FrancophonIA/ELRC3.0 huggingface dataset:
English: Docetaxel Teva is used with cisplatin and 5-fluorouracil.
Maltese: Docetaxel Teva jintuża ma' ċisplatinu u 5-fluorouracil.
English: Docetaxel Teva is a ‘generic medicine'.
Maltese: Docetaxel Teva huwa “mediċina ġenerika”.
English: This is a summary of the European public assessment report (EPAR) for Docetaxel Teva.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Docetaxel Teva.
English: Docetaxel Teva is used with cisplatin and 5-fluorouracil (other anticancer medicines);
Maltese: Docetaxel Teva jintuża ma' ċisplatinu u 5-fluorouracil (mediċini oħra kontra l-kanċer).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Docetaxel Teva on 26 January 2010.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Docetaxel Teva valida fl-Unjoni Ewropea kollha fis-26 ta' Jannar 2010.
English: Other information about Docetaxel Teva
Maltese: Informazzjoni oħra dwar Docetaxel Teva
English: The active substance in Docetaxel Teva, docetaxel, belongs to the group of anticancer medicines known as the taxanes.
Maltese: Is-sustanza attiva f'Docetaxel Teva, id-docetaxel, tagħmel parti mill-grupp ta' mediċini kontra l-kanċer magħrufa bħala t-tassani.
English: Docetaxel Teva is a concentrate and solvent to be made up into a solution for infusion (drip) into a vein.
Maltese: Docetaxel Teva huwa konċentrat u solvent li jsiru soluzzjoni għal infużjoni (dripp) ġol-vina.
English: Because Docetaxel Teva is a generic medicine, the company has provided data from the published literature on docetaxel.
Maltese: Billi Docetaxel Teva huwa mediċina ġenerika, il-kumpanija pprovdiet dejta mil-letteratura ppubblikata dwar docetaxel.
English: This means that Docetaxel Teva is similar to a ‘reference medicine' already authorised in the European Union (EU) called Taxotere.
Maltese: Dan ifisser li Docetaxel Teva huwa simili għall-‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Ewropea (UE) li jisimha Taxotere.
English: Docetaxel Teva is used with prednisone or prednisolone (anti-inflammatory medicines);
Maltese: Docetaxel Teva jintuża ma' prednisone jew prednisolone (mediċini antiinfjammatorji).
English: Because Docetaxel Teva is a generic medicine, its benefit and risk are taken as being the same as the reference medicine.
Maltese: Peress li Docetaxel Teva huwa mediċina ġenerika, il-benefiċċju u r-riskju tiegħu huma meqjusa l-istess bħal dawk tal-mediċina ta' referenza.
English: Therefore, the CHMP's view was that, as for Taxotere, the benefit outweighs the identified risk.
Maltese: Għaldaqstant, ilfehma tas-CHMP kienet li, bħal fil-każ ta' Taxotere, il-benefiċċju huwa akbar mir-riskju identifikati.
English: Docetaxel Teva should be used in wards specialised in chemotherapy (medicines to treat cancer) and it should only be given under the supervision of a doctor who is qualified in the use of cancer chemotherapy.
Maltese: Docetaxel Teva għandu jintuża fi swali speċjalizzati fil-kimoterapija (mediċini għat-trattament talkanċer) u għandu jingħata biss taħt is-sorveljanza ta' tabib li jkun kwalifikat fl-użu tal-kimoterapija kontra l-kanċer.
English: What is Docetaxel Teva?
Maltese: X'inhu Docetaxel Teva?
English: No additional studies were needed as Docetaxel Teva is given by infusion and contains the same active substance as the reference medicine, Taxotere.
Maltese: Ma kien jinħtieġ l-ebda studju addizzjonali billi Docetaxel Teva jingħata permezz ta' infużjoni u fih l-istess sustanza attiva bħal dik tal-mediċina ta' referenza, Taxotere.
English: The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Docetaxel Teva has been shown to have comparable quality to Taxotere.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) ikkonkluda li, b'mod konformi marrekwiżiti tal-UE, Docetaxel Teva wera li għandu kwalità komparabbli ma' Taxotere.
English: • gastric adenocarcinoma (a type of stomach cancer) in patients who have not yet received any treatment for their cancer.
