium lake (E110).
English: Tybost 150 mg film-coated tablets
Maltese: Tybost 150 mg pilloli miksija b'rita