Maltese: • adenokarċinoma gastrika (tip ta' kanċer fl-istonku) fuq pazjenti li jkunu għadhom ma rċevew lebda trattament għall-kanċer tagħhom.
English: Docetaxel Teva is an anticancer medicine.
Maltese: Docetaxel Teva huwa mediċina kontra l-kanċer.
English: What benefit and risk of Docetaxel Teva?
Maltese: X'inhu l-benefiċċju u r-riskju ta' Docetaxel Teva?
English: Why has Docetaxel Teva been approved?
Maltese: Għaliex ġie approvat Docetaxel Teva ?
English: It can also be used with other anticancer medicines (doxorubicin, cyclophosphamide, trastuzumab or capecitabine) in patients who have not yet received any treatment for their cancer or after other treatments have failed, depending on the type and stage of the breast cancer being treated;
Maltese: Jista' jintuża wkoll ma' mediċini oħra kontra l-kanċer (id-doksorubiċina, iċċiklofosfamide, it-trastużumab jew il-kapeċitabina), fuq pazjenti li jkunu għadhom ma rċevew lebda trattament għall-kanċer tagħhom jew wara li jkunu ħadu trattamenti oħra li ma jkunux ħadmu.
English: Docetaxel Teva is only used when the neutrophil count (the level of a type of white blood cell) is normal (at least 1,500 cells/mm3.)
Maltese: Docetaxel Teva jintuża biss meta n-numru ta' newtrofili (il-livell ta' tip ta' ċelloli bojod fid-demm) ikun normali (millinqas 1,500 ċellola/mm3.) Dexamethasone (mediċina antinfjammatorja) għandu jingħata wkoll lillpazjent, u jinbeda fil-jum qabel l-infużjoni ta' Docetaxel Teva.
English: EU/1/13/830/001 EU/1/13/830/002
Maltese: EU/1/13/830/002
English: Black/African American Asian
Maltese: Suwed/Afrikani Amerikani
English: Observed:
Maltese: Osservat:
English: ATC code: J05AR09
Maltese: J05AR09
English: Stribild contains lactose monohydrate.
Maltese: Stribild fih lactose monohydrate.
English: Disopyramide Flecainide Systemic lidocaine Mexiletine Propafenone
Maltese: Disopyramide Flecainide Lidocaine sistemiku Mexiletine Propafenone
English: Demographic characteristics
Maltese: Karatteristiċi Demografiċi
English: rosuvastatin, atorvastatin, pravastatin, fluvastatin and pitavastatin
Maltese: rosuvastatin, atorvastatin, pravastatin, fluvastatin u pitavastatin
English: EU/1/13/830/001 30 film-coated tablets EU/1/13/830/002 90 (3 bottles of 30) film-coated tablets
Maltese: EU/1/13/830/001 30 pillola miksija b'rita EU/1/13/830/002 90 (3 fliexken ta' 30) pillola miksija b'rita
English: Titanium dioxide (E171) Yellow iron oxide (E172)
Maltese: Yellow iron oxide (E172)
English: Indigo carmine aluminium lake (E132), macrogol 3350 (E1521), polyvinyl alcohol (partially hydrolysed) (E1203), talc (E553B), titanium dioxide (E171), yellow iron oxide (E172).
Maltese: Indigo carmine aluminium lake (E132), macrogol 3350 (E1521), polyvinyl alcohol (parzjalment idrolizzat) (E1203), talc (E553B), titanium dioxide (E171), yellow iron oxide (E172).
English: The transporters that cobicistat inhibits include P-gp, BCRP, OATP1B1 and OATP1B3.
Maltese: It-trasportaturi li cobicistat jinibixxi jinkludu P-gp, BCRP, OATP1B1 u OATP1B3.
English: The substitutions that emerged were M184V/I (n = 17) and K65R (n = 5) in reverse transcriptase and E92Q (n = 9), N155H (n = 5), Q148R (n = 3), T66I (n = 2), and T97A (n = 1) in integrase.
Maltese: Is-sostituzzjonijiet li żviluppaw kienu M184V/I (n = 17) u K65R (n = 5) f'reverse transcriptase u E92Q (n = 9), N155H (n = 5), Q148R (n = 3), T66I (n = 2) u T97A (n = 1) f'integrase.
English: Voxilaprevir (400 mg/100 mg/ 100 mg+100 mg once daily)6 +
Maltese: Voxilaprevir (400 mg/100 mg/ 100 mg+100 mg darba kuljum)6 +
English: 7 Study conducted with emtricitabine/tenofovir disoproxil + darunavir (800 mg) + ritonavir (100 mg).
Maltese: 7 Studju mwettaq b'emtricitabine/tenofovir disoproxil + darunavir (800 mg) + ritonavir (100 mg).
English: PHOSPHODIESTERASE TYPE 5 (PDE-5) INHIBITORS Sildenafil
Maltese: TA' PHOSPHODIESTERASE TA' TIP 5 (PDE-5)
English: Date of first authorisation: 24 May 2013 Date of latest renewal: 19 April 2018
Maltese: Data tal-aħħar tiġdid: 19 ta' April 2018
English: angioedema1
Maltese: anġjoedema1
English: • any other medicines containing: tenofovir disoproxil tenofovir alafenamide lamivudine adefovir dipivoxil
Maltese: • kwalunkwe mediċini oħrajn li fihom: tenofovir disoproxil tenofovir alafenamide lamivudine adefovir dipivoxil
English: b Week 144 window is between Day 967 and 1,050 (inclusive).
Maltese: b L-intervall ta' żmien tal-Ġimgħa 144 hu bejn Jum 967 u 1,050 (inklużiv).
English: NARCOTIC ANALGESICS Methadone/Elvitegravir/Cobicistat Methadone:
Maltese: Methadone/Elvitegravir/Cobicistat Methadone:
English: Stribild contains lactose
Maltese: Stribild fih lactose
English: The active substances are elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil.
Maltese: Is-sustanzi attivi huma elvitegravir, cobicistat, emtricitabine u tenofovir disoproxil.
English: Stribild [Outer packaging only]
Maltese: Stribild [Pakkett ta' barra biss]
English: Each tablet contains 10.9 mg lactose (as monohydrate).
Maltese: 9 mg ta' lactose (bħala monohydrate).
English: Drospirenone:
Maltese: Mistenni Drospirenone:
English: Reduced susceptibility to elvitegravir was most commonly associated with the integrase substitutions T66I, E92Q and Q148R.
Maltese: Suxxettibbilita mnaqqsa għal elvitegravir kienet b'mod l-aktar komuni assoċjata mas-sostituzzjonijiet ta' integrase T66I, E92Q u Q148R.
English: 4 See section 4.8, Description of selected adverse reactions for more details.
Maltese: 4 Ara sezzjoni 4.8, Deskrizzjoni ta' reazzjonijiet avversi magħżula għal aktar dettalji.
English: hepatic steatosis1, hepatitis1
Maltese: stejatożi epatika1, epatite1
English: • sedatives and hypnotics, used to treat anxiety: buspirone, clorazepate, diazepam, estazolam, flurazepam and zolpidem
Maltese: • sedattivi u mediċini ipnotiċi, li jintużaw għal trattament tal-ansjetà: buspirone, clorazepate, diazepam, estazolam, flurazepam u zolpidem
English: Mean percentage decreases in BMD from baseline to Week 144 in the Stribild group were comparable to the ATV/r+FTC/tenofovir disoproxil group at the lumbar spine (-1.43% versus -3.68%, respectively) and at the hip (-2.83% versus -3.77%, respectively).
Maltese: Il-medja ta' tnaqqis perċentwali fil-BMD mil-linja bażi sal-Ġimgħa 144 fil-grupp ta' Stribild kienet komparabbli mal-grupp ta' ATV/r+FTC/tenofovir disoproxil fis-sinsla tad-dahar lumbari (-1.43% kontra -3.68%, rispettivament) u fil-ġenbejn (-2.83% kontra -3.77%, rispettivament).
English: In vitro studies indicate that emtricitabine is not an inhibitor of human CYP450 enzymes.
Maltese: Studji in vitro jindikaw li emtricitabine mhuwiex impeditur ta' enzimi CYP450 tal-bniedem.
English: (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100) or rare (≥ 1/10,000
Maltese: mhux komuni (≥ 1/1,000 sa < 1/100) jew rari (≥ 1/10,000 sa < 1/1,000).
English: • tenofovir disoproxil, an antiretroviral medicine known as a nucleotide reverse transcriptase inhibitor (NtRTI)
Maltese: • tenofovir disoproxil, mediċina antiretrovirali magħrufa bħala impeditur tan-nucleotide reverse transcriptase (NtRTI - nucleotide reverse transcriptase inhibitor)
English: The mean change in estimated glomerular filtration rate (eGFR) by Cockcroft-Gault method after 144 weeks of treatment was -14.0 ± 16.6 mL/min for Stribild, -1.9 ± 17.9 mL/min for EFV/FTC/tenofovir disoproxil, and -9.8 ± 19.4 mL/min for ATV/r+FTC/tenofovir disoproxil.
Maltese: Il-bidla medja fir-rata tal-filtrazzjoni glomerulari stmata (eGFR) skont il-metodu Cockcroft-Gault wara 144 ġimgħa ta' trattament kienet ta' -14.0 ± 16.6 mL/min għal Stribild, -1.9 ± 17.9 mL/min għal EFV/FTC/tenofovir disoproxil, u -9.8 ± 19.4 mL/min għal ATV/r+FTC/tenofovir disoproxil.
English: Renal failure, renal impairment, elevated creatinine, hypophosphataemia and proximal tubulopathy (including Fanconi syndrome) have been reported with the use of tenofovir disoproxil (see section 4.8).
Maltese: Kollass renali, indeboliment renali, krejatinina għolja, ipofosfatimja u tubulopatija prossimali (inkluż is-sindromu ta' Fanconi) kienu rrappurtati bl-użu ta' tenofovir disoproxil (ara sezzjoni 4.8).
English: Table 4: Virologic outcome of randomised treatment of studies GS-US-236-0102 and GS-US-236-0103 at Week 48 (snapshot analysis)a and Week 144b
Maltese: GS-US-236-0102 u GS-US-236-0103 f'Ġimgħa 48 (analiżi snapshot)a u Ġimgħa 144b
English: Study GS-US-236-0102
Maltese: GS-US-236-0102
English: elevated creatine kinase1
Maltese: creatine kinase għolja1
English: Amlodipine Diltiazem Felodipine Nicardipine Nifedipine Verapamil
Maltese: Felodipine Nicardipine Nifedipine Verapamil
English: anaemia1,2
Maltese: anemija1,2
English: Croscarmellose sodium Hydroxypropyl cellulose Lactose (as monohydrate) Magnesium stearate Microcrystalline cellulose Silicon dioxide Sodium lauryl sulfate
Maltese: Magnesium stearate Microcrystalline cellulose Silicon dioxide Sodium lauryl sulfate
English: • antifungals, used to treat fungal infections, such as: ketoconazole, itraconazole, voriconazole, fluconazole and posaconazole
Maltese: - ketoconazole, itraconazole, voriconazole, fluconazole u posaconazole
English: In Study GS-US-236-0121, virologic success rates were: Stribild 93.4% (271 of 290 patients) and SBR 88.1% (126 of 143 patients).
Maltese: Fi studju GS-US-236-0121, ir-rati ta' suċċess viroloġiku kienu: Stribild 93.4% (271 minn 290 pazjent) u SBR 88.1% (126 minn 143 pazjent).
English: Study GS-US-236-0103
Maltese: GS-US-236-0103
English: Tenofovir disoproxil should be avoided in patients with HIV-1 harbouring the K65R substitution.
Maltese: Tenofovir disoproxil għandu jkun evitat f'pazjenti bl-HIV-1 bis-sostituzzjoni ta' K65R.
English: It is recommended that digoxin levels be monitored when digoxin is combined with Stribild.
Maltese: digoxin jiġu mmonitorjati meta digoxin jiġi kkombinat ma' Stribild.
English: Three (0.8%) subjects who received ATV/r+FTC/tenofovir disoproxil developed laboratory findings consistent with proximal renal tubular dysfunction leading to discontinuation of ATV/r+FTC/tenofovir disoproxil after Week 96 (see section 4.4).
Maltese: Tliet (0.8%) individwi li rċevew ATV/r+FTC/tenofovir disoproxil żviluppaw riżultati tal-laboratorju li kienu konsistenti ma' disfunzjoni tubulari renali prossimali li wasslu għat-twaqqif ta' ATV/r+FTC/tenofovir disoproxil wara l-Ġimgħa 96 (ara sezzjoni 4.4).
English: Clinical monitoring is recommended for patients with ClCr < 90 mL/min.
Maltese: Monitoraġġ kliniku hu rakkomandat għal pazjenti b'ClCr ta' < 90 mL/min.
English: 5 The predominant circulating metabolite of sofosbuvir.
Maltese: Il-metabolit predominanti ta' sofosbuvir fiċ-ċirkolazzjoni.
English: Exposures of elvitegravir and tenofovir in paediatric patients aged 12 to <18 years who received Stribild in GS-US-236-0112 were increased by 30% and 37% respectively, when compared with historical adult controls.
Maltese: L-esponimenti għal elvitegravir u tenofovir f'pazjenti pedjatriċi b'età ta' 12 sa <18-il sena li rċevew Stribild f'GS-US-236-0112 żdiedu bi 30% u 37% rispettivament, meta mqabbla ma' kontrolli storiċi fl-adulti.
English: In study GS-US-104-0352, 8 out of 89 paediatric patients (9.0%) exposed to tenofovir disoproxil discontinued study drug due to renal adverse events.
Maltese: Fl-istudju GS-US-104-0352, 8 minn 89 pazjent pedjatriku (9.0%) esposti għal tenofovir disoproxil waqqfu l-mediċina tal-istudju minħabba avveniment avversi renali.
English: At Week 48, 44 of 50 (88%) adolescent patients treated with Stribild achieved HIV-1 RNA <50 copies/mL and 4 achieved HIV-1 RNA ≥50 copies/mL; 1 patient discontinued study drug, and 1 had no virologic data at Week 48.
Maltese: F'Ġimgħa 48, 44 minn 50 (88%) pazjent adolexxenti ttrattati bi Stribild kisbu RNA ta' HIV-1 ta' < 50 kopja/mL u 4 kisbu RNA ta' HIV-1 ≥50 kopja/mL; pazjent wieħed waqqaf il-mediċina tal-istudju, u wieħed ma kellu l-ebda dejta viroloġika f'Ġimgħa 48.
English: Indigo carmine aluminium lake (E132) Macrogol 3350 (E1521) Polyvinyl alcohol (partially hydrolysed) (E1203) Talc (E553B)
Maltese: Indigo carmine aluminium lake (E132) Macrogol 3350 (E1521)
English: Midazolam and triazolam are primarily metabolised by CYP3A.
Maltese: Midazolam u triazolam huma primarjament metabolizzati minn CYP3A.
English: Elvitegravir/Cobicistat (150 mg/150 mg once daily)8
Maltese: Elvitegravir/Cobicistat (150 mg/150 mg darba kuljum)8
English: hypokalaemia1,3
Maltese: ipofosfatimja1,3
English: Renal adverse reactions consistent with proximal renal tubulopathy have been reported in HIV-1 infected paediatric patients aged 2 to < 12 years in a clinical study of tenofovir disoproxil (GS-US-104-0352) (see sections 4.8 and 5.1).
Maltese: Ġew irrappurtati reazzjonijiet avversi tal-kliewi konsistenti ma' tubulopatija renali prossimali f'pazjenti pedjatriċi infettati bl-HIV-1 b'età ta' sentejn sa < 12-il sena fi studju kliniku ta' tenofovir disoproxil (GS-US-104-0352) (ara sezzjonijiet 4.8 u 5.1).
English: Elvitegravir undergoes oxidative metabolism by CYP3A (major route), and glucuronidation by UGT1A1/3 enzymes (minor route).
Maltese: Elvitegravir jgħaddi minn metaboliżmu ossidattiv minn CYP3A (rotta maġġuri), u glukoronidazzjoni minn enzimi UGT1A1/3 (rotta minuri).
English: digoxin, disopyramide, flecainide, lidocaine, mexiletine, propafenone, metoprolol, timolol, amlodipine, diltiazem, felodipine, nicardipine, nifedipine and verapamil
Maltese: digoxin, disopyramide, flecainide, lidocaine, mexiletine, propafenone, metoprolol,
English: acute tubular necrosis1, nephritis (including acute interstitial nephritis)1,5, nephrogenic diabetes insipidus1
Maltese: nekrożi tubulari akuta1, nefrite (li tinkludi nefrite interstizjali akuta)1,5, dijabete insipidus nefroġenika1
English: • alpha 1-adrenoreceptor antagonists: alfuzosin
Maltese: • antagonisti tal-adrenoriċettur alpha 1: alfuzosin • mediċini antiarritmiċi: amiodarone, quinidine
English: Moreover, at concentrations substantially higher (approximately 300-fold) than those observed in vivo, tenofovir did not inhibit in vitro drug metabolism mediated by any of the major human CYP450 isoforms involved in drug biotransformation (CYP3A4, CYP2D6, CYP2C9, CYP2E1, or CYP1A1/2).
Maltese: minn dawk osservati in vivo, tenofovir in vitro ma inibixxiex l-metaboliżmu tal-mediċina medjat minn xi wieħed mill-iżoformi umani maġġuri ta' CYP450 involuti fil-bijotrasformazzjoni tal-mediċina (CYP3A4, CYP2D6, CYP2C9, CYP2E1, jew CYP1A1/2).
English: Adults with renal impairment
Maltese: Adulti b'indeboliment renali
English: Inhibition of CYP3A-mediated metabolism by cobicistat enhances the systemic exposure of CYP3A substrates, such as elvitegravir, where bioavailability is limited and half-life is shortened by CYP3A-dependent metabolism.
Maltese: L-inibizzjoni tal-metaboliżmu medjat minn CYP3A minn cobicistat ittejjeb l-esponiment sistemiku ta' substrati ta' CYP3A, bħal elvitegravir, fejn il-bijodisponibilità hi limitata u l-half-life titqassar mill-metaboliżmu dipendenti fuq CYP3A.
English: Stribild 150 mg/150 mg/200 mg/245 mg film-coated tablets elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil
Maltese: Stribild 150 mg/150 mg/200 mg/245 mg pilloli miksija b'rita elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil
English: Both emtricitabine and tenofovir have activity that is specific to human immunodeficiency virus (HIV-1 and HIV-2) and hepatitis B virus.
Maltese: Kemm emtricitabine kif ukoll tenofovir għandhom attività li hi speċifika għall-virus tal immunodefiċjenza uman (HIV-1 u HIV-2) u l-virus tal-epatite B.
English: Exposures of cobicistat and emtricitabine in paediatric patients aged 12 to <18 years were similar to exposures achieved in adults.
Maltese: L-esponimenti għal cobicistat u emtricitabine f'pazjenti pedjatriċi b'età ta' 12 sa <18-il sena kienu simili għall-esponimenti miksuba fl-adulti.
English: Emtricitabine-resistant viruses with the M184V/I substitution were cross-resistant to lamivudine, but retained sensitivity to didanosine, stavudine, tenofovir and zidovudine.
Maltese: Il-viruses reżistenti għal emtricitabine bis-sostituzzjoni ta' M184V/I kienu cross-resistant għal lamivudine, iżda żammew is-sensittività għal didanosine, stavudine, tenofovir u zidovudine.
English: The frequency category was estimated from a statistical calculation based on the total number of patients exposed to emtricitabine in randomised controlled clinical studies (n = 1,563) or tenofovir disoproxil in randomised controlled clinical studies and the expanded access program (n = 7,319).
Maltese: Il-kategorija ta' frekwenza kienet stmata mill-kalkulazzjoni statistika bbażata fuq in-numru totali ta' pazjenti esposti għal emtricitabine fi studji kliniċi kkontrollati randomised (n = 1,563) jew tenofovir disoproxil fi studji kliniċi kkontrollati randomised u l-programm ta' aċċess imkabbar (n = 7,319).
English: Virologic success HIV-1 RNA < 50 copies/mL Treatment difference
Maltese: HIV-1 RNA < 50 kopja/mL
English: AUCtau, and Ctrough (mean ± SD) were 1.1 ± 0.40 µg/mL, 8.3 ± 3.8 µg•h/mL, and 0.05 ± 0.13 µg/mL for cobicistat, 1.9 ± 0.5 µg/mL, 13 ± 4.5 µg•h/mL, and 0.14 ± 0.25 µg/mL for emtricitabine, and 0.45 ± 0.16 µg/mL, 4.4 ± 2.2 µg•h/mL, and 0.1 ± 0.08 µg/mL for tenofovir.
Maltese: 0.14 ± 0.25 µg/mL għal emtricitabine, u 0.45 ± 0.16 µg/mL, 4.4 ± 2.2 µg•h/mL, u 0.1 ± 0.08 µg/mL
English: • difficulty sleeping (insomnia), abnormal dreams
Maltese: • diffikultà biex torqod (insomnja), ħolm anormali
English: • antivirals, used to treat hepatitis C infection: ledipasvir/sofosbuvir, sofosbuvir/velpatasvir and sofosbuvir/velpatasvir/voxilaprevir
Maltese: ledipasvir/sofosbuvir, sofosbuvir/velpatasvir u sofosbuvir/velpatasvir/voxilaprevir
English: Norgestimate: AUC: ↑ 126% Cmin: ↑ 167% Cmax: ↑ 108%
Maltese: AUC: ↑ 126% Cmin: ↑ 167% Cmax: ↑ 108%
English: Percentage of subjects with CD4+ cell counts ≤ 200 cells/mm3
Maltese: Perċentwali ta' individwi b'għadd ta' ċelluli CD4+ ta' ≤ 200 ċellula/mm3
English: In the Phase 3 studies GS-US-236-0102 and GS-US-236-0103, bone fractures occurred in 27 subjects (3.9%) in the Stribild group, 8 subjects (2.3%) in the EFV/FTC/tenofovir disoproxil group, and 19 subjects (5.4%) in the ATV/r+FTC/tenofovir disoproxil group.
Maltese: Fl-istudji ta' Fażi 3 GS-US-236-0102 u GS-US-236-0103, seħħ ksur fl-għadam f'27-il individwu (3.9%) fil-grupp ta' Stribild, 8 individwi (2.3%) fil-grupp ta' EFV/FTC/tenofovir disoproxil, u 19il individwu (5.4%) fil-grupp ta' ATV/r+FTC/tenofovir disoproxil.
English: renal failure4, proximal renal tubulopathy including Fanconi syndrome acquired4, proteinuria
Maltese: kollass renali4, tubulopatija renali prossimali inkluż is-sindromu miksub ta'
English: The biotransformation of emtricitabine includes oxidation of the thiol moiety to form the 3'-sulfoxide diastereomers (~ 9% of dose) and conjugation with glucuronic acid to form 2'-O-glucuronide (~ 4% of dose).
Maltese: Ilbijotrasformazzjoni ta' emtricitabine tinkludi l-ossidazzjoni tat-thiol moiety biex tifforma 3'-sulphoxide diastereomers (madwar 9% tad-doża) u l-konjugazzjoni ma' glucuronic acid biex tifforma 2'-O-glucuronide (madwar 4% tad-doża).
English: Stribild 150 mg/150 mg/200 mg/245 mg film-coated tablets
Maltese: (150 mg/150 mg/200 mg/245 mg darba kuljum)
English: Cobicistat is a selective, mechanism-based inhibitor of cytochromes P450 of the CYP3A subfamily.
Maltese: Cobicistat hu impeditur selettiv, ibbażat fuq il-mekkaniżmu, ta' ċitokromi P450 tas-sottofamilja ta' CYP3A.
English: How to store Stribild
Maltese: Studji bi Stribild
English: rhabdomyolysis1,3, muscular weakness1,3
Maltese: rabdomijolosi1,3, dgħjufija fil-muskoli1,3
English: ANTIARRHYTHMICS Digoxin (0.5 mg single dose)/Cobicistat (150 mg multiple doses)
Maltese: Digoxin (0.5 mg doża waħda)/Cobicistat (150 mg dożi multipli)
English: Macrolide antibiotics Clarithromycin
Maltese: Antibijotiċi makrolidi
English: Stribild is a single tablet regimen for the treatment of human immunodeficiency virus (HIV) infection in adults.
Maltese: Stribild hu kors ta' pillola waħda għat-trattament għal virus ta' l-immunodefiċjenza umana (HIV) fl adulti